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Antwort auf Beitrag Nr.: 33.864.998 von bernie55 am 11.04.08 11:49:43ja ja."Ernstnehmen von "Frauenproblemen"(Was immer DAS sein soll....).Wer´s glaubt........
-WIESO habe ich hier bloss keine weibliche Unterstützung an Bord
:cry
wahrscheinlich habt Ihr die schon alle vergrault...:mad
Frauen-outet Euch---und DAAAAAAAAAANNNNN......
-WIESO habe ich hier bloss keine weibliche Unterstützung an Bord
:cry
wahrscheinlich habt Ihr die schon alle vergrault...:mad
Frauen-outet Euch---und DAAAAAAAAAANNNNN......
ELN msg # 217027 4/11/2008 7:56:08 AMBy: ipar4s2
I would suggest with the advertising of the Phase III for the Lilly/Elan AD Gamma Secretase Inhibitor [LY450139 – Eli Lilly] now at www.elan.com, we are exercising our free option for 50%
http://www.elan.com/research_development/pipeline_products/
Gamma Secretase Inhibitor [LY450139 – Eli Lilly]
Antwort auf Beitrag Nr.: 33.866.384 von Birgit.Tersteegen am 11.04.08 14:05:42Als Frau hier im Thread hast Du schwer
Lass bloss von den Jungs nicht runterkriegen 
Leutschen, ab Samstag bin ich unterwegs nach Indonesien bis 3. Woche Mai.
Passe bloss auf unser ELAN auf
Lass bloss von den Jungs nicht runterkriegen
Leutschen, ab Samstag bin ich unterwegs nach Indonesien bis 3. Woche Mai.
Passe bloss auf unser ELAN auf
Antwort auf Beitrag Nr.: 33.867.942 von surga am 11.04.08 16:33:33---nee-keine Sorge--
Heute werden wir wieder mit dem Gesamtmarkt gedrückt....schade,gestern gings so super UP...
Surga,wünsche Dir viele,viele gute Erlebnisse in Deiner Heimat....bring ein paar Photos mit.....+ komm mal ab und zu ins Netz--es wird ja spannend werden mit Elan.....Ciao+ See you soon!!
---nee-keine Sorge--
Heute werden wir wieder mit dem Gesamtmarkt gedrückt....schade,gestern gings so super UP...
Surga,wünsche Dir viele,viele gute Erlebnisse in Deiner Heimat....bring ein paar Photos mit.....+ komm mal ab und zu ins Netz--es wird ja spannend werden mit Elan.....Ciao+ See you soon!!
Antwort auf Beitrag Nr.: 33.868.756 von Birgit.Tersteegen am 11.04.08 17:44:30ELN msg # 217206 4/11/2008 1:26:09 PM
By: djpope
If today's share price action doesn't phase you
or make you run outside, look up and check that the sky is still intact...
Then you have passed one of the initial tests on being a true - long term
battle scarred ELANIAN in good standing. If not I suggest you get a good
helmet for your next trip out because you're going to need it a bunch
more times before this journey is anywhere close to being done.
Relax and Enjoy.
dp
ELN msg # 217206 4/11/2008 1:26:09 PMBy: djpope
If today's share price action doesn't phase you
or make you run outside, look up and check that the sky is still intact...
Then you have passed one of the initial tests on being a true - long term
battle scarred ELANIAN in good standing. If not I suggest you get a good
helmet for your next trip out because you're going to need it a bunch
more times before this journey is anywhere close to being done.
Relax and Enjoy.
dp
Trading Spotlight
Pinning High Hopes on Amyloid for Alzheimer
By Catherine Hollingsworth
Staff Writer
The limited effects of leading treatments for Alzheimer's disease has helped spur a growing field of research into new drug targets that could slow the course of the disease.
There is a general consensus in the industry that current cognitive-enhancing drugs - Eisai Co. and Pfizer Inc.'s market leader Aricept and two other drugs in the same class Novartis AG's Exelon and Shire Plc's Razadyne - work to ease the symptoms of Alzheimer's disease. But these drugs, known as cholinesterase inhibitors, stop working after six to 12 months and have some unpleasant side effects, such as nausea, vomiting and diarrhea.
Another approved therapy in Alzheimer's disease is memantine, sold as Namenda by Forest Pharmaceuticals Inc. for more severe Alzheimer's also is aimed at improving symptoms.
No approved drug actually stops Alzheimer's disease, according to the National Institute on Aging (NIA).
But a new crop of products in the pipeline -Myriad Genetics Inc.'s Flurizan, Medivation Inc.'s Dimebon, and Elan Corp. and partner Wyeth's bapineuzumab, all in Phase III development - seek to target a key pathway known as amyloid beta, a sticky protein that clumps together and forms plaques in the brain. It is believed that amyloid beta affects the ability of neurons in the brain to function properly, leading to cognitive and other disruptions typically associated with Alzheimer's disease. Numerous other development programs also are hinging on this theory that amyloid beta is at the center of the pathogenesis of Alzheimers's disease.
Elan began its Phase III program for bapineuzumab in December 2007, Myriad Genetics has completed enrollment in U.S. and global Phase III trials of Flurizan in Alzheimer's disease and top-line results are expected in June, and Medivation has completed one of two pivotal trials required to support registration of Dimebon for mild-to-moderate Alzheimer's disease.
Subset analysis data from Medivation's first pivotal trial of Dimebon is set to be released at the annual meeting of the American Academy of Neurology annual now underway. The San Francisco, Calif.-based company is set to begin its second, confirmatory pivotal Phase III Alzheimer's disease trial in the second quarter of 2008.
Neurochem Inc., of Laval, Quebec, last year terminated development of its amyloid beta antagonist Alzhemed (tramiprosate) in the U.S., Canada and Europe, after disappointing Phase III results.
Multiple Targets Exist
Although a great deal of industry and academic research remains focused on amyloid beta as key to fighting Alzheimer's disease, there are several other targets that are seen as holding promise in treating the disease. Suzana Petanceska, program director of the neuroscience and neuropsychology of Aging Program at the NIA, told BioWorld Financial Watch. "There are multiple targets for Alzheimer's disease, the major ones being amyloid beta, Tau and ApoE."
ApoE, which stands for apolipoprotein E, is a major risk factor gene for Alzheimer's disease, she said, as its ApoE e4 isoform confers greater risk for late onset of Alzheimer's.
Tau pathology, in the form of neurofibrillary tangles, is a major hallmark of Alzheimer's disease and it exists side by side with amyloid, Petanceska said. While tau has "played second fiddle" to amyloid, she said, it is an attractive target that has been recognized by major pharmaceutical companies such as Merck and is being actively pursued by a number of academic investigators involved in Alzheimer's drug discovery.
With the availability of animal models for tau that have neurofibrillary tangle pathology, it is "now possible to tackle this target quite forcefully," Petanceska said.
Other potential drug targets for Alzheimer's disease include heat shock protein-90 (HSP90), a tau-related target that is the subject of early studies at university laboratories. In addition, there are a number of neuroprotective therapeutic strategies in preclinical development spearheaded by academic investigators, Petanceska said, who oversees a program at NIA that coordinates Alzheimer's drug discovery efforts at universities.
Amyolid Takes the Spotlight
Amyloid beta, however, is a major focus of drug development in Alzheimer's disease and has stolen the spotlight from the other potential targets.
"The most widely accepted view of the pathogenic events that ultimately result in Alzheimer's disease centers around the . . . amyloid beta peptide and its accumulation in the brain," Petanceska said. This prevailing theory of "amyloid beta cascade" "postulates that the accumulation of aggregated amyloid beta species is the key initiating event in the development of Alzheimer's disease."
Although this hypothesis is supported by "compelling genetic evidence," she said, it "is not without controversy and has yet to be formally tested." For example, she said "much remains to be resolved regarding what the precise species of amyloid beta that drive neurotoxicity are."
She added that the amyloid beta cascade hypothesis has provided the rationale and a framework for therapeutic interventions targeting Amyloid beta production, aggregation or clearance. This together with the availability of animal models of Alzheimer's amyloidosis has enabled the advancement of multiple anti-amyloid therapeutic strategies.
Still, she said, additional targets may need to be pursued to effectively treat Alzheimer's disease.
"As we are learning more about the complexities of [Alzheimer's disease] pathogenesis, it is becoming apparent that targeting amyloid alone may not be sufficient to improve functional deficits during the course of the disease," Petanceska said. "Therefore alternative targets, such as the Tau protein and apolipoprotein E, are being more actively pursued in the recent years."
"I think the field is responding rapidly to this and pursuing novel targets as they become identified," Petanceska said. "From what I see, everyone is on board."
Drug companies and biotech firms, along with NIH and private foundations such as the Azheimer's Drug Discovery Foundation, each are taking their own tack in supporting discovery and development of new therapeutics for Alzheimer's disease, she said. And a great deal of collaboration is taking place among them, she added.
Development Strategies Vary
Both pharmaceutical and biotechnology firms have drugs in various stages of clinical development aimed at the therapeutic target amyloid beta. These companies, according to Petanceska, include Elan and Wyeth, Eli Lilly & Co., Merck & Co., GlaxoSmithKline plc, Pfizer Inc., Myriad Genetics and CoMentis Inc.
These companies are using several different strategies to reduce the production and aggregation of amyloid beta, or to increase its clearance in order to alleviate its deleterious effects on the brain, Petanceska said.
The immunotherapy approach (passive immunization) is being pursued by Elan and Wyeth, Lilly, Baxter, and GSK. Active immunization also is being studied by Elan, Novartis and Merck.
The inhibition of the enzymes beta and gamma secretase, responsible for production of amyloid gamma secretase inhibitors is yet another approach. Myriad and Lilly are testing the efficacy of gamma secretase inbibitors, while has just begun the clinical testing of a beta secretase inhibitor.
Elan and Prana Biotechnology Ltd. are pursuing various anti-aggregation strategies aimed at precluding the formation of toxic amyloid beta species and their deleterious effects on synaptic function and neuronal survival.
Each of these approaches has its limitations, but "there is a perception that the beta secretase enzyme may be a more attractive drug target to inhibit production of [toxic] beta amyloid 1-42," William Tanner, an analyst with Leerink Swann, wrote in a research note, in which he recapped discussions at the recent Keystone Symposium on Alzheimer's Disease in Colorado.
Common Pathway
Many companies have focused on amyloid beta as a way to slow the progression of the disease, said Michael Kauffman, chief executive officer of EPIX Pharmaceuti-cals Inc.
EPIX and Sanofi Aventis are among the companies focused on the alpha-secretase pathway in Alzheimer's disease. This pathway, Kauffman said, is responsible for preventing the production of amyloid beta and stimulating the neuroprotective protein sAPPalpha that keeps neurons alive and healthy.
When the enzymes beta- and gamma-secretase cut APP into pieces, toxic forms of amyloid beta can form, he said. But if alpha secretase gets there first, the body is unable to make amyloid beta plaques in the brain, Kauffman explained.
EPIX is developing PRX-3140, which has been shown in animal studies to reduce amyloid beta 1-42 and 1-40 (toxic forms). The Lexington, Mass.-based company plans to initiate two Phase IIb studies with its partner GSK during second quarter. One of these studies will evaluate PRX-03140 alone, while the other will be a combination study with Aricept.
Elan has preclinical and clinical programs that focus on all aspects of the amyloid beta progression, Andrew Lewis, director of corporate communications, said. This includes blocking the formation of amyloid beta, preventing amyloid beta from clumping together, and clearing both soluble and deposited (plaque) forms of amyloid beta from the brain.
The bapineuzumab antibody that Elan is developing with Wyeth is a potential intravenous treatment for Alzheimer's disease. It works by clearing soluble amyloid beta and breaking down amyloid beta plaques. Dublin, Ireland-based Elan also has initiated a Phase II clinical study of ELND005 (AZD-103) in Alzheimer's patients, in a partnership with Toronto-based Transition Therapeutics Inc.
Lewis noted the Elan has a long history in the Alzheimer's space spanning at least two decades, having made such contributions as the first mouse model that expresses amyloid beta pathology. He also said Lilly's compound, LY450139, arose out of a prior research collaboration between Elan and Lilly and that Elan retains some of the commercial rights.
David Hung, chief executive officer of Medivation, said regardless of where the process of Alzheimer's disease begins, Dimebon appears to address a "common pathway" leading to the disease: neuron death. Studies have shown that Dimebon has a profound effect in stabilizing mitochondrial membranes, Hung said, "improving mitochondrial and overall cellular health and thus reducing mitochondrially-mediated neuron death."
By Catherine Hollingsworth
Staff Writer
The limited effects of leading treatments for Alzheimer's disease has helped spur a growing field of research into new drug targets that could slow the course of the disease.
There is a general consensus in the industry that current cognitive-enhancing drugs - Eisai Co. and Pfizer Inc.'s market leader Aricept and two other drugs in the same class Novartis AG's Exelon and Shire Plc's Razadyne - work to ease the symptoms of Alzheimer's disease. But these drugs, known as cholinesterase inhibitors, stop working after six to 12 months and have some unpleasant side effects, such as nausea, vomiting and diarrhea.
Another approved therapy in Alzheimer's disease is memantine, sold as Namenda by Forest Pharmaceuticals Inc. for more severe Alzheimer's also is aimed at improving symptoms.
No approved drug actually stops Alzheimer's disease, according to the National Institute on Aging (NIA).
But a new crop of products in the pipeline -Myriad Genetics Inc.'s Flurizan, Medivation Inc.'s Dimebon, and Elan Corp. and partner Wyeth's bapineuzumab, all in Phase III development - seek to target a key pathway known as amyloid beta, a sticky protein that clumps together and forms plaques in the brain. It is believed that amyloid beta affects the ability of neurons in the brain to function properly, leading to cognitive and other disruptions typically associated with Alzheimer's disease. Numerous other development programs also are hinging on this theory that amyloid beta is at the center of the pathogenesis of Alzheimers's disease.
Elan began its Phase III program for bapineuzumab in December 2007, Myriad Genetics has completed enrollment in U.S. and global Phase III trials of Flurizan in Alzheimer's disease and top-line results are expected in June, and Medivation has completed one of two pivotal trials required to support registration of Dimebon for mild-to-moderate Alzheimer's disease.
Subset analysis data from Medivation's first pivotal trial of Dimebon is set to be released at the annual meeting of the American Academy of Neurology annual now underway. The San Francisco, Calif.-based company is set to begin its second, confirmatory pivotal Phase III Alzheimer's disease trial in the second quarter of 2008.
Neurochem Inc., of Laval, Quebec, last year terminated development of its amyloid beta antagonist Alzhemed (tramiprosate) in the U.S., Canada and Europe, after disappointing Phase III results.
Multiple Targets Exist
Although a great deal of industry and academic research remains focused on amyloid beta as key to fighting Alzheimer's disease, there are several other targets that are seen as holding promise in treating the disease. Suzana Petanceska, program director of the neuroscience and neuropsychology of Aging Program at the NIA, told BioWorld Financial Watch. "There are multiple targets for Alzheimer's disease, the major ones being amyloid beta, Tau and ApoE."
ApoE, which stands for apolipoprotein E, is a major risk factor gene for Alzheimer's disease, she said, as its ApoE e4 isoform confers greater risk for late onset of Alzheimer's.
Tau pathology, in the form of neurofibrillary tangles, is a major hallmark of Alzheimer's disease and it exists side by side with amyloid, Petanceska said. While tau has "played second fiddle" to amyloid, she said, it is an attractive target that has been recognized by major pharmaceutical companies such as Merck and is being actively pursued by a number of academic investigators involved in Alzheimer's drug discovery.
With the availability of animal models for tau that have neurofibrillary tangle pathology, it is "now possible to tackle this target quite forcefully," Petanceska said.
Other potential drug targets for Alzheimer's disease include heat shock protein-90 (HSP90), a tau-related target that is the subject of early studies at university laboratories. In addition, there are a number of neuroprotective therapeutic strategies in preclinical development spearheaded by academic investigators, Petanceska said, who oversees a program at NIA that coordinates Alzheimer's drug discovery efforts at universities.
Amyolid Takes the Spotlight
Amyloid beta, however, is a major focus of drug development in Alzheimer's disease and has stolen the spotlight from the other potential targets.
"The most widely accepted view of the pathogenic events that ultimately result in Alzheimer's disease centers around the . . . amyloid beta peptide and its accumulation in the brain," Petanceska said. This prevailing theory of "amyloid beta cascade" "postulates that the accumulation of aggregated amyloid beta species is the key initiating event in the development of Alzheimer's disease."
Although this hypothesis is supported by "compelling genetic evidence," she said, it "is not without controversy and has yet to be formally tested." For example, she said "much remains to be resolved regarding what the precise species of amyloid beta that drive neurotoxicity are."
She added that the amyloid beta cascade hypothesis has provided the rationale and a framework for therapeutic interventions targeting Amyloid beta production, aggregation or clearance. This together with the availability of animal models of Alzheimer's amyloidosis has enabled the advancement of multiple anti-amyloid therapeutic strategies.
Still, she said, additional targets may need to be pursued to effectively treat Alzheimer's disease.
"As we are learning more about the complexities of [Alzheimer's disease] pathogenesis, it is becoming apparent that targeting amyloid alone may not be sufficient to improve functional deficits during the course of the disease," Petanceska said. "Therefore alternative targets, such as the Tau protein and apolipoprotein E, are being more actively pursued in the recent years."
"I think the field is responding rapidly to this and pursuing novel targets as they become identified," Petanceska said. "From what I see, everyone is on board."
Drug companies and biotech firms, along with NIH and private foundations such as the Azheimer's Drug Discovery Foundation, each are taking their own tack in supporting discovery and development of new therapeutics for Alzheimer's disease, she said. And a great deal of collaboration is taking place among them, she added.
Development Strategies Vary
Both pharmaceutical and biotechnology firms have drugs in various stages of clinical development aimed at the therapeutic target amyloid beta. These companies, according to Petanceska, include Elan and Wyeth, Eli Lilly & Co., Merck & Co., GlaxoSmithKline plc, Pfizer Inc., Myriad Genetics and CoMentis Inc.
These companies are using several different strategies to reduce the production and aggregation of amyloid beta, or to increase its clearance in order to alleviate its deleterious effects on the brain, Petanceska said.
The immunotherapy approach (passive immunization) is being pursued by Elan and Wyeth, Lilly, Baxter, and GSK. Active immunization also is being studied by Elan, Novartis and Merck.
The inhibition of the enzymes beta and gamma secretase, responsible for production of amyloid gamma secretase inhibitors is yet another approach. Myriad and Lilly are testing the efficacy of gamma secretase inbibitors, while has just begun the clinical testing of a beta secretase inhibitor.
Elan and Prana Biotechnology Ltd. are pursuing various anti-aggregation strategies aimed at precluding the formation of toxic amyloid beta species and their deleterious effects on synaptic function and neuronal survival.
Each of these approaches has its limitations, but "there is a perception that the beta secretase enzyme may be a more attractive drug target to inhibit production of [toxic] beta amyloid 1-42," William Tanner, an analyst with Leerink Swann, wrote in a research note, in which he recapped discussions at the recent Keystone Symposium on Alzheimer's Disease in Colorado.
Common Pathway
Many companies have focused on amyloid beta as a way to slow the progression of the disease, said Michael Kauffman, chief executive officer of EPIX Pharmaceuti-cals Inc.
EPIX and Sanofi Aventis are among the companies focused on the alpha-secretase pathway in Alzheimer's disease. This pathway, Kauffman said, is responsible for preventing the production of amyloid beta and stimulating the neuroprotective protein sAPPalpha that keeps neurons alive and healthy.
When the enzymes beta- and gamma-secretase cut APP into pieces, toxic forms of amyloid beta can form, he said. But if alpha secretase gets there first, the body is unable to make amyloid beta plaques in the brain, Kauffman explained.
EPIX is developing PRX-3140, which has been shown in animal studies to reduce amyloid beta 1-42 and 1-40 (toxic forms). The Lexington, Mass.-based company plans to initiate two Phase IIb studies with its partner GSK during second quarter. One of these studies will evaluate PRX-03140 alone, while the other will be a combination study with Aricept.
Elan has preclinical and clinical programs that focus on all aspects of the amyloid beta progression, Andrew Lewis, director of corporate communications, said. This includes blocking the formation of amyloid beta, preventing amyloid beta from clumping together, and clearing both soluble and deposited (plaque) forms of amyloid beta from the brain.
The bapineuzumab antibody that Elan is developing with Wyeth is a potential intravenous treatment for Alzheimer's disease. It works by clearing soluble amyloid beta and breaking down amyloid beta plaques. Dublin, Ireland-based Elan also has initiated a Phase II clinical study of ELND005 (AZD-103) in Alzheimer's patients, in a partnership with Toronto-based Transition Therapeutics Inc.
Lewis noted the Elan has a long history in the Alzheimer's space spanning at least two decades, having made such contributions as the first mouse model that expresses amyloid beta pathology. He also said Lilly's compound, LY450139, arose out of a prior research collaboration between Elan and Lilly and that Elan retains some of the commercial rights.
David Hung, chief executive officer of Medivation, said regardless of where the process of Alzheimer's disease begins, Dimebon appears to address a "common pathway" leading to the disease: neuron death. Studies have shown that Dimebon has a profound effect in stabilizing mitochondrial membranes, Hung said, "improving mitochondrial and overall cellular health and thus reducing mitochondrially-mediated neuron death."
ELN msg # 217476 4/11/2008 7:35:34 PM
By: phition42
this is why
A youtube for why we are here, this will suprise for all who haven't listen to much Elvis Costello
http://youtube.com/watch?v=g-rF4COOd9c
By: phition42
this is why
A youtube for why we are here, this will suprise for all who haven't listen to much Elvis Costello
http://youtube.com/watch?v=g-rF4COOd9c
ELN msg # 217822 4/13/2008 3:54:56 AMBy: smellybadger2003
Sunday Independent, Business Section, Apologies for Typos
Dan White
Hang on for the
ride with Elan
THE Elan share price was unaffected by the news that Carl Icahn is suing Biogen, its partner in the MS drug 'lysabri.
The American corporate raider is seeking records of Biogen's recent unsuccessful effort to sell itself, which he claims the Biogen board deliberately sabotaged.
Last October, Icahn offered to pay $23bn for Biogen. This would have worked out at about $81 a share. Biogen responded by putting itself up for sale and, when by December no firm offers had been received, took itself back off the market. The Biogen share price stands at $66.
Despite the ructions at Biogen, the Elan share price actually rose during the week from $21.67 to $23.28 (remember, virtually all trading in Elan shares takes place in New York). Investors are betting that the latest move from Icahn, who already owns about 1 per cent of Biogen, is designed to restart the sale process.
Last October, analysts reckoned that the Icahn offer valued Tysabri at somewhere between $9.5bn and $14bn. This put a value of $10 and $15 a share on Elan's 50 per cent share of the drug. Then, last month, Elan boss Kelly Martin passed on a $lm cash bonus
KELLY MARTIN: Took options
in favour of options over almost 74,000 shares exercisable at a price of $25.01 per share. That's putting your money where your mouth is.
Since briefly dipping under $19 in mid-March the Elan share price has risen by almost 25 per cent. With Icahn having a history of getting his way, Elan shareholders should hang on for the ride.
..ich weiß zwar nicht, was zur Zeit mit dem WO Board los ist ( es funzt mal wieder überhaupt nicht ), aber die Hauptsache ist, dass ich die " volle Checkung " habe....
...den letzten Beitrag , den ich lesen kann , ist folgender:
#19000 von Birgit.Tersteegen 11.04.08 15:27:49 Beitrag Nr.: 33.867.195
Antwort auf Beitrag Nr.: 33.875.451 von bernie55 am 13.04.08 18:10:30
WOAH---ich hatte die 19000 und hab´s gar nicht gescheckert......-ich werde alt....aber Hauptsache nächste Woche gehts UP/UP and UP mit unserem Schätzchen...
WOAH---ich hatte die 19000 und hab´s gar nicht gescheckert......-ich werde alt....aber Hauptsache nächste Woche gehts UP/UP and UP mit unserem Schätzchen...
Birgit, vielleicht kannst du cyberhexe aktivieren - und schon hätten wir geballte Frauenpower.
posimist
posimist
die Nachrichtenlage ist einfach zu gut in den letzten Tagen.
Am Freitag über 7% nach unten in den USA.
Am Freitag über 7% nach unten in den USA.
Antwort auf Beitrag Nr.: 33.877.078 von Poppholz am 14.04.08 08:52:20....ja,das war blöd----kann nur besser werden....hoffentlich heute...Grüsse!
Test.
(anscheinend werden keine neuen Beiträge gepostet)
(anscheinend werden keine neuen Beiträge gepostet)
...so ein MIST !!!!! . ..ich kann immer noch nicht die aktuellsten Beiträge lesen und das schon seit 3 Tagen !!!!.......der letzte Beitrag ist 19000 !!!!
@ Technische Dienst
Bitte - macht was !!!!!!!
Antwort auf Beitrag Nr.: 33.878.363 von bernie55 am 14.04.08 11:45:34....Lösung (hoffentlich nur vorrübergehend...):Auf "umgekehrte Sortierung" klicken und dann evtl.noch auf "letzten Beitrag".....Grüsse!Birgit
Antwort auf Beitrag Nr.: 33.878.589 von Birgit.Tersteegen am 14.04.08 12:15:46Danke.
Leider können nur die Leute Deinen Beitrag nur lesen wenn Sie die Umstellung schon gemacht haben.
Leider können nur die Leute Deinen Beitrag nur lesen wenn Sie die Umstellung schon gemacht haben.
Antwort auf Beitrag Nr.: 33.878.589 von Birgit.Tersteegen am 14.04.08 12:15:46
funzt wieder, aber der kurs.
funzt wieder, aber der kurs.
Antwort auf Beitrag Nr.: 33.882.763 von GuHu1 am 14.04.08 19:43:05morgen ist die AAN-u.a. mit safty updates zu ty....ich hoffe dann gehts up!
Antwort auf Beitrag Nr.: 33.884.768 von Birgit.Tersteegen am 15.04.08 01:30:54dann müssen die NEWS aber schon schlecht sein, kann ich mir nicht vorstellen.
Dow Jones
Rückschlag für Roche-Tochter Genentech und Biogen bei "Rituxan"
Dienstag 15. April 2008, 07:14 Uhr
DJ Rückschlag für Roche-Tochter Genentech und Biogen bei "Rituxan"
SAN FRANCISCO (Dow Jones)--Das US-Biotechnologieunternehmen Biogen Idec Inc und die Roche-Tochter Genentech Inc haben bei der Entwicklung eines Medikaments zur Behandlung der multiplen Sklerose, "Rituxan", einen Rückschlag erlitten. In einer Phase II/III-Studie zur Wirksamkeit des Medikaments wurde der primäre Endpunkt nicht erreicht.
Beide Unternehmen wollen die Ergebnisse der Studie, die 122 Wochen lang die Wirksamkeit des Medikaments an 439 Patienten getestet hat, weiter auswerten und die Rolle der B-Zellen bei der schweren multiplen Sklerose besser erforschen.
Webseite: http://www.gene.com
http://www.roche.com
DJG/DJN/phf
(END) Dow Jones Newswires
April 15, 2008 02:14 ET (06:14 GMT)
Copyright (c) 2008 Dow Jones & Company, Inc.
http://de.biz.yahoo.com/15042008/341/r-252-ckschlag-f-252-r-…
Rückschlag für Roche-Tochter Genentech und Biogen bei "Rituxan"
Dienstag 15. April 2008, 07:14 Uhr
DJ Rückschlag für Roche-Tochter Genentech und Biogen bei "Rituxan"
SAN FRANCISCO (Dow Jones)--Das US-Biotechnologieunternehmen Biogen Idec Inc und die Roche-Tochter Genentech Inc haben bei der Entwicklung eines Medikaments zur Behandlung der multiplen Sklerose, "Rituxan", einen Rückschlag erlitten. In einer Phase II/III-Studie zur Wirksamkeit des Medikaments wurde der primäre Endpunkt nicht erreicht.
Beide Unternehmen wollen die Ergebnisse der Studie, die 122 Wochen lang die Wirksamkeit des Medikaments an 439 Patienten getestet hat, weiter auswerten und die Rolle der B-Zellen bei der schweren multiplen Sklerose besser erforschen.
Webseite: http://www.gene.com
http://www.roche.com
DJG/DJN/phf
(END) Dow Jones Newswires
April 15, 2008 02:14 ET (06:14 GMT)
Copyright (c) 2008 Dow Jones & Company, Inc.
http://de.biz.yahoo.com/15042008/341/r-252-ckschlag-f-252-r-…
Antwort auf Beitrag Nr.: 33.885.858 von Poppholz am 15.04.08 10:01:02NCB, "Rituxan failure may make Ty more important to BIIB"
BIIB and Genentech last night (April 14th) released disappointing headline data from their Phase II/III study on Rituxan as a potential treatment for primaryprogressive MS (PPMS). The 439-patient study did not meet its primary endpoint, defined as time to confirmed disease progression. The full data will now be
reviewed ahead of a decision on the product's future. PPMS accounts for approximately 10% of the MS population and has been notoriously difficult to treat effectively.
Failure here is disappointing for BIIB as it seeks to extend its MS franchise. Looking at it another way, Tysabri may become that little bit more important in its franchise as a result.
Meanwhile, the Elan share price has given up the gains made over the last two weeks and is now 22% off its 2008 high of $26.70. This may reflect some nervousness ahead of AAN presentations and the release of updated Tysabri numbers for Q1. To recap, a patient addition rate of approximately 380/week would meet our 25,300 forecast for the period. In contrast, an addition rate in linewith the Q4 outturn (i.e. 340/week) would result in a Q1 total of 24,800.
http://www.rte.ie/business/2008/morningrep/download/0415davy…
BIIB and Genentech last night (April 14th) released disappointing headline data from their Phase II/III study on Rituxan as a potential treatment for primaryprogressive MS (PPMS). The 439-patient study did not meet its primary endpoint, defined as time to confirmed disease progression. The full data will now be
reviewed ahead of a decision on the product's future. PPMS accounts for approximately 10% of the MS population and has been notoriously difficult to treat effectively.
Failure here is disappointing for BIIB as it seeks to extend its MS franchise. Looking at it another way, Tysabri may become that little bit more important in its franchise as a result.
Meanwhile, the Elan share price has given up the gains made over the last two weeks and is now 22% off its 2008 high of $26.70. This may reflect some nervousness ahead of AAN presentations and the release of updated Tysabri numbers for Q1. To recap, a patient addition rate of approximately 380/week would meet our 25,300 forecast for the period. In contrast, an addition rate in linewith the Q4 outturn (i.e. 340/week) would result in a Q1 total of 24,800.
http://www.rte.ie/business/2008/morningrep/download/0415davy…
Antwort auf Beitrag Nr.: 33.886.045 von bernie55 am 15.04.08 10:23:22sehe ich genau so.
Vielleicht kaufe ich heute oder morgen noch ein paar Stücke ein.
Gebe Euch dann bescheid, damit Ihr noch günstiger einkaufen könnt.
Vielleicht kaufe ich heute oder morgen noch ein paar Stücke ein.
Gebe Euch dann bescheid, damit Ihr noch günstiger einkaufen könnt.
Antwort auf Beitrag Nr.: 33.886.098 von Poppholz am 15.04.08 10:30:18über 12% runter in den letzten Tagen.
Da sollte es doch bald wieder nach oben gehen.
Da sollte es doch bald wieder nach oben gehen.
Antwort auf Beitrag Nr.: 33.886.098 von Poppholz am 15.04.08 10:30:18Gebe Euch dann bescheid, damit Ihr noch günstiger einkaufen könnt.
...du bist ja ein " richtig Sozialer ".....
...du bist ja ein " richtig Sozialer ".....
Antwort auf Beitrag Nr.: 33.886.385 von Poppholz am 15.04.08 10:59:43....eben einfach ein Schatz....
ELN msg # 218712 4/14/2008 11:54:16 PM
By: zendiver66
AAN 2008 reporting to the board
Good evening from the windy city. I arrived yesterday just before noon, I checked into the Sheraton Towers, chilled and headed to the meeting. The shuttle buses should arrive every 10-15 minutes but 30 minutes later this poor Alabama boy chilled to the bone got on the bus to the McCormick Place West Convention Center. The only interesting site was Soldier Field the rest was a dingy rided on a pot-holed road by some dingy railroad tracks. Unlike Jive I had my own name tag. The first course I was registered to attend was "Hot Topics in Multiple Sclerosis". The first lecture was from a neuroimmunologiIn his hand out st from McGill University in Montreal (my original Home town) entitled Neuroimmunology of MS: " A Guide for the Perplexed; Understanding the Ratione for Current and Future Therapy". It was a very polished presentation. In his hand out he discusses natalizumab action based on anti-adhesion principles as an anti-VLA-4 antibody. He acknowledges impressive efficacy but states that " initial enthusiasm was tempered by the emergence of afew cases of PML". However in his presentation he even fails to discuss Natalizumab but spends a significant amount of time on an approach to suppress B cells. He pushes Rituxan as a very promising thearapeutic approach to threat M.S. By the way he receives grants from Genentech for rituxan trials. After his presentation there is question and answer period. I'm sittin by the mike and I can't stand it, so I'm the first to get up and speak. I actually didn't ask a direct question, but I congradulated him on afine presentation but I told him since the subtitle of the presentations was "Controversies and Consensus", I needed to generate some controversity. I told the meeting (there were several hundred people present). I told him that I was amazed that he did not even mention the most effective therapy for MS, natilizumab, but he mentions it in the handout but it was associated with " a few cases" of PML! I proceeded to mention that it was only associated with 3 cases of PML and the FDA has reversed its opinion that in the case of Crohn's patient that azo. a significant immunosuppresant as the probable primary cause and natalizumab as being associated. I then asked him why he didn't even mention that Rituxan that he is promoting was associated with at least 16 cases of PML of which most were in lymphoma patients but that not too long ago it was briefly used in systemic Lupus resultin in two fatalities. This was followed by some moans from the audience. He was slow in responding but before he really could, Dr. A. Miller the chair of this meeting said whaaoo and said that therapy would be discussed at an upcoming meeting this week.
The third presentation I found personaly interesting. It was by a neuro-ohthalmologist from Dallas. He discussed the use of optical coherence tomography (OTC) of the retina. This is actually a sophisicated ultra- sound of the retina. For the non-medical people on this board, the retina is actually brain tissue and is the only placed where we can observe the brain without openeing the skull. He presented images of the retina in MS optic neuritis and showed dramatic thining of the retina. But more interesting were images of retinas in patients that never suffered optic neurities, even without direct insult the retinas also showed a distinct atrophy as well. He did then showed images of retinas of patients on natalizumab. Guess what? they preserved their thickness.
The last presentation was given by Dr. A. Miller about being able to predict the progression of MS. It was well presented.
After the presentaions I spoke with the ophthalmologist. I asked him if he believed open angle glaucoma to be a degenerative process. I then asked him if he read about the European neurologist that simulated open angle glaucoma and had dramatically improved the symptoms with Bap. He smiled back and just said we're on it as you speak. I told him I had some ophthalomolgy training before I decided to get into ER medicine. He then said that what I asked in the meeting was appropriate, and that made me feel better since I felt that me questioning was too much in your face.
Now let's finish with today. I attended the day long update on MS. It was chaired by Dr. Claudia F. Lucchinetti. Six presentations today pathology,neuroimaging,genetics,diagnosis,rational therapeutics, and emerging MS therapy. A very good summation except for the genetics which was a bit dry and I don't believe relavent at the present time maybe in the future. the last two discussions were interactive we had remote devices where we could punch in the multiple choice questions. By the answers it seems progressively that the neuros are finding more value in tysabri. However Dr. Miller showed little love for tysabri, not denying its efficacity, he said most of the pml occured while the patients were on it for more than two years and he would consider using it after several thousand more patients remained free from pml at that time.
At 5 pm the exhibits opened for the first time with plenty of finger food and wine. I did go by the Biogen exhibit and examened their Tysabri display which was beside the Avenox display. The Biogen staff were very courtious. I did introduce myself as a non neurologist but an Elan shareholder, with a big smile on my face I said that I just wanted to see how my partners were promoting my drug. They did just that gave me their presentaion which was very effective, I cut them short by thanking them sincerely but that the people standing behind me needed their attention. I shook hands and asked them nicely to sell the heck out of tysabri.
I was getting hungry so I walked over to the food my hands were full so I went to the large tables and found a larger vacant area so I laid down my bag and went to one of the many tables ladened with food, loaded up a paper plate and returned to ny seat.
Here's were it gets freaky and I'm not making this up. There was a gentleman who sat in the chair beside mine. We made some simple conversation and he asked me were I practiced neurology. I explained that I was a retired ER physician who was in the Urgent Care business but with a special interest in MS and alzheimer's. He then mentioned that he was a senior clinical investigator in Seatle and they were waiting to get the go ahead to start the phase 3 trial for Bap. I said that was great and then he started discribing the trail and its medical significance he was so into it that I didn't want to interrrupt by saying that I was well informed and some because of you. He emphacised that all that needed to occur was to show that they could slow progression. I responded by saying why stop there show me some regression. After a few minutes he had to meet I could have sat there for another hour. Not even a minute went by before a younger physcian sat on the other side of me. As we nodded I asked him were he was from and in a European accent he mentioned he was from Switzerland. I asked him what part and he said originally from Geneva but worked in a university reseach center in Lauzanne, I hoped I spelled that accurately. I asked him if he spoke french he said he did so we started to talk in French I told him I graduated from the University de Montreal. Again I told him that I wasn't a neuro but was very interested in MS. It turns out I with a neuroimmunologist who's expertise is PML so we talk about it for 10 minutes. He was hired by Biogen to investigate Tysabri. He said everyone was taken by surprise and didn't know what they were dealing with and believed it was a relapse of MS so the neuros treated the cases with high doses of steroids.We looked at each other and almost simultaneously said gas on the fire, he actually said oil. He's very supportive of Ty and believes when treated early PML is quite manageable. I said you mean by plasmophoresis. He nodded and said and by not giving anymore. We shook hands and went our separate ways.
Are there any elanians here would be nice to get together for a drink or meal. Tomorrow is Tuesday. I'm staying at the Sheraton.
ELN msg # 218712 4/14/2008 11:54:16 PMBy: zendiver66
AAN 2008 reporting to the board
Good evening from the windy city. I arrived yesterday just before noon, I checked into the Sheraton Towers, chilled and headed to the meeting. The shuttle buses should arrive every 10-15 minutes but 30 minutes later this poor Alabama boy chilled to the bone got on the bus to the McCormick Place West Convention Center. The only interesting site was Soldier Field the rest was a dingy rided on a pot-holed road by some dingy railroad tracks. Unlike Jive I had my own name tag. The first course I was registered to attend was "Hot Topics in Multiple Sclerosis". The first lecture was from a neuroimmunologiIn his hand out st from McGill University in Montreal (my original Home town) entitled Neuroimmunology of MS: " A Guide for the Perplexed; Understanding the Ratione for Current and Future Therapy". It was a very polished presentation. In his hand out he discusses natalizumab action based on anti-adhesion principles as an anti-VLA-4 antibody. He acknowledges impressive efficacy but states that " initial enthusiasm was tempered by the emergence of afew cases of PML". However in his presentation he even fails to discuss Natalizumab but spends a significant amount of time on an approach to suppress B cells. He pushes Rituxan as a very promising thearapeutic approach to threat M.S. By the way he receives grants from Genentech for rituxan trials. After his presentation there is question and answer period. I'm sittin by the mike and I can't stand it, so I'm the first to get up and speak. I actually didn't ask a direct question, but I congradulated him on afine presentation but I told him since the subtitle of the presentations was "Controversies and Consensus", I needed to generate some controversity. I told the meeting (there were several hundred people present). I told him that I was amazed that he did not even mention the most effective therapy for MS, natilizumab, but he mentions it in the handout but it was associated with " a few cases" of PML! I proceeded to mention that it was only associated with 3 cases of PML and the FDA has reversed its opinion that in the case of Crohn's patient that azo. a significant immunosuppresant as the probable primary cause and natalizumab as being associated. I then asked him why he didn't even mention that Rituxan that he is promoting was associated with at least 16 cases of PML of which most were in lymphoma patients but that not too long ago it was briefly used in systemic Lupus resultin in two fatalities. This was followed by some moans from the audience. He was slow in responding but before he really could, Dr. A. Miller the chair of this meeting said whaaoo and said that therapy would be discussed at an upcoming meeting this week.
The third presentation I found personaly interesting. It was by a neuro-ohthalmologist from Dallas. He discussed the use of optical coherence tomography (OTC) of the retina. This is actually a sophisicated ultra- sound of the retina. For the non-medical people on this board, the retina is actually brain tissue and is the only placed where we can observe the brain without openeing the skull. He presented images of the retina in MS optic neuritis and showed dramatic thining of the retina. But more interesting were images of retinas in patients that never suffered optic neurities, even without direct insult the retinas also showed a distinct atrophy as well. He did then showed images of retinas of patients on natalizumab. Guess what? they preserved their thickness.
The last presentation was given by Dr. A. Miller about being able to predict the progression of MS. It was well presented.
After the presentaions I spoke with the ophthalmologist. I asked him if he believed open angle glaucoma to be a degenerative process. I then asked him if he read about the European neurologist that simulated open angle glaucoma and had dramatically improved the symptoms with Bap. He smiled back and just said we're on it as you speak. I told him I had some ophthalomolgy training before I decided to get into ER medicine. He then said that what I asked in the meeting was appropriate, and that made me feel better since I felt that me questioning was too much in your face.
Now let's finish with today. I attended the day long update on MS. It was chaired by Dr. Claudia F. Lucchinetti. Six presentations today pathology,neuroimaging,genetics,diagnosis,rational therapeutics, and emerging MS therapy. A very good summation except for the genetics which was a bit dry and I don't believe relavent at the present time maybe in the future. the last two discussions were interactive we had remote devices where we could punch in the multiple choice questions. By the answers it seems progressively that the neuros are finding more value in tysabri. However Dr. Miller showed little love for tysabri, not denying its efficacity, he said most of the pml occured while the patients were on it for more than two years and he would consider using it after several thousand more patients remained free from pml at that time.
At 5 pm the exhibits opened for the first time with plenty of finger food and wine. I did go by the Biogen exhibit and examened their Tysabri display which was beside the Avenox display. The Biogen staff were very courtious. I did introduce myself as a non neurologist but an Elan shareholder, with a big smile on my face I said that I just wanted to see how my partners were promoting my drug. They did just that gave me their presentaion which was very effective, I cut them short by thanking them sincerely but that the people standing behind me needed their attention. I shook hands and asked them nicely to sell the heck out of tysabri.
I was getting hungry so I walked over to the food my hands were full so I went to the large tables and found a larger vacant area so I laid down my bag and went to one of the many tables ladened with food, loaded up a paper plate and returned to ny seat.
Here's were it gets freaky and I'm not making this up. There was a gentleman who sat in the chair beside mine. We made some simple conversation and he asked me were I practiced neurology. I explained that I was a retired ER physician who was in the Urgent Care business but with a special interest in MS and alzheimer's. He then mentioned that he was a senior clinical investigator in Seatle and they were waiting to get the go ahead to start the phase 3 trial for Bap. I said that was great and then he started discribing the trail and its medical significance he was so into it that I didn't want to interrrupt by saying that I was well informed and some because of you. He emphacised that all that needed to occur was to show that they could slow progression. I responded by saying why stop there show me some regression. After a few minutes he had to meet I could have sat there for another hour. Not even a minute went by before a younger physcian sat on the other side of me. As we nodded I asked him were he was from and in a European accent he mentioned he was from Switzerland. I asked him what part and he said originally from Geneva but worked in a university reseach center in Lauzanne, I hoped I spelled that accurately. I asked him if he spoke french he said he did so we started to talk in French I told him I graduated from the University de Montreal. Again I told him that I wasn't a neuro but was very interested in MS. It turns out I with a neuroimmunologist who's expertise is PML so we talk about it for 10 minutes. He was hired by Biogen to investigate Tysabri. He said everyone was taken by surprise and didn't know what they were dealing with and believed it was a relapse of MS so the neuros treated the cases with high doses of steroids.We looked at each other and almost simultaneously said gas on the fire, he actually said oil. He's very supportive of Ty and believes when treated early PML is quite manageable. I said you mean by plasmophoresis. He nodded and said and by not giving anymore. We shook hands and went our separate ways.
Are there any elanians here would be nice to get together for a drink or meal. Tomorrow is Tuesday. I'm staying at the Sheraton.
zu HEUTE AAN
ELN msg # 218667 4/14/2008 8:44:43 PM
By: stop_farking_with_me
Quite a conincidence, huh?
So, on the eve of the Tysabri safety update, Curly releases the goods on Rituxan. And I'd like to know who the bozo is at BIIB who was leaking misinformation?
This is all pointing to one thing-a string of great news is coming for ELan, and WS is performing every trick in the books to wrestle shares from the weak before the good news comes out.
We once again have weathered another attack on ELN; now it's OUR turn. And I beleive the string of good-news events will come out in intervals that will make it very difficult for this thing to happen again. We've got:
1) safety update tomorrow. How could it not be good? (NO PML in MONO, PERIOD)
2) Miracle stories about Ty's efficacy (tomorrow)
3) uptake info at the earnings CC (if not tomorrow);
4) accelerating revenue growth reported at the CC;
5) uncontrollable enthusiasm expressed concerning BAP at the CC;
6) ELN analyst events in May;
7) BAP news in June
ELN msg # 218667 4/14/2008 8:44:43 PM
By: stop_farking_with_me
Quite a conincidence, huh?
So, on the eve of the Tysabri safety update, Curly releases the goods on Rituxan. And I'd like to know who the bozo is at BIIB who was leaking misinformation?
This is all pointing to one thing-a string of great news is coming for ELan, and WS is performing every trick in the books to wrestle shares from the weak before the good news comes out.
We once again have weathered another attack on ELN; now it's OUR turn. And I beleive the string of good-news events will come out in intervals that will make it very difficult for this thing to happen again. We've got:
1) safety update tomorrow. How could it not be good? (NO PML in MONO, PERIOD)
2) Miracle stories about Ty's efficacy (tomorrow)
3) uptake info at the earnings CC (if not tomorrow);
4) accelerating revenue growth reported at the CC;
5) uncontrollable enthusiasm expressed concerning BAP at the CC;
6) ELN analyst events in May;
7) BAP news in June
NO NEW PML UP ELN!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
komm birgit, du den rest
komm birgit, du den rest
Antwort auf Beitrag Nr.: 33.892.529 von GuHu1 am 15.04.08 21:21:21
21:21:21 schaut auf die uhrzeit meines postings, wow was für ein timing.
21:21:21 schaut auf die uhrzeit meines postings, wow was für ein timing.
PUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUHH News out...auf AAN:26000 auf Ty und KEINE PML-FÄLLE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
ELN msg # 219160 4/15/2008 3:17:58 PM
By: Dr_bjchilds
Re: 26100, no pml
Biogen Idec and Elan Present New TYSABRI(R) Data at the 60th Annual Meeting of the American Academy of Neurology-- Approximately 26,000 Patients on Commercial and Clinical Therapy Worldwide -- -- Additional Analyses Show TYSABRI Significantly Increased the Proportion of Multiple Sclerosis (MS) Patients Who are Considered Disease Free for Over Two Years --
CHICAGO, Apr 15, 2008 (BUSINESS WIRE) --
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced new data on the global utilization, safety and overall patient exposure of TYSABRI(R) (natalizumab). As of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide with no cases of progressive multifocal leukoencephalopathy (PML) reported since re-launch in the U.S. and launch internationally in July 2006. Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of TYSABRI indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010. These data were presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN).
"These data suggest that neurologists and patients are increasingly choosing TYSABRI for the treatment of their disease. The significant clinical benefits are established and TYSABRI continues to offer the potential for compelling efficacy and hope for those patients living with MS," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.
"Positive outcomes for patients continue to support TYSABRI's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world. We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive TYSABRI treatment in the U.S.," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.
According to data available as of the end of March 2008:
-- In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;
-- Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;
-- In global clinical trials, more than 600 patients were on TYSABRI therapy; and
-- There have been no cases of PML since re-launch in the US and launch internationally in July 2006.
Cumulatively, in the combined clinical trial and post-marketing settings:
-- More than 36,700 patients have been treated with TYSABRI; and
-- Of those patients, over 9,900 have received at least one year of TYSABRI therapy and more than 3,600 patients have been on therapy for 18 months or longer.
TYSABRI is available in the U.S. through the TOUCH(TM) Prescribing Program. All U.S. prescribers, infusion sites, and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy.
The abstract for this study, "Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH(TM) and TYGRIS" (Presentation #S02.002), is available online at the AAN's Web site.
TYSABRI Increases the Proportion of MS Patients Considered Disease Free
Biogen Idec and Elan also announced today at the meeting that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of the AFFIRM and SENTINEL clinical trials. The proportion of patients considered disease free in the studies was determined based upon both clinical and MRI criteria. In the studies, the proportion of patients considered disease free over two years was significantly higher in the TYSABRI-treated group compared with the placebo group, regardless of how disease free was defined.
Clinically, disease free was defined as no relapses and no progression of disability (as defined by > or =1.0-point increase in Expanded Disability Status Scale (EDSS) score from a baseline score of > or =1.0, or a > or =1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over two years. MRI disease free was defined as no gadolinium-enhancing lesions seen on annual MRI scans and no new or enlarging T2-hyperintense lesions over two years.
"The ultimate goal of an MS treatment is to help patients remain symptom free for as long as possible. These data show natalizumab may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients," said the study's lead author, Steven Galetta, MD, Professor of Neurology, University of Pennsylvania School of Medicine.
In the AFFIRM trial, patients were randomized to receive TYSABRI or placebo, while in the SENTINEL trial, randomized patients received TYSABRI plus interferon beta-1a or placebo plus interferon beta-1a. Over a two-year period, patients were evaluated utilizing clinical criteria, MRI criteria and combined criteria with both trials demonstrating TYSABRI treatment significantly increased the proportions of patients considered disease free. Using clinical and MRI disease-free criteria combined, a stringent definition of disease free, 36.7% and 31.7% of patients in the TYSABRI groups were disease free compared with 7.2% and 10.9% given placebo in the AFFIRM and SENTINEL trials, respectively. By individual criteria, TYSABRI benefit was also demonstrated using clinical (AFFIRM: 64.3% vs. 38.9%; SENTINEL: 47.4% vs. 28.0%) and MRI definitions of disease free (AFFIRM: 57.7% vs. 14.2%; SENTINEL: 65.5% vs. 27.6%). In both studies, results were similar in patients with highly-active and non-highly active MS.
The abstract for this study, "Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis" (Poster #P02.156), is available online at the AAN's Web site.
About TOUCH(TM) and TYGRIS
Before initiating treatment, all U.S. patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, other serious OIs, deaths and discontinuation of therapy on an ongoing basis.
TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected to enroll 5,000 patients worldwide, including approximately 2,000 - 2,500 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies.
Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.
About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).
TYSABRI was recently approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.
TYSABRI is approved in more than 30 countries including the United States and many countries throughout the European Union, as well as Switzerland, Canada, Australia, New Zealand and Israel.
ELN msg # 219160 4/15/2008 3:17:58 PMBy: Dr_bjchilds
Re: 26100, no pml
Biogen Idec and Elan Present New TYSABRI(R) Data at the 60th Annual Meeting of the American Academy of Neurology-- Approximately 26,000 Patients on Commercial and Clinical Therapy Worldwide -- -- Additional Analyses Show TYSABRI Significantly Increased the Proportion of Multiple Sclerosis (MS) Patients Who are Considered Disease Free for Over Two Years --
CHICAGO, Apr 15, 2008 (BUSINESS WIRE) --
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced new data on the global utilization, safety and overall patient exposure of TYSABRI(R) (natalizumab). As of the end of March 2008, approximately 26,000 patients were on commercial and clinical therapy worldwide with no cases of progressive multifocal leukoencephalopathy (PML) reported since re-launch in the U.S. and launch internationally in July 2006. Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of TYSABRI indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010. These data were presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN).
"These data suggest that neurologists and patients are increasingly choosing TYSABRI for the treatment of their disease. The significant clinical benefits are established and TYSABRI continues to offer the potential for compelling efficacy and hope for those patients living with MS," said Michael Panzara, MD, MPH, Vice President and Chief Medical Officer, Neurology Strategic Business Unit, Biogen Idec.
"Positive outcomes for patients continue to support TYSABRI's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world. We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive TYSABRI treatment in the U.S.," said Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.
According to data available as of the end of March 2008:
-- In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;
-- Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;
-- In global clinical trials, more than 600 patients were on TYSABRI therapy; and
-- There have been no cases of PML since re-launch in the US and launch internationally in July 2006.
Cumulatively, in the combined clinical trial and post-marketing settings:
-- More than 36,700 patients have been treated with TYSABRI; and
-- Of those patients, over 9,900 have received at least one year of TYSABRI therapy and more than 3,600 patients have been on therapy for 18 months or longer.
TYSABRI is available in the U.S. through the TOUCH(TM) Prescribing Program. All U.S. prescribers, infusion sites, and patients receiving TYSABRI are required to enroll in TOUCH. Safety information is also collected through ongoing clinical trials and registries, including TYGRIS and the pregnancy registry, making this the largest long-term patient follow-up effort undertaken for any MS therapy.
The abstract for this study, "Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH(TM) and TYGRIS" (Presentation #S02.002), is available online at the AAN's Web site.
TYSABRI Increases the Proportion of MS Patients Considered Disease Free
Biogen Idec and Elan also announced today at the meeting that TYSABRI treatment significantly increases the proportion of patients with MS considered to be disease free, according to post-hoc analyses of the AFFIRM and SENTINEL clinical trials. The proportion of patients considered disease free in the studies was determined based upon both clinical and MRI criteria. In the studies, the proportion of patients considered disease free over two years was significantly higher in the TYSABRI-treated group compared with the placebo group, regardless of how disease free was defined.
Clinically, disease free was defined as no relapses and no progression of disability (as defined by > or =1.0-point increase in Expanded Disability Status Scale (EDSS) score from a baseline score of > or =1.0, or a > or =1.5-point increase from a baseline score of 0.0, sustained for 12 weeks) over two years. MRI disease free was defined as no gadolinium-enhancing lesions seen on annual MRI scans and no new or enlarging T2-hyperintense lesions over two years.
"The ultimate goal of an MS treatment is to help patients remain symptom free for as long as possible. These data show natalizumab may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients," said the study's lead author, Steven Galetta, MD, Professor of Neurology, University of Pennsylvania School of Medicine.
In the AFFIRM trial, patients were randomized to receive TYSABRI or placebo, while in the SENTINEL trial, randomized patients received TYSABRI plus interferon beta-1a or placebo plus interferon beta-1a. Over a two-year period, patients were evaluated utilizing clinical criteria, MRI criteria and combined criteria with both trials demonstrating TYSABRI treatment significantly increased the proportions of patients considered disease free. Using clinical and MRI disease-free criteria combined, a stringent definition of disease free, 36.7% and 31.7% of patients in the TYSABRI groups were disease free compared with 7.2% and 10.9% given placebo in the AFFIRM and SENTINEL trials, respectively. By individual criteria, TYSABRI benefit was also demonstrated using clinical (AFFIRM: 64.3% vs. 38.9%; SENTINEL: 47.4% vs. 28.0%) and MRI definitions of disease free (AFFIRM: 57.7% vs. 14.2%; SENTINEL: 65.5% vs. 27.6%). In both studies, results were similar in patients with highly-active and non-highly active MS.
The abstract for this study, "Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis" (Poster #P02.156), is available online at the AAN's Web site.
About TOUCH(TM) and TYGRIS
Before initiating treatment, all U.S. patients, prescribers and infusion sites must be enrolled in the TOUCH Prescribing Program (TYSABRI Outreach: Unified Commitment to Health). TOUCH is designed to determine the incidence of and risk factors for serious opportunistic infections (OIs), including PML, and to monitor patients for signs and symptoms of PML while promoting informed benefit-risk discussions prior to initiating TYSABRI treatment. Physicians report on PML, other serious OIs, deaths and discontinuation of therapy on an ongoing basis.
TYGRIS (TYSABRI Global ObseRvation Program In Safety) is expected to enroll 5,000 patients worldwide, including approximately 2,000 - 2,500 patients from TOUCH. Patients in TYGRIS are evaluated at baseline and every six months thereafter for five years. Researchers will evaluate data including medical/MS history; prior TYSABRI use; prior use of immunomodulatory, antineoplastic, or immunosuppressive agents; and all serious adverse events, including PML and other serious OIs and malignancies.
Adverse event reporting in the post-marketing setting is voluntary. It is possible that not all reactions have been reported, or that some reactions are not reported to Biogen Idec or Elan in a timely manner.
About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p<0.001).
TYSABRI was recently approved to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha.
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis) and infections. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS and CD clinical trials, the incidence and rate of other serious adverse events, including serious infections, were similar in patients receiving TYSABRI and those receiving placebo. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash. Other common adverse events reported in TYSABRI-treated CD patients include respiratory tract infections and nausea. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting.
TYSABRI is approved in more than 30 countries including the United States and many countries throughout the European Union, as well as Switzerland, Canada, Australia, New Zealand and Israel.
....huch...ich bin ja garnicht so alleine ...wurde sogar schon erwartet.....-----------bin ja doch erleichtert.....
-----------bin ja doch erleichtert..... ELN msg # 219174 4/15/2008 3:24:21 PMBy: stockhound4
US Accrual Rate 171/WK EU Accrual Rate 192/WK Total Accrual Rate 363/WK 250 New Docs Prescribing Drug
Antwort auf Beitrag Nr.: 33.892.598 von Birgit.Tersteegen am 15.04.08 21:28:07
erleichtert bin ich auch, hatte schon mit dem schlimmsten gerechnet.
....huch...ich bin ja garnicht so alleine ...
ist heute news day oder nicht, außerdem zur info, lese jeden tag im thread, muss aber nicht immer was schreiben.
erleichtert bin ich auch, hatte schon mit dem schlimmsten gerechnet.
....huch...ich bin ja garnicht so alleine ...
ist heute news day oder nicht, außerdem zur info, lese jeden tag im thread, muss aber nicht immer was schreiben.
ELN msg # 219259 4/15/2008 4:00:11 PMBy: JBWIN
JPM re BIIB - Accelerating Tysabri Usage and No PML
Biogen Idec : Accelerating Tysabri Usage, and No PML - ALERT
*
* We are attending the American Academy of Neurology (AAN) meeting where Biogen and Elan announced the positive 1Q Tysabri utilization and safety update. Usage continues to accelerate worldwide while no cases of PML have arisen with nearly 10,000 patients on drug for more than a year. Worldwide net patient adds on Tysabri accelerated in 1Q to 392 per week, well ahead of the previous high of 338 and was largely driven by increasing usage in Europe. The patient numbers are higher than expected, and we now see $10M+ of upside to our above-consensus 1Q Tysabri estimate (JPMe: $160M; cons $157M). We expect upside in BIIB shares as execution has been strong in the last two quarters, while Biogen management is clearly strengthening its case to shareholders that it is driving fundamental upside ahead of a likely proxy fight.
*
* Strong Tysabri uptake: is it an inflection point? Utilization in the US continued to be strong, with 185 adds per week maintaining record levels of patient adds from 4Q07. With no new cases of PML, the risk-benefit for Tysabri appears to be more attractive. Tysabri OUS growth (the territory Biogen is responsible for) was particularly impressive with 208 adds per week, up dramatically from the record 154 in 4Q07. Worldwide, the patient adds were 392/week, up from the record 338 in 4Q07. In the Q&A session of the presentation, Dr. Bozic stated that the discontinuation rate is significantly lower than the ABCRs (which are generally around 20%). In our view, the lower discontinuation rate could imply higher than expected utilization long term.
*
* Upside to our and consensus 1Q Tysabri estimates. In our view, the upside patient numbers announced today imply 1Q sales will significantly beat our $160M and the cons $157M ests for WW end-user Tysabri sales, and could be over $170M depending on the extent of discounting and FX impact.
*
* PML risk may be lower than anticipated, a positive. With no cases of PML in over 25,000 commercial patients treated and over 36,000 cumulative patients exposed in commercial settings and clinical trials, the risk of PML looks lower than assumed by all stakeholders at the re-introduction (FDA assumed 1:1,000). Comparably lower safety risk is starting to look realistic given that 10,000 pts have been on drug for more than a year, and 3,600 have been on for more than 18 months.
*
* Reiterating OW rating on BIIB shares. In our view, expectations remain low for Biogen in 2008, and we expect continued share upside as the Street consistently underestimates strong underlying fundamentals.
ReutersBiogen says no new brain infections with Tysabri
Tue Apr 15, 2008 3:43pm EDT
NEW YORK (Reuters) - Biogen Idec and its partner Elan Corp said on Tuesday no new cases of a potentially deadly brain infection have been seen among patients taking their Tysabri multiple sclerosis drug since it was re-introduced in July 2006.
The companies said no cases of progressive multifocal leukoencephalopathy, or PML, were seen by the end of March among about 26,000 patients taking the drug.
Given the favorable safety findings, the companies said they were moving towards their goal of having 100,000 patients on the medicine by the end of 2010.
Tysabri, which has been shown highly effective in treating the progressive neurological disease, was temporarily suspended from the market in 2005 after several patients developed PML. But it was allowed back in 2006 -- with certain restrictions -- after U.S. regulators decided MS patients were willing to accept the risks in return for the potential benefits.
The new safety data were presented on Tuesday at the annual meeting of the American Academy of Neurology in Chicago.
(Reporting by Ransdell Pierson; Editing by Braden Reddall)
ELN msg # 219302 4/15/2008 4:20:11 PMBy: rickmeoff
im sorry, but its so rare when we see something positive about us in print
that i wanted to see it again....this time, with feeling:
[b]"Those patients were also taking other drugs that may have weakened their immune systems and played a role in their infections. There has never been a case of PML in an MS patient taking Tysabri as a monotherapy." [/b]
was hälste von dem?
Eur J Paediatr Neurol. 2008 Apr 10; [Epub ahead of print] Related Articles
Natalizumab treatment in pediatric multiple sclerosis: A case report.
Borriello G, Prosperini L, Luchetti A, Pozzilli C.
Multiple Sclerosis Center, S. Andrea Hospital, University of Rome "La Sapienza", Via di Grottarossa 1037, 00189, Rome, Italy.
Pediatric multiple sclerosis (MS) with manifestations before 16 years of age occurs in 0.4-10.5% of whole MS population. The initial course of the disease is relapsing-remitting with a relapse rate generally higher than that of adults, less than 3% have a primary progressive form. Some recent reports have shown that Interferon beta (IFNbeta) has a strong effect in reducing the relapse rate in children with MS and is well tolerated. We report a 12-year-old girl with MS and a high relapse rate from the onset. Frequent magnetic resonance imaging (MRI) detected persisting inflammatory activity and increase of lesion burden. She continued to present acute relapses and progression of disability in spite of a treatment with IFNbeta-1a at different dosages and the addition of pulse IV steroid treatment. Then, we opted for Natalizumab treatment, recently approved as a monotherapy for patients with MS who experienced inadequate response to other disease modifying therapies and never used till now in pediatric MS. Our patient showed a complete response to Natalizumab with clinical and MRI suppression of disease activity.
PMID: 18406645 [PubMed - as supplied by publisher]
Eur J Paediatr Neurol. 2008 Apr 10; [Epub ahead of print] Related Articles
Natalizumab treatment in pediatric multiple sclerosis: A case report.
Borriello G, Prosperini L, Luchetti A, Pozzilli C.
Multiple Sclerosis Center, S. Andrea Hospital, University of Rome "La Sapienza", Via di Grottarossa 1037, 00189, Rome, Italy.
Pediatric multiple sclerosis (MS) with manifestations before 16 years of age occurs in 0.4-10.5% of whole MS population. The initial course of the disease is relapsing-remitting with a relapse rate generally higher than that of adults, less than 3% have a primary progressive form. Some recent reports have shown that Interferon beta (IFNbeta) has a strong effect in reducing the relapse rate in children with MS and is well tolerated. We report a 12-year-old girl with MS and a high relapse rate from the onset. Frequent magnetic resonance imaging (MRI) detected persisting inflammatory activity and increase of lesion burden. She continued to present acute relapses and progression of disability in spite of a treatment with IFNbeta-1a at different dosages and the addition of pulse IV steroid treatment. Then, we opted for Natalizumab treatment, recently approved as a monotherapy for patients with MS who experienced inadequate response to other disease modifying therapies and never used till now in pediatric MS. Our patient showed a complete response to Natalizumab with clinical and MRI suppression of disease activity.
PMID: 18406645 [PubMed - as supplied by publisher]
Antwort auf Beitrag Nr.: 33.893.474 von GuHu1 am 15.04.08 22:45:52supi!!!!!------(Trotzdem musst Du bei Deiner Freundesliste auf "annehmen" drücken------
normalerweise biete ich nämlich meine Freundschaft nicht 2 mal an.....
------(Trotzdem musst Du bei Deiner Freundesliste auf "annehmen" drücken------
normalerweise biete ich nämlich meine Freundschaft nicht 2 mal an.....
Antwort auf Beitrag Nr.: 33.893.536 von Birgit.Tersteegen am 15.04.08 22:53:36oh mein gott, was hab ich getan ich thor, hab ich dich etwa verschmäht?
nein es war unwissenheit und hiermit erledigt.
nein es war unwissenheit und hiermit erledigt.
Antwort auf Beitrag Nr.: 33.893.775 von GuHu1 am 15.04.08 23:37:22......da bin ich jetzt aber wirklich froh.....
ELN msg # 219402 4/15/2008 6:01:27 PM
By: lndmvr
Dow Jones Article: NO PML in Monotherapy
At least it has been said. Sorry of already posted.
NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) and Elan PLC (ELN) reported that about 26,000 patients are using their Tysabri multiple-sclerosis treatment, as of the end of March.
Notably, since the drug's relaunch in July 2006 there have been no cases of a rare, but often deadly, brain infection called progressive multifocal leukoencephalopathy, or PML, that caused the drug to be pulled from the market in early 2005.
The U.S. Food and Drug Administration allowed Tysabri, co-marketed by the companies, to return to the market, citing its effectiveness and with strict prescribing restrictions.
The news is noteworthy because, after Biogen's failed bid to sell itself last year, the Cambridge, Mass.-based biotech company has pointed to the potential risk of acquiring Tysabri as too much for potential suitors.
That explanation contrasts with billionaire investor Carl Icahn's claims that the company put up barriers in the auction process that discouraged companies from bidding the $20 billion to $25 billion needed to complete the deal.
Icahn is using his 4.2% stake to nominate three directors to Biogen's board and has threatened to make further nominations next year to gain a majority. Biogen's board hasn't yet responded to the nominations and Icahn recently filed a lawsuit seeking documents related to the sale attempt.
In the meantime, the quarterly Tysabri data updates are being closely watched as the first takers of Tysabri since its relaunch hit their two-year anniversary later this year.
There are currently 15,300 patients on the drug in the U.S., 10,200 overseas and 600 in global clinical trials.
The length of therapy is important, because two of the three patients that acquired the brain infection had been using the drug to treat MS for more than two years. The third patient was taking the drug for Crohn's disease.
Biogen, Elan: Tysabri Maintains Growth, Safety Profile
DOW JONES NEWSWIRES
April 15, 2008 3:39 p.m.
By Thomas Gryta
Of DOW JONES NEWSWIRES
Those patients were also taking other drugs that may have weakened their immune systems and played a role in their infections. There has never been a case of PML in an MS patient taking Tysabri as a monotherapy.
Biogen has consistently projected 100,000 patients for Tysabri by the end of 2010, a goal challenged by some on Wall Street because of worries that cases of PML will arise as patients remain on the drug for longer periods.
Bear Stearns analyst Mark Schoenebaum projects the total will be about 81,000 at that time, using Tuesday's figure, assuming no change in weekly patients additions.
But Biogen has said its 2010 goal assumes some cases of PML will emerge at a rate that is consistent with the drug's label for 1 case per 1,000 patients or better.
ELN msg # 219402 4/15/2008 6:01:27 PMBy: lndmvr
Dow Jones Article: NO PML in Monotherapy
At least it has been said. Sorry of already posted.
NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) and Elan PLC (ELN) reported that about 26,000 patients are using their Tysabri multiple-sclerosis treatment, as of the end of March.
Notably, since the drug's relaunch in July 2006 there have been no cases of a rare, but often deadly, brain infection called progressive multifocal leukoencephalopathy, or PML, that caused the drug to be pulled from the market in early 2005.
The U.S. Food and Drug Administration allowed Tysabri, co-marketed by the companies, to return to the market, citing its effectiveness and with strict prescribing restrictions.
The news is noteworthy because, after Biogen's failed bid to sell itself last year, the Cambridge, Mass.-based biotech company has pointed to the potential risk of acquiring Tysabri as too much for potential suitors.
That explanation contrasts with billionaire investor Carl Icahn's claims that the company put up barriers in the auction process that discouraged companies from bidding the $20 billion to $25 billion needed to complete the deal.
Icahn is using his 4.2% stake to nominate three directors to Biogen's board and has threatened to make further nominations next year to gain a majority. Biogen's board hasn't yet responded to the nominations and Icahn recently filed a lawsuit seeking documents related to the sale attempt.
In the meantime, the quarterly Tysabri data updates are being closely watched as the first takers of Tysabri since its relaunch hit their two-year anniversary later this year.
There are currently 15,300 patients on the drug in the U.S., 10,200 overseas and 600 in global clinical trials.
The length of therapy is important, because two of the three patients that acquired the brain infection had been using the drug to treat MS for more than two years. The third patient was taking the drug for Crohn's disease.
Biogen, Elan: Tysabri Maintains Growth, Safety Profile
DOW JONES NEWSWIRES
April 15, 2008 3:39 p.m.
By Thomas Gryta
Of DOW JONES NEWSWIRES
Those patients were also taking other drugs that may have weakened their immune systems and played a role in their infections. There has never been a case of PML in an MS patient taking Tysabri as a monotherapy.
Biogen has consistently projected 100,000 patients for Tysabri by the end of 2010, a goal challenged by some on Wall Street because of worries that cases of PML will arise as patients remain on the drug for longer periods.
Bear Stearns analyst Mark Schoenebaum projects the total will be about 81,000 at that time, using Tuesday's figure, assuming no change in weekly patients additions.
But Biogen has said its 2010 goal assumes some cases of PML will emerge at a rate that is consistent with the drug's label for 1 case per 1,000 patients or better.
ELN msg # 219426 4/15/2008 6:43:12 PM
By: JBWIN
Citi - Flash: BIIB: Ex-U.S. Gains Boosts Tysabri Utilization, U.S. Gains Flat
* Conclusion(s) - Today Biogen Idec announced Tysabri utilization data at AAN. The number of patients on Tysabri was slightly ahead of our estimates, with weekly patient gains flat in the U.S. and significantly higher ex-U.S. We expect Q1:08 Tysabri sales numbers to be strong, given the large gains ex-U.S. (which should also receive an Fx boost) and a U.S. Jan. price increase. No PML cases are encouraging, but this issue should remain an overhang until the late summer when a set of patients will have been on the drug for 2 years.
* Tysabri Patient Gains - There were 15,300 U.S. pts and 10,200 pts ex-U.S. on Tysabri by the end of March, suggesting that weekly patient gains have increased to 392 pts/wk from 338 pts/wk (U.S. gains of 185 pts/wk flat from Dec.; ex-U.S. 208 pts/wk from 154 pts/wk). To attain mgt's guidance of 100K pts by YE '10, weekly gains would still have to ramp up to an average of ~415 pts/wk in '08, ~540 pts/wk in '09 and ~650 pts/wk in '10. This is still a tough hurdle, but the trends are encouraging.
* Ahead of Our Estimates - We had modeled that at the end of Q1:08 there were 24,801 patients on Tysabri worldwide (24,158 from MS and 643 from Crohn's). Thus, current utilization of 25,500 is slightly higher than our estimates.
* Tysabri IMS Sales Strong - IMS data suggests that in Q1:08 Tysabri will post U.S. sales of ~$96M (consensus $84M-$106M, Citi $96M). We estimate WW Q1:08 sales to be $156M (consensus $144M-$167M). Recall that Tysabri prices were increased by 2.5% in January and mgt has announced that small, incremental price increases throughout '08 are likely. We currently model a ~5% YoY price increase in '08.
* No PML - This issue is gaining increased importance as the two-year anniversary of Tysabri's re-launch is approaching in July. Importantly, there are now ~3,600 patients that have received the drug for 18 months or longer and ~9,900 that have received the drug for one year or longer. In our view, the PML issue will remain an overhang although the trends continue to be very encouraging.
By: JBWIN
Citi - Flash: BIIB: Ex-U.S. Gains Boosts Tysabri Utilization, U.S. Gains Flat
* Conclusion(s) - Today Biogen Idec announced Tysabri utilization data at AAN. The number of patients on Tysabri was slightly ahead of our estimates, with weekly patient gains flat in the U.S. and significantly higher ex-U.S. We expect Q1:08 Tysabri sales numbers to be strong, given the large gains ex-U.S. (which should also receive an Fx boost) and a U.S. Jan. price increase. No PML cases are encouraging, but this issue should remain an overhang until the late summer when a set of patients will have been on the drug for 2 years.
* Tysabri Patient Gains - There were 15,300 U.S. pts and 10,200 pts ex-U.S. on Tysabri by the end of March, suggesting that weekly patient gains have increased to 392 pts/wk from 338 pts/wk (U.S. gains of 185 pts/wk flat from Dec.; ex-U.S. 208 pts/wk from 154 pts/wk). To attain mgt's guidance of 100K pts by YE '10, weekly gains would still have to ramp up to an average of ~415 pts/wk in '08, ~540 pts/wk in '09 and ~650 pts/wk in '10. This is still a tough hurdle, but the trends are encouraging.
* Ahead of Our Estimates - We had modeled that at the end of Q1:08 there were 24,801 patients on Tysabri worldwide (24,158 from MS and 643 from Crohn's). Thus, current utilization of 25,500 is slightly higher than our estimates.
* Tysabri IMS Sales Strong - IMS data suggests that in Q1:08 Tysabri will post U.S. sales of ~$96M (consensus $84M-$106M, Citi $96M). We estimate WW Q1:08 sales to be $156M (consensus $144M-$167M). Recall that Tysabri prices were increased by 2.5% in January and mgt has announced that small, incremental price increases throughout '08 are likely. We currently model a ~5% YoY price increase in '08.
* No PML - This issue is gaining increased importance as the two-year anniversary of Tysabri's re-launch is approaching in July. Importantly, there are now ~3,600 patients that have received the drug for 18 months or longer and ~9,900 that have received the drug for one year or longer. In our view, the PML issue will remain an overhang although the trends continue to be very encouraging.
Guten Morgen 
...na, ausgeschlafen , Birgit ????...DANKE für deine eingelegte Nachtschicht !!!...tja, ich würde sagen, Super-News !!!...keine PML Fälle in Mono !!!!...immer mehr Docs verschreiben Tysabri !!!! ...25,500 Patienten nehmen aktuell Tysabri !!!!
After Hours
Last: $ 22
After Hours
High: $ 22
After Hours
Volume: 54,700
After Hours
Low: $ 21.85
Last: $ 22
After Hours
High: $ 22
After Hours
Volume: 54,700
After Hours
Low: $ 21.85
Antwort auf Beitrag Nr.: 33.894.332 von bernie55 am 16.04.08 07:51:40UPGRADE - UPGRADE - UPGRADE - UPGRADE - UPGRADE - UPGRADE
Goldmann Sachs setzt ELAN auf buy !!!
zur Zeit im IV Board zu lesen:
http://www.investorvillage.com/smbd.asp?mb=160&mn=219561&pt=…
http://www.investorvillage.com/smbd.asp?mb=160&mn=219562&pt=…
Goldmann Sachs setzt ELAN auf buy !!!
zur Zeit im IV Board zu lesen:
http://www.investorvillage.com/smbd.asp?mb=160&mn=219561&pt=…
http://www.investorvillage.com/smbd.asp?mb=160&mn=219562&pt=…
habe mich gestern auch zusammen gerissen und wollte die guten News nicht durch einen Kauf meinerseits gefährden.
Bei der Newslage wäre der Kurs wahrscheinlich auch nach unten gegangen. Durch meinen NICHT-KAUF habe ich somit eine Gegenreaktion erzeugt.
Bei der Newslage wäre der Kurs wahrscheinlich auch nach unten gegangen. Durch meinen NICHT-KAUF habe ich somit eine Gegenreaktion erzeugt.
Antwort auf Beitrag Nr.: 33.894.594 von Poppholz am 16.04.08 08:39:23Bei der Newslage wäre der Kurs wahrscheinlich auch nach unten gegangen. Durch meinen NICHT-KAUF habe ich somit eine Gegenreaktion erzeugt.
..stell dir mal die Gegenreaktion vor, wenn du deinen Anteil der PBB Company verkauft hättest.....
..stell dir mal die Gegenreaktion vor, wenn du deinen Anteil der PBB Company verkauft hättest.....
Antwort auf Beitrag Nr.: 33.894.953 von bernie55 am 16.04.08 09:23:12dann hättet Ihr alle nicht mehr arbeiten müssen.
Da ich aber mit Euch noch das ein oder andere Treffen haben möchte, werde ich Euch den Gefallen nicht tun.
(da hört meine soziale Ader dann doch auf)
Da ich aber mit Euch noch das ein oder andere Treffen haben möchte, werde ich Euch den Gefallen nicht tun.
(da hört meine soziale Ader dann doch auf)
mich wundert allerdings, dass der Kurs in den USA nicht stärker gestiegen ist.
Die Daten waren ja schon vor Börsenschluss bekannt.
Die Daten waren ja schon vor Börsenschluss bekannt.
Antwort auf Beitrag Nr.: 33.894.441 von bernie55 am 16.04.08 08:18:53....nicht schlecht.... bisschen langsam sind sie ja die Analysten....aber besser spät als nie (sagt man sich ja bei den Kids auch immer;meiner macht sogar einen TANGO Kurs jetzt....--wenn ich ihm das vor 3 Jahren vorgeschlagen hätte...)
bisschen langsam sind sie ja die Analysten....aber besser spät als nie (sagt man sich ja bei den Kids auch immer;meiner macht sogar einen TANGO Kurs jetzt....--wenn ich ihm das vor 3 Jahren vorgeschlagen hätte...)
Antwort auf Beitrag Nr.: 33.896.088 von Poppholz am 16.04.08 11:07:08... mich wundert allerdings, dass der Kurs in den USA nicht stärker gestiegen ist.
Warum ... wir müssen doch noch etwas Luft behalten, wenn im Juni/Juli die AAB-News kommen und der Kurs dann auf 25 Dollar steigen soll.
Warum ... wir müssen doch noch etwas Luft behalten, wenn im Juni/Juli die AAB-News kommen und der Kurs dann auf 25 Dollar steigen soll.
16.04.2008 12:20
Biogen Idec und Elan legen neue TYSABRI(R)-Daten beim 60. Jahrestreffen der American Academy of Neurology vor
Die Partnerunternehmen Biogen Idec (NASDAQ: BIIB) und Elan Corporation, (News) plc (NYSE: ELN) haben heute neue Daten über allgemeinen Gebrauch, Sicherheit und Gesamtexposition von TYSABRI® (Natalizumab) bekannt gegeben. Ende März 2006 befanden sich weltweit rund 26.000 Patienten in kommerziellen und klinischen Therapien, wobei in keinem einzigen Fall seit der Wiederaufnahme der Studie in den USA und dem Beginn der internationalen Studie im Juli 2006 eine progressive multifokale Leukenzephalopathie (PML) erfasst wurde. Die Zunahme der weltweiten Anwendung sowie das wachsende Vertrauen in das günstige Nutzen-Risiko-Profil von TYSABRI bedeuten einen beachtlichen Fortschritt der beiden Unternehmen auf dem Weg zu ihrem selbst gesteckten Ziel von 100.000 behandelten Patienten bis Ende 2010. Diese Daten wurden heute im Rahmen des 60th Annual Meeting of the American Academy of Neurology (AAN) vorgestellt.
"Diese Daten legen den Schluss nahe, dass sich Neurologen und Patienten immer häufiger für eine MS-Behandlung mit TYSABRI entscheiden. Die bedeutenden klinischen Vorteile sind schon jetzt unbestritten. TYSABRI verfügt darüber hinaus über eine potenziell hohe Wirksamkeit und gibt Patienten mit MS neue Hoffnung", so Dr. med. Michael Panzara, Master of Public Health, Vizepräsident und Chief Medical Officer, Geschäftssparte Neurologische Produkte, Biogen Idec.
"Positive Behandlungsresultate deuten weiterhin auf eine hohe Wirksamkeit von TYSABRI als Behandlungsform für Multiple-Sklerose-Patienten in weltweit mehr als 30 Ländern hin. Wir freuen uns außerdem über die Entwicklung, dass sich immer mehr Morbus-Crohn-Patienten für das TOUCH-Programm anmelden und in den USA eine TYSABRI-Behandlung erhalten", erklärte Dr. med. Gordon Francis, geschäftsführender Vizepräsident, Geschäftsbereich Global Clinical Development, Elan.
Folgende Daten lagen uns Ende März 2008 vor:
In den USA wurden rund 15.300 Patienten kommerziell mit TYSABRI behandelt und rund 2.750 Ärzte haben die Behandlung verschrieben
Außerhalb der USA wurden mehr als 10.200 Patienten kommerziell mit TYSABRI behandelt
In globalen klinischen Studien wurden mehr als 600 Patienten mit TYSABRI behandelt
Es wurden keine Fälle von progressiven multifokalen Leukenzephalopathien (PML) seit der Wiederaufnahme der Studie in den USA und dem Beginn der internationalen Studie im Juli 2006 erfasst.
Die kumulativen Daten der kombinierten klinischen Studien und Postmarketing-Studien ergeben:
Mehr als 36.700 wurden mit TYSABRI behandelt
Von diesen Patienten wurden mehr als 9.900 über einen Zeitraum von mindestens einem Jahr mit TYSABRI behandelt, mehr als 3.600 Patienten haben eine TYSABRI-Therapie über einen Zeitraum von mindestens 18 Monaten erhalten.
TYSABRI ist in den USA über das Vertriebsprogramms TOUCH™ erhältlich. Sämtliche TYSABRI verschreibenden Ärzte, Infusionsstellen und TYSABRI-behandelten Patienten in den USA müssen am TOUCH-Programm teilnehmen. Daten über die Produktsicherheit werden zusätzlich in den fortgeführten klinischen Studien und Registern erhoben, darunter TYGRIS und das Schwangerschaftsregister. Damit erhält TYSABRI die umfangreichste Folgestudie unter allen existierenden MS-Therapien.
Eine Kurzfassung dieser Studie unter dem Titel "Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH™ and TYGRIS" (Presentation #S02.002), ist online auf der AAN-Website erhältlich.
TYSABRI erhöht den Anteil der erkrankungsfreien MS-Patienten
Beim Jahrestreffen berichteten Biogen Idec und Elan außerdem heute, dass die TYSABRI-Behandlung den Anteil der Multiple-Sklerose-Patienten, die als erkrankungsfrei eingestuft werden, einer Post-hoc-Analyse der klinischen Studien AFFIRM und SENTINEL zufolge erheblich vergrößert hat. Der Anteil der erkrankungsfreien Patienten der Studien wurde auf der Basis von klinischen und kernspintomographischen Kriterien bestimmt. Der Anteil der über einen Zeitraum von zwei Jahren erkrankungsfreien Patienten war in der TYSABRI-Gruppe deutlich höher als in der Placebogruppe, unabhängig von der Definition des erkrankungsfreien Zustands.
Unter klinischen Aspekten wurde "erkrankungsfrei" als Nichtauftreten von Rückfällen und als Nichtfortentwicklung des Behinderungsgrads nach der EDSS-Skala (definiert als Erhöhung von ≥1,0-Punkten bei einer Basislinie von ≥1,0 und als Erhöhung von ≥1,5-Punkte bei einer Basislinie von 0,0 Punkten über den Zeitraum von 12 Wochen) über einen Zeitraum von zwei Jahren definiert. "Erkrankungsfrei" nach kernspintomographischen Kriterien war ein Patient, wenn bei ihm zwei Jahre lang auf einmal jährlich durchgeführten Kernspintomographien weder Gadolinium anreichernde noch neue oder vergrößerte T2-hyperintense Läsionen festgestellt wurden.
"Das übergeordnete Ziel einer Behandlung von MS besteht darin, den Patienten so lange wie möglich frei von Symptomen zu halten. Diese Daten belegen, dass durch Natalizumab genau dies erreicht werden kann: Bei etwa einem Drittel der Patienten wurden keine Rückfälle, kein Fortschreiten der Behinderung und keine neuen CT-Marker festgestellt. Mit Natalizumab lässt sich demnach ein wahrhaft dramatischer Erfolg für eine große Gruppe von Patienten erzielen", erklärte der Chefautor der Studie, Dr. med. Steven Galetta, Professor der Neurologie an der University of Pennsylvania School of Medicine.
In der AFFIRM-Studie wurde den teilnehmenden Patienten TYSABRI oder Placebo randomisiert verabreicht, während die Patienten der SENTINEL-Studie ebenfalls randomisiert TYSABRI plus Interferon Beta-1a oder Placebo plus Interferon Beta-1a erhielten. Über einen Zeitraum von zwei Jahren wurden die Patienten anhand von klinischen Kriterien, MRT-Kriterien sowie einer Kombination beider Kriteriengruppen eingestuft. In beiden Studien konnte eine erhebliche Zunahme des Anteils der erkrankungsfreien Patienten durch die TYSABRI-Behandlung nachgewiesen werden. Bei Anwendung einer Kombination von klinischen und kernspintomographischen Kriterien für die Einstufung als "erkrankungsfrei", traf die strikte Auslegung des erkrankungsfreien Zustands auf 36,7 Prozent (AFFIRM-Studie) bzw. 31,7 Prozent (SENTINEL-Studie) der Patienten zu. In der Placebogruppe trafen dieselben Kriterien auf 7,2 Prozent (AFFIRM-Studie) bzw. 10,9 Prozent (SENTINEL-Studie) zu. Der medizinische Nutzen von TYSABRI wurde ebenfalls bei jeweils ausschließlicher Anwendung der klinischen Kriterien (AFFIRM: 64,3% gegenüber 38,9% “” SENTINEL: 47,4% gegenüber 28,0%) und der MRT-Kriterien (AFFIRM: 57,7% gegenüber 14,2% “” SENTINEL: 65,5% gegenüber 27,6%) für "erkrankungsfrei" deutlich. Beide Studien ergaben ähnliche Resultate für Patienten mit hochaktiver und nicht hochaktiver Multipler Sklerose.
Eine Kurzfassung dieser Studie unter dem Titel "Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis" (Poster #P02.156), ist online auf der AAN-Website erhältlich.
Über TOUCH™ und TYGRIS
Vor Behandlungsbeginn müssen sich alle US-amerikanischen Patienten, verschreibende Ärzte und Infusionsstellen in das TOUCH-Vertriebsprogramm (TYSABRI Outreach: Unified Commitment to Health) einschreiben. Das TOUCH-Programm wurde mit dem Ziel entwickelt, die Häufigkeit und die vorhandenen Risikofaktoren von opportunistischen Infektionen (OI) wie PML zu bestimmen und das Auftreten von PML-Anzeichen und -Symptomen an Patienten zu überwachen. Auf diese Weise sollen möglichst viele Daten für die Nutzen-Risiko-Abwägung vor Beginn der TYSABRI-Therapie erfasst werden. Ärzte berichten kontinuierlich über Fälle von PML und sonstigen OI, Todesfälle und Behandlungsabbrüche.
Für TYGRIS (TYSABRI Global ObseRvation Program In Safety) wird die Teilnahme von weltweit 5.000 Patienten erwartet, einschließlich 2.000 bis 2.500 Teilnehmer des TOUCH-Programms. Die Patienten des TYGRIS-Programms werden vor Behandlungsbeginn und danach über den Zeitraum von fünf Jahren alle sechs Monate untersucht. Die Forscher werden Daten wie die medizinische Vorgeschichte des Patienten, frühere TYSABRI-Behandlungen, frühere Verabreichung von Immunmodulatoren, Antineoplastika, immunsupressive Medikamente sowie sämtliche ernsten Nebenwirkungen wie PML sowie andere schweren opportunistischen Infektionen und Malignome auswerten.
In der Postmarketing-Studie sind Angaben über unerwünschte Vorfälle freiwillig. Unvollständige oder verspätete Angaben über unerwünschte Vorfälle gegenüber Biogen Idec oder Elan sind möglich.
Über TYSABRI
TYSABRI ist ein Arzneimittel, das in den USA für rezidivierende Formen von MS und in der EU für rezidivierende-remittierende MS zugelassen ist. Nach Angaben, die im New England Journal of Medicine veröffentlicht wurden, führte die Therapie mit TYSABRI nach zwei Jahren zu einer 68-prozentigen relativen Verringerung (p<0,001) der auf ein Jahr umgerechneten Schubrate, verglichen mit einem Placebo, und das relative Risiko der Behinderungsprogression reduzierte sich um 42-54 Prozent (p<0,001).
TYSABRI wurde kürzlich zur Induzierung und Erhaltung eines klinischen Ansprechens und einer klinischen Remission bei erwachsenen Patienten mit mäßig bis schwer aktivem Morbus Crohn (MC) zugelassen, bei denen Anzeichen für eine Entzündung vorliegen und die auf herkömmliche MC-Therapien und TNF-alpha-Hemmer nicht genügend ansprachen bzw. diese nicht vertragen.
TYSABRI erhöht das Risiko einer progressiven, multifokalen Leukenzephalopathie (PML), einer opportunistischen Virusinfektion des Gehirns, die im Allgemeinen zum Tod oder zu schweren Behinderungen führt. Zu den wesentlichen Nebenwirkungen, die bei Patienten im Verlauf der TYSABRI-Therapie beobachtet wurden, zählen hypersensible Reaktionen (z.B. Anaphylaxie) und Infektionen. Schwere opportunistische und andere atypische Infektionen wurden bei TYSABRI-behandelten Patienten beobachtet, wobei einigen von ihnen gleichzeitig Immunsuppressiva verabreicht wurden. Herpes-Infektionen traten geringfügig häufiger bei Patienten auf, die mit TYSABRI behandelt wurden. In klinischen MS- und Morbus-Crohn-Studien waren Auftreten und Häufigkeit anderer ernster Vorfällen (einschließlich ernsten Infektionen) zwischen der TYSABRI- und der Placebogruppe ausgeglichen. Zu den häufigen unerwünschten Nebenwirkungen, die bei TYSABRI-behandelten MS-Patienten auftraten, gehörten Kopfschmerzen, Erschöpfung, Infusionsreaktionen, Harnwegsinfektionen, Gelenk- und Gliederschmerzen und Hautausschläge. Andere häufige unerwünschte Vorfälle, die bei mit TYSABRI behandelten Morbus-Crohn-Patienten auftraten, waren Atemwegsinfektionen und Übelkeit. In der Postmarketing-Studie wurden bei mit TYSABRI behandelten Patienten klinisch bedeutende Leberschäden beobachtet.
TYSABRI ist in mehr als 30 Ländern zugelassen, beispielsweise in den USA und in vielen Ländern der EU sowie in der Schweiz, in Kanada, Australien, Neuseeland und Israel.
Nähere Informationen über TYSABRI sind im Internet auf www.tysabri.com, www.biogenidec.com oder www.elan.com erhältlich sowie telefonisch unter +1 800 456-2255 .
Über Biogen Idec
Biogen Idec setzt in Bereichen mit erheblichen medizinischen Versorgungslücken neue Maßstäbe. Das 1978 gegründete Unternehmen ist bei der Erforschung, Entwicklung, Herstellung und Vermarktung innovativer Therapien weltweit führend. In mehr als 90 Ländern profitieren Patienten von den wirksamen Biogen-Idec- (News) Produkten zur Behandlung von Lymphknotenerkrankungen, multipler Sklerose und rheumatoider Arthritis. Produktinformationen, Pressemitteilungen und weitergehende Informationen über das Unternehmen finden Sie im Internet auf www.biogenidec.com.
Über Elan
Die Elan Corporation, plc ist ein Biotechnologie-Unternehmen mit neurowissenschaftlicher Ausrichtung und strebt danach, das Leben der Patienten und ihrer Familien zu verbessern. Das Unternehmen setzt sich dafür ein, wissenschaftliche Innovationen für ernste, nicht gelöste medizinische Probleme nutzbar zu machen, die nach wie vor weltweit anzutreffen sind. Die Aktien von Elan werden an den Börsen in New York, London und Dublin gehandelt. Weitere Informationen über das Unternehmen erhalten Sie unterwww.elan.com.
Safe-Harbor-Erklärung über zukunftsbezogene Aussagen
Diese Presseinformation enthält zukunftsbezogene Aussagen über TYSABRI. Diese Aussagen beruhen auf gegenwärtigen Annahmen und Erwartungen der Unternehmen. Das Marktpotenzial von TYSABRI unterliegt verschiedener Risiken und Unwägbarkeiten. Zu den Faktoren, die wesentliche Abweichungen der tatsächlichen Ergebnisse von den gegenwärtigen Erwartungen der Unternehmen bewirken können, zählt das Risiko, dass wir nicht angemessen auf Bedenken oder Anfragen der US-amerikanischen Arzneimittelbehörde FDA oder anderer Regulierungsbehörden reagieren können, dass zusätzlich erhobene Daten neue Bedenken aufwerfen, dass das Auftreten und/oder das Risiko von PML oder anderen opportunistischen Infektionen bei mit TYSABRI behandelten Patienten höher als in klinischen Studien beobachtet ausfällt, dass die Unternehmen auf andere unerwartete Hindernisse stoßen oder dass neue, wirksamere oder sicherere Therapieformen für MS oder angenehmere Verabreichungsformen auf den Markt gebracht werden. Die Entwicklung und Vermarktung von Arzneimitteln ist mit hohen Risiken verbunden.
Nähere Informationen über Risiken und Unwägbarkeiten, die mit den Aktivitäten der Unternehmen in der Arzneimittelentwicklung und anderen Bereichen verbunden sind, finden Sie in den periodisch verfassten und aktuellen Berichten, die Biogen Idec und Elan bei der US-amerikanischen Börsenaufsicht SEC eingereicht haben. Die Unternehmen verpflichten sich in keiner Weise zur öffentlichen Aktualisierung zukunftsbezogener Aussagen aufgrund von neuen Informationen, zukünftigen Ereignissen oder sonstigen Umständen.
Wichtige Informationen über Biogen Idec
Biogen Idec und ihre Vorstandsmitglieder, Mitglieder der Geschäftsführung sowie andere Manager und Mitarbeiter können an der Aufforderung zur Stimmabgabe an die Aktionäre der Biogen Idec im Zusammenhang mit der Jahreshauptversammlung 2008 des Unternehmens beteiligt sein. Jede im Vorfeld der Jahreshauptversammlung 2008 durch die Biogen Idec eingereichte Aktionärsinformation ("proxy statement") wird Angaben über die Interessen der Beteiligten enthalten. Die Biogen Idec wird außerdem die periodischen Jahres- und Quartalsberichte sowie Sonderberichte bei der US-Börsenaufsichtsbehörde SEC hinterlegen. Herausgegebene Aktionärsinformationen und sonstige Berichte stehen kostenlos auf der SEC-Website www.sec.gov und auf der Website der Biogen Idec, www.biogenidec.com, zur Verfügung. Wir empfehlen unseren Aktionären, vor einer Stimmabgabe oder Investitionsentscheidung die im Zusammenhang mit der Jahreshauptversammlung 2008 veröffentlichten Aktionärsinformationen aufmerksam zu lesen. Die Aktionärsinformationen können kostenlos per Post über die Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142 bezogen werden. Kopien der Aktionärsinformationen können außerdem über unseren Proxy-Solicitor Innisfree M&A Incorporated über die gebührenfreie Rufnummer (877) 750-5836 oder die Emailadresse info@innisfreema.com angefordert werden.
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Biogen Idec und Elan legen neue TYSABRI(R)-Daten beim 60. Jahrestreffen der American Academy of Neurology vor
Die Partnerunternehmen Biogen Idec (NASDAQ: BIIB) und Elan Corporation, (News) plc (NYSE: ELN) haben heute neue Daten über allgemeinen Gebrauch, Sicherheit und Gesamtexposition von TYSABRI® (Natalizumab) bekannt gegeben. Ende März 2006 befanden sich weltweit rund 26.000 Patienten in kommerziellen und klinischen Therapien, wobei in keinem einzigen Fall seit der Wiederaufnahme der Studie in den USA und dem Beginn der internationalen Studie im Juli 2006 eine progressive multifokale Leukenzephalopathie (PML) erfasst wurde. Die Zunahme der weltweiten Anwendung sowie das wachsende Vertrauen in das günstige Nutzen-Risiko-Profil von TYSABRI bedeuten einen beachtlichen Fortschritt der beiden Unternehmen auf dem Weg zu ihrem selbst gesteckten Ziel von 100.000 behandelten Patienten bis Ende 2010. Diese Daten wurden heute im Rahmen des 60th Annual Meeting of the American Academy of Neurology (AAN) vorgestellt.
"Diese Daten legen den Schluss nahe, dass sich Neurologen und Patienten immer häufiger für eine MS-Behandlung mit TYSABRI entscheiden. Die bedeutenden klinischen Vorteile sind schon jetzt unbestritten. TYSABRI verfügt darüber hinaus über eine potenziell hohe Wirksamkeit und gibt Patienten mit MS neue Hoffnung", so Dr. med. Michael Panzara, Master of Public Health, Vizepräsident und Chief Medical Officer, Geschäftssparte Neurologische Produkte, Biogen Idec.
"Positive Behandlungsresultate deuten weiterhin auf eine hohe Wirksamkeit von TYSABRI als Behandlungsform für Multiple-Sklerose-Patienten in weltweit mehr als 30 Ländern hin. Wir freuen uns außerdem über die Entwicklung, dass sich immer mehr Morbus-Crohn-Patienten für das TOUCH-Programm anmelden und in den USA eine TYSABRI-Behandlung erhalten", erklärte Dr. med. Gordon Francis, geschäftsführender Vizepräsident, Geschäftsbereich Global Clinical Development, Elan.
Folgende Daten lagen uns Ende März 2008 vor:
In den USA wurden rund 15.300 Patienten kommerziell mit TYSABRI behandelt und rund 2.750 Ärzte haben die Behandlung verschrieben
Außerhalb der USA wurden mehr als 10.200 Patienten kommerziell mit TYSABRI behandelt
In globalen klinischen Studien wurden mehr als 600 Patienten mit TYSABRI behandelt
Es wurden keine Fälle von progressiven multifokalen Leukenzephalopathien (PML) seit der Wiederaufnahme der Studie in den USA und dem Beginn der internationalen Studie im Juli 2006 erfasst.
Die kumulativen Daten der kombinierten klinischen Studien und Postmarketing-Studien ergeben:
Mehr als 36.700 wurden mit TYSABRI behandelt
Von diesen Patienten wurden mehr als 9.900 über einen Zeitraum von mindestens einem Jahr mit TYSABRI behandelt, mehr als 3.600 Patienten haben eine TYSABRI-Therapie über einen Zeitraum von mindestens 18 Monaten erhalten.
TYSABRI ist in den USA über das Vertriebsprogramms TOUCH™ erhältlich. Sämtliche TYSABRI verschreibenden Ärzte, Infusionsstellen und TYSABRI-behandelten Patienten in den USA müssen am TOUCH-Programm teilnehmen. Daten über die Produktsicherheit werden zusätzlich in den fortgeführten klinischen Studien und Registern erhoben, darunter TYGRIS und das Schwangerschaftsregister. Damit erhält TYSABRI die umfangreichste Folgestudie unter allen existierenden MS-Therapien.
Eine Kurzfassung dieser Studie unter dem Titel "Natalizumab Utilization and Safety in Patients with Relapsing Multiple Sclerosis: Updated Results from TOUCH™ and TYGRIS" (Presentation #S02.002), ist online auf der AAN-Website erhältlich.
TYSABRI erhöht den Anteil der erkrankungsfreien MS-Patienten
Beim Jahrestreffen berichteten Biogen Idec und Elan außerdem heute, dass die TYSABRI-Behandlung den Anteil der Multiple-Sklerose-Patienten, die als erkrankungsfrei eingestuft werden, einer Post-hoc-Analyse der klinischen Studien AFFIRM und SENTINEL zufolge erheblich vergrößert hat. Der Anteil der erkrankungsfreien Patienten der Studien wurde auf der Basis von klinischen und kernspintomographischen Kriterien bestimmt. Der Anteil der über einen Zeitraum von zwei Jahren erkrankungsfreien Patienten war in der TYSABRI-Gruppe deutlich höher als in der Placebogruppe, unabhängig von der Definition des erkrankungsfreien Zustands.
Unter klinischen Aspekten wurde "erkrankungsfrei" als Nichtauftreten von Rückfällen und als Nichtfortentwicklung des Behinderungsgrads nach der EDSS-Skala (definiert als Erhöhung von ≥1,0-Punkten bei einer Basislinie von ≥1,0 und als Erhöhung von ≥1,5-Punkte bei einer Basislinie von 0,0 Punkten über den Zeitraum von 12 Wochen) über einen Zeitraum von zwei Jahren definiert. "Erkrankungsfrei" nach kernspintomographischen Kriterien war ein Patient, wenn bei ihm zwei Jahre lang auf einmal jährlich durchgeführten Kernspintomographien weder Gadolinium anreichernde noch neue oder vergrößerte T2-hyperintense Läsionen festgestellt wurden.
"Das übergeordnete Ziel einer Behandlung von MS besteht darin, den Patienten so lange wie möglich frei von Symptomen zu halten. Diese Daten belegen, dass durch Natalizumab genau dies erreicht werden kann: Bei etwa einem Drittel der Patienten wurden keine Rückfälle, kein Fortschreiten der Behinderung und keine neuen CT-Marker festgestellt. Mit Natalizumab lässt sich demnach ein wahrhaft dramatischer Erfolg für eine große Gruppe von Patienten erzielen", erklärte der Chefautor der Studie, Dr. med. Steven Galetta, Professor der Neurologie an der University of Pennsylvania School of Medicine.
In der AFFIRM-Studie wurde den teilnehmenden Patienten TYSABRI oder Placebo randomisiert verabreicht, während die Patienten der SENTINEL-Studie ebenfalls randomisiert TYSABRI plus Interferon Beta-1a oder Placebo plus Interferon Beta-1a erhielten. Über einen Zeitraum von zwei Jahren wurden die Patienten anhand von klinischen Kriterien, MRT-Kriterien sowie einer Kombination beider Kriteriengruppen eingestuft. In beiden Studien konnte eine erhebliche Zunahme des Anteils der erkrankungsfreien Patienten durch die TYSABRI-Behandlung nachgewiesen werden. Bei Anwendung einer Kombination von klinischen und kernspintomographischen Kriterien für die Einstufung als "erkrankungsfrei", traf die strikte Auslegung des erkrankungsfreien Zustands auf 36,7 Prozent (AFFIRM-Studie) bzw. 31,7 Prozent (SENTINEL-Studie) der Patienten zu. In der Placebogruppe trafen dieselben Kriterien auf 7,2 Prozent (AFFIRM-Studie) bzw. 10,9 Prozent (SENTINEL-Studie) zu. Der medizinische Nutzen von TYSABRI wurde ebenfalls bei jeweils ausschließlicher Anwendung der klinischen Kriterien (AFFIRM: 64,3% gegenüber 38,9% “” SENTINEL: 47,4% gegenüber 28,0%) und der MRT-Kriterien (AFFIRM: 57,7% gegenüber 14,2% “” SENTINEL: 65,5% gegenüber 27,6%) für "erkrankungsfrei" deutlich. Beide Studien ergaben ähnliche Resultate für Patienten mit hochaktiver und nicht hochaktiver Multipler Sklerose.
Eine Kurzfassung dieser Studie unter dem Titel "Natalizumab Increases the Proportion of Patients Free of Clinical or MRI Disease Activity in Relapsing Multiple Sclerosis" (Poster #P02.156), ist online auf der AAN-Website erhältlich.
Über TOUCH™ und TYGRIS
Vor Behandlungsbeginn müssen sich alle US-amerikanischen Patienten, verschreibende Ärzte und Infusionsstellen in das TOUCH-Vertriebsprogramm (TYSABRI Outreach: Unified Commitment to Health) einschreiben. Das TOUCH-Programm wurde mit dem Ziel entwickelt, die Häufigkeit und die vorhandenen Risikofaktoren von opportunistischen Infektionen (OI) wie PML zu bestimmen und das Auftreten von PML-Anzeichen und -Symptomen an Patienten zu überwachen. Auf diese Weise sollen möglichst viele Daten für die Nutzen-Risiko-Abwägung vor Beginn der TYSABRI-Therapie erfasst werden. Ärzte berichten kontinuierlich über Fälle von PML und sonstigen OI, Todesfälle und Behandlungsabbrüche.
Für TYGRIS (TYSABRI Global ObseRvation Program In Safety) wird die Teilnahme von weltweit 5.000 Patienten erwartet, einschließlich 2.000 bis 2.500 Teilnehmer des TOUCH-Programms. Die Patienten des TYGRIS-Programms werden vor Behandlungsbeginn und danach über den Zeitraum von fünf Jahren alle sechs Monate untersucht. Die Forscher werden Daten wie die medizinische Vorgeschichte des Patienten, frühere TYSABRI-Behandlungen, frühere Verabreichung von Immunmodulatoren, Antineoplastika, immunsupressive Medikamente sowie sämtliche ernsten Nebenwirkungen wie PML sowie andere schweren opportunistischen Infektionen und Malignome auswerten.
In der Postmarketing-Studie sind Angaben über unerwünschte Vorfälle freiwillig. Unvollständige oder verspätete Angaben über unerwünschte Vorfälle gegenüber Biogen Idec oder Elan sind möglich.
Über TYSABRI
TYSABRI ist ein Arzneimittel, das in den USA für rezidivierende Formen von MS und in der EU für rezidivierende-remittierende MS zugelassen ist. Nach Angaben, die im New England Journal of Medicine veröffentlicht wurden, führte die Therapie mit TYSABRI nach zwei Jahren zu einer 68-prozentigen relativen Verringerung (p<0,001) der auf ein Jahr umgerechneten Schubrate, verglichen mit einem Placebo, und das relative Risiko der Behinderungsprogression reduzierte sich um 42-54 Prozent (p<0,001).
TYSABRI wurde kürzlich zur Induzierung und Erhaltung eines klinischen Ansprechens und einer klinischen Remission bei erwachsenen Patienten mit mäßig bis schwer aktivem Morbus Crohn (MC) zugelassen, bei denen Anzeichen für eine Entzündung vorliegen und die auf herkömmliche MC-Therapien und TNF-alpha-Hemmer nicht genügend ansprachen bzw. diese nicht vertragen.
TYSABRI erhöht das Risiko einer progressiven, multifokalen Leukenzephalopathie (PML), einer opportunistischen Virusinfektion des Gehirns, die im Allgemeinen zum Tod oder zu schweren Behinderungen führt. Zu den wesentlichen Nebenwirkungen, die bei Patienten im Verlauf der TYSABRI-Therapie beobachtet wurden, zählen hypersensible Reaktionen (z.B. Anaphylaxie) und Infektionen. Schwere opportunistische und andere atypische Infektionen wurden bei TYSABRI-behandelten Patienten beobachtet, wobei einigen von ihnen gleichzeitig Immunsuppressiva verabreicht wurden. Herpes-Infektionen traten geringfügig häufiger bei Patienten auf, die mit TYSABRI behandelt wurden. In klinischen MS- und Morbus-Crohn-Studien waren Auftreten und Häufigkeit anderer ernster Vorfällen (einschließlich ernsten Infektionen) zwischen der TYSABRI- und der Placebogruppe ausgeglichen. Zu den häufigen unerwünschten Nebenwirkungen, die bei TYSABRI-behandelten MS-Patienten auftraten, gehörten Kopfschmerzen, Erschöpfung, Infusionsreaktionen, Harnwegsinfektionen, Gelenk- und Gliederschmerzen und Hautausschläge. Andere häufige unerwünschte Vorfälle, die bei mit TYSABRI behandelten Morbus-Crohn-Patienten auftraten, waren Atemwegsinfektionen und Übelkeit. In der Postmarketing-Studie wurden bei mit TYSABRI behandelten Patienten klinisch bedeutende Leberschäden beobachtet.
TYSABRI ist in mehr als 30 Ländern zugelassen, beispielsweise in den USA und in vielen Ländern der EU sowie in der Schweiz, in Kanada, Australien, Neuseeland und Israel.
Nähere Informationen über TYSABRI sind im Internet auf www.tysabri.com, www.biogenidec.com oder www.elan.com erhältlich sowie telefonisch unter +1 800 456-2255 .
Über Biogen Idec
Biogen Idec setzt in Bereichen mit erheblichen medizinischen Versorgungslücken neue Maßstäbe. Das 1978 gegründete Unternehmen ist bei der Erforschung, Entwicklung, Herstellung und Vermarktung innovativer Therapien weltweit führend. In mehr als 90 Ländern profitieren Patienten von den wirksamen Biogen-Idec- (News) Produkten zur Behandlung von Lymphknotenerkrankungen, multipler Sklerose und rheumatoider Arthritis. Produktinformationen, Pressemitteilungen und weitergehende Informationen über das Unternehmen finden Sie im Internet auf www.biogenidec.com.
Über Elan
Die Elan Corporation, plc ist ein Biotechnologie-Unternehmen mit neurowissenschaftlicher Ausrichtung und strebt danach, das Leben der Patienten und ihrer Familien zu verbessern. Das Unternehmen setzt sich dafür ein, wissenschaftliche Innovationen für ernste, nicht gelöste medizinische Probleme nutzbar zu machen, die nach wie vor weltweit anzutreffen sind. Die Aktien von Elan werden an den Börsen in New York, London und Dublin gehandelt. Weitere Informationen über das Unternehmen erhalten Sie unterwww.elan.com.
Safe-Harbor-Erklärung über zukunftsbezogene Aussagen
Diese Presseinformation enthält zukunftsbezogene Aussagen über TYSABRI. Diese Aussagen beruhen auf gegenwärtigen Annahmen und Erwartungen der Unternehmen. Das Marktpotenzial von TYSABRI unterliegt verschiedener Risiken und Unwägbarkeiten. Zu den Faktoren, die wesentliche Abweichungen der tatsächlichen Ergebnisse von den gegenwärtigen Erwartungen der Unternehmen bewirken können, zählt das Risiko, dass wir nicht angemessen auf Bedenken oder Anfragen der US-amerikanischen Arzneimittelbehörde FDA oder anderer Regulierungsbehörden reagieren können, dass zusätzlich erhobene Daten neue Bedenken aufwerfen, dass das Auftreten und/oder das Risiko von PML oder anderen opportunistischen Infektionen bei mit TYSABRI behandelten Patienten höher als in klinischen Studien beobachtet ausfällt, dass die Unternehmen auf andere unerwartete Hindernisse stoßen oder dass neue, wirksamere oder sicherere Therapieformen für MS oder angenehmere Verabreichungsformen auf den Markt gebracht werden. Die Entwicklung und Vermarktung von Arzneimitteln ist mit hohen Risiken verbunden.
Nähere Informationen über Risiken und Unwägbarkeiten, die mit den Aktivitäten der Unternehmen in der Arzneimittelentwicklung und anderen Bereichen verbunden sind, finden Sie in den periodisch verfassten und aktuellen Berichten, die Biogen Idec und Elan bei der US-amerikanischen Börsenaufsicht SEC eingereicht haben. Die Unternehmen verpflichten sich in keiner Weise zur öffentlichen Aktualisierung zukunftsbezogener Aussagen aufgrund von neuen Informationen, zukünftigen Ereignissen oder sonstigen Umständen.
Wichtige Informationen über Biogen Idec
Biogen Idec und ihre Vorstandsmitglieder, Mitglieder der Geschäftsführung sowie andere Manager und Mitarbeiter können an der Aufforderung zur Stimmabgabe an die Aktionäre der Biogen Idec im Zusammenhang mit der Jahreshauptversammlung 2008 des Unternehmens beteiligt sein. Jede im Vorfeld der Jahreshauptversammlung 2008 durch die Biogen Idec eingereichte Aktionärsinformation ("proxy statement") wird Angaben über die Interessen der Beteiligten enthalten. Die Biogen Idec wird außerdem die periodischen Jahres- und Quartalsberichte sowie Sonderberichte bei der US-Börsenaufsichtsbehörde SEC hinterlegen. Herausgegebene Aktionärsinformationen und sonstige Berichte stehen kostenlos auf der SEC-Website www.sec.gov und auf der Website der Biogen Idec, www.biogenidec.com, zur Verfügung. Wir empfehlen unseren Aktionären, vor einer Stimmabgabe oder Investitionsentscheidung die im Zusammenhang mit der Jahreshauptversammlung 2008 veröffentlichten Aktionärsinformationen aufmerksam zu lesen. Die Aktionärsinformationen können kostenlos per Post über die Biogen Idec Inc., 14 Cambridge Center, Cambridge, MA 02142 bezogen werden. Kopien der Aktionärsinformationen können außerdem über unseren Proxy-Solicitor Innisfree M&A Incorporated über die gebührenfreie Rufnummer (877) 750-5836 oder die Emailadresse info@innisfreema.com angefordert werden.
Die Ausgangssprache, in der der Originaltext veröffentlicht wird, ist die offizielle und autorisierte Version. Übersetzungen werden zur besseren Verständigung mitgeliefert. Nur die Sprachversion, die im Original veröffentlicht wurde, ist rechtsgültig. Gleichen Sie deshalb Übersetzungen mit der originalen Sprachversion der Veröffentlichung ab.
http://www.finanznachrichten.de/nachrichten-2008-04/artikel-…
Financial Times Deutschland
Dax & Stoxx am Vormittag: Intel-Zahlen stärken Infineon von Sven Lilienthal (Frankfurt)
Mittwoch 16. April 2008, 10:52 Uhr
Der Dax gewann 1,1 % auf 6653 Punkte. Auch europaweit legten die Indizes zu: Der Stoxx 50, Frankreichs CAC 40 und der Londoner FTSE 100 legten 0,7 bis 1 % zu.
Trotz der kurzfrisitg einsetzenen Euphorie erwarten Börsianer einen zurückhaltenden Handel mit geringen Umsätzen. Viele Investoren warten die Veröffentlichung weiterer Unternehmenszahlen und Konjunkturdaten aus den USA im Handelsverlauf ab. So werden um 14.30 Uhr MESZ US-Verbraucherpreise veröffentlicht.
Dank unerwartet guter Quartalszahlen des Chipherstellers Intel am Dienstagabend legten auch die Branchenmitstreiter in Europa zu. Im Dax glänzte beispielsweise Infineon(Xetra: 623100 - Nachrichten) mit einem satten Plus von 7 %. Auch Finanzkonzerne kletterten auf die ersten Plätze: Hypo Real Estate (Xetra: 802770 - Nachrichten) und Commerzbank (Xetra: 803200 - Nachrichten) verteuerten sich um 2,5 und 2,2 %. Deutsche-Bank-Aktien rückten 1,5 % vor. 29 der 30 Dax (Xetra: Nachrichten) -Unternehmen verzeichneten Aufschläge.
Nokia (Xetra: "http://de.finance.yahoo.com/q?s=NOA3.DE">870737 - Nachrichten) gesucht, France Telecom verliert=
Auch in Europas Stoxx 50 war die Gewinnerliste lang: Nokia-Aktien stiegen um 3,2 %, gefolgt von den britisch-australischen Bergbaukonzernen Anglo American und BHP Billiton (London: BLT.L - Nachrichten) , die 1,8 und 1,6 % vorrückten. Auch Nokias Konkurrent Ericsson stieg mit plus 1,5 % signifikant.
Noch stärkerer Aufmerksamkeit erfreuten sich die britischen Bankwerte: HBOS (London: HBOS.L - Nachrichten) und Barclays (London: BARC.L - Nachrichten) verbesserten sich um 3,5 und 3,0 %. Royal Bank of Scotland erklomm mit 3,8 % die Spitzenposition. Laut einem Bericht der Financial Times ist die Bank of England kurz vor Veröffentlichung von Bedingungen für gezielte Stützungsmaßnahmen für Finanzkonzerne an den Finanzmärkten.
Auf der Gegenseite trübte France Telecom mit einem Verlust von 3,4 % die Stimmung der Investoren. Das Unternehmen will einem Zeitungsbericht zufolge den schwedischen Telekommunikationskonzern TeliaSonera übernehmen. TeliaSonera (Stockholm: TLSN.ST - Nachrichten) -Aktien gewannen in Stockholm 6,3 %.
Außerhalb des Stoxx 50 gaben vor allem Unternehmen mit neuesten Quartalszahlen den Takt an. So verteuerten sich die Papiere des französischen Luxus-Herstellers LVMH um 4,4 %, nachdem der Konzern seinen Umsatz auf 4 Mrd. Euro steigern konnte. Analysten hatten mit 3,87 Mrd. Euro gerechnet. Noch stärker zogen die Aktien des irischen Pharmaunternehmens Elan an, die sich mit plus 7 % an die Spitze des marktbreiten Stoxx 600 setzten. Elan (Dublin: DRX.IR - Nachrichten) hatte seine Geschäftsziele für das laufende Jahr bekräftigt.
Der weltgrößte Kosmetikkonzern L'Oreal (Paris: FR0000120321 - Nachrichten) sackte dagegen um mehr als 6 % ab: Das Unternehmen hatte mit Umsatzzahlen enttäuscht. Hier senkte zudem die Schweizer Bank UBS ihre Einschätzung für die Papiere von "Kaufen" auf "Neutral".
Asiens Börsen schließen im Plus
Zuvor hatten die asiatischen Börsen nach den guten Intel (NASDAQ: INTC - Nachrichten) -Quartalszahlen im Plus geschlossen. In Tokio schloss der Nikkei (Nachrichten) 1,2 Prozent höher bei 13.146 Punkten. Der breiter gefasste Topix gewann 1,3 Prozent auf 1271 Zähler. Vor allem exportorientierte Aktien aus der Elektronikindustrie standen auf den Kauflisten der Börsianer exportorientierte Hochtechnologiewerte. So legte der Sony (München: 853687 - Nachrichten) -Kurs um 3,5 Prozent zu. Canon (Berlin: CNN1.BE - Nachrichten) -Aktien verteuerten sich um 2,6 Prozent, Tokyo-Electron-Papiere verteuerten sich um über fünf Prozent.
Auch die Börsen in Singapur, Südkorea, Hongkong und Taiwan legten zu. Am Vorabend hatte in New York alle drei Leitindizes den Handel mit einem Aufschlag von 0,5 Prozent beendet.
http://de.biz.yahoo.com/16042008/345/dax-amp-amp-stoxx-vormi…
Dax & Stoxx am Vormittag: Intel-Zahlen stärken Infineon von Sven Lilienthal (Frankfurt)
Mittwoch 16. April 2008, 10:52 Uhr
Der Dax gewann 1,1 % auf 6653 Punkte. Auch europaweit legten die Indizes zu: Der Stoxx 50, Frankreichs CAC 40 und der Londoner FTSE 100 legten 0,7 bis 1 % zu.
Trotz der kurzfrisitg einsetzenen Euphorie erwarten Börsianer einen zurückhaltenden Handel mit geringen Umsätzen. Viele Investoren warten die Veröffentlichung weiterer Unternehmenszahlen und Konjunkturdaten aus den USA im Handelsverlauf ab. So werden um 14.30 Uhr MESZ US-Verbraucherpreise veröffentlicht.
Dank unerwartet guter Quartalszahlen des Chipherstellers Intel am Dienstagabend legten auch die Branchenmitstreiter in Europa zu. Im Dax glänzte beispielsweise Infineon(Xetra: 623100 - Nachrichten) mit einem satten Plus von 7 %. Auch Finanzkonzerne kletterten auf die ersten Plätze: Hypo Real Estate (Xetra: 802770 - Nachrichten) und Commerzbank (Xetra: 803200 - Nachrichten) verteuerten sich um 2,5 und 2,2 %. Deutsche-Bank-Aktien rückten 1,5 % vor. 29 der 30 Dax (Xetra: Nachrichten) -Unternehmen verzeichneten Aufschläge.
Nokia (Xetra: "http://de.finance.yahoo.com/q?s=NOA3.DE">870737 - Nachrichten) gesucht, France Telecom verliert=
Auch in Europas Stoxx 50 war die Gewinnerliste lang: Nokia-Aktien stiegen um 3,2 %, gefolgt von den britisch-australischen Bergbaukonzernen Anglo American und BHP Billiton (London: BLT.L - Nachrichten) , die 1,8 und 1,6 % vorrückten. Auch Nokias Konkurrent Ericsson stieg mit plus 1,5 % signifikant.
Noch stärkerer Aufmerksamkeit erfreuten sich die britischen Bankwerte: HBOS (London: HBOS.L - Nachrichten) und Barclays (London: BARC.L - Nachrichten) verbesserten sich um 3,5 und 3,0 %. Royal Bank of Scotland erklomm mit 3,8 % die Spitzenposition. Laut einem Bericht der Financial Times ist die Bank of England kurz vor Veröffentlichung von Bedingungen für gezielte Stützungsmaßnahmen für Finanzkonzerne an den Finanzmärkten.
Auf der Gegenseite trübte France Telecom mit einem Verlust von 3,4 % die Stimmung der Investoren. Das Unternehmen will einem Zeitungsbericht zufolge den schwedischen Telekommunikationskonzern TeliaSonera übernehmen. TeliaSonera (Stockholm: TLSN.ST - Nachrichten) -Aktien gewannen in Stockholm 6,3 %.
Außerhalb des Stoxx 50 gaben vor allem Unternehmen mit neuesten Quartalszahlen den Takt an. So verteuerten sich die Papiere des französischen Luxus-Herstellers LVMH um 4,4 %, nachdem der Konzern seinen Umsatz auf 4 Mrd. Euro steigern konnte. Analysten hatten mit 3,87 Mrd. Euro gerechnet. Noch stärker zogen die Aktien des irischen Pharmaunternehmens Elan an, die sich mit plus 7 % an die Spitze des marktbreiten Stoxx 600 setzten. Elan (Dublin: DRX.IR - Nachrichten) hatte seine Geschäftsziele für das laufende Jahr bekräftigt.
Der weltgrößte Kosmetikkonzern L'Oreal (Paris: FR0000120321 - Nachrichten) sackte dagegen um mehr als 6 % ab: Das Unternehmen hatte mit Umsatzzahlen enttäuscht. Hier senkte zudem die Schweizer Bank UBS ihre Einschätzung für die Papiere von "Kaufen" auf "Neutral".
Asiens Börsen schließen im Plus
Zuvor hatten die asiatischen Börsen nach den guten Intel (NASDAQ: INTC - Nachrichten) -Quartalszahlen im Plus geschlossen. In Tokio schloss der Nikkei (Nachrichten) 1,2 Prozent höher bei 13.146 Punkten. Der breiter gefasste Topix gewann 1,3 Prozent auf 1271 Zähler. Vor allem exportorientierte Aktien aus der Elektronikindustrie standen auf den Kauflisten der Börsianer exportorientierte Hochtechnologiewerte. So legte der Sony (München: 853687 - Nachrichten) -Kurs um 3,5 Prozent zu. Canon (Berlin: CNN1.BE - Nachrichten) -Aktien verteuerten sich um 2,6 Prozent, Tokyo-Electron-Papiere verteuerten sich um über fünf Prozent.
Auch die Börsen in Singapur, Südkorea, Hongkong und Taiwan legten zu. Am Vorabend hatte in New York alle drei Leitindizes den Handel mit einem Aufschlag von 0,5 Prozent beendet.
http://de.biz.yahoo.com/16042008/345/dax-amp-amp-stoxx-vormi…
Antwort auf Beitrag Nr.: 33.897.105 von Poppholz am 16.04.08 12:36:04der original Link
http://www.businesswire.de/portal/site/de/template.NDM/menui…
http://www.businesswire.de/portal/site/de/template.NDM/menui…
....kommt Ihr ins IV?:O
Antwort auf Beitrag Nr.: 33.897.283 von Birgit.Tersteegen am 16.04.08 12:55:05bin dort nicht vertreten.
Antwort auf Beitrag Nr.: 33.897.283 von Birgit.Tersteegen am 16.04.08 12:55:05....kommt Ihr ins IV?
NÖ ...
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NCB
BiogenIdec and Elan have provided an update on the number of patients on Tysabri and its safety profile at the 60th annual AAN (American Academy of Neurology) meeting. The global Tysabri utilisation data as of the end of March (Q1 2008) is ahead of our expectations with a strong uptick in EU/RoW patient numbers. Elan continues to provide very strong data supporting Tysabri’s efficacy with the latest data from the AFFIRM and SENTINEL trials showing that circa one-third of Tysabri treated patients were considered “disease free”, under both clinical and MRI definitions of the term, after over two years of treatment.
• The latest utilisation data shows that to the end of March, 25,500 patients were on Tysabri internationally with 15,300 of those patients treated in the US and 10,200 treated in EU/RoW. These patient numbers equate to an estimated weekly run rate of
c.392 patients - 184 new patients treated per week in US and 208 new patients treated per week in EU/RoW. This compares to last quarter’s weekly run rate of 338 new patients - 184 new patients treated per week in the US and 154 new patients treated
per week in EU/RoW.
• A safety update (based on data available to BIIB/Elan) as of the end of March showed no cases of PML since re-launch. This latest Tysabri safety update on PML is positive and should continue to support expansion of the prescriber base. The target of 100,000
MS patients on therapy by year-end 2010 was reaffirmed in the update. In Q1 2008 the number of physicians prescribing Tysabri increased sequentially from 2,500 to 2,750.
• Overall, the patient numbers to the end of March indicates that Elan is on track to report global in market revenues of c.$160m (c.$5m ahead of our expectations) when the company reports Q1 results on 24 April 2008.
• We maintain our BUY recommendation.
http://www.investorvillage.com/smbd.asp?mb=160&mn=219606&pt=…
BiogenIdec and Elan have provided an update on the number of patients on Tysabri and its safety profile at the 60th annual AAN (American Academy of Neurology) meeting. The global Tysabri utilisation data as of the end of March (Q1 2008) is ahead of our expectations with a strong uptick in EU/RoW patient numbers. Elan continues to provide very strong data supporting Tysabri’s efficacy with the latest data from the AFFIRM and SENTINEL trials showing that circa one-third of Tysabri treated patients were considered “disease free”, under both clinical and MRI definitions of the term, after over two years of treatment.
• The latest utilisation data shows that to the end of March, 25,500 patients were on Tysabri internationally with 15,300 of those patients treated in the US and 10,200 treated in EU/RoW. These patient numbers equate to an estimated weekly run rate of
c.392 patients - 184 new patients treated per week in US and 208 new patients treated per week in EU/RoW. This compares to last quarter’s weekly run rate of 338 new patients - 184 new patients treated per week in the US and 154 new patients treated
per week in EU/RoW.
• A safety update (based on data available to BIIB/Elan) as of the end of March showed no cases of PML since re-launch. This latest Tysabri safety update on PML is positive and should continue to support expansion of the prescriber base. The target of 100,000
MS patients on therapy by year-end 2010 was reaffirmed in the update. In Q1 2008 the number of physicians prescribing Tysabri increased sequentially from 2,500 to 2,750.
• Overall, the patient numbers to the end of March indicates that Elan is on track to report global in market revenues of c.$160m (c.$5m ahead of our expectations) when the company reports Q1 results on 24 April 2008.
• We maintain our BUY recommendation.
http://www.investorvillage.com/smbd.asp?mb=160&mn=219606&pt=…
Elan says 26,000 use Tysabri
Wed 16 Apr 2008
LONDON (SHARECAST) - Elan is up Wednesday on news that Tysabri users now total 26,000 and that the proportion of multiple sclerosis patients on the drug considered disease free over two years has risen significantly.
“In the studies, the proportion of patients considered disease free over two years was significantly higher in the Tysabri-treated group compared with the placebo group, regardless of how disease free was defined,” it said.
Elan added that around 26,000 patients were using Tysabri at the end of March this year, with no cases of progressive multifocal leukoencephalopathy, a potentially fatal disease of the central nervous system, since the US relaunch and international launch in 2006.
“Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of Tysabri indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010,” said Elan and partner Biogen Idec.
“Positive outcomes for patients continue to support Tysabri's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world,” added Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.
“We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive Tysabri treatment in the US.”
http://www.sharecast.com/cgi-bin/sharecast/story.cgi?story_i…
Wed 16 Apr 2008
LONDON (SHARECAST) - Elan is up Wednesday on news that Tysabri users now total 26,000 and that the proportion of multiple sclerosis patients on the drug considered disease free over two years has risen significantly.
“In the studies, the proportion of patients considered disease free over two years was significantly higher in the Tysabri-treated group compared with the placebo group, regardless of how disease free was defined,” it said.
Elan added that around 26,000 patients were using Tysabri at the end of March this year, with no cases of progressive multifocal leukoencephalopathy, a potentially fatal disease of the central nervous system, since the US relaunch and international launch in 2006.
“Growth in global utilization plus increasing confidence in the favorable benefit-risk profile of Tysabri indicate the companies are making great progress toward the goal of 100,000 patients on therapy by year-end 2010,” said Elan and partner Biogen Idec.
“Positive outcomes for patients continue to support Tysabri's strength as a valuable treatment for multiple sclerosis patients in more than 30 countries around the world,” added Gordon Francis, MD, Senior Vice President, Global Clinical Development, Elan.
“We are also excited that patients with Crohn's Disease are now enrolling in the TOUCH program and beginning to receive Tysabri treatment in the US.”
http://www.sharecast.com/cgi-bin/sharecast/story.cgi?story_i…
sollte der Knoten heute platzen?
es geht steil nach oben.
Aktuell: $23,70
(ich habe übrigens immer noch nicht gekauft)
es geht steil nach oben.
Aktuell: $23,70
(ich habe übrigens immer noch nicht gekauft)
woah--der Kurs hat aber einen Sprung gemacht23,56$
23,56$ ELN msg # 219663 4/16/2008 9:07:55 AMBy: peadar_og
Elan
That’s a home run in my view.
You probably now have a free run now at the AD data without having to worry about an issue arising with Tysabri in the meantime. There is a lead-time before anything can be investigated or reported.
Safety profile is great. Inflection point will arrive very shortly if this continues. Stock price clearly doesn’t come close to reflecting the value of Tysabri let alone anything else.
Number of patients far exceeds my estimate of 25k and is just 200 short of my best-case scenario of 24.6k.
Current rate is very close to required avg of 412 per week to get us to 100k by 2010 – and because we reached that number during the first qtr, there will be no ground to make up later. In fact, by the end of the current qtr, that avg will start to come down significantly. We’ll soon be making statements like, ‘current rate would get us to 150/200/250k by 2010’.
When is somebody that matters going to ask why all MS patients aren’t on Tysabri? There are almost 500k patients on lesser therapies and perhaps as many dropouts. It would take just 340k of those on Tysabri to drive $10 billion annual revenue. Probably more like 300k if you factor for price adjustments to match future inflation.
Perhaps the FDA should or will take the lead and direct Tysabri before other treatments. There are now a lot of MS patients clinically disease free because of Tysabri. There should be a lot more. Current suspected safety issues, imagined/manufactured or otherwise are also becoming manageable to a point where the efficacy cannot be denied.
Looking for $30+ of pure Tysabri related value in quick time on the back of this AAN. It'll be worth a lot more in the not too distant future. Also, any Alzheimer’s disease driven shareholder value to date has been swallowed by the rising value of Tysabri.
Kind regards
Peadar ‘Og
ELN msg # 219653 4/16/2008 8:57:20 AMBy: rickmeoff
in relation to aab-001/bap p2 data, goldman says:
goldman: "There is a wide disparity of opinions on the data end-points and content, as well as the likely share price reaction to publication of the data. It cannot be ignored that on the basis of interim (c.6-18 month) phase II data, multiple regulatory agencies have allowed Elan and partner Wyeth to begin an extensive phase III programme. Hence, debates about end-points are academic, in our view, and are likely red herrings that mask what could be positive and compelling phase II data around mid-year that could support a sub part E filing for approval."
translation:
"we have read adam feurstein at the street.com, and in our view he is not only a complete idiot, but theres the possibility he suffers from some sort of ailment which renders him unable to understand simple logic. either that, or he works for teva."
ELN msg # 219609 4/16/2008 8:23:04 AMBy: smellybadger2003
Davy, Jack Gorman
Elan's AAN press release reveals that Q1 was a very strong quarter for Tysabri
enrolment, with more than 5,000 patients added in the period, bringing the total
on commercial therapy to 25,500. This was 200 ahead of our forecast and
demonstrates that the rollout of the product is still successful as neurologists
become more comfortable with the safety profile of the product. We are
comfortable with our FY forecasts.
The net addition rate was 392 a week, based on 13 weeks. This is the highest yet
recorded, up from 338 a week in Q4 2007 and a little above our own 380 a week
target. The increase was driven by territories outside the US (RoW improved from
154 a week to 208 a week) as take-up increases following country launches in H2
2007. The US addition rate remained stable at 185 a week, notwithstanding a
10% increase in the number of prescribing physicians in the region (to 2,750).
The update on the TOUCH and TYGRIS trials also indicated that no cases of PML
have been reported since launch in July 2006. This will increase confidence in
Tysabri’s risk/benefit profile and allow neurologists to more readily prescribe the
drug in an increasingly larger proportion of patients going forward. We presume
that the latter will be the primary focus in the US market especially.
Elan/BIIB also reported on a post-hoc analysis of its AFFIRM and SENTINEL clinical
trials which indicated that Tysabri could increase the proportion of MS patients
considered disease-free. Using stringent criteria, it was found that approximately
31-37% of patients in the Tysabri groups were considered disease-free over two
years, compared to 7-11% in the placebo groups.
The stock closed stronger in the US last night (the press release was issued towards
end of trading), and we would expect that this momentum can continue as
markets digest the strong patient data.
ELN msg # 219805 4/16/2008 10:27:53 AMBy: splaylaywahtheepi
Elan is UnderValued
Elan now has a P/S of 10 with revenues growing at a 20% quarter over quarter clip and with a pipeline that is unmatched. When AAB results are published - and IMO anyone who expects them to be "mixed" is being either disingenuous or simple - Elan's risk/reward will be deemed to be extremely attractive and the price will move sharply up. If the P2 results support a subpart E filing near year end and the company says that this is their intention then we can expect real fireworks.
Then Elan becomes the main story in biopharma world: Tysabri, AAB and then the pipeline - ELND-005, -002, PD, ACC, and the host of nano products.
Press Release
Source: Alzheimer's Drug Discovery Foundation
Alzheimer's Drug Discovery Foundation and Elan Announce Winners of Third Annual Novel Discovery Award Program
Wednesday April 16, 11:47 am ET
NEW YORK CITY, NY--(MARKET WIRE)--Apr 16, 2008 -- The Alzheimer's Drug Discovery Foundation (ADDF), a biomedical venture philanthropy, and Elan Corporation, plc (NYSE:ELN - News), a neuroscience-based biotechnology company, are pleased to announce the winners of their third annual research award program, Novel Approaches to Drug Discovery for Alzheimer's Disease. Four international scientists received a total of $530,000 in grant funding.
ADVERTISEMENT
The award winners are: Luciano D'Adamio, MD, Founder, Remegenix, Inc.; Birgit Tersteegen (*l*), PhD, Professor of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago; Yung-Feng Liao, PhD, Assistant Research Fellow, Academia Sinica, Taiwan; and Horacio Saragovi, PhD, Professor, Lady Davis Institute for Medical Research, Montréal, Canada. An independent panel of 15 experts from ADDF's Scientific Review Board evaluated 24 applications submitted from the USA, Canada, China, Israel, Taiwan and the United Kingdom. The ADDF/Elan program has provided a total of $1,630,000 in research grants for Alzheimer's disease in the past three years.
"The awards highlight that there are many promising and innovative drug discovery research programs for Alzheimer's disease throughout the world," said ADDF Executive Director Howard Fillit, MD. "Our continued collaboration with Elan enables us to increase our capability to fund these programs."
There are still no new drugs to prevent or slow the rate of progression in Alzheimer's disease. In fact, there are only four drugs on the market that are only mildly effective in treating the symptoms of the disease. The ADDF/Elan awards program aims to accelerate the development of new drugs to treat, prevent or cure the disease.
"Elan is committed to working with forward-thinking organizations like ADDF to bring new therapeutic options to Alzheimer's patients and their caregivers," said Lars Ekman, MD, PhD, Member of the Board of Directors and past President of Global Research and Development, Elan. "We are dedicated to making tangible progress in the fight against this disease and are proud to support the work of this year's award recipients."
The four scientists were honored at the 3rd Annual ADDF/Elan Alzheimer's Disease Drug Discovery Awards luncheon, held at the Explorers Club in New York City. The event emphasized the urgent need to fund more scientists conducting early-stage high risk research in Alzheimer's disease.
"The luncheon is a wonderful opportunity to meet the scientists who work so passionately to improve the lives of those suffering from Alzheimer's disease," said ADDF Board President Nancy Corzine, who co-hosted the event with Dr. Ekman. "With each award presented, we get one step closer to finding a cure."
Source: Alzheimer's Drug Discovery Foundation
Alzheimer's Drug Discovery Foundation and Elan Announce Winners of Third Annual Novel Discovery Award Program
Wednesday April 16, 11:47 am ET
NEW YORK CITY, NY--(MARKET WIRE)--Apr 16, 2008 -- The Alzheimer's Drug Discovery Foundation (ADDF), a biomedical venture philanthropy, and Elan Corporation, plc (NYSE:ELN - News), a neuroscience-based biotechnology company, are pleased to announce the winners of their third annual research award program, Novel Approaches to Drug Discovery for Alzheimer's Disease. Four international scientists received a total of $530,000 in grant funding.
ADVERTISEMENT
The award winners are: Luciano D'Adamio, MD, Founder, Remegenix, Inc.; Birgit Tersteegen (*l*), PhD, Professor of Medicinal Chemistry and Pharmacognosy, University of Illinois at Chicago; Yung-Feng Liao, PhD, Assistant Research Fellow, Academia Sinica, Taiwan; and Horacio Saragovi, PhD, Professor, Lady Davis Institute for Medical Research, Montréal, Canada. An independent panel of 15 experts from ADDF's Scientific Review Board evaluated 24 applications submitted from the USA, Canada, China, Israel, Taiwan and the United Kingdom. The ADDF/Elan program has provided a total of $1,630,000 in research grants for Alzheimer's disease in the past three years.
"The awards highlight that there are many promising and innovative drug discovery research programs for Alzheimer's disease throughout the world," said ADDF Executive Director Howard Fillit, MD. "Our continued collaboration with Elan enables us to increase our capability to fund these programs."
There are still no new drugs to prevent or slow the rate of progression in Alzheimer's disease. In fact, there are only four drugs on the market that are only mildly effective in treating the symptoms of the disease. The ADDF/Elan awards program aims to accelerate the development of new drugs to treat, prevent or cure the disease.
"Elan is committed to working with forward-thinking organizations like ADDF to bring new therapeutic options to Alzheimer's patients and their caregivers," said Lars Ekman, MD, PhD, Member of the Board of Directors and past President of Global Research and Development, Elan. "We are dedicated to making tangible progress in the fight against this disease and are proud to support the work of this year's award recipients."
The four scientists were honored at the 3rd Annual ADDF/Elan Alzheimer's Disease Drug Discovery Awards luncheon, held at the Explorers Club in New York City. The event emphasized the urgent need to fund more scientists conducting early-stage high risk research in Alzheimer's disease.
"The luncheon is a wonderful opportunity to meet the scientists who work so passionately to improve the lives of those suffering from Alzheimer's disease," said ADDF Board President Nancy Corzine, who co-hosted the event with Dr. Ekman. "With each award presented, we get one step closer to finding a cure."
Antwort auf Beitrag Nr.: 33.901.228 von Holgus am 16.04.08 18:43:15...ich wusste doch,es muss noch verborgene Talente bei mir geben....
(hab´ich mich erschrocken.....)
...ich wusste doch,es muss noch verborgene Talente bei mir geben....
(hab´ich mich erschrocken.....) GOLDMAN UPS ELN TO BUY FROM NEUTRAL. ADDS TO BUY LIST.S&P Marketscope -
SNPMarketScope ViewsNews 2008-04-16 10:35:26.000 ELNELAN CORP., PLCJanet Freund GOLDMAN UPS ELN TO BUY FROM NEUTRAL. ADDS TO BUY LIST. Analyst Stephen McGarry tells salesforce ups his Tysabri forecasts closer to co.'s target of 100,000 patients on drug by '10; leads to his new '09 EPS view of $0.35. Says his model doesn't incl. early launch of Bapineuzumab, but should this occur, numbers would require revisions. Says most significant NT catalyst is Ph. II data in Alzheimer's with Bapineuzumab, due around June. Says can't be ignored that on basis of interim Ph. II data, multiple regulatory agencies okayed ELN, partner WYE to begin extensive Ph. III program. Thinks we could see positive Ph. II data around mid-yr that could support sub part E filing for approval. Ups 6-mo. target to $34.20 from $29.30./Freund |US;ELN|1429|97764
wenn das kein netter anstieg war.
closed @ 24.24
closed @ 24.24
Data Presented at the 60th Annual Meeting of the American Academy of Neurology Offers Additional Support for Plasma Exchange as a Potential Tool to Accelerate TYSABRI(R) Removal
Wednesday April 16, 4:00 pm ET
CHICAGO--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) today announced additional findings from the PLEX study which shows that plasma exchange accelerates the removal of TYSABRI® (natalizumab) from blood serum in patients and may help improve central nervous system immune response based on an in vitro model. The data was presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN). Plasma exchange is one of several research efforts the companies have underway to learn more about potential interventions or treatments for progressive multifocal leukoencephalopathy (PML).
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“The goal of these studies is to evaluate the value of plasma exchange in patients who may develop PML. The data are encouraging as they show that removal of TYSABRI through plasma exchange may be a potential intervention to rapidly clear TYSABRI and restore immune function when clinically appropriate,” said the study’s lead author, Bhupendra O. Khatri, MD, Medical Director of the Regional MS Center, Aurora St. Luke’s Medical Center, Milwaukee, WI.
PLEX is an open-label, single-arm, multicenter exploratory study involving 12 patients with relapsing-remitting multiple sclerosis (MS), designed to explore whether plasma exchange could significantly reduce the concentration of TYSABRI in blood serum and alpha 4-integrin receptor saturation. Plasma exchange is an established method of removing large molecules from the body’s blood circulation. Based on the PLEX findings, plasma exchange was effective at accelerating the normal decline of TYSABRI serum concentrations.
A sub-study of PLEX, also presented today at the meeting, evaluated the effect of plasma exchange on the migration of certain immune cells, called leukocytes, across an in vitro model of the blood-brain barrier. TYSABRI was shown to reduce the migration of these cells across the blood-brain barrier. The results showed that plasma exchange improved the ability of these cells to migrate across the blood brain barrier, potentially reestablishing normal central nervous system immune response.
Plasma exchange was generally well tolerated with no increase in MS disease activity. There were no study discontinuations due to adverse events and all patients returned to TYSABRI treatment without complications. While further studies are being conducted, plasma exchange has been shown to hold potential as an intervention in the setting of PML.
Abstracts from the larger PLEX study, “Plasma Exchange Accelerates the Decline of Serum Natalizumab Concentration in Patients with Multiple Sclerosis: Results of the Natalizumab PLEX Study” (Presentation #S22.005) and the sub-analysis, “Plasma Exchange Augments Leukocyte Transmigration Across an In Vitro Blood-Brain Barrier In Natalizumab-Treated Patients with Multiple Sclerosis” (Presentation #S27.005) are available on-line at the AAN’s website.
Wednesday April 16, 4:00 pm ET
CHICAGO--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) today announced additional findings from the PLEX study which shows that plasma exchange accelerates the removal of TYSABRI® (natalizumab) from blood serum in patients and may help improve central nervous system immune response based on an in vitro model. The data was presented today at the 60th Annual Meeting of the American Academy of Neurology (AAN). Plasma exchange is one of several research efforts the companies have underway to learn more about potential interventions or treatments for progressive multifocal leukoencephalopathy (PML).
ADVERTISEMENT
“The goal of these studies is to evaluate the value of plasma exchange in patients who may develop PML. The data are encouraging as they show that removal of TYSABRI through plasma exchange may be a potential intervention to rapidly clear TYSABRI and restore immune function when clinically appropriate,” said the study’s lead author, Bhupendra O. Khatri, MD, Medical Director of the Regional MS Center, Aurora St. Luke’s Medical Center, Milwaukee, WI.
PLEX is an open-label, single-arm, multicenter exploratory study involving 12 patients with relapsing-remitting multiple sclerosis (MS), designed to explore whether plasma exchange could significantly reduce the concentration of TYSABRI in blood serum and alpha 4-integrin receptor saturation. Plasma exchange is an established method of removing large molecules from the body’s blood circulation. Based on the PLEX findings, plasma exchange was effective at accelerating the normal decline of TYSABRI serum concentrations.
A sub-study of PLEX, also presented today at the meeting, evaluated the effect of plasma exchange on the migration of certain immune cells, called leukocytes, across an in vitro model of the blood-brain barrier. TYSABRI was shown to reduce the migration of these cells across the blood-brain barrier. The results showed that plasma exchange improved the ability of these cells to migrate across the blood brain barrier, potentially reestablishing normal central nervous system immune response.
Plasma exchange was generally well tolerated with no increase in MS disease activity. There were no study discontinuations due to adverse events and all patients returned to TYSABRI treatment without complications. While further studies are being conducted, plasma exchange has been shown to hold potential as an intervention in the setting of PML.
Abstracts from the larger PLEX study, “Plasma Exchange Accelerates the Decline of Serum Natalizumab Concentration in Patients with Multiple Sclerosis: Results of the Natalizumab PLEX Study” (Presentation #S22.005) and the sub-analysis, “Plasma Exchange Augments Leukocyte Transmigration Across an In Vitro Blood-Brain Barrier In Natalizumab-Treated Patients with Multiple Sclerosis” (Presentation #S27.005) are available on-line at the AAN’s website.
.....WIR freuen uns,ODER???????????????????????
Antwort auf Beitrag Nr.: 33.902.259 von Birgit.Tersteegen am 16.04.08 20:28:44(hab´ich mich erschrocken.....)
Lach ... ich hab schon Angst gehabt, Du überliest es wohlmöglich.
Aber Du liest alles aufmerksam durch ... braves Mädchen
Den Anderen ist das gar nicht aufgefallen ... lol
Lach ... ich hab schon Angst gehabt, Du überliest es wohlmöglich.
Aber Du liest alles aufmerksam durch ... braves Mädchen
Den Anderen ist das gar nicht aufgefallen ... lol
Antwort auf Beitrag Nr.: 33.903.676 von Holgus am 16.04.08 22:41:38JAAAAAA-immer brav + fleissig.....
Antwort auf Beitrag Nr.: 33.903.922 von Holgus am 16.04.08 23:18:23...Holgus----ich glaube Deine Wahrnehmungseinschränkung ist bestimmt signifikant" und trifft alle statistischen Endpunkte.....mit jeder Testbatterie......Diagnose "SEXUALISIERUNGSMUSS".....
.....Gut´s Nächtle nach Elanville....
.....Gut´s Nächtle nach Elanville....
...den noch
ELN msg # 220210 4/16/2008 4:56:24 PM
By: Powershares_ie
CSFB €30 (c. $31.50) Target for Elan - Tysabri Update
In case this hasn't been posted - from CSFB:
Tysabri
What’s New
Elan and Biogen Idec presented an update on Tysabri utilisation and safety at the American Academy of Neurology last night. At the end Q1’08, 15,300 patients were on commercial Tysabri in the US (1% better than our expectation of 15,100 patients) and 10,200 patients in international markets (6% better than our expectations of 9,650). No cases of PML have occurred since the re-launch. More than 3,600 patients have been on Tysbari for 18 months and we expect 5000 – 6000 patients will be on Tysabri for 2 years by the end of the year.
This update plays to our thesis on Tysabri
■ We believe consensus is underestimating the contribution of international markets to Tysabri revenues (c 30% of consensus Tysabri revenues Vs Biogen Idec and Elan’s expectations of c55% )
■ With continued patient experience and confidence in Tysabri we expect to see more physicians prescribing and more scripts per physician. This pattern has been building since Tysabri’s launch.
■ Whilst we view potential developmental oral therapies for MS as promising – we wait to get a better indication of the safety profile of these drugs after the completion of larger Phase III studies. To reflect the potential threat of these drugs to the currently marketed MS treatments, we assume rapid adoption of oral treatments within our modelling from 2010.
We believe that Tysabri is on track to become a c$2bn treatment globally by 2010. Our estimates are c30% below management’s implicit targets of c$3bn by 2010. This reflects our more cautious stance on the impact on Tysabri’s re-launch momentum should future cases of PML occur within the labelling.
Ex Alzheimer’s valuation support at $18
On our Tysabri numbers, we believe that our SOTP valuation of Elan’s base business (ex Alzheimer’s related corporate costs) grant’s valuation support of $18 per ADR for Elan (€€ 11.50 at current FX rates). At current levels, with a longer-term view on the stock, we believe there is an attractive asymmetry ahead of Key Phase II Alzheimer data in June /July. We rate Elan with an Outperform rating and a €€ 20 target price. – See our recent initiation (Thinking Big – 4th March 2008).
ELN msg # 220210 4/16/2008 4:56:24 PMBy: Powershares_ie
CSFB €30 (c. $31.50) Target for Elan - Tysabri Update
In case this hasn't been posted - from CSFB:
Tysabri
What’s New
Elan and Biogen Idec presented an update on Tysabri utilisation and safety at the American Academy of Neurology last night. At the end Q1’08, 15,300 patients were on commercial Tysabri in the US (1% better than our expectation of 15,100 patients) and 10,200 patients in international markets (6% better than our expectations of 9,650). No cases of PML have occurred since the re-launch. More than 3,600 patients have been on Tysbari for 18 months and we expect 5000 – 6000 patients will be on Tysabri for 2 years by the end of the year.
This update plays to our thesis on Tysabri
■ We believe consensus is underestimating the contribution of international markets to Tysabri revenues (c 30% of consensus Tysabri revenues Vs Biogen Idec and Elan’s expectations of c55% )
■ With continued patient experience and confidence in Tysabri we expect to see more physicians prescribing and more scripts per physician. This pattern has been building since Tysabri’s launch.
■ Whilst we view potential developmental oral therapies for MS as promising – we wait to get a better indication of the safety profile of these drugs after the completion of larger Phase III studies. To reflect the potential threat of these drugs to the currently marketed MS treatments, we assume rapid adoption of oral treatments within our modelling from 2010.
We believe that Tysabri is on track to become a c$2bn treatment globally by 2010. Our estimates are c30% below management’s implicit targets of c$3bn by 2010. This reflects our more cautious stance on the impact on Tysabri’s re-launch momentum should future cases of PML occur within the labelling.
Ex Alzheimer’s valuation support at $18
On our Tysabri numbers, we believe that our SOTP valuation of Elan’s base business (ex Alzheimer’s related corporate costs) grant’s valuation support of $18 per ADR for Elan (€€ 11.50 at current FX rates). At current levels, with a longer-term view on the stock, we believe there is an attractive asymmetry ahead of Key Phase II Alzheimer data in June /July. We rate Elan with an Outperform rating and a €€ 20 target price. – See our recent initiation (Thinking Big – 4th March 2008).
Elan Corp. plc (ELN)
Last Price 24.30 USD
Change + 2.47 USD
Change + 11.31 %
...so langsam kommen wir mal wieder in die Pötte....
Last Price 24.30 USD
Change + 2.47 USD
Change + 11.31 %
...so langsam kommen wir mal wieder in die Pötte....
After Hours
Last: $ 24.30
After Hours
Volume: 67,658
After Hours
High: $ 24.50
After Hours
Low: $ 23.5129
Last: $ 24.30
After Hours
Volume: 67,658
After Hours
High: $ 24.50
After Hours
Low: $ 23.5129
Antwort auf Beitrag Nr.: 33.903.984 von Birgit.Tersteegen am 16.04.08 23:33:32 Testosteron im Blut, Glück an der Börse
..also, dann mal los, Männer...
Wenn beim Mann der Hormonpegel steigt, winkt an der Börse das große Glück. Börsenhändler können laut einer in den USA veröffentlichten Studie dann mit guten Gewinnen am Aktienmarkt rechnen, wenn ihr Stand des männlichen Sexualhormons Testosteron besonders hoch ist. Für die Untersuchung begleiteten Forscher der britischen Universität Cambridge 17 Aktienmakler acht Tage lang aufs Londoner Börsenparkett.
Die Wissenschaftler maßen jeweils um 11.00 Uhr und um 16.00 Uhr den Testosteronpegel ihrer Probanden. Die Ergebnisse wurden abgeglichen mit den Gewinnen oder Verlusten, die sie am jeweiligen Tag eingefahren hatten.
Das Ergebnis in Kurzform: Viele Hormone - hohe Gewinne.
..ups, dann muss es aber viele " hormonlose" Männer geben....bei GENTA stimmte dann wohl mein Hormonspiegel überhaupt nicht, dafür aber bei ELAN umso mehr.....
Den Zusammenhang zwischen Börsenkurve und Hormonspiegel erklären die Wissenschaftler damit, dass Testosteron das Selbstvertrauen stärke und Lust auf Risiko wecke. "Das Steigen des Testosteron verführt die Börsenmakler zu riskanteren Entscheidungen", urteilt Studienautor John Coates aus Cambridge.
Die Risikobereitschaft könne sich durch höhere Gewinnmargen bezahlt machen...
..hätte ich nicht gedacht.......aber oft ist auch das Gegenteil der FAll.....
Das Sieger-Gefühl setze wiederum weiteres Testosteron frei - und könne letztlich auch zu Selbstüberschätzung führen, mit riskanten Konsequenzen: "Wenn der Testosteronstand exzessiv wird, wie dies etwa bei Spekulationsblasen der Fall ist, kann die Lust auf Risiko obsessiv werden", warnt Coates.
In ihrer Studie fanden die Forscher auch heraus, dass das Hormon Cortisol, ein körpereigener Gegenspieler des Testosteron, ebenfalls Börsenentscheidungen beeinflussen kann. Cortisol wird bei Stress ausgeschüttet und kann die gute Laune dämpfen - eine Gefahr, die gerade angesichts der aktuellen Konjunktureintrübung besteht. "Die gegenwärtige Kreditkrise könnte bei Händlern Unwohlsein auslösen und sie in einen Zustand psychischer Verzweiflung stürzen, weil sie einen hohen Cortisol-Überschuss haben", erklärt Coates. In solchen Fällen würden auch gut gemeinte Leitzinssenkungen der Zentralbanken nicht helfen, weil die Männer unter dem Diktat ihrer Hormone zu irrationalen Börsenentscheidungen neigten, welche die Krise noch verschärfen.
Die Studie hilft nach Einschätzung ihrer Autoren jene komplexen marktpsychologischen Faktoren zu verstehen, die gerade bei Börsen-Crashs oder Spekulationsblasen wirksam werden. Der Cambridger Hirnforscher Joe Herbert erläutert: "Die Aktienmakler arbeiten unter extremem Druck, der sie selbst tiefgreifend beeinflussen kann und mit ihnen die gesamten Märkte." Veröffentlicht wurde die Studie im US-Fachmagazin "Proceedings of the National Academy of Sciences".
http://portal.gmx.net/de/themen/finanzen/wirtschaft/5738790-…
Testosteron im Blut, Glück an der Börse ..also, dann mal los, Männer...
Wenn beim Mann der Hormonpegel steigt, winkt an der Börse das große Glück. Börsenhändler können laut einer in den USA veröffentlichten Studie dann mit guten Gewinnen am Aktienmarkt rechnen, wenn ihr Stand des männlichen Sexualhormons Testosteron besonders hoch ist. Für die Untersuchung begleiteten Forscher der britischen Universität Cambridge 17 Aktienmakler acht Tage lang aufs Londoner Börsenparkett.
Die Wissenschaftler maßen jeweils um 11.00 Uhr und um 16.00 Uhr den Testosteronpegel ihrer Probanden. Die Ergebnisse wurden abgeglichen mit den Gewinnen oder Verlusten, die sie am jeweiligen Tag eingefahren hatten.
Das Ergebnis in Kurzform: Viele Hormone - hohe Gewinne.
..ups, dann muss es aber viele " hormonlose" Männer geben....bei GENTA stimmte dann wohl mein Hormonspiegel überhaupt nicht, dafür aber bei ELAN umso mehr.....
Den Zusammenhang zwischen Börsenkurve und Hormonspiegel erklären die Wissenschaftler damit, dass Testosteron das Selbstvertrauen stärke und Lust auf Risiko wecke. "Das Steigen des Testosteron verführt die Börsenmakler zu riskanteren Entscheidungen", urteilt Studienautor John Coates aus Cambridge.
Die Risikobereitschaft könne sich durch höhere Gewinnmargen bezahlt machen...
..hätte ich nicht gedacht....
...aber oft ist auch das Gegenteil der FAll.....Das Sieger-Gefühl setze wiederum weiteres Testosteron frei - und könne letztlich auch zu Selbstüberschätzung führen, mit riskanten Konsequenzen: "Wenn der Testosteronstand exzessiv wird, wie dies etwa bei Spekulationsblasen der Fall ist, kann die Lust auf Risiko obsessiv werden", warnt Coates.
In ihrer Studie fanden die Forscher auch heraus, dass das Hormon Cortisol, ein körpereigener Gegenspieler des Testosteron, ebenfalls Börsenentscheidungen beeinflussen kann. Cortisol wird bei Stress ausgeschüttet und kann die gute Laune dämpfen - eine Gefahr, die gerade angesichts der aktuellen Konjunktureintrübung besteht. "Die gegenwärtige Kreditkrise könnte bei Händlern Unwohlsein auslösen und sie in einen Zustand psychischer Verzweiflung stürzen, weil sie einen hohen Cortisol-Überschuss haben", erklärt Coates. In solchen Fällen würden auch gut gemeinte Leitzinssenkungen der Zentralbanken nicht helfen, weil die Männer unter dem Diktat ihrer Hormone zu irrationalen Börsenentscheidungen neigten, welche die Krise noch verschärfen.
Die Studie hilft nach Einschätzung ihrer Autoren jene komplexen marktpsychologischen Faktoren zu verstehen, die gerade bei Börsen-Crashs oder Spekulationsblasen wirksam werden. Der Cambridger Hirnforscher Joe Herbert erläutert: "Die Aktienmakler arbeiten unter extremem Druck, der sie selbst tiefgreifend beeinflussen kann und mit ihnen die gesamten Märkte." Veröffentlicht wurde die Studie im US-Fachmagazin "Proceedings of the National Academy of Sciences".
http://portal.gmx.net/de/themen/finanzen/wirtschaft/5738790-…
Antwort auf Beitrag Nr.: 33.904.619 von bernie55 am 17.04.08 08:16:39....HILFE,Bernie---denk bitte dran, Holgie liest mit....
Antwort auf Beitrag Nr.: 33.904.646 von Birgit.Tersteegen am 17.04.08 08:21:37Testosteron im Blut, Glück an der Börse
Mein Testospiegel gelüstet mich im Moment nach der Preisgabe eines kräftigen Schlucks aus der Tasche
Mein Testospiegel gelüstet mich im Moment nach der Preisgabe eines kräftigen Schlucks aus der Tasche
After Hour ging es sogar noch ein wenig höher, obwohl einige Male versucht wurde den Kurs nach unten zu drücken:
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
18:41 $ 24.30 100
18:40 $ 24.29 100
18:28 $ 24.24 358
18:03 $ 24.23 200
17:53 $ 24.30 100
17:43 $ 24.20 142
17:43 $ 24.20 150
17:43 $ 24.50 108
17:43 $ 24.50 1,000
17:43 $ 24.48 100
17:43 $ 24.50 142
17:43 $ 24.20 100
17:43 $ 24.20 358
17:24 $ 23.92 125
17:19 $ 23.97 175
17:19 $ 23.95 400
17:01 $ 24.03 300
17:00 $ 24.03 200
16:55 $ 24.05 100
16:46 $ 24.10 200
16:38 $ 24.20 300
16:19 $ 23.7505 31,000
16:19 $ 23.5129 20,000
16:17 $ 24.20 400
16:11 $ 23.7438 10,500
16:04 $ 24.20 1,000
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
18:41 $ 24.30 100
18:40 $ 24.29 100
18:28 $ 24.24 358
18:03 $ 24.23 200
17:53 $ 24.30 100
17:43 $ 24.20 142
17:43 $ 24.20 150
17:43 $ 24.50 108
17:43 $ 24.50 1,000
17:43 $ 24.48 100
17:43 $ 24.50 142
17:43 $ 24.20 100
17:43 $ 24.20 358
17:24 $ 23.92 125
17:19 $ 23.97 175
17:19 $ 23.95 400
17:01 $ 24.03 300
17:00 $ 24.03 200
16:55 $ 24.05 100
16:46 $ 24.10 200
16:38 $ 24.20 300
16:19 $ 23.7505 31,000
16:19 $ 23.5129 20,000
16:17 $ 24.20 400
16:11 $ 23.7438 10,500
16:04 $ 24.20 1,000
Antwort auf Beitrag Nr.: 33.905.635 von Poppholz am 17.04.08 10:08:00also, wenn ich in ELAN short wäre, dann wäre ich ganz schön nervös.
NCB
Following on from the positive Tysabri utilisation data announced on Tuesday, BiogenIdec and Elan have presented additional findings from the PLEX study at the annual AAN meeting. Specifically, details were provided on PML research efforts to
manage the risk if patients do develop PML on Tysabri treatment.
• The findings show (i) an accelerated removal of Tysabri from the blood by plasma exchange, (ii) that plasma exchange was generally well tolerated with no increase in MS disease activity and (iii) no study discontinuations occurred due to adverse events with all patients returning to Tysabri treatment without complications. Plasma exchange is a method of removing large molecules from the body’s blood circulation and is routinely performed in hospitals. BiogenIdec and Elan are seeking to recommend this method should patients develop PML while on treatment.
• The risk of developing PML has been established by the FDA as 1 in 1000 patients treated. Developing recommendations and treatments for PML would be an important step in helping convince the more conservative neurologists to prescribe Tysabri.
http://www.investorvillage.com/smbd.asp?mb=160&mn=220420&pt=…
Following on from the positive Tysabri utilisation data announced on Tuesday, BiogenIdec and Elan have presented additional findings from the PLEX study at the annual AAN meeting. Specifically, details were provided on PML research efforts to
manage the risk if patients do develop PML on Tysabri treatment.
• The findings show (i) an accelerated removal of Tysabri from the blood by plasma exchange, (ii) that plasma exchange was generally well tolerated with no increase in MS disease activity and (iii) no study discontinuations occurred due to adverse events with all patients returning to Tysabri treatment without complications. Plasma exchange is a method of removing large molecules from the body’s blood circulation and is routinely performed in hospitals. BiogenIdec and Elan are seeking to recommend this method should patients develop PML while on treatment.
• The risk of developing PML has been established by the FDA as 1 in 1000 patients treated. Developing recommendations and treatments for PML would be an important step in helping convince the more conservative neurologists to prescribe Tysabri.
http://www.investorvillage.com/smbd.asp?mb=160&mn=220420&pt=…
GoodbodyElan (Add, Closing Price $24.30)
Further Tysabri data presented at AAN meeting
Analyst: Ian Hunter
As we previewed yesterday, Elan and partner Biogen Idec released data at the 60th annual meeting of the American Academy of Neurology that show that plasma exchange accelerates the removal of Tysabri from blood serum in patients. The on-going study (designated PLEX) is one of a number of experiments designed to help develop an intervention protocol for patients should they show any signs of having PML. The PLEX findings show that plasma exchange is effective in accelerating the normal decline of Tysabri serum concentrations. An additional study showed that plasma exchange also helped restore the migration of leukocytes (cells active in the immune response) across the blood-brain barrier in an in vitro model. Rapid removal of Tysabri from a patient's system is seen as a first step in treatment, should they develop PML. Although not of direct relevance to the commercial development of Tysabri, the additional work on safety protocols gives incremental comfort to patients and physicians considering taking or prescribing the drug.
http://www.investorvillage.com/smbd.asp?mb=160&mn=220418&pt=…
Further Tysabri data presented at AAN meeting
Analyst: Ian Hunter
As we previewed yesterday, Elan and partner Biogen Idec released data at the 60th annual meeting of the American Academy of Neurology that show that plasma exchange accelerates the removal of Tysabri from blood serum in patients. The on-going study (designated PLEX) is one of a number of experiments designed to help develop an intervention protocol for patients should they show any signs of having PML. The PLEX findings show that plasma exchange is effective in accelerating the normal decline of Tysabri serum concentrations. An additional study showed that plasma exchange also helped restore the migration of leukocytes (cells active in the immune response) across the blood-brain barrier in an in vitro model. Rapid removal of Tysabri from a patient's system is seen as a first step in treatment, should they develop PML. Although not of direct relevance to the commercial development of Tysabri, the additional work on safety protocols gives incremental comfort to patients and physicians considering taking or prescribing the drug.
http://www.investorvillage.com/smbd.asp?mb=160&mn=220418&pt=…
davy
Elan Corp (USc)
Strong patient numbers underpin share price recovery;
PLEX study highlights potential method of safety intervention
Jack Gorman
-------------------------------------------------------------------
The strong patient numbers for Tysabri in Q1, which were modestly ahead of our own forecasts, leave us confident that Q1 revenues will be close to, or exceed, our $158m estimate. Putting that in context, 25,500 patients at an average price of say, $27,000 means that Tysabri is currently on an annual rate of $689m. Our own FY forecast of $840m is thus very achievable as enrolment accelerates. After burning off its gains of the last two weeks, the stock has deservedly recovered.
After the US close, Elan and BIIB released highlights of the PLEX study. This 12-patient open-label study explores whether plasma exchange can quickly and safely reduce Tysabri concentrations in blood serum. It was found that the procedure accelerates the removal of Tysabri, and also helps to restore immune function. As such, plasma exchange may be a potential safety intervention if required. Although further work needs to be done on this approach, it strengthens the risk/benefit profile of Tysabri.
Meanwhile, Abbott reported Q1 results, with revenue up 14% to $6.77bn and EPS up 35% to 63c, ahead of the expected $6.53bn and 62c respectively. The good outturn was due to strong sales of its rheumatoid arthritis medication, Humira, which were up 54% to $878m. Sales of TriCor, the cholesterol therapy which uses Elan’s nanosystems drug technology, were up 9.8% to $245m, although this had slowed somewhat from the previous quarter which had shown a 21% increase. Elan receives a 5% royalty on TriCor
http://www.investorvillage.com/smbd.asp?mb=160&mn=220412&pt=…
Elan Corp (USc)
Strong patient numbers underpin share price recovery;
PLEX study highlights potential method of safety intervention
Jack Gorman
-------------------------------------------------------------------
The strong patient numbers for Tysabri in Q1, which were modestly ahead of our own forecasts, leave us confident that Q1 revenues will be close to, or exceed, our $158m estimate. Putting that in context, 25,500 patients at an average price of say, $27,000 means that Tysabri is currently on an annual rate of $689m. Our own FY forecast of $840m is thus very achievable as enrolment accelerates. After burning off its gains of the last two weeks, the stock has deservedly recovered.
After the US close, Elan and BIIB released highlights of the PLEX study. This 12-patient open-label study explores whether plasma exchange can quickly and safely reduce Tysabri concentrations in blood serum. It was found that the procedure accelerates the removal of Tysabri, and also helps to restore immune function. As such, plasma exchange may be a potential safety intervention if required. Although further work needs to be done on this approach, it strengthens the risk/benefit profile of Tysabri.
Meanwhile, Abbott reported Q1 results, with revenue up 14% to $6.77bn and EPS up 35% to 63c, ahead of the expected $6.53bn and 62c respectively. The good outturn was due to strong sales of its rheumatoid arthritis medication, Humira, which were up 54% to $878m. Sales of TriCor, the cholesterol therapy which uses Elan’s nanosystems drug technology, were up 9.8% to $245m, although this had slowed somewhat from the previous quarter which had shown a 21% increase. Elan receives a 5% royalty on TriCor
http://www.investorvillage.com/smbd.asp?mb=160&mn=220412&pt=…
Today's Irish Times - Finance section
Elan rises on drug trial data
DOMINIC COYLE
SHARES IN biotech group Elan jumped almost 12 per cent yesterday following a bullish update on patient numbers for its multiple sclerosis drug, Tysabri.
Addressing the 60th American Academy of Neurology conference, Elan and its US partner Biogen said about 26,000 MS patients were now being treated with the drug.
They also reported that there had been no further cases of the fatal brain disease progressive multifocal leukoencephalopathy (PML) since the drug returned to the market in June 2006. Two cases of PML led to the drug being pulled from shelves shortly after it first went on sale in 2005.
The increase in patient numbers, which was ahead of market expectations, was driven by sales outside the United States.
In the first three months of the year, 208 new Tysabri patients were beginning therapy on average each week. That is a 35 per cent increase on the previous quarter and means that, for the first time, the take-up rate for the drug is faster in the rest of the world than in the US market.
Davy analyst Jack Gorman noted that, within the US, the company was adding new patients at the same rates as in previous quarters, despite a 10 per cent increase in the number of doctors prescribing the medicine.
Analysts now expect Elan's first-quarter financial figures next week to come in at the top end of forecasts.
The companies also released results of a number of trials monitoring patients over a two-year period, showing that a significant percentage of MS patients on the therapy were "disease free".
The Affirm and Sentinel trials measured the number of relapses experienced by patients on Tysabri against a group receiving a placebo. Elan and Biogen said that 36.7 per cent of Tysabri patients remained free of any MS activity over the two-year period compared with 7.2 per cent of those on a placebo. The Sentinel figures (31.7 per cent versus 10.9 per cent) were similarly significant.
"The ultimate goal of an MS treatment is to help patients remain symptom-free for as long as possible. These data show natalizumab [ Tysabri] may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients," said the study's lead author, Steven Galetta, professor of neurology at the University of Pennsylvania school of medicine.
In a note to clients yesterday, Goodbody analyst Ian Hunter said: "The continued increase in patient numbers on Tysabri without any sign of PML or other untoward adverse reactions continues to shift the focus away from the safety profile towards the drug's superior efficacy."
© 2008 The Irish Times
http://www.investorvillage.com/smbd.asp?mb=160&mn=220419&pt=…
Elan rises on drug trial data
DOMINIC COYLE
SHARES IN biotech group Elan jumped almost 12 per cent yesterday following a bullish update on patient numbers for its multiple sclerosis drug, Tysabri.
Addressing the 60th American Academy of Neurology conference, Elan and its US partner Biogen said about 26,000 MS patients were now being treated with the drug.
They also reported that there had been no further cases of the fatal brain disease progressive multifocal leukoencephalopathy (PML) since the drug returned to the market in June 2006. Two cases of PML led to the drug being pulled from shelves shortly after it first went on sale in 2005.
The increase in patient numbers, which was ahead of market expectations, was driven by sales outside the United States.
In the first three months of the year, 208 new Tysabri patients were beginning therapy on average each week. That is a 35 per cent increase on the previous quarter and means that, for the first time, the take-up rate for the drug is faster in the rest of the world than in the US market.
Davy analyst Jack Gorman noted that, within the US, the company was adding new patients at the same rates as in previous quarters, despite a 10 per cent increase in the number of doctors prescribing the medicine.
Analysts now expect Elan's first-quarter financial figures next week to come in at the top end of forecasts.
The companies also released results of a number of trials monitoring patients over a two-year period, showing that a significant percentage of MS patients on the therapy were "disease free".
The Affirm and Sentinel trials measured the number of relapses experienced by patients on Tysabri against a group receiving a placebo. Elan and Biogen said that 36.7 per cent of Tysabri patients remained free of any MS activity over the two-year period compared with 7.2 per cent of those on a placebo. The Sentinel figures (31.7 per cent versus 10.9 per cent) were similarly significant.
"The ultimate goal of an MS treatment is to help patients remain symptom-free for as long as possible. These data show natalizumab [ Tysabri] may do just that as about one-third of patients were shown to have no relapses, no disability progression and no new MRI markers. This is further evidence that treatment with natalizumab can result in truly dramatic outcomes for a large group of patients," said the study's lead author, Steven Galetta, professor of neurology at the University of Pennsylvania school of medicine.
In a note to clients yesterday, Goodbody analyst Ian Hunter said: "The continued increase in patient numbers on Tysabri without any sign of PML or other untoward adverse reactions continues to shift the focus away from the safety profile towards the drug's superior efficacy."
© 2008 The Irish Times
http://www.investorvillage.com/smbd.asp?mb=160&mn=220419&pt=…
wenn man bedenkt, wie sich der Kurs 2004 entwickelt hat, ist für dieses Jahr noch viel möglich.
Zumal heute die Sachlage eine viel bessere ist.
Zumal heute die Sachlage eine viel bessere ist.
in den USA wird munteres STOP LOSS FISHING betrieben:
Da haben die guten Nachrichten gestern mal ein wenig Sicherheit in die Investorengemeinde gebracht ... und schon kommt heute die nächste Hiobsbotschaft.
Wie sollen Anleger jemals Vertrauen in dieses Unternehmen bekommen,
wenn ständig solch Scheiß passiert ?
Es ist zum Kotzen.
Wie sollen Anleger jemals Vertrauen in dieses Unternehmen bekommen,
wenn ständig solch Scheiß passiert ?
Es ist zum Kotzen.
bin gerade rein und was sehen meine entzündeten augen.
nachdem was ich mal auf die schnelle mitbekommen habe, liegt hier eine fehlannahme in den bezeichnungen vor, nicht AAB001 sondern ACC001, stimmt das oder bin ich vorn bus gelaufen?
nachdem was ich mal auf die schnelle mitbekommen habe, liegt hier eine fehlannahme in den bezeichnungen vor, nicht AAB001 sondern ACC001, stimmt das oder bin ich vorn bus gelaufen?
Antwort auf Beitrag Nr.: 33.912.404 von GuHu1 am 17.04.08 20:45:14Die haben ACC001 im Zusammenhang mit AN1792 genannt ... und schon ist die Verwirrung komplett.
War wohl wieder dieser bekloppte Feuerstein.
War wohl wieder dieser bekloppte Feuerstein.
Antwort auf Beitrag Nr.: 33.912.404 von GuHu1 am 17.04.08 20:45:14mal ebend kurz aus dem IV.
http://www.investorvillage.com/mbthread.asp?mb=160&tid=45813…
Ok Folks Here It Is On ACC-001 (NOT AAB-001) 1 Patient Out Of 228 To Be Enrolled Got An Unexpected Skin Rash, Thought To Be Vasculitis A Non Life Threatening Event
Upon examination and treatment the rash resolved. Biopsy could not confirm the rash as vasculitis.
Next steps, Wyeth and Elan will need to alert the clinical sites about the possibility of the rash and amend the protocol to have this checked for. If seen it will need to be immediately reported to the sponsor.
This sort of thing happens all of the time in Pharma world take it from one who lives this stuff 9-5.
ACC-001 is the active vaccine that is the second generation to AN-1792 which caused Encephalitic reactions in a small percentage of patients tested back a few years ago.
AAB-001 is the passive form and mechanistically is a whole different animal to ACC-001.
THIS IS A NON EVENT.
Hound
http://www.investorvillage.com/mbthread.asp?mb=160&tid=45813…
Ok Folks Here It Is On ACC-001 (NOT AAB-001) 1 Patient Out Of 228 To Be Enrolled Got An Unexpected Skin Rash, Thought To Be Vasculitis A Non Life Threatening Event
Upon examination and treatment the rash resolved. Biopsy could not confirm the rash as vasculitis.
Next steps, Wyeth and Elan will need to alert the clinical sites about the possibility of the rash and amend the protocol to have this checked for. If seen it will need to be immediately reported to the sponsor.
This sort of thing happens all of the time in Pharma world take it from one who lives this stuff 9-5.
ACC-001 is the active vaccine that is the second generation to AN-1792 which caused Encephalitic reactions in a small percentage of patients tested back a few years ago.
AAB-001 is the passive form and mechanistically is a whole different animal to ACC-001.
THIS IS A NON EVENT.
Hound
Antwort auf Beitrag Nr.: 33.912.449 von Holgus am 17.04.08 20:49:27yep
Street.com
If you are educated, and know how the author at the street.com, he is usually is the first to post negative articles, and, well get used to it.
Lets look at few things.
1) No one knows what caused this reaction to the skin
2) The person that had some type of reaction, is fine and released from hospital
Look if you know ELN, then you know what will follow here, little sell off, some news will surface, and give, in much greater detail, the reasoning behind the removal of the high dose.
So, if your long and Strong sit tight, if not sell, and ride the wave.
Street.com
If you are educated, and know how the author at the street.com, he is usually is the first to post negative articles, and, well get used to it.
Lets look at few things.
1) No one knows what caused this reaction to the skin
2) The person that had some type of reaction, is fine and released from hospital
Look if you know ELN, then you know what will follow here, little sell off, some news will surface, and give, in much greater detail, the reasoning behind the removal of the high dose.
So, if your long and Strong sit tight, if not sell, and ride the wave.
Antwort auf Beitrag Nr.: 33.912.464 von GuHu1 am 17.04.08 20:50:58Statt das dieser blöde Elan-Laden mal eine Pressemitteilung rausgibt.
Aber nee ... die machen wie immer nichts.
Morgen laufen ja schließlich die Optionen aus und Kelly beschert seinen Bankerfreunden mit seiner Haltung jeden Monat aufs Neue deftige Gewinne ... würg.
Aber nee ... die machen wie immer nichts.
Morgen laufen ja schließlich die Optionen aus und Kelly beschert seinen Bankerfreunden mit seiner Haltung jeden Monat aufs Neue deftige Gewinne ... würg.
$23,82 geht doch.
Antwort auf Beitrag Nr.: 33.912.498 von GuHu1 am 17.04.08 20:54:39ELN msg # 220850 4/17/2008 1:38:09 PM
By: stockhound4
Ok Folks Here It Is On ACC-001 (NOT AAB-001) 1 Patient Out Of 228 To Be Enrolled Got An Unexpected Skin Rash, Thought To Be Vasculitis A Non Life Threatening Event
Upon examination and treatment the rash resolved. Biopsy could not confirm the rash as vasculitis.
Next steps, Wyeth and Elan will need to alert the clinical sites about the possibility of the rash and amend the protocol to have this checked for. If seen it will need to be immediately reported to the sponsor.
This sort of thing happens all of the time in Pharma world take it from one who lives this stuff 9-5.
ACC-001 is the active vaccine that is the second generation to AN-1792 which caused Encephalitic reactions in a small percentage of patients tested back a few years ago.
AAB-001 is the passive form and mechanistically is a whole different animal to ACC-001.
THIS IS A NON EVENT.
Hound KEEP COOL!
By: stockhound4
Ok Folks Here It Is On ACC-001 (NOT AAB-001) 1 Patient Out Of 228 To Be Enrolled Got An Unexpected Skin Rash, Thought To Be Vasculitis A Non Life Threatening Event
Upon examination and treatment the rash resolved. Biopsy could not confirm the rash as vasculitis.
Next steps, Wyeth and Elan will need to alert the clinical sites about the possibility of the rash and amend the protocol to have this checked for. If seen it will need to be immediately reported to the sponsor.
This sort of thing happens all of the time in Pharma world take it from one who lives this stuff 9-5.
ACC-001 is the active vaccine that is the second generation to AN-1792 which caused Encephalitic reactions in a small percentage of patients tested back a few years ago.
AAB-001 is the passive form and mechanistically is a whole different animal to ACC-001.
THIS IS A NON EVENT.
Hound KEEP COOL!
Antwort auf Beitrag Nr.: 33.911.654 von Holgus am 17.04.08 19:31:27Holgus,in einem BIOTECH Wert hast Du nie Deine Ruhe.....die FORSCHEN nämlich "in echt"-und da gibts eben auch mal Komplikationen.....vielleicht solltest Du lieber Beate Uhse kaufen--wie Du weisst,ist auf dieses "Underlying"Verlass....
ELN msg # 220814 4/17/2008 1:13:25 PM
By: Dr_bjchilds
Re: From another board
I sent Elizabeth Lopatto an e-mail advising her that the story should have specified which drug was suspended as many erroneously thought she was referring to AAB-001. I also advised her that only one of the two ACC-001 PII trials was suspended and that the lower dose trial was still active and suggested that in a correction she should include both of these pieces of info.
ELN msg # 220814 4/17/2008 1:13:25 PM
By: Dr_bjchilds
Re: From another board
I sent Elizabeth Lopatto an e-mail advising her that the story should have specified which drug was suspended as many erroneously thought she was referring to AAB-001. I also advised her that only one of the two ACC-001 PII trials was suspended and that the lower dose trial was still active and suggested that in a correction she should include both of these pieces of info.
ELN msg # 221065 4/17/2008 4:56:31 PM
By: vocex1
A Better Day Than Yesterday
In spite of the huge intraday volatility today, on balance, my intuition tells me this is a better day, at least for pissant ELN shareholders, than yesterday.
WYE?
Because yesterday we had the market react to huge good news on all Tysabri fronts, efficacy, disease process termination, safety, the whole nine yards, even a quick and effective method to reverse ANY signs of PML is now in place and before the doubting neuros.
Today, we had an 'ELN Event' which consisted of one person on trial having a reaction to the vaccine, the cause of which cannot be known at this time. And the vaccine is years off, and not a major AD effort in the arsenal, anyway. And it was only a higher dosage issue that resulted in the termination of that portion of the trial, the trial continues with lower dosage.
Today, the 'financial media' broadcast in mid day trading shrieking headlines, to wit: 'Elan stops Alzheimer's Trial'. (details to follow, LOL).
Stock price plummets right on cue, trading activity suspect with huge spreads, same as it ever was for our specialist, and then, mirable visu, Goldman comes to the fore and broadcasts the real news and perspective, with the bullhorn the baddest player on the Street can only have.
Dr. Childs had contacted ELN IR directly earlier today, (Thank you ,Sir) and brought this potential FUD-driver to the 'fast response' team at IR, and a few minutes prior to close, we FINALLY got them off there butts to write a quick response with the proper perspective of this event, in context of AAB-001.
So, to me, this is a big day for shareholders, who have suffered endlessly at the hands of the 'financial media' that highlights any potential negative for ELN, and ignores or downplays our positives(see Barron's 17 mentions of WYE irt Bap vs. 1 to ELN, for example).
I don't know if the impetus for ELN IR doing the right thing was the fact the Goldman felt this material event was important enough that they would weigh in, intraday, and at that point, apparently ELN IR/Management did not, but, whatever, IR finally got off the dime and did their job, and pro-activily defended the lead AD drug with this release.
Note to ELN IR:
So cheers to ELN IR, you earned your salaries today, all it took was writing a couple of paragraphs to PUT THE EVENT IN PERSPECTIVE.
Once you have done it, it will feel good to do it again, and you can bet the FUD will continue, so sharpen up your speed typing skills.
Also, revisit the manual which defines 'Material Event' so you don't have to have cover from the likes of Goldman to do your job. Thank you so very much.
vocex1
By: vocex1
A Better Day Than Yesterday
In spite of the huge intraday volatility today, on balance, my intuition tells me this is a better day, at least for pissant ELN shareholders, than yesterday.
WYE?
Because yesterday we had the market react to huge good news on all Tysabri fronts, efficacy, disease process termination, safety, the whole nine yards, even a quick and effective method to reverse ANY signs of PML is now in place and before the doubting neuros.
Today, we had an 'ELN Event' which consisted of one person on trial having a reaction to the vaccine, the cause of which cannot be known at this time. And the vaccine is years off, and not a major AD effort in the arsenal, anyway. And it was only a higher dosage issue that resulted in the termination of that portion of the trial, the trial continues with lower dosage.
Today, the 'financial media' broadcast in mid day trading shrieking headlines, to wit: 'Elan stops Alzheimer's Trial'. (details to follow, LOL).
Stock price plummets right on cue, trading activity suspect with huge spreads, same as it ever was for our specialist, and then, mirable visu, Goldman comes to the fore and broadcasts the real news and perspective, with the bullhorn the baddest player on the Street can only have.
Dr. Childs had contacted ELN IR directly earlier today, (Thank you ,Sir) and brought this potential FUD-driver to the 'fast response' team at IR, and a few minutes prior to close, we FINALLY got them off there butts to write a quick response with the proper perspective of this event, in context of AAB-001.
So, to me, this is a big day for shareholders, who have suffered endlessly at the hands of the 'financial media' that highlights any potential negative for ELN, and ignores or downplays our positives(see Barron's 17 mentions of WYE irt Bap vs. 1 to ELN, for example).
I don't know if the impetus for ELN IR doing the right thing was the fact the Goldman felt this material event was important enough that they would weigh in, intraday, and at that point, apparently ELN IR/Management did not, but, whatever, IR finally got off the dime and did their job, and pro-activily defended the lead AD drug with this release.
Note to ELN IR:
So cheers to ELN IR, you earned your salaries today, all it took was writing a couple of paragraphs to PUT THE EVENT IN PERSPECTIVE.
Once you have done it, it will feel good to do it again, and you can bet the FUD will continue, so sharpen up your speed typing skills.
Also, revisit the manual which defines 'Material Event' so you don't have to have cover from the likes of Goldman to do your job. Thank you so very much.
vocex1
Antwort auf Beitrag Nr.: 33.913.563 von GuHu1 am 17.04.08 22:38:49wird halt nicht langweilig mit unserem Baby
Gute Nacht alle miteinander.
Wünsche angenehme Träume.
Wünsche angenehme Träume.
dann wollen wir doch mal schauen was der heutige Tag so bringt.
Freitag ist in der Regel ja gar nicht so schlecht für uns.
(habe immer noch nicht gekauft, werde ich wohl auch nicht mehr, somit kann der Kurs jetzt auch richtig steigen)
Freitag ist in der Regel ja gar nicht so schlecht für uns.
(habe immer noch nicht gekauft, werde ich wohl auch nicht mehr, somit kann der Kurs jetzt auch richtig steigen)
After Hour:
After Hours
Last: $ 23.50
After Hours
High: $ 23.90
After Hours
Volume: 24,400
After Hours
Low: $ 23.3482
After Hours
Time (ET) After Hours Price After Hours Share Volume
18:50 $ 23.50 100
18:40 $ 23.50 200
18:21 $ 23.57 100
18:20 $ 23.57 400
18:19 $ 23.60 100
18:06 $ 23.65 1,000
17:47 $ 23.89 100
17:47 $ 23.89 900
17:47 $ 23.90 100
17:39 $ 23.80 100
17:39 $ 23.60 400
17:39 $ 23.60 500
16:47 $ 23.90 400
16:18 $ 23.3482 20,000
After Hours
Last: $ 23.50
After Hours
High: $ 23.90
After Hours
Volume: 24,400
After Hours
Low: $ 23.3482
After Hours
Time (ET) After Hours Price After Hours Share Volume
18:50 $ 23.50 100
18:40 $ 23.50 200
18:21 $ 23.57 100
18:20 $ 23.57 400
18:19 $ 23.60 100
18:06 $ 23.65 1,000
17:47 $ 23.89 100
17:47 $ 23.89 900
17:47 $ 23.90 100
17:39 $ 23.80 100
17:39 $ 23.60 400
17:39 $ 23.60 500
16:47 $ 23.90 400
16:18 $ 23.3482 20,000
gefällt mir!ELN msg # 221221 4/17/2008 10:16:24 PMBy: keeferlit
NEWS: Goldman upgraded by Elan Investor Village Message Board
Goldman Sachs upgraded by Elan Investor Village Messsage Board
Friday April 18, 10:00 pm ET
NEW YORK--(BUSINESS WIRE)-- Elan Investor Village Message Board (NYSE: ELN - Message Board) today announced that it had upgraded Goldman Sachs (NYSE: GS) to a rating of "Friend of Elan", from its previous rating of "Can we really trust these guys?". A board spokeman stated "Goldman have demonstrated that with a little effort they can appreciate some of the true value of Elan's drugs. They also correctly see that the arm of the ACC-001 trial that failed was worth only $0.04." The spokesman also stated that all board members were being advised to stop referring to them as Goldman Sucks, because "they're turning out to be nicer guys than we thought".
In a subsequent PR, Elan Investor Village Message Board also notified that it was downgrading Leechman Bros (NYSE:LEH) to its lowest rating 'Scum of the Earth' because, "these guys really are the scum of the earth". Leechman analyst Dick Silver was unavailable for comment despite being seen drowning his sorrows in Manhattan with financial journalist Adam Fudstein.
Ratings for Merril Lynchmob (NYSE:ML) and Credit Suisse Feckin Bastards (NYSE:CSFB) remain unchanged at "Haven't Got a Clue".
....und Elan hat DOCH eine PR-Abteilung (ob die wohl durchbezahlt werden wenn sie nur 3 Tage im Jahr arbeiten?????)
ELN msg # 221306 4/18/2008 5:17:24 AM
By: ArbourHill_D7
Comments from Jonathan Birt, a spokesman for Ireland-based Elan - Irish Times - Breaking News Section.
Last Updated: 18/04/2008 09:19
Elan, Wyeth suspend Alzheimer's study
Biotech group Elan said last night that a mid-stage clinical trial of an Alzheimer's vaccine it is developing with Wyeth has been suspended while the companies look into a potentially serious side effect suffered by one patient in the study.
Dosing in the study of the experimental vaccine, ACC-001, was halted after the patient was hospitalized with skin lesions from what the physician serving as lead researcher suspected was a case of vasculitis, an inflammation of blood vessels.
"Following discussion with the FDA, all further dosing has been suspended while this particular event is fully evaluated," Jonathan Birt, a spokesman for Ireland-based Elan, said.
The companies are in talks with health regulators and the physician to further understand the clinical and scientific issues, Mr Birt added.
He said the patient has been released from the hospital and the lesions are healing.
companies stressed that the vaccine and study in question has no connection to bapineuzumab, their lead Alzheimer's drug candidate alsoThe being developed with Wyeth that is in late-stage clinical testing.
At 9am shares in Elan were trading at €15.77 on the Dublin market, up over 3 per cent on yesterday’s closing price.
ELN msg # 221306 4/18/2008 5:17:24 AM
By: ArbourHill_D7
Comments from Jonathan Birt, a spokesman for Ireland-based Elan - Irish Times - Breaking News Section.
Last Updated: 18/04/2008 09:19
Elan, Wyeth suspend Alzheimer's study
Biotech group Elan said last night that a mid-stage clinical trial of an Alzheimer's vaccine it is developing with Wyeth has been suspended while the companies look into a potentially serious side effect suffered by one patient in the study.
Dosing in the study of the experimental vaccine, ACC-001, was halted after the patient was hospitalized with skin lesions from what the physician serving as lead researcher suspected was a case of vasculitis, an inflammation of blood vessels.
"Following discussion with the FDA, all further dosing has been suspended while this particular event is fully evaluated," Jonathan Birt, a spokesman for Ireland-based Elan, said.
The companies are in talks with health regulators and the physician to further understand the clinical and scientific issues, Mr Birt added.
He said the patient has been released from the hospital and the lesions are healing.
companies stressed that the vaccine and study in question has no connection to bapineuzumab, their lead Alzheimer's drug candidate alsoThe being developed with Wyeth that is in late-stage clinical testing.
At 9am shares in Elan were trading at €15.77 on the Dublin market, up over 3 per cent on yesterday’s closing price.
Interessanter Chart Heute:
Antwort auf Beitrag Nr.: 33.919.870 von Poppholz am 18.04.08 16:01:05....da kann man doch nicht meckern...
...so, nun mal wieder ein paar News.....PR kommt langsam in die Pötte....
18 April 2008
Elan to Present at the Morgan Stanley Global Healthcare Unplugged Conference and Host Company Day
DUBLIN, Ireland--(BUSINESS WIRE)--April 18, 2008
--Elan Corporation, plc (NYSE: ELN) today announced that it will present at the Morgan Stanley Global Healthcare Unplugged Conference on Thursday, May 1, 2008 at 11:20am EDT in Miami, Florida.
Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com, then clicking on the event icon.
In addition, Elan will hold a Company Day on Wednesday May 7, 2008, beginning at 8am EDT and ending around 12pm EDT. The event will include strategic overviews of Research, Development, Commercial and Elan Drug Technology activities.
Interested parties may access a live audio web cast of the event by visiting the Investor Relations section of the Elan website at www.elan.com, then clicking on the event icon.
http://www.elan.com/news/full.asp?ID=1132085
18 April 2008
Elan to Present at the Morgan Stanley Global Healthcare Unplugged Conference and Host Company Day
DUBLIN, Ireland--(BUSINESS WIRE)--April 18, 2008
--Elan Corporation, plc (NYSE: ELN) today announced that it will present at the Morgan Stanley Global Healthcare Unplugged Conference on Thursday, May 1, 2008 at 11:20am EDT in Miami, Florida.
Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com, then clicking on the event icon.
In addition, Elan will hold a Company Day on Wednesday May 7, 2008, beginning at 8am EDT and ending around 12pm EDT. The event will include strategic overviews of Research, Development, Commercial and Elan Drug Technology activities.
Interested parties may access a live audio web cast of the event by visiting the Investor Relations section of the Elan website at www.elan.com, then clicking on the event icon.
http://www.elan.com/news/full.asp?ID=1132085
Antwort auf Beitrag Nr.: 33.922.890 von bernie55 am 18.04.08 21:01:31Hi ELANis.
Ich grüße Euch aus dem noch vorhandenen Urwald in Sumatra. Aber ich glaube wird bald auch verschwinden, da hier sehr viel Palmölplantagen eröffnet wird. Mit dem Palmöln wird auch BIODIESEL gewonnen
Schön, dass Ihr gut auf unseren ELAN aufgepasst habt
Ich grüße Euch aus dem noch vorhandenen Urwald in Sumatra. Aber ich glaube wird bald auch verschwinden, da hier sehr viel Palmölplantagen eröffnet wird. Mit dem Palmöln wird auch BIODIESEL gewonnen
Schön, dass Ihr gut auf unseren ELAN aufgepasst habt
Antwort auf Beitrag Nr.: 33.924.339 von surga am 19.04.08 03:21:56....also Surga--Wir beschützen Elanie-und Du den sumatrischen Urwald,ok?????....gibts Bilder von da wo Du bist????????????????????????
Schöne Zeit!!!Birgit
Schöne Zeit!!!Birgit
ELN msg # 221852 4/19/2008 12:51:17 AM
By: Creedster_99
What are we waiting for?
1. Passover?
2. The Second Coming?
3. EDT spin off/sale?
4. Tysabri sales to hit 500/wk?
5. AAB topline data?
6. BLA filing for AAB?
7. The bidding war or fight for Independence?
8. The chance to prove to everyone who knows you that you were right all along and Elan WAS worth investing in!
I submit to you that as importantas #1 and #2 are, most everyone who has been here for any length of time just wants #8.
Tysabri is still in the "show me phase..until they get to 75-100K patients.
EDT works well but not nearly enough to make Elan a "household" name
At this point, it's not so much about the money (though that would be nice)....it's about vindication!
I want to be able to hold my head up with pride, when Elan scientists win the Nobel prize for Medicine, to be able to say, "Elan.....oh yes, I've supported their science for years!"
And further, ....as I point to that nice home on the hill...."That's the home that Elan built for me!"
I don't seek riches, for I'm already blessed with so many graces, including a beautiful family, friends, and several hundred cyberfriends here, I'm waiting for the validation of my faith and belief in a small, beaten up, left for dead, little shit of a company that wouldn't say "uncle" and die!
I still own shares I purchased for the low $1's....I still thank Garo for giving me hope when all seemed lost. I thank Kelly for his part in keeping the listing ship afloat and allowing the science to continue!
I want to be able to tell David Maris, Jessie Eisenger, Adam Fuerstein, Dick Silver, Erika Whittaker, and so many others......"You were wrong!"
Should that day come, when I go to Sweden to congratulate and celebrate our common victory over doubt and despair, I will smile broadly and say, "It was worth it all, just for today!"
We may not cure Alzheimer's disease but I sincerely hope that we can preserve the dignity of our Mothers and Fathers for years to come.
God Bless Elan.
By: Creedster_99
What are we waiting for?
1. Passover?
2. The Second Coming?
3. EDT spin off/sale?
4. Tysabri sales to hit 500/wk?
5. AAB topline data?
6. BLA filing for AAB?
7. The bidding war or fight for Independence?
8. The chance to prove to everyone who knows you that you were right all along and Elan WAS worth investing in!
I submit to you that as importantas #1 and #2 are, most everyone who has been here for any length of time just wants #8.
Tysabri is still in the "show me phase..until they get to 75-100K patients.
EDT works well but not nearly enough to make Elan a "household" name
At this point, it's not so much about the money (though that would be nice)....it's about vindication!
I want to be able to hold my head up with pride, when Elan scientists win the Nobel prize for Medicine, to be able to say, "Elan.....oh yes, I've supported their science for years!"
And further, ....as I point to that nice home on the hill...."That's the home that Elan built for me!"
I don't seek riches, for I'm already blessed with so many graces, including a beautiful family, friends, and several hundred cyberfriends here, I'm waiting for the validation of my faith and belief in a small, beaten up, left for dead, little shit of a company that wouldn't say "uncle" and die!
I still own shares I purchased for the low $1's....I still thank Garo for giving me hope when all seemed lost. I thank Kelly for his part in keeping the listing ship afloat and allowing the science to continue!
I want to be able to tell David Maris, Jessie Eisenger, Adam Fuerstein, Dick Silver, Erika Whittaker, and so many others......"You were wrong!"
Should that day come, when I go to Sweden to congratulate and celebrate our common victory over doubt and despair, I will smile broadly and say, "It was worth it all, just for today!"
We may not cure Alzheimer's disease but I sincerely hope that we can preserve the dignity of our Mothers and Fathers for years to come.
God Bless Elan.
Antwort auf Beitrag Nr.: 33.924.979 von Birgit.Tersteegen am 19.04.08 11:38:55
Ja, ich schicke Euch den Link wenn ich wieder in Deutschland bin, da die Internetverbindung nicht gerade schnell ist
Ja, ich schicke Euch den Link wenn ich wieder in Deutschland bin, da die Internetverbindung nicht gerade schnell ist
der Freitag (wie erwartet) gut gelaufen.
Wäre doch nett, wenn dieser Trend noch ein paar Tage anhalten würde.
Wäre doch nett, wenn dieser Trend noch ein paar Tage anhalten würde.
Irland und London stehen bei €16,00
Ist sehr schön anzusehen.
Bin gespannt, wo wir um 15:00 Uhr stehen.
Ist sehr schön anzusehen.
Bin gespannt, wo wir um 15:00 Uhr stehen.
besonders gut gefällt mir das hohe Volumen, das zu einem kontinuierlichen Anstieg gesorgt hat.
Antwort auf Beitrag Nr.: 33.930.945 von Poppholz am 21.04.08 10:58:23ALLES prima in Elanville....(wenn der blöde Dollar nicht wäre,wäre unser + DEUTLICHST grösser...)
NCB Update: With Q1 Tysabri numbers disclosed, focus to be on Crohn’s roll-out and AD pipeline
Q1 Forecasts: Elan reports Q1 2008 results on 24 April where the focus will be on (i) the roll-out of Tysabri in the US for Crohn’s Disease, (ii) the AD pipeline -bapineuzumab (AAB-001) in particular and (iii) any update on the guidance of total revenues c.$1bn for FY2008 given last quarter. Q1 forecasts are shown on page 2. We are anticipating total revenues of $216.1m, a 23% increase, operating losses (precharges) of $51.6m and the EPS (adjusted) loss is expected to be -$0.18 compared to a -$0.16 loss in the comparable period. Ahead of Elan’s results, BiogenIdec will report Tysabri global in-market sales in the quarter in its Q1 release on 23 April. Patient numbers for the quarter were disclosed at the annual AAN meeting last week.
Product Revenue Forecasts: We are expecting product revenues to increase 26% to $211.1m primarily reflecting sales of Tysabri. The hospital product revenues are expected to decline y-o-y as generic competition continues to affect Maxipime. No generic of Azactam has been approved to our knowledge and management noted last quarter that they expect this to remain the case through 2008. Prialt should continue showing improvements with revenues of $4.0m anticipated.
Tysabri utilisation data and forecasts: The global Tysabri utilisation data as of the end of March was ahead of our expectations for the quarter with a strong uptick in EU/RoW patient numbers. The Tysabri patient numbers to the end of March were 25,500 patients internationally on therapy with 15,300 on treatment in the US and 10,200 patients on treatment in EU/RoW. The global patient numbers as of the end of March indicates that Elan is on track to report global in-market sales of $159.3m, comprising US revenues of $96.6m with in-market sales in EU/RoW of $62.7m.
Pipeline Update: An update is also likely on the AD pipeline following the recent suspension of ACC-001. The focus will be on the advancement of clinical trials for AAB-001 and ELND-005. AAB-001 headline Phase II data is expected in June, while the entire Phase II data is expected to be released at the ICAD conference in late July. Initial enrollments for the AAB-001 RoW Phase III study is expected in H1 (US Phase III study commenced in December 2007).
Outlook: Key near-term drivers of the share include positive headline Phase II AAB-001 data (expected in June), which could allow for upward revision to forecasts. The post results conference call is at 13.30 GMT/8.30 ET. Call in details: + 888 434 1984 (US) or +1 706 758 4972 (non US).
(wenn der blöde Dollar nicht wäre,wäre unser + DEUTLICHST grösser...)NCB Update: With Q1 Tysabri numbers disclosed, focus to be on Crohn’s roll-out and AD pipelineQ1 Forecasts: Elan reports Q1 2008 results on 24 April where the focus will be on (i) the roll-out of Tysabri in the US for Crohn’s Disease, (ii) the AD pipeline -bapineuzumab (AAB-001) in particular and (iii) any update on the guidance of total revenues c.$1bn for FY2008 given last quarter. Q1 forecasts are shown on page 2. We are anticipating total revenues of $216.1m, a 23% increase, operating losses (precharges) of $51.6m and the EPS (adjusted) loss is expected to be -$0.18 compared to a -$0.16 loss in the comparable period. Ahead of Elan’s results, BiogenIdec will report Tysabri global in-market sales in the quarter in its Q1 release on 23 April. Patient numbers for the quarter were disclosed at the annual AAN meeting last week.
Product Revenue Forecasts: We are expecting product revenues to increase 26% to $211.1m primarily reflecting sales of Tysabri. The hospital product revenues are expected to decline y-o-y as generic competition continues to affect Maxipime. No generic of Azactam has been approved to our knowledge and management noted last quarter that they expect this to remain the case through 2008. Prialt should continue showing improvements with revenues of $4.0m anticipated.
Tysabri utilisation data and forecasts: The global Tysabri utilisation data as of the end of March was ahead of our expectations for the quarter with a strong uptick in EU/RoW patient numbers. The Tysabri patient numbers to the end of March were 25,500 patients internationally on therapy with 15,300 on treatment in the US and 10,200 patients on treatment in EU/RoW. The global patient numbers as of the end of March indicates that Elan is on track to report global in-market sales of $159.3m, comprising US revenues of $96.6m with in-market sales in EU/RoW of $62.7m.
Pipeline Update: An update is also likely on the AD pipeline following the recent suspension of ACC-001. The focus will be on the advancement of clinical trials for AAB-001 and ELND-005. AAB-001 headline Phase II data is expected in June, while the entire Phase II data is expected to be released at the ICAD conference in late July. Initial enrollments for the AAB-001 RoW Phase III study is expected in H1 (US Phase III study commenced in December 2007).
Outlook: Key near-term drivers of the share include positive headline Phase II AAB-001 data (expected in June), which could allow for upward revision to forecasts. The post results conference call is at 13.30 GMT/8.30 ET. Call in details: + 888 434 1984 (US) or +1 706 758 4972 (non US).
Antwort auf Beitrag Nr.: 33.931.029 von Birgit.Tersteegen am 21.04.08 11:09:33Birgit, wieso interessiert Dich der Dollar so ? Ihr habt Eure Papiere doch alle in Frankfurt gekauft, oder ?
Also mußt Du doch nie zurücktauschen.
Also mußt Du doch nie zurücktauschen.
Antwort auf Beitrag Nr.: 33.931.076 von Holgus am 21.04.08 11:16:11Hallo Holger,
Birgit meint sicherlich, dass der Dollar gegenüber dem Euro seit dem letzten Jahr immer weniger wert wird und somit Kurssteigerungen für uns nicht so in die Prozente gehen.
Bei einem imaginären Wechsel-Kurs USD/ € von z. B. 1,30 wären wir bei 25 USD mit 19,23 € dabei .......
... und nicht, wie aktuell, bei ca. 15,80 € -16,00 €.
that`s all...
Birgit meint sicherlich, dass der Dollar gegenüber dem Euro seit dem letzten Jahr immer weniger wert wird und somit Kurssteigerungen für uns nicht so in die Prozente gehen.
Bei einem imaginären Wechsel-Kurs USD/ € von z. B. 1,30 wären wir bei 25 USD mit 19,23 € dabei .......
... und nicht, wie aktuell, bei ca. 15,80 € -16,00 €.
that`s all...
Antwort auf Beitrag Nr.: 33.931.076 von Holgus am 21.04.08 11:16:11Hallo Holgie,
leider ist es so, dass sich der Kurs in Europa nur an den Kursen in den USA anlehnt.
Wenn wir also einen Wechselkurs von 1 zu 1,10 hätten und nicht wie aktuell einen Kurs von 1 zu 1,6, dann wären wir viel höher im Kurs.
Das ist halt unser "Wechselkursrisiko".
leider ist es so, dass sich der Kurs in Europa nur an den Kursen in den USA anlehnt.
Wenn wir also einen Wechselkurs von 1 zu 1,10 hätten und nicht wie aktuell einen Kurs von 1 zu 1,6, dann wären wir viel höher im Kurs.
Das ist halt unser "Wechselkursrisiko".
Antwort auf Beitrag Nr.: 33.931.460 von bernie55 am 21.04.08 12:06:57sorry, habe Deine Erklärung zu spät gesehen.
Antwort auf Beitrag Nr.: 33.931.639 von Poppholz am 21.04.08 12:30:32Wenn der Kurs über die € 16,- Marke klettert, dann habe ich nur noch eine Position im roten Bereich.
Antwort auf Beitrag Nr.: 33.931.660 von Poppholz am 21.04.08 12:33:11Wenn der Kurs über die € 16,- Marke klettert, dann habe ich nur noch eine Position im roten Bereich.
..ich wusste gar nicht, dass du noch Beate Uhse Aktien im Depot hast...
..ich wusste gar nicht, dass du noch Beate Uhse Aktien im Depot hast...
Antwort auf Beitrag Nr.: 33.931.700 von bernie55 am 21.04.08 12:38:24..sicherlich meintest du ELAN Aktien, ne ???
Antwort auf Beitrag Nr.: 33.931.076 von Holgus am 21.04.08 11:16:11ich habe beide europäischen Aktien und zusätzlich die 871331 in Dollar gekauft....aber da der Kurs bei uns sich ja -leider- immer an USA orientiert,rechnet man natürlich mit dem ungünstigen Dollarkurs um....
Antwort auf Beitrag Nr.: 33.931.915 von Birgit.Tersteegen am 21.04.08 13:06:34871331 ???
Wieviel hast Du in Dollar gekauuuuuuf ????
Aber ich geb Euch recht, war ein falscher Gedankengang von mir.
Zum Glück hab ich direkt in Dollar gekauft ... da juckt mich der Wechselkurs nich ... zumindest im Moment nich.
Da ich aber meine Kohle bei 1,18 eingetauscht habe, werd ich beim ev. Rückholen des Geldes natürlich genauso leiden wie Ihr.
Wieviel hast Du in Dollar gekauuuuuuf ????
Aber ich geb Euch recht, war ein falscher Gedankengang von mir.
Zum Glück hab ich direkt in Dollar gekauft ... da juckt mich der Wechselkurs nich ... zumindest im Moment nich.
Da ich aber meine Kohle bei 1,18 eingetauscht habe, werd ich beim ev. Rückholen des Geldes natürlich genauso leiden wie Ihr.
Zwischendruch mal `nen Gruß an unsere Russenschnepfe.
Nosta, warum hast Du Dich so sang- und klanglos hier abgemeldet ?
Nur noch gefrustet über den ganzen Scheiß ?
Wenn dat Mädel überhaupt noch mitliest ...
Nosta, warum hast Du Dich so sang- und klanglos hier abgemeldet ?
Nur noch gefrustet über den ganzen Scheiß ?
Wenn dat Mädel überhaupt noch mitliest ...
Antwort auf Beitrag Nr.: 33.932.188 von Holgus am 21.04.08 13:37:43871331 ???
...das ist die WKN NR. !!!
...das ist die WKN NR. !!!
Antwort auf Beitrag Nr.: 33.932.225 von bernie55 am 21.04.08 13:42:56...das ist die WKN NR. !!!
Achsooo, dann sach dat doch ... menno.
In den USA is nix mit WKN-Nummer, dan nimmt man einfach das Kürzel ELN und das wars dann, zumindest wenn man da direkt tradet.
Achsooo, dann sach dat doch ... menno.
In den USA is nix mit WKN-Nummer, dan nimmt man einfach das Kürzel ELN und das wars dann, zumindest wenn man da direkt tradet.
von zenman 06.06.05 09:03:17 Beitrag Nr.: 16.813.097
yep leute
DAS is nen neuen thread wert Cool
hier der beitrag aussm yahoo-board
der mich dazu inspiriert hat
by: raging_bull_10
Long-Term Sentiment: Strong Buy 06/03/05 02:09 pm
Msg: 677509 of 677528
Sitting at $7 right now.
BIIB just gave you some thoughts from a few patients around the country. Those voices are the tip of the iceberg. The Companies and FDA get calls and letters every day. You saw the need for the drug. 100,000 not on therapy, 30,000 new patients a year, 150,000 failing the therapy they are on. That is in the US only. Double those numbers for the EU. Once the FDA and ELN/BIIB tell everyone that Tysabri is very effective, actually stops MS in most patients and reverses the disability in many, we will again see major gains. Potential market is 500,000 patients in the short term. I bet 200,000 are on drug after 1-2 years. That would equate to revenues of $4.6 bill. Don’t be shocked when the revenues are so massive that production is still an issue. The estimate above could end up being low. Then we have crohns. Crohns has a similar number of patients and they have no effective treatment. Don’t be surprised if we see another 100,000 patients on Tysabri in that indication in a few years. Add $2.3 bill in revenues. Next comes RA. A phase 3 trial will begin later this year in RA. I have faith in that. If so within a couple years we will see revenues in RA. Could be $2 – 4 billion at some point. Tysabri will again be the best in class.
All the above is dependent on hearing that Tysabri is a safe drug. That is never a certainty but things are looking good thus far. No PML cases in mono therapy = safety. Infections and other SAEs have actually been better that other treatments. Eliminate the PML and everything will be great. If patients have an issue all they need to do it stop taking the drug for a month and the immune system will resolve the issue.
What is Tysabri worth when the Fda says it is safe and doesn’t even require a black box warning? Sales of $7 - $10 bill with half going to ELN. Margins in the mid 80%. You are looking at a $70 – 100 stock just on Tysabri alone.
When you add in Prialt, DD, AD and Parkinsons that share price will likely be a lot higher. This is only 2 – 3 years away. I am willing to wait if needed.
.................................................................................
Soviel zum Thema Timing an der Börse ... lol
yep leute
DAS is nen neuen thread wert Cool
hier der beitrag aussm yahoo-board
der mich dazu inspiriert hat
by: raging_bull_10
Long-Term Sentiment: Strong Buy 06/03/05 02:09 pm
Msg: 677509 of 677528
Sitting at $7 right now.
BIIB just gave you some thoughts from a few patients around the country. Those voices are the tip of the iceberg. The Companies and FDA get calls and letters every day. You saw the need for the drug. 100,000 not on therapy, 30,000 new patients a year, 150,000 failing the therapy they are on. That is in the US only. Double those numbers for the EU. Once the FDA and ELN/BIIB tell everyone that Tysabri is very effective, actually stops MS in most patients and reverses the disability in many, we will again see major gains. Potential market is 500,000 patients in the short term. I bet 200,000 are on drug after 1-2 years. That would equate to revenues of $4.6 bill. Don’t be shocked when the revenues are so massive that production is still an issue. The estimate above could end up being low. Then we have crohns. Crohns has a similar number of patients and they have no effective treatment. Don’t be surprised if we see another 100,000 patients on Tysabri in that indication in a few years. Add $2.3 bill in revenues. Next comes RA. A phase 3 trial will begin later this year in RA. I have faith in that. If so within a couple years we will see revenues in RA. Could be $2 – 4 billion at some point. Tysabri will again be the best in class.
All the above is dependent on hearing that Tysabri is a safe drug. That is never a certainty but things are looking good thus far. No PML cases in mono therapy = safety. Infections and other SAEs have actually been better that other treatments. Eliminate the PML and everything will be great. If patients have an issue all they need to do it stop taking the drug for a month and the immune system will resolve the issue.
What is Tysabri worth when the Fda says it is safe and doesn’t even require a black box warning? Sales of $7 - $10 bill with half going to ELN. Margins in the mid 80%. You are looking at a $70 – 100 stock just on Tysabri alone.
When you add in Prialt, DD, AD and Parkinsons that share price will likely be a lot higher. This is only 2 – 3 years away. I am willing to wait if needed.
.................................................................................
Soviel zum Thema Timing an der Börse ... lol
Antwort auf Beitrag Nr.: 33.932.417 von Holgus am 21.04.08 14:08:24da werden wohl noch einmal ein paar STOP LOSS gefischt:
Antwort auf Beitrag Nr.: 33.934.487 von Poppholz am 21.04.08 17:42:43....besser über 24 als unter 18....
Antwort auf Beitrag Nr.: 33.934.508 von Birgit.Tersteegen am 21.04.08 17:44:11da kann ich Dir absolut recht geben.
Guten Morgen....ein kleiner Wachmacher für die " frühen " Morgenstunden....
After Hours Last: $ 25.24
After Hours High: $ 25.24
After Hours Volume: 2,700
After Hours Low: $ 24.8242
After Hours Last: $ 25.24
After Hours High: $ 25.24
After Hours Volume: 2,700
After Hours Low: $ 24.8242
Leerink Swann (Morning Call)
Pt1 + Pt2
21-Apr-08 03:55 pm
Biotechnology – (Bill Tanner)
MEDACorp update on MS from AAN
● Bottom Line: MEDACorp hosted a PCS call yesterday with a leading MS neurologist to provide an update on late-breaking news from the ongoing AAN (American Academy of Neurology) meeting in Chicago (April 12-19). The call reaffirms our positive outlook on Tysabri, which is a major driver of value for Top Picks BIIB and ELN.
● Update on PML. The safety update provided by BIIB and ELN on Tuesday verified that no new cases of PML have occurred since Tysabri was re-introduced into the market 18 months ago. The MEDACorp consultant was of the opinion that the finding is encouraging as he would have expected some cases to have appeared by now. Further confidence may be gained once patient treatment eclipses the two-year mark (when PML appeared previously in patients treated with Tysabri). Clinical experience data suggest that development of PML may have been due to the combination of Tysabri with Avonex (or immunosuppressive agents in the Crohn's patient). The next safety update may come at the European Neurological Society (6/7-6/11), or more likely at ECTRIMS (9/17-9/20).
● PCR-Based Screening. One abstract discussed use of PCR screening to detect JC virus. The MEDACorp consultant feels such screening is not very illustrative as there tends to be a high rate of positive background positive blood tests (1-2%). Moreover, in the AFFIRM and SENTINEL studies, patients with PML did not present with high viral titers. Another criticism of the study by a PML expert was the higher-than-expected numbers of patients who were positive for BK virus in the CSF vs. numbers of patients who were positive for the JC virus.
● Plasmapharesis Update. New data were presented at AAN showing enhanced ability to reconstitute the immune system using plasmapharesis. Previous data (presented at ECTRIMS in October 2007) demonstrated that the procedure accelerates removal of Tysabri as well as desaturates the alpha 4 beta 7 receptors on T cells. The current abstract described the ability of white blood cells obtained from Tysabri-treated patients who were subjected to plasmapharesis to cross a synthetic blood/brain barrier. The MEDACorp consultant believes these data provide a theoretical groundwork supporting the use of plasmapharesis to accelerate patient recovery. The consultant noted that attendees at AAN found the recent observations encouraging, which may lead to accelerated adoption of Tysabri as physician concerns ease. As we noted earlier this week following the Tysabri safety and utilization update, increased adoption in the U.S. appears to be driven in large part by more physicians prescribing the drug (on average, approximately 5 patients/physician). Logic suggests to us that, an improving safety profile or a "rescue therapy" could induce physicians to prescribe the drug more broadly.
● Rituxan for MS. Phase I data for Rituxan in RRMS (relapsing remitting MS) showed no serious side effects. As discussed earlier this week, though, safety data from the Rituxan OLYMPUS study in primary progressive MS (PPMS) may not bode well for use of the drug because of the risk of infections associated with its use. We wonder whether use of Rituxan for treating chronic diseases is appropriate. The MEDACorp consultant indicated that the humanized version, ocrelizumab, may be the preferred option. A Phase II
trial in RRMS is currently underway.
● Future MS Treatments. The MEDACorp consultant believes that patients are anxiously awaiting oral MS treatments, the first of which is expected to be launched in 2011. The sub-group analysis of BIIB's BG 12 showed differing efficacy, which the consultant attributed to a smaller sample size. Overall, he views BG 12 as among the best of the five oral drugs in development, all of which he views as approvable.
● Conclusion. We believe Tysabri uptake will be the main driver of BIIB shares and are of the opinion that consensus expectations will be surpassed by actual results.
Reiterate Outperform on BIIB and ELN, Market Perform on DNA.
Pt1
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
Pt2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
Pt1 + Pt2
21-Apr-08 03:55 pm
Biotechnology – (Bill Tanner)
MEDACorp update on MS from AAN
● Bottom Line: MEDACorp hosted a PCS call yesterday with a leading MS neurologist to provide an update on late-breaking news from the ongoing AAN (American Academy of Neurology) meeting in Chicago (April 12-19). The call reaffirms our positive outlook on Tysabri, which is a major driver of value for Top Picks BIIB and ELN.
● Update on PML. The safety update provided by BIIB and ELN on Tuesday verified that no new cases of PML have occurred since Tysabri was re-introduced into the market 18 months ago. The MEDACorp consultant was of the opinion that the finding is encouraging as he would have expected some cases to have appeared by now. Further confidence may be gained once patient treatment eclipses the two-year mark (when PML appeared previously in patients treated with Tysabri). Clinical experience data suggest that development of PML may have been due to the combination of Tysabri with Avonex (or immunosuppressive agents in the Crohn's patient). The next safety update may come at the European Neurological Society (6/7-6/11), or more likely at ECTRIMS (9/17-9/20).
● PCR-Based Screening. One abstract discussed use of PCR screening to detect JC virus. The MEDACorp consultant feels such screening is not very illustrative as there tends to be a high rate of positive background positive blood tests (1-2%). Moreover, in the AFFIRM and SENTINEL studies, patients with PML did not present with high viral titers. Another criticism of the study by a PML expert was the higher-than-expected numbers of patients who were positive for BK virus in the CSF vs. numbers of patients who were positive for the JC virus.
● Plasmapharesis Update. New data were presented at AAN showing enhanced ability to reconstitute the immune system using plasmapharesis. Previous data (presented at ECTRIMS in October 2007) demonstrated that the procedure accelerates removal of Tysabri as well as desaturates the alpha 4 beta 7 receptors on T cells. The current abstract described the ability of white blood cells obtained from Tysabri-treated patients who were subjected to plasmapharesis to cross a synthetic blood/brain barrier. The MEDACorp consultant believes these data provide a theoretical groundwork supporting the use of plasmapharesis to accelerate patient recovery. The consultant noted that attendees at AAN found the recent observations encouraging, which may lead to accelerated adoption of Tysabri as physician concerns ease. As we noted earlier this week following the Tysabri safety and utilization update, increased adoption in the U.S. appears to be driven in large part by more physicians prescribing the drug (on average, approximately 5 patients/physician). Logic suggests to us that, an improving safety profile or a "rescue therapy" could induce physicians to prescribe the drug more broadly.
● Rituxan for MS. Phase I data for Rituxan in RRMS (relapsing remitting MS) showed no serious side effects. As discussed earlier this week, though, safety data from the Rituxan OLYMPUS study in primary progressive MS (PPMS) may not bode well for use of the drug because of the risk of infections associated with its use. We wonder whether use of Rituxan for treating chronic diseases is appropriate. The MEDACorp consultant indicated that the humanized version, ocrelizumab, may be the preferred option. A Phase II
trial in RRMS is currently underway.
● Future MS Treatments. The MEDACorp consultant believes that patients are anxiously awaiting oral MS treatments, the first of which is expected to be launched in 2011. The sub-group analysis of BIIB's BG 12 showed differing efficacy, which the consultant attributed to a smaller sample size. Overall, he views BG 12 as among the best of the five oral drugs in development, all of which he views as approvable.
● Conclusion. We believe Tysabri uptake will be the main driver of BIIB shares and are of the opinion that consensus expectations will be surpassed by actual results.
Reiterate Outperform on BIIB and ELN, Market Perform on DNA.
Pt1
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
Pt2
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
Antwort auf Beitrag Nr.: 33.939.028 von bernie55 am 22.04.08 09:36:05
....läuft doch
ELN msg # 222680 4/22/2008 12:06:04 PM
By: peadar_og
Re: Close to the vest...
You’re not wrong. Of course they know the results. The first cohort finished Dec ’06.
Some possible events this year (mostly this summer):
Increased manufacturing capacity for Tysabri approved.
New factory to produce Bap to be built in Dublin (Ireland), partially funded by Irish Gov.
Elan and Lilly agree deal on Lilly’s lead AD product. (Up front cash and life time royalty to Elan vs 50% for 7 yrs).
FDA recommends that Tysabri should be used as a first line therapy for MS patients.
Bap data released.
Announce intention to file Bap for approval on phase II data + 6-month safety for 1000 patients.
Tysabri inflection point mid year.
Elan profitable by end of 3rd qtr.
FDA approval of paliperidone palmitate.
New phase II trials for other Tysabri indications.
Biogen receives takeover offer.
Elan ….
Other pipeline news.
ELN msg # 222680 4/22/2008 12:06:04 PMBy: peadar_og
Re: Close to the vest...
You’re not wrong. Of course they know the results. The first cohort finished Dec ’06.
Some possible events this year (mostly this summer):
Increased manufacturing capacity for Tysabri approved.
New factory to produce Bap to be built in Dublin (Ireland), partially funded by Irish Gov.
Elan and Lilly agree deal on Lilly’s lead AD product. (Up front cash and life time royalty to Elan vs 50% for 7 yrs).
FDA recommends that Tysabri should be used as a first line therapy for MS patients.
Bap data released.
Announce intention to file Bap for approval on phase II data + 6-month safety for 1000 patients.
Tysabri inflection point mid year.
Elan profitable by end of 3rd qtr.
FDA approval of paliperidone palmitate.
New phase II trials for other Tysabri indications.
Biogen receives takeover offer.
Elan ….
Other pipeline news.
ZUR INFO :
UCB erhält FDA-Zulassung für Cimzia,
Aktie deutlich im Plus
Brüssel (aktiencheck.de AG) - Der belgische Pharmakonzern UCB S.A (ISIN BE0003739530/ WKN 852738) hat von der US-Gesundheitsbehörde FDA die Marktzulassung für das Medikament Cimzia erhalten.
Wie der Konzern am Mittwoch erklärte, wurde das Medikament zur Behandlung von erwachsenen Patienten zugelassen, die an Morbus Chron erkrankt sind. Zuvor wurde eine umfangreiche Versuchsreihe mit mehr als 1.500 Patienten, die an einer gemäßigten bis schweren Form dieser chronischen Magen-Darm-Erkrankung leiden, erfolgreich abgeschlossen. Im Rahmen der klinischen Testreihen habe sich eine Abschwächung der Symptome und Auswirkungen der Krankheit bei den betroffenen Patienten gezeigt, die auf eine konventionelle Behandlung von Morbus Chron nur bedingt angesprochen hätten, teilte UCB weiter mit.
Die Aktie von UCB gewinnt derzeit an der Heimatbörse 21,28 Prozent auf 27,13 Euro. (23.04.2008/ac/n/a)
http://www.wallstreet-online.de/nachrichten/nachricht/235126…
UCB erhält FDA-Zulassung für Cimzia,
Aktie deutlich im Plus
Brüssel (aktiencheck.de AG) - Der belgische Pharmakonzern UCB S.A (ISIN BE0003739530/ WKN 852738) hat von der US-Gesundheitsbehörde FDA die Marktzulassung für das Medikament Cimzia erhalten.
Wie der Konzern am Mittwoch erklärte, wurde das Medikament zur Behandlung von erwachsenen Patienten zugelassen, die an Morbus Chron erkrankt sind. Zuvor wurde eine umfangreiche Versuchsreihe mit mehr als 1.500 Patienten, die an einer gemäßigten bis schweren Form dieser chronischen Magen-Darm-Erkrankung leiden, erfolgreich abgeschlossen. Im Rahmen der klinischen Testreihen habe sich eine Abschwächung der Symptome und Auswirkungen der Krankheit bei den betroffenen Patienten gezeigt, die auf eine konventionelle Behandlung von Morbus Chron nur bedingt angesprochen hätten, teilte UCB weiter mit.
Die Aktie von UCB gewinnt derzeit an der Heimatbörse 21,28 Prozent auf 27,13 Euro. (23.04.2008/ac/n/a)
http://www.wallstreet-online.de/nachrichten/nachricht/235126…
Biogen Idec Reports First Quarter 2008 Results
Wednesday April 23, 7:15 am ET
-- 32% Revenue Growth --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec Inc. (NASDAQ: BIIB - News), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its first quarter 2008 results.
First Quarter 2008 Highlights:
First quarter revenues were $942 million, an increase of 32% from $716 million in the first quarter of 2007, driven primarily by
AVONEX® (interferon beta-1a) sales up 19% to $536 million,
TYSABRI® (natalizumab) sales up!!! 283% !!! to $115 million, ...nicht schlecht Herr Specht...
and RITUXAN® (rituximab) revenues from the unconsolidated joint business arrangement up 19% to $247 million.
http://www.investorvillage.com/smbd.asp?mb=160&mn=222908&pt=…
Wednesday April 23, 7:15 am ET
-- 32% Revenue Growth --
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec Inc. (NASDAQ: BIIB - News), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its first quarter 2008 results.
First Quarter 2008 Highlights:
First quarter revenues were $942 million, an increase of 32% from $716 million in the first quarter of 2007, driven primarily by
AVONEX® (interferon beta-1a) sales up 19% to $536 million,
TYSABRI® (natalizumab) sales up!!! 283% !!! to $115 million, ...nicht schlecht Herr Specht...
and RITUXAN® (rituximab) revenues from the unconsolidated joint business arrangement up 19% to $247 million.
http://www.investorvillage.com/smbd.asp?mb=160&mn=222908&pt=…
http://www.investorvillage.com/smbd.asp?mb=160&mn=222917&pt=…
Everyone interested in Aab-001 (Bapineuzumab) needs to read this post.
There is a video circulating of a gentleman discussing an investigational Alzheimer's drug his wife is on, from the Pharmacology Research Institute, awhile back. Here is a link to that video.
http://www.priresearch.com/presser_mov.html
I know this gentleman is real. I will not share how, not personal association rest assured, to protect his privacy. I know his wife is a participant in the Aab-001 Phase II Clinical Trial at the Orange County Pharmacology Research Institute in LA.
It is one of several PRI centers our Bap has been in clinical trial at. In fact, Aab-001 is the only Alzheimer's Clinical Trial currently ongoing at the Pharmacology Research Institute.
So you ask how would I know that this individual is discussing Bapineuzumab? Easy.
If there is only one Alzheimer's Clinical Trial currently ongoing at the Pharmacology Research Institute, and the drug in the trial is as effective as this Gentleman is advertising on behalf of the PRI, why would that same drug not be for sale or currently enrolling at the Pharmacology Research Institute in additional Clinical Trials.
Rather easy when you think about it for a moment, isn't it.
TSW.
Welcome aboard to all the newbies GS is bringing, and that ML is about to bring. :-)!!!
www.priresearch.com
Everyone interested in Aab-001 (Bapineuzumab) needs to read this post.
There is a video circulating of a gentleman discussing an investigational Alzheimer's drug his wife is on, from the Pharmacology Research Institute, awhile back. Here is a link to that video.
http://www.priresearch.com/presser_mov.html
I know this gentleman is real. I will not share how, not personal association rest assured, to protect his privacy. I know his wife is a participant in the Aab-001 Phase II Clinical Trial at the Orange County Pharmacology Research Institute in LA.
It is one of several PRI centers our Bap has been in clinical trial at. In fact, Aab-001 is the only Alzheimer's Clinical Trial currently ongoing at the Pharmacology Research Institute.
So you ask how would I know that this individual is discussing Bapineuzumab? Easy.
If there is only one Alzheimer's Clinical Trial currently ongoing at the Pharmacology Research Institute, and the drug in the trial is as effective as this Gentleman is advertising on behalf of the PRI, why would that same drug not be for sale or currently enrolling at the Pharmacology Research Institute in additional Clinical Trials.
Rather easy when you think about it for a moment, isn't it.
TSW.
Welcome aboard to all the newbies GS is bringing, and that ML is about to bring. :-)!!!
www.priresearch.com
Antwort auf Beitrag Nr.: 33.951.440 von bernie55 am 23.04.08 13:36:52BIIB
“Global in-market net sales of TYSABRI® (natalizumab) in the first quarter of 2008 were $160 million. Based on our collaboration structure with Elan, Biogen Idec recognized revenue of $115 million related to TYSABRI in the first quarter of 2008”
Comments:
We will also book about $115 million revenue for the qtr as is always the case.
Definitely seems there is no discounting with Tysabri with revenue consistently trailing infusions by about five or six weeks. This has been absolutely consistent for the last 12 months. The actual revenue run rate was therefore $750m by the end of March, and at the same rate, will be more than $800m by the end of next week and $900m by the end of the qtr.
“As of the end of March 2008, approximately 26,000 patients were on commercial and clinical TYSABRI therapy worldwide. According to data available as of the end of March 2008:
· In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;
· Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;
· In global clinical trials, more than 600 patients were on TYSABRI therapy; and
· There have been no cases of PML since re-launch in the US and launch internationally in July 2006.
“
This is 100 patients higher than I thought, i.e. 25.5k vs 25.4k, bring the weekly run rate from 338 to 392 qtr/qtr. This is just 20 per week shy of the avg required throughout ’08, ’09 and ’10 to reach that 100k number, and because we’re only in the first qtr used to work out the average, there will be no need to make up ground later. The current quarter should see the required average start to com down already. Soon we’ll be saying that the current rate will get us to 100k/110k/150k and so on, while the avg required to get to 100k will start to come down immediately.
Great to see Avonex sales so high, albeit on the back of price hikes. This should increase estimates of the size of the overall MS market.
Peadar ‘Og
http://www.investorvillage.com/smbd.asp?mb=160&mn=222918&pt=…
“Global in-market net sales of TYSABRI® (natalizumab) in the first quarter of 2008 were $160 million. Based on our collaboration structure with Elan, Biogen Idec recognized revenue of $115 million related to TYSABRI in the first quarter of 2008”
Comments:
We will also book about $115 million revenue for the qtr as is always the case.
Definitely seems there is no discounting with Tysabri with revenue consistently trailing infusions by about five or six weeks. This has been absolutely consistent for the last 12 months. The actual revenue run rate was therefore $750m by the end of March, and at the same rate, will be more than $800m by the end of next week and $900m by the end of the qtr.
“As of the end of March 2008, approximately 26,000 patients were on commercial and clinical TYSABRI therapy worldwide. According to data available as of the end of March 2008:
· In the U.S., approximately 15,300 patients were on TYSABRI therapy commercially and approximately 2,750 physicians have prescribed the therapy;
· Outside of the U.S., more than 10,200 patients were on TYSABRI therapy commercially;
· In global clinical trials, more than 600 patients were on TYSABRI therapy; and
· There have been no cases of PML since re-launch in the US and launch internationally in July 2006.
“
This is 100 patients higher than I thought, i.e. 25.5k vs 25.4k, bring the weekly run rate from 338 to 392 qtr/qtr. This is just 20 per week shy of the avg required throughout ’08, ’09 and ’10 to reach that 100k number, and because we’re only in the first qtr used to work out the average, there will be no need to make up ground later. The current quarter should see the required average start to com down already. Soon we’ll be saying that the current rate will get us to 100k/110k/150k and so on, while the avg required to get to 100k will start to come down immediately.
Great to see Avonex sales so high, albeit on the back of price hikes. This should increase estimates of the size of the overall MS market.
Peadar ‘Og
http://www.investorvillage.com/smbd.asp?mb=160&mn=222918&pt=…
Elan Corporation, plc Earnings Conference Call (Q1 2008)
Scheduled to start Thu, Apr 24, 2008, 8:30 am Eastern
Check back at the scheduled start time for
the audio link to appear in this spot.
http://biz.yahoo.com/cc/4/91304.html
Scheduled to start Thu, Apr 24, 2008, 8:30 am Eastern
Check back at the scheduled start time for
the audio link to appear in this spot.
http://biz.yahoo.com/cc/4/91304.html
aktuell in den USA:
25,71 - 25,72
25,71 - 25,72
Abschlusskurs: ELN
$ 25.81 > + $ 0.76 > 3.03%
$ 25.81 > + $ 0.76 > 3.03%
Press Release Source: Elan Corporation, plc ...auf die schnelle...
Elan Reports First Quarter 2008 Financial Results
Thursday April 24, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc today announced its first quarter 2008 financial results and provided a business update. Commenting on Elan’s business, Kelly Martin, Elan’s president and chief executive officer, said, “We continued to demonstrate successful execution and delivery of tangible results in the first quarter. We remain highly focused on advancing our mid to late stage clinical pipeline as well as supporting physicians and their patients in choosing Tysabri in MS and also now in Crohn’s. Our disciplined management and the repeatability of our scientific process combined with risk minimization enable Elan to pursue a unique pathway forward in what remains a challenging and changing global industry environment.”
Commenting on Elan’s first quarter financial results, Shane Cooke, Elan’s executive vice president and chief financial officer, said, “We are very pleased with the strong start to the year, highlights of which include: a 22% increase in revenues; the approval and launch of Tysabri in Crohn’s disease; the continued advancement of our development pipeline; and strong cost control reflected in an 18% reduction in SG&A costs, which more than offset increased R&D costs.” Mr. Cooke added, “We are particularly pleased to see the acceleration in the number of new patients who are benefiting from Tysabri, with over 26,000 on therapy at the end of March 2008. This increase underscores our confidence that Elan’s total revenues for this year will approach the $1 billion mark and that we will achieve our target of having 100,000 patients on Tysabri therapy by the end of 2010.”
Unaudited Consolidated Income Statement Data auf:
http://biz.yahoo.com/bw/080424/20080423006271.html?.v=1
...bis gleich, ELANITES und ELANIACS, muss `ne Runde arbeiten....
Elan Reports First Quarter 2008 Financial Results
Thursday April 24, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc today announced its first quarter 2008 financial results and provided a business update. Commenting on Elan’s business, Kelly Martin, Elan’s president and chief executive officer, said, “We continued to demonstrate successful execution and delivery of tangible results in the first quarter. We remain highly focused on advancing our mid to late stage clinical pipeline as well as supporting physicians and their patients in choosing Tysabri in MS and also now in Crohn’s. Our disciplined management and the repeatability of our scientific process combined with risk minimization enable Elan to pursue a unique pathway forward in what remains a challenging and changing global industry environment.”
Commenting on Elan’s first quarter financial results, Shane Cooke, Elan’s executive vice president and chief financial officer, said, “We are very pleased with the strong start to the year, highlights of which include: a 22% increase in revenues; the approval and launch of Tysabri in Crohn’s disease; the continued advancement of our development pipeline; and strong cost control reflected in an 18% reduction in SG&A costs, which more than offset increased R&D costs.” Mr. Cooke added, “We are particularly pleased to see the acceleration in the number of new patients who are benefiting from Tysabri, with over 26,000 on therapy at the end of March 2008. This increase underscores our confidence that Elan’s total revenues for this year will approach the $1 billion mark and that we will achieve our target of having 100,000 patients on Tysabri therapy by the end of 2010.”
Unaudited Consolidated Income Statement Data auf:
http://biz.yahoo.com/bw/080424/20080423006271.html?.v=1
...bis gleich, ELANITES und ELANIACS, muss `ne Runde arbeiten....
dpa-afx
Hugin-News: BB BIOTECH AG
Donnerstag 24. April 2008, 07:31 Uhr
Gute Entwicklung der Beteiligungen von BB BIOTECH
(BIO.SW - Nachrichten)
----------------------------------------------------------------------
--------------
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
----------------------------------------------------------------------
--------------
Quartalsbericht per 31. März 2008
Das erste Quartal 2008 war durch turbulente Finanzmärkte und durch eine deutliche Abwertung des US-Dollars geprägt. Trotz der widrigen Umstände konnten die Beteiligungen im Portfolio von
BB BIOTECH durch eine gute Performance überzeugen. Der Innere Wert von BB BIOTECH blieb auf CHF-Basis konstant und legte auf USD-Basis um 13% zu. Die Beteiligungen des Unternehmens schnitten erneut deutlich besser als vergleichbare Märkte ab. So verlor beispielsweise der Nasdaq Biotech Index im abgelaufenen Quartal auf USD-Basis 6%.
Der Aktienkurs von BB BIOTECH blieb von den Marktturbulenzen nicht verschont und erlitt einen Kursrückgang von 11% auf CHF 76.
Die Anlagestrategie von BB BIOTECH, gezielt in Titel zu investieren, die aussagekräftige klinische Daten für ihre Produkte vorweisen können, zahlt sich weiterhin aus. Die Entwicklung und Zulassung neuer Medikamente bleibt nach wie vor eine grosse Herausforderung.
Erfolgreiche Medikamente müssen heute überzeugende Wirksamkeit mit möglichst wenigen, beherrschbaren Nebenwirkungen kombinieren. Um diesen Anforderungen gerecht zu werden, entwickelten einige unserer Beteiligungen, darunter u.a. Actelion (ATLN.SW - Nachrichten) , Celgene
(NASDAQ: CELG - Nachrichten) , Biogen Idec
(NASDAQ: BIIB - Nachrichten) und Elan
(Dublin: DRX.IR - Nachrichten)
Pharmaceuticals, Kontrollsysteme, mit denen sich auch seltene
Nebenwirkungen rechtzeitig erfassen lassen. Diese Systeme ermöglichen
heute die erfolgreiche Anwendung wirkungsvoller Medikamente bei einer
grossen Anzahl von Patienten.
Wir gehen davon aus, dass die Anforderungen, die an die Wirksamkeit,
an das Nebenwirkungsprofil und an das Preis-Leistungs-Verhältnis von
Medikamenten gestellt werden, auch in Zukunft weiter steigen werden.
Daher werden wir an unserer Strategie, Beteiligungen an
Gesellschaften zu erwerben, die sich durch grosses Know-how, in
Kombination mit ausgezeichneten klinischen Daten neuer Wirkstoffe,
auszeichnen, mit noch mehr Nachdruck verfolgen.
Die Kernbeteiligungen Celgene, Gilead, Actelion und Genentech (NYSE: DNA - Nachrichten) haben
sich im 1. Quartal 2008 sehr gut entwickelt und konnten
Kurssteigerungen verzeichnen, sowohl auf USD- als auch auf CHF-Basis.
Die erfreulichste Kursentwicklung zeigte die Aktie unserer
Kernbeteiligung Celgene, obgleich es sich zum Teil um eine
Kurserholung vom 4. Quartal 2007 handelte. Der Kursanstieg wurde
durch solide Geschäftsergebnisse und durch das starke klinische
Profil des Celgene-Schlüsselproduktes Revlimid, welches im
Berichtsquartal für viele Investoren sichtbar wurde, ermöglicht.
Genentech konnte über die Indikationserweiterung seines Blockbusters
Avastin berichten, der in den USA zusätzlich für die Behandlung von
metastasierendem Brustkrebs zugelassen wurde. Auch unsere
Kernbeteiligung Gilead entwickelte sich erfolgreich, dank des
hervorragenden klinischen Profils ihrer Schlüsselprodukte. Neue
klinische Studien zeigten weitere Vorteile auf, durch die sich
Gileads Arzneimittel von den Konkurrenzprodukten differenzieren
können.
Keryx Pharmaceuticals, eine unserer kleineren Beteiligungen, erlitt
einen signifikanten Rückschlag. Die viel versprechenden Ergebnisse
der Phase-II-Studie für das Medikament Sulodexide konnten durch die
anschliessende Phase-III-Studie nicht bestätigt werden.
Am 3. April 2008 haben wir unser viertes Aktienrückkaufprogramm
beendet. An der Generalversammlung am 4. April 2008 wurden die
Vernichtung dieser Aktien und der Start eines fünften
Aktienrückkaufprogramms beschlossen, um zu gewährleisten, dass
Aktienkurs und Innerer Wert von BB BIOTECH möglichst nah beieinander
liegen.
Wir sehen dem zweiten Quartal 2008 mit Freude entgegen, da einige
unserer Portfoliounternehmen wichtige Ergebnisse klinischer Studien
präsentieren werden. Viele Biotech-Unternehmen sind derzeit äusserst
attraktiv bewertet. Wir werden auch in Zukunft in die Unternehmen
investieren, welche die attraktivsten Bewertungen aufweisen.
Das Portfolio der BB BIOTECH setzt sich per 31. März 2008 prozentual
wie folgt zusammen:
KERNBETEILIGUNGEN
Actelion 27.8%
Celgene 16.8%
Gilead 15.3%
Genentech 14.0%
Vertex Pharmaceuticals (NASDAQ: VRTX - Nachrichten) 6.5%
KLEINERE BETEILIGUNGEN
Elan 4.1%
Biogen Idec 3.5%
Roche Holding GS 3.1%
Zymogenetics (ZGEN - Nachrichten) 2.1%
Affymetrix (NASDAQ: AFFX -
Nachrichten) 1.9%
The Medicines Company (NASDAQ: MDCO - Nachrichten) 1.1%
NicOx (Paris: FR0000074130 - Nachrichten) 0.8%
BioXell (BXLN.SW - Nachrichten) 0.6%
Incyte 0.5%
Jerini (Xetra: 678747 -
Nachrichten) 0.5%
Rigel Pharmaceuticals (RIGL - Nachrichten) 0.4%
Arena Pharmaceuticals (ARNA - Nachrichten) 0.4%
Optimer Pharmaceuticals (OPTR - Nachrichten) 0.2%
Epigenomics (Xetra: A0BVT9 - Nachrichten) 0.1%
Keryx Biopharmaceuticals (KERX - Nachrichten) <0.1%
Acambis (London: ACM.L -
Nachrichten) <0.1%
Genentech Call-Optionen (long) 0.1%
Actelion Call-Optionen (short) <(0.1%)
Actelion Call-Optionen (short) <(0.1%)
Celgene Call-Optionen (short) <(0.1%)
Biogen Idec Call-Optionen (short) <(0.1%)
SWAP Agreement auf eigene Aktien 0.2%
Total Wertschriften CHF 1 837.1 Mio.
Flüssige Mittel (netto) CHF (137.4) Mio.
Übrige Aktiven CHF 22.1 Mio.
Andere Verbindlichkeiten CHF (113.4) Mio.
Total Eigenkapital CHF 1 608.4 Mio.
Eigene Aktien (in % der Gesellschaft) 19.2%
Der vollständige Quartalsbericht ist auf www.bbbiotech.com verfügbar.
Für weitere Informationen:
Bellevue Asset Management AG, Seestrasse 16, 8700 Küsnacht, Schweiz
Christian Lach, Tel. +41 44 267 67 10
--- Ende der Mitteilung ---
BB BIOTECH AG
Vordergasse 3 Schaffhausen Schweiz
WKN: 888509; ISIN:
CH0001441580; Index: SBIOM, IGSP, SLIFE;
Notiert: Investment Companies in SWX Swiss Exchange;
Copyright © Hugin AS 2008. All rights reserved.
http://de.biz.yahoo.com/24042008/36/hugin-news-bb-biotech-ag…
Hugin-News: BB BIOTECH AG
Donnerstag 24. April 2008, 07:31 Uhr
Gute Entwicklung der Beteiligungen von BB BIOTECH
(BIO.SW - Nachrichten)
----------------------------------------------------------------------
--------------
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin.
Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
----------------------------------------------------------------------
--------------
Quartalsbericht per 31. März 2008
Das erste Quartal 2008 war durch turbulente Finanzmärkte und durch eine deutliche Abwertung des US-Dollars geprägt. Trotz der widrigen Umstände konnten die Beteiligungen im Portfolio von
BB BIOTECH durch eine gute Performance überzeugen. Der Innere Wert von BB BIOTECH blieb auf CHF-Basis konstant und legte auf USD-Basis um 13% zu. Die Beteiligungen des Unternehmens schnitten erneut deutlich besser als vergleichbare Märkte ab. So verlor beispielsweise der Nasdaq Biotech Index im abgelaufenen Quartal auf USD-Basis 6%.
Der Aktienkurs von BB BIOTECH blieb von den Marktturbulenzen nicht verschont und erlitt einen Kursrückgang von 11% auf CHF 76.
Die Anlagestrategie von BB BIOTECH, gezielt in Titel zu investieren, die aussagekräftige klinische Daten für ihre Produkte vorweisen können, zahlt sich weiterhin aus. Die Entwicklung und Zulassung neuer Medikamente bleibt nach wie vor eine grosse Herausforderung.
Erfolgreiche Medikamente müssen heute überzeugende Wirksamkeit mit möglichst wenigen, beherrschbaren Nebenwirkungen kombinieren. Um diesen Anforderungen gerecht zu werden, entwickelten einige unserer Beteiligungen, darunter u.a. Actelion (ATLN.SW - Nachrichten) , Celgene
(NASDAQ: CELG - Nachrichten) , Biogen Idec
(NASDAQ: BIIB - Nachrichten) und Elan
(Dublin: DRX.IR - Nachrichten)
Pharmaceuticals, Kontrollsysteme, mit denen sich auch seltene
Nebenwirkungen rechtzeitig erfassen lassen. Diese Systeme ermöglichen
heute die erfolgreiche Anwendung wirkungsvoller Medikamente bei einer
grossen Anzahl von Patienten.
Wir gehen davon aus, dass die Anforderungen, die an die Wirksamkeit,
an das Nebenwirkungsprofil und an das Preis-Leistungs-Verhältnis von
Medikamenten gestellt werden, auch in Zukunft weiter steigen werden.
Daher werden wir an unserer Strategie, Beteiligungen an
Gesellschaften zu erwerben, die sich durch grosses Know-how, in
Kombination mit ausgezeichneten klinischen Daten neuer Wirkstoffe,
auszeichnen, mit noch mehr Nachdruck verfolgen.
Die Kernbeteiligungen Celgene, Gilead, Actelion und Genentech (NYSE: DNA - Nachrichten) haben
sich im 1. Quartal 2008 sehr gut entwickelt und konnten
Kurssteigerungen verzeichnen, sowohl auf USD- als auch auf CHF-Basis.
Die erfreulichste Kursentwicklung zeigte die Aktie unserer
Kernbeteiligung Celgene, obgleich es sich zum Teil um eine
Kurserholung vom 4. Quartal 2007 handelte. Der Kursanstieg wurde
durch solide Geschäftsergebnisse und durch das starke klinische
Profil des Celgene-Schlüsselproduktes Revlimid, welches im
Berichtsquartal für viele Investoren sichtbar wurde, ermöglicht.
Genentech konnte über die Indikationserweiterung seines Blockbusters
Avastin berichten, der in den USA zusätzlich für die Behandlung von
metastasierendem Brustkrebs zugelassen wurde. Auch unsere
Kernbeteiligung Gilead entwickelte sich erfolgreich, dank des
hervorragenden klinischen Profils ihrer Schlüsselprodukte. Neue
klinische Studien zeigten weitere Vorteile auf, durch die sich
Gileads Arzneimittel von den Konkurrenzprodukten differenzieren
können.
Keryx Pharmaceuticals, eine unserer kleineren Beteiligungen, erlitt
einen signifikanten Rückschlag. Die viel versprechenden Ergebnisse
der Phase-II-Studie für das Medikament Sulodexide konnten durch die
anschliessende Phase-III-Studie nicht bestätigt werden.
Am 3. April 2008 haben wir unser viertes Aktienrückkaufprogramm
beendet. An der Generalversammlung am 4. April 2008 wurden die
Vernichtung dieser Aktien und der Start eines fünften
Aktienrückkaufprogramms beschlossen, um zu gewährleisten, dass
Aktienkurs und Innerer Wert von BB BIOTECH möglichst nah beieinander
liegen.
Wir sehen dem zweiten Quartal 2008 mit Freude entgegen, da einige
unserer Portfoliounternehmen wichtige Ergebnisse klinischer Studien
präsentieren werden. Viele Biotech-Unternehmen sind derzeit äusserst
attraktiv bewertet. Wir werden auch in Zukunft in die Unternehmen
investieren, welche die attraktivsten Bewertungen aufweisen.
Das Portfolio der BB BIOTECH setzt sich per 31. März 2008 prozentual
wie folgt zusammen:
KERNBETEILIGUNGEN
Actelion 27.8%
Celgene 16.8%
Gilead 15.3%
Genentech 14.0%
Vertex Pharmaceuticals (NASDAQ: VRTX - Nachrichten) 6.5%
KLEINERE BETEILIGUNGEN
Elan 4.1%
Biogen Idec 3.5%
Roche Holding GS 3.1%
Zymogenetics (ZGEN - Nachrichten) 2.1%
Affymetrix (NASDAQ: AFFX -
Nachrichten) 1.9%
The Medicines Company (NASDAQ: MDCO - Nachrichten) 1.1%
NicOx (Paris: FR0000074130 - Nachrichten) 0.8%
BioXell (BXLN.SW - Nachrichten) 0.6%
Incyte 0.5%
Jerini (Xetra: 678747 -
Nachrichten) 0.5%
Rigel Pharmaceuticals (RIGL - Nachrichten) 0.4%
Arena Pharmaceuticals (ARNA - Nachrichten) 0.4%
Optimer Pharmaceuticals (OPTR - Nachrichten) 0.2%
Epigenomics (Xetra: A0BVT9 - Nachrichten) 0.1%
Keryx Biopharmaceuticals (KERX - Nachrichten) <0.1%
Acambis (London: ACM.L -
Nachrichten) <0.1%
Genentech Call-Optionen (long) 0.1%
Actelion Call-Optionen (short) <(0.1%)
Actelion Call-Optionen (short) <(0.1%)
Celgene Call-Optionen (short) <(0.1%)
Biogen Idec Call-Optionen (short) <(0.1%)
SWAP Agreement auf eigene Aktien 0.2%
Total Wertschriften CHF 1 837.1 Mio.
Flüssige Mittel (netto) CHF (137.4) Mio.
Übrige Aktiven CHF 22.1 Mio.
Andere Verbindlichkeiten CHF (113.4) Mio.
Total Eigenkapital CHF 1 608.4 Mio.
Eigene Aktien (in % der Gesellschaft) 19.2%
Der vollständige Quartalsbericht ist auf www.bbbiotech.com verfügbar.
Für weitere Informationen:
Bellevue Asset Management AG, Seestrasse 16, 8700 Küsnacht, Schweiz
Christian Lach, Tel. +41 44 267 67 10
--- Ende der Mitteilung ---
BB BIOTECH AG
Vordergasse 3 Schaffhausen Schweiz
WKN: 888509; ISIN:
CH0001441580; Index: SBIOM, IGSP, SLIFE;
Notiert: Investment Companies in SWX Swiss Exchange;
Copyright © Hugin AS 2008. All rights reserved.
http://de.biz.yahoo.com/24042008/36/hugin-news-bb-biotech-ag…
After Hour lag übrigens bei $25,89
Antwort auf Beitrag Nr.: 33.959.860 von Poppholz am 24.04.08 10:17:37und das bei einem schönen Kursverlauf zum Ende des Tages:
finanzen.net
Elan kann Verlust im ersten Quartal reduzieren
Donnerstag 24. April 2008, 11:31 Uhr
Dublin (aktiencheck.de AG) - Der irische Pharmakonzern Elan Corp. plc (ISIN IE0003072950/ WKN 903801) konnte den Verlust im ersten Quartal reduzieren.
Wie der Konzern am Donnerstag erklärte, lag der Umsatz im Berichtszeitraum bei 214,7 Mio. Dollar, nach 176,0 Mio. Dollar im Vorjahresquartal. Beim Nettoergebnis konnte der Verlust von zuletzt 93,0 Mio. Dollar bzw. 290 Cents je Aktie auf 85,5 Mio. Dollar bzw. 18 Cents je Aktie reduziert werden. Wesentlichen Anteil an der Ergebnisverbesserung hatten die deutlich gestiegenen Umsatzerlöse des zur Behandlung von Morbus Chron eingesetzten Medikaments Tsybari.
Die Aktie von Elan (Dublin: DRX.IR - Nachrichten) notierte zuletzt in London mit einem Minus von 0,74 Prozent bei 16,11 Euro. (24.04.2008/ac/n/a)
http://de.biz.yahoo.com/24042008/85/elan-verlust-quartal-red…
Elan kann Verlust im ersten Quartal reduzieren
Donnerstag 24. April 2008, 11:31 Uhr
Dublin (aktiencheck.de AG) - Der irische Pharmakonzern Elan Corp. plc (ISIN IE0003072950/ WKN 903801) konnte den Verlust im ersten Quartal reduzieren.
Wie der Konzern am Donnerstag erklärte, lag der Umsatz im Berichtszeitraum bei 214,7 Mio. Dollar, nach 176,0 Mio. Dollar im Vorjahresquartal. Beim Nettoergebnis konnte der Verlust von zuletzt 93,0 Mio. Dollar bzw. 290 Cents je Aktie auf 85,5 Mio. Dollar bzw. 18 Cents je Aktie reduziert werden. Wesentlichen Anteil an der Ergebnisverbesserung hatten die deutlich gestiegenen Umsatzerlöse des zur Behandlung von Morbus Chron eingesetzten Medikaments Tsybari.
Die Aktie von Elan (Dublin: DRX.IR - Nachrichten) notierte zuletzt in London mit einem Minus von 0,74 Prozent bei 16,11 Euro. (24.04.2008/ac/n/a)
http://de.biz.yahoo.com/24042008/85/elan-verlust-quartal-red…
Hi
Schluchz:Versatel hat mich abgehängt:O--so konnte ich 1,5 Tage nix von Biogen+ Elanscall hören--bin jetzt bei meinem Liebsten im Internet-Exil + muss mich mal einlesen....Birgit
Schluchz:Versatel hat mich abgehängt:O--so konnte ich 1,5 Tage nix von Biogen+ Elanscall hören
--bin jetzt bei meinem Liebsten im Internet-Exil + muss mich mal einlesen....Birgit
Antwort auf Beitrag Nr.: 33.962.422 von Birgit.Tersteegen am 24.04.08 14:15:15Über die website kann man sich für den CC anmelden (unproblematisch)
http://www.elan.com/investorrelations/events/webcast_details…
http://www.elan.com/investorrelations/events/webcast_details…
CC ist angefangen....ALLES ADVANCED!!
ELN msg # 223508 4/24/2008 3:33:32 AM
By: beechlawn0202
davy
Elan Corp (USc)
ELN US
Q1 EBITDA loss expands year-on-year but is lower than forecast; focus now turns to Company Day and Bapineuzumab data
Jack Gorman
Price $25.81 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
Elan posted a solid set of Q1 numbers. Revenues grew by 22% year-on-year (yoy) to $214.7m, broadly in line with our $216.1m forecast. However, lower-than-expected operating costs meant that the EBITDA loss of $14.7m, though more than double last year's outturn, was some $21m lower than our expectation.
Tysabri global revenues, at $159.7m, were known after yesterday's BIIB results (April 23rd), but given the lower proportion of US revenues in the mix, Elan's reported outturn was lower than our forecast. Slightly better-than-expected Azactam revenues offset the performance of Maxipime (generics impact) and Prialt (still a pedestrian performance).
Total operating costs fell by 3% yoy, despite a 20% increase in R&D costs associated with the Alzheimer's Phase III programme. We had front-ended these costs a little more aggressively in our numbers with a c.40% increase. This drove the outperformance at the EBITDA level.
This is the second quarter in which Elan has broken out its results by division. Of the adjusted EBITDA loss of $14.7m, EDT (drug delivery) division posted 4% growth and positive EBITDA to $24.8m, while Biopharmaceuticals recorded a $39.4m loss.
On finances, net debt at end-Q1 was $1,077m, up $65m quarter-on-quarter but a tad below our $1,100m forecast. Elan flags that it expects to make a $75m milestone payment this year to BIIB to maintain its share of Tysabri profits. This is already in our numbers.
With no major pipeline news in the release, we suspect the focus will quickly return to the near-term newsflow including the Company Day and the Bapineuzumab Phase II data.
Conference call at 13.30 (Ireland/UK time) at +1 706 758 4972 (outside US); 888 434 1984 (US).
ELN msg # 223508 4/24/2008 3:33:32 AMBy: beechlawn0202
davy
Elan Corp (USc)
ELN US
Q1 EBITDA loss expands year-on-year but is lower than forecast; focus now turns to Company Day and Bapineuzumab data
Jack Gorman
Price $25.81 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
Elan posted a solid set of Q1 numbers. Revenues grew by 22% year-on-year (yoy) to $214.7m, broadly in line with our $216.1m forecast. However, lower-than-expected operating costs meant that the EBITDA loss of $14.7m, though more than double last year's outturn, was some $21m lower than our expectation.
Tysabri global revenues, at $159.7m, were known after yesterday's BIIB results (April 23rd), but given the lower proportion of US revenues in the mix, Elan's reported outturn was lower than our forecast. Slightly better-than-expected Azactam revenues offset the performance of Maxipime (generics impact) and Prialt (still a pedestrian performance).
Total operating costs fell by 3% yoy, despite a 20% increase in R&D costs associated with the Alzheimer's Phase III programme. We had front-ended these costs a little more aggressively in our numbers with a c.40% increase. This drove the outperformance at the EBITDA level.
This is the second quarter in which Elan has broken out its results by division. Of the adjusted EBITDA loss of $14.7m, EDT (drug delivery) division posted 4% growth and positive EBITDA to $24.8m, while Biopharmaceuticals recorded a $39.4m loss.
On finances, net debt at end-Q1 was $1,077m, up $65m quarter-on-quarter but a tad below our $1,100m forecast. Elan flags that it expects to make a $75m milestone payment this year to BIIB to maintain its share of Tysabri profits. This is already in our numbers.
With no major pipeline news in the release, we suspect the focus will quickly return to the near-term newsflow including the Company Day and the Bapineuzumab Phase II data.
Conference call at 13.30 (Ireland/UK time) at +1 706 758 4972 (outside US); 888 434 1984 (US).
tja,der Call ist zu Ende und was Neues habe ich nicht gehört...alles prima-----KELLY BRAUCHT EINE RHETORIK_SCHULUNG;ich sag´s schon 3 Jahre.....
ELN msg # 223669 4/24/2008 9:39:05 AM
By: JBWIN
Unfiltered Notes from ELN 1Q2008 Earnings CC
* Chris Burns, SVP, IR, ELN
* Good morning. Welcome to 1Q2008 fin results call
* Hope reviewed PR, on website
* Joining me, CEO Kelly Martin, EVP/CFO Shane Cooke, EVP Karen Kim
* Fin and R&D updates
* Safe harbor
* KM
* Thanks, Chris. Appreciate taking time to present 1Q2008 results
* Before turning over to Shane Cooke re fin results, few comments
* First and foremost, overall assessment 1Q2008, cont execution, discipline. Rev up, costs under ctl, managed aggr, absolute terms and P/F basis.
* Pipeline adv, Tysabri adv, recruiting talent.
* Second item, aab-001, both P II and P III, partner WYE and ourselves, signif incr in inquiry about program, re timing of data and program
* Take few minutes to recenter, remind people re P II, movement P II to P III , P III trial itself
* Recount aab-001 P II and p III
* P II remains on-going
* Expect data from P II mid-yr
* Anticipate w/WYE announce top-line mid-yr, target ICAD for full sci review
* P II DB PC mult ascending dose, 4 cohorts, n=240, mild to mod AD
* Study run n 30 diff sites in US
* Endpts (EP) incl ADAS-cog, NTB, DAD, CDR sum of boxzes, also Tau and PET PIB biomarkers
* 2 cogn and 2 fn EP, biomarkers
* Decision to move from P II to P III, in coord w/ELN/WYE, FDA/EMEA
* Decision based on # clin meaningful pobservations, incl but not ltd
* Interim look ltd # of people at P II aab-001, assessment of P I data, assessment analysis AN1792 active vaccine program and patients following 4.5 yrs
* Grouping of data allowed to move to P III
* P III program, to be clear, understand what is, 4 DB PC P III, 2 sub-pops, 4K patients, mild to mod AD Tx area
* Ultimately 350 sites globally, duration 18M, equal distr US and intl
* ELN resp US, WYE intl
* Stratify by APOE4 positive and negative patients
* Carrier studies single dose 0.5 mg vs placebo for carriers, non-carriers 0.5mg, 1.0, 2.0
* Co-primary EP cogn and functional
* EP not specified
* Expect to specify at concl of P II aab-001 and ELN/WYE , agencies review
* ADAS-cog, NTB, DAD, CDR sum of boxes
* Asked re interim looks, not willing to comment with specifics
* Re P III, pleased w/progress N America, site recruitment, patient screens, enrollment
* Antic progress across next few months re enrollment
* On intl, WYE moving forward, in next couple of months begin enrolling
* Take opp to provide aab-001 clarity re P II and P III to all S/H given amts of interest, Q, activity
* Hope you found this useful to spend time, provide clarity, remind people re timeline and data, useful way to remind what P II and P III are
* SC, CFO
* Couple of opening remarks before review of 1Q2008. Metrics re Tysabri end of Mar2008, same as presented at AAN and BIIB’s call
* Secondly, as said in Feb2008, Appendix 1, analysis EDT vs bio business
* Most appropriate to look at bus segments, way mgt structures set up and way reported, e.g. 20f
* Highlight key features of 1Q2008 before more compreh re T
* Overall, pleased strong start, Tysabri, rev 22% up 227M, compensate for lower Maxipine
* SG&A down 18%, sgn op leverage re Tysabri
* Offset incr in R&D
* WW T 160M, recorded sales exceeding 100M, came in 107M, 350%+ incr YoY
* Generic maxipine appr Jun2007, launched shortly, more last month
* Max decr 87% 57.9M to 10.1M
* Axac grw, 3% seq 24.2M
* Strong start, confident T help grow 1B in 2008, 30%+ incr YoY
* In absolute terms, 103.9M incr in GM
* From incr Tysabri, offset Max decr
* GM 48% from 59% down, change in mix of revs
* Re generc max, took immediate steps, change hospital sales footprint, decr 100M costs SG&A, was achieved by 24.2M in 1Q2008
* Annualized basis, approx 100M savings, 40M cash and 60M reduced amortization
* Partialy offset by incr SG&A re T launch in CD
* SG&A as %rev decr 34% vs 51% YoY and 37%4Q2007, lev cont
* Drived by bio business
* 42% of bus, down from 725
* Before R&D and other, 39.4M op profit, more than 2x YoY
* As prev guided, R&D incr 20% 73+M, adv AD programs thru clinic, particularly aab-001 into P III, ELND-005 into P II
* EBDITDA loss incr re R&D
* Expect EBITDA move thru B/E, expect 2008 yr less 50M
* SG&A +R&D 625-675M in 2008
* Aggr costs 146.5M in 1Q2008, comfortable w/guidance, rest of yr, R&D incr over 1Q2008 run rate
* EDT rev up 4%, 69.4M, 24.8M EBITDA
* Luvox CR appr, P III MAP nano
* Luvox CR 1x/day, using SODAS, launched by Jazz earlier thi smonth
* Imp and prof segment, 25M COGS adj EBITDA, 1/3 of revs
* Bio diff profile than EDT
* At some pt, as bio bus evolves, may make sense to put more structures in palce to achieve goals
* EDT imp pt of ELN, provide transparency of perf
* Net loss decr by 8%, 85.5M, net charge 18.8M debt retirement, offset by net interest expense decr
* Tysabry ww 160M, ELN record 107M, incr >350%, 18% sequentially
* End of Mar2008, 25.5K, incr 5.xK
* Sustainable accel 5.1K added this qtr, 16% vs 4.4K added in 4Q2007
* Over half added ex-US, global mkt share over 6%
* Admin by infusion 13x/yr
* Driven by # of nfusions, # patients and some inventory
* Launched in 20 countriesMay be diff patient addit and rev growth
* LT driven by patient growth
* AAN update util, safety, uage
* PLEX plasma exchange accel removal of T, may impr CNS fn
* Approach second, 10K on 12M, 9600 18M, safety profile clearer
* Grower util, incr comfort, superior, reach blockbuster potential by YE2008 run rate
* On track 100K by 2010
* Some may recall, said in 1Q2007
* Cont incr benefiting from T, incr # docs, incr # patients curr docs add
* More comfortable safety profile and see how well doing
* US 15.3K on Tx, incr 13% seq, 42% incr YoY
* 2700 docs Rx T, almost double YoY
* FDA approved TOUCH online, rolling out
* Ex-US, launched in 22, approved in 30
* 6 fold incr, 39% incr seq
* Incr driven across mult geo
* Ex-US recorded 20.7M, our share of profit+reimb iof costs
* Approval in CD Jan2008, largely completed launch
* Avail to patients, 1st patiets received in CD comm. Setting
* Primary and secondary CD failures w/docs familiar w/biologics
* 350K in US, 40-50 on biologics, expect
* Expect 2.5-3K in 12-18M
* Excellent T progress, disc mgt
* Total ELN rev 1B, EBITDA BE in 2H2008
* KM
* Few comments
* 2 imp dates for ELN
* 7May2008, Company Day, approx 4 hrs, provide compreh update on clin pipeline from P/F PoV
* Share updates re programs not prev discussed publicly
* Also review science, approach to science
* Discovery PoV
* Also talk re commercial cap, philosophy, how extend forward
* Disc re EDT business, how look at re risk/reward
* Secondly, 22May2008, AGM in Dublin, broad disc to S/H
* 7May2008 webcast, ltd space, lots of demand, trying to accommodate, encourage to listen if can’t attend
* Q&A
* Q1: Corey Davis, Natixis
* Is Subpart E filing likely, will you know after PR, if file w/just 6M safety data or req interim look at 6 or 12M
* A1: KM – Subpart E always viable path as laid out in books. Reg instructions, as disc in past, in terms of AD and pop, small P II. Everything dep on P II data. Once have data and disc w/FDA, we/they disc reg path forward. Also said ma be diff routes re reg/filing PoV, alert mkts at appr time after disc w/regulators. Nothing cut off for us. As said # times, regardless of P II, reg need fair amt of safety data re disease and pop size. Don’t know parameters re safety needs.
* Q2: Will know filing path by midyr and disclose?
* A2: Depends what data says, clarity of data, discussion w/FDA. Can’t say definitely know at midyr, reqs time w/agencies.
* Q3: Any change re expect for P III enrollment?
* A3: Very comfortable w/process, site sel, certif., patient interest. Very comf w/trajectory of enrollment. See no issues there. Wrt WYE get going country by country, enroll soon.
* Q4: Rich Silverman, Lehman
* T profits, whether benefit from tax benefits where dev and M/F?
* A4: SC – First, 3B tax loss forward use to shelter profits earn on T and other pts of bus. Second, when use up losses then pay at rate 12.5-15% because Irish company. All IP re T and other programs funded and managed in Ireland.
* Q5: Jack Gorman, Daveys
* Firstly, re T, KM can you provide flavor milestones, trigger, re modify label re PML? Secondly, any update re acc-001 trials suspension? And maybe relevance and impact re aab-001.
* A5: KM – know discussed on BIIB, PML attrib morebroadly to immunosuppressives. Talk w/FDA on regular basis. Premature to comment on what req re regulators and change regulators. TOUCH program very effective. Re T, all clin trials, indications, commercial activity, never had case of monoTx. Gets stronger over time. Regulators will be very cautious, move slowly, req more and more data. That said, label, current TOUCH program, while diff in some neuro offices, MS or CD, efficacy speaks for self. Takes care of self. Work w/BIIB, FDA and EMEA, don’t see that absolutely need in NT to change uptake in T, particularly ex-US. Acc-001 suspended, in env of being cautious, ELN/WYE, agencies, AE observed w/1 patient, doing fine, reviewed by investigator, physicians at ELN/WYE, back in discussions w/FDA re acc-001. Everything seen, no reason to believe wouldn’t get back up after few more disc on acc-001. Re acc-001 and rel aab-001, both immuno, one is passive IV aab-001, acc-001 is active vaccine.
* Q6: Annie Chen, JPM
* First re T in Cd, launch trajectory, pent up demand, expects changed? BAP in midyr data release, provide biomarkers, study results? Inventory of T in channels, order of magnitude?
* A6: SC – Low inventory, 3-4 wks forward demand in US. More diff to get handle ex-US. Don’t believ T is big issue in inventory. As look at rapid growth, could have diff patient growth vs rev growth on Q to Q basis. Re CD, initial launch, focus on docs getting enrolle din TOUCH. Half 1/3 of docs targeted, get other 2/3 in next few months. Started to get enrollment forms. Early yet re trajectory. KM – re CD, launched mid-March, target 1400, now have 500 up to speed. Trajectory bodes well, more 2Q2008. BAP re biomarkers, goal w/WYE topline communicate # of things, first and foremost, efficacy of aab-001, does t work, bio activity, secondly, comment re safety. Understand efficacy vs EP and safety. Not yet determined full extent of top-line announcement. At ICAD mtg, complete and transparent review. Goal of top-line, as much clarity re efficacy and safety against patients pops. Not yet det how much more detail.
* Q7: New anti-TNF?
* A7: Simzere, another TNF, it is 3rd in CD. In CD population, mkt evol, 350-400K CD patients in US, 50K on biologics. As end biologic options, #s grow. From clin data, half or more will fail TNF Tx. How initially target T in CD. As 50K grows, T positioning diff MofA, opps for TNF failures. Benefits by expanding biologic mkt in CD.
* Q8: Ian, Goodbodys
* T US patient growth stable vs fast intl. Will run rate stay same over next 3 Q, come off or move up. ROW faster, can it be sustained?
* A*: KM – Start w/US, making progress. We lebieve much mre US upside. Re slope of line and amplit, more competitive in US,mktplace for dozen yrs was stagnant re options, big mkt, work constructively re slope and height w/partner BIIB. Like to se US results improve from uptake. Intl, said originally way back when, MS population, vary from 400K to 1.2M, most of swing outside US, US covered by mkt analytics. OUS BIIB and ELN are learning about new patients, strength of Tysabri, taking share from others more aggressively than in US. Don’t know specifically if grow next 3 qtrs same, but upside sign. Drawing patients into mkt, drawing patients back into mkt, reimb, BIIB working hard on it, some don’t reimb alternatives, but do reimb T. Cautiously optimistic growth rates continue.
* Q9: May make strategic sense re bio vs EDT structures SC?
* A9: Ian, if you look at ELN overall, risk profile biopharms vs EDT, EDT spread across # of prods, modest R&D, categ as low risk. Tysabri just turned profitable, moving AD further. That business becomes less risky. Future potential for both, EDT could benefit from capital alloc sep. Bio could benefit focus on CNS, AD. Combo of both is both to move forward, recogn may sat some pt make sense to be separate.
* Q10: Martin Wills, UBS
* Re BAP, you thought unlikely accept P II w/o mor safety data?
* A10: KM – Stand-alone P II would not be enough by itself.
* Q11: 18M safety, is it based for rolling filing?
* A11: KM – way to think reg path as follows, P II very imp component, particularly re efficacy, if efficacy bxes all checks, then up to regulators how much safety data to be comf re safety. AD space, similar to non-US MS, EU+N AM 12 million patients. Regulators and ELN/WYE make sure enough info re safety and efficacy, move forward to patients, very good handle on safety and safety challenges, have good handle. See top-line safety and efficacy from P II, plug into P III and how designed. Assume discussions agencies, WYE/ELN determine best way forward. Be very clear, P II on its own not adequate for either companies or regulators re filing, too small.
* Q12: Re Tysabri, rapid growth, perhaps diff patient #s, rev #s on qtrly basis? Can you provide more précis info?
* A12: SC patient growth in 1Q2008, patient growth higher than rev growth in US, over last 6m patients grow 46%, rev 46%. Look over longer time than qtr. Will coincide. Patient growth and rev growth in line globally, but may be diff Q vs Q.
* Q13: Scott, Credit Suisse
* Re P II aab-001, any new findings re safety from July decision to go to P III? Comments re enrollments, # of BAP patients screened, expects re YE2008?
* A13: KM – Safety re P II, external DSMB for all key programs, they monitor aab-001 P II, monitor on-going basis. P II on-going, nearing completion, reviewed constantly, assume nothing changed re safety characteristics of program. Re enrollment, not comment on specific re screened, enrolled. In my comments gave some sense, 2 trial N Am and 2 intl, ELN N am, WYE intl. We are ahead, easier place to start. WYE couple months away re enrollment. Comfortable re site sel, screening, investigators. Tremendous comfort enrollment won’t be issue whatsoever. Alert mkt when fully enrolled.
* Q14: Filed lawsuit against Abraxis, start in next few months? What benefits if succ?
* A14: KM – can’t comment on specific litigation. Due to go to trial in NT, can’t comment on Abraxis, get resolved in court setting in near future. More generically, over last couple of decades, invested in larges amts of innovation both techn and science, biopharma. Tremendous amt of IP, while don’t look to be active re IP litig, IP is part of our value proposition as move company forward. Where think using our discoveries, defend in appropriate way.
* CB: Thanks everyone for joining call.
By: JBWIN
Unfiltered Notes from ELN 1Q2008 Earnings CC
* Chris Burns, SVP, IR, ELN
* Good morning. Welcome to 1Q2008 fin results call
* Hope reviewed PR, on website
* Joining me, CEO Kelly Martin, EVP/CFO Shane Cooke, EVP Karen Kim
* Fin and R&D updates
* Safe harbor
* KM
* Thanks, Chris. Appreciate taking time to present 1Q2008 results
* Before turning over to Shane Cooke re fin results, few comments
* First and foremost, overall assessment 1Q2008, cont execution, discipline. Rev up, costs under ctl, managed aggr, absolute terms and P/F basis.
* Pipeline adv, Tysabri adv, recruiting talent.
* Second item, aab-001, both P II and P III, partner WYE and ourselves, signif incr in inquiry about program, re timing of data and program
* Take few minutes to recenter, remind people re P II, movement P II to P III , P III trial itself
* Recount aab-001 P II and p III
* P II remains on-going
* Expect data from P II mid-yr
* Anticipate w/WYE announce top-line mid-yr, target ICAD for full sci review
* P II DB PC mult ascending dose, 4 cohorts, n=240, mild to mod AD
* Study run n 30 diff sites in US
* Endpts (EP) incl ADAS-cog, NTB, DAD, CDR sum of boxzes, also Tau and PET PIB biomarkers
* 2 cogn and 2 fn EP, biomarkers
* Decision to move from P II to P III, in coord w/ELN/WYE, FDA/EMEA
* Decision based on # clin meaningful pobservations, incl but not ltd
* Interim look ltd # of people at P II aab-001, assessment of P I data, assessment analysis AN1792 active vaccine program and patients following 4.5 yrs
* Grouping of data allowed to move to P III
* P III program, to be clear, understand what is, 4 DB PC P III, 2 sub-pops, 4K patients, mild to mod AD Tx area
* Ultimately 350 sites globally, duration 18M, equal distr US and intl
* ELN resp US, WYE intl
* Stratify by APOE4 positive and negative patients
* Carrier studies single dose 0.5 mg vs placebo for carriers, non-carriers 0.5mg, 1.0, 2.0
* Co-primary EP cogn and functional
* EP not specified
* Expect to specify at concl of P II aab-001 and ELN/WYE , agencies review
* ADAS-cog, NTB, DAD, CDR sum of boxes
* Asked re interim looks, not willing to comment with specifics
* Re P III, pleased w/progress N America, site recruitment, patient screens, enrollment
* Antic progress across next few months re enrollment
* On intl, WYE moving forward, in next couple of months begin enrolling
* Take opp to provide aab-001 clarity re P II and P III to all S/H given amts of interest, Q, activity
* Hope you found this useful to spend time, provide clarity, remind people re timeline and data, useful way to remind what P II and P III are
* SC, CFO
* Couple of opening remarks before review of 1Q2008. Metrics re Tysabri end of Mar2008, same as presented at AAN and BIIB’s call
* Secondly, as said in Feb2008, Appendix 1, analysis EDT vs bio business
* Most appropriate to look at bus segments, way mgt structures set up and way reported, e.g. 20f
* Highlight key features of 1Q2008 before more compreh re T
* Overall, pleased strong start, Tysabri, rev 22% up 227M, compensate for lower Maxipine
* SG&A down 18%, sgn op leverage re Tysabri
* Offset incr in R&D
* WW T 160M, recorded sales exceeding 100M, came in 107M, 350%+ incr YoY
* Generic maxipine appr Jun2007, launched shortly, more last month
* Max decr 87% 57.9M to 10.1M
* Axac grw, 3% seq 24.2M
* Strong start, confident T help grow 1B in 2008, 30%+ incr YoY
* In absolute terms, 103.9M incr in GM
* From incr Tysabri, offset Max decr
* GM 48% from 59% down, change in mix of revs
* Re generc max, took immediate steps, change hospital sales footprint, decr 100M costs SG&A, was achieved by 24.2M in 1Q2008
* Annualized basis, approx 100M savings, 40M cash and 60M reduced amortization
* Partialy offset by incr SG&A re T launch in CD
* SG&A as %rev decr 34% vs 51% YoY and 37%4Q2007, lev cont
* Drived by bio business
* 42% of bus, down from 725
* Before R&D and other, 39.4M op profit, more than 2x YoY
* As prev guided, R&D incr 20% 73+M, adv AD programs thru clinic, particularly aab-001 into P III, ELND-005 into P II
* EBDITDA loss incr re R&D
* Expect EBITDA move thru B/E, expect 2008 yr less 50M
* SG&A +R&D 625-675M in 2008
* Aggr costs 146.5M in 1Q2008, comfortable w/guidance, rest of yr, R&D incr over 1Q2008 run rate
* EDT rev up 4%, 69.4M, 24.8M EBITDA
* Luvox CR appr, P III MAP nano
* Luvox CR 1x/day, using SODAS, launched by Jazz earlier thi smonth
* Imp and prof segment, 25M COGS adj EBITDA, 1/3 of revs
* Bio diff profile than EDT
* At some pt, as bio bus evolves, may make sense to put more structures in palce to achieve goals
* EDT imp pt of ELN, provide transparency of perf
* Net loss decr by 8%, 85.5M, net charge 18.8M debt retirement, offset by net interest expense decr
* Tysabry ww 160M, ELN record 107M, incr >350%, 18% sequentially
* End of Mar2008, 25.5K, incr 5.xK
* Sustainable accel 5.1K added this qtr, 16% vs 4.4K added in 4Q2007
* Over half added ex-US, global mkt share over 6%
* Admin by infusion 13x/yr
* Driven by # of nfusions, # patients and some inventory
* Launched in 20 countriesMay be diff patient addit and rev growth
* LT driven by patient growth
* AAN update util, safety, uage
* PLEX plasma exchange accel removal of T, may impr CNS fn
* Approach second, 10K on 12M, 9600 18M, safety profile clearer
* Grower util, incr comfort, superior, reach blockbuster potential by YE2008 run rate
* On track 100K by 2010
* Some may recall, said in 1Q2007
* Cont incr benefiting from T, incr # docs, incr # patients curr docs add
* More comfortable safety profile and see how well doing
* US 15.3K on Tx, incr 13% seq, 42% incr YoY
* 2700 docs Rx T, almost double YoY
* FDA approved TOUCH online, rolling out
* Ex-US, launched in 22, approved in 30
* 6 fold incr, 39% incr seq
* Incr driven across mult geo
* Ex-US recorded 20.7M, our share of profit+reimb iof costs
* Approval in CD Jan2008, largely completed launch
* Avail to patients, 1st patiets received in CD comm. Setting
* Primary and secondary CD failures w/docs familiar w/biologics
* 350K in US, 40-50 on biologics, expect
* Expect 2.5-3K in 12-18M
* Excellent T progress, disc mgt
* Total ELN rev 1B, EBITDA BE in 2H2008
* KM
* Few comments
* 2 imp dates for ELN
* 7May2008, Company Day, approx 4 hrs, provide compreh update on clin pipeline from P/F PoV
* Share updates re programs not prev discussed publicly
* Also review science, approach to science
* Discovery PoV
* Also talk re commercial cap, philosophy, how extend forward
* Disc re EDT business, how look at re risk/reward
* Secondly, 22May2008, AGM in Dublin, broad disc to S/H
* 7May2008 webcast, ltd space, lots of demand, trying to accommodate, encourage to listen if can’t attend
* Q&A
* Q1: Corey Davis, Natixis
* Is Subpart E filing likely, will you know after PR, if file w/just 6M safety data or req interim look at 6 or 12M
* A1: KM – Subpart E always viable path as laid out in books. Reg instructions, as disc in past, in terms of AD and pop, small P II. Everything dep on P II data. Once have data and disc w/FDA, we/they disc reg path forward. Also said ma be diff routes re reg/filing PoV, alert mkts at appr time after disc w/regulators. Nothing cut off for us. As said # times, regardless of P II, reg need fair amt of safety data re disease and pop size. Don’t know parameters re safety needs.
* Q2: Will know filing path by midyr and disclose?
* A2: Depends what data says, clarity of data, discussion w/FDA. Can’t say definitely know at midyr, reqs time w/agencies.
* Q3: Any change re expect for P III enrollment?
* A3: Very comfortable w/process, site sel, certif., patient interest. Very comf w/trajectory of enrollment. See no issues there. Wrt WYE get going country by country, enroll soon.
* Q4: Rich Silverman, Lehman
* T profits, whether benefit from tax benefits where dev and M/F?
* A4: SC – First, 3B tax loss forward use to shelter profits earn on T and other pts of bus. Second, when use up losses then pay at rate 12.5-15% because Irish company. All IP re T and other programs funded and managed in Ireland.
* Q5: Jack Gorman, Daveys
* Firstly, re T, KM can you provide flavor milestones, trigger, re modify label re PML? Secondly, any update re acc-001 trials suspension? And maybe relevance and impact re aab-001.
* A5: KM – know discussed on BIIB, PML attrib morebroadly to immunosuppressives. Talk w/FDA on regular basis. Premature to comment on what req re regulators and change regulators. TOUCH program very effective. Re T, all clin trials, indications, commercial activity, never had case of monoTx. Gets stronger over time. Regulators will be very cautious, move slowly, req more and more data. That said, label, current TOUCH program, while diff in some neuro offices, MS or CD, efficacy speaks for self. Takes care of self. Work w/BIIB, FDA and EMEA, don’t see that absolutely need in NT to change uptake in T, particularly ex-US. Acc-001 suspended, in env of being cautious, ELN/WYE, agencies, AE observed w/1 patient, doing fine, reviewed by investigator, physicians at ELN/WYE, back in discussions w/FDA re acc-001. Everything seen, no reason to believe wouldn’t get back up after few more disc on acc-001. Re acc-001 and rel aab-001, both immuno, one is passive IV aab-001, acc-001 is active vaccine.
* Q6: Annie Chen, JPM
* First re T in Cd, launch trajectory, pent up demand, expects changed? BAP in midyr data release, provide biomarkers, study results? Inventory of T in channels, order of magnitude?
* A6: SC – Low inventory, 3-4 wks forward demand in US. More diff to get handle ex-US. Don’t believ T is big issue in inventory. As look at rapid growth, could have diff patient growth vs rev growth on Q to Q basis. Re CD, initial launch, focus on docs getting enrolle din TOUCH. Half 1/3 of docs targeted, get other 2/3 in next few months. Started to get enrollment forms. Early yet re trajectory. KM – re CD, launched mid-March, target 1400, now have 500 up to speed. Trajectory bodes well, more 2Q2008. BAP re biomarkers, goal w/WYE topline communicate # of things, first and foremost, efficacy of aab-001, does t work, bio activity, secondly, comment re safety. Understand efficacy vs EP and safety. Not yet determined full extent of top-line announcement. At ICAD mtg, complete and transparent review. Goal of top-line, as much clarity re efficacy and safety against patients pops. Not yet det how much more detail.
* Q7: New anti-TNF?
* A7: Simzere, another TNF, it is 3rd in CD. In CD population, mkt evol, 350-400K CD patients in US, 50K on biologics. As end biologic options, #s grow. From clin data, half or more will fail TNF Tx. How initially target T in CD. As 50K grows, T positioning diff MofA, opps for TNF failures. Benefits by expanding biologic mkt in CD.
* Q8: Ian, Goodbodys
* T US patient growth stable vs fast intl. Will run rate stay same over next 3 Q, come off or move up. ROW faster, can it be sustained?
* A*: KM – Start w/US, making progress. We lebieve much mre US upside. Re slope of line and amplit, more competitive in US,mktplace for dozen yrs was stagnant re options, big mkt, work constructively re slope and height w/partner BIIB. Like to se US results improve from uptake. Intl, said originally way back when, MS population, vary from 400K to 1.2M, most of swing outside US, US covered by mkt analytics. OUS BIIB and ELN are learning about new patients, strength of Tysabri, taking share from others more aggressively than in US. Don’t know specifically if grow next 3 qtrs same, but upside sign. Drawing patients into mkt, drawing patients back into mkt, reimb, BIIB working hard on it, some don’t reimb alternatives, but do reimb T. Cautiously optimistic growth rates continue.
* Q9: May make strategic sense re bio vs EDT structures SC?
* A9: Ian, if you look at ELN overall, risk profile biopharms vs EDT, EDT spread across # of prods, modest R&D, categ as low risk. Tysabri just turned profitable, moving AD further. That business becomes less risky. Future potential for both, EDT could benefit from capital alloc sep. Bio could benefit focus on CNS, AD. Combo of both is both to move forward, recogn may sat some pt make sense to be separate.
* Q10: Martin Wills, UBS
* Re BAP, you thought unlikely accept P II w/o mor safety data?
* A10: KM – Stand-alone P II would not be enough by itself.
* Q11: 18M safety, is it based for rolling filing?
* A11: KM – way to think reg path as follows, P II very imp component, particularly re efficacy, if efficacy bxes all checks, then up to regulators how much safety data to be comf re safety. AD space, similar to non-US MS, EU+N AM 12 million patients. Regulators and ELN/WYE make sure enough info re safety and efficacy, move forward to patients, very good handle on safety and safety challenges, have good handle. See top-line safety and efficacy from P II, plug into P III and how designed. Assume discussions agencies, WYE/ELN determine best way forward. Be very clear, P II on its own not adequate for either companies or regulators re filing, too small.
* Q12: Re Tysabri, rapid growth, perhaps diff patient #s, rev #s on qtrly basis? Can you provide more précis info?
* A12: SC patient growth in 1Q2008, patient growth higher than rev growth in US, over last 6m patients grow 46%, rev 46%. Look over longer time than qtr. Will coincide. Patient growth and rev growth in line globally, but may be diff Q vs Q.
* Q13: Scott, Credit Suisse
* Re P II aab-001, any new findings re safety from July decision to go to P III? Comments re enrollments, # of BAP patients screened, expects re YE2008?
* A13: KM – Safety re P II, external DSMB for all key programs, they monitor aab-001 P II, monitor on-going basis. P II on-going, nearing completion, reviewed constantly, assume nothing changed re safety characteristics of program. Re enrollment, not comment on specific re screened, enrolled. In my comments gave some sense, 2 trial N Am and 2 intl, ELN N am, WYE intl. We are ahead, easier place to start. WYE couple months away re enrollment. Comfortable re site sel, screening, investigators. Tremendous comfort enrollment won’t be issue whatsoever. Alert mkt when fully enrolled.
* Q14: Filed lawsuit against Abraxis, start in next few months? What benefits if succ?
* A14: KM – can’t comment on specific litigation. Due to go to trial in NT, can’t comment on Abraxis, get resolved in court setting in near future. More generically, over last couple of decades, invested in larges amts of innovation both techn and science, biopharma. Tremendous amt of IP, while don’t look to be active re IP litig, IP is part of our value proposition as move company forward. Where think using our discoveries, defend in appropriate way.
* CB: Thanks everyone for joining call.
Antwort auf Beitrag Nr.: 33.963.465 von Birgit.Tersteegen am 24.04.08 15:43:17brauche ich mir ja gar nicht durchzulesen.
Scheint ja viel gutes drin zu stehen, der Kurs geht ja runter.
Scheint ja viel gutes drin zu stehen, der Kurs geht ja runter.
ELN msg # 223718 4/24/2008 10:17:37 AM
By: snugpharma
Today Wyeth AGM. Bernard Pousout CEO re Bapineuzumab
Wyeth AGM, Bernard Pousout - "We believe we are making very advanced steps in treating Alzheimer's. Present therapies are only smptomatic. Bapineuzumab, possibility to confirm halt or slow down . Know by June. Ball is rolling, hope this will be a good solution for Alzheimers." Bapineuzumab can be an economical miracle
By: snugpharma
Today Wyeth AGM. Bernard Pousout CEO re Bapineuzumab
Wyeth AGM, Bernard Pousout - "We believe we are making very advanced steps in treating Alzheimer's. Present therapies are only smptomatic. Bapineuzumab, possibility to confirm halt or slow down . Know by June. Ball is rolling, hope this will be a good solution for Alzheimers." Bapineuzumab can be an economical miracle
super rebound!25,50$!
25,50$!
Antwort auf Beitrag Nr.: 33.965.211 von Birgit.Tersteegen am 24.04.08 17:56:1525,90 schön, scheinbar aber nichts für schwache nerven.
Antwort auf Beitrag Nr.: 33.967.129 von GuHu1 am 24.04.08 21:08:03von uns SUPER-LONGIES hat doch keiner schwache Nerven.
Antwort auf Beitrag Nr.: 33.967.209 von Poppholz am 24.04.08 21:18:25
das ist mir schon klar, von euch rede ich auch nicht.
das ist mir schon klar, von euch rede ich auch nicht.
Antwort auf Beitrag Nr.: 33.967.240 von GuHu1 am 24.04.08 21:21:01After Hour bei $26,15
Antwort auf Beitrag Nr.: 33.967.831 von Poppholz am 24.04.08 22:24:16und der Dollar-Kurs geht auch in die richtige Richtung:
aktuell 1 zu 1,5687
aktuell 1 zu 1,5687
Guten Morgen...
Irish Independent
"Firm has no intention of selling medicaton share" ie. Kelly Martin has no intention of selling its stake in Tysabri
Independent.ie
Firm has 'no intention' of selling medication share
By John Mulligan
Friday April 25 2008
Elan chief executive Kelly Martin said that the company has "no intention" of selling its stake in Tysabri, which is expected to be a blockbuster treatment for multiple sclerosis.
Elan's development partner, Biogen Idec, is currently facing a major battle with legendary activist-investor Carl Ichan, who has said the US firm should be sold to realise value for shareholders.
After trying to buy Biogen in 2006, billionaire Icahn is pressuring the company to sell itself to a bigger drugmaker. He is proposing three members to its board of directors and is suing Biogen, contending the company's failed attempt to find buyers last year wasn't sincere. A court hearing on the action is scheduled for next month in the US.
Biogen lost more than $5bn in market value in December when it abandoned sale plans. Elan has first refusal rights over Biogen Idec's 50pc stake in Tysabri.
Mr Kelly said that should a situation arise where the option of acquiring Biogen Idec's stake in the drug, that Elan will "do what's in the best interest of Elan and its shareholders, and what's in the best interest of Tysabri".
He described the product as "quite a unique asset" that could have other applications outside its current multiple sclerosis and Crohn's disease stable. Earlier this month Mr Icahn proposed a number of nominee directors for the Biogen Idec board, but they were rejected by the company.
The company said they had been deemed unsuitable because they were committed to Mr Icahn's "single-minded agenda" to sell the firm. Biogen said that such a plan would compromise its ability to attract talented employees and form partnerships with other companies. This week Biogen Idec upped its earnings guidance for the year on the back of strong Tysabri sales.
- John Mulligan
http://www.investorvillage.com/smbd.asp?mb=160&mn=224239&pt=…
Irish Independent
"Firm has no intention of selling medicaton share" ie. Kelly Martin has no intention of selling its stake in Tysabri
Independent.ie
Firm has 'no intention' of selling medication share
By John Mulligan
Friday April 25 2008
Elan chief executive Kelly Martin said that the company has "no intention" of selling its stake in Tysabri, which is expected to be a blockbuster treatment for multiple sclerosis.
Elan's development partner, Biogen Idec, is currently facing a major battle with legendary activist-investor Carl Ichan, who has said the US firm should be sold to realise value for shareholders.
After trying to buy Biogen in 2006, billionaire Icahn is pressuring the company to sell itself to a bigger drugmaker. He is proposing three members to its board of directors and is suing Biogen, contending the company's failed attempt to find buyers last year wasn't sincere. A court hearing on the action is scheduled for next month in the US.
Biogen lost more than $5bn in market value in December when it abandoned sale plans. Elan has first refusal rights over Biogen Idec's 50pc stake in Tysabri.
Mr Kelly said that should a situation arise where the option of acquiring Biogen Idec's stake in the drug, that Elan will "do what's in the best interest of Elan and its shareholders, and what's in the best interest of Tysabri".
He described the product as "quite a unique asset" that could have other applications outside its current multiple sclerosis and Crohn's disease stable. Earlier this month Mr Icahn proposed a number of nominee directors for the Biogen Idec board, but they were rejected by the company.
The company said they had been deemed unsuitable because they were committed to Mr Icahn's "single-minded agenda" to sell the firm. Biogen said that such a plan would compromise its ability to attract talented employees and form partnerships with other companies. This week Biogen Idec upped its earnings guidance for the year on the back of strong Tysabri sales.
- John Mulligan
http://www.investorvillage.com/smbd.asp?mb=160&mn=224239&pt=…
dann wollen wir doch mal schauen, was uns der heutige Freitag so bringen wird.
(auf ein grünes Wochenende)
(auf ein grünes Wochenende)
Hi, hat eigentlich jemand den Bericht auf ARTE über Alzheimer gesehen? Oder wurde das hier gar schon ausgewertet? Laienhafte Kurzusf.: angeblich soll Alz. eine Hirninfektion sein ähnlich wie Rheuma. Wer billige Rheumamittel nimmt soll auch kein Alzheimer bekommen?! Einem Prof. in der Charite / Berlin, der dazu eine kompetente Aussage treffen sollte, wurde vom WYETH mittels einer einstweiligen Vfg. ein Maulkorb verpasst. Hat mich innerlich gefreut und im Ggs. zu Biogen, habe ich hier ein besseres Gefühl.
Schönes WE noch HAL.
Schönes WE noch HAL.
Antwort auf Beitrag Nr.: 33.969.797 von HAL11000 am 25.04.08 09:47:55Einem Prof. in der Charite / Berlin, der dazu eine kompetente Aussage treffen sollte ...
Schade, hab ich leider nicht gesehn. Aber es zeigt doch mal wieder, selbst in Deutschland ist man nicht sicher vor irgendwelchem Scheiß, der nur dazu dient, auf irgendeine Art und Weise den Leuten die Kohle aus der Tasche zu ziehn.
Prima Wyeth ... gute Maßnahme.
Schade, hab ich leider nicht gesehn. Aber es zeigt doch mal wieder, selbst in Deutschland ist man nicht sicher vor irgendwelchem Scheiß, der nur dazu dient, auf irgendeine Art und Weise den Leuten die Kohle aus der Tasche zu ziehn.
Prima Wyeth ... gute Maßnahme.
Antwort auf Beitrag Nr.: 33.969.797 von HAL11000 am 25.04.08 09:47:55..vor 3 Wochen durchdiskutiert im IV-Board + die Quintessenz habe ich hier eingestellt:Keine Bedrohung für uns,AAB löst nicht nur die Plaque ZWISCHEN den Zellen sondern wirkt auch IN den Zellen----und die Nonnen hätten vielleicht später auch ALZ bekommem denn die Plaquen verhindern zunehmend den Kontakt der Zellen untereinander (LAIENHAFT gesagt + ohne Gewähr...) Grüsse!
(PS.Falls ALZ auch was mit Entzündungen zu tun hat---vielleicht würde ja TY wirken.....????)
(Ps2.JUUUUUUUUUUUUUUUUUUUHUUUUUUUUUUUUUUUUUU:ich hab wieder Netz)
(PS3 Toller Rebound gestern ins PLUS nach Absacker:25,98$)
(PS.Falls ALZ auch was mit Entzündungen zu tun hat---vielleicht würde ja TY wirken.....????
)(Ps2.JUUUUUUUUUUUUUUUUUUUHUUUUUUUUUUUUUUUUUU:ich hab wieder Netz
)(PS3 Toller Rebound gestern ins PLUS nach Absacker:25,98$)
Antwort auf Beitrag Nr.: 33.969.797 von HAL11000 am 25.04.08 09:47:55Laienhafte Kurzusf.: angeblich soll Alz. eine Hirninfektion sein ähnlich wie Rheuma. Wer billige Rheumamittel nimmt soll auch kein Alzheimer bekommen?! Einem Prof. in der Charite / Berlin, der dazu eine kompetente Aussage treffen sollte, wurde vom WYETH mittels einer einstweiligen Vfg. ein Maulkorb verpasst. Hat mich innerlich gefreut und im Ggs. zu Biogen, habe ich hier ein besseres Gefühl.
Prof.Dr.Mathias Riepe von der Charite hat das Interview zurückziehen müssen, da in den Statuten der Vereinbarungen über die Trials bei Alzheimer von WYETH (+ELAN) klar festgelegt worden ist, dass keine " inhaltlichen Aussagen " während der Durchführung von Trials getätigt werden dürfen.
Im Grunde genommen eigentlich eine klare Kiste :
> Aus einer Argumentation seitens von Mathias Riepe hätten durchaus eventuelle neue Erkenntnisse aus den laufenden Trials heraussickern können.....
FAZIT: Reden ist Silber, Schweigen ist Gold.
Prof.Dr.Mathias Riepe von der Charite hat das Interview zurückziehen müssen, da in den Statuten der Vereinbarungen über die Trials bei Alzheimer von WYETH (+ELAN) klar festgelegt worden ist, dass keine " inhaltlichen Aussagen " während der Durchführung von Trials getätigt werden dürfen.
Im Grunde genommen eigentlich eine klare Kiste :
> Aus einer Argumentation seitens von Mathias Riepe hätten durchaus eventuelle neue Erkenntnisse aus den laufenden Trials heraussickern können.....
FAZIT: Reden ist Silber, Schweigen ist Gold.
Antwort auf Beitrag Nr.: 33.970.609 von bernie55 am 25.04.08 11:03:57> Aus einer Argumentation seitens von Mathias Riepe hätten durchaus eventuelle neue Erkenntnisse aus den laufenden Trials heraussickern können.....
Ich denke, er wollte was zum Thema "Rheumamittel und ihre Wirksamkeit bei Alzheimer" sagen (und ist deshalb gestoppt worden) ?!
Ich denke, er wollte was zum Thema "Rheumamittel und ihre Wirksamkeit bei Alzheimer" sagen (und ist deshalb gestoppt worden) ?!
Es geht hierbei noch einmal um die Diskussion der Standards für die Festlegung der " end points ".
in relation to aab-001/bap p2 data, goldman says:
goldman: "There is a wide disparity of opinions on the data end-points and content, as well as the likely share price reaction to publication of the data. It cannot be ignored that on the basis of interim (c.6-18 month) phase II data, multiple regulatory agencies have allowed Elan and partner Wyeth to begin an extensive phase III programme.
Hence, debates about end-points are academic, in our view, and are likely red herrings that mask what could be positive and compelling phase II data around mid-year that could support a sub part E filing for approval."
http://www.investorvillage.com/smbd.asp?mb=160&mn=219653&pt=…
in relation to aab-001/bap p2 data, goldman says:
goldman: "There is a wide disparity of opinions on the data end-points and content, as well as the likely share price reaction to publication of the data. It cannot be ignored that on the basis of interim (c.6-18 month) phase II data, multiple regulatory agencies have allowed Elan and partner Wyeth to begin an extensive phase III programme.
Hence, debates about end-points are academic, in our view, and are likely red herrings that mask what could be positive and compelling phase II data around mid-year that could support a sub part E filing for approval."
http://www.investorvillage.com/smbd.asp?mb=160&mn=219653&pt=…
und wenn jetzt der $ noch weiter fallen würde, dann würden wir noch schönere Kursverläufe sehen können:
Antwort auf Beitrag Nr.: 33.970.812 von Holgus am 25.04.08 11:21:27Ich denke, er wollte was zum Thema "Rheumamittel und ihre Wirksamkeit bei Alzheimer" sagen (und ist deshalb gestoppt worden) ?!
Ja klar !!
...nochmals .....
>Die Frage ist die , ob Mathias Riepe nicht in irgendeiner Form Argumente gebracht hätte ,aus denen man inhaltliche Rückschlüsse aus den laufenden Trials bei Alzheimer hätte ziehen können.
Diese möglichen Informationen könnten für die andere BIGS vielleicht wichtige Denkanstöße für die Durchführung von Trials bei Alzheimer sein.
> Cyberhexe hatte mich darüber informiert ( an dieser Stelle mal ein netten Gruß an dich ) ,dass grundsätzlich keine vorherigen Ergebnisse bzw. Erkenntnisse aus den laufenden Trials publik gemacht werden dürfen.Klare Bestimmungen,die von der FDA aufgestellt werden worden sind.
Somit ist dieser " Maulkorb " für mich nachzuvollziehbar.
...alles nur meine Gedanken...wie gesagt...aus dem Munde eines Laien....
Ja klar !!
...nochmals .....
>Die Frage ist die , ob Mathias Riepe nicht in irgendeiner Form Argumente gebracht hätte ,aus denen man inhaltliche Rückschlüsse aus den laufenden Trials bei Alzheimer hätte ziehen können.
Diese möglichen Informationen könnten für die andere BIGS vielleicht wichtige Denkanstöße für die Durchführung von Trials bei Alzheimer sein.
> Cyberhexe hatte mich darüber informiert ( an dieser Stelle mal ein netten Gruß an dich ) ,dass grundsätzlich keine vorherigen Ergebnisse bzw. Erkenntnisse aus den laufenden Trials publik gemacht werden dürfen.Klare Bestimmungen,die von der FDA aufgestellt werden worden sind.
Somit ist dieser " Maulkorb " für mich nachzuvollziehbar.
...alles nur meine Gedanken...wie gesagt...aus dem Munde eines Laien....
Antwort auf Beitrag Nr.: 33.971.138 von bernie55 am 25.04.08 11:48:18..aus dem Munde eines Laien
Achso ... ach deshalb ... ach jaaa
Achso ... ach deshalb ... ach jaaa
Antwort auf Beitrag Nr.: 33.971.462 von Holgus am 25.04.08 12:19:04......irgendwie schön, dass wir alle ein " bisschen Laien " sind......
Ich tue es kund,
mit meinem Mund,
ich bin ein Laie,
" Au wei e "
Ich tue es kund,
mit meinem Mund,
ich bin ein Laie,
" Au wei e "
Antwort auf Beitrag Nr.: 33.971.462 von Holgus am 25.04.08 12:19:04Holgus,Du musst das so sehen :"Unsere" Forschung wird vor den bösen,bösen Jungs der Konkurrenz geschützt---deshalb sagen "wir"nix...wir haben ja immerhin (hoffentlich...!) einen Blockbuster in der Tasche,der "uns"schon viel gekostet hat und da spielen "wir" Fort Knocks und sagen,wie unser CEO immer nur "ÄHM;EHM;EHH;ÄHH"....
Antwort auf Beitrag Nr.: 33.971.570 von bernie55 am 25.04.08 12:27:43Ich tue es kund, mit meinem Mund, ich bin ein Laie, " Au wei e "
Birgitmaus so kugelrund
machts so schön mit ihrem Mund
damit tut sie ganz oft kund
von alzbedingtem Gedächtisschwund
Ich bin ein Pööt .... yuchheeee
Birgitmaus so kugelrund
machts so schön mit ihrem Mund
damit tut sie ganz oft kund
von alzbedingtem Gedächtisschwund
Ich bin ein Pööt .... yuchheeee
Antwort auf Beitrag Nr.: 33.971.981 von Holgus am 25.04.08 13:09:07holgus
Holgus ist so frech und dreist
da wünscht man sich ,dass ihn wer beisst
wohin?- und das auch nicht zu knapp -
wie sagts die Emma? na......? SCHWANZ AB!!
Holgus ist so frech und dreist
da wünscht man sich ,dass ihn wer beisst
wohin?- und das auch nicht zu knapp -
wie sagts die Emma? na......? SCHWANZ AB!!
ELN msg # 224239 4/25/2008 12:33:49 AMBy: godivatruffles6
Irish Independent "Firm has no intention of selling medicaton share" ie. Kelly Martin has no intention of selling its stake in Tysabri
Independent.ie
Firm has 'no intention' of selling medication share
::: Analysis
By John Mulligan
Friday April 25 2008
Elan chief executive Kelly Martin said that the company has "no intention" of selling its stake in Tysabri, which is expected to be a blockbuster treatment for multiple sclerosis.
Elan's development partner, Biogen Idec, is currently facing a major battle with legendary activist-investor Carl Ichan, who has said the US firm should be sold to realise value for shareholders.
After trying to buy Biogen in 2006, billionaire Icahn is pressuring the company to sell itself to a bigger drugmaker. He is proposing three members to its board of directors and is suing Biogen, contending the company's failed attempt to find buyers last year wasn't sincere. A court hearing on the action is scheduled for next month in the US.
Biogen lost more than $5bn in market value in December when it abandoned sale plans. Elan has first refusal rights over Biogen Idec's 50pc stake in Tysabri.
Mr Kelly said that should a situation arise where the option of acquiring Biogen Idec's stake in the drug, that Elan will "do what's in the best interest of Elan and its shareholders, and what's in the best interest of Tysabri".
He described the product as "quite a unique asset" that could have other applications outside its current multiple sclerosis and Crohn's disease stable. Earlier this month Mr Icahn proposed a number of nominee directors for the Biogen Idec board, but they were rejected by the company.
The company said they had been deemed unsuitable because they were committed to Mr Icahn's "single-minded agenda" to sell the firm. Biogen said that such a plan would compromise its ability to attract talented employees and form partnerships with other companies. This week Biogen Idec upped its earnings guidance for the year on the back of strong Tysabri sales.
ob wir heute ein neues 3-Jahres-Hoch erreichen?
Wäre doch mal wieder Zeit.
Wäre doch mal wieder Zeit.
aktuell:
$26,25
$26,25
Antwort auf Beitrag Nr.: 33.973.425 von Poppholz am 25.04.08 15:36:46nee,26,47....bin nun auf kultour!Passt schön auf hier...will heute die 28 sehen....
Antwort auf Beitrag Nr.: 33.972.437 von Birgit.Tersteegen am 25.04.08 13:54:53da wünscht man sich ,dass ihn wer beisst
Oh ja, beiss mal ... hmm ... lechz ... sabber
Oh ja, beiss mal ... hmm ... lechz ... sabber
Antwort auf Beitrag Nr.: 33.973.473 von Birgit.Tersteegen am 25.04.08 15:42:14habe nichts dagegen, aber die Drückerkolonne ist schon wieder am Werk.
Mal sehen, wie viel die heute "investieren" wollen.
Beim aktuellen Kursverlauf möchte ich echt nicht SHORT sein.
Mal sehen, wie viel die heute "investieren" wollen.
Beim aktuellen Kursverlauf möchte ich echt nicht SHORT sein.
ob wir heute den gleichen Kursverlauf sehen werden wie am gestrigen Tag?
Antwort auf Beitrag Nr.: 33.973.617 von Poppholz am 25.04.08 15:56:47Beim aktuellen Kursverlauf möchte ich echt nicht SHORT sein.
Ach ich find Shorts toll ... besonders bei dem Wetter
Ach ich find Shorts toll ... besonders bei dem Wetter
Antwort auf Beitrag Nr.: 33.973.631 von Poppholz am 25.04.08 15:57:50der heutige Tag hat auf jeden Fall schon einmal Ähnlichkeit mit dem gestrigen Tag:
Antwort auf Beitrag Nr.: 33.973.669 von Holgus am 25.04.08 16:01:57
Antwort auf Beitrag Nr.: 33.973.758 von Poppholz am 25.04.08 16:10:28und wieder ein grüner Wochenausklang und entlich über $26,00.
Nächste Woche erreichen wir ein neues 3-Jahres-Hoch.
Nächste Woche erreichen wir ein neues 3-Jahres-Hoch.
ELN msg # 224638 4/26/2008 2:52:53 AMBy: okz45
Get ready, Get set and GO======ML and Institutions==3/31/2008
Blackrock adds 237K to 1.122M shares
Blackrock Advisors adds 311K to 916K shares
Blackrock Group adds 123K shares {new}
Blackrock is 51% owned by Merrill Lynch
George Wood adds 222K to 721K shares
Good start. The reports are all due in by May 15.
The early ML signal is nice to see.
MOIN!
ELN msg # 224847 4/27/2008 7:49:13 PM
By: shoulda
elan, lars, wye, essner ad aother assorted factoids
1. Lars, did not leave the company. He is a director. He was given a very nice "retirement" package in recognition of his enormous contribution to elan. He is located in San Diego. Elan closed the SD campus and relocated it to SF. Lars has a special needs child and a life that is very SanDiego centric. He did not want to move to SF, and the status of the trials and pipeline and the depth of the Elan bench allowed him to stay connected and give up the day to day and Elan to keep his expertise, meet his needs and not damage either trials or pipline. Win-win for all
2. Essner announced his desire to leave several years ago. It has absolutely notheing to do with fears about the phase 2 trials. I actually believe he may be heading for a great non-profit perch that will be involved in Alzheimers. Essner is the man who began talking about the coming AD epidemic at a White House dinner/meeting two or so years ago and has followed up with an Oped in the NYT and many other speeches. That prefigured the creation of AD/Act. I am pretty sure that he is considered a near saint in AD circles because of his publicizing the problem no less than wye's role in ab development.
3. TSW or TSRW is a matter of opinion. Everyone has one. After the release of the phase 2 data, we will know the sweet ones. (G) I am firmly in the TSRW column for many reasons. Probably none of which involve major brainwashing. a.. 1792, the aborted dosing trial that keeps on giving. I bought into elan because it was a buck and change and I deal with AD on a daily basis. 1792 was, as Lars said, :Proof of concept" even tho Phase 2 dosing was aborted and not a single participant received the full number of doses and most had a single dose. It cleared plaques. (Good in my opinion.). There was evidence of some improvement in some participants. (Extraordinary in my opinion). Follow up studies continue to appear, autosies of participants continue to be reported on, yada, yada, yada. Was anyone cured. Nope. Were any dramatically improved? nope. Were there sustained, long term improvements for some - yes. A lot? No. I have read all the studies, and articles and to me it says, "proof of concept. I got them to first base.
2b. Phase 1, aab trial. with an N of 8, it got some efficacy signials that was statistically significant. Clearly, with an N of 8, any effect must have been pretty damn strong to get to stat sig. Definitive? No. Suggestive? Very. I am not sure, but I would not be surprised if it is the only AD phase 1 to even suggest efficacy. So this was second base.
2c aab phase 2 trial. Results are still out. However, several responsible professionals have said publically that efficacy is not the issue for phase 3, it is safety. Now, really, in AD efficacy is not the issue? Ad is the disease that has "hope in a bottle" as it's only weapon and efficacy in not the issue. Spoke volumes to me. Then there are the trial participants, I know of two. One improved and has remained stable for the course of the study and the open label extension to date, the other declined until the open label extension and has since shown improvement. Could be random chance, could be bad reporting, could be total bullshit. But, I don't think so. I think it is a close as any outsider will ever get to KNOWING tsw. Then there are the guarded statements of some of the trial docs in rint and on videos, some with testomonials from phase2 particpants ... not a one of them was suggesting that this shit doesn't work, each was suggesting tht they had seen improvements. Definitive? No. Suggestive? Very.
2c. Elan and Wye statements. Now, elan is about as closemouthed as a company can be. Wye, post litigation hell, is not far behind. Both have talked about aab as being potentially trnsformative to their companies and indeed the nations's health care system. Ole pimp daddy has talked about managing to the upside and the importance of taking it carefully given the millions in need and the pressure to get a drug into market. Then there are the commercializastion hires, the talk about major new biologic plants, Lars spoke time and time again about the need to keep the area under the curve away from competitors, yada, yada, yada. Now if this were many companies I would dismiss it all as "window dressing", but this is elan talking about managing to the upside with debt up the wazoo and a seeming lifetime of negative earnings. Elan one of whose major claims to fame is avoiding the abyss and avoiding BK. Elan who watched a sure fire b;lockbuster crash and burn months afer intorduction and brought it back from the brink of extinction. If the boyz did not believe it worked, they would not have said any of this in my opinion. It would have been the classic, "tough disease, we are hoping for the best" or they could been looking for a nutripharma partner. (G) I think this is all collectively very suggestive.
2d. Phase 3 initiated a year ahead of schedule. Estimated cost of this trial is about $300 million dollars -4000 particpants, multiple mris. burdensome level of testing, tough exclusion criteria, apoe4 carrier and non carrier arms. Not exactly a minor, romp in the park undertaking. Big, bucks, biig numbers lots of investigators and on-going fda consultation. Perhaps everybody begins phase 3s before the phase 2 has completed dosing, let alone data complilation and analysis.. Nah. Now, there was a peek at the data, and before the peek, WYE said, it would have to be "spectaculular" to go to phase 3 early. They did go to phase 3 a year early. Seems to me that that suggests the results of the peek were somewhere in the neighborhood of spectacular. Amazingly spectacular, markedly spectacular or merely spectacular seems to define the possibilities. All those choices stronlgy support TSW. Could it be that two pharms fresh from the litigation wars decided to just take a flyer? Highly unlikely. I think Phase 2 gets aab to third base with 0 outs and men on first and second, and a friendly ref.
Is a home run guaranteed? No, but if phase 2 is good, and phase 2 demonstrates which form of spectacular is at hand, I think, we, as investors, can just sit back and wave all the runners, begin to think about a financial advisor and start the manual dexterity exercises that will help us count our money.
ELN msg # 224847 4/27/2008 7:49:13 PMBy: shoulda
elan, lars, wye, essner ad aother assorted factoids
1. Lars, did not leave the company. He is a director. He was given a very nice "retirement" package in recognition of his enormous contribution to elan. He is located in San Diego. Elan closed the SD campus and relocated it to SF. Lars has a special needs child and a life that is very SanDiego centric. He did not want to move to SF, and the status of the trials and pipeline and the depth of the Elan bench allowed him to stay connected and give up the day to day and Elan to keep his expertise, meet his needs and not damage either trials or pipline. Win-win for all
2. Essner announced his desire to leave several years ago. It has absolutely notheing to do with fears about the phase 2 trials. I actually believe he may be heading for a great non-profit perch that will be involved in Alzheimers. Essner is the man who began talking about the coming AD epidemic at a White House dinner/meeting two or so years ago and has followed up with an Oped in the NYT and many other speeches. That prefigured the creation of AD/Act. I am pretty sure that he is considered a near saint in AD circles because of his publicizing the problem no less than wye's role in ab development.
3. TSW or TSRW is a matter of opinion. Everyone has one. After the release of the phase 2 data, we will know the sweet ones. (G) I am firmly in the TSRW column for many reasons. Probably none of which involve major brainwashing. a.. 1792, the aborted dosing trial that keeps on giving. I bought into elan because it was a buck and change and I deal with AD on a daily basis. 1792 was, as Lars said, :Proof of concept" even tho Phase 2 dosing was aborted and not a single participant received the full number of doses and most had a single dose. It cleared plaques. (Good in my opinion.). There was evidence of some improvement in some participants. (Extraordinary in my opinion). Follow up studies continue to appear, autosies of participants continue to be reported on, yada, yada, yada. Was anyone cured. Nope. Were any dramatically improved? nope. Were there sustained, long term improvements for some - yes. A lot? No. I have read all the studies, and articles and to me it says, "proof of concept. I got them to first base.
2b. Phase 1, aab trial. with an N of 8, it got some efficacy signials that was statistically significant. Clearly, with an N of 8, any effect must have been pretty damn strong to get to stat sig. Definitive? No. Suggestive? Very. I am not sure, but I would not be surprised if it is the only AD phase 1 to even suggest efficacy. So this was second base.
2c aab phase 2 trial. Results are still out. However, several responsible professionals have said publically that efficacy is not the issue for phase 3, it is safety. Now, really, in AD efficacy is not the issue? Ad is the disease that has "hope in a bottle" as it's only weapon and efficacy in not the issue. Spoke volumes to me. Then there are the trial participants, I know of two. One improved and has remained stable for the course of the study and the open label extension to date, the other declined until the open label extension and has since shown improvement. Could be random chance, could be bad reporting, could be total bullshit. But, I don't think so. I think it is a close as any outsider will ever get to KNOWING tsw. Then there are the guarded statements of some of the trial docs in rint and on videos, some with testomonials from phase2 particpants ... not a one of them was suggesting that this shit doesn't work, each was suggesting tht they had seen improvements. Definitive? No. Suggestive? Very.
2c. Elan and Wye statements. Now, elan is about as closemouthed as a company can be. Wye, post litigation hell, is not far behind. Both have talked about aab as being potentially trnsformative to their companies and indeed the nations's health care system. Ole pimp daddy has talked about managing to the upside and the importance of taking it carefully given the millions in need and the pressure to get a drug into market. Then there are the commercializastion hires, the talk about major new biologic plants, Lars spoke time and time again about the need to keep the area under the curve away from competitors, yada, yada, yada. Now if this were many companies I would dismiss it all as "window dressing", but this is elan talking about managing to the upside with debt up the wazoo and a seeming lifetime of negative earnings. Elan one of whose major claims to fame is avoiding the abyss and avoiding BK. Elan who watched a sure fire b;lockbuster crash and burn months afer intorduction and brought it back from the brink of extinction. If the boyz did not believe it worked, they would not have said any of this in my opinion. It would have been the classic, "tough disease, we are hoping for the best" or they could been looking for a nutripharma partner. (G) I think this is all collectively very suggestive.
2d. Phase 3 initiated a year ahead of schedule. Estimated cost of this trial is about $300 million dollars -4000 particpants, multiple mris. burdensome level of testing, tough exclusion criteria, apoe4 carrier and non carrier arms. Not exactly a minor, romp in the park undertaking. Big, bucks, biig numbers lots of investigators and on-going fda consultation. Perhaps everybody begins phase 3s before the phase 2 has completed dosing, let alone data complilation and analysis.. Nah. Now, there was a peek at the data, and before the peek, WYE said, it would have to be "spectaculular" to go to phase 3 early. They did go to phase 3 a year early. Seems to me that that suggests the results of the peek were somewhere in the neighborhood of spectacular. Amazingly spectacular, markedly spectacular or merely spectacular seems to define the possibilities. All those choices stronlgy support TSW. Could it be that two pharms fresh from the litigation wars decided to just take a flyer? Highly unlikely. I think Phase 2 gets aab to third base with 0 outs and men on first and second, and a friendly ref.
Is a home run guaranteed? No, but if phase 2 is good, and phase 2 demonstrates which form of spectacular is at hand, I think, we, as investors, can just sit back and wave all the runners, begin to think about a financial advisor and start the manual dexterity exercises that will help us count our money.
Astellas, CoMentis Sign $760M Alzheimer's Deal; Awaiting Wyeth's Results
by: Eben Tessari posted on: April 27, 2008 |
Astellas Pharma, Inc. (ALPMF.PK) and CoMentis, Inc. announced Friday that the companies have entered into an agreement to develop products from CoMentis’ beta-secretase inhibitor program, including the recently initiated, phase 2, lead candidate compound CTS-21166, an oral beta-secretase inhibitor for the treatment of Alzheimer’s disease. The agreement also includes a research collaboration to develop additional beta-secretase inhibitors.
Upon closing, CoMentis will receive an upfront payment of $80 million and an equity investment of $20 million. CoMentis has the opportunity to receive up to $660 million in development milestones and may also receive performance-based commercialization milestones. In addition, CoMentis has the right to receive development milestones for next-generation beta-secretase inhibitors discovered under the terms of the research collaboration. Astellas will fund 100% of the pre-Phase III global development costs and CoMentis will share the Phase III development costs. Astellas has exclusive worldwide commercialization rights while CoMentis retains the right to co-promote in the U.S., where profit will be shared. CoMentis will receive royalties on sales outside the U.S.
Not a bad day for CoMentis; $100M upfront is a nice chunk of change for any program, let alone one that barely cleared phase I and showed no cognitive improvements (they weren’t measured, go figure). The mechanism of action of CTS-21166 centers around inhibiting one of the enzymes (beta-secretase) that clips off a part of a larger protein [APP] to form amyloid-beta, which comprises the plaques found in the brains of Alzheimer’s patients. It is thought by reducing the amount of amyloid, the disease course may be reversed or, at least slowed; a treatment outcome that is not currently possible. There is a sort of chicken and egg game over the origin of these plaques in Alzheimer’s. Some believe the formation of these plaques is the origin of Alzheimer’s and others take the opposite tack saying the disease itself creates the plaque.
There is controversy however, as Derek Lowe points out on his blog In The Pipeline. A one year old PNAS paper shows that mice which over express APP but lack beta-secretase, actually do worse on cognitive tests than mice that only over express APP. In the clinical realm, bapineuzumab, a mAb targeting amyloid-beta from Wyeth (WYE) and Elan (ELN), is currently in phase 2 and 3 and has yet to release any data including the all important ADAS-Cog score. If these therapies do not reverse the cognition score (as measured by ADAS-Cog) the FDA might not approve them regardless.
Alzheimer's is a tough disease and eventually, given enough shots on goal, one or two will go in. If bapineuzumab is successful, CTS-21166, would potentially have an advantage long term due to the oral (or so they say, the ph1 was IV) dosing and I’m sure the BD people at CoMentis delightfully highlighted that fact. This proof of concept for the mechanism of action will come mid to late ‘08 when Wyeth releases results of the extended phase 2 of bapineuzumab. I’ll be keeping my eyes peeled.
Disclosure: none
http://www.finanznachrichten.de/nachrichten-aktien/wyeth.asp
by: Eben Tessari posted on: April 27, 2008 |
Astellas Pharma, Inc. (ALPMF.PK) and CoMentis, Inc. announced Friday that the companies have entered into an agreement to develop products from CoMentis’ beta-secretase inhibitor program, including the recently initiated, phase 2, lead candidate compound CTS-21166, an oral beta-secretase inhibitor for the treatment of Alzheimer’s disease. The agreement also includes a research collaboration to develop additional beta-secretase inhibitors.
Upon closing, CoMentis will receive an upfront payment of $80 million and an equity investment of $20 million. CoMentis has the opportunity to receive up to $660 million in development milestones and may also receive performance-based commercialization milestones. In addition, CoMentis has the right to receive development milestones for next-generation beta-secretase inhibitors discovered under the terms of the research collaboration. Astellas will fund 100% of the pre-Phase III global development costs and CoMentis will share the Phase III development costs. Astellas has exclusive worldwide commercialization rights while CoMentis retains the right to co-promote in the U.S., where profit will be shared. CoMentis will receive royalties on sales outside the U.S.
Not a bad day for CoMentis; $100M upfront is a nice chunk of change for any program, let alone one that barely cleared phase I and showed no cognitive improvements (they weren’t measured, go figure). The mechanism of action of CTS-21166 centers around inhibiting one of the enzymes (beta-secretase) that clips off a part of a larger protein [APP] to form amyloid-beta, which comprises the plaques found in the brains of Alzheimer’s patients. It is thought by reducing the amount of amyloid, the disease course may be reversed or, at least slowed; a treatment outcome that is not currently possible. There is a sort of chicken and egg game over the origin of these plaques in Alzheimer’s. Some believe the formation of these plaques is the origin of Alzheimer’s and others take the opposite tack saying the disease itself creates the plaque.
There is controversy however, as Derek Lowe points out on his blog In The Pipeline. A one year old PNAS paper shows that mice which over express APP but lack beta-secretase, actually do worse on cognitive tests than mice that only over express APP. In the clinical realm, bapineuzumab, a mAb targeting amyloid-beta from Wyeth (WYE) and Elan (ELN), is currently in phase 2 and 3 and has yet to release any data including the all important ADAS-Cog score. If these therapies do not reverse the cognition score (as measured by ADAS-Cog) the FDA might not approve them regardless.
Alzheimer's is a tough disease and eventually, given enough shots on goal, one or two will go in. If bapineuzumab is successful, CTS-21166, would potentially have an advantage long term due to the oral (or so they say, the ph1 was IV) dosing and I’m sure the BD people at CoMentis delightfully highlighted that fact. This proof of concept for the mechanism of action will come mid to late ‘08 when Wyeth releases results of the extended phase 2 of bapineuzumab. I’ll be keeping my eyes peeled.
Disclosure: none
http://www.finanznachrichten.de/nachrichten-aktien/wyeth.asp
Antwort auf Beitrag Nr.: 33.984.493 von Poppholz am 28.04.08 13:41:32das ist natürlich der richtige Link.
http://seekingalpha.com/article/74228-astellas-comentis-sign…
http://seekingalpha.com/article/74228-astellas-comentis-sign…
aktuell:
26,35 USD = 16,88 €
Aktuelle Wechselkurse:
1 EUR = 1,56100 USD (28.04. 15:53)
26,35 USD = 16,88 €
Aktuelle Wechselkurse:
1 EUR = 1,56100 USD (28.04. 15:53)
will den heute gar keiner mehr so richtig verkaufen?
Kaufen wollen auf jeden Fall ein paar Leute:
Kaufen wollen auf jeden Fall ein paar Leute:
betrachte mir momentan noch den Kursverlauf bei Thielert (WKN 605207).
Ist mir aber zu gefährlich gewesen.
Hier wären 100% von gestern zu heute drin gewesen und das bei einem SDAX Unternehmen.
Aber ich bin nun einmal lieber in so sicheren Aktien wie unserer ELAN.
Ist mir aber zu gefährlich gewesen.
Hier wären 100% von gestern zu heute drin gewesen und das bei einem SDAX Unternehmen.
Aber ich bin nun einmal lieber in so sicheren Aktien wie unserer ELAN.
Antwort auf Beitrag Nr.: 33.985.688 von bernie55 am 28.04.08 15:54:57871331
Geld
16,83
Brief
17,09
Zeit
28.04. 15:57
Geld
16,83
Brief
17,09
Zeit
28.04. 15:57
Antwort auf Beitrag Nr.: 33.985.688 von bernie55 am 28.04.08 15:54:57903801
Geld
16,71
Brief
17,24
Zeit
28.04. 15:58
Geld
16,71
Brief
17,24
Zeit
28.04. 15:58
Antwort auf Beitrag Nr.: 33.985.722 von Poppholz am 28.04.08 15:57:44Aber ich bin nun einmal lieber in so sicheren Aktien wie unserer ELAN.
..wie wahr, POPPIE...
..wie wahr, POPPIE...
damit wir den heutigen Chart nicht aus den Augen verlieren:
Antwort auf Beitrag Nr.: 33.985.893 von Poppholz am 28.04.08 16:13:20...Mannomann...wir kommen ja richtig in die Pötte...
aktuell 26,52 - 26,54...
aktuell 26,52 - 26,54...
Antwort auf Beitrag Nr.: 33.985.910 von bernie55 am 28.04.08 16:15:17 ..26,71 - 26,73 USD
.....noch mehr...." in die Pötte ".....YEPP!!!!
..26,71 - 26,73 USD .....noch mehr...." in die Pötte ".....YEPP!!!!
Antwort auf Beitrag Nr.: 33.985.910 von bernie55 am 28.04.08 16:15:17ist Birgit heimlich in den Urlaub gefahren?
Antwort auf Beitrag Nr.: 33.985.992 von bernie55 am 28.04.08 16:23:47ich habe meine Kaufpläne immer noch nicht umgesetzt.
Antwort auf Beitrag Nr.: 33.985.993 von Poppholz am 28.04.08 16:23:48ist Birgit heimlich in den Urlaub gefahren?
YEPP.....für ein Jahr.....ELAN - PAUSE:...
YEPP.....für ein Jahr.....ELAN - PAUSE:...
Antwort auf Beitrag Nr.: 33.986.003 von Poppholz am 28.04.08 16:24:34ch habe meine Kaufpläne immer noch nicht umgesetzt.
..lasssssssssssss es sein, POPPIE....
...zum Wohle aller ELANITES ....
..lasssssssssssss es sein, POPPIE....
...zum Wohle aller ELANITES ....
Antwort auf Beitrag Nr.: 33.986.037 von bernie55 am 28.04.08 16:28:42ich warte halt immer noch auf einen "Rücksetzer". Wenn dieser natürlich nicht kommt, dann kann ich mir auch keine Aktien kaufen.
Schlussfolgerung: Der Kurs wird die nächsten zwei Jahre nur nach oben gehen.
(klingt doch logisch)
Schlussfolgerung: Der Kurs wird die nächsten zwei Jahre nur nach oben gehen.
(klingt doch logisch)
die Kursdrücker scheinen jetzt auch mitbekommen zu haben, dass der Kurs stark gestiegen ist.
Jetzt wird erst einmal eine Haltelinie bei $26,50 festgemacht.
Mal sehen, wie viele Aktien die zu diesem Kurs verbrennen wollen.
Jetzt wird erst einmal eine Haltelinie bei $26,50 festgemacht.
Mal sehen, wie viele Aktien die zu diesem Kurs verbrennen wollen.
Antwort auf Beitrag Nr.: 33.986.203 von Poppholz am 28.04.08 16:46:54Kurs klettert langsam wieder nach oben.
Mal sehen was passiert, wenn wir die $26,90 hinter uns lassen.
Dann haben wir ein neues 3-Jahres-Hoch.
Mal sehen was passiert, wenn wir die $26,90 hinter uns lassen.
Dann haben wir ein neues 3-Jahres-Hoch.
das war es doch:
Schnell den alten Wiederstand durchbrochen.
Jetzt bin ich aber mal gespannt, wie sich unser Baby hier oben so verhält
Schnell den alten Wiederstand durchbrochen.
Jetzt bin ich aber mal gespannt, wie sich unser Baby hier oben so verhält
das hat doch gut geklappt:
Bin gespannt, wie sich unser Baby hier oben so verhält
Bin gespannt, wie sich unser Baby hier oben so verhält
Antwort auf Beitrag Nr.: 33.986.027 von bernie55 am 28.04.08 16:27:29...von wegen Urlaub.... Bootshaus streichen,Büro managen,Menschen helfen,Auto reparieren lassen (bei meinem Kultourtrip am freitag haben sie mir nachts die Scheibe eingeschlagen und das Navi geklaut:O),Gartenarbeit.....etc. Bin aber begeistert vom Kurs.....was sagt denn unser Nörgeli Holgerli dazu ????--So,jetzt mal lesen im IV....
Bootshaus streichen,Büro managen,Menschen helfen,Auto reparieren lassen (bei meinem Kultourtrip am freitag haben sie mir nachts die Scheibe eingeschlagen und das Navi geklaut:O),Gartenarbeit.....etc. Bin aber begeistert vom Kurs.....was sagt denn unser Nörgeli Holgerli dazu ????--So,jetzt mal lesen im IV.... ELN msg # 225054 4/28/2008 12:06:46 PMBy: peadar_og
Elan
Looking at the DNA five-year chart may give you an idea of what to expect should things go fairly well. Even this chart won’t cut it if things go as well as they could.
They had three major PPS jumps during a period of about 18 months. These were based on cancer drug news flow.
The first was from $17 to $40 in a day or two. That represented a market cap increase of about $23b.
The stock then quickly accelerated from $40 to $60 (another $20b) before dropping back to $45.
The third was a jump from $45 to 4100 in days, representing a market cap increase of almost $60b in days.
The company was making a loss.
As I say, I believe we’re in this category should things go fairly well over the coming months/weeks/days. Even this chart won’t cut it if things go as well as they could.
As I say, every day without a major safety concern is now adding very considerable intrinsic value. Timeframes have become extremely compressed. All my fingers and toes remain crossed. Third time lucky?
$27 is peanuts in my view. DNA’s market cap would get us to $200.
Peadar ‘Og
Antwort auf Beitrag Nr.: 33.987.648 von Birgit.Tersteegen am 28.04.08 19:32:40was sagt denn unser Nörgeli Holgerli dazu ????
Holgus träumt von Koitus without Lattus
Holgus träumt von Koitus without Lattus
Apropos Birgit ...
Wie macht eine Blondine Marmelade ???
Sie schält `nen Berliner
Und warum läuft Birgit immer auf Zehenspitzen an der Apotheke vorbei ?
Sie will nicht, daß die Schlaftabletten aufwachen
Wie macht eine Blondine Marmelade ???
Sie schält `nen Berliner
Und warum läuft Birgit immer auf Zehenspitzen an der Apotheke vorbei ?
Sie will nicht, daß die Schlaftabletten aufwachen
Antwort auf Beitrag Nr.: 33.988.182 von Holgus am 28.04.08 20:32:14
Antwort auf Beitrag Nr.: 33.987.648 von Birgit.Tersteegen am 28.04.08 19:32:40Oh Birgit.
Da wäre es doch besser gewesen, wenn Du geschrieben hättest, dass Du im tiefsten Urwald bist und erst einmal keine Lust mehr hast nach Deutschland zurück zu kommen.
Kurz nachdem Du Dein Posting veröffentlicht hast, dass Du nicht im Urlaub bist, ist der Kurs runter gegangen.
Gute Vorraussetzungen für Kurssteigerungen:
Poppholz hat verkauft oder will kaufen und Birgit ist im Urlaub.
Da wäre es doch besser gewesen, wenn Du geschrieben hättest, dass Du im tiefsten Urwald bist und erst einmal keine Lust mehr hast nach Deutschland zurück zu kommen.
Kurz nachdem Du Dein Posting veröffentlicht hast, dass Du nicht im Urlaub bist, ist der Kurs runter gegangen.
Gute Vorraussetzungen für Kurssteigerungen:
Poppholz hat verkauft oder will kaufen und Birgit ist im Urlaub.
Antwort auf Beitrag Nr.: 33.989.873 von Poppholz am 29.04.08 08:36:04....aber Poppi--ich bin so eine ehrliche Seele--ich KANN NICHT LÜGEN....auch nicht für unser Schätzchen..--aber es wird die nächsten Tage eh weiter hoch gehen ,weil alle gespannt sind auf den Investors Day am 7.5.,auf dem über Hintergründe,Pipeline etc über 4 Stunden berichtet wird.....auf zur 100
....auch nicht für unser Schätzchen..--aber es wird die nächsten Tage eh weiter hoch gehen ,weil alle gespannt sind auf den Investors Day am 7.5.,auf dem über Hintergründe,Pipeline etc über 4 Stunden berichtet wird.....auf zur 100
Antwort auf Beitrag Nr.: 33.989.873 von Poppholz am 29.04.08 08:36:04
Gute Vorraussetzungen für Kurssteigerungen:
Poppholz hat verkauft oder will kaufen und Birgit ist im Urlaub.
..und bernie55 beobachtetalles von der Seitenlinie aus und wartet darauf, dass Poppie verkauft hat bzw. kaufen will und dass Birgit endlich in den Urlaub fährt und dann für ein halbes Jahr in D nicht mehr gesichtet wird......
Guten Morgen , ELANITES + ELANIACS
Gute Vorraussetzungen für Kurssteigerungen:
Poppholz hat verkauft oder will kaufen und Birgit ist im Urlaub.
..und bernie55 beobachtet
alles von der Seitenlinie aus und wartet darauf, dass Poppie verkauft hat bzw. kaufen will und dass Birgit endlich in den Urlaub fährt und dann für ein halbes Jahr in D nicht mehr gesichtet wird......Guten Morgen , ELANITES + ELANIACS
After Hours
Last: $ 26.50
After Hours
High: $ 26.641
After Hours
Volume: 39,340
After Hours
Low: $ 26.50
After Hours
Share Volume
18:02 $ 26.50 100
16:13 $ 26.6357 5,700
16:03 $ 26.641 33,540
Last: $ 26.50
After Hours
High: $ 26.641
After Hours
Volume: 39,340
After Hours
Low: $ 26.50
After Hours
Share Volume
18:02 $ 26.50 100
16:13 $ 26.6357 5,700
16:03 $ 26.641 33,540
FDA Drug Oversight
The slow rate of drug approvals, with Andrew Von Eschenbach, FDA
http://www.cnbc.com/id/15840232?video=724593015&play=1
The slow rate of drug approvals, with Andrew Von Eschenbach, FDA
http://www.cnbc.com/id/15840232?video=724593015&play=1
und hier noch der einzige Chart, der schön ist wenn er fällt:
Antwort auf Beitrag Nr.: 33.990.564 von bernie55 am 29.04.08 09:48:47das wären bei einem Umrechnungskurs von 1:1,56 immer noch 16,98 Euro.
Antwort auf Beitrag Nr.: 33.991.497 von Poppholz am 29.04.08 11:21:14....genau genommen 16,987€ ....
.....somit ganz klar 16,99 €......
.....somit ganz klar 16,99 €......
Antwort auf Beitrag Nr.: 33.992.335 von bernie55 am 29.04.08 12:46:36..jetzt runden wir die Stelle noch nach dem Komma auf, aber......wenn....dann......aber hallo........
...dann natürlich nur noch vor dem Komma......
...dann natürlich nur noch vor dem Komma......
Antwort auf Beitrag Nr.: 33.992.352 von bernie55 am 29.04.08 12:49:00..jetzt runden wir
Runden ? Rundungen ?? Birgit ???
Wie nennt man eine Blondine in einer Ritterrüstung
"Blechblasinstrument"
Runden ? Rundungen ?? Birgit ???
Wie nennt man eine Blondine in einer Ritterrüstung
"Blechblasinstrument"
Antwort auf Beitrag Nr.: 33.992.455 von Holgus am 29.04.08 13:01:05Du scheinst ja zur Zeit einen " Blondinen- Ticker " in Dir zu haben...
...mmmmhhhh....wie kann ich Dir helfen ????
...mmmmhhhh....wie kann ich Dir helfen ????
Antwort auf Beitrag Nr.: 33.992.771 von bernie55 am 29.04.08 13:32:08oh ja BITTE---Herr Therapeut übernehmen SIE 
(oder soll ich doch Viagra mit Zyankalibeimischung bestellen??)Was hätte Miss Marple gemacht??
(oder soll ich doch Viagra mit Zyankalibeimischung bestellen??)Was hätte Miss Marple gemacht??
Antwort auf Beitrag Nr.: 33.992.907 von Birgit.Tersteegen am 29.04.08 13:46:51 -oder soll ich doch Viagra mit Zyankalibeimischung bestellen?? -
Mensch, Birgit, du bist ja eine richtige " blonde Giftmischerin" ...
-oder soll ich doch Viagra mit Zyankalibeimischung bestellen?? - Mensch, Birgit, du bist ja eine richtige " blonde Giftmischerin" ...
Antwort auf Beitrag Nr.: 33.992.771 von bernie55 am 29.04.08 13:32:08..mmmmhhhh....wie kann ich Dir helfen ???
Mir kann keiner helfen ... denn schon Konfuzius sagte (zu Birgit):
Wenn Du einschläfst am Abend mit Popo der kratzt,
dann Du aufwachst am Morgen mit Finger der stinkt
Mir kann keiner helfen ... denn schon Konfuzius sagte (zu Birgit):
Wenn Du einschläfst am Abend mit Popo der kratzt,
dann Du aufwachst am Morgen mit Finger der stinkt
Antwort auf Beitrag Nr.: 33.993.066 von bernie55 am 29.04.08 14:06:35...jaaaaa--ich kann auch anders----nicht immer nur nett....
WYETH > AFTERHOURS !!!!
16:17 $ 44.82 205,000
16:10 $ 44.82 187,900
16:17 $ 44.82 205,000
16:10 $ 44.82 187,900
Antwort auf Beitrag Nr.: 33.993.517 von bernie55 am 29.04.08 14:55:24PREMARKET : WYETH > > 47 USD
Flashquote vom 28.04.08 > 44,82 USD
Flashquote vom 28.04.08 > 44,82 USD
..und wieder ein Dämpfer für BIOGEN:
DOW JONES NEWSWIRES
Genentech Inc. (DNA) and Biogen Idec Inc. (BIIB) said Tuesday that their Phase II/III study of Rituxan for systemic lupus erythematosus did not meet its primary endpoint.
The drug makers also said the study did not meet any of its six secondary endpoints.
Although estimates vary, about 400,000 people in the U.S. are believed to have lupus, which is an autoimmune disease that damages organs and tissues.
Shares of Genentech closed Monday at $73.16, while shares of Biogen Idec ended at $64.67.
-Michelle Donley; 415-439-6400; AskNewswires@dowjones.com
Order free Annual Report for Genentech Incorporated
Visit http://djnewswires.ar.wilink.com/?link=DNA or call 1-888-301-0513
> Dow Jones Newswires
04-29-08 0915ET
DOW JONES NEWSWIRES
Genentech Inc. (DNA) and Biogen Idec Inc. (BIIB) said Tuesday that their Phase II/III study of Rituxan for systemic lupus erythematosus did not meet its primary endpoint.
The drug makers also said the study did not meet any of its six secondary endpoints.
Although estimates vary, about 400,000 people in the U.S. are believed to have lupus, which is an autoimmune disease that damages organs and tissues.
Shares of Genentech closed Monday at $73.16, while shares of Biogen Idec ended at $64.67.
-Michelle Donley; 415-439-6400; AskNewswires@dowjones.com
Order free Annual Report for Genentech Incorporated
Visit http://djnewswires.ar.wilink.com/?link=DNA or call 1-888-301-0513
> Dow Jones Newswires
04-29-08 0915ET
Antwort auf Beitrag Nr.: 33.993.877 von bernie55 am 29.04.08 15:29:04....das tut uns aber leid für unseren "Partner",gelle ??
??
unser Baby will nach oben.
Es wird aber immer wieder zurück geschubst.
Mal sehen wie es heute Abend aussieht.
Rechnerisch sind wir aber trotzdem über €17,-
Es wird aber immer wieder zurück geschubst.
Mal sehen wie es heute Abend aussieht.
Rechnerisch sind wir aber trotzdem über €17,-
ELN msg # 225807 4/30/2008 6:03:13 AMBy: sunsetends
Re: J P Morgan weighing in........I really like the bold part
....................We expect positive efficacy signal, but not for treatment effect to reach
statistical significance due to small numbers. An interim analysis in
May ‘07 supported progression into Phase III. Additionally, in an
unusual step, the FDA allowed the primary cognitive endpoint to be
finalized at the completion of Phase II. We believe the FDA would not
allow this special consideration in the absence of a clear efficacy signal.
Antwort auf Beitrag Nr.: 34.001.073 von Birgit.Tersteegen am 30.04.08 12:36:09...also, dann schauen wir mal, was der Mai/ Juni 2008 uns bringen wird...
...so, jetzt bin ich gleich " on the road "...ich fahre heute nach Neumarkt in die O.Pfalz.......muss dort ein bisschen " seminaren "....
@ELANITES ...... haltet die Stellung......
@ elanvolle VÄTER.......sauft morgen nicht so viel......und wenn ihr morgen schon saufen wollt, dann wenigstens irischen Whiskey oder Guinness...
......so nach dem Motto..." meine Güte habe ich heute eine irische Birne "....
...so, jetzt bin ich gleich " on the road "...ich fahre heute nach Neumarkt in die O.Pfalz.......muss dort ein bisschen " seminaren "....
@ELANITES ...... haltet die Stellung......
@ elanvolle VÄTER.......sauft morgen nicht so viel......und wenn ihr morgen schon saufen wollt, dann wenigstens irischen Whiskey oder Guinness...
......so nach dem Motto..." meine Güte habe ich heute eine irische Birne "....
Antwort auf Beitrag Nr.: 34.001.387 von bernie55 am 30.04.08 13:11:33Viel Spass + Erfolg! Bin ab Morgen auch 4 Tage am Bootshäuschen--also Kurzurlaub-somit könnte unser Schätzchen mal kurz weitersteigen....
Bin ab Morgen auch 4 Tage am Bootshäuschen--also Kurzurlaub-somit könnte unser Schätzchen mal kurz weitersteigen....
ätsch bätsch--bin noch gar nicht im Urlaub und wir haben TROTZDEM ein neues 3 Jahres HIGH!!!
ELN msg # 226105 4/30/2008 2:00:42 PM
By: cg2003jan
Elan at Morgan Stanley 2008 Global Healthcare tomorrow
Link here:
http://www.elan.com/investorrelations/events/webcast_details…
By: cg2003jan
Elan at Morgan Stanley 2008 Global Healthcare tomorrow
Link here:
http://www.elan.com/investorrelations/events/webcast_details…
Antwort auf Beitrag Nr.: 34.004.931 von Birgit.Tersteegen am 30.04.08 18:47:56ätsch bätsch
Siehste, kaum tauchst Du wieder auf der Bildfläche auf, semmelt der Kurs ab.
Lad gefälligst Euer Bootshaus auf´n Hänger und düs mit Deinem Kerl an die Küste bis Sonntach ... das ist ein BEFEHL
Siehste, kaum tauchst Du wieder auf der Bildfläche auf, semmelt der Kurs ab.
Lad gefälligst Euer Bootshaus auf´n Hänger und düs mit Deinem Kerl an die Küste bis Sonntach ... das ist ein BEFEHL
Antwort auf Beitrag Nr.: 34.004.931 von Birgit.Tersteegen am 30.04.08 18:47:56ist aber doch wieder echt bezeichnend gewesen.
Urlaubsankündigung ausgesprochen und der Kurs geht auf $27,40 hoch.
Kaum wird die Urlaubsanküdigung zurück genommen, geht der Kurs in den roten Bereich runter.
@ Birgit: Vielleicht solltest Du Dir wirklich mal ein paar Wochen Urlaub gönnen.
Urlaubsankündigung ausgesprochen und der Kurs geht auf $27,40 hoch.
Kaum wird die Urlaubsanküdigung zurück genommen, geht der Kurs in den roten Bereich runter.
@ Birgit: Vielleicht solltest Du Dir wirklich mal ein paar Wochen Urlaub gönnen.
Antwort auf Beitrag Nr.: 34.007.517 von Poppholz am 01.05.08 00:17:25also Jungs ,WENN Ihr das so seht...dann bitte ich um grosszügige Spenden auf ein von mir bald eingerichtetes Urlaubskonto....dafür kriegt Ihr dann auch viele bunte Postkarten von Thailand,Bali,NY,LA.....OK??
dafür kriegt Ihr dann auch viele bunte Postkarten von Thailand,Bali,NY,LA.....OK??
Antwort auf Beitrag Nr.: 34.008.180 von Birgit.Tersteegen am 01.05.08 10:10:54Nix da ... Du hast genug Kohle !!!
Kriegst aber `n Elan-Vatertagsgedicht:
Oh schau da hinten auf´n Acker
ein total besoffner ELANacker
Gräbt da rum und sucht die Asche
eine Hand tief in der Tasche
Plötzlich schaut er wie ein Geier
statt Kohle spürt er weiche Eier
"Was solls" sagt er ... war eh ein Test
die kneif ich bunt für´s Osterfest
Kriegst aber `n Elan-Vatertagsgedicht:
Oh schau da hinten auf´n Acker
ein total besoffner ELANacker
Gräbt da rum und sucht die Asche
eine Hand tief in der Tasche
Plötzlich schaut er wie ein Geier
statt Kohle spürt er weiche Eier
"Was solls" sagt er ... war eh ein Test
die kneif ich bunt für´s Osterfest
Antwort auf Beitrag Nr.: 34.008.508 von Holgus am 01.05.08 11:20:14:O
--------------------------------------------------------------
SUPER NEWS--finde ich!
ELN msg # 226947 5/2/2008 3:58:52 AM
By: smellybadger2003
NCB
We had a good meeting yesterday with Elan. Whilst no new news emerged, the tone for
the outlook was very much positive.
• AAB-001 Phase II end points: Much market comment has surrounded whether
ADAS-Cog or NTB would be used as the primary cognitive endpoint. Elan highlighted
that ADAS-Cog is viewed as a benchmark rather than a gold standard and that the FDA
consider NTB as a perfectly acceptable primary endpoint. At present no decision has
been formalised on the primary endpoints for the study.
• AAB-001 Subpart E opportunity: The company was clear that the Phase II data on
its own would not be sufficient to support a Subpart E filing. This is on the basis that the
small size of the Phase II study population (240 patients) will not provide sufficient
safety data.
• AAB-001 Manufacturing: Elan views it as strategically important to be involved in the
manufacturing of AAB-001. A decision on committing resources to the manufacturing
set-up will not be made until the Phase II data has been assessed.
• Tysabri: Elan expects a 60:40 split in favour of ex-US patients in the Tysabri patient
profile going forward. The company recently reported a strong uptick in EU/RoW
patients for Q1, while the US run rate was flat on the previous quarter. At present
c.6,000 physicians in the US prescribe biologics. At the end of Q1, 2,750 of these
physicians were prescribing Tysabri for MS. The company sees an uptick in new US
patients being achieved through an increase in the number of physicians prescribing
Tysabri and expects some of the more conservative physicians to take this step as the
risk/benefit profile of the drug becomes more evident.
• ACC-001: The suspension of ACC-001 has no impact on the progession of AAB-001
through clinical trials. While both ACC-001 and AAB-001 support the amyloid
hypothesis, they operate differently in that ACC-001 is an active vaccine, while AAB-
001 is passive IV. Elan expects ACC-001 to be taken off clinical hold in the coming
weeks.
• Pipeline: Elan has a strong pipeline ranging from pre-clinical to Phase III studies and
spanning Alzheimer’s, MS, Crohn’s, Oncology and Parkinson’s. One such program is
bapineuzumab Sub Q which is currently in Phase II. Bapineuzumab Sub Q is
administered by injection rather than infusion making it commercially more valuable.
• Newsflow: On May 7, Elan hosts its inaugural “company day”. A number of topics will
be covered on this day, with an update on the clinical pipeline and details of programs
not previously disclosed being of particular interest. The company holds its AGM in
Dublin on May 22. AAB-001 topline Phase II data is expected mid-year, with the full
Phase II data to be presented at the ICAD conference in late July. The release of
Phase II data will act as a near-term share price catalyst, with positive data offering the
potential to transform Elan’s investment case.
http://www.rte.ie/business/2008/morningrep/download/0502ncb.…
--------------------------------------------------------------
SUPER NEWS--finde ich!
ELN msg # 226947 5/2/2008 3:58:52 AM
By: smellybadger2003
NCB
We had a good meeting yesterday with Elan. Whilst no new news emerged, the tone for
the outlook was very much positive.
• AAB-001 Phase II end points: Much market comment has surrounded whether
ADAS-Cog or NTB would be used as the primary cognitive endpoint. Elan highlighted
that ADAS-Cog is viewed as a benchmark rather than a gold standard and that the FDA
consider NTB as a perfectly acceptable primary endpoint. At present no decision has
been formalised on the primary endpoints for the study.
• AAB-001 Subpart E opportunity: The company was clear that the Phase II data on
its own would not be sufficient to support a Subpart E filing. This is on the basis that the
small size of the Phase II study population (240 patients) will not provide sufficient
safety data.
• AAB-001 Manufacturing: Elan views it as strategically important to be involved in the
manufacturing of AAB-001. A decision on committing resources to the manufacturing
set-up will not be made until the Phase II data has been assessed.
• Tysabri: Elan expects a 60:40 split in favour of ex-US patients in the Tysabri patient
profile going forward. The company recently reported a strong uptick in EU/RoW
patients for Q1, while the US run rate was flat on the previous quarter. At present
c.6,000 physicians in the US prescribe biologics. At the end of Q1, 2,750 of these
physicians were prescribing Tysabri for MS. The company sees an uptick in new US
patients being achieved through an increase in the number of physicians prescribing
Tysabri and expects some of the more conservative physicians to take this step as the
risk/benefit profile of the drug becomes more evident.
• ACC-001: The suspension of ACC-001 has no impact on the progession of AAB-001
through clinical trials. While both ACC-001 and AAB-001 support the amyloid
hypothesis, they operate differently in that ACC-001 is an active vaccine, while AAB-
001 is passive IV. Elan expects ACC-001 to be taken off clinical hold in the coming
weeks.
• Pipeline: Elan has a strong pipeline ranging from pre-clinical to Phase III studies and
spanning Alzheimer’s, MS, Crohn’s, Oncology and Parkinson’s. One such program is
bapineuzumab Sub Q which is currently in Phase II. Bapineuzumab Sub Q is
administered by injection rather than infusion making it commercially more valuable.
• Newsflow: On May 7, Elan hosts its inaugural “company day”. A number of topics will
be covered on this day, with an update on the clinical pipeline and details of programs
not previously disclosed being of particular interest. The company holds its AGM in
Dublin on May 22. AAB-001 topline Phase II data is expected mid-year, with the full
Phase II data to be presented at the ICAD conference in late July. The release of
Phase II data will act as a near-term share price catalyst, with positive data offering the
potential to transform Elan’s investment case.
http://www.rte.ie/business/2008/morningrep/download/0502ncb.…
ELN msg # 226954 5/2/2008 5:55:47 AM
By: peadar_og
Elan
The man in the brown suit did well again. I reckon that man is a fantastic person and CEO.
I believe I’m right too that the value of the stock is an important focus for management as we approach the release of the Bap data. Hopefully, as the stock is indeed setting new highs not seen for a while, some have already benefited from this advice provided for free.
With regard to the CC itself, a signal I’ve been looking for was delivered. The analysts have been confused by the continuous references to AN-1792 and its links to Bap, particularly with regard to the early move to phase III. They’ve been viewing these references as perhaps a signal that Bap data didn’t quite stand up on its own. Well, we heard yesterday that the phII data will speak for itself with regard to timing of pIII commencement, so I guess a few worries have been addresses in that regard.
The statement pasted below though is the one I believe is the important link to AN-1792. It’s a statistical fact now that AN-1792 removed the plaque. This was proven via autopsy and is known by diligent long-term Elan investors. Bap is a passive version of AN-1792. What they were looking for was to retain the efficacy of AN-1792 while making the product safer, i.e. passive. The next question was whether removing the plaque was the key to unlocking the disease.
From Kelly martin yesterday:
“All data we have, clear plaque, at minimum stabilize cognition and improve function, massive step for AD and continue there. “
In my view, the continued references to AN-1792 are telling loyal holders that the passive approach does remove the plaque as seen with AN-1792. You were told yesterday that removing the plaque is the key to controlling the disease. All eyes eagerly look now to the safety profile.
Peadar ‘Og
By: peadar_og
Elan
The man in the brown suit did well again. I reckon that man is a fantastic person and CEO.
I believe I’m right too that the value of the stock is an important focus for management as we approach the release of the Bap data. Hopefully, as the stock is indeed setting new highs not seen for a while, some have already benefited from this advice provided for free.
With regard to the CC itself, a signal I’ve been looking for was delivered. The analysts have been confused by the continuous references to AN-1792 and its links to Bap, particularly with regard to the early move to phase III. They’ve been viewing these references as perhaps a signal that Bap data didn’t quite stand up on its own. Well, we heard yesterday that the phII data will speak for itself with regard to timing of pIII commencement, so I guess a few worries have been addresses in that regard.
The statement pasted below though is the one I believe is the important link to AN-1792. It’s a statistical fact now that AN-1792 removed the plaque. This was proven via autopsy and is known by diligent long-term Elan investors. Bap is a passive version of AN-1792. What they were looking for was to retain the efficacy of AN-1792 while making the product safer, i.e. passive. The next question was whether removing the plaque was the key to unlocking the disease.
From Kelly martin yesterday:
“All data we have, clear plaque, at minimum stabilize cognition and improve function, massive step for AD and continue there. “
In my view, the continued references to AN-1792 are telling loyal holders that the passive approach does remove the plaque as seen with AN-1792. You were told yesterday that removing the plaque is the key to controlling the disease. All eyes eagerly look now to the safety profile.
Peadar ‘Og
ELN msg # 226916 5/1/2008 11:05:10 PMBy: liposghost
before i go over posting quota, update on TSW
i have for a while now said all we need to know bout TSW is how well, how long for how many.
After today's cc and a couple of phone calls i can now say
It works very well for a long time for at least a good many.
Give us a couple of years and elmo will be light on his prediction, we may however have a way to go to catch up with the great Og.
ELN msg # 226846 5/1/2008 6:36:11 PM
By: stop_farking_with_me
Why Wall Street Doesn't Quite get it yet
You know, given Tysabri's new status as well as BAP, ELN should be going much higher than it has. I think there is a reason that the real move hasn;t happened yet, and I think it's because of KM...
No, I'm not critical of KM; in fact I admire him greatly. He is a no BS CEO who tells the truth based on what he knows. He doesn't pump, and he is not thinking about impressing WS--he' trying to build a company to become one of the pharm giants.
Which brings me to WS. Half of the people on WS would sell their Mothers if it brought in a commission. The other half are pretty decent and smart people. But they have become very cynical about management across the corporate landscape because they have burned so many times before.
So now they come across this kind of "odd" guy in the Brown Suit. He gets up there, and tells everything he can, and delivers it in a matter-of-fact matter. Does AAB work? Probably(almost definitely), but I can't really add much more than that. Was the P2 data spectacular? Well I can't really tell you that except I'll let you consider that fact WYE and we went ahead with p3. And by the way, I don't spend 300 million for the fun of it. So draw your own conclusions. And so on and so on.....
So these people on WS are probably thinking--what is this guy all about? He CAN'T be telling the truth. What is he REALLY trying to hide?
BOttom line is- WS is going to find out what the guy in the brown suit is all about. And hopefully the success he going to surely enjoy will set a standard for CEO behavior for the future.
Finally, when WS "gets it", ELN is going to run in a way not seen in a long time in the pharma space.
Thank you KM, and ELN scientists.
By: stop_farking_with_me
Why Wall Street Doesn't Quite get it yet
You know, given Tysabri's new status as well as BAP, ELN should be going much higher than it has. I think there is a reason that the real move hasn;t happened yet, and I think it's because of KM...
No, I'm not critical of KM; in fact I admire him greatly. He is a no BS CEO who tells the truth based on what he knows. He doesn't pump, and he is not thinking about impressing WS--he' trying to build a company to become one of the pharm giants.
Which brings me to WS. Half of the people on WS would sell their Mothers if it brought in a commission. The other half are pretty decent and smart people. But they have become very cynical about management across the corporate landscape because they have burned so many times before.
So now they come across this kind of "odd" guy in the Brown Suit. He gets up there, and tells everything he can, and delivers it in a matter-of-fact matter. Does AAB work? Probably(almost definitely), but I can't really add much more than that. Was the P2 data spectacular? Well I can't really tell you that except I'll let you consider that fact WYE and we went ahead with p3. And by the way, I don't spend 300 million for the fun of it. So draw your own conclusions. And so on and so on.....
So these people on WS are probably thinking--what is this guy all about? He CAN'T be telling the truth. What is he REALLY trying to hide?
BOttom line is- WS is going to find out what the guy in the brown suit is all about. And hopefully the success he going to surely enjoy will set a standard for CEO behavior for the future.
Finally, when WS "gets it", ELN is going to run in a way not seen in a long time in the pharma space.
Thank you KM, and ELN scientists.
Alle Beiträge beziehen sich auf Äusserungen von Kelly Martin auf der gestrigen HealthCare Konferenz...
ELN msg # 226759 5/1/2008 3:59:39 PM
By: foolishcase
Didn't anyone notice on the call that Kelly let the cat out of the bag, "Cognitive Improvement"
Direct transcription of Kellys words, some jumping around, but this is great.
Answer to question 12,
.....Amyloid clearly a central central actor on in the play, and may not be the only one but clearly is one of the main.... This is the first approach to what will be a much longer journey therapeutic and scientific and therefore therapeutic treating AD...
We have a lot of data (on amyloid)... a lot of which is validated, this is clearly one of the main pieces of the puzzle...We are open to the fact that there may be other things... There are many people who argue very emotionally that it has to be this or that..on approaches...either or black and white, and it's too complicated a disease to be just one piece of the puzzle, .just be one thing. But this is clearly a core central part to the AD story, and we have reams and reams of information, data, a lot of which is proprietary, that lead us down this path, over and over and over again and is validated by a lot of external people we work with
Question 13:
Right but.....You would be the only people that had a clinical data that shows that reduction of amyloid load was associated with cognitive improvement, I mean I don't know of any other data, that's why I'm asking.
We have a lot of data, not sure what others people have,.. but clearly the immunotherapeudic approach to AD, in the last several years, has become if not the hottest, thing in biotech pharma, one of the top few, so others are clearly sort of seeing.. that there is something here.. and a lot of resources are being put to it... All of the data that we have, would show that if you clear the plaque, that you, that you could you could stabilize, at a minimum stabilize cognition and improve function, and if you can do that, that's certainly a massive step forward in AD, and from there you can iterate forward with other things.
Case
ELN msg # 226759 5/1/2008 3:59:39 PMBy: foolishcase
Didn't anyone notice on the call that Kelly let the cat out of the bag, "Cognitive Improvement"
Direct transcription of Kellys words, some jumping around, but this is great.
Answer to question 12,
.....Amyloid clearly a central central actor on in the play, and may not be the only one but clearly is one of the main.... This is the first approach to what will be a much longer journey therapeutic and scientific and therefore therapeutic treating AD...
We have a lot of data (on amyloid)... a lot of which is validated, this is clearly one of the main pieces of the puzzle...We are open to the fact that there may be other things... There are many people who argue very emotionally that it has to be this or that..on approaches...either or black and white, and it's too complicated a disease to be just one piece of the puzzle, .just be one thing. But this is clearly a core central part to the AD story, and we have reams and reams of information, data, a lot of which is proprietary, that lead us down this path, over and over and over again and is validated by a lot of external people we work with
Question 13:
Right but.....You would be the only people that had a clinical data that shows that reduction of amyloid load was associated with cognitive improvement, I mean I don't know of any other data, that's why I'm asking.
We have a lot of data, not sure what others people have,.. but clearly the immunotherapeudic approach to AD, in the last several years, has become if not the hottest, thing in biotech pharma, one of the top few, so others are clearly sort of seeing.. that there is something here.. and a lot of resources are being put to it... All of the data that we have, would show that if you clear the plaque, that you, that you could you could stabilize, at a minimum stabilize cognition and improve function, and if you can do that, that's certainly a massive step forward in AD, and from there you can iterate forward with other things.
Case
der Kurs steht vorbörslich in den USA bei
$28,30 zu $30,00
das sind
€18,25 zu €19,35
$28,30 zu $30,00
das sind
€18,25 zu €19,35
Antwort auf Beitrag Nr.: 34.015.525 von Poppholz am 02.05.08 13:58:13wollte noch schnell in FFM kaufen, aber gerade heute hat der Händler aufgepasst.
(somit lauer ich weiterhin auf gute Kaufkurse)
(somit lauer ich weiterhin auf gute Kaufkurse)
Antwort auf Beitrag Nr.: 34.015.546 von Poppholz am 02.05.08 13:59:5618,46€ in Irland! K L A S S E !!!!!!!!!!!!!!!!!!!
Antwort auf Beitrag Nr.: 34.015.675 von Birgit.Tersteegen am 02.05.08 14:14:19UND ICH WILL IMMER NOCH KAUFEN !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Antwort auf Beitrag Nr.: 34.015.920 von Poppholz am 02.05.08 14:38:11...bleib bei dieser Haltung....----ab 16.30h bin ich weier urlauben und DAAAAAAAAAAAAAAAANNN---up to the moon....
----ab 16.30h bin ich weier urlauben und DAAAAAAAAAAAAAAAANNN---up to the moon....
Antwort auf Beitrag Nr.: 34.016.067 von Birgit.Tersteegen am 02.05.08 14:53:03hättest Du den Urlaub nicht 3 Stunden vorverlegen können?
Der Kurs stand so schön hoch.
(ich glaube das funktioniert wirklich)
Der Kurs stand so schön hoch.
(ich glaube das funktioniert wirklich)
der Kurs steht aktuell bei $26,88.
In 5 Minuten ist Birgit in Urlaub und ich versuche mal ein paar Aktien zu kaufen.
(mal sehen was passiert)
In 5 Minuten ist Birgit in Urlaub und ich versuche mal ein paar Aktien zu kaufen.
(mal sehen was passiert)
Ken Kam on his fave stock(sorry if posted)http://video.msn.com/?mkt=en-us&brand=money&vid=c20e057a-1ad…
Antwort auf Beitrag Nr.: 34.025.997 von Birgit.Tersteegen am 05.05.08 09:09:20...ja..ja...unser KEN KAM......ELAN = die größte Position in seinem Depot...
@Birgit @ Poppie.......wie bei uns, nicht wahr....
...echt lässig......ELAN - der " Verdoppler " schlechthin......sogar bei aktuell 26 USD sieht KENNIE KAMMIE die Perspektive bei ELAN weiterhin als Verdoppler.....( aber nicht nur er.... )
...der Mann kommt gut und tut gut........und dass schon seit 2005/2006...
...aber wie gesagt,KENNIE KAM , wir ( PBB Company ) sind schon seit April / Mai 2005 dabei...
@Birgit @ Poppie.......wie bei uns, nicht wahr....
...echt lässig......ELAN - der " Verdoppler " schlechthin......sogar bei aktuell 26 USD sieht KENNIE KAMMIE
die Perspektive bei ELAN weiterhin als Verdoppler.....( aber nicht nur er.... )...der Mann kommt gut und tut gut....
....und dass schon seit 2005/2006......aber wie gesagt,KENNIE KAM , wir ( PBB Company ) sind schon seit April / Mai 2005 dabei...
Antwort auf Beitrag Nr.: 34.026.963 von bernie55 am 05.05.08 11:21:39Genau! Moin Bernie
Im IV gibt es von "Stillorgan 1"eine wörtliche Niederschrift von Kelly Martin auf der ML-Healthcare-Konferenz.....ein Tal davon wie folgt...
"Kelly Martin presentation at Morgan Stanley Global Healthcare, pt3
Question [4]
Just to be clear on the question of whether we should expect significance or not, understanding that this is a relatively small study, and particularly at the interim [look] it was even smaller, the data set you had to look at, would we expect significance in any one dose? Would you expect significance in all three of the doses that you took eventually into Phase III? Would we expect significance on maybe a combined analysis of those three dosing cohorts? Or should we just not expect any kind of statistical significance and just pay attention to trends? How would we look at, how would you want us to look at it?
KM [flat tone, very matter of fact]: I think it should be very obvious why we moved to Phase III. So without answering that specifically, I think it will be .. it should be OBVIOUS why we moved to Phase III. And I think that whether it’s statistical significance in all or parts, supported by trends, or trends with different combinations of data points, I think that the reason we moved to Phase III was [that] we clearly saw ENOUGH DATA to move forward. It’s a huge decision for us and for Wyeth. And it’s one we don’t take lightly. I also remind people that Elan has been working on immunotherapy for 20 years. So, as much pressure as there is to get to the last piece of information for the Phase II, we’re not going to screw it up, you know, because we have a lot of other things in immunotherapy which we think are going to be relevant for years to come. So, we are as anxious as anybody to look at the Phase II data. We have done a lot of work internally trying to predict what it would be. Um, but our goal would be, that as participants in the market place, that when you see the Phase II data, that there’s unequivocal evidence why we moved to Phase III. Whether it’s statistical in everything, some things or combinations of statistical plus trends, our goal would be that it would be very clear to all of you sort of why we moved to Phase III.
I would also say to people that it would have been far easier for me, sitting here, to say “we moved to Phase III and here’s all the data.” Because for a year, we have been trying to answer the questions in a way that is helpful to investors, but not, but keep the Phase II “pure.” So if you want to take it from that point of view, clearly we saw enough, between Wyeth and ourselves and the Agencies, that we have attempted, I think pretty well, to try to keep Phase II as blinded as possible, and start to Phase III. And also by the design of the Phase III, by definition we are giving out a lot of information out about what we saw. So, we’re very much looking forward to sharing the Phase II data.
Question [5]: One more take on this. So, just to be clear, I think you’re saying it is possible that it could be, that you could have just had trends, but it would still be obvious to move forward. In other words, if the Bapineuzumab arms were flat and the other arms were declining and it didn’t hit significance, but that would be an obvious [decision], you know, “let’s move forward”? Is that a plausible scenario based on what you are saying?
KM [tone of voice distancing himself from this interpretation]: I’m saying that there is [are] obvious reasons why a move to Phase III was a good business decision and a good development decision. And it could be any combination of things."
Im IV gibt es von "Stillorgan 1"eine wörtliche Niederschrift von Kelly Martin auf der ML-Healthcare-Konferenz.....ein Tal davon wie folgt...
"Kelly Martin presentation at Morgan Stanley Global Healthcare, pt3Question [4]
Just to be clear on the question of whether we should expect significance or not, understanding that this is a relatively small study, and particularly at the interim [look] it was even smaller, the data set you had to look at, would we expect significance in any one dose? Would you expect significance in all three of the doses that you took eventually into Phase III? Would we expect significance on maybe a combined analysis of those three dosing cohorts? Or should we just not expect any kind of statistical significance and just pay attention to trends? How would we look at, how would you want us to look at it?
KM [flat tone, very matter of fact]: I think it should be very obvious why we moved to Phase III. So without answering that specifically, I think it will be .. it should be OBVIOUS why we moved to Phase III. And I think that whether it’s statistical significance in all or parts, supported by trends, or trends with different combinations of data points, I think that the reason we moved to Phase III was [that] we clearly saw ENOUGH DATA to move forward. It’s a huge decision for us and for Wyeth. And it’s one we don’t take lightly. I also remind people that Elan has been working on immunotherapy for 20 years. So, as much pressure as there is to get to the last piece of information for the Phase II, we’re not going to screw it up, you know, because we have a lot of other things in immunotherapy which we think are going to be relevant for years to come. So, we are as anxious as anybody to look at the Phase II data. We have done a lot of work internally trying to predict what it would be. Um, but our goal would be, that as participants in the market place, that when you see the Phase II data, that there’s unequivocal evidence why we moved to Phase III. Whether it’s statistical in everything, some things or combinations of statistical plus trends, our goal would be that it would be very clear to all of you sort of why we moved to Phase III.
I would also say to people that it would have been far easier for me, sitting here, to say “we moved to Phase III and here’s all the data.” Because for a year, we have been trying to answer the questions in a way that is helpful to investors, but not, but keep the Phase II “pure.” So if you want to take it from that point of view, clearly we saw enough, between Wyeth and ourselves and the Agencies, that we have attempted, I think pretty well, to try to keep Phase II as blinded as possible, and start to Phase III. And also by the design of the Phase III, by definition we are giving out a lot of information out about what we saw. So, we’re very much looking forward to sharing the Phase II data.
Question [5]: One more take on this. So, just to be clear, I think you’re saying it is possible that it could be, that you could have just had trends, but it would still be obvious to move forward. In other words, if the Bapineuzumab arms were flat and the other arms were declining and it didn’t hit significance, but that would be an obvious [decision], you know, “let’s move forward”? Is that a plausible scenario based on what you are saying?
KM [tone of voice distancing himself from this interpretation]: I’m saying that there is [are] obvious reasons why a move to Phase III was a good business decision and a good development decision. And it could be any combination of things."
ELAN - Investor Company Day
Date: 7th May 2008
Start Time: 8:00 AM ET
http://www.elan.com/investorrelations/events/webcast_details…
Date: 7th May 2008
Start Time: 8:00 AM ET
http://www.elan.com/investorrelations/events/webcast_details…
26,12 USD - 28,00 USD
....na, wohin wird wohl die Reise gehen ????
....na, wohin wird wohl die Reise gehen ????
Antwort auf Beitrag Nr.: 34.028.970 von bernie55 am 05.05.08 15:26:5626,87 USD - 26,93 USD
Antwort auf Beitrag Nr.: 34.029.082 von bernie55 am 05.05.08 15:38:13und steigt.
die Insel hat heute keine Börse.
Antwort auf Beitrag Nr.: 34.029.137 von Poppholz am 05.05.08 15:42:10aktuell
27,36 USD = 17,70 €
Aktuelle Wechselkurse:
1 EUR = 1,54610 USD (05.05. 16:41)
27,36 USD = 17,70 €
Aktuelle Wechselkurse:
1 EUR = 1,54610 USD (05.05. 16:41)
77 1/2 Minute Report
Pps of 27.26, up 45 cents (1.68%)
High of day 27.42 .....Volume is weak with only 467,533 shares traded.
Two days to investor's day. All ducks swimming in a straight line.
Buy and hold for 2 1/2 months. You will be well rewarded!
Abundantly. (Buy and hold for 2 1/2 years and never work again.)
http://www.investorvillage.com/smbd.asp?mb=160&mn=227817&pt=…
Pps of 27.26, up 45 cents (1.68%)
High of day 27.42 .....Volume is weak with only 467,533 shares traded.
Two days to investor's day. All ducks swimming in a straight line.
Buy and hold for 2 1/2 months. You will be well rewarded!
Abundantly. (Buy and hold for 2 1/2 years and never work again.) http://www.investorvillage.com/smbd.asp?mb=160&mn=227817&pt=…
Antwort auf Beitrag Nr.: 34.027.506 von Birgit.Tersteegen am 05.05.08 12:27:45Hier mal der Link zu der " wörtlichen Niederschrift " von KM auf der Healthcare Konferenz > von Stillorgan 1
ELAN CEO Kelly Martin presentation at Morgan Stanley Global Healthcare
http://www.investorvillage.com/smbd.asp?mb=160&mn=227615&pt=…
ELAN CEO Kelly Martin presentation at Morgan Stanley Global Healthcare
http://www.investorvillage.com/smbd.asp?mb=160&mn=227615&pt=…
Vielen Dank für den Link, Bernie!
Zunehmend wird deutlicher:
Unsere Geduld wird belohnt werden!
posimist
Zunehmend wird deutlicher:
Unsere Geduld wird belohnt werden!
posimist
Antwort auf Beitrag Nr.: 34.035.834 von posimist am 06.05.08 11:58:48so sieht es aus.
und so wird es auch kommen.
2008 wird wohl endlich mal wieder ein gutes ELAN Jahr werden
(2007 war ja nun auch nicht so schlecht)
und so wird es auch kommen.
2008 wird wohl endlich mal wieder ein gutes ELAN Jahr werden
(2007 war ja nun auch nicht so schlecht)
Antwort auf Beitrag Nr.: 34.036.241 von Poppholz am 06.05.08 12:47:06so sieht es aus.
und so wird es auch kommen.
2008 wird wohl endlich mal wieder ein gutes ELAN Jahr werden
(2007 war ja nun auch nicht so schlecht)
genauer gesagt > ca. ein Plus von 54 % <
und so wird es auch kommen.
2008 wird wohl endlich mal wieder ein gutes ELAN Jahr werden
(2007 war ja nun auch nicht so schlecht)
genauer gesagt > ca. ein Plus von 54 % <
Antwort auf Beitrag Nr.: 34.036.300 von bernie55 am 06.05.08 12:53:27!
!
Antwort auf Beitrag Nr.: 34.036.300 von bernie55 am 06.05.08 12:53:27sag ich ja, fast ein gutes Jahr
Morgen wirds spannend! Investorsday
Investor Day Full Page And Link
Link: http://www.corporate-ir.net/media_files/irol/88/88326/Agenda…
Investor Day Full Page And Link
Link: http://www.corporate-ir.net/media_files/irol/88/88326/Agenda…
speaker bios for tomorrow's meeting
Kelly Martin
President and Chief Executive Officer
Kelly Martin was appointed President and Chief Executive Officer in February 2003. He is also a member of the Board of Directors of Elan. Prior to joining Elan, Mr. Martin dedicated more than 20 years at Merrill Lynch & Co., Inc. in a breadth of operating and executive responsibilities around the world. Mr. Martin holds a B.A. in politics from Princeton University. Under Mr. Martin’s leadership, Elan has maintained its research leadership in the neuro-degeneration and neuro-inflammation sciences and renewed its focus on development, commercial and drug delivery capabilities. During his tenure, the company implemented a comprehensive plan to simplify its balance sheet and divest non-core assets, positioning the company for growth. The management team under his guidance brought to market novel therapies in Multiple Sclerosis, Crohn’s Disease and Severe Chronic Pain.
Shane Cooke
Executive Vice President, Chief Financial Officer and Head of Elan Drug Technologies
Shane Cooke joined Elan as Executive Vice President and Chief Financial Officer in July 2001. He was appointed a member of the Board of Directors of Elan in 2005. In 2007, Mr. Cooke expanded his responsibilities to include head of Elan Drug Technologies (EDT). He also serves as an executive member of the Joint Steering Committee with Biogen Idec. Prior to joining Elan, Mr. Cooke was Chief Executive Officer of Pembroke Capital Limited, an aviation leasing company, and held a number of senior positions in finance in the banking and aviation industries. Mr. Cooke is a chartered accountant and a graduate of University College Dublin. As Chief Financial Officer, Mr. Cooke oversees all of the company’s finances and drove key aspects of the company’s recovery plan, resulting in the company’s current financial stability. As Head of Elan Drug Technologies, Mr. Cooke and his management team have demonstrated continued growth in profits and client service.
Allison Hulme, PhD
Executive Vice President, Head of Global Development
Allison Hulme was appointed Executive Vice President and Head of Global Development in 2006. Dr. Hulme oversees all development programs in Elan. She also serves as an executive member of Joint Steering Committees with Wyeth for the Immunotherapy Programs and with Transition Therapeutics for ELND005. Prior to joining Elan in October 1995, Dr. Hulme held positions in Clinical Research at Glaxo Wellcome Pharmaceuticals (United Kingdom) and served as a lecturer at Luton University. She holds a degree in science from Luton University and earned her PhD from Cranfield Institute of Technology. As EVP of Elan’s Autoimmune/TYSABRI franchise, Dr. Hulme led in the clinical development, commercialization, and safety evaluation of TYSABRI, obtaining regulatory approval for TYSABRI for MS in the U.S. and Europe; and for TYSABRI for CD in the U.S. She has also served as an executive member of the Joint Steering Committee with Biogen Idec.
Karen S. Kim
Executive Vice President, Commercial, Communications & Corporate Development
Karen Kim joined Elan as Senior Vice President, Head of Corporate Strategy and Strategic Alliances. She was appointed Executive Vice President of Communications and Head of Commercial by 2006. She currently oversees the company’s commercial activities, corporate/business development and external communications – media relations and branding. She also serves as an executive member of Joint Steering Committees with Wyeth for the Immunotherapy Programs and with Transition Therapeutics for ELND005. Prior to joining Elan, Ms. Kim held senior management positions at Merrill Lynch, the Cambridge Group and The MAC Group/Gemini Consulting. She is a graduate of Wellesley College and earned her MBA from the Harvard Graduate School of Business Administration. As head of Corporate Development, working with Elan’s CSO, Ms. Kim oversaw the completion of new research collaborations with organizations like the ADDF and the MJ Fox Foundation; new development collaboration with Transition Therapeutics and divestment of the European marketing rights to PRIALT. As head of Commercial, Ms. Kim directed the realignment of the hospital business, the consolidation and strategic repositioning of Prialt in the U.S., and the launch of TYSABRI for Crohn’s in the U.S.
Dale Schenk, PhD
Executive Vice President and Chief Scientific Officer
Dale Schenk is a globally recognized authority in the study and treatment of Alzheimer’s disease. He was appointed Chief Scientific Officer in 2003. His responsibilities include; representing Elan in scientific forums across the world; overseeing external lab collaborations/networks; and managing Elan’s Scientific Advisory Boards in Alzheimer’s and Parkinson’s disease. He also serves as an executive member of Joint Steering Committees with Wyeth for the Immunotherapy Programs and with Transition Therapeutics for ELND005. Dr. Schenk’s previous positions at Elan include serving as co-head of Discovery Research. Dr. Schenk earned his Bachelor's degree cum laude in Biology from the University of California, San Diego and a PhD in Physiology and Pharmacology from the University of California, San Diego. Dr. Schenk has received numerous scientific honors and recognitions including the prestigious 2001 Potamkin Prize in Neurology. He is the President of the Neurological Disease Foundation, a non-profit organization whose goal is to increase awareness of neurological diseases in our society and chairman of the Alzheimer’s Association Research Roundtable. He also serves on the scientific advisory board of the Alzheimer’s Association Research Roundtable and the Alzheimer’s Drug Discovery Foundation. Dr. Schenk’s research and clinical efforts over the past 20 years have focused specifically on the amyloid hypothesis and its potential utility in the treatment and perhaps even future prevention of Alzheimer’s. Among his many scientific publications, Dr. Schenk’s 1999 paper on immunotherapeutic approaches to Alzheimer’s disease stands out as a contribution that significantly advanced the entire field’s understanding of the disease.
Ted Yednock, PhD
Executive Vice President, Head of Global Research
Ted Yednock oversees all of Elan’s research efforts, continuing to maintain the company’s scientific leadership in neuro-degeneration and neuro-inflammation. Dr. Yednock’s previous positions at Elan include serving as has Head of Biology. He earned his Bachelor's degree in Biology and Chemistry from the University of Illinois and his PhD in Immunology from the University of California, San Francisco, where he worked on mechanisms of immune cell migration into specific tissues. He continued his postdoctoral work at UCSF, where he held a Howard Hughes fellowship studying immune cell receptors critical to pathogen recognition. Dr. Yednock’s research efforts at Elan led to the discovery of a receptor pathway used by immune cells to enter the CNS during inflammatory responses, which resulted in the development and commercialization of natalizumab (TYSABRI). Dr. Yednock has also made significant contributions to Elan's neurodegenerative programs, defining mechanisms by which both vaccines and humanized antibodies can induce the clearance of amyloid plaques from the brain, and restore neuronal function. Among several pivotal scientific publications, two stand out. Dr. Yednock’s 1992 Nature publication on the prevention of experimental autoimmune encephalomyelitis by antibodies against alpha-4 beta 1 integrin and his Nature Medicine (2000) publication on the Peripherally administered antibodies against amyloid beta-peptide entering the central nervous system. Dr. Yednock and his team are actively focused on leveraging Elan’s research strengths to expand the company’s programs to include the chronic neurodegeneration aspects of Multiple Sclerosis, and the molecular and cellular processes involved in the loss of specific neuronal populations in Parkinson’s disease.
Kelly Martin
President and Chief Executive Officer
Kelly Martin was appointed President and Chief Executive Officer in February 2003. He is also a member of the Board of Directors of Elan. Prior to joining Elan, Mr. Martin dedicated more than 20 years at Merrill Lynch & Co., Inc. in a breadth of operating and executive responsibilities around the world. Mr. Martin holds a B.A. in politics from Princeton University. Under Mr. Martin’s leadership, Elan has maintained its research leadership in the neuro-degeneration and neuro-inflammation sciences and renewed its focus on development, commercial and drug delivery capabilities. During his tenure, the company implemented a comprehensive plan to simplify its balance sheet and divest non-core assets, positioning the company for growth. The management team under his guidance brought to market novel therapies in Multiple Sclerosis, Crohn’s Disease and Severe Chronic Pain.
Shane Cooke
Executive Vice President, Chief Financial Officer and Head of Elan Drug Technologies
Shane Cooke joined Elan as Executive Vice President and Chief Financial Officer in July 2001. He was appointed a member of the Board of Directors of Elan in 2005. In 2007, Mr. Cooke expanded his responsibilities to include head of Elan Drug Technologies (EDT). He also serves as an executive member of the Joint Steering Committee with Biogen Idec. Prior to joining Elan, Mr. Cooke was Chief Executive Officer of Pembroke Capital Limited, an aviation leasing company, and held a number of senior positions in finance in the banking and aviation industries. Mr. Cooke is a chartered accountant and a graduate of University College Dublin. As Chief Financial Officer, Mr. Cooke oversees all of the company’s finances and drove key aspects of the company’s recovery plan, resulting in the company’s current financial stability. As Head of Elan Drug Technologies, Mr. Cooke and his management team have demonstrated continued growth in profits and client service.
Allison Hulme, PhD
Executive Vice President, Head of Global Development
Allison Hulme was appointed Executive Vice President and Head of Global Development in 2006. Dr. Hulme oversees all development programs in Elan. She also serves as an executive member of Joint Steering Committees with Wyeth for the Immunotherapy Programs and with Transition Therapeutics for ELND005. Prior to joining Elan in October 1995, Dr. Hulme held positions in Clinical Research at Glaxo Wellcome Pharmaceuticals (United Kingdom) and served as a lecturer at Luton University. She holds a degree in science from Luton University and earned her PhD from Cranfield Institute of Technology. As EVP of Elan’s Autoimmune/TYSABRI franchise, Dr. Hulme led in the clinical development, commercialization, and safety evaluation of TYSABRI, obtaining regulatory approval for TYSABRI for MS in the U.S. and Europe; and for TYSABRI for CD in the U.S. She has also served as an executive member of the Joint Steering Committee with Biogen Idec.
Karen S. Kim
Executive Vice President, Commercial, Communications & Corporate Development
Karen Kim joined Elan as Senior Vice President, Head of Corporate Strategy and Strategic Alliances. She was appointed Executive Vice President of Communications and Head of Commercial by 2006. She currently oversees the company’s commercial activities, corporate/business development and external communications – media relations and branding. She also serves as an executive member of Joint Steering Committees with Wyeth for the Immunotherapy Programs and with Transition Therapeutics for ELND005. Prior to joining Elan, Ms. Kim held senior management positions at Merrill Lynch, the Cambridge Group and The MAC Group/Gemini Consulting. She is a graduate of Wellesley College and earned her MBA from the Harvard Graduate School of Business Administration. As head of Corporate Development, working with Elan’s CSO, Ms. Kim oversaw the completion of new research collaborations with organizations like the ADDF and the MJ Fox Foundation; new development collaboration with Transition Therapeutics and divestment of the European marketing rights to PRIALT. As head of Commercial, Ms. Kim directed the realignment of the hospital business, the consolidation and strategic repositioning of Prialt in the U.S., and the launch of TYSABRI for Crohn’s in the U.S.
Dale Schenk, PhD
Executive Vice President and Chief Scientific Officer
Dale Schenk is a globally recognized authority in the study and treatment of Alzheimer’s disease. He was appointed Chief Scientific Officer in 2003. His responsibilities include; representing Elan in scientific forums across the world; overseeing external lab collaborations/networks; and managing Elan’s Scientific Advisory Boards in Alzheimer’s and Parkinson’s disease. He also serves as an executive member of Joint Steering Committees with Wyeth for the Immunotherapy Programs and with Transition Therapeutics for ELND005. Dr. Schenk’s previous positions at Elan include serving as co-head of Discovery Research. Dr. Schenk earned his Bachelor's degree cum laude in Biology from the University of California, San Diego and a PhD in Physiology and Pharmacology from the University of California, San Diego. Dr. Schenk has received numerous scientific honors and recognitions including the prestigious 2001 Potamkin Prize in Neurology. He is the President of the Neurological Disease Foundation, a non-profit organization whose goal is to increase awareness of neurological diseases in our society and chairman of the Alzheimer’s Association Research Roundtable. He also serves on the scientific advisory board of the Alzheimer’s Association Research Roundtable and the Alzheimer’s Drug Discovery Foundation. Dr. Schenk’s research and clinical efforts over the past 20 years have focused specifically on the amyloid hypothesis and its potential utility in the treatment and perhaps even future prevention of Alzheimer’s. Among his many scientific publications, Dr. Schenk’s 1999 paper on immunotherapeutic approaches to Alzheimer’s disease stands out as a contribution that significantly advanced the entire field’s understanding of the disease.
Ted Yednock, PhD
Executive Vice President, Head of Global Research
Ted Yednock oversees all of Elan’s research efforts, continuing to maintain the company’s scientific leadership in neuro-degeneration and neuro-inflammation. Dr. Yednock’s previous positions at Elan include serving as has Head of Biology. He earned his Bachelor's degree in Biology and Chemistry from the University of Illinois and his PhD in Immunology from the University of California, San Francisco, where he worked on mechanisms of immune cell migration into specific tissues. He continued his postdoctoral work at UCSF, where he held a Howard Hughes fellowship studying immune cell receptors critical to pathogen recognition. Dr. Yednock’s research efforts at Elan led to the discovery of a receptor pathway used by immune cells to enter the CNS during inflammatory responses, which resulted in the development and commercialization of natalizumab (TYSABRI). Dr. Yednock has also made significant contributions to Elan's neurodegenerative programs, defining mechanisms by which both vaccines and humanized antibodies can induce the clearance of amyloid plaques from the brain, and restore neuronal function. Among several pivotal scientific publications, two stand out. Dr. Yednock’s 1992 Nature publication on the prevention of experimental autoimmune encephalomyelitis by antibodies against alpha-4 beta 1 integrin and his Nature Medicine (2000) publication on the Peripherally administered antibodies against amyloid beta-peptide entering the central nervous system. Dr. Yednock and his team are actively focused on leveraging Elan’s research strengths to expand the company’s programs to include the chronic neurodegeneration aspects of Multiple Sclerosis, and the molecular and cellular processes involved in the loss of specific neuronal populations in Parkinson’s disease.
Antwort auf Beitrag Nr.: 34.042.281 von Birgit.Tersteegen am 06.05.08 23:00:082008 Company Day
Wednesday, 7 May 2008
Presentations 8:15am - 12:15pm
Agenda
Opening Remarks
Kelly Martin, President and Chief Executive Officer
Research: Systematic Approach
Ted Yednock, PhD, Executive Vice President, Head of Global Research
Dale Schenk, PhD, Executive Vice President and Chief Scientific Officer
Development: Disciplined Advancement
Allison Hulme, PhD, Executive Vice President, Head of Global Development
Commercial: Adept Connections
Karen Kim, Executive Vice President, Commercial, Communications & Corporate Development
EDT: Enabling Technologies
Shane Cooke, Executive Vice President, Chief Financial Officer and Head of Elan Drug Technologies
Elan plc: Shaping Unconditional Leadership
Kelly Martin, President and Chief Executive Officer
http://www.corporate-ir.net/media_files/irol/88/88326/Agenda…
Wednesday, 7 May 2008
Presentations 8:15am - 12:15pm
Agenda
Opening Remarks
Kelly Martin, President and Chief Executive Officer
Research: Systematic Approach
Ted Yednock, PhD, Executive Vice President, Head of Global Research
Dale Schenk, PhD, Executive Vice President and Chief Scientific Officer
Development: Disciplined Advancement
Allison Hulme, PhD, Executive Vice President, Head of Global Development
Commercial: Adept Connections
Karen Kim, Executive Vice President, Commercial, Communications & Corporate Development
EDT: Enabling Technologies
Shane Cooke, Executive Vice President, Chief Financial Officer and Head of Elan Drug Technologies
Elan plc: Shaping Unconditional Leadership
Kelly Martin, President and Chief Executive Officer
http://www.corporate-ir.net/media_files/irol/88/88326/Agenda…
Antwort auf Beitrag Nr.: 34.043.057 von bernie55 am 07.05.08 08:00:13Moin Bernie!
WANN ist das nach unserer Zeit? Jetzt gleich oder in einer Stunde (irische Zeit??)
Bernie!WANN ist das nach unserer Zeit? Jetzt gleich oder in einer Stunde (irische Zeit??)
Antwort auf Beitrag Nr.: 34.043.114 von Birgit.Tersteegen am 07.05.08 08:18:21....Schlafmützen-ALLES muss frau selbst herausfinden...der Investorsday beginnt um 14.15h unserer Zeit....
Antwort auf Beitrag Nr.: 34.044.828 von Birgit.Tersteegen am 07.05.08 11:19:46......einer von den vielen männlichen Schlafmützen, sprich ICH, ging einer anderen monetären Beschäftigung nach ......
.......ich gehe mal davon aus, dass meine männlichen Kollegen der gleichen Muße nachgingen.......
...deshalb , " geliebte Matrona " aller männlichen Elanites.....
..Du, Aufrechterhalterin unseres WO Boards....
verzeih uns.....
.......ich gehe mal davon aus, dass meine männlichen Kollegen der gleichen Muße nachgingen..........deshalb , " geliebte Matrona " aller männlichen Elanites.....
..Du, Aufrechterhalterin unseres WO Boards....
verzeih uns.....
Antwort auf Beitrag Nr.: 34.044.828 von Birgit.Tersteegen am 07.05.08 11:19:46der Investorsday beginnt um 14.15h unserer Zeit
Bist du dabei, Birgit ????
Ich habe heute bis 16.30 Termine......kann mich somit erst später einklinken...
Bist du dabei, Birgit ????
Ich habe heute bis 16.30 Termine......kann mich somit erst später einklinken...
NCB this morning
Elan hosts its company day in Boston later today. A number of topics will be coveredduring the day, with an update on the clinical pipeline and details of programs not previously disclosed being of particular interest. The event is being webcast and can be
accessed through Elan’s website from 1:15pm BST (8:15am ET).
• It is not anticipated that any major news will emerge on AAB-001 given that the toplinePhase II data is not expected until June, with the full Phase II data to be presented at the ICAD conference in late July. After today, the next event in Elan’s calendar is its
AGM in Dublin on May 22.
Paraic Quinn +353 1 611 5863 paraic.quinn@ncb.ie
Orla Hartford PHD +353 1 611 5844 orla.hartford@ncb.ie
http://www.investorvillage.com/smbd.asp?mb=160&mn=228498&pt=…
Elan hosts its company day in Boston later today. A number of topics will be coveredduring the day, with an update on the clinical pipeline and details of programs not previously disclosed being of particular interest. The event is being webcast and can be
accessed through Elan’s website from 1:15pm BST (8:15am ET).
• It is not anticipated that any major news will emerge on AAB-001 given that the toplinePhase II data is not expected until June, with the full Phase II data to be presented at the ICAD conference in late July. After today, the next event in Elan’s calendar is its
AGM in Dublin on May 22.
Paraic Quinn +353 1 611 5863 paraic.quinn@ncb.ie
Orla Hartford PHD +353 1 611 5844 orla.hartford@ncb.ie
http://www.investorvillage.com/smbd.asp?mb=160&mn=228498&pt=…
Antwort auf Beitrag Nr.: 34.045.071 von bernie55 am 07.05.08 11:43:46....na klar verzeihe ich.....-gehe übrigens PARALLEL monetärer Beschäftigung nach (aber wir wissen ja,dass gerade DAS Euren Genen so schwerfällt....)--ich höre auf alle Fälle gleich rein---aber oft verstehe ich leider sprachlich nicht so viel wie ich gern hätte--stelle aber die Erkenntnisse aus dem IV hier rein----
ALSO AB MIT LAPTOPP UND COOLEM UNALKOHOLISCHEM DRINK AUF DIE TERASSE
und unseren "REICHMACHERN"(?!)zuhören....
-gehe übrigens PARALLEL monetärer Beschäftigung nach (aber wir wissen ja,dass gerade DAS Euren Genen so schwerfällt....)--ich höre auf alle Fälle gleich rein---aber oft verstehe ich leider sprachlich nicht so viel wie ich gern hätte--stelle aber die Erkenntnisse aus dem IV hier rein----ALSO AB MIT LAPTOPP UND COOLEM UNALKOHOLISCHEM DRINK AUF DIE TERASSE
und unseren "REICHMACHERN"(?!)zuhören....
..kein neue PML Fälle.........37000 > Tysabri....
"Virtually eliminated the risk for PML" (speaking of small molecule alpha-4 research)
..so muss wieder arbeiten...
Grüße
bernie55
Grüße
bernie55
Der Call ist SUPER--irre Optionen-super präsentiert--ich glaube, sie sind wirklich das grösste Biotec-Unternehmen in ein paar Jahren---ALZ,Krtebs,Parkinson ;MS,Colitis....2010 haben sie 10 Medikamente in Phase 3.....---WENN ICH NOCH KÖNNTE;WÜRDE ICH WEITER KAUFEN...
Die Shorties werden den Kurs nicht mehr lange aufhalten!!!
Die Shorties werden den Kurs nicht mehr lange aufhalten!!!
Antwort auf Beitrag Nr.: 34.047.776 von Birgit.Tersteegen am 07.05.08 16:17:11..nun mal ein kleiner Look auf die Pipeline 2010..
EDT Pipeline - Shane Cooke
Blue = Nano
Green = OCR
Blue = Nano
Green = OCR
> aktuelle Pipeline 2008 <
KM zu AD
.....The extreme confidence in their AD programs is palpable and very exciting.
."spectacular" in terms of effects on people...patients...and shareholders.
.....The extreme confidence in their AD programs is palpable and very exciting.
."spectacular" in terms of effects on people...patients...and shareholders.
Antwort auf Beitrag Nr.: 34.048.369 von bernie55 am 07.05.08 17:19:43ich sage nur :KAUFEN!
.......auf jeden Fall hat KM bei seinem Vortrag eine Super-Performance hingelegt....
.....scheint wohl einen guten Coach gehabt zu haben, der ihn aus den vergangenen Fehler hat lernen lassen....
.....scheint wohl einen guten Coach gehabt zu haben, der ihn aus den vergangenen Fehler hat lernen lassen....
Antwort auf Beitrag Nr.: 34.048.458 von Birgit.Tersteegen am 07.05.08 17:29:48ich sage nur : KAUFEN!
NÖ !!!!!
ich sage nur : KAUFEN !
NÖ !!!!!
ich sage nur : KAUFEN !
Was die Wallstreet und die übrige Welt von dem heutigen Tag hält,
zeigt sie uns grad am aktuellen Kursverlauf ... lol
zeigt sie uns grad am aktuellen Kursverlauf ... lol
Antwort auf Beitrag Nr.: 34.050.232 von Holgus am 07.05.08 21:01:26...wie wärs mal mit etwas differenzierter Marktanalyse,Holgus?!
ELN msg # 229018 5/7/2008 4:03:24 PMBy: delta_squared
I’m really impressed with today’s presentation….
it was remarkably well put together to serve the purpose of bringing general investors up to speed with respect to what Elan is all about…
For those who follow Elan closely on this board, it is easy to lose perspective on the degree of lack of overall understanding of Elan as a whole many-trick pony on the part of investors who do not have their noses perpetually glued to this board; and for whom it is too easy to miss the real substance of Elan as it gets lost and distorted in scattered piecemeal day-to-day news and misrepresentations…today’s presentation served to gather a lot of this information over broad topics and present it clearly in a summarized and readily understandable form.
Of course, for anone that expected significant news on AD it may be a disappointment, but this would be out of the question on today’s forum, since any important announcement will have to be made in conjunction with Wyeth…lack of this news will be seized upon by institutions who will now clearly understand why they need to accumulate Elan quickly, and any shorts who can still escape….and their mock disappointment will be used to advantage as an excuse to downshift the pps into accumulation mode.
still, there were a number of very significant tidbits of new and important information that are of great interest to those more intimately familiar with Elan’s pipeline projects.
I do not see how this presentation could have been made in any way better for its intended purpose---
to establish an important foundation of general understanding for the remarkable pps increases that will soon be forthcoming.
It was a total and remarkable treat to hear today’s presentations
ELN msg # 229160 5/7/2008 11:31:38 PMBy: goodtoreadthis
Re: two cents worth- Lars there
Sorry to disappoint folks but Lars was there. He did not present;but he held court with about 20 people in front of room AFTER formal presentations ended. Everyone hung on his every word for about an hour.
Lars then did as others did and took a sandwich bag out to the sunshine in the front of the building and it was like a swarm of bees moving in unison as folks drifted into the sun with Lars.
The Lars special session then went on for about another hour or so.
Elan's science guys Yednock and Schenck had me and just about everyone in that room - possibly including the Chairman of Fidelity who came personally and stayed for full three plus hours- thinking - do I own enough of this stock.
KM's wrap up pitch was a bases loaded game ending grand slam in the 7th game of the World Series. The Elan business model is sophisticated, flexible, yet artistically simple.
For the first time - for me - the totality of the Elan pipeline was clear.
LN msg # 229133 5/7/2008 9:29:44 PM
By: JBWIN
Unfiltered Notes from &may2008 Elan Company Day
Electronic notes for most of the session, but battery died for last sections.
* KM, CEO ELN
* Good morning. Thanks for 1st Company Day particip, since 5 yrs ago mgt team came together
* Webcast, hundreds, physically, investors around the world, know how busy everyone is, taking time out of sched
* Many asked mgt team, what is Company Day vs Investor Day
* Last 5 yrs bldg company, next 5 yrs bldg
* Share w/key investors progress making
* Focus on existing prods like Tysabri, BAP (ImmunoTx)
* Other parts of company imp for investors to understand ST, MT, LT
* Safe harbor
* Format PoV after opening remarks
* Turn over to Yednock, Head of Research, Dale Schenk, CSO
* 1 hr 20 min how approach research in systematic way
* From ELN persp how think about and manage science, proceed in future
* 15 Min break
* Dr. Alison Hume, Head of Dev, go thru Dev P/F
* Disciplined approach drugs thru clinic
* Update re P/F as stands in 2008 and possibilities in 2010
* That is just organic part of P/F, what curr have in-house
* Not incl re bus dev, corp dev PoV
* Karen Kim walk thru commercial
* Understand how think about commercial given innovative science, dev prods to patients, deliver integrated way, integration o fn
* Shane Cooke, EDT
* Almost sep, distinct from biotech
* Provide future thoughts
* KM wrap up, concluding remarks
* Members of operating committee, members of BoD, Dennis Selkoe, Lars Ekman, Kevin McIntyre
* Appreciate taking time out
* How interesting and beneficial to you, share progress, future
* Ted Yednock, Research
* Been w/ELN 18 yrs, reason here same as why joined
* Disease path of CNS
* Focus on what see with own eyes, use thera to change pathology
* Our edge pathology changing
* Animal models, cellular assays
* Comfortable w/antibodies, small molecules
* 20 yrs CNS, focus on brain from 3 diff dire
* MS, AD, PD Lewy Bodies
* In common chronic neurodegen
* Understand how neurons die
* Validated process
* Many familiar w/research
* Validated over time Late 1980s
* Focusing on AD, a-beta peptide re plaques, central to disease process
* A-beta secreted into extracellular
* Fund to how plaque init
* Discovered soluble abeta
* Alpha 4 integrin, led to Tysabri
* 1st small mol
* Alpha 4 prevented disease progression in MS
* In AD, succ in 1st animal model
* 1st gamma secretase inh, protect in vivo, 1st direct support for amyloid hypothesis
* 1st BACE lead, inh protetctice
* Invented AIP, use passive AB, enter CNS, trigger plaque clearance in AD
* 2 AB, one in MS , 1 in AD, both neurodegen
* Then Parkinson’s Disease (PD)
* Synuclein
* Dev animal models
* Viral and genomic models in D
* Potential immunoTx
* Pot small mol modifying enzyme in pathology
* A lot of 1sts
* Imp validated
* Systematic approach
* Pathology in animal models, functional screens, succ in MS, AD, working on PD
* MS pathology immune cells infiltrate CNS
* Demylenation, chronic nerve degen
* Focused on animal models, dev fn screening
* Took sections, exposed, I/A w/inflamed
* Screened thousands of AB, alpha 4 w/integrin
* # of AB tools
* Take back to animal models, diff endpts
* Block migration of immune cells into CNS
* Able to show by blocking, reverse accumulation of cells, prevent loss of myelin
* Re clin fn, allow animals achieve score, some paralysis, reverse disease progression, cont inhibition
* Even late time, alpha 4 mech rel
* By preventing path over time, look at plaques over time, extensive demylenation
* Led to Tysabri, human MAB
* Init dev in 1995
* In mkt since Jul2006 MS, recently in CD
* Gd enh lesions closest way to measure infiltr
* T 92%
* Reduction rate 68% Yrs 1, 2, 3
* Preclin very predictive of clinic
* About 37K exposed to T, 10K 1 yr
* No new cases of PML
* Expanded use of T in UC, other targets
* Small molecule inh, tailored to disease, distinctive safety profile re alpha 4 integrin
* Imp re immune cell I/A
* T by inh alpha 4, inh vasc and tissue I/A
* Inh vasc vs matrix I/A
* Small molecules give tools, go back to preclin
* Alpha 4 vasc I/A critical re CNS infl
* Matrix I/A imp for IBD and RA
* Elim risk for PML
* Isolated peptide, narrow down to critical region, to build small mols
* Rapidly incr potency, as potent as MAB
* Some I/A w/beta chain other alpha 4
* As Alison will present, 2 small mol in P I
* 1 in MS, 1 in IBD
* ELND004 does not inh immune cell
* Effective reversing path re IBD
* Given # tools beyond alpha 4
* One region int in macrophage I/A w/neurons and microglia
* Demylenation and cell infiltr in MS animal model
* How affect macrophage/micro chronic demylenation
* Regions demylenated brightly positive for amyloid precursor as marker
* W/chronic demyl, preclin model showed neuroregen
* Closer look in cross section
* Purple are axons, directly in contact w/macrophages
* Reproduced in culture model
* Green spines as synapses, activate macrophages, see stripped
* If differentiate macrophages, can product distinct outcomes
* Regulate cell I/A
* Focus on immune cell infiltr
* Led to additional targets
* Neurodegen
* Macrophage kinase inh
* Induction of disease, impacts chronic phase of disease in animal model of MS
* Remylenation
* Led to T, ELND002, ELND004
* Macrophage IA
* Animals models predictive of clin efficacy
* Disc tools for other targets and indications
* AB
* Small molecules
* Dale Schenk, CSO
* Thanks for attending
* AD one of most devastating disease today
* 5M in US, 20M ww
* At present only modestly effective Tx, nothing for LT, nothing for pathology
* Take page from succ endeavors
* If go after pathology, treat future of disease
* Cancer, go after tumor
* True in CV, remove atheroscl, works re disease
* AD, plaques and tangles, eventually neuronal death
* Last several decade, dedicated lives to beta amyloid target
* What heard Ted descry is process
* Target pathology, build animal models, dev create Tx
* PDAPP mouse 1st IDed in mid 1990s broke open field
* 1st time look at thera agents in underlying
* See plaques in mouse model, APP staining
* Pathology of PDAPP strikingly similar to AD
* 3D sense, vessel amyloid, Cerebral Amyloid
* Beta amyloid deposits disrupt vessel structure
* Some have this indep of AD
* Dev techn Z plan, slices and reconstruct into 3D image
* As do subtle immunoTx or secretase inh or anti-aggr like ELND005
* Talk about vasc
* Targets disc at great length
* Amyloid precursor (APP), secretase, ELND005 oligomers, immunoTX w/AB active make own AB or provide AB passive BAP
* If untreated plaques, reduces synaptic, tangles, neurons die
* Interfere w//process
* Big discussion whether soluble, plaques, etc.
* While ongoing research, imp sci question
* BAP neutralize all 4 forms
* AB binds to all forms
* Gamma secretase goes after all, if go after monomer get all
* Never goes on
* Approach deals w/all forms
* Result of worl, both preclin and clin
* Allison Hume talk about clin progress, I’ll walk thru underpinning sci in AD
* A beta immunoTx
* Was surprise could immunize re a beta
* After immunize dir diff in plaque burden
* It does work for simple reason, antibodies circulate in brain, trigger clearance
* Went beyond active immunization to passive
* Del AB dir to animal model, mouse
* Dramatically reduce w/BAP w/diff amyloid loads
* Expanded by # of groups, in multiple mouse models, mice did much better
* Reduced path, improved fn
* Techn adv
* When treated in mouse model
* Now use 3D image
* Want to know exactly what doing
* Lit vessel stain in this slide, dramatic effect on pathology
* In 3D space, quantify volume
* One of biggest surprises, CAA
* 2 rpts in lit said immunoTx incr amyloid
* BAP decr amyloid on vessel wall
* Be careful which AB
* Helped clarify confusion
* When do certain task, blood flow goes to part of brain
* In AB in vessels, blood can’t go to it
* Reduce amyloid, can know change blood flow
* AB ImmunoTx red plaques, red inflammation, red vasc amyloid, dystrophy, incr synaptic #s or help stop decr
* Why imp? When use animal model, don’t know how rel to patients
* Now over 12 autopsies from AN1792 trials, mult indep pathologists look at brain tissue, concl plaque reduced
* Critical pt
* LT vision to change pathology of patients true, can do it
* If not enough, from AN1792 despite stoppage of dosing at 1 yr, look at 4.5 yrs later, patients doing sign better
* At 4.5 yrs could sep out low AB loads not, mult EPs, daily living
* Was proof of concept for BAP and acc-001
* ELND005 diff MoA
* Oral small mol
* 1st ID at U of Toronto
* Interacts w/AB, blocks, anti-aggregation
* Small molecule interesting things in animal models from U of T
* APP transgenic mouse model
* Treated, survive longer, reduced amyloid burden
* Re cogn testing, ask animals to perform, find in swimming
* Transgenic never learn, but if given it do learn
* Classic demo of impr cognition
* Allison Hume tell more re ELND005
* Believe works in great unison w/other approaches, immunoTx
* Reduction of production w/gamma secretase inh
* Ted mentioned, we were 1st to ID gamma secr
* Multiple entities
* If go to basic biology can go after and dev meaningful inh
* 1st inh show at left, DAPT
* Anyone works on it, what does DAPT do, worked w/Lilly
* Compound in center, picomolar to inh gamma secretase, almost made to clinic, could get some probs, not only inh cleavage, also notch
* Lilly solved w/another compound LY450139
* Now in PIII clin trials for AD
* We have vested interest in their succ
* Showed can reduce plaque burden in PDAPP mouse
* Today, worked hard on biology and chemistry how make gamma secretase, better index w/o interfering w/Notch
* Substrait specific
* These inh we dev, block APP, but not other substraits
* That is where we are heading
* Gamma modulators, Flurizan, change which abeta formed
* We are focused on substrait inh
* In science, think 10 yrs ahead, 5 yrs, 2 yrs
* In AD, world w/reduced pathology, greatly improved sitn
* Protect neurons
* New targets, kinase that can be neuroprotective
* Another integrin not alpha 4, neuroprot
* Examples of what doing internally
* Also reached out to outside comm., stay focused internally
* One way of advancing w/field
* ADDF, non-profit, we support them, # of good labs beyond abeta
* One example, Nick Webster, UCSD, small molecule cell permeable NGF mimetics
* Summary of AD
* Like idea from outside, take in, add value
* Focus on Pathology and Genetics
* Multiple AB approaches in clin trials
* Alternative approaches
* Parkinson’s Diseases
* Ted intro nicely
* See Lewy Body, inside
* Synuclein and mutations cause PD
* See analogies
* Lewy bodies dead and dying dopamine neurons
* PD more gen than thought
* Think as motor disease, but much more
* Lewy bodies can be in brain
* 25-30% of AD have Lewy bodies
* When looking at PD, on continuum w/AD
* Disease progresses throughout brain, affects mult fns of brain
* Pathology, pathway key
* Extends to neutrites
* Gives clues how attack disease
* Animal models, field had tough time, but encouraging progress w/animal model
* Mimic pathology to test new agents’
* Overexpressed synuclein in imp pt of brain
* See loss of neurons w/overexpr of synuclein
* If stain for dopamine, see cell loss in sunstantia nigra and striatum
* Diff levels of dopamine, loss of neurons
* Feel good, sign progress in animal model
* Remember fow critical for AD re animal models
* If Lewy body, isol synuclein, can understand molecular changes in protein
* Bottom, cleavage events, ubiquination
* Led to some very imp ideas
* Look at phosphorylation disease vs non-disease
* Alpha synuclein immunization
* June2005 Neuron publication
* Red # of synclein, incr # of synapses
* W/synuclein immuno, similar Qs, which antibodies, eptiopes
* Synucelin probably lives in membrane, AB stim
* Summary on PD
* Focus on pathology, synuclein
* Working w/Michael J. Fox Foundation
* Multiple genes involved
* Many labs around the world
* As they make progress, work w/them, make progress
* Pathology extends across AD, PS and MS
* Ted Yednock wrap up
* Extend focus across MS, AD, PD
* Both Tysabri and AD immunoTX derived from this space
* Focus intensified at ELN
* Immune cell infilt CSN in MS
* Modulation of immune cell activity
* Immune cell I/As in PD
* Dev of animal models and functional screens critical
* Functional screens w/disease relevance
* Helps to dir and modify agents
* Very excited about systematic approach
* Continually maintain focus
* Make assays, groundbreaking in science, go to therapeutics
* Same approach across MS, AD, PD
* Hope convinced approach is valuable
* Thanks for attn
* Allison Hume, EVP Global Dev
* Welcome back, hope refreshed
* Fortunate position to be Head of Global Dev
* 13 yrs ago joined due to phenomenal science, producing novel compound
* Opp to translate into novel thera in areas of unmet need
* Tremendous amt of excitement in dev org
* Our goal, take seriously, responsibly del cutting edge sci in disc manner and process
* Make novel thera to patients w/high unmet need
* 4 key objs
* Imperative del and exec to highest stds in 4 areas to del novel thera to mkt
* First, establish efficacy and also safety, proper benefit/risk profile
* Meet reg reqs of agencies ww
* Incr imp, provide pharmacoec data, gather early, not just ec and humanistic cost, but show benefit of therapeutic, so can get reimb and get prod for patients
* Huge resp, gather tremendous knowledge, transfer education to docs and patients, get rt patients on thera
* Key objs for dev
* W/in dev org at ELN, all capabilities to be able to del on those goals
* Integrate caps very early on, so freq have bursts
* We have lots of bursts that result in novel thera
* Tremendous expertise in neurology
* Demo in MS, 1st thera appr in 1 yr data, AD, PD succ
* Also gastro expertise
* Able to design novel protocols, cutting edge, know KOLs, key thought leaders
* Tremendous clin org
* Large CD trials, were largest ever conducted
* Freq P III, involving 100-200 sites, w/so many sites have consistent approach, minimize noise, minimize variation
* Great deal of reg expertise, particularly US and EMEA
* 5 sign filings and approvals
* Succ 2 yrs in a row, advisory committees
* Gained thru Tysabri, TOUCH, risk mgt programs
* Will again face when bring out novel thera
* Imp to gather pharmacoec to show cost effectiveness, we have one of best in industry
* Demo that by getting pos opinion in MS w/NICE, 1st thera in MS to get a pos opinion
* Medical affairs expertise translate to mktplace, docs and physicians
* W/all that cap, delighted to share tremendous progress in 2007
* Manage 12 ongoing programs, also init 10 new clin trials
* Don’t have time to cover every single one
* Highlight some progress w/AD
* Advancement of BAP from P II to P III, finalizing P III protocols w/regs, get sites up and running, succ 1st patient dosing in Dec2007
* Excitement at ELN and w/docs and patients
* Adv 2nd AD P I to P II ELND005, prevent aggregation of beta amyloid
* Dosed 1st patient before YE2007
* 2nd is Active Immunization, P II acc-001
* In parallel, succ AC in CD for Tysabri, approval 14Jan2008
* Moving on, what do to pipeline in 2008
* What sharing now what pipeline could and should look like in 2008
* Start w/AD programs, if all according to plan, 9 programs in clinic in AD, dir or indir w/collaborators
* Passive remove of abeta, BAP, active immunization acc001 P II, anti-aggr ELND005
* Rt at botton small molecule elnd006, inh of synthesis inh gamma ecretase
* Add autoimmune pt of P/F
* Another 8 programs running dir or indir thru collaborators
* Around primarily Tysabri life cycle, and 2 small molecules ELND002, ELND004
* Share from select # of programs
* Start w/BAP, IV infusion every 13 wks, collab w/WYE, passive removal whether circulating or solid AB
* Fast track, FDA recogn pot of mtg unmet med need in AD
* Affords opp for rapid review either thru rapid review, rolling submission
* Starting w/P II, large multictr, DB PC, n=250, located across 30 sites in North America
* Data antic mid-2008, full data presented at ICAD Jul2008 in Chicago
* Have P II investigator mgt, share
* Also preclin and health outcomes, poster of NTB study as well
* Those patients particip in P II, option to continue in open label, provide valuable LT data
* Slotted opp to do some PET PIB to correlate what we saw w/clinical work
* P III program, decision to move into P II, based on # observations, P I BAP, interim P II, only few people privy, AN1792 data Dale disc, particularly 4.5 yr data
* Incl disc w/WYE, FDA< EMEA, designed P III believe incredibly robust, perfectly powered
* 4 pivotal trials, approx 4.1K patients 350 sites globally
* 2 sub-pops, those w/o APOE4 allele, 1 in NAM, 1 ROW, 2 studies w/APOE4, 1 Nam, 1 ROW
* ELN resp for North America, WYE ROW
* All 4 pivotal studies co-parimary EPs, functional and cognitive
* Cogn ADAS-cog, NTB, functional DAD, CDR-SOB
* Which primary after P II and mtg w/regulators
* Incr excited
* Started to dose in Nam end of 2007, enrollment progressing well, lots of excitement for patients to come in
* On sched to complete enrollment by YE2008
* WYE trickier, lots of companies to get reg into, close to starting dosing
* Continuing re immunoTx, active immune, acc001
* Novel beta amyloid conjugate, fragment of AB attached to protein creates response to remove beta amyloid
* Compl P I, moved in P II
* Planned n=227
* Dose 59 patients
* 4Apr2008 suspended dosing to eval AE, termed vasculitis by investigator
* Submitted response to regulator, conf return to dosing
* Not seen w/any other immunoTx, not BAP, keep to continue
* Wrapping up immunoTx, another formulation of subQ BAP
* Ready to embark on P II
* First get P III up, then resume subQ P II 2H2008
* A couple of back-up compounds, aab-002 for passive
* Back-up for active is acc002
* Another approach around amyloid
* Anti-aggr ELND005
* Oral compound, scyllo-inositol, working w.Transition Therapeutics
* Fast track status
* In P II large DB PC study, dose ranging, safety and efficacy, n=340, 65 N Am sites
* Duration 18M, 3 Tx groups, complete enrolled YE2008
* Due to MofA early in amyloid cascade, able to use to study early AD
* Working on protocol for early AD, optimistic rt trial design, select appr patients
* Look forward to go to FDA, toward end of 2008, 1H2009
* Novel cutting edge approach re early AD
* 3rd AD approach
* Inh of amyloid re inh of gamma secretase
* ELND006 file IND soon, in clinic P I 2H2008
* ELND007 IND file 2H2009
* Autoimmune pt of pipeline
* Majority focused on Tysabri life cycle mgt
* Still in MS
* Post mktg commitment re TIGRIS 5K patients
* Small P II study re formulation, subQ vs IV intramusc
* In secondary progressive to learn
* Started dev path in Japan for MS
* CD INFORM observational study, recruit 2K patients
* Very exciting finally study in Ulcerative Colitis
* See if go straight into P III
* Another area is oncology
* P II to treat MM
* Enrolling before end of yr
* Mechanism lends to potentially solid tumors
* Perhaps put into solid tumors
* ELND002 SQ pegylated small mol
* SubQ injections
* In P I SAD study in healthy subj
* See whether secondary progress or primary
* Data 2H2008
* Also put into hema malign
* IND in 1H2008
* ELND004 Oral
* Small molecule, follow-on to Tysabri
* Greater spec re matrix I/A
* IND appr Jan2008
* P I SAD 1st patient Mar2008
* P II MAD 2H2008
* Key highlights from pipeline 2008
* Into 2009
* Disc adv
* Enrollment compl BAP P III, disclose P II BAP data, start w/ICAD in Jul2008
* ELND005 comp enrollment P II
* In clinic w/early AD ELND005
* 3rd approach gamma secretase in P I before YE2008
* Life cycle mgt for Tysabri, pot due UC and oncology
* SubQ vs IV
* 2 small molecules ELND002, 004 in clinic
* 2010 Pipeline
* What could pipeline look like just w/programs described
* AD programs
* Green bars new phases
* In AD alone go from 2 P III to 6 P III programs
* Span active and passive remove, anti-aggr of amyloid
* Pathology already proven by AN1792, autopsy data
* Our job in dev shepherd thru to get to endpts
* Also have gamma secretase in P II
* Pretty impressive pipeline
* Resp to move forward in disc manner
* That’s not all
* Autoimmune pipeline, lots of green areas
* Tysabri life cycle mgt, UC, MM
* Bottom rows, ELND002 MS, oncology, ELND004 UC, CD
* By 2010 could have 10 P III programs in operation
* Tremendous opp
* Close that key goal ensure resp del cutting edge sci, novel compounds from sci into novel thera, patients w/devastating diseases
* Have every possibility o have thera for AD, UC, oncology
* Karen Kim, Commercial and Corp Dev
* Adept Connections
* Novel therapies w/new MofA in chronic diseases like MS and CD, education main focus
* Med ed, benefit risk profile, qualify rt patients, Tx ed, algorithm of Tx over time
* Integrated model to specific audiences enables clin succ
* 1st and foremost, docs, reimb, specialty pharma providers for dstrib
* Example commercial model for Tysabri in MS
* Trained med liaisons, trained infusion support at site, case mgrs, patient admin, health economics, all need to work together
* Not one size fits all, customize for neurologists, their practice
* Both ELN and BIIB perform specific fns
* Was in place when intro TOUCH program, patients, docs, distributors, indiv education
* Pleased T launched in CD, launched mid-Mar2008
* Obj, max value of T as total
* Expand in disc basis in CD
* BE 18M after launch
* Position for primary and secondary anti-TNF failures
* Make sure use appr
* Lev comm. Infrastructure ELN/BIIB for Tysabri
* Similar CD as MS
* Imp to note besides sales, mkt, specific, other core team fns, infusion, SPP, M/F reimb, shared asset
* Whether GI or neurologists
* Allows to extend to specific audiences, other indications like UC
* Hone comm. For CD, expand to mult indications
* Target 1400 GI in US, 60-70% of CD opp
* Focus on 1st movers, familiar w/novel Tx, key influencers
* Assigned key acct mgr re med ed, Tx ed, service reqs
* Focus on first movers to admin, cascade to GI based on solid foundation of med and Tx knowledge
* In summary, recognize Tx in chronic diseases req ed as main focus
* Adopt integrated commercial and team model focus on med and Tx ed
* Dynamic teams focused
* KOLs and influencers segments by expertise, beh, influence matter
* Diverse specialties
* Extend from MS, CD to UC other
* AD, PD
* Integrated commercial team model process
* Shane Cooke, CFO< Head of EDT Business
* Addr as Head of EDT, no info re role as CFO
* Don’t ask how pay for dev work
* EDT business profitable
* Consistently prof last 7 yrs, EBITDA grown 3x since 2002
* Very interesting time, favorable ind trends
* Broad suite of comm. Val and prop techn
* One of features extensive partnering caps
* Over 24 companies from emerging pharma to big pharma
* 23 licensed prods incorp our techn in mkt
* 14clin programs, 2 filed, 5 in P III, 4 in P II
* Affect 2.5M patients
* 1969 ELN started as drug tech del business
* 1981 Gainesville facility
* 1984 IPO
* 1998 acq nanotechnology
* Acq Athena 1996
* Recently refocus impr productivity, expand patent estate, nanocrystal techn, coming thru in prods
* Older prod techn help fill out business
* Looking at industry, significant patent expirations next 5 yrs
* Comm opp, 100B coming off patent, about same size as AD mkt
* Two areas, help pharma cos replace lost rev, second, own proprietary prods
* Growth 4-5 yrs
* Reformulations grown 15% CAGR, NCE down 3%
* Those are industry stats
* EDT refocus on extensive exp, technologies, dev and comm. Innov prods bring patients benefits
* Get rev from partners to cover dev an dmilestones as progress, when approved particp w/succ via royalties, also inv in some cases re M/F
* No sales force, no large P III funded
* Leverage off partners
* 2 key technologies: nano and Oral ctled release
* Nano better absorption, improve perf
* W/oral ctled release impact to either extend, delay release, impr effectiveness or new prods
* Nano impr bioavail, dosing, faster onset, can decr SE
* Oral prods on mkt, Abbott Tricor, WYE ?, Amend by MRK
* All significant improvement Megas Wt loss for AIDS patients, decr vol by 75%, vsc reduced by 16x, elim need to take w/food re AIDS patients
* 9 prods in clinic
* 2 near, paliperidone palmitate J&J, MAP product
* OCR techn in # of drugs
* MXDAS, SODAS, CODAS, PDAS, PRODAS
* Luvox from Jazz most recent approval, OCD, SAD just launching
* One of most promising in pipeline is Fampridine SR
* Summarize provide benefit to existing prods, NCE
* Impr clin outcome, safety, efficacy, patient compliance, dosing, convenience
* Comm benefit thru patent protection/extension
* See benefits on mkted prods slide
* Fully integrated from concept to caps to M/F comm. Supplies at Athlone and Gainesville
* R&D caps in both sites
* Key site nano in King of Prussia
* Further come alond w/dev, more expensive it becomes
* Get to retain more of economics
* Typically won’t go beyond P II
* Look at P/F basis, re alloc of resources and capital
* Real focus on growth, move existing prods to mkt
* Look selectively invest, have int entrée to mkt
* Continue to outlicense cos want to enh prods
* Maintain leadership position re drug del technologies
* Throughout process, key pt of what due is IP
* Suc dep on patent
* 1700 patents and patent apps
* Key asset, vigorously defend
* Monitor other prods to see if infringe and take action as appr
* Last 3 yrs filed about 500 patents, primarily nanocrystal, specific molecules
* Going to be imp aspect of growth going forward
* 23 prods on mkt incorp techn
* 6 launched in last 5 yrs, ex[ect 8 in next 4-5 yrs
* Receive royalties from in-mkt sales, M/F fees where involved
* Evol of bus, royalties now about 50%, M/F other 50%
* Of prods, majority we M/F
* Royalties range 5-10%, if M/F 15-20%
* Imp source of rev
* Lev off tech to get upside from succ of prods inv in
* Looking at pipeline
* 14 prods in clinic, 2 filed, 5 in P III
* 2 rel to morphine and rts OUS
* Expect 8 prods launched in next 4 yrs
* Blue w/nano, blue w/OCR
* Sign # of candidates preclin
* Royalties range dep when outlic and got inv
* Paliperidone palmitate 5-9%
* High teens for Fampridine
* 20% for ZX002 Zogenix
* W/PP not inv in MF
* NT prod launches 8 all could be significant
* Mkted by range from emerging to big pharma
* Partnered w/24-25 companies, who’s who in this industry
* Continue to add new names, more deals w/existing partners
* Done repeat transactions w/many partners
* Key sites, Athlone in Ireland, Gainesville and King of Prussia
* Athlone and Gainesville primarily M/F
* King of Prussia nano center of excellenece
* Imp to have 2 sites, Gainesville authorized for ctled substances
* Consistently prof
* Rev grew 70%, rev 11% CAGR, 27% adj EBITDA CAGR from 2002
* 2007 296M rev, 124M EBITDA
* EBITDA grow double digits next 4 yrs
* Next 12M
* Watch Jazz Luvox US launch
* Zogenics file IPO, pay for P III from proceeds
Antwort auf Beitrag Nr.: 34.052.946 von Birgit.Tersteegen am 08.05.08 09:56:06Davys
Elan Corp (USc)
ELN US
Company Day increases optimism about long-term outlook
Jack Gorman
Elan sounded both optimistic and outward-looking in its presentations and subsequent management interaction at the Company Day in Boston. The breadth and depth of its research and development activities in neurology and autoimmune disorders leave us more confident in the company’s capacity to build a profitable, fully integrated biotech company over the medium to long term.
Over the last five years intensive restructuring, combined with investment in core research, has provided the foundation stone for its late-stage development and commercialisation plans. Elan is now active in this phase, led by Tysabri and more latterly by Bapineuzumab. Elan has arrived at this inflection point just as big pharma are also grappling with the same conundrum of restructuring and research (albeit from the perspective of a bloated, generic-ridden agenda in big pharma’s case).
It is clear that the scale of required investment significantly increases – witness the current investment in the Bapineuzumab Phase III programme as an indicator of this. It will also involve infrastructure investment over time. Excitingly, the ground work laid in the last five years and more will also allow Elan to become more outward-looking as regards investment (the 2006 Transition deal was an early marker of this). To this end, Elan can leverage its own research reputation in neurology and autoimmune disorders to access an attractive flow of potential in-licensing/partnering opportunities.
As flagged by management, there were no material announcements on late-stage or corporate newsflow. However, there were plenty of incremental highlights from the day:
potential ten candidates in Phase III development by 2010,
including six in AD and four across its autoimmune activities in MS, CD, UC;
the confluence of its neurodegenerative and neuro-inflammatory research efforts has resulted in the emergence of a third arm beyond AD and MS – that of Parkinson’s Disease (PD); there is a substantial programme underway to sustain and extend Tysabri into other areas such as UC and oncology; deeper MS research has allowed Elan to investigate several interesting early-stage small molecules that may help secure the company’s franchise position in the MS area.
http://www.investorvillage.com/smbd.asp?mb=160&mn=229195&pt=…
Elan Corp (USc)
ELN US
Company Day increases optimism about long-term outlook
Jack Gorman
Elan sounded both optimistic and outward-looking in its presentations and subsequent management interaction at the Company Day in Boston. The breadth and depth of its research and development activities in neurology and autoimmune disorders leave us more confident in the company’s capacity to build a profitable, fully integrated biotech company over the medium to long term.
Over the last five years intensive restructuring, combined with investment in core research, has provided the foundation stone for its late-stage development and commercialisation plans. Elan is now active in this phase, led by Tysabri and more latterly by Bapineuzumab. Elan has arrived at this inflection point just as big pharma are also grappling with the same conundrum of restructuring and research (albeit from the perspective of a bloated, generic-ridden agenda in big pharma’s case).
It is clear that the scale of required investment significantly increases – witness the current investment in the Bapineuzumab Phase III programme as an indicator of this. It will also involve infrastructure investment over time. Excitingly, the ground work laid in the last five years and more will also allow Elan to become more outward-looking as regards investment (the 2006 Transition deal was an early marker of this). To this end, Elan can leverage its own research reputation in neurology and autoimmune disorders to access an attractive flow of potential in-licensing/partnering opportunities.
As flagged by management, there were no material announcements on late-stage or corporate newsflow. However, there were plenty of incremental highlights from the day:
potential ten candidates in Phase III development by 2010,
including six in AD and four across its autoimmune activities in MS, CD, UC;
the confluence of its neurodegenerative and neuro-inflammatory research efforts has resulted in the emergence of a third arm beyond AD and MS – that of Parkinson’s Disease (PD); there is a substantial programme underway to sustain and extend Tysabri into other areas such as UC and oncology; deeper MS research has allowed Elan to investigate several interesting early-stage small molecules that may help secure the company’s franchise position in the MS area.
http://www.investorvillage.com/smbd.asp?mb=160&mn=229195&pt=…
Antwort auf Beitrag Nr.: 34.052.946 von Birgit.Tersteegen am 08.05.08 09:56:06Goodbody
Elan (Add: closing price $26.03)
Investor day gives insight into broad pipeline
Analyst: Ian Hunter
We attended the Elan investor day in Boston yesterday, where management provided a comprehensive overview of its drug pipeline and the Elan Drug Technology (EDT) division. That said, nothing was particularly new to the market. The company did, however, demonstrate that it is developing a broad pipeline of drug candidates which could, by 2010, see the company with ten drugs at Phase III (six against Alzheimer's and four against other CNS targets) and five at Phase II. EDT was presented as a profitable business within Elan; with growing potential as more drugs incorporating the company's delivery systems make it to the market. The company did give further detail on its work in Parkinson's disease. With a good pre-clinical model now in place, Elan considers that it is now in a position to move Parkinson drug development forward. The main catalyst for the stock in the short term, however, remains the release of AAB-001 Phase II headline data in "mid year", with the full data to be presented at ICAD in the last week of July.
What the investor day demonstrated was that the pipeline is continuing to broaden and that it has the potential to continue that momentum over the coming years.
http://www.goodbody.ie/news/morn.html#7
Elan (Add: closing price $26.03)
Investor day gives insight into broad pipeline
Analyst: Ian Hunter
We attended the Elan investor day in Boston yesterday, where management provided a comprehensive overview of its drug pipeline and the Elan Drug Technology (EDT) division. That said, nothing was particularly new to the market. The company did, however, demonstrate that it is developing a broad pipeline of drug candidates which could, by 2010, see the company with ten drugs at Phase III (six against Alzheimer's and four against other CNS targets) and five at Phase II. EDT was presented as a profitable business within Elan; with growing potential as more drugs incorporating the company's delivery systems make it to the market. The company did give further detail on its work in Parkinson's disease. With a good pre-clinical model now in place, Elan considers that it is now in a position to move Parkinson drug development forward. The main catalyst for the stock in the short term, however, remains the release of AAB-001 Phase II headline data in "mid year", with the full data to be presented at ICAD in the last week of July.
What the investor day demonstrated was that the pipeline is continuing to broaden and that it has the potential to continue that momentum over the coming years.
http://www.goodbody.ie/news/morn.html#7
ELN msg # 229207 5/8/2008 6:51:02 AMBy: ramsfan
12/31/07 Goldman Had 700K Shares .... 5/7/2008 Goldman Has 15M Shares
That's a pretty big bet. Goldman had to buy most of those shares in the 20's and they're pretty smart over there (ie. the only ones not to get hit by the sub-prime mess).
Chart sieht bisher ganz gut aus.
Die Erholung nach den guten News gestern:
Die Erholung nach den guten News gestern:
Holgus--wir sind gut im Plus--and where is your comment---now??
Antwort auf Beitrag Nr.: 34.057.194 von Birgit.Tersteegen am 08.05.08 16:30:20Gut im Plus ???? Pfffft ... heiße Luft.
Dat is ja grad mal dat, was wir gestern verloren haben.
Nochmal ... Pfffft .... weck mich, wenn wir die 40ig überschritten haben
Dat is ja grad mal dat, was wir gestern verloren haben.
Nochmal ... Pfffft .... weck mich, wenn wir die 40ig überschritten haben
Antwort auf Beitrag Nr.: 34.057.802 von Holgus am 08.05.08 17:21:47Du bist einfach MASSLOS!!!!!!!!!!!!!!!!!!!!!!!!!! 
Antwort auf Beitrag Nr.: 34.060.520 von Birgit.Tersteegen am 08.05.08 22:53:56Maßlos, zügellos, hemmungslos ... guts Nächtle.
Sleep very well in your klappri Bettgestell ... gell
Sleep very well in your klappri Bettgestell ... gell
Antwort auf Beitrag Nr.: 34.060.545 von Holgus am 08.05.08 22:58:16JA--den Keks nehm ich---ALLES Nervennahrung --brauch ich wegen eines Boardjungens namens H........ 
Elanians msg # 8973 5/8/2008 8:18:48 PM
By: liposghost
Re: Ghost: does this stuff really work? How long until a BLA filed?
i showed TSW to one in the know and asked if he saw anything he disagreed with, said we left out an R. I see bla late 09
By: liposghost
Re: Ghost: does this stuff really work? How long until a BLA filed?
i showed TSW to one in the know and asked if he saw anything he disagreed with, said we left out an R. I see bla late 09
auf einen grünen Freitag.
Wünsche allen Investierten (und denen die es noch werden möchten) ein schönes und erholsames Wochenende.
(Mallorca Regen und 16 Grad Celsius; Flensburg Sonne und 26 Grad Celsius)
Wünsche allen Investierten (und denen die es noch werden möchten) ein schönes und erholsames Wochenende.
(Mallorca Regen und 16 Grad Celsius; Flensburg Sonne und 26 Grad Celsius)
Antwort auf Beitrag Nr.: 34.066.221 von Poppholz am 09.05.08 16:23:33Das wünsch ich Dir auch Poppie ... und den Anderen natürlich auch.
Aus Sicht der zugeschifften Malleinsel ist Bad Segeberg ein Vorort von Flensburg ... smile ... kommt jemand mit zur Ostsee ??
Aus Sicht der zugeschifften Malleinsel ist Bad Segeberg ein Vorort von Flensburg ... smile ... kommt jemand mit zur Ostsee ??
HUI HUI--wir gehen aber High High27,65$(und das bei diesem Minus Markt....
)
....aus einem Analystenhaus,das sich auskennt....
Re: Leerink Swann & Company /recap
We believe a fair
value of ELN shares at end-2008 is approximately
$44 derived from Monte Carlo simulation. Risks to investment in ELN shares
include whether Tysabri treatment results in serious opportunistic infections
that could jeopardize its commercial viability and successful development of
AAB-001.
Re: Leerink Swann & Company /recap
We believe a fair
value of ELN shares at end-2008 is approximately
$44 derived from Monte Carlo simulation. Risks to investment in ELN shares
include whether Tysabri treatment results in serious opportunistic infections
that could jeopardize its commercial viability and successful development of
AAB-001.
e: Leerink Swann & Company
What a great statement!
"We continue to believe ELN could emerge as one of
the most important companies in the biopharma industry in the next decade. "
What a great statement!
"We continue to believe ELN could emerge as one of
the most important companies in the biopharma industry in the next decade. "
Eighteenth Meeting of the
European Neurological SocietyJune 7 – 11, 2008
Programme 20th Anniversary of the first ENS Meeting in Nice
http://www.akm.ch/ens2008/
Tuesday, June 10, 2008
12:15 - 13:45
Biogen Idec / Elan Satellite
Targeting the pathophysiology of MS: transforming discovery into care
Chair: D. Bates (Newcastle upon Tyne, UK)
12:15 - 12:45 Avonex® – Optimising MS therapy to fit patients lives
M. Kita (Seattle, US)
12:45 - 13:15 Tysabri® – Raising the efficacy bar
N. Putzki (Essen, DE)
13:15 - 13:45 BG-12 – An emerging oral therapy for MS patients
R. Fox (Cleveland, US)
Satellite symposium organised by Biogen Idec / Elan
----------------------------------------------------------------------
14:45 - 15:00 Multiple sclerosis 3 (Plenary Hall)
Complete clinical and magnetic resonance imaging response with natalizumab in multiple sclerosis
C. Confavreux, S.L. Galetta, G. Giovannoni, E. Havrdova, M. Hutchinson, F.D. Lublin, P.W. O'Connor, J.T. Phillips, C.H. Polman, R.A. Rudick, A. Pace, R. Hyde, M.A. Panzara (Lyon, FR; Philadelphia, US; London, UK; Prague, CZ; Dublin, IE; New York, US; Toronto, CA; Dallas, US; Amsterdam, NL; Cleveland, Cambridge, US)
European Neurological SocietyJune 7 – 11, 2008
Programme 20th Anniversary of the first ENS Meeting in Nice
http://www.akm.ch/ens2008/
Tuesday, June 10, 2008
12:15 - 13:45
Biogen Idec / Elan Satellite
Targeting the pathophysiology of MS: transforming discovery into care
Chair: D. Bates (Newcastle upon Tyne, UK)
12:15 - 12:45 Avonex® – Optimising MS therapy to fit patients lives
M. Kita (Seattle, US)
12:45 - 13:15 Tysabri® – Raising the efficacy bar
N. Putzki (Essen, DE)
13:15 - 13:45 BG-12 – An emerging oral therapy for MS patients
R. Fox (Cleveland, US)
Satellite symposium organised by Biogen Idec / Elan
----------------------------------------------------------------------
14:45 - 15:00 Multiple sclerosis 3 (Plenary Hall)
Complete clinical and magnetic resonance imaging response with natalizumab in multiple sclerosis
C. Confavreux, S.L. Galetta, G. Giovannoni, E. Havrdova, M. Hutchinson, F.D. Lublin, P.W. O'Connor, J.T. Phillips, C.H. Polman, R.A. Rudick, A. Pace, R. Hyde, M.A. Panzara (Lyon, FR; Philadelphia, US; London, UK; Prague, CZ; Dublin, IE; New York, US; Toronto, CA; Dallas, US; Amsterdam, NL; Cleveland, Cambridge, US)
May 13, 2008 (Nelson's Broker Summaries via COMTEX) --Company: ELAN CORP PLC
Report Headline: "ELN.I: Elan Corp - Bringing up to speed ahead of key data"
Report Date: May 08, 2008
Current FY EPS Estimate [FY2008]: -0.31
Previous EPS Estimate for Current FY [FY2008]: -0.28
Current Quarter EPS Estimate [Q2]: -0.19
Previous EPS Estimate for Current Quarter [Q2]: N/A
Next FY EPS Estimate [FY2009]: -0.05
Previous EPS Estimate for Next FY [FY2009]: -0.01
Current Recommendation: OUTPERF/MKTWT
Research Firm: FIA
Analyst: SCOTT BARDO MR
Industry: HEALTH/HEALTH
Estimates reported in EUR
http://www.thomsonfinancial.com
Copyright 2008, Nelson Information, a Thomson Financial company
-0-
Hallo ELANITES und ELANIACS -
einen spontanen Pfimgstferien-Gruß aus dem Westerwald -
ich werde am 19.05 wieder " back at home " sein .
Nichtsdestotrotz - hier der Realtimekurs aus den USA`:
27,87 - 27,88
= 18,02 €
..read you....
Grüße bernie55
einen spontanen Pfimgstferien-Gruß aus dem Westerwald -
ich werde am 19.05 wieder " back at home " sein .
Nichtsdestotrotz - hier der Realtimekurs aus den USA`:
27,87 - 27,88
= 18,02 €
..read you....
Grüße bernie55
Am 15.11.2004 erzielte ELAN ein ALLTIME Hoch von 30,09 USD
> basierend auf dem Chart der letzten 15 Jahre !!! <
...das werden wir wohl bald knacken...
> basierend auf dem Chart der letzten 15 Jahre !!! <
...das werden wir wohl bald knacken...
Antwort auf Beitrag Nr.: 34.085.741 von bernie55 am 13.05.08 21:30:04http://www.investorvillage.com/smbd.asp?mb=160&mn=231120&pt=…
If I'm Correct.......
this option expiration has the potential to blow out on the upside! Naturally, charts are not perfect, but this pattern looks like a perfect timing and is taking on the look of a powerful expiration. 30 is a strong possibility. .....looks like a PARABOLIC RUN is not out of the question!!!! Hang on.
If I'm Correct.......
this option expiration has the potential to blow out on the upside! Naturally, charts are not perfect, but this pattern looks like a perfect timing and is taking on the look of a powerful expiration. 30 is a strong possibility. .....looks like a PARABOLIC RUN is not out of the question!!!! Hang on.
Antwort auf Beitrag Nr.: 34.085.848 von HeinzBork am 13.05.08 21:42:40.....look of a powerful expiration...........looks like a PARABOLIC RUN is not out of the question!!!!
..diesen Worten des Users vom IV sei an dieser Stelle nichts mehr hinzuzufügen....
TIME WILL TELL
..diesen Worten des Users vom IV sei an dieser Stelle nichts mehr hinzuzufügen....
TIME WILL TELL
Antwort auf Beitrag Nr.: 34.085.741 von bernie55 am 13.05.08 21:30:04...hier mal wieder was für die Augen...
...hier mal wieder was für die Augen...
Antwort auf Beitrag Nr.: 34.087.639 von bernie55 am 14.05.08 08:52:25....fein!
...geniess die Tage!LG Birgit
...geniess die Tage!LG Birgit
Spaß muß sein sprach Wallenstein
und schob sich noch mehr Elan rein
und schob sich noch mehr Elan rein
Der US-Chart von gestern ist sehr schön gelungen.
Besonders das Ansteigen der Ordergrößen zum Ende ist sehr gut.
Besonders das Ansteigen der Ordergrößen zum Ende ist sehr gut.
Antwort auf Beitrag Nr.: 34.087.672 von Birgit.Tersteegen am 14.05.08 08:57:21...geniess die Tage!LG Birgit
...werde mich weiterhin im " Hier und Jetzt " der Ayurveda Philosopie hingeben und die Tage genießen......
.....und dann wieder mit ELAN in die Zukunft rauschen......
LG bernie55
bernie55
...werde mich weiterhin im " Hier und Jetzt " der Ayurveda Philosopie hingeben und die Tage genießen......
.....und dann wieder mit
ELAN in die Zukunft rauschen......LG bernie55
bernie55
MS AUSTRALIA THANKS FEDERAL GOVERNMENT FOR PBS LISTING
MS Australia is pleased to learn that the Federal Government has committed to subsidise the MS treatment, Tysabri, on the Pharmaceutical Benefits Scheme (PBS) as of 1 July, 2008.
Dr Bill Carroll, Chairman of MS Australia’s Research Committees said that this is the first new MS drug to gain PBS listing in some time and will be a most welcome addition to the range of treatment options for patients and their doctors.
“MS Australia would like to acknowledge the Federal Government for making such a large economic commitment and in doing so recognising the hope this treatment brings to many people with Multiple Sclerosis,” said Dr Carroll.
“For those suited to this treatment, it is possible their MS progression and accumulated disability may be minimised. Staying in the workforce longer,remaining in the family home and continuing to be active members of the community is a real benefit this treatment may offer.”
Tysabri is suitable for those with Relapsing Remitting MS only and people should discuss this treatment option with their neurologist.
Multiple sclerosis is a chronic and debilitating disease, characterised by damage to the nerve pathways that transmit signals from the brain to the rest of the body.
Each working day five Australians are diagnosed with MS.
ENDS
http://www.msaustralia.org.au/documents/Tysabri_PBS_listing_…
MS Australia is pleased to learn that the Federal Government has committed to subsidise the MS treatment, Tysabri, on the Pharmaceutical Benefits Scheme (PBS) as of 1 July, 2008.
Dr Bill Carroll, Chairman of MS Australia’s Research Committees said that this is the first new MS drug to gain PBS listing in some time and will be a most welcome addition to the range of treatment options for patients and their doctors.
“MS Australia would like to acknowledge the Federal Government for making such a large economic commitment and in doing so recognising the hope this treatment brings to many people with Multiple Sclerosis,” said Dr Carroll.
“For those suited to this treatment, it is possible their MS progression and accumulated disability may be minimised. Staying in the workforce longer,remaining in the family home and continuing to be active members of the community is a real benefit this treatment may offer.”
Tysabri is suitable for those with Relapsing Remitting MS only and people should discuss this treatment option with their neurologist.
Multiple sclerosis is a chronic and debilitating disease, characterised by damage to the nerve pathways that transmit signals from the brain to the rest of the body.
Each working day five Australians are diagnosed with MS.
ENDS
http://www.msaustralia.org.au/documents/Tysabri_PBS_listing_…
Das war wohl das STOP LOSS Fishing für heute.
Mal sehen wo wir heute schließen.
Mal sehen wo wir heute schließen.
Antwort auf Beitrag Nr.: 34.093.146 von Poppholz am 14.05.08 17:31:23Das war wohl das STOP LOSS Fishing für heute.
Nö, das kommt durch die Optionen. Die 27er sind dabei die stärkste Fraktion, also werden sie uns bis Montag wohl unter 27ig halten.
Oder auch doch ... ich weiß dat nich
Nö, das kommt durch die Optionen. Die 27er sind dabei die stärkste Fraktion, also werden sie uns bis Montag wohl unter 27ig halten.
Oder auch doch ... ich weiß dat nich
Antwort auf Beitrag Nr.: 34.093.811 von Birgit.Tersteegen am 14.05.08 18:43:43Anschauen!
Wüüürg .... dat is ja auf englisch
Wüüürg .... dat is ja auf englisch
Antwort auf Beitrag Nr.: 34.093.811 von Birgit.Tersteegen am 14.05.08 18:43:43Will Muggia auf CNBC über Elan
Yeah, Elan, another great positioned company. It's an Irish-based drug company,but with big operations in the US.
Elan is two core franchises: one in auto-immunedisorders, Multiple Sclerosis; the other in Alzheimer's. And very simply,Tysabri, their MS drug, was launched a little over a year ago. They've already got 26,000 patients on the drug. So annualizing at $800 million, and there's 400,000 multiple sclerosis patients in the world today, so a $12 billion market. So Tysabri will drive them $2, 3, 4 billion in revenue.
But the most exciting thing with Elan is their Alzheimer's program.
And we'll get some data on Alzheimer's at the end of July. It's one of the largest unmet medical needs in the world today. You've got 5 million Alzheimer's patients in the US, 15 million outside the US. So a $100 to 200 billion market.
Yeah, Elan, another great positioned company. It's an Irish-based drug company,but with big operations in the US.
Elan is two core franchises: one in auto-immunedisorders, Multiple Sclerosis; the other in Alzheimer's. And very simply,Tysabri, their MS drug, was launched a little over a year ago. They've already got 26,000 patients on the drug. So annualizing at $800 million, and there's 400,000 multiple sclerosis patients in the world today, so a $12 billion market. So Tysabri will drive them $2, 3, 4 billion in revenue.
But the most exciting thing with Elan is their Alzheimer's program.
And we'll get some data on Alzheimer's at the end of July. It's one of the largest unmet medical needs in the world today. You've got 5 million Alzheimer's patients in the US, 15 million outside the US. So a $100 to 200 billion market.
Antwort auf Beitrag Nr.: 34.094.294 von Holgus am 14.05.08 19:40:45Wüüürg .... dat is ja auf englisch
..vielleicht klappt es mit dem Lesen besser...
....siehe Posting #19335....
..vielleicht klappt es mit dem Lesen besser...
....siehe Posting #19335....
Antwort auf Beitrag Nr.: 34.094.362 von bernie55 am 14.05.08 19:49:46..vielleicht klappt es mit dem Lesen besser
Toll, französich kann ich leider auch nich
Toll, französich kann ich leider auch nich
Antwort auf Beitrag Nr.: 34.094.877 von Holgus am 14.05.08 20:45:13....tja--mal das Hirn trainieren und nicht immer nur die unteren Extremitäten ....(oder ist das eine schon komplett nach unten gerutscht??) Schööönen Abend!
) Schööönen Abend!
Antwort auf Beitrag Nr.: 34.095.677 von Birgit.Tersteegen am 14.05.08 22:11:41noch was auf russisch....
ELN msg # 231588 5/14/2008 4:20:50 PM
By: godivatruffles6
Schaeffers research - Short sellers, options players, and analysts remain bearish toward uptrending drug maker Elan (ELN)
http://www.schaeffersresearch.com/commentary/observations.as…
Short Interest Report: Despite an Uptrend, Elan Faces a Slew of Skeptics
Keywords: ELN stocks options
Playing with one of the awesome filters on SchaeffersResearch.com, I decided to check out some uptrending stocks with heavy short interest – a bullish implication from a contrarian standpoint. Delving through the results, I came across an equity that caught my eye: pharmaceutical firm Elan( ELN: View sentiment for elnsentiment, chart, options) .
To see how I utilized the filter, check out yesterday's edition of Short Interest Highlights, focusing on intelligent network infrastructure company VeriSign (VRSN).
The Stock
Elan is an Ireland-based biotechnology firm, manufacturing drugs targeting various ailments including Alzheimers, ADHD, Parkinson's, and Crohn's disease.
Since hitting a bottom near the 3 level in March 2005, the shares of ELN have rallied more than 800%, currently sitting atop the 27.25 level. The stock has been led higher on long-term support from its 10-month moving average, with pullbacks contained by its 50-month trendline. Should the security continue its trek higher, it may find resistance near the 30 neighborhood, site of its late-2004/early-2005 highs.
A Short Story
On to what caught my eye... Despite ELN's long-term uptrend, short sellers have been increasingly skeptical of the shares since August 2007. In fact, just since the latest reporting period, short interest has increased by more than 16.5% on ELN. According to the filter results, more than 5.69% of the stock's total float is now sold short. Should these bears get spooked into covering their bets, it would take nearly 6 trading days at the stock's average daily trading volume for these bets to unwind, leaving ample potential for a short-covering rally.
In parity with the skepticism in the short-selling arena is that in the near-term options realm. The stock's Schaeffer's put/call open interest ratio (SOIR) – measuring options slated to expire within 3 months – of 0.86 ranks in the 83rd annual percentile. In other words, near-term options speculators have been more bearishly aligned only 17% of the time during the past 52 weeks. However, it seems the bears are getting fewer, as the current ratio is lower than its former spot at 1.53 (in the 100th annual percentile) on May 6. Should the equity continue its uptrend, an unwinding of this skepticism could give the shares a boost.
The Street
Besides the aforementioned high short interest on ELN, the other primary tidbit that caught my eye was the sentiment on the Street. According to Zacks, 6 of the 7 ranking analysts rate ELN a "hold" or worse, regardless of its long-term trek higher. What's more, Thomson Financial reports that ELN's current 12-month price target stands at $21.48 – approximately 20% below the stock's current price.
As it stands, this bearish configuration leaves plenty of room for upgrades and/or price-target revisions – both possible catalysts to the upside.
The Bottom Line
Investors should keep an eye on the overhead 30 level, as this range capped the shares' trek higher a few years ago. ELN followers should also be aware of the skepticism surrounding the stock. Should the equity continue to inch higher, these bears – whether it be options players, analysts, or short sellers – may be inclined to change their tunes. Any reversal of sentiment toward the bulls' pen could spark additional buying pressure.
ELN msg # 231588 5/14/2008 4:20:50 PMBy: godivatruffles6
Schaeffers research - Short sellers, options players, and analysts remain bearish toward uptrending drug maker Elan (ELN)
http://www.schaeffersresearch.com/commentary/observations.as…
Short Interest Report: Despite an Uptrend, Elan Faces a Slew of Skeptics
Keywords: ELN stocks options
Playing with one of the awesome filters on SchaeffersResearch.com, I decided to check out some uptrending stocks with heavy short interest – a bullish implication from a contrarian standpoint. Delving through the results, I came across an equity that caught my eye: pharmaceutical firm Elan( ELN: View sentiment for elnsentiment, chart, options) .
To see how I utilized the filter, check out yesterday's edition of Short Interest Highlights, focusing on intelligent network infrastructure company VeriSign (VRSN).
The Stock
Elan is an Ireland-based biotechnology firm, manufacturing drugs targeting various ailments including Alzheimers, ADHD, Parkinson's, and Crohn's disease.
Since hitting a bottom near the 3 level in March 2005, the shares of ELN have rallied more than 800%, currently sitting atop the 27.25 level. The stock has been led higher on long-term support from its 10-month moving average, with pullbacks contained by its 50-month trendline. Should the security continue its trek higher, it may find resistance near the 30 neighborhood, site of its late-2004/early-2005 highs.
A Short Story
On to what caught my eye... Despite ELN's long-term uptrend, short sellers have been increasingly skeptical of the shares since August 2007. In fact, just since the latest reporting period, short interest has increased by more than 16.5% on ELN. According to the filter results, more than 5.69% of the stock's total float is now sold short. Should these bears get spooked into covering their bets, it would take nearly 6 trading days at the stock's average daily trading volume for these bets to unwind, leaving ample potential for a short-covering rally.
In parity with the skepticism in the short-selling arena is that in the near-term options realm. The stock's Schaeffer's put/call open interest ratio (SOIR) – measuring options slated to expire within 3 months – of 0.86 ranks in the 83rd annual percentile. In other words, near-term options speculators have been more bearishly aligned only 17% of the time during the past 52 weeks. However, it seems the bears are getting fewer, as the current ratio is lower than its former spot at 1.53 (in the 100th annual percentile) on May 6. Should the equity continue its uptrend, an unwinding of this skepticism could give the shares a boost.
The Street
Besides the aforementioned high short interest on ELN, the other primary tidbit that caught my eye was the sentiment on the Street. According to Zacks, 6 of the 7 ranking analysts rate ELN a "hold" or worse, regardless of its long-term trek higher. What's more, Thomson Financial reports that ELN's current 12-month price target stands at $21.48 – approximately 20% below the stock's current price.
As it stands, this bearish configuration leaves plenty of room for upgrades and/or price-target revisions – both possible catalysts to the upside.
The Bottom Line
Investors should keep an eye on the overhead 30 level, as this range capped the shares' trek higher a few years ago. ELN followers should also be aware of the skepticism surrounding the stock. Should the equity continue to inch higher, these bears – whether it be options players, analysts, or short sellers – may be inclined to change their tunes. Any reversal of sentiment toward the bulls' pen could spark additional buying pressure.
Davy and NCB
DAVY
Elan Corp (USc)
Enrolment for ELND005's Phase II trial is on target; FDA review of Maxipime continues, but is not hugely material
In its Q1 results, Transition Therapeutics has reported that enrolment in the Phase II study for ELND005, its oral AD candidate being developed with Elan, is ongoing and that its progress is on target. This is an 18-month, dose-ranging efficacy and safety study in 340 patients (from 65 North American sites) with mild to moderate AD. In April 2007, the FDA granted the drug candidate a fast-track designation.
Elan began its collaboration with Transition Therapeutics in September 2006. To date, $15m in milestone payments have been paid to Transition. Meanwhile, the FDA has revealed that its review of safety issues for Maxipime remains ongoing. In November 2007, the agency said that it had requested data from Maxipime’s manufacturer, Bristol Myers Squibb, so that it could complete a review of the drug’s safety profile. This had been expected to take four months, but not all data has yet been received by the FDA. A previous issue of Lancet Infectious Diseases had published a meta-analysis suggesting that Maxipime carried a higher relative mortality risk than other beta-lactam antibiotics. We do not view the issue as hugely material to Elan given that Maxipime is now genericised and is forecast to account for only 1.7% of forecast 2009 revenues.
http://www.rte.ie/business/2008/morningrep/download/0515davy…
NCB
Elan Corporation $27.33 BUY FDA Safety Review Of Maxipime Remains Ongoing
• In November 2007, the FDA initiated a safety review of Maxipime after an article in the May 2007 issue of The Lancet Infectious Diseases journal raised the question of increased risk of death in patients treated with the drug. The FDA requested additional data from Bristol Myers Squibb (the developer of the product) to further evaluate the safety profile of the product.
• It was expected that it would take c.4 months for the FDA to complete their safety review, however the agency yesterday announced that it had “not reached a definitive conclusion” as yet. Maxipime has been exposed to generic competition since Q2 2007 and Elan has now restructured its hospital salesforce. In Q1 2008 Maxipime revenues accounted for only c.4% of total revenues in the quarter.
Paraic Quinn +353 1 611 5863 paraic.quinn@ncb.ie
Orla Hartford PHD +353 1 611 5844 orla.hartford@ncb.ie
http://www.rte.ie/business/2008/morningrep/download/0515ncb.…
DAVY
Elan Corp (USc)
Enrolment for ELND005's Phase II trial is on target; FDA review of Maxipime continues, but is not hugely material
In its Q1 results, Transition Therapeutics has reported that enrolment in the Phase II study for ELND005, its oral AD candidate being developed with Elan, is ongoing and that its progress is on target. This is an 18-month, dose-ranging efficacy and safety study in 340 patients (from 65 North American sites) with mild to moderate AD. In April 2007, the FDA granted the drug candidate a fast-track designation.
Elan began its collaboration with Transition Therapeutics in September 2006. To date, $15m in milestone payments have been paid to Transition. Meanwhile, the FDA has revealed that its review of safety issues for Maxipime remains ongoing. In November 2007, the agency said that it had requested data from Maxipime’s manufacturer, Bristol Myers Squibb, so that it could complete a review of the drug’s safety profile. This had been expected to take four months, but not all data has yet been received by the FDA. A previous issue of Lancet Infectious Diseases had published a meta-analysis suggesting that Maxipime carried a higher relative mortality risk than other beta-lactam antibiotics. We do not view the issue as hugely material to Elan given that Maxipime is now genericised and is forecast to account for only 1.7% of forecast 2009 revenues.
http://www.rte.ie/business/2008/morningrep/download/0515davy…
NCB
Elan Corporation $27.33 BUY FDA Safety Review Of Maxipime Remains Ongoing
• In November 2007, the FDA initiated a safety review of Maxipime after an article in the May 2007 issue of The Lancet Infectious Diseases journal raised the question of increased risk of death in patients treated with the drug. The FDA requested additional data from Bristol Myers Squibb (the developer of the product) to further evaluate the safety profile of the product.
• It was expected that it would take c.4 months for the FDA to complete their safety review, however the agency yesterday announced that it had “not reached a definitive conclusion” as yet. Maxipime has been exposed to generic competition since Q2 2007 and Elan has now restructured its hospital salesforce. In Q1 2008 Maxipime revenues accounted for only c.4% of total revenues in the quarter.
Paraic Quinn +353 1 611 5863 paraic.quinn@ncb.ie
Orla Hartford PHD +353 1 611 5844 orla.hartford@ncb.ie
http://www.rte.ie/business/2008/morningrep/download/0515ncb.…
Antwort auf Beitrag Nr.: 34.098.170 von Birgit.Tersteegen am 15.05.08 10:23:47 - http://www.rte.ie/business/2008/morningrep/download/0515davy…
- http://www.rte.ie/business/2008/morningrep/download/0515ncb.…
- http://www.rte.ie/business/2008/morningrep/download/0515davy… - http://www.rte.ie/business/2008/morningrep/download/0515ncb.…
KM auf der Morgan Stanley Health Care Conference vor ein paar Wochen
“....when you see the Phase II results, you will understand why the move (to p3) was obvious.”
dazu als Kontrast CARIS & COMPANY:
08:44 ELN Elan initiated with a Sell (27.33 )
Caris initiates ELN with a Sell and $18 tgt. Firm says perception is everything, and when it comes to their ability to retain cognition as they age, the promise of a new treatment to help firm do so becomes an extremely important topic. With the long-awaited release of Phase II clinical results for ELN's Alzheimer's disease treatment, bapineuzumab, anticipated in June, the excitement has pushed ELN shares up to its 52-week high. Should the product fail to deliver strong Phase II results in June, firm believes the downside could be significantly more aggressive than our price target implies.
http://www.investorvillage.com/smbd.asp?mb=160&mn=231760&pt=…
“....when you see the Phase II results, you will understand why the move (to p3) was obvious.”
dazu als Kontrast CARIS & COMPANY:
08:44 ELN Elan initiated with a Sell (27.33 )
Caris initiates ELN with a Sell and $18 tgt. Firm says perception is everything, and when it comes to their ability to retain cognition as they age, the promise of a new treatment to help firm do so becomes an extremely important topic. With the long-awaited release of Phase II clinical results for ELN's Alzheimer's disease treatment, bapineuzumab, anticipated in June, the excitement has pushed ELN shares up to its 52-week high. Should the product fail to deliver strong Phase II results in June, firm believes the downside could be significantly more aggressive than our price target implies.
http://www.investorvillage.com/smbd.asp?mb=160&mn=231760&pt=…
Caris hört sich sowieso schon an wie Karies....und das produziert ja auch nur Löcher....
Antwort auf Beitrag Nr.: 34.101.418 von bernie55 am 15.05.08 15:43:08aktuell 27,29 USD
..na dann schauen wir mal, was die Jungs ( diesmal irgend ein CARIS-HEINZEL, den keiner kennt ) noch so versuchen , um den Kurs nach unten zu drücken.
Da scheinen einige von den SHORTIES langsam kalte Füße zu kriegen , zumal der Kurs in den letzten Tagen ganz schön hochging.
Ich bin mal gespannt, wann diese Nerverei endlich aufhört.
TIME WILL TELL
..na dann schauen wir mal, was die Jungs ( diesmal irgend ein CARIS-HEINZEL, den keiner kennt ) noch so versuchen , um den Kurs nach unten zu drücken.
Da scheinen einige von den SHORTIES langsam kalte Füße zu kriegen , zumal der Kurs in den letzten Tagen ganz schön hochging.
Ich bin mal gespannt, wann diese Nerverei endlich aufhört.
TIME WILL TELL
Antwort auf Beitrag Nr.: 34.101.614 von bernie55 am 15.05.08 15:57:24TIME WILL TELL
Will Tell ??? Meinst Du etwa Wilhelm Tell ??
Und wer verdammt ist TIME ?
Will Tell ??? Meinst Du etwa Wilhelm Tell ??
Und wer verdammt ist TIME ?
Antwort auf Beitrag Nr.: 34.101.690 von Holgus am 15.05.08 16:02:02..ist doch klar wie Kloßbrühe, Holger...
Time ( Kurzform von TIMY) will den Tell ( Kurzform TELLY ) > mit Haut und Haaren vernaschen <
Time ( Kurzform von TIMY) will den Tell ( Kurzform TELLY ) > mit Haut und Haaren vernaschen <
Betrifft unser Baby nur indirekt.
dpa-afx
HINTERGRUND: Gerüchte um Übernahmen wecken wieder Interesse an Biotechwerten
Freitag 16. Mai 2008, 07:00 Uhr
FRANKFURT (dpa-AFX) - Gerüchte um Übernahmen in der deutschen Biotechszene und die Hoffnung auf satte Kursgewinne haben das Interesse der Anleger an der lange vernachlässigten Branche wieder aufleben lassen. Die börsennotierten Biotech-Aktien reagieren seit Wochen mit teils heftigen Kursaufschlägen auf echte Nachrichten und gezielt gestreute Gerüchte. "Ich würde mir wünschen, dass Studienerfolge und nicht Gerüchte für Schlagzeilen sorgen", sagt Thomas Strüngmann, Aufsichtsratsmitglied bei MediGene (Xetra: 502090 - Nachrichten) und intimer Kenner der Pharma- und Biotechbranche im Gespräch mit der Finanz-Nachrichtenagentur dpa-AFX. Zeitweise mehr als 15 Prozent zogen die Papiere von MediGene am Mittwoch an, nachdem in Branchenkreisen über ein Interesse des weltgrößten Pharmakonzerns Pfizer an deutschen Biotech-Unternehmen und besonders an MediGene spekuliert wurde.
Pfizer (NYSE: PFE - Nachrichten) müsste für eine Übernahme von MediGene nach Ansicht aus Branchenkreisen wohl rund 400 Millionen Euro auf den Tisch legen. Bei einer Börsenkapitalisierung von zuletzt rund 211 Millionen Euro wäre dies ein Aufpreis von fast 100 Prozent. Analysiert man die Übernahmen der letzten 18 Monate, "werden für kleine Biotech-Firmen mit interessanter Pipeline Aufschläge von 100 Prozent und mehr bezahlt", sagt Christian Lach, Mitglied des Managementteams der auf Biotech-Werte spezialisierten BB BIOTECH (BIO.SW - Nachrichten) . 400 Millionen Euro könnte der Pharmakonzern, der 2007 einen Umsatz von 48,6 Milliarden Dollar verbuchte und mit dem Blutfettsenker Lipitor im gleichen Jahr knapp 13 Milliarden Dollar umsetzte, locker aus der Portokasse zahlen.
Analysten hatten Pfizer geraten, Übernahmen in einer Höhe von 15 Milliarden Dollar zu stemmen, um den Nachschub an neuen Medikamenten nach dem Patentablauf für Lipitor zu sichern. Lipitor ist das weltweit meistverkaufte Medikament und verliert in den USA 2012 seinen lukrativen Patentschutz. Pfizer präferiert derzeit eher kleinere Zukäufe und hat sich in jüngsten Zeit durch die Übernahme von Biotech-Gesellschaften verstärkt. "Große Übernahmen wie der Kauf von MedImmune (NASDAQ: MEDI - Nachrichten) durch AstraZeneca (London: AZN.L - Nachrichten) für mehr als 15 Milliarden Dollar sind in der Branche derzeit eher eine Seltenheit", so Biotech-Experte Lach. Vielmehr stelle man fest, dass Pharma-Firmen anstatt Mega-Deals selektiv kleine Transaktionen bevorzugen, mit besserem Chancen/Risiko-Profil. Der Trend gehe damit auch weg vom Outsourcing der Forschungs- und Entwicklungsaktivitäten, welche in der Vergangenheit den Grundstein für viele erfolgreiche Biotech-Firmen gelegt hätte.
MEDIGENE NICHT NUR FÜR PFIZER INTERESSANT
"MediGene ist mit dem Schwerpunkt Krebsforschung im Grunde für jeden größeren Pharmakonzern mit Aktivitäten auf dem Gebiet interessant", sagt Analyst Hanns Frohnmeyer von der Landesbank Baden-Württemberg. Ähnlich wie Lach hält Frohnmeyer bei einer nicht auszuschließenden Übernahme von MediGene einen Preis von 400 Millionen Euro nicht für unmöglich. "Seit 2007 wurden bei Übernahmen teilweise Aufschläge von 50 bis 150 Prozent auf den Aktienkurs gezahlt." Bei einer weiter steigenden Marktkapitalisierung und einem hohen Handelsvolumen wäre auch ein erneuter Einzug von MediGene in den TecDAX (Xetra: Nachrichten) möglich.
MediGene ist die einzige deutsche Biotechfirma, die mit dem Prostatamittel Eligard und der Genitalwarzensalbe Veregen bereits zwei Medikamente auf dem Markt hat. Unternehmenschef Peter Heinrich sieht die Aussichten auf eine Partnerschaft für das Krebsmittel Endotag durch die jüngsten Studien zur Behandlung von Bauchspeicheldrüsenkrebs deutlich gestärkt. "Mehrere führende Pharmaunternehmen haben bereits starkes Interesse angemeldet und Gespräche zur Zusammenarbeit bei Endotag begonnen", hatte Heinrich kürzlich ohne Verweis auf Pfizer gesagt. MediGene traut alleine dem Mittel Spitzenumsätze von mehr als einer Milliarde Euro zu. Eine Partnerschaft würde MediGene finanziellen Spielraum bringen: Ende März verfügte die Gesellschaft noch über Barmittel in Höhe von knapp 38 Millionen Euro.
Nach Ansicht der Biotech-Experten von Ernst&Young kommt die deutsche Biotech-Szene ungeachtet der Rückschläge bei GPC Biotech (Xetra: 585150 - Nachrichten) und Jerini (Xetra: 678747 - Nachrichten) gut voran. "Insgesamt ist die Zahl der Wirkstoffe in der Medikamentenentwicklung von 322 auf 316 gesunken. In der klinischen Prüfung - also in den Phasen I bis III- befinden sich aber derzeit mit 129 Wirkstoffen mehr Projekte als im Vorjahr die 124 des Vorjahres. Zudem sind aktuell sechs Wirkstoffe (VJ: 2) in der Zulassungsphase", erklärt die Autorin des Biotech-Reports 2008, Julia Schüler.
Die Branche ist nervös und so werden in den kommenden Tagen wohl erneut Übernahmegerüchte die Runde machen. Ein überzeugender Befreiungsschlag wäre jedoch für das Ansehen der Branche wünschenswerter als hypothetische Übernahmespiele wie die jüngsten um GPC Biotech und Wilex (Frankfurt: 661472 - Nachrichten) ./ep/he
--- Von Elke Pfeifer, dpa-AFX ---
http://de.biz.yahoo.com/16052008/36/hintergrund-geruechte-ue…
dpa-afx
HINTERGRUND: Gerüchte um Übernahmen wecken wieder Interesse an Biotechwerten
Freitag 16. Mai 2008, 07:00 Uhr
FRANKFURT (dpa-AFX) - Gerüchte um Übernahmen in der deutschen Biotechszene und die Hoffnung auf satte Kursgewinne haben das Interesse der Anleger an der lange vernachlässigten Branche wieder aufleben lassen. Die börsennotierten Biotech-Aktien reagieren seit Wochen mit teils heftigen Kursaufschlägen auf echte Nachrichten und gezielt gestreute Gerüchte. "Ich würde mir wünschen, dass Studienerfolge und nicht Gerüchte für Schlagzeilen sorgen", sagt Thomas Strüngmann, Aufsichtsratsmitglied bei MediGene (Xetra: 502090 - Nachrichten) und intimer Kenner der Pharma- und Biotechbranche im Gespräch mit der Finanz-Nachrichtenagentur dpa-AFX. Zeitweise mehr als 15 Prozent zogen die Papiere von MediGene am Mittwoch an, nachdem in Branchenkreisen über ein Interesse des weltgrößten Pharmakonzerns Pfizer an deutschen Biotech-Unternehmen und besonders an MediGene spekuliert wurde.
Pfizer (NYSE: PFE - Nachrichten) müsste für eine Übernahme von MediGene nach Ansicht aus Branchenkreisen wohl rund 400 Millionen Euro auf den Tisch legen. Bei einer Börsenkapitalisierung von zuletzt rund 211 Millionen Euro wäre dies ein Aufpreis von fast 100 Prozent. Analysiert man die Übernahmen der letzten 18 Monate, "werden für kleine Biotech-Firmen mit interessanter Pipeline Aufschläge von 100 Prozent und mehr bezahlt", sagt Christian Lach, Mitglied des Managementteams der auf Biotech-Werte spezialisierten BB BIOTECH (BIO.SW - Nachrichten) . 400 Millionen Euro könnte der Pharmakonzern, der 2007 einen Umsatz von 48,6 Milliarden Dollar verbuchte und mit dem Blutfettsenker Lipitor im gleichen Jahr knapp 13 Milliarden Dollar umsetzte, locker aus der Portokasse zahlen.
Analysten hatten Pfizer geraten, Übernahmen in einer Höhe von 15 Milliarden Dollar zu stemmen, um den Nachschub an neuen Medikamenten nach dem Patentablauf für Lipitor zu sichern. Lipitor ist das weltweit meistverkaufte Medikament und verliert in den USA 2012 seinen lukrativen Patentschutz. Pfizer präferiert derzeit eher kleinere Zukäufe und hat sich in jüngsten Zeit durch die Übernahme von Biotech-Gesellschaften verstärkt. "Große Übernahmen wie der Kauf von MedImmune (NASDAQ: MEDI - Nachrichten) durch AstraZeneca (London: AZN.L - Nachrichten) für mehr als 15 Milliarden Dollar sind in der Branche derzeit eher eine Seltenheit", so Biotech-Experte Lach. Vielmehr stelle man fest, dass Pharma-Firmen anstatt Mega-Deals selektiv kleine Transaktionen bevorzugen, mit besserem Chancen/Risiko-Profil. Der Trend gehe damit auch weg vom Outsourcing der Forschungs- und Entwicklungsaktivitäten, welche in der Vergangenheit den Grundstein für viele erfolgreiche Biotech-Firmen gelegt hätte.
MEDIGENE NICHT NUR FÜR PFIZER INTERESSANT
"MediGene ist mit dem Schwerpunkt Krebsforschung im Grunde für jeden größeren Pharmakonzern mit Aktivitäten auf dem Gebiet interessant", sagt Analyst Hanns Frohnmeyer von der Landesbank Baden-Württemberg. Ähnlich wie Lach hält Frohnmeyer bei einer nicht auszuschließenden Übernahme von MediGene einen Preis von 400 Millionen Euro nicht für unmöglich. "Seit 2007 wurden bei Übernahmen teilweise Aufschläge von 50 bis 150 Prozent auf den Aktienkurs gezahlt." Bei einer weiter steigenden Marktkapitalisierung und einem hohen Handelsvolumen wäre auch ein erneuter Einzug von MediGene in den TecDAX (Xetra: Nachrichten) möglich.
MediGene ist die einzige deutsche Biotechfirma, die mit dem Prostatamittel Eligard und der Genitalwarzensalbe Veregen bereits zwei Medikamente auf dem Markt hat. Unternehmenschef Peter Heinrich sieht die Aussichten auf eine Partnerschaft für das Krebsmittel Endotag durch die jüngsten Studien zur Behandlung von Bauchspeicheldrüsenkrebs deutlich gestärkt. "Mehrere führende Pharmaunternehmen haben bereits starkes Interesse angemeldet und Gespräche zur Zusammenarbeit bei Endotag begonnen", hatte Heinrich kürzlich ohne Verweis auf Pfizer gesagt. MediGene traut alleine dem Mittel Spitzenumsätze von mehr als einer Milliarde Euro zu. Eine Partnerschaft würde MediGene finanziellen Spielraum bringen: Ende März verfügte die Gesellschaft noch über Barmittel in Höhe von knapp 38 Millionen Euro.
Nach Ansicht der Biotech-Experten von Ernst&Young kommt die deutsche Biotech-Szene ungeachtet der Rückschläge bei GPC Biotech (Xetra: 585150 - Nachrichten) und Jerini (Xetra: 678747 - Nachrichten) gut voran. "Insgesamt ist die Zahl der Wirkstoffe in der Medikamentenentwicklung von 322 auf 316 gesunken. In der klinischen Prüfung - also in den Phasen I bis III- befinden sich aber derzeit mit 129 Wirkstoffen mehr Projekte als im Vorjahr die 124 des Vorjahres. Zudem sind aktuell sechs Wirkstoffe (VJ: 2) in der Zulassungsphase", erklärt die Autorin des Biotech-Reports 2008, Julia Schüler.
Die Branche ist nervös und so werden in den kommenden Tagen wohl erneut Übernahmegerüchte die Runde machen. Ein überzeugender Befreiungsschlag wäre jedoch für das Ansehen der Branche wünschenswerter als hypothetische Übernahmespiele wie die jüngsten um GPC Biotech und Wilex (Frankfurt: 661472 - Nachrichten) ./ep/he
--- Von Elke Pfeifer, dpa-AFX ---
http://de.biz.yahoo.com/16052008/36/hintergrund-geruechte-ue…
Antwort auf Beitrag Nr.: 34.108.089 von Poppholz am 16.05.08 10:36:17Betrifft unser Baby nur indirekt.
Die Afterhours-Kurse aber nicht
17:55 $ 27.50 635
16:47 $ 27.25 100
16:43 $ 27.25 100
16:41 $ 27.45 60.000
16:23 $ 27.25 100
16:23 $ 27.25 200
16:01 $ 27.50 17.520
Die Afterhours-Kurse aber nicht
17:55 $ 27.50 635
16:47 $ 27.25 100
16:43 $ 27.25 100
16:41 $ 27.45 60.000
16:23 $ 27.25 100
16:23 $ 27.25 200
16:01 $ 27.50 17.520
Hier schreibt ridge 303 im IV Board über SternTV - hier war TYSABRI ein BIG Thema:
Lots of advertising for TY on German TV -SternTV
Hello my IV friends,
After I have been "under the weather" a bit for the last week,
I started going through some ms boards again.
Of course, the first thread I look into, has the title "Natalizumab".
MS patients are talking about an interview re. MS on RTL`s famous "SternTV" program hosted by Germany`s best liked moderator Günther Jauch, on Wed. night.
Big promotion for Tysabri :
ie. " ... people on Tysabri " are able to dance again "
So, shortly after Biogen had been put down as an illegal pharma player re advertising on another channel, we have G. Jauch talking about Tysabri ....
this is super fantastic - IMO -
http://www.stern.de/tv/
http://www.stern.de/tv/sterntv/620251.html?aid=47&start=40" target="_blank" rel="nofollow ugc noopener">http://www.stern.de/tv/
http://www.stern.de/tv/sterntv/620251.html?aid=47&start=40
I have linked this post to my last one, in case people have missed the video
during which TY was the only med shown by brand name,
whereas all other meds were covered.
Seems like advertising for the best MS treatment is kicking in here !
http://www.investorvillage.com/smbd.asp?mb=160&mn=232175&pt=…
Lots of advertising for TY on German TV -SternTV
Hello my IV friends,
After I have been "under the weather" a bit for the last week,
I started going through some ms boards again.
Of course, the first thread I look into, has the title "Natalizumab".
MS patients are talking about an interview re. MS on RTL`s famous "SternTV" program hosted by Germany`s best liked moderator Günther Jauch, on Wed. night.
Big promotion for Tysabri :
ie. " ... people on Tysabri " are able to dance again "
So, shortly after Biogen had been put down as an illegal pharma player re advertising on another channel, we have G. Jauch talking about Tysabri ....
this is super fantastic - IMO -
http://www.stern.de/tv/
http://www.stern.de/tv/sterntv/620251.html?aid=47&start=40" target="_blank" rel="nofollow ugc noopener">http://www.stern.de/tv/
http://www.stern.de/tv/sterntv/620251.html?aid=47&start=40
I have linked this post to my last one, in case people have missed the video
during which TY was the only med shown by brand name,
whereas all other meds were covered.
Seems like advertising for the best MS treatment is kicking in here !
http://www.investorvillage.com/smbd.asp?mb=160&mn=232175&pt=…
Hi Jungs!
nach viel Kultur + Natur am WE nun wieder zu unserem Schätzchen....
Die nächste Zeit wird spannend!! Grüsse!
ELN msg # 232622 5/18/2008 11:20:30 AM
By: Creedster_99
Institutions...who has what...
Interesting to look at the market cap of total investments for our top ten holders and then to see what % of their money is invested in Elan and what position Elan is among all of the stocks they own...
1. Fidelity...71.5M shares....$621B under mgmt...Elan is their 64th largest holding out of 3,224 positions
2. Wellington ....43M shares...$296B managed....Elan is their 65th largest holding out of 2,176 positions
3.Capital World Investors (Prev Cap Res Mgmt)....20.8M shares (Just added 5.9M last Q)....$333B...Elan is 137th out of 616 positions
4.Westfield....17.6M shares...$11B under mgmt...Elan is their LARGEST POSITION out of 312 stocks
5. Jennison...14.8 M shares....$61B managed...Elan is their 48th largest holding out of 597 positions
6.T. Rowe Price....13.1M shares....$253B managed...Elan is their 190th largest position out of 2,210 positions
7.Tudor.....9.2 M shares (as of 12/31/07)...$5B managed...Elan is their 4th largest position out of 140
8. Bank of Ireland.....7.5M shares (almost all added last Q)....$4.2B managed...Elan is their SECOND largest position
9. Invus....7.2 M shares....$0.58B managed...Elan is their LARGEST HOLDING REPRESENTING ALMOST 30% OF THE ENTIRE FUND!
10. CR Intrinsic.....7M shares...$2.3B managed...Elan is their second largest position representing almost 10% of the fund
11.SAC Capital advisors....5.9 M shares...$9B managed...Elan is their 3rd largest holding out of 1,790 positions!!!
12. Oracle Investments...5.5M shares...$0.8B managed...Elan is their LARGEST POSITION representing 20+% of the entire fund! (WYE is 2nd lagest position...but Elan's weighting is almost twice that of any other stock!)
http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…
If you look at these companies and their positions, they either represent very large funds who prudently are along for the ride...or very small companies who have bet the farm along with the other Koolaid drinkers here.....Let's see who wins
nach viel Kultur + Natur am WE nun wieder zu unserem Schätzchen....
Die nächste Zeit wird spannend!! Grüsse!
ELN msg # 232622 5/18/2008 11:20:30 AMBy: Creedster_99
Institutions...who has what...
Interesting to look at the market cap of total investments for our top ten holders and then to see what % of their money is invested in Elan and what position Elan is among all of the stocks they own...
1. Fidelity...71.5M shares....$621B under mgmt...Elan is their 64th largest holding out of 3,224 positions
2. Wellington ....43M shares...$296B managed....Elan is their 65th largest holding out of 2,176 positions
3.Capital World Investors (Prev Cap Res Mgmt)....20.8M shares (Just added 5.9M last Q)....$333B...Elan is 137th out of 616 positions
4.Westfield....17.6M shares...$11B under mgmt...Elan is their LARGEST POSITION out of 312 stocks
5. Jennison...14.8 M shares....$61B managed...Elan is their 48th largest holding out of 597 positions
6.T. Rowe Price....13.1M shares....$253B managed...Elan is their 190th largest position out of 2,210 positions
7.Tudor.....9.2 M shares (as of 12/31/07)...$5B managed...Elan is their 4th largest position out of 140
8. Bank of Ireland.....7.5M shares (almost all added last Q)....$4.2B managed...Elan is their SECOND largest position
9. Invus....7.2 M shares....$0.58B managed...Elan is their LARGEST HOLDING REPRESENTING ALMOST 30% OF THE ENTIRE FUND!
10. CR Intrinsic.....7M shares...$2.3B managed...Elan is their second largest position representing almost 10% of the fund
11.SAC Capital advisors....5.9 M shares...$9B managed...Elan is their 3rd largest holding out of 1,790 positions!!!
12. Oracle Investments...5.5M shares...$0.8B managed...Elan is their LARGEST POSITION representing 20+% of the entire fund! (WYE is 2nd lagest position...but Elan's weighting is almost twice that of any other stock!)
http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…
If you look at these companies and their positions, they either represent very large funds who prudently are along for the ride...or very small companies who have bet the farm along with the other Koolaid drinkers here.....Let's see who wins
Intellect Neuroscience Press release With Elan And Wyeth
Press Release Source: Intellect Neurosciences, Inc.
Intellect Neurosciences, Inc. Grants License for Certain Patents and Patent Applications to Wyeth and Elan Pharma International Ltd.
Monday May 19, 7:45 am ET
NEW YORK, May 19 /PRNewswire-FirstCall/ -- Intellect Neurosciences, Inc. (OTC Bulletin Board: ILNS - News), a biopharmaceutical company focused on development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease (AD), announced today that it has entered into a license agreement with Wyeth (NYSE: WYE - News) and Elan Pharma International Ltd. ("Elan") regarding certain of Intellect's patents and patent applications related to antibodies and methods of treatment for Alzheimer's disease. Under the terms of the agreement, Wyeth and Elan may pay Intellect potential future milestone payments and royalties based on sales of potential products, if it is determined that they are covered by patents that issue from Intellect's patent applications.
Dr. Chain, Intellect's Chairman and CEO and inventor of the licensed patents and patent applications, commented: "We are delighted to enter into this licensing agreement, which provides Intellect a share in the future success of potential Wyeth and Elan products while we continue to develop our proprietary monoclonal antibodies for the treatment of AD."
http://biz.yahoo.com/prnews/080519/nym019.html?.v=101
Press Release Source: Intellect Neurosciences, Inc.
Intellect Neurosciences, Inc. Grants License for Certain Patents and Patent Applications to Wyeth and Elan Pharma International Ltd.
Monday May 19, 7:45 am ET
NEW YORK, May 19 /PRNewswire-FirstCall/ -- Intellect Neurosciences, Inc. (OTC Bulletin Board: ILNS - News), a biopharmaceutical company focused on development of disease-modifying therapeutic agents for the treatment and prevention of Alzheimer's disease (AD), announced today that it has entered into a license agreement with Wyeth (NYSE: WYE - News) and Elan Pharma International Ltd. ("Elan") regarding certain of Intellect's patents and patent applications related to antibodies and methods of treatment for Alzheimer's disease. Under the terms of the agreement, Wyeth and Elan may pay Intellect potential future milestone payments and royalties based on sales of potential products, if it is determined that they are covered by patents that issue from Intellect's patent applications.
Dr. Chain, Intellect's Chairman and CEO and inventor of the licensed patents and patent applications, commented: "We are delighted to enter into this licensing agreement, which provides Intellect a share in the future success of potential Wyeth and Elan products while we continue to develop our proprietary monoclonal antibodies for the treatment of AD."
http://biz.yahoo.com/prnews/080519/nym019.html?.v=101
Elan "underweight," target price raised
10:22a.m. - Lehman Brothers
NEW YORK, May 19 (newratings.com) - Analysts at Lehman Brothers reiterate their "underweight" rating on Elan Corp (ELN).
The target price has been raised from $16 to $19.
10:22a.m. - Lehman Brothers
NEW YORK, May 19 (newratings.com) - Analysts at Lehman Brothers reiterate their "underweight" rating on Elan Corp (ELN).
The target price has been raised from $16 to $19.
Antwort auf Beitrag Nr.: 34.126.502 von bernie55 am 19.05.08 17:32:49http://www.newratings.com/en/main/company_headline.m?id=1748…
.....Fieslinge,Spielverderber
Sie haben aber nur kurze "Halbwehrzeit"...
Sie haben aber nur kurze "Halbwehrzeit"...
Antwort auf Beitrag Nr.: 34.136.536 von GuHu1 am 20.05.08 19:41:32tja---die Chance der Shorties---ich schätze,ab Morgen gehts wieder in die andere Richtung...I HOPE SO!
Antwort auf Beitrag Nr.: 34.136.536 von GuHu1 am 20.05.08 19:41:32!Ab Morgen up...< (Und Wo spinnt auch....!!
!Ab Morgen up...< (Und Wo spinnt auch....!!
Antwort auf Beitrag Nr.: 34.136.601 von Birgit.Tersteegen am 20.05.08 19:47:13I HOPE SO!
Hope Hope Reiter, wenn Elan fällt, dann schreit er
Hope Hope Reiter, wenn Elan fällt, dann schreit er
Antwort auf Beitrag Nr.: 34.136.853 von Holgus am 20.05.08 20:18:08!
!
GRÜN
GRÜN
GRÜN
GRÜN
GRÜN
GRÜN
GRÜN
Was ein bißchen verwundert ist das hohe Volumen die letzten beiden Tage in den USA.
Entweder ist da was im Busch oder da ist nix im Busch.
Oder soll ich lieber Obama sagen ? Ich sag Busch.
Is aber auch egal, rasiert is eh schöner ... lol
Entweder ist da was im Busch oder da ist nix im Busch.
Oder soll ich lieber Obama sagen ? Ich sag Busch.
Is aber auch egal, rasiert is eh schöner ... lol
ELN msg # 233773 5/21/2008 4:21:02 AM
By: Shanaflid
Goodbodys this morning
Elan (Add, Closing Price $25.27); AAB-001 update whetting the appetite.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Elan yesterday reiterated that the AAB-001 Phase II data will be out in mid-year and that within that data it is looking for confirmation that the drug works, in terms of its clinical and biological effect and safety. Hitting statistical significance for trial endpoints was considered very unrealistic, given the size of the patient population - 240 patients, half on placebo, the remaining 120 in one of three treatment arms. Management noted that when the market sees the Phase II data it will be clear why the drug was moved into Phase III. It also stated that to be "compelling" at the interim look, implied that the data gave enough information to design the Phase III trial, plus unequivocal evidence that it could indeed move into Phase III. Management noted that in clinical terms, the data would probably not be as "binary" as the market is suggesting and that the majority of observers are only looking for evidence of trend/line separation in the data (i.e. when plotted over time, the patient assessment scores show a divergence between treatments and placebo). Whether this is statistically significant or not is another matter. The 30-patient MRI imaging study is on-going, with no data available until the end of 2008 or early 2009. On filing strategy, the company reiterated that guidelines indicate that data from 1,000 patients would be required to provide an adequate safety profile and that whatever the strength of the Phase II data, the 240 patients in the Phase II trial would not be enough. Management stated that it will not communicate the filing strategy to be used until it and partner Wyeth have discussed the issue with the FDA, a process that could take "months". On AAB-001 commercial production, in the contract between the partners, Elan is accountable for production and how it will be done. In reality, both parties will produce the drug, with Wyeth responsible for the initial production, as Elan looks to develop a new production system, build a facility in Ireland and have the process validated and the production facility certified by the relevant authorities. There was nothing new from Elan, but the refresher continues to whet the appetite for the headline data in mid-year and sight of the actual data at ICAD, which this year is in Chicago from the 26th to the 31st of July.
By: Shanaflid
Goodbodys this morning
Elan (Add, Closing Price $25.27); AAB-001 update whetting the appetite.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Elan yesterday reiterated that the AAB-001 Phase II data will be out in mid-year and that within that data it is looking for confirmation that the drug works, in terms of its clinical and biological effect and safety. Hitting statistical significance for trial endpoints was considered very unrealistic, given the size of the patient population - 240 patients, half on placebo, the remaining 120 in one of three treatment arms. Management noted that when the market sees the Phase II data it will be clear why the drug was moved into Phase III. It also stated that to be "compelling" at the interim look, implied that the data gave enough information to design the Phase III trial, plus unequivocal evidence that it could indeed move into Phase III. Management noted that in clinical terms, the data would probably not be as "binary" as the market is suggesting and that the majority of observers are only looking for evidence of trend/line separation in the data (i.e. when plotted over time, the patient assessment scores show a divergence between treatments and placebo). Whether this is statistically significant or not is another matter. The 30-patient MRI imaging study is on-going, with no data available until the end of 2008 or early 2009. On filing strategy, the company reiterated that guidelines indicate that data from 1,000 patients would be required to provide an adequate safety profile and that whatever the strength of the Phase II data, the 240 patients in the Phase II trial would not be enough. Management stated that it will not communicate the filing strategy to be used until it and partner Wyeth have discussed the issue with the FDA, a process that could take "months". On AAB-001 commercial production, in the contract between the partners, Elan is accountable for production and how it will be done. In reality, both parties will produce the drug, with Wyeth responsible for the initial production, as Elan looks to develop a new production system, build a facility in Ireland and have the process validated and the production facility certified by the relevant authorities. There was nothing new from Elan, but the refresher continues to whet the appetite for the headline data in mid-year and sight of the actual data at ICAD, which this year is in Chicago from the 26th to the 31st of July.
ELN msg # 233769 5/21/2008 3:29:01 AM
By: beechlawn0202
Davy
Elan Corp (USc)
ELN US
Confident tone to management comments ahead of AGM
Jack Gorman
Price $25.27 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
Further discussions with Elan's senior management team ahead of the AGM on Thursday May 22nd indicated a continued strong level of confidence in the prospects for its AD pipeline, and in particular Bapineuzumab.
Although nothing new was divulged, several key messages were reiterated. On Bapineuzumab, the company stressed that upcoming Phase II data should make it clear why Elan/Wyeth chose an accelerated path to Phase III. This would imply clear clinical evidence that the drug worked, alongside a safety record that is consistent with what is known to date.
The FDA has made it clear that for ultimate approval, efficacy must be demonstrated on a cognitive and functional endpoint. However, the agency is indifferent to whether NTB or ADAS-Cog is used as the cognitive endpoint and on DAD or CDR-SoB as the functional endpoint. The Phase II data will be interpreted in this light despite recent speculation in the market on the merits of each measurement scale.
Management estimates that finalising its filing strategy on Bapineuzumab will take a number of months given a desire to share the full detail of Phase II with regulators. The requirement for safety data on at least 1,000 patients (for a minimum of six months but more likely 12) means that Phase II cannot be filed solely (as we knew).
On AD pricing, Elan intends to set prices so that broad, deep penetration of the market can be achieved (we would read this as lower than conventional biotech pricing). This is also influenced by the fact that the company has a franchise of potential AD products that follow beyond Bapineuzumab.
Some time was also spent on manufacturing strategy. Employing the latest single-use process technology, where cylindrical disposable bags may be used instead of stainless steel bioreactors, could offer Elan a much more cost-effective and flexible solution than the first and second-generation technologies in use today. Cell line technology improvements are also allowing companies to increase production yield, even at relatively low volumes. We would expect Elan to talk in more detail about its specific plans as the year progresses, but this certainly sounds like a less costly undertaking for the company.
Elsewhere, management reiterated that 100,000 patients on Tysabri is an achievable target for 2010 and that this assumption is based on no expansions to the current label. That only 55% of US neurologists have prescribed the drug leaves scope for further growth off current levels. Finally on EDT, although revenues can be lumpy due to milestones (+) and generics (-), Elan remains confident of achieving double-digit growth over the short to medium term.
By: beechlawn0202
Davy
Elan Corp (USc)
ELN US
Confident tone to management comments ahead of AGM
Jack Gorman
Price $25.27 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
Further discussions with Elan's senior management team ahead of the AGM on Thursday May 22nd indicated a continued strong level of confidence in the prospects for its AD pipeline, and in particular Bapineuzumab.
Although nothing new was divulged, several key messages were reiterated. On Bapineuzumab, the company stressed that upcoming Phase II data should make it clear why Elan/Wyeth chose an accelerated path to Phase III. This would imply clear clinical evidence that the drug worked, alongside a safety record that is consistent with what is known to date.
The FDA has made it clear that for ultimate approval, efficacy must be demonstrated on a cognitive and functional endpoint. However, the agency is indifferent to whether NTB or ADAS-Cog is used as the cognitive endpoint and on DAD or CDR-SoB as the functional endpoint. The Phase II data will be interpreted in this light despite recent speculation in the market on the merits of each measurement scale.
Management estimates that finalising its filing strategy on Bapineuzumab will take a number of months given a desire to share the full detail of Phase II with regulators. The requirement for safety data on at least 1,000 patients (for a minimum of six months but more likely 12) means that Phase II cannot be filed solely (as we knew).
On AD pricing, Elan intends to set prices so that broad, deep penetration of the market can be achieved (we would read this as lower than conventional biotech pricing). This is also influenced by the fact that the company has a franchise of potential AD products that follow beyond Bapineuzumab.
Some time was also spent on manufacturing strategy. Employing the latest single-use process technology, where cylindrical disposable bags may be used instead of stainless steel bioreactors, could offer Elan a much more cost-effective and flexible solution than the first and second-generation technologies in use today. Cell line technology improvements are also allowing companies to increase production yield, even at relatively low volumes. We would expect Elan to talk in more detail about its specific plans as the year progresses, but this certainly sounds like a less costly undertaking for the company.
Elsewhere, management reiterated that 100,000 patients on Tysabri is an achievable target for 2010 and that this assumption is based on no expansions to the current label. That only 55% of US neurologists have prescribed the drug leaves scope for further growth off current levels. Finally on EDT, although revenues can be lumpy due to milestones (+) and generics (-), Elan remains confident of achieving double-digit growth over the short to medium term.
ELN msg # 234463 5/22/2008 11:35:48 AMBy: stockhound4
Some Of The Things I Heard Today
Ms market is roughly 33% under reported and growing at a very significant rate so there is even larger market potential then what was originally estimated by both the company and the “ANAL”ists.
Tysabri uptake continues to accelerate we added 5,100 or 392 patients per week in Q4 2007 so Q1 numbers will be better.
Just under 3,000 doctors in the US are Touch Enrolled.
Elan un-partnered small molecule Gamma Secretase program to enter the clinic before year end.
Tysabri Multiple Myeloma trial to begin in the very near future.
ELND-005 Second Phase II trial for Early AD (A new Indication) is to start in the 2nd half of 2008.
2009 will show profitability by years end but we will have a net loss for the full year.
The Tysabri MS franchise is now fully profitable.
The Tysabri Crohn’s franchise will not be profitable for 18 months after launch.
Company is targeting 25% market share by year end 2010.
Tysabri for UC is moving forward.
Abraxis trial starts in the next 1-2 weeks and we feel we have a very serious and substantial case in our favor. If we were to loose we will appeal to a higher court.
Elan Biologics manufacturing plans have continued behind the scenes and Elan and Wyeths mfg plans will be shared after the phase II data is released.
We also have mfg plans with Wyeth for other programs and follow on programs.
Lilly Secretase program we can opt into at any time but feel that we should have some sort of agreement in place by the end of Q1 2009.
EDT is projected to have 15 – 20% growth for the next several years.
ACC-001 Data has been submitted to the FDA to restart the trial and should be back on track and restarted in the very near future.
We are the foremost company in the science, IP, Clinical activity and research experience in ALZ in the world.
ELND-002 Small VLA-4 Inhibitor for MS is hoped to show similar efficacy as the biologic (Tysabri) and is safer (ie no PML risk) and is in the clinic.
ELND-002 Small VLA-4 Inhibitor for Multiple Myeloma which is safer than Tysabri (ie no PML risk) and is in the clinic.
Thes eare just a few things I heard today.
Hound
Elan --- new members of board of directors
Elan Announces Changes in Board of Directors
Elan Corporation, plc (NYSE: ELN) today announced the appointments of Mr. Patrick Kennedy and Mr. Donal O’Connor, and the retirement of Mr. Laurence Crowley, as non-executive directors of the company, effective as of May 22, 2008. Mr. Kyran McLaughlin, Chairman of Elan, said, "We are delighted to welcome Mr. Kennedy and Mr. O’Connor to the Board of Elan. Their experience and enthusiasm for the Company and its objectives will add greatly to the operations of our Board.” Mr. McLaughlin continued, "On behalf of the full Board of Directors, we also would like to thank Mr. Crowley for his outstanding contributions and dedicated service as a member of the Board over the past 12 years. We wish him all the best in his future endeavors.” Board Appointments: Mr. Patrick Kennedy (39) is Chief Executive of Paddy Power plc, an international betting and gaming group listed on both the London and Irish Stock Exchanges. Mr. Kennedy was previously Chief Financial Officer of Greencore Group plc and prior to that worked with McKinsey & Company and KPMG. Mr. Kennedy is a graduate of University College Dublin and a Fellow of the Institute of Chartered Accountants in Ireland. Mr. Donal O’Connor (57) was a Senior Partner of PricewaterhouseCoopers in Ireland from 1995 until 2007. He is a member of the PricewaterhouseCoopers Global Board and a former Chairman of the Eurofirms Board. He is chairman of the Dublin Docks Development Authority, a member of the board of the Irish Auditing and Accounting Supervisory Authority and the Administrator of Icarom plc. He is a graduate of University College Dublin and a Fellow of the Institute of Chartered Accountants in Ireland. About Elan Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.
© Die Welt
erschienen am 22.05.2008 um 20:30 Uhr
Elan Announces Changes in Board of Directors
Elan Corporation, plc (NYSE: ELN) today announced the appointments of Mr. Patrick Kennedy and Mr. Donal O’Connor, and the retirement of Mr. Laurence Crowley, as non-executive directors of the company, effective as of May 22, 2008. Mr. Kyran McLaughlin, Chairman of Elan, said, "We are delighted to welcome Mr. Kennedy and Mr. O’Connor to the Board of Elan. Their experience and enthusiasm for the Company and its objectives will add greatly to the operations of our Board.” Mr. McLaughlin continued, "On behalf of the full Board of Directors, we also would like to thank Mr. Crowley for his outstanding contributions and dedicated service as a member of the Board over the past 12 years. We wish him all the best in his future endeavors.” Board Appointments: Mr. Patrick Kennedy (39) is Chief Executive of Paddy Power plc, an international betting and gaming group listed on both the London and Irish Stock Exchanges. Mr. Kennedy was previously Chief Financial Officer of Greencore Group plc and prior to that worked with McKinsey & Company and KPMG. Mr. Kennedy is a graduate of University College Dublin and a Fellow of the Institute of Chartered Accountants in Ireland. Mr. Donal O’Connor (57) was a Senior Partner of PricewaterhouseCoopers in Ireland from 1995 until 2007. He is a member of the PricewaterhouseCoopers Global Board and a former Chairman of the Eurofirms Board. He is chairman of the Dublin Docks Development Authority, a member of the board of the Irish Auditing and Accounting Supervisory Authority and the Administrator of Icarom plc. He is a graduate of University College Dublin and a Fellow of the Institute of Chartered Accountants in Ireland. About Elan Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.
© Die Welt
erschienen am 22.05.2008 um 20:30 Uhr
http://business.timesonline.co.uk/tol/business/economics/art…Elan speeds up demerger
ELAN, the pharmaceutical company, is stepping up plans to demerge its drug-technology division as a separate listed entity worth up to $1.5 billion (£760,000) this year.
The drugs firm will wait until after publishing phase II data on its Alzheimer’s research in July before making a final decision on the scheme. Sources close to the company said a special team had been set up to prepare the demerger of the business, called Elan Drug Technologies (EDT), and float it in New York as well as London or Dublin. Shane Cooke, Elan’s chief financial officer and head of EDT, is expected to lead the new company.
Elan has also had a number of inquiries from potential trade and private-equity buyers about EDT, but has received no firm offers yet.
Antwort auf Beitrag Nr.: 34.166.723 von Birgit.Tersteegen am 25.05.08 11:27:43Elan Drug Technologies (EDT),
Also mir ist jetzt nicht ganz klar, was darunter zu verstehen ist. Ich vermute mal, daß es sich hier um Technologien zur Entwicklungen von Arzneien und nicht um bestimmte Medikamente handelt.(?)
Also mir ist jetzt nicht ganz klar, was darunter zu verstehen ist. Ich vermute mal, daß es sich hier um Technologien zur Entwicklungen von Arzneien und nicht um bestimmte Medikamente handelt.(?)
Elan (Add, Closing Price $24.85); Speculation on the future of EDT continues.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Speculation continued in the press over the weekend that Elan Drug Technology (EDT) division would be either sold off or spun out in an IPO, with various reports valuing the new entity at up to $1.5bn. As we noted last week after the pre-AGM briefing, EDT was presented as a profitable business within Elan, which although with considerable potential fro growth, could be eclipsed by the biotech side of the business, should Tysabri reach full potential and AAB-001 come to market against Alzheimer’s with a better profile than drugs already on the market. As such,management is keeping its options open and has noted that there could be a point where the progress of both businesses might be better served if they were run separately. We currently value EDT in the $1.1bn to $1.4bn range. Monies generated from any sale or spin-off could be used to fund Elan’s proposed development of manufacturing facilities for AAB-001, although any such plans depend on the quality of AAB-001 Phase II data, due to be released by “mid-year”.
http://www.investorvillage.com/smbd.asp?mb=160&mn=235178&pt=…
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Speculation continued in the press over the weekend that Elan Drug Technology (EDT) division would be either sold off or spun out in an IPO, with various reports valuing the new entity at up to $1.5bn. As we noted last week after the pre-AGM briefing, EDT was presented as a profitable business within Elan, which although with considerable potential fro growth, could be eclipsed by the biotech side of the business, should Tysabri reach full potential and AAB-001 come to market against Alzheimer’s with a better profile than drugs already on the market. As such,management is keeping its options open and has noted that there could be a point where the progress of both businesses might be better served if they were run separately. We currently value EDT in the $1.1bn to $1.4bn range. Monies generated from any sale or spin-off could be used to fund Elan’s proposed development of manufacturing facilities for AAB-001, although any such plans depend on the quality of AAB-001 Phase II data, due to be released by “mid-year”.
http://www.investorvillage.com/smbd.asp?mb=160&mn=235178&pt=…
Elan (Add, Closing Price $24.85);
Novartis interferon drug approved to treat MS in the EU.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Novartis this morning announced that it has gained EU approval to market Extavia for the treatment of early and relapse-remitting MS. Extavia is the Novartis version of interferon beta- 1b, an established drug that is already prescribed for 700,000 MS patients under the Avonex (Biogen Idec), Rebif (Merck Serono) and Betaseron (Bayer Schering) brand names. It is actually
the same molecule as Betaseron. Novartis gained rights to its own branded version in an agreement with Bayer-Schering. The company plans to launch the drug in the US and Europe in the first half of 2009. Novartis also confirmed that it plans to file for the approval of FTY720 (Fingolimod) “by the end of 2009”. The approval of Extavia in the EU will have no impact on Tysabri sales. As it is the same as drugs already on the market, it will compete with them for market share, rather than Tysabri. Tysabri recorded global sales of $159.7m in Q108, which we forecast will rise to $195.4m in Q208 and total $867.1m for FY08.
http://www.investorvillage.com/smbd.asp?mb=160&mn=235177&pt=…
Novartis interferon drug approved to treat MS in the EU.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Novartis this morning announced that it has gained EU approval to market Extavia for the treatment of early and relapse-remitting MS. Extavia is the Novartis version of interferon beta- 1b, an established drug that is already prescribed for 700,000 MS patients under the Avonex (Biogen Idec), Rebif (Merck Serono) and Betaseron (Bayer Schering) brand names. It is actually
the same molecule as Betaseron. Novartis gained rights to its own branded version in an agreement with Bayer-Schering. The company plans to launch the drug in the US and Europe in the first half of 2009. Novartis also confirmed that it plans to file for the approval of FTY720 (Fingolimod) “by the end of 2009”. The approval of Extavia in the EU will have no impact on Tysabri sales. As it is the same as drugs already on the market, it will compete with them for market share, rather than Tysabri. Tysabri recorded global sales of $159.7m in Q108, which we forecast will rise to $195.4m in Q208 and total $867.1m for FY08.
http://www.investorvillage.com/smbd.asp?mb=160&mn=235177&pt=…
Antwort auf Beitrag Nr.: 34.171.549 von bernie55 am 26.05.08 13:41:49EDT was presented as a profitable business within Elan, which although with considerable potential fro growth,
could be eclipsed by the biotech side of the business,
OK, das macht es klar.
should Tysabri reach full potential and AAB-001 come to market against Alzheimer’s with a better profile than drugs already on the market.
Das hoffen wir doch alle sehr.
could be eclipsed by the biotech side of the business,
OK, das macht es klar.
should Tysabri reach full potential and AAB-001 come to market against Alzheimer’s with a better profile than drugs already on the market.
Das hoffen wir doch alle sehr.
Antwort auf Beitrag Nr.: 34.166.876 von Henrig am 25.05.08 12:05:57Bei Elans Drug Technology geht es um verschiedene Technologien, mit welchen die physikalischen Eigenschaften von Aktivsubstanzen derart modifiziert werden, dass beispielsweise die Bioverfügbarkeit von wasserunlöslichen Wirkstoffen drastisch erhöht wird. Das Potential ist auch deswegen riesig, da man sich mit derartigen Verfahren gegenüber generischen Anbietern abgrenzen kann und über eine verbesserte Produkteigenschaft einen Wettbewerbsvorteil gegenüber generischen Anbietern erzielen kann. Gerade in Anbetracht von auslaufenden Patenten auf umsatzträchtige Blockbuster ist eine derartige Technologie auch bei vielen Pharmagrössen heiss begehrt und kommt in den vielfältigen Kooperationsverträgen zum Ausdruck:
http://www.elan.com/EDT/EDT_news/
http://www.elan.com/EDT/
In der Regel werden bei Zulassung von derartig modifizierten Wirkstoffen "fette" Lizenzzahlungen fällig ("double digits"...also grösser als 10%), die voll umfänglich in den Deckungsbeitrag eingehen, also (fast) keinen Aufwand generieren!
http://www1.investorvillage.com/smbd.asp?mb=160&pt=msg&mid=4…
http://www.elan.com/EDT/EDT_news/
http://www.elan.com/EDT/
In der Regel werden bei Zulassung von derartig modifizierten Wirkstoffen "fette" Lizenzzahlungen fällig ("double digits"...also grösser als 10%), die voll umfänglich in den Deckungsbeitrag eingehen, also (fast) keinen Aufwand generieren!
http://www1.investorvillage.com/smbd.asp?mb=160&pt=msg&mid=4…
Antwort auf Beitrag Nr.: 34.175.222 von Cyberhexe am 26.05.08 22:26:44Clients
At Elan we are happy to work with the large, speciality and small pharmaceutical and biotechnology companies. Our current client list includes such companies as Merck, Wyeth, and Abbott as well as smaller companies such as MAP and EntreMed. At present 10 out of the top 12 pharmaceutical companies are clients of ours. The cohabitation of development and manufacturing capabilities on the same sites is also a benefit to many companies as it allows for streamlined scale-up and transfer to commercial scale manufacturing activities.
http://www.elan.com/EDT/clients_and_products/
At Elan we are happy to work with the large, speciality and small pharmaceutical and biotechnology companies. Our current client list includes such companies as Merck, Wyeth, and Abbott as well as smaller companies such as MAP and EntreMed. At present 10 out of the top 12 pharmaceutical companies are clients of ours. The cohabitation of development and manufacturing capabilities on the same sites is also a benefit to many companies as it allows for streamlined scale-up and transfer to commercial scale manufacturing activities.
http://www.elan.com/EDT/clients_and_products/
Antwort auf Beitrag Nr.: 34.175.236 von Cyberhexe am 26.05.08 22:29:33anbei ab Seite 36/50 eine Übersicht über Elans DT:
http://www.csfb.com/conferences/pharma2007/pdf/elan.pdf
Seite 37:
Royalty rates mid single digits to high-teens %
http://www.csfb.com/conferences/pharma2007/pdf/elan.pdf
Seite 37:
Royalty rates mid single digits to high-teens %
Antwort auf Beitrag Nr.: 34.175.222 von Cyberhexe am 26.05.08 22:26:44Spitzeinfos! Danke auch von mir!
Es ist immer gut, wenn man weiß, um was es sich handelt!
Danke auch von mir! Es ist immer gut, wenn man weiß, um was es sich handelt!
ELN msg # 235279 5/27/2008 5:04:04 AMBy: smellybadger2003
Goodbody on EDT
Elan (Add, Closing Price 24.85); EDT business diverging from Elan’s biotech core.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Elan Drug Technology (EDT) is the profitable, Athlone-based division of Elan, focused on drug
delivery technologies and manufacturing. At the heart of Elan, since it was established in 1969,
Elan’s drug delivery now centres around two different technologies, namely NanoCrystal
(reducing particle size to enhance absorption) and oral controlled release technologies
(providing different delayed release profiles for drugs). There are currently 23 licensed products
on the market using EDT technology and 14 programmes in the clinic. A number of which, once
developed with partners, are then manufactured by the division. Speculation continues that EDT
could either be sold or spun out of Elan, given that its business focus and growth potential differs
from the biotech focus of the rest of the company, should Tysabri track towards its full potential
and AAB-001 prove to have better efficacy than existing Alzheimer’s drugs on the market.
Disposal or spin off of the division could generate over $1bn, which could be used to fund Elan’s
potential development of AAB-001 manufacturing facilities in Ireland. This all depends, however,
on the Phase II data, which is due “mid-year”.
" target="_blank" rel="nofollow ugc noopener">http://www.rte.ie/business/2008/morningrep/download/0527goodbody.pdf
Letter to Biogen shareholders from Carl Icahn
[/b]
CARL C. ICAHN
767 FIFTH AVENUE, 47TH FLOOR
NEW YORK, NEW YORK 10153
May 27, 2008
Dear Fellow Shareholders:
We are writing to ask you to support our slate of directors for Biogen Idec: Dr.
Anne B. Young, Professor Richard C. Mulligan and Dr. Alexander J. Denner. These
are our nominees who are seeking to unseat three of management's nominees for
directors. Each member of our slate has pledged to seek to enhance shareholder
value at Biogen.
We believe our nominees are highly qualified to serve on Biogen's Board. For
example, Alexander Denner, Managing Director of Icahn Partners LP who holds a
doctorate in biomedical engineering, and Richard Mulligan, Professor at Harvard
Medical School, both led the recent turnaround of ImClone Systems where they
improved ImClone's relationships with its partners, fixed many operational
issues such as reducing expenses while improving performance, settled a number
of legal disputes, and importantly, initiated an extensive development program
for Erbitux and ImClone's promising pipeline.
Anne Young, Chief of Neurology Service at Massachusetts General Hospital, is,
without doubt, one of the best regarded neurologists in the world; it seems
strange to us that Biogen does not have someone with her expertise in neurology
on its Board.
When you consider how to vote at the 2008 Annual Meeting, we ask that you
remember that the current Board announced that it had determined to seek a buyer
for the company. Then they spent time and money and failed to come up with any
buyers; in fact, no one even made a definitive bid. We have asked ourselves how
this could be possible? We believe it is because the company and its advisors
designed a process that was, from the outset, doomed for the following reason.
Biogen has partnered with Elan and Genentech in connection with some of its most
important products and has granted these partners certain change of control
rights that could effectively prevent a sale. Obviously potential bidders sought
to have discussions with Elan and Genentech in order to better understand the
growth potential and toxicity profile of the products as well as determine
whether these partners would exercise their change of control rights in each
case. Biogen refused to allow such discussions unless the bidders made "binding
offers." A "binding offer" would have required a bidder to obtain both board
approval and incur significant costs to obtain commitments for any necessary
financing. Why should a potential bidder incur these extremely high expenses
without first being permitted to complete one of the most important parts of its
due diligence? You have to ask yourself why the Board would adopt a process that
made it difficult if not impossible for potential bidders to comply with if they
really wanted to sell the company. Why put this roadblock in the way of the sale
when it almost certainly ensures failure?
We currently own more Biogen stock than all members of the Board and management
combined. (This was true even before Biogen's CEO Jim Mullen sold approximately
$50 million of stock last month.) As shareholders, our interests are aligned
with yours. On the other hand, as illustrated by the failed sales process, it is
unclear whose interests the directors and management have in mind.
Despite Biogen's statements to the contrary, we are not seeking to immediately
sell the company. Because of the failed sales process, we do not believe that
now is the time to initiate another process. However, if the company received a
bid at a significant premium, you can be certain that our nominees, as minority
directors on the Board would, consistent with their fiduciary duties, fight to
ensure that such an offer was properly evaluated. If the bid was credible and
had a large enough premium, our nominees would make sure the offer saw the light
of day, rather than having it possibly rejected by the Board for reasons which
have little, if anything, to do with shareholder value.
If elected, our nominees will work diligently with the remaining incumbents to
maximize shareholder value. We believe that research and development is at
Biogen's core and our nominees would look to renew the passions of Biogen's
researchers and scientists much as Alexander Denner and Richard Mulligan have
done at ImClone. Why is Biogen fighting so hard to keep our three qualified
nominees off the board? Are they afraid that they will finally be held
accountable? Our nominees fully intend to work with the current board to put
into action the strategy that will improve the research and commercial
activities at the company.
We believe it is imperative that shareholder-nominated directors serve on the
Board especially in light of the events that have taken place. We strongly
believe that with Biogen's dedicated employees and a renewed, strong and
accountable Board, shareholder value at Biogen can be vastly improved. We urge
all shareholders and employees to vote for our slate.
Your vote is important, no matter how many or how few shares you own. To vote
your shares, please sign, date and return the enclosed GOLD proxy card by
mailing it in the enclosed pre-addressed, stamped envelope. You may also vote by
phone or Internet by following the instructions on the enclosed proxy card.
Thank you for your support.
Very truly yours,
/s/ Carl C. Icahn
[/b]
CARL C. ICAHN
767 FIFTH AVENUE, 47TH FLOOR
NEW YORK, NEW YORK 10153
May 27, 2008
Dear Fellow Shareholders:
We are writing to ask you to support our slate of directors for Biogen Idec: Dr.
Anne B. Young, Professor Richard C. Mulligan and Dr. Alexander J. Denner. These
are our nominees who are seeking to unseat three of management's nominees for
directors. Each member of our slate has pledged to seek to enhance shareholder
value at Biogen.
We believe our nominees are highly qualified to serve on Biogen's Board. For
example, Alexander Denner, Managing Director of Icahn Partners LP who holds a
doctorate in biomedical engineering, and Richard Mulligan, Professor at Harvard
Medical School, both led the recent turnaround of ImClone Systems where they
improved ImClone's relationships with its partners, fixed many operational
issues such as reducing expenses while improving performance, settled a number
of legal disputes, and importantly, initiated an extensive development program
for Erbitux and ImClone's promising pipeline.
Anne Young, Chief of Neurology Service at Massachusetts General Hospital, is,
without doubt, one of the best regarded neurologists in the world; it seems
strange to us that Biogen does not have someone with her expertise in neurology
on its Board.
When you consider how to vote at the 2008 Annual Meeting, we ask that you
remember that the current Board announced that it had determined to seek a buyer
for the company. Then they spent time and money and failed to come up with any
buyers; in fact, no one even made a definitive bid. We have asked ourselves how
this could be possible? We believe it is because the company and its advisors
designed a process that was, from the outset, doomed for the following reason.
Biogen has partnered with Elan and Genentech in connection with some of its most
important products and has granted these partners certain change of control
rights that could effectively prevent a sale. Obviously potential bidders sought
to have discussions with Elan and Genentech in order to better understand the
growth potential and toxicity profile of the products as well as determine
whether these partners would exercise their change of control rights in each
case. Biogen refused to allow such discussions unless the bidders made "binding
offers." A "binding offer" would have required a bidder to obtain both board
approval and incur significant costs to obtain commitments for any necessary
financing. Why should a potential bidder incur these extremely high expenses
without first being permitted to complete one of the most important parts of its
due diligence? You have to ask yourself why the Board would adopt a process that
made it difficult if not impossible for potential bidders to comply with if they
really wanted to sell the company. Why put this roadblock in the way of the sale
when it almost certainly ensures failure?
We currently own more Biogen stock than all members of the Board and management
combined. (This was true even before Biogen's CEO Jim Mullen sold approximately
$50 million of stock last month.) As shareholders, our interests are aligned
with yours. On the other hand, as illustrated by the failed sales process, it is
unclear whose interests the directors and management have in mind.
Despite Biogen's statements to the contrary, we are not seeking to immediately
sell the company. Because of the failed sales process, we do not believe that
now is the time to initiate another process. However, if the company received a
bid at a significant premium, you can be certain that our nominees, as minority
directors on the Board would, consistent with their fiduciary duties, fight to
ensure that such an offer was properly evaluated. If the bid was credible and
had a large enough premium, our nominees would make sure the offer saw the light
of day, rather than having it possibly rejected by the Board for reasons which
have little, if anything, to do with shareholder value.
If elected, our nominees will work diligently with the remaining incumbents to
maximize shareholder value. We believe that research and development is at
Biogen's core and our nominees would look to renew the passions of Biogen's
researchers and scientists much as Alexander Denner and Richard Mulligan have
done at ImClone. Why is Biogen fighting so hard to keep our three qualified
nominees off the board? Are they afraid that they will finally be held
accountable? Our nominees fully intend to work with the current board to put
into action the strategy that will improve the research and commercial
activities at the company.
We believe it is imperative that shareholder-nominated directors serve on the
Board especially in light of the events that have taken place. We strongly
believe that with Biogen's dedicated employees and a renewed, strong and
accountable Board, shareholder value at Biogen can be vastly improved. We urge
all shareholders and employees to vote for our slate.
Your vote is important, no matter how many or how few shares you own. To vote
your shares, please sign, date and return the enclosed GOLD proxy card by
mailing it in the enclosed pre-addressed, stamped envelope. You may also vote by
phone or Internet by following the instructions on the enclosed proxy card.
Thank you for your support.
Very truly yours,
/s/ Carl C. Icahn
ANALYSIS-Tysabri faces uphill battle in Crohn's disease
05.25.08, 12:07 PM ET
United States - By Bill Berkrot
NEW YORK (Reuters) - Crohn's disease will have to make a significant contribution for Biogen Idec Inc (nasdaq: BIIB - news - people ) to hit its stated goal of 100,000 patients on Tysabri by 2010. But it faces an uphill battle as a treatment for the bowel disorder even as it shows impressive growth against multiple sclerosis.
Tysabri, which is co-marketed by Ireland's Elan Corp PLC (nyse: ELN - news - people ) , won U.S. approval this year to treat adults with moderate to severe Crohn's disease who have had a poor response to, or cannot take, other therapies, such as Humira from Abbott Laboratories (nyse: ABT - news - people ) or Johnson & Johnson's Remicade.
"Crohn's is a much more challenging indication for Tysabri than MS is," Sanford Bernstein analyst Geoffrey Porges said.
Crohn's disease is a bowel inflammation that causes sometimes disabling abdominal pain, weight loss, fever and rectal bleeding. An estimated 500,000 people in the United States suffer from Crohn's, according to the companies.
"You already have approved biologics in Crohn's that are really pretty impressively effective in Remicade and Humira," Porges said. "And there are other products around the corner that look as though they're going to be at least as good."
Tysabri, even with its daunting safety issues, tackles a major unmet need in multiple sclerosis, where older drugs were not stopping or significantly improving the disease.
"Tysabri is a significant step up on that disease but is nothing like as much of a step up in Crohn's," Porges said.
Sales of the drug were suspended in 2005 after three cases of a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML, cropped up. Tysabri returned to the market in 2006 with limits after the Food and Drug Administration decided MS patients were willing to accept the risks given the potential benefits.
There have been no reports of PML since Tysabri's relaunch, but any new cases would likely have a devastating effect, especially in Crohn's revenue, analysts said.
"The safety profile in either indication still would be some cause for concern," said Cowen & Co analyst Eric Schmidt. "Our expectation is Crohn's disease will be a small fraction of the product's overall market opportunity."
Porges foresees Tysabri sales in Crohn's of "no more than $300 million to $400 million" four years from now.
Tysabri had sales of $160 million in the first quarter with about 26,000 patients on the drug at the end of March.
Biogen and Elan both declined to reveal what percentage of the 100,000-patient goal they expect to come from Crohn's.
Some analysts have predicted Crohn's would account for between 5 percent and 10 percent of Tysabri sales.
Crohn's will have to be much more of a major player to reach the 100,000-patient mark by 2010, Porges said.
"If MS continues at the current (growth) rate it looks as though at least 20 percent of it would have to come from Crohn's by 2010 and that's a pretty aggressive ramp," he said.
Bennett Weintraub, an analyst for Reuters Insight, which tracks industry trends for institutional investors, was far more optimistic about Tysabri's future in Crohn's barring no new cases of PML and favorable reimbursement policies from Medicare and other health plans.
Data presented at the Digestive Disease Week meeting this week in San Diego suggested that treatment with Tysabri could reduce expensive hospitalizations in patients with severe Crohn's flare-ups -- a potential catalyst for favorable insurance reimbursement decisions.
Weintraub believes 17,000 Crohn's patients could be on Tysabri by the end of 2008, with use approaching 60,000 patients by 2012.
A Reuters Insight survey of U.S. gastroenterologists suggests that 20 percent of their Crohn's disease patients are failing all current therapies.
"Given that half a million people in the U.S. have Crohn's disease, that represents a sizable opportunity even when stacked up against the MS market," Weintraub said. (Editing by Phil Berlowitz)
http://www.forbes.com/reuters/feeds/reuters/2008/05/25/2008-…
05.25.08, 12:07 PM ET
United States - By Bill Berkrot
NEW YORK (Reuters) - Crohn's disease will have to make a significant contribution for Biogen Idec Inc (nasdaq: BIIB - news - people ) to hit its stated goal of 100,000 patients on Tysabri by 2010. But it faces an uphill battle as a treatment for the bowel disorder even as it shows impressive growth against multiple sclerosis.
Tysabri, which is co-marketed by Ireland's Elan Corp PLC (nyse: ELN - news - people ) , won U.S. approval this year to treat adults with moderate to severe Crohn's disease who have had a poor response to, or cannot take, other therapies, such as Humira from Abbott Laboratories (nyse: ABT - news - people ) or Johnson & Johnson's Remicade.
"Crohn's is a much more challenging indication for Tysabri than MS is," Sanford Bernstein analyst Geoffrey Porges said.
Crohn's disease is a bowel inflammation that causes sometimes disabling abdominal pain, weight loss, fever and rectal bleeding. An estimated 500,000 people in the United States suffer from Crohn's, according to the companies.
"You already have approved biologics in Crohn's that are really pretty impressively effective in Remicade and Humira," Porges said. "And there are other products around the corner that look as though they're going to be at least as good."
Tysabri, even with its daunting safety issues, tackles a major unmet need in multiple sclerosis, where older drugs were not stopping or significantly improving the disease.
"Tysabri is a significant step up on that disease but is nothing like as much of a step up in Crohn's," Porges said.
Sales of the drug were suspended in 2005 after three cases of a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML, cropped up. Tysabri returned to the market in 2006 with limits after the Food and Drug Administration decided MS patients were willing to accept the risks given the potential benefits.
There have been no reports of PML since Tysabri's relaunch, but any new cases would likely have a devastating effect, especially in Crohn's revenue, analysts said.
"The safety profile in either indication still would be some cause for concern," said Cowen & Co analyst Eric Schmidt. "Our expectation is Crohn's disease will be a small fraction of the product's overall market opportunity."
Porges foresees Tysabri sales in Crohn's of "no more than $300 million to $400 million" four years from now.
Tysabri had sales of $160 million in the first quarter with about 26,000 patients on the drug at the end of March.
Biogen and Elan both declined to reveal what percentage of the 100,000-patient goal they expect to come from Crohn's.
Some analysts have predicted Crohn's would account for between 5 percent and 10 percent of Tysabri sales.
Crohn's will have to be much more of a major player to reach the 100,000-patient mark by 2010, Porges said.
"If MS continues at the current (growth) rate it looks as though at least 20 percent of it would have to come from Crohn's by 2010 and that's a pretty aggressive ramp," he said.
Bennett Weintraub, an analyst for Reuters Insight, which tracks industry trends for institutional investors, was far more optimistic about Tysabri's future in Crohn's barring no new cases of PML and favorable reimbursement policies from Medicare and other health plans.
Data presented at the Digestive Disease Week meeting this week in San Diego suggested that treatment with Tysabri could reduce expensive hospitalizations in patients with severe Crohn's flare-ups -- a potential catalyst for favorable insurance reimbursement decisions.
Weintraub believes 17,000 Crohn's patients could be on Tysabri by the end of 2008, with use approaching 60,000 patients by 2012.
A Reuters Insight survey of U.S. gastroenterologists suggests that 20 percent of their Crohn's disease patients are failing all current therapies.
"Given that half a million people in the U.S. have Crohn's disease, that represents a sizable opportunity even when stacked up against the MS market," Weintraub said. (Editing by Phil Berlowitz)
http://www.forbes.com/reuters/feeds/reuters/2008/05/25/2008-…
HI!
Davy
Elan Corp (USc)
ELN US
Myriad shares fall back as deal questioned
Jack Gorman
Price $25.41 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
The recent strong performance of Myriad Genetics' share price was clipped a little yesterday (May 28th) when a broker covering its European partner Lundbeck cast doubt over the prospects for its lead AD drug Flurizan. Myriad shares fell 3.5% yesterday, after the stock had risen from $35 to touch $50 in the last two months.
Myriad is scheduled to release Phase III results from its gamma secretase modulator Flurizan sometime in June. Flurizan's Phase II results were mixed: efficacy trends were only observed in mild AD patients at the highest administered dosage. Lundbeck signed a commercialisation deal with Myriad for EU rights to the product this month.
Bapineuzumab, in contrast, is currently being investigated in a much larger cohort of the AD population (mild-to-moderate patients). For further detail, see our research note 'Setting the scene for Bapineuzumab, Elan's key catalyst for 2008' issued May 27th.
Back
Davy
Elan Corp (USc)
ELN US
Myriad shares fall back as deal questioned
Jack Gorman
Price $25.41 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
The recent strong performance of Myriad Genetics' share price was clipped a little yesterday (May 28th) when a broker covering its European partner Lundbeck cast doubt over the prospects for its lead AD drug Flurizan. Myriad shares fell 3.5% yesterday, after the stock had risen from $35 to touch $50 in the last two months.
Myriad is scheduled to release Phase III results from its gamma secretase modulator Flurizan sometime in June. Flurizan's Phase II results were mixed: efficacy trends were only observed in mild AD patients at the highest administered dosage. Lundbeck signed a commercialisation deal with Myriad for EU rights to the product this month.
Bapineuzumab, in contrast, is currently being investigated in a much larger cohort of the AD population (mild-to-moderate patients). For further detail, see our research note 'Setting the scene for Bapineuzumab, Elan's key catalyst for 2008' issued May 27th.
Back
ELN msg # 236059 5/28/2008 11:39:46 PMBy: edmanmri
My top 10 take aways from the AGM
With apologies to Doodah95 who does this so much better:
10) Several patients attended the meeting and started crying as they described how Ty has given them hope when they had none before. By the end of their testimonies, including a huge thank you to Lauren Roberts for all her effort, there wasn’t a dry eye in the room.
9) KM made it clear that 1/3 of the TY patients were either new to treatment, or had tried something else that wasn’t as effective, and therefore all estimates of the MS market were too low.
8) While the gating agent in the US MS market is just marketing efforts to add to the 3000 clinicians they have already signed up, overseas the gating agent is reimbursement which is why they are only in 30 other countries.
7) KM reminded analysts that for every 10,000 new MS patients for TY, ELN makes an additional $100,000.
6) KM said that the only long term MS forecast made for TY patients is 100,000 patients by the end of 2010. However that was based on a 25% market share of the market assumed before TY has had so much success in the US. The additional 1/3 of the TY patients implies that the 100,000 forecast is too low. Looks to me like a 130,000+ estimate will be made later this year.
5) KM said he would update investors on TY for Crohn’s disease in July when ELN reports their 2Q. Currently they have 1400 doctors in the US and he expects the Crohn’s application will break even in 18 months.
4) ELN and WYE have resubmitted data to both the FDA and the EU for AAC001 and expect to restart the phase II trial soon.
3) Not only can ELN opt into the LLY phase III trial for gamma-secretase if they want to, but ELN expects to start their own phase II gamma-secretase trial for early AD which if successful would greatly expand the market size potential for their AD portfolio. The LLY dosing trial is expected to last 2 years.
2) KM made a 5 year forecast of 15-20% growth for EDT which appears to be a precursor to getting investors to think about this as a standalone business. It sounds like the announcement about a potential spin off will come after the ICAD meetings at the end of July.
1) ELN is now considering holding an investor meeting or call after the ICAD meetings to explain their interpretation of the results. KM claimed everyone would understand why they jumped to Phase III after they see the data, it will be that obvious.
I will also be at the ICAD meetings in July, so if anyone plans on attending, we should have an I Village celebration at Kitty O’Sheas or another appropriate spot.
Acorda, Elan drug improves walking for MS patients
Mon Jun 2, 2008 6:01am EDT
By Ransdell Pierson
NEW YORK, June 2 (Reuters) - Acorda Therapeutics Inc. (ACOR.O: Quote, Profile, Research) said on Monday it will seek U.S. marketing approval early next year for the first medicine to improve walking among patients with multiple sclerosis, following highly favorable results of a second late-stage study.
The latest Phase 3 trial involved 240 MS patients in the United States and Canada with some degree of walking disability, divided into groups that either took the Acorda medicine or placebos twice daily.
Almost 43 percent of patients taking the medicine, called fampridine, showed consistent improvement in walking speed during the two-month study, compared with 9.3 percent of patients taking placebos, Acorda said.
The results were highly statistically significant and similar to those seen in an earlier 14-week study of the medicine. Patients who responded to the medicine in both Phase 3 studies, on average, required about 25 percent less time to to walk a distance of 25 feet.
Moreover, leg strength improved by a statistically significant degree among the fampridine group in the latest trial, meeting a secondary goal of the study.
"There is no approved treatment today that addresses walking disability for patients with multiple sclerosis," Ron Cohen, Acorda's chief executive, said in an interview late on Sunday.
"Walking disability is a fundamental feature of multiple sclerosis and one of the most worrisome features because it can imply loss of independence," said Cohen, whose tiny biotechnology company is based in Hawthorne, New York.
Cohen cautioned that although fampridine has been shown to improve the mobility of patients, it does not slow the progression of multiple sclerosis. Therefore, he said it will likely be used alongside standard interferon treatments that do slow progression, which include Biogen Idec Inc's (BIIB.O: Quote, Profile, Research) Avonex and the newer treatment Tysabri developed by Biogen Idec and Elan Corp (ELN.L: Quote, Profile, Research)
He noted, however, that the interferon treatments have not been shown to improve walking abilities, as fampridine has done.
Multiple sclerosis is a progressive disease in which the body's immune system attacks, and thereby wears away, the protective layer of a protein called myelin that insulates nerve fibers in the brain and spinal cord. More than 400,000 Americans are estimated to have the disease, a high percentage of whom eventually develop walking difficulties or related motor problems.
The Acorda drug, which is being developed in partnership with Elan and will guarantee the Irish drugmaker about 20 percent of its net sales, works by preventing potassium from leaking from nerve fibers whose myelin sheath has been denuded.
Cohen said Acorda, based on the favorable results of the two late-stage studies, aims to seek U.S. approval for fampridine in the first quarter of 2009. It could reach the market later that year or in 2010, he said, and might cost between $5,000 to $10,000 per year.
Although industry analysts have estimated the medicine could generate U.S. sales of up to $500 million, and considerable sales overseas, Cohen declined to comment on its commercial potential. (Editing by Lincoln Feast)
http://www.reuters.com/article/marketsNews/idINN014094622008…
Mon Jun 2, 2008 6:01am EDT
By Ransdell Pierson
NEW YORK, June 2 (Reuters) - Acorda Therapeutics Inc. (ACOR.O: Quote, Profile, Research) said on Monday it will seek U.S. marketing approval early next year for the first medicine to improve walking among patients with multiple sclerosis, following highly favorable results of a second late-stage study.
The latest Phase 3 trial involved 240 MS patients in the United States and Canada with some degree of walking disability, divided into groups that either took the Acorda medicine or placebos twice daily.
Almost 43 percent of patients taking the medicine, called fampridine, showed consistent improvement in walking speed during the two-month study, compared with 9.3 percent of patients taking placebos, Acorda said.
The results were highly statistically significant and similar to those seen in an earlier 14-week study of the medicine. Patients who responded to the medicine in both Phase 3 studies, on average, required about 25 percent less time to to walk a distance of 25 feet.
Moreover, leg strength improved by a statistically significant degree among the fampridine group in the latest trial, meeting a secondary goal of the study.
"There is no approved treatment today that addresses walking disability for patients with multiple sclerosis," Ron Cohen, Acorda's chief executive, said in an interview late on Sunday.
"Walking disability is a fundamental feature of multiple sclerosis and one of the most worrisome features because it can imply loss of independence," said Cohen, whose tiny biotechnology company is based in Hawthorne, New York.
Cohen cautioned that although fampridine has been shown to improve the mobility of patients, it does not slow the progression of multiple sclerosis. Therefore, he said it will likely be used alongside standard interferon treatments that do slow progression, which include Biogen Idec Inc's (BIIB.O: Quote, Profile, Research) Avonex and the newer treatment Tysabri developed by Biogen Idec and Elan Corp (ELN.L: Quote, Profile, Research)
He noted, however, that the interferon treatments have not been shown to improve walking abilities, as fampridine has done.
Multiple sclerosis is a progressive disease in which the body's immune system attacks, and thereby wears away, the protective layer of a protein called myelin that insulates nerve fibers in the brain and spinal cord. More than 400,000 Americans are estimated to have the disease, a high percentage of whom eventually develop walking difficulties or related motor problems.
The Acorda drug, which is being developed in partnership with Elan and will guarantee the Irish drugmaker about 20 percent of its net sales, works by preventing potassium from leaking from nerve fibers whose myelin sheath has been denuded.
Cohen said Acorda, based on the favorable results of the two late-stage studies, aims to seek U.S. approval for fampridine in the first quarter of 2009. It could reach the market later that year or in 2010, he said, and might cost between $5,000 to $10,000 per year.
Although industry analysts have estimated the medicine could generate U.S. sales of up to $500 million, and considerable sales overseas, Cohen declined to comment on its commercial potential. (Editing by Lincoln Feast)
http://www.reuters.com/article/marketsNews/idINN014094622008…
Antwort auf Beitrag Nr.: 34.216.862 von bernie55 am 02.06.08 12:32:28----Hi!
Ist wie immer:Gute Nachrichten und unser Schätzchen fällt.....
Geniesst die Sonne...Grüsse! Birgit
Ist wie immer:Gute Nachrichten und unser Schätzchen fällt.....
Geniesst die Sonne...Grüsse! Birgit
Davy
Acorda Therapeutics shares rose 31% in trading yesterday (June 2nd) following positive results from a second Phase III trial for Fampridine for the treatment of MS.
The trial showed improved mobility in some patients. Acorda intends to file for licensing to market the drug in the first quarter of 2009 which could lead to a potential launch that year. Elan granted Acorda worldwide rights to Fampridine in 2003. Elan will manufacture Fampridine and receive 20% royalty payments under
the licensing agreement with Acorda.
In walking tests involving 240 patients (who continued to take their usual MS medications such as Avonex and Tysabri), 43% had consistent improvement in speed compared with 9.3% on placebo. A larger Phase III trial has already been completed.
Meanwhile, the US federal jury trial brought by Elan against Abraxis BioScience for alleged patent infringement for a cancer medicine opened yesterday. Elan sued Abraxis two years ago, contending that the company's Abraxane, for the treatment of breast cancer, by Elan’s patuses technology protected ent for anti-cancer nanoparticles. Abraxis sold $288m worth of Abraxane in 2007 and the drug has been administered to more than 30,000 patients. Elan is seeking royalties on the sale of the drug. Elan was down 1% in weak US markets yesterday.
http://www.rte.ie/business/2008/morningrep/download/0603davy…
Acorda Therapeutics shares rose 31% in trading yesterday (June 2nd) following positive results from a second Phase III trial for Fampridine for the treatment of MS.
The trial showed improved mobility in some patients. Acorda intends to file for licensing to market the drug in the first quarter of 2009 which could lead to a potential launch that year. Elan granted Acorda worldwide rights to Fampridine in 2003. Elan will manufacture Fampridine and receive 20% royalty payments under
the licensing agreement with Acorda.
In walking tests involving 240 patients (who continued to take their usual MS medications such as Avonex and Tysabri), 43% had consistent improvement in speed compared with 9.3% on placebo. A larger Phase III trial has already been completed.
Meanwhile, the US federal jury trial brought by Elan against Abraxis BioScience for alleged patent infringement for a cancer medicine opened yesterday. Elan sued Abraxis two years ago, contending that the company's Abraxane, for the treatment of breast cancer, by Elan’s patuses technology protected ent for anti-cancer nanoparticles. Abraxis sold $288m worth of Abraxane in 2007 and the drug has been administered to more than 30,000 patients. Elan is seeking royalties on the sale of the drug. Elan was down 1% in weak US markets yesterday.
http://www.rte.ie/business/2008/morningrep/download/0603davy…
Antwort auf Beitrag Nr.: 34.224.305 von bernie55 am 03.06.08 10:41:30Meanwhile, the US federal jury trial brought by Elan against Abraxis BioScience for alleged patent infringement for a cancer medicine opened yesterday. Elan sued Abraxis two years ago, contending that the company's Abraxane, for the treatment of breast cancer, by Elan’s patuses technology protected ent for anti-cancer nanoparticles. Abraxis sold $288m worth of Abraxane in 2007 and the drug has been administered to more than 30,000 patients. Elan is seeking royalties on the sale of the drug. Elan was down 1% in weak US markets yesterday.
Elan sues rival in US over cancer medicine
By Phil Milford
Wednesday June 04 2008
A unit of drugmaker Elan has accused competitor Abraxis BioScience of infringing a US patent for cancer medicine as a federal jury trial began.
Elan sued two years ago in Wilmington, Delaware, contending Abraxis' intravenous paclitaxel drug Abraxane for the treatment of metastatic breast cancer uses technology protected by Elan's 1995 patent for tiny anti-cancer nanoparticles.
"We're just asking for our fair share in royalties and are not intent on keeping Abraxane off the market,'' Elan lawyer Stephen Scheve said in his opening statement.
He didn't specify the amount of damages sought, pending expert testimony.
"Elan just can't prove that case" and filed the lawsuit after "it couldn't make an anti-cancer drug of its own," said Abraxis lawyer Michael A Jacobs as the trial began before Chief US District Judge Gregory M Sleet. Jacobs said the patent and another one awarded in 1998 don't work and are unenforceable.
Abraxis, based in Los Angeles, with $333.6m (€216m) in total revenue last year, sold $288million worth of Abraxane in 2007, and the drug has been given to more than 30,000 patients, according to court papers. Elan reported $516.4 million in 2007 revenue.
Abraxane, introduced in 2005, is marketed in the US under an agreement with AstraZeneca and has been the subject of studies presented at a meeting of the American Society of Clinical Oncology in Chicago that began May 30.
Trial
In one clinical trial, an Abraxane combination led to median progression-free survival of almost 16 months, Abraxis said in a statement yesterday from the meeting. Breast cancer affects one in eight women and an estimated 155,000 women in the US are living with metastatic breast cancer, according to the Abraxis statement.
Elan said last month it is expecting rapid growth in sales of its multiple sclerosis drug Tysabri, hoping to help 100,000 patients by 2010. Elan sells Tysabri with Cambridge, Massachusetts-based Biogen Idec. (©Bloomberg)
http://www.independent.ie/business/irish/elan-sues-rival-in-…
Elan sues rival in US over cancer medicine
By Phil Milford
Wednesday June 04 2008
A unit of drugmaker Elan has accused competitor Abraxis BioScience of infringing a US patent for cancer medicine as a federal jury trial began.
Elan sued two years ago in Wilmington, Delaware, contending Abraxis' intravenous paclitaxel drug Abraxane for the treatment of metastatic breast cancer uses technology protected by Elan's 1995 patent for tiny anti-cancer nanoparticles.
"We're just asking for our fair share in royalties and are not intent on keeping Abraxane off the market,'' Elan lawyer Stephen Scheve said in his opening statement.
He didn't specify the amount of damages sought, pending expert testimony.
"Elan just can't prove that case" and filed the lawsuit after "it couldn't make an anti-cancer drug of its own," said Abraxis lawyer Michael A Jacobs as the trial began before Chief US District Judge Gregory M Sleet. Jacobs said the patent and another one awarded in 1998 don't work and are unenforceable.
Abraxis, based in Los Angeles, with $333.6m (€216m) in total revenue last year, sold $288million worth of Abraxane in 2007, and the drug has been given to more than 30,000 patients, according to court papers. Elan reported $516.4 million in 2007 revenue.
Abraxane, introduced in 2005, is marketed in the US under an agreement with AstraZeneca and has been the subject of studies presented at a meeting of the American Society of Clinical Oncology in Chicago that began May 30.
Trial
In one clinical trial, an Abraxane combination led to median progression-free survival of almost 16 months, Abraxis said in a statement yesterday from the meeting. Breast cancer affects one in eight women and an estimated 155,000 women in the US are living with metastatic breast cancer, according to the Abraxis statement.
Elan said last month it is expecting rapid growth in sales of its multiple sclerosis drug Tysabri, hoping to help 100,000 patients by 2010. Elan sells Tysabri with Cambridge, Massachusetts-based Biogen Idec. (©Bloomberg)
http://www.independent.ie/business/irish/elan-sues-rival-in-…
gute Nachrichten, fallender Dollar und steigende Kurse in Europa?
Kann das alles sein?
Kann das alles sein?
Antwort auf Beitrag Nr.: 34.234.309 von Poppholz am 04.06.08 11:36:45871331
Geld
16,21
Brief
16,53
Zeit
04.06. 11:37
Geld Stk.
2.100
Brief Stk.
2.100
-------------------------------------------------
903801
Geld
16,12
Brief
16,63
Zeit
04.06. 11:37
Geld Stk.
500
Brief Stk.
500
Geld
16,21
Brief
16,53
Zeit
04.06. 11:37
Geld Stk.
2.100
Brief Stk.
2.100
-------------------------------------------------
903801
Geld
16,12
Brief
16,63
Zeit
04.06. 11:37
Geld Stk.
500
Brief Stk.
500
http://youtube.com/watch?v=L9hbf-No29U--Grüsse!" target="_blank" rel="nofollow ugc noopener">
http://youtube.com/watch?v=L9hbf-No29U--Grüsse!
" target="_blank" rel="nofollow ugc noopener">http://youtube.com/watch?v=L9hbf-No29U--Grüsse!
.Guten Morgen !!!Elan to Present at Goldman Sachs Global Healthcare Conference
Thursday June 5, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the Goldman Sachs 29th Annual Global Healthcare Conference on Wednesday, June 11, 2008 at 8:40 am PDT. The conference takes place at the Ritz-Carlton Laguna Niguel in Dana Point, California. Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com, then clicking on the event icon.
http://biz.yahoo.com/bw/080605/20080604006150.html?.v=1
Moin!
ELN msg # 237878 6/5/2008 4:27:32 AM
By: smellybadger2003
NCB
The status of Elan/Wyeth’s active vaccine ACC-001 has be reinstated according to
details on the ClinicalTrials.gov website. Phase II trials of the AD treatment had been
suspended since mid-April after a single patient suffered from vasculitis which
manifested as skin lesions. Post the suspension, Elan had stated that it was in
discussions with the FDA and expected ACC-001 to be taken off clinical hold in the
near future.
• The Phase II studies with ACC-001 commenced in Q2 2007 and 59 patients had been
enrolled up to the time of the suspension. The two Phase II studies (US and EU) will
have a total patient population of 284 when recruitment has been completed and are
expected to run until mid-2012.
• The reinstatement of ACC-001 is a boost for Elan and while no other treatments were
directly affected by the suspension its return to clinical trials can be viewed as a positive
for the remainder of Elan’s AD pipeline which is predicated on the amyloid beta
hypothesis.
http://www.rte.ie/business/2008/morningrep/download/0605ncb.…
ELN msg # 237878 6/5/2008 4:27:32 AM
By: smellybadger2003
NCB
The status of Elan/Wyeth’s active vaccine ACC-001 has be reinstated according to
details on the ClinicalTrials.gov website. Phase II trials of the AD treatment had been
suspended since mid-April after a single patient suffered from vasculitis which
manifested as skin lesions. Post the suspension, Elan had stated that it was in
discussions with the FDA and expected ACC-001 to be taken off clinical hold in the
near future.
• The Phase II studies with ACC-001 commenced in Q2 2007 and 59 patients had been
enrolled up to the time of the suspension. The two Phase II studies (US and EU) will
have a total patient population of 284 when recruitment has been completed and are
expected to run until mid-2012.
• The reinstatement of ACC-001 is a boost for Elan and while no other treatments were
directly affected by the suspension its return to clinical trials can be viewed as a positive
for the remainder of Elan’s AD pipeline which is predicated on the amyloid beta
hypothesis.
http://www.rte.ie/business/2008/morningrep/download/0605ncb.…
10 Tage Chart 
Antwort auf Beitrag Nr.: 34.246.848 von surga am 05.06.08 16:59:55Fieberkurve....
Sunday June 08 2008
KELLY Martin (above) of €8bn pharma group Elan offered to help a bidder take over drug firm Biogen, regulatory filings reveal.
Corporate raider Carl Icahn has alleged that Elan agreed not to change its Tysabri drug development partnership with Biogen if the pharmaceutical company was taken over.
Last October a bidder for Biogen asked for talks with Elan over the future ownership of Tysabri.
- Nick Webb
-Schönes WE!
Some companies are doing just fine," she said. "If there was a protracted recession, well-diversified companies such as Novartis,Sanofi-Aventis and Bayer would probably hold up better than the broader market."
Bayer is a favorite with many mainstream fund managers because of its businesses in crop protection and materials science. Novartis and Sanofi-Aventis are highly rated for their decent pipelines of new drugs and limited exposure to patent expirations.
Debbie Wang, a health care analyst with Morningstar in New York, agreed with Marden and suggested that valuations in the sector were compelling.
"Clearly some companies are not worth the risk;
Elan Pharmaceutical fits into this category because of side-effect issues with its blockbuster drug Tysabri," a multiple sclerosis treatment, she said.
"But there are many other companies that would make nice investments in a downturn." ....ein weiser Spruch...
Wang cited Schering-Plough and Novartis as good defensive calls.
http://www.iht.com/articles/2008/06/07/yourmoney/mhealth.php
Ich weiß nicht , wie ich das verstehen soll !!!!
Ich frage mich doch ernsthaft, wie Tysabri als BLOCKBUSTER - Standard bestehen kann bei soooooooo " ernsthaften" Nebenwirkungen....
Bayer is a favorite with many mainstream fund managers because of its businesses in crop protection and materials science. Novartis and Sanofi-Aventis are highly rated for their decent pipelines of new drugs and limited exposure to patent expirations.
Debbie Wang, a health care analyst with Morningstar in New York, agreed with Marden and suggested that valuations in the sector were compelling.
"Clearly some companies are not worth the risk;
Elan Pharmaceutical fits into this category because of side-effect issues with its blockbuster drug Tysabri," a multiple sclerosis treatment, she said.
"But there are many other companies that would make nice investments in a downturn." ....ein weiser Spruch...
Wang cited Schering-Plough and Novartis as good defensive calls.
http://www.iht.com/articles/2008/06/07/yourmoney/mhealth.php
Ich weiß nicht , wie ich das verstehen soll !!!!
Ich frage mich doch ernsthaft, wie Tysabri als BLOCKBUSTER - Standard bestehen kann bei soooooooo " ernsthaften" Nebenwirkungen....
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease
This study is currently recruiting participants.
Verified by Elan Pharmaceuticals, June 2008
Sponsored by: Elan Pharmaceuticals
Information provided by: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00575055
ClinicalTrials.gov Identifier: NCT00574132
http://clinicaltrials.gov/ct2/show/NCT00575055?term=aab-001&…
http://clinicaltrials.gov/ct2/show/NCT00574132?term=aab-001&…
This study is currently recruiting participants.
Verified by Elan Pharmaceuticals, June 2008
Sponsored by: Elan Pharmaceuticals
Information provided by: Elan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00575055
ClinicalTrials.gov Identifier: NCT00574132
http://clinicaltrials.gov/ct2/show/NCT00575055?term=aab-001&…
http://clinicaltrials.gov/ct2/show/NCT00574132?term=aab-001&…
Antwort auf Beitrag Nr.: 34.241.675 von bernie55 am 05.06.08 08:13:55zur Erinnerung und schön in den Terminkalender eintragen...
Elan to Present at Goldman Sachs Global Healthcare Conference
Thursday June 5, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the Goldman Sachs 29th Annual Global Healthcare Conference on Wednesday, June 11, 2008 at 8:40 am PDT.
The conference takes place at the Ritz-Carlton Laguna Niguel in Dana Point, California. Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com, then clicking on the event icon.
http://biz.yahoo.com/bw/080605/20080604006150.html?.v=1
Elan to Present at Goldman Sachs Global Healthcare Conference
Thursday June 5, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the Goldman Sachs 29th Annual Global Healthcare Conference on Wednesday, June 11, 2008 at 8:40 am PDT.
The conference takes place at the Ritz-Carlton Laguna Niguel in Dana Point, California. Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com, then clicking on the event icon.
http://biz.yahoo.com/bw/080605/20080604006150.html?.v=1
Antwort auf Beitrag Nr.: 34.241.675 von bernie55 am 05.06.08 08:13:55PDT = UTC-7
PDT > 08.40 AM < PDT ( Pacific Daylight Time )
UTC > 15.40 PM < UTC (Koordinierte Universalzeit)
MSZE = UTC + 2
MSZE> 17.40 PM < MSZE ( Mitteleuropäische Sommerzeit)
..so, dann hoffe ich mal, dass ich alles richtig gerechnet habe...und wenn nicht..... bitte nicht schlagen...
PDT > 08.40 AM < PDT ( Pacific Daylight Time )
UTC > 15.40 PM < UTC (Koordinierte Universalzeit)
MSZE = UTC + 2
MSZE> 17.40 PM < MSZE ( Mitteleuropäische Sommerzeit)
..so, dann hoffe ich mal, dass ich alles richtig gerechnet habe...und wenn nicht..... bitte nicht schlagen...
Antwort auf Beitrag Nr.: 34.263.459 von Birgit.Tersteegen am 08.06.08 16:29:32Reuters
Icahn challenges Biogen on effort to sell itself
Thursday June 5, 9:21 am ET
NEW YORK (Reuters) - Investor Carl Icahn is disputing statements by Biogen Idec (NasdaqGS:BIIB - News) over the biotechnology company's efforts to sell itself last year, stepping up pressure in a proxy fight that will come to a head later this month.
Icahn, who is seeking to add three directors to Biogen's board, said in a memorandum to shareholders released in a proxy filing on Thursday, that documents made public last week about the sale process show that a number of company statements made in connection with the sale process are "untrue."
Biogen released the documents following a lawsuit by Icahn filed in Delaware Chancery Court earlier this year. Icahn in the memo claimed a number of Biogen's assertions about the sale process "are not consistent with their own documents."
A Biogen spokeswoman said the company "completely disagree(s) with his allegations."
The documents "confirm what we said all along, which was that the process was professional, thorough, objective," spokeswoman Naomi Aoki said.
Icahn, a billionaire who is also engaged in a high-profile battle with Yahoo Inc (NasdaqGS:YHOO - News) management, has been critical of Biogen after the company ended an auction to sell itself in December without an offer.
In the memorandum, Icahn said Biogen's books and records show the board had "very little input in designing and supervising the sales process."
He also said at least one potential bidder was denied a request to talk to Elan Corp Plc (ISO:ELN - News), Biogen's partner on the multiple sclerosis drug Tysabri, potentially causing that bidder to walk away.
Aoki disputed those assertions, saying the documents confirm the board had a lot of input and was fully informed. "They were very much involved in the design of sale process and then they were fully informed every step of the way," she said.
Regarding the Elan claims, she said the company made clear from the outset that talking to partners would be part of the last stage of the sale process, in order to maximize value for Biogen shareholders. "We clearly communicated the process to all interested parties," Aoki said.
Biogen will hold its annual meeting on June 19. The shares, which closed at $62.25 on Wednesday on the Nasdaq, are up about 9 percent this year.
(Reporting by Lewis Krauskopf, editing by Maureen Bavdek)
http://biz.yahoo.com/rb/080605/biogen_icahn.html?.v=1
Icahn challenges Biogen on effort to sell itself
Thursday June 5, 9:21 am ET
NEW YORK (Reuters) - Investor Carl Icahn is disputing statements by Biogen Idec (NasdaqGS:BIIB - News) over the biotechnology company's efforts to sell itself last year, stepping up pressure in a proxy fight that will come to a head later this month.
Icahn, who is seeking to add three directors to Biogen's board, said in a memorandum to shareholders released in a proxy filing on Thursday, that documents made public last week about the sale process show that a number of company statements made in connection with the sale process are "untrue."
Biogen released the documents following a lawsuit by Icahn filed in Delaware Chancery Court earlier this year. Icahn in the memo claimed a number of Biogen's assertions about the sale process "are not consistent with their own documents."
A Biogen spokeswoman said the company "completely disagree(s) with his allegations."
The documents "confirm what we said all along, which was that the process was professional, thorough, objective," spokeswoman Naomi Aoki said.
Icahn, a billionaire who is also engaged in a high-profile battle with Yahoo Inc (NasdaqGS:YHOO - News) management, has been critical of Biogen after the company ended an auction to sell itself in December without an offer.
In the memorandum, Icahn said Biogen's books and records show the board had "very little input in designing and supervising the sales process."
He also said at least one potential bidder was denied a request to talk to Elan Corp Plc (ISO:ELN - News), Biogen's partner on the multiple sclerosis drug Tysabri, potentially causing that bidder to walk away.
Aoki disputed those assertions, saying the documents confirm the board had a lot of input and was fully informed. "They were very much involved in the design of sale process and then they were fully informed every step of the way," she said.
Regarding the Elan claims, she said the company made clear from the outset that talking to partners would be part of the last stage of the sale process, in order to maximize value for Biogen shareholders. "We clearly communicated the process to all interested parties," Aoki said.
Biogen will hold its annual meeting on June 19. The shares, which closed at $62.25 on Wednesday on the Nasdaq, are up about 9 percent this year.
(Reporting by Lewis Krauskopf, editing by Maureen Bavdek)
http://biz.yahoo.com/rb/080605/biogen_icahn.html?.v=1
Emergence of Drugs from Elan/Wyeth...National Press Release
Emergence of Drugs from Elan/Wyeth, Eli Lilly, Myriad Genetics and Medivation Will Drive the Alzheimer's Disease Drug Market to Nearly Triple by 2017
WALTHAM, Mass.,
June 9 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the emergence of four novel therapies -- Elan/Wyeth's bapineuzumab, Eli Lilly's LY-2062430, Myriad Genetics' Flurizan and Medivation's Dimebon -- will drive the Alzheimer's disease drug market to nearly triple by 2017.
The new Pharmacor report entitled Alzheimer's Disease finds that sales of Alzheimer's disease drugs will increase from $3 billion in 2007 to nearly $9 billion in 2017 in the United States, France, Germany, Italy, Spain, United Kingdom and Japan. Because of their anticipated superior efficacy over small-molecule therapies, the two new biologic agents driving most of this growth will be bapineuzumab and LY-2062430. Although bapineuzumab and LY-2062430 may present greater safety risks than other emerging agents, the two drugs are estimated to collectively garner 71 percent of the Alzheimer's disease drug market in 2017, according to the report.
"We expect the monoclonal antibodies bapineuzumab and LY-2062430 to collectively garner $6 billion in sales by 2017," said Nitasha Manchanda, Ph.D., analyst at Decision Resources. "The emerging small-molecule agents Flurizan and Dimebon will also contribute to market growth, although to a lesser extent, accounting for $900 million in combined sales in 2017. However, if the monoclonal antibodies cannot establish superior efficacy over small-molecule agents in pivotal trials, Flurizan and Dimebon will have greater uptake."
The report also finds that sales of acetylcholinesterase inhibitors, the agents that currently dominate the Alzheimer's disease market, will drop by nearly half between 2007 and 2017. In 2007, acetylcholinesterase inhibitors accounted for 70 percent of market share; in 2017, they will represent only 13 percent, due to generic erosion, competition from emerging agents and a dramatic increase in the overall size of the market.
About Decision Resources
Decision Resources (http://www.decisionresources.com) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
emarshall@dresources.com
SOURCE Decision Resources
http://www.bizjournals.com/birmingham/prnewswire/press_relea…
ELN msg # 238790 6/9/2008 11:09:37 AMBy: Powershares_ie
Word on the street
AD
• June Announcement.
• The Phase II trials were to determine dosing levels and safety and the data is good.
• There was a range of trials and there will be a series of results that should be positively viewed by the market.
• However, the data is not unequivocal and statistical significance may not be met.
• There are no safety issues which is excellent.
• There is evidence of efficacy.
• Diagnoses is now possible (with mental imaging, deterioration of the brain is visible and familial AD is diagnosable).
• Phase III is enrolling very well and ahead of schedule.
• Company is very confident and advancements are being made on all fronts.
EDT
When biologics goes profitable (driven by reaching a certain number of Tysabri patients) Elan will demerge. Elan will remain Irish for fiscal purposes & there will be two separate Irish companies. Demerger will probably occur in late 2008.
Antwort auf Beitrag Nr.: 34.266.336 von bernie55 am 09.06.08 12:56:26Wyeth to Present at the Goldman Sachs Annual Global Healthcare Conference
Monday June 9, 12:30 pm ET
MADISON, N.J., June 9 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that it will present at the Goldman Sachs Twenty-Ninth Annual Global Healthcare Conference on June 11, 2008 at 2:20 p.m. Eastern Time.
Presenting for Wyeth will be Bernard Poussot, President and Chief Executive Officer, Wyeth.
Wyeth's presentation will be webcast live for investors at www.wyeth.com and available for replay following the conference.
--------------------------------------------------------------------------------------------------------------------------------------
Elan to Present at Goldman Sachs Global Healthcare Conference
Thursday June 5, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the Goldman Sachs 29th Annual Global Healthcare Conference on Wednesday, June 11, 2008 at 8:40 am PDT.
The conference takes place at the Ritz-Carlton Laguna Niguel in Dana Point, California. Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com , then clicking on the event icon.
Monday June 9, 12:30 pm ET
MADISON, N.J., June 9 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that it will present at the Goldman Sachs Twenty-Ninth Annual Global Healthcare Conference on June 11, 2008 at 2:20 p.m. Eastern Time.
Presenting for Wyeth will be Bernard Poussot, President and Chief Executive Officer, Wyeth.
Wyeth's presentation will be webcast live for investors at www.wyeth.com and available for replay following the conference.
--------------------------------------------------------------------------------------------------------------------------------------
Elan to Present at Goldman Sachs Global Healthcare Conference
Thursday June 5, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the Goldman Sachs 29th Annual Global Healthcare Conference on Wednesday, June 11, 2008 at 8:40 am PDT.
The conference takes place at the Ritz-Carlton Laguna Niguel in Dana Point, California. Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com , then clicking on the event icon.
Zur Vorfreude auf Bapineuzumab:
Villes Thema des Monats Juni: Antikörper gegen Amyloid-beta
http://www.wallstreet-online.de/diskussion/1134050-neustebei…
Villes Thema des Monats Juni: Antikörper gegen Amyloid-beta
http://www.wallstreet-online.de/diskussion/1134050-neustebei…
Antwort auf Beitrag Nr.: 34.272.160 von Ville7 am 10.06.08 10:45:41Hi @ all!
eeeennndddlich tut sich mal wieder was....wir steigen einfach klasse!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!Hoffen wir,dass die guten Ergebnisse bald kommen!!!!!!!!!!!!!!!!!!!!!!!
PS.bin ziemlich geschafft und sitze hier mit Eisbeutel und dicken Schmerztabletten nach einer Zahn-Wurzelspitzenresektion......da wird der Kiefer aufgebohrt und die Wurzelspitze abgeschnitten....war gar nicht lustig weil der Chirurg 3x nachspritzen musste weil die Entzündung direkt auf dem Nerv lag....Shit happens halt....
Viele Grüsse!Birgit
eeeennndddlich tut sich mal wieder was....wir steigen einfach klasse!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Hoffen wir,dass die guten Ergebnisse bald kommen!!!!!!!!!!!!!!!!!!!!!!!PS.bin ziemlich geschafft und sitze hier mit Eisbeutel und dicken Schmerztabletten nach einer Zahn-Wurzelspitzenresektion......da wird der Kiefer aufgebohrt und die Wurzelspitze abgeschnitten....war gar nicht lustig weil der Chirurg 3x nachspritzen musste weil die Entzündung direkt auf dem Nerv lag....Shit happens halt....
Viele Grüsse!
Birgit
Antwort auf Beitrag Nr.: 34.275.827 von Birgit.Tersteegen am 10.06.08 17:41:33und ich bin em geschädigt, möchte mit dir aber auf keinen fall tauschen. hoffe es geht dir bald besser.
+ $ 1,27
+ $ 1,27
Antwort auf Beitrag Nr.: 34.275.827 von Birgit.Tersteegen am 10.06.08 17:41:33gute Besserung, Birgit
Antwort auf Beitrag Nr.: 34.275.827 von Birgit.Tersteegen am 10.06.08 17:41:33 - Hi Birgit, -
dir eine supergute Besserung..
Grüße bernie55
- Hi Birgit, - dir eine supergute Besserung..
Grüße bernie55
AFTERHOURS ELAN:
17:45 $ 25.83 1,000
16:49 $ 25.90 500
16:41 $ 26.14 200
16:41 $ 26.14 300
16:10 $ 24.43 > 50,000
16:10 $ 24.43 > 50,000
16:09 $ 24.43 > 50,000
16:05 $ 25.855 > 90,000
16:00 $ 25.90 300
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
17:45 $ 25.83 1,000
16:49 $ 25.90 500
16:41 $ 26.14 200
16:41 $ 26.14 300
16:10 $ 24.43 > 50,000
16:10 $ 24.43 > 50,000
16:09 $ 24.43 > 50,000
16:05 $ 25.855 > 90,000
16:00 $ 25.90 300
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
Antwort auf Beitrag Nr.: 34.275.827 von Birgit.Tersteegen am 10.06.08 17:41:33Gute Besserung auch von meiner Seite.
Zähne sind eine teure und unangenehme Sache.
(wenn diese Beschwerden verursachen)
Zähne sind eine teure und unangenehme Sache.
(wenn diese Beschwerden verursachen)
Antwort auf Beitrag Nr.: 34.278.461 von bernie55 am 11.06.08 07:58:17Die Schwankungen sind ganz schön heftig bei den großen Mengen. von 25,855 auf 24,43 auf 26,14.
Mal sehen was die letzten Tage der Woche noch so bringen.
Mal sehen was die letzten Tage der Woche noch so bringen.
Herzlichen Dank für Eure lieben Genesungswünsche!!!Ich sehe aus wie ein "einseitiger" Hamster--als Selbständige nützt einem der gelbe Schein ziemlich wenig---also gehe ich gleich ins Büro + nuschele vor mich hin....
Heute könnte es spannend werden mit unserem Schätzchen....es ist die Goldman-Sachs-Investorenkonferenz und sie präsentieren dort....wahrscheinlich zwar noch nicht die Top-line-Daten aber vielleicht schon die Tendenz...we will see...GRÜSSE!
http://www.elan.com/investorrelations/events/webcast_details…
Goodbody TodayElan (Add, Closing Price $25.92); AAB-001 headline data - what can we expect?
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
In the run up to the publication of headline Phase II data on AAB-001 for the treatment of Alzheimer’s disease (AD) “mid-year”, we have published a 32-page report looking at different potential outcomes, the prospects for the AD drug market and the impact the data release should have on Elan’s share price. We expect that on the primary endpoints, the drug will demonstrate that it is safe and well tolerated with no change in the side effect profile noted in the Phase I trial.
On efficacy, given the relatively small number of patients in the trial (240), significant differences between treatment and placebo patients in overall cognition and functional parameters are extremely unlikely. As drug effect is being measured using the Neuropsychological Test Battery (NTB) and/or the Alzheimer’s disease Assessment Scale (ADAS-Cog), there should, however, be clear evidence of a trend towards better outcomes for patients on the drug relative to those on the placebo. There may be some statistical significance within individual modules that make up the NTB and ADAS-Cog battery of tests. We have reviewed the Alzheimer’s market.
Translating increasing patient numbers and drug market penetration into potential market size could see the Alzheimer’s drug market hit $11.5bn by 2015, rising to c.$19bn by 2025. Within this growing market, we forecast that AAB-001 could generate peak sales of $3.2bn to $6.5bn five years after launch, depending on efficacy and competition from other drugs entering the market. On the latter, we have reviewed c.90 pipeline candidates and highlight eight (including AAB-001 and three others with Elan connections), which currently show the greatest potential.
Elan’s value in the short to medium-term will depend on the AAB-001 headline data. We have run a number of sum-of-the parts scenarios, valuing the company should the drug (i) fail to deliver ($12.53 per share); (ii) show some promise - trend data ($24.56); (iii) show potential as a disease modifier ($29.37); or (iv) show significant impact on Alzheimer’s ($37.43). Our balance of probabilities between the scenarios indicates a fair value of $28.65, which is our new price target. Our caveat remains that the stock is high risk and data either substantially better or worse than expected will have a marked effect on the share price.
" target="_blank" rel="nofollow ugc noopener">http://www.rte.ie/business/2008/morningrep/download/0611goodbody.pdf
Antwort auf Beitrag Nr.: 34.278.780 von Birgit.Tersteegen am 11.06.08 09:02:19Ich sehe aus wie ein "einseitiger" Hamster--als Selbständige nützt einem der gelbe Schein ziemlich wenig---also gehe ich gleich ins Büro + nuschele vor mich hin....
..solange du eine Banane nicht quer essen musst , geht alles seinen gewohnten Genesungsweg....
..vielleicht wir die die CC bei GS auch dazu beitragen...
..solange du eine Banane nicht quer essen musst , geht alles seinen gewohnten Genesungsweg....
..vielleicht wir die die CC bei GS auch dazu beitragen...
Wyeth to Present at the Goldman Sachs Annual Global Healthcare Conference
Monday June 9, 12:30 pm ET
MADISON, N.J., June 9 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that it will present at the Goldman Sachs Twenty-Ninth Annual Global Healthcare Conference on June 11, 2008 at 2:20 p.m. Eastern Time.
Presenting for Wyeth will be Bernard Poussot, President and Chief Executive Officer, Wyeth.
Wyeth's presentation will be webcast live for investors at www.wyeth.com and available for replay following the conference.
--------------------------------------------------------------------------------------------------------------------------------------
Elan to Present at Goldman Sachs Global Healthcare Conference
Thursday June 5, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the Goldman Sachs 29th Annual Global Healthcare Conference on Wednesday, June 11, 2008 at 8:40 am PDT.
The conference takes place at the Ritz-Carlton Laguna Niguel in Dana Point, California. Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com , then clicking on the event icon.
> MSZE 17.40 Uhr <
Monday June 9, 12:30 pm ET
MADISON, N.J., June 9 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE - News) announced today that it will present at the Goldman Sachs Twenty-Ninth Annual Global Healthcare Conference on June 11, 2008 at 2:20 p.m. Eastern Time.
Presenting for Wyeth will be Bernard Poussot, President and Chief Executive Officer, Wyeth.
Wyeth's presentation will be webcast live for investors at www.wyeth.com and available for replay following the conference.
--------------------------------------------------------------------------------------------------------------------------------------
Elan to Present at Goldman Sachs Global Healthcare Conference
Thursday June 5, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the Goldman Sachs 29th Annual Global Healthcare Conference on Wednesday, June 11, 2008 at 8:40 am PDT.
The conference takes place at the Ritz-Carlton Laguna Niguel in Dana Point, California. Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at www.elan.com , then clicking on the event icon.
> MSZE 17.40 Uhr <
Hallo Ihr Alle,
dann will ich als gelegentlicher "Mitleser" auch einmal meine guten Wünsche für heute mit in die Waagschale werfen. Sieht ja schon nach einem nicht unwichtigen "Vorentscheid" aus.
Also, in der Hoffnung, dass sich Geduld letztendlich doch auszahlt (will aber noch nicht verkaufen) - good luck!!!
dann will ich als gelegentlicher "Mitleser" auch einmal meine guten Wünsche für heute mit in die Waagschale werfen. Sieht ja schon nach einem nicht unwichtigen "Vorentscheid" aus.
Also, in der Hoffnung, dass sich Geduld letztendlich doch auszahlt (will aber noch nicht verkaufen) - good luck!!!
Antwort auf Beitrag Nr.: 34.280.925 von bernie55 am 11.06.08 13:10:50
Goodbody Extract on AAB-001
Elan and Wyeth wanting to show that AAB-001 “works”
Elan has always stated that it wants the headline data release to be as clear as possible
and that it will indicate: (i) whether or not the drug is safe; and (ii) whether or not it works.
The companies’ definition of “works” is debatable, but the expectation that the trial will
show statistically significant differences between the treatments and placebo over a
range of tests has been flagged as very unrealistic, given the size of the patient
population. Elan has guided that the data would probably not be as "binary" as the market
is suggesting and that the majority of observers are only looking for evidence of trend/line
separation in the memory and functional data (i.e. when plotted over time, the patient
assessment scores show a divergence between treatments and placebo). Whether this
is statistically significant or not is another matter.
Prana Biotech released a similar type of announcement this February ...
An example of what might be provided is the headline data released by Prana Biotech on
its Phase II AD drug candidate PBT2. This was a small, 78-patient, trial in which AD
sufferers received either a 50mg PBT2, 250mg PBT2 or placebo capsule once a day for
12 weeks. On 26 February, the company issued a brief release, noting that the drug:
• demonstrated safety and tolerability at both dose levels;
• reduced beta-amyloid 42 in the CSF (a key biomarker for Alzheimer’s) - at the 250mg
level the reduction was “highly significant”;
• showed “encouraging signs of cognitive improvement” as measured by the NTB tests
- it showed “statistically significant improvement” in two of the four executive function
tests within the battery at the higher dose level; but
• had no effect on patient progress as measured by ADAS-Cog.
... but the sustainable price movement had been six weeks previous, on safety data
The company reported a mixed set of results over a range of parameters with no single
outstanding feature. Significance was observed, despite the trial size (78 patients), on
what the authorities consider an Alzheimer’s biomarker (beta-amyloid in the CSF) and
two of the NTB range of tests. On the day, the stock price jumped 36% from $4.10 to
$5.59, before returning to pre-announcement levels within a few days. This level (which
it is currently holding), however, was reached after a 115% rise over a one-month period,
six weeks previously, when an interim opinion from the independent data safety
monitoring board was published, noting that the drug was safe and well tolerated.
Goodbody Extract on AAB-001Elan and Wyeth wanting to show that AAB-001 “works”
Elan has always stated that it wants the headline data release to be as clear as possible
and that it will indicate: (i) whether or not the drug is safe; and (ii) whether or not it works.
The companies’ definition of “works” is debatable, but the expectation that the trial will
show statistically significant differences between the treatments and placebo over a
range of tests has been flagged as very unrealistic, given the size of the patient
population. Elan has guided that the data would probably not be as "binary" as the market
is suggesting and that the majority of observers are only looking for evidence of trend/line
separation in the memory and functional data (i.e. when plotted over time, the patient
assessment scores show a divergence between treatments and placebo). Whether this
is statistically significant or not is another matter.
Prana Biotech released a similar type of announcement this February ...
An example of what might be provided is the headline data released by Prana Biotech on
its Phase II AD drug candidate PBT2. This was a small, 78-patient, trial in which AD
sufferers received either a 50mg PBT2, 250mg PBT2 or placebo capsule once a day for
12 weeks. On 26 February, the company issued a brief release, noting that the drug:
• demonstrated safety and tolerability at both dose levels;
• reduced beta-amyloid 42 in the CSF (a key biomarker for Alzheimer’s) - at the 250mg
level the reduction was “highly significant”;
• showed “encouraging signs of cognitive improvement” as measured by the NTB tests
- it showed “statistically significant improvement” in two of the four executive function
tests within the battery at the higher dose level; but
• had no effect on patient progress as measured by ADAS-Cog.
... but the sustainable price movement had been six weeks previous, on safety data
The company reported a mixed set of results over a range of parameters with no single
outstanding feature. Significance was observed, despite the trial size (78 patients), on
what the authorities consider an Alzheimer’s biomarker (beta-amyloid in the CSF) and
two of the NTB range of tests. On the day, the stock price jumped 36% from $4.10 to
$5.59, before returning to pre-announcement levels within a few days. This level (which
it is currently holding), however, was reached after a 115% rise over a one-month period,
six weeks previously, when an interim opinion from the independent data safety
monitoring board was published, noting that the drug was safe and well tolerated.
Bloomerg gerade: Carl Iccahn bietet 82$ für Biogen-Aktie....
26,93$--!
!
Antwort auf Beitrag Nr.: 34.282.273 von Birgit.Tersteegen am 11.06.08 15:52:39da werden bald ein paar Leute den Kurs wieder nach unten drücken wollen.
(warum auch immer)
(warum auch immer)
Antwort auf Beitrag Nr.: 34.281.589 von Birgit.Tersteegen am 11.06.08 14:37:14Biotech firm Biogen Idec (BIIB 60.44) is receiving attention this morning on reports that the company received an $82 per share offer, or $15 billion, last year.
Das war letztes Jahr, Icahn versucht nun 3 "seiner Leute" in den Aufsichtsrat wählen zu lassen.
Das war letztes Jahr, Icahn versucht nun 3 "seiner Leute" in den Aufsichtsrat wählen zu lassen.
CC geht los...
km: "process to review aab data is ongoing, and not complete yet."
km: "process to review aab data is ongoing, and not complete yet."
...muss los...
..hoffe auf Zusammenfassung vom IV Board...
..hoffe auf Zusammenfassung vom IV Board...
Antwort auf Beitrag Nr.: 34.283.593 von bernie55 am 11.06.08 17:55:32...musste auch leider arbeiten....Daten sind nicht veröffentlicht aber Alles Bestens soweit!!
ELN msg # 239621 6/11/2008 12:19:08 PM
By: classicat6
Conf Call
All AD ontrack - no new updates.
Ty - next update on numbers 2nd quarter - 5000 per quarter added - each 10,000 patients equals $100.000 in profit.
Ty - oncology - BIIB lead
Ty - Colitis - ELN lead.
very comfortable
EDT - mid to upper teens growth very possible.
Excellent relations with Acorda. J&J progress in schitz drug.
Excellent cash flow - less risk. Expand portfolio with different companies.
Phase 2 data will get it out by mid year after review and brief.
Questions:
Sub Q forward - manufacturing facilities: EDT future as well:
Phase 2 data important to ELN - if points to confidence for Phase 3 - leads to dif decisions. Manufacturing important. Would like to be in position to control and not rely on partners.
EDT - reviewed and zero based once more clarity. By 2010 - at least 10 phase 2 programs. Want to make sure we can fully fund ourselves. Inflection point for planning next 5 years. Plan on 3-5 year cycles.
Details on Wye collaboration: Most pretty public. Asset split down the middle - work very hard with Wye - material point of view - up to councils - when all is released. For now - all shared and work extremely well together. Council tells us when to release.
Multiple AD products - pricing - huge topic - all AD patients not the same - dif biologic opportunities - where you are in slope of disease - AAC-001 - could be used very early on - pricing complex - philosophy - portfolio - makes more sense to have lower price to reach broader base. Mild to Mod AD - 10-15 mil, early - 25-50 mil - earlier explode even bigger. Move into all these areas over time.
What is Elan doing for other opportunities - number of beta amyloind sopecific - cognitive pathologies. Others not related. Working internally with Wye - premature - some resources are looking at this - don't want to dilute focus yet. 6-12 months - with more clarity - may move forward on other disease areas.
Park disease - timelines - very complicated - progression takes many years - complex - certain immuno could apply - research budget - shifted many more resources to Park. 24 months - talk very specifically and into clinic asap after that. US - 1.5 mil patients.
Role of FDA in BAP - Both FDA and EMEa - very good relationship - both agencies saw interim data - both had input to phase 3 design.
Diversify - yes - other things we are looking at - some of our best people looking at that. We have a lot of insights that are proprietary - can triagulate what that would mean to AD patient. After AD portfolio further along - will add 1 or 2 other approaches. More we learn - more we have thoughts - focused on mild to mod AD - real questions from bio marker - can you get that earlier - much better for patients. Immuno applicable earlier as well.
Ty - 100,000 patients by 2010 - how much above by 2010 - MS all about efficacy - 40% showed 0 decline - data on patients - 1/3 are new patients - 9 plus billion $ market. From MS point of view, momentum and patient - 100,000 isn't a ceiling. 100,000 is only base number.
Aggressive plans for clinical trials - cash support? - Watch cash closely - is a portfolio - pipeline cost and option value - farther along - more option value - good quality programs creates much more value. Will make sure we have cash to move porducts forward. AD space - no company has as many products as we do - always kept 1Bil in cash. Very disciplined and focused on finance.
Very best AD off of program and put on Park.? Idicates where we are. Shenk and team since 80's - but now in clinic. Big overlap with AD and PD. We are very confident - beta-amyloid and immuno therapies. Feel very good about it. PD - little for patients - so moving assets there since AD is in clinic. About 50% of time switched from AD to PD.
ELN msg # 239621 6/11/2008 12:19:08 PMBy: classicat6
Conf Call
All AD ontrack - no new updates.
Ty - next update on numbers 2nd quarter - 5000 per quarter added - each 10,000 patients equals $100.000 in profit.
Ty - oncology - BIIB lead
Ty - Colitis - ELN lead.
very comfortable
EDT - mid to upper teens growth very possible.
Excellent relations with Acorda. J&J progress in schitz drug.
Excellent cash flow - less risk. Expand portfolio with different companies.
Phase 2 data will get it out by mid year after review and brief.
Questions:
Sub Q forward - manufacturing facilities: EDT future as well:
Phase 2 data important to ELN - if points to confidence for Phase 3 - leads to dif decisions. Manufacturing important. Would like to be in position to control and not rely on partners.
EDT - reviewed and zero based once more clarity. By 2010 - at least 10 phase 2 programs. Want to make sure we can fully fund ourselves. Inflection point for planning next 5 years. Plan on 3-5 year cycles.
Details on Wye collaboration: Most pretty public. Asset split down the middle - work very hard with Wye - material point of view - up to councils - when all is released. For now - all shared and work extremely well together. Council tells us when to release.
Multiple AD products - pricing - huge topic - all AD patients not the same - dif biologic opportunities - where you are in slope of disease - AAC-001 - could be used very early on - pricing complex - philosophy - portfolio - makes more sense to have lower price to reach broader base. Mild to Mod AD - 10-15 mil, early - 25-50 mil - earlier explode even bigger. Move into all these areas over time.
What is Elan doing for other opportunities - number of beta amyloind sopecific - cognitive pathologies. Others not related. Working internally with Wye - premature - some resources are looking at this - don't want to dilute focus yet. 6-12 months - with more clarity - may move forward on other disease areas.
Park disease - timelines - very complicated - progression takes many years - complex - certain immuno could apply - research budget - shifted many more resources to Park. 24 months - talk very specifically and into clinic asap after that. US - 1.5 mil patients.
Role of FDA in BAP - Both FDA and EMEa - very good relationship - both agencies saw interim data - both had input to phase 3 design.
Diversify - yes - other things we are looking at - some of our best people looking at that. We have a lot of insights that are proprietary - can triagulate what that would mean to AD patient. After AD portfolio further along - will add 1 or 2 other approaches. More we learn - more we have thoughts - focused on mild to mod AD - real questions from bio marker - can you get that earlier - much better for patients. Immuno applicable earlier as well.
Ty - 100,000 patients by 2010 - how much above by 2010 - MS all about efficacy - 40% showed 0 decline - data on patients - 1/3 are new patients - 9 plus billion $ market. From MS point of view, momentum and patient - 100,000 isn't a ceiling. 100,000 is only base number.
Aggressive plans for clinical trials - cash support? - Watch cash closely - is a portfolio - pipeline cost and option value - farther along - more option value - good quality programs creates much more value. Will make sure we have cash to move porducts forward. AD space - no company has as many products as we do - always kept 1Bil in cash. Very disciplined and focused on finance.
Very best AD off of program and put on Park.? Idicates where we are. Shenk and team since 80's - but now in clinic. Big overlap with AD and PD. We are very confident - beta-amyloid and immuno therapies. Feel very good about it. PD - little for patients - so moving assets there since AD is in clinic. About 50% of time switched from AD to PD.
ELN msg # 239622 6/11/2008 12:20:01 PMBy: NIGHTRADER44
from briefing.com
12:18 ELN Elan: Goldman Sachs healthcare conference (26.19 +0.27) -Update-
Co speaks on EDT, Tysabri and Alzheimer's. On immunotherapy: ACC001 -- partnership with Wyeth -- is the lead program in multiple programs they have in Immunotherapeutic platform -- have divided groups by genotype. Co says that it's "back on track". Their second alzheimer's drug (deals with transition therapeutics) is in phase II in mild to moderate stage, and going well from a recruitment point of view. Tysabri: announced reiterates the 26,000 patients, and next update will be in 1H in July, during the Q2 announcement... Crones indication: getting touch program undergoing. Life cycle in Tysabri: a lot of investment and traction. On EDT: less risk than biotech business, they are trying to expand portfolio with partners... From analyst questions, co says they have split the assets with Wyeth (WYE) down the middle in terms of responsibility and p&l. On pipeline pricing between multiple Alzheimer's drugs developed by ELN and Wyeth: co says there are different biologic paths that can be treated -- basically says that the disease remains very differentiated, but still trying to hit on pricing as to appeal to a larger audience. Pricing depends on population...Reaching more than 100,000 patients by 2010 in Tysabri - efficacy and patient churn is very impactful. Think there could be upside to that number, and investors could expect an announcement by either Biogen (BIIB) or them on upside guidance... Co says that from a risk diversification perspective, co presents enormous risk/reward opportunity in their Alzheimer's portfolio for investors, despite entire pipeline being beta-centric. Co feels very secure from a cash perspective.
http://www.cnbc.com/id/25098115/site/14081545?__source=yahoo…" target="_blank" rel="nofollow ugc noopener">http://www.cnbc.com/id/25098115/site/14081545?__source=yahoo…
ELN msg # 239692 6/11/2008 1:34:34 PMBy: longtimelong
Rough notes from today's talk by KM
Tysabri:
Adding roughly 5000 patients/qtr.
10,000 Tysabri patients is 100 million in profit for Elan
July is two-year anniversary of re-introduction.
For Crohn's: Focus is on getting doctors and patients on the TOUCH program.
Significant Tysabri opportunity for oncology.
Biogen taking the lead on this.
Tysabri for Ulcerative colitits: at least phase II by end of year.
Elan takes the lead.
EDT: an excellent cash flow business with great growth prospects.
------
Q&A:
The phase II data is extremely important to Elan.
Everything will be reviewed once we have more clarity on the Phase II data.
Pricing for bap: it probably makes sense to have pricing that gives you access to
a broader population.
10 to 15 million mild to moderate patients in US and Europe.
Early Alz: much bigger market.
Pricing is complex. (Elan won't have just a single AD drug.)
Our collective goal is to move into early Alz.
Parkinson's disease timeline?
PD very complicated. Progression takes many years. Pathology more complex.
We spend more on PD than on Alz.
Have shifted resources toward PD over the
last 2.5 years. In the next couple of years we should be able to talk about it.
Est. 1.5 million patients; vastly understated. Working closely with multiple
foundations in the US. Some of our best scientists working on it.
Both FDA and EMEA --- very good relationships with both organizations.
Both were involved in looking at the Phase III design. (Bap)
Exploring other hypotheses besides amyloid?
Yes. Some of our best people
internally are working on that.
We have a lot of proprietary insights.
After immunotherapy is further along, and the portfolio is further along,
from a research point of view you will hear that we have added one or two
other approaches to AD. Particularly at different stages of AD.
The real question is ... can you get that earlier and earlier,
and if you can it is obviously much better for patients.
Yes we are looking at other things
and we think that over time we will probably add other approaches.
Tysabri: How much above 100,000 patients do you think you can get by 2010?
30 to 35% of MS patients on Tysabri show no further decline.
Hard to argue against
the efficacy of Tysabri.
It's a $6 billion before Tysabri,
a $9 billion market with Ty. ...
There's no reason that number (100,000) needs to be a ceiling. ...
We will make sure we have more than enough cash for our pipeline as we move forward.
A very big overlap in the research between AD and PD. Very confident but not
overconfident in the beta amyloid hypothesis and the immunotherapeutic approach to it.
Both opportunity and cross-over knowledge.
Antwort auf Beitrag Nr.: 34.284.890 von Birgit.Tersteegen am 11.06.08 20:27:37Davy
Elan Corp (USc)
ELN US
Analysis of Bapineuzumab data ongoing but not complete; ACC-001's return confirmed
Jack Gorman
Price $26.35 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
CEO Kelly Martin's presentation at a US investor conference contained little new information about the business and most importantly about Bapineuzumab. The analysis of the Phase II data is ongoing but not yet complete. The CEO also confirmed that dosing was restarted last week in the Phase II trials for its AD vaccine ACC-001, which was suspended in April.
Elsewhere, the CEO indicated that the next Tysabri update will be provided at Elan's Q2 results in July. The product is demonstrating 'continued progress' and is nearing its two-year anniversary on the market — this could be an important milestone for some neurologists as they assess the risk/benefit profile for their patients.
On EDT, the outlook remains positive and the prospect of mid-to-upper-teens growth was reiterated.
http://www.investorvillage.com/smbd.asp?mb=160&mn=239899&pt=…
Elan Corp (USc)
ELN US
Analysis of Bapineuzumab data ongoing but not complete; ACC-001's return confirmed
Jack Gorman
Price $26.35 Target: $25.50 Issued: 23/01/08 Previous: $21.00 Issued: 21/05/07
--------------------------------------------------------------------------------
CEO Kelly Martin's presentation at a US investor conference contained little new information about the business and most importantly about Bapineuzumab. The analysis of the Phase II data is ongoing but not yet complete. The CEO also confirmed that dosing was restarted last week in the Phase II trials for its AD vaccine ACC-001, which was suspended in April.
Elsewhere, the CEO indicated that the next Tysabri update will be provided at Elan's Q2 results in July. The product is demonstrating 'continued progress' and is nearing its two-year anniversary on the market — this could be an important milestone for some neurologists as they assess the risk/benefit profile for their patients.
On EDT, the outlook remains positive and the prospect of mid-to-upper-teens growth was reiterated.
http://www.investorvillage.com/smbd.asp?mb=160&mn=239899&pt=…
Antwort auf Beitrag Nr.: 34.284.890 von Birgit.Tersteegen am 11.06.08 20:27:37Goodbodys
Elan (Add, Closing Price $26.35)
ACC-001 back in trials: AAB-001 data being analysed: Tysabri patient numbers on track
Analyst: Ian Hunter
Elan yesterday indicated that dosing restarted last week in its ACC-001 Phase II trial, originally suspended in mid-April. The drug, which takes an active immunisation approach to the potential treatment of Alzheimer's, is the follow-on from AN-1792, which was withdrawn from trials in 2002. The current trial started in November 2007. Fifty of a planned 228 patients had enrolled and were on treatment when one in Europe developed vasculitis, which manifested itself as skin lesions on the patient's finger and toes. The trial is now back on track and, given the two month delay, we presume is now scheduled for completion by May 2012. Elan also indicated that the review of Phase II data of AAB-001 for the treatment of Alzheimer's is on-going and has not yet been completed. Management will then be presented with a review of the data and the intention is to release top-line data by mid-year. On Tysabri, management noted that there are roughly 5,000 patients being added every quarter. With 26,000 patients on the drug by the end of Q108, this would imply c.31,000 by the end of Q208. We have 30,700 pencilled in for the end of Q208. The return of ACC-001 into trials is an incremental positive for Elan at a time when the market is awaiting the release of AAB-001 Phase II data.
http://www.investorvillage.com/smbd.asp?mb=160&mn=239900&pt=…
Elan (Add, Closing Price $26.35)
ACC-001 back in trials: AAB-001 data being analysed: Tysabri patient numbers on track
Analyst: Ian Hunter
Elan yesterday indicated that dosing restarted last week in its ACC-001 Phase II trial, originally suspended in mid-April. The drug, which takes an active immunisation approach to the potential treatment of Alzheimer's, is the follow-on from AN-1792, which was withdrawn from trials in 2002. The current trial started in November 2007. Fifty of a planned 228 patients had enrolled and were on treatment when one in Europe developed vasculitis, which manifested itself as skin lesions on the patient's finger and toes. The trial is now back on track and, given the two month delay, we presume is now scheduled for completion by May 2012. Elan also indicated that the review of Phase II data of AAB-001 for the treatment of Alzheimer's is on-going and has not yet been completed. Management will then be presented with a review of the data and the intention is to release top-line data by mid-year. On Tysabri, management noted that there are roughly 5,000 patients being added every quarter. With 26,000 patients on the drug by the end of Q108, this would imply c.31,000 by the end of Q208. We have 30,700 pencilled in for the end of Q208. The return of ACC-001 into trials is an incremental positive for Elan at a time when the market is awaiting the release of AAB-001 Phase II data.
http://www.investorvillage.com/smbd.asp?mb=160&mn=239900&pt=…
Unfiltered Notes from ELN at Goldman Sachs 11Jun2008
Many thoughtful posters have already provided notes or feedback, but here are my notes having finally listened to the presentation:
http://www.investorvillage.com/smbd.asp?mb=160&mn=239966&pt=…
Many thoughtful posters have already provided notes or feedback, but here are my notes having finally listened to the presentation:
http://www.investorvillage.com/smbd.asp?mb=160&mn=239966&pt=…
Antwort auf Beitrag Nr.: 34.291.453 von bernie55 am 12.06.08 17:07:48HI Birgit und Bernie, was hat ELAN mit Abraxis zu tun.
Hi,
falls das noch nicht gepostet wurde, untenstehend ein Link zu einem Artikel über:
"Wyeth and Elan Face Big Test on Alzheimer's Drug"
http://seekingalpha.com/article/81057-wyeth-and-elan-face-bi…
Beste Grüße,
d.H.
falls das noch nicht gepostet wurde, untenstehend ein Link zu einem Artikel über:
"Wyeth and Elan Face Big Test on Alzheimer's Drug"
http://seekingalpha.com/article/81057-wyeth-and-elan-face-bi…
Beste Grüße,
d.H.
Antwort auf Beitrag Nr.: 34.292.852 von surga am 12.06.08 20:57:05HI Birgit und Bernie, was hat ELAN mit Abraxis zu tun.
Hallo surga,
es geht darum, dass ELAN gegen die Firma ABRAXIS BioScience klagt, da letztere mit dem Mittel Abraxane ( Brustkrebs) angeblich ein geschütztes Patent verletzt haben soll. ELAN will vor einem Gericht Umsatzlizenzgebühren für den Verkauf diese Mittels ( Umsatz 2007 ca. $288 Millionen ) einfordern.
Grüße bernie55
PS: ....kannst du nochmal nachlesen in # 19384 / # 19385
Hallo surga,
es geht darum, dass ELAN gegen die Firma ABRAXIS BioScience klagt, da letztere mit dem Mittel Abraxane ( Brustkrebs) angeblich ein geschütztes Patent verletzt haben soll. ELAN will vor einem Gericht Umsatzlizenzgebühren für den Verkauf diese Mittels ( Umsatz 2007 ca. $288 Millionen ) einfordern.
Grüße bernie55
PS: ....kannst du nochmal nachlesen in # 19384 / # 19385
Antwort auf Beitrag Nr.: 34.293.684 von dasHaendchen am 12.06.08 23:14:47THX " Haendchen "
Wyeth and Elan Face Big Test on Alzheimer's Drug
by: Mike Huckman posted on: June 12, 2008
Cancer, diabetes and Alzheimer's Disease. Three of the biggest areas of unmet medical need have been or will be in focus at a series of important scientific meetings in June or July.
We just finished back-to-back coverage of the world's largest oncology and diabetes conferences. Now we get a bit of a break before shifting our attention to Alzheimer's.
Specifically, analysts say Wyeth (WYE) and Elan (ELN) could be out with basic results on a mid-stage test for their drug by the end of this month.
Then they're expected to present the detailed data at the International Conference on Alzheimer's Disease in late July.
Some analysts think if the drug shows promise it could become the biggest selling drug in history.
Bill Tanner at Leerink Swann wrote in a research note to clients yesterday that "investors should not expect to see significant treatment effects given the relatively small size of the trial and the heterogeneity of the patients population." (Dear Elanians: I'm just reporting what the man said, please do not flood my inbox with complaints about what you might see as his bearish analysis.)
Nonetheless, he believes there will probably be enough positive data for the companies to continue to move forward. Coincidentally, Brian McCarthy, a biotech analyst at Merriman Curhan Ford initiated coverage yesterday of ELN with a Buy rating.
But he agrees with Tanner about the pending test results. "We believe a statistically significant response in Phase 2 (mid-stage clinical trial) is unlikely given the small number of patients," McCarthy writes.
He justifies his Buy rating by saying, "Positive Phase 2 Alzheimer's data could add approximately $7 in the near-term, or approximately $15 longer term if (the drug) succeeds for AD."
But buyer beware. Both analysts also say that ELN shares could be volatile in the coming weeks.
Leerink Swann may trade ELN shares. Typically, if a company doesn't have any disclosures on a stock I won't mention it. I only point them out if they exist. But since MCF is initiating coverage I will say it has none to make.
An estimated five million Americans have Alzheimer's. That number is expected to multiply.
http://seekingalpha.com/article/81057-wyeth-and-elan-face-bi…
Wyeth and Elan Face Big Test on Alzheimer's Drug
by: Mike Huckman posted on: June 12, 2008
Cancer, diabetes and Alzheimer's Disease. Three of the biggest areas of unmet medical need have been or will be in focus at a series of important scientific meetings in June or July.
We just finished back-to-back coverage of the world's largest oncology and diabetes conferences. Now we get a bit of a break before shifting our attention to Alzheimer's.
Specifically, analysts say Wyeth (WYE) and Elan (ELN) could be out with basic results on a mid-stage test for their drug by the end of this month.
Then they're expected to present the detailed data at the International Conference on Alzheimer's Disease in late July.
Some analysts think if the drug shows promise it could become the biggest selling drug in history.
Bill Tanner at Leerink Swann wrote in a research note to clients yesterday that "investors should not expect to see significant treatment effects given the relatively small size of the trial and the heterogeneity of the patients population." (Dear Elanians: I'm just reporting what the man said, please do not flood my inbox with complaints about what you might see as his bearish analysis.)
Nonetheless, he believes there will probably be enough positive data for the companies to continue to move forward. Coincidentally, Brian McCarthy, a biotech analyst at Merriman Curhan Ford initiated coverage yesterday of ELN with a Buy rating.
But he agrees with Tanner about the pending test results. "We believe a statistically significant response in Phase 2 (mid-stage clinical trial) is unlikely given the small number of patients," McCarthy writes.
He justifies his Buy rating by saying, "Positive Phase 2 Alzheimer's data could add approximately $7 in the near-term, or approximately $15 longer term if (the drug) succeeds for AD."
But buyer beware. Both analysts also say that ELN shares could be volatile in the coming weeks.
Leerink Swann may trade ELN shares. Typically, if a company doesn't have any disclosures on a stock I won't mention it. I only point them out if they exist. But since MCF is initiating coverage I will say it has none to make.
An estimated five million Americans have Alzheimer's. That number is expected to multiply.
http://seekingalpha.com/article/81057-wyeth-and-elan-face-bi…
Antwort auf Beitrag Nr.: 34.294.387 von bernie55 am 13.06.08 08:21:29Danke Bernie für Deine Info
http://www.cnbc.com/id/25123902/site/14081545
Wyeth & Elan Are Real Hot Topic At Investor Meeting
Posted By:Mike Huckman
I'm at the Needham & Company biotech conference in New York City. Whenever possible I like to attend events like this. It's a good place to get story ideas. The Needham meeting is competing this year with a similar one being put on by Goldman Sachs in Laguna Beach, CA.
Hmmm...midtown Manhattan in scorching summer heat and humidity or the Pacific Ocean? I didn't choose wisely, but something tells me my bosses just might have pushed back if I said, "I really need to go to this healthcare investment conference in Laguna to network."
Anyway, in addition to all of the company presentations there are a number of "Meet the Experts" sessions featuring rock star docs talking about hot topics.
So, I went to the one at lunch today on Alzheimer's Disease. Dr. Steven Ferris from NYU was the speaker. He has done consulting and worked on clinical trials for nearly all of the major companies developing or selling AD drugs.
He opened his talk by saying he could sense the level of anticipation in the room. "I see a lot of tea leaves out on the tables," Dr. Ferris said, referring to the pending Wyeth
"I don't have any inside information," he continued. "And I wouldn't give it to you if I did."
"Everybody's holding their breath for the phase two (mid-stage) Elan-Wyeth data," Dr. Ferris said.
He talked about the various classes of drugs, including the one from WYE and ELN that are designed to attack the plaque in the brain that many experts believe may cause Alzheimer's. "This is where all of the excitement is," Dr. Ferris said.
But the suspected culprit of the disease is the subject of much debate. One thing that everyone seems to agree on, though, is that Alzheimer's is a fast-growing problem. Dr. Ferris said the number of people with it will triple or quadruple in the next half a century. "Alzheimer's is gonna bankrupt Medicare," he said bluntly.
Finally, a shout out to Isis Pharmaceuticals
ISIS PHARMACEUTICAL Executive VP Dr. Jeff Jonas for refreshing brevity. (CEO Stanley Crooke is on vacation.) The presenters from publicly held companies always have to recite what's called a "Safe Harbor Statement". It's a Securities and Exchange Commission regulatory thing that is usually full of legalese. Most execs just put up the PowerPoint page with the 17 or so lines of fine print and say something like, "Here's the safe harbor statement" and then read a few sentences or sometimes all of it. Yawn.
They rarely, if ever, deviate from that script. So, that's why I applaud Dr. Jonas' cool paraphrase during his session this afternoon. First of all, his very last slide was the safe harbor statement--it's normally toward the top. And then he said, "I'm not gonna read it. Take everything with a grain of salt. It's a risky business." Couldn't have said it better myself.
UPDATE: Part of a press release from the CDC late this afternoon: Alzheimer's disease is now the sixth leading cause of death in the United States, according to the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics. The CDC estimates that 72,914 Americans died of Alzheimer's disease in 2006. With an unprecedented historic population shift of 78 million aging baby boomers in the country and this disease poised to strike 10 million boomers - it is clear this escalating epidemic must be addressed now.
http://www.cnbc.com/id/25123902/site/14081545
Wyeth & Elan Are Real Hot Topic At Investor Meeting
Posted By:Mike Huckman
I'm at the Needham & Company biotech conference in New York City. Whenever possible I like to attend events like this. It's a good place to get story ideas. The Needham meeting is competing this year with a similar one being put on by Goldman Sachs in Laguna Beach, CA.
Hmmm...midtown Manhattan in scorching summer heat and humidity or the Pacific Ocean? I didn't choose wisely, but something tells me my bosses just might have pushed back if I said, "I really need to go to this healthcare investment conference in Laguna to network."
Anyway, in addition to all of the company presentations there are a number of "Meet the Experts" sessions featuring rock star docs talking about hot topics.
So, I went to the one at lunch today on Alzheimer's Disease. Dr. Steven Ferris from NYU was the speaker. He has done consulting and worked on clinical trials for nearly all of the major companies developing or selling AD drugs.
He opened his talk by saying he could sense the level of anticipation in the room. "I see a lot of tea leaves out on the tables," Dr. Ferris said, referring to the pending Wyeth
"I don't have any inside information," he continued. "And I wouldn't give it to you if I did."
"Everybody's holding their breath for the phase two (mid-stage) Elan-Wyeth data," Dr. Ferris said.
He talked about the various classes of drugs, including the one from WYE and ELN that are designed to attack the plaque in the brain that many experts believe may cause Alzheimer's. "This is where all of the excitement is," Dr. Ferris said.
But the suspected culprit of the disease is the subject of much debate. One thing that everyone seems to agree on, though, is that Alzheimer's is a fast-growing problem. Dr. Ferris said the number of people with it will triple or quadruple in the next half a century. "Alzheimer's is gonna bankrupt Medicare," he said bluntly.
Finally, a shout out to Isis Pharmaceuticals
ISIS PHARMACEUTICAL Executive VP Dr. Jeff Jonas for refreshing brevity. (CEO Stanley Crooke is on vacation.) The presenters from publicly held companies always have to recite what's called a "Safe Harbor Statement". It's a Securities and Exchange Commission regulatory thing that is usually full of legalese. Most execs just put up the PowerPoint page with the 17 or so lines of fine print and say something like, "Here's the safe harbor statement" and then read a few sentences or sometimes all of it. Yawn.
They rarely, if ever, deviate from that script. So, that's why I applaud Dr. Jonas' cool paraphrase during his session this afternoon. First of all, his very last slide was the safe harbor statement--it's normally toward the top. And then he said, "I'm not gonna read it. Take everything with a grain of salt. It's a risky business." Couldn't have said it better myself.
UPDATE: Part of a press release from the CDC late this afternoon: Alzheimer's disease is now the sixth leading cause of death in the United States, according to the Centers for Disease Control and Prevention (CDC) National Center for Health Statistics. The CDC estimates that 72,914 Americans died of Alzheimer's disease in 2006. With an unprecedented historic population shift of 78 million aging baby boomers in the country and this disease poised to strike 10 million boomers - it is clear this escalating epidemic must be addressed now.
gute Nachrichten, zeigt sich auch am Kursverlauf:
(sauber nach unten)
(sauber nach unten)
Antwort auf Beitrag Nr.: 34.294.584 von Poppholz am 13.06.08 08:57:29hat das auch mit Option zu tun, die am Freitag nächste Woche fällig ist?
http://finance.yahoo.com/q/op?s=ELN
http://finance.yahoo.com/q/op?s=ELN
Antwort auf Beitrag Nr.: 34.294.621 von surga am 13.06.08 09:03:23kann sehr gut sein.
Wahrscheinlich wird sich diesbezüglich der Kurs auf die $25,- Marke einpendeln.
(aber wer weiß das schon)
Wahrscheinlich wird sich diesbezüglich der Kurs auf die $25,- Marke einpendeln.
(aber wer weiß das schon)
CSFB on Elan
Fundamentals Strong Ahead of Likely Volatility
Surrounding Key Catalyst
■ Since mid- March Elan shares have risen by 40% in absolute terms and outperformed the pan Euro Pharma index by some 34%.
■ We believe Elan has the most innovative and advanced Alzheimer’s
pipelines within the industry and view the upcoming Phase II data for AAB-001 as potentially providing strong affirmation of the decision to progress a year early into Phase III trails.
■ However with the uncertainty of the Phase II data outcomes ahead of us, trading over the coming weeks around the headline data release is likely to be volatile
■ We believe some investors enjoying a recent run up in the stock may see this as an opportune time to lock in profits and we would not fight this, - however, in our view, longer-term investors willing to factor in management’s 2010 Tysabri targets for sales of c$3bn (consensus $1.5bn) may well have very attractive asymmetry ahead of any possible positive data surprises which could result in a significant positive inflection in the shares.
■ For these reasons we maintain our Outperform rating but choose to remove Elan from the Credit Suisse Pan Euro Focus List.
■ On our current Tysabri estimates should AAB-001- be approved we see over 60% upside to the current share price as justified - should the product fail we see around 30% downside to the current price. We will not know the outcome of either of these scenarios until data reads out from the ongoing Phase III trails over the coming 2 years
http://www.investorvillage.com/smbd.asp?mb=160&mn=240305&pt=…
Fundamentals Strong Ahead of Likely Volatility
Surrounding Key Catalyst
■ Since mid- March Elan shares have risen by 40% in absolute terms and outperformed the pan Euro Pharma index by some 34%.
■ We believe Elan has the most innovative and advanced Alzheimer’s
pipelines within the industry and view the upcoming Phase II data for AAB-001 as potentially providing strong affirmation of the decision to progress a year early into Phase III trails.
■ However with the uncertainty of the Phase II data outcomes ahead of us, trading over the coming weeks around the headline data release is likely to be volatile
■ We believe some investors enjoying a recent run up in the stock may see this as an opportune time to lock in profits and we would not fight this, - however, in our view, longer-term investors willing to factor in management’s 2010 Tysabri targets for sales of c$3bn (consensus $1.5bn) may well have very attractive asymmetry ahead of any possible positive data surprises which could result in a significant positive inflection in the shares.
■ For these reasons we maintain our Outperform rating but choose to remove Elan from the Credit Suisse Pan Euro Focus List.
■ On our current Tysabri estimates should AAB-001- be approved we see over 60% upside to the current share price as justified - should the product fail we see around 30% downside to the current price. We will not know the outcome of either of these scenarios until data reads out from the ongoing Phase III trails over the coming 2 years
http://www.investorvillage.com/smbd.asp?mb=160&mn=240305&pt=…
NCB
Opexa Therapeutics yesterday announced positive safety and efficacy data for Tovaxin,its investigational T-cell vaccination therapy for MS, in the second year of open-label clinical retreatment studies.
• The patient population of 22, comprised 13 patients with relapsing remitting MS and 9with secondary progressive MS.
• The analysis of disease progression of the disability over a 2 year period, showed that 73% of patients remained relapse-free at two years. The combined analysis included involved in a Phase I/II dose-escalation study and a Phase I/II re-treatment study. Patients did not receive any other disease modifying therapies during the two year study . At present, Tovaxin is not scheduled to reach the filing stage until 2012.
• Tovaxin is administered via the subcutaneous (Sub-Q) route which would offer a commercial advantage over IV infusion alternatives. Elan/BiogenIdec are currently in Phase II with a Sub Q formulation for Tysabri which would further underpin its share of the MS market.
http://www.investorvillage.com/smbd.asp?mb=160&mn=240310&pt=…
Opexa Therapeutics yesterday announced positive safety and efficacy data for Tovaxin,its investigational T-cell vaccination therapy for MS, in the second year of open-label clinical retreatment studies.
• The patient population of 22, comprised 13 patients with relapsing remitting MS and 9with secondary progressive MS.
• The analysis of disease progression of the disability over a 2 year period, showed that 73% of patients remained relapse-free at two years. The combined analysis included involved in a Phase I/II dose-escalation study and a Phase I/II re-treatment study. Patients did not receive any other disease modifying therapies during the two year study . At present, Tovaxin is not scheduled to reach the filing stage until 2012.
• Tovaxin is administered via the subcutaneous (Sub-Q) route which would offer a commercial advantage over IV infusion alternatives. Elan/BiogenIdec are currently in Phase II with a Sub Q formulation for Tysabri which would further underpin its share of the MS market.
http://www.investorvillage.com/smbd.asp?mb=160&mn=240310&pt=…
ELN msg # 240305 6/13/2008 3:44:03 AMBy: Powershares_ie
CSFB on Elan - Fundamentals Strong Ahead of Likely Volatility
Fundamentals Strong Ahead of Likely Volatility
Surrounding Key Catalyst
■
Since mid- March Elan shares have risen by 40% in absolute terms and
outperformed the pan Euro Pharma index by some 34%.
■
We believe Elan has the most innovative and advanced Alzheimer’s
pipelines within the industry and view the upcoming Phase II data for
AAB-001 as potentially providing strong affirmation of the decision to
progress a year early into Phase III trails.
■
However with the uncertainty of the Phase II data outcomes ahead of
us, trading over the coming weeks around the headline data release is
likely to be volatile
■
We believe some investors enjoying a recent run up in the stock may
see this as an opportune time to lock in profits and we would not fight
this, - however, in our view, longer-term investors willing to factor in
management’s 2010 Tysabri targets for sales of c$3bn (consensus
$1.5bn) may well have very attractive asymmetry ahead of any possible
positive data surprises which could result in a significant positive
inflection in the shares.
■
For these reasons we maintain our Outperform rating but choose to
remove Elan from the Credit Suisse Pan Euro Focus List.
■
On our current Tysabri estimates should AAB-001- be approved we see
over 60% upside to the current share price as justified - should the
product fail we see around 30% downside to the current price. We will
not know the outcome of either of these scenarios until data reads out
from the ongoing Phase III trails over the coming 2 years
Antwort auf Beitrag Nr.: 34.296.854 von Birgit.Tersteegen am 13.06.08 13:14:35sorry.....doppelt:rolleyesBin immer nnoch angeschlagen---nun Entzündung am operierten Zahn---jetzt sollen Antibiotika helfen....grrrhh!!) Grüsse--Wo ist eigentlich Holgus??
Bin immer nnoch angeschlagen---nun Entzündung am operierten Zahn---jetzt sollen Antibiotika helfen....grrrhh!!) Grüsse--Wo ist eigentlich Holgus?? Goldman SachsDespite speculation by investors that the phase II data for Bapineuzumab in Alzheimer’s Disease might be announced at the Goldman Sachs Healthcare Conference, investors will need to be patient for a few more weeks before the data will be announced and potentially a few weeks more until the detailed data are presented at the ICAD Meeting (July 26-31).
Implications
We expect the stock to remain range-bound but volatile ahead of the announcement of the Bapineuzumab data. We remain bullish on the long-term outlook for Bapineuzumab and for Elan’s Alzheimer’s Disease franchise, however, the detail of the phase II results announcement cannot be predicted with any certainty. In addition, the group announced that ACC-001 has re-commenced dosing in the phase II study. Although investors remain very focused on the phase II data, in our view, the implications of positive data for Elan are significantly more important, as it will help determine the group’s strategic direction for the next several years.
Valuation
Our 6-month, risk-adjusted DCF-based target price is unchanged at US$34.20. This assumes success for Bapineuzumab in the upcoming phase II trials and c.100,000 patients on Tysabri treatment by 2010. At the Conference, the group also commented that every additional 5,000 patients on Tysabri adds US$100 mn of profit to Elan. We remain of the view that investors still do not appreciate the leveraging effect of Tysabri for the group.
ELN msg # 240375 6/13/2008 9:27:54 AMBy: ramsfan
Leerink & Phase II Data ... They Say Its Good News
Leerink issued a new research paper on Elan dated 6/2 (not the old one on Thomson). In the report it states, Leerink met with Elan management AFTER company day. Elan management reiterated its statement that it will be crystal clear why they moved to Phase III when the data from Phase II is released.
Also, Elan management stated they expect an INFLECTION of patients enrolling in Phase III after the full data set is presented at ICAD ... you don't have to be a rocket scientist to figure out what this means.
Leerink hypothesizes that the data will not stat. sig (too few patients on the drug) but that trends will be clear.
Leerink keeps their YE 2008 PPS target at $44.
sind doch eigentlich weiterhin gute Nachrichten und Einschätzungen.
Warum steigt der Kurs denn jetzt plötzlich?
(das macht mir Angst)
Warum steigt der Kurs denn jetzt plötzlich?
(das macht mir Angst)
Antwort auf Beitrag Nr.: 34.298.257 von Poppholz am 13.06.08 15:54:28und der Dollar fällt auch noch:
Antwort auf Beitrag Nr.: 34.298.257 von Poppholz am 13.06.08 15:54:28elan wins
12:09 ELN Elan wins jury award in patent case against Abraxis - Bloomberg (35.85 +1.00)
elan wins12:09 ELN Elan wins jury award in patent case against Abraxis - Bloomberg (35.85 +1.00)
Adam Feuerstein backt schon kleinere Brötchen.....
http://www.thestreet.com/story/10421299/1/biotech-watch-elan…
http://www.thestreet.com/story/10421299/1/biotech-watch-elan…
Antwort auf Beitrag Nr.: 34.299.836 von Birgit.Tersteegen am 13.06.08 18:53:09
ELN Elan wins jury award of $55.2 mln in patent case against Abraxisyoukei// Could treble on wilful infringement. The beauty of this is that perfects the IP in a Court-Should have had a better pop..
http://www.investorvillage.com/smbd.asp?mb=160&mn=240535&pt=…
ELN Elan wins jury award of $55.2 mln in patent case against Abraxisyoukei// Could treble on wilful infringement. The beauty of this is that perfects the IP in a Court-Should have had a better pop..
http://www.investorvillage.com/smbd.asp?mb=160&mn=240535&pt=…
Antwort auf Beitrag Nr.: 34.300.051 von surga am 13.06.08 19:20:33REALTIME: 25,91 USD
Antwort auf Beitrag Nr.: 34.300.123 von bernie55 am 13.06.08 19:35:12http://finance.yahoo.com/q/op?s=ELN
Sehen wir 30$ nächste Freitag
Sehen wir 30$ nächste Freitag
Super Schlusskurs--26.20$
Jetzt 2 Fragen ans Board was den folgenden Text betrifft:
Erstens : Um welche Firma handelt es sich????Zweitens,wer von uns bewirbt sich??
Director of Quality Assurance, CMC Regulatory Affairs & Compliance
Reference: 08084RS
Location: Ireland
Salary: Competitive
You will join a neuroscience-based biotechnology company, focused on discovering, developing, manufacturing and marketing advanced therapies in neurology, autoimmune diseases, and severe pain. With a strong pipeline of biological products, including a potential blockbuster for the treatment of Alzheimer's disease, the decision has been made to build a state-of-the-art biologics manufacturing facility close to the company's Headquarters in Dublin.
Reporting to the SVP, Head of Biologics Strategy, Planning and Operations you will be part of the senior management team recruited to establish and run the new manufacturing facility. In this newly created role, you will be responsible for all aspects of Quality Assurance, CMC Regulatory Affairs and Compliance. You will define, develop, execute and maintain all systems, policies, standards and procedures associated with QA, CMC Regulatory Affairs and Compliance - with a strong emphasis on the establishment of lean and smart systems. You will also act as the QP for batch release.
Educated to degree or PhD level in Engineering, Biology, Chemistry or Biotechnology, and eligible as a QP, you will bring to the role significant experience in QA, CMC Regulatory Affairs and/or Compliance leadership, gained within the biotechnology / biologics industry. With extensive experience in both facility and product filing and inspection management with the FDA, IMB and other Regulatory Agencies, you will demonstrate significant experience of technology transfer and capital project support, combined with a knowledge of, or interest in, novel, emerging and single-use processing technologies.
To apply please click here.
The consultant leading this assignment is Chantal Williams who can be contacted on +44 (0)1707 259333 if you would like to have a confidential discussion. Sarah Bryce provides administrative support. The job reference is 08084RS. Please quote it when you correspond with us, it will help us to serve you better.
Jetzt 2 Fragen ans Board was den folgenden Text betrifft:
Erstens : Um welche Firma handelt es sich????Zweitens,wer von uns bewirbt sich??
Director of Quality Assurance, CMC Regulatory Affairs & Compliance
Reference: 08084RS
Location: Ireland
Salary: Competitive
You will join a neuroscience-based biotechnology company, focused on discovering, developing, manufacturing and marketing advanced therapies in neurology, autoimmune diseases, and severe pain. With a strong pipeline of biological products, including a potential blockbuster for the treatment of Alzheimer's disease, the decision has been made to build a state-of-the-art biologics manufacturing facility close to the company's Headquarters in Dublin.
Reporting to the SVP, Head of Biologics Strategy, Planning and Operations you will be part of the senior management team recruited to establish and run the new manufacturing facility. In this newly created role, you will be responsible for all aspects of Quality Assurance, CMC Regulatory Affairs and Compliance. You will define, develop, execute and maintain all systems, policies, standards and procedures associated with QA, CMC Regulatory Affairs and Compliance - with a strong emphasis on the establishment of lean and smart systems. You will also act as the QP for batch release.
Educated to degree or PhD level in Engineering, Biology, Chemistry or Biotechnology, and eligible as a QP, you will bring to the role significant experience in QA, CMC Regulatory Affairs and/or Compliance leadership, gained within the biotechnology / biologics industry. With extensive experience in both facility and product filing and inspection management with the FDA, IMB and other Regulatory Agencies, you will demonstrate significant experience of technology transfer and capital project support, combined with a knowledge of, or interest in, novel, emerging and single-use processing technologies.
To apply please click here.
The consultant leading this assignment is Chantal Williams who can be contacted on +44 (0)1707 259333 if you would like to have a confidential discussion. Sarah Bryce provides administrative support. The job reference is 08084RS. Please quote it when you correspond with us, it will help us to serve you better.
Antwort auf Beitrag Nr.: 34.300.954 von Birgit.Tersteegen am 13.06.08 22:18:55Jetzt 2 Fragen ans Board was den folgenden Text betrifft:
Erstens : Um welche Firma handelt es sich????
Zweitens,wer von uns bewirbt sich??
Frage 1 : ALDI NORTH EUROPE
Frage 2 : * Fred Kasulke
* ..bisher hielt er sich im WO Board immer im Hintergrund , aber jetzt ist seine Stunde gekommen....in einem Telefonat ließ er es mich mit folgenden Worten wissen..." ICH WILL ES TUN "!!!
Erstens : Um welche Firma handelt es sich????
Zweitens,wer von uns bewirbt sich??
Frage 1 : ALDI NORTH EUROPE
Frage 2 : * Fred Kasulke
* ..bisher hielt er sich im WO Board immer im Hintergrund , aber jetzt ist seine Stunde gekommen....in einem Telefonat ließ er es mich mit folgenden Worten wissen..." ICH WILL ES TUN "!!!
Antwort auf Beitrag Nr.: 34.301.681 von bernie55 am 14.06.08 08:30:40--nur weil DU Dich nicht traust Dich bei unserer Schätzchen-Firma mit Deinen therapeutischen Fähigkeiten einzubringen....was ich nämlich vergass zu schreiben ist,dass die dort ALLE STOTTERN oder sonstige Probleme haben sich "kursgerecht" auszudrücken--also-wird Dir jetzt klarer wo Deine Mission in diesem Leben liegt?????????naaaaa?????--EBEN--und um zu wissen dass Du immer schon in Irland Deinen wirlichen Platz in dieser Welt hast,müssen Andere viel an Coaching Gebühren zahlen....ich nehme auch Elan-Aktien für diese Lebensberatung...(So 50 Stück...)
Abraxis Irish Times
Elan wins $55.2m in damages after rival infringes medical patents
From ireland.comSaturday, 14th June, 2008
PHARMACEUTICAL FIRM Elan has won $55.2 million (€35.99 million) in damages following a case it brought against its rival, Abraxis BioScience, a US biotechnology company.
Following an eight-day trial, a federal court in Wilmington, Delaware, ruled yesterday that Abraxis BioScience had infringed a US patent for medicine used to fight breast cancer.
The court, which was supervised by chief US district judge Gregory M Sleet, also decided that the patent is valid and enforceable.
The patent covers tiny coated nanoparticles used intravenously to deliver paclitaxel for the treatment of metastatic breast cancer. The jury also decided another patent held by Elan, on a similar technology to deliver the particles, is valid and enforceable.
Elan first brought the case against Abraxis BioScience in 2006 claiming that the Abraxis drug, Abraxane, a nanoparticle formulation of paclitaxel, trespassed on two patents issued in the 1990s that cover methods of formulating anticancer drugs.
"Elan believes in the protection of its intellectual property," Gregory Bokar, the company's vice-president for intellectual property and litigation, said after the verdict. The court's $55.2 million award, which covers infringement since January 7th, 2005, represents 17 per cent of Abraxis's 2007 sales.
The company's drug, Abraxane, which accounted for 86 per cent of its revenue last year, was introduced three years ago and is sold in the US in agreement with AstraZeneca. Last year Abraxis recorded $288 million in sales of the drug. Breast cancer affects one in eight women and an estimated 155,000 women in the US are living with metastatic breast cancer. The medicine has been given to more than 30,000 patients, according to court papers.
Abraxane has been the subject of some studies at the American Society of Clinical Oncology. In one clinical trial, an Abraxane combination led to median progression-free survival of almost 16 months.
Industry commentators say the case may spark a big wave of new patent infringement cases dealing with nanotechnology, as more patents in nanotechnology accumulate and more products reach the market.
The award did not boost Elan's share performance. The stock closed down 1.7 per cent at €16.82 in Dublin. - (Additional reporting, Bloomberg)
--nur weil DU Dich nicht traust Dich bei unserer Schätzchen-Firma mit Deinen therapeutischen Fähigkeiten einzubringen....was ich nämlich vergass zu schreiben ist,dass die dort ALLE STOTTERN oder sonstige Probleme haben sich "kursgerecht" auszudrücken--also-wird Dir jetzt klarer wo Deine Mission in diesem Leben liegt?????????naaaaa?????--EBEN--und um zu wissen dass Du immer schon in Irland Deinen wirlichen Platz in dieser Welt hast,müssen Andere viel an Coaching Gebühren zahlen....ich nehme auch Elan-Aktien für diese Lebensberatung...(So 50 Stück...)Abraxis Irish TimesElan wins $55.2m in damages after rival infringes medical patents
From ireland.comSaturday, 14th June, 2008
PHARMACEUTICAL FIRM Elan has won $55.2 million (€35.99 million) in damages following a case it brought against its rival, Abraxis BioScience, a US biotechnology company.
Following an eight-day trial, a federal court in Wilmington, Delaware, ruled yesterday that Abraxis BioScience had infringed a US patent for medicine used to fight breast cancer.
The court, which was supervised by chief US district judge Gregory M Sleet, also decided that the patent is valid and enforceable.
The patent covers tiny coated nanoparticles used intravenously to deliver paclitaxel for the treatment of metastatic breast cancer. The jury also decided another patent held by Elan, on a similar technology to deliver the particles, is valid and enforceable.
Elan first brought the case against Abraxis BioScience in 2006 claiming that the Abraxis drug, Abraxane, a nanoparticle formulation of paclitaxel, trespassed on two patents issued in the 1990s that cover methods of formulating anticancer drugs.
"Elan believes in the protection of its intellectual property," Gregory Bokar, the company's vice-president for intellectual property and litigation, said after the verdict. The court's $55.2 million award, which covers infringement since January 7th, 2005, represents 17 per cent of Abraxis's 2007 sales.
The company's drug, Abraxane, which accounted for 86 per cent of its revenue last year, was introduced three years ago and is sold in the US in agreement with AstraZeneca. Last year Abraxis recorded $288 million in sales of the drug. Breast cancer affects one in eight women and an estimated 155,000 women in the US are living with metastatic breast cancer. The medicine has been given to more than 30,000 patients, according to court papers.
Abraxane has been the subject of some studies at the American Society of Clinical Oncology. In one clinical trial, an Abraxane combination led to median progression-free survival of almost 16 months.
Industry commentators say the case may spark a big wave of new patent infringement cases dealing with nanotechnology, as more patents in nanotechnology accumulate and more products reach the market.
The award did not boost Elan's share performance. The stock closed down 1.7 per cent at €16.82 in Dublin. - (Additional reporting, Bloomberg)
Moin Ihr Langschläfer......
Folgendes hört sich doch SUPER an,oder??????
"Elan on brink of Alzheimer's cure" -Irish Daily Mail ------ states NEXT week could mark a major milestone in the history of Elan
http://www.therapeuticsdaily.com/news/article.cfm?contenttyp…
Elan on brink of Alzheimer's cure
Irish Daily Mail - Jun. 14, 2008
NEXT week could mark a major milestone in the his-tory of Athlone-based drug developer Elan, as it updates the market on progress on a treatment for Alzheimer?s that has the potential to transform the lives of millions.
Elan is staking its future on fighting the brain degenera-tive disease that destroys the lives of millions of older peo-ple around the world and is currently in the middle phase of two key drug trials.
The drugs have yet to be given a clinical name but AAB-001 is an experimental treatment for early-stage Alzheimer?s while AAC-001 is the potential Holy Grail of the drug world ? a vac-cine that prevents the disease?s onset. Elan believes that AAB-001 will not just treat the symp-toms of Alzheimer?s but actually put the disease in to reverse.
The AAB-1 trials are the most keenly awaited results this year in the global biotech world and speculation ahead of next week?s update has lifted Elan shares in recent trading sessions.
Irish pharmaceutical industry analysts are upbeat about the prospects for AAB-1 with Davy Research expecting that Elan?s chief executive, Kelly Martin, will announce that the drug is safe and well tolerated with no change in the side-effect profile noted in the Phase I trial.
A major report from Davy said it expects Elan will demonstrate clear evidence of a trend towards better outcomes for patients on the drug relative to those on the placebo.
AAB-1 aims to fight deposits called beta amyloid plaques, which are linked to the degener-ative brain condition. If it works, Elan will have a multibillion-dol-lar seller on their hands.
The Davy report said that, if all goes well with current and future trials, the drug could be worth up to ?4.2bn to Elan and its part-ner in the development of the treatment, Wyeth.
?Translating increasing patient numbers and drug market pene-tration into potential market size could see the Alzheimer?s drug market hit ?7.4bn by 2015, rising to around ?12.4bn by 2025,? it said.
?Everybody?s holding their breath for the phase two (mid-stage) Elan-Wyeth data,? accord-ing to Dr. Steven Ferris a world-renowned expert on the disease at New York University.
Alzheimer?s disease is now the sixth leading cause of death in the US and the seventh in Europe, according to the Cen-tres for Disease Control and Pre-vention (CDC) with estimates that 72,914 Americans died of Alzheimer?s disease in 2006 and a similar number of Europeans.
More than 40,000 people are affected by the disease here.
AAC-1, still in early trials, hopes to target the build up of plaque in the brain that causes the dementia and eventual death of Alzheimer?s patients.
However, Davy notes that the US Food and Drug Administra-tion is being cautious with this drug and has yet to give the go-ahead for Phase II trials to resume as it has with AAB-001.
Folgendes hört sich doch SUPER an,oder??????
"Elan on brink of Alzheimer's cure" -Irish Daily Mail ------ states NEXT week could mark a major milestone in the history of Elanhttp://www.therapeuticsdaily.com/news/article.cfm?contenttyp…
Elan on brink of Alzheimer's cure
Irish Daily Mail - Jun. 14, 2008
NEXT week could mark a major milestone in the his-tory of Athlone-based drug developer Elan, as it updates the market on progress on a treatment for Alzheimer?s that has the potential to transform the lives of millions.
Elan is staking its future on fighting the brain degenera-tive disease that destroys the lives of millions of older peo-ple around the world and is currently in the middle phase of two key drug trials.
The drugs have yet to be given a clinical name but AAB-001 is an experimental treatment for early-stage Alzheimer?s while AAC-001 is the potential Holy Grail of the drug world ? a vac-cine that prevents the disease?s onset. Elan believes that AAB-001 will not just treat the symp-toms of Alzheimer?s but actually put the disease in to reverse.
The AAB-1 trials are the most keenly awaited results this year in the global biotech world and speculation ahead of next week?s update has lifted Elan shares in recent trading sessions.
Irish pharmaceutical industry analysts are upbeat about the prospects for AAB-1 with Davy Research expecting that Elan?s chief executive, Kelly Martin, will announce that the drug is safe and well tolerated with no change in the side-effect profile noted in the Phase I trial.
A major report from Davy said it expects Elan will demonstrate clear evidence of a trend towards better outcomes for patients on the drug relative to those on the placebo.
AAB-1 aims to fight deposits called beta amyloid plaques, which are linked to the degener-ative brain condition. If it works, Elan will have a multibillion-dol-lar seller on their hands.
The Davy report said that, if all goes well with current and future trials, the drug could be worth up to ?4.2bn to Elan and its part-ner in the development of the treatment, Wyeth.
?Translating increasing patient numbers and drug market pene-tration into potential market size could see the Alzheimer?s drug market hit ?7.4bn by 2015, rising to around ?12.4bn by 2025,? it said.
?Everybody?s holding their breath for the phase two (mid-stage) Elan-Wyeth data,? accord-ing to Dr. Steven Ferris a world-renowned expert on the disease at New York University.
Alzheimer?s disease is now the sixth leading cause of death in the US and the seventh in Europe, according to the Cen-tres for Disease Control and Pre-vention (CDC) with estimates that 72,914 Americans died of Alzheimer?s disease in 2006 and a similar number of Europeans.
More than 40,000 people are affected by the disease here.
AAC-1, still in early trials, hopes to target the build up of plaque in the brain that causes the dementia and eventual death of Alzheimer?s patients.
However, Davy notes that the US Food and Drug Administra-tion is being cautious with this drug and has yet to give the go-ahead for Phase II trials to resume as it has with AAB-001.
Appropriate lyrics to ElanI was listening to Stairway to Heaven while cooking up some bacon and eggs and singing along
when all of a sudden I sang a stanza that is very appropriate to Elan:
And it's whispered that soon, if we all call the tune
Then the piper will lead us to reason
And a new day will dawn for those who stand long
And the forest will echo with laughter
Aus Gründen der Depotgewichtung
dürfte ich nicht zukaufen,
aber es juckt gewaltig in den Fingern.
Nächste Woche ist ein Meilenstein nicht nur für Wyeth und Elan,
sondern vor allem für uns.
Et hätt noch immer jot jejange!
posimist
dürfte ich nicht zukaufen,
aber es juckt gewaltig in den Fingern.
Nächste Woche ist ein Meilenstein nicht nur für Wyeth und Elan,
sondern vor allem für uns.
Et hätt noch immer jot jejange!
posimist
Antwort auf Beitrag Nr.: 34.305.907 von posimist am 15.06.08 19:07:57.....das musst Du mit Deinem Namen ja auch sagen--aber in DIESEM Fall glaube ich das auch....!Schönen Abend + Gruss!Birgit
--aber in DIESEM Fall glaube ich das auch....!Schönen Abend + Gruss!Birgit
Auf eine spannende Woche.
(nicht nur bei der EM)
(nicht nur bei der EM)
Elan, Wyeth Take an Inside-Out Approach to Alzheimer's Vaccine
by: Derek Lowe posted on: June 15, 2008 |
about stocks: ELN / WYE
The long-running saga of Elan's (ELN) attempt to come up with a vaccine for Alzheimer's disease continues. There have been bold attempts, setbacks, rethinks, more setbacks, and now they're starting up again. Dosing of the latest version of their vaccine against the beta-amyloid protein, known as ACC-001, was suddenly halted in April when one patient came down with a skin lesion which was thought to be possibly autoimmune-linked vasculitis.
Biopsy results didn't confirm that, though, and the Elan/Wyeth (WYE) partnership is resuming clinical studies. I'm not sure what that couple of months has done to their trial design; I assume that they've just started enrolling new patients and will continue with them, while continuing to monitor the former dosage groups. Maybe, though, there's a way to continue with some of those people and not lose all the time, effort, and data.
The idea of an amyloid vaccine has always excited and alarmed me in equal measure. But that's how I feel about the immune system in general, come to think of it. We have enough cellular firepower to completely destroy ourselves from the inside out - keeping that on a leash to where it (mostly) only goes after what it's supposed to is extremely impressive.
Now, I think that the usual sorts of vaccines are one of the great public health advances of civilization, but they work so well because they're targeted to outside agents (viral coat proteins and the like). Even so, there's a disturbingly large part of the population that remain suspicious of all vaccinations - I say "disturbing" not least because if that population gets too large, the efficacy of vaccination in general could be crippled. But what will these people think about a vaccine that's targeted to an endogenous protein? My immunology may need brushing up, but I can't think of any other example of such.
One thing that may keep this from becoming a huge issue, though, is that an amyloid vaccine, if it succeeds, will be targeted at the elderly rather than at children. And it'll be something that will have an effect against a disease that everyone can see right in front of them, rather than preventing diseases that most people have only read about in books. We'll be back at the situation that prevailed when the polio vaccine was introduced: no one had much doubt that the vaccine was better than the disease.
But even a vaccine fan like me still has room to admire, from a distance, the nerve of this approach. The brain is a special case, immunologically, and letting slip the dogs of war in there is not an intrinsically safe idea. But Alzheimer's is an intrinsically nasty disease...
http://seekingalpha.com/article/81350-elan-wyeth-take-an-ins…
by: Derek Lowe posted on: June 15, 2008 |
about stocks: ELN / WYE
The long-running saga of Elan's (ELN) attempt to come up with a vaccine for Alzheimer's disease continues. There have been bold attempts, setbacks, rethinks, more setbacks, and now they're starting up again. Dosing of the latest version of their vaccine against the beta-amyloid protein, known as ACC-001, was suddenly halted in April when one patient came down with a skin lesion which was thought to be possibly autoimmune-linked vasculitis.
Biopsy results didn't confirm that, though, and the Elan/Wyeth (WYE) partnership is resuming clinical studies. I'm not sure what that couple of months has done to their trial design; I assume that they've just started enrolling new patients and will continue with them, while continuing to monitor the former dosage groups. Maybe, though, there's a way to continue with some of those people and not lose all the time, effort, and data.
The idea of an amyloid vaccine has always excited and alarmed me in equal measure. But that's how I feel about the immune system in general, come to think of it. We have enough cellular firepower to completely destroy ourselves from the inside out - keeping that on a leash to where it (mostly) only goes after what it's supposed to is extremely impressive.
Now, I think that the usual sorts of vaccines are one of the great public health advances of civilization, but they work so well because they're targeted to outside agents (viral coat proteins and the like). Even so, there's a disturbingly large part of the population that remain suspicious of all vaccinations - I say "disturbing" not least because if that population gets too large, the efficacy of vaccination in general could be crippled. But what will these people think about a vaccine that's targeted to an endogenous protein? My immunology may need brushing up, but I can't think of any other example of such.
One thing that may keep this from becoming a huge issue, though, is that an amyloid vaccine, if it succeeds, will be targeted at the elderly rather than at children. And it'll be something that will have an effect against a disease that everyone can see right in front of them, rather than preventing diseases that most people have only read about in books. We'll be back at the situation that prevailed when the polio vaccine was introduced: no one had much doubt that the vaccine was better than the disease.
But even a vaccine fan like me still has room to admire, from a distance, the nerve of this approach. The brain is a special case, immunologically, and letting slip the dogs of war in there is not an intrinsically safe idea. But Alzheimer's is an intrinsically nasty disease...
http://seekingalpha.com/article/81350-elan-wyeth-take-an-ins…
Wyeth, Elan Halt Alzheimer Drug Trial
04/17/08 - 01:01 PM EDT
BIIB ELN WYE
Adam Feuerstein
Wyeth (WYE - Cramer's Take - Stockpickr) and Elan (ELN - Cramer's Take - Stockpickr) suspended a clinical trial involving their experimental Alzheimer vaccine ACC-001 after a single patient was hospitalized due to a skin lesion.
ACC-001 is a vaccine designed to prime the body's immune system to create antibodies against beta amyloid, the toxic protein that forms plaques in the brain believed to play a key role in Alzheimer disease.
Wyeth and Elan are developing ACC-001 as a second-generation version of an older Alzheimer vaccine, AN1792. The latter vaccine's development was stopped in 2001 after some patients were hospitalized due to swelling in the brain.
According to Elan spokesman Jonathan Birt, one patient dosed with ACC-001 in a phase II trial was hospitalized with what the patient's physician described as a "skin lesion, possibly vasculitis." The patient was treated successfully and has since been discharged from the hospital.
Vasculitis is an inflammation of blood vessels that can be caused by an immune, or allergic, reaction. The severity of vasculitis can vary widely, but Birt had no more information about the ACC-001 patient.
A later biopsy, however, did not confirm vasculitis, according to a Wyeth spokesperson.
Elan and Wyeth have informed regulators both in the U.S. and Europe about the hospitalization, which led to the suspension of the ACC-001 clinical trial. The study has not been permanently halted, Birt says.
A notice of the ACC-001 study suspension was posted on the ClinicalTrials.gov Web site.
The negative safety signal detected with ACC-001 has not affected the ongoing clinical trials of bapineuzumab, the other major Alzheimer drug being developed by Elan and Wyeth, Birt says.
Thursday's news comes one day after Elan shares rose sharply after the company and partner Biogen Idec (BIIB - Cramer's Take - Stockpickr) reported a stronger-than-expected increase in the number of patients treated with their multiple sclerosis drug Tysabri.
Elan shares were down 4.1% at $23.31 in recent trading, while Wyeth shares were losing 1.5% to $43.57.
P.S. Profit from Insider Trading Data with Our NEW InsiderInsights.
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Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
http://www.thestreet.com/s/wyeth-elan-halt-alzheimer-drug-tr…
04/17/08 - 01:01 PM EDT
BIIB ELN WYE
Adam Feuerstein
Wyeth (WYE - Cramer's Take - Stockpickr) and Elan (ELN - Cramer's Take - Stockpickr) suspended a clinical trial involving their experimental Alzheimer vaccine ACC-001 after a single patient was hospitalized due to a skin lesion.
ACC-001 is a vaccine designed to prime the body's immune system to create antibodies against beta amyloid, the toxic protein that forms plaques in the brain believed to play a key role in Alzheimer disease.
Wyeth and Elan are developing ACC-001 as a second-generation version of an older Alzheimer vaccine, AN1792. The latter vaccine's development was stopped in 2001 after some patients were hospitalized due to swelling in the brain.
According to Elan spokesman Jonathan Birt, one patient dosed with ACC-001 in a phase II trial was hospitalized with what the patient's physician described as a "skin lesion, possibly vasculitis." The patient was treated successfully and has since been discharged from the hospital.
Vasculitis is an inflammation of blood vessels that can be caused by an immune, or allergic, reaction. The severity of vasculitis can vary widely, but Birt had no more information about the ACC-001 patient.
A later biopsy, however, did not confirm vasculitis, according to a Wyeth spokesperson.
Elan and Wyeth have informed regulators both in the U.S. and Europe about the hospitalization, which led to the suspension of the ACC-001 clinical trial. The study has not been permanently halted, Birt says.
A notice of the ACC-001 study suspension was posted on the ClinicalTrials.gov Web site.
The negative safety signal detected with ACC-001 has not affected the ongoing clinical trials of bapineuzumab, the other major Alzheimer drug being developed by Elan and Wyeth, Birt says.
Thursday's news comes one day after Elan shares rose sharply after the company and partner Biogen Idec (BIIB - Cramer's Take - Stockpickr) reported a stronger-than-expected increase in the number of patients treated with their multiple sclerosis drug Tysabri.
Elan shares were down 4.1% at $23.31 in recent trading, while Wyeth shares were losing 1.5% to $43.57.
P.S. Profit from Insider Trading Data with Our NEW InsiderInsights.
Up 40.4% over 3 years! If you're looking for gains like this, check out InsiderInsights, where Jonathan Moreland gives you both long and short picks — complete with buy, sell, hold ratings — that are based on his exhaustive research and analysis. Introductory $50 savings — limited time.
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
http://www.thestreet.com/s/wyeth-elan-halt-alzheimer-drug-tr…
Antwort auf Beitrag Nr.: 34.307.452 von Poppholz am 16.06.08 09:36:51sorry, ist ein alter Bericht gewesen.
Antwort auf Beitrag Nr.: 34.307.114 von Poppholz am 16.06.08 08:39:27Auf eine spannende Woche.
YYYEEEPPPPPP
> Realtime USA 26,59 - 26,64 <
YYYEEEPPPPPP
> Realtime USA 26,59 - 26,64 <
ELN msg # 241233 6/16/2008 12:36:54 PMBy: vocex1
ELN Hype on CNBS now
Kris Jenner of T Rowe Price
Guest pharma analyst dude likes ELN/WYE 'on the verge of having a new treatment for Alzheimers'. One to really pay attention to, he said.
Asked about Nov election, what to invest in should one or other candidate win; says invest without concern to this as much as value biopharma companies products bring to the table.
V. Farrell says avoid Big Pharma, assuming Obama wins, health care costs will be under pressure; likes the biotech picks by Kris, including CELG, Gilead and ELN.
Jenner also likes Gilead, gone from $1B to $48 billion market cap.
CELG, on way to become a big player in lung cancer area.
Nice weather today, LOL.
vocex1
Analyst awaits data on Wyeth-Elan Alzheimer's drugAP
Analyst awaits data on Wyeth-Elan Alzheimer's drug
Monday June 16, 3:28 pm ET
By Marley Seaman, AP Business Writer
Upcoming data for Alzheimer's drug may disappoint, analyst says, but predicts eventual success
NEW YORK (AP) -- By the end of the month, a Cowen and Co. analyst says, Wyeth and Elan Corp. PLC will report clinical trial data for a new kind of Alzheimer's disease treatment -- one that could slow the progress of the disease rather than fighting its symptoms.
ADVERTISEMENT
Analyst Ian Sanderson calls the test results for bapineuzumab "one of the most anticipated phase II trials in pharmaceutical industry history." He expects Elan and Wyeth to report their findings by the end of June.
The Alzheimer's treatment market is led by four drugs: Pfizer Inc.'s Aricept, Forest Laboratories Inc.'s Namenda, Razadyne from Johnson & Johnson and Shire Ltd., and Novartis AG's Exelon. Those drugs fight the symptoms of Alzheimer's disease -- for example, Aricept is thought to slow the damage done to thinking and memory -- but can't stop its ultimate progress.
"The reason there's so much interest in this particular agent, bapineuzumab, is it could be the first drug to change the course of Alzheimer's disease," Sanderson said in a telephone interview.
In Alzheimer's disease, a naturally occurring protein is broken down into component parts called peptides. A peptide called Amyloid Beta 42 is toxic and forms plaques that can kill neurons in the brain. But bapineuzumab binds to those proteins, Sanderson said, allowing them to be cleared out of the brain.
Sanderson thinks the phase II trial is going to be modestly disappointing. It's too small and uses too many different doses to achieve its main goal, he said -- but the trial will still indicate that the drug works, and he thinks late-stage trial data will be clearer.
The analyst expects Elan and Wyeth to report phase III results in mid-to-late 2010, with the drug approved for sale the following year, around a year and a half before similar competitors. He said sales could peak at about $7 billion worldwide.
The total market for Alzheimer's treatments could be more than $10 billion to $12 billion, Sanderson said. That compares with about $2.7 billion for the four current top drugs.
Eli Lilly is working on two other Alzheimer's candidates, including LY450139. But Sanderson said that drug has been linked to ulcers and gastrointestinal bleeding, which could complicate the approval process. The Food and Drug Administration does not seem concerned about the safety of bapineuzumab, although Sanderson said some trial patients have experienced a fluid buildup in the brain.
Pfizer has an antibody, like bapineuzumab, early in clinical development.
In afternoon trading, shares of Wyeth dipped 22 cents to $43.20, and Elan stock rose 74 cents, or 2.8 percent, to $27.01.
Shares of Eli Lilly picked up 34 cents to $47.99.
Pfizer shares declined 14 cents to $17.85.
Hi Jungs!Die Ergebnisse sind da-----und die Investorvillage Seite ist nicht zu erreichen (Überlastung...??)
Elan and Wyeth Announce Encouraging Top-line Results from Phase 2 Clinical Trial of Bapineuzumab for Alzheimer's Disease-- Safety And Efficacy Findings Support Design Of Phase 3 Program
-- Primary Efficacy Endpoints In Overall Study Population Not
Statistically Significant
-- Statistically Significant And Clinically Meaningful Benefits
Seen In ApoE4 Non-Carriers
-- Overall Results Support Prior Decision To Initiate Phase 3
-- Detailed Data Presentation At ICAD July 29, 2008
DUBLIN, Ireland & MADISON, N.J.--(BUSINESS WIRE)--June 17, 2008--Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE) today announced encouraging preliminary findings from a Phase 2 study of bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer's disease. In the 18-month trial, bapineuzumab appeared to have clinical activity in treating Alzheimer's disease.
Efficacy Findings
The study did not attain statistical significance on the primary efficacy endpoints in the overall study population. Post-hoc analyses did show statistically significant and clinically meaningful benefits in important subgroups.
In non-carriers of the Apolipoprotein E4 (ApoE4) allele, estimated in the literature to be from 40 to 70 percent of the Alzheimer's disease population, post-hoc analyses showed statistically significant and clinically meaningful benefits associated with bapineuzumab treatment on several key efficacy endpoints, including the Alzheimer's Disease Assessment Scale (ADAS-cog), the Neuropsychological Test Battery (NTB), the Mini Mental State Examination (MMSE) and the Clinical Dementia Rating - Sum of Boxes (CDR-SB). A favorable directional change was seen on the Disability Assessment Scale for Dementia (DAD), although this was not statistically significant.
Additionally in non-carriers, preliminary evaluation of MRI results showed less loss of brain volume among treated patients versus placebo patients, a finding that was statistically significant. Smaller increases in ventricular volume were seen in treated patients compared to placebo patients, although this finding was not statistically significant. Progression of Alzheimer's disease is generally associated with loss in brain volume and increases in ventricular volume. Further, treatment-related benefits seen on MRI were correlated to the favorable clinical changes observed in non-carriers.
In similar post-hoc analyses of carriers of the ApoE4 allele, no clinical benefits or statistically significant effects were observed on efficacy endpoints or the brain volume endpoint. However, favorable directional changes were observed on a number of endpoints. Preliminary analyses suggest possible increase of ventricular volume in treated patients versus placebo patients. The clinical significance of this finding is currently unclear and analyses are ongoing.
Safety Findings
As expected given the nature of the population studied, adverse events were very common in both placebo and bapineuzumab-treated patients. In non-carriers, the number of patients experiencing serious adverse events was similar between placebo and bapineuzumab-treated patients. In carriers, serious adverse events were more frequently observed in bapineuzumab-treated patients than in placebo patients. In addition, vasogenic edema was reported in the treated population with an increased frequency in carriers and at higher doses. No cases were reported in placebo patients. In the ongoing Phase 3 studies, carriers of the ApoE4 allele are being treated with a lower dose to minimize the risk of vasogenic edema. The Companies believe that the overall safety findings from this Phase 2 trial support their prior decision to move to Phase 3 studies.
CEO Comments
"The preliminary analyses of the Phase 2 study are a continued validation of the amyloid approach to Alzheimer's disease and an important milestone in our companies' ongoing commitment to bring new treatment options to patients," said Kelly Martin, President and CEO of Elan. "These results clinically support our decision to move into Phase 3 last year."
"We are encouraged by these findings. We remain driven by science and focused on patients as we work to bring this treatment to those who desperately need new options," said Bernard Poussot, President and CEO, Wyeth. "We recognize there is a great deal of hard work left as we move from this phase of learning towards confirming the potential of bapineuzumab."
Elan and Wyeth plan to continue all four studies in the previously disclosed bapineuzumab Phase 3 clinical program and will review and discuss these data with regulatory authorities and leading medical experts.
These findings reflect preliminary analyses of the Phase 2 data and its implications for ongoing clinical development of bapineuzumab. In this trial, there were imbalances in patient numbers and characteristics at baseline between subgroups studied that may or may not have affected these results. Further analysis will continue in advance of a planned scientific presentation of detailed results of this study at the International Conference on Alzheimer's Disease (ICAD) in Chicago, July 29, 2008.
http://www.elan.com/news/full.asp?ID=1166655
Elan, Wyeth Alzheimer's study showed encouraging findings
By Sarah Turner
Last update: 2:28 a.m. EDT June 17, 2008
Comments: 1
LONDON (MarketWatch) -- Irish drug maker Elan Corp. (ELN:
Elan Corporation, plc
:
UK:ELA 18.11, +0.87, +5.1%) and U.S. drug maker Wyeth (WYE:
wyeth com
News, chart, profile, more
Last: 43.08-0.34-0.78%
4:01pm 06/16/2008
WYE 43.08, -0.34, -0.8%) said Tuesday that a Phase 2 study of bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer's disease showed encouraging preliminary findings. The study did not attain statistical significance on the primary efficacy endpoints in the overall study population. Post-hoc analyses did show statistically significant and clinically meaningful benefits in important subgroups. "These results clinically support our decision to move into Phase 3 last year," said Kelly Martin, President and CEO of Elan. Elan and Wyeth plan to continue all four studies in the previously disclosed bapineuzumab Phase 3 clinical program. End of Story
Comments: 1
Yippee! Fantastic news! Hope is on the way.
- paul1149
comments Add Comment
(1) - View Comments on this story
By Sarah Turner
Last update: 2:28 a.m. EDT June 17, 2008
Comments: 1
LONDON (MarketWatch) -- Irish drug maker Elan Corp. (ELN:
Elan Corporation, plc
:
UK:ELA 18.11, +0.87, +5.1%) and U.S. drug maker Wyeth (WYE:
wyeth com
News, chart, profile, more
Last: 43.08-0.34-0.78%
4:01pm 06/16/2008
WYE 43.08, -0.34, -0.8%) said Tuesday that a Phase 2 study of bapineuzumab (AAB-001) in patients with mild to moderate Alzheimer's disease showed encouraging preliminary findings. The study did not attain statistical significance on the primary efficacy endpoints in the overall study population. Post-hoc analyses did show statistically significant and clinically meaningful benefits in important subgroups. "These results clinically support our decision to move into Phase 3 last year," said Kelly Martin, President and CEO of Elan. Elan and Wyeth plan to continue all four studies in the previously disclosed bapineuzumab Phase 3 clinical program. End of Story
Comments: 1
Yippee! Fantastic news! Hope is on the way.
- paul1149
comments Add Comment
(1) - View Comments on this story
Antwort auf Beitrag Nr.: 34.313.918 von Birgit.Tersteegen am 17.06.08 09:31:22Birgit, wie sind die Ergebnisse ?
So "spektakulär" gut wie erwartet oder was meinst DU ?
Ich kanns aufgrund des Textes nicht einschätzen.
So "spektakulär" gut wie erwartet oder was meinst DU ?
Ich kanns aufgrund des Textes nicht einschätzen.
goodbody - data 'much better than we expected' !! 6 minutes ago
Elan (Add, Closing Price $27.11); AAB- 001 Phase II data - significant effect on ApoE4
non-carriers.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
This morning Elan issued the headline phase II data for AAB-001 for the treatment of Alzheimer’s
disease. The data show statistical significance and clinically meaningful benefits as measured by
ADAS-Cog, NTB, MMSE and the CDR-SB examination scales in the sub-set of patients that are
non-carriers of the ApoE4 allele (c.40% of the patient population). The loss of brain volume
compared to patients on placebo was also significantly less in this sub-set of patients. A
favourable directional change (trend) was also observed on the DAD functional assessment. In
ApoE4 carriers, favourable directional changes were observed on a number of endpoints but
none were statistically significant. There was a suggestion of a greater increase in ventricular
volume in ApoE4 carriers versus placebo, a finding generally associated with Alzheimer’s
progression. The findings are currently being analysed. On safety, in ApoE4 non-carriers,
adverse events were similar between treated and placebo populations. In ApoE4 carriers, there
were increased incidences of serious adverse advents, including vasogenic edema. Overall,
these set of data are much better than we expected, given the strong response observed in non-
APOE4 carriers. This clarifies the split of Phase III trials into ApoE4 carrier and non-carrier
populations and the potential significance of 1000 patient populations of each group for safety
issues. Within our recently published range of scenarios (AAB-001 headline data - what can we
expect”), this data increases our fair value for Elan to c.$30 (from $28.50).
Antwort auf Beitrag Nr.: 34.314.135 von Birgit.Tersteegen am 17.06.08 09:56:18... much better than we expected
Na dann mal Leinen los ... oder besser ... zünd mal einer die Zündschnur an
Na dann mal Leinen los ... oder besser ... zünd mal einer die Zündschnur an
wie sieht es mit der SHORTQUOTE aus?
Antwort auf Beitrag Nr.: 34.314.130 von Holgus am 17.06.08 09:54:44sie sind spektakulär füe den einen Strang der Testpersonen:
aus dem Yahoo-Board
Looks like TS might W for the carriers
and
TSRRRWs for the non-carriers....
Congratulations everyone and especially the patients and their families !
aus dem Yahoo-Board
Looks like TS might W for the carriers
and
TSRRRWs for the non-carriers....
Congratulations everyone and especially the patients and their families !
Antwort auf Beitrag Nr.: 34.314.167 von Poppholz am 17.06.08 09:59:59Wenn die Shortys heute alle glattstellen, sollte das zusätzlich `nen Bums geben.
Letztens waren es doch noch über 20 Mio. Stück.
Letztens waren es doch noch über 20 Mio. Stück.
Antwort auf Beitrag Nr.: 34.314.187 von Holgus am 17.06.08 10:02:42EBEN :BRENNEN solln se-und Adam F.gleich mit!!
Re: PII results out - stat significant in APOe4 non-carriers! 17-Jun-08 02:20 am
More than nice; absolutely outstanding! Non-carriers comprise the majority of people suffering with AD, and to achieve stat sig with such small numbers of trial participants is truly exceptional. And despite not reaching stat sig with the carriers, there were many positive trends observed. The PIII trials will very likely be successful with the carriers as well
I've been unable to access IV, which appears to be completely down. What an unfortunate time for that to happen—it'll be fascinating to hear what our neuros have to say tonight.
Wonder where the PPS will open tomorrow....
Cheers!
-und Adam F.gleich mit!!Re: PII results out - stat significant in APOe4 non-carriers! 17-Jun-08 02:20 am
More than nice; absolutely outstanding! Non-carriers comprise the majority of people suffering with AD, and to achieve stat sig with such small numbers of trial participants is truly exceptional. And despite not reaching stat sig with the carriers, there were many positive trends observed. The PIII trials will very likely be successful with the carriers as well
I've been unable to access IV, which appears to be completely down. What an unfortunate time for that to happen—it'll be fascinating to hear what our neuros have to say tonight.
Wonder where the PPS will open tomorrow....
Cheers!
IV- Board geht wieder!
ELN msg # 241506 6/17/2008 4:15:32 AMBy: AyLucy
If not a home run, at least a triple
The non-ApoE are absolutely fantastic! Statistically significant and clinically meaningful on ADAS-cog and NTB. AEs similar to placebo. Less loss of brain volume.
IMO, probability of licensure in non-ApoE is >80%; probably >50% even in ApoEs. What more could you ask for?
For some reason I found myself up at 2:300 and thought I'd check. IV was down, but Yahoo was up..Great day!
-----------------------------------------------------------------
Die Ergebnisse sind -glaube ich--SEHR gut--für diese kleine Testpersonenanzahl ist die stat.Signifikanz (whatever this is...)scheinbar super....Aber Elan neigt leider n icht zu euphorischen PR-Aktivitäten.....sie sind irgendwie schrecklich solide....
--na gut,den Rest müssen wir eben übernehmen....
In der Vergangenheit hat unser Baby "immer" Abgegeben, wenn wir gute News bekommen haben.
Momentan sind die Nachrichten aber so interessant, dass hier auch ein paar große Aufmerksam werden sollten. Besonders, da WYETH hier mit im Boot ist und die in dem Bereich ja schon eine richtig große Nummer sind.
(wir werden sehen)
Momentan sind die Nachrichten aber so interessant, dass hier auch ein paar große Aufmerksam werden sollten. Besonders, da WYETH hier mit im Boot ist und die in dem Bereich ja schon eine richtig große Nummer sind.
(wir werden sehen)
ELN msg # 241507 6/17/2008 4:17:06 AM
By: deferoy7
Yes its OBVIOUS :-)
Stat sig on almost every measure for the non carriers...
And a great safety profile for this group as well..
Also obvious now why manufacturing is going ahead :-)
By: deferoy7
Yes its OBVIOUS :-)
Stat sig on almost every measure for the non carriers...
And a great safety profile for this group as well..
Also obvious now why manufacturing is going ahead :-)
Davyhttp://www.davy.ie/Generic?page=MorningNews2
Many questions still have to be answered, and the devil will be in the detail on issues such as specific dose response and the actual magnitude of the various results outlined here. We believe the stock will go better today, and our first instinct is that our own risked valuation target may move above the $30 level (with unrisked exceeding $40 or so). This is based on increased confidence in both the development and commercial prospects for the drug and indeed the follow-on products in the rest of Elan's AD pipeline.
Elan, Wyeth drug helps some Alzheimer's patients
6/17/2008 3:07:00 AM (Reuters)
By Ben Hirschler LONDON (Reuters) -
Elan and Wyeth's key new drug bapineuzumab helped a proportion of patients with Alzheimer's disease in an intermediate clinical trial, supporting a prior decision to start final Phase III tests. The two companies said on Tuesday the drug did not achieve overall statistically significant results in the main goals of the Phase II clinical trial, but did achieve significance results in important subgroups in the study. Shares in Irish drugmaker Elan rose 5.1 percent to 18.08 euros on the news by 8:55 a.m.
The update on the antibody medicine, also known as AAB-001, is perhaps the year's most keenly awaited biotech trial result. If successful in final-stage trials, the medicine could be the world's first drug to modify the course of Alzheimer's, the most common cause of dementia, rather than just relieving its symptoms. Some analysts have forecast eventual annual sales of $13 billion (6.6 billion pounds), which would make it the biggest drug ever. But the project remains high risk for Elan and its U.S. partner Wyeth, given past failures in the Alzheimer's treatment field and looming competition from others companies, such as Eli Lilly and Myriad Genetics. Because of the nature of the clinical study and the limited number of patients involved, the Phase II trial had not been expected to show overall statistical significance. But Elan and Wyeth said statistically significant and clinically meaningful benefits were seen in a genetic sub-group of patients known as ApoE4 non-carriers, who make up between 40 and 70 percent of the Alzheimer's disease population.
'BETTER THAN EXPECTED' "Overall, these sets of data are much better than we expected, given the strong response observed in non-ApoE4 carriers," said Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin. He increased his fair-value estimate for Elan's U.S. shares to around $30 from $28.50 previously on the back of the results. The stock closed in New York on Monday at $27.11. People who carry a gene that causes their bodies to produce a substance called apolipoprotein (Apo) E4 are known to be at increased risk of developing Alzheimer's, but many patients still get the condition without this genetic variation. Bapineuzumab aims to fight deposits called beta amyloid plaques, which are linked to the degenerative brain condition. "The preliminary analyses of the Phase II study are a continued validation of the amyloid approach to Alzheimer's disease," Elan Chief Executive Kelly Martin said. "These results clinically support our decision to move into Phase III last year." Detailed results will be presented at the International Conference on Alzheimer's Disease in Chicago on July 29. In the Phase II trial, ApoE4 non-carriers showed benefit from bapineuzumab treatment based on a number of different scoring systems that measure Alzheimer's disease. Loss of brain volume, which is associated with Alzheimer's, was also significantly less in this set of patients. Given the world's ageing population and the unmet need for an effective treatment, new medicines for Alzheimer's are seen as one of the big untapped opportunities for the pharmaceuticals industry. Existing acetylcholinesterase inhibitor drugs, like Eisai and Pfizer's market-leader Aricept, can reduce symptoms but do not modify the course of the disease. For a background story on bapineuzumab, please click on (Additional reporting by Mark Potter; Editing by David Holmes and Quentin Bryar)
http://www.investorvillage.com/mbnews.asp?mb=160&pt=qn&xid=4…
6/17/2008 3:07:00 AM (Reuters)
By Ben Hirschler LONDON (Reuters) -
Elan and Wyeth's key new drug bapineuzumab helped a proportion of patients with Alzheimer's disease in an intermediate clinical trial, supporting a prior decision to start final Phase III tests. The two companies said on Tuesday the drug did not achieve overall statistically significant results in the main goals of the Phase II clinical trial, but did achieve significance results in important subgroups in the study. Shares in Irish drugmaker Elan rose 5.1 percent to 18.08 euros on the news by 8:55 a.m.
The update on the antibody medicine, also known as AAB-001, is perhaps the year's most keenly awaited biotech trial result. If successful in final-stage trials, the medicine could be the world's first drug to modify the course of Alzheimer's, the most common cause of dementia, rather than just relieving its symptoms. Some analysts have forecast eventual annual sales of $13 billion (6.6 billion pounds), which would make it the biggest drug ever. But the project remains high risk for Elan and its U.S. partner Wyeth, given past failures in the Alzheimer's treatment field and looming competition from others companies, such as Eli Lilly and Myriad Genetics. Because of the nature of the clinical study and the limited number of patients involved, the Phase II trial had not been expected to show overall statistical significance. But Elan and Wyeth said statistically significant and clinically meaningful benefits were seen in a genetic sub-group of patients known as ApoE4 non-carriers, who make up between 40 and 70 percent of the Alzheimer's disease population.
'BETTER THAN EXPECTED' "Overall, these sets of data are much better than we expected, given the strong response observed in non-ApoE4 carriers," said Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin. He increased his fair-value estimate for Elan's U.S. shares to around $30 from $28.50 previously on the back of the results. The stock closed in New York on Monday at $27.11. People who carry a gene that causes their bodies to produce a substance called apolipoprotein (Apo) E4 are known to be at increased risk of developing Alzheimer's, but many patients still get the condition without this genetic variation. Bapineuzumab aims to fight deposits called beta amyloid plaques, which are linked to the degenerative brain condition. "The preliminary analyses of the Phase II study are a continued validation of the amyloid approach to Alzheimer's disease," Elan Chief Executive Kelly Martin said. "These results clinically support our decision to move into Phase III last year." Detailed results will be presented at the International Conference on Alzheimer's Disease in Chicago on July 29. In the Phase II trial, ApoE4 non-carriers showed benefit from bapineuzumab treatment based on a number of different scoring systems that measure Alzheimer's disease. Loss of brain volume, which is associated with Alzheimer's, was also significantly less in this set of patients. Given the world's ageing population and the unmet need for an effective treatment, new medicines for Alzheimer's are seen as one of the big untapped opportunities for the pharmaceuticals industry. Existing acetylcholinesterase inhibitor drugs, like Eisai and Pfizer's market-leader Aricept, can reduce symptoms but do not modify the course of the disease. For a background story on bapineuzumab, please click on (Additional reporting by Mark Potter; Editing by David Holmes and Quentin Bryar)
http://www.investorvillage.com/mbnews.asp?mb=160&pt=qn&xid=4…
Antwort auf Beitrag Nr.: 34.314.459 von bernie55 am 17.06.08 10:40:09.....geil finde ich es einfach, dass in allen bekannten ALZ Testverfahren signifikante und klinisch relevante Ergebnisse aufzeigen....
Efficacy Findings
The study did not attain statistical significance on the primary efficacy endpoints in the overall study population. Post-hoc analyses did show statistically significant and clinically meaningful benefits in important subgroups.
In non-carriers of the Apolipoprotein E4 (ApoE4) allele, estimated in the literature to be from 40 to 70 percent of the Alzheimers disease population, post-hoc analyses showed statistically significant and clinically meaningful benefits associated with bapineuzumab treatment on several key efficacy endpoints, including the Alzheimers Disease Assessment Scale (ADAS-cog), the Neuropsychological Test Battery (NTB), the Mini Mental State Examination (MMSE) and the Clinical Dementia Rating Sum of Boxes (CDR-SB). A favorable directional change was seen on the Disability Assessment Scale for Dementia (DAD), although this was not statistically significant.
Additionally in non-carriers, preliminary evaluation of MRI results showed less loss of brain volume among treated patients versus placebo patients, a finding that was statistically significant. Smaller increases in ventricular volume were seen in treated patients compared to placebo patients, although this finding was not statistically significant. Progression of Alzheimers disease is generally associated with loss in brain volume and increases in ventricular volume. Further, treatment-related benefits seen on MRI were correlated to the favorable clinical changes observed in non-carriers.
In similar post-hoc analyses of carriers of the ApoE4 allele, no clinical benefits or statistically significant effects were observed on efficacy endpoints or the brain volume endpoint. However, favorable directional changes were observed on a number of endpoints. Preliminary analyses suggest possible increase of ventricular volume in treated patients versus placebo patients. The clinical significance of this finding is currently unclear and analyses are ongoing.
http://www.investorvillage.com/mbnews.asp?mb=160&pt=qn&xid=4…
Efficacy Findings
The study did not attain statistical significance on the primary efficacy endpoints in the overall study population. Post-hoc analyses did show statistically significant and clinically meaningful benefits in important subgroups.
In non-carriers of the Apolipoprotein E4 (ApoE4) allele, estimated in the literature to be from 40 to 70 percent of the Alzheimers disease population, post-hoc analyses showed statistically significant and clinically meaningful benefits associated with bapineuzumab treatment on several key efficacy endpoints, including the Alzheimers Disease Assessment Scale (ADAS-cog), the Neuropsychological Test Battery (NTB), the Mini Mental State Examination (MMSE) and the Clinical Dementia Rating Sum of Boxes (CDR-SB). A favorable directional change was seen on the Disability Assessment Scale for Dementia (DAD), although this was not statistically significant.
Additionally in non-carriers, preliminary evaluation of MRI results showed less loss of brain volume among treated patients versus placebo patients, a finding that was statistically significant. Smaller increases in ventricular volume were seen in treated patients compared to placebo patients, although this finding was not statistically significant. Progression of Alzheimers disease is generally associated with loss in brain volume and increases in ventricular volume. Further, treatment-related benefits seen on MRI were correlated to the favorable clinical changes observed in non-carriers.
In similar post-hoc analyses of carriers of the ApoE4 allele, no clinical benefits or statistically significant effects were observed on efficacy endpoints or the brain volume endpoint. However, favorable directional changes were observed on a number of endpoints. Preliminary analyses suggest possible increase of ventricular volume in treated patients versus placebo patients. The clinical significance of this finding is currently unclear and analyses are ongoing.
http://www.investorvillage.com/mbnews.asp?mb=160&pt=qn&xid=4…
Antwort auf Beitrag Nr.: 34.314.289 von Birgit.Tersteegen am 17.06.08 10:19:52in London ist der Kurs > 18 Euro
Antwort auf Beitrag Nr.: 34.314.701 von surga am 17.06.08 11:06:23Off topic: Ich finde das Leben ist SCHÖN!!!!!!!!!!!!!!!!!
ELN msg # 241599 6/17/2008 6:04:29 AM
By: murko
Signs of disease modification
The fact that the results showed no stat sig should not come as a surprise. The most important question, what was the effect size in non-carriers, will be answered only at ICAD. So far we have to live with the statement that the results are clinically meaningful. My interpretation would be that there was at least 30-50% reduction in the decline rate.
The most important message from the PR for me is this:
<<Additionally in non-carriers, preliminary evaluation of MRI results showed less loss of brain volume among treated patients versus placebo patients, a finding that was statistically significant. Smaller increases in ventricular volume were seen in treated patients compared to placebo patients, although this finding was not statistically significant. >>
Loss of brain volume and increase in ventricular volume are signs of AD progression. It looks that BAP patients continued to lose some brain volume, however at a lower pace than placebos. This finding was correlated to an improvement in clinical symptoms. This is a clear sign of disease modifying properties of AAB-001.
By: murko
Signs of disease modificationThe fact that the results showed no stat sig should not come as a surprise. The most important question, what was the effect size in non-carriers, will be answered only at ICAD. So far we have to live with the statement that the results are clinically meaningful. My interpretation would be that there was at least 30-50% reduction in the decline rate.
The most important message from the PR for me is this:
<<Additionally in non-carriers, preliminary evaluation of MRI results showed less loss of brain volume among treated patients versus placebo patients, a finding that was statistically significant. Smaller increases in ventricular volume were seen in treated patients compared to placebo patients, although this finding was not statistically significant. >>
Loss of brain volume and increase in ventricular volume are signs of AD progression. It looks that BAP patients continued to lose some brain volume, however at a lower pace than placebos. This finding was correlated to an improvement in clinical symptoms. This is a clear sign of disease modifying properties of AAB-001.
ELN msg # 241623 6/17/2008 6:46:57 AMBy: BEZAGRE
Sounds to me that early filing is a good possibility...
In the press release we read the following quote...
"Elan and Wyeth plan to continue all four studies in the previously disclosed bapineuzumab Phase 3 clinical program and will review and discuss these data with regulatory authorities and leading medical experts."
This is a strong suggestion that ongoing safety data will be followed closely by the regulatory agencies allowing for a subpart e filing. I would not be surprised to see this announced after we get the bottomline data at ICAD.
Could not be more pleased wih the topline results.
Now we just sit back and watch the story unfold.
Hallo an Alle!
Also irgendwie überschlagen sich die Ereignisse. Also erhöhte (positive) Aufmerksamkeit birgt kurzfristig ja schon ein Potenzial in sich. Aber ich bin mittel- bis langfristig bedient, das beruhigt meine Nerven.
Das Rad beginnt sich zu drehen.
Gruß an Alle,
d.H.
Also irgendwie überschlagen sich die Ereignisse. Also erhöhte (positive) Aufmerksamkeit birgt kurzfristig ja schon ein Potenzial in sich. Aber ich bin mittel- bis langfristig bedient, das beruhigt meine Nerven.
Das Rad beginnt sich zu drehen.
Gruß an Alle,
d.H.
Antwort auf Beitrag Nr.: 34.315.644 von dasHaendchen am 17.06.08 13:03:50....YEP-PRIMA!
Reuters
Elan, Wyeth drug helps some Alzheimer's patients
06.17.08, 6:39 AM ET
Ireland -
(Adds further analyst comment, latest Elan and Wyeth shares)
By Ben Hirschler
LONDON, June 17 (Reuters) - Elan (nyse: ELN - news - people ) and Wyeth's key new drug bapineuzumab worked for a substantial proportion of Alzheimer's disease patients in an intermediate clinical trial, supporting a prior decision to start final Phase III tests.
The two companies said on Tuesday that although the drug did not achieve overall statistically significant results in the Phase II study, its benefits over placebo were significant in important subgroups.
Shares in Irish drugmaker Elan rose 5.8 percent to 18.20 euros on the news by 1015 GMT, while Wyeth's stock gained 2.3 percent to 28.13 euros in Frankfurt.
The update on the antibody medicine, also known as AAB-001, is perhaps the year's most keenly awaited biotech trial result.
If successful in final-stage trials, the medicine could be the world's first drug to modify the course of Alzheimer's, the most common cause of dementia, rather than just relieving its symptoms.
Some analysts have forecast eventual annual sales of $13 billion, which would make it the biggest drug ever.
But the project remains high risk for Elan and its U.S. partner Wyeth, given past failures in the Alzheimer's treatment field and looming competition from others companies, such as Eli Lilly (nyse: LLY - news - people ) and Myriad Genetics (nasdaq: MYGN - news - people ).
Because of the design of the clinical study and the limited number of patients involved, the Phase II trial had not been expected to show overall statistical significance.
Significant and clinically meaningful benefits were, however, seen in a genetic sub-group of patients known as ApoE4 non-carriers, who make up between 40 and 70 percent of the Alzheimer's disease population.
'BETTER THAN EXPECTED'
"Overall, these sets of data are much better than we expected, given the strong response observed in non-ApoE4 carriers," said Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin.
He increased his fair-value estimate for Elan's U.S. shares to around $30 from $28.50 previously on the back of the results. The stock closed in New York on Monday at $27.11.
Jack Gorman of Davy Stockbrokers, describing the results as "very encouraging", said his price target could rise above $30.
People who carry a gene that causes their bodies to produce a substance called apolipoprotein (Apo) E4 are known to be at increased risk of developing Alzheimer's, but many patients still get the condition without this genetic variation.
Bapineuzumab aims to fight deposits called beta amyloid plaques, which are linked to the degenerative brain condition.
"The preliminary analyses of the Phase II study are a continued validation of the amyloid approach to Alzheimer's disease," Elan Chief Executive Kelly Martin said in a statement.
"These results clinically support our decision to move into Phase III last year."
Detailed results will be presented at the International Conference on Alzheimer's Disease in Chicago on July 29.
In the Phase II trial, ApoE4 non-carriers showed benefit from bapineuzumab treatment based on a number of different scoring systems that measure Alzheimer's disease. Loss of brain volume, which is associated with Alzheimer's, was also significantly less in this set of patients.
Given the world's ageing population and the unmet need for an effective treatment, new medicines for Alzheimer's are seen as one of the big untapped opportunities for the pharmaceuticals industry.
Existing acetylcholinesterase inhibitor drugs, like Eisai and Pfizer (nyse: PFE - news - people )'s market-leader Aricept, can reduce symptoms but do not modify the course of the disease.
For a background story on bapineuzumab, please click on (Additional reporting by Mark Potter; Editing by Quentin Bryar and Elizabeth Fullerton)
Copyright 2008 Reuters,
Reuters
Elan, Wyeth drug helps some Alzheimer's patients
06.17.08, 6:39 AM ET
Ireland -
(Adds further analyst comment, latest Elan and Wyeth shares)
By Ben Hirschler
LONDON, June 17 (Reuters) - Elan (nyse: ELN - news - people ) and Wyeth's key new drug bapineuzumab worked for a substantial proportion of Alzheimer's disease patients in an intermediate clinical trial, supporting a prior decision to start final Phase III tests.
The two companies said on Tuesday that although the drug did not achieve overall statistically significant results in the Phase II study, its benefits over placebo were significant in important subgroups.
Shares in Irish drugmaker Elan rose 5.8 percent to 18.20 euros on the news by 1015 GMT, while Wyeth's stock gained 2.3 percent to 28.13 euros in Frankfurt.
The update on the antibody medicine, also known as AAB-001, is perhaps the year's most keenly awaited biotech trial result.
If successful in final-stage trials, the medicine could be the world's first drug to modify the course of Alzheimer's, the most common cause of dementia, rather than just relieving its symptoms.
Some analysts have forecast eventual annual sales of $13 billion, which would make it the biggest drug ever.
But the project remains high risk for Elan and its U.S. partner Wyeth, given past failures in the Alzheimer's treatment field and looming competition from others companies, such as Eli Lilly (nyse: LLY - news - people ) and Myriad Genetics (nasdaq: MYGN - news - people ).
Because of the design of the clinical study and the limited number of patients involved, the Phase II trial had not been expected to show overall statistical significance.
Significant and clinically meaningful benefits were, however, seen in a genetic sub-group of patients known as ApoE4 non-carriers, who make up between 40 and 70 percent of the Alzheimer's disease population.
'BETTER THAN EXPECTED'
"Overall, these sets of data are much better than we expected, given the strong response observed in non-ApoE4 carriers," said Ian Hunter, an analyst at Goodbody Stockbrokers in Dublin.
He increased his fair-value estimate for Elan's U.S. shares to around $30 from $28.50 previously on the back of the results. The stock closed in New York on Monday at $27.11.
Jack Gorman of Davy Stockbrokers, describing the results as "very encouraging", said his price target could rise above $30.
People who carry a gene that causes their bodies to produce a substance called apolipoprotein (Apo) E4 are known to be at increased risk of developing Alzheimer's, but many patients still get the condition without this genetic variation.
Bapineuzumab aims to fight deposits called beta amyloid plaques, which are linked to the degenerative brain condition.
"The preliminary analyses of the Phase II study are a continued validation of the amyloid approach to Alzheimer's disease," Elan Chief Executive Kelly Martin said in a statement.
"These results clinically support our decision to move into Phase III last year."
Detailed results will be presented at the International Conference on Alzheimer's Disease in Chicago on July 29.
In the Phase II trial, ApoE4 non-carriers showed benefit from bapineuzumab treatment based on a number of different scoring systems that measure Alzheimer's disease. Loss of brain volume, which is associated with Alzheimer's, was also significantly less in this set of patients.
Given the world's ageing population and the unmet need for an effective treatment, new medicines for Alzheimer's are seen as one of the big untapped opportunities for the pharmaceuticals industry.
Existing acetylcholinesterase inhibitor drugs, like Eisai and Pfizer (nyse: PFE - news - people )'s market-leader Aricept, can reduce symptoms but do not modify the course of the disease.
For a background story on bapineuzumab, please click on (Additional reporting by Mark Potter; Editing by Quentin Bryar and Elizabeth Fullerton)
Copyright 2008 Reuters,
Antwort auf Beitrag Nr.: 34.315.877 von Birgit.Tersteegen am 17.06.08 13:30:49REUTERS!!!
Jetzt besteht auch mal die Möglichkeit für die breite Masse über unser Baby Informationen zu bekommen.
Jetzt besteht auch mal die Möglichkeit für die breite Masse über unser Baby Informationen zu bekommen.
Aktuell liegen wir bei $28,50.
Also ca. 18,38 Euro.
Somit haben wir ein neues 3-Jahres-Hoch erreicht.
Hier sollten doch Charttechnisch einige Hürden fallen.
Also ca. 18,38 Euro.
Somit haben wir ein neues 3-Jahres-Hoch erreicht.
Hier sollten doch Charttechnisch einige Hürden fallen.
Antwort auf Beitrag Nr.: 34.316.074 von Poppholz am 17.06.08 13:54:10ich meine natürlich $28,70.
(hat sich somit mit den Hürden geklärt)
(hat sich somit mit den Hürden geklärt)
Antwort auf Beitrag Nr.: 34.316.077 von Poppholz am 17.06.08 13:54:51$28,90
€18,65
nicht schlecht, nicht schlecht.
Bin gespannt wie wir um 15:30 Uhr eröffnen und wie sich die "Kursdrücker" verhalten werden.
Vielleicht ist heute der Tag gekommen, wo sie aufgeben.
€18,65
nicht schlecht, nicht schlecht.
Bin gespannt wie wir um 15:30 Uhr eröffnen und wie sich die "Kursdrücker" verhalten werden.
Vielleicht ist heute der Tag gekommen, wo sie aufgeben.
Antwort auf Beitrag Nr.: 34.316.140 von Poppholz am 17.06.08 14:03:34die $29,- Hürde ist gefallen.
Antwort auf Beitrag Nr.: 34.315.877 von Birgit.Tersteegen am 17.06.08 13:30:49Reuters
Elan, Wyeth drug helps some Alzheimer's patients
Dieses some nervt mich irgendwie in der Headline, wie viele sind denn damit gemeint ?
20 % der Patienten oder 50ig oder wieviel ?
Weiß das jemand ?
Elan, Wyeth drug helps some Alzheimer's patients
Dieses some nervt mich irgendwie in der Headline, wie viele sind denn damit gemeint ?
20 % der Patienten oder 50ig oder wieviel ?
Weiß das jemand ?
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