ELAN - 1.000 % for the LONG-time - 500 Beiträge pro Seite (Seite 32)
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Antwort auf Beitrag Nr.: 30.329.439 von Birgit.Tersteegen am 26.06.07 17:35:19WAS ist hier LOS???
...ich weiß es... ich weiß es....ich weiß es.....
...ich weiß es... ich weiß es....ich weiß es.....
Antwort auf Beitrag Nr.: 30.329.620 von bernie55 am 26.06.07 17:42:30Dr. Selkoe hat gerade bei mir angerufen...
......er fragte mich, ob die PBB Company mit einem Übernahmepreis von 100 USD einverstanden sei....
...ich sagte mit einem Lächeln auf den Lippen....YES ...
......er fragte mich, ob die PBB Company mit einem Übernahmepreis von 100 USD einverstanden sei....
...ich sagte mit einem Lächeln auf den Lippen....YES ...
Mir ist UHHHHHNHEIMLICH:::::::::::::::::::::::::::::::::.:
22,20 eek:
22,20 eek:
Antwort auf Beitrag Nr.: 30.329.684 von Birgit.Tersteegen am 26.06.07 17:45:26du meinst 22,35
Antwort auf Beitrag Nr.: 30.329.684 von Birgit.Tersteegen am 26.06.07 17:45:26Mir ist UHHHHHNHEIMLICH:::::::::::::::::::::::::::::::::.
....OOOOOHHHHMMMMMMMMMMMMMMM......
....OOOOOHHHHMMMMMMMMMMMMMMM......
Antwort auf Beitrag Nr.: 30.331.976 von bernie55 am 26.06.07 19:13:21
Antwort auf Beitrag Nr.: 30.329.648 von bernie55 am 26.06.07 17:43:57......er fragte mich, ob die PBB Company mit einem Übernahmepreis von 100 USD einverstanden sei....
...ich sagte mit einem Lächeln auf den Lippen....YES
hättest du nicht die lippen zusammenpressen können und 150 $ rausföten können.
spaß beiseite, weiß derzeit echt keiner was los ist?
...ich sagte mit einem Lächeln auf den Lippen....YES
hättest du nicht die lippen zusammenpressen können und 150 $ rausföten können.
spaß beiseite, weiß derzeit echt keiner was los ist?
Antwort auf Beitrag Nr.: 30.334.880 von GuHu1 am 26.06.07 21:18:59Msg: 123522 of 123562 6/26/2007 4:17:36 PM Recs: 41
By: huntsmann_ie
Why do many of you fall for this every time?
When Elan makes a decent move, until if and when the reason is known the knee-jerk comment is always a 'buyout rumour.'
Elan is now at the stage where the pps could go up or down a dollar on any trading day. Doesn't have to be something behind either such a move. IMO we're just taking another run at $22 and it's no dig deal. AZErnie called it correctly today IMO.
Elan is not being sold, will not be sold. Get used to it.
---------------------------------------------------------------
Also ist Elan nur gestiegen weil es soooooooooogut ist----und endlich merkens auch die Anderen????
Gute Nacht an die Elan-Fraktion Auf alle Fälle :KLASSE!
By: huntsmann_ie
Why do many of you fall for this every time?
When Elan makes a decent move, until if and when the reason is known the knee-jerk comment is always a 'buyout rumour.'
Elan is now at the stage where the pps could go up or down a dollar on any trading day. Doesn't have to be something behind either such a move. IMO we're just taking another run at $22 and it's no dig deal. AZErnie called it correctly today IMO.
Elan is not being sold, will not be sold. Get used to it.
---------------------------------------------------------------
Also ist Elan nur gestiegen weil es soooooooooogut ist----und endlich merkens auch die Anderen????
Gute Nacht an die Elan-Fraktion Auf alle Fälle :KLASSE!
dann bin ich ja mal auf den Start in den USA gespannt.
Aktuell liegen wir bei $16,65 zu $16,78.
Aktuell liegen wir bei $16,65 zu $16,78.
Antwort auf Beitrag Nr.: 30.348.237 von Poppholz am 27.06.07 14:29:1816 $ ?????????????????
Antwort auf Beitrag Nr.: 30.348.502 von Poppholz am 27.06.07 14:40:55so ist dass, wenn man stänig in den verschiedenen Währungen herumspringt.
Wollte hier wirklich niemanden verunsichern.
Wollte hier wirklich niemanden verunsichern.
Antwort auf Beitrag Nr.: 30.348.548 von Poppholz am 27.06.07 14:43:31ok, dan keeee
wir sind wieder bei den $22,- angekommen.
Somit sollte FFM so bei €16,30 stehen.
Aber das kennen wir ja auch schon zur genüge.
Somit sollte FFM so bei €16,30 stehen.
Aber das kennen wir ja auch schon zur genüge.
beim aktuellen Kursverlauf (gestern und heute) habe ich das Gefühl, dass wir auf einem Pulverfaß sitzen und die brennende Lunte bereits in diesem verschwunden ist.
Antwort auf Beitrag Nr.: 30.351.675 von Poppholz am 27.06.07 17:03:47...einfach mal ein kleines Bonbon für zwischendurch......
...die Shorties werden sich bald so fühlen wie alle Akteure in diesem Film...( insbesondere der bzw.die Fahradfahrer )...
http://www.youtube.com/watch?v=yRybFHD_CTc&NR=1
...die Shorties werden sich bald so fühlen wie alle Akteure in diesem Film...( insbesondere der bzw.die Fahradfahrer )...
http://www.youtube.com/watch?v=yRybFHD_CTc&NR=1
Antwort auf Beitrag Nr.: 30.355.314 von bernie55 am 27.06.07 20:08:13 ...ja da lacht die Welt....
Antwort auf Beitrag Nr.: 30.348.730 von YoungRich am 27.06.07 14:52:25...siehste--was wir Dir schon vor 2 Jahren versucht haben nahe zu bringen--: mit Geduld wirste reich UND bleibst jung
Bin von Merlot auf Pinot G.umgestiegen... GUTE NACHT!
Bin von Merlot auf Pinot G.umgestiegen... GUTE NACHT!
Eine Superzusammenfassung zu AAB-001
240 patients, 4 cohorts of 60 each.
For AAB-001 Phase II trial setup see also:
http://www.alzforum.org/drg/drc/detail.asp?id=101
http://www.clinicaltrials.gov/ct/show/NCT00112073
Peeks are done by 'an independant 3rd party'.
My assumption is that it is done by the trials DSMB.
http://www1.investorvillage.com/smbd.asp?mb=160&mn=76777&pt=…
We know the Phase I results for AAB-001.
This trial looked more like a Phase II in it's setup than a typical Phase I.
They showed positive efficacy (not stat sig, too few people) in the 0.5 dose and statistical significant efficacy (despite not that many patients in trial) in the 1.5 dose.
"At week 16, the prespecified primary timepoint for analysis, the treatment difference relative to placebo favored the treated group at the 0.5mg/kg dose (treatment vs. placebo difference of 2.0, p=.152) and reached statistical significance at the 1.5mg/kg dose (treatment vs. placebo difference of 2.5, p=.047)."
Ronald S. Black et.al.
Background: Bapineuzumab (AAB-001) is a humanized monoclonal antibody to A-beta being developed by Wyeth and Elan for the treatment of AD.
http://library.corporate-ir.net/library/88/883/88326/items/1…
We had an extensive discussion about the peeks & the schedule, but be warned that most information is only fragmentary and much of what is reported is at best only likely (that includes information as to what dosage group was first, when each group started, when it is likely to end etc).
See for a part of one of those discussions last January where we talk about the interim peek schedule:
http://www1.investorvillage.com/smbd.asp?mb=160&mn=67245&pt…
We seem to be following this schedule (as explained in above post):
"May-07: peek at Cohort 3, Jun-07: Study results, July-07: Move to P3 (or not) ..."
Then we had a good PR in May:
"On 21 May 2007, Elan and Wyeth announced their plans to initiate phase 3 clinical trials of Bapineuzumab. The decision to launch phase 3 studies prior to the conclusion of the ongoing phase 2 was based on the totality of the accumulated clinical data from phase 1, phase 2 and a 4.5- year follow-up study of those patients involved in the original AN-1792 trial."
Now the fact that May-07 was spot on is likely just a coincidence, so the move to P3 need not be already in this month (as in officially start recruiting patients, not already the start of dosing; dosing would start no earlier than a few months later, say September 2007 (all IMHO as usual) ).
Apart from the Business & Finance article, which gave us some clues, we also have this post by living_with_elan which describes what KM said about it:
http://www1.investorvillage.com/smbd.asp?mb=160&mn=89426&pt=…
The important part of the B&F article is (posted by hunstmann_ie, msg 2139 at elanians):
B&F interview with KM. Extract #2.
"The decision to move from Phase 2 to Phase 3 is a large one because we have responsibilities to the patients. If you publicly annouce that you are at the last stage of a disease modifying therapy for alzheimer's, first you better be really sure that you are. And second, you better be ready to handle hundreds of thousands of calls and enquiries from people wanting to get their loved ones into the trial and onto the drug. that is a big social responsibility. We have had 15 to 20 years of work on this. The data will tell us whether we can move from Phase 2 to Phase 3 in February, July or next November. It might feel like a big deal in the short term but we have come very far and the responsibility is awful big. For the sake of a few weeks or months, let's not screw it up"
Zamboni_kid updated us in April 2007 that one of the cohorts ended in June 2007 (went OLE, would happen after 18 months according to some, after 15 or 16 months according to most).
Likely this was the cohort #3 which was peeked at in May 2007 (assuming the above mentioned schedule is somewhat correct).
http://www1.investorvillage.com/smbd.asp?mb=160&mn=100013&p…
240 patients, 4 cohorts of 60 each.
For AAB-001 Phase II trial setup see also:
http://www.alzforum.org/drg/drc/detail.asp?id=101
http://www.clinicaltrials.gov/ct/show/NCT00112073
Peeks are done by 'an independant 3rd party'.
My assumption is that it is done by the trials DSMB.
http://www1.investorvillage.com/smbd.asp?mb=160&mn=76777&pt=…
We know the Phase I results for AAB-001.
This trial looked more like a Phase II in it's setup than a typical Phase I.
They showed positive efficacy (not stat sig, too few people) in the 0.5 dose and statistical significant efficacy (despite not that many patients in trial) in the 1.5 dose.
"At week 16, the prespecified primary timepoint for analysis, the treatment difference relative to placebo favored the treated group at the 0.5mg/kg dose (treatment vs. placebo difference of 2.0, p=.152) and reached statistical significance at the 1.5mg/kg dose (treatment vs. placebo difference of 2.5, p=.047)."
Ronald S. Black et.al.
Background: Bapineuzumab (AAB-001) is a humanized monoclonal antibody to A-beta being developed by Wyeth and Elan for the treatment of AD.
http://library.corporate-ir.net/library/88/883/88326/items/1…
We had an extensive discussion about the peeks & the schedule, but be warned that most information is only fragmentary and much of what is reported is at best only likely (that includes information as to what dosage group was first, when each group started, when it is likely to end etc).
See for a part of one of those discussions last January where we talk about the interim peek schedule:
http://www1.investorvillage.com/smbd.asp?mb=160&mn=67245&pt…
We seem to be following this schedule (as explained in above post):
"May-07: peek at Cohort 3, Jun-07: Study results, July-07: Move to P3 (or not) ..."
Then we had a good PR in May:
"On 21 May 2007, Elan and Wyeth announced their plans to initiate phase 3 clinical trials of Bapineuzumab. The decision to launch phase 3 studies prior to the conclusion of the ongoing phase 2 was based on the totality of the accumulated clinical data from phase 1, phase 2 and a 4.5- year follow-up study of those patients involved in the original AN-1792 trial."
Now the fact that May-07 was spot on is likely just a coincidence, so the move to P3 need not be already in this month (as in officially start recruiting patients, not already the start of dosing; dosing would start no earlier than a few months later, say September 2007 (all IMHO as usual) ).
Apart from the Business & Finance article, which gave us some clues, we also have this post by living_with_elan which describes what KM said about it:
http://www1.investorvillage.com/smbd.asp?mb=160&mn=89426&pt=…
The important part of the B&F article is (posted by hunstmann_ie, msg 2139 at elanians):
B&F interview with KM. Extract #2.
"The decision to move from Phase 2 to Phase 3 is a large one because we have responsibilities to the patients. If you publicly annouce that you are at the last stage of a disease modifying therapy for alzheimer's, first you better be really sure that you are. And second, you better be ready to handle hundreds of thousands of calls and enquiries from people wanting to get their loved ones into the trial and onto the drug. that is a big social responsibility. We have had 15 to 20 years of work on this. The data will tell us whether we can move from Phase 2 to Phase 3 in February, July or next November. It might feel like a big deal in the short term but we have come very far and the responsibility is awful big. For the sake of a few weeks or months, let's not screw it up"
Zamboni_kid updated us in April 2007 that one of the cohorts ended in June 2007 (went OLE, would happen after 18 months according to some, after 15 or 16 months according to most).
Likely this was the cohort #3 which was peeked at in May 2007 (assuming the above mentioned schedule is somewhat correct).
http://www1.investorvillage.com/smbd.asp?mb=160&mn=100013&p…
Msg: 124086 of 124112 6/28/2007 12:04:20 AM
By: kcchris S
ELN
I have heard many that believe ELN will be sold. Personally I doubt it happens. If it does we are going to need a hefty price. The BOD isn't stupid. ELN has terrific prospects. Assuming AAB works and Tysabri doesn't cause PML the company could be a $100 stock in a year or 2. In 3 - 4 years it could be double that. If anyone understands this it would be the BOD. They won't entertain cheap offers.
We will lose significant revenues next year from generic competition. That isn't a huge problem. Tysabri and our first of many nano drugs will more than make up for the loss.
I have been thinking about Tysabri. I think it is getting really close to an explosion. The MS boards are full of patients talking about how great they feel on the drug. This is like anything else. A few get on the drug early. If results are good they tell their friends and doctor. Then those people take the drug and if they like it they tell more patients. After a while there are 10,000 patients telling 5 or 6 other patients how great they feel. With no PMl developing they will jump on the Tysabri bandwagon.
In trials there were 3000 patients taking the drug a little over 2 years. That would be 65,000 doses. Something like that with 3 cases of PML. I think the actual odds of developing PML was 1 in 18,000 doses. Think how many doses there have been since approval. Every month that passes the safety of Tysabri looks better. If PML doesn't present itself soon tysabri could kill the competition.
AAB and the other AD drugs in the pipeline continue march forward. Within a year 1 or 2 could find their way to a BLA. That is the holy grail. The AD program alone is worth $10 - $20 a share IMO.
Nano drugs will begin to be filed for approval in the 4th qtr. The hockey stick might start to turn up. Many more to come.
Parkinsons will enter trials in the 2nd half. About time and could be worth a lot. Lets see how the drug does in phase 1.
In the end we could see a company 6 months from now that is worth well over the $22 a share it is priced at now.
By: kcchris S
ELN
I have heard many that believe ELN will be sold. Personally I doubt it happens. If it does we are going to need a hefty price. The BOD isn't stupid. ELN has terrific prospects. Assuming AAB works and Tysabri doesn't cause PML the company could be a $100 stock in a year or 2. In 3 - 4 years it could be double that. If anyone understands this it would be the BOD. They won't entertain cheap offers.
We will lose significant revenues next year from generic competition. That isn't a huge problem. Tysabri and our first of many nano drugs will more than make up for the loss.
I have been thinking about Tysabri. I think it is getting really close to an explosion. The MS boards are full of patients talking about how great they feel on the drug. This is like anything else. A few get on the drug early. If results are good they tell their friends and doctor. Then those people take the drug and if they like it they tell more patients. After a while there are 10,000 patients telling 5 or 6 other patients how great they feel. With no PMl developing they will jump on the Tysabri bandwagon.
In trials there were 3000 patients taking the drug a little over 2 years. That would be 65,000 doses. Something like that with 3 cases of PML. I think the actual odds of developing PML was 1 in 18,000 doses. Think how many doses there have been since approval. Every month that passes the safety of Tysabri looks better. If PML doesn't present itself soon tysabri could kill the competition.
AAB and the other AD drugs in the pipeline continue march forward. Within a year 1 or 2 could find their way to a BLA. That is the holy grail. The AD program alone is worth $10 - $20 a share IMO.
Nano drugs will begin to be filed for approval in the 4th qtr. The hockey stick might start to turn up. Many more to come.
Parkinsons will enter trials in the 2nd half. About time and could be worth a lot. Lets see how the drug does in phase 1.
In the end we could see a company 6 months from now that is worth well over the $22 a share it is priced at now.
$21,10 zu $22,10
ein $ Luft zwischen den Pfosten.
(nicht schlecht)
ein $ Luft zwischen den Pfosten.
(nicht schlecht)
Antwort auf Beitrag Nr.: 30.368.186 von Poppholz am 28.06.07 15:06:18Treffpunkt zwischen 21,98 - 21,99
..Vorbereitung für den " home run "....
..Vorbereitung für den " home run "....
Antwort auf Beitrag Nr.: 30.368.903 von bernie55 am 28.06.07 15:41:08Schlusskurs über $22,30
Tageshoch $22,34
(mein Tipp für heute)
Tageshoch $22,34
(mein Tipp für heute)
Antwort auf Beitrag Nr.: 30.369.003 von Poppholz am 28.06.07 15:44:52..die Lottozahlen vom Donnerstag......
..ich denke heute mal über 22,50 USD.....ich schrieb ja vor´hin " home run " und nicht " home runchen "....
..ich denke heute mal über 22,50 USD.....ich schrieb ja vor´hin " home run " und nicht " home runchen "....
Antwort auf Beitrag Nr.: 30.369.141 von bernie55 am 28.06.07 15:51:22Du weißt doch, ich bin eher einer von der "Vorsichtigen" Sorte.
Antwort auf Beitrag Nr.: 30.369.233 von Poppholz am 28.06.07 15:55:09freue mich natürlich um so mehr, wenn Du recht behalten solltest.
nah jungs, sieht eher nach unter $22,00 aus.
ist aber noch ein bischen zeit.
ist aber noch ein bischen zeit.
Msg: 124519 of 124523 6/29/2007 9:40:28 AM
By: splaylaywahtheepi
End of 2nd Quarter Elan
Revenues are very solid now - ~$190m this quarter.
Growth is spectacular right now - about 15% Q over Q
Pipeline progress is spectacular right now - several huge AD products progressing, T for CD, nano
Elan is in excellent shape and getting stronger every day. The PPS will rise to 3X-4X by end of 2008 - so whether it progresses 20 cents today or no, it will get to the heights we all expect.
By: splaylaywahtheepi
End of 2nd Quarter Elan
Revenues are very solid now - ~$190m this quarter.
Growth is spectacular right now - about 15% Q over Q
Pipeline progress is spectacular right now - several huge AD products progressing, T for CD, nano
Elan is in excellent shape and getting stronger every day. The PPS will rise to 3X-4X by end of 2008 - so whether it progresses 20 cents today or no, it will get to the heights we all expect.
Was ist ein BLA?
Antwort auf Beitrag Nr.: 30.394.401 von moneyseeker am 29.06.07 16:13:34ein BLA (Biologic License Application) ist die Zulassung der FDA für ein biologisches Präparat beispielsweise eines Antikörpers; bei konventionellen Wirkstoffen spricht man hingegen von einem NDA (New Drug Application)
Totenstille hier - selbst wenn der Kurs steigt. Früher war das hier anders
Antwort auf Beitrag Nr.: 30.450.553 von moneyseeker am 02.07.07 16:13:52...wir sparen uns die Energie für die wirklichen Hypes auf....
Antwort auf Beitrag Nr.: 30.450.886 von bernie55 am 02.07.07 16:30:53so ist es.
Das der Kurs mal 50 Cent rauf oder runter geht, ist bei unserem Baby leider kein zur Freude, bzw. kein Grund zum Jammern.
Das der Kurs mal 50 Cent rauf oder runter geht, ist bei unserem Baby leider kein zur Freude, bzw. kein Grund zum Jammern.
Antwort auf Beitrag Nr.: 30.450.553 von moneyseeker am 02.07.07 16:13:52Wir geniessen eben STILL.
...Hi Ihr Lieben
Es gibt ja auch nix Neues--und der Rest des Marktes erfordert im Moment ja so Einiges an Aufmersamkeit!!
Folgendes ist auch nicht schlecht----:
eek:By: elanarchist
Today is my 5th year wedding aniversary...
being married to my one true love, ELN. Until death (or buyout / triple digits) do we part.
7/2/2002 - $1.67
7/2/2007 - $22.32
+1237%
...Hi Ihr Lieben
Es gibt ja auch nix Neues--und der Rest des Marktes erfordert im Moment ja so Einiges an Aufmersamkeit!!
Folgendes ist auch nicht schlecht----:
eek:By: elanarchist
Today is my 5th year wedding aniversary...
being married to my one true love, ELN. Until death (or buyout / triple digits) do we part.
7/2/2002 - $1.67
7/2/2007 - $22.32
+1237%
GUUUT--anhören!!!http://www.bbc.co.uk/radio4/youandyours/items/03/2007_27_mon…
KuckKuck
Antwort auf Beitrag Nr.: 30.466.205 von [KERN]Codex am 03.07.07 11:25:52Haben sie Dich wieder aus dem Käfig gelassen, Kernie ??
Grüße bernie55
Grüße bernie55
ich denke heute mal über 22,50 USD.....ich schrieb ja vor´hin " home run " und nicht " home runchen "....
...nach den News aus England vielleicht heute der erste " homerun " ????
...nach den News aus England vielleicht heute der erste " homerun " ????
Antwort auf Beitrag Nr.: 30.466.748 von bernie55 am 03.07.07 11:52:412 July 2007
TYSABRI(R) Recommended by NICE for Use in Highly Active Relapsing Remitting Multiple Sclerosis in the Final Appraisal Determination
New Hope For People With Highly Active Multiple Sclerosis
ZUG, Switzerland & DUBLIN, Ireland--(BUSINESS WIRE)--July 2, 2007--Biogen Idec (NASDAQ: BIIB) and Elan Corporation (NYSE: ELN) welcome today's announcement by the National Institute for Health and Clinical Excellence (NICE) in the final appraisal determination which recommended use of TYSABRI(R) (natalizumab) in people with highly active relapsing remitting multiple sclerosis (RRMS). TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE.
"This decision offers people with highly active relapsing remitting multiple sclerosis hope of regaining control of their disease," commented Professor Gavin Giovannoni, The Royal London Hospital. "TYSABRI represents a significant advance in MS treatment, offering real hope of delaying the progression of disability and reducing the frequency of relapses."
Highly active RRMS (defined as two or more disabling relapses in one year and an active MRI scan) has a devastating effect on the lives of the individual and their families. These patients experience more relapses and will become disabled more quickly than those people with typical RRMS. This inevitably means that they will not be able to enjoy an active life combined with the strong probability that they, and the family members who care for them, will be unable to work. In these patients, MS progresses twice as quickly as those with less active forms of the disease.
TYSABRI is the first treatment to be specifically licensed for highly active RRMS. Over two years, treatment with TYSABRI leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.
Hans Peter Hasler, Head of Biogen Idec International, added, "Multiple sclerosis can be a devastating condition if not treated appropriately, and we are very pleased that NICE has recommended in the final appraisal determination that patients with highly active relapsing remitting multiple sclerosis should have access to treatments like TYSABRI. With successful treatment with TYSABRI, highly active relapsing remitting multiple sclerosis patients are more likely to be able to continue to work, maintain active social lives, and spend quality time with their families."
"TYSABRI is the first treatment to be recommended for use by NICE, a significant milestone for patients suffering from MS. This final appraisal firmly supports patients and their physicians having access to TYSABRI with its compelling benefits in the treatment of MS," said Dr. Menghis Bairu, SVP, Head of Elan International.
As of late May, TYSABRI is already offering hope to approximately 12,000 patients on therapy in both commercial use and clinical trials in the US, Germany, France, Ireland and many other countries.
http://www.elan.com/News/full.asp?ID=1022211
TYSABRI(R) Recommended by NICE for Use in Highly Active Relapsing Remitting Multiple Sclerosis in the Final Appraisal Determination
New Hope For People With Highly Active Multiple Sclerosis
ZUG, Switzerland & DUBLIN, Ireland--(BUSINESS WIRE)--July 2, 2007--Biogen Idec (NASDAQ: BIIB) and Elan Corporation (NYSE: ELN) welcome today's announcement by the National Institute for Health and Clinical Excellence (NICE) in the final appraisal determination which recommended use of TYSABRI(R) (natalizumab) in people with highly active relapsing remitting multiple sclerosis (RRMS). TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE.
"This decision offers people with highly active relapsing remitting multiple sclerosis hope of regaining control of their disease," commented Professor Gavin Giovannoni, The Royal London Hospital. "TYSABRI represents a significant advance in MS treatment, offering real hope of delaying the progression of disability and reducing the frequency of relapses."
Highly active RRMS (defined as two or more disabling relapses in one year and an active MRI scan) has a devastating effect on the lives of the individual and their families. These patients experience more relapses and will become disabled more quickly than those people with typical RRMS. This inevitably means that they will not be able to enjoy an active life combined with the strong probability that they, and the family members who care for them, will be unable to work. In these patients, MS progresses twice as quickly as those with less active forms of the disease.
TYSABRI is the first treatment to be specifically licensed for highly active RRMS. Over two years, treatment with TYSABRI leads to a 68% relative reduction in clinical relapses and a 54% relative reduction in the risk of sustained disability progression compared with placebo.
Hans Peter Hasler, Head of Biogen Idec International, added, "Multiple sclerosis can be a devastating condition if not treated appropriately, and we are very pleased that NICE has recommended in the final appraisal determination that patients with highly active relapsing remitting multiple sclerosis should have access to treatments like TYSABRI. With successful treatment with TYSABRI, highly active relapsing remitting multiple sclerosis patients are more likely to be able to continue to work, maintain active social lives, and spend quality time with their families."
"TYSABRI is the first treatment to be recommended for use by NICE, a significant milestone for patients suffering from MS. This final appraisal firmly supports patients and their physicians having access to TYSABRI with its compelling benefits in the treatment of MS," said Dr. Menghis Bairu, SVP, Head of Elan International.
As of late May, TYSABRI is already offering hope to approximately 12,000 patients on therapy in both commercial use and clinical trials in the US, Germany, France, Ireland and many other countries.
http://www.elan.com/News/full.asp?ID=1022211
Antwort auf Beitrag Nr.: 30.466.748 von bernie55 am 03.07.07 11:52:41..der erste homerun über 23 USD !!!!
Antwort auf Beitrag Nr.: 30.466.772 von bernie55 am 03.07.07 11:54:16HI!
Wollt`ich auch gerade schreiben....Bernie war wieder so´n schneller Streber....----Bin nächste Woche mal eine Woche Sommer in Griechenland geniessen (hier scheint er ja gerade ausverkauft zu sein)---Ihr wisst ja was das für den Kurs bedeutet....
:coo
So long!
Wollt`ich auch gerade schreiben....Bernie war wieder so´n schneller Streber....----Bin nächste Woche mal eine Woche Sommer in Griechenland geniessen (hier scheint er ja gerade ausverkauft zu sein)---Ihr wisst ja was das für den Kurs bedeutet....
:coo
So long!
und SO,Ihr Lieben werden wir auch unser Schätzchen bald feiern
http://youtube.com/watch?v=R8lq-4UDFHg
Bernie sammelt die Spenden dafür ein.....
http://youtube.com/watch?v=R8lq-4UDFHg
Bernie sammelt die Spenden dafür ein.....
Antwort auf Beitrag Nr.: 30.468.793 von Birgit.Tersteegen am 03.07.07 13:45:01
Nix Birgit, Urlaub gestrichen !!!
Die letzten Male semmelte immer der Kurs ab, wenn Du weg warst.
Nix Birgit, Urlaub gestrichen !!!
Die letzten Male semmelte immer der Kurs ab, wenn Du weg warst.
Antwort auf Beitrag Nr.: 30.469.985 von Holgus am 03.07.07 14:58:04Holgie----aber DAVOR war´s gaaaaaaaaaaaaaaaaaanz anders.....
By: LovesJohnDory
Posted as a reply to msg 125441 by chucky_r_law
Tysabri Uptake
There were approximately 12,500 Tysabri patients worldwide as of May 23, 2007, the most recent data released by Biogen Idec (presented on Tuesday, June 26 at an FDA RiskMAP workshop I attended). Add approximately 300 net new patients each week since then (six weeks tomorrow) brings us to 14,300 (including approximately 1,000 patients in the clinical trials, so 13,200 commercial patients).
By: LovesJohnDory
Posted as a reply to msg 125441 by chucky_r_law
Tysabri Uptake
There were approximately 12,500 Tysabri patients worldwide as of May 23, 2007, the most recent data released by Biogen Idec (presented on Tuesday, June 26 at an FDA RiskMAP workshop I attended). Add approximately 300 net new patients each week since then (six weeks tomorrow) brings us to 14,300 (including approximately 1,000 patients in the clinical trials, so 13,200 commercial patients).
Elan "add"
Tuesday, July 03, 2007 4:26:43 AM ET
Goodbody Stockbrokers
LONDON, July 3 (newratings.com) -
Analyst Ian Hunter of Goodbody Stockbrokers maintains his "add" rating on Elan Corp Plc (DRX.FSE).
In a research note published this morning, the analyst mentions that the UK National Institute for Health and Clinical Excellence (NICE) has approved Tysabri for NHS reimbursement. This is likely to boost Tysabri sales in Europe, since MS patients in the UK represent around 8% of Tysabri’s addressable market globally, the analyst says. The announcement reinforces the view that the drug’s total worldwide sales are likely to reach $468.8 million in FY07, and rise to $1.2 billion in FY08, Goodbody Stockbrokers adds.
http://www.newratings.com/analyst_news/article_1563438.html
Tuesday, July 03, 2007 4:26:43 AM ET
Goodbody Stockbrokers
LONDON, July 3 (newratings.com) -
Analyst Ian Hunter of Goodbody Stockbrokers maintains his "add" rating on Elan Corp Plc (DRX.FSE).
In a research note published this morning, the analyst mentions that the UK National Institute for Health and Clinical Excellence (NICE) has approved Tysabri for NHS reimbursement. This is likely to boost Tysabri sales in Europe, since MS patients in the UK represent around 8% of Tysabri’s addressable market globally, the analyst says. The announcement reinforces the view that the drug’s total worldwide sales are likely to reach $468.8 million in FY07, and rise to $1.2 billion in FY08, Goodbody Stockbrokers adds.
http://www.newratings.com/analyst_news/article_1563438.html
Antwort auf Beitrag Nr.: 30.479.044 von bernie55 am 04.07.07 07:57:53noch zusätzlich gefunden....
....He added this is the first MS treatment to be recommended by the National Health Service.
According to NCB Stockbrokers, there are about 70,000 patients in England and Wales with MS.
An estimated 15pc to 20pc of these patients eligible for treatment under the new NICE decision.
http://www.investorvillage.com/smbd.asp?mb=160&mn=125720&pt=…
....He added this is the first MS treatment to be recommended by the National Health Service.
According to NCB Stockbrokers, there are about 70,000 patients in England and Wales with MS.
An estimated 15pc to 20pc of these patients eligible for treatment under the new NICE decision.
http://www.investorvillage.com/smbd.asp?mb=160&mn=125720&pt=…
Hi Ihr Süssen!
Wollten Sie doch unser Schätzchen heute mal wieder drücken---hab´ich aus Solidarität mal wider 70 Kleine addiert----Bernie--Jetzt bist Du wieder dran... Schönen Abend!
Ps+++Holgit--und ich bin noch NICHT im Urlaub....
Wollten Sie doch unser Schätzchen heute mal wieder drücken---hab´ich aus Solidarität mal wider 70 Kleine addiert----Bernie--Jetzt bist Du wieder dran... Schönen Abend!
Ps+++Holgit--und ich bin noch NICHT im Urlaub....
Antwort auf Beitrag Nr.: 30.514.148 von Birgit.Tersteegen am 05.07.07 23:04:18und ich bin noch NICHT im Urlaub...
Aber Du siehst Birgit, selbst wenn Du Dich auf Urlaub vorbereitest,
fängt der Kurs an abzusemmeln
Du bleibst gefälligst hier !!!
Aber Du siehst Birgit, selbst wenn Du Dich auf Urlaub vorbereitest,
fängt der Kurs an abzusemmeln
Du bleibst gefälligst hier !!!
wer lust auf ne goldene nase hast, bm an mich
Antwort auf Beitrag Nr.: 30.515.672 von [KERN]Codex am 06.07.07 07:56:10Kernie,wir HABEN sie hier schon....--und haben keine Lust,sie ggfls in eine "blutige" einzutauschen ----Spässchen,natürlich.....
PS.Holgus---wenn Du weiter nölst, verkauf ich ALL MEINE Schätzchen AUF EINMAL und gehe 5 Jahre auf Weltreise.....------------(würde ich natürlich NIE machen,lasse Euch doch nicht im Stich und wenn Elan auf 100$ steht-könnte ich ja dann 15 Jahre--d.h. bis zur "Rente"fahren....is´doch besser...)
PS.Holgus---wenn Du weiter nölst, verkauf ich ALL MEINE Schätzchen AUF EINMAL und gehe 5 Jahre auf Weltreise.....------------(würde ich natürlich NIE machen,lasse Euch doch nicht im Stich und wenn Elan auf 100$ steht-könnte ich ja dann 15 Jahre--d.h. bis zur "Rente"fahren....is´doch besser...)
Antwort auf Beitrag Nr.: 30.516.119 von Birgit.Tersteegen am 06.07.07 08:48:02
Wieso erst in 15 Jahren ... willst Du etwa mit 75 in Rente ??
Wieso erst in 15 Jahren ... willst Du etwa mit 75 in Rente ??
Antwort auf Beitrag Nr.: 30.521.032 von Holgus am 06.07.07 13:34:55!!
WISST IHR WAS??????????????WIR HABEN HEUTE BEI 22,55$ (letzte Taxe war
sogar 22,56$ zu 22,59$)geschlossen....das sind 16,55€ und das ist das
-----------------30 Monats Hoch----------------------------------
----------------und,was sagt Ihr jetzt?? Kann ich jetzt beruhigt in Urlaub fahren???????????????????????.....
Antwort auf Beitrag Nr.: 30.529.935 von Birgit.Tersteegen am 06.07.07 22:48:07Um Holgie zu beruhigen kannst Du ja ständig ein "Notfallticket" bei Dir tragen.
Ansonsten glaube ich, ist unser Baby bei uns in guten Händen.
Ansonsten glaube ich, ist unser Baby bei uns in guten Händen.
Antwort auf Beitrag Nr.: 30.530.351 von Poppholz am 06.07.07 23:20:19!
Elan Corporation, plc (ADR): Stock Rating Summary
StockScouter Rating: 10
Elan Corporation, plc (ADR), a mid-cap company in the health care sector, is expected to significantly outperform the market over the next six months with less than average risk.
10 is the best possible rating.
Quick Summary
Details
Pro
The StockScouter measure of relative price change and consistency is very high. Very positive
Previous day's closing price for ELN was significantly above its 50-day moving average. Very positive
One or more analysts has modestly increased quarterly earnings estimates for ELN. Positive
Con
The most recent quarterly earnings report was slightly lower than analysts’ consensus forecast. Neutral/Negative
Msg: 126426 of 126496 7/6/2007 5:44:03 PM
By: stillholdun
An interesting dynamic about the SOON TO COME phase 3 study
July is racing by already, and we should begin dosing Alz patients with AAB phase three study in the next two to five months - wow.
The dynamic I wanted to bring up is this...
Soon, over 1,000 people nationwide will begin getting infusions of AAB. If this stuff "works", as KM says and we believe (that's why we're here folks), then consider the potential "anecdotal stories" that may begin to emerge as early as Christmas '07/early '08.
"Wow- Uncle Harry is in this study, and he is starting to remember his grandkid's names again!"
Now I don't pretend to know diddly about clinical studies and being a participant in same, but I'm sure that one of the many conditions of being a test patient includes silence and discretion.
Well, it's one thing to agree to that, but if Uncle Harry starts remembering his grandkids names, or grandma suddenly starts coming around and speaking in ways that she hadn't previously, and this starts going on with 400-500 people around the country, these people (who have kids, grandkids, spouses, caregivers, neighbors, etc.) and their behavior modifications will be tough to sequester.
KM says AN-1792 continues to work after all this time - how soon can AAB show noticible results, and how, if it does, can we expect the world to not find out about it - like 8-9 months from now?
Something to think about, and perhaps look forward to.
Elan Corporation, plc (ADR): Stock Rating Summary
StockScouter Rating: 10
Elan Corporation, plc (ADR), a mid-cap company in the health care sector, is expected to significantly outperform the market over the next six months with less than average risk.
10 is the best possible rating.
Quick Summary
Details
Pro
The StockScouter measure of relative price change and consistency is very high. Very positive
Previous day's closing price for ELN was significantly above its 50-day moving average. Very positive
One or more analysts has modestly increased quarterly earnings estimates for ELN. Positive
Con
The most recent quarterly earnings report was slightly lower than analysts’ consensus forecast. Neutral/Negative
Msg: 126426 of 126496 7/6/2007 5:44:03 PM
By: stillholdun
An interesting dynamic about the SOON TO COME phase 3 study
July is racing by already, and we should begin dosing Alz patients with AAB phase three study in the next two to five months - wow.
The dynamic I wanted to bring up is this...
Soon, over 1,000 people nationwide will begin getting infusions of AAB. If this stuff "works", as KM says and we believe (that's why we're here folks), then consider the potential "anecdotal stories" that may begin to emerge as early as Christmas '07/early '08.
"Wow- Uncle Harry is in this study, and he is starting to remember his grandkid's names again!"
Now I don't pretend to know diddly about clinical studies and being a participant in same, but I'm sure that one of the many conditions of being a test patient includes silence and discretion.
Well, it's one thing to agree to that, but if Uncle Harry starts remembering his grandkids names, or grandma suddenly starts coming around and speaking in ways that she hadn't previously, and this starts going on with 400-500 people around the country, these people (who have kids, grandkids, spouses, caregivers, neighbors, etc.) and their behavior modifications will be tough to sequester.
KM says AN-1792 continues to work after all this time - how soon can AAB show noticible results, and how, if it does, can we expect the world to not find out about it - like 8-9 months from now?
Something to think about, and perhaps look forward to.
By: chucky_r_law
Re: Here is the magic question. Ipar - Its even simpler than that!
<AN-1792 has demonstrated that 4.5 years after response, patients deteriorated at a 50% clip relative to placebo.
Something like 2% of responders suffered encephalitis.
Given the known consequences of AD, who wouldn't take that chance?
I would. You probably would as well. >
Now what if the efficacy is even better?
Oh, and this time there are no side effects!!!!! This we have been told.
Unmet medical need?
Stand back!!
G
Re: Here is the magic question. Ipar - Its even simpler than that!
<AN-1792 has demonstrated that 4.5 years after response, patients deteriorated at a 50% clip relative to placebo.
Something like 2% of responders suffered encephalitis.
Given the known consequences of AD, who wouldn't take that chance?
I would. You probably would as well. >
Now what if the efficacy is even better?
Oh, and this time there are no side effects!!!!! This we have been told.
Unmet medical need?
Stand back!!
G
Hello all,
ich vermisse Reime von Holgus-....
ich vermisse Reime von Holgus-....
Antwort auf Beitrag Nr.: 30.556.661 von Nostarowie am 08.07.07 02:52:03"Raime"......$....$.....€.....
Antwort auf Beitrag Nr.: 30.556.661 von Nostarowie am 08.07.07 02:52:03ICH NICHT!! Moin!Schönes WE!
Elan Announces Webcast of Second Quarter 2007 Financial Results
DUBLIN, Ireland--(BUSINESS WIRE)--July 9, 2007
--Elan Corporation, plc announced today that it will host a conference call on Thursday, July 26, 2007 at 8:30 a.m. Eastern Time (ET), 1:30 p.m. British Summer Time (BST) with the investment community to discuss Elan's second quarter 2007 financial results, which will be released before the U.S. and European financial markets open.
Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to investors, members of the news media and the general public.
This event can be accessed by visiting Elan's website at www.elan.com and clicking on the Investor Relations section, then on the event icon. Following the live webcast, an archived version of the call will be available at the same URL.
http://www.elan.com/News/full.asp?ID=1023835
DUBLIN, Ireland--(BUSINESS WIRE)--July 9, 2007
--Elan Corporation, plc announced today that it will host a conference call on Thursday, July 26, 2007 at 8:30 a.m. Eastern Time (ET), 1:30 p.m. British Summer Time (BST) with the investment community to discuss Elan's second quarter 2007 financial results, which will be released before the U.S. and European financial markets open.
Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to investors, members of the news media and the general public.
This event can be accessed by visiting Elan's website at www.elan.com and clicking on the Investor Relations section, then on the event icon. Following the live webcast, an archived version of the call will be available at the same URL.
http://www.elan.com/News/full.asp?ID=1023835
Antwort auf Beitrag Nr.: 30.601.332 von bernie55 am 09.07.07 22:43:16SOOOO GEMEIN---Du warst schon wieder schneller--aber dafür findet der Call auf
MEINEM Geburtstag statt----ALSO KÖNNEN DIE ERGEBNISSE NUR GUT werden.....guts Nächtle!
MEINEM Geburtstag statt----ALSO KÖNNEN DIE ERGEBNISSE NUR GUT werden.....guts Nächtle!
Antwort auf Beitrag Nr.: 30.601.503 von Birgit.Tersteegen am 09.07.07 22:52:30Du warst schon wieder schneller--aber dafür findet der Call auf
MEINEM Geburtstag statt
...isch weissss....isch weisssss...
..es hat aber auch von meiner Seite her viel Zeit und Telefonate gekostet, Kelly Martin davon zu überzeugen, diesen Termin der Bekanntgabe genau auf diesen Tag zu legen.....
Auf jeden Fall habe ich das Gefühl, dass wir den Laden so langsam in den GRIFF bekommen....
..es wurde aber auch ZEIT....
MEINEM Geburtstag statt
...isch weissss....isch weisssss...
..es hat aber auch von meiner Seite her viel Zeit und Telefonate gekostet, Kelly Martin davon zu überzeugen, diesen Termin der Bekanntgabe genau auf diesen Tag zu legen.....
Auf jeden Fall habe ich das Gefühl, dass wir den Laden so langsam in den GRIFF bekommen....
..es wurde aber auch ZEIT....
Antwort auf Beitrag Nr.: 30.608.874 von bernie55 am 10.07.07 09:58:28Das war aber nett von Dir Bernie.....unser qualitatives Fern-Coaching zeigt doch wirklich langsam Wirkung.... PBB eben.....
Msg: 127372 of 127379 7/11/2007 3:52:12 AM
By: beechlawn0202
NCB
http://www.rte.ie/business/2007/morningrep/download/0711ncb.…
By: beechlawn0202
NCB
http://www.rte.ie/business/2007/morningrep/download/0711ncb.…
Re: NCB - text format
Elan Corporation USD22.06 BUY Generic Maxipime Approved
• As highlighted yesterday, a generic of Maxipime (cefepime hydrochloride) has been
approved in the US. Three injectable formulations (500mg, 1mg and 2 mg) covering the
Maxipime franchise have been approved as generic. We had expected generic
competition as Apotex had previously indicated that they intended launching a
Maxipime generic once FDA approval was granted. Although Azactam currently
remains free of generic competition, it is likely that Elan will now restructure its hospital
infrastructure to maximise the cashflow from the hospital products.
• Conclusion & Action: Generic Maxipime was approved by the FDA on 18th June
2007 although we are not aware that the generic has yet been launched. Although
there may have been some de-stocking ahead of generic approval, we continue to
expect $47m in revenues this quarter. Given that a generic of Maxipime was imminent,
our recently revised SOTP of $22.30-$24.44 included 20c a share for Maxipime.
Elan Corporation USD22.06 BUY Generic Maxipime Approved
• As highlighted yesterday, a generic of Maxipime (cefepime hydrochloride) has been
approved in the US. Three injectable formulations (500mg, 1mg and 2 mg) covering the
Maxipime franchise have been approved as generic. We had expected generic
competition as Apotex had previously indicated that they intended launching a
Maxipime generic once FDA approval was granted. Although Azactam currently
remains free of generic competition, it is likely that Elan will now restructure its hospital
infrastructure to maximise the cashflow from the hospital products.
• Conclusion & Action: Generic Maxipime was approved by the FDA on 18th June
2007 although we are not aware that the generic has yet been launched. Although
there may have been some de-stocking ahead of generic approval, we continue to
expect $47m in revenues this quarter. Given that a generic of Maxipime was imminent,
our recently revised SOTP of $22.30-$24.44 included 20c a share for Maxipime.
Antwort auf Beitrag Nr.: 30.630.280 von Birgit.Tersteegen am 11.07.07 13:23:05Es wird rum gedrückt wie es geht. Bin gespannt, wo wir heute abschließen
Antwort auf Beitrag Nr.: 30.634.547 von surga am 11.07.07 17:07:15Ich glaube grün!Habe nochmal 70 St.zu 21,65$ zugekauft.Eben ist Elan auf CNBC empfohlen worden.DAS WIRD SCHON
Antwort auf Beitrag Nr.: 30.634.871 von Birgit.Tersteegen am 11.07.07 17:19:25By: jivetalkin03
that cnbc piece was dynamite
its so great to hear other people who walk like us
talk like us speak intelligently about what we have in our grasp.
dont let the summertime blues get you down folks.
WE HAVE A WINNER!
that cnbc piece was dynamite
its so great to hear other people who walk like us
talk like us speak intelligently about what we have in our grasp.
dont let the summertime blues get you down folks.
WE HAVE A WINNER!
Antwort auf Beitrag Nr.: 30.634.957 von Birgit.Tersteegen am 11.07.07 17:22:40wow bist Du gut! Ich habe viel zu früh gekauft, ich habe 500 zu 21,78 bezahlt!
Antwort auf Beitrag Nr.: 30.635.043 von surga am 11.07.07 17:25:59kommt aber nicht wirklich drauf an--bei den Perspektiven die wir haben...
By: Shakertexas
Posted as a reply to msg 127490 by jivetalkin03
Re: that cnbc piece was dynamite/jive
You are absolute correct. It's really the first time I've seen ELAN pumped alone apart from a shirt-tail like mention either of BIIB or WYE.
What this mean to me. The word is growing. Words are some of the most powerful tools according to the Bible. As the word about the pipeline of ELAN grows the powers of the world will take notice. From a beaten down "one pony show" company concept to what ELAN really has is a great distance. We are just now beginning to get attention. The day will come in the not to distant future when ELAN will be very big in the public eye and the powers of Wall Street will fight it out for a piece.
Shaker
By: Shakertexas
Posted as a reply to msg 127490 by jivetalkin03
Re: that cnbc piece was dynamite/jive
You are absolute correct. It's really the first time I've seen ELAN pumped alone apart from a shirt-tail like mention either of BIIB or WYE.
What this mean to me. The word is growing. Words are some of the most powerful tools according to the Bible. As the word about the pipeline of ELAN grows the powers of the world will take notice. From a beaten down "one pony show" company concept to what ELAN really has is a great distance. We are just now beginning to get attention. The day will come in the not to distant future when ELAN will be very big in the public eye and the powers of Wall Street will fight it out for a piece.
Shaker
Antwort auf Beitrag Nr.: 30.635.231 von Birgit.Tersteegen am 11.07.07 17:34:05
CNBC Morning Call Buying Bio Tech Video:
http://www.cnbc.com/id/15840232?video=419789743&play=1
Am Besten mit Microsoft Explorer
CNBC Morning Call Buying Bio Tech Video:
http://www.cnbc.com/id/15840232?video=419789743&play=1
Am Besten mit Microsoft Explorer
Hier ist der Bericht als Video...CNBC Morning Call Buying Bio Tech Video:
http://www.cnbc.com/id/15840232?video=419789743&play=1
SUUUUUUUUUUUUPER!And this is just the beginning....
http://www.cnbc.com/id/15840232?video=419789743&play=1
SUUUUUUUUUUUUPER!And this is just the beginning....
Msg: 127500 of 127501 7/11/2007 11:35:37 AM
By: lomac222
I liked the $ 40.00 target price by L. Swann eom
ICH AUCH!
By: lomac222
I liked the $ 40.00 target price by L. Swann eom
ICH AUCH!
Gratuliere zur erfolgreichen (und günstigen) Aufstockung.
Antwort auf Beitrag Nr.: 30.635.479 von Poppholz am 11.07.07 17:45:08Danke Poppi
Msg: 127504 of 127506 7/11/2007 11:46:36 AM
By: stillholdun
MULTI-MULTI Billion Dollar Market
Bill Tanner said the Alz market will be a "MULTI-MULTI billion dollar market".
He also said that the US has "4 million Alz sufferers", which will increase to 15 million by the middle of the century.
4 million NOW is compelling enough. What he FAILED to mention is that WORLDWIDE, there are more like 20-25 million Alz sufferers.
And last time I checked, ELN/Wyeth is planning on selling BAP in other countries BESIDES the US.
So my back of envelope numbers say...
- If KM holds to his recent word and keeps this ALZ treatment from breaking the banks of medicare and health insurance, we are talking $6,000-$8,000 per year (lets say $7,000)
- If we simply can treat 10% of the CURRENT worldwide Alz patients, that's
2 million x $7,000 = $14 BILLION per year (half to ELN).
So if by 2009 we can get this drug approved and on the market, and only TEN PERCENT of the worldwide Alz population goes on it, AND by 2009 Tysabri is doing close to 100K patients a year, AND nano gets its shit together...
ELN could be producing revenues of $8-$10 billion ANNUALLY. Very profitable revenue too, I might add.
What's that worth as a total market cap? Today we are at $10 billion market cap. So at 10x sales that would equal a shareprice of about $200.
AM I REALLY DREAMING HERE, OR IS THIS DOABLE? And again, I make this assumption based on AAB working, AND only going to 10% of the WW Alz patients.
I think Bill Tanner was right when he said "MULTI-MULTI Billion Dollar Market"...or, he may have left out one or two "MULTI's".
-
By: stillholdun
MULTI-MULTI Billion Dollar Market
Bill Tanner said the Alz market will be a "MULTI-MULTI billion dollar market".
He also said that the US has "4 million Alz sufferers", which will increase to 15 million by the middle of the century.
4 million NOW is compelling enough. What he FAILED to mention is that WORLDWIDE, there are more like 20-25 million Alz sufferers.
And last time I checked, ELN/Wyeth is planning on selling BAP in other countries BESIDES the US.
So my back of envelope numbers say...
- If KM holds to his recent word and keeps this ALZ treatment from breaking the banks of medicare and health insurance, we are talking $6,000-$8,000 per year (lets say $7,000)
- If we simply can treat 10% of the CURRENT worldwide Alz patients, that's
2 million x $7,000 = $14 BILLION per year (half to ELN).
So if by 2009 we can get this drug approved and on the market, and only TEN PERCENT of the worldwide Alz population goes on it, AND by 2009 Tysabri is doing close to 100K patients a year, AND nano gets its shit together...
ELN could be producing revenues of $8-$10 billion ANNUALLY. Very profitable revenue too, I might add.
What's that worth as a total market cap? Today we are at $10 billion market cap. So at 10x sales that would equal a shareprice of about $200.
AM I REALLY DREAMING HERE, OR IS THIS DOABLE? And again, I make this assumption based on AAB working, AND only going to 10% of the WW Alz patients.
I think Bill Tanner was right when he said "MULTI-MULTI Billion Dollar Market"...or, he may have left out one or two "MULTI's".
-
Antwort auf Beitrag Nr.: 30.635.641 von Birgit.Tersteegen am 11.07.07 17:51:25Elan für risikobereite Anleger
Kulmbach (aktiencheck.de AG) - Die Experten vom Anlegermagazin "Der Aktionär" empfehlen die Aktie von Elan (ISIN IE0003072950/ WKN 903801) für risikobereite Anleger.
In den vergangenen Monaten habe der Anteilsschein von Elan an der Börse eine bemerkenswerte Renaissance erlebt. Die Aktie habe allein seit Anfang des Jahres um 60 Prozent zugelegt. Für den letzten Aufschwung gebe es mehrere gute Gründe. Die allmähliche Rückkehr des Medikamentes Tysabri, das auch von einigen Fachleuten schon abgemeldet gewesen sei, sei ein Grund.
Tysabri sei ab Ende Februar 2005 nicht mehr auf dem Markt erhältlich gewesen, da drei behandelte Patienten an der seltenen Viruserkrankung des Gehirns, PML, gestorben seien. Man könne das Medikament inzwischen in den USA und Europa wieder erhalten, wenn auch unter strengen Auflagen.
Die Gesellschaft habe auch über Tysabri hinaus in den vergangenen Jahren ihre Entwicklungspipeline sukzessiv erweitert. Ein potenzielles Mittel zur Behandlung von Alzheimer, das Elan in Zusammenarbeit mit Wyeth entwickle, sei besonders interessant. Die Unternehmen hätten nach sehr guten Ergebnissen in der zweiten Phase klinischer Studien schon den Start von finalen Phase-III-Tests gemeldet.
Jedoch würden Analysten munkeln, dass das bislang vorliegende Datenmaterial so gut sein solle, dass eine Beantragung der Zulassung seitens der Unternehmen bereits jetzt möglich sei. Der monoklonale Antikörper mit dem Forschungsnamen AAB-001 wäre dann vielleicht bereits Ende 2008 erhältlich.
Besondere Fantasie erhalte der Titel von Elan von der bevorstehenden Tysabri-Entscheidung für die Indikation Morbus Crohn. Faktoren würden jedoch auch auf mittlere und lange Sicht für ein Engagement sprechen.
Nach Ansicht der Experten von "Der Aktionär" sollten Investoren mit einem gewissen Maß an Risikobereitschaft einige Stücke der Elan-Aktie ins Depot legen. Das Kursziel werde bei 22 Euro gesehen. Zur Absicherung sollte ein Stopp bei 13 Euro platziert werden. (Ausgabe 29) (12.07.2007/ac/a/a)Analyse-Datum: 12.07.2007
Kulmbach (aktiencheck.de AG) - Die Experten vom Anlegermagazin "Der Aktionär" empfehlen die Aktie von Elan (ISIN IE0003072950/ WKN 903801) für risikobereite Anleger.
In den vergangenen Monaten habe der Anteilsschein von Elan an der Börse eine bemerkenswerte Renaissance erlebt. Die Aktie habe allein seit Anfang des Jahres um 60 Prozent zugelegt. Für den letzten Aufschwung gebe es mehrere gute Gründe. Die allmähliche Rückkehr des Medikamentes Tysabri, das auch von einigen Fachleuten schon abgemeldet gewesen sei, sei ein Grund.
Tysabri sei ab Ende Februar 2005 nicht mehr auf dem Markt erhältlich gewesen, da drei behandelte Patienten an der seltenen Viruserkrankung des Gehirns, PML, gestorben seien. Man könne das Medikament inzwischen in den USA und Europa wieder erhalten, wenn auch unter strengen Auflagen.
Die Gesellschaft habe auch über Tysabri hinaus in den vergangenen Jahren ihre Entwicklungspipeline sukzessiv erweitert. Ein potenzielles Mittel zur Behandlung von Alzheimer, das Elan in Zusammenarbeit mit Wyeth entwickle, sei besonders interessant. Die Unternehmen hätten nach sehr guten Ergebnissen in der zweiten Phase klinischer Studien schon den Start von finalen Phase-III-Tests gemeldet.
Jedoch würden Analysten munkeln, dass das bislang vorliegende Datenmaterial so gut sein solle, dass eine Beantragung der Zulassung seitens der Unternehmen bereits jetzt möglich sei. Der monoklonale Antikörper mit dem Forschungsnamen AAB-001 wäre dann vielleicht bereits Ende 2008 erhältlich.
Besondere Fantasie erhalte der Titel von Elan von der bevorstehenden Tysabri-Entscheidung für die Indikation Morbus Crohn. Faktoren würden jedoch auch auf mittlere und lange Sicht für ein Engagement sprechen.
Nach Ansicht der Experten von "Der Aktionär" sollten Investoren mit einem gewissen Maß an Risikobereitschaft einige Stücke der Elan-Aktie ins Depot legen. Das Kursziel werde bei 22 Euro gesehen. Zur Absicherung sollte ein Stopp bei 13 Euro platziert werden. (Ausgabe 29) (12.07.2007/ac/a/a)Analyse-Datum: 12.07.2007
Antwort auf Beitrag Nr.: 30.654.116 von Poppholz am 12.07.07 14:59:46Wahrscheinlich wissen sie immer noch nicht was sie wollen heute
Antwort auf Beitrag Nr.: 30.657.591 von surga am 12.07.07 17:51:40noch mehr zum Lesen
Building IP: Patent Application re Nanoparticulate and Controlled Release Compositions Comprising a Cephalosporin (think nano and antibiotics)
http://www.investorvillage.com/smbd.asp?mb=160&mn=127853&pt=…
Building IP: Patent Application re Nanoparticulate and Controlled Release Compositions Comprising a Cephalosporin (think nano and antibiotics)
http://www.investorvillage.com/smbd.asp?mb=160&mn=127853&pt=…
Antwort auf Beitrag Nr.: 30.657.699 von surga am 12.07.07 17:57:06Noch was
Re: I feel good about ELN
As much as the AC the committee decides 1 in 1,000 for PML may sound bad to people it also means the FDA won't get involved with a new case of PML unless Tysabri shows a greater percentage of PML cases than 1 in 1,000. As an investor that gives me comfort that we won't have another BM off of a PML case. ----- ..............
http://www.investorvillage.com/smbd.asp?mb=160&mn=127862&pt=…
Re: I feel good about ELN
As much as the AC the committee decides 1 in 1,000 for PML may sound bad to people it also means the FDA won't get involved with a new case of PML unless Tysabri shows a greater percentage of PML cases than 1 in 1,000. As an investor that gives me comfort that we won't have another BM off of a PML case. ----- ..............
http://www.investorvillage.com/smbd.asp?mb=160&mn=127862&pt=…
heute wird es wohl einen schönen grünen Start über der $22,00 Marke geben.
Über einen schönen grünen Schluss würde ich mich natürlich noch ein wenig mehr freuen.
Über einen schönen grünen Schluss würde ich mich natürlich noch ein wenig mehr freuen.
Antwort auf Beitrag Nr.: 30.669.561 von Poppholz am 13.07.07 14:24:40yeeeep, sieht gut aus heute
Antwort auf Beitrag Nr.: 30.671.100 von surga am 13.07.07 15:51:53Leider wird bei unserem Baby schon seit Monaten der Kurs immer wieder gedrückt.
Vielleicht hat dies ja Ende Juli, nach Bekanntgabe der Zahlen, endlich ein Ende.
Allerdings ist der Kurs in der Vergangenheit immer nach guten Zahlen und Ereignissen der Kurs nach unten gegangen.
Vielleicht hat dies ja Ende Juli, nach Bekanntgabe der Zahlen, endlich ein Ende.
Allerdings ist der Kurs in der Vergangenheit immer nach guten Zahlen und Ereignissen der Kurs nach unten gegangen.
Antwort auf Beitrag Nr.: 30.673.337 von Poppholz am 13.07.07 17:57:30wir warten einfach weiterhin ab.
So wie in den letzten (vielen) Monaten.
Die Zeit hat uns bisher Recht gegeben und wird dies auch in den nächsten Monaten tun.
So wie in den letzten (vielen) Monaten.
Die Zeit hat uns bisher Recht gegeben und wird dies auch in den nächsten Monaten tun.
der Kurs ist heute um die $22,00 wie festgenagelt.
Große Positionen auf beiden Seiten.
mal sehen wohin die Reise heute noch geht.
Große Positionen auf beiden Seiten.
mal sehen wohin die Reise heute noch geht.
Netten Gruss aus Rhodos!
Hier ist es bilderbuchmaessig und uns gehts"saugut".....Fast[ koennte ich die Boerse hier vergessen----aber natuerlich NIE unsere Elan und die netten Threadgenossen...
Die Preisdrueckerei ist wohl wieder der preiswerten Aufstockung der Grossen geschuldet.....Ich fuehle mich SEHR wohl mit diesen Schaetzen im Depot...Bis bald---und 23 $ faend ich bis zu meiner Rueckkehr auch OK....!!!
Hier ist es bilderbuchmaessig und uns gehts"saugut".....Fast[ koennte ich die Boerse hier vergessen----aber natuerlich NIE unsere Elan und die netten Threadgenossen...
Die Preisdrueckerei ist wohl wieder der preiswerten Aufstockung der Grossen geschuldet.....Ich fuehle mich SEHR wohl mit diesen Schaetzen im Depot...Bis bald---und 23 $ faend ich bis zu meiner Rueckkehr auch OK....!!!
Antwort auf Beitrag Nr.: 30.686.765 von Birgit.Tersteegen am 14.07.07 17:24:53Netten Gruss aus Rhodos!
...ja, dann einfach mal einen netten Gruß aus Deutschland ....
...irgendwie sind wir zur Zeit doch alle börsentechnisch und wettermäßig gesehen " ein Sommerloch "....
...und jetzt brauchen wir nur eigentlich nur noch auf das nächste " Sommermärchen " zu warten....
...ja, dann einfach mal einen netten Gruß aus Deutschland ....
...irgendwie sind wir zur Zeit doch alle börsentechnisch und wettermäßig gesehen " ein Sommerloch "....
...und jetzt brauchen wir nur eigentlich nur noch auf das nächste " Sommermärchen " zu warten....
Salute...
hi Biggi, das Eiland brät doch in der Sonne wie ein Ei im Tiegel.
wenn man sich mal die langfristcharts anderer Bios reinzieht,
hier Biib zB. dann könnte mans Gefühl kriegen die Branche will hoch..
zumal der Rest dem Solarzeug hinterhertrampelt.
genentech scheint auch nochmal Luft zu holen...über 100 bricht dort der Wahnsinn aus.
wyeth auch Ausbruch aus steigendem Dreieck (anfang 02 bis ende 06)
ja und eln, ein Mords Dreieck! Nur wo gehts hin?
selbst wenn (am 31.7.?) Ty nur für Hustensaft taugt und ein Rücksetzer kommt kann man bis ~$10/8 alles wegkaufen. Solche Rülpser gehören ja zum Zyklus bei dem Papier und es ist ja anscheinend noch mehr in der Pipe der irren Iren.
Ist nur meine wahrnehmung, muß nicht hinhauen.
Grüße von einem Threadgenossen...
hi Biggi, das Eiland brät doch in der Sonne wie ein Ei im Tiegel.
wenn man sich mal die langfristcharts anderer Bios reinzieht,
hier Biib zB. dann könnte mans Gefühl kriegen die Branche will hoch..
zumal der Rest dem Solarzeug hinterhertrampelt.
genentech scheint auch nochmal Luft zu holen...über 100 bricht dort der Wahnsinn aus.
wyeth auch Ausbruch aus steigendem Dreieck (anfang 02 bis ende 06)
ja und eln, ein Mords Dreieck! Nur wo gehts hin?
selbst wenn (am 31.7.?) Ty nur für Hustensaft taugt und ein Rücksetzer kommt kann man bis ~$10/8 alles wegkaufen. Solche Rülpser gehören ja zum Zyklus bei dem Papier und es ist ja anscheinend noch mehr in der Pipe der irren Iren.
Ist nur meine wahrnehmung, muß nicht hinhauen.
Grüße von einem Threadgenossen...
...hatte in letzter Zeit kaum Gelegenheit, das Forum zu verfolgen - vielleicht wurde dies schon mitgeteilt?
Elan in Frank Philipps Realdepot - nach intensiver Hexerei - dazu sein Bericht in der letzten Aktionärs-Ausgabe:
http://www.depotliga.de/xist4c/web/realdepot-biotech-report_…
Elan in Frank Philipps Realdepot - nach intensiver Hexerei - dazu sein Bericht in der letzten Aktionärs-Ausgabe:
http://www.depotliga.de/xist4c/web/realdepot-biotech-report_…
Antwort auf Beitrag Nr.: 30.716.438 von Cyberhexe am 16.07.07 20:28:47"Elan" ins Depot
Die Aktie der irischen Pharmafirma Elan feiert ein starkes Comeback. Die Rückkehr einer schon fast abgeschriebenen Arznei sorgt für Fantasie.
Die Aktie des irischen Pharmaunternehmens Elan hat an der Börse in den letzten Monaten eine bemerkenswerte Renaissance erlebt. Allein seit Jahresbeginn hat das Papier 60 Prozent an Wert gewonnen. Für den jüngsten Aufschwung gibt es mehrere gute Gründe. Einer davon ist die allmähliche Rückkehr eines Medikamentes, das auch von einigen Fachleuten bereits abgeschrieben war.
Tysabris Rückkehr
Das Medikament Tysabri hat Elan gemeinsam mit dem US-Biotech-Konzern Biogen Idec entwickelt. Schon vor der Zulassung war die Arznei gegen Multiple Sklerose (MS) von den Analysten als potenzielles Multi-Milliarden-Dollar- Produkt gefeiert worden. Doch dann der Schock: Ende Februar 2005 wurde Tysabri vom Markt genommen, weil drei behandelte Patienten an der seltenen Viruserkrankung des Gehirns, PML, gestorben waren. Inzwischen ist das Präparat sowohl in den USA als auch in Europa wieder im Verkauf, wenn auch unter strengen Auflagen. So darf es zum Beispiel nur unter Einhaltung eines besonderen Risikomanagement- Plans angewendet werden. Seit der erneuten Einführung im Sommer 2006 sind keine weiteren Fälle von PML bekannt geworden, obwohl mittlerweile mehr als 10.000 Menschen mit Tysabri behandelt wurden. Zudem haben die Unternehmen eine klinische Studie der Phase III mit Tysabri zur Behandlung der chronischentzündlichen Magen-Darm-Erkrankung Morbus Crohn erfolgreich abgeschlossen. Am 15. Oktober wird die USGesundheitsbehörde FDA über eine Zulassung entscheiden. Aber schon vorher wird es spannend: Am 31. Juli gibt ein Expertengremium der Behörde eine Empfehlung ab. In der Regel folgt die FDA dem Rat ihrer Experten.
Weiterer Trumpf
Auch über Tysabri hinaus hat Elan in den letzten Jahren seine Entwicklungspipeline sukzessiv ausgebaut. Besonders interessant ist ein potenzielles Mittel gegen Alzheimer, das Elan in Kooperation mit Wyeth entwickelt. Nach sehr guten Ergebnissen in der zweiten Phase klinischer Studien haben die Unternehmen bereits den Start von finalen Phase-III-Tests angekündigt. Unter Analysten kursieren jedoch Gerüchte, nach denen das bisher vorliegende Datenmaterial so gut sein soll, dass die Unternehmen schon auf dieser Basis eine Zulassung beantragen könnten. Dann wäre der monoklonale Antikörper mit dem Forschungsnamen AAB- 001 vielleicht schon Ende nächsten Jahres auf dem Markt.
Tysabri und mehr
Besondere Fantasie geht bei der Elan-Aktie von der bevorstehenden Tysabri-Entscheidung für die Indikation Morbus Crohn aus. Doch auch auf mittlere und lange Sicht gibt es Faktoren, die für ein Engagement sprechen.
Investoren mit einem gewissen Maß an Risikobereitschaft legen sich deshalb einige Stücke ins Depot.
...einige Stücke !!!.....haben wir....haben wir...
Kursziel bei Elan: 22,00 Euro. Stopp: 13,00 Euro.
Erschienen in DER AKTIONÄR Ausgabe 29/2007.
http://www.deraktionaer.de/xist4c/web/-Elan--ins-Depot_id_44…
Die Aktie der irischen Pharmafirma Elan feiert ein starkes Comeback. Die Rückkehr einer schon fast abgeschriebenen Arznei sorgt für Fantasie.
Die Aktie des irischen Pharmaunternehmens Elan hat an der Börse in den letzten Monaten eine bemerkenswerte Renaissance erlebt. Allein seit Jahresbeginn hat das Papier 60 Prozent an Wert gewonnen. Für den jüngsten Aufschwung gibt es mehrere gute Gründe. Einer davon ist die allmähliche Rückkehr eines Medikamentes, das auch von einigen Fachleuten bereits abgeschrieben war.
Tysabris Rückkehr
Das Medikament Tysabri hat Elan gemeinsam mit dem US-Biotech-Konzern Biogen Idec entwickelt. Schon vor der Zulassung war die Arznei gegen Multiple Sklerose (MS) von den Analysten als potenzielles Multi-Milliarden-Dollar- Produkt gefeiert worden. Doch dann der Schock: Ende Februar 2005 wurde Tysabri vom Markt genommen, weil drei behandelte Patienten an der seltenen Viruserkrankung des Gehirns, PML, gestorben waren. Inzwischen ist das Präparat sowohl in den USA als auch in Europa wieder im Verkauf, wenn auch unter strengen Auflagen. So darf es zum Beispiel nur unter Einhaltung eines besonderen Risikomanagement- Plans angewendet werden. Seit der erneuten Einführung im Sommer 2006 sind keine weiteren Fälle von PML bekannt geworden, obwohl mittlerweile mehr als 10.000 Menschen mit Tysabri behandelt wurden. Zudem haben die Unternehmen eine klinische Studie der Phase III mit Tysabri zur Behandlung der chronischentzündlichen Magen-Darm-Erkrankung Morbus Crohn erfolgreich abgeschlossen. Am 15. Oktober wird die USGesundheitsbehörde FDA über eine Zulassung entscheiden. Aber schon vorher wird es spannend: Am 31. Juli gibt ein Expertengremium der Behörde eine Empfehlung ab. In der Regel folgt die FDA dem Rat ihrer Experten.
Weiterer Trumpf
Auch über Tysabri hinaus hat Elan in den letzten Jahren seine Entwicklungspipeline sukzessiv ausgebaut. Besonders interessant ist ein potenzielles Mittel gegen Alzheimer, das Elan in Kooperation mit Wyeth entwickelt. Nach sehr guten Ergebnissen in der zweiten Phase klinischer Studien haben die Unternehmen bereits den Start von finalen Phase-III-Tests angekündigt. Unter Analysten kursieren jedoch Gerüchte, nach denen das bisher vorliegende Datenmaterial so gut sein soll, dass die Unternehmen schon auf dieser Basis eine Zulassung beantragen könnten. Dann wäre der monoklonale Antikörper mit dem Forschungsnamen AAB- 001 vielleicht schon Ende nächsten Jahres auf dem Markt.
Tysabri und mehr
Besondere Fantasie geht bei der Elan-Aktie von der bevorstehenden Tysabri-Entscheidung für die Indikation Morbus Crohn aus. Doch auch auf mittlere und lange Sicht gibt es Faktoren, die für ein Engagement sprechen.
Investoren mit einem gewissen Maß an Risikobereitschaft legen sich deshalb einige Stücke ins Depot.
...einige Stücke !!!.....haben wir....haben wir...
Kursziel bei Elan: 22,00 Euro. Stopp: 13,00 Euro.
Erschienen in DER AKTIONÄR Ausgabe 29/2007.
http://www.deraktionaer.de/xist4c/web/-Elan--ins-Depot_id_44…
man braucht schon echt starke Nerven, wenn hier auf fallende Kurse gesetzt werden soll.
Antwort auf Beitrag Nr.: 30.733.826 von Poppholz am 17.07.07 20:53:09für mich wäre das nichts.
Ich warte lieber auf steigende Kurse auch wenn dieses noch einige Wochen (Monate) dauern wird.
Ich warte lieber auf steigende Kurse auch wenn dieses noch einige Wochen (Monate) dauern wird.
NCB On 2nd Qtr Results
Group Forecasts:
Elan reports Q2 2007 results on 26th July 2007 where the focus will be on Tysabri’s weekly run rate, generic competition to Maxipime, the upcoming advisory panel meeting on Tysabri for Crohn’s disease and progress on the Alzheimer’s Disease pipeline. Ahead of Elan’s results, BiogenIdec will report specific details on Tysabri’s uptake in the quarter in its Q2 release/CC on 24th July 2007. This quarter, we are anticipating total revenues of $179.3m, operating losses (pre-charges) of $51.5m and the EPS (adjusted) loss is expected to be -$0.17 compared to a -$0.20 loss in the comparable period. With a Maxipime generic approved and a potential launch imminent it is likely that management will revise both the full year revenue guidance ($500m excess expected) and the adjusted EBITDA guidance (a loss of less than $50m).
• Product Revenue Forecasts:
We are expecting product revenues to increase 33% y-o-y primarily reflecting sales of Tysabri. A generic of Maxipime was approved in June 2007 although it has not been confirmed if the generic has yet been launched. Although there may be some destocking of the brand ahead of generic approval, we continue to expect $47m in revenues in the quarter. To our knowledge no generic of Azactam has been approved and our quarter revenue estimate is $18m. We expect that Prialt will continue to underperform. Although Azactam currently remains free of generic competition, it is
likely that management will restructure the hospital infrastructure to maximise the cashflow from this franchise. Further details are likely on the post results CC.
• Tysabri Revenue Forecasts:
Patient enrollments have accelerated q-o-q although there has been a slower than anticipated rate of conversion in the US from enrollment to infusion. BiogenIdec reported that 7,600 patients in the US and 3,200 patients in EU/RoW had received Tysabri commercially as of 23rd May 2007. Our Tysabri forecasts to the end of June 2007 assume that 8,700 new patients were infused with Tysabri in the US and that 3,450 new patients were treated with Tysabri in EU/RoW – 12,150 treated patients globally. Our US and EU/RoW revenue estimates for the quarter are $52.2m and $21.2m respectively - $73.4m globally. Should BiogenIdec/Elan provide patient numbers as of mid-July, we would expect to see 9,250 patients on the drug in the US and 3,650 patients on treatment in EU/RoW. We would expect, overall, to see better traction of Tysabri in the US this quarter and for EU/RoW to continue
showing strong growth. In addition to the patient demand in the quarter, Elan will likely provide an update on (i) the current weekly run rate, (ii) infusion centre registration in the US, (iii) reimbursement and roll out in Europe and (iv) MS market trends.
• Conclusion & Action: Pipeline Update:
Further details may be available on specific Phase III timelines for AAB-001 for Alzheimer’s Disease. Phase II studies with ACC-001 (immunoconjugate for AD) are expected to have started this quarter. An update is also likely on the timeline for a decison from the EMEA for Tysabri for Crohn’s disease. An FDA Advisory committee meeting is scheduled for Tysabri in Crohn’s Disease for 31st July 2007.
http://www.investorvillage.com/smbd.asp?mb=160&mn=129532&pt=…
Group Forecasts:
Elan reports Q2 2007 results on 26th July 2007 where the focus will be on Tysabri’s weekly run rate, generic competition to Maxipime, the upcoming advisory panel meeting on Tysabri for Crohn’s disease and progress on the Alzheimer’s Disease pipeline. Ahead of Elan’s results, BiogenIdec will report specific details on Tysabri’s uptake in the quarter in its Q2 release/CC on 24th July 2007. This quarter, we are anticipating total revenues of $179.3m, operating losses (pre-charges) of $51.5m and the EPS (adjusted) loss is expected to be -$0.17 compared to a -$0.20 loss in the comparable period. With a Maxipime generic approved and a potential launch imminent it is likely that management will revise both the full year revenue guidance ($500m excess expected) and the adjusted EBITDA guidance (a loss of less than $50m).
• Product Revenue Forecasts:
We are expecting product revenues to increase 33% y-o-y primarily reflecting sales of Tysabri. A generic of Maxipime was approved in June 2007 although it has not been confirmed if the generic has yet been launched. Although there may be some destocking of the brand ahead of generic approval, we continue to expect $47m in revenues in the quarter. To our knowledge no generic of Azactam has been approved and our quarter revenue estimate is $18m. We expect that Prialt will continue to underperform. Although Azactam currently remains free of generic competition, it is
likely that management will restructure the hospital infrastructure to maximise the cashflow from this franchise. Further details are likely on the post results CC.
• Tysabri Revenue Forecasts:
Patient enrollments have accelerated q-o-q although there has been a slower than anticipated rate of conversion in the US from enrollment to infusion. BiogenIdec reported that 7,600 patients in the US and 3,200 patients in EU/RoW had received Tysabri commercially as of 23rd May 2007. Our Tysabri forecasts to the end of June 2007 assume that 8,700 new patients were infused with Tysabri in the US and that 3,450 new patients were treated with Tysabri in EU/RoW – 12,150 treated patients globally. Our US and EU/RoW revenue estimates for the quarter are $52.2m and $21.2m respectively - $73.4m globally. Should BiogenIdec/Elan provide patient numbers as of mid-July, we would expect to see 9,250 patients on the drug in the US and 3,650 patients on treatment in EU/RoW. We would expect, overall, to see better traction of Tysabri in the US this quarter and for EU/RoW to continue
showing strong growth. In addition to the patient demand in the quarter, Elan will likely provide an update on (i) the current weekly run rate, (ii) infusion centre registration in the US, (iii) reimbursement and roll out in Europe and (iv) MS market trends.
• Conclusion & Action: Pipeline Update:
Further details may be available on specific Phase III timelines for AAB-001 for Alzheimer’s Disease. Phase II studies with ACC-001 (immunoconjugate for AD) are expected to have started this quarter. An update is also likely on the timeline for a decison from the EMEA for Tysabri for Crohn’s disease. An FDA Advisory committee meeting is scheduled for Tysabri in Crohn’s Disease for 31st July 2007.
http://www.investorvillage.com/smbd.asp?mb=160&mn=129532&pt=…
Wyeth Reports Earnings Results for the 2007 Second Quarter and First Half
Thursday July 19, 7:00 am ET
...unter anderem....\" worth to be mentioned \"...
During May and June, Wyeth presented important clinical data for four potential new products - bifeprunox for schizophrenia, PRISTIQ(TM) (desvenlafaxine succinate) for prevention of vasomotor symptoms and major depressive disorder, and Torisel.
In addition, Wyeth and its partner, Elan Corporation, plc, announced that a Phase 3 clinical trial for its Alzheimer\'s compound, bapineuzumab (AAB-001), would be initiated later this year to treat patients with mild to moderate Alzheimer\'s disease.
http://biz.yahoo.com/prnews/070719/nyth017.html?.v=97
Thursday July 19, 7:00 am ET
...unter anderem....\" worth to be mentioned \"...
During May and June, Wyeth presented important clinical data for four potential new products - bifeprunox for schizophrenia, PRISTIQ(TM) (desvenlafaxine succinate) for prevention of vasomotor symptoms and major depressive disorder, and Torisel.
In addition, Wyeth and its partner, Elan Corporation, plc, announced that a Phase 3 clinical trial for its Alzheimer\'s compound, bapineuzumab (AAB-001), would be initiated later this year to treat patients with mild to moderate Alzheimer\'s disease.
http://biz.yahoo.com/prnews/070719/nyth017.html?.v=97
Antwort auf Beitrag Nr.: 30.759.458 von bernie55 am 19.07.07 13:58:31EU drug experts rebuff Elan's Tysabri in Crohn\'s
LONDON, July 19 (Reuters) - European drug regulators said on Thursday that multiple sclerosis treatment Tysabri should not be approved as a treatment for Crohn\'s disease.
The European Medicines Agency said the effects of the medicine, from Ireland\'s Elan Corp (ELN.I: Quote, Profile, Research) and Biogen Idec (BIIB.O: Quote, Profile, Research), were modest and there was a risk of serious infections.
The product will be reviewed by U.S. experts for use in Crohn\'s, a serious bowel disorder, at an advisory meeting on July 31.
http://www.reuters.com/article/topNews/idUKWLB911920070719?r…
LONDON, July 19 (Reuters) - European drug regulators said on Thursday that multiple sclerosis treatment Tysabri should not be approved as a treatment for Crohn\'s disease.
The European Medicines Agency said the effects of the medicine, from Ireland\'s Elan Corp (ELN.I: Quote, Profile, Research) and Biogen Idec (BIIB.O: Quote, Profile, Research), were modest and there was a risk of serious infections.
The product will be reviewed by U.S. experts for use in Crohn\'s, a serious bowel disorder, at an advisory meeting on July 31.
http://www.reuters.com/article/topNews/idUKWLB911920070719?r…
Antwort auf Beitrag Nr.: 30.765.773 von surga am 19.07.07 20:25:52Was bedeutet das für ELAN?
Antwort auf Beitrag Nr.: 30.765.789 von surga am 19.07.07 20:26:52Elan and Biogen Idec Preparing to Appeal Ruling on European Application for Natalizumab for the Treatment of Crohn's Disease
DUBLIN, Ireland & ZUG, Switzerland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) and Biogen Idec (NASDAQ: BIIB - News) announced today that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008.
"Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications, intravenous nutritional therapies or clinical trials with unproven experimental agents, depending upon on the patients' condition," said Professor Jean-Frederick Colombel, University of Lille. "There is a need for new therapies for this very difficult disease."
An application for approval of TYSABRI® (natalizumab) for treatment of moderate to severe Crohn's disease was filed in the US on December 15, 2006. The FDA is holding an advisory committee to discuss the application on July 31, 2007.
.......
http://biz.yahoo.com/bw/070719/20070719005888.html?.v=1
DUBLIN, Ireland & ZUG, Switzerland--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) and Biogen Idec (NASDAQ: BIIB - News) announced today that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008.
"Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications, intravenous nutritional therapies or clinical trials with unproven experimental agents, depending upon on the patients' condition," said Professor Jean-Frederick Colombel, University of Lille. "There is a need for new therapies for this very difficult disease."
An application for approval of TYSABRI® (natalizumab) for treatment of moderate to severe Crohn's disease was filed in the US on December 15, 2006. The FDA is holding an advisory committee to discuss the application on July 31, 2007.
.......
http://biz.yahoo.com/bw/070719/20070719005888.html?.v=1
Elan says EMEA adopts negative opinion on natalizumab
By Sarah Turner
Last Update: 2:37 AM ET Jul 20, 2007
LONDON (MarketWatch) -- Elan Corp. (ELN
Elan Corporation, plc
News , chart , profile , more
UK:ELA ) said Friday that it has been informed tby the European Medicines Agency that the Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and partner Biogen Idec (BIIB
BIIB ) plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by the first quarter of 2008.
By Sarah Turner
Last Update: 2:37 AM ET Jul 20, 2007
LONDON (MarketWatch) -- Elan Corp. (ELN
Elan Corporation, plc
News , chart , profile , more
UK:ELA ) said Friday that it has been informed tby the European Medicines Agency that the Committee for Medicinal Products for Human Use has adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn's disease. In accordance with European regulations, Elan and partner Biogen Idec (BIIB
BIIB ) plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by the first quarter of 2008.
Hi
na, da habt Ihr Euch aber wohl nicht soviel Mühe gegeben.... aber das wird schon noch...
---------------------------------------------------------------
Goodbody: No revenues anyway for T/Crohns; WYE CC not much BAP News
Elan (Add, Closing Price $21.19); EU reject application for use of Tysabri against Crohn’s.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Elan and its partner Biogen Idec last night announced that the European Medicines Agency (EMEA) had “adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn’s disease”. The decision was made balancing the level of efficacy against the risk of PML. Elan and Biogen Idec plan to apply for a re-examination of the opinion and expect a decision on the appeal by Q108. The FDA is holding an advisory committee meeting on 31 July to discuss the application for approval of the drug for the treatment of Crohn’s in the US. The EMEA decision has no impact on our model as we have no revenue factored in against Tysabri for the treatment of Crohn’s in either the EU or the US. We have always believed that: (i) given the efficacy of the drug against Crohn’s;
(ii) the drugs already on the market for the treatment of Crohn’s; and (iii) the safety profile, the use of Tysabri to treat the disease would be marginal at best. In the US, we believe that the potential of a drug targeting a gastro-intestinal disease, which requires a neurologicalbased safety management programme, would greatly limit its uptake, even if approved.
Elan (Add, Closing Price $21.19); Wyeth reports strong Q207, upgrades guidance but nothing new on AAB-001
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Wyeth, Elan’s partner in the development of its Alzheimer’s drug candidate Bapineuzumab (AAB-001), yesterday reported a strong set of Q207 results and took the opportunity to increase FY07 guidance. The company reported EPS of $0.90 (5% ahead of consensus at $0.86) from net revenue of $5.6bn, 3.5% ahead of market expectations ($5.4bn). Management attributed the strong performance to growth in its drug Enbrel (principally used for rheumatoid arthritis) and its vaccine Prevnar. Given its strong H107, the company raised FY07 earnings guidance to the $3.48 to $3.56 range from previous guidance of $3.40 to $3.50.
Of relevance to Elan, there was little mention of Bapineuzumab in the results release or the prepared remarks in the conference call. In response to three specific questions, management noted that: (i) it was preparing to talk to regulators on Phase III trial protocols; (ii) the decision to move to Phase III was taken after a composite look at Phase II interim data, Phase I data, AN1792 data, the mechanism of action and patient need; and (iii) any thought of testing the drug on pre-senile dementia would have to be discussed with regulators. This proved to be a good quarter for Wyeth but, as expected, the results provided little read through for Elan
na, da habt Ihr Euch aber wohl nicht soviel Mühe gegeben.... aber das wird schon noch...
---------------------------------------------------------------
Goodbody: No revenues anyway for T/Crohns; WYE CC not much BAP News
Elan (Add, Closing Price $21.19); EU reject application for use of Tysabri against Crohn’s.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Elan and its partner Biogen Idec last night announced that the European Medicines Agency (EMEA) had “adopted a negative opinion on the marketing application for the use of natalizumab in patients with Crohn’s disease”. The decision was made balancing the level of efficacy against the risk of PML. Elan and Biogen Idec plan to apply for a re-examination of the opinion and expect a decision on the appeal by Q108. The FDA is holding an advisory committee meeting on 31 July to discuss the application for approval of the drug for the treatment of Crohn’s in the US. The EMEA decision has no impact on our model as we have no revenue factored in against Tysabri for the treatment of Crohn’s in either the EU or the US. We have always believed that: (i) given the efficacy of the drug against Crohn’s;
(ii) the drugs already on the market for the treatment of Crohn’s; and (iii) the safety profile, the use of Tysabri to treat the disease would be marginal at best. In the US, we believe that the potential of a drug targeting a gastro-intestinal disease, which requires a neurologicalbased safety management programme, would greatly limit its uptake, even if approved.
Elan (Add, Closing Price $21.19); Wyeth reports strong Q207, upgrades guidance but nothing new on AAB-001
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Wyeth, Elan’s partner in the development of its Alzheimer’s drug candidate Bapineuzumab (AAB-001), yesterday reported a strong set of Q207 results and took the opportunity to increase FY07 guidance. The company reported EPS of $0.90 (5% ahead of consensus at $0.86) from net revenue of $5.6bn, 3.5% ahead of market expectations ($5.4bn). Management attributed the strong performance to growth in its drug Enbrel (principally used for rheumatoid arthritis) and its vaccine Prevnar. Given its strong H107, the company raised FY07 earnings guidance to the $3.48 to $3.56 range from previous guidance of $3.40 to $3.50.
Of relevance to Elan, there was little mention of Bapineuzumab in the results release or the prepared remarks in the conference call. In response to three specific questions, management noted that: (i) it was preparing to talk to regulators on Phase III trial protocols; (ii) the decision to move to Phase III was taken after a composite look at Phase II interim data, Phase I data, AN1792 data, the mechanism of action and patient need; and (iii) any thought of testing the drug on pre-senile dementia would have to be discussed with regulators. This proved to be a good quarter for Wyeth but, as expected, the results provided little read through for Elan
Antwort auf Beitrag Nr.: 30.770.777 von Birgit.Tersteegen am 20.07.07 10:32:48Hi Birgit,
bist Du wieder da vom Urlaub?
Sehr ruhig hier ohne Dich!
Scheint mir, dass solche Nachricht sehr gelassen angenommen wird, oder sehe ich falsch?
bist Du wieder da vom Urlaub?
Sehr ruhig hier ohne Dich!
Scheint mir, dass solche Nachricht sehr gelassen angenommen wird, oder sehe ich falsch?
Antwort auf Beitrag Nr.: 30.771.076 von surga am 20.07.07 10:51:38Hi Surga
Heute Nacht sind wir zurückgekommen---gleich mal nach unserem Elan-Schätzchen geguckt und war leicht irritiert....
So wie ich es verstanden habe, ist es nicht die Entscheidung der Emea sondern nur die Empfehlung des sie beratenden Gremiums und Elan will den Prozess dieser Beratung neu aufrollen---also noch nix entschieden und Chrons wird ja eh nicht als so relevant für die Umsätze von Elan gesehehen...
Falls der Kurs heute in Amiland nochmal nach unten gehen sollte werde ich wieder ein bisschen zukaufen...
Mit Elan wird es eben nie langweilig...
Gruss in die Runde....Birgit
PS.Hexchen, wie beurteilst Du diese Situation?
Heute Nacht sind wir zurückgekommen---gleich mal nach unserem Elan-Schätzchen geguckt und war leicht irritiert....
So wie ich es verstanden habe, ist es nicht die Entscheidung der Emea sondern nur die Empfehlung des sie beratenden Gremiums und Elan will den Prozess dieser Beratung neu aufrollen---also noch nix entschieden und Chrons wird ja eh nicht als so relevant für die Umsätze von Elan gesehehen...
Falls der Kurs heute in Amiland nochmal nach unten gehen sollte werde ich wieder ein bisschen zukaufen...
Mit Elan wird es eben nie langweilig...
Gruss in die Runde....Birgit
PS.Hexchen, wie beurteilst Du diese Situation?
Antwort auf Beitrag Nr.: 30.771.395 von Birgit.Tersteegen am 20.07.07 11:12:12Ahaaaaaaaaa, deswegen war der Kurs ziemlich moderat "gesunken"!
Danke
Wellcome back Biggi!
Danke
Wellcome back Biggi!
Antwort auf Beitrag Nr.: 30.771.547 von surga am 20.07.07 11:22:45By: teknowizz
Finfacts article on the EMEA opinion & the opposing opinion from an expert
This article quotes a EU Professor who has quite a different opinion on Tysabri for CD than the EU CHMP ...
http://www.finfacts.com/irelandbusinessnews/publish/printer_…
Elan's Tysabri drug rejected by European Medicines Agency for treatment of patients with Crohn's disease
By Finfacts Team
Jul 20, 2007, 07:59
Irish drugs firm Elan and its US partner Biogen Idec announced today that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of its Tysabri natalizumab drug in patients with Crohn's disease.
In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008.
"Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications, intravenous nutritional therapies or clinical trials with unproven experimental agents, depending upon on the patients' condition," said Professor Jean-Frederick Colombel, University of Lille. "There is a need for new therapies for this very difficult disease."
An application for approval of Tysabri (natalizumab) for treatment of moderate to severe Crohn's disease was filed in the US on December 15, 2006. The FDA is holding an advisory committee to discuss the application on July 31, 2007.
Approximately one million people worldwide have Crohn's disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.
The disease usually causes diarrhea and crampy abdominal pain, often associated with fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), and malnutrition. Most patients eventually require surgery, which has both risks and potential short- and long-term complications.
Finfacts article on the EMEA opinion & the opposing opinion from an expert
This article quotes a EU Professor who has quite a different opinion on Tysabri for CD than the EU CHMP ...
http://www.finfacts.com/irelandbusinessnews/publish/printer_…
Elan's Tysabri drug rejected by European Medicines Agency for treatment of patients with Crohn's disease
By Finfacts Team
Jul 20, 2007, 07:59
Irish drugs firm Elan and its US partner Biogen Idec announced today that they have been informed by the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion on the marketing application for the use of its Tysabri natalizumab drug in patients with Crohn's disease.
In accordance with European regulations, Elan and Biogen Idec plan to apply for a re-examination of the negative opinion through the appeal procedure. A decision on the appeal is expected by 1Q 2008.
"Without natalizumab, European patients with severely active disease who failed other therapies and who are suffering from continuous symptoms may be offered surgery, with its potential complications, intravenous nutritional therapies or clinical trials with unproven experimental agents, depending upon on the patients' condition," said Professor Jean-Frederick Colombel, University of Lille. "There is a need for new therapies for this very difficult disease."
An application for approval of Tysabri (natalizumab) for treatment of moderate to severe Crohn's disease was filed in the US on December 15, 2006. The FDA is holding an advisory committee to discuss the application on July 31, 2007.
Approximately one million people worldwide have Crohn's disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.
The disease usually causes diarrhea and crampy abdominal pain, often associated with fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), and malnutrition. Most patients eventually require surgery, which has both risks and potential short- and long-term complications.
....und 100 St.zu 20,68$ sind meine
Antwort auf Beitrag Nr.: 30.775.312 von Birgit.Tersteegen am 20.07.07 15:50:45gratuliere Biggi!!!
ich hoffe, geht es wieder aufwärt
ich hoffe, geht es wieder aufwärt
Antwort auf Beitrag Nr.: 30.776.214 von surga am 20.07.07 16:39:26Das tut es bestimmt!!
Hallo ihr Lieben.
Schon wieder Achterbahn
und leider imo mehr Luft nach unten als nach oben.
Schon wieder Achterbahn
und leider imo mehr Luft nach unten als nach oben.
Antwort auf Beitrag Nr.: 30.778.197 von mikel_ann am 20.07.07 18:18:23letztendlich doch auch egal wenn die Perspektive stimmt....
hatte heute eine Kauforder für die EAN zu €14,80 in FFM.
Leider nicht ausgeführt.
Vielleicht wird es ja am Montag noch etwas.
Dann beginnt die letzte Woche vor den Quartalszahlen.
Leider nicht ausgeführt.
Vielleicht wird es ja am Montag noch etwas.
Dann beginnt die letzte Woche vor den Quartalszahlen.
MOIN! Auf eine grüne Woche....(...und Elan hat DOCH eine PR-Abteilung)
By: Corleyone2004
Press release on the One Year anniversary of Tysabri
Press Release Source: Biogen Idec and Elan Corporation, plc
TYSABRI(R) Celebrates One-Year Anniversary as a Treatment for Multiple Sclerosis
Monday July 23, 2:30 am ET
As of Mid-July, Approximately 14,000 Patients on Therapy Worldwide
CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today the one-year anniversary of TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). One year following its return to market in the US and introduction in the European Union, the companies estimate that as of mid-July 2007 in both commercial use and clinical trials approximately 14,000 patients are currently on TYSABRI therapy worldwide.
As of mid-July 2007:
In the US, over 8,600 patients are on TYSABRI commercially and over 1,800 physicians have prescribed the therapy;
In the EU, over 4,300 patients are on TYSABRI therapy commercially; and
In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.
"Over the past year I have seen my patients benefit greatly from TYSABRI. As expected from clinical trials, TYSABRI is having a positive impact on their lives. The compelling efficacy of TYSABRI offers MS patients hope in the management of their disease," said Dr. Howard Rossman, Medical Director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Michigan, and Clinical Professor of Neurology at Michigan State University. "Increased experience with TYSABRI will continue to inform us and contribute to our understanding of the important role of this therapy for people living with MS."
"TYSABRI has had an incredible effect, and the improvements I have experienced are very real. I understand there are important risks to this therapy, but the benefits of TYSABRI were far too important for my family and me to overlook," said TYSABRI patient, Mike Lynch.
In July 2006, TYSABRI was reintroduced in the US under the TOUCH Prescribing Program, a restricted distribution program, and was also introduced in the EU under a risk management plan. These programs were developed due to the increased risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.
About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the US 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 increases the risk of PML. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. 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 trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
TYSABRI is approved in the United States, European Union, Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
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 www.elan.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected hurdles. Drug development and commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
MEDIA CONTACTS
Biogen Idec
Amy Reilly, 617-914-6524
or
Elan
Matt Dallas, 212-850-5664
Elizabeth Headon, 353 1 498 0300
or
INVESTOR CONTACTS
Biogen Idec
Eric Hoffman, 617-679-2812
or
Elan
Chris Burns, 353 1 709 4444
800 252 3526
--------------------------------------------------------------------------------
Source: Biogen Idec and Elan Corporation, plc
By: Corleyone2004
Press release on the One Year anniversary of Tysabri
Press Release Source: Biogen Idec and Elan Corporation, plc
TYSABRI(R) Celebrates One-Year Anniversary as a Treatment for Multiple Sclerosis
Monday July 23, 2:30 am ET
As of Mid-July, Approximately 14,000 Patients on Therapy Worldwide
CAMBRIDGE, Mass. & DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today the one-year anniversary of TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). One year following its return to market in the US and introduction in the European Union, the companies estimate that as of mid-July 2007 in both commercial use and clinical trials approximately 14,000 patients are currently on TYSABRI therapy worldwide.
As of mid-July 2007:
In the US, over 8,600 patients are on TYSABRI commercially and over 1,800 physicians have prescribed the therapy;
In the EU, over 4,300 patients are on TYSABRI therapy commercially; and
In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.
"Over the past year I have seen my patients benefit greatly from TYSABRI. As expected from clinical trials, TYSABRI is having a positive impact on their lives. The compelling efficacy of TYSABRI offers MS patients hope in the management of their disease," said Dr. Howard Rossman, Medical Director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Michigan, and Clinical Professor of Neurology at Michigan State University. "Increased experience with TYSABRI will continue to inform us and contribute to our understanding of the important role of this therapy for people living with MS."
"TYSABRI has had an incredible effect, and the improvements I have experienced are very real. I understand there are important risks to this therapy, but the benefits of TYSABRI were far too important for my family and me to overlook," said TYSABRI patient, Mike Lynch.
In July 2006, TYSABRI was reintroduced in the US under the TOUCH Prescribing Program, a restricted distribution program, and was also introduced in the EU under a risk management plan. These programs were developed due to the increased risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.
About TYSABRI
TYSABRI is a treatment approved for relapsing forms of MS in the US 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 increases the risk of PML. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. 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 trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
TYSABRI is approved in the United States, European Union, Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
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 www.elan.com.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, or that the companies may encounter other unexpected hurdles. Drug development and commercialization involves a high degree of risk.
For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact:
MEDIA CONTACTS
Biogen Idec
Amy Reilly, 617-914-6524
or
Elan
Matt Dallas, 212-850-5664
Elizabeth Headon, 353 1 498 0300
or
INVESTOR CONTACTS
Biogen Idec
Eric Hoffman, 617-679-2812
or
Elan
Chris Burns, 353 1 709 4444
800 252 3526
--------------------------------------------------------------------------------
Source: Biogen Idec and Elan Corporation, plc
der Kurs kämpft sich langsam nach oben.
Die letzten Tage vor den Q-Zahlen.
(habe übrigens keine weiteren Aktien von ELAN bekommen)
Die letzten Tage vor den Q-Zahlen.
(habe übrigens keine weiteren Aktien von ELAN bekommen)
Antwort auf Beitrag Nr.: 30.815.004 von Poppholz am 23.07.07 17:36:50(habe übrigens keine weiteren Aktien von ELAN bekommen)
greif tiefer in die Taschen
Noogmann
greif tiefer in die Taschen
Noogmann
Antwort auf Beitrag Nr.: 30.815.030 von noogmann am 23.07.07 17:38:37genau!
Very Bullish WSJ Article
Elan Says About 14,000 People
Are Taking MS Drug Tsyabri
By QUENTIN FOTTRELL
July 23, 2007 8:37 a.m.
DUBLIN -- Elan Corp. said Monday that about 14,000 commercial patients world-wide were currently taking its multiple-sclerosis drug Tysabri, one year after its launch in Europe and re-launch in the U.S.
Elan and its U.S. partner Biogen Idec Inc. starting rolling out their 50-50 joint venture Tysabri in the U.S. and EU in June 2006 after it was temporarily suspended on safety grounds in 2005.
With 8,600 patients in the U.S., 4,300 in the EU and 1,000 in the rest of the world as of mid-July, this is 8.5% over NCB Stockbrokers' forecast, which says a slower U.S. uptake is being offset elsewhere.
Elan and Biogen in a statement quoted Howard Rossman, medical director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Mich., who said the drug had "compelling efficacy."
Dublin-based Goodbody Stockbrokers said Tysabri could have peak annual sales of $2.1 billion within three to four years, while AAB-001 -- if successful -- could have peak annual sales of up to $2.5 billion by 2015.
Davy Stockbrokers, which has a $21 target on Elan, "remains comfortable with our long-term projections for Tysabri for 2010, with global revenues of approximately $1.6 billion and patient numbers approaching 60,000."
Elan's share price has had a rollercoaster ride over the last five years: falling from its 2002 high of €50.27, leading some analysts to say that it may be significantly undervalued, given its Alzheimer's pipeline and MS drug.
Elan was down 1.4%, or €0.22, at €14.43 in Dublin in a week overall market; shares already fell from €15.55 last week after EU regulators advised against Tysabri's use for Crohn's disease.
The EU regulators cited the risk of serious infection given the relatively modest benefits, while the U.S. Food and Drug Administration's advisory panel is due to discuss Tysabri's use for Crohn's next week.
On the upside, the stock has still risen about 23% since late May on news of the imminent move of its Phase III trialsAlzheimer's treatment AAB-001, which is another 50/50 joint venture with Wyeth.
Elan Says About 14,000 People
Are Taking MS Drug Tsyabri
By QUENTIN FOTTRELL
July 23, 2007 8:37 a.m.
DUBLIN -- Elan Corp. said Monday that about 14,000 commercial patients world-wide were currently taking its multiple-sclerosis drug Tysabri, one year after its launch in Europe and re-launch in the U.S.
Elan and its U.S. partner Biogen Idec Inc. starting rolling out their 50-50 joint venture Tysabri in the U.S. and EU in June 2006 after it was temporarily suspended on safety grounds in 2005.
With 8,600 patients in the U.S., 4,300 in the EU and 1,000 in the rest of the world as of mid-July, this is 8.5% over NCB Stockbrokers' forecast, which says a slower U.S. uptake is being offset elsewhere.
Elan and Biogen in a statement quoted Howard Rossman, medical director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Mich., who said the drug had "compelling efficacy."
Dublin-based Goodbody Stockbrokers said Tysabri could have peak annual sales of $2.1 billion within three to four years, while AAB-001 -- if successful -- could have peak annual sales of up to $2.5 billion by 2015.
Davy Stockbrokers, which has a $21 target on Elan, "remains comfortable with our long-term projections for Tysabri for 2010, with global revenues of approximately $1.6 billion and patient numbers approaching 60,000."
Elan's share price has had a rollercoaster ride over the last five years: falling from its 2002 high of €50.27, leading some analysts to say that it may be significantly undervalued, given its Alzheimer's pipeline and MS drug.
Elan was down 1.4%, or €0.22, at €14.43 in Dublin in a week overall market; shares already fell from €15.55 last week after EU regulators advised against Tysabri's use for Crohn's disease.
The EU regulators cited the risk of serious infection given the relatively modest benefits, while the U.S. Food and Drug Administration's advisory panel is due to discuss Tysabri's use for Crohn's next week.
On the upside, the stock has still risen about 23% since late May on news of the imminent move of its Phase III trialsAlzheimer's treatment AAB-001, which is another 50/50 joint venture with Wyeth.
Hi Ihr!
Heute war unser Baby schon mal wieder grün----und morgen ist der CC von Biogen um 14.30h unserer Zeit.
Link zur Anmeldung des Calls:http://investor.biogenidec.com/phoenix.zhtml?c=148682&p=irol…
Vielleicht kann ja jmd mal mit hereinhören....
Schlaft gut!
Heute war unser Baby schon mal wieder grün----und morgen ist der CC von Biogen um 14.30h unserer Zeit.
Link zur Anmeldung des Calls:http://investor.biogenidec.com/phoenix.zhtml?c=148682&p=irol…
Vielleicht kann ja jmd mal mit hereinhören....
Schlaft gut!
So Ihr lieben,
ich habe mir eben noch einmal 170 EAN in FFM zu €14,72 besorgt.
Bin gespannt, wie die Börse heute reagiert.
Biogen hat ja gute Zahlen gebracht.
(somit schon zwei Gründe, das der Kurs nach unten gehen müßte)
ich habe mir eben noch einmal 170 EAN in FFM zu €14,72 besorgt.
Bin gespannt, wie die Börse heute reagiert.
Biogen hat ja gute Zahlen gebracht.
(somit schon zwei Gründe, das der Kurs nach unten gehen müßte)
ist zwar von BIIB, aber bezüglich Tysabri ist dies ja nicht so entscheidend:
Biogen Idec Reports Second Quarter 2007 Results
Cambridge, MA, July 24, 2007 --
Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its second quarter 2007 results.
Second Quarter 2007 Highlights:
Second quarter revenues were $773 million, an increase of 17% from $660 million in the prior year. There were three main drivers of this growth.
AVONEX® (interferon beta-1a) sales increased 8% to $462 million
RITUXAN® (rituximab) revenues from the unconsolidated joint business arrangement increased 12% to $231 million
Global in-market net sales of TYSABRI® (natalizumab) in the second quarter of 2007 totaled $72 million. Based on the collaboration structure with Elan, Biogen Idec recognized revenue of $48 million related to TYSABRI.
On July 2, 2007, Biogen Idec announced the final results of its "Dutch Auction" tender offer which expired at 12:00 midnight ET on Tuesday, June 26, 2007. Biogen Idec accepted for payment an aggregate of 56,424,155 shares of its common stock at a purchase price of $53.00 per share, for an aggregate share repurchase of approximately $3 billion. These shares represented approximately 16.4% of the shares outstanding as of June 26, 2007. The share repurchase was funded by approximately equal parts cash and debt.
On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), second quarter 2007 diluted earnings per share (EPS) were $0.54, an increase from a loss of $0.50 in the second quarter of 2006. GAAP net income for the quarter was $186 million, an increase from a $171 million loss in the second quarter of 2006.
Second quarter 2007 non-GAAP diluted EPS were $0.70, an increase of 23% over non-GAAP diluted EPS of $0.57 in the second quarter 2006. Non-GAAP net income for the second quarter was $240 million, an increase of 22% over non-GAAP net income of $197 million in the second quarter of 2006. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense, and other items.
"We are quite pleased with our second quarter performance. Fueled by the strong uptake of TYSABRI, we hit a new corporate milestone as our MS franchise exceeded $500 million in quarterly revenue for the first time in Biogen Idec’s history. We successfully completed our $3 billion share repurchase while continuing to advance and strengthen our pipeline, particularly with the anticipated addition of the late stage Lixivaptan compound," said James Mullen, Biogen Idec’s Chief Executive Officer.
Financial Performance
On a reported basis, calculated in accordance with GAAP, Biogen Idec reported net income of $186 million (or diluted EPS of $0.54) in the second quarter of 2007.
On a non-GAAP basis, Biogen Idec reported net income of $240 million in the second quarter of 2007. Non-GAAP diluted EPS were $0.70 for the second quarter of 2007.
The reconciling items of note between GAAP net income and diluted GAAP EPS and adjusted non-GAAP net income and diluted non-GAAP EPS in the second quarter, as itemized in Table 3 within this press release, were primarily as follows:
Pre-tax charges of $61 million for the amortization of intangibles related to the 2003 Biogen and Idec merger, the 2006 acquisitions of Conforma and Fumapharm, and the 2007 acquisition of Syntonix;
Pre-tax share-based compensation expense under SFAS No. 123R of $8 million; and
Tax benefit of $16 million related to the pre-tax reconciling items.
Revenue Performance
Revenues from AVONEX, Biogen Idec’s therapy for patients with relapsing forms of multiple sclerosis (MS), increased 8% in the second quarter to $462 million. U.S. sales increased 3% to $270 million and international sales increased 14% to $192 million.
Revenues for the second quarter 2007 included $231 million from Biogen Idec’s joint business arrangement related to RITUXAN, a treatment for certain B-cell non-Hodgkin’s lymphomas (NHL) and rheumatoid arthritis (RA) that Biogen Idec co-promotes in the U.S. with Genentech, Inc. All U.S. sales of RITUXAN are recognized by Genentech, and Biogen Idec records its share of the pretax co-promotion profits. U.S. net sales of RITUXAN were $582 million in the second quarter (Q2 2006 were $526 million), as reported by Genentech.
During the second quarter of 2007, Biogen Idec recognized revenue of $48 million related to TYSABRI. This amount is comprised of:
$22.3 million related to product sold through Elan in the U.S. (based on $46.8 million of in-market sales); and
$25.2 million related to product sold by Biogen Idec in Europe.
As of mid-July 2007, approximately 14,000 patients are on TYSABRI therapy worldwide in the commercial and clinical trials settings.
In the US, approximately 8,600 patients are on TYSABRI therapy commercially.
In the EU, approximately 4,300 patients are on TYSABRI therapy commercially.
In clinical trial settings, approximately 1,000 patients are on TYSABRI therapy.
Revenue from FUMADERM® (fumaric acid esters) in the second quarter of 2007 was $5 million. Biogen Idec did not recognize any revenue in Q1 2007 related to sales of FUMADERM.
Table 4 provides individual product revenues.
Royalties were $23 million and $18 million in the second quarter 2007 and 2006, respectively.
Share Repurchase Program
Biogen Idec did not repurchase any shares in the second quarter 2007 under the 20 million share repurchase program authorized by Biogen Idec’s Board of Directors in October 2006.
Financial Guidance
Biogen Idec today increased its guidance for the full year 2007, including:
Total revenue growth of 16%-18% over 2006;
Similar financial margins for 2006 and 2007, except for R&D, which will be approximately 28%-30% of revenue. This includes a $50 million milestone payment in Q3 related to the anticipated Cardiokine deal;
Non-GAAP diluted EPS, incorporating the impact of the recent tender offer, in the range of $2.60-$2.70 which represents 16%-20% annual growth. This non-GAAP diluted EPS estimate excludes the impact of purchase accounting, merger-related adjustments, stock option expense, and other items and their related tax effects;
Fully diluted weighted average shares outstanding for the first half of the year totaled approximately 343 million. Due to the tender offer, the Company expects fully diluted share count to be approximately 290-296 million for the second half of the year and 316 -322 million for the full year.
The Company anticipates that 2007 capital expenditures will be in the range of $250 - $300 million.
Full year 2007 GAAP diluted EPS is estimated to be in the range of $1.84 - $1.94 versus $0.63 per share in 2006. This estimate includes the impact of the anticipated Cardiokine deal but excludes any other future acquisitions or transactions. In order to reconcile GAAP and non-GAAP EPS guidance, we have excluded the following items from our non-GAAP EPS guidance provided above:
Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, is estimated to be $287 million, or approximately $0.90 per share, for already completed transactions;
Stock option expense due to FAS 123R in 2007 is estimated to be in the range of $30-$40 million, or approximately $ 0.07-$ 0.09 per share.
Because the Company cannot predict with certainty the nature or the amount of non-operating or unusual charges for 2007, we have made no assumption regarding future purchase accounting charges in this GAAP guidance. The Company may incur charges or realize income in 2007 which could cause actual results to vary from this guidance.
Recent Highlights
On April 26th, Biogen Idec announced the national launch of the new AVONEX Nurse Services program which is designed to help people with multiple sclerosis as they begin and continue treatment with AVONEX, the most prescribed treatment for relapsing forms of MS worldwide. This new program underscores Biogen Idec's commitment to the MS community, which includes offering the best support services to patients and undertaking innovative research efforts to develop new therapeutic options.
On May 1st, Genentech and Biogen Idec announced that positive data from a Phase II clinical study of RITUXAN in patients with relapsing-remitting multiple sclerosis (RRMS) were presented at the American Academy of Neurology annual meeting held in Boston.
On May 3rd, Biogen Idec and Elan Corporation announced that new data from the TOUCH Prescribing Program(TM) and TYGRIS safety study confirm the safety profile from previous clinical studies of TYSABRI. Also presented at the 59th annual meeting of the American Academy of Neurology in Boston, MA were extension study data that showed that TYSABRI has a sustained treatment effect on clinical relapses and the risk of disability progression in multiple sclerosis patients treated for up to three years.
On May 8th, Biogen Idec and Vernalis announced the initiation of the Phase II program of BIIB014 (also known as V2006), an oral compound for the treatment of Parkinson's disease. BIIB014 is an adenosine A2A receptor antagonist that may offer a non-dopaminergic therapy for patients with Parkinson's disease.
On June 26th, Biogen Idec and UCB announced the initiation of a Phase II study of CDP323 (an oral VLA-4 antagonist) under development for relapsing-remitting multiple sclerosis . The double-blind, randomized Phase II study commenced with dosing of the first patient. The study is designed to enroll over 200 patients with relapsing-remitting MS who have failed earlier treatment with a beta-interferon.
On July 2nd, Biogen Idec Inc announced the final results of its modified "Dutch Auction" tender offer, which expired at 12:00 midnight ET on Tuesday, June 26, 2007. Biogen Idec accepted for payment an aggregate of 56,424,155 shares of its common stock at a purchase price of $53.00 per share, for an aggregate share repurchase of approximately $3 billion. These shares represented approximately 16.4% of the shares outstanding as of June 26, 2007.
On July 2nd, Biogen Idec and Elan Corporation welcomed the announcement by the National Institute for Health and Clinical Excellence (NICE) in the final appraisal determination that recommended use of TYSABRI in people with highly active relapsing-remitting multiple sclerosis. TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE.
On July 2nd, Biogen Idec and Cardiokine announced they agreed to jointly develop lixivaptan, an oral compound being tested for treatment of hyponatremia in patients with congestive heart failure. Lixivaptan is expected to enter a late-stage clinical trial this year. Under terms of the agreement, which is expected to become effective in the third quarter of 2007, Cardiokine, will receive a $50 million upfront payment and up to $170 million in additional milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. Biogen Idec will be responsible for the global commercialization of lixivaptan, and Cardiokine will have an option for limited co-promotion in the U.S.
Use of Non-GAAP Financial Measures
Our "non-GAAP net income" and "non-GAAP diluted EPS" financial measures are defined as reported, or GAAP, net income and diluted EPS excluding, for the reasons discussed below, (1) purchase accounting and merger-related adjustments, (2) stock option expense and the cumulative effect of an accounting change relating to the initial adoption of SFAS No. 123R and (3) other items. Our management uses these non-GAAP financial measures to establish financial goals and to gain an understanding of the comparative financial performance of the Company from year to year and quarter to quarter. Accordingly, we believe investors’ understanding of the Company’s financial performance is enhanced as a result of our disclosing these non-GAAP financial measures. Non-GAAP net income and diluted EPS should not be viewed in isolation or as a substitute for reported, or GAAP, net income and diluted EPS.
Purchase accounting and merger-related adjustments – Non-GAAP net income and diluted EPS exclude certain purchase accounting impacts such as those related to the merger with Biogen, Inc. (the "Merger") and the acquisitions of Fumapharm AG, Conforma Therapeutics Corporation and Syntonix Pharmaceuticals, Inc. These include charges for in process research and development and the incremental charge to cost of goods sold from our sale of acquired inventory that was written up to fair value at the acquisition date. Additionally, these excluded impacts include the incremental charges related to the amortization of the acquired intangible assets. Excluding these charges allows management and investors an alternative view of our financial results "as if" the acquired intangible asset had been developed internally rather than acquired and, therefore, provides a supplemental measure of performance in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property.
Stock option expense and the cumulative effect of an accounting change relating to the initial adoption of SFAS No. 123R – Non-GAAP net income and diluted EPS exclude the impact of our stock option expense recorded in accordance with SFAS No. 123R and the cumulative effect of an accounting change relating to its initial adoption. We believe that excluding the impact of expensing stock options better reflects the recurring economic characteristics of our integrated business. We do include the P&L impact of restricted stock awards and other cash incentives in our non-GAAP results.
Other items – Non-GAAP net income and diluted EPS exclude other unusual or non-recurring items that are evaluated on an individual basis. Our evaluation of whether to exclude an item for purposes of determining our non-GAAP financial measures considers both the quantitative and qualitative aspects of the item, including, among other things (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. Items excluded for purposes of determining non-GAAP net income and diluted EPS are severance and restructuring charges and a gain on sale of long-lived assets.
The Company has reconciled the GAAP net income and diluted EPS for the three-month periods ended June 30, 2007 and 2006 to the non-GAAP measures of net income and diluted EPS in Table 3 of this press release.
Conference Call and Webcast
The Company's earnings conference call for the second quarter will be broadcast via the internet at 8:30 a.m. ET on July 24th, 2007, and will be accessible through the investor relations section of Biogen Idec's homepage, www.biogenidec.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet at the time of the earnings conference call, and will remain on the Biogen Idec website through at least August 31, 2007.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Safe Harbor
This press release contains forward-looking statements, which appear under the heading "Financial Guidance", "Revenue Performance", and "Recent Highlights" above and in the comments from James Mullen, our CEO. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include our continued dependence on our two principal products, AVONEX and RITUXAN, the uncertainty of success in commercializing other products including the launch of TYSABRI, the occurrence of adverse safety events with our products, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing business internationally and the other risks and uncertainties that are described in our most recent Form 10-Q filing with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
MEDIA CONTACT:
Naomi Aoki
Director, Public Affairs
(617) 914-6524
INVESTOR CONTACT:
Keith Regnante
Director, Investor Relations
(617) 679-2812
http://www.biogenidec.com/site/019_0.html?pr_id=../news/Biog…
Biogen Idec Reports Second Quarter 2007 Results
Cambridge, MA, July 24, 2007 --
Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today reported its second quarter 2007 results.
Second Quarter 2007 Highlights:
Second quarter revenues were $773 million, an increase of 17% from $660 million in the prior year. There were three main drivers of this growth.
AVONEX® (interferon beta-1a) sales increased 8% to $462 million
RITUXAN® (rituximab) revenues from the unconsolidated joint business arrangement increased 12% to $231 million
Global in-market net sales of TYSABRI® (natalizumab) in the second quarter of 2007 totaled $72 million. Based on the collaboration structure with Elan, Biogen Idec recognized revenue of $48 million related to TYSABRI.
On July 2, 2007, Biogen Idec announced the final results of its "Dutch Auction" tender offer which expired at 12:00 midnight ET on Tuesday, June 26, 2007. Biogen Idec accepted for payment an aggregate of 56,424,155 shares of its common stock at a purchase price of $53.00 per share, for an aggregate share repurchase of approximately $3 billion. These shares represented approximately 16.4% of the shares outstanding as of June 26, 2007. The share repurchase was funded by approximately equal parts cash and debt.
On a reported basis, calculated in accordance with accounting principles generally accepted in the U.S. (GAAP), second quarter 2007 diluted earnings per share (EPS) were $0.54, an increase from a loss of $0.50 in the second quarter of 2006. GAAP net income for the quarter was $186 million, an increase from a $171 million loss in the second quarter of 2006.
Second quarter 2007 non-GAAP diluted EPS were $0.70, an increase of 23% over non-GAAP diluted EPS of $0.57 in the second quarter 2006. Non-GAAP net income for the second quarter was $240 million, an increase of 22% over non-GAAP net income of $197 million in the second quarter of 2006. These non-GAAP results exclude purchase accounting and merger-related accounting impacts, stock option expense, and other items.
"We are quite pleased with our second quarter performance. Fueled by the strong uptake of TYSABRI, we hit a new corporate milestone as our MS franchise exceeded $500 million in quarterly revenue for the first time in Biogen Idec’s history. We successfully completed our $3 billion share repurchase while continuing to advance and strengthen our pipeline, particularly with the anticipated addition of the late stage Lixivaptan compound," said James Mullen, Biogen Idec’s Chief Executive Officer.
Financial Performance
On a reported basis, calculated in accordance with GAAP, Biogen Idec reported net income of $186 million (or diluted EPS of $0.54) in the second quarter of 2007.
On a non-GAAP basis, Biogen Idec reported net income of $240 million in the second quarter of 2007. Non-GAAP diluted EPS were $0.70 for the second quarter of 2007.
The reconciling items of note between GAAP net income and diluted GAAP EPS and adjusted non-GAAP net income and diluted non-GAAP EPS in the second quarter, as itemized in Table 3 within this press release, were primarily as follows:
Pre-tax charges of $61 million for the amortization of intangibles related to the 2003 Biogen and Idec merger, the 2006 acquisitions of Conforma and Fumapharm, and the 2007 acquisition of Syntonix;
Pre-tax share-based compensation expense under SFAS No. 123R of $8 million; and
Tax benefit of $16 million related to the pre-tax reconciling items.
Revenue Performance
Revenues from AVONEX, Biogen Idec’s therapy for patients with relapsing forms of multiple sclerosis (MS), increased 8% in the second quarter to $462 million. U.S. sales increased 3% to $270 million and international sales increased 14% to $192 million.
Revenues for the second quarter 2007 included $231 million from Biogen Idec’s joint business arrangement related to RITUXAN, a treatment for certain B-cell non-Hodgkin’s lymphomas (NHL) and rheumatoid arthritis (RA) that Biogen Idec co-promotes in the U.S. with Genentech, Inc. All U.S. sales of RITUXAN are recognized by Genentech, and Biogen Idec records its share of the pretax co-promotion profits. U.S. net sales of RITUXAN were $582 million in the second quarter (Q2 2006 were $526 million), as reported by Genentech.
During the second quarter of 2007, Biogen Idec recognized revenue of $48 million related to TYSABRI. This amount is comprised of:
$22.3 million related to product sold through Elan in the U.S. (based on $46.8 million of in-market sales); and
$25.2 million related to product sold by Biogen Idec in Europe.
As of mid-July 2007, approximately 14,000 patients are on TYSABRI therapy worldwide in the commercial and clinical trials settings.
In the US, approximately 8,600 patients are on TYSABRI therapy commercially.
In the EU, approximately 4,300 patients are on TYSABRI therapy commercially.
In clinical trial settings, approximately 1,000 patients are on TYSABRI therapy.
Revenue from FUMADERM® (fumaric acid esters) in the second quarter of 2007 was $5 million. Biogen Idec did not recognize any revenue in Q1 2007 related to sales of FUMADERM.
Table 4 provides individual product revenues.
Royalties were $23 million and $18 million in the second quarter 2007 and 2006, respectively.
Share Repurchase Program
Biogen Idec did not repurchase any shares in the second quarter 2007 under the 20 million share repurchase program authorized by Biogen Idec’s Board of Directors in October 2006.
Financial Guidance
Biogen Idec today increased its guidance for the full year 2007, including:
Total revenue growth of 16%-18% over 2006;
Similar financial margins for 2006 and 2007, except for R&D, which will be approximately 28%-30% of revenue. This includes a $50 million milestone payment in Q3 related to the anticipated Cardiokine deal;
Non-GAAP diluted EPS, incorporating the impact of the recent tender offer, in the range of $2.60-$2.70 which represents 16%-20% annual growth. This non-GAAP diluted EPS estimate excludes the impact of purchase accounting, merger-related adjustments, stock option expense, and other items and their related tax effects;
Fully diluted weighted average shares outstanding for the first half of the year totaled approximately 343 million. Due to the tender offer, the Company expects fully diluted share count to be approximately 290-296 million for the second half of the year and 316 -322 million for the full year.
The Company anticipates that 2007 capital expenditures will be in the range of $250 - $300 million.
Full year 2007 GAAP diluted EPS is estimated to be in the range of $1.84 - $1.94 versus $0.63 per share in 2006. This estimate includes the impact of the anticipated Cardiokine deal but excludes any other future acquisitions or transactions. In order to reconcile GAAP and non-GAAP EPS guidance, we have excluded the following items from our non-GAAP EPS guidance provided above:
Purchase accounting charges, including amortization of acquired intangible assets and IPR&D, is estimated to be $287 million, or approximately $0.90 per share, for already completed transactions;
Stock option expense due to FAS 123R in 2007 is estimated to be in the range of $30-$40 million, or approximately $ 0.07-$ 0.09 per share.
Because the Company cannot predict with certainty the nature or the amount of non-operating or unusual charges for 2007, we have made no assumption regarding future purchase accounting charges in this GAAP guidance. The Company may incur charges or realize income in 2007 which could cause actual results to vary from this guidance.
Recent Highlights
On April 26th, Biogen Idec announced the national launch of the new AVONEX Nurse Services program which is designed to help people with multiple sclerosis as they begin and continue treatment with AVONEX, the most prescribed treatment for relapsing forms of MS worldwide. This new program underscores Biogen Idec's commitment to the MS community, which includes offering the best support services to patients and undertaking innovative research efforts to develop new therapeutic options.
On May 1st, Genentech and Biogen Idec announced that positive data from a Phase II clinical study of RITUXAN in patients with relapsing-remitting multiple sclerosis (RRMS) were presented at the American Academy of Neurology annual meeting held in Boston.
On May 3rd, Biogen Idec and Elan Corporation announced that new data from the TOUCH Prescribing Program(TM) and TYGRIS safety study confirm the safety profile from previous clinical studies of TYSABRI. Also presented at the 59th annual meeting of the American Academy of Neurology in Boston, MA were extension study data that showed that TYSABRI has a sustained treatment effect on clinical relapses and the risk of disability progression in multiple sclerosis patients treated for up to three years.
On May 8th, Biogen Idec and Vernalis announced the initiation of the Phase II program of BIIB014 (also known as V2006), an oral compound for the treatment of Parkinson's disease. BIIB014 is an adenosine A2A receptor antagonist that may offer a non-dopaminergic therapy for patients with Parkinson's disease.
On June 26th, Biogen Idec and UCB announced the initiation of a Phase II study of CDP323 (an oral VLA-4 antagonist) under development for relapsing-remitting multiple sclerosis . The double-blind, randomized Phase II study commenced with dosing of the first patient. The study is designed to enroll over 200 patients with relapsing-remitting MS who have failed earlier treatment with a beta-interferon.
On July 2nd, Biogen Idec Inc announced the final results of its modified "Dutch Auction" tender offer, which expired at 12:00 midnight ET on Tuesday, June 26, 2007. Biogen Idec accepted for payment an aggregate of 56,424,155 shares of its common stock at a purchase price of $53.00 per share, for an aggregate share repurchase of approximately $3 billion. These shares represented approximately 16.4% of the shares outstanding as of June 26, 2007.
On July 2nd, Biogen Idec and Elan Corporation welcomed the announcement by the National Institute for Health and Clinical Excellence (NICE) in the final appraisal determination that recommended use of TYSABRI in people with highly active relapsing-remitting multiple sclerosis. TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE.
On July 2nd, Biogen Idec and Cardiokine announced they agreed to jointly develop lixivaptan, an oral compound being tested for treatment of hyponatremia in patients with congestive heart failure. Lixivaptan is expected to enter a late-stage clinical trial this year. Under terms of the agreement, which is expected to become effective in the third quarter of 2007, Cardiokine, will receive a $50 million upfront payment and up to $170 million in additional milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. Biogen Idec will be responsible for the global commercialization of lixivaptan, and Cardiokine will have an option for limited co-promotion in the U.S.
Use of Non-GAAP Financial Measures
Our "non-GAAP net income" and "non-GAAP diluted EPS" financial measures are defined as reported, or GAAP, net income and diluted EPS excluding, for the reasons discussed below, (1) purchase accounting and merger-related adjustments, (2) stock option expense and the cumulative effect of an accounting change relating to the initial adoption of SFAS No. 123R and (3) other items. Our management uses these non-GAAP financial measures to establish financial goals and to gain an understanding of the comparative financial performance of the Company from year to year and quarter to quarter. Accordingly, we believe investors’ understanding of the Company’s financial performance is enhanced as a result of our disclosing these non-GAAP financial measures. Non-GAAP net income and diluted EPS should not be viewed in isolation or as a substitute for reported, or GAAP, net income and diluted EPS.
Purchase accounting and merger-related adjustments – Non-GAAP net income and diluted EPS exclude certain purchase accounting impacts such as those related to the merger with Biogen, Inc. (the "Merger") and the acquisitions of Fumapharm AG, Conforma Therapeutics Corporation and Syntonix Pharmaceuticals, Inc. These include charges for in process research and development and the incremental charge to cost of goods sold from our sale of acquired inventory that was written up to fair value at the acquisition date. Additionally, these excluded impacts include the incremental charges related to the amortization of the acquired intangible assets. Excluding these charges allows management and investors an alternative view of our financial results "as if" the acquired intangible asset had been developed internally rather than acquired and, therefore, provides a supplemental measure of performance in which the Company’s acquired intellectual property is treated in a comparable manner to its internally developed intellectual property.
Stock option expense and the cumulative effect of an accounting change relating to the initial adoption of SFAS No. 123R – Non-GAAP net income and diluted EPS exclude the impact of our stock option expense recorded in accordance with SFAS No. 123R and the cumulative effect of an accounting change relating to its initial adoption. We believe that excluding the impact of expensing stock options better reflects the recurring economic characteristics of our integrated business. We do include the P&L impact of restricted stock awards and other cash incentives in our non-GAAP results.
Other items – Non-GAAP net income and diluted EPS exclude other unusual or non-recurring items that are evaluated on an individual basis. Our evaluation of whether to exclude an item for purposes of determining our non-GAAP financial measures considers both the quantitative and qualitative aspects of the item, including, among other things (i) its size and nature, (ii) whether or not it relates to our ongoing business operations, and (iii) whether or not we expect it to occur as part of our normal business on a regular basis. Items excluded for purposes of determining non-GAAP net income and diluted EPS are severance and restructuring charges and a gain on sale of long-lived assets.
The Company has reconciled the GAAP net income and diluted EPS for the three-month periods ended June 30, 2007 and 2006 to the non-GAAP measures of net income and diluted EPS in Table 3 of this press release.
Conference Call and Webcast
The Company's earnings conference call for the second quarter will be broadcast via the internet at 8:30 a.m. ET on July 24th, 2007, and will be accessible through the investor relations section of Biogen Idec's homepage, www.biogenidec.com. Supplemental information in the form of a slide presentation will also be accessible at the same location on the internet at the time of the earnings conference call, and will remain on the Biogen Idec website through at least August 31, 2007.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Safe Harbor
This press release contains forward-looking statements, which appear under the heading "Financial Guidance", "Revenue Performance", and "Recent Highlights" above and in the comments from James Mullen, our CEO. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include our continued dependence on our two principal products, AVONEX and RITUXAN, the uncertainty of success in commercializing other products including the launch of TYSABRI, the occurrence of adverse safety events with our products, the failure to execute our growth strategy successfully or to compete effectively in our markets, our dependence on collaborations over which we may not always have full control, possible adverse impact of government regulation and changes in the availability of reimbursement for our products, problems with our manufacturing processes and our reliance on third parties, fluctuations in our operating results, our ability to protect our intellectual property rights and the cost of doing so, the risks of doing business internationally and the other risks and uncertainties that are described in our most recent Form 10-Q filing with the SEC. These forward-looking statements speak only as of the date of this press release, and we do not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
MEDIA CONTACT:
Naomi Aoki
Director, Public Affairs
(617) 914-6524
INVESTOR CONTACT:
Keith Regnante
Director, Investor Relations
(617) 679-2812
http://www.biogenidec.com/site/019_0.html?pr_id=../news/Biog…
Antwort auf Beitrag Nr.: 30.830.594 von Poppholz am 24.07.07 17:41:42also ich finde, dass sich das schon ganz gut anhört.
Antwort auf Beitrag Nr.: 30.830.629 von Poppholz am 24.07.07 17:43:43Danke Poppi!Hört sich gut an UND DIES AUCH:
------------------------------------
"Msg: 131162 of 131205 7/24/2007
By: Creedster_99 Send PM Profile Ignore Recommend Add To Favorites
"We have an AC with the FDA next week and we're pretty excited about that" JM
That's encouraging!
Many may not like JM but over time what he says usually turns out to be true!
I'd expect a POSITIVE REC from the AC next week..Thanks Jim!!!"
--------------------------------------------------------------------
------------------------------------
"Msg: 131162 of 131205 7/24/2007
By: Creedster_99 Send PM Profile Ignore Recommend Add To Favorites
"We have an AC with the FDA next week and we're pretty excited about that" JM
That's encouraging!
Many may not like JM but over time what he says usually turns out to be true!
I'd expect a POSITIVE REC from the AC next week..Thanks Jim!!!"
--------------------------------------------------------------------
wer hätte das gedacht: Schlusskurs unter $20,-.
Es ist nicht zu begreifen, aber aus der Vergangenheit bekannt, dass unser Baby zum Spielball der MM wird. Besonders, wenn Zahlen anstehen.
Vielleicht kaufe ich morgen noch eine kleine Position EAN ein.
(ich wünsche allen eine ruhige Nacht)
Es ist nicht zu begreifen, aber aus der Vergangenheit bekannt, dass unser Baby zum Spielball der MM wird. Besonders, wenn Zahlen anstehen.
Vielleicht kaufe ich morgen noch eine kleine Position EAN ein.
(ich wünsche allen eine ruhige Nacht)
Antwort auf Beitrag Nr.: 30.835.328 von Poppholz am 24.07.07 22:02:55TJA.....Es wird bessere Tage geben....
Trotz alledem ALLen eine gute Nacht
(statt in einem Allianzcall zu hängen ,sollte ich es lieber ALLES in Elan investieren....:mad
Trotz alledem ALLen eine gute Nacht
(statt in einem Allianzcall zu hängen ,sollte ich es lieber ALLES in Elan investieren....:mad
Antwort auf Beitrag Nr.: 30.835.630 von Birgit.Tersteegen am 24.07.07 22:19:24mir geht es momentan ähnlich bescheiden mit meinen DELPHI Aktien.
Was soll es, ist ja nur Geld und das auch nur auf dem Papier.
Was soll es, ist ja nur Geld und das auch nur auf dem Papier.
Antwort auf Beitrag Nr.: 30.835.717 von Poppholz am 24.07.07 22:23:52stimmt Poppi und meine beiden grossen Kinder kommen mich morgen besuchen....da kann ich nicht immer an die blöden Kurse denken....schick mal wieder bm-mässig ein Bild mit Eurem MINI Gut´s Nächtle
So meine Lieben,
ich habe eben weitere 63 EAN in FFM bekommen.
Zu sagenhaften €14,18.
(dies wird jetzt wahrscheinlich zu einem Kursrutsch führen, da ich diese Woche schon zwei Positionen gekauft habe)
ich habe eben weitere 63 EAN in FFM bekommen.
Zu sagenhaften €14,18.
(dies wird jetzt wahrscheinlich zu einem Kursrutsch führen, da ich diese Woche schon zwei Positionen gekauft habe)
Antwort auf Beitrag Nr.: 30.839.259 von Poppholz am 25.07.07 09:47:34aktuell könnt Ihr EAN in FFM zu @14,13 bekommen.
Die DRX stehen sogar nur bei €13,77.
Freitag kommen Zahlen, bin sehr gespannt, wie diese sind und wie diese von der Börse aufgenommen werden.
Die DRX stehen sogar nur bei €13,77.
Freitag kommen Zahlen, bin sehr gespannt, wie diese sind und wie diese von der Börse aufgenommen werden.
Antwort auf Beitrag Nr.: 30.839.351 von Poppholz am 25.07.07 09:53:11was habe ich Euch gesagt: EA in FFM könnt Ihr zu €13,80 kaufen.
Antwort auf Beitrag Nr.: 30.839.530 von Poppholz am 25.07.07 10:04:21ich werde demnächst mal ausprobieren, ob das Posten von Käufen meinerseits auch schon zu einem Kursrutsch führt. Dann bringt traden richtig spass.
Erst schreibe ich, dass ich verkaufe, dann steigt der Kurs und ich verkaufe wirklich. Anschließend schreibe ich, dass ich kaufe und der Kurs fällt. Anschließend kaufe ich dann wirklich.
(Börse ist so einfach)
Erst schreibe ich, dass ich verkaufe, dann steigt der Kurs und ich verkaufe wirklich. Anschließend schreibe ich, dass ich kaufe und der Kurs fällt. Anschließend kaufe ich dann wirklich.
(Börse ist so einfach)
Antwort auf Beitrag Nr.: 30.839.530 von Poppholz am 25.07.07 10:04:21GRATULIERE: Demjenigen, der in FFM die 2.440 DRX zu €13,38 bekommen hat.
Antwort auf Beitrag Nr.: 30.839.578 von Poppholz am 25.07.07 10:07:16So, der Genosse Fahrdienstleiter meldet sich mal wieder.
Ist zurzeit sehr interessant, ma gucken ob die $20 hält was bei mir ne kleine Unterstützung ist.
Naja sodann darunter ist die 19 gleich die nächste.
Wenn die zerstäubt werden sollte könnte es einen freien Fall bis 16 oder 15/50 geben.
Aber für longs gilt Ruhe bewahren und Huflattichtee saufen.
Ist zurzeit sehr interessant, ma gucken ob die $20 hält was bei mir ne kleine Unterstützung ist.
Naja sodann darunter ist die 19 gleich die nächste.
Wenn die zerstäubt werden sollte könnte es einen freien Fall bis 16 oder 15/50 geben.
Aber für longs gilt Ruhe bewahren und Huflattichtee saufen.
Antwort auf Beitrag Nr.: 30.839.803 von Nostarowie am 25.07.07 10:19:53Den Hufflattichtee kannste alleine trinken-brrrrrrrhh:O:O.Wir trinken derweil Pinot und Merlot während wir auf die 23$ warten....
Davy - Tysabri generated $72m of revenues in Q2; momentum still building on EU launches, increased US penetration
Price $19.92 Target: $21.00 Issued: 21/05/07 Previous: $16.10 Issued: 16/02/07
We were satisfied with the Tysabri revenue out-turn for Q2 – the $72m total was
in line with market consensus, and recent patient data had told us that our own
number ($87m) was too high. We will formally review our Tysabri forecasts
following Elan’s Q2 results and are likely to adjust our 2007 forecast downwards
but maintain our longer-term projections.
The US accounted for 65% (or $46.8m) of the Q2 out-turn. This represented a
31% increase quarter-on-quarter (qoq). Judged on patient numbers, the net
addition rate has softened over the last three months from 178/week to 143/week.
Although BIIB management was loathe to describe it as such (more a “steady
state”), we will look for this trend to turn upwards again through H2.
Approximately 35% of US patients are returning quitters, naïve patients or those
not on ABCR therapy. Twenty percent of patients were formerly on Avonex.
The EU/Rest of World accounted for 35% (or $25.2m) of the Q2 total and was up
98% qoq. Weekly net additions have surged by 57% in the last three months, still
driven by Germany (4% market share) and Sweden (8% share).
We anticipate further acceleration in H2 given recent developments in two large
European markets. In France, the product was launched in early June. In the UK,
NICE partly overturned an earlier refusal and has sanctioned NHS reimbursement
for patients with “severe MS”, i.e. those with two or more disabling relapses in
one year and an active MRI scan.
Price $19.92 Target: $21.00 Issued: 21/05/07 Previous: $16.10 Issued: 16/02/07
We were satisfied with the Tysabri revenue out-turn for Q2 – the $72m total was
in line with market consensus, and recent patient data had told us that our own
number ($87m) was too high. We will formally review our Tysabri forecasts
following Elan’s Q2 results and are likely to adjust our 2007 forecast downwards
but maintain our longer-term projections.
The US accounted for 65% (or $46.8m) of the Q2 out-turn. This represented a
31% increase quarter-on-quarter (qoq). Judged on patient numbers, the net
addition rate has softened over the last three months from 178/week to 143/week.
Although BIIB management was loathe to describe it as such (more a “steady
state”), we will look for this trend to turn upwards again through H2.
Approximately 35% of US patients are returning quitters, naïve patients or those
not on ABCR therapy. Twenty percent of patients were formerly on Avonex.
The EU/Rest of World accounted for 35% (or $25.2m) of the Q2 total and was up
98% qoq. Weekly net additions have surged by 57% in the last three months, still
driven by Germany (4% market share) and Sweden (8% share).
We anticipate further acceleration in H2 given recent developments in two large
European markets. In France, the product was launched in early June. In the UK,
NICE partly overturned an earlier refusal and has sanctioned NHS reimbursement
for patients with “severe MS”, i.e. those with two or more disabling relapses in
one year and an active MRI scan.
Hallo,
nur mal am rande, ich hatte heute einen kontakt zu jemandem der tysabri hier in deutschland auf rezept bekommt. Dieser kontakt sprach davon, dass das rezept nur mit einer zuzahlung von 10€ bei der apotheke eingelöst wurde. Die person erleuterte mir das es kein versuch wär. Der person geht es gut und die werte wären nun stabil ...
vg
nur mal am rande, ich hatte heute einen kontakt zu jemandem der tysabri hier in deutschland auf rezept bekommt. Dieser kontakt sprach davon, dass das rezept nur mit einer zuzahlung von 10€ bei der apotheke eingelöst wurde. Die person erleuterte mir das es kein versuch wär. Der person geht es gut und die werte wären nun stabil ...
vg
...aktuell in den USA 19,68 - 19,76 USD
....Birgit, ich tippel schon an der Seitenlinie herum und mach mich warm......
....Birgit, ich tippel schon an der Seitenlinie herum und mach mich warm......
Prohost raises target to 30
ELAN (ELN): Tysabri is born to become a blockbuster and it will and the story of the dangerous PML is not unique to this drug, as it seems to be observed with other cytokine inhibitor combinations, and with chemotherapy combinations. The drug celebrated one year of its return to the market, during which time, no problems, small or large were enciuntered. We expect the drug sales to continue to grow, as the difference between this drug’s efficacy and other available drugs is huge. Physicians are more comfortable with Tysabri’s safety and more prone to prescribe it for their patients who demand it. Now, we have another promising drug in Phase 3 trials for Alzheimer’s disease. It is the most promising of all investigational products. That’s what the co-developer, Wyeth, stated time and time again.
The stock was boosted on Alzheimer’s drug good news and has almost reached our $23 target. The price retreated a little on news about a European committee rejection for using Tysabri for Crohn’s disease., which was expected anyway.
We decided not to sell this stock and instead, raise our tarhget from $23 to $30.
http://www.investorvillage.com/smbd.asp?mb=160&mn=131593&pt=…
ELAN (ELN): Tysabri is born to become a blockbuster and it will and the story of the dangerous PML is not unique to this drug, as it seems to be observed with other cytokine inhibitor combinations, and with chemotherapy combinations. The drug celebrated one year of its return to the market, during which time, no problems, small or large were enciuntered. We expect the drug sales to continue to grow, as the difference between this drug’s efficacy and other available drugs is huge. Physicians are more comfortable with Tysabri’s safety and more prone to prescribe it for their patients who demand it. Now, we have another promising drug in Phase 3 trials for Alzheimer’s disease. It is the most promising of all investigational products. That’s what the co-developer, Wyeth, stated time and time again.
The stock was boosted on Alzheimer’s drug good news and has almost reached our $23 target. The price retreated a little on news about a European committee rejection for using Tysabri for Crohn’s disease., which was expected anyway.
We decided not to sell this stock and instead, raise our tarhget from $23 to $30.
http://www.investorvillage.com/smbd.asp?mb=160&mn=131593&pt=…
Antwort auf Beitrag Nr.: 30.847.443 von bernie55 am 25.07.07 17:43:4920,66 - 20,69 USD
Antwort auf Beitrag Nr.: 30.847.708 von bernie55 am 25.07.07 17:57:57wird von den BÖSEN JUNGS schon wieder runter gedrückt.
Freue mich über die guten Kaufkurse.
Freue mich über die guten Kaufkurse.
Antwort auf Beitrag Nr.: 30.847.930 von Poppholz am 25.07.07 18:10:47YEPPPP !!!!!!!!!!!!!
Antwort auf Beitrag Nr.: 30.848.032 von bernie55 am 25.07.07 18:17:05YEPPPP !!!!!!!!!!!!!
hab auch noch mal nachgelegt
gruß Noogmann
hab auch noch mal nachgelegt
gruß Noogmann
Ihr Raffzähne..... Unser Schätzchen ist grün und sonst ist bei mir Alles:O:O:O Ich tu mir schon selber leid.....(Ob ich auch noch welche..............;Bernie--was meinst Du???)
Antwort auf Beitrag Nr.: 30.848.225 von Birgit.Tersteegen am 25.07.07 18:30:19.....(Ob ich auch noch welche..............;Bernie--was meinst Du??? )
...bitte ...bitte...nicht....
..ich habe heute nachmittag meine Kauforder bei 19,63 USD reingesetzt ...leider nicht gekommen.....jetzt werde ich mal die ersten Angelversuche im Bereich von 20,30 - 20,50 USD machen .....
...bitte ...bitte...nicht....
..ich habe heute nachmittag meine Kauforder bei 19,63 USD reingesetzt ...leider nicht gekommen.....jetzt werde ich mal die ersten Angelversuche im Bereich von 20,30 - 20,50 USD machen .....
Wieso ist unser duller Partner Biogen eigentlich 5% im Plus;wegen ihres doofen Avonex,was eh nicht so gut wirkt wie unser TY?????????
Wer hört sich morgen den CC an?
Auf zum Pinot!Bis morgen!Gruss
Wer hört sich morgen den CC an?
Auf zum Pinot!Bis morgen!Gruss
Antwort auf Beitrag Nr.: 30.851.072 von Birgit.Tersteegen am 25.07.07 21:42:40werde morgen nicht reinhören können.
warte somit auf die News, die in den Foren eingestellt werden, bzw. durch die Presse gehen.
warte somit auf die News, die in den Foren eingestellt werden, bzw. durch die Presse gehen.
Antwort auf Beitrag Nr.: 30.852.990 von Poppholz am 26.07.07 05:57:16... und wer ist eigentlich Biogen?
HAPPY BIRTHDAY
HAPPY BIRTHDAY HAPPY BIRTHDAY HAPPY BIRTHDAY
- - - - - - - - - - - - - - - - -
...für diesen " besonderen " Tag wünsche ich Dir alles Gute, Liebe , positive Energie und Gedanken...und ...und ...und natürlich für die Zukunft weiterhin so viel ELAN und FrauenPOWER wie bisher...
liebe Grüße auch von Ulla und Moritz
bernie55
HAPPY BIRTHDAY HAPPY BIRTHDAY HAPPY BIRTHDAY
- - - - - - - - - - - - - - - - -
...für diesen " besonderen " Tag wünsche ich Dir alles Gute, Liebe , positive Energie und Gedanken...und ...und ...und natürlich für die Zukunft weiterhin so viel ELAN und FrauenPOWER wie bisher...
liebe Grüße auch von Ulla und Moritz
bernie55
Antwort auf Beitrag Nr.: 30.853.764 von bernie55 am 26.07.07 08:58:33
Wie jetzt, Birgit hat Geburtstach ???????
Na dann auch von mir aus alles alles Gute zu DEINEM Tag !!!!
Sie wird wahrscheinlich reingefeiert haben und heute etwas
brummschädeliger auf dieser Bühne erscheinen.
Hihi ... einen ausgeben muß sie trotzdem.
Wie jetzt, Birgit hat Geburtstach ???????
Na dann auch von mir aus alles alles Gute zu DEINEM Tag !!!!
Sie wird wahrscheinlich reingefeiert haben und heute etwas
brummschädeliger auf dieser Bühne erscheinen.
Hihi ... einen ausgeben muß sie trotzdem.
Zwischendurch mal andere Fakten:
Elan Reports Second Quarter 2007 Financial Results
Elan Corporation, plc today announced its second quarter 2007 financial results and provided a business update. Commenting on Elan’s business, Kelly Martin, Elan’s president and chief executive officer, said, “We continue to make progress in our pipeline and focus on moving our science towards the patients. Business discipline and growth in both Tysabri and EDT should provide a solid platform for continued advancement throughout the balance of the year.”
Commenting on Elan’s second quarter financial results, Shane Cooke, Elan’s executive vice president and chief financial officer, said, “We are very pleased with the progress we have made in the second quarter of the year with revenue growth of 38% and a reduction of two-thirds in Adjusted EBITDA losses as we continue to carefully manage our cost base. The net loss increased to $141.1 million, mainly due to a non-cash charge of $52.2 million related to the write down of intangible assets as a result of the approval of a generic competitor to Maxipime.
Tysabri had a solid quarter with approximately 14,000 patients on therapy as of mid-July 2007, an increase of over 40% from when we reported last quarter.
We expect Tysabri to continue to drive revenue growth.”
Mr. Cooke added, “With the earlier than expected entry of generic competition to Maxipime, we will immediately adjust our commercial infrastructure, reducing related selling and administration costs, and we are targeting to contain Adjusted EBITDA losses for 2007 at the previously guided $50 million level.”
http://www.investorvillage.com/smbd.asp?mb=160&pt=qn
Elan Reports Second Quarter 2007 Financial Results
Elan Corporation, plc today announced its second quarter 2007 financial results and provided a business update. Commenting on Elan’s business, Kelly Martin, Elan’s president and chief executive officer, said, “We continue to make progress in our pipeline and focus on moving our science towards the patients. Business discipline and growth in both Tysabri and EDT should provide a solid platform for continued advancement throughout the balance of the year.”
Commenting on Elan’s second quarter financial results, Shane Cooke, Elan’s executive vice president and chief financial officer, said, “We are very pleased with the progress we have made in the second quarter of the year with revenue growth of 38% and a reduction of two-thirds in Adjusted EBITDA losses as we continue to carefully manage our cost base. The net loss increased to $141.1 million, mainly due to a non-cash charge of $52.2 million related to the write down of intangible assets as a result of the approval of a generic competitor to Maxipime.
Tysabri had a solid quarter with approximately 14,000 patients on therapy as of mid-July 2007, an increase of over 40% from when we reported last quarter.
We expect Tysabri to continue to drive revenue growth.”
Mr. Cooke added, “With the earlier than expected entry of generic competition to Maxipime, we will immediately adjust our commercial infrastructure, reducing related selling and administration costs, and we are targeting to contain Adjusted EBITDA losses for 2007 at the previously guided $50 million level.”
http://www.investorvillage.com/smbd.asp?mb=160&pt=qn
Antwort auf Beitrag Nr.: 30.854.129 von bernie55 am 26.07.07 09:22:44Davy: EBITDA Losses in line
Given that Tysabri's outturn was already known, and that no major pipeline newsflow was anticipated, it is Elan's Q2 numbers themselves which are in focus. The headline outturn is much as expected. EBITDA losses of $6.9m were broadly in line with our $9.4m forecast, and adjusted loss per share was 16c versus our 17c forecast. But the mix was a little different. Q2 revenues were 7% below forecast, due to Tysabri. Elsewhere, lower Maxipime revenues (ahead of generics) were offset by a very strong result from the drug technology division. Operating costs were also 6% below our own estimates.
The genericisation of Maxipime was expected, though until recent weeks its timing was uncertain. Now that a generic has been approved, Elan is writing down the asset on its balance sheet and restructuring its hospital cost base in H2. A generic for Azactam is also still anticipated.
The restructuring will reduce SG&A costs by $100m per annum, including $60m in amortisation. This will result in up-front charges of $10-15m in the second half. Elan's FY guidance, as previously, is that group EBITDA losses will be $50m. Our sense is that EBITDA losses will now accelerate somewhat in H2 and breakeven may be pushed out to early 2008.
http://www.investorvillage.com/smbd.asp?mb=160&mn=131940&pt=…
Given that Tysabri's outturn was already known, and that no major pipeline newsflow was anticipated, it is Elan's Q2 numbers themselves which are in focus. The headline outturn is much as expected. EBITDA losses of $6.9m were broadly in line with our $9.4m forecast, and adjusted loss per share was 16c versus our 17c forecast. But the mix was a little different. Q2 revenues were 7% below forecast, due to Tysabri. Elsewhere, lower Maxipime revenues (ahead of generics) were offset by a very strong result from the drug technology division. Operating costs were also 6% below our own estimates.
The genericisation of Maxipime was expected, though until recent weeks its timing was uncertain. Now that a generic has been approved, Elan is writing down the asset on its balance sheet and restructuring its hospital cost base in H2. A generic for Azactam is also still anticipated.
The restructuring will reduce SG&A costs by $100m per annum, including $60m in amortisation. This will result in up-front charges of $10-15m in the second half. Elan's FY guidance, as previously, is that group EBITDA losses will be $50m. Our sense is that EBITDA losses will now accelerate somewhat in H2 and breakeven may be pushed out to early 2008.
http://www.investorvillage.com/smbd.asp?mb=160&mn=131940&pt=…
DAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAANKE!!
Stimmt,ein bisschen drömelig--Wein+Sekt+erst um eh ins Bett....
Und----Was sagen wir nun zu den Ergebnissen??Nicht schlecht,oder??
Kann gerade engl.Texte noch nicht übersetzen....vielleicht gleich...
Stimmt,ein bisschen drömelig--Wein+Sekt+erst um eh ins Bett....
Und----Was sagen wir nun zu den Ergebnissen??Nicht schlecht,oder??
Kann gerade engl.Texte noch nicht übersetzen....vielleicht gleich...
Antwort auf Beitrag Nr.: 30.854.307 von Birgit.Tersteegen am 26.07.07 09:32:11ehm ...meinte 3h ins Bett....
Antwort auf Beitrag Nr.: 30.854.307 von Birgit.Tersteegen am 26.07.07 09:32:11Kann gerade engl.Texte noch nicht übersetzen....vielleicht gleich...
Und wenn Du das Englische reingezogen hast, dann übersetzt Du das nochmal für uns alle, ok ?
Frei nach dem Wörterbuch Deutsch-Birgit/Birgit-Deutsch
Und wenn Du das Englische reingezogen hast, dann übersetzt Du das nochmal für uns alle, ok ?
Frei nach dem Wörterbuch Deutsch-Birgit/Birgit-Deutsch
Antwort auf Beitrag Nr.: 30.854.469 von Holgus am 26.07.07 09:41:48püh-----Holgie jetzt zeig mal was Du so englischmässig drauf hast----kannst den Quatalsbericht auch im Reim übersetzen...
Antwort auf Beitrag Nr.: 30.854.511 von Birgit.Tersteegen am 26.07.07 09:44:38Oh, alles gute zum 28ten.
ein Merlot ist nie zu verachten
bei Tag sowie bei Nachten
doch in stiller Morgenstunde
ist dann ein Tee die bessere kunde
der den betäubten Gedanken der Nacht
sogleich wieder den gar aus macht.
ein Merlot ist nie zu verachten
bei Tag sowie bei Nachten
doch in stiller Morgenstunde
ist dann ein Tee die bessere kunde
der den betäubten Gedanken der Nacht
sogleich wieder den gar aus macht.
Antwort auf Beitrag Nr.: 30.854.711 von Nostarowie am 26.07.07 09:55:59
NCB: Results in-line; 2007 Guidance Broadly Maintained.
- Q2 2007 results this morning were ahead of expectations at the revenue level and in-line at the EPS (adjusted) level. Product sales of $182.9m were 5% ahead of our $174.9m forecast and with higher than expected costs, the EPS (adjusted) loss was -$0.16 compared to our -$0.17 expectation. Although a Maxipime generic has been approved earlier than expected (approved in June ’07) the guidance for 2007 has been broadly maintained. Previous guidance was for revenues (ex-Tysabri) to exceed $500m and adjusted EBITDA losses to be less than $50m -Elan now expects revenues “to approach, if not exceed” $500m and “to try and contain” adjusted EBITDA losses at approximately $50m for the year. Further clarity is expected later on whether the group can get to breakeven by the end of the year. As a result of early generic competition, Elan is to restructure its hospital infrastructure which is expected to yield annual cash cost savings of c.$40m.
• The outperformance of product revenues of $182.9m, a 40% increase y-o-y were underpinned by stronger than expected revenues from contract manufacturing. Product gross margins of 55% were in-line with our 56% expectation. Operating costs were in-line with costs in the prior year (2.5% less than forecasts) leaving the operating loss (precharges) of -$43.4m compared to our -$50.4m loss expectation. Net charges totalling $67m on an impairment charge of $52m related to the intangible assets of the hospital antibiotics and restructuring charges of $15m (closure of San Diego facility) resulted in a net loss of $141m (on an adjusted basis the net loss was -$74m) compared to our -$78.9m loss expectation. Negative adjusted EBITDA for the group was $6.9m, which resulted in Elan reporting negative adjusted EBITDA for the first six months of $13.3m.
• This quarter revenues of Maxipime declined 16% due to generic competition and Azactam revenues increased 4% y-o-y. The performance of Prialt was modest again this quarter with revenues of $3.3m. Notably, contract manufacturing was strong with revenues increasing 30% y-o-y to $74m, 35% ahead of expectations. Contract manufacturing revenues continue to be primarily underpinned by Tricor ($16.3m), Skelaxin ($11.3m), Verelan ($6.1m) and Focalin ($8.5m)
• Q2 Tysabri in-market sales of $72m were in-line with our expectations although the geographic revenue mix in the quarter was different than expected (US revenues were 10% behind expectations and EU/RoW revenues were 19% ahead of expectations). We have revised the geographic mix of our forecasts although we expect the rate of increase in EU/RoW to broadly offset the slower than anticipated uptake of Tysabri in the US. Our revised 2007 forecasts assume that 11,750 new patients will be infused with Tysabri in the US and that 8,800 new patients will be treated with Tysabri in EU/RoW – 20,550 new patients globally by year-end. Our previous estimate was for 16,050 patients treated in the US and for 6,150 to be treated in EU/RoW – globally 22,200 patients. Based on our revised patient numbers our 2007 revenue forecasts are $355m ($222m in the US and $133m in EU/RoW) compared to $365m previously ($261m in the US and $104m in EU/RoW). Our revised 2008 forecasts are c.$800m compared to our previous estimate of c.$870m.
• The post results call at 13.30 BST may provide further details on (i) TOUCH enrollments, (ii) reimbursement of Tysabri and country roll out in Europe, (iii) 2007 guidance, (iv) restructuring of the hospital infrastruture, (v) recent decision from Europe on Tysabri for Crohn’s Disease and the upcoming FDA advisory committee meeting in the US (31st July). Additionally of interest will be any details on a Phase III timeline for AAB-001 for Alzheimer’s Disease (the plan is to initiate Phase III before year-end). Phase II studies with ACC-001 (immunoconjugate for AD) started in Q2.
NCB: Results in-line; 2007 Guidance Broadly Maintained.
- Q2 2007 results this morning were ahead of expectations at the revenue level and in-line at the EPS (adjusted) level. Product sales of $182.9m were 5% ahead of our $174.9m forecast and with higher than expected costs, the EPS (adjusted) loss was -$0.16 compared to our -$0.17 expectation. Although a Maxipime generic has been approved earlier than expected (approved in June ’07) the guidance for 2007 has been broadly maintained. Previous guidance was for revenues (ex-Tysabri) to exceed $500m and adjusted EBITDA losses to be less than $50m -Elan now expects revenues “to approach, if not exceed” $500m and “to try and contain” adjusted EBITDA losses at approximately $50m for the year. Further clarity is expected later on whether the group can get to breakeven by the end of the year. As a result of early generic competition, Elan is to restructure its hospital infrastructure which is expected to yield annual cash cost savings of c.$40m.
• The outperformance of product revenues of $182.9m, a 40% increase y-o-y were underpinned by stronger than expected revenues from contract manufacturing. Product gross margins of 55% were in-line with our 56% expectation. Operating costs were in-line with costs in the prior year (2.5% less than forecasts) leaving the operating loss (precharges) of -$43.4m compared to our -$50.4m loss expectation. Net charges totalling $67m on an impairment charge of $52m related to the intangible assets of the hospital antibiotics and restructuring charges of $15m (closure of San Diego facility) resulted in a net loss of $141m (on an adjusted basis the net loss was -$74m) compared to our -$78.9m loss expectation. Negative adjusted EBITDA for the group was $6.9m, which resulted in Elan reporting negative adjusted EBITDA for the first six months of $13.3m.
• This quarter revenues of Maxipime declined 16% due to generic competition and Azactam revenues increased 4% y-o-y. The performance of Prialt was modest again this quarter with revenues of $3.3m. Notably, contract manufacturing was strong with revenues increasing 30% y-o-y to $74m, 35% ahead of expectations. Contract manufacturing revenues continue to be primarily underpinned by Tricor ($16.3m), Skelaxin ($11.3m), Verelan ($6.1m) and Focalin ($8.5m)
• Q2 Tysabri in-market sales of $72m were in-line with our expectations although the geographic revenue mix in the quarter was different than expected (US revenues were 10% behind expectations and EU/RoW revenues were 19% ahead of expectations). We have revised the geographic mix of our forecasts although we expect the rate of increase in EU/RoW to broadly offset the slower than anticipated uptake of Tysabri in the US. Our revised 2007 forecasts assume that 11,750 new patients will be infused with Tysabri in the US and that 8,800 new patients will be treated with Tysabri in EU/RoW – 20,550 new patients globally by year-end. Our previous estimate was for 16,050 patients treated in the US and for 6,150 to be treated in EU/RoW – globally 22,200 patients. Based on our revised patient numbers our 2007 revenue forecasts are $355m ($222m in the US and $133m in EU/RoW) compared to $365m previously ($261m in the US and $104m in EU/RoW). Our revised 2008 forecasts are c.$800m compared to our previous estimate of c.$870m.
• The post results call at 13.30 BST may provide further details on (i) TOUCH enrollments, (ii) reimbursement of Tysabri and country roll out in Europe, (iii) 2007 guidance, (iv) restructuring of the hospital infrastruture, (v) recent decision from Europe on Tysabri for Crohn’s Disease and the upcoming FDA advisory committee meeting in the US (31st July). Additionally of interest will be any details on a Phase III timeline for AAB-001 for Alzheimer’s Disease (the plan is to initiate Phase III before year-end). Phase II studies with ACC-001 (immunoconjugate for AD) started in Q2.
Antwort auf Beitrag Nr.: 30.855.114 von Birgit.Tersteegen am 26.07.07 10:17:33@Birgit
...natürlich auch von mir "Happy Börsdei"!
Die Ergebnisse sind - wie immer- grundsolide aber nicht spektakulär - Phase 3 für Bapieneuzumab vor Ende des Jahres.
...natürlich auch von mir "Happy Börsdei"!
Die Ergebnisse sind - wie immer- grundsolide aber nicht spektakulär - Phase 3 für Bapieneuzumab vor Ende des Jahres.
auch von mir die besten Wünsche für das nächste Jahr.
Lass es Dir gut gehen.
Lass es Dir gut gehen.
Antwort auf Beitrag Nr.: 30.854.711 von Nostarowie am 26.07.07 09:55:59Oh, alles gute zum 28ten.
Nosta, da verwechselst Du was ... heut ist erst der 26zigste
Nosta, da verwechselst Du was ... heut ist erst der 26zigste
Danke Euch!
finanzen.net
Elan weite Verlust im zweiten Quartal aus
Donnerstag 26. Juli 2007, 11:55 Uhr
Dublin (aktiencheck.de AG) - Der irische Pharmakonzern Elan Corp. plc (ISIN IE0003072950/ WKN 903801) verbuchte im zweiten Quartal aufgrund höherer Forschungsaufwendungen sowie negativer Einmaleffekte einen höheren Verlust.
Wie der Konzern am Donnerstag erklärte, lag der Nettoverlust im Berichtszeitraum bei 141,1 Mio. Dollar, nach einem Minus von 90,5 Mio. Dollar im Vorjahreszeitraum. Der Verlust je Aktie erhöhte sich im Vorjahresvergleich von 21 Cents auf 30 Cents.
Dabei beinhaltet das Ergebnis im Berichtszeitraum negative Einmaleffekte in Zusammenhang mit Wertberichtigungen in Höhe von 52,2 Mio. Dollar, teilte der Konzern weiter mit.
Der Gesamtumsatz verbesserte sich im Vorjahresvergleich von 136,4 Mio. Dollar auf 188,5 Mio. Dollar.
Für das Gesamtjahr bestätigte Elan (Dublin: DRX.IR - Nachrichten) die Prognose, wonach man beim bereinigten EBITDA einen Verlust von 50 Mio. Dollar erwirtschaften wird.
Die Aktie von Elan notiert aktuell in London mit einem Minus von 2,01 Prozent bei 14,15 Euro. (26.07.2007/ac/n/a)
(ist ein wenig einseitig von der Betrachtung her)
Elan weite Verlust im zweiten Quartal aus
Donnerstag 26. Juli 2007, 11:55 Uhr
Dublin (aktiencheck.de AG) - Der irische Pharmakonzern Elan Corp. plc (ISIN IE0003072950/ WKN 903801) verbuchte im zweiten Quartal aufgrund höherer Forschungsaufwendungen sowie negativer Einmaleffekte einen höheren Verlust.
Wie der Konzern am Donnerstag erklärte, lag der Nettoverlust im Berichtszeitraum bei 141,1 Mio. Dollar, nach einem Minus von 90,5 Mio. Dollar im Vorjahreszeitraum. Der Verlust je Aktie erhöhte sich im Vorjahresvergleich von 21 Cents auf 30 Cents.
Dabei beinhaltet das Ergebnis im Berichtszeitraum negative Einmaleffekte in Zusammenhang mit Wertberichtigungen in Höhe von 52,2 Mio. Dollar, teilte der Konzern weiter mit.
Der Gesamtumsatz verbesserte sich im Vorjahresvergleich von 136,4 Mio. Dollar auf 188,5 Mio. Dollar.
Für das Gesamtjahr bestätigte Elan (Dublin: DRX.IR - Nachrichten) die Prognose, wonach man beim bereinigten EBITDA einen Verlust von 50 Mio. Dollar erwirtschaften wird.
Die Aktie von Elan notiert aktuell in London mit einem Minus von 2,01 Prozent bei 14,15 Euro. (26.07.2007/ac/n/a)
(ist ein wenig einseitig von der Betrachtung her)
Hi Birgit
auch von mir alles gute zum Geburstag
auch von mir alles gute zum Geburstag
Antwort auf Beitrag Nr.: 30.862.375 von noogmann am 26.07.07 17:11:06danke!
Die Börse hat echt ein komisches Geschenk zu meinem Geburtstag....
Die Börse hat echt ein komisches Geschenk zu meinem Geburtstag....
Antwort auf Beitrag Nr.: 30.863.289 von Birgit.Tersteegen am 26.07.07 17:53:51das macht die nur, damit Du später Deinen Enkelkindern erzählen kannst, dass der Kurs nach Deinem Geburtstag zu steigen angefangen hat.
Antwort auf Beitrag Nr.: 30.863.289 von Birgit.Tersteegen am 26.07.07 17:53:51Dein Geburtstag hat meinem Depot aber auch nicht gerade gut getan.
Meine DELPHI ist seit einigen Tagen im Sturzflug.
Bin zum größten Teil raus.
Meine DELPHI ist seit einigen Tagen im Sturzflug.
Bin zum größten Teil raus.
Antwort auf Beitrag Nr.: 30.863.396 von Poppholz am 26.07.07 17:59:18ich finde Elan hält sich noch tapfer--wenn ich so an ALV und KCo denke.....
Ist jemand von Euch am Dienstag live beim AC?
Ich denke, ich werde im IV-Forum "schmarotzen" - dort dürften doch sicherlich ein paar Freaks online sein und die "community" auf dem Laufenden halten.
PRODUCT RATING
Cost:
Single viewer license - $140.00 - $200.00 (per person-per PC)
Allows for a single viewer to view the webcast on their desktop
http://www.fdalive.com/view_detail.cfm?meetingkey=1008
http://www.fdalive.com/webcast.cfm
Ich denke, ich werde im IV-Forum "schmarotzen" - dort dürften doch sicherlich ein paar Freaks online sein und die "community" auf dem Laufenden halten.
PRODUCT RATING
Cost:
Single viewer license - $140.00 - $200.00 (per person-per PC)
Allows for a single viewer to view the webcast on their desktop
http://www.fdalive.com/view_detail.cfm?meetingkey=1008
http://www.fdalive.com/webcast.cfm
from Forbes
Elan still has a lot to prove.
On Thursday, the Dublin-based pharmaceutical company said its net loss widened to $141.1 million, or 30 cents a share, from $90.5 million, or 21 cents a share. A major portion of the loss was related to the one-time write down of Maxipime, a pneumonia drug, after the U.S. Food and Drug Administration approved a generic version earlier-than-anticipated.
Excluding one-time charges, the company's loss actually narrowed to 74.0 million, from 90.5 million.
Despite the Maxipime setback, global sales of the company's multiple-sclerosis drug, Tysabri, rose 49% in the first quarter, helping total revenues climb 38.1% to $188.5 million. That gain in revenues was slighly ablove the Street's call--analysts were expecting revenues of $188.2 million and a total net loss of 13 cents a share.
Tysabri's advance may not have been enough for investors, many of whom once regarded Tysabri as an up-and-coming blockbuster drug.
In Thursday afternoon trading, shares of Elan (nyse: ELN - news - people ) tumbled 2.9%, or 58 cents, to $19.67.
Though drugs such as Maxipime make up a large part of Elan's current portfolio, investors are closely watching Tysabri and the company's Alzheimer's drug pipeline.
"The base business is not worth a lot, many of their drugs are going generic so it's not the reason why you own or sell the stock," Natexis Bleichroeder analyst Corey Davis told Forbes.com Thursday. However, the real key to Elan's future growth may not be Tysabri, which has been plagued by concerns that it triggers a rare brain disorder, but rather, its promising trove of Alzheimer drugs.
One drug, Bapineuzumab (AAB-001), was recently rushed into a late stage, phase three, human trial, after apparently positive phase two interim results. On May 21, the day that Elan announced the upgrade, the stock soared 12.6%. “The Alzheimer’s drugs are the sexiest aspect of Elan, the whole pharmaceutical industry is struggling to find an effective treatment, they have the best shot of hitting the holy grail," Davis said. Elan, and its partner Wyeth Pharmaceuticals, are pouring $250 million into the latest study, which is expected to consist of 2,000 to 3,000 patients.
Natexis Bleichroeder's Davis, who has a $26 price target on the stock, calls it one of his top picks.
http://www.forbes.com/2007/07/26/elan-pharmaceutical-drug-ma…
Elan still has a lot to prove.
On Thursday, the Dublin-based pharmaceutical company said its net loss widened to $141.1 million, or 30 cents a share, from $90.5 million, or 21 cents a share. A major portion of the loss was related to the one-time write down of Maxipime, a pneumonia drug, after the U.S. Food and Drug Administration approved a generic version earlier-than-anticipated.
Excluding one-time charges, the company's loss actually narrowed to 74.0 million, from 90.5 million.
Despite the Maxipime setback, global sales of the company's multiple-sclerosis drug, Tysabri, rose 49% in the first quarter, helping total revenues climb 38.1% to $188.5 million. That gain in revenues was slighly ablove the Street's call--analysts were expecting revenues of $188.2 million and a total net loss of 13 cents a share.
Tysabri's advance may not have been enough for investors, many of whom once regarded Tysabri as an up-and-coming blockbuster drug.
In Thursday afternoon trading, shares of Elan (nyse: ELN - news - people ) tumbled 2.9%, or 58 cents, to $19.67.
Though drugs such as Maxipime make up a large part of Elan's current portfolio, investors are closely watching Tysabri and the company's Alzheimer's drug pipeline.
"The base business is not worth a lot, many of their drugs are going generic so it's not the reason why you own or sell the stock," Natexis Bleichroeder analyst Corey Davis told Forbes.com Thursday. However, the real key to Elan's future growth may not be Tysabri, which has been plagued by concerns that it triggers a rare brain disorder, but rather, its promising trove of Alzheimer drugs.
One drug, Bapineuzumab (AAB-001), was recently rushed into a late stage, phase three, human trial, after apparently positive phase two interim results. On May 21, the day that Elan announced the upgrade, the stock soared 12.6%. “The Alzheimer’s drugs are the sexiest aspect of Elan, the whole pharmaceutical industry is struggling to find an effective treatment, they have the best shot of hitting the holy grail," Davis said. Elan, and its partner Wyeth Pharmaceuticals, are pouring $250 million into the latest study, which is expected to consist of 2,000 to 3,000 patients.
Natexis Bleichroeder's Davis, who has a $26 price target on the stock, calls it one of his top picks.
http://www.forbes.com/2007/07/26/elan-pharmaceutical-drug-ma…
By: olderyser
Today's CC: Best in Years
Rhetorically speaking, today’s conference call was the very best since KM took over as CEO. He, Shane and Lars handled the call with a straightforwardness and control not previously heard by me. Indeed, they exhibited, what I used to call in my professorial days, a sense of ‘matter-of-fact confidence.”
During the entire call there was no sense of hesitation, nor any attempt to gloss over critical points. They not only brought up some excellent news……….revenue growth, margin stability, pipeline progress……..but they turned every potential negative into a positive position.
Noting a possible short-term slowing of U.S. TY uptake, they used the moment to reiterate their plan for spending more time and effort ensuring that their goal of registering the most influential 2500 nationwide neurologists (representing 70% of potential TY population) would be achieved this year. They clearly and cleanly explained that TY patient uptake would rapidly follow physician uptake, and cleanly took the onus off of patient numbers only.
When discussing revenue loss associated with Maxipine generics, they quickly noted that overall annual revenue goals for 2007 would not be reduced by this loss, and, indeed, they were pleased about the continued growth off other revenue streams. When decisively handling the recent negative decision of the European community regarding TY for Crohns, they seized the opportunity to talk about the strength of their upcoming appeal, and, more importantly, about the disconnect between a Euro decision and the forthcoming USA decision.
There was plenty of information in the call to make me extremely confident of the future of my large investment in this company. Today, however, Elan added a new dimension. KM, Shane and Lars are definitely in control now. They are supremely confident, knowledgeable and prepared for the future. I’ve been waiting for this for years. Today, it was front and center. They know the future is going to be powerful for Elan, and they expressed that knowledge with commitment and confidence this morning.
Just some thoughts
Hi!
Schriftliche Aufzeichnung vom CC gibts hier---und gute Nachkaufkurse heute auch...
http://seekingalpha.com/article/42570
Schriftliche Aufzeichnung vom CC gibts hier---und gute Nachkaufkurse heute auch...
http://seekingalpha.com/article/42570
Antwort auf Beitrag Nr.: 30.876.754 von Birgit.Tersteegen am 27.07.07 14:42:01momentan geht der Kurs in USA ordentlich runter
$18,73 zu $18,80
$18,73 zu $18,80
Antwort auf Beitrag Nr.: 30.878.081 von Poppholz am 27.07.07 15:52:10
Multiple Sclerosis Treatments Market will Reach $11.9 Billion by 2011
NewswireToday - /newswire/ - London, United Kingdom, 07/27/2007 - Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report showing the growth of MS treatments from $4.4 billion in 2004 to nearly $5.9 billion in 2006. .........
http://www.newswiretoday.com/news/21629/
Multiple Sclerosis Treatments Market will Reach $11.9 Billion by 2011
NewswireToday - /newswire/ - London, United Kingdom, 07/27/2007 - Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report showing the growth of MS treatments from $4.4 billion in 2004 to nearly $5.9 billion in 2006. .........
http://www.newswiretoday.com/news/21629/
Antwort auf Beitrag Nr.: 30.882.072 von surga am 27.07.07 20:23:47sehr schöner Artikel.
Bei ELAN fühle ich mich gut aufgehoben, auch wenn selbst diese Aktie zu manipulieren ist.
Ich werde weiterhin mit dem Großteil meines Depots LONG bleiben und erst in 2-3 Jahren mit der Ernte beginnen.
Bei ELAN fühle ich mich gut aufgehoben, auch wenn selbst diese Aktie zu manipulieren ist.
Ich werde weiterhin mit dem Großteil meines Depots LONG bleiben und erst in 2-3 Jahren mit der Ernte beginnen.
Goldman Sachs July 27,2007
Key healthcare events for the week ahead
Biogen Idec (BIIB, Neutral): July 31: We expect the FDA Advisory Committees to
review Tysabri for induction and maintenance of moderate to severe Crohn's disease.
We expect an FDA decision in mid-October 2007. We believe the Phase 3 data
support the efficacy of Tysabri for maintenance and, to a lesser degree, induction
therapy. The Advisory Committees will likely focus on the safety, optimal patient
population, and risk management program due to the risk of progressive multifocal
leukoencephalopathy (PML).
Key healthcare events for the week ahead
Biogen Idec (BIIB, Neutral): July 31: We expect the FDA Advisory Committees to
review Tysabri for induction and maintenance of moderate to severe Crohn's disease.
We expect an FDA decision in mid-October 2007. We believe the Phase 3 data
support the efficacy of Tysabri for maintenance and, to a lesser degree, induction
therapy. The Advisory Committees will likely focus on the safety, optimal patient
population, and risk management program due to the risk of progressive multifocal
leukoencephalopathy (PML).
Antwort auf Beitrag Nr.: 30.900.726 von Birgit.Tersteegen am 28.07.07 20:02:32@all
das hört sich leider nicht wirklich gut an....
UPDATE 2-US FDA staff questions use of MS drug for Crohn's
Reuters - July 27, 2007 2:46 PM ET
By Lisa Richwine
WASHINGTON, July 27 (Reuters) - The multiple sclerosis drug Tysabri is no more effective against the bowel disorder Crohn's disease than other approved therapies, U.S. drug reviewers said in documents released on Friday.
Biogen Idec (BIIB) and Elan Corp. ELN.I (ELN) are seeking approval to market Tysabri for Crohn's.
U.S. Food and Drug Administration staff said there may be some Crohn's patients for whom Tysabri's risks, which include a rare and serious brain infection, may be more acceptable.
Shares of Biogen Idec fell 1.5 percent to $57.27 in afternoon trading on Nasdaq. Elan shares fell 3.5 percent to $19.04 on the New York Stock Exchange.
The FDA will ask a panel of outside advisers on Monday if Tysabri should be approved for Crohn's disease, a use that European regulators recommended against earlier this month. The FDA usually follows panel recommendations.
Tysabri sales were suspended in 2005 because of the brain infection, known as progressive multifocal leukoencephalopathy, or PML. Two of three patients who developed the infection died. The drug was returned to the market last year with some limits after the FDA decided MS patients were willing to accept the risks in light of possible benefits.
"The benefit and risk considerations in the (Crohn's) population are considerably different from those in the MS population," FDA reviewers said.
"The treatment effect in the (Crohn's) population ... was not as high as that in the MS population ... nor is it clearly distinguished" from approved Crohn's therapies, they said.
The FDA reviewers said Biogen has not performed all of the desired analyses to help determine if certain patients may be more at risk for complications.
In a separate summary, Biogen said Tysabri, known generically as natalizumab, was a "highly effective" treatment for Crohn's disease. It said risks could be minimized through label warnings, a controlled distribution system and other measures.
Elan's president of global research and development, Lars Ekman, said in a statement the company was "optimistic regarding the strength of the file under review by the FDA."
The optimism is based on two pivotal trials that met all primary and secondary goals, he said.
Tysabri sales were $72 million in the second quarter, Biogen reported this month.
Natixis Bleichroeder analyst Corey Davis said approval for Tysabri to marketed as a treatment for Crohn's appeared unlikely. The FDA documents "do not look favorable for a positive recommendation," Davis said in a research note.
Other drugs approved for Crohn's disease include Abbott Laboratories Inc.'s (ABT) Humira and Johnson & Johnson's (JNJ) Remicade.
Tysabri's makers have said they will appeal the decision by European regulators, who said the risk of serious infection outweighed relatively modest benefits for Crohn's patients.
Summaries from FDA staff and Biogen were posted on the FDA Web site at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-…
das hört sich leider nicht wirklich gut an....
UPDATE 2-US FDA staff questions use of MS drug for Crohn's
Reuters - July 27, 2007 2:46 PM ET
By Lisa Richwine
WASHINGTON, July 27 (Reuters) - The multiple sclerosis drug Tysabri is no more effective against the bowel disorder Crohn's disease than other approved therapies, U.S. drug reviewers said in documents released on Friday.
Biogen Idec (BIIB) and Elan Corp. ELN.I (ELN) are seeking approval to market Tysabri for Crohn's.
U.S. Food and Drug Administration staff said there may be some Crohn's patients for whom Tysabri's risks, which include a rare and serious brain infection, may be more acceptable.
Shares of Biogen Idec fell 1.5 percent to $57.27 in afternoon trading on Nasdaq. Elan shares fell 3.5 percent to $19.04 on the New York Stock Exchange.
The FDA will ask a panel of outside advisers on Monday if Tysabri should be approved for Crohn's disease, a use that European regulators recommended against earlier this month. The FDA usually follows panel recommendations.
Tysabri sales were suspended in 2005 because of the brain infection, known as progressive multifocal leukoencephalopathy, or PML. Two of three patients who developed the infection died. The drug was returned to the market last year with some limits after the FDA decided MS patients were willing to accept the risks in light of possible benefits.
"The benefit and risk considerations in the (Crohn's) population are considerably different from those in the MS population," FDA reviewers said.
"The treatment effect in the (Crohn's) population ... was not as high as that in the MS population ... nor is it clearly distinguished" from approved Crohn's therapies, they said.
The FDA reviewers said Biogen has not performed all of the desired analyses to help determine if certain patients may be more at risk for complications.
In a separate summary, Biogen said Tysabri, known generically as natalizumab, was a "highly effective" treatment for Crohn's disease. It said risks could be minimized through label warnings, a controlled distribution system and other measures.
Elan's president of global research and development, Lars Ekman, said in a statement the company was "optimistic regarding the strength of the file under review by the FDA."
The optimism is based on two pivotal trials that met all primary and secondary goals, he said.
Tysabri sales were $72 million in the second quarter, Biogen reported this month.
Natixis Bleichroeder analyst Corey Davis said approval for Tysabri to marketed as a treatment for Crohn's appeared unlikely. The FDA documents "do not look favorable for a positive recommendation," Davis said in a research note.
Other drugs approved for Crohn's disease include Abbott Laboratories Inc.'s (ABT) Humira and Johnson & Johnson's (JNJ) Remicade.
Tysabri's makers have said they will appeal the decision by European regulators, who said the risk of serious infection outweighed relatively modest benefits for Crohn's patients.
Summaries from FDA staff and Biogen were posted on the FDA Web site at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-…
Antwort auf Beitrag Nr.: 30.912.863 von nirpf am 29.07.07 12:07:13
Antwort auf Beitrag Nr.: 30.912.863 von nirpf am 29.07.07 12:07:13Hi!
Tja,wissen tut es Niemand was Dienstag herauskommt;allerdings ist es die Aufgabe der FDA in diesem Spiel, dem Advisory Commitee die kritischen Fragen zu übermitteln und prüfen zu lassen....Ich hoffe auf Empfehlung zur Zulassung mit Touch-Programm wie bei MS....Alles andere wäre grrrrrrrrrrrrrrrhh....
Tja,wissen tut es Niemand was Dienstag herauskommt;allerdings ist es die Aufgabe der FDA in diesem Spiel, dem Advisory Commitee die kritischen Fragen zu übermitteln und prüfen zu lassen....Ich hoffe auf Empfehlung zur Zulassung mit Touch-Programm wie bei MS....Alles andere wäre grrrrrrrrrrrrrrrhh....
Antwort auf Beitrag Nr.: 30.932.206 von Birgit.Tersteegen am 30.07.07 09:53:38
ELAN wird echt richtig geschlachet
ELAN wird echt richtig geschlachet
Unglaublich!Es scheinen fake PMs in Ameika umzugehen--ähnlich der Geschichte mit Ty + Aids im letzten Jahr-----------Shorts + Konkurrenten schrecken vor nichts zurück scheinbar.....KEEP COOL!!
Richtig geschlachtet finde ich nicht.
Da wären wir bei 5$.
Da wären wir bei 5$.
Antwort auf Beitrag Nr.: 30.939.249 von Birgit.Tersteegen am 30.07.07 17:10:20Biggi, hast Du noch zugekauft?
Antwort auf Beitrag Nr.: 30.939.288 von surga am 30.07.07 17:12:51Die letzten vor ca 1 Woche....aber ich bin "Gewehr bei Fuss"....und Bernie ist in Urlaub!
Antwort auf Beitrag Nr.: 30.939.286 von mikel_ann am 30.07.07 17:12:38BITTE!:O
By: dexter66stinks Send PM Profile Ignore Recommend Add To Favorites
Fun to read the message board today...
Today it is entertaining to read the message board, as the true feelings of posters get exposed for what they are and who they are. Under normal, boring, no action days, there are those who boldly define themselves as one thing, or another and strongly defend their views, sometimes showing excessive hostility towards anyone who questions these views. But on days such as this, the real person emerges, and the bullshit goes out the window. No need to wring one's hands and worry, just sit back and enjoy the show. For nothing has changed...all our ducks are lined up in a row, Aab-001 phase III is one day closer, and Tysabri sales marches on! And the sun will come up tomorrow.
-------ist nur nicht so einfach.........
By: dexter66stinks Send PM Profile Ignore Recommend Add To Favorites
Fun to read the message board today...
Today it is entertaining to read the message board, as the true feelings of posters get exposed for what they are and who they are. Under normal, boring, no action days, there are those who boldly define themselves as one thing, or another and strongly defend their views, sometimes showing excessive hostility towards anyone who questions these views. But on days such as this, the real person emerges, and the bullshit goes out the window. No need to wring one's hands and worry, just sit back and enjoy the show. For nothing has changed...all our ducks are lined up in a row, Aab-001 phase III is one day closer, and Tysabri sales marches on! And the sun will come up tomorrow.
-------ist nur nicht so einfach.........
sind halt turbulente Zeiten für unser Baby (und für mein Depot)
Antwort auf Beitrag Nr.: 30.941.460 von Poppholz am 30.07.07 19:40:00hi
heute hab ich elan gekauft
fuer 17 usd
Elan ADR (NYX) Price: 17.67 USD Chg. (in%): -1.33 USD (-7.00%
Last: 17.67 -1.33-7.00% Volume last: 100 (13:27:40)
Cum. volume: 4'985'600 (13:27:40)
Open: 17.87 (09:31:06)
Previous day close: 19 (27.07.07) Prev. Chg.: -0.73 (-3.70%)
Year change %: +19.80%
Previous year close: 14.75
gruss
heute hab ich elan gekauft
fuer 17 usd
Elan ADR (NYX) Price: 17.67 USD Chg. (in%): -1.33 USD (-7.00%
Last: 17.67 -1.33-7.00% Volume last: 100 (13:27:40)
Cum. volume: 4'985'600 (13:27:40)
Open: 17.87 (09:31:06)
Previous day close: 19 (27.07.07) Prev. Chg.: -0.73 (-3.70%)
Year change %: +19.80%
Previous year close: 14.75
gruss
Antwort auf Beitrag Nr.: 30.941.609 von mmeureka2164 am 30.07.07 19:50:01Gratuliere.
(willkommen im CLUB)
(willkommen im CLUB)
...das mit den erhöhten Leberwerten -->
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-…
ist eine absolute Panikmache. Bei monoklonalen Antikörpern gibts nun einmal eine Tendenz dazu. Allerdings ist bei Infliximab (brand name Remicade), dem Goldstandard zur Behandlung von MC, das Risiko weitaus grösser:
http://www.fda.gov/cder/foi/label/2007/103772s5189lbl.pdf
...weshalb die geringe Anzahl an hauptsächlich milden Anzeichen eher als Vorteil für Natalizumab zu werten ist.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-…
ist eine absolute Panikmache. Bei monoklonalen Antikörpern gibts nun einmal eine Tendenz dazu. Allerdings ist bei Infliximab (brand name Remicade), dem Goldstandard zur Behandlung von MC, das Risiko weitaus grösser:
http://www.fda.gov/cder/foi/label/2007/103772s5189lbl.pdf
...weshalb die geringe Anzahl an hauptsächlich milden Anzeichen eher als Vorteil für Natalizumab zu werten ist.
Antwort auf Beitrag Nr.: 30.942.089 von Cyberhexe am 30.07.07 20:24:45...und zudem gibts diese Probleme auch bei den Interferonen:
"Despite the calls I am getting from some of you of Tysabri deaths, funerals, obituaries, etc. confirmed by x, NCB & FDA… I thought you might be interested in hearing (a large sharholder's) take. They think trading as usual is overdone… the usual Elan mugging we’ve come to expect in times of trading of weakness… according to a very knowledgeable biotech analyst (who has followed Elan as close as any of us for 5 years) he compared the serious liver incidence rates related to Tysabri to the same events for the CRABs… the rate is 0.03 per 1,000 for Tysabri versus 0.40 per 1,000 for the CRABs…
Bei den klinischen Studien sind diese Nebenwirkungen zudem nicht häufiger aufgetreten als unter einem Scheinpräparat - aber die Panikmache wundert mich nicht, das scheint wohl Strategie zu sein.
"Despite the calls I am getting from some of you of Tysabri deaths, funerals, obituaries, etc. confirmed by x, NCB & FDA… I thought you might be interested in hearing (a large sharholder's) take. They think trading as usual is overdone… the usual Elan mugging we’ve come to expect in times of trading of weakness… according to a very knowledgeable biotech analyst (who has followed Elan as close as any of us for 5 years) he compared the serious liver incidence rates related to Tysabri to the same events for the CRABs… the rate is 0.03 per 1,000 for Tysabri versus 0.40 per 1,000 for the CRABs…
Bei den klinischen Studien sind diese Nebenwirkungen zudem nicht häufiger aufgetreten als unter einem Scheinpräparat - aber die Panikmache wundert mich nicht, das scheint wohl Strategie zu sein.
Antwort auf Beitrag Nr.: 30.942.089 von Cyberhexe am 30.07.07 20:24:45morgen werden wir mehr wissen.
(auf jeden Fall lassen wir uns keine Angst machen)
(auf jeden Fall lassen wir uns keine Angst machen)
Antwort auf Beitrag Nr.: 30.941.855 von mmeureka2164 am 30.07.07 20:07:10Kein schlechter Einstieg!
Antwort auf Beitrag Nr.: 30.942.133 von Cyberhexe am 30.07.07 20:28:28Leberprobleme bei Interferonen:
http://www.neurology.org/cgi/content/full/62/4/E8
Interferon drugs can affect the liver In this issue of Neurology, Tremlett and colleagues reviewed the liver function tests of 835 patients with MS who were using one of the three available interferon drugs. The investigators reviewed medical records for patients aged 18 to 60 years who had two or more attacks of MS during the 2 years prior to entering the study. Liver function tests were checked before treatment with interferon drugs and at 3, 6, and 12 months after treatment was started. After the first year of interferon treatment, liver function tests were checked every year. Patients who had been on interferon treatment in the past or who had any other medical problems that could cause liver abnormalities were not included in the study.
Overall, nearly one third (36%) of the patients treated with interferon drugs developed abnormal liver function tests. All of the three interferon drugs caused some abnormality in liver function tests. Avonex caused slightly less problems than Betaseron and Rebif. Most patients had minimal abnormalities (33 to 38%), 4 to 7% had mild to moderate abnormalities, and only 1 to 2% had severe abnormalities on the liver function tests. The "highest risk" period for developing liver abnormalities seemed to be in the first 12 months of beginning treatment.
http://www.neurology.org/cgi/content/full/62/4/E8
Interferon drugs can affect the liver In this issue of Neurology, Tremlett and colleagues reviewed the liver function tests of 835 patients with MS who were using one of the three available interferon drugs. The investigators reviewed medical records for patients aged 18 to 60 years who had two or more attacks of MS during the 2 years prior to entering the study. Liver function tests were checked before treatment with interferon drugs and at 3, 6, and 12 months after treatment was started. After the first year of interferon treatment, liver function tests were checked every year. Patients who had been on interferon treatment in the past or who had any other medical problems that could cause liver abnormalities were not included in the study.
Overall, nearly one third (36%) of the patients treated with interferon drugs developed abnormal liver function tests. All of the three interferon drugs caused some abnormality in liver function tests. Avonex caused slightly less problems than Betaseron and Rebif. Most patients had minimal abnormalities (33 to 38%), 4 to 7% had mild to moderate abnormalities, and only 1 to 2% had severe abnormalities on the liver function tests. The "highest risk" period for developing liver abnormalities seemed to be in the first 12 months of beginning treatment.
...und es sind anscheinend doch nur 16 stimmberechtigte Teilnehmer beim AC - ich dachte ursprünglich es wären 19 -, von denen 3 Verbindungen zur Konkurrenz offenlegen:
http://www.pharmalot.com/2007/07/fda-tysabri-panel-violates-…
...bin mal gespannt auf deren Abstimmungsverhalten!
Mein Tipp:
11-5 auf Zulassung unter Auflagen (Risikoplan)
http://www.pharmalot.com/2007/07/fda-tysabri-panel-violates-…
...bin mal gespannt auf deren Abstimmungsverhalten!
Mein Tipp:
11-5 auf Zulassung unter Auflagen (Risikoplan)
Auf 18$ konnten wir uns noch retten (vom Tief bei 16.30$)
Heute haben unsere Konkurrenten und die aus der kurzen Ecke das gesamte Repertoire der Verdrehung,Lüge und Manipulation aufgefahren -----ich HOFFE,es nützt ihnen für morgen nichts....
Morgen Abend um 23h wissen wirs.......
Ach ist das Leben schön....
Gute Nacht!Birgit
Heute haben unsere Konkurrenten und die aus der kurzen Ecke das gesamte Repertoire der Verdrehung,Lüge und Manipulation aufgefahren -----ich HOFFE,es nützt ihnen für morgen nichts....
Morgen Abend um 23h wissen wirs.......
Ach ist das Leben schön....
Gute Nacht!Birgit
Törööö, Moin mal schnell
gap ist gestern zugemacht worden...
die ~16 is ne solide Unterstützung...ma
un wieder weg.....
gap ist gestern zugemacht worden...
die ~16 is ne solide Unterstützung...ma
un wieder weg.....
Antwort auf Beitrag Nr.: 30.945.495 von Nostarowie am 31.07.07 08:44:07Nosta,WIE kommt es eigentlich dass mich Deine charttechnischen Überlegungen nie beruhigen???
Heute werden wir positiv korrigieren---und ich bin wieder besserer Laune.Ich bekomme heute Abend aus Amiland eine Zusammenfassung des AC gemailt und werde sie hier natürlich reinstellen.
Good luck to all (heute scheint hier mal die Sonne,unglaublich....)
Heute werden wir positiv korrigieren---und ich bin wieder besserer Laune.Ich bekomme heute Abend aus Amiland eine Zusammenfassung des AC gemailt und werde sie hier natürlich reinstellen.
Good luck to all (heute scheint hier mal die Sonne,unglaublich....)
Antwort auf Beitrag Nr.: 30.947.145 von Birgit.Tersteegen am 31.07.07 10:36:57heute wird ein guter Tag.
Bisher steigt der Kurs in Irland und London gut an. BID und ASK klettern auch in FFM weiter nach oben (nur kaufen oder verkaufen tut keiner).
Wenn heute wirklich die Zulassung (mit Auflagen) kommen sollte, machen wir einen schönen Sprung. Falls die Zulassung nicht kommt geht es wieder auf $16.80 runter.
Wir werden sehen.
Bisher steigt der Kurs in Irland und London gut an. BID und ASK klettern auch in FFM weiter nach oben (nur kaufen oder verkaufen tut keiner).
Wenn heute wirklich die Zulassung (mit Auflagen) kommen sollte, machen wir einen schönen Sprung. Falls die Zulassung nicht kommt geht es wieder auf $16.80 runter.
Wir werden sehen.
So,das Advisory Commitee hat begonnen und Elan´s Vorschlag zur Risikominimierung ist,dass die Behandlung bei Chron mit Ty nach 3 Monaten abgebrochen wird ,falls es keine Fortschritte inder Behandlung gibt.
"Elan's RiskMAP will recommend that treatment stop after three months if no improvement"
Das ist ein geschickter Schachzug + erhöht m.E.n.die Chance auf Zulassung.
"Elan's RiskMAP will recommend that treatment stop after three months if no improvement"
Das ist ein geschickter Schachzug + erhöht m.E.n.die Chance auf Zulassung.
Antwort auf Beitrag Nr.: 30.951.196 von Birgit.Tersteegen am 31.07.07 14:51:17hört sich wirklich gut an.
Halt uns auf dem Laufenden, Birgit
(das wird schon)
Halt uns auf dem Laufenden, Birgit
(das wird schon)
Antwort auf Beitrag Nr.: 30.951.196 von Birgit.Tersteegen am 31.07.07 14:51:17...der modifizierte Risikoplan scheint ein guter Schachzug zu sein.
Updated Meeting Agenda From LJD
8:20 am. Introduction -- David Feigal, MD, SVP Regulatory Affairs, Biometrics and Global Pharmacovigilance & Risk Management at Elan.
8:25 am. Crohn's Disease -- William Sandborn, MD, Prof of Med, Gastro, Mayo Clinic
8:35 am. Efficacy Data -- Stephen Jones, MBBS, Director, Clinical Development, Elan
8:55 am. Safety Data -- Gordon Francis, MD, SVP, Clinical Development, Elan
9:20 am. Risk-Management Plan -- William Maier, MPH, PhD, Senior Director, Epidemiology, Elan
9:40 am. Clinical Perspective -- William Sandborn, MD, Prof of Med, Gastro, Mayo Clinic
9:50 am. Questions to the Sponsor
10:10 am. Break
10:25 am. PML -- Margo Smith, MD, Associate Program Director, Dept of Medicine, Washington Hospital Center
10:40 am. Clinical Review -- Anil Rajpal, MD, Medical Reviewer, Div of Gastro Products, CDER/FDA
11:15 am. Postmarketing Safety and RiskMAP -- Claudia Karwoski, PharmD, Risk Mgmt Team Leader, OSE, CDER/FDA
11:35 am. Questions to the FDA
12:00 pm. Lunch
1:00 pm. Open Public Hearing
2:30 pm. Questions to the Committee and Recommendations (15 min. break at 3:00 pm)
5:00 pm. Adjourn
Hound
Updated Meeting Agenda From LJD
8:20 am. Introduction -- David Feigal, MD, SVP Regulatory Affairs, Biometrics and Global Pharmacovigilance & Risk Management at Elan.
8:25 am. Crohn's Disease -- William Sandborn, MD, Prof of Med, Gastro, Mayo Clinic
8:35 am. Efficacy Data -- Stephen Jones, MBBS, Director, Clinical Development, Elan
8:55 am. Safety Data -- Gordon Francis, MD, SVP, Clinical Development, Elan
9:20 am. Risk-Management Plan -- William Maier, MPH, PhD, Senior Director, Epidemiology, Elan
9:40 am. Clinical Perspective -- William Sandborn, MD, Prof of Med, Gastro, Mayo Clinic
9:50 am. Questions to the Sponsor
10:10 am. Break
10:25 am. PML -- Margo Smith, MD, Associate Program Director, Dept of Medicine, Washington Hospital Center
10:40 am. Clinical Review -- Anil Rajpal, MD, Medical Reviewer, Div of Gastro Products, CDER/FDA
11:15 am. Postmarketing Safety and RiskMAP -- Claudia Karwoski, PharmD, Risk Mgmt Team Leader, OSE, CDER/FDA
11:35 am. Questions to the FDA
12:00 pm. Lunch
1:00 pm. Open Public Hearing
2:30 pm. Questions to the Committee and Recommendations (15 min. break at 3:00 pm)
5:00 pm. Adjourn
Hound
Updated with FDA comments in the fourth paragraph.)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--Officials from Elan Corp. (ELN) said Tuesday that the
benefit of using Tysabri in patients with Crohn's disease outweighs the risk of
a rare brain infection.
Elan officials are appearing before a U.S. Food and Drug Administration panel
of outside medical experts who have been called to help the agency decide if
Tysabri should be approved for that use. Tysabri is co-marketed with Biogen
Idec Inc. (BIIB). The FDA usually follows its panel's advice but isn't required
to do so.
Tysabri, originally approved to treat multiple sclerosis, was pulled off the
U.S. market in February 2005 after two patients developed a serious brain
infection called progressive multifocal leukoencephalopathy, or PML. The drug
was allowed back on the U.S. market last year under a restricted distribution
system and program designed to monitor patients for PML and other side effects.
In a presentation about Tysabri to the panel, Anil Rajpal, a medical officer
in the FDA's division of gastroenterology products, said "no new safety issues"
have emerged since Tysabri was allowed back on the market.
David Feigal, Elan's senior vice president for regulatory affairs, said,
"Tysabri can offer people with Crohn's disease a new treatment option when
others have failed," adding, "We feel Tysabri has a favorable risk-to-benefit
profile to support approval."
Crohn's disease is a chronic, progressive disease marked by inflammation of
the bowel. The condition often causes abdominal pain and bleeding. About
600,000 Americans have the disease.
In documents prepared for Tuesday's meeting, the FDA said one of the reasons
Tysabri was allowed back on the market was the "unprecedented treatment effect"
among multiple-sclerosis patients.
However, the agency said the treatment effect of Tysabri in Crohn's disease
is "considerably different from those in the MS population" and that the drug
wasn't "clearly distinguished" from other approved Crohn's treatments.
The companies are seeking approval for use of Tysabri in Crohn's patients who
have failed other therapies.
William Sandborn, a professor of medicine at the Mayo Clinic, told the panel
Tuesday that about 30% of patients with Crohn's disease initially don't respond
to other therapies, including newer drugs like Johnson & Johnson's (JNJ)
Remicade and Abbott Laboratories' (ABT) Humira and, in another group of
patients, the therapies stop working.
"There's a big unmet need in Crohn's disease for the most severe patients,"
he said. He also said gastroenterologists who treat the disease are used to
managing potentially severe side effects with currently available drugs and
would be able to do the same with Tysabri.
One of the two main studies looking at Tysabri as a Crohn's treatment didn't
show a statistically significant treatment effect for the drug compared to
placebo, although it showed a numeric increase of 56% of patients achieving a
clinical response after 10 weeks compared to 49% of patients on a placebo, or
fake treatment.
A subsequent analysis of patient sub-groups, however, suggested patients with
more inflammation had more benefit from Tysabri. A second clinical study showed
48% of patients on Tysabri had a clinical response, compared to 32% of patients
on placebo.
A third study of patients who were considered responders in the first two
studies looked at patients over six months and showed 61% those receiving
Tysabri maintained a clinical response, compared to 28% in a placebo group.
The FDA said patients with Crohn's are more likely to be on steroids or
chronic immunosuppressant therapy than MS patients and noted that there is
concern the risk of PML rises with immunosuppression. In MS patients, Tysabri
is approved as a standalone treatment, and doctors are warned not to use it in
combination with immune-system modifying drugs. The FDA said that, in clinical
practice, it could be hard to attain a goal of using Tysabri as a standalone
drug, or monotherapy, in Crohn's patients where steroids and immunosuppressants
are used to reduce flare-ups.
Immunosuppressant drugs often are used in new patients first before doctors
move to Remicade and Humira. Those drugs are designed to block a substance in
the body known as tumor necrosis factor that is believed to be involved with
certain kinds of inflammatory diseases such as Crohn's and rheumatoid
arthritis.
Elan said Tysabri would be available only under the same restricted
distribution and monitoring system that is currently set up for MS prescribers
and patients.
Shares of Biogen traded recently at $55.84, up 0.7%, while Elan's American
depositary receipts were up 1.4% at $18.30.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
Jennifer.Corbett@dowjones.com
(END) Dow Jones Newswires
07-31-07 1152ET
Copyright (c) 2007 Dow Jones & Company, Inc.
11:52 073107
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--Officials from Elan Corp. (ELN) said Tuesday that the
benefit of using Tysabri in patients with Crohn's disease outweighs the risk of
a rare brain infection.
Elan officials are appearing before a U.S. Food and Drug Administration panel
of outside medical experts who have been called to help the agency decide if
Tysabri should be approved for that use. Tysabri is co-marketed with Biogen
Idec Inc. (BIIB). The FDA usually follows its panel's advice but isn't required
to do so.
Tysabri, originally approved to treat multiple sclerosis, was pulled off the
U.S. market in February 2005 after two patients developed a serious brain
infection called progressive multifocal leukoencephalopathy, or PML. The drug
was allowed back on the U.S. market last year under a restricted distribution
system and program designed to monitor patients for PML and other side effects.
In a presentation about Tysabri to the panel, Anil Rajpal, a medical officer
in the FDA's division of gastroenterology products, said "no new safety issues"
have emerged since Tysabri was allowed back on the market.
David Feigal, Elan's senior vice president for regulatory affairs, said,
"Tysabri can offer people with Crohn's disease a new treatment option when
others have failed," adding, "We feel Tysabri has a favorable risk-to-benefit
profile to support approval."
Crohn's disease is a chronic, progressive disease marked by inflammation of
the bowel. The condition often causes abdominal pain and bleeding. About
600,000 Americans have the disease.
In documents prepared for Tuesday's meeting, the FDA said one of the reasons
Tysabri was allowed back on the market was the "unprecedented treatment effect"
among multiple-sclerosis patients.
However, the agency said the treatment effect of Tysabri in Crohn's disease
is "considerably different from those in the MS population" and that the drug
wasn't "clearly distinguished" from other approved Crohn's treatments.
The companies are seeking approval for use of Tysabri in Crohn's patients who
have failed other therapies.
William Sandborn, a professor of medicine at the Mayo Clinic, told the panel
Tuesday that about 30% of patients with Crohn's disease initially don't respond
to other therapies, including newer drugs like Johnson & Johnson's (JNJ)
Remicade and Abbott Laboratories' (ABT) Humira and, in another group of
patients, the therapies stop working.
"There's a big unmet need in Crohn's disease for the most severe patients,"
he said. He also said gastroenterologists who treat the disease are used to
managing potentially severe side effects with currently available drugs and
would be able to do the same with Tysabri.
One of the two main studies looking at Tysabri as a Crohn's treatment didn't
show a statistically significant treatment effect for the drug compared to
placebo, although it showed a numeric increase of 56% of patients achieving a
clinical response after 10 weeks compared to 49% of patients on a placebo, or
fake treatment.
A subsequent analysis of patient sub-groups, however, suggested patients with
more inflammation had more benefit from Tysabri. A second clinical study showed
48% of patients on Tysabri had a clinical response, compared to 32% of patients
on placebo.
A third study of patients who were considered responders in the first two
studies looked at patients over six months and showed 61% those receiving
Tysabri maintained a clinical response, compared to 28% in a placebo group.
The FDA said patients with Crohn's are more likely to be on steroids or
chronic immunosuppressant therapy than MS patients and noted that there is
concern the risk of PML rises with immunosuppression. In MS patients, Tysabri
is approved as a standalone treatment, and doctors are warned not to use it in
combination with immune-system modifying drugs. The FDA said that, in clinical
practice, it could be hard to attain a goal of using Tysabri as a standalone
drug, or monotherapy, in Crohn's patients where steroids and immunosuppressants
are used to reduce flare-ups.
Immunosuppressant drugs often are used in new patients first before doctors
move to Remicade and Humira. Those drugs are designed to block a substance in
the body known as tumor necrosis factor that is believed to be involved with
certain kinds of inflammatory diseases such as Crohn's and rheumatoid
arthritis.
Elan said Tysabri would be available only under the same restricted
distribution and monitoring system that is currently set up for MS prescribers
and patients.
Shares of Biogen traded recently at $55.84, up 0.7%, while Elan's American
depositary receipts were up 1.4% at $18.30.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
Jennifer.Corbett@dowjones.com
(END) Dow Jones Newswires
07-31-07 1152ET
Copyright (c) 2007 Dow Jones & Company, Inc.
11:52 073107
Den Mutigen gehört die Welt;oder so----und mir gehören 200 Schätzchen zu 18,58$.....Die Sucht nennt sich "ELANITES"--und ist nur mit TY in virtueller Form zu heilen...
Voting Starts At 3:15
Antwort auf Beitrag Nr.: 30.957.264 von Birgit.Tersteegen am 31.07.07 20:38:47nah wiedermal alle beisammen zum showdown?
hoffe auf einen netten abend mit nem guten tröpfchen zum abschluss.
good luck
hoffe auf einen netten abend mit nem guten tröpfchen zum abschluss.
good luck
Antwort auf Beitrag Nr.: 30.957.755 von GuHu1 am 31.07.07 21:08:33echt,Krimi....Der Wein ist schon geöffnet
Antwort auf Beitrag Nr.: 30.957.914 von Birgit.Tersteegen am 31.07.07 21:18:28zum wein hats bei mir nicht gereicht, hab nur ein gepflegtes bier und das ein oder andere ist kaltgestellt.
lassen wir uns mal überraschen.
lassen wir uns mal überraschen.
By: stockhound4
Delayed Vote To Begin Now Take Your Seat Folks Fireworks Are Starting After 5 Minute Overview By Chair
Delayed Vote To Begin Now Take Your Seat Folks Fireworks Are Starting After 5 Minute Overview By Chair
Antwort auf Beitrag Nr.: 30.958.330 von Birgit.Tersteegen am 31.07.07 21:44:22I will post vote within seconds of when I hear it - Doubt after Elans last clarification there will be much debate EOM
level 2
racing ahead of stremmer. 18.95 ask on level 2. GO ELAN!!!-BUCKO
racing ahead of stremmer. 18.95 ask on level 2. GO ELAN!!!-BUCKO
The discussion continues. That's the game. Efficacy has been proven.
Must be going well $19.15/19.24
MANNOMETER--bin ich nervös--und die machen einfach ne Pause...
Antwort auf Beitrag Nr.: 30.959.308 von Birgit.Tersteegen am 31.07.07 22:37:55gönn ihnen den keks, wenn sie dann in unserem sinne entscheiden.
Antwort auf Beitrag Nr.: 30.959.545 von GuHu1 am 31.07.07 22:54:57...ich glaub,sie kriegen KEINEN....
JUUUUUUUUUUUUUUUUUUUUHUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUUU
Antwort auf Beitrag Nr.: 30.960.111 von Birgit.Tersteegen am 31.07.07 23:32:2212 YES 3 NO 2 Abstain. Welcome Aboard!!!!
Antwort auf Beitrag Nr.: 30.960.120 von adin am 31.07.07 23:32:57Viele leise Elanianer sind heute abend dabei und drücken
die Daumen. Grüße an Alle die uns auf dem Laufenden halten
Long gesehen, wird es nur aufwärts.
Euer Irlandfreund
die Daumen. Grüße an Alle die uns auf dem Laufenden halten
Long gesehen, wird es nur aufwärts.
Euer Irlandfreund
Antwort auf Beitrag Nr.: 30.960.234 von tame99 am 31.07.07 23:44:04Das freut mich!
US panel backs Biogen, Elan MS drug for Crohn's
US panel backs Biogen, Elan MS drug for Crohn's
Tue Jul 31, 2007 5:39PM EDT
GAITHERSBURG, Md., July 31 (Reuters) - Biogen Idec (BIIB.O: Quote, Profile, Research) and Elan Corp.'s (ELN.I: Quote, Profile, Research) multiple sclerosis drug Tysabri should be approved for treating the bowel disorder Crohn's disease, a U.S. advisory panel said on Tuesday.
The Food and Drug Administration usually follows advisory panel recommendations. A final decision is expected by mid-October.
(Reporting by Lisa Richwine)
US panel backs Biogen, Elan MS drug for Crohn's
US panel backs Biogen, Elan MS drug for Crohn's
Tue Jul 31, 2007 5:39PM EDT
GAITHERSBURG, Md., July 31 (Reuters) - Biogen Idec (BIIB.O: Quote, Profile, Research) and Elan Corp.'s (ELN.I: Quote, Profile, Research) multiple sclerosis drug Tysabri should be approved for treating the bowel disorder Crohn's disease, a U.S. advisory panel said on Tuesday.
The Food and Drug Administration usually follows advisory panel recommendations. A final decision is expected by mid-October.
(Reporting by Lisa Richwine)
Antwort auf Beitrag Nr.: 30.960.234 von tame99 am 31.07.07 23:44:04hallo tame 99,
freue mich von Dir zu hören,
wenn wir elan das nächste mal in Irland besuchen, sollten wir
als Miteigentümer wenigstens eine gute Flasche Whis... für unsere
Überstunden verlangen
liebe Grüsse an alle und bis bald
freue mich von Dir zu hören,
wenn wir elan das nächste mal in Irland besuchen, sollten wir
als Miteigentümer wenigstens eine gute Flasche Whis... für unsere
Überstunden verlangen
liebe Grüsse an alle und bis bald
After Hour Schlusskurs lag bei $19,64 (€14,34)
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
Antwort auf Beitrag Nr.: 30.960.256 von Birgit.Tersteegen am 31.07.07 23:45:59Hallo Biggi,
danke für Deine Durchhaltevermögens und Motivationen hier an Board
http://www.elan.com/News/full.asp?ID=1034453
...........
Joint FDA Advisory Committee Recommends Approval of TYSABRI(R) for the Treatment of Moderate to Severe Crohn's Disease
GAITHERSBURG, Md.--(BUSINESS WIRE)--July 31, 2007--Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 12 in favor to 3 opposed, with 2 abstaining, to recommend approval of TYSABRI(R) (natalizumab) as a treatment for moderate-to-severe Crohn's disease in patients who have failed or cannot tolerate available therapies.
.....
danke für Deine Durchhaltevermögens und Motivationen hier an Board
http://www.elan.com/News/full.asp?ID=1034453
...........
Joint FDA Advisory Committee Recommends Approval of TYSABRI(R) for the Treatment of Moderate to Severe Crohn's Disease
GAITHERSBURG, Md.--(BUSINESS WIRE)--July 31, 2007--Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 12 in favor to 3 opposed, with 2 abstaining, to recommend approval of TYSABRI(R) (natalizumab) as a treatment for moderate-to-severe Crohn's disease in patients who have failed or cannot tolerate available therapies.
.....
Antwort auf Beitrag Nr.: 30.961.035 von Poppholz am 01.08.07 07:13:35aktuell wird der Start in FFM verschlafen.
€13,25 zu €13,45 für die DRX
€13,45 zu €13,86 für die EAN
€13,25 zu €13,45 für die DRX
€13,45 zu €13,86 für die EAN
Antwort auf Beitrag Nr.: 30.962.168 von Poppholz am 01.08.07 09:26:02moin
noch mal 150 zu 13.99 bekommen
gruß Noogmann
noch mal 150 zu 13.99 bekommen
gruß Noogmann
Antwort auf Beitrag Nr.: 30.962.756 von noogmann am 01.08.07 10:00:48Gratuliere.
Vielleicht hast Du somit die letzten Stücke unter der €14,00 bekommen.
Vielleicht hast Du somit die letzten Stücke unter der €14,00 bekommen.
Antwort auf Beitrag Nr.: 30.964.726 von Poppholz am 01.08.07 11:56:57Hat er wohl, der wert nimmt fahrt auf.
In diesem Markt ist unser Schätzchen TOP!!--SONST natürlich auch...und in Zukunft--(NÄCHSTES JAHR mit vielleicht dem 1.wirksamen ALZ-Medikament...)SWIESO)
Antwort auf Beitrag Nr.: 30.965.652 von Birgit.Tersteegen am 01.08.07 13:03:56hi
ELAN CP PLC ADR (NYSE:ELN)
Pre-Market: 20.25 1.52 (8.12%) as of 7:22AM ET on 08/01/07
Last Trade: 18.73
Trade Time: Jul 31
Change: 0.00 (0.00%)
Prev Close: 18.73
Open: N/A
Bid: N/A
Ask: N/A
1y Target Est: 19.28
Day's Range: N/A - N/A
52wk Range: 11.70 - 23.00
Volume: 9,000
Avg Vol (3m): 6,210,920
Market Cap: 8.76B
P/E (ttm): N/A
EPS (ttm): -0.835
Div & Yield: N/A (N/A)
New! Try our new Charts in Beta
1d 5d 3m 6m 1y 2y 5y max
Market Updates Hourly from Fox Business
der wert nimmt fahrt auf
gruss
ELAN CP PLC ADR (NYSE:ELN)
Pre-Market: 20.25 1.52 (8.12%) as of 7:22AM ET on 08/01/07
Last Trade: 18.73
Trade Time: Jul 31
Change: 0.00 (0.00%)
Prev Close: 18.73
Open: N/A
Bid: N/A
Ask: N/A
1y Target Est: 19.28
Day's Range: N/A - N/A
52wk Range: 11.70 - 23.00
Volume: 9,000
Avg Vol (3m): 6,210,920
Market Cap: 8.76B
P/E (ttm): N/A
EPS (ttm): -0.835
Div & Yield: N/A (N/A)
New! Try our new Charts in Beta
1d 5d 3m 6m 1y 2y 5y max
Market Updates Hourly from Fox Business
der wert nimmt fahrt auf
gruss
Antwort auf Beitrag Nr.: 30.966.221 von mmeureka2164 am 01.08.07 13:44:58vorbörslich bereits um die 20$
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
apclrk
Reuters Research - Upgrades Elan From Neutral to Outperform
For those with E-Trade, the TA folks have been very bullish on Elan, the Reuters Research group just upgraded Elan.
Analyst Research
Reuters Research - Upgrades Elan From Neutral to Outperform
For those with E-Trade, the TA folks have been very bullish on Elan, the Reuters Research group just upgraded Elan.
Analyst Research
Antwort auf Beitrag Nr.: 30.967.940 von Birgit.Tersteegen am 01.08.07 15:41:21Dann nix wie raus kann ich dazu nur sagen!
Antwort auf Beitrag Nr.: 30.967.965 von Bonaire am 01.08.07 15:42:38---nee;geht nicht--leide ja an der Elanaktienkaufsucht....
Aber die Jungs von der (hoffentlich vorhandenen:rolleyesPR-Abtg.von Elan waren doch wieder zu :Ofaul :O,eine eigene PR zu der AC-Empfehlung von gestern zu machen....auf ihrer Website befindet sich
nur eine externe von BusinessWire....
Ich würde diese Leute schon vor 2 Jahren gefeuert haben-wegen Dienstverweigerung
Aber die Jungs von der (hoffentlich vorhandenen:rolleyesPR-Abtg.von Elan waren doch wieder zu :Ofaul :O,eine eigene PR zu der AC-Empfehlung von gestern zu machen....auf ihrer Website befindet sich
nur eine externe von BusinessWire....
Ich würde diese Leute schon vor 2 Jahren gefeuert haben-wegen Dienstverweigerung
Was sind das für Kurse?
war das ergebniss schon in den kursen eingepreißt?
schon komisch der verlauf derzeit, hatte mir etwas mehr versprochen.
schon komisch der verlauf derzeit, hatte mir etwas mehr versprochen.
Elan ADR (NYX) Price: 18.24 USD Chg. (in%): -0.49 USD (-2.62%)
Antwort auf Beitrag Nr.: 30.972.214 von GuHu1 am 01.08.07 20:25:38NEIN!Da verkauft jmd 2 Millionen und kauft 3 Millionen billiger zurück--und Naked shorts werden auch dabei sein.
Wenn die Regulatoren der Märkte an solchen Punkten nicht aktiv werden,werden irgendwann die Kleinanleger aus dem Markt verschwunden sein.Denn wenn NUR Manipulation den Preis bestimmt,wer ausser Daytradern will da auf Dauer mitspielen?
Es kauft jetzt z.B. hier kein Kleinanleger, weil er nach gestern diese
Kursbewegung überhaupt NICHT erklären kann und wenn der Preis SO zu manipulieren ist,ist ja auch nicht klar wo dann der Boden ist.
Wenn die Regulatoren der Märkte an solchen Punkten nicht aktiv werden,werden irgendwann die Kleinanleger aus dem Markt verschwunden sein.Denn wenn NUR Manipulation den Preis bestimmt,wer ausser Daytradern will da auf Dauer mitspielen?
Es kauft jetzt z.B. hier kein Kleinanleger, weil er nach gestern diese
Kursbewegung überhaupt NICHT erklären kann und wenn der Preis SO zu manipulieren ist,ist ja auch nicht klar wo dann der Boden ist.
Antwort auf Beitrag Nr.: 30.972.763 von Birgit.Tersteegen am 01.08.07 21:13:06hey birgit,
ich lass mich so schnell nicht verrückt machen.
hoffe nur das du deine 3 mille weiter hälst .
mal im ernst, das mit der mainipuliererei geht mir echt schwer auf die nerven. ich hoffe immer noch das ich dabei bin wenn diese gangster z.b auch bei dndn voll vor die wand fahren.
ich lass mich so schnell nicht verrückt machen.
hoffe nur das du deine 3 mille weiter hälst .
mal im ernst, das mit der mainipuliererei geht mir echt schwer auf die nerven. ich hoffe immer noch das ich dabei bin wenn diese gangster z.b auch bei dndn voll vor die wand fahren.
Antwort auf Beitrag Nr.: 30.972.892 von GuHu1 am 01.08.07 21:22:43Es sind über 6K und ich halte auf alle Fälle (hier passt der Media-Markt-Spruch...Ich bin doch nicht....)
MY SHARES ARE NOT TO SELL!!
MY SHARES ARE NOT TO SELL!!
Wenn der Kurs nicht bald wieder über die 19 kommt dann ist das
extrem Gully für den Chart, meiner Meinung nach.
extrem Gully für den Chart, meiner Meinung nach.
Antwort auf Beitrag Nr.: 30.973.476 von Nostarowie am 01.08.07 21:56:43Nosta---- bitte nur was tröstliches sagen
Wir haben schon wieder gute Nachrichten.....
Msg: 135965 of 135975 8/1/2007 3:55:26 PM
By: donewithpunting
NEWS M J FOX
The Michael J. Fox Foundation for Parkinson's Research Announces $1.2 Million in Funding to Advance Development of Drug Targets for PD
NEW YORK, Aug. 1 /PRNewswire-USNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) announced $1.2 million in total awards to four research teams working to advance potentially disease-modifying therapeutic targets for PD along the drug development pipeline. The funding was awarded under the Novel Approaches to Drug Discovery for Parkinson's Disease program, made possible by generous leadership funding from Elan Corporation, plc (NYSE: ELN), a neuroscience-based biotechnology company.
'For successful translation into real-world PD therapies, early stage therapeutic approaches must be chaperoned through the necessary preclinical and clinical stages of drug development,' said Sarah Orsay, MJFF's CEO. 'The Foundation uses creative strategies to provide the opportunity for researchers working on novel therapeutic strategies to partner with first class, large industry organizations. If projects funded under Novel Approaches to Drug Discovery for Parkinson's Disease warrant further development, Elan has the option to participate more actively and further the progress made by the awardees -- taking us that much closer to our shared goal of delivering new treatments to patients.'
Novel Approaches complements the Foundation's annual Target Validation initiative, whose awardees were announced last month. Whereas the latter program supports initial work to determine the validity of cellular proteins and pathways as potentially promising drug targets, Novel Approaches seeks to push work forward in developing therapies against targets that already have some promising initial data. Both programs provide critical resources for underfunded stages of the drug development process and reflect the Foundation's emphasis on bridging early discovery work and late-stage translational research to reduce industry's risk around investment in new PD therapeutics.
The Novel Approaches program is also an important element of the Foundation's increasing engagement with pharmaceutical and biotech company partners. This engagement is multi-pronged, including not only funding industry researchers under any Foundation initiative, but also working with companies as strategic partners to accelerate the rate at which new PD therapeutics are brought to market. Awardees under Novel Approaches include both academic and industry scientists.
'We are very pleased to work side by side with The Michael J. Fox Foundation in the pursuit of effective treatment options for patients suffering from Parkinson's disease,' said Dale Schenk, PhD, Elan's Chief Scientific Officer. 'We congratulate the awardees and are impressed that the Novel Approaches program has attracted such high-quality proposals for potential treatment of Parkinson's disease. We look forward to working together to move us closer to a therapy that can slow or stop progression of this terrible disease.'
Awardee Asa Abeliovich, PhD, of Columbia University is targeting the autophagy pathway, a cellular pathway involved in clearing away protein such as alpha-synuclein, whose clumping is a hallmark of PD pathology. Disruption of this pathway in animals leads to loss of dopamine neurons. Dr. Abeliovich will test small-molecule drugs that can enhance the autophagy pathway to see if they can reduce deficits seen in animal models.
Neil Howell, PhD, of San Diego-based MIGENIX Corporation will work in rodent models to optimize administration of the compound MX-4565, a non- feminizing estrogen analog that has been shown to be effective in protecting nerve cells from toxic stresses.
Peter Jenner , PhD, of Proximagen Neuroscience in the United Kingdom will investigate the potential of the protein osteopontin (OPN) as a PD treatment. Expression of OPN is decreased in PD, and Dr. Jenner 's team has previously shown that it is neuroprotective for dopaminergic neurons. The researchers will now investigate a gene therapy approach to deliver the protein to the brains of rodent models of Parkinson's using viral vectors.
Pamela Maher , PhD, of the Salk Institute in La Jolla has identified a neuroprotective small molecule called fisetin. At least part of fisetin's neuroprotective effect is due to its ability to maintain levels of glutathione (GSH), a molecule cells produce naturally as a defense against oxidative stress. There is good evidence that GSH levels decrease in PD, and this decrease may contribute to disease progression. Dr. Maher's team will use medicinal chemistry to create fisetin derivatives with improved potency and efficacy, and then will test these derivatives in cell-based and rodent models of PD.
Grant abstracts and researcher bios are available on the Foundation's Web site, http://www.michaeljfox.org. The selection of awardees was made exclusively by the Foundation via its standard peer-review process.
About The Michael J. Fox Foundation
Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within this decade through an aggressively funded research agenda. The Foundation has funded more than $95 million in research to date, either directly or through partnerships.
About Elan
Elan Corporation, plc (NYSE: ELN) 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.
SOURCE Michael J. Fox Foundation
Wir haben schon wieder gute Nachrichten.....
Msg: 135965 of 135975 8/1/2007 3:55:26 PM
By: donewithpunting
NEWS M J FOX
The Michael J. Fox Foundation for Parkinson's Research Announces $1.2 Million in Funding to Advance Development of Drug Targets for PD
NEW YORK, Aug. 1 /PRNewswire-USNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) announced $1.2 million in total awards to four research teams working to advance potentially disease-modifying therapeutic targets for PD along the drug development pipeline. The funding was awarded under the Novel Approaches to Drug Discovery for Parkinson's Disease program, made possible by generous leadership funding from Elan Corporation, plc (NYSE: ELN), a neuroscience-based biotechnology company.
'For successful translation into real-world PD therapies, early stage therapeutic approaches must be chaperoned through the necessary preclinical and clinical stages of drug development,' said Sarah Orsay, MJFF's CEO. 'The Foundation uses creative strategies to provide the opportunity for researchers working on novel therapeutic strategies to partner with first class, large industry organizations. If projects funded under Novel Approaches to Drug Discovery for Parkinson's Disease warrant further development, Elan has the option to participate more actively and further the progress made by the awardees -- taking us that much closer to our shared goal of delivering new treatments to patients.'
Novel Approaches complements the Foundation's annual Target Validation initiative, whose awardees were announced last month. Whereas the latter program supports initial work to determine the validity of cellular proteins and pathways as potentially promising drug targets, Novel Approaches seeks to push work forward in developing therapies against targets that already have some promising initial data. Both programs provide critical resources for underfunded stages of the drug development process and reflect the Foundation's emphasis on bridging early discovery work and late-stage translational research to reduce industry's risk around investment in new PD therapeutics.
The Novel Approaches program is also an important element of the Foundation's increasing engagement with pharmaceutical and biotech company partners. This engagement is multi-pronged, including not only funding industry researchers under any Foundation initiative, but also working with companies as strategic partners to accelerate the rate at which new PD therapeutics are brought to market. Awardees under Novel Approaches include both academic and industry scientists.
'We are very pleased to work side by side with The Michael J. Fox Foundation in the pursuit of effective treatment options for patients suffering from Parkinson's disease,' said Dale Schenk, PhD, Elan's Chief Scientific Officer. 'We congratulate the awardees and are impressed that the Novel Approaches program has attracted such high-quality proposals for potential treatment of Parkinson's disease. We look forward to working together to move us closer to a therapy that can slow or stop progression of this terrible disease.'
Awardee Asa Abeliovich, PhD, of Columbia University is targeting the autophagy pathway, a cellular pathway involved in clearing away protein such as alpha-synuclein, whose clumping is a hallmark of PD pathology. Disruption of this pathway in animals leads to loss of dopamine neurons. Dr. Abeliovich will test small-molecule drugs that can enhance the autophagy pathway to see if they can reduce deficits seen in animal models.
Neil Howell, PhD, of San Diego-based MIGENIX Corporation will work in rodent models to optimize administration of the compound MX-4565, a non- feminizing estrogen analog that has been shown to be effective in protecting nerve cells from toxic stresses.
Peter Jenner , PhD, of Proximagen Neuroscience in the United Kingdom will investigate the potential of the protein osteopontin (OPN) as a PD treatment. Expression of OPN is decreased in PD, and Dr. Jenner 's team has previously shown that it is neuroprotective for dopaminergic neurons. The researchers will now investigate a gene therapy approach to deliver the protein to the brains of rodent models of Parkinson's using viral vectors.
Pamela Maher , PhD, of the Salk Institute in La Jolla has identified a neuroprotective small molecule called fisetin. At least part of fisetin's neuroprotective effect is due to its ability to maintain levels of glutathione (GSH), a molecule cells produce naturally as a defense against oxidative stress. There is good evidence that GSH levels decrease in PD, and this decrease may contribute to disease progression. Dr. Maher's team will use medicinal chemistry to create fisetin derivatives with improved potency and efficacy, and then will test these derivatives in cell-based and rodent models of PD.
Grant abstracts and researcher bios are available on the Foundation's Web site, http://www.michaeljfox.org. The selection of awardees was made exclusively by the Foundation via its standard peer-review process.
About The Michael J. Fox Foundation
Founded in 2000, The Michael J. Fox Foundation for Parkinson's Research is dedicated to ensuring the development of a cure for Parkinson's disease within this decade through an aggressively funded research agenda. The Foundation has funded more than $95 million in research to date, either directly or through partnerships.
About Elan
Elan Corporation, plc (NYSE: ELN) 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.
SOURCE Michael J. Fox Foundation
Antwort auf Beitrag Nr.: 30.973.809 von Birgit.Tersteegen am 01.08.07 22:11:44Ach Biggi scha ma auf den Dow...das is irre in ner letzten halben stunde ham die Amis nen durchknaller gekriegt.
Wenn bei eln manipulation vorliegt was is das dann in dem Käsesammelbecken genannt DOW?
Wenn bei eln manipulation vorliegt was is das dann in dem Käsesammelbecken genannt DOW?
Antwort auf Beitrag Nr.: 30.973.946 von Nostarowie am 01.08.07 22:17:53....ich such mir bald ein anderes Hobby--Makramee oder Segeln
oder GOLF (brrrrrrrrrrhh:laugh
oder GOLF (brrrrrrrrrrhh:laugh
Antwort auf Beitrag Nr.: 30.974.161 von Birgit.Tersteegen am 01.08.07 22:28:10Ja Golf fahrn fetzt
Wist zum kotzen, bin dauernd am einlocken.
Werd aus machen sonst krieg ich Rote Finger.
Wird schon wieder mit dem ganzen Senf
äh Elan....!
Wist zum kotzen, bin dauernd am einlocken.
Werd aus machen sonst krieg ich Rote Finger.
Wird schon wieder mit dem ganzen Senf
äh Elan....!
SENF???????????GOLF FAHREN???????????---Sei nicht so frech
Motley fool on ELN
http://www.fool.com/investing/high-growth/2007/08/01/elan-ge…
Elan Gets a Vote of Confidence
By Brian Lawler August 1, 2007
0 Recommendations
Yesterday Elan (NYSE: ELN) and partner Biogen Idec (Nasdaq: BIIB) got an unexpected boost when an FDA advisory panel recommended that its lead drug Tysabri be approved to treat Crohn's disease.
In a positive 12-3 vote (with two abstaining), the advisory committee recommended that the FDA approve the use of Tysabri as a treatment for Crohn's disease sufferers who aren't responding to other therapies like steroid treatment and possibly biologics such as Johnson and Johnson's (NYSE: JNJ) Remicade or Abbott's (NYSE: ABT) Humira.
Considering the recent negative regulatory decision on the use of Tysabri for Crohn's in the European Union and some of the concerns raised in briefing documents released just before the advisory committee meeting, I was surprised that the panel vote was so positive in favor of Tysabri.
It's important to remember that the FDA doesn't always follow the advice of its advisory panels. For example, earlier in the year Dendreon's (Nasdaq: DNDN) prostate cancer compound received an approvable letter despite a positive advisory panel vote.
It's still too early to know whether this panel vote was as positive as the vote indicates since the FDA has not yet posted a transcript of the meeting on its website. Nonetheless, gaining regulatory approval in the coming months to treat Crohn's disease should provide some modest upside to the 20,000 patients on Tysabri that are expected by the end of the year.
Johnson and Johnson is an Income Investor selection, and Biogen Idec is a Stock Advisor recommendation.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
Motley fool on ELN
http://www.fool.com/investing/high-growth/2007/08/01/elan-ge…
Elan Gets a Vote of Confidence
By Brian Lawler August 1, 2007
0 Recommendations
Yesterday Elan (NYSE: ELN) and partner Biogen Idec (Nasdaq: BIIB) got an unexpected boost when an FDA advisory panel recommended that its lead drug Tysabri be approved to treat Crohn's disease.
In a positive 12-3 vote (with two abstaining), the advisory committee recommended that the FDA approve the use of Tysabri as a treatment for Crohn's disease sufferers who aren't responding to other therapies like steroid treatment and possibly biologics such as Johnson and Johnson's (NYSE: JNJ) Remicade or Abbott's (NYSE: ABT) Humira.
Considering the recent negative regulatory decision on the use of Tysabri for Crohn's in the European Union and some of the concerns raised in briefing documents released just before the advisory committee meeting, I was surprised that the panel vote was so positive in favor of Tysabri.
It's important to remember that the FDA doesn't always follow the advice of its advisory panels. For example, earlier in the year Dendreon's (Nasdaq: DNDN) prostate cancer compound received an approvable letter despite a positive advisory panel vote.
It's still too early to know whether this panel vote was as positive as the vote indicates since the FDA has not yet posted a transcript of the meeting on its website. Nonetheless, gaining regulatory approval in the coming months to treat Crohn's disease should provide some modest upside to the 20,000 patients on Tysabri that are expected by the end of the year.
Johnson and Johnson is an Income Investor selection, and Biogen Idec is a Stock Advisor recommendation.
Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
After Hours Trade Reporting Elan
After Hours
Last: $ 19.04 After Hours
High: $ 19.04
After Hours
Volume: 112,500 After Hours
Low: $ 18.2761
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:44 $ 19.04 37,500
16:35 $ 18.2934 50,000
16:23 $ 18.61 600
16:22 $ 18.55 400
16:22 $ 18.61 200
16:15 $ 18.6957 2,300
16:02 $ 18.2761 21,500
1
After Hours
Last: $ 19.04 After Hours
High: $ 19.04
After Hours
Volume: 112,500 After Hours
Low: $ 18.2761
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:44 $ 19.04 37,500
16:35 $ 18.2934 50,000
16:23 $ 18.61 600
16:22 $ 18.55 400
16:22 $ 18.61 200
16:15 $ 18.6957 2,300
16:02 $ 18.2761 21,500
1
Antwort auf Beitrag Nr.: 30.974.669 von Birgit.Tersteegen am 01.08.07 22:57:57Es wird wieder gut, heute war fast überall rot
Antwort auf Beitrag Nr.: 30.974.800 von surga am 01.08.07 23:06:07...aber bei Elan nach gestern....???Auf alle Fälle hat jmd billige shares eingesackt---jmd der um unsere Perspektive weiss....
Ty jetzt schon bei MS und Chrons;bald auch Krebs,Rheuma,Parkinson??
Posted as a reply to msg 136003 by optimistic_bottom_fisher
When I was in med school
I had saw several patients with crohns and I can recall the big message was that you never want to take a crohns patient to surgery. These poor patient did so poorly after surgery. If you take a histiologic slide of a crohns bowel it usually shows significant inflammation-predominantly T-cells. That is where T comes in it blocks the t-cells from translocating across blood vessels because it blocks a receptor that allows them to cross. Correct me if I am wrong PIN. Same mechanism in Rheumatoid arthritis, similar in cancer the receptor will keep the cancer cells from translocating. See T is a wonderful drug-huge promise. Don't let one day get you down. By the way it only blocks about 78% of the receptors and as the cells die you need to block the new cells.
Ty jetzt schon bei MS und Chrons;bald auch Krebs,Rheuma,Parkinson??
Posted as a reply to msg 136003 by optimistic_bottom_fisher
When I was in med school
I had saw several patients with crohns and I can recall the big message was that you never want to take a crohns patient to surgery. These poor patient did so poorly after surgery. If you take a histiologic slide of a crohns bowel it usually shows significant inflammation-predominantly T-cells. That is where T comes in it blocks the t-cells from translocating across blood vessels because it blocks a receptor that allows them to cross. Correct me if I am wrong PIN. Same mechanism in Rheumatoid arthritis, similar in cancer the receptor will keep the cancer cells from translocating. See T is a wonderful drug-huge promise. Don't let one day get you down. By the way it only blocks about 78% of the receptors and as the cells die you need to block the new cells.
Msg: 136027 of 136032 8/1/2007 5:12:12 PM Recs:
By: doodah95
Things I've learned after a decade of Elan investing....
Things I've learned after a decade as an ELN investor:
1) Despite all fabulous & diligent analyses of very smart people and despite very rational conclusions that ELN shares at any given time are undervalued, an unexpected event can throw everything out the window (see PML/"Black Monday.")
2) The nicest pps pops occur with "surprises" (see Tysabri MS filing based on one-year data, recent AAB developments, etc). By "surprise" I don't mean something that wasn't on anyone's radars as possibilities, just that timing of developments come as a surprise to the market at large (not the savvy IVMB, of course).
3) Short-term pps reactions to certain favorable developments usually lead to intense disappointment, i.e. pps doesn't rise as much as it should or, in some cases, even DROPS(!). However, I note that in many of these cases, there was usually some degree of pps "run-up" leading up to the favorable development in question.
4) Often, the best buying opportunities are NOT in the wake of favorable announcements, but in the wake of FUD-fueled drops in pps. Buying shares when the pps plunged after the recent "liver damage" fears turned out to be smart. So was buying shares after the Boston Globe trumpeted the 4th PML "death." To be sure, only folks savvy enough to recognize the FUD's as such can take advantage of these opportunities. That's when the value of the collective savvy-inducing IVMB expertise really come into play.
5) When it comes to management, investors who are pro-mgmt or mgmt-neutral are a much happier lot than those who are mgmt-critical (note I'm not theorizing who is right or wrong...). This makes sense: the pro-mgmt folks are invested in a company run by a leader they trust to take them to the promised land, while many mgmt-critical folks live in constant anguish that crappy mgmt will destroy the company they've invested in at any time. Perhaps the peace-of-mind provided by a little "Kool-aid drinking" isn't all terrible...(at least if/when Elan reaches the promised land, your blood pressure will be at a level that you can enjoy your investment rewards).
6. Over the long haul, focusing on developments is preferable to focusing on short-term pps movements/reactions (and healthier too!). Yesterday's development of an AC "thumbs-up" on Tysabri for Crohn's is a positive development, despite today's not so impressive pps reaction. If you're a long-term investor, it's just the latest in a line of developments that indicate improvement health/strength of the company. Ultimately, if enough favorable developments occur, no amount of manipulating hedgies, Sliverous analysts, non-proofreading journalists can have any material impact (heck, we may even overcome the jinx of expobear being an ELN long....).
7. Despite imperfections, the Elan cult is a nice cult to belong to.
By: doodah95
Things I've learned after a decade of Elan investing....
Things I've learned after a decade as an ELN investor:
1) Despite all fabulous & diligent analyses of very smart people and despite very rational conclusions that ELN shares at any given time are undervalued, an unexpected event can throw everything out the window (see PML/"Black Monday.")
2) The nicest pps pops occur with "surprises" (see Tysabri MS filing based on one-year data, recent AAB developments, etc). By "surprise" I don't mean something that wasn't on anyone's radars as possibilities, just that timing of developments come as a surprise to the market at large (not the savvy IVMB, of course).
3) Short-term pps reactions to certain favorable developments usually lead to intense disappointment, i.e. pps doesn't rise as much as it should or, in some cases, even DROPS(!). However, I note that in many of these cases, there was usually some degree of pps "run-up" leading up to the favorable development in question.
4) Often, the best buying opportunities are NOT in the wake of favorable announcements, but in the wake of FUD-fueled drops in pps. Buying shares when the pps plunged after the recent "liver damage" fears turned out to be smart. So was buying shares after the Boston Globe trumpeted the 4th PML "death." To be sure, only folks savvy enough to recognize the FUD's as such can take advantage of these opportunities. That's when the value of the collective savvy-inducing IVMB expertise really come into play.
5) When it comes to management, investors who are pro-mgmt or mgmt-neutral are a much happier lot than those who are mgmt-critical (note I'm not theorizing who is right or wrong...). This makes sense: the pro-mgmt folks are invested in a company run by a leader they trust to take them to the promised land, while many mgmt-critical folks live in constant anguish that crappy mgmt will destroy the company they've invested in at any time. Perhaps the peace-of-mind provided by a little "Kool-aid drinking" isn't all terrible...(at least if/when Elan reaches the promised land, your blood pressure will be at a level that you can enjoy your investment rewards).
6. Over the long haul, focusing on developments is preferable to focusing on short-term pps movements/reactions (and healthier too!). Yesterday's development of an AC "thumbs-up" on Tysabri for Crohn's is a positive development, despite today's not so impressive pps reaction. If you're a long-term investor, it's just the latest in a line of developments that indicate improvement health/strength of the company. Ultimately, if enough favorable developments occur, no amount of manipulating hedgies, Sliverous analysts, non-proofreading journalists can have any material impact (heck, we may even overcome the jinx of expobear being an ELN long....).
7. Despite imperfections, the Elan cult is a nice cult to belong to.
Antwort auf Beitrag Nr.: 30.975.099 von Birgit.Tersteegen am 01.08.07 23:28:35nah dann, geduld und der richtige riecher.
Antwort auf Beitrag Nr.: 30.975.276 von GuHu1 am 01.08.07 23:44:23Geduld haben die meisten hier im Thread schon seit vielen Monaten bewiesen.
Dies wird sich auch in den nächsten Monaten nicht ändern.
Dies wird sich auch in den nächsten Monaten nicht ändern.
Poppi, was heißt hier Monate...
Der Tag wird kommen... und wir kommen jeden Tag einen Tag näher.
posimist
Der Tag wird kommen... und wir kommen jeden Tag einen Tag näher.
posimist
@ Elanites und Elaniacs
..einfach mal ein paar sonnige und windige Gruesse aus NL...
bernie55
..einfach mal ein paar sonnige und windige Gruesse aus NL...
bernie55
Antwort auf Beitrag Nr.: 30.983.733 von bernie55 am 02.08.07 13:48:39
Na ist doch alles Bambule.
Hauptsache es bleibt über $19 und ist nicht nur dem fake gestern bei den Indis geschuldet.
Am ende war es gar kein fake und die Rally geht weiter.....
Hauptsache es bleibt über $19 und ist nicht nur dem fake gestern bei den Indis geschuldet.
Am ende war es gar kein fake und die Rally geht weiter.....
After Hours Trade Reporting
After Hours
Last: $ 19.30 After Hours
High: $ 19.3501
After Hours
Volume: 23,100 After Hours
Low: $ 19.1796
After Hours
Last: $ 19.30 After Hours
High: $ 19.3501
After Hours
Volume: 23,100 After Hours
Low: $ 19.1796
Antwort auf Beitrag Nr.: 30.995.051 von Birgit.Tersteegen am 02.08.07 22:54:38
eigentlich macht es doch immer wieder Freude, unserem Baby beim wachsen zuzusehen.
eigentlich macht es doch immer wieder Freude, unserem Baby beim wachsen zuzusehen.
Antwort auf Beitrag Nr.: 30.999.370 von Poppholz am 03.08.07 09:48:50...der Kleine ist ja süüüss!
Antwort auf Beitrag Nr.: 31.002.473 von Birgit.Tersteegen am 03.08.07 12:31:02und wenn er noch ein wenig gewachsen ist, dann wartet er nur auf seinen Befehl, dass der Kurs rauf gehen soll.
Vielleicht hast Du somit die letzten Stücke unter der €14,00 bekommen.
und nun mußte ich noch welche für 13.69 einsacken
Noogmann
und nun mußte ich noch welche für 13.69 einsacken
Noogmann
Antwort auf Beitrag Nr.: 31.005.267 von noogmann am 03.08.07 15:22:19wie es scheint wärst du da auch preiswerter rangekommen.
die 19$ sind auch am wanken.
schon ein eigenartiges verhalten was der wert hier an den tag legt, besonders nach der positiven news.
die 19$ sind auch am wanken.
schon ein eigenartiges verhalten was der wert hier an den tag legt, besonders nach der positiven news.
Antwort auf Beitrag Nr.: 31.007.229 von GuHu1 am 03.08.07 16:49:45wie es scheint wärst du da auch preiswerter rangekommen
da haste recht aber wann ist der richtige zeitpunkt
noogmann
da haste recht aber wann ist der richtige zeitpunkt
noogmann
Antwort auf Beitrag Nr.: 31.007.229 von GuHu1 am 03.08.07 16:49:45verrückte Kurse gehören zu Elan;unser Schätzchen liebt halt die Überraschungen---hat nichts zu sagen...
By: formerlyjt
Gee...
Begin the week at 19, go down into the 16's on false rumour FUD,back to 19 before AC vote, down 10 cents after positive AC vote, three days later on Friday (infamous three day rule), we finish the week down 40-50 cents despite the AC approval for Ty-Crohn's. But don't be bothered by this or the fact we are down twenty percent from recent highs, just look at it as another buying opportunity. Regards, JT
____________________________________________________________________
Cool + strong Our shares are not to sell!
By: formerlyjt
Gee...
Begin the week at 19, go down into the 16's on false rumour FUD,back to 19 before AC vote, down 10 cents after positive AC vote, three days later on Friday (infamous three day rule), we finish the week down 40-50 cents despite the AC approval for Ty-Crohn's. But don't be bothered by this or the fact we are down twenty percent from recent highs, just look at it as another buying opportunity. Regards, JT
____________________________________________________________________
Cool + strong Our shares are not to sell!
Schönes WE,Ihr Lieben....habe "sturmfrei":Kind in HH,Mann in CH und ich geh´mal aus.....---unser Schätzchen bei 19$;könnte in DIESEM Markt auch schlechter sein...Ciao!Birgit
Antwort auf Beitrag Nr.: 31.007.355 von noogmann am 03.08.07 16:55:27da haste recht aber wann ist der richtige zeitpunkt
klar weiß man das vorher nicht, ist doch auch kein vorwurf.
wenn du vom wert überzeugt bist ok.
ich bin jedenfalls über den kursverlauf schon etwas verblüfft.
klar weiß man das vorher nicht, ist doch auch kein vorwurf.
wenn du vom wert überzeugt bist ok.
ich bin jedenfalls über den kursverlauf schon etwas verblüfft.
Antwort auf Beitrag Nr.: 31.014.117 von GuHu1 am 03.08.07 21:59:01gewöhn Dich dran.
Elan hat den Vorteil, dass hier "echte" Zukunftspläne geschmiedet werden und nicht alles auf einer Luftnummer aufgebaut ist.
Der Kurs ist allerdings schon immer irrational gewesen.
(aus diesem Grunde sind wir "Alt-Longies" auch nicht so scharf auf SUPER-NEWS)
Elan hat den Vorteil, dass hier "echte" Zukunftspläne geschmiedet werden und nicht alles auf einer Luftnummer aufgebaut ist.
Der Kurs ist allerdings schon immer irrational gewesen.
(aus diesem Grunde sind wir "Alt-Longies" auch nicht so scharf auf SUPER-NEWS)
Antwort auf Beitrag Nr.: 31.015.199 von Poppholz am 03.08.07 22:37:55na ja ich werde ja derzeit trainiert gelle.
was sagst du zu cramer?
was sagst du zu cramer?
Antwort auf Beitrag Nr.: 31.015.199 von Poppholz am 03.08.07 22:37:55Elan hat den Vorteil, dass hier "echte" Zukunftspläne geschmiedet werden und nicht alles auf einer Luftnummer aufgebaut ist.
das ist aber eine gewagte aussage!
ob das alles wie geplant läuft bleibt erstmal reine spekulation.
ich glaube auch daran, sehe die möglichkeiten, bleibe aber immer vorsichtig.
das ist aber eine gewagte aussage!
ob das alles wie geplant läuft bleibt erstmal reine spekulation.
ich glaube auch daran, sehe die möglichkeiten, bleibe aber immer vorsichtig.
Antwort auf Beitrag Nr.: 31.014.117 von GuHu1 am 03.08.07 21:59:01Moin
klar weiß man das vorher nicht, ist doch auch kein vorwurf.
so habe ich es auch nicht verstanden
wenn du vom wert überzeugt bist ok.jaaaaaaaaaaaaaaaaaaaaa
Gruß Noogmann
klar weiß man das vorher nicht, ist doch auch kein vorwurf.
so habe ich es auch nicht verstanden
wenn du vom wert überzeugt bist ok.jaaaaaaaaaaaaaaaaaaaaa
Gruß Noogmann
Moin---ohhh,verkatert....:O
Von unserem Hexchen vom Nachbarthread
Cyberhexe 04.08.07 10:50:08
...Elans Technologien werden in den F&E-Abteilungen von Pharmaschwergewichten eingesetzt. Es scheint nur eine Frage der Zeit zu sein, bis sich dieser Eisberg auch in den Zahlen niederschlägt.
Oryx Pharmaceuticals announces launch of NAPRELAN(TM)
MISSISSAUGA, ON, July 16 /CNW/ - Oryx Pharmaceuticals Inc. (Oryx) is
pleased to announce the introduction of prescription NAPRELAN(TM) tablets (naproxen sodium tablets) for the management of the signs and symptoms of osteoarthritis and rheumatoid arthritis.
NAPRELAN(TM) is a novel, controlled-release formulation of naproxen sodium, developed by Elan Corporation plc. It uses Elan's Intestinal Protective Drug Absorption System (IPDAS(TM) Technology), which is designed to provide rapid attainment of effective plasma concentrations and to maintain therapeutic concentrations over a 24-hour period. NAPRELAN(TM) was developed
in an attempt to reduce the impact on the mucosa of the stomach and duodenum compared with standard naproxen formulations.
http://www.newswire.ca/en/releases/archive/July2007/16/c6478…
Von unserem Hexchen vom Nachbarthread
Cyberhexe 04.08.07 10:50:08
...Elans Technologien werden in den F&E-Abteilungen von Pharmaschwergewichten eingesetzt. Es scheint nur eine Frage der Zeit zu sein, bis sich dieser Eisberg auch in den Zahlen niederschlägt.
Oryx Pharmaceuticals announces launch of NAPRELAN(TM)
MISSISSAUGA, ON, July 16 /CNW/ - Oryx Pharmaceuticals Inc. (Oryx) is
pleased to announce the introduction of prescription NAPRELAN(TM) tablets (naproxen sodium tablets) for the management of the signs and symptoms of osteoarthritis and rheumatoid arthritis.
NAPRELAN(TM) is a novel, controlled-release formulation of naproxen sodium, developed by Elan Corporation plc. It uses Elan's Intestinal Protective Drug Absorption System (IPDAS(TM) Technology), which is designed to provide rapid attainment of effective plasma concentrations and to maintain therapeutic concentrations over a 24-hour period. NAPRELAN(TM) was developed
in an attempt to reduce the impact on the mucosa of the stomach and duodenum compared with standard naproxen formulations.
http://www.newswire.ca/en/releases/archive/July2007/16/c6478…
Msg: 137194 of 137252 8/5/2007 11:40:58 AM Recs: 41 Sentiment: Strong Buy
By: elmer92692
Only The Lonely......
As we approach an important time in Elan's evolution, I believe Charles T. Munger (Warren Buffett's partner) says it best.....
"Our experience tends to confirm a long-held notion that being prepared, on a few occasions in a lifetime, to act promptly in scale, in doing some simple and logical thing, will often dramatically improve the financial results of that lifetime.
"A few major opportunities, clearly recognizable as such, will usually come to one who continuously searches and waits, with a curious mind that loves to diagnosis involving multiple variables.
"And then all that is required is a willingness to bet heavily when the odds are extremely favorable, using resources available as a result of prudence and patience in the past."
The above quotation has been a cornerstone of my investment philosphy. Elan is, and has always been, the ticket I was looking for. Now we wait. Cheers
By: elmer92692
Only The Lonely......
As we approach an important time in Elan's evolution, I believe Charles T. Munger (Warren Buffett's partner) says it best.....
"Our experience tends to confirm a long-held notion that being prepared, on a few occasions in a lifetime, to act promptly in scale, in doing some simple and logical thing, will often dramatically improve the financial results of that lifetime.
"A few major opportunities, clearly recognizable as such, will usually come to one who continuously searches and waits, with a curious mind that loves to diagnosis involving multiple variables.
"And then all that is required is a willingness to bet heavily when the odds are extremely favorable, using resources available as a result of prudence and patience in the past."
The above quotation has been a cornerstone of my investment philosphy. Elan is, and has always been, the ticket I was looking for. Now we wait. Cheers
By: ridge303 Send PM Profile Ignore Recommend Add To Favorites
Pssst ...
Just got an e-mail from a good friend, very trustworthy.
He was at dinner last night and met an Irish couple.
She is a neurologist in some clinic -
they are screening people for ph.3
part from the e-mail:
"Noch ganz kurz - ich habe gestern Abend ein Irisches Ehepaar kennengelernt
Sie ist Neurologin in irgend einer Klinik und sagte, dass in der Klinik momentan
Leute fuer die 3 Phase AAB ausgesucht werden. "
Email this page to a friend
Pssst ...
Just got an e-mail from a good friend, very trustworthy.
He was at dinner last night and met an Irish couple.
She is a neurologist in some clinic -
they are screening people for ph.3
part from the e-mail:
"Noch ganz kurz - ich habe gestern Abend ein Irisches Ehepaar kennengelernt
Sie ist Neurologin in irgend einer Klinik und sagte, dass in der Klinik momentan
Leute fuer die 3 Phase AAB ausgesucht werden. "
Email this page to a friend
Antwort auf Beitrag Nr.: 31.015.377 von GuHu1 am 03.08.07 22:45:03Kann ich leider nicht so richtig einschätzen.
Ty 1 yr anniversary (article)
Tysabri® Celebrates One-Year Anniversary As A Treatment For Multiple Sclerosis
06 Aug 2007
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced the one-year anniversary of TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). One year following its return to market in the US and introduction in the European Union, the companies estimate that as of mid-July 2007 in both commercial use and clinical trials approximately 14,000 patients are currently on TYSABRI therapy worldwide.
As of mid-July 2007:
-- In the US, over 8,600 patients are on TYSABRI commercially and over 1,800 physicians have prescribed the therapy;
-- In the EU, over 4,300 patients are on TYSABRI therapy commercially; and
-- In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.
"Over the past year I have seen my patients benefit greatly from TYSABRI. As expected from clinical trials, TYSABRI is having a positive impact on their lives. The compelling efficacy of TYSABRI offers MS patients hope in the management of their disease," said Dr. Howard Rossman, Medical Director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Michigan, and Clinical Professor of Neurology at Michigan State University. "Increased experience with TYSABRI will continue to inform us and contribute to our understanding of the important role of this therapy for people living with MS."
"TYSABRI has had an incredible effect, and the improvements I have experienced are very real. I understand there are important risks to this therapy, but the benefits of TYSABRI were far too important for my family and me to overlook," said TYSABRI patient, Mike Lynch.
In July 2006, TYSABRI was reintroduced in the US under the TOUCH Prescribing Program, a restricted distribution program, and was also introduced in the EU under a risk management plan. These programs were developed due to the increased risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.
Tysabri® Celebrates One-Year Anniversary As A Treatment For Multiple Sclerosis
06 Aug 2007
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced the one-year anniversary of TYSABRI® (natalizumab) as a treatment for relapsing forms of multiple sclerosis (MS). One year following its return to market in the US and introduction in the European Union, the companies estimate that as of mid-July 2007 in both commercial use and clinical trials approximately 14,000 patients are currently on TYSABRI therapy worldwide.
As of mid-July 2007:
-- In the US, over 8,600 patients are on TYSABRI commercially and over 1,800 physicians have prescribed the therapy;
-- In the EU, over 4,300 patients are on TYSABRI therapy commercially; and
-- In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.
"Over the past year I have seen my patients benefit greatly from TYSABRI. As expected from clinical trials, TYSABRI is having a positive impact on their lives. The compelling efficacy of TYSABRI offers MS patients hope in the management of their disease," said Dr. Howard Rossman, Medical Director, MS Center, Michigan Institute for Neurological Disorders in Farmington Hills, Michigan, and Clinical Professor of Neurology at Michigan State University. "Increased experience with TYSABRI will continue to inform us and contribute to our understanding of the important role of this therapy for people living with MS."
"TYSABRI has had an incredible effect, and the improvements I have experienced are very real. I understand there are important risks to this therapy, but the benefits of TYSABRI were far too important for my family and me to overlook," said TYSABRI patient, Mike Lynch.
In July 2006, TYSABRI was reintroduced in the US under the TOUCH Prescribing Program, a restricted distribution program, and was also introduced in the EU under a risk management plan. These programs were developed due to the increased risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability.
Elan out of San Diego
Aug. 4--Irish drug maker Elan Pharmaceuticals plans to close its San Diego offices and consolidate some positions in South San Francisco as part of an effort to trim costs and regain profitability.
Elan has operated in San Diego since 2000, when it established itself as a significant player in the biotechnology hub by paying $1.8 billion for Dura Pharmaceuticals, a company with 400 employees. At the time, it was the second-largest biotech acquisition ever in San Diego.
Through the ensuing years, however, Elan has struggled and the staff in San Diego has felt the effects. Last year Elan eliminated 107 San Diego jobs, but did not say how many were left.
The number of positions affected in the shutdown could not be determined yesterday, but a company spokesman said they include research and development, legal and administrative jobs. Elan employs 1,734 people worldwide.
"The main factors for consolidation include continued progress in the immune therapy programs, commitment to a return to profitability and the recent extension of the lease at the Oyster Point facility in South San Francisco," said Jonathan Birt, a company spokesman.
"This is not about job losses, but about consolidating jobs. There will be some relocation," he said.
The company has not said when it will close the San Diego office because it is still having discussions with its employees, he said.
Last week, the Dublin-based company said its quarterly losses widened to $141.1 million, or 30 cents a share, from $90.5 million, or 21 cents a share a year earlier. A major portion of the loss was related to the one-time write down of Maxipime, a pneumonia drug that Elan acquired with Dura, after the U.S. Food and Drug Administration approved a generic version earlier than anticipated.
The company said it expects the San Diego closure and the consolidation in South San Francisco to cost $50 million.
Elan and Biogen Idec, which also has a San Diego unit, are co-developers of the multiple sclerosis drug Tysabri. This week, a Food and Drug Administration advisory panel recommended the FDA approve Tysabri for the treatment of moderate to severe Crohn's disease, a chronic ailment of the gastrointestinal system.
In San Diego, most of the research work is on other neurodegenerative disease therapies, including the company's experimental products for Alzheimer's disease.
To see more of The San Diego Union-Tribune, or to subscribe to the newspaper, go to http://www.uniontrib.com.
Copyright (c) 2007, The San Diego Union-Tribune
Aug. 4--Irish drug maker Elan Pharmaceuticals plans to close its San Diego offices and consolidate some positions in South San Francisco as part of an effort to trim costs and regain profitability.
Elan has operated in San Diego since 2000, when it established itself as a significant player in the biotechnology hub by paying $1.8 billion for Dura Pharmaceuticals, a company with 400 employees. At the time, it was the second-largest biotech acquisition ever in San Diego.
Through the ensuing years, however, Elan has struggled and the staff in San Diego has felt the effects. Last year Elan eliminated 107 San Diego jobs, but did not say how many were left.
The number of positions affected in the shutdown could not be determined yesterday, but a company spokesman said they include research and development, legal and administrative jobs. Elan employs 1,734 people worldwide.
"The main factors for consolidation include continued progress in the immune therapy programs, commitment to a return to profitability and the recent extension of the lease at the Oyster Point facility in South San Francisco," said Jonathan Birt, a company spokesman.
"This is not about job losses, but about consolidating jobs. There will be some relocation," he said.
The company has not said when it will close the San Diego office because it is still having discussions with its employees, he said.
Last week, the Dublin-based company said its quarterly losses widened to $141.1 million, or 30 cents a share, from $90.5 million, or 21 cents a share a year earlier. A major portion of the loss was related to the one-time write down of Maxipime, a pneumonia drug that Elan acquired with Dura, after the U.S. Food and Drug Administration approved a generic version earlier than anticipated.
The company said it expects the San Diego closure and the consolidation in South San Francisco to cost $50 million.
Elan and Biogen Idec, which also has a San Diego unit, are co-developers of the multiple sclerosis drug Tysabri. This week, a Food and Drug Administration advisory panel recommended the FDA approve Tysabri for the treatment of moderate to severe Crohn's disease, a chronic ailment of the gastrointestinal system.
In San Diego, most of the research work is on other neurodegenerative disease therapies, including the company's experimental products for Alzheimer's disease.
To see more of The San Diego Union-Tribune, or to subscribe to the newspaper, go to http://www.uniontrib.com.
Copyright (c) 2007, The San Diego Union-Tribune
By: herdsmangs
Glaucoma Story Getting More Press
http://www.guardian.co.uk/science/2007/aug/07/3
New Alzheimer's drugs might help prevent glaucoma
* Ian Sample, science correspondent
* The Guardian
* Tuesday August 7 2007
Drugs being developed to treat Alzheimer's disease might help prevent one of the most common causes of blindness, according to research published yesterday.
British eye specialists have shown for the first time that nerve-destroying proteins linked to Alzheimer's play a key role in glaucoma which can cause irreversible blindness and affects over half a million people in the UK. The discovery suggests Alzheimer's and glaucoma are triggered by a similar process in nerve cells.
Scientists at the Institute of Ophthalmology at University College London have conducted successful trials in which animals with glaucoma were treated with drugs intended to prevent proteins called beta amyloid building up in the brain. A small-scale trial in humans is set to go ahead later this year or early in 2008.
The link between the two diseases suggests glaucoma may be used as an early warning sign of future Alzheimer's, and monitoring the health of nerves in the eyes could help gauge if an Alzheimer's patient is responding to treatment. Glaucoma is associated with abnormally high pressure in the eye, which causes damage to the optic nerve. Treatment focuses on reducing pressure, but up to a third of sufferers continue to suffer loss of vision even after pressure returns to normal.
The UCL team, led by Francesca Cordeiro, used a new technique to highlight retinal nerve cells damaged by glaucoma, and found that a build-up of beta amyloid proteins was often to blame.
Tests in rats revealed that administering a drug called Bapineuzumab, which is undergoing clinical trials for Alzheimer's, stopped the proteins building up, they report in the Proceedings of the National Academy of Sciences.
Glaucoma Story Getting More Press
http://www.guardian.co.uk/science/2007/aug/07/3
New Alzheimer's drugs might help prevent glaucoma
* Ian Sample, science correspondent
* The Guardian
* Tuesday August 7 2007
Drugs being developed to treat Alzheimer's disease might help prevent one of the most common causes of blindness, according to research published yesterday.
British eye specialists have shown for the first time that nerve-destroying proteins linked to Alzheimer's play a key role in glaucoma which can cause irreversible blindness and affects over half a million people in the UK. The discovery suggests Alzheimer's and glaucoma are triggered by a similar process in nerve cells.
Scientists at the Institute of Ophthalmology at University College London have conducted successful trials in which animals with glaucoma were treated with drugs intended to prevent proteins called beta amyloid building up in the brain. A small-scale trial in humans is set to go ahead later this year or early in 2008.
The link between the two diseases suggests glaucoma may be used as an early warning sign of future Alzheimer's, and monitoring the health of nerves in the eyes could help gauge if an Alzheimer's patient is responding to treatment. Glaucoma is associated with abnormally high pressure in the eye, which causes damage to the optic nerve. Treatment focuses on reducing pressure, but up to a third of sufferers continue to suffer loss of vision even after pressure returns to normal.
The UCL team, led by Francesca Cordeiro, used a new technique to highlight retinal nerve cells damaged by glaucoma, and found that a build-up of beta amyloid proteins was often to blame.
Tests in rats revealed that administering a drug called Bapineuzumab, which is undergoing clinical trials for Alzheimer's, stopped the proteins building up, they report in the Proceedings of the National Academy of Sciences.
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Researchers show Alzheimer's, Glaucoma link
Mon Aug 6, 2007 5:05PM EDT
By Michael Kahn
LONDON (Reuters) - A protein that damages tissue in the brains of Alzheimer's patients is also the main cause of blindness worldwide, British researchers said in a new finding that may lead to better treatment for both diseases.
In a study published in the U.S. journal, Proceedings of the National Academy of Sciences, on Monday the scientists said the same protein, beta-amyloid, which plays a key role in the brain-wasting illness also causes nerve cell damage in the eye from blindness-inducing glaucoma.
Recent studies have suggested connections between Alzheimer's and glaucoma and the new finding bolsters that evidence, said Francesca Cordeiro, a glaucoma specialist at London's University College and leader of the study.
"This is the first time anybody has provided evidence that the same protein in Alzheimer's causes retinal nerve cell loss," she said in a telephone interview.
Scientists do not know what causes glaucoma which affects some 65 million people worldwide.
Most treatments seek to lower the build-up in pressure from fluids in the eye, but the treatment does not work for as many as 30 percent of glaucoma patients, Cordeiro said.
She hoped the study of laboratory rats would lead to an alternative treatment for humans one day.
After the team identified the protein link between the two diseases, they administered a combination of experimental Alzheimer's drugs to laboratory rats, Cordeiro said.
The drugs stopped nerve cell death in rats with glaucoma and suggested that using more than one therapy at a time could also prove effective for treating Alzheimer's, Cordeiro added.
"In Alzheimer's when you treat a patient you give them one drug that works on one protein," she said. "If you combine treatments you might have a better way of achieving your goal."
One of the drugs -- Bapineuzumab -- is already used in clinical trials and Cordeiro said it could be available within a few years. Bapineuzumab is made by Ireland's Elan Corp and its U.S. partner, Wyeth.
She also said the technology used in the research to examine nerve cell damage in the eye caused by the build-up of proteins gave doctors one more tool to detect Alzheimer's disease.
"The eye is an extension of the brain and we often forget that," she said. "This work emphasizes it is the only organ in the body you can look through and it is a tool people can use to look into the brain."
der Kurs sieht auch schon ganz gut aus.
USA über $19,00
Europa orientiert sich recht schnell.
(ungewöhnlich)
Vielleicht wird dies heut ja noch ein besonders schöner Tag.
USA über $19,00
Europa orientiert sich recht schnell.
(ungewöhnlich)
Vielleicht wird dies heut ja noch ein besonders schöner Tag.
Antwort auf Beitrag Nr.: 31.064.014 von Poppholz am 07.08.07 14:18:47wird aber bis 15:30 Uhr bestimmt wieder nach unten gedrückt.
dpa-afx
Hugin-News: BB BIOTECH AG
Dienstag 7. August 2007, 07:31 Uhr
Halbjahresbericht per 30. Juni 2007
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin. Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
----------------------------------------------------------------------
--------------
Gutes Halbjahresresultat dank hervorragender klinischer Ergebnisse
Das langfristige solide Wachstum der Biotechnologie-Branche setzte sich auch im ersten Halbjahr 2007 fort. Viele Unternehmen konnten über sehr gute Verkaufszahlen und beeindruckende Ergebnisse klinischer Studien berichten. Gleichzeitig hatten jedoch einige wenige Unternehmen mit Rückschlägen Anzeige
zu kämpfen. Insbesondere Amgen, eines der grössten und ältesten Unternehmen der Industrie, sah sich mit verschiedenen neuen Herausforderungen konfrontiert. Dies hatte Auswirkungen auf die allgemeine Wahrnehmung der Biotechnologie in den Finanzmärkten.
Der Aktienkurs von BB BIOTECH (BIO.SW - Nachrichten) legte im Vergleich zum Jahresbeginn um 6.2% zu (einschliesslich Dividende) und schloss bei CHF 97.50. Diese Wertsteigerung im ersten Halbjahr 2007 war im Einklang mit der Entwicklung des Marktes.
Unsere Kernbeteiligung Gilead erzielte mit ihrem Blockbuster-Medikament Atripla Rekordumsätze. Atripla verbindet hervorragende Wirksamkeit mit geringen Nebenwirkungen und einer patientenfreundlichen Darreichungsform. Zusätzlich erhielt Gilead am 15. Juni von der US-amerikanischen Arzneimittelbehörde FDA die Marktzulassung für das neue Medikament Letairis. Nach dem Produkt Tracleer von Actelion (ATLN.SW - Nachrichten) ist Letairis der zweite zugelassene Endothelin-Rezeptor-Antagonist zur Behandlung der pulmonalen arteriellen Hypertonie (PAH). Letairis wird insbesondere für die beschränkte Zahl von Patienten, die nicht gut auf Tracleer ansprechen, von Bedeutung sein. Wir gehen davon aus, dass Actelions Tracleer aufgrund seiner nachhaltigen Wirksamkeit, bei gleichzeitig guter Verträglichkeit, weiterhin das Medikament der Wahl für die PAH-Behandlung bleiben wird.
Unsere Kernbeteiligung Celgene stellte ausserordentlich überzeugende klinische Resultate des Medikaments Revlimid bei Multiplem Myelom und verschiedenen anderen Tumoren vor. Dies bestärkt uns in unserer Einschätzung, dass Revlimid einen wichtigen medizinischen Durchbruch darstellt. Celgene (NASDAQ: CELG - Nachrichten) gab ausserdem positive klinische Ergebnisse von seinem Forschungsprojekt CC-10004 bekannt, welches das erste in Tablettenform verabreichbare Medikament gegen verschiedene Autoimmunerkrankungen werden könnte, bei dem eine gute Wirksamkeit mit einem günstigen Nebenwirkungsprofil einhergeht.
Unser Portfoliounternehmen Elan Pharmaceuticals berichtete über gute Fortschritte seines Programms zur Entwicklung eines Medikaments gegen Alzheimer. Gemeinsam mit dem Partner Wyeth entschied Elan (Dublin: DRX.IR - Nachrichten) , die Phase III der klinischen Entwicklung des Antikörpers AAB-001 einzuleiten. Diese Entscheidung beruhte auf einer vorläufigen Prüfung der laufenden Phase-II-Studie. Wenn die klinischen Studien weiterhin positive Ergebnisse liefern, könnte AAB (Kopenhagen: AABB.CO - Nachrichten) -001 das erste Therapeutikum werden, welches das Fortschreiten der Alzheimer-Krankheit stoppt. Tysabri, der zweite potenzielle Blockbuster von Elan, das im dritten Quartal 2006 erneut auf den Markt gebracht wurde, überzeugt weiterhin Ärzte und Patienten. Das Medikament gegen Multiple Sklerose verfügt über eine einzigartige Wirksamkeit. Darüber hinaus sind seit der erneuten Markteinführung im letzten Jahr keine schwerwiegenden Nebenwirkungen mehr aufgetreten. Wir sind mehr denn je überzeugt, dass sich Tysabri zum Medikament der Wahl gegen Multiple Sklerose entwickeln wird. Ausserdem erwarten wir, dass Tysabri im zweiten Halbjahr 2007 für die Behandlung von Morbus Crohn zugelassen wird.
Unsere Beteiligungen an Elan Pharmaceuticals und Vertex Pharmaceuticals (NASDAQ: VRTX - Nachrichten) wurden deutlich aufgestockt. Ausserdem erwarben wir neue Beteiligungen an NicOx (Paris: FR0000074130 - Nachrichten) , Optimer Pharmaceuticals und Jerini (Xetra: 678747 - Nachrichten) .
Für die zweite Hälfte des Jahres erwarten wir mehrere neue Ergebnisse klinischer Studien von unseren Portfoliounternehmen wie Actelion und Vertex. Diese Resultate sollten in Kombination mit den sehr attraktiven Unternehmensbewertungen zu einem erneuten Interesse der Finanzmärkte an Biotechnologie führen.
Das Portfolio der BB BIOTECH setzt sich per 30. Juni 2007 prozentual wie folgt zusammen:
KERNBETEILIGUNGEN Actelion 21.7% Celgene 17.2% Gilead 11.6% Genentech (NYSE: DNA - Nachrichten) 10.4% Biogen Idec (NASDAQ: BIIB - Nachrichten) 7.6%
KLEINERE BETEILIGUNGEN Vertex Pharmaceuticals 6.0% Elan 5.0% Roche Holding GS 4.3% Genzyme (NASDAQ: GENZ - Nachrichten) 3.4% Affymetrix (NASDAQ: AFFX - Nachrichten) 2.3% Basilea Pharmaceutica (BSLN.SW - Nachrichten) 2.0% Zymogenetics (ZGEN - Nachrichten) 2.0% Amgen (NASDAQ: AMGN - Nachrichten) 1.3% BioXell (BXLN.SW - Nachrichten) 0.9% NicOx 0.8% The Medicines Company (NASDAQ: MDCO - Nachrichten) 0.6% Arena Pharmaceuticals (ARNA - Nachrichten) 0.5% Jerini 0.5% Keryx Biopharmaceuticals (KERX - Nachrichten) 0.4% Rigel Pharmaceuticals (RIGL - Nachrichten) 0.4% Incyte 0.3% Epigenomics (Xetra: A0BVT9 - Nachrichten) 0.2% Optimer Pharmaceuticals 0.2%
Basilea Pharmaceutica Call Optionen (short) (0.1%) SWAP Agreement auf eigene Aktien 0.5%
Total Wertschriften CHF 2 658 Mio. Eigene Aktien (in % der Gesellschaft) 9.2% Flüssige Mittel (netto) CHF (339.2) Mio. Übrige Aktiven 26.5 Mio. Andere Verbindlichkeiten CHF (118.5) Mio.
Der vollständige Halbjahresbericht ist auf www.bbbiotech.com verfügbar.
Für weitere Informationen: Bellevue Asset Management AG, Seestrasse 16, 8700 Küsnacht, Schweiz Anja Stubenrauch, Tel. +41 44 267 67 00
--- 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 ASA 2007. All rights reserved.
http://de.biz.yahoo.com/07082007/36/hugin-news-bb-biotech-ag…
Hugin-News: BB BIOTECH AG
Dienstag 7. August 2007, 07:31 Uhr
Halbjahresbericht per 30. Juni 2007
Corporate news- Mitteilung verarbeitet und übermittelt durch Hugin. Für den Inhalt der Mitteilung ist der Emittent verantwortlich.
----------------------------------------------------------------------
--------------
Gutes Halbjahresresultat dank hervorragender klinischer Ergebnisse
Das langfristige solide Wachstum der Biotechnologie-Branche setzte sich auch im ersten Halbjahr 2007 fort. Viele Unternehmen konnten über sehr gute Verkaufszahlen und beeindruckende Ergebnisse klinischer Studien berichten. Gleichzeitig hatten jedoch einige wenige Unternehmen mit Rückschlägen Anzeige
zu kämpfen. Insbesondere Amgen, eines der grössten und ältesten Unternehmen der Industrie, sah sich mit verschiedenen neuen Herausforderungen konfrontiert. Dies hatte Auswirkungen auf die allgemeine Wahrnehmung der Biotechnologie in den Finanzmärkten.
Der Aktienkurs von BB BIOTECH (BIO.SW - Nachrichten) legte im Vergleich zum Jahresbeginn um 6.2% zu (einschliesslich Dividende) und schloss bei CHF 97.50. Diese Wertsteigerung im ersten Halbjahr 2007 war im Einklang mit der Entwicklung des Marktes.
Unsere Kernbeteiligung Gilead erzielte mit ihrem Blockbuster-Medikament Atripla Rekordumsätze. Atripla verbindet hervorragende Wirksamkeit mit geringen Nebenwirkungen und einer patientenfreundlichen Darreichungsform. Zusätzlich erhielt Gilead am 15. Juni von der US-amerikanischen Arzneimittelbehörde FDA die Marktzulassung für das neue Medikament Letairis. Nach dem Produkt Tracleer von Actelion (ATLN.SW - Nachrichten) ist Letairis der zweite zugelassene Endothelin-Rezeptor-Antagonist zur Behandlung der pulmonalen arteriellen Hypertonie (PAH). Letairis wird insbesondere für die beschränkte Zahl von Patienten, die nicht gut auf Tracleer ansprechen, von Bedeutung sein. Wir gehen davon aus, dass Actelions Tracleer aufgrund seiner nachhaltigen Wirksamkeit, bei gleichzeitig guter Verträglichkeit, weiterhin das Medikament der Wahl für die PAH-Behandlung bleiben wird.
Unsere Kernbeteiligung Celgene stellte ausserordentlich überzeugende klinische Resultate des Medikaments Revlimid bei Multiplem Myelom und verschiedenen anderen Tumoren vor. Dies bestärkt uns in unserer Einschätzung, dass Revlimid einen wichtigen medizinischen Durchbruch darstellt. Celgene (NASDAQ: CELG - Nachrichten) gab ausserdem positive klinische Ergebnisse von seinem Forschungsprojekt CC-10004 bekannt, welches das erste in Tablettenform verabreichbare Medikament gegen verschiedene Autoimmunerkrankungen werden könnte, bei dem eine gute Wirksamkeit mit einem günstigen Nebenwirkungsprofil einhergeht.
Unser Portfoliounternehmen Elan Pharmaceuticals berichtete über gute Fortschritte seines Programms zur Entwicklung eines Medikaments gegen Alzheimer. Gemeinsam mit dem Partner Wyeth entschied Elan (Dublin: DRX.IR - Nachrichten) , die Phase III der klinischen Entwicklung des Antikörpers AAB-001 einzuleiten. Diese Entscheidung beruhte auf einer vorläufigen Prüfung der laufenden Phase-II-Studie. Wenn die klinischen Studien weiterhin positive Ergebnisse liefern, könnte AAB (Kopenhagen: AABB.CO - Nachrichten) -001 das erste Therapeutikum werden, welches das Fortschreiten der Alzheimer-Krankheit stoppt. Tysabri, der zweite potenzielle Blockbuster von Elan, das im dritten Quartal 2006 erneut auf den Markt gebracht wurde, überzeugt weiterhin Ärzte und Patienten. Das Medikament gegen Multiple Sklerose verfügt über eine einzigartige Wirksamkeit. Darüber hinaus sind seit der erneuten Markteinführung im letzten Jahr keine schwerwiegenden Nebenwirkungen mehr aufgetreten. Wir sind mehr denn je überzeugt, dass sich Tysabri zum Medikament der Wahl gegen Multiple Sklerose entwickeln wird. Ausserdem erwarten wir, dass Tysabri im zweiten Halbjahr 2007 für die Behandlung von Morbus Crohn zugelassen wird.
Unsere Beteiligungen an Elan Pharmaceuticals und Vertex Pharmaceuticals (NASDAQ: VRTX - Nachrichten) wurden deutlich aufgestockt. Ausserdem erwarben wir neue Beteiligungen an NicOx (Paris: FR0000074130 - Nachrichten) , Optimer Pharmaceuticals und Jerini (Xetra: 678747 - Nachrichten) .
Für die zweite Hälfte des Jahres erwarten wir mehrere neue Ergebnisse klinischer Studien von unseren Portfoliounternehmen wie Actelion und Vertex. Diese Resultate sollten in Kombination mit den sehr attraktiven Unternehmensbewertungen zu einem erneuten Interesse der Finanzmärkte an Biotechnologie führen.
Das Portfolio der BB BIOTECH setzt sich per 30. Juni 2007 prozentual wie folgt zusammen:
KERNBETEILIGUNGEN Actelion 21.7% Celgene 17.2% Gilead 11.6% Genentech (NYSE: DNA - Nachrichten) 10.4% Biogen Idec (NASDAQ: BIIB - Nachrichten) 7.6%
KLEINERE BETEILIGUNGEN Vertex Pharmaceuticals 6.0% Elan 5.0% Roche Holding GS 4.3% Genzyme (NASDAQ: GENZ - Nachrichten) 3.4% Affymetrix (NASDAQ: AFFX - Nachrichten) 2.3% Basilea Pharmaceutica (BSLN.SW - Nachrichten) 2.0% Zymogenetics (ZGEN - Nachrichten) 2.0% Amgen (NASDAQ: AMGN - Nachrichten) 1.3% BioXell (BXLN.SW - Nachrichten) 0.9% NicOx 0.8% The Medicines Company (NASDAQ: MDCO - Nachrichten) 0.6% Arena Pharmaceuticals (ARNA - Nachrichten) 0.5% Jerini 0.5% Keryx Biopharmaceuticals (KERX - Nachrichten) 0.4% Rigel Pharmaceuticals (RIGL - Nachrichten) 0.4% Incyte 0.3% Epigenomics (Xetra: A0BVT9 - Nachrichten) 0.2% Optimer Pharmaceuticals 0.2%
Basilea Pharmaceutica Call Optionen (short) (0.1%) SWAP Agreement auf eigene Aktien 0.5%
Total Wertschriften CHF 2 658 Mio. Eigene Aktien (in % der Gesellschaft) 9.2% Flüssige Mittel (netto) CHF (339.2) Mio. Übrige Aktiven 26.5 Mio. Andere Verbindlichkeiten CHF (118.5) Mio.
Der vollständige Halbjahresbericht ist auf www.bbbiotech.com verfügbar.
Für weitere Informationen: Bellevue Asset Management AG, Seestrasse 16, 8700 Küsnacht, Schweiz Anja Stubenrauch, Tel. +41 44 267 67 00
--- 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 ASA 2007. All rights reserved.
http://de.biz.yahoo.com/07082007/36/hugin-news-bb-biotech-ag…
Kursverlauf ist wie erwartet von statten gegangen.
Nachdem wir vorbörslich bei $19,10 gestanden haben wurde der Kurs ab 15:30 Uhr nach unten gedrückt (bis $18,61).
Anschließend ist die Aktie schön nach oben gelaufen und hat bei $19,41 ihr Tageshoch verzeichnet.
Die Kursdrückerei wurde anschließend wieder verstärkt betrieben, so dass wir letztendlich einen Schlusskurs von $19,19 (+2,72%) erreicht haben.
Alles in allem ein guter Tag, ohne große Überraschungen.
Nachdem wir vorbörslich bei $19,10 gestanden haben wurde der Kurs ab 15:30 Uhr nach unten gedrückt (bis $18,61).
Anschließend ist die Aktie schön nach oben gelaufen und hat bei $19,41 ihr Tageshoch verzeichnet.
Die Kursdrückerei wurde anschließend wieder verstärkt betrieben, so dass wir letztendlich einen Schlusskurs von $19,19 (+2,72%) erreicht haben.
Alles in allem ein guter Tag, ohne große Überraschungen.
Short Interest
| Full listShort Interest Date:Jul 10 2007
Short Interest Shares:19,208,933
Short Interest Ratio:4.2
Float:n/a
Short Interest as a % of Float:n/a
Average Daily Volume:4,620,100
Outstanding Shares:466,800,000
Am 10. Juli hatten waren 4,2% der Aktien short.
http://money.cnn.com/quote/quote.html?symb=ELN
(wie viele es heute wohl sind?)
| Full listShort Interest Date:Jul 10 2007
Short Interest Shares:19,208,933
Short Interest Ratio:4.2
Float:n/a
Short Interest as a % of Float:n/a
Average Daily Volume:4,620,100
Outstanding Shares:466,800,000
Am 10. Juli hatten waren 4,2% der Aktien short.
http://money.cnn.com/quote/quote.html?symb=ELN
(wie viele es heute wohl sind?)
Mologen springt auch wieder an, kommt die Zeit für Biotechs?!
Evening Herald today.
Under the ‘IN BRIEF’ section on page 17 of today’s edition of the Evening Herald, the following small section appears.
“
NEW DRUG OFFERS DUAL ILLNESS HOPE.
A drug being developed in Ireland for the treatment of Alzheimer’s sufferers will also offer new hope to those who suffer from glaucoma, according to scientists.
Bapineuzumab is a type of antibody designed to enhance the body’s own immune response.
“
Peadar ‘Og
Under the ‘IN BRIEF’ section on page 17 of today’s edition of the Evening Herald, the following small section appears.
“
NEW DRUG OFFERS DUAL ILLNESS HOPE.
A drug being developed in Ireland for the treatment of Alzheimer’s sufferers will also offer new hope to those who suffer from glaucoma, according to scientists.
Bapineuzumab is a type of antibody designed to enhance the body’s own immune response.
“
Peadar ‘Og
heute wieder über 2% im Plus.
So kann es noch einige Wochen weiter gehen.
So kann es noch einige Wochen weiter gehen.
schöner Start heute morgen.
Auf der Insel sind wir schon mit 7% im Plus.
Rechnerisch auf den Schlusskurs in USA sollten wir bei €14,20 liegen. London liegt aktuell bei €14,80 und Irland bei €14,75.
Normalerweise sind die nicht so "mutig" da drüben.
Mal sehen was heute noch passiert.
Auf der Insel sind wir schon mit 7% im Plus.
Rechnerisch auf den Schlusskurs in USA sollten wir bei €14,20 liegen. London liegt aktuell bei €14,80 und Irland bei €14,75.
Normalerweise sind die nicht so "mutig" da drüben.
Mal sehen was heute noch passiert.
Antwort auf Beitrag Nr.: 31.091.148 von Poppholz am 09.08.07 10:14:27Gerüchte munkeln es gäbe Montag gute News.....
Antwort auf Beitrag Nr.: 31.092.092 von Birgit.Tersteegen am 09.08.07 11:10:10dann sollten wir am Freitag aussteigen.
(gute News -> Kurs geht runter)
(gute News -> Kurs geht runter)
Antwort auf Beitrag Nr.: 31.092.145 von Poppholz am 09.08.07 11:13:24...Poppi--wir steigen bei 100$ aus im nächsten Jahr....
Antwort auf Beitrag Nr.: 31.092.469 von Birgit.Tersteegen am 09.08.07 11:31:51stimmt, wir sind ja keine Zocker, sondern eher die konservativen LONGIES.
Antwort auf Beitrag Nr.: 31.093.040 von Poppholz am 09.08.07 12:07:36Auf alle Fälle bei DIESEM Wert
Davy: Lars move for personal reasons; No replacement
President of R&D at Elan, Lars Ekman, will transition from his current operational position to a more strategic role over the remainder of 2007. He will continue to chair the Science and Technology Committee and will continue to co-chair the Joint Steering Committee with Wyeth. He will primarily provide strategic insight and input to the chairman and CEO.
We understand that his decision is purely for personal reasons. The transition is expected to be seamless. No direct replacement will be made. Instead, the three reporting heads (of research, development and the CSO) will now report directly to CEO Kelly Martin.
-------ob,wenn er dann etwas mehr Überblick hat,mal die PR-Abtg. feuert??-------------------------
President of R&D at Elan, Lars Ekman, will transition from his current operational position to a more strategic role over the remainder of 2007. He will continue to chair the Science and Technology Committee and will continue to co-chair the Joint Steering Committee with Wyeth. He will primarily provide strategic insight and input to the chairman and CEO.
We understand that his decision is purely for personal reasons. The transition is expected to be seamless. No direct replacement will be made. Instead, the three reporting heads (of research, development and the CSO) will now report directly to CEO Kelly Martin.
-------ob,wenn er dann etwas mehr Überblick hat,mal die PR-Abtg. feuert??-------------------------
Ekman transitioning to BOD
http://biz.yahoo.com/bw/070809/20070808005887.html?.v=1
Dr. Lars Ekman, President of Research and Development, Transitions to Board of Director Role
Thursday August 9, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Dr. Lars Ekman, currently President of Research and Development at Elan, member of the Operating Committee and the Board of Directors, will transition from his current operational role to become an advisor as a member of the Board of Directors effective December 31, 2007.
ADVERTISEMENT
Dr. Ekman will continue to chair the Science and Technology Committee, which has as its charter to provide long-term strategic guidance and input to the Chairman and CEO on matters relating to Elan's research platform and portfolio. Other board members of the Science and Technology Committee include Dr. Dennis Selkoe and Dr. Floyd Bloom.
During his transition through year-end, Dr. Ekman will remain an integral part of the company's science, clinical development and corporate activities and will continue as key senior spokesperson for Elan as President of Research and Development. Dr. Ekman will continue as co-chair on the Joint Steering Committee with Wyeth. As the year progresses, Dr. Ekman's focus and energies will shift toward Elan's intermediate and long-term plans as he dedicates his time to provide strategic advice to the Chairman and the CEO in his continuing role as a member of the Board of Directors.
Dr. Ekman joined Elan in January 2001 after holding a number of senior executive positions in the pharmaceutical industry. His leadership over the past seven years has been instrumental in advancing Elan's pipeline. During this period, Elan received approval for four U.S. New Drug Applications; three European Marketing Approval Applications; and five Investigational New Drug Applications. These efforts resulted in bringing to market PRIALT and TYSABRI, innovative drugs that are addressing patients' unmet needs and significant progress was achieved in several of Elan's Alzheimer's Immunotherapy Programs.
Reflecting on his transition, Dr. Ekman said, "After nearly twenty-five years in multiple senior operational roles, I look forward to devoting my time and energy to tackling broader strategic issues. As a Board member and Chairman of the Science and Technology Committee, I will have the forum to do so. We have made great advancements in our pipeline and I look forward to continuing to be intimately involved in the coming years."
Commenting on Dr. Ekman's contribution to Elan, Mr. Kyran McLaughlin, Chairman of the Board, stated, "Lars has been an invaluable member of Elan's management team. We are delighted and fortunate to have Lars remain on our Board, and we look forward to his continued guidance, support and leadership as we move this company forward."
Mr. Kelly Martin, President & CEO, added, "Lars is a truly unique individual and his contribution to Elan has and will continue to be immeasurable. I have the highest degree of respect and admiration for Lars from both a professional as well as personal point of view. I look forward to working closely with Lars as a member of the Board for years to come."
About Elan
Elan Corporation, plc (NYSE: ELN - News) 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.
http://biz.yahoo.com/bw/070809/20070808005887.html?.v=1
Dr. Lars Ekman, President of Research and Development, Transitions to Board of Director Role
Thursday August 9, 2:00 am ET
DUBLIN, Ireland--(BUSINESS WIRE)--Dr. Lars Ekman, currently President of Research and Development at Elan, member of the Operating Committee and the Board of Directors, will transition from his current operational role to become an advisor as a member of the Board of Directors effective December 31, 2007.
ADVERTISEMENT
Dr. Ekman will continue to chair the Science and Technology Committee, which has as its charter to provide long-term strategic guidance and input to the Chairman and CEO on matters relating to Elan's research platform and portfolio. Other board members of the Science and Technology Committee include Dr. Dennis Selkoe and Dr. Floyd Bloom.
During his transition through year-end, Dr. Ekman will remain an integral part of the company's science, clinical development and corporate activities and will continue as key senior spokesperson for Elan as President of Research and Development. Dr. Ekman will continue as co-chair on the Joint Steering Committee with Wyeth. As the year progresses, Dr. Ekman's focus and energies will shift toward Elan's intermediate and long-term plans as he dedicates his time to provide strategic advice to the Chairman and the CEO in his continuing role as a member of the Board of Directors.
Dr. Ekman joined Elan in January 2001 after holding a number of senior executive positions in the pharmaceutical industry. His leadership over the past seven years has been instrumental in advancing Elan's pipeline. During this period, Elan received approval for four U.S. New Drug Applications; three European Marketing Approval Applications; and five Investigational New Drug Applications. These efforts resulted in bringing to market PRIALT and TYSABRI, innovative drugs that are addressing patients' unmet needs and significant progress was achieved in several of Elan's Alzheimer's Immunotherapy Programs.
Reflecting on his transition, Dr. Ekman said, "After nearly twenty-five years in multiple senior operational roles, I look forward to devoting my time and energy to tackling broader strategic issues. As a Board member and Chairman of the Science and Technology Committee, I will have the forum to do so. We have made great advancements in our pipeline and I look forward to continuing to be intimately involved in the coming years."
Commenting on Dr. Ekman's contribution to Elan, Mr. Kyran McLaughlin, Chairman of the Board, stated, "Lars has been an invaluable member of Elan's management team. We are delighted and fortunate to have Lars remain on our Board, and we look forward to his continued guidance, support and leadership as we move this company forward."
Mr. Kelly Martin, President & CEO, added, "Lars is a truly unique individual and his contribution to Elan has and will continue to be immeasurable. I have the highest degree of respect and admiration for Lars from both a professional as well as personal point of view. I look forward to working closely with Lars as a member of the Board for years to come."
About Elan
Elan Corporation, plc (NYSE: ELN - News) 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.
new News
Press Release Source: Commonwealth Biotechnologies, Inc. (CBI)
Tripos Discovery Research, Ltd., a Subsidiary of Commonwealth Biotechnologies, Inc., Signs Library Analysis Agreement with Elan Pharmaceuticals, Inc.
Thursday August 9, 9:00 am ET
RICHMOND, Va. & BUDE, England--(BUSINESS WIRE)--Tripos Discovery Research Limited (TDR), a wholly owned subsidiary within the Commonwealth Biotechnologies, Inc. (CBI) group of companies (NASDAQ Capital Market:CBTE), announced today that it has entered into a Master Service Agreement with Elan Pharmaceuticals, Inc. to assist in analyzing and enhancing the diversity of its corporate small molecule screening collection.
ADVERTISEMENT
Under the terms of the agreement, TDR shall provide its computational design expertise to perform an analysis on the Elan screening collection of small molecule compounds to perform computational clustering of key subsets and determine optimal areas for expansion. Additionally, TDR shall provide high throughput quality control analyses of legacy compounds via mass spectrometry.
Commenting on the agreement, Paul D'Sylva CEO of CBI, stated, "This announcement is evidence of another leading pharmaceutical company demonstrating its confidence in TDR and the global reach of our services and products. TDR has been providing world-class computational analysis, design expertise and compound screening enhancement services to many leading pharmaceutical companies over the past ten years. Corporate small molecule collections are key assets for pharmaceutical companies, and Elan's investment in this project is testimony to its desire to ensure that it has an optimal collection to maximize its return from screening of disease targets and minimize time-wasting false positives. We are privileged to be working with Elan."
About Tripos Discovery Research Limited
Press Release Source: Commonwealth Biotechnologies, Inc. (CBI)
Tripos Discovery Research, Ltd., a Subsidiary of Commonwealth Biotechnologies, Inc., Signs Library Analysis Agreement with Elan Pharmaceuticals, Inc.
Thursday August 9, 9:00 am ET
RICHMOND, Va. & BUDE, England--(BUSINESS WIRE)--Tripos Discovery Research Limited (TDR), a wholly owned subsidiary within the Commonwealth Biotechnologies, Inc. (CBI) group of companies (NASDAQ Capital Market:CBTE), announced today that it has entered into a Master Service Agreement with Elan Pharmaceuticals, Inc. to assist in analyzing and enhancing the diversity of its corporate small molecule screening collection.
ADVERTISEMENT
Under the terms of the agreement, TDR shall provide its computational design expertise to perform an analysis on the Elan screening collection of small molecule compounds to perform computational clustering of key subsets and determine optimal areas for expansion. Additionally, TDR shall provide high throughput quality control analyses of legacy compounds via mass spectrometry.
Commenting on the agreement, Paul D'Sylva CEO of CBI, stated, "This announcement is evidence of another leading pharmaceutical company demonstrating its confidence in TDR and the global reach of our services and products. TDR has been providing world-class computational analysis, design expertise and compound screening enhancement services to many leading pharmaceutical companies over the past ten years. Corporate small molecule collections are key assets for pharmaceutical companies, and Elan's investment in this project is testimony to its desire to ensure that it has an optimal collection to maximize its return from screening of disease targets and minimize time-wasting false positives. We are privileged to be working with Elan."
About Tripos Discovery Research Limited
JIPIEEEEEEEEEEEEEEEEEEEEEEEEEEEE
Antwort auf Beitrag Nr.: 30.939.482 von Birgit.Tersteegen am 30.07.07 17:22:51@Birgit und alle
Yepp, ich bin immer noch im Urlaub und wuerde gerne vor Ort sein...aber es geht leider nicht.....
...also haltet die Stellung .....
Viele Gruesse
bernie55
Yepp, ich bin immer noch im Urlaub und wuerde gerne vor Ort sein...aber es geht leider nicht.....
...also haltet die Stellung .....
Viele Gruesse
bernie55
Antwort auf Beitrag Nr.: 31.097.481 von bernie55 am 09.08.07 16:17:45Grüss das Meer von mir! ----------20,20$
Antwort auf Beitrag Nr.: 31.097.589 von Birgit.Tersteegen am 09.08.07 16:22:50..mach ich....bis bald...
Antwort auf Beitrag Nr.: 31.097.997 von bernie55 am 09.08.07 16:42:16...Ende August - Anfang September..
...zwischendurch aus NL....
...zwischendurch aus NL....
Antwort auf Beitrag Nr.: 31.098.034 von bernie55 am 09.08.07 16:43:47...dass diese Therapeuten immer so viel Urlaub haben...
@ Birgit: Waren das die guten News, die gerüchteweise am Montag kommen sollten oder ist das heute (im Vergleich zu den News am Montag) eher "unspektakulär" gewesen?
gute News und anschließend steigende Kurse haben wir bei unserem Baby auf jeden Fall lange nicht mehr so deutlich gesehen.
na mal sehen wie lange die euphorie anhält.
das liest sich ja nicht schlecht, das muss dem baby wohl nur noch das laufen lehren.
ich will mal nicht nur maulen $20,40.
das liest sich ja nicht schlecht, das muss dem baby wohl nur noch das laufen lehren.
ich will mal nicht nur maulen $20,40.
da hat wohl jemand etwas gegen einen Schlusskurs von über $20,- gehabt.
Ordentlich Stücke auf den Markt geworfen und in der letzten Stunde den Kurs um 40 Cent gedrückt.
Dann warten wir mal weiter ab, was uns die nächsten Tage bringen werden.
(wünsche allen eine angenehme Nacht)
Ordentlich Stücke auf den Markt geworfen und in der letzten Stunde den Kurs um 40 Cent gedrückt.
Dann warten wir mal weiter ab, was uns die nächsten Tage bringen werden.
(wünsche allen eine angenehme Nacht)
Antwort auf Beitrag Nr.: 31.099.499 von Poppholz am 09.08.07 18:00:36...habe leider auch keine Ahnung.Vielleicht kommt die konkrete Ansage der Phase3??Aber SO eine Performance in DIESEM Markt ist doch irre,oder?
sah doch so gut aus
Antwort auf Beitrag Nr.: 31.107.479 von GuHu1 am 10.08.07 00:08:382% (gerundet) plus haben wir ja auch am gestrigen Tag gemacht.
Lieber jeden Tag 2% hoch als ständig hin und her.
Lieber jeden Tag 2% hoch als ständig hin und her.
Goodbody: Elan pipeline development a continuous process
Elan (Add, Closing Price $19.91); Pipeline development a continuous process.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Tripos Discovery Ltd, a wholly owned subsidiary of Commonwealth Biotechnologies Inc, this morning announced an agreement with Elan in which it will use its computation design technology to analyse Elan’s screening collection of small molecule compounds for potential candidates for further development. This is the type of service required at the very early stages of compound and molecule screening. Evidence of such agreements is a reminder that while looking to commercialise its latest drug on the market (Tysabri) and bring its most advanced candidate drugs (e.g. AAB-001, ACC-001 and ELND-005) through the regulatory process, Elan continues to search for new compounds to develop, a process which can take eight to ten years.
Elan (Add, Closing Price $19.91); Pipeline development a continuous process.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Tripos Discovery Ltd, a wholly owned subsidiary of Commonwealth Biotechnologies Inc, this morning announced an agreement with Elan in which it will use its computation design technology to analyse Elan’s screening collection of small molecule compounds for potential candidates for further development. This is the type of service required at the very early stages of compound and molecule screening. Evidence of such agreements is a reminder that while looking to commercialise its latest drug on the market (Tysabri) and bring its most advanced candidate drugs (e.g. AAB-001, ACC-001 and ELND-005) through the regulatory process, Elan continues to search for new compounds to develop, a process which can take eight to ten years.
Hi Ihr
Elan scheint sich schon auf die Alzheimer-Medikament-Vermarktung vorzubereiten.... ALLES WIRD GUUUUUUUUUUUUT
By: lndmvr
Strategic Marketing Alzheimer's Disease
This sounds great.
Also sounds like sooner rather than later.
If a Sub-E is around the corner, I'd be bringing this individual into the fold now too.
Sorry if posted already.
Job Title: Senior Director/Team leader - Strategic Marketing Alzheimer's Disease
Req #: 5170901
Location: New York NY
At Elan, we hold a fundamental belief that our science has the potential to improve patients' lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.
Elan's commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.
Primary Objective of Position:
Leader of US Alzheimer's program marketing team ' responsible for all aspects of US commercial planning for new immuno-therapeutics within the Elan-Wyeth Partnership. Located in New York. 3-4 direct reports overtime.
Major Duties and Responsibilities:
-US Team Leader of Alzheimer's program marketing team ' oversees preparation market development activities, and eventual introduction of a breakthrough biologic therapy, with potential to change the treatment paradigm for Alzheimer's disease.
-Guide preparation and efficient execution of a comprehensive US anticipated launch strategy for a new bio-therapeutic.
-Co-lead the AIP Alliance marketing working group with responsibility to ensure that all market development and promotional efforts are strategically sound, efficient, and based upon rigorous analytics.
-Secure senior leadership endorsement of launch plans and resourcing to maximize product value generation for Elan/Wyeth.
-Support a strong Alliance partnership through frequent communication, and respectful representation of Elan interests with designated counterparts at Wyeth.
-Provide strong customer insights on the US Neurodegeneration market to support Elan drug Discovery and Development efforts.
-Contribute to the development of operating excellence within the Elan Neurodegeneration commercial group by maintaining high standards of professionalism, and active contribution increase the organizational effectiveness of the group.
Minimum Job Qualifications:
B.S. Degree as minimum. Graduate level academic attainment in Science or Business Administration preferred.
Skills and Abilities:
-Results-oriented marketing professional with 10+ years experience and technical capability in developing global strategy and operational marketing in Specialty Neuro-science and/or Bio-therapeutics (Oncology/Immunology, Virology).
-Evidenced leadership skills in managing a high performance team to successful launch of a revolutionary new therapeutic.
-Depth of experience to provide insightful, and innovative strategic thinking across the US pharmaceutical commercialization spectrum including: professional, consumer, and managed markets customers.
-Excellent written, and oral communications skills, with demonstrated ability to influence and guide execution of winning brand plans, and secure endorsement of plans by Senior Leadership.
-Ability to align across the organization and Alliance partner (Wyeth), to gain support from peer group leaders in key functions, to mobilize the Elan/Wyeth organization for a successful launch.
-Team-oriented approach to delivering business results in a manner which exemplifies the highest standards of business ethics and respect for people.
-Ability to assimilate highly scientific information and interact comfortably with thought leaders in Alzheimer's disease and Immunotherapeutics.
Elan scheint sich schon auf die Alzheimer-Medikament-Vermarktung vorzubereiten.... ALLES WIRD GUUUUUUUUUUUUT
By: lndmvr
Strategic Marketing Alzheimer's Disease
This sounds great.
Also sounds like sooner rather than later.
If a Sub-E is around the corner, I'd be bringing this individual into the fold now too.
Sorry if posted already.
Job Title: Senior Director/Team leader - Strategic Marketing Alzheimer's Disease
Req #: 5170901
Location: New York NY
At Elan, we hold a fundamental belief that our science has the potential to improve patients' lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.
Elan's commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.
Primary Objective of Position:
Leader of US Alzheimer's program marketing team ' responsible for all aspects of US commercial planning for new immuno-therapeutics within the Elan-Wyeth Partnership. Located in New York. 3-4 direct reports overtime.
Major Duties and Responsibilities:
-US Team Leader of Alzheimer's program marketing team ' oversees preparation market development activities, and eventual introduction of a breakthrough biologic therapy, with potential to change the treatment paradigm for Alzheimer's disease.
-Guide preparation and efficient execution of a comprehensive US anticipated launch strategy for a new bio-therapeutic.
-Co-lead the AIP Alliance marketing working group with responsibility to ensure that all market development and promotional efforts are strategically sound, efficient, and based upon rigorous analytics.
-Secure senior leadership endorsement of launch plans and resourcing to maximize product value generation for Elan/Wyeth.
-Support a strong Alliance partnership through frequent communication, and respectful representation of Elan interests with designated counterparts at Wyeth.
-Provide strong customer insights on the US Neurodegeneration market to support Elan drug Discovery and Development efforts.
-Contribute to the development of operating excellence within the Elan Neurodegeneration commercial group by maintaining high standards of professionalism, and active contribution increase the organizational effectiveness of the group.
Minimum Job Qualifications:
B.S. Degree as minimum. Graduate level academic attainment in Science or Business Administration preferred.
Skills and Abilities:
-Results-oriented marketing professional with 10+ years experience and technical capability in developing global strategy and operational marketing in Specialty Neuro-science and/or Bio-therapeutics (Oncology/Immunology, Virology).
-Evidenced leadership skills in managing a high performance team to successful launch of a revolutionary new therapeutic.
-Depth of experience to provide insightful, and innovative strategic thinking across the US pharmaceutical commercialization spectrum including: professional, consumer, and managed markets customers.
-Excellent written, and oral communications skills, with demonstrated ability to influence and guide execution of winning brand plans, and secure endorsement of plans by Senior Leadership.
-Ability to align across the organization and Alliance partner (Wyeth), to gain support from peer group leaders in key functions, to mobilize the Elan/Wyeth organization for a successful launch.
-Team-oriented approach to delivering business results in a manner which exemplifies the highest standards of business ethics and respect for people.
-Ability to assimilate highly scientific information and interact comfortably with thought leaders in Alzheimer's disease and Immunotherapeutics.
Antwort auf Beitrag Nr.: 31.114.118 von Birgit.Tersteegen am 10.08.07 14:10:53Leute einstellen ist immer gut.
der Kurs wird mit aller Gewalt unten gehalten.
Vorhin war ein 11.000 Block in den ASK geschmissen worden und das zu 10 bis 15 Cent unter dem derzeitigen Gleichgewichtspreis.
Laufen demnächst größere Mengen an Optionen aus oder sind die nicht an feste Termine gebunden?
Anscheinend möchten einige nicht, dass der Kurs über die $20,00 steigt.
Vorhin war ein 11.000 Block in den ASK geschmissen worden und das zu 10 bis 15 Cent unter dem derzeitigen Gleichgewichtspreis.
Laufen demnächst größere Mengen an Optionen aus oder sind die nicht an feste Termine gebunden?
Anscheinend möchten einige nicht, dass der Kurs über die $20,00 steigt.
Antwort auf Beitrag Nr.: 31.114.118 von Birgit.Tersteegen am 10.08.07 14:10:53
August 7, 2007, 5:01 pm
Old Drug Takes New Turn in Alzheimer’s Test
Posted by Scott Hensley
http://blogs.wsj.com/health/2007/08/07/old-drug-takes-new-tu…
August 7, 2007, 5:01 pm
Old Drug Takes New Turn in Alzheimer’s Test
Posted by Scott Hensley
http://blogs.wsj.com/health/2007/08/07/old-drug-takes-new-tu…
Antwort auf Beitrag Nr.: 31.121.039 von surga am 10.08.07 20:42:19
Some News for Monday Morning - Aug 13 Los Angelos Times, Health Section - Chron's - Relief in sight?
http://www.latimes.com/features/health/la-he-lab13aug13,1,14…
Relief in sight?
People with Crohn's disease, an inflammation of the bowel, live with embarrassment, pain and surgery. Two new drugs may soon help.
By Amber Dance, Los Angeles Times Staff Writer
August 13, 2007
The gnarled lines across his abdomen are the mementos of three major surgeries on his digestive system. The slashes along each side are reminders of the time the stitches broke and the doctors put him into a drug-induced coma for seven weeks, keeping his abdomen open for repeated washes. The doctors made the slits so that they would have enough skin to stretch over the opening when they finally sewed him together.
Gray, 46, was diagnosed 24 years ago with Crohn's disease, a chronic inflammation of the bowel and intestines that afflicts nearly 1 million people worldwide. Crohn's patients suffer from diarrhea and abdominal pain, and 80% will eventually face the surgeon's knife to remove damaged portions of bowel.
Gray, who lives in Long Beach, is nearly 6 feet tall but weighs only 125 pounds -- yet his situation is better than it used to be. Lately, scientific research has started catching up with the disease, and modern treatments -- notably, anti-inflammatory medications called TNF blockers -- work for many patients.
With two new drugs poised to hit the market, and if all goes well, things should soon improve further for Crohn's patients.
On July 31, a Food and Drug Administration advisory committee recommended approval of the drug Tysabri as a medication for Crohn's. Tysabri is already in use for treatment of about 14,000 patients with multiple sclerosis, another autoimmune disease in which the body attacks the sheath surrounding nerve cells. Although the committee's decision is nonbinding, it will allow the FDA to move toward approval of Tysabri for Crohn's.
And in two studies published in the July 19 issue of the New England Journal of Medicine, researchers reported that another drug, Cimzia, was effective at treating about one-third of the studies' 1,330 patients with moderate to severe Crohn's. In addition, 62% of patients who responded to Cimzia continued to benefit from the treatment after six months.
UCB, the Belgium-based company that makes Cimzia, has begun filing paperwork with the FDA and plans to seek formal approval soon.
Blocking the inflammation
IN Crohn's disease, the immune system attacks the digestive system, most commonly the end of the small intestine and the beginning of the colon.
The inflammation can cause ulcers or swelling, damaging the walls of the digestive tract and ultimately narrowing the passageway. Sometimes, ulcers can extend through the intestinal wall, forming abnormal tunnels between the bowels and other organs or the skin.
The exact cause of Crohn's disease is unclear, but there appears to be a genetic link. A person is 10 times more likely to have Crohn's if a relative has it.
Symptoms include diarrhea, abdominal pain and bloody stool. Patients with severe Crohn's disease have to do "bathroom mapping," identifying nearby restrooms whenever they plan to go out.
In treating Crohn's, doctors and patients consider a variety of medications. Patients frequently start out with anti-inflammatory drugs such as Azulfidine and Rowasa, then progress to steroids, which are stronger but toxic and can be taken only for a short time. The long-term solution is often to suppress the immune system even further.
Since 1998, many Crohn's patients have been helped by medications called TNF blockers, which stymie the action of a molecule called TNF. TNF is produced by immune cells and activates further inflammation.
Two of these drugs, Remicade and Humira, are antibodies that bind to TNF, interfering with its function and helping to prevent symptoms.
Remicade and Humira are the first drugs to make a noticeable dent in the rates of hospitalization and surgery for Crohn's patients, says Dr. Stephen Hanauer, chief of gastroenterology at the University of Chicago.
But they don't work for everyone. Although the antibodies block TNF, they can induce a damaging immune response of their own. Some patients are allergic to them.
For others, the drugs work for a while, and then stop.
Cimzia is also a TNF blocker, but unlike the others it contains only part of the antibody -- the portion that recognizes TNF. The rest of the antibody -- the part that can induce its own immune response -- is replaced with a compound called PEG.
This PEG tail stabilizes the drug, allowing it to stay in the patient's body much longer, explains Hanauer, who was a coauthor on one of the recently published Cymzia studies.
That means patients would only require treatment every other month, as opposed to every other week with Humira.
Many of the patients in the two trials had nearly exhausted their treatment options, says Dr. William Sandborn, a gastroenterologist at the Mayo Clinic in Minnesota, who oversaw one of the studies.
"Gains that you see in those patients are particularly important and interesting," he says.
Ongoing studies are assessing Cimzia's efficacy over a longer period of time than six months, and preliminary data indicate that it can remain effective for at least 18 months.
Tysabri, the second new approach to Crohn's, works by interfering with a different part of the immune response.
During inflammation, infection-fighting white blood cells of the immune system cruise through capillaries, searching for infection. When tissues are infected, they put out signals to slow down the blood cells and coax them to enter the tissue. "They're kind of like the exit signs on the expressway," Hanauer says.
Tysabri binds to those exit signs -- blocking them from recognition by the immune cells that are causing the Crohn's. So the white blood cells keep on moving, and the course of inflammation is stopped.
Two clinical trials involving 848 patients published in the New England Journal of Medicine in 2005 and 2007 reported that Tysabri was effective for about one-third of Crohn's patients, and 59% of those patients continued to see benefits after one year.
However, three patients out of 3,000 in clinical trials for Crohn's or MS, developed a viral infection in the brain -- and two died. Because of this, Tysabri use is closely monitored.
Lars Ekman, president of global research and development at Elan Pharmaceuticals, which markets Tysabri, noted that the viral infections occurred when Tysabri was used with other immunosuppressants. He recommends that Tysabri be taken only on its own.
"With multiple sclerosis, we have been very successful in screening out the patients that are at risk," he says.
Gray no longer has to worry about mapping bathrooms -- by 2001 his condition had become so serious that surgeons had to remove his colon and rectum. Instead, waste drains into a pouch he wears on the front of his abdomen.
With Remicade, his condition is more manageable than it has been in years. Although he has been on disability for a decade, he hopes to return to work soon.
"It's much better to get Crohn's disease in 2007 than 1987," Sandborn says. "I think the future looks very different for these groups of patients."
http://www.latimes.com/features/health/la-he-lab13aug13,1,14…
Relief in sight?
People with Crohn's disease, an inflammation of the bowel, live with embarrassment, pain and surgery. Two new drugs may soon help.
By Amber Dance, Los Angeles Times Staff Writer
August 13, 2007
The gnarled lines across his abdomen are the mementos of three major surgeries on his digestive system. The slashes along each side are reminders of the time the stitches broke and the doctors put him into a drug-induced coma for seven weeks, keeping his abdomen open for repeated washes. The doctors made the slits so that they would have enough skin to stretch over the opening when they finally sewed him together.
Gray, 46, was diagnosed 24 years ago with Crohn's disease, a chronic inflammation of the bowel and intestines that afflicts nearly 1 million people worldwide. Crohn's patients suffer from diarrhea and abdominal pain, and 80% will eventually face the surgeon's knife to remove damaged portions of bowel.
Gray, who lives in Long Beach, is nearly 6 feet tall but weighs only 125 pounds -- yet his situation is better than it used to be. Lately, scientific research has started catching up with the disease, and modern treatments -- notably, anti-inflammatory medications called TNF blockers -- work for many patients.
With two new drugs poised to hit the market, and if all goes well, things should soon improve further for Crohn's patients.
On July 31, a Food and Drug Administration advisory committee recommended approval of the drug Tysabri as a medication for Crohn's. Tysabri is already in use for treatment of about 14,000 patients with multiple sclerosis, another autoimmune disease in which the body attacks the sheath surrounding nerve cells. Although the committee's decision is nonbinding, it will allow the FDA to move toward approval of Tysabri for Crohn's.
And in two studies published in the July 19 issue of the New England Journal of Medicine, researchers reported that another drug, Cimzia, was effective at treating about one-third of the studies' 1,330 patients with moderate to severe Crohn's. In addition, 62% of patients who responded to Cimzia continued to benefit from the treatment after six months.
UCB, the Belgium-based company that makes Cimzia, has begun filing paperwork with the FDA and plans to seek formal approval soon.
Blocking the inflammation
IN Crohn's disease, the immune system attacks the digestive system, most commonly the end of the small intestine and the beginning of the colon.
The inflammation can cause ulcers or swelling, damaging the walls of the digestive tract and ultimately narrowing the passageway. Sometimes, ulcers can extend through the intestinal wall, forming abnormal tunnels between the bowels and other organs or the skin.
The exact cause of Crohn's disease is unclear, but there appears to be a genetic link. A person is 10 times more likely to have Crohn's if a relative has it.
Symptoms include diarrhea, abdominal pain and bloody stool. Patients with severe Crohn's disease have to do "bathroom mapping," identifying nearby restrooms whenever they plan to go out.
In treating Crohn's, doctors and patients consider a variety of medications. Patients frequently start out with anti-inflammatory drugs such as Azulfidine and Rowasa, then progress to steroids, which are stronger but toxic and can be taken only for a short time. The long-term solution is often to suppress the immune system even further.
Since 1998, many Crohn's patients have been helped by medications called TNF blockers, which stymie the action of a molecule called TNF. TNF is produced by immune cells and activates further inflammation.
Two of these drugs, Remicade and Humira, are antibodies that bind to TNF, interfering with its function and helping to prevent symptoms.
Remicade and Humira are the first drugs to make a noticeable dent in the rates of hospitalization and surgery for Crohn's patients, says Dr. Stephen Hanauer, chief of gastroenterology at the University of Chicago.
But they don't work for everyone. Although the antibodies block TNF, they can induce a damaging immune response of their own. Some patients are allergic to them.
For others, the drugs work for a while, and then stop.
Cimzia is also a TNF blocker, but unlike the others it contains only part of the antibody -- the portion that recognizes TNF. The rest of the antibody -- the part that can induce its own immune response -- is replaced with a compound called PEG.
This PEG tail stabilizes the drug, allowing it to stay in the patient's body much longer, explains Hanauer, who was a coauthor on one of the recently published Cymzia studies.
That means patients would only require treatment every other month, as opposed to every other week with Humira.
Many of the patients in the two trials had nearly exhausted their treatment options, says Dr. William Sandborn, a gastroenterologist at the Mayo Clinic in Minnesota, who oversaw one of the studies.
"Gains that you see in those patients are particularly important and interesting," he says.
Ongoing studies are assessing Cimzia's efficacy over a longer period of time than six months, and preliminary data indicate that it can remain effective for at least 18 months.
Tysabri, the second new approach to Crohn's, works by interfering with a different part of the immune response.
During inflammation, infection-fighting white blood cells of the immune system cruise through capillaries, searching for infection. When tissues are infected, they put out signals to slow down the blood cells and coax them to enter the tissue. "They're kind of like the exit signs on the expressway," Hanauer says.
Tysabri binds to those exit signs -- blocking them from recognition by the immune cells that are causing the Crohn's. So the white blood cells keep on moving, and the course of inflammation is stopped.
Two clinical trials involving 848 patients published in the New England Journal of Medicine in 2005 and 2007 reported that Tysabri was effective for about one-third of Crohn's patients, and 59% of those patients continued to see benefits after one year.
However, three patients out of 3,000 in clinical trials for Crohn's or MS, developed a viral infection in the brain -- and two died. Because of this, Tysabri use is closely monitored.
Lars Ekman, president of global research and development at Elan Pharmaceuticals, which markets Tysabri, noted that the viral infections occurred when Tysabri was used with other immunosuppressants. He recommends that Tysabri be taken only on its own.
"With multiple sclerosis, we have been very successful in screening out the patients that are at risk," he says.
Gray no longer has to worry about mapping bathrooms -- by 2001 his condition had become so serious that surgeons had to remove his colon and rectum. Instead, waste drains into a pouch he wears on the front of his abdomen.
With Remicade, his condition is more manageable than it has been in years. Although he has been on disability for a decade, he hopes to return to work soon.
"It's much better to get Crohn's disease in 2007 than 1987," Sandborn says. "I think the future looks very different for these groups of patients."
Antwort auf Beitrag Nr.: 31.123.469 von Birgit.Tersteegen am 11.08.07 10:02:10da bin ich ja mal gespannt, wie der Bericht aufgenommen werden wird.
Antwort auf Beitrag Nr.: 31.127.009 von Poppholz am 11.08.07 21:53:20ich will es glaub ich gar nicht wissen wie der markt den bericht aufnimmt.
London und Irland kurz bis auf €15,00 Euro gelaufen und aktuell wieder auf dem Rückmarsch zur €14,50 Marke.
Mal sehen was ab 15:30 Uhr so geht.
Mal sehen was ab 15:30 Uhr so geht.
By: peadar_og
Elan
“Research by University College London’s Institute of Opthalmology published last week in the US Proceedings of the National Academy of Science has found that beta amyloid proteins associated with Alzheimer’s Disease are also found in the optic nerves of rats suffering from glaucoma. The proteins were found to build up leading to retinal nerve cell death. The researchers hypothesis that stress caused by Glaucoma progression results in build up of beta amyloid in the eye. Three chemicals, including Elan’s AAB-001, were tested on the glaucoma model and AAB-001 was found to be the most effective. This is a very early stage pre-clinical academic trial, which may show an alternative use for AAB-001, but one that is years from commercial reality. Glaucoma is estimated to affect 65m people worldwide.”
In reality, many patients suffering from Glaucoma should have immediate access to AAB-001 when it’s approved for Alzheimer’s disease. As far as I’m aware, these are related illnesses, and if you suffer from Glaucoma, then you will look to any product known to remove plaque. You should have no problem getting diagnosed with AD - if you're not already.
IMO, one of the questions hanging over Elan’s approach to Alzheimer’s is not if AAB can remove the plaque, but whether the plaque is the cause or a symptom of AD, and whether its removal can have real effect on AD symptoms. Old timers will recall a certain unnamed scientist (and no friend of DS) making claims to the contrary.
One significant aspect of the Glaucoma news, other than providing hope to millions of sufferers, is that regardless of which camp you belong to, it would be difficult to make a case now that a product which can remove the plaque will not have a huge market, if even for Glaucoma alone. It seems to me that Glaucoma and the plaque itself are directly related.
“Evidence of beta amyloid plaque reduction was observed in
three autopsy cases that have been examined from the Phase I
and IIa AN-1792 trials. The observed plaque clearance is
consistent with those findings of numerous laboratories
investigating beta amyloid immunotherapy in animal models of
Alzheimer's disease. An analysis is in progress of a fourth
autopsy case showing evidence of active plaque removal.”
" target="_blank" rel="nofollow ugc noopener">http://www.elan.com/News/full.asp?ID=594662
Elan
“Research by University College London’s Institute of Opthalmology published last week in the US Proceedings of the National Academy of Science has found that beta amyloid proteins associated with Alzheimer’s Disease are also found in the optic nerves of rats suffering from glaucoma. The proteins were found to build up leading to retinal nerve cell death. The researchers hypothesis that stress caused by Glaucoma progression results in build up of beta amyloid in the eye. Three chemicals, including Elan’s AAB-001, were tested on the glaucoma model and AAB-001 was found to be the most effective. This is a very early stage pre-clinical academic trial, which may show an alternative use for AAB-001, but one that is years from commercial reality. Glaucoma is estimated to affect 65m people worldwide.”
In reality, many patients suffering from Glaucoma should have immediate access to AAB-001 when it’s approved for Alzheimer’s disease. As far as I’m aware, these are related illnesses, and if you suffer from Glaucoma, then you will look to any product known to remove plaque. You should have no problem getting diagnosed with AD - if you're not already.
IMO, one of the questions hanging over Elan’s approach to Alzheimer’s is not if AAB can remove the plaque, but whether the plaque is the cause or a symptom of AD, and whether its removal can have real effect on AD symptoms. Old timers will recall a certain unnamed scientist (and no friend of DS) making claims to the contrary.
One significant aspect of the Glaucoma news, other than providing hope to millions of sufferers, is that regardless of which camp you belong to, it would be difficult to make a case now that a product which can remove the plaque will not have a huge market, if even for Glaucoma alone. It seems to me that Glaucoma and the plaque itself are directly related.
“Evidence of beta amyloid plaque reduction was observed in
three autopsy cases that have been examined from the Phase I
and IIa AN-1792 trials. The observed plaque clearance is
consistent with those findings of numerous laboratories
investigating beta amyloid immunotherapy in animal models of
Alzheimer's disease. An analysis is in progress of a fourth
autopsy case showing evidence of active plaque removal.”
" target="_blank" rel="nofollow ugc noopener">http://www.elan.com/News/full.asp?ID=594662
Antwort auf Beitrag Nr.: 31.146.798 von GuHu1 am 13.08.07 21:58:09
Antwort auf Beitrag Nr.: 31.146.866 von Birgit.Tersteegen am 13.08.07 22:02:37es ist doch wohl nicht zu begreifen.
Antwort auf Beitrag Nr.: 31.147.413 von Poppholz am 13.08.07 22:46:48na mal ehrlich, da postet birgit eine positive meldung nach der anderen und was macht der kurs, ich sags leiber nicht
derzeit ist ein klein wenig leidensfähigkeit gefragt, jedenfalls für die etwas später zugestiegenden fahrgäste.
derzeit ist ein klein wenig leidensfähigkeit gefragt, jedenfalls für die etwas später zugestiegenden fahrgäste.
Antwort auf Beitrag Nr.: 31.147.710 von GuHu1 am 13.08.07 23:24:19Die Bewegungen des Elankurses waren heute Abend ziemlich syncron zum Dow....die unterschwellige Verunsicherung im Markt ist noch ziemlich gross....-----------------trotzdem GUTE NACHT!
Antwort auf Beitrag Nr.: 31.147.710 von GuHu1 am 13.08.07 23:24:19wie schon von mir geschrieben, sind gute Nachrichten nicht so gut für den Kursverlauf.
Es wird seit Monaten versucht den Kurs unten zu halten. Dies wahrscheinlich auch durch Shorties bewirkt.
Es bleibt halt weiterhin abzuwarten, wann der Kurs endlich nach oben gehen wird.
Die Zukunft von ELAN ist nach wie vor positiv und irgendwann wird dies auch von der breiten Masse erkannt werden.
Es wird seit Monaten versucht den Kurs unten zu halten. Dies wahrscheinlich auch durch Shorties bewirkt.
Es bleibt halt weiterhin abzuwarten, wann der Kurs endlich nach oben gehen wird.
Die Zukunft von ELAN ist nach wie vor positiv und irgendwann wird dies auch von der breiten Masse erkannt werden.
Antwort auf Beitrag Nr.: 31.147.753 von Poppholz am 13.08.07 23:31:51HÄÄÄÄ ?
dann zieh doch mal den vergleich zu dndn.
das argument hinkt aber gewaltig, das solltest du wissen.
dann zieh doch mal den vergleich zu dndn.
das argument hinkt aber gewaltig, das solltest du wissen.
Mahlzeit,
SKS im 6Monat ?
SKS selbst im 5Tag ?
In anbetracht der Marktmisere Kauflimit erst wieder über ~$22.
Denke irgendwie die 16/15 wird nochmal getestet!?
SKS im 6Monat ?
SKS selbst im 5Tag ?
In anbetracht der Marktmisere Kauflimit erst wieder über ~$22.
Denke irgendwie die 16/15 wird nochmal getestet!?
Habe immer den Kram im Hinterkopf:
-Bedeutet 2010/11 kann man kaufen bis der Arzt kommt.
Doch vorerst Vorsicht walten lassen- bei einigen Einzeltiteln
kann es natürlich anders kommen.
-Bedeutet 2010/11 kann man kaufen bis der Arzt kommt.
Doch vorerst Vorsicht walten lassen- bei einigen Einzeltiteln
kann es natürlich anders kommen.
Antwort auf Beitrag Nr.: 31.148.022 von GuHu1 am 14.08.07 00:43:41ein Vergleich zu DNDN passt hier natürlich nicht, da dort die Zukunft nicht so sicher ist wie bei ELAN.
In der Vergangenheit ist bei Elan zu beobachten gewesen, dass das Börsenmotto "Sell on good news" hier besonders stark betrieben wird.
Dies wird durch den Kursverlauf in den letzten beiden Tagen auch wieder bestätigt.
In der Vergangenheit ist bei Elan zu beobachten gewesen, dass das Börsenmotto "Sell on good news" hier besonders stark betrieben wird.
Dies wird durch den Kursverlauf in den letzten beiden Tagen auch wieder bestätigt.
Antwort auf Beitrag Nr.: 31.147.753 von Poppholz am 13.08.07 23:31:51...allerdings ist die Bewerung mit einer Marktkapitalisierung von ca. 9 Mrd$ bereits ambitiös. Und solange bei den Umsätzen kein Quantensprung bzw. beim Ergebnis keine schwarzen Zahlen in Sicht sind, wird es keine herbeigesehnten Kurskapriolen geben.
Momentan zählen folgende Fakten:
Das Tysabri-Wachstum blieb bisher unter den Erwartungen, Maxipime mit Generika-Konkurrenz, Prialt mit mehr als dürftigen Umsätzen und dazu keine neuen Nano-Vereinbarungen!
Und das sind die Hoffnungsschimmer:
Mögliche Zulassung von Tysabri zur Behandlung von MC, zunehmende Akzeptanz von Tysabri zur Behandlung der MS, Beginn der Phase III von Bapineuzumab und weitere Entwicklungs-Fortschritte bei neurodegenerativen Erkrankungen z.B. Parkinson, AD etc.
Momentan zählen folgende Fakten:
Das Tysabri-Wachstum blieb bisher unter den Erwartungen, Maxipime mit Generika-Konkurrenz, Prialt mit mehr als dürftigen Umsätzen und dazu keine neuen Nano-Vereinbarungen!
Und das sind die Hoffnungsschimmer:
Mögliche Zulassung von Tysabri zur Behandlung von MC, zunehmende Akzeptanz von Tysabri zur Behandlung der MS, Beginn der Phase III von Bapineuzumab und weitere Entwicklungs-Fortschritte bei neurodegenerativen Erkrankungen z.B. Parkinson, AD etc.
By: stockhound4
UBS AG Stepping Up In Q2 Added 1.362 Million Shares
UBS AG 6/30/2007 1,691,761 1,362,821 414.31% $32,448
UBS AG Stepping Up In Q2 Added 1.362 Million Shares
UBS AG 6/30/2007 1,691,761 1,362,821 414.31% $32,448
By: LovesJohnDory
MERRILL LYNCH & CO., INC 13F-HR AS OF 06/29/2007
Increased ELN holdings to 2,843,827 shares, from 1,171,288 as of March 31, 2007.
MERRILL LYNCH & CO., INC 13F-HR AS OF 06/29/2007
Increased ELN holdings to 2,843,827 shares, from 1,171,288 as of March 31, 2007.
Elan
Corporation, plc announced today the appointment of five new members to
the company's Board of Directors. The three new non-executive board
members are Goran Ando MD, Gary Kennedy and Nancy Lurker and the two
new executive board members are Shane Cooke and Lars Ekman MD, PhD.
http://www.elan.com/News/2005/20050531.asp
Gary Kennedy (47) is Group Director, Finance & Enterprise Technology, Allied
Irish Banks, plc (AIB) an Irish registered company and Ireland's largest bank;
he has been with AIB since 1997.
http://www.secinfo.com/dsVst.zy2.d.htm
Corporation, plc announced today the appointment of five new members to
the company's Board of Directors. The three new non-executive board
members are Goran Ando MD, Gary Kennedy and Nancy Lurker and the two
new executive board members are Shane Cooke and Lars Ekman MD, PhD.
http://www.elan.com/News/2005/20050531.asp
Gary Kennedy (47) is Group Director, Finance & Enterprise Technology, Allied
Irish Banks, plc (AIB) an Irish registered company and Ireland's largest bank;
he has been with AIB since 1997.
http://www.secinfo.com/dsVst.zy2.d.htm
Antwort auf Beitrag Nr.: 31.155.299 von Birgit.Tersteegen am 14.08.07 15:38:28Diese Analysten sind einfach ein durchtriebenes Pack:Merryll Lynch kauft sich ordentlich bei Elan ein ,während sie zuvor ein "SELL"Rating die ganze Zeit hatten und dann das Covering ganz aufgaben---klar,oder?
Sie wollten eben billig einkaufen...
------------------
On January 4, 2007, Merrill Lynch's Eric Ende said that "[o]ur top [biotechnology] Sell idea for 2007 remains Elan."
On March 20, 2007, Merrill Lynch's Erica Whittaker placed a "fair value" for Elan at about $5.50, including $2.50 for the Alzheimer's program," and even "nder a bullish Tysabri scenario, Elan's fair value would be $12.50/ADR, which is still below the current share price."
As of March 31, 2007, Merrill Lynch held 1,171,288 shares of Elan, a reduction of 218,562 shares from its holdings as of December 31, 2006.
On April 18, 2007, Merrill Lynch published a report on Elan entitled "Suspension of Coverage," that began as follows:
Suspending Elan coverage for the time being
Due to a re-allocation of resources, we are temporarily suspending coverage of Elan and moving our investment opinion to “No Rating”. As a result, investors should not rely on our previous opinion or estimates.
Apparently, Merrill Lynch reallocated some of those resources into Elan.
Sie wollten eben billig einkaufen...
------------------
On January 4, 2007, Merrill Lynch's Eric Ende said that "[o]ur top [biotechnology] Sell idea for 2007 remains Elan."
On March 20, 2007, Merrill Lynch's Erica Whittaker placed a "fair value" for Elan at about $5.50, including $2.50 for the Alzheimer's program," and even "nder a bullish Tysabri scenario, Elan's fair value would be $12.50/ADR, which is still below the current share price."
As of March 31, 2007, Merrill Lynch held 1,171,288 shares of Elan, a reduction of 218,562 shares from its holdings as of December 31, 2006.
On April 18, 2007, Merrill Lynch published a report on Elan entitled "Suspension of Coverage," that began as follows:
Suspending Elan coverage for the time being
Due to a re-allocation of resources, we are temporarily suspending coverage of Elan and moving our investment opinion to “No Rating”. As a result, investors should not rely on our previous opinion or estimates.
Apparently, Merrill Lynch reallocated some of those resources into Elan.
Antwort auf Beitrag Nr.: 31.155.903 von Birgit.Tersteegen am 14.08.07 16:09:07es gibt halt keine guten Menschen mehr und schon gar keine "guten" Analysten.
Der momentane Kursverlauf erzeugt bei mir auch nur ein Kopfschütteln. Da wird der Kurs auch wieder runter manipuliert, damit "große" Adressen weiter günstig einkaufen können.
Meine Aktien bleiben weiterhin im Depot.
Der momentane Kursverlauf erzeugt bei mir auch nur ein Kopfschütteln. Da wird der Kurs auch wieder runter manipuliert, damit "große" Adressen weiter günstig einkaufen können.
Meine Aktien bleiben weiterhin im Depot.
59.9% with latest update
http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…
=&movingaverage=&lowerstudy=&comparison=&index=&symbol=ELN&symbol=&symbol=&symbol=&symbol=&symbol=&s
ymbol=&symbol=&symbol=&symbol=&FormType=Institutional&mkttype=after&pathname=&page=holdings&selected=ELN
http://www.nasdaq.com/asp/holdings.asp?mode=&kind=&timeframe…
=&movingaverage=&lowerstudy=&comparison=&index=&symbol=ELN&symbol=&symbol=&symbol=&symbol=&symbol=&s
ymbol=&symbol=&symbol=&symbol=&FormType=Institutional&mkttype=after&pathname=&page=holdings&selected=ELN
Antwort auf Beitrag Nr.: 31.163.076 von Birgit.Tersteegen am 15.08.07 02:44:39dafür dass unser Baby keinerlei KAUF-Empfehlungen bekommt, steigen die "Großen" ganz gut ein.
Vielleicht kommen die Kaufempehlungen ja bei einer Insti-Quote von 60%.
Vielleicht kommen die Kaufempehlungen ja bei einer Insti-Quote von 60%.
Antwort auf Beitrag Nr.: 31.164.094 von Poppholz am 15.08.07 09:10:19Vielleicht kommen die Kaufempehlungen ja bei einer Insti-Quote von 60%
Genau Poppi, Birgit sollte die fehlenden 0,1 Prozent heute Nachmittag ankaufen.
Wat is bloß mit dem Papier los, meine Optionen zerbröseln bald vollständig ... heul.
Genau Poppi, Birgit sollte die fehlenden 0,1 Prozent heute Nachmittag ankaufen.
Wat is bloß mit dem Papier los, meine Optionen zerbröseln bald vollständig ... heul.
Antwort auf Beitrag Nr.: 31.169.982 von Holgus am 15.08.07 15:17:47Bin im Moment ziemlich ausgenockt---musste gestern meinen Liebsten mit Blaulicht ins Krankenhaus bringen--heute OP----Darmverschluss---sah vorher ziemlich existenziell aus----Drückt mal die Daumen und haltet die Elanfahne hoch....Gute Nacht!Birgit
Antwort auf Beitrag Nr.: 31.176.393 von Birgit.Tersteegen am 15.08.07 22:21:19hui, na dann mal gute besserung.
Antwort auf Beitrag Nr.: 31.176.393 von Birgit.Tersteegen am 15.08.07 22:21:19Gute Besserung wünschen wir
Antwort auf Beitrag Nr.: 31.193.757 von surga am 16.08.07 21:31:19Danke schön;so langsam gehts aufwärts--und ich komme zum ersten Mal heute zum essen...-frau lernt die kleinen Freuden wieder schätzen...
Antwort auf Beitrag Nr.: 31.195.687 von Birgit.Tersteegen am 16.08.07 23:01:54ich hoffe es hat geschmeckt.
jetzt biste wahrscheinlich dreifach stark gefordert.
aber wir wissen ja, frauen können, besser als männer, mehrere dinge gleichzeitig.
kopf hoch, das wird schon.
jetzt biste wahrscheinlich dreifach stark gefordert.
aber wir wissen ja, frauen können, besser als männer, mehrere dinge gleichzeitig.
kopf hoch, das wird schon.
Antwort auf Beitrag Nr.: 31.176.393 von Birgit.Tersteegen am 15.08.07 22:21:19Hallo Birgit, das sind so Sachen die niemand braucht ....
alles Gute und Kopf hoch !
Micha
alles Gute und Kopf hoch !
Micha
kopf hoch, das wird schon.
ich hoffe das gilt auch für eln.
ich hoffe das gilt auch für eln.
und wieder voll auf die 12!
Antwort auf Beitrag Nr.: 31.212.082 von GuHu1 am 17.08.07 22:16:33Sag, wen willst Du mit dermaßen Schwachsinnigen postings beglücken?
Andere?Irgendwen?mich?
Nun; ist Dir in dem Maße gelungen als solche;- ich Dir antworte,
jedoch sei gewiß das die Wahrheit nicht nur auf einer Seite schlägt!
Selbst verliebt in irgend einen Wert ist es der Ruin der einen zum scheitern verurteilt, und sei es aus niedertracht.
"Klagt nicht die menschliche Natur an, wenn ihr Bosheit, Dummheit, Niederträchtigkeit, Unglück und jede Art von Elend in unserer Gesellschaft findet - klagt die unmenschlichen Verhältnisse an, die das beste, humanste, tätigste Geschöpf in Elend und Laster stürzen können."
Andere?Irgendwen?mich?
Nun; ist Dir in dem Maße gelungen als solche;- ich Dir antworte,
jedoch sei gewiß das die Wahrheit nicht nur auf einer Seite schlägt!
Selbst verliebt in irgend einen Wert ist es der Ruin der einen zum scheitern verurteilt, und sei es aus niedertracht.
"Klagt nicht die menschliche Natur an, wenn ihr Bosheit, Dummheit, Niederträchtigkeit, Unglück und jede Art von Elend in unserer Gesellschaft findet - klagt die unmenschlichen Verhältnisse an, die das beste, humanste, tätigste Geschöpf in Elend und Laster stürzen können."
Msg: 141924 of 141961 8/18/2007
By: allineln
From the Street.com today re: Elan/Transition Therapeutics
"Let's start with a question about Alzheimer's disease drugs. Peter R. asks: "I was wondering if you have any opinion on Transition Therapeutics? ... What is interesting is [Transition's] Alzheimer's drug, which is in phase II fast track. It is partnered with Elan (ELN - Cramer's Take - Stockpickr) on this drug, and Elan seems more excited about this partnered drug than some of the other Azheimer's drugs that Elan is also working on."
The drug in question is called ELND-005, and while still in phase I testing, the drug's early data showed enough potential to attract the attention of several big companies with aggressive Alzheimer's disease programs.
Last year, Transition inked a favorable partnership with Elan to co-develop ELND-005. While I'm not sure Elan is more excited about ELND-005 than it is about the other Alzheimer's drugs in its deep pipeline, Elan executives have talked up about the drug's potential.
All this is good for Transition Therapeutics, which is a company that should be on the radar screen of any biotech investor interested in the Alzheimer's disease field"
http://www.thestreet.com:80/s/feuersteins-biotech-stock-mailbag/newsanalysis/biotech/10375055.html?
cm_ven=CNNMONEY&cm_cat=Free&cm_pla=Feed&cm_ite=Feed&puc=cnnmoney&?puc=_cnnmoney
By: allineln
From the Street.com today re: Elan/Transition Therapeutics
"Let's start with a question about Alzheimer's disease drugs. Peter R. asks: "I was wondering if you have any opinion on Transition Therapeutics? ... What is interesting is [Transition's] Alzheimer's drug, which is in phase II fast track. It is partnered with Elan (ELN - Cramer's Take - Stockpickr) on this drug, and Elan seems more excited about this partnered drug than some of the other Azheimer's drugs that Elan is also working on."
The drug in question is called ELND-005, and while still in phase I testing, the drug's early data showed enough potential to attract the attention of several big companies with aggressive Alzheimer's disease programs.
Last year, Transition inked a favorable partnership with Elan to co-develop ELND-005. While I'm not sure Elan is more excited about ELND-005 than it is about the other Alzheimer's drugs in its deep pipeline, Elan executives have talked up about the drug's potential.
All this is good for Transition Therapeutics, which is a company that should be on the radar screen of any biotech investor interested in the Alzheimer's disease field"
http://www.thestreet.com:80/s/feuersteins-biotech-stock-mailbag/newsanalysis/biotech/10375055.html?
cm_ven=CNNMONEY&cm_cat=Free&cm_pla=Feed&cm_ite=Feed&puc=cnnmoney&?puc=_cnnmoney
Einfach KLASSE soetwas zu lesen.....Von daher bringen mich Kursturbolenzen bei Elan nicht in Unruhe -denn- Qualität setzt sich einfach langfristig durch....
By: msladyinca
Why is it I NEVER see posts like this regarding the ABCRs?
I think we all know why...Have a good weekend everyone, Lauren
http://tinyurl.com/2nqlht
Here's the good and the not so bad...
« Thread Started on Today at 8:02pm »
By: msladyinca
Why is it I NEVER see posts like this regarding the ABCRs?
I think we all know why...Have a good weekend everyone, Lauren
http://tinyurl.com/2nqlht
Here's the good and the not so bad...
« Thread Started on Today at 8:02pm »
I am just giving an update pertaining to my thread from last week. I had an MRI on Wed. but the radiologist wouldn't do the contrast because I had an allergic reaction 4 mo. ago. So what it showed is there were NO new lesions relating to "T". I KNEW there wouldn't be any. Also, some of the small lesions DISAPPEARED and some were SMALLER!!! I have a fairly large one that got alitttle bigger so that may be the answer to what is going on or part of it anyway. I have very bad arthritis in my neck where the pain is generating from. Or I may need surgery. He is giving me 2 wks. to improve and then we talk about more tests. I have to go to PT for my neck (YEAH! I HATE PT!) and stay on the Vicoden. So it is good....I can stay on "T" and call him after I have my 5th infusion the 31st. He was impressed by my accomplishments since starting "T". I can tie my shoes and hold a pencil and that is saying ALOT! I want to THANK ALL OF YOU for your support, concern and kind words. You are all a very special group of people. I hope I can return your kindnesses. In this week from HELL, I never for one minute regretted being on "T". Not once. Aside from my fear from the excruciating pain I feared being taken off of it just as much. Thanks again and take care
Antwort auf Beitrag Nr.: 31.212.905 von Nostarowie am 17.08.07 23:32:37Sag, wen willst Du mit dermaßen Schwachsinnigen postings beglücken?
Andere?Irgendwen?mich?
na sagen wir mal das es einfach nur frustbewältigung ist.so ganz unberührt scheinst du auch nicht zu sein.
Nun; ist Dir in dem Maße gelungen als solche;- ich Dir antworte,
das ist aber schön von dir eine antwort zu bekommen.
jedoch sei gewiß das die Wahrheit nicht nur auf einer Seite schlägt!
ich bin gewiß, du auch?
Selbst verliebt in irgend einen Wert ist es der Ruin der einen zum scheitern verurteilt, und sei es aus niedertracht.
ganz genau so sehe ich das auch
Andere?Irgendwen?mich?
na sagen wir mal das es einfach nur frustbewältigung ist.so ganz unberührt scheinst du auch nicht zu sein.
Nun; ist Dir in dem Maße gelungen als solche;- ich Dir antworte,
das ist aber schön von dir eine antwort zu bekommen.
jedoch sei gewiß das die Wahrheit nicht nur auf einer Seite schlägt!
ich bin gewiß, du auch?
Selbst verliebt in irgend einen Wert ist es der Ruin der einen zum scheitern verurteilt, und sei es aus niedertracht.
ganz genau so sehe ich das auch
Antwort auf Beitrag Nr.: 31.221.012 von GuHu1 am 19.08.07 11:05:52Na ja nimmst es wenigstens locker.
War auch nicht so ernst gemeint. Ist wohl wieder ein Tourette-Syndrom
bei mir durchgeknallt....
War auch nicht so ernst gemeint. Ist wohl wieder ein Tourette-Syndrom
bei mir durchgeknallt....
Antwort auf Beitrag Nr.: 31.222.905 von Nostarowie am 19.08.07 20:35:20so ganz unrecht hast du nicht, bin z.Zt. schon oft am maulen.
sei es drum.
sei es drum.
Antwort auf Beitrag Nr.: 31.226.150 von GuHu1 am 20.08.07 11:48:49Ihr seid süss Wir haben hier für WO -Verhältnisse so einen netten Doppelthread (DANKE HEXCHEN)--in dem darf auch mal gemault werden...
Re: TYSABRI(R) Demonstrates Significant Health-Related Quality-of-Life Improvements for Multiple Sclerosis Patients in Study Published in Annals of Neurology
TYSABRI(R) Demonstrates Significant Health-Related Quality-of-Life Improvements for Multiple Sclerosis Patients in Study Published in Annals of Neurology
Monday August 20, 2:00 am ET
CAMBRIDGE, Mass.& DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today the publication of results demonstrating that patients treated with TYSABRI® (natalizumab) showed a significant improvement in health-related quality-of-life (HRQoL) measures when compared to placebo. These results are from the first Phase III multiple sclerosis (MS) studies that have demonstrated improvement on HRQoL measures in patients with relapsing forms of MS. The results have been published in today's issue of Annals of Neurology.
ADVERTISEMENT
"These data showed that patients treated with TYSABRI were more likely to experience statistically important improvement in the quality-of-life measures used to assess meaningful disease improvement or progression. These findings have not been previously observed in clinical studies involving MS patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, the lead investigator of the study.
These two-year, randomized, double-blind, placebo-controlled, multicenter, Phase III clinical trials (AFFIRM and SENTINEL) were conducted in 2,113 patients with relapsing forms of MS. The objective was to assess the relationship between disease activity and HRQoL in relapsing forms of MS, and the impact of TYSABRI on these measures.
In the studies, HRQoL was assessed using two different measures at baseline and weeks 24, 52 and 104:
* The Short Form-36 (SF-36), a standardized, well-validated survey that has been used extensively in many disease areas, including MS to review health status. The SF-36 is comprised of 36 questions designed to assess physical (Physical Component Summary or PCS) and mental (Mental Component Summary or MCS) well-being from the perspective of the patient.
* The Visual Analogue Scale (VAS), a measure of well-being as assessed by the patient and marked on a scale of 0 to 100, with 0 indicating "poor" and 100 indicating "excellent."
Results from the AFFIRM monotherapy trial include:
* A statistically significant improvement in SF-36 PCS beginning at week 24 and all subsequent time points compared with a decline in the placebo-treated group.
* A statistically significant improvement in SF-36 MCS at week 104 compared with a decline in the placebo-treated group.
* Statistically significant benefits using the VAS when compared with placebo at week 52 and at week 104.
* Patients showed sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
* HRQoL measures correlated with common measures of MS severity, including EDSS, sustained disability progression, relapse number, MSFC and volume of T2-hyperintense and T1-hypointense lesions.
Improvements on quality-of-life measures were also observed in the SENTINEL study, in which TYSABRI was added to AVONEX® (Interferon beta-1a). This publication is in addition to a presentation of preliminary results from the same study presented at the 2006 American Academy of Neurology Annual Meeting.
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 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), infections, depression and gallstones. 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 trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups.
Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
In addition to the United States and European Union, TYSABRI is also approved in Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
TYSABRI(R) Demonstrates Significant Health-Related Quality-of-Life Improvements for Multiple Sclerosis Patients in Study Published in Annals of Neurology
Monday August 20, 2:00 am ET
CAMBRIDGE, Mass.& DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today the publication of results demonstrating that patients treated with TYSABRI® (natalizumab) showed a significant improvement in health-related quality-of-life (HRQoL) measures when compared to placebo. These results are from the first Phase III multiple sclerosis (MS) studies that have demonstrated improvement on HRQoL measures in patients with relapsing forms of MS. The results have been published in today's issue of Annals of Neurology.
ADVERTISEMENT
"These data showed that patients treated with TYSABRI were more likely to experience statistically important improvement in the quality-of-life measures used to assess meaningful disease improvement or progression. These findings have not been previously observed in clinical studies involving MS patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, the lead investigator of the study.
These two-year, randomized, double-blind, placebo-controlled, multicenter, Phase III clinical trials (AFFIRM and SENTINEL) were conducted in 2,113 patients with relapsing forms of MS. The objective was to assess the relationship between disease activity and HRQoL in relapsing forms of MS, and the impact of TYSABRI on these measures.
In the studies, HRQoL was assessed using two different measures at baseline and weeks 24, 52 and 104:
* The Short Form-36 (SF-36), a standardized, well-validated survey that has been used extensively in many disease areas, including MS to review health status. The SF-36 is comprised of 36 questions designed to assess physical (Physical Component Summary or PCS) and mental (Mental Component Summary or MCS) well-being from the perspective of the patient.
* The Visual Analogue Scale (VAS), a measure of well-being as assessed by the patient and marked on a scale of 0 to 100, with 0 indicating "poor" and 100 indicating "excellent."
Results from the AFFIRM monotherapy trial include:
* A statistically significant improvement in SF-36 PCS beginning at week 24 and all subsequent time points compared with a decline in the placebo-treated group.
* A statistically significant improvement in SF-36 MCS at week 104 compared with a decline in the placebo-treated group.
* Statistically significant benefits using the VAS when compared with placebo at week 52 and at week 104.
* Patients showed sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
* HRQoL measures correlated with common measures of MS severity, including EDSS, sustained disability progression, relapse number, MSFC and volume of T2-hyperintense and T1-hypointense lesions.
Improvements on quality-of-life measures were also observed in the SENTINEL study, in which TYSABRI was added to AVONEX® (Interferon beta-1a). This publication is in addition to a presentation of preliminary results from the same study presented at the 2006 American Academy of Neurology Annual Meeting.
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 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), infections, depression and gallstones. 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 trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups.
Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
In addition to the United States and European Union, TYSABRI is also approved in Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
For more information about TYSABRI please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.
By: omahavet6644
Goodbody Brokers (Ian Hunter) Maintains "ADD" Rating on Elan
Monday, August 20, 2007 9:51:49 AM ET
Goodbody Stockbrokers
NEW YORK, August 20 (newratings.com) ? Analyst Ian Hunter of Goodbody Stockbrokers maintains his "add" rating on Elan Corp Plc (ELN.NYS).
In a research note published this morning, the analyst mentions that the company and its partner, Biogen Idec, recently declared that the clinical trial data on Tysabri?s impact on health-related quality of life measures in MS patients has been published in a peer review journal, the Annals of Neurology. The data indicates that the chances of patients on Tysabri experiencing a statistically vital improvement in the quality of life measures have increased, the analyst says. These data also reaffirms that Tysabri?s potential benefits overshadow the risks, which is expected to boost the drug's sales during the remainder of FY08 and into FY08.
Goodbody Brokers (Ian Hunter) Maintains "ADD" Rating on Elan
Monday, August 20, 2007 9:51:49 AM ET
Goodbody Stockbrokers
NEW YORK, August 20 (newratings.com) ? Analyst Ian Hunter of Goodbody Stockbrokers maintains his "add" rating on Elan Corp Plc (ELN.NYS).
In a research note published this morning, the analyst mentions that the company and its partner, Biogen Idec, recently declared that the clinical trial data on Tysabri?s impact on health-related quality of life measures in MS patients has been published in a peer review journal, the Annals of Neurology. The data indicates that the chances of patients on Tysabri experiencing a statistically vital improvement in the quality of life measures have increased, the analyst says. These data also reaffirms that Tysabri?s potential benefits overshadow the risks, which is expected to boost the drug's sales during the remainder of FY08 and into FY08.
Antwort auf Beitrag Nr.: 31.227.827 von Birgit.Tersteegen am 20.08.07 14:31:54da bin ich mal ein paar Tage unterwegs (ohne Internet) und dann geht der Kurs in den Keller.
da wollen die INSTS wohl ganz schnell auf 70% kommen.
(aber meine bekommen die nicht)
da wollen die INSTS wohl ganz schnell auf 70% kommen.
(aber meine bekommen die nicht)
Antwort auf Beitrag Nr.: 31.234.286 von Poppholz am 20.08.07 23:13:02--nee, meine auch nicht....
Gute Nacht!
Gute Nacht!
By: zamboni_kid S
ELN /WYE Front page of Business Section NJ Star-Ledger
http://www.nj.com/business/ledger/index.ssf?/base/business-1…
"Two years after Wyeth partnered with Elan, the companies suspended clinical trials of the experimental Alzheimer's vaccine after it caused brain inflammation in 18 patients. The vaccine was designed to produce antibodies that would trigger the body's immune system to attack the protein deposits known as amyloid plaque.
After suspending the clinical trials, the companies reformulated the original therapy into two other products, a new vaccine and AAB-001, a monoclonal antibody that is designed to be injected into patients to attack the debilitating brain plaque.
The product is currently in late-stage clinical trials, and Wyeth hopes to gain Food and Drug Administration approval to market the drug in 2009. That could make it the first disease-modifying treatment to reach the market."
ELN /WYE Front page of Business Section NJ Star-Ledger
http://www.nj.com/business/ledger/index.ssf?/base/business-1…
"Two years after Wyeth partnered with Elan, the companies suspended clinical trials of the experimental Alzheimer's vaccine after it caused brain inflammation in 18 patients. The vaccine was designed to produce antibodies that would trigger the body's immune system to attack the protein deposits known as amyloid plaque.
After suspending the clinical trials, the companies reformulated the original therapy into two other products, a new vaccine and AAB-001, a monoclonal antibody that is designed to be injected into patients to attack the debilitating brain plaque.
The product is currently in late-stage clinical trials, and Wyeth hopes to gain Food and Drug Administration approval to market the drug in 2009. That could make it the first disease-modifying treatment to reach the market."
Moin, da man vorsichtigerweise nun nicht investiert ist, warten wir mal den Verlauf ruhig ab.
bei spätestens $14,50/15 rum erinnert sich das
Ge(z)socks wieder an nen Buybutten. Dann vielleicht kleinen Doppelaufschlag dort abwarten und sollte das so sein wieder rin in die Pampe. Ansonsten nächster halt 12.
Über 22,60 rum ist die Welt generell wieder rosa und alle kaufen wieder wie bekloppt.
keine Ahnung ob das richtig ist...
bei spätestens $14,50/15 rum erinnert sich das
Ge(z)socks wieder an nen Buybutten. Dann vielleicht kleinen Doppelaufschlag dort abwarten und sollte das so sein wieder rin in die Pampe. Ansonsten nächster halt 12.
Über 22,60 rum ist die Welt generell wieder rosa und alle kaufen wieder wie bekloppt.
keine Ahnung ob das richtig ist...
Antwort auf Beitrag Nr.: 31.235.024 von Nostarowie am 21.08.07 06:56:01Also ICH warte GEDULDIG ab OBWOHL ich vollständig investiert bin...
Interesting Analyst Note Today on WYE and Bapineuzumab
Credit Suisse put out a long Research Report today entitled What to Do with Wyeth.The report is well done and fairly comprehensive. It says (in part, the full report is 20 pages long):
"The recent share price decline could increase WYE acquisition attraction and our SOTP analysis implies a take-out value of $69/share."
They go on to say that"a PFE/WYE combination is strategically and financially attractive.."
Now comes the interesting part:
"It is important to account for the change of control provision with bapineuzumab. The collaberation agreement provides that if either WYE or ELN is acquired by a third party, the other company has the opportunity to buy out the rights to this collaberation. In our sum-of-the parts standalone valuation, the pipeline component contains the value of bapineuzumab. We assume that if WYE is acquired, ELN will exercise its buyout, and thus we deduct the value of bapineuzumab from our takeout valuation. Our $6 per share valuation of bapineuzumab assumes peak sales of approximately $5 billion, which could be conservative, as discussed in our May 21,2007 note "WYE:Alzheimer's Drug Could Be Landscape Altering."
If we do a little math, if BAP is worth $6/share to WYE, times 1.344 billion WYE shares outstanding, the value would be $8.064 billion. Taking that figure and dividing by ELN's 468 million shares outstanding, provides a value of $17.23 per ELN share. That is present value for a drug not yet in Phase3.
What was the closing price of ELN today?
Also sind wir jetzt NUR NOCH mit unserer Alz-Forschung bewertet....
Ich bin sehr optimistisch, dass auch der Markt dies erkennt---NACH dem allgemeinen depressiven Tunnelblick...
Credit Suisse put out a long Research Report today entitled What to Do with Wyeth.The report is well done and fairly comprehensive. It says (in part, the full report is 20 pages long):
"The recent share price decline could increase WYE acquisition attraction and our SOTP analysis implies a take-out value of $69/share."
They go on to say that"a PFE/WYE combination is strategically and financially attractive.."
Now comes the interesting part:
"It is important to account for the change of control provision with bapineuzumab. The collaberation agreement provides that if either WYE or ELN is acquired by a third party, the other company has the opportunity to buy out the rights to this collaberation. In our sum-of-the parts standalone valuation, the pipeline component contains the value of bapineuzumab. We assume that if WYE is acquired, ELN will exercise its buyout, and thus we deduct the value of bapineuzumab from our takeout valuation. Our $6 per share valuation of bapineuzumab assumes peak sales of approximately $5 billion, which could be conservative, as discussed in our May 21,2007 note "WYE:Alzheimer's Drug Could Be Landscape Altering."
If we do a little math, if BAP is worth $6/share to WYE, times 1.344 billion WYE shares outstanding, the value would be $8.064 billion. Taking that figure and dividing by ELN's 468 million shares outstanding, provides a value of $17.23 per ELN share. That is present value for a drug not yet in Phase3.
What was the closing price of ELN today?
Also sind wir jetzt NUR NOCH mit unserer Alz-Forschung bewertet....
Ich bin sehr optimistisch, dass auch der Markt dies erkennt---NACH dem allgemeinen depressiven Tunnelblick...
By: goodtoreadthis
News bump = $2-3 or am I kidding myself ?
Next week we have the Tysabri safety discussion at a conference that was actually promised for Oct. Any chance they are accelerating release of the data cause it's terrible ? Nah - or at least I hope- Nah.
Have heard poop from inside FDA that FDA is breaking all kinds of organization precedents to get aab-001 into phase 3 trial soonest. Understand that conf on aab with WYE/Elan is early Sept. Lars told us to watch gov/trials for announcement.
Ridge told us that patient evaluations already going on in Ireland. Trials.gov announcement in states followed by similar announcement or preceeding announcement in EU. We need 6 months data. Phase 2 for aab-001 ends end of Qtr 1 08. Six months timeline for phase 3 data with a Sept start date is end of qtr 1 08. Subpart E filing in May and approval for symptom relief in July - or Sept with AC and summer vacation.
It has been a very, very long time since Olga told us that management is being VERY conservative with scheduling. It has been since at Least May since Km told us that getting quickly into phase 3 trial for aab-001 is imperative.
If these happen, and crohns decision and T safety data are positive, is the bump in the post title realistic or just wishful thinking ?
News bump = $2-3 or am I kidding myself ?
Next week we have the Tysabri safety discussion at a conference that was actually promised for Oct. Any chance they are accelerating release of the data cause it's terrible ? Nah - or at least I hope- Nah.
Have heard poop from inside FDA that FDA is breaking all kinds of organization precedents to get aab-001 into phase 3 trial soonest. Understand that conf on aab with WYE/Elan is early Sept. Lars told us to watch gov/trials for announcement.
Ridge told us that patient evaluations already going on in Ireland. Trials.gov announcement in states followed by similar announcement or preceeding announcement in EU. We need 6 months data. Phase 2 for aab-001 ends end of Qtr 1 08. Six months timeline for phase 3 data with a Sept start date is end of qtr 1 08. Subpart E filing in May and approval for symptom relief in July - or Sept with AC and summer vacation.
It has been a very, very long time since Olga told us that management is being VERY conservative with scheduling. It has been since at Least May since Km told us that getting quickly into phase 3 trial for aab-001 is imperative.
If these happen, and crohns decision and T safety data are positive, is the bump in the post title realistic or just wishful thinking ?
Hallo Birgit,
super Arbeit, die Du hier in den letzten Tagen ablieferst.
Da mir momentan die Zeit und der "Full-Time-Internetzugang" fehlt fällt meine Recherche momentan mager aus.
Bei den momentanen Kursverläufen fehlen mir allerdings auch die aufmunternden Worte. Alle Longies kennen meine Einschätzung und an der hat sich auch nichts geändert (warum auch). Für Neuleser würde meine Meinung bei dem momentanen Kursverlauf nur nach "pusherei" aussehen.
super Arbeit, die Du hier in den letzten Tagen ablieferst.
Da mir momentan die Zeit und der "Full-Time-Internetzugang" fehlt fällt meine Recherche momentan mager aus.
Bei den momentanen Kursverläufen fehlen mir allerdings auch die aufmunternden Worte. Alle Longies kennen meine Einschätzung und an der hat sich auch nichts geändert (warum auch). Für Neuleser würde meine Meinung bei dem momentanen Kursverlauf nur nach "pusherei" aussehen.
By: delta_squared
Sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
http://fdanews.com/newsletter/article?issueId=10609&articleI…
sounds good to me:
RxTrials Institute Drug Pipeline Alert
Aug. 21, 2007 | Vol. 5 No. 164
Biogen Idec, Elan Publish Tysabri Results
Biogen Idec and Elan announced the publication of results of Phase III studies of Tysabri in the Annals of Neurology, demonstrating that patients with relapsing forms of multiple sclerosis treated with the drug showed significant improvement in health-related quality-of-life measures when compared with placebo.
According to Biogen and Elan, 2,113 patients participated in the two-year, randomized, double-blind, placebo-controlled, multicenter Phase III clinical trials, AFFIRM and SENTINEL.
Published results from the AFFIRM included:
* A statistically significant improvement in physical wellbeing beginning at week 24 and all subsequent time points, compared with a decline in the placebo-treated group;
* A statistically significant improvement in me at week 104, compared with a decline in the placebo-treated group;
* Statistically significant benefits using the visual analogue scale — a measure of wellbeing as assessed by the patient — when compared with placebo at weeks 52 and 104; and
* Sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
Improvements on quality-of-life measures were also observed in the SENTINEL study, in which Tysabri was added to Avonex (interferon beta-1a), the article added.
Sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
http://fdanews.com/newsletter/article?issueId=10609&articleI…
sounds good to me:
RxTrials Institute Drug Pipeline Alert
Aug. 21, 2007 | Vol. 5 No. 164
Biogen Idec, Elan Publish Tysabri Results
Biogen Idec and Elan announced the publication of results of Phase III studies of Tysabri in the Annals of Neurology, demonstrating that patients with relapsing forms of multiple sclerosis treated with the drug showed significant improvement in health-related quality-of-life measures when compared with placebo.
According to Biogen and Elan, 2,113 patients participated in the two-year, randomized, double-blind, placebo-controlled, multicenter Phase III clinical trials, AFFIRM and SENTINEL.
Published results from the AFFIRM included:
* A statistically significant improvement in physical wellbeing beginning at week 24 and all subsequent time points, compared with a decline in the placebo-treated group;
* A statistically significant improvement in me at week 104, compared with a decline in the placebo-treated group;
* Statistically significant benefits using the visual analogue scale — a measure of wellbeing as assessed by the patient — when compared with placebo at weeks 52 and 104; and
* Sustained improvement from baseline quality-of-life measures, not just a slowing down of quality-of-life deterioration.
Improvements on quality-of-life measures were also observed in the SENTINEL study, in which Tysabri was added to Avonex (interferon beta-1a), the article added.
mhhh der Kurs schaut ja richtig lecker zum Einsteigen aus !!?
Antwort auf Beitrag Nr.: 31.248.333 von vegiwulu am 21.08.07 23:40:08...na dann aber FLOTT
Antwort auf Beitrag Nr.: 31.248.333 von vegiwulu am 21.08.07 23:40:08Einstiegskurse liegen auch bei $18,- und $19,-.
Antwort auf Beitrag Nr.: 31.248.467 von Poppholz am 21.08.07 23:53:14natürlich machen die Steigerungen von $17,xx noch ein wenig mehr Spass.
News for 'ELN' - (DJ Elan Corp: NICE Recommends TYSABRI(R) >ELN)
Edited Press Release
LONDON (Dow Jones)--Biogen Idec and Elan Corporation, said Wednesday that the National Institute for Health and Clinical Excellence (NICE) has recommended the use of TYSABRI(R) (nataliz! umab) in people with highly active relapsing remitting multiple sclerosis (RRMS).
TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE.
Professor Gavin Giovannoni, The Royal London Hospital commented: "Following Wednesday's NICE guidance, our priority now must be to ensure that those patients with the most highly active form of MS have access to this treatment".
Following a positive NICE decision, there is a legal requirement for funding to be put in place to cover treatment within three months of the recommendation. In addition, clinicians are required to take the NICE guidance into account when reaching decisions about appropriate care for patients.
In addition to the European Union and the United States, TYSABRI is approved in Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
(END) Dow Jones Newswi! res
August 22, 2007 02:11 ET (06:11 GMT)
C opyright (c) 2007 Dow Jones & Company, Inc.- - 02 11 AM EDT 08-22-07
Edited Press Release
LONDON (Dow Jones)--Biogen Idec and Elan Corporation, said Wednesday that the National Institute for Health and Clinical Excellence (NICE) has recommended the use of TYSABRI(R) (nataliz! umab) in people with highly active relapsing remitting multiple sclerosis (RRMS).
TYSABRI is the first treatment for multiple sclerosis to be recommended for use by NICE.
Professor Gavin Giovannoni, The Royal London Hospital commented: "Following Wednesday's NICE guidance, our priority now must be to ensure that those patients with the most highly active form of MS have access to this treatment".
Following a positive NICE decision, there is a legal requirement for funding to be put in place to cover treatment within three months of the recommendation. In addition, clinicians are required to take the NICE guidance into account when reaching decisions about appropriate care for patients.
In addition to the European Union and the United States, TYSABRI is approved in Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
(END) Dow Jones Newswi! res
August 22, 2007 02:11 ET (06:11 GMT)
C opyright (c) 2007 Dow Jones & Company, Inc.- - 02 11 AM EDT 08-22-07
NHS agrees to fund 'vital' MS drug-----Daily Mail
Last updated at 23:39pm on 21st August 2007
The drug has been shown to cut relapses by 68%
An MS drug that cuts the chance of relapse by nearly three-quarters is to be made available on the NHS.
Around 3,000 patients with the most severe form of multiple sclerosis could benefit from the decision by the Government's 'rationing' body.
The National Institute for Health and Clinical Excellence will confirm today that patients with a rapidly disabling form of MS can be treated with Tysabri.
The drug, which has been shown to cut relapses by 68 per cent and reduce the risk of disability progression by 54 per cent, works by stopping immune cells leaving the bloodstream to attack the spinal cord.
Made by Irish drugs company Elan, the medication costs around £12,000 a year and is given intravenously each month.
Neurologist Professor Gavin Giovannoni, of The Royal London Hospital, said: "This is an important decision that will transform people, allowing them to enjoy a more active and fulfilled life."
Simon Gillespie, chief executive of the MS Society, said: "We welcome confirmation of NICE's decision, which represents a vital treatment option."
Last updated at 23:39pm on 21st August 2007
The drug has been shown to cut relapses by 68%
An MS drug that cuts the chance of relapse by nearly three-quarters is to be made available on the NHS.
Around 3,000 patients with the most severe form of multiple sclerosis could benefit from the decision by the Government's 'rationing' body.
The National Institute for Health and Clinical Excellence will confirm today that patients with a rapidly disabling form of MS can be treated with Tysabri.
The drug, which has been shown to cut relapses by 68 per cent and reduce the risk of disability progression by 54 per cent, works by stopping immune cells leaving the bloodstream to attack the spinal cord.
Made by Irish drugs company Elan, the medication costs around £12,000 a year and is given intravenously each month.
Neurologist Professor Gavin Giovannoni, of The Royal London Hospital, said: "This is an important decision that will transform people, allowing them to enjoy a more active and fulfilled life."
Simon Gillespie, chief executive of the MS Society, said: "We welcome confirmation of NICE's decision, which represents a vital treatment option."
By: goodtoreadthis
Wow- Elan discovers Public Relations and Press Releases
The NICE PR follows close behind the Quality of Life re-release of data PR.
This is a new feature.
--------------------------genau,unser Management hat das Instrument "Presseerklärungen" entdeckt.....
Wow- Elan discovers Public Relations and Press Releases
The NICE PR follows close behind the Quality of Life re-release of data PR.
This is a new feature.
--------------------------genau,unser Management hat das Instrument "Presseerklärungen" entdeckt.....
...und weil sie`s jetzt entdeckt haben,machen sie hoffentlich gaaaaaaaaaaaaaaaaaaaaaanz viele davon.....
NICE Recommends TYSABRI(R) for Use in Highly Active Relapsing Remitting Multiple Sclerosis
http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew…
Final Guidance Issued on First MS Treatment Recommended by NICE
Elan Corporation PLC
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) welcome final
guidance announced today by the National Institute for Health and Clinical
Excellence (NICE) recommending use of TYSABRI(R) (natalizumab) in people with
highly active relapsing remitting multiple sclerosis (RRMS). TYSABRI is the
first treatment for multiple sclerosis to be recommended for use by NICE.
'This is an important decision that offers to transform the lives of people with
highly active relapsing remitting multiple sclerosis by delaying the progression
of their disease, thereby allowing them to enjoy a more active and fulfilled
life,' commented Professor Gavin Giovannoni, The Royal London Hospital.
'Following today's NICE guidance, our priority now must be to ensure that those
patients with the most highly active form of MS have access to this treatment.'
Following a positive NICE decision, there is a legal requirement for funding to
be put in place to cover treatment within three months of the recommendation. In
addition, clinicians are required to take the NICE guidance into account when
reaching decisions about appropriate care for patients.
Highly active RRMS (defined in the NICE final guidance as two or more disabling
relapses in one year and an active MRI scan) has a devastating effect on the
lives of the individual and their families. These patients experience more
relapses and will become disabled more quickly than those people with typical
RRMS. Disability often means that these patients are unable to work, adversely
affecting their families as well.
TYSABRI is the first treatment to be specifically licensed for highly active
RRMS. Over two years, treatment with TYSBARI for highly active RRMS, defined as
those with two or more relapses and MRI activity, leads to a 64% reduction in
the risk of disability progression and an 81% reduction in annualised relapse
rate compared with placebo.(1)
As of mid-July 2007, approximately 14,000 MS patients worldwide are currently
receiving therapy with TYSABRI, either in the commercial setting or in clinical
trials.
Guidance on the use of TYSABRI has been issued through the NICE Single
Technology Appraisal (STA) process, which is designed to produce guidance more
quickly on life-saving drugs that have already been licensed and on new
medicines close to when they first become available.
NICE Recommends TYSABRI(R) for Use in Highly Active Relapsing Remitting Multiple Sclerosis
http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew…
Final Guidance Issued on First MS Treatment Recommended by NICE
Elan Corporation PLC
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) welcome final
guidance announced today by the National Institute for Health and Clinical
Excellence (NICE) recommending use of TYSABRI(R) (natalizumab) in people with
highly active relapsing remitting multiple sclerosis (RRMS). TYSABRI is the
first treatment for multiple sclerosis to be recommended for use by NICE.
'This is an important decision that offers to transform the lives of people with
highly active relapsing remitting multiple sclerosis by delaying the progression
of their disease, thereby allowing them to enjoy a more active and fulfilled
life,' commented Professor Gavin Giovannoni, The Royal London Hospital.
'Following today's NICE guidance, our priority now must be to ensure that those
patients with the most highly active form of MS have access to this treatment.'
Following a positive NICE decision, there is a legal requirement for funding to
be put in place to cover treatment within three months of the recommendation. In
addition, clinicians are required to take the NICE guidance into account when
reaching decisions about appropriate care for patients.
Highly active RRMS (defined in the NICE final guidance as two or more disabling
relapses in one year and an active MRI scan) has a devastating effect on the
lives of the individual and their families. These patients experience more
relapses and will become disabled more quickly than those people with typical
RRMS. Disability often means that these patients are unable to work, adversely
affecting their families as well.
TYSABRI is the first treatment to be specifically licensed for highly active
RRMS. Over two years, treatment with TYSBARI for highly active RRMS, defined as
those with two or more relapses and MRI activity, leads to a 64% reduction in
the risk of disability progression and an 81% reduction in annualised relapse
rate compared with placebo.(1)
As of mid-July 2007, approximately 14,000 MS patients worldwide are currently
receiving therapy with TYSABRI, either in the commercial setting or in clinical
trials.
Guidance on the use of TYSABRI has been issued through the NICE Single
Technology Appraisal (STA) process, which is designed to produce guidance more
quickly on life-saving drugs that have already been licensed and on new
medicines close to when they first become available.
Als "Gegengift zur Jammerei über den Kurs finde ich RXDUDETTE immer wieder klasse----sie tringt auch gern Pinot....
By: rxdudette Send PM Profile Ignore Recommend Add To Favorites
Wow ......you all have too much time on your hands
Downsizing as a result of generic Maxipime.......... OLD NEWS
Refocus on Neurology........shocking and OLD NEWS
Restructuring to accomplish the above.........OLD NEWS.
Restructuring is a good thing and proper under the circumstances.
Why is it that everyone is analyzing this at a "micro" level.......it ALL makes sense and has been known for months. Gee whizzzzzzz.
You have got to be patient and let this market shake out.... your investment has not changed.......it just got better.
I'm sorry about trying to minimize this drop in pps, but it is just another "storm to weather" and it will be short lived. I just can't repeat all the info that you need to feel "comfi"......I don't have the energy today. For heaven's sake.....chill out - go take a vacation, whether it be from this board or a real one in "Tahiti" or somewhere lovely.
LIFE IS REAL DAMNED GOOD IF YOU WILL JUST BE PATIENT FOR A LITTLE WHILE LONGER!!!!!!!!!!!!!!!!!
I Know this gets tiresome.....but have a BIG OLD GLASS OF PINOT and cram some cheese and crackers in you mouth and BE HAPPY.....otherwise SELL SELL SELL.
as always,
CHEEEEEERS,
RX
By: rxdudette Send PM Profile Ignore Recommend Add To Favorites
Wow ......you all have too much time on your hands
Downsizing as a result of generic Maxipime.......... OLD NEWS
Refocus on Neurology........shocking and OLD NEWS
Restructuring to accomplish the above.........OLD NEWS.
Restructuring is a good thing and proper under the circumstances.
Why is it that everyone is analyzing this at a "micro" level.......it ALL makes sense and has been known for months. Gee whizzzzzzz.
You have got to be patient and let this market shake out.... your investment has not changed.......it just got better.
I'm sorry about trying to minimize this drop in pps, but it is just another "storm to weather" and it will be short lived. I just can't repeat all the info that you need to feel "comfi"......I don't have the energy today. For heaven's sake.....chill out - go take a vacation, whether it be from this board or a real one in "Tahiti" or somewhere lovely.
LIFE IS REAL DAMNED GOOD IF YOU WILL JUST BE PATIENT FOR A LITTLE WHILE LONGER!!!!!!!!!!!!!!!!!
I Know this gets tiresome.....but have a BIG OLD GLASS OF PINOT and cram some cheese and crackers in you mouth and BE HAPPY.....otherwise SELL SELL SELL.
as always,
CHEEEEEERS,
RX
momentan kommen angenehme News zu unserem Baby und bald wird dieses auch von der breiten Öffenlichkeit erkannt werden.
(nicht nur von den Insties und von uns)
(nicht nur von den Insties und von uns)
...bin wieder kurzfristig anderweitig beschäftigt :Lungenentzündung im Krankenhaus und Hochwasser im Ferienhaus....kann also nur besser werden...Gute Nacht!
Msg: 143075 of 143266 8/22/2007 10:42:52 AM
By: Norwoodone Send PM Profile Ignore Recommend Add
From the T Rowe Price semi annual "Health Science Fund" report dated June 30th 2007
The portfolio’s second-best first-half contributor was Elan. A little over two years ago, its multiple sclerosis medication Tysabri, at that time the most promising drug we had ever evaluated, suffered a near-fatal blow due to revelations that it was associated with a very rare and serious side effect called progressive multifocal leukoen-cephalopathy (PML). Three patients taking Tysabri in combination with other drugs contracted this viral infection while on the drug in clinical trials. After voluntarily withdrawing the drug from the market in 2005, Elan reintroduced it in mid-2006 after the risk of contracting PML was better characterized and a risk management program was implemented to minimize the danger. More than 10,000 commercial patients are currently taking Tysabri, and we believe the drug will enjoy strong sales as long as the risk of PML remains low.
Following a flat stock performance in 2006, Elan’s shares rallied strongly in 2007, as the market came to share our enthusiasm for Elan’s pipeline of drugs to treat Alzheimer’s. The company has partnered with Wyeth to develop AAB-001, a monoclonal antibody to treat Alzheimer’s. While there are still plenty of uncertainties, AAB-001 could become just the type of drug we look for to transform a company.
By: Norwoodone Send PM Profile Ignore Recommend Add
From the T Rowe Price semi annual "Health Science Fund" report dated June 30th 2007
The portfolio’s second-best first-half contributor was Elan. A little over two years ago, its multiple sclerosis medication Tysabri, at that time the most promising drug we had ever evaluated, suffered a near-fatal blow due to revelations that it was associated with a very rare and serious side effect called progressive multifocal leukoen-cephalopathy (PML). Three patients taking Tysabri in combination with other drugs contracted this viral infection while on the drug in clinical trials. After voluntarily withdrawing the drug from the market in 2005, Elan reintroduced it in mid-2006 after the risk of contracting PML was better characterized and a risk management program was implemented to minimize the danger. More than 10,000 commercial patients are currently taking Tysabri, and we believe the drug will enjoy strong sales as long as the risk of PML remains low.
Following a flat stock performance in 2006, Elan’s shares rallied strongly in 2007, as the market came to share our enthusiasm for Elan’s pipeline of drugs to treat Alzheimer’s. The company has partnered with Wyeth to develop AAB-001, a monoclonal antibody to treat Alzheimer’s. While there are still plenty of uncertainties, AAB-001 could become just the type of drug we look for to transform a company.
Msg: 143393 of 143398 8/23/2007 8:35:30 AM Recs: 13 Sentiment: Not Disclosed
By: peadar_og
NICE
I feel the NICE news is significant.
Not only does is separate Tysabri from the crowd again, it represents a very big marketing opportunity. From a cost basis alone, Tysabri is now the only MS treatment option available to many UK sufferers.
No other MS therapy is approved by NICE.
Peadar ‘Og
By: peadar_og
NICE
I feel the NICE news is significant.
Not only does is separate Tysabri from the crowd again, it represents a very big marketing opportunity. From a cost basis alone, Tysabri is now the only MS treatment option available to many UK sufferers.
No other MS therapy is approved by NICE.
Peadar ‘Og
Msg: 143296 of 143406 8/22/2007
By: ipar4s2
Wyeth is hiring a Senior Director - New Business to "Develop and execute aligned commercial strategy for the portfolio of partnered prelaunch and pipeline products within the Wyeth-Elan partnership for short-term profitability and long-term investment."
I think sooner rather than later. Dr. Melinkova appears on to something. I'm thinking Symptom Management Sub E "Rolling" BLA very soon.
Sr Director - New Business
Requisition ID 17884
Location Collegeville, PA
Description At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.
Job Summary
Develop and execute aligned commercial strategy for the portfolio of partnered prelaunch and pipeline products within the Wyeth-Elan partnership for short-term profitability and long-term investment. Expected to coordinate launch components and strategic marketing efforts for BAPINEUZUMAB (AAB-001) and any other partnered compounds as they move forward through clinical phases.
Job Responsibilities
*Provide commercial leadership to prepare BAPINEUZUMAB for global market introduction. Lead development of strong communications strategies to assure successful global market introduction and long term product performance. Lead prelaunch preparations including development of global/U.S. commercialization plan, launch timing assessment, affiliate coordination and interface, forecasting,. Develop pricing, reimbursement and payer/access strategies and tactics to secure access for the largest number of appropriate patients worldwide. Lead Working Groups for Wyeth-Elan Alliance as required to achieve Commercial goals. Assure advertising, publication, convention, medical education, and promotional plans are in place and implemented. Act as liaison to GTT and TO&PS departments to develop a global distribution strategy that will ensure an uninterrupted product supply.
*Represent commercial interests on Confim/Global Brand Team to prepare BAPINEUZUMAB for global market introduction. Assure that key commercial requirements are addressed within all clinical development plans (including global reimbursement requirements).
By: ipar4s2
Wyeth is hiring a Senior Director - New Business to "Develop and execute aligned commercial strategy for the portfolio of partnered prelaunch and pipeline products within the Wyeth-Elan partnership for short-term profitability and long-term investment."
I think sooner rather than later. Dr. Melinkova appears on to something. I'm thinking Symptom Management Sub E "Rolling" BLA very soon.
Sr Director - New Business
Requisition ID 17884
Location Collegeville, PA
Description At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business.
Job Summary
Develop and execute aligned commercial strategy for the portfolio of partnered prelaunch and pipeline products within the Wyeth-Elan partnership for short-term profitability and long-term investment. Expected to coordinate launch components and strategic marketing efforts for BAPINEUZUMAB (AAB-001) and any other partnered compounds as they move forward through clinical phases.
Job Responsibilities
*Provide commercial leadership to prepare BAPINEUZUMAB for global market introduction. Lead development of strong communications strategies to assure successful global market introduction and long term product performance. Lead prelaunch preparations including development of global/U.S. commercialization plan, launch timing assessment, affiliate coordination and interface, forecasting,. Develop pricing, reimbursement and payer/access strategies and tactics to secure access for the largest number of appropriate patients worldwide. Lead Working Groups for Wyeth-Elan Alliance as required to achieve Commercial goals. Assure advertising, publication, convention, medical education, and promotional plans are in place and implemented. Act as liaison to GTT and TO&PS departments to develop a global distribution strategy that will ensure an uninterrupted product supply.
*Represent commercial interests on Confim/Global Brand Team to prepare BAPINEUZUMAB for global market introduction. Assure that key commercial requirements are addressed within all clinical development plans (including global reimbursement requirements).
Dr menikova ist mir sympatisch, egal wie sie aussehen mag.
posimist
posimist
Antwort auf Beitrag Nr.: 31.269.395 von Birgit.Tersteegen am 23.08.07 15:23:57
sieht gut aus heute
sieht gut aus heute
Antwort auf Beitrag Nr.: 31.285.428 von surga am 24.08.07 19:18:15
Antwort auf Beitrag Nr.: 31.285.428 von surga am 24.08.07 19:18:15
Scheinbar gibt es drei Familien im Investorvillage/Group (Elanians),die Angehörige in Elan/Whyths Phase 2 ALZ-Tests haben....--ist natürlich klasse,weil wir dann mal was erfahren...
By: liposghost
good news for us better news for our friend
one of our Elanian friends has young wife in the aab 001 PII and for 18 months it was a contnued downhill run for her.
But last month she went Open Label, the real thing for sure.
This week she is reading the newspaper, reading menu, ordering own food and discussing with the waiter.
Having conversations with family.
At least for one family we know it works well. Lets hope for a long time.
We are happy for you EC.
the haint and all of elania
By: liposghost
good news for us better news for our friend
one of our Elanian friends has young wife in the aab 001 PII and for 18 months it was a contnued downhill run for her.
But last month she went Open Label, the real thing for sure.
This week she is reading the newspaper, reading menu, ordering own food and discussing with the waiter.
Having conversations with family.
At least for one family we know it works well. Lets hope for a long time.
We are happy for you EC.
the haint and all of elania
$19.69,
HI!
Es gibt Übernahmegerüchte bzgl Biogen und im IV-Board wird spekuliert,was das für Elan bedeuten würde---z.B. ob wir -ähm ich meine Elan-Biogen die andere Hälfte Tysabri abkaufen könnte--fragt sich nur von welchem Geld (müsste also ein Geldgeber /Partner her),oder ob Elan Ty.an Biogen verkauft,die Schulden los wäre-eine reine Entwicklungsfirma würde und sich voll auf ALZ konzentriert....leider verstehe ich sprachlich nicht Alles...
Icahn May Boost Biogen Stake, Forecasts Takeover (Update1)
By Luke Timmerman
Aug. 25 (Bloomberg) -- Billionaire investor Carl C. Icahn may increase his stake in Biogen Idec Inc. because he says the company is undervalued and a takeover candidate, according to a person familiar with Icahn's thinking.
The Federal Trade Commission cleared the New York investor to buy more shares in Biogen, the world's largest maker of drugs for multiple sclerosis, according to a message posted yesterday on the agency's Web site.
A big drugmaker with expiring patents on top-selling medicines may want to buy Biogen, the person said. Icahn bought shares in MedImmune Inc. before helping to force a sale of the biotechnology company in April to AstraZeneca Plc for $15 billion, double the market value a month earlier. Biogen is valued at 27 times profit, down from 48 times in February 2005, when its multiple sclerosis drug Tysabri was withdrawn because of a link to rare brain infections.
``As a matter of policy, we don't comment on the activities of specific investors,'' Biogen spokesman Tim Hunt said in a telephone interview. ``The management of Biogen is focused on building value for all the company's owners by continuing to execute its strategic plan.''
The Cambridge, Massachusetts-based company rose $2.92, or 4.9 percent, to a 52-week high of $62.89 yesterday in Nasdaq Stock Market composite trading. The stock has risen 28 percent this year and 85 percent since the temporary withdrawal of Tysabri two years ago.
MedImmune Investment
Earlier this month, Icahn reported acquiring 2.74 million shares, or almost 1 percent, of Biogen. A call to Icahn's office in New York after business hours yesterday wasn't returned.
Icahn increased his holdings of MedImmune, based in Gaithersburg, Maryland, by almost 50 percent before the company agreed to be bought by AstraZeneca. He had 2.78 million shares at the end of 2006, raising his stake to 4.13 million, or 1.7 percent, as of March 31, according to data compiled by Bloomberg.
The purchases paid off. The shares traded as low as $30.64 on March 5 then doubled in the next month to $58, when MedImmune, the maker of the FluMist nasal-spray influenza vaccine, agreed to be bought by London-based AstraZeneca.
ImClone
Besides its MS drugs, Biogen co-markets the cancer treatment Rituxan with Genentech Inc., based in South San Francisco, California. Rituxan, a treatment for non-Hodgkin's lymphoma and rheumatoid arthritis, had $2.1 billion in sales in 2006.
Biogen is the No. 5 U.S. biotech company ranked by sales, with $2.7 billion in revenue in 2006, based on data compiled by Bloomberg. It follows Amgen Inc., Genentech, Genzyme Corp. and Gilead Sciences Inc.
In October, Icahn took control of the board at another large biotech company, New York-based ImClone Systems Inc., the maker of the colorectal cancer drug Erbitux. Icahn ousted directors and ImClone's interim chief executive officer, criticizing them for failing to support research needed to expand the approved uses for Erbitux and boost its sales. ImClone shares, which fell 4 cents to $32.17 yesterday, have gained 20 percent this year.
Icahn also owns a 7.9 percent stake in Telik Inc., a biotech based in Palo Alto, California, and has 3.8 percent of Adventrx Pharmaceuticals, a drug developer in San Diego.
To contact the reporter on this story: Luke Timmerman in San Francisco at ltimmerman@bloomberg.net
Last Updated: August 25, 2007 15:48 EDT
Es gibt Übernahmegerüchte bzgl Biogen und im IV-Board wird spekuliert,was das für Elan bedeuten würde---z.B. ob wir -ähm ich meine Elan-Biogen die andere Hälfte Tysabri abkaufen könnte--fragt sich nur von welchem Geld (müsste also ein Geldgeber /Partner her),oder ob Elan Ty.an Biogen verkauft,die Schulden los wäre-eine reine Entwicklungsfirma würde und sich voll auf ALZ konzentriert....leider verstehe ich sprachlich nicht Alles...
Icahn May Boost Biogen Stake, Forecasts Takeover (Update1)
By Luke Timmerman
Aug. 25 (Bloomberg) -- Billionaire investor Carl C. Icahn may increase his stake in Biogen Idec Inc. because he says the company is undervalued and a takeover candidate, according to a person familiar with Icahn's thinking.
The Federal Trade Commission cleared the New York investor to buy more shares in Biogen, the world's largest maker of drugs for multiple sclerosis, according to a message posted yesterday on the agency's Web site.
A big drugmaker with expiring patents on top-selling medicines may want to buy Biogen, the person said. Icahn bought shares in MedImmune Inc. before helping to force a sale of the biotechnology company in April to AstraZeneca Plc for $15 billion, double the market value a month earlier. Biogen is valued at 27 times profit, down from 48 times in February 2005, when its multiple sclerosis drug Tysabri was withdrawn because of a link to rare brain infections.
``As a matter of policy, we don't comment on the activities of specific investors,'' Biogen spokesman Tim Hunt said in a telephone interview. ``The management of Biogen is focused on building value for all the company's owners by continuing to execute its strategic plan.''
The Cambridge, Massachusetts-based company rose $2.92, or 4.9 percent, to a 52-week high of $62.89 yesterday in Nasdaq Stock Market composite trading. The stock has risen 28 percent this year and 85 percent since the temporary withdrawal of Tysabri two years ago.
MedImmune Investment
Earlier this month, Icahn reported acquiring 2.74 million shares, or almost 1 percent, of Biogen. A call to Icahn's office in New York after business hours yesterday wasn't returned.
Icahn increased his holdings of MedImmune, based in Gaithersburg, Maryland, by almost 50 percent before the company agreed to be bought by AstraZeneca. He had 2.78 million shares at the end of 2006, raising his stake to 4.13 million, or 1.7 percent, as of March 31, according to data compiled by Bloomberg.
The purchases paid off. The shares traded as low as $30.64 on March 5 then doubled in the next month to $58, when MedImmune, the maker of the FluMist nasal-spray influenza vaccine, agreed to be bought by London-based AstraZeneca.
ImClone
Besides its MS drugs, Biogen co-markets the cancer treatment Rituxan with Genentech Inc., based in South San Francisco, California. Rituxan, a treatment for non-Hodgkin's lymphoma and rheumatoid arthritis, had $2.1 billion in sales in 2006.
Biogen is the No. 5 U.S. biotech company ranked by sales, with $2.7 billion in revenue in 2006, based on data compiled by Bloomberg. It follows Amgen Inc., Genentech, Genzyme Corp. and Gilead Sciences Inc.
In October, Icahn took control of the board at another large biotech company, New York-based ImClone Systems Inc., the maker of the colorectal cancer drug Erbitux. Icahn ousted directors and ImClone's interim chief executive officer, criticizing them for failing to support research needed to expand the approved uses for Erbitux and boost its sales. ImClone shares, which fell 4 cents to $32.17 yesterday, have gained 20 percent this year.
Icahn also owns a 7.9 percent stake in Telik Inc., a biotech based in Palo Alto, California, and has 3.8 percent of Adventrx Pharmaceuticals, a drug developer in San Diego.
To contact the reporter on this story: Luke Timmerman in San Francisco at ltimmerman@bloomberg.net
Last Updated: August 25, 2007 15:48 EDT
the Joker in the Deck
August 24, 2007, 11:04 am
Icahn’s Biogen Lust
Posted by Dennis K. Berman
Turns out Carl Icahn is more interested in Biogen Idec than we first imagined. The New York investor has just received federal Hart-Scott-Rodino clearance to up his stake in the biotech firm, according to Dow Jones Newswires.
Icahn doesn’t typically make these filings unless he’s interested in accumulating a far larger stake (up to 9.9%) or getting active against the company’s management.
This is a scenario Deal Journal considered early this morning in this related post: Are Conditions Finally Ripe for a Biogen Deal?
But frankly we didn’t expect Icahn to act so soon.
So far Biogen shares are up 3% on the day, on a generally flat day for the Dow.
Keep your eyes peeled for more as this story develops. But we reckon this isn’t the last you’ve heard about Biogen in the coming months.
August 24, 2007, 11:04 am
Icahn’s Biogen Lust
Posted by Dennis K. Berman
Turns out Carl Icahn is more interested in Biogen Idec than we first imagined. The New York investor has just received federal Hart-Scott-Rodino clearance to up his stake in the biotech firm, according to Dow Jones Newswires.
Icahn doesn’t typically make these filings unless he’s interested in accumulating a far larger stake (up to 9.9%) or getting active against the company’s management.
This is a scenario Deal Journal considered early this morning in this related post: Are Conditions Finally Ripe for a Biogen Deal?
But frankly we didn’t expect Icahn to act so soon.
So far Biogen shares are up 3% on the day, on a generally flat day for the Dow.
Keep your eyes peeled for more as this story develops. But we reckon this isn’t the last you’ve heard about Biogen in the coming months.
meines Wissens nach ist zwischen Biogen und Elan vereinbart, dass im Falle einer Übernahme eines der beiden Unternehmen, die Rechte an Tysabri vollständig an den anderen Partner übergehen.
Sollte Biogen somit übernommen werden, würde Elan die Einnahmen an Tysabri kommplett erhalten.
Sollte Biogen somit übernommen werden, würde Elan die Einnahmen an Tysabri kommplett erhalten.
Antwort auf Beitrag Nr.: 31.295.214 von Poppholz am 25.08.07 23:45:16POPPI:Wer soll das bezahlen?????Elan kanns nicht!Ausserdem haben sie weder die Produktions-noch die Vermarktungskapazitäten..Wird Spannend!!Vielleicht behält der potentielle Übernehmer die 50% und vermarktet Ty mal vernünftig.Das wäre super für uns!!
By: Creedster_99
Posted as a reply to msg 144285 by goodtoreadthis
Re: Threading the needle...buyout issues!
Frank,
I realize that the change in control of ownership clause assoc with a BIIB buyout could potentially offer Elan full ownership of Tysabri, but I don't think Elan wants that right now. With no production facilities, sales force, marketing team , etc....what a disaster!!! Elan already has $1.7B debt (roughly) ...they want to take on more debt now, to buy the other half of Tysabri for billions more??...NOPE.
Elan might have to scramble to find another partner to mfg and sell Tysabri...another mess....and distraction from AAB and the 5 products for AD under development now...
Much simpler to just sell Tysabri, collect the billions, pay off debt and move forward with AD program, oral Tysabri, nano, DD etc...
Oh, sell off prialt for a few chips while they're simplifying the balance sheets ....that should allow the write-off of a few hundred million of development costs for future taxgain credits...in addition to the $2B or so that they already have....
Elan, with the loss of it's sales force as of next month, has become a PURE Biotech DEVELOPMENT COMPANY. Other than maybe a few hundred secretaries and janitors, Elan prob has 1200 employees. Several hundred in mfg (nano, DD) and several hundred researchers!!!!!!!
This is one slimmed down company....with a little success, we could EXPLODE!!! The next 12-18 mos will be very telling!!!!!
Buyout, merger, independent ...no matter...we should be worth more than today....barring 1929 again!
By: Creedster_99
Posted as a reply to msg 144285 by goodtoreadthis
Re: Threading the needle...buyout issues!
Frank,
I realize that the change in control of ownership clause assoc with a BIIB buyout could potentially offer Elan full ownership of Tysabri, but I don't think Elan wants that right now. With no production facilities, sales force, marketing team , etc....what a disaster!!! Elan already has $1.7B debt (roughly) ...they want to take on more debt now, to buy the other half of Tysabri for billions more??...NOPE.
Elan might have to scramble to find another partner to mfg and sell Tysabri...another mess....and distraction from AAB and the 5 products for AD under development now...
Much simpler to just sell Tysabri, collect the billions, pay off debt and move forward with AD program, oral Tysabri, nano, DD etc...
Oh, sell off prialt for a few chips while they're simplifying the balance sheets ....that should allow the write-off of a few hundred million of development costs for future taxgain credits...in addition to the $2B or so that they already have....
Elan, with the loss of it's sales force as of next month, has become a PURE Biotech DEVELOPMENT COMPANY. Other than maybe a few hundred secretaries and janitors, Elan prob has 1200 employees. Several hundred in mfg (nano, DD) and several hundred researchers!!!!!!!
This is one slimmed down company....with a little success, we could EXPLODE!!! The next 12-18 mos will be very telling!!!!!
Buyout, merger, independent ...no matter...we should be worth more than today....barring 1929 again!
CNN - Update: Biogen/Icahn
UPDATE: Biogen Idec Climbs After FTC Approves Icahn Stock Buy
Dow jones
August 26, 2007: 09:43 PM EST
BOSTON (Dow Jones) -- Biogen Idec shares moved higher Friday on news that the Federal Trade Commission has approved activist investor Carl Icahn to purchase more of the company's shares.
Shares of Biogen (BIIB) were up 5% at $62.89 on Friday, a 52-week high.
According to an FTC statement, Icahn was granted early termination of the Hart-Scott-Rodino Act waiting period, meaning his investment group is now free to pursue certain transactions. The waiting period is intended to allow regulators to determine if the intended transactions are antitrust in nature.
The document did not specify the type or size of the transaction that Icahn's group is interested in pursuing. As of Friday afternoon, Icahn's various corporate entities had made no new filings with the Securities and Exchange Commission in regard to Biogen stock.
The FTC announcement comes just days after Icahn first revealed an interest in Biogen, one of the industry's oldest biotechnology companies.
On Aug. 15, Icahn Management revealed in an SEC filing that it had purchased a small but notable stake in the Cambridge, Mass.-based biotech giant.
The group said it bought 2.74 million shares of Biogen Idec stock worth $ 146.59 million. As of June 30, Biogen had 343.39 million diluted shares outstanding.
Calling himself an "activist investor," Icahn has grabbed headlines in recent years by moving in on companies whose shares he believes are undervalued and then pushing management for significant changes in corporate strategy, which could include a sale of the company.
A former medical student, Icahn has made several high-profile investments in the biotechnology and pharmaceutical arena, most recently in ImClone Systems ( IMCL) , where he was named chairman last fall after a protracted battle with the board.
Earlier this year, Icahn also moved in on another biotechnology stalwart, MedImmune Inc. (MEDI) In April, Icahn threatened a proxy contest at the company's annual meeting if it did not soon find a buyer. Several days later, AstraZeneca PLC (AZN) announced it planned to buy MedImmune for $15.6 billion.
Biogen is one of the industry's most profitable players, with 2006 revenue of $2.69 billion. But Biogen's top-line has also been under scrutiny in recent quarters as it is heavily dependent on an older multiple sclerosis drug, Avonex, and an oncology drug co-marketed with Genentech Inc. (DNA) called Rituxan.
Biogen shares took a severe hit in 2005, when its promising multiple sclerosis drug Tysabri was abruptly pulled from the market after three users developed a rare but deadly brain disease called PML. Because of its effectiveness in treating MS, the FDA allowed the drug back on the market last summer, but with very strict prescribing guidelines.
Approved in late 2004, Tysabri was co-developed with Irish drugmaker Elan Corp. (ELN)
In the days following the recall, Biogen's stock plunged from around $70 a share to the $35 range. Since Tysabri's re-introduction to the market, however, shares have been on the rebound.
Prior to the PML scare, analysts forecasted Tysabri would soon become the hottest MS drug on the market, with sales estimates ranging from $2 billion to as high as $6 billion. Although analysts have since greatly scaled back those estimates, many believe the drug still has strong market potential. Cowen & Co. analysts, for example, recently estimated Tysabri sales will reach around $1 billion by 2010.
Tysabri brought in total sales of $72 million for the second quarter, with Biogen's take being $48 million.
(END) Dow Jones Newswires
08-26-07 2143ET
Copyright (c) 2007 Dow Jones & Company, Inc.
UPDATE: Biogen Idec Climbs After FTC Approves Icahn Stock Buy
Dow jones
August 26, 2007: 09:43 PM EST
BOSTON (Dow Jones) -- Biogen Idec shares moved higher Friday on news that the Federal Trade Commission has approved activist investor Carl Icahn to purchase more of the company's shares.
Shares of Biogen (BIIB) were up 5% at $62.89 on Friday, a 52-week high.
According to an FTC statement, Icahn was granted early termination of the Hart-Scott-Rodino Act waiting period, meaning his investment group is now free to pursue certain transactions. The waiting period is intended to allow regulators to determine if the intended transactions are antitrust in nature.
The document did not specify the type or size of the transaction that Icahn's group is interested in pursuing. As of Friday afternoon, Icahn's various corporate entities had made no new filings with the Securities and Exchange Commission in regard to Biogen stock.
The FTC announcement comes just days after Icahn first revealed an interest in Biogen, one of the industry's oldest biotechnology companies.
On Aug. 15, Icahn Management revealed in an SEC filing that it had purchased a small but notable stake in the Cambridge, Mass.-based biotech giant.
The group said it bought 2.74 million shares of Biogen Idec stock worth $ 146.59 million. As of June 30, Biogen had 343.39 million diluted shares outstanding.
Calling himself an "activist investor," Icahn has grabbed headlines in recent years by moving in on companies whose shares he believes are undervalued and then pushing management for significant changes in corporate strategy, which could include a sale of the company.
A former medical student, Icahn has made several high-profile investments in the biotechnology and pharmaceutical arena, most recently in ImClone Systems ( IMCL) , where he was named chairman last fall after a protracted battle with the board.
Earlier this year, Icahn also moved in on another biotechnology stalwart, MedImmune Inc. (MEDI) In April, Icahn threatened a proxy contest at the company's annual meeting if it did not soon find a buyer. Several days later, AstraZeneca PLC (AZN) announced it planned to buy MedImmune for $15.6 billion.
Biogen is one of the industry's most profitable players, with 2006 revenue of $2.69 billion. But Biogen's top-line has also been under scrutiny in recent quarters as it is heavily dependent on an older multiple sclerosis drug, Avonex, and an oncology drug co-marketed with Genentech Inc. (DNA) called Rituxan.
Biogen shares took a severe hit in 2005, when its promising multiple sclerosis drug Tysabri was abruptly pulled from the market after three users developed a rare but deadly brain disease called PML. Because of its effectiveness in treating MS, the FDA allowed the drug back on the market last summer, but with very strict prescribing guidelines.
Approved in late 2004, Tysabri was co-developed with Irish drugmaker Elan Corp. (ELN)
In the days following the recall, Biogen's stock plunged from around $70 a share to the $35 range. Since Tysabri's re-introduction to the market, however, shares have been on the rebound.
Prior to the PML scare, analysts forecasted Tysabri would soon become the hottest MS drug on the market, with sales estimates ranging from $2 billion to as high as $6 billion. Although analysts have since greatly scaled back those estimates, many believe the drug still has strong market potential. Cowen & Co. analysts, for example, recently estimated Tysabri sales will reach around $1 billion by 2010.
Tysabri brought in total sales of $72 million for the second quarter, with Biogen's take being $48 million.
(END) Dow Jones Newswires
08-26-07 2143ET
Copyright (c) 2007 Dow Jones & Company, Inc.
Antwort auf Beitrag Nr.: 31.299.078 von Birgit.Tersteegen am 27.08.07 08:18:44der Kurs von Biogen läuft schon mal schön nach oben.
Aktuell: $63,75
Aktuell: $63,75
Antwort auf Beitrag Nr.: 31.303.997 von Poppholz am 27.08.07 15:48:14BIIB hat die $64,00 Marke überwunden.
Langsam kommt auch der Kurs von ELN in Gang, nachdem wir in den USA im roten Bereich gestartet sind.
Langsam kommt auch der Kurs von ELN in Gang, nachdem wir in den USA im roten Bereich gestartet sind.
Msg: 5919 of 5935
By: kcchris
Waiting
Waiting on Tysabri sales
Waiting on AAB
Waiting on the Nano drug to be filed.
Lots of great things in the works. All we need is to hit that point where it all comes together.
Ty sales will likely be start increasing in the months to come. No PML means higher sales. It is all good so far.
AAB - We all know this is all good. Hopefully we get phase 2 results in ealry 08. Then the world will know what we know.
Nano. - Our first big drug is going to be filed in Dec. This could mean $100 - 250 million in profit for ELN.
Looks to me like those wanting in better do it prior to year end. After Dec this stock could start running again. Profits are just around the corner. Profit isn't as important to me as cash flow positive. Then we can know that our cash reserves will be increasing.
By: kcchris
Waiting
Waiting on Tysabri sales
Waiting on AAB
Waiting on the Nano drug to be filed.
Lots of great things in the works. All we need is to hit that point where it all comes together.
Ty sales will likely be start increasing in the months to come. No PML means higher sales. It is all good so far.
AAB - We all know this is all good. Hopefully we get phase 2 results in ealry 08. Then the world will know what we know.
Nano. - Our first big drug is going to be filed in Dec. This could mean $100 - 250 million in profit for ELN.
Looks to me like those wanting in better do it prior to year end. After Dec this stock could start running again. Profits are just around the corner. Profit isn't as important to me as cash flow positive. Then we can know that our cash reserves will be increasing.
Hat mich schon gewundert, warum der Kurs seit gestern nach süden geht
Die Aktionäre sind vorsichtiger geworden.
No new brain infection cases with MS drug Tysabri
http://www.reuters.com/article/marketsNews/idUKN282321612007…
BOSTON, Aug 28 (Reuters) - Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) said on Tuesday that as of mid-July there have been no new reported cases of a potentially deadly brain infection in patients taking its multiple sclerosis drug Tysabri.
The Cambridge, Massachusetts-based biotechnology company made the disclosure as part of a slide presentation for a conference in Belgium.
According to the slide, there have been no new reports of progressive multifocal leukoencephalopathy, or PML, a rare brain disease since mid-July, which means there have been no new reports of the disease since the drug was reintroduced to the market a year ago.
Tysabri, developed with Irish drugmaker Elan Corp. (ELN.I: Quote, Profile, Research), was taken off the market in 2005 after being linked with three cases of the infection. The U.S. Food and Drug Administration allowed the drug back last July because it is effective and patients asked for it to be returned.
Through mid-July, 2007, there were about 14,000 patients taking Tysabri worldwide, of which roughly 12,900 were commercial patients and 1,000 clinical trial patients.
Tysabri is available in the United States through a safety-monitoring program known as TOUCH. All prescribers, infusion sites and patients are required to enroll in the program, which is designed to monitor patients for any signs or symptoms of PML. (Reporting by Toni Clarke)
Die Aktionäre sind vorsichtiger geworden.
No new brain infection cases with MS drug Tysabri
http://www.reuters.com/article/marketsNews/idUKN282321612007…
BOSTON, Aug 28 (Reuters) - Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) said on Tuesday that as of mid-July there have been no new reported cases of a potentially deadly brain infection in patients taking its multiple sclerosis drug Tysabri.
The Cambridge, Massachusetts-based biotechnology company made the disclosure as part of a slide presentation for a conference in Belgium.
According to the slide, there have been no new reports of progressive multifocal leukoencephalopathy, or PML, a rare brain disease since mid-July, which means there have been no new reports of the disease since the drug was reintroduced to the market a year ago.
Tysabri, developed with Irish drugmaker Elan Corp. (ELN.I: Quote, Profile, Research), was taken off the market in 2005 after being linked with three cases of the infection. The U.S. Food and Drug Administration allowed the drug back last July because it is effective and patients asked for it to be returned.
Through mid-July, 2007, there were about 14,000 patients taking Tysabri worldwide, of which roughly 12,900 were commercial patients and 1,000 clinical trial patients.
Tysabri is available in the United States through a safety-monitoring program known as TOUCH. All prescribers, infusion sites and patients are required to enroll in the program, which is designed to monitor patients for any signs or symptoms of PML. (Reporting by Toni Clarke)
Antwort auf Beitrag Nr.: 31.333.696 von surga am 29.08.07 19:35:29Aber es ist SOOOOOOOOOOOOOOOOOOOOOOOOOOOOO idiotisch:Es gibt KEINEN einzigen PML von TYSABRI wenn es allein angewandt wird.....bei VIELEN anderen Medikamenten gibt es diverse Fälle....Aber längerfristig wird sich das auch wirklich herumsprechen...!
Msg: 145670 of 145675 8/30/2007 2:03:02 AM Recs: 16
By: pfaffova
NEWS
Press Release Source: Transition Therapeutics Inc.
Transition Therapeutics Announces Completion of Phase I Clinical Studies with Alzheimer's Disease Drug Candidate ELND-005/AZD-103
Thursday August 30, 2:00 am ET
TORONTO, Aug. 30 /PRNewswire-FirstCall/ - Transition Therapeutics Inc. ("Transition") (NASDAQ: TTHI, TSX: TTH) announced today the completion of Phase I clinical studies with Alzheimer's disease drug candidate ELND-005/AZD-103. Transition and its development partner Elan Corporation, plc. ("Elan") (NYSE: ELN - News) have performed multiple Phase I studies evaluating the safety, tolerability and pharmacokinetic profile of ELND-005/AZD-103 in healthy volunteers. Orally administered ELND-005/AZD-103 may act through the unique mechanism of preventing and reversing the fibrilization of beta-amyloid in preclinical studies, presumed to be the toxic peptide in the brain of Alzheimer's patients. ELND-005/AZD-103 is well positioned as a potential Alzheimer's therapy as it is a small molecule that crosses the blood brain barrier and has exhibited a favourable safety profile.
ADVERTISEMENT
"We are very pleased with the Phase I data showing that the drug is safe and well tolerated at all doses examined and achieves levels in the CSF and brain that have been shown to be effective in breaking down beta-amyloid fibrils in preclinical studies," said Dr. Tony Cruz, CEO of Transition. "ELND-005/AZD-103 continues to show very favourable properties for the treatment of Alzheimer's disease."
Approximately 110 subjects have been exposed to ELND-005/AZD-103 in multiple Phase I studies, including single and multiple ascending dosing; pharmacokinetic evaluation of levels in the brain; and CSF and plasma studies. ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimens examined. There were no severe or serious adverse events observed. ELND-005/AZD-103 was also shown to be orally bioavailable, cross the blood-brain barrier and achieve levels in the human brain and CSF that were shown to be effective in animal models for Alzheimer's disease. The pharmacokinetic data and safety data obtained in the Phase I studies will be used to select the appropriate doses for the Phase II studies.
The next steps in the development of ELND-005/AZD-103 will be submission of data supporting Phase II studies to the FDA. Transition and Elan anticipate starting Phase II by the end of 2007 or early 2008.
By: pfaffova
NEWS
Press Release Source: Transition Therapeutics Inc.
Transition Therapeutics Announces Completion of Phase I Clinical Studies with Alzheimer's Disease Drug Candidate ELND-005/AZD-103
Thursday August 30, 2:00 am ET
TORONTO, Aug. 30 /PRNewswire-FirstCall/ - Transition Therapeutics Inc. ("Transition") (NASDAQ: TTHI, TSX: TTH) announced today the completion of Phase I clinical studies with Alzheimer's disease drug candidate ELND-005/AZD-103. Transition and its development partner Elan Corporation, plc. ("Elan") (NYSE: ELN - News) have performed multiple Phase I studies evaluating the safety, tolerability and pharmacokinetic profile of ELND-005/AZD-103 in healthy volunteers. Orally administered ELND-005/AZD-103 may act through the unique mechanism of preventing and reversing the fibrilization of beta-amyloid in preclinical studies, presumed to be the toxic peptide in the brain of Alzheimer's patients. ELND-005/AZD-103 is well positioned as a potential Alzheimer's therapy as it is a small molecule that crosses the blood brain barrier and has exhibited a favourable safety profile.
ADVERTISEMENT
"We are very pleased with the Phase I data showing that the drug is safe and well tolerated at all doses examined and achieves levels in the CSF and brain that have been shown to be effective in breaking down beta-amyloid fibrils in preclinical studies," said Dr. Tony Cruz, CEO of Transition. "ELND-005/AZD-103 continues to show very favourable properties for the treatment of Alzheimer's disease."
Approximately 110 subjects have been exposed to ELND-005/AZD-103 in multiple Phase I studies, including single and multiple ascending dosing; pharmacokinetic evaluation of levels in the brain; and CSF and plasma studies. ELND-005/AZD-103 was safe and well-tolerated at all doses and dosing regimens examined. There were no severe or serious adverse events observed. ELND-005/AZD-103 was also shown to be orally bioavailable, cross the blood-brain barrier and achieve levels in the human brain and CSF that were shown to be effective in animal models for Alzheimer's disease. The pharmacokinetic data and safety data obtained in the Phase I studies will be used to select the appropriate doses for the Phase II studies.
The next steps in the development of ELND-005/AZD-103 will be submission of data supporting Phase II studies to the FDA. Transition and Elan anticipate starting Phase II by the end of 2007 or early 2008.
.....HAllo....Halllllloooooo.....:k
...der Urlaub neigt sich dem Ende zu und wir werden langsam wieder Richtung Heimat " tuckern...."
...dann werden ab der nächsten Woche wieder spannende ELAN Zeiten auf uns zukommen.....
..in diesem Sinne...
..allen ELANITES und ELANIACS - best wishes -
bernie55, yet on the road...
...der Urlaub neigt sich dem Ende zu und wir werden langsam wieder Richtung Heimat " tuckern...."
...dann werden ab der nächsten Woche wieder spannende ELAN Zeiten auf uns zukommen.....
..in diesem Sinne...
..allen ELANITES und ELANIACS - best wishes -
bernie55, yet on the road...
Msg: 146225 of 146225
By: Mad_Money
Goodbody-AD Candidate ELN-005 Sucessfully Completes Phase I Trials
Elan (Add, Closing Price $18.85); AD candidate ELND-005 successfully completes Phase I trials.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Elan and its development partner Transition Therapeutics yesterday announced that they have successfully completed a series of Phase
I studies on their drug candidate ELND-005 / AZD-103, which is targeting the treatment of Alzheimer’s Disease (AD). The companies
will now submit data to the FDA in support of a Phase II study, which they anticipate will start by the end of 2007 or early 2008. ELND-
005 has been in multiple, single and ascending dosage Phase I studies in healthy volunteers to assess safety, tolerability and
pharmacokinetic profile. Almost 110 people were exposed to the drug, which proved to be safe and well-tolerated at all doses. No severe
or serious adverse events were reported. In the pharmacokinetic studies, drug levels were observed in the brain and cerebrospinal fluid
consistent with levels required to be effective in treating animal models with AD. ELND-005 is a small molecule that has been shown to
breakdown beta-amyloid fibrils in preclinical studies. It may also prevent and reverse the fibrilization (build up) of beta-amyloid - the
characteristic plaque in the brain associated with AD. This is one of a variety of approaches being taken by Elan in the potential
treatment of AD, including the break up of existing plaques (AAB-001 and ACC-001) and the prevention of excessive beta-amyloid
production (drug candidates taking the secretase approach - currently at the preclinical stage). Elan noted in its Q207 results that it
anticipated that ELND-005 would move into Phase II clinical studies “around the end of 2007.” This update gives us comfort that the
development timeline is on track.
By: Mad_Money
Goodbody-AD Candidate ELN-005 Sucessfully Completes Phase I Trials
Elan (Add, Closing Price $18.85); AD candidate ELND-005 successfully completes Phase I trials.
Analyst: Ian Hunter T +353-1-6410498 E ian.g.hunter@goodbody.ie
Elan and its development partner Transition Therapeutics yesterday announced that they have successfully completed a series of Phase
I studies on their drug candidate ELND-005 / AZD-103, which is targeting the treatment of Alzheimer’s Disease (AD). The companies
will now submit data to the FDA in support of a Phase II study, which they anticipate will start by the end of 2007 or early 2008. ELND-
005 has been in multiple, single and ascending dosage Phase I studies in healthy volunteers to assess safety, tolerability and
pharmacokinetic profile. Almost 110 people were exposed to the drug, which proved to be safe and well-tolerated at all doses. No severe
or serious adverse events were reported. In the pharmacokinetic studies, drug levels were observed in the brain and cerebrospinal fluid
consistent with levels required to be effective in treating animal models with AD. ELND-005 is a small molecule that has been shown to
breakdown beta-amyloid fibrils in preclinical studies. It may also prevent and reverse the fibrilization (build up) of beta-amyloid - the
characteristic plaque in the brain associated with AD. This is one of a variety of approaches being taken by Elan in the potential
treatment of AD, including the break up of existing plaques (AAB-001 and ACC-001) and the prevention of excessive beta-amyloid
production (drug candidates taking the secretase approach - currently at the preclinical stage). Elan noted in its Q207 results that it
anticipated that ELND-005 would move into Phase II clinical studies “around the end of 2007.” This update gives us comfort that the
development timeline is on track.
By: godivatruffles6 Send PM Profile Ignore Recommend Add To Favorites
Nano news - Crestor
http://biz.yahoo.com/prnews/070831/aqf010.html?.v=24
Press Release Source: Abbott
Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
Friday August 31, 9:01 am ET
First Statin and Fibrate Combination in a Single Pill to Target Three Major Lipid Components Moves Forward to Next Phase of Development
ABBOTT PARK, Ill. and LONDON, Aug. 31 /PRNewswire-FirstCall/ -- Abbott and AstraZeneca confirmed today they will advance the development of Abbott's next-generation fenofibrate ABT-335 and AstraZeneca's CRESTOR® (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III clinical trials. The single pill would target all three major blood lipids -- LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides.
ABT-335 is Abbott's next-generation fenofibrate currently in late-stage clinical trials. Based on the significant progress made in the ABT-335 and CRESTOR fixed-dose combination development program, the companies have jointly decided to move forward with this fixed-dose combination therapy. The studies are proceeding on schedule.
"This decision highlights the opportunity for broader treatment in many higher at-risk populations," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "We're looking forward to exploring the potential of a combination treatment to address the needs of patients."
"AstraZeneca is committed to continually investigate new treatment options for patients at risk for cardiovascular disease," said James Blasetto M.D., Vice President, Strategic Development, AstraZeneca. "The combination of CRESTOR and ABT-335 may be an important option to help patients with mixed dyslipidemia achieve their treatment goals."
ABT-335 and CRESTOR are both lipid-regulating agents. ABT-335 is an investigational compound that is part of a class of medications called fibrates. Fibrates have been shown to raise HDL-C, reduce triglycerides and moderately lower LDL-C.
CRESTOR is part of a class of medication called statins, which has been shown to significantly reduce LDL-C while raising HDL-C. This combination therapy is being investigated to address LDL-C, HDL-C and triglycerides simultaneously in a single pill, which could improve convenience and lipid outcomes.
Abbott will continue executing the clinical trial program and be responsible for regulatory registration of the new combination therapy. AstraZeneca will hold the New Drug Application. Following successful completion of the clinical program, a regulatory application for the new combination therapy is targeted for submission in 2009. This collaboration relates to the US market.
About ABT-335
ABT-335 is a next-generation fenofibrate in clinical development for abnormal lipids in the bloodstream, including cholesterol and triglycerides. In addition, based on the positive results from ABT-335's clinical trial program, Abbott plans to file ABT-335 as a monotherapy (as an adjunct to diet) by the end of 2007. Abbott is currently evaluating ABT-335 as a
co-administered therapy with other on-market statins, including CRESTOR, and expects to present data from the clinical trials in the first half of 2008.
About CRESTOR®
CRESTOR (rosuvastatin calcium) is a once-daily, lipid-lowering agent prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C>190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
From The ELN Website
6 July 2006
Elan Signs License Agreement with Abbott for Elan's Proprietary NanoCrystal® Technology; To Develop a Single Fixed-Dose Combination of TriCor® and Crestor® for High Cholesterol Patients
DUBLIN, Ireland--(BUSINESS WIRE)--July 6, 2006--Elan Corporation, plc (NYSE:ELN) today announced that it has entered into a License Agreement with Abbott Pharmaceutical PR Ltd (NYSE:ABT) in which Abbott has been granted US rights, in a partnership with AstraZeneca Pharmaceuticals, LP, to utilize Elan's proprietary NanoCrystal Technology to develop and commercialize a single fixed-dose combination product containing the active pharmaceutical ingredients in Abbott's TriCor® 145 (fenofibrate) and AstraZeneca's Crestor® (rosuvastatin calcium) products. Under the terms of the License Agreement, Elan will receive payments upon the achievement of development, clinical, and regulatory milestones for such new combination product. Additionally, Elan will receive royalty payments based on US sales of the combination product, if successfully developed and commercialized.
Under the License Agreement, Elan's NanoCrystal Technology may be utilized in the combination product in order to optimize bioavailability and absorption in patients. TriCor® 145 and Crestor® are both currently marketed and used to treat adults with high cholesterol. TriCor, part of a class of medications called fibrates, has been shown to predominately reduce triglycerides, a form of fat or lipid obtained through food sources, raise HDL cholesterol and lower LDL cholesterol. Crestor is part of a class of medications called statins, which have been shown to reduce LDL cholesterol. The successful combination of the two products into one oral dosage form, could provide patients with a single treatment.
Presently, health care professionals are advised to consider carefully the benefits of the combined use of fibrate and statin drugs, in light of concerns regarding potentially serious side effects that could lead to acute renal failure. Rigorous clinical study of these agents in combination to evaluate their safety and efficacy is important for patients and warranted, and could produce an important new comprehensive cholesterol treatment tool for physicians.
"We are very pleased to execute this agreement, which follows on from the successful application of our NanoCrystal Technology in the current TriCor 145 product. We hope applying this technology will result in the successful development and launch of a combination product that will benefit patients", commented Paul V. Breen, Executive Vice President and Head, Elan Drug Technologies.
About NanoCrystal® Technology and Elan Drug Technologies
Elan's NanoCrystal technology is a proven, robust, drug optimization technology enabling solubility easily and effectively for many poorly water-soluble compounds. The technology which can offer enhanced commercialization opportunities is covered by 1,077 U.S. and foreign patents and patent applications and is part of a suite of technologies which Elan's Drug Technologies business offers to third party clients. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, and sterile forms for injection, with the potential for substantial improvements to clinical performance.
Currently four products marketed in the United States utilize Elan's NanoCrystal Technology, including TriCor® (marketed by Abbott), Megace® ES (marketed by Par Pharmaceuticals) and Rapamune® (marketed by Wyeth).
The NanoCrystal Technology is part of a suite of capabilities available through Elan Drug Technologies (EDT). With over 30 products launched in 40 countries, EDT has a proven track record of collaborating with pharmaceutical companies. For more information about Elan Drug Technologies please visit www.elan.com/EDT.
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.
About Crestor®
Crestor (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. Crestor has not been determined to prevent heart disease, heart attacks or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of Crestor is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C greater than 190 mg/dL) and aggressive lipid targets, a 20mg starting dose may be considered. AstraZeneca licensed worldwide rights to Crestor from the Japanese pharmaceutical company Shionogi & Co., Ltd.
Crestor (rosuvastatin calcium) Important Safety Information
Crestor is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Crestor and with other drugs in this class. The 40mg dose of Crestor is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose of Crestor once daily. When initiating statin therapy or switching from another statin therapy, the appropriate Crestor starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy. The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with rosuvastatin and gemfibrozil should generally be avoided.
Crestor should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Crestor is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to Crestor were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).
About TriCor
TriCor (fenofibrate tablets) is a member of the fibrate class of medications, used to treat abnormal lipid levels in the bloodstream, including cholesterol and triglycerides. TriCor is a once-daily treatment available in 145 mg and 48 mg tablets that can be taken with or without food.
TriCor, in addition to appropriate diet, is used to treat adults with high cholesterol, with or without elevated triglycerides (Fredrickson types IIa, IIb). TriCor reduces elevated LDL-C ("bad" cholesterol), total cholesterol, triglycerides and apolipoprotein B, and increases HDL-C ("good" cholesterol). The independent effect of raising HDL cholesterol or lowering triglycerides on the risk of cardiovascular morbidity and mortality has not been established with TriCor. Abbott markets TriCor in the U.S. through an agreement with Solvay Pharmaceuticals, Inc.
TriCor, in addition to appropriate diet, is also used to treat adults with high triglycerides (Fredrickson types IV and V). Excessive body weight, drinking alcohol, diseases such as diabetes and hypothyroidism, and various drugs can contribute to high triglyceride levels and these should be assessed before a patient is prescribed TriCor tablets. TriCor should only be prescribed after reasonable attempts to modify lipid profile with diet modification, exercise and decreased alcohol consumption have failed. It is important for patients to stay on a diet restricted in saturated fat and cholesterol while taking TriCor.
TriCor Important Safety Information
TriCor tablets are not for everyone. TriCor should not be taken by people with serious liver, kidney or gallbladder disease, or by those who may be allergic or sensitive to the drug.
The combined use of TriCor and HMG-CoA reductase inhibitors (statins) has not been advised because of a potential for serious side effects that could lead to acute renal failure. The benefit of further alterations in lipid levels needs to be weighed against the increased risks of this drug combination.
TriCor tablets may cause changes in laboratory reports, especially in liver chemistry results. Regular periodic liver tests should be performed while patients are taking TriCor. Patients should contact their doctors if they feel pain in the stomach area while taking TriCor, as this can be a sign of gallstones or inflammation of the pancreas. TriCor may cause muscle pain or serious muscle disease, allergic type reactions and possible changes in blood chemistry. If patients experience unexpected muscle pain, tenderness or weakness while taking TriCor, a health care provider should be contacted immediately.
Patients should notify their doctor if they are taking any other drugs while taking TriCor including any other cholesterol-lowering medications. TriCor may have an effect on drugs that help prevent blood clotting, such as the blood thinner Coumadin® (warfarin sodium tablets, USP), and doctors should monitor blood-clotting tests more frequently.
Patients should tell their doctors about any side effects they experience, including breathing problems, back pain and headaches.
For more information about TriCor (fenofibrate) Tablets, including full prescribing information, please visit www.tricortablets.com.
NanoCrystal® Technology is a registered trademark of Elan Pharma International Limited, Ireland.
TriCor® is a registered trademark owned by Abbott Laboratories Corporation.
Megace® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
Rapamune® is a registered trademark owned by Wyeth Pharmaceuticals.
Crestor® is a registered trademark of the AstraZeneca group of companies.
Coumadin® is a registered trademark of Bristol-Myers Squibb Company.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding the license agreement between Elan and Abbott. These statements are based on Elan's current beliefs and expectations. The license agreement may not result in the successful development or commercialization of a combination product and Elan may not receive any milestone or royalty payments under the license agreement. Factors which could cause actual results to differ materially from Elan's current expectations include the risks that Elan's NanoCrystal Technology may not be successfully utilized in creating a combination product, a combination product may have potentially serious side effects, Elan may lose proprietary protection for its NanoCrystal Technology, the license agreement is terminated early or Elan may encounter other unexpected delays or hurdles. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with Elan's drug development and other activities, see the periodic and current reports that Elan has filed with the Securities and Exchange Commission. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Elan Corporation, plc
Investor Relations:
Emer Reynolds, 353-1-709-4000
or
Chris Burns, 800-252-3526
or
Media Relations:
Davia Temin, 212-407-5740
or
Elizabeth Headon, 353-1-498-0300
SOURCE: Elan Corporation, plc
Nano news - Crestor
http://biz.yahoo.com/prnews/070831/aqf010.html?.v=24
Press Release Source: Abbott
Abbott and AstraZeneca Announce Selection of Next-Generation Fenofibrate ABT-335 and CRESTOR(R) Fixed-Dose Combination
Friday August 31, 9:01 am ET
First Statin and Fibrate Combination in a Single Pill to Target Three Major Lipid Components Moves Forward to Next Phase of Development
ABBOTT PARK, Ill. and LONDON, Aug. 31 /PRNewswire-FirstCall/ -- Abbott and AstraZeneca confirmed today they will advance the development of Abbott's next-generation fenofibrate ABT-335 and AstraZeneca's CRESTOR® (rosuvastatin calcium) in a fixed-dose combination treatment into Phase III clinical trials. The single pill would target all three major blood lipids -- LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides.
ABT-335 is Abbott's next-generation fenofibrate currently in late-stage clinical trials. Based on the significant progress made in the ABT-335 and CRESTOR fixed-dose combination development program, the companies have jointly decided to move forward with this fixed-dose combination therapy. The studies are proceeding on schedule.
"This decision highlights the opportunity for broader treatment in many higher at-risk populations," said Eugene Sun, M.D., vice president, Global Pharmaceutical Clinical Development, Abbott. "We're looking forward to exploring the potential of a combination treatment to address the needs of patients."
"AstraZeneca is committed to continually investigate new treatment options for patients at risk for cardiovascular disease," said James Blasetto M.D., Vice President, Strategic Development, AstraZeneca. "The combination of CRESTOR and ABT-335 may be an important option to help patients with mixed dyslipidemia achieve their treatment goals."
ABT-335 and CRESTOR are both lipid-regulating agents. ABT-335 is an investigational compound that is part of a class of medications called fibrates. Fibrates have been shown to raise HDL-C, reduce triglycerides and moderately lower LDL-C.
CRESTOR is part of a class of medication called statins, which has been shown to significantly reduce LDL-C while raising HDL-C. This combination therapy is being investigated to address LDL-C, HDL-C and triglycerides simultaneously in a single pill, which could improve convenience and lipid outcomes.
Abbott will continue executing the clinical trial program and be responsible for regulatory registration of the new combination therapy. AstraZeneca will hold the New Drug Application. Following successful completion of the clinical program, a regulatory application for the new combination therapy is targeted for submission in 2009. This collaboration relates to the US market.
About ABT-335
ABT-335 is a next-generation fenofibrate in clinical development for abnormal lipids in the bloodstream, including cholesterol and triglycerides. In addition, based on the positive results from ABT-335's clinical trial program, Abbott plans to file ABT-335 as a monotherapy (as an adjunct to diet) by the end of 2007. Abbott is currently evaluating ABT-335 as a
co-administered therapy with other on-market statins, including CRESTOR, and expects to present data from the clinical trials in the first half of 2008.
About CRESTOR®
CRESTOR (rosuvastatin calcium) is a once-daily, lipid-lowering agent prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. CRESTOR has not been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of CRESTOR is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C>190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
From The ELN Website
6 July 2006
Elan Signs License Agreement with Abbott for Elan's Proprietary NanoCrystal® Technology; To Develop a Single Fixed-Dose Combination of TriCor® and Crestor® for High Cholesterol Patients
DUBLIN, Ireland--(BUSINESS WIRE)--July 6, 2006--Elan Corporation, plc (NYSE:ELN) today announced that it has entered into a License Agreement with Abbott Pharmaceutical PR Ltd (NYSE:ABT) in which Abbott has been granted US rights, in a partnership with AstraZeneca Pharmaceuticals, LP, to utilize Elan's proprietary NanoCrystal Technology to develop and commercialize a single fixed-dose combination product containing the active pharmaceutical ingredients in Abbott's TriCor® 145 (fenofibrate) and AstraZeneca's Crestor® (rosuvastatin calcium) products. Under the terms of the License Agreement, Elan will receive payments upon the achievement of development, clinical, and regulatory milestones for such new combination product. Additionally, Elan will receive royalty payments based on US sales of the combination product, if successfully developed and commercialized.
Under the License Agreement, Elan's NanoCrystal Technology may be utilized in the combination product in order to optimize bioavailability and absorption in patients. TriCor® 145 and Crestor® are both currently marketed and used to treat adults with high cholesterol. TriCor, part of a class of medications called fibrates, has been shown to predominately reduce triglycerides, a form of fat or lipid obtained through food sources, raise HDL cholesterol and lower LDL cholesterol. Crestor is part of a class of medications called statins, which have been shown to reduce LDL cholesterol. The successful combination of the two products into one oral dosage form, could provide patients with a single treatment.
Presently, health care professionals are advised to consider carefully the benefits of the combined use of fibrate and statin drugs, in light of concerns regarding potentially serious side effects that could lead to acute renal failure. Rigorous clinical study of these agents in combination to evaluate their safety and efficacy is important for patients and warranted, and could produce an important new comprehensive cholesterol treatment tool for physicians.
"We are very pleased to execute this agreement, which follows on from the successful application of our NanoCrystal Technology in the current TriCor 145 product. We hope applying this technology will result in the successful development and launch of a combination product that will benefit patients", commented Paul V. Breen, Executive Vice President and Head, Elan Drug Technologies.
About NanoCrystal® Technology and Elan Drug Technologies
Elan's NanoCrystal technology is a proven, robust, drug optimization technology enabling solubility easily and effectively for many poorly water-soluble compounds. The technology which can offer enhanced commercialization opportunities is covered by 1,077 U.S. and foreign patents and patent applications and is part of a suite of technologies which Elan's Drug Technologies business offers to third party clients. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, and sterile forms for injection, with the potential for substantial improvements to clinical performance.
Currently four products marketed in the United States utilize Elan's NanoCrystal Technology, including TriCor® (marketed by Abbott), Megace® ES (marketed by Par Pharmaceuticals) and Rapamune® (marketed by Wyeth).
The NanoCrystal Technology is part of a suite of capabilities available through Elan Drug Technologies (EDT). With over 30 products launched in 40 countries, EDT has a proven track record of collaborating with pharmaceutical companies. For more information about Elan Drug Technologies please visit www.elan.com/EDT.
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.
About Crestor®
Crestor (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. Crestor has not been determined to prevent heart disease, heart attacks or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of Crestor is 10 mg. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C greater than 190 mg/dL) and aggressive lipid targets, a 20mg starting dose may be considered. AstraZeneca licensed worldwide rights to Crestor from the Japanese pharmaceutical company Shionogi & Co., Ltd.
Crestor (rosuvastatin calcium) Important Safety Information
Crestor is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with Crestor and with other drugs in this class. The 40mg dose of Crestor is reserved only for those patients who have not achieved their LDL-C goal utilizing the 20 mg dose of Crestor once daily. When initiating statin therapy or switching from another statin therapy, the appropriate Crestor starting dose should first be utilized, and only then titrated according to the patient's individualized goal of therapy. The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with rosuvastatin and gemfibrozil should generally be avoided.
Crestor should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness or weakness, particularly if accompanied by malaise or fever. Crestor is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to Crestor were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).
About TriCor
TriCor (fenofibrate tablets) is a member of the fibrate class of medications, used to treat abnormal lipid levels in the bloodstream, including cholesterol and triglycerides. TriCor is a once-daily treatment available in 145 mg and 48 mg tablets that can be taken with or without food.
TriCor, in addition to appropriate diet, is used to treat adults with high cholesterol, with or without elevated triglycerides (Fredrickson types IIa, IIb). TriCor reduces elevated LDL-C ("bad" cholesterol), total cholesterol, triglycerides and apolipoprotein B, and increases HDL-C ("good" cholesterol). The independent effect of raising HDL cholesterol or lowering triglycerides on the risk of cardiovascular morbidity and mortality has not been established with TriCor. Abbott markets TriCor in the U.S. through an agreement with Solvay Pharmaceuticals, Inc.
TriCor, in addition to appropriate diet, is also used to treat adults with high triglycerides (Fredrickson types IV and V). Excessive body weight, drinking alcohol, diseases such as diabetes and hypothyroidism, and various drugs can contribute to high triglyceride levels and these should be assessed before a patient is prescribed TriCor tablets. TriCor should only be prescribed after reasonable attempts to modify lipid profile with diet modification, exercise and decreased alcohol consumption have failed. It is important for patients to stay on a diet restricted in saturated fat and cholesterol while taking TriCor.
TriCor Important Safety Information
TriCor tablets are not for everyone. TriCor should not be taken by people with serious liver, kidney or gallbladder disease, or by those who may be allergic or sensitive to the drug.
The combined use of TriCor and HMG-CoA reductase inhibitors (statins) has not been advised because of a potential for serious side effects that could lead to acute renal failure. The benefit of further alterations in lipid levels needs to be weighed against the increased risks of this drug combination.
TriCor tablets may cause changes in laboratory reports, especially in liver chemistry results. Regular periodic liver tests should be performed while patients are taking TriCor. Patients should contact their doctors if they feel pain in the stomach area while taking TriCor, as this can be a sign of gallstones or inflammation of the pancreas. TriCor may cause muscle pain or serious muscle disease, allergic type reactions and possible changes in blood chemistry. If patients experience unexpected muscle pain, tenderness or weakness while taking TriCor, a health care provider should be contacted immediately.
Patients should notify their doctor if they are taking any other drugs while taking TriCor including any other cholesterol-lowering medications. TriCor may have an effect on drugs that help prevent blood clotting, such as the blood thinner Coumadin® (warfarin sodium tablets, USP), and doctors should monitor blood-clotting tests more frequently.
Patients should tell their doctors about any side effects they experience, including breathing problems, back pain and headaches.
For more information about TriCor (fenofibrate) Tablets, including full prescribing information, please visit www.tricortablets.com.
NanoCrystal® Technology is a registered trademark of Elan Pharma International Limited, Ireland.
TriCor® is a registered trademark owned by Abbott Laboratories Corporation.
Megace® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
Rapamune® is a registered trademark owned by Wyeth Pharmaceuticals.
Crestor® is a registered trademark of the AstraZeneca group of companies.
Coumadin® is a registered trademark of Bristol-Myers Squibb Company.
Safe Harbor/Forward Looking Statements
This press release contains forward-looking statements regarding the license agreement between Elan and Abbott. These statements are based on Elan's current beliefs and expectations. The license agreement may not result in the successful development or commercialization of a combination product and Elan may not receive any milestone or royalty payments under the license agreement. Factors which could cause actual results to differ materially from Elan's current expectations include the risks that Elan's NanoCrystal Technology may not be successfully utilized in creating a combination product, a combination product may have potentially serious side effects, Elan may lose proprietary protection for its NanoCrystal Technology, the license agreement is terminated early or Elan may encounter other unexpected delays or hurdles. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with Elan's drug development and other activities, see the periodic and current reports that Elan has filed with the Securities and Exchange Commission. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Elan Corporation, plc
Investor Relations:
Emer Reynolds, 353-1-709-4000
or
Chris Burns, 800-252-3526
or
Media Relations:
Davia Temin, 212-407-5740
or
Elizabeth Headon, 353-1-498-0300
SOURCE: Elan Corporation, plc
da wollte in Irland wohl jemand unbedingt seine Order bedient bekommen:
Antwort auf Beitrag Nr.: 31.362.798 von Poppholz am 31.08.07 23:53:43oder aber er hat bei seiner Kauforder $ und € durcheinander gebracht.
(in einem Jahr ist dies aber auch egal)
(in einem Jahr ist dies aber auch egal)
Antwort auf Beitrag Nr.: 31.362.812 von Poppholz am 31.08.07 23:57:03schönes WE
Sollte unser geschätzter Partner Biogen Tysabri nun doch anständig vermarkten wollen...???
By: msladyinca
OMG, I HAD to post THIS tonight! Because it wasn't there last night! Wooooohooooooo!
From their main Tysabri (Natalizumab) Information Center:
http://www.biogenidec.com/site/news-and-media.html?pr_id=../site/tysabriinfo_letter6.htm
I guess the squeaky wheel DOES get the job done! Whoa!
Goodnight everyone and have a great weekend! Wooohooooo! Lauren
August 2007
To the MS Community:
It has been a little more than a year since Biogen Idec and Elan reintroduced TYSABRI® (natalizumab) in the U.S. and launched in countries throughout the European Union, and we are pleased to see this therapy making an important impact on the lives of patients across the globe.
Over the past year, we responsibly reintroduced TYSABRI in the U.S. under one of the most comprehensive risk management plans in the industry - the TOUCH Prescribing Program - which is designed to facilitate the appropriate use of TYSABRI. We also launched TYSABRI in 20 countries; and most importantly, offered new hope to patients living with a serious, debilitating disease. Many patients have chosen to start TYSABRI therapy - as of mid-July 2007, approximately 14,000 patients are on therapy worldwide in commercial and clinical trial settings. Specifically:
* In the US, over 8,600 patients are on TYSABRI commercially and over 1,800 physicians have prescribed the therapy;
* In the EU, over 4,300 patients are on TYSABRI therapy commercially; and
* In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.
We continue to hear remarkable stories of how TYSABRI has benefited patients and their families. There remains a significant unmet medical need in MS, and we believe TYSABRI can help address this need. We understand there is a lot of interest in TYSABRI, and we expect to continue to communicate important information to the MS community, including providing periodic safety updates at medical meetings. For more information on TYSABRI please visit www.tysabri.com or call 1-800-456-2255.
TYSABRI is a compelling therapy for the treatment of MS and we are pleased to make it available to patients. We remain committed as ever to offering therapeutic options for patients and continuing our leading research and development efforts in pursuit of breakthrough therapies in the fight against MS.
Sincerely,
Alfred Sandrock, MD, PhD
Senior Vice President, Neurology Research and Development
By: msladyinca
OMG, I HAD to post THIS tonight! Because it wasn't there last night! Wooooohooooooo!
From their main Tysabri (Natalizumab) Information Center:
http://www.biogenidec.com/site/news-and-media.html?pr_id=../site/tysabriinfo_letter6.htm
I guess the squeaky wheel DOES get the job done! Whoa!
Goodnight everyone and have a great weekend! Wooohooooo! Lauren
August 2007
To the MS Community:
It has been a little more than a year since Biogen Idec and Elan reintroduced TYSABRI® (natalizumab) in the U.S. and launched in countries throughout the European Union, and we are pleased to see this therapy making an important impact on the lives of patients across the globe.
Over the past year, we responsibly reintroduced TYSABRI in the U.S. under one of the most comprehensive risk management plans in the industry - the TOUCH Prescribing Program - which is designed to facilitate the appropriate use of TYSABRI. We also launched TYSABRI in 20 countries; and most importantly, offered new hope to patients living with a serious, debilitating disease. Many patients have chosen to start TYSABRI therapy - as of mid-July 2007, approximately 14,000 patients are on therapy worldwide in commercial and clinical trial settings. Specifically:
* In the US, over 8,600 patients are on TYSABRI commercially and over 1,800 physicians have prescribed the therapy;
* In the EU, over 4,300 patients are on TYSABRI therapy commercially; and
* In global clinical trials, approximately 1,000 patients are on TYSABRI therapy.
We continue to hear remarkable stories of how TYSABRI has benefited patients and their families. There remains a significant unmet medical need in MS, and we believe TYSABRI can help address this need. We understand there is a lot of interest in TYSABRI, and we expect to continue to communicate important information to the MS community, including providing periodic safety updates at medical meetings. For more information on TYSABRI please visit www.tysabri.com or call 1-800-456-2255.
TYSABRI is a compelling therapy for the treatment of MS and we are pleased to make it available to patients. We remain committed as ever to offering therapeutic options for patients and continuing our leading research and development efforts in pursuit of breakthrough therapies in the fight against MS.
Sincerely,
Alfred Sandrock, MD, PhD
Senior Vice President, Neurology Research and Development
Hi @all!
By: splaylaywahtheepi
Quick Recap: Avonex and Rebif going generic (BioPartners's Biferonex) and AAB-001 works
------------------------------------------------------------------
Earthtimes Article on BAP, sales $8.8 billion by 2016, 82% of sales.
Earthtimes.org: USA WALTHAM, Mass., (11 June 2007, by PRNewswire) -- Decision Resources, Inc., one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Elan/Wyeth's bapineuzumab, the first biologic agent for the treatment of Alzheimer's disease, will drive the Alzheimer's disease drug market to more than triple by 2016, reaching $8.8 billion. According to the new Pharmacor report Alzheimer's Disease, bapineuzumab -- a monoclonal antibody that is poised to begin Phase III trials and is expected to launch by 2011 in the United States and Europe -- will account for more than $5 billion in sales in 2016. A second monoclonal antibody, Eli Lilly's LY-2062430, may also launch by 2016 and contribute to market expansion. The report finds that bapineuzumab, Neurochem's Alzhemed, and Myriad Genetics' Flurizan -- three disease-modifying therapies that will launch over the next several years -- will account for 82% of Alzheimer's disease drug sales in 2016. Bapineuzumab will garner 61% of sales, while Alzhemed and Flurizan will garner 13% and 8%, respectively. However, the report finds that significant safety concerns may limit the overall sales potential of bapineuzumab. "The launch of bapineuzumab will be the most important factor driving growth in the Alzheimer's disease drug market," said Nitasha Manchanda, Ph.D., analyst at Decision Resources. "Despite being priced considerably lower than monoclonal antibodies in other markets, we expect bapineuzumab to enter the market priced nearly eightfold higher than current small molecule therapies. Nevertheless, we anticipate significant uptake of this agent -- particularly in patients with mild Alzheimer's disease -- despite the safety concerns. Alzhemed and Flurizan, both in Phase III development, have shown modest efficacy in trials to date and are likely to offer a better safety profile than bapineuzumab."
-----------------------------------------------------------
Zu der obigen Analysteneinschätzung:
By: agedwardssucks Send PM Profile Ignore Recommend Add To Favorites
Posted as a reply to msg 146651 by AZErnie
Re: Earthtimes Article on BAP, sales $8.8 billion by 2016, 82% of sales.
Yet another typical dump article designed to try to sell over-priced reports from Decision Resources (why this group is still in business is beyond me). Let's use one of the "assumptions" of the report, the one that BAP will be priced at 8X from the current small molecule acetylcholinesterase inhibitor compounds, such as donepezil (aka Aricept). In the States, a years supply of Aricept costs $2K ($185 per month) and it does not go generic until 2010 (and then it may only drop in price to $1K per year). That means the assumption is that BAP will cost $16K per year per patient (in my worthless opinion, that is too high because healthcare third party payors will go BK and the cost of healthcare (in if ever gets fixed in the States) will consume the GDP of the country and Medicare will go bust).
So if 50% of Alz patients in the U.S go on BAP (a reasonable assumption and less than the 61% assumed by Decision Resources), that is about 2 mil patients at $16K per year of annual revenue to eln/wye of $32Bil. Makes Lipitor looks like small potatos.
The stupidity of the Decision Resources "intelligence" (please pardon my sarcasm) is that they are looking at the current Alz market that is poorly served by acetylcholinesterase inhibotors that don't work and then tripling the market. But one should ignore the current market size because the market for Aricept and its sibligs (Exelon and galantamine) is weak because these drugs don't work. So what happens to the market when a drug is introduced that does work, even to a disease modifying nature? If we cut the price of BAP in half to $8K per patient per year, it is still a $16Bil market for BAP now at a price that may keep Medicare solvent.
Thanks for posting yet another idiotic report from the self-annointed experts at Decision Resources who actually try to sell this drivel as "intelligence."
AGES
By: splaylaywahtheepi
Quick Recap: Avonex and Rebif going generic (BioPartners's Biferonex) and AAB-001 works
------------------------------------------------------------------
Earthtimes Article on BAP, sales $8.8 billion by 2016, 82% of sales.
Earthtimes.org: USA WALTHAM, Mass., (11 June 2007, by PRNewswire) -- Decision Resources, Inc., one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that Elan/Wyeth's bapineuzumab, the first biologic agent for the treatment of Alzheimer's disease, will drive the Alzheimer's disease drug market to more than triple by 2016, reaching $8.8 billion. According to the new Pharmacor report Alzheimer's Disease, bapineuzumab -- a monoclonal antibody that is poised to begin Phase III trials and is expected to launch by 2011 in the United States and Europe -- will account for more than $5 billion in sales in 2016. A second monoclonal antibody, Eli Lilly's LY-2062430, may also launch by 2016 and contribute to market expansion. The report finds that bapineuzumab, Neurochem's Alzhemed, and Myriad Genetics' Flurizan -- three disease-modifying therapies that will launch over the next several years -- will account for 82% of Alzheimer's disease drug sales in 2016. Bapineuzumab will garner 61% of sales, while Alzhemed and Flurizan will garner 13% and 8%, respectively. However, the report finds that significant safety concerns may limit the overall sales potential of bapineuzumab. "The launch of bapineuzumab will be the most important factor driving growth in the Alzheimer's disease drug market," said Nitasha Manchanda, Ph.D., analyst at Decision Resources. "Despite being priced considerably lower than monoclonal antibodies in other markets, we expect bapineuzumab to enter the market priced nearly eightfold higher than current small molecule therapies. Nevertheless, we anticipate significant uptake of this agent -- particularly in patients with mild Alzheimer's disease -- despite the safety concerns. Alzhemed and Flurizan, both in Phase III development, have shown modest efficacy in trials to date and are likely to offer a better safety profile than bapineuzumab."
-----------------------------------------------------------
Zu der obigen Analysteneinschätzung:
By: agedwardssucks Send PM Profile Ignore Recommend Add To Favorites
Posted as a reply to msg 146651 by AZErnie
Re: Earthtimes Article on BAP, sales $8.8 billion by 2016, 82% of sales.
Yet another typical dump article designed to try to sell over-priced reports from Decision Resources (why this group is still in business is beyond me). Let's use one of the "assumptions" of the report, the one that BAP will be priced at 8X from the current small molecule acetylcholinesterase inhibitor compounds, such as donepezil (aka Aricept). In the States, a years supply of Aricept costs $2K ($185 per month) and it does not go generic until 2010 (and then it may only drop in price to $1K per year). That means the assumption is that BAP will cost $16K per year per patient (in my worthless opinion, that is too high because healthcare third party payors will go BK and the cost of healthcare (in if ever gets fixed in the States) will consume the GDP of the country and Medicare will go bust).
So if 50% of Alz patients in the U.S go on BAP (a reasonable assumption and less than the 61% assumed by Decision Resources), that is about 2 mil patients at $16K per year of annual revenue to eln/wye of $32Bil. Makes Lipitor looks like small potatos.
The stupidity of the Decision Resources "intelligence" (please pardon my sarcasm) is that they are looking at the current Alz market that is poorly served by acetylcholinesterase inhibotors that don't work and then tripling the market. But one should ignore the current market size because the market for Aricept and its sibligs (Exelon and galantamine) is weak because these drugs don't work. So what happens to the market when a drug is introduced that does work, even to a disease modifying nature? If we cut the price of BAP in half to $8K per patient per year, it is still a $16Bil market for BAP now at a price that may keep Medicare solvent.
Thanks for posting yet another idiotic report from the self-annointed experts at Decision Resources who actually try to sell this drivel as "intelligence."
AGES
By: okz45
S E P T E M B E R
Do we see the protocol for P III for BAP?
With preparations well on their way in both Europe and the US, the Abeta direction that Elan/Wyeth have steadfastly
pursued seems to have the results they were looking for. Nobody ever claimed this would be a cure, but they did indicate that they expected a better quality of life for both the patient and the caregiver.
Phase II was considered a pivotal trial. In as much as the Sponsors and the FDA have given a go ahead for the P III
you would think that the "pivotal" threshold was met on the Peek, otherwise we would not be here waiting for the protocols.
How important is BAP? Quite important to everyone concerned. That includes those involved in Socialized Medicine and Medicare from all viewpoints.
A L Z H E I M E R is going to touch most families reaching the age of 60 whether it be as a spouse or caretaker of a parent or relative. With the Baby Boomers just hitting the age threshold, the problem is just getting recognized as an epidemic. Elan has been ahead of the curve on this subject for quite a few years. Wyeth joined them interesting enough as probably a long shot. AN-1792 changed everything. Since that halting in early 2002, it has become a mission of both organizations to get the flaws corrected as the initial results looked very promising.
After 100s of Millions of dollars, Elan/Wyeth looked set to enter, hopefully, the final stage before commercialization of BAP. The protocol should indicate how serious both the Collaborators and the FDA are.
It is closer than many of you think
my opinion as we
Watch Elan Grow
S E P T E M B E R
Do we see the protocol for P III for BAP?
With preparations well on their way in both Europe and the US, the Abeta direction that Elan/Wyeth have steadfastly
pursued seems to have the results they were looking for. Nobody ever claimed this would be a cure, but they did indicate that they expected a better quality of life for both the patient and the caregiver.
Phase II was considered a pivotal trial. In as much as the Sponsors and the FDA have given a go ahead for the P III
you would think that the "pivotal" threshold was met on the Peek, otherwise we would not be here waiting for the protocols.
How important is BAP? Quite important to everyone concerned. That includes those involved in Socialized Medicine and Medicare from all viewpoints.
A L Z H E I M E R is going to touch most families reaching the age of 60 whether it be as a spouse or caretaker of a parent or relative. With the Baby Boomers just hitting the age threshold, the problem is just getting recognized as an epidemic. Elan has been ahead of the curve on this subject for quite a few years. Wyeth joined them interesting enough as probably a long shot. AN-1792 changed everything. Since that halting in early 2002, it has become a mission of both organizations to get the flaws corrected as the initial results looked very promising.
After 100s of Millions of dollars, Elan/Wyeth looked set to enter, hopefully, the final stage before commercialization of BAP. The protocol should indicate how serious both the Collaborators and the FDA are.
It is closer than many of you think
my opinion as we
Watch Elan Grow
aktuell wird in den USA $19,45 zu $19.67 getaxt.
Bei dem aktuellen Wechselkurs entspricht dies €14,34 zu €14,50.
Bei dem aktuellen Wechselkurs entspricht dies €14,34 zu €14,50.
It is closer than many of you think... .Wenn das so ist, müssen wir uns bald über ganz andere Zahlen unterhalten Poppy.
posimist
posimist
Antwort auf Beitrag Nr.: 31.395.143 von posimist am 05.09.07 11:27:09das wird wohl auch so kommen.
Irland ist schon wieder schön am handeln.
Eben ist eine Order von über 20.000 Stück über den Tresen gegangen.
Irland ist schon wieder schön am handeln.
Eben ist eine Order von über 20.000 Stück über den Tresen gegangen.
By: goodtoreadthis
End of 08
KM's speech at Cowen 07 keeps running thru my head. "If we have 17% of the MS market, we have $1 in earnings per share for Elan." is what I recall him saying. Later at the break out session - I asked "When do we hit 17% of the MS market for tysabri sales? Ans " I really don't want to get into the when, or I can't answer that right now" - is what i think I heard.
When the BIIB break out session occured a little later, I asked JM the same question a little differently- when does T hit 20% market share for MS ? Mouse who was sitting beside me surely remembers this - E Woo shaking her head - like don't answer this. Jm and P Kellogg throwing numbers back and forth, and finally after maybe three minutes of in the head computations - JM said -end of 08. PK then said _ "Well you have now seen in real time, a market forecast analysis."
Mid Oct 07 we should have 16,400 commercial users of T. 17% of 400,000 is 68,000. So JM expects HUGE enrollment change over the 15 months following Oct 07.
Here's the REAL KICKER. KM stressed that this $1 in earnings is TYSARBRI ALONE. We have Nano earnings that are increasing and we have Phase 2 aab-001 results due in April 08. If anecdotal info means anything - and I think it means a lot- aab-001 will eventually get approved.
Lars told us the aab-001 meeting with FDA is early Sept. Our stock price has been up in a down market- wonder if the meeting is happening; and big boys know it ? If they approve test protocol and start infusions this month, what does that "action consistent with urgency" tell the market - and BERKSTUMP - What does it do to near term PPS value ?
End of 08
KM's speech at Cowen 07 keeps running thru my head. "If we have 17% of the MS market, we have $1 in earnings per share for Elan." is what I recall him saying. Later at the break out session - I asked "When do we hit 17% of the MS market for tysabri sales? Ans " I really don't want to get into the when, or I can't answer that right now" - is what i think I heard.
When the BIIB break out session occured a little later, I asked JM the same question a little differently- when does T hit 20% market share for MS ? Mouse who was sitting beside me surely remembers this - E Woo shaking her head - like don't answer this. Jm and P Kellogg throwing numbers back and forth, and finally after maybe three minutes of in the head computations - JM said -end of 08. PK then said _ "Well you have now seen in real time, a market forecast analysis."
Mid Oct 07 we should have 16,400 commercial users of T. 17% of 400,000 is 68,000. So JM expects HUGE enrollment change over the 15 months following Oct 07.
Here's the REAL KICKER. KM stressed that this $1 in earnings is TYSARBRI ALONE. We have Nano earnings that are increasing and we have Phase 2 aab-001 results due in April 08. If anecdotal info means anything - and I think it means a lot- aab-001 will eventually get approved.
Lars told us the aab-001 meeting with FDA is early Sept. Our stock price has been up in a down market- wonder if the meeting is happening; and big boys know it ? If they approve test protocol and start infusions this month, what does that "action consistent with urgency" tell the market - and BERKSTUMP - What does it do to near term PPS value ?
Antwort auf Beitrag Nr.: 31.402.346 von Birgit.Tersteegen am 05.09.07 19:03:48
Alle Achtung, beim negativen Umfeld ackert unser BABY hoch
Alle Achtung, beim negativen Umfeld ackert unser BABY hoch
Msg: 147136 of 147155 9/5/2007 3:50:44 PM Recs: 20
By: splaylaywahtheepi
Maybe...
1. It's the Biopartners' writing on the wall: cheap substitutes that are equally as ineffective as branded INFb-1A alternatives (Avonex and Rebif) are on the way.
2. AAB-001, ACC-001, ELND-005 and LLY gamma secretase programs are each about to move in lockstep to their next respective phase of clinical trials.
3. There are a couple of nano announcements pending - beyond those already announced. The hockey stick lives.
4. Tysabri has 17,000 patients on drug and there has been zero PML. ZERO. Not surprising, but when the general population has a PML incidence of 1:30,000, that seems significant. If you smoke, you have a 1:3 chance of dying from smoking related complications...strange comparison to have to make.
5. The Elan business model continues to evolve towards "highly leveraged" - the company just dropped 250 employees (almost 20% of workforce) but revenues are rising sharply.
6. The pipeline is about to reveal next generation autoimmune and neurology drugs that promise to keep Elan growing beyond the current commercial and late stage pipeline.
Msg: 147226 of 147236 9/5/2007 11:28:52 PM
By: biobetter
The real seismic advance in MS
The real seismic advance in the pharmacological treatment of MS in selected cases has been the introduction of Tysabri natalizumab for those patients with highly active relapsing/remitting multiple sclerosis. This is the first drug used to treat some forms of MS to receive the blessing of the National Institute for Health and Clinical Excellence (NICE). Professor Gavin Giovannoni, of the Royal London Hospital, said that Tysabri offers the ability to transform the lives of people with this type of MS. It may well, in his opinion, delay the progress of their disease and so allow them to enjoy a more active life. NICE defined active remitting/relapsing MS as having two or more disabling relapses in one year and evidence of active MS on an MRI scan. Tysabri reduces by 64 per cent the risk of disability progressing and reduces the likelihood of a relapse by 81 per cent.
http://www.timesonline.co.uk/tol/life_and_style/health/our_e…
By: biobetter
The real seismic advance in MS
The real seismic advance in the pharmacological treatment of MS in selected cases has been the introduction of Tysabri natalizumab for those patients with highly active relapsing/remitting multiple sclerosis. This is the first drug used to treat some forms of MS to receive the blessing of the National Institute for Health and Clinical Excellence (NICE). Professor Gavin Giovannoni, of the Royal London Hospital, said that Tysabri offers the ability to transform the lives of people with this type of MS. It may well, in his opinion, delay the progress of their disease and so allow them to enjoy a more active life. NICE defined active remitting/relapsing MS as having two or more disabling relapses in one year and evidence of active MS on an MRI scan. Tysabri reduces by 64 per cent the risk of disability progressing and reduces the likelihood of a relapse by 81 per cent.
http://www.timesonline.co.uk/tol/life_and_style/health/our_e…
06.09.2007 - 10:13 Uhr
Elan Ersteinschätzung
Rating-Update:
Minneapolis (aktiencheck.de AG) - Die Analysten von Piper Jaffray stufen die Aktie von Elan (ISIN US2841312083/ WKN 871331) in einer Ersteinschätzung mit \"market perform\" ein. (06.09.2007/ac/a/u) Analyse-Datum: 06.09.2007
Quelle: Finanzen.net
Elan Ersteinschätzung
Rating-Update:
Minneapolis (aktiencheck.de AG) - Die Analysten von Piper Jaffray stufen die Aktie von Elan (ISIN US2841312083/ WKN 871331) in einer Ersteinschätzung mit \"market perform\" ein. (06.09.2007/ac/a/u) Analyse-Datum: 06.09.2007
Quelle: Finanzen.net
Antwort auf Beitrag Nr.: 31.414.491 von surga am 06.09.07 13:45:26..ach nee sind die DOOF!
Analyse-Datum: 06.09.2007
Elan > nicht Ersteinschätzung < ( mal etwas von der anderen Seite)
Rating-Update:
Germanien (aktiensupercheck-society)
Die Cracker-Super-Analysten von PBB Company stufen die Aktie von Elan (ISIN US2841312083/ WKN 871331)
in einer SUPER - DUPER - MULTIeinschätzung weiterhin mit "market outer than outperform" ein.
Quelle: we want more
Elan > nicht Ersteinschätzung < ( mal etwas von der anderen Seite)
Rating-Update:
Germanien (aktiensupercheck-society)
Die Cracker-Super-Analysten von PBB Company stufen die Aktie von Elan (ISIN US2841312083/ WKN 871331)
in einer SUPER - DUPER - MULTIeinschätzung weiterhin mit "market outer than outperform" ein.
Quelle: we want more
Antwort auf Beitrag Nr.: 31.416.092 von bernie55 am 06.09.07 15:39:45..diese Ankündigung ist kein Aufruf zum Kauf dieser Aktie...
Antwort auf Beitrag Nr.: 31.416.119 von bernie55 am 06.09.07 15:41:21
Rsearch Note from JP Morgan re BIIB and T
Tysabri is clearly the centerpiece of their bullish LT view of BIIB from 2007-2010:
Biogen Idec provided bullish long-term EPS and revenue guidance that is
well above Street forecasts. The key upside driver is the expectation of
100,000 MS patients on Tysabri in 2010, a number that implies upwards of
$2.8B in WW end user Tysabri sales in 2010 (more than double our
$1.25B forecast). In our view, the announcement signals confidence in
fundamentals and the business outlook based on a commanding presence in
the multiple sclerosis market. Street numbers are likely to come up based
on fundamentals which are clearly improving well beyond expectations.
We reiterate our OW rating on BIIB, a Top Pick in large cap biotech.
• EPS and revenue 07-10 CAGR well above expectations on Tysabri
growth. In addition to reiterating 2007 guidance, Biogen announced a
2007-10 EPS and revenue CAGRs that are well above our and the
Street's estimates, with non-GAAP EPS CAGR of 20% (JPMe: 18%;
consensus 12%) and revenue CAGR of 15% (JPMe: 12%; consensus
9%). The upside guidance is driven primarily by growth in Tysabri,
where the company now expects 100,000 patients to be treated with
Tysabri by YE 2010. These patient numbers imply about $2.8B in 2010
WW end user Tysabri sales even without price increases, a view that is
more than double our 2010 estimate of $1.25B in WW end user sales.
• Clear upward bias to Street forecasts. Given Biogen’s bullish
expectations and increased visibility into the MS commercial outlook,
we believe Street forecasts are considerably lower than reality. We
named BIIB as one of our Top Picks for 2007 in January on the basis of
low and beatable expectations, and we continue to believe that there is a
valuation disconnect that implies further upside potential to BIIB shares.
• Valuation not a challenge, catalysts ahead. Trading only fractionally
higher than the large cap biotech group (17.7x on 2008 ests vs. the group
ex-CELG at 17.0x), we believe that potentially higher Street estimates
will drive further BIIB appreciation. Catalyst-wise, a positive Tysabri
safety update at ECTRIMS (Oct 11-14) and strong 3Q performance
should also be meaningful value drivers this fall.
Rsearch Note from JP Morgan re BIIB and T
Tysabri is clearly the centerpiece of their bullish LT view of BIIB from 2007-2010:
Biogen Idec provided bullish long-term EPS and revenue guidance that is
well above Street forecasts. The key upside driver is the expectation of
100,000 MS patients on Tysabri in 2010, a number that implies upwards of
$2.8B in WW end user Tysabri sales in 2010 (more than double our
$1.25B forecast). In our view, the announcement signals confidence in
fundamentals and the business outlook based on a commanding presence in
the multiple sclerosis market. Street numbers are likely to come up based
on fundamentals which are clearly improving well beyond expectations.
We reiterate our OW rating on BIIB, a Top Pick in large cap biotech.
• EPS and revenue 07-10 CAGR well above expectations on Tysabri
growth. In addition to reiterating 2007 guidance, Biogen announced a
2007-10 EPS and revenue CAGRs that are well above our and the
Street's estimates, with non-GAAP EPS CAGR of 20% (JPMe: 18%;
consensus 12%) and revenue CAGR of 15% (JPMe: 12%; consensus
9%). The upside guidance is driven primarily by growth in Tysabri,
where the company now expects 100,000 patients to be treated with
Tysabri by YE 2010. These patient numbers imply about $2.8B in 2010
WW end user Tysabri sales even without price increases, a view that is
more than double our 2010 estimate of $1.25B in WW end user sales.
• Clear upward bias to Street forecasts. Given Biogen’s bullish
expectations and increased visibility into the MS commercial outlook,
we believe Street forecasts are considerably lower than reality. We
named BIIB as one of our Top Picks for 2007 in January on the basis of
low and beatable expectations, and we continue to believe that there is a
valuation disconnect that implies further upside potential to BIIB shares.
• Valuation not a challenge, catalysts ahead. Trading only fractionally
higher than the large cap biotech group (17.7x on 2008 ests vs. the group
ex-CELG at 17.0x), we believe that potentially higher Street estimates
will drive further BIIB appreciation. Catalyst-wise, a positive Tysabri
safety update at ECTRIMS (Oct 11-14) and strong 3Q performance
should also be meaningful value drivers this fall.
Biogen wegen der erhöhten TY zahlen +5%:O
Antwort auf Beitrag Nr.: 31.416.092 von bernie55 am 06.09.07 15:39:45und dabei handelt es sich ausnahmsweise mal um "seriöse" Analysten.
Antwort auf Beitrag Nr.: 31.417.535 von Birgit.Tersteegen am 06.09.07 16:40:41bei uns wird halt erfahrungsbemäß wieder gedrückt.
Antwort auf Beitrag Nr.: 31.418.005 von Poppholz am 06.09.07 17:01:45
Hi Poppi, schaumal bei NB3 vorbei, ist was los heute
Hi Poppi, schaumal bei NB3 vorbei, ist was los heute
Antwort auf Beitrag Nr.: 31.421.239 von surga am 06.09.07 20:15:41nett, nett heute.
wieder mehr leben im thread.
bitte nicht schimpfen
wieder mehr leben im thread.
bitte nicht schimpfen
Antwort auf Beitrag Nr.: 16.813.097 von zenman am 06.06.05 09:03:17Gibts neues Infos zum Unternehmen? Der Kurs schmiert ja ganz schön ab!
DrKursplus
DrKursplus
Antwort auf Beitrag Nr.: 31.433.531 von DrKursplus am 07.09.07 09:31:31WIE BITTE WEN ODER WAS MEINST DU DENN JETZT???Der Thread wurde vor 2 Jahren eröffnet....
Antwort auf Beitrag Nr.: 31.433.836 von Birgit.Tersteegen am 07.09.07 09:43:31
Hi Biggi, ruhig Blut
Hi Biggi, ruhig Blut
Antwort auf Beitrag Nr.: 31.434.562 von surga am 07.09.07 10:12:56...ist doch wahr....
By: mrbluechip
Credit Suisse Comment Today
CS issued a Research Report dated 9/6/07 on Biogen, containing some interesting spin on Tysabri:
"The major difference between the companys revenue/EPS goals and consensus is management's aggressive Tysabri estimate. By comparison we are ahead of consensus for Tysabri revenue and only predict -50K patients on Tysabri by the end of 2007. While we are reassured by the lack of PML since launch, we remind investors that none of the three cases of PML occurred before 18 months of therapy. As such 2008 will be an important inflection point as safety after 18 months of therapy can be assessed. If multiple cases of PML emerge, managements estimates will be at risk"
Interesting negative spin. Might they have said "that none of the three cases of PML occurred in patients on Tysabri monotherapy, in fact no patient on Tysabri monotherapy has ever been diagnosed with PML."
By: mrbluechip
Credit Suisse Comment Today
CS issued a Research Report dated 9/6/07 on Biogen, containing some interesting spin on Tysabri:
"The major difference between the companys revenue/EPS goals and consensus is management's aggressive Tysabri estimate. By comparison we are ahead of consensus for Tysabri revenue and only predict -50K patients on Tysabri by the end of 2007. While we are reassured by the lack of PML since launch, we remind investors that none of the three cases of PML occurred before 18 months of therapy. As such 2008 will be an important inflection point as safety after 18 months of therapy can be assessed. If multiple cases of PML emerge, managements estimates will be at risk"
Interesting negative spin. Might they have said "that none of the three cases of PML occurred in patients on Tysabri monotherapy, in fact no patient on Tysabri monotherapy has ever been diagnosed with PML."
NCB
BiogenIdec provided long term revenue and EPS guidance yesterday, which was
ahead of consensus expectations along with reviewing its long-term strategic goals.
BiogenIdec’s financial goal is to generate revenue growth of 15% CAGR (‘07 to ‘10)
and EPS of 20% CAGR which compares to consensus of 9% and 12% CAGR,
respectively. The upside from consensus partly relates to the Tysabri target of 100,000
patients on drug by year-end 2010 (at the current price this is equivalent to $2.8bn in
end user Tysabri sales) with c.80%-90% of these patients expected to be MS patients.
This long-term MS patient target is well in excess of our MS patient estimates and
those of consensus. We are currently forecasting c.65k patients on Tysabri treatment
by the end of 2010.
• BiogenIdec noted yesterday that the uptake of Tysabri continues to be “very steady” in
the US, while accelerating modestly after the 1-year re-launch milestone. Management
also noted very steady progress on a country-by-country basis in Europe, with the
uptake of Tysabri accelerating overall with recent launches in Spain, Italy and France.
In mid-July the global Tysabri run rate was 300 patients per week compared to 283
patients reported at the end of May with EU/RoW driving the uptick in new patient
numbers. At this point with Tysabri re-launched over 12 months in the US, we would
expect to see better traction of Tysabri in the US this quarter and for EU/RoW to
continue showing strong growth with the roll-out of the product in a number of new
European countries.
• For Elan the main newsflow over the next month includes the FDA decision on Tysabri
for Crohn’s disease (while the FDA advisory committee strong recommended approval
of Tysabri for Crohn’s disease it remains possible that the FDA could overrule this
decision and request further clinical studies particularly in patients that have failed
previous therapies) and safety updates from the TOUCH program at ECTRIMS (11-13th
October). Additionally at ECTRIMS will be data on the effect of plasma exchange in
accelerating the clearance of Tysabri in MS patients. Over the coming months the start
of the Phase III study with bapineuzumab (AAB-001) is also expected to be confirmed.
Orla Hartford, PhD +353 1 611 5844 orla.hartford@ncb.ie
http://ftp.ncb.ie/equities/NCBLatestIrishEquities.pdf
BiogenIdec provided long term revenue and EPS guidance yesterday, which was
ahead of consensus expectations along with reviewing its long-term strategic goals.
BiogenIdec’s financial goal is to generate revenue growth of 15% CAGR (‘07 to ‘10)
and EPS of 20% CAGR which compares to consensus of 9% and 12% CAGR,
respectively. The upside from consensus partly relates to the Tysabri target of 100,000
patients on drug by year-end 2010 (at the current price this is equivalent to $2.8bn in
end user Tysabri sales) with c.80%-90% of these patients expected to be MS patients.
This long-term MS patient target is well in excess of our MS patient estimates and
those of consensus. We are currently forecasting c.65k patients on Tysabri treatment
by the end of 2010.
• BiogenIdec noted yesterday that the uptake of Tysabri continues to be “very steady” in
the US, while accelerating modestly after the 1-year re-launch milestone. Management
also noted very steady progress on a country-by-country basis in Europe, with the
uptake of Tysabri accelerating overall with recent launches in Spain, Italy and France.
In mid-July the global Tysabri run rate was 300 patients per week compared to 283
patients reported at the end of May with EU/RoW driving the uptick in new patient
numbers. At this point with Tysabri re-launched over 12 months in the US, we would
expect to see better traction of Tysabri in the US this quarter and for EU/RoW to
continue showing strong growth with the roll-out of the product in a number of new
European countries.
• For Elan the main newsflow over the next month includes the FDA decision on Tysabri
for Crohn’s disease (while the FDA advisory committee strong recommended approval
of Tysabri for Crohn’s disease it remains possible that the FDA could overrule this
decision and request further clinical studies particularly in patients that have failed
previous therapies) and safety updates from the TOUCH program at ECTRIMS (11-13th
October). Additionally at ECTRIMS will be data on the effect of plasma exchange in
accelerating the clearance of Tysabri in MS patients. Over the coming months the start
of the Phase III study with bapineuzumab (AAB-001) is also expected to be confirmed.
Orla Hartford, PhD +353 1 611 5844 orla.hartford@ncb.ie
http://ftp.ncb.ie/equities/NCBLatestIrishEquities.pdf
Ebb & Flow Focus
Bringing up BIIB
By Stacy Lawrence
Senior Writer
Biogen Idec Inc. has been on a tear of
late, boosted by its updated guidance last
week, ongoing acquisition rumors fueled
by the Federal Trade Commission’s approval
of a stock purchase by activist
investor Carl Icahn in late August, and its
stock buyback in early July.
Last Thursday, BIIB (Cambridge, Mass.)
committed to maintaining its rates of both
top and bottom line growth over the next
three years. At the Thomas Weisel conference
in Boston, the company offered
guidance that revenues from 2008 to
2010 are expected to achieve 15% compound
annual growth, with non-GAAP
EPS up 20% annually on average over that
period.
Since the merger between Biogen and
Idec, the company noted it will likely
achieve 14% CAGR on revenues and 21%
on EPS from 2004 to 2007. It originally
had laid out a goal of 15% revenue growth
and 20% EPS growth for those years.
BIIB reiterated its FY07 non-GAAP
diluted EPS guidance of $2.60-$2.70. The Street is expecting
$2.68.
The Street rewarded BIIB by pushing the stock up $3.66 to
$66.53 on Thursday. On the week, the shares gained $1.96 to
$65.78. Since a low of $43.68 on April 11, the stock has gained
$22.10 (51%).
But maintaining top line growth will become increasingly
difficult as the revenue base expands. Indeed, in FY06, revenue
grew at 11%, while EPS was up 43%.
“If they can achieve their guidance it would be very admirable;
I think some Street observers view the guidance as on the
aggressive side,” said Bear Stearns analyst Mark Schoenebaum.
The Street is also trying to figure out how to relate these
numbers to Icahn’s play in the stock. Kurt von Emster of MPM
Capital also called the new guidance “aggressive,” and suggested
“some might view that as seeking to boost the share price for an
acquisition.”
FTC’s approval of Icahn’s share purchase has fanned persistent
rumors on the Street that BIIB could be snapped up, perhaps by
Pfizer Inc. (PFE, New York, N.Y.). When PFE restructured in
January, it said it wanted one-fifth of its pipeline to be biotherapeutics,
but it’s still unclear how the pharma is going to make good on this
new priority (see BioCentury, Aug. 27 & Jan. 29).
“People think that Icahn is going to push Biogen Idec into
selling,” said Evan McCulloch of Franklin Templeton.
On Thursday, President and CEO James Mullen deflected a
question about why Icahn has taken a position in the stock.
Oliver Marti of Columbus Circle Investors noted the BIIB/PFE
acquisition talk first surfaced in April after AstraZeneca plc
(LSE:AZN; AZN, London, U.K.) announced it would acquire
MedImmune Inc. for $15.6 billion. He suggested the rumors are
rooted in a note from Schoenebaum in late June in which the
analyst speculated on which large cap biotechs could be up next
for acquisition.
Even with BIIB’s rapid rise since then, Schoenebaum still
thinks the biotech makes a good acquisition candidate. He
suggested the price could be as much as the high $70s or low
$80s. An $80 takeout would be a 22% premium to Friday’s close,
and an 83% premium over the April low (see “BIIB: Pharma or
Biotech?” A19).
Schoenebaum said BIIB’s “best-in-class” multiple sclerosis
commercial infrastructure, as well as potential excess
biotherapeutic manufacturing capacity, which he expects in
2009, could be attractive to an acquirer.
But BIIB isn’t the only company in the rumor mill. “At this
point, I’ve heard rumors that Pfizer was going to buy Gilead,
Amgen and Biogen Idec,” Marti told Ebb & Flow.
A contrarian view came from Stuart Wisebrod of Merlin
BioMed. He noted the terms of BIIB partnerships on Rituxan
rituximab with Genentech Inc. (DNA, South San Francisco,
Calif.) and Tysabri natalizumab with Elan Corp. plc (ELN,
Dublin, Ireland) have change of control provisions that would
mean “an acquirer could potentially get a reduced value out of
those products.”
Rituxan is marketed for non-Hodgkin’s lymphoma (NHL) and
rheumatoid arthritis, while Tysabri is used in MS.
Both DNA and ELN would have the right to bid to obtain
BIIB’s interest in partnered product sales in the event of an
acquisition. But Marti doesn’t see this as an insurmountable
barrier, but rather as one that would require complex negotiations
by the acquirer to circumvent.
He noted that “Genentech has the right to make a real,
legitimate offer for the Rituxan franchise” under a change of
control scenario. But as the terms allow BIIB to either buy or sell
the business on those terms, then a potential acquirer would be
able to negotiate with DNA.
BIIB’s share of the Rituxan franchise is also expected to shrink
if ocrelizumab is launched. The second-generation anti-CD20
antibody, also partnered with DNA, is in Phase III trials to treat
RA. With the advent of ocrelizumab sales, BIIB’s share of all anti-
CD20 revenue would eventually shrink from 40% to 30%,
according to Schoenebaum.
In addition, he noted the ex-U.S. royalty stream on Rituxan
from Roche (SWX:ROG, Basel, Switzerland) begins to expire in
2009.
Bringing up BIIB
By Stacy Lawrence
Senior Writer
Biogen Idec Inc. has been on a tear of
late, boosted by its updated guidance last
week, ongoing acquisition rumors fueled
by the Federal Trade Commission’s approval
of a stock purchase by activist
investor Carl Icahn in late August, and its
stock buyback in early July.
Last Thursday, BIIB (Cambridge, Mass.)
committed to maintaining its rates of both
top and bottom line growth over the next
three years. At the Thomas Weisel conference
in Boston, the company offered
guidance that revenues from 2008 to
2010 are expected to achieve 15% compound
annual growth, with non-GAAP
EPS up 20% annually on average over that
period.
Since the merger between Biogen and
Idec, the company noted it will likely
achieve 14% CAGR on revenues and 21%
on EPS from 2004 to 2007. It originally
had laid out a goal of 15% revenue growth
and 20% EPS growth for those years.
BIIB reiterated its FY07 non-GAAP
diluted EPS guidance of $2.60-$2.70. The Street is expecting
$2.68.
The Street rewarded BIIB by pushing the stock up $3.66 to
$66.53 on Thursday. On the week, the shares gained $1.96 to
$65.78. Since a low of $43.68 on April 11, the stock has gained
$22.10 (51%).
But maintaining top line growth will become increasingly
difficult as the revenue base expands. Indeed, in FY06, revenue
grew at 11%, while EPS was up 43%.
“If they can achieve their guidance it would be very admirable;
I think some Street observers view the guidance as on the
aggressive side,” said Bear Stearns analyst Mark Schoenebaum.
The Street is also trying to figure out how to relate these
numbers to Icahn’s play in the stock. Kurt von Emster of MPM
Capital also called the new guidance “aggressive,” and suggested
“some might view that as seeking to boost the share price for an
acquisition.”
FTC’s approval of Icahn’s share purchase has fanned persistent
rumors on the Street that BIIB could be snapped up, perhaps by
Pfizer Inc. (PFE, New York, N.Y.). When PFE restructured in
January, it said it wanted one-fifth of its pipeline to be biotherapeutics,
but it’s still unclear how the pharma is going to make good on this
new priority (see BioCentury, Aug. 27 & Jan. 29).
“People think that Icahn is going to push Biogen Idec into
selling,” said Evan McCulloch of Franklin Templeton.
On Thursday, President and CEO James Mullen deflected a
question about why Icahn has taken a position in the stock.
Oliver Marti of Columbus Circle Investors noted the BIIB/PFE
acquisition talk first surfaced in April after AstraZeneca plc
(LSE:AZN; AZN, London, U.K.) announced it would acquire
MedImmune Inc. for $15.6 billion. He suggested the rumors are
rooted in a note from Schoenebaum in late June in which the
analyst speculated on which large cap biotechs could be up next
for acquisition.
Even with BIIB’s rapid rise since then, Schoenebaum still
thinks the biotech makes a good acquisition candidate. He
suggested the price could be as much as the high $70s or low
$80s. An $80 takeout would be a 22% premium to Friday’s close,
and an 83% premium over the April low (see “BIIB: Pharma or
Biotech?” A19).
Schoenebaum said BIIB’s “best-in-class” multiple sclerosis
commercial infrastructure, as well as potential excess
biotherapeutic manufacturing capacity, which he expects in
2009, could be attractive to an acquirer.
But BIIB isn’t the only company in the rumor mill. “At this
point, I’ve heard rumors that Pfizer was going to buy Gilead,
Amgen and Biogen Idec,” Marti told Ebb & Flow.
A contrarian view came from Stuart Wisebrod of Merlin
BioMed. He noted the terms of BIIB partnerships on Rituxan
rituximab with Genentech Inc. (DNA, South San Francisco,
Calif.) and Tysabri natalizumab with Elan Corp. plc (ELN,
Dublin, Ireland) have change of control provisions that would
mean “an acquirer could potentially get a reduced value out of
those products.”
Rituxan is marketed for non-Hodgkin’s lymphoma (NHL) and
rheumatoid arthritis, while Tysabri is used in MS.
Both DNA and ELN would have the right to bid to obtain
BIIB’s interest in partnered product sales in the event of an
acquisition. But Marti doesn’t see this as an insurmountable
barrier, but rather as one that would require complex negotiations
by the acquirer to circumvent.
He noted that “Genentech has the right to make a real,
legitimate offer for the Rituxan franchise” under a change of
control scenario. But as the terms allow BIIB to either buy or sell
the business on those terms, then a potential acquirer would be
able to negotiate with DNA.
BIIB’s share of the Rituxan franchise is also expected to shrink
if ocrelizumab is launched. The second-generation anti-CD20
antibody, also partnered with DNA, is in Phase III trials to treat
RA. With the advent of ocrelizumab sales, BIIB’s share of all anti-
CD20 revenue would eventually shrink from 40% to 30%,
according to Schoenebaum.
In addition, he noted the ex-U.S. royalty stream on Rituxan
from Roche (SWX:ROG, Basel, Switzerland) begins to expire in
2009.
News Release
Monday 10 September 2007, 13:01 GMT
Monday 10 September 2007 Date
HEALTH topic
Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) company
Scotland Advises TYSABRI(R) Use in Highly Active Relapsing Remitting Multiple Sclerosis
MAIDENHEAD, England and DUBLIN, Ireland, September 10 /PRNewswire/ -- Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) welcome today's announcement by the Scottish Medicines Consortium (SMC) advising the use of TYSABRI(R) (natalizumab) in people with highly active relapsing remitting multiple sclerosis (RRMS)(1).
In view of evidence supporting the efficacy, safety and cost effectiveness of TYSABRI, all NHS Health Boards in Scotland are now obliged to consider the SMC's advice and ensure that TYSABRI is made available to meet patient's clinical needs.
Similar positive guidance on TYSABRI was issued in England by the National Institute for Health and Clinical Excellence (NICE) in August 2007.
"This decision offers real hope of a more active and fulfilled life to MS patients in Scotland with highly active relapsing remitting multiple sclerosis," commented Dr. Belinda Weller, Western General Hospital, Edinburgh. "Access to appropriate therapy is particularly vital in Scotland as we have the highest number of people with MS per capita in the world. Our priority now must be to ensure that treatment is made available to those with the most highly active form of the disease."
Highly active RRMS (defined in the SMC advice as two or more disabling relapses in one year and an active MRI scan) has a devastating effect on the lives of the individual and their families. These patients experience more relapses and will become disabled more quickly than those people with typical RRMS. Disability often means that these patients are unable to work, adversely affecting their families as well.
TYSABRI is the first treatment to be specifically licensed for highly active RRMS. Over two years, treatment with TYSBARI for highly active RRMS (as defined by the SMC) leads to a 64% reduction in the risk of disability progression and an 81% reduction in annualised relapse rate compared with placebo(2).
As of mid-July 2007, approximately 14,000 MS patients worldwide are currently receiving therapy with TYSABRI, either in the commercial setting or in clinical trials.
The Scottish Medicines Consortium (SMC) provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licenced from January 2002). This advice is made available as soon as practical after the launch of the product involved.
About TYSABRI (natalizumab)
TYSABRI is a treatment approved for relapsing forms of multiple sclerosis (MS) in the US 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 annualised relapse rate compared to placebo and reduced the relative risk of disability progression by 54% (p<0.001)(3).
TYSABRI use has been associated with an increased 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 in MS trials. Herpes infections were slightly more common in patients treated with TYSABRI. The rate and nature of other infections was similar to placebo. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, rash, infusion reactions, urinary tract infections, joint and limb pain.
In addition to the European Union and the United States, TYSABRI is approved in Switzerland, Canada, Australia and Israel. TYSABRI was discovered by Elan and is co-developed with Biogen Idec.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
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.
Safe Harbor/Forward Looking Statements
This press release contains forward looking statements regarding TYSABRI that are subject to risks and uncertainties that could cause actual results to differ materially from that which we expect. Important factors that could cause our actual results to differ include the possibility that our competitors may offer treatment options that gain greater acceptance than TYSABRI, regulatory and safety risks of TYSABRI, and the other risks and uncertainties that are described in the periodic and current reports that Biogen Idec and Elan have filed with the Securities and Exchange Commission, including the "Risk Factors" sections of such filings. These forward looking statements speak only as of the date of this press release, and the companies do not undertake any obligation to update any forward looking statements, whether as a result of new information, future events, or otherwise.
NEW | 2007-09-10
SMC approves Tysabri for the treatment of MS in Scotland
The MS Trust welcomes the decision by the Scottish Medicines Consortium (SMC) to allow the use of Tysabri (natalizumab) for the treatment of rapidly evolving severe relapsing/remitting multiple sclerosis.
Christine Jones, Chief Executive of the MS Trust, said: "The MS Trust is delighted that the SMC has taken this decision and that people in Scotland with this severe form of MS have now got access to treatment."
"Due to the rapid disease progression of this particularly aggressive form of MS it is imperative that patients get this treatment without further delay and we hope that neurologists and commissioners will react swiftly to this decision," she added.
Rapidly evolving severe relapsing/remitting multiple sclerosis affects a small number of people but it is a serious and rapidly debilitating type of MS. It is defined by two or more disabling relapses in one year with evidence of increasing lesions on two consecutive MRI scans.
The decision by the SMC follows the similar decision taken by NICE (the National Istitute for Health and Clinical Excellence), which approved Tysabri for use in the NHS in Engalnd and Wales in August.
SMC approves Tysabri for the treatment of MS in Scotland
The MS Trust welcomes the decision by the Scottish Medicines Consortium (SMC) to allow the use of Tysabri (natalizumab) for the treatment of rapidly evolving severe relapsing/remitting multiple sclerosis.
Christine Jones, Chief Executive of the MS Trust, said: "The MS Trust is delighted that the SMC has taken this decision and that people in Scotland with this severe form of MS have now got access to treatment."
"Due to the rapid disease progression of this particularly aggressive form of MS it is imperative that patients get this treatment without further delay and we hope that neurologists and commissioners will react swiftly to this decision," she added.
Rapidly evolving severe relapsing/remitting multiple sclerosis affects a small number of people but it is a serious and rapidly debilitating type of MS. It is defined by two or more disabling relapses in one year with evidence of increasing lesions on two consecutive MRI scans.
The decision by the SMC follows the similar decision taken by NICE (the National Istitute for Health and Clinical Excellence), which approved Tysabri for use in the NHS in Engalnd and Wales in August.
NCB ...
A decision was taken yesterday by the Scottish Medicines Consortium (SMC) to
reverse its initial recommendation of reimbursing Tysabri for Scottish MS patients. Post
its initial decision, the SMC re-opened negotiations on reimbursement and now advises
use in MS patients with highly active relapsing disease (RRMS). This recommendation
by SMC is positive and is in-line with the NICE recommendation earlier this year to
NHS boards in England and Wales. Tysabri’s launch in the UK with reimbursement
along with the recent launch of the product in France, Spain and Italy is expected to
underpin our patient numbers/revenues near-term. On a longer-term basis, the efficacy
profile of Tysabri and long-term safety data should support demand for the product.
• As outlined by BiogenIdec last week (and re-iterated yesterday at an investor
conference), the year-end 2010 Tysabri patient target (majority to be MS patients) is
100,000. This target for patient use is well in excess of our patient estimates (we are
forecasting c.65k patients on Tysabri treatment by the end of 2010) and implies
c.$350m of additional net income to Elan in 2011.
Orla Hartford, PhD +353 1 611 5844 orla.hartford@ncb.ie
A decision was taken yesterday by the Scottish Medicines Consortium (SMC) to
reverse its initial recommendation of reimbursing Tysabri for Scottish MS patients. Post
its initial decision, the SMC re-opened negotiations on reimbursement and now advises
use in MS patients with highly active relapsing disease (RRMS). This recommendation
by SMC is positive and is in-line with the NICE recommendation earlier this year to
NHS boards in England and Wales. Tysabri’s launch in the UK with reimbursement
along with the recent launch of the product in France, Spain and Italy is expected to
underpin our patient numbers/revenues near-term. On a longer-term basis, the efficacy
profile of Tysabri and long-term safety data should support demand for the product.
• As outlined by BiogenIdec last week (and re-iterated yesterday at an investor
conference), the year-end 2010 Tysabri patient target (majority to be MS patients) is
100,000. This target for patient use is well in excess of our patient estimates (we are
forecasting c.65k patients on Tysabri treatment by the end of 2010) and implies
c.$350m of additional net income to Elan in 2011.
Orla Hartford, PhD +353 1 611 5844 orla.hartford@ncb.ie
Antwort auf Beitrag Nr.: 31.522.896 von Birgit.Tersteegen am 11.09.07 10:16:16das hört sich alles viel zu gut an.
11.09.2007 16:52
Biogen Idec gibt anlässlich Investorenkonferenzen Aktualisierungen der Unternehmensstrategie bekannt
James C. Mullen, CEO von Biogen Idec (Nachrichten) (NASDAQ: BIIB), wird Investoren heute und im Lauf der kommenden Woche im Rahmen von Präsentationen wichtige Wachstumschancen vorstellen und die langfristigen strategischen und finanziellen Ziele des Unternehmens besprechen. Mullen wird heute anlässlich der Thomas Weisel Partners Healthcare Conference um 8.00 Uhr morgens in Boston und am 10. September anlässlich der Bear Stearns Healthcare Conference in New York sprechen. Beide Präsentationen sind per Webcast unter www.biogenidec.com unter der Überschrift Investor Relations verfügbar. Zusätzliche Informationen in Form von Diapräsentationen werden online zum Zeitpunkt der Referate an derselben Stelle zur Verfügung gestellt. Sie bleiben auf der Website von Biogen Idec bis mindestens zum 30. September 2007 verfügbar.
Finanzielle Zielsetzungen
Biogen Idec wird die Zielsetzungen des Unternehmens bekannt geben, zwischen 2007 und 2010 Erträge mit einer kumulierten jährlichen Wachstumsrate (CAGR) von 15 % zu steigern und eine Erhöhung der Gewinne je Aktie auf Nicht-GAAP-Basis von 20 % CAGR zu erzielen.
Diese finanziellen Zielsetzungen spiegeln das starke Wachstumsmoment wider, das Biogen Idec derzeit bereits vorantreibt. Das Unternehmen erwartet besonders starke Wachstumsimpulse durch:
-- anhaltend solide Leistung von AVONEX(R) (Interferon beta-1a), der weltweit führenden Behandlung für multiple Sklerose;
-- Expansion von RITUXAN(R) (Rituximab), der weltweit führenden Krebsbehandlung, in die Behandlung von Autoimmunerkrankungen;
-- Erzielung des Meilensteins von 100.000 Patienten für TYSABRI(R) (Natalizumab) bis zum Jahresende 2010 und
-- fortgesetzte geographische Diversifizierung der Ertragsbasis des Unternehmens mit Erzielung von über 40 % der Erträge aus internationaler Geschäftstätigkeit bis 2010.
„Biogen Idec hat TYSABRI in den USA bereits vor über einem Jahr lanciert, und wir haben diese wichtige Therapie nun auch in großen europäischen Märkten eingeführt und erzielen dort Umsätze. So können wir unser langfristiges Wachstum detaillierter prognostizieren,“ meinte Mullen. „Kurz- bis mittelfristig erwarten wir weiterhin starke Leistung von AVONEX und RITUXAN und die Entwicklung von TYSABRI zum weltweit führenden Therapeutikum für Patienten mit multipler Sklerose.“
Highlights in der Pipeline
Das Unternehmen hat 15 Produktkandidaten in Studien der klinischen Phase 2 oder höher, und mehr als zehn Datenergebnisse werden bis Ende 2008 erwartet. Diese Programme werden laut Erwartungen langfristig zu ähnlichem Top-Line-Wachstum beitragen. Bis 2010 hat es sich das Unternehmen zum Ziel gesetzt, vier neue Produkte zu lancieren und/oder existierende Produkte für neue Indikationen einzuführen sowie sechs Programme in den späten Phasen der klinischen Entwicklung zu haben.
„Unsere Wachstumsziele reflektieren den Beitrag unserer robusten Pipeline“, kommentierte Mullen. „In den vergangenen beiden Jahren konnten wir mehrere interne Programme erfolgreich weiter vorantreiben. Zugleich haben wir eine Strategie für die Entwicklung unserer Geschäftstätigkeit verfolgt, die es uns ermöglicht hat, auf mehr als zehn Moleküle für weniger als 640 Mio. Dollar an Vorauszahlungen zuzugreifen. Wir beabsichtigen, das Wachstum unserer zentralen therapeutischen Bereiche fortzusetzen und zugleich mit Konzentration auf First-in-Class- und Best-in-Class-Produkte in neue Bereiche zu expandieren.“
Als Teil der Präsentation wird Mullen verschiedene viel versprechende Programme diskutieren: Lumiliximab für chronisch-lymphozytische Leukämie, RITUXAN für Lupus, LTBR-Fc für rheumatoide Arthritis, langfristig wirksamen Faktor IX für Hämophilie B und HSP90-Inhibition für Blutkrebserkrankungen und solide Tumoren.
Wiederholung der Finanzprognosen für 2007
Mullen wird die Finanzprognosen für das Gesamtjahr 2007 wiederholen. Am 24. Juli hob das Unternehmen die Finanzprognosen für das Gesamtjahr anlässlich seines Finanzberichts für das zweite Quartal folgendermaßen an:
-- Gesamtes Ertragswachstum von 16-18 % verglichen mit 2006;
-- verwässerte Gewinne je Aktie auf Nicht-GAAP-Basis im Bereich von 2,60 bis 2,70 $ je Aktie, d. h. 16-20 % Jahreswachstum - diese spiegeln den Rückkauf von Aktien im Wert von 3 Mrd. $ im Rahmen des kürzlich abgeschlossenen niederländischen Übernahmeangebots wider. Diese Schätzung der verwässerten Gewinne je Aktie auf Nicht-GAAP-Basis schließt die Auswirkungen von Purchase Accounting, fusionsbedingten Anpassungen, Belastungen für Aktienoptionen, sonstige Posten und ihre entsprechenden steuerlichen Auswirkungen nicht ein;
-- verwässerte Gewinne je Aktie auf GAAP-Basis im Bereich von 1,84 bis 1,94 $, verglichen mit 0,63 $ je Aktie für 2006. Diese Schätzung beinhaltet die Auswirkungen des Cardokine-Geschäfts, aber keine weiteren künftigen Übernahmen oder Transaktionen. Um die Prognosen für Gewinne je Aktie auf GAAP- und Nicht-GAAP-Basis abzugleichen, haben wir die folgenden Posten aus unserer obigen Prognose für Gewinne je Aktie auf Nicht-GAAP-Basis ausgenommen:
-- Belastungen für Purchase Accounting, einschließlich Abschreibung von erworbenen immateriellen Gütern und aktueller Forschung und Entwicklung, geschätzt auf 287 Mio. $ oder ungefähr 0,90 $ je Aktie, für bereits abgeschlossene Transaktionen;
-- Belastungen für Aktienoptionen auf Grundlage von FAS 123R werden für 2007 auf 30-40 Mio. $ oder ungefähr 0,07-0,09 $ je Aktie geschätzt.
Da das Unternehmen für 2007 keine sicheren Prognosen über die Art oder die Höhe betriebsfremder oder ungewöhnlicher Belastungen abgeben kann, haben wir in dieser GAAP-Prognose keine Annahmen bezüglich künftiger Purchase-Accounting-Belastungen gemacht. Dem Unternehmen können 2007 Belastungen oder Gewinne entstehen, aufgrund denen tatsächliche Ergebnisse von dieser Prognose abweichen können.
Zum Zeitpunkt der Fusion im Jahr 2003 prognostizierte das Unternehmen bis Ende 2007 für die Erträge eine kumulierte jährliche Wachstumsrate von 15 % und für die Gewinne je Aktie auf Nicht-GAAP-Basis eine kumulierte jährliche Wachstumsrate von 15 %. Mit Umsetzung dieser Prognose für das Gesamtjahr 2007 könnte das Unternehmen diese finanziellen Zielsetzungen erreichen, indem es bis Ende 2007 eine kumulierte jährliche Wachstumsrate von 14 % bei den Erträgen und von 21 % bei Gewinnen je Aktie auf Nicht-GAAP-Basis erzielt.
Abgleich der Gewinne je Aktie auf GAAP-Basis
Auf Basis der gemeldeten Ergebnisse strebt das Unternehmen für die Gewinne je Aktie auf GAAP-Basis, d. h. entsprechend den US-amerikanischen Grundsätzen ordnungsgemäßer Buchführung berechnete Gewinne je Aktie, zwischen 2007 und 2010 eine kumulierte jährliche Wachstumsrate von 25 % an. Das langfristige Ziel für die Gewinne je Aktie auf Nicht-GAAP-Basis schließt die Auswirkungen von Purchase Accounting, fusionsbedingten Anpassungen, Belastungen für Aktienoptionen und ihre entsprechenden steuerlichen Auswirkungen nicht ein. Um die Zahlen für langfristige Gewinne je Aktie auf GAAP-Basis und Nicht-GAAP-Basis abzugleichen, hat das Unternehmen die folgenden Posten für 2008 bis 2010 aus den oben angeführten Zielsetzungen für Gewinne je Aktie auf Nicht-GAAP-Basis ausgeschlossen:
-- Belastungen für Purchase Accounting, einschließlich Abschreibung von immateriellen Gütern und aktueller Forschung und Entwicklung, werden für bereits abgeschlossene Transaktionen auf 760-$800 Mio. $ geschätzt.
-- Belastungen für Aktienoptionen auf Grundlage von FAS 123R werden auf 80-90 Mio. $ geschätzt.
-- Steuervorteile im Zusammenhang mit dem Postenabgleich vor Steuern werden auf 220-240 Mio. $ geschätzt.
Da das Unternehmen bis 2010 keine sicheren Prognosen über die Art oder die Höhe betriebsfremder oder ungewöhnlicher Belastungen abgeben kann, haben wir in dieser Prognose über Gewinne je Aktie auf GAAP-Basis keine Annahmen bezüglich neuer Purchase-Accounting-Belastungen gemacht. Dem Unternehmen können bis 2010 Belastungen oder Gewinne entstehen, aufgrund denen tatsächliche Ergebnisse von dieser Zielsetzung abweichen können.
Verwendung von Finanzmaßnahmen auf Nicht-GAAP-Basis
Finanzmaßnahmen auf Nicht-GAAP-Basis sind wie berichtet definiert oder aus den unten angegebenen Gründen als GAAP, Gewinne je Aktie ausgenommen; (1) Purchase Accounting und fusionsbedingte Anpassungen; (2) Belastungen für Aktienoptionen und (3) sonstige Posten. Die Unternehmensleitung verwendet diese Finanzmaßnahmen auf Nicht-GAAP-Basis, um finanzielle Zielsetzungen zu erarbeiten und ein Verständnis der relativen finanziellen Leistung des Unternehmens von Jahr zu Jahr bzw. Quartal zu Quartal zu gewinnen. Dementsprechend ist Biogen Idec der Ansicht, dass unsere Offenlegung dieser Finanzmaßnahmen auf Nicht-GAAP-Basis das Verständnis von Investoren bezüglich der finanziellen Leistung des Unternehmens fördert. Nettogewinne auf Nicht-GAAP-Basis und verwässerte Gewinne je Aktie sollten nicht isoliert betrachtet oder als Ersatz für gemeldete Gewinne je Aktie oder Gewinne je Aktie auf GAAP-Basis verwendet werden.
Purchase Accounting und fusionsbedingte Anpassungen - Gewinne je Aktie auf Nicht-GAAP-Basis schließen bestimmte Purchase-Accounting-Auswirkungen, z. B. diejenigen im Zusammenhang mit der Fusionierung mit Biogen, Inc. („Fusion“) und der Übernahme von Fumapharm AG, Conforma Therapeutics Corp. und Syntonix Pharmaceuticals, Inc., aus. Diese beinhalten Belastungen für aktuelle Forschung und Entwicklung sowie die inkrementalen Belastungen für Warenkosten, die das Unternehmen als übernommenes Inventar verkaufte, das zum Übernahmezeitpunkt buchtechnisch auf den fairen Marktwert festgesetzt wurde. Darüber hinaus beinhalten diese ausgeschlossenen Auswirkungen die inkrementalen Belastungen im Zusammenhang mit der Abschreibung der übernommenen immateriellen Güter. Der Ausschluss dieser Belastungen gibt der Unternehmensleitung und Investoren eine alternative Sicht der Finanzergebnisse des Unternehmens, als wären die übernommenen immateriellen Güter intern entwickelt und nicht übernommen worden. Er bietet so einen zusätzlichen Leistungsmaßstab, in dem die erworbenen geistigen Güter des Unternehmens auf vergleichbare Weise zu den intern entwickelten geistigen Gütern behandelt werden.
Belastungen für Aktienoptionen - Nettogewinne auf Nicht-GAAP-Basis und verwässerte Gewinne je Aktie schließen die Auswirkungen unserer Belastungen für Aktienoptionen auf Grundlage von SFAS Nr. 123R und die kumulative Wirkung der Buchhaltungsumstellung im Zusammenhang mit der ursprünglichen Einführung aus. Das Unternehmen ist der Ansicht, dass der Ausschluss der Auswirkungen von Belastungen für Aktienoptionen die wiederkehrenden wirtschaftlichen Charakteristiken unserer integrierten Geschäftstätigkeit besser widerspiegelt. Das Unternehmen schließt die Auswirkungen eingeschränkter Aktienzuteilungen und anderer Cash-Incentives auf die Gewinn- und Verlustrechnung in die Ergebnisse auf Nicht-GAAP-Basis ein.
Sonstige Posten - Nettogewinne auf Nicht-GAAP-Basis und verwässerte Gewinne je Aktie schließen andere ungewöhnliche oder nicht wiederkehrende Posten aus, die individuell beurteilt werden. Die Einschätzung, ob ein Posten für die Bestimmung unserer Finanzmaßnahmen auf Nicht-GAAP-Basis auszuschließen ist, berücksichtigt sowohl die quantitativen als auch die qualitativen Aspekte des Postens, darunter auch (i) seinen Umfang und seine Art, (ii) ob er sich auf die laufende Geschäftstätigkeit des Unternehmens bezieht und (iii) ob das Unternehmen erwartet, dass der Posten regelmäßig als Teil seiner normalen Geschäftstätigkeit auftreten wird. Für die Zwecke der Bestimmung der Nettogewinne auf Nicht-GAAP-Basis und verwässerten Gewinne je Aktie ausgeschlossene Posten sind Belastungen für Abfindungen und Umstrukturierung sowie Gewinne beim Verkauf langlebiger Güter.
Über Biogen Idec
Biogen Idec setzt in therapeutischen Bereichen mit erheblichen medizinischen Versorgungslücken neue Standards. Das Unternehmen wurde 1978 gegründet und ist bei der Entwicklung, Herstellung und Kommerzialisierung innovativer Therapien weltweit führend. Patienten in mehr als 90 Ländern profitieren von Biogen Idecs leistungsfähigen Produkten für die Behandlung von Lymphknotenerkrankungen und Krankheiten wie multipler Sklerose und Gelenkrheumatismus. Produktauszeichnungen, Pressemitteilungen und zusätzliche Informationen über das Unternehmen finden Sie unter http://www.biogenidec.com.
Safe Harbor
Diese Pressemitteilung enthält zukunftsorientierte Aussagen über unsere erwarteten Einkünfte, Erträge, Produktumsätze, Produktentwicklungen und andere Angelegenheiten. Zukunftsorientierte Aussagen unterliegen bestimmten Risiken und Unwägbarkeiten, aufgrund denen tatsächliche Ergebnisse von unseren Erwartungen wesentlich abweichen können. Wichtige Faktoren, die Abweichungen unserer tatsächlichen Ergebnisse verursachen könnten, beinhalten unsere anhaltende Abhängigkeit von unseren zwei wichtigsten Produkten AVONEX und RITUXAN, die Unsicherheit des Erfolgs bei der Kommerzialisierung anderer Produkte, darunter TYSABRI, das Auftreten negativer Sicherheitsereignisse bei unseren Produkten, das Versäumnis, unsere Wachstumsstrategie erfolgreich umzusetzen oder in unseren Märkten effektiv zu konkurrieren, unsere Abhängigkeit von Kollaborationen, über die wir nicht immer volle Kontrolle haben, mögliche negative Auswirkungen staatlicher Regelungen und Veränderungen in der Verfügbarkeit von Vergütungen für unsere Produkte, Probleme mit unseren Herstellungsverfahren und unserem Vertrauen auf Dritte, Schwankungen unserer betrieblichen Ergebnisse, unsere Fähigkeit, unsere geistigen Eigentumsrechte zu schützen, sowie damit verbundene Kosten, Risiken einer internationalen Geschäftstätigkeit sowie andere Risiken und Unwägbarkeiten, die in unserem aktuellen, bei der SEC eingereichten Formblatt 10-Q unter Position 1A Risikofaktoren beschrieben sind. Diese zukunftsgerichteten Aussagen sind nur zum Zeitpunkt dieser Pressemitteilung aktuell, und wir lehnen jegliche Verpflichtung zur öffentlichen Aktualisierung jeglicher zukunftsgerichteter Aussagen ab, ob als Resultat neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen.
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-2007-09/artikel-…
Biogen Idec gibt anlässlich Investorenkonferenzen Aktualisierungen der Unternehmensstrategie bekannt
James C. Mullen, CEO von Biogen Idec (Nachrichten) (NASDAQ: BIIB), wird Investoren heute und im Lauf der kommenden Woche im Rahmen von Präsentationen wichtige Wachstumschancen vorstellen und die langfristigen strategischen und finanziellen Ziele des Unternehmens besprechen. Mullen wird heute anlässlich der Thomas Weisel Partners Healthcare Conference um 8.00 Uhr morgens in Boston und am 10. September anlässlich der Bear Stearns Healthcare Conference in New York sprechen. Beide Präsentationen sind per Webcast unter www.biogenidec.com unter der Überschrift Investor Relations verfügbar. Zusätzliche Informationen in Form von Diapräsentationen werden online zum Zeitpunkt der Referate an derselben Stelle zur Verfügung gestellt. Sie bleiben auf der Website von Biogen Idec bis mindestens zum 30. September 2007 verfügbar.
Finanzielle Zielsetzungen
Biogen Idec wird die Zielsetzungen des Unternehmens bekannt geben, zwischen 2007 und 2010 Erträge mit einer kumulierten jährlichen Wachstumsrate (CAGR) von 15 % zu steigern und eine Erhöhung der Gewinne je Aktie auf Nicht-GAAP-Basis von 20 % CAGR zu erzielen.
Diese finanziellen Zielsetzungen spiegeln das starke Wachstumsmoment wider, das Biogen Idec derzeit bereits vorantreibt. Das Unternehmen erwartet besonders starke Wachstumsimpulse durch:
-- anhaltend solide Leistung von AVONEX(R) (Interferon beta-1a), der weltweit führenden Behandlung für multiple Sklerose;
-- Expansion von RITUXAN(R) (Rituximab), der weltweit führenden Krebsbehandlung, in die Behandlung von Autoimmunerkrankungen;
-- Erzielung des Meilensteins von 100.000 Patienten für TYSABRI(R) (Natalizumab) bis zum Jahresende 2010 und
-- fortgesetzte geographische Diversifizierung der Ertragsbasis des Unternehmens mit Erzielung von über 40 % der Erträge aus internationaler Geschäftstätigkeit bis 2010.
„Biogen Idec hat TYSABRI in den USA bereits vor über einem Jahr lanciert, und wir haben diese wichtige Therapie nun auch in großen europäischen Märkten eingeführt und erzielen dort Umsätze. So können wir unser langfristiges Wachstum detaillierter prognostizieren,“ meinte Mullen. „Kurz- bis mittelfristig erwarten wir weiterhin starke Leistung von AVONEX und RITUXAN und die Entwicklung von TYSABRI zum weltweit führenden Therapeutikum für Patienten mit multipler Sklerose.“
Highlights in der Pipeline
Das Unternehmen hat 15 Produktkandidaten in Studien der klinischen Phase 2 oder höher, und mehr als zehn Datenergebnisse werden bis Ende 2008 erwartet. Diese Programme werden laut Erwartungen langfristig zu ähnlichem Top-Line-Wachstum beitragen. Bis 2010 hat es sich das Unternehmen zum Ziel gesetzt, vier neue Produkte zu lancieren und/oder existierende Produkte für neue Indikationen einzuführen sowie sechs Programme in den späten Phasen der klinischen Entwicklung zu haben.
„Unsere Wachstumsziele reflektieren den Beitrag unserer robusten Pipeline“, kommentierte Mullen. „In den vergangenen beiden Jahren konnten wir mehrere interne Programme erfolgreich weiter vorantreiben. Zugleich haben wir eine Strategie für die Entwicklung unserer Geschäftstätigkeit verfolgt, die es uns ermöglicht hat, auf mehr als zehn Moleküle für weniger als 640 Mio. Dollar an Vorauszahlungen zuzugreifen. Wir beabsichtigen, das Wachstum unserer zentralen therapeutischen Bereiche fortzusetzen und zugleich mit Konzentration auf First-in-Class- und Best-in-Class-Produkte in neue Bereiche zu expandieren.“
Als Teil der Präsentation wird Mullen verschiedene viel versprechende Programme diskutieren: Lumiliximab für chronisch-lymphozytische Leukämie, RITUXAN für Lupus, LTBR-Fc für rheumatoide Arthritis, langfristig wirksamen Faktor IX für Hämophilie B und HSP90-Inhibition für Blutkrebserkrankungen und solide Tumoren.
Wiederholung der Finanzprognosen für 2007
Mullen wird die Finanzprognosen für das Gesamtjahr 2007 wiederholen. Am 24. Juli hob das Unternehmen die Finanzprognosen für das Gesamtjahr anlässlich seines Finanzberichts für das zweite Quartal folgendermaßen an:
-- Gesamtes Ertragswachstum von 16-18 % verglichen mit 2006;
-- verwässerte Gewinne je Aktie auf Nicht-GAAP-Basis im Bereich von 2,60 bis 2,70 $ je Aktie, d. h. 16-20 % Jahreswachstum - diese spiegeln den Rückkauf von Aktien im Wert von 3 Mrd. $ im Rahmen des kürzlich abgeschlossenen niederländischen Übernahmeangebots wider. Diese Schätzung der verwässerten Gewinne je Aktie auf Nicht-GAAP-Basis schließt die Auswirkungen von Purchase Accounting, fusionsbedingten Anpassungen, Belastungen für Aktienoptionen, sonstige Posten und ihre entsprechenden steuerlichen Auswirkungen nicht ein;
-- verwässerte Gewinne je Aktie auf GAAP-Basis im Bereich von 1,84 bis 1,94 $, verglichen mit 0,63 $ je Aktie für 2006. Diese Schätzung beinhaltet die Auswirkungen des Cardokine-Geschäfts, aber keine weiteren künftigen Übernahmen oder Transaktionen. Um die Prognosen für Gewinne je Aktie auf GAAP- und Nicht-GAAP-Basis abzugleichen, haben wir die folgenden Posten aus unserer obigen Prognose für Gewinne je Aktie auf Nicht-GAAP-Basis ausgenommen:
-- Belastungen für Purchase Accounting, einschließlich Abschreibung von erworbenen immateriellen Gütern und aktueller Forschung und Entwicklung, geschätzt auf 287 Mio. $ oder ungefähr 0,90 $ je Aktie, für bereits abgeschlossene Transaktionen;
-- Belastungen für Aktienoptionen auf Grundlage von FAS 123R werden für 2007 auf 30-40 Mio. $ oder ungefähr 0,07-0,09 $ je Aktie geschätzt.
Da das Unternehmen für 2007 keine sicheren Prognosen über die Art oder die Höhe betriebsfremder oder ungewöhnlicher Belastungen abgeben kann, haben wir in dieser GAAP-Prognose keine Annahmen bezüglich künftiger Purchase-Accounting-Belastungen gemacht. Dem Unternehmen können 2007 Belastungen oder Gewinne entstehen, aufgrund denen tatsächliche Ergebnisse von dieser Prognose abweichen können.
Zum Zeitpunkt der Fusion im Jahr 2003 prognostizierte das Unternehmen bis Ende 2007 für die Erträge eine kumulierte jährliche Wachstumsrate von 15 % und für die Gewinne je Aktie auf Nicht-GAAP-Basis eine kumulierte jährliche Wachstumsrate von 15 %. Mit Umsetzung dieser Prognose für das Gesamtjahr 2007 könnte das Unternehmen diese finanziellen Zielsetzungen erreichen, indem es bis Ende 2007 eine kumulierte jährliche Wachstumsrate von 14 % bei den Erträgen und von 21 % bei Gewinnen je Aktie auf Nicht-GAAP-Basis erzielt.
Abgleich der Gewinne je Aktie auf GAAP-Basis
Auf Basis der gemeldeten Ergebnisse strebt das Unternehmen für die Gewinne je Aktie auf GAAP-Basis, d. h. entsprechend den US-amerikanischen Grundsätzen ordnungsgemäßer Buchführung berechnete Gewinne je Aktie, zwischen 2007 und 2010 eine kumulierte jährliche Wachstumsrate von 25 % an. Das langfristige Ziel für die Gewinne je Aktie auf Nicht-GAAP-Basis schließt die Auswirkungen von Purchase Accounting, fusionsbedingten Anpassungen, Belastungen für Aktienoptionen und ihre entsprechenden steuerlichen Auswirkungen nicht ein. Um die Zahlen für langfristige Gewinne je Aktie auf GAAP-Basis und Nicht-GAAP-Basis abzugleichen, hat das Unternehmen die folgenden Posten für 2008 bis 2010 aus den oben angeführten Zielsetzungen für Gewinne je Aktie auf Nicht-GAAP-Basis ausgeschlossen:
-- Belastungen für Purchase Accounting, einschließlich Abschreibung von immateriellen Gütern und aktueller Forschung und Entwicklung, werden für bereits abgeschlossene Transaktionen auf 760-$800 Mio. $ geschätzt.
-- Belastungen für Aktienoptionen auf Grundlage von FAS 123R werden auf 80-90 Mio. $ geschätzt.
-- Steuervorteile im Zusammenhang mit dem Postenabgleich vor Steuern werden auf 220-240 Mio. $ geschätzt.
Da das Unternehmen bis 2010 keine sicheren Prognosen über die Art oder die Höhe betriebsfremder oder ungewöhnlicher Belastungen abgeben kann, haben wir in dieser Prognose über Gewinne je Aktie auf GAAP-Basis keine Annahmen bezüglich neuer Purchase-Accounting-Belastungen gemacht. Dem Unternehmen können bis 2010 Belastungen oder Gewinne entstehen, aufgrund denen tatsächliche Ergebnisse von dieser Zielsetzung abweichen können.
Verwendung von Finanzmaßnahmen auf Nicht-GAAP-Basis
Finanzmaßnahmen auf Nicht-GAAP-Basis sind wie berichtet definiert oder aus den unten angegebenen Gründen als GAAP, Gewinne je Aktie ausgenommen; (1) Purchase Accounting und fusionsbedingte Anpassungen; (2) Belastungen für Aktienoptionen und (3) sonstige Posten. Die Unternehmensleitung verwendet diese Finanzmaßnahmen auf Nicht-GAAP-Basis, um finanzielle Zielsetzungen zu erarbeiten und ein Verständnis der relativen finanziellen Leistung des Unternehmens von Jahr zu Jahr bzw. Quartal zu Quartal zu gewinnen. Dementsprechend ist Biogen Idec der Ansicht, dass unsere Offenlegung dieser Finanzmaßnahmen auf Nicht-GAAP-Basis das Verständnis von Investoren bezüglich der finanziellen Leistung des Unternehmens fördert. Nettogewinne auf Nicht-GAAP-Basis und verwässerte Gewinne je Aktie sollten nicht isoliert betrachtet oder als Ersatz für gemeldete Gewinne je Aktie oder Gewinne je Aktie auf GAAP-Basis verwendet werden.
Purchase Accounting und fusionsbedingte Anpassungen - Gewinne je Aktie auf Nicht-GAAP-Basis schließen bestimmte Purchase-Accounting-Auswirkungen, z. B. diejenigen im Zusammenhang mit der Fusionierung mit Biogen, Inc. („Fusion“) und der Übernahme von Fumapharm AG, Conforma Therapeutics Corp. und Syntonix Pharmaceuticals, Inc., aus. Diese beinhalten Belastungen für aktuelle Forschung und Entwicklung sowie die inkrementalen Belastungen für Warenkosten, die das Unternehmen als übernommenes Inventar verkaufte, das zum Übernahmezeitpunkt buchtechnisch auf den fairen Marktwert festgesetzt wurde. Darüber hinaus beinhalten diese ausgeschlossenen Auswirkungen die inkrementalen Belastungen im Zusammenhang mit der Abschreibung der übernommenen immateriellen Güter. Der Ausschluss dieser Belastungen gibt der Unternehmensleitung und Investoren eine alternative Sicht der Finanzergebnisse des Unternehmens, als wären die übernommenen immateriellen Güter intern entwickelt und nicht übernommen worden. Er bietet so einen zusätzlichen Leistungsmaßstab, in dem die erworbenen geistigen Güter des Unternehmens auf vergleichbare Weise zu den intern entwickelten geistigen Gütern behandelt werden.
Belastungen für Aktienoptionen - Nettogewinne auf Nicht-GAAP-Basis und verwässerte Gewinne je Aktie schließen die Auswirkungen unserer Belastungen für Aktienoptionen auf Grundlage von SFAS Nr. 123R und die kumulative Wirkung der Buchhaltungsumstellung im Zusammenhang mit der ursprünglichen Einführung aus. Das Unternehmen ist der Ansicht, dass der Ausschluss der Auswirkungen von Belastungen für Aktienoptionen die wiederkehrenden wirtschaftlichen Charakteristiken unserer integrierten Geschäftstätigkeit besser widerspiegelt. Das Unternehmen schließt die Auswirkungen eingeschränkter Aktienzuteilungen und anderer Cash-Incentives auf die Gewinn- und Verlustrechnung in die Ergebnisse auf Nicht-GAAP-Basis ein.
Sonstige Posten - Nettogewinne auf Nicht-GAAP-Basis und verwässerte Gewinne je Aktie schließen andere ungewöhnliche oder nicht wiederkehrende Posten aus, die individuell beurteilt werden. Die Einschätzung, ob ein Posten für die Bestimmung unserer Finanzmaßnahmen auf Nicht-GAAP-Basis auszuschließen ist, berücksichtigt sowohl die quantitativen als auch die qualitativen Aspekte des Postens, darunter auch (i) seinen Umfang und seine Art, (ii) ob er sich auf die laufende Geschäftstätigkeit des Unternehmens bezieht und (iii) ob das Unternehmen erwartet, dass der Posten regelmäßig als Teil seiner normalen Geschäftstätigkeit auftreten wird. Für die Zwecke der Bestimmung der Nettogewinne auf Nicht-GAAP-Basis und verwässerten Gewinne je Aktie ausgeschlossene Posten sind Belastungen für Abfindungen und Umstrukturierung sowie Gewinne beim Verkauf langlebiger Güter.
Über Biogen Idec
Biogen Idec setzt in therapeutischen Bereichen mit erheblichen medizinischen Versorgungslücken neue Standards. Das Unternehmen wurde 1978 gegründet und ist bei der Entwicklung, Herstellung und Kommerzialisierung innovativer Therapien weltweit führend. Patienten in mehr als 90 Ländern profitieren von Biogen Idecs leistungsfähigen Produkten für die Behandlung von Lymphknotenerkrankungen und Krankheiten wie multipler Sklerose und Gelenkrheumatismus. Produktauszeichnungen, Pressemitteilungen und zusätzliche Informationen über das Unternehmen finden Sie unter http://www.biogenidec.com.
Safe Harbor
Diese Pressemitteilung enthält zukunftsorientierte Aussagen über unsere erwarteten Einkünfte, Erträge, Produktumsätze, Produktentwicklungen und andere Angelegenheiten. Zukunftsorientierte Aussagen unterliegen bestimmten Risiken und Unwägbarkeiten, aufgrund denen tatsächliche Ergebnisse von unseren Erwartungen wesentlich abweichen können. Wichtige Faktoren, die Abweichungen unserer tatsächlichen Ergebnisse verursachen könnten, beinhalten unsere anhaltende Abhängigkeit von unseren zwei wichtigsten Produkten AVONEX und RITUXAN, die Unsicherheit des Erfolgs bei der Kommerzialisierung anderer Produkte, darunter TYSABRI, das Auftreten negativer Sicherheitsereignisse bei unseren Produkten, das Versäumnis, unsere Wachstumsstrategie erfolgreich umzusetzen oder in unseren Märkten effektiv zu konkurrieren, unsere Abhängigkeit von Kollaborationen, über die wir nicht immer volle Kontrolle haben, mögliche negative Auswirkungen staatlicher Regelungen und Veränderungen in der Verfügbarkeit von Vergütungen für unsere Produkte, Probleme mit unseren Herstellungsverfahren und unserem Vertrauen auf Dritte, Schwankungen unserer betrieblichen Ergebnisse, unsere Fähigkeit, unsere geistigen Eigentumsrechte zu schützen, sowie damit verbundene Kosten, Risiken einer internationalen Geschäftstätigkeit sowie andere Risiken und Unwägbarkeiten, die in unserem aktuellen, bei der SEC eingereichten Formblatt 10-Q unter Position 1A Risikofaktoren beschrieben sind. Diese zukunftsgerichteten Aussagen sind nur zum Zeitpunkt dieser Pressemitteilung aktuell, und wir lehnen jegliche Verpflichtung zur öffentlichen Aktualisierung jeglicher zukunftsgerichteter Aussagen ab, ob als Resultat neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen.
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-2007-09/artikel-…
Gratulation an den Käufer der 959 Elan DRX in FFM zu 13,27 Euro.
Antwort auf Beitrag Nr.: 31.562.164 von Poppholz am 13.09.07 16:27:52ich glaube, es war ein SL. Oder Verzweifelungstat eines Ungeduldigen?
Antwort auf Beitrag Nr.: 31.562.309 von surga am 13.09.07 16:37:39ich habe ja auch dem Käufer gratuliert und nicht dem Verkäufer.
in den letzten Tagen wurde ordentlich SL-Fishing betrieben. Für Deutschland ist schon interessant, dass hier kaum SL ausgelöst wurde und somit auch kaum glückliche Käufer.
in den letzten Tagen wurde ordentlich SL-Fishing betrieben. Für Deutschland ist schon interessant, dass hier kaum SL ausgelöst wurde und somit auch kaum glückliche Käufer.
NEWS
Elan Announces New Board of Director Members
via COMTEX
September 14, 2007
DUBLIN, Ireland, Sep 14, 2007 (BUSINESS WIRE) --
Elan Corporation, plc (NYSE: ELN) today announced the appointment of Mr. Jonas Frick and Mr. Giles Kerr as non-executive directors of the company with immediate effect.
Mr. Jonas Frick (49) is the former Chief Executive Officer of Scandinavian Life Science Ventures (SLS Ventures), which is one of the largest investors in the life science sector in Scandinavia. Before joining SLS Ventures, Mr. Frick was the CEO and President of the publicly traded biotech company Medivir AB. His prior experiences include senior executive positions in Pharmacia's international businesses in the CNS and Autoimmune areas across Italy, Sweden and Japan. Mr. Frick is a founding member of the Swedish Biotechnology Industry Organization and is a graduate of the University of Uppsala.
Mr. Giles Kerr (48) is currently the Director of Finance with the University of Oxford, England, and a Fellow of Keble College. He is also a Director and Chairman of the Audit Committee of Victrex plc and a Director of Isis Innovation Ltd. Previously Mr. Kerr was the Group Finance Director and Chief Financial Officer of Amersham plc, the leading medical diagnostics and life science company acquired by GE Healthcare in 2004. Prior to his role at Amersham, he was a partner with the accounting firm Arthur Andersen in the United Kingdom. He is a graduate of the University of York and a Fellow of the Institute of Chartered Accountants in England and Wales.
Mr. Kyran McLaughlin, Chairman of Elan, and Mr. Kieran McGowan, Lead Independent Director, said, "We are delighted to welcome Mr. Frick and Mr. Kerr to our board. Their experience and enthusiasm will add greatly to the overall board and to the Company. This represents another important step in developing the board's composition to achieve the appropriate mix of backgrounds and industry experience."
About Elan
Elan Corporation, plc (NYSE: ELN) 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.
SOURCE: Elan Corporation, plc
Elan Corporation, plc Media: Jonathan Birt, 212-850-5664 Elizabeth Headon, 353 1 498 0300 or Investors: Chris Burns, 353 1 709 4444 / 800-252-3526
Copyright Business Wire 2007
Elan Announces New Board of Director Members
via COMTEX
September 14, 2007
DUBLIN, Ireland, Sep 14, 2007 (BUSINESS WIRE) --
Elan Corporation, plc (NYSE: ELN) today announced the appointment of Mr. Jonas Frick and Mr. Giles Kerr as non-executive directors of the company with immediate effect.
Mr. Jonas Frick (49) is the former Chief Executive Officer of Scandinavian Life Science Ventures (SLS Ventures), which is one of the largest investors in the life science sector in Scandinavia. Before joining SLS Ventures, Mr. Frick was the CEO and President of the publicly traded biotech company Medivir AB. His prior experiences include senior executive positions in Pharmacia's international businesses in the CNS and Autoimmune areas across Italy, Sweden and Japan. Mr. Frick is a founding member of the Swedish Biotechnology Industry Organization and is a graduate of the University of Uppsala.
Mr. Giles Kerr (48) is currently the Director of Finance with the University of Oxford, England, and a Fellow of Keble College. He is also a Director and Chairman of the Audit Committee of Victrex plc and a Director of Isis Innovation Ltd. Previously Mr. Kerr was the Group Finance Director and Chief Financial Officer of Amersham plc, the leading medical diagnostics and life science company acquired by GE Healthcare in 2004. Prior to his role at Amersham, he was a partner with the accounting firm Arthur Andersen in the United Kingdom. He is a graduate of the University of York and a Fellow of the Institute of Chartered Accountants in England and Wales.
Mr. Kyran McLaughlin, Chairman of Elan, and Mr. Kieran McGowan, Lead Independent Director, said, "We are delighted to welcome Mr. Frick and Mr. Kerr to our board. Their experience and enthusiasm will add greatly to the overall board and to the Company. This represents another important step in developing the board's composition to achieve the appropriate mix of backgrounds and industry experience."
About Elan
Elan Corporation, plc (NYSE: ELN) 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.
SOURCE: Elan Corporation, plc
Elan Corporation, plc Media: Jonathan Birt, 212-850-5664 Elizabeth Headon, 353 1 498 0300 or Investors: Chris Burns, 353 1 709 4444 / 800-252-3526
Copyright Business Wire 2007
http://www.youtube.com/user/schubfrei angucken!
Antwort auf Beitrag Nr.: 31.573.801 von Birgit.Tersteegen am 14.09.07 15:30:13habe nicht gewußt, dass dort so viele Berichte vorhanden sind.
Kurs wurde in den USA ordentlich gedrückt.
Jetzt geht es wieder hoch.
Mal schauen ob der Händler in FFM den Kurs auch so schnell wieder hoch zieht.
Jetzt geht es wieder hoch.
Mal schauen ob der Händler in FFM den Kurs auch so schnell wieder hoch zieht.
Antwort auf Beitrag Nr.: 31.574.506 von Poppholz am 14.09.07 16:12:23Mal schauen ob der Händler in FFM den Kurs auch so schnell wieder hoch zieht
13,36 sind meine
Gruß Noogmann
13,36 sind meine
Gruß Noogmann
Antwort auf Beitrag Nr.: 31.575.508 von noogmann am 14.09.07 17:20:28Super noogmann Welche Idioten da wohl mal wieder am Werke waren....
DAS MUSS MAN SICH MAL VORSTELLEN;"Schweinebande"
By: elmer92692
That's Odd......
UBS says PML could be a problem, yet in the last quarter they added 1,362,821 shares of Elan, an increase of 414%.
By: elmer92692
That's Odd......
UBS says PML could be a problem, yet in the last quarter they added 1,362,821 shares of Elan, an increase of 414%.
Antwort auf Beitrag Nr.: 31.576.233 von Birgit.Tersteegen am 14.09.07 18:18:47aber, welche Idioten schmeissen denn seine Stücke?
Was für eine Unruhe und hohes Volume heute
Antwort auf Beitrag Nr.: 31.578.097 von surga am 14.09.07 20:17:28ich glaube,es sind jede Menge Stopp-loss-Order ausgelöst worden...
Die Ursache war wohl dass die Konkurrenz wieder Gerüchte in die Welt gesetzt hatte...bzgl. es könnten ja PML-Fälle auftreten---hat ja kurzfristig funktioniert....Alles Quatsch natürlich---14000 Patienten und KEINEN PML-Fall... GRÜSSE!!
Die Ursache war wohl dass die Konkurrenz wieder Gerüchte in die Welt gesetzt hatte...bzgl. es könnten ja PML-Fälle auftreten---hat ja kurzfristig funktioniert....Alles Quatsch natürlich---14000 Patienten und KEINEN PML-Fall... GRÜSSE!!
Antwort auf Beitrag Nr.: 31.622.461 von Birgit.Tersteegen am 16.09.07 21:18:39
Wenn wir den Chart zwischen 10:30 und 11:30 ansehen, sieht nach SL aus.
Wenn wir den Chart zwischen 10:30 und 11:30 ansehen, sieht nach SL aus.
hallo na wie ist die lage bei den elanies?
gruß hb
gruß hb
Antwort auf Beitrag Nr.: 31.636.097 von hechtbarsch am 17.09.07 19:53:19tja--sie ärgern uns wieder....:O
Hallo Surga, Elan und ich dämmern vor uns hin, NOCH !
posimist
posimist
Antwort auf Beitrag Nr.: 31.667.251 von surga am 19.09.07 21:02:53
Prohost Sept 12 opinion on Elan
The stock had a good performance following the past Prohost E-Letter issue. The price crossed the $20 barrier and then slightly retreated on profit taking. The question is? Is there any specific reason that motivate investors to keep this firm as a top current pick?
We, among others, are expecting Tysabri to reach 40.000 to 50.000 patients in mid-2008 Why? Simply because the drug is a real breakthrough treatment with no comparable efficacy. Of equal importance is the fact that the drug has proven safe. Not a single case of PML occurred since it returned back to the market. If it was not safe, the independent FDA advisory committee wouldn’t have recommended it for Crohn’s disease that has many effective treatments. Currently, Tysabri is being used by around 12,000 patients. The good news is that the increase in the number of new patients seems progressive and related to patients’ and physicians’ increased confidence in its safety. Time will come, probably, at the end of 2008’s first quarter, when we will see the drug capturng a large percentage of the big market. We do expect the number of patients on Tysabri to double every quarter with a possibility of reaching over 50 thousand patients by the end of next year. If this happens, it would translate to over $1.2 B in revenues. This will not be the ceiling. We believe the drug will be used by at least 60% of M.S. patients, added to them those who suffer from Crohn’s disease resistant to current treatment. Some analysts believe that Tysabri’s sales could reach $2.4 billion in 2010. We did not mention the promise of the firm’s Alzheimer drug in Phase 3 trials, because we did in several previous issues, which are posted for subscribers only on www.prohostbiotech.com. The stock is trading at $18.86
Prohost Sept 12 opinion on Elan
The stock had a good performance following the past Prohost E-Letter issue. The price crossed the $20 barrier and then slightly retreated on profit taking. The question is? Is there any specific reason that motivate investors to keep this firm as a top current pick?
We, among others, are expecting Tysabri to reach 40.000 to 50.000 patients in mid-2008 Why? Simply because the drug is a real breakthrough treatment with no comparable efficacy. Of equal importance is the fact that the drug has proven safe. Not a single case of PML occurred since it returned back to the market. If it was not safe, the independent FDA advisory committee wouldn’t have recommended it for Crohn’s disease that has many effective treatments. Currently, Tysabri is being used by around 12,000 patients. The good news is that the increase in the number of new patients seems progressive and related to patients’ and physicians’ increased confidence in its safety. Time will come, probably, at the end of 2008’s first quarter, when we will see the drug capturng a large percentage of the big market. We do expect the number of patients on Tysabri to double every quarter with a possibility of reaching over 50 thousand patients by the end of next year. If this happens, it would translate to over $1.2 B in revenues. This will not be the ceiling. We believe the drug will be used by at least 60% of M.S. patients, added to them those who suffer from Crohn’s disease resistant to current treatment. Some analysts believe that Tysabri’s sales could reach $2.4 billion in 2010. We did not mention the promise of the firm’s Alzheimer drug in Phase 3 trials, because we did in several previous issues, which are posted for subscribers only on www.prohostbiotech.com. The stock is trading at $18.86
Irland und London gehen steil nach oben und dies mit großen Umsätzen.
Wird eine schöner Wochenausklang.
Wird eine schöner Wochenausklang.
Antwort auf Beitrag Nr.: 31.686.237 von Poppholz am 21.09.07 12:47:41ob der Kursanstieg mit dem Hexensabbat zu tun hat? Kann ansonsten keine News finden.
Antwort auf Beitrag Nr.: 31.686.475 von Poppholz am 21.09.07 13:06:15das jetzt plötzlich die "Werthaltigkeit" der Aktie festgestellt wurde, kann doch wohl nicht sein, oder?
Antwort auf Beitrag Nr.: 31.686.517 von Poppholz am 21.09.07 13:08:41Die Meisten brauchen eben etwas länger....
wir sind über $20,-
wenn nur der Euro nicht so stark wäre.
Antwort auf Beitrag Nr.: 31.690.143 von surga am 21.09.07 17:05:09...forever,oder?
Antwort auf Beitrag Nr.: 31.690.422 von Birgit.Tersteegen am 21.09.07 17:22:48dann wollen wir mal hoffen, schönes WE Biggi
ist sicher nichts neues für euch aber ich stells mal rein.
aus dem IV board:
Tysabri doing great
I was at an infusion center yesterday and noticed a box of tissues with Tysabri logo. I asked infusion nurse about Tysabri and she said it was a \"magical\" drug and their nearly 100 patients on TY love it. The biggest benefits were increased energy, lack of flu symptoms and most importantly stopping, and in some cases reversing, the progression of lesions.
A young girl was getting infused with TY while i was there and i asked her about her experience with TY. She said she had been on for almost a year and just loved it. She had been on betasaron, copaxone and avonex the last 6 years and while she felt ok, other then flu symptoms, her lesions had progressed to the point where she had 2 that had doubled to 2 cm. Her doctor was very worried last summer and said she had to switch to Novantrone or Tysabri since Avonex had failed to stop the progression and he was afraid she would wake up one day with severe neurologic defecit. She asked doctor what he would do if she were his daughter and he said TY and then explained the benefits of TY and the risk of PML. She didn\'t know about Ty but trusted her doctor\'s advise.
She just got results of her MRI back and the 2 lesions have shrunk 50% to about 1 cm. She is extremely happy with TY and feels like she doesn\'t even have MS anymore. No numbness, no flu symptoms, etc...
In any event, it was great to hear an infusion nurse talk about this \"magical\" drug called Tysabri, and even better to hear an MS patient with 1 year experience discuss the 50% reduction in lesions that had her and her doctor so worried just a year ago!!!!
aus dem IV board:
Tysabri doing great
I was at an infusion center yesterday and noticed a box of tissues with Tysabri logo. I asked infusion nurse about Tysabri and she said it was a \"magical\" drug and their nearly 100 patients on TY love it. The biggest benefits were increased energy, lack of flu symptoms and most importantly stopping, and in some cases reversing, the progression of lesions.
A young girl was getting infused with TY while i was there and i asked her about her experience with TY. She said she had been on for almost a year and just loved it. She had been on betasaron, copaxone and avonex the last 6 years and while she felt ok, other then flu symptoms, her lesions had progressed to the point where she had 2 that had doubled to 2 cm. Her doctor was very worried last summer and said she had to switch to Novantrone or Tysabri since Avonex had failed to stop the progression and he was afraid she would wake up one day with severe neurologic defecit. She asked doctor what he would do if she were his daughter and he said TY and then explained the benefits of TY and the risk of PML. She didn\'t know about Ty but trusted her doctor\'s advise.
She just got results of her MRI back and the 2 lesions have shrunk 50% to about 1 cm. She is extremely happy with TY and feels like she doesn\'t even have MS anymore. No numbness, no flu symptoms, etc...
In any event, it was great to hear an infusion nurse talk about this \"magical\" drug called Tysabri, and even better to hear an MS patient with 1 year experience discuss the 50% reduction in lesions that had her and her doctor so worried just a year ago!!!!
Antwort auf Beitrag Nr.: 31.690.948 von GuHu1 am 21.09.07 17:54:10das kann alles gar nicht oft genug geschrieben werden.
Wenn man das liest muß man sich doch fragen, warum Ty nur bei sonst hoffnungslosen Fällen angewendet werden darf. Schließlich dürfte es sich inzwischen rumgesprochen haben, daß es bei der Mono Ty Behandlung keinen PML Fall gegeben hat. In diese Richtung dürfte auch Biogen Druck machen.
posimist
posimist
Antwort auf Beitrag Nr.: 31.697.295 von posimist am 22.09.07 18:12:28Das stimmt so nicht.Tysabri kann auch als "First-line"-Medikament genutzt werden....nach wie vor möchte Biogen aber auch ihr Avonex loswerden und der PML-Mythos hängt leider-völlig zu Unrecht-an dem Namen Tysabri....Es braucht einfach Zeit-v.a. weil Elans PR-Abteilung aus irischen Schnarchnasen zu bestehen scheint....
Schönes WE
Schönes WE
Antwort auf Beitrag Nr.: 31.697.732 von Birgit.Tersteegen am 22.09.07 20:02:26Hallo Birgit, ich bin mir nicht sicher, ob du da nicht einigen Leuten Unrecht tust. Die Promotion von Medis wie Tysabri ist nicht zu vergleichen mit der eines Hustensaftes. Das Label und der Risikoplan waren Voraussetzung für die Zulassung und erst eine längere Anwendung mit entsprechend positiven Ergebnissen wird hierbei eine Änderung herbeiführen. Elan sind deswegen die Hände gebunden - einer offensiveren Vermarktung sind regulatorische und ethische Grenzen gesetzt. Mittel- bis langfristig ist diese vorsichtige Vorgehensweise sehr wahrscheinlich der einzig vernünftige Weg, um dieses Medikament nachhaltig am Markt zu platzieren - zum Wohle der Patienten aber auch der Shareholder.
Antwort auf Beitrag Nr.: 31.697.842 von Cyberhexe am 22.09.07 20:50:14nee,sehe ich anders-- auf viele Verfälschungen der Konkurrenz hätte Elan reagieren müssen;viele andere Medikamente können scheinbar auch PML erzeugen--es scheint aber in der Öffentlickkeit ,als sei PML ein Tysabri-Phänomen---Elan hätte DRINGEND seit 1,5 Jahren deutlich machen müssen,dass die 3 Fälle mit PML ausschliesslich das Problem der vorherigen Immunkräftereduktion + des gleichzeitigen Gebrauchs von Avonex geschuldet waren---m.A.n.gibt es dafür PR-Abteilungen dieses geschickt und ethisch vertretbar zu publizieren.... Grüsse
Antwort auf Beitrag Nr.: 31.698.100 von Birgit.Tersteegen am 22.09.07 22:11:27...ich bin mir nicht sicher, ob diese Aufklärung eine PR-Angelegenheit hätte sein können - die FDA hätte dies sehr wahrscheinlich nicht akzeptiert. Andererseits hätte Elan in existentielle Schwierigkeiten geraten können, wäre das PML-Risiko ausschliesslich auf die gleichzeitige Medikation von immunsupprimierenden/immunmodulierenden Wirkstoffen reduziert worden und das Gegenteil wäre eingetreten! Denn davon auszugehen, dass Natalizumab in Monotherapie das PML-Risiko nicht erhöht, ist sicherlich nicht korrekt. Mittel- bis langfristig geht es sowieso nur darum, die Ärzteschaft von den Vorzügen von Natalizumab zu überzeugen, und eine PR-Kampagne könnte diesbezüglich auch kontraproduktiv sein. Lediglich eine objektive Aufklärung in Verbindung mit positiven Fakten erscheint hier die vertrauensbildende Massnahme zu sein - und diese Aufklärung trägt langsam Früchte.
"Denn davon auszugehen, dass Natalizumab in Monotherapie das PML-Risiko nicht erhöht, ist sicherlich nicht korrekt."---das verstehe ich jetzt nicht;es gibt doch bisher keineIndizien dass bei nicht in den Immunkräften herabgesetzten Patienten,die mit Ty behandelt werden,PML überhaupt je aufgetreten ist,oder?
http://www.youtube.com/watch?v=RD3eKlh8Juw -----Ty-Bericht!
Antwort auf Beitrag Nr.: 31.702.061 von Birgit.Tersteegen am 23.09.07 09:30:41das PML-Risiko ist dann massiv erhöht, wenn Individuen aus medizinisch erforderlichen (Organtransplantation) oder aber aus pathologischen Gründen (AIDS) über eine geschwächte Immunabwehr verfügen. Dann kann das bei ca. 80% der Bevölkerung latent vorhandene JC Virus PML verursachen.
Bei der Wirkungsweise von Natalzumab werden T-Lymphozyten gebunden, so dass diese die Blut-Hirnschranke nicht durchqueren können, wonach im ZNS eine verringerte Anzahl an T-Lymphozyten präsent sind und somit auch geringeren Schaden bewirken können. Wenn ich nun richtig informiert bin - ich bin kein Mediziner- ist es jedoch erforderlich, dass diese T-Lymphozyten im ZNS nicht auf Null reduziert werden, da ansonsten diese latent vorhandenen Viren ausser Kontrolle geraten. Dies würde bedeuten, dass eine zu hohe Gabe an Natalizumab das PML-Risiko entsprechend erhöhen würde.
Obwohl die Zusammenhänge noch nicht vollständig verstanden werden, hatte ich einmal von einer Theorie gelesen, dass unter gleichzeitiger Gabe von Interferon (Avonex) die Eliminationhalbwertzeit von Natalizumab zunehmen würde, so dass bei diesen Patienten die Konzentration an Natalizumab über die Zeit zugenommen haben soll und somit das PML-Risiko ungünstig beeinflusst haben soll. In wie fern diese Theorie bestätigt wurde, ist mir jedoch nicht bekannt. Auf alle Fälle liegt es in der Natur der Sache, dass eine eingeschränkte T-Lymphozytenaktivität das PML-Risiko erhöht. Deswegen erscheint mir auch der Risikoplan und TOUCH als sinnvolles Intrument, um diese Risiko zu handhaben - und dass dies handhabbar ist, davon bin ich voll überzeugt.
Grüsse vom Hochrhein
ch
Bei der Wirkungsweise von Natalzumab werden T-Lymphozyten gebunden, so dass diese die Blut-Hirnschranke nicht durchqueren können, wonach im ZNS eine verringerte Anzahl an T-Lymphozyten präsent sind und somit auch geringeren Schaden bewirken können. Wenn ich nun richtig informiert bin - ich bin kein Mediziner- ist es jedoch erforderlich, dass diese T-Lymphozyten im ZNS nicht auf Null reduziert werden, da ansonsten diese latent vorhandenen Viren ausser Kontrolle geraten. Dies würde bedeuten, dass eine zu hohe Gabe an Natalizumab das PML-Risiko entsprechend erhöhen würde.
Obwohl die Zusammenhänge noch nicht vollständig verstanden werden, hatte ich einmal von einer Theorie gelesen, dass unter gleichzeitiger Gabe von Interferon (Avonex) die Eliminationhalbwertzeit von Natalizumab zunehmen würde, so dass bei diesen Patienten die Konzentration an Natalizumab über die Zeit zugenommen haben soll und somit das PML-Risiko ungünstig beeinflusst haben soll. In wie fern diese Theorie bestätigt wurde, ist mir jedoch nicht bekannt. Auf alle Fälle liegt es in der Natur der Sache, dass eine eingeschränkte T-Lymphozytenaktivität das PML-Risiko erhöht. Deswegen erscheint mir auch der Risikoplan und TOUCH als sinnvolles Intrument, um diese Risiko zu handhaben - und dass dies handhabbar ist, davon bin ich voll überzeugt.
Grüsse vom Hochrhein
ch
Antwort auf Beitrag Nr.: 31.715.313 von Cyberhexe am 23.09.07 22:00:30 Hexchen! Birgit.
Gut dass es heutzutage noch Hexen gibt.
posimist
posimist
Wäre doch schön, wenn wir die $20,- Marke jetzt dauerhaft hinter uns lassen könnten.
Elan Corporation PLC
25 September 2007
Standard Form TR-1
Voting rights attached to shares- Article 12(1) of directive 2004/109/EC
Financial instruments - Article 11(3) of the Commission Directive 2007/14/EC
1. Identity of the issuer or the underlying issuer of existing shares to
which voting rights are attached: Elan Corporation plc
2. Reason for the notification (please tick the appropriate box or
boxes): ......................
http://www.investegate.co.uk/Article.aspx?id=200709251521294…
25 September 2007
Standard Form TR-1
Voting rights attached to shares- Article 12(1) of directive 2004/109/EC
Financial instruments - Article 11(3) of the Commission Directive 2007/14/EC
1. Identity of the issuer or the underlying issuer of existing shares to
which voting rights are attached: Elan Corporation plc
2. Reason for the notification (please tick the appropriate box or
boxes): ......................
http://www.investegate.co.uk/Article.aspx?id=200709251521294…
Wyeth at UBS, Greg Norden, EVP & CFO - Brief Alzheimer's Remarks
"I haven't even spoken totally about the Alzheimer's product. Probably a little bit too early to talk about but we expect that to go into Phase III shortly. That's liable to be, that has the opportunity, certainly the potential to be a remarkable product."
http://www.investorvillage.com/smbd.asp?mb=160&mn=154031&pt=…
"I haven't even spoken totally about the Alzheimer's product. Probably a little bit too early to talk about but we expect that to go into Phase III shortly. That's liable to be, that has the opportunity, certainly the potential to be a remarkable product."
http://www.investorvillage.com/smbd.asp?mb=160&mn=154031&pt=…
Antwort auf Beitrag Nr.: 31.739.388 von bernie55 am 25.09.07 17:33:04WO treibst Du Dich eigentlich immer herum??????????????????????????
und unser Bordpoet Holgus ist seit über 5 Wochen verschollen...
....und dabei steigt unser Baby tapfer vor sich hin
GRÜSSE!
und unser Bordpoet Holgus ist seit über 5 Wochen verschollen...
....und dabei steigt unser Baby tapfer vor sich hin
GRÜSSE!
Antwort auf Beitrag Nr.: 31.742.852 von Birgit.Tersteegen am 25.09.07 22:07:37Vielleicht sollten wir alle einen Depot-Thread eröffnen, damit die anderen immer sehen können, wo sich wer gerade rumtreibt.
Antwort auf Beitrag Nr.: 31.742.852 von Birgit.Tersteegen am 25.09.07 22:07:37Schlusskurs in den USA bei $20,65.
Jeden Tag so ein bis zwei Prozent wären schon eine schöne Sache. Ich fürchte nur, dass die MM in den nächsten Tagen noch einmal den Kurs drücken werden.
Vielleicht haben sich die entsprechenden Personen auch inzwischen mal fertig eingedeckt, so dass der Kurs "ungestört" nach oben laufen kann.
Jeden Tag so ein bis zwei Prozent wären schon eine schöne Sache. Ich fürchte nur, dass die MM in den nächsten Tagen noch einmal den Kurs drücken werden.
Vielleicht haben sich die entsprechenden Personen auch inzwischen mal fertig eingedeckt, so dass der Kurs "ungestört" nach oben laufen kann.
Antwort auf Beitrag Nr.: 31.743.237 von Poppholz am 25.09.07 22:50:27genau--mit Webcams--ob Bernies Küche wohl aufgeräumt ist....
Antwort auf Beitrag Nr.: 31.743.264 von Birgit.Tersteegen am 25.09.07 22:53:42
Antwort auf Beitrag Nr.: 31.745.977 von bernie55 am 26.09.07 10:41:09.... das glaube ich nur wenn Ulla das bestätigt
14:12 Uhr
USA taxt aktuell $20,91 zu $21,07
Daraus ergibt sich bei einem Wechselkurs von 1,4 zu 1:
€14,92 uzu €15,05
USA taxt aktuell $20,91 zu $21,07
Daraus ergibt sich bei einem Wechselkurs von 1,4 zu 1:
€14,92 uzu €15,05
Antwort auf Beitrag Nr.: 31.748.761 von Poppholz am 26.09.07 14:11:31ich kann aber noch nicht glauben, dass der Kurs wirklich hoch gehen sollte.
Kann es wirklich sein, dass der Kurs jetzt "frei gelassen" wird?
(dies ist keine Kauf- oder Verkaufsempfehlung)
Kann es wirklich sein, dass der Kurs jetzt "frei gelassen" wird?
(dies ist keine Kauf- oder Verkaufsempfehlung)
Antwort auf Beitrag Nr.: 31.748.784 von Poppholz am 26.09.07 14:12:50der Händler für die ADR in FFM läuft die ganze Zeit parallel mit dem Händler für die DRX in London.
(bei uns kauft und verkauft ja auch kein Mensch)
(bei uns kauft und verkauft ja auch kein Mensch)
Antwort auf Beitrag Nr.: 31.747.398 von Birgit.Tersteegen am 26.09.07 12:23:20das glaube ich nur wenn Ulla das bestätigt
...da gibt es nichts zu bestätigen...
...ich bin ein fleißiger Helfer und jetzt noch mehr als vorher, da Ulla sich seit Anfang August den 1. Handwurzelknochen der rechten Hand gebrochen hat ....
...... aber nun fängt sie wieder langsam an , zu greifen.....
..that`s life...
...da gibt es nichts zu bestätigen...
...ich bin ein fleißiger Helfer und jetzt noch mehr als vorher, da Ulla sich seit Anfang August den 1. Handwurzelknochen der rechten Hand gebrochen hat ....
...... aber nun fängt sie wieder langsam an , zu greifen.....
..that`s life...
.aktuell USA 20,90 - 20,98 ...
..heute fallen die 21 USD !!!!
..heute fallen die 21 USD !!!!
Antwort auf Beitrag Nr.: 31.749.698 von bernie55 am 26.09.07 15:19:33
wer verkauft denn jetzt seine DRX in FFM zu 14,54 Euro?
Antwort auf Beitrag Nr.: 31.749.969 von Poppholz am 26.09.07 15:36:03...ein Dussel....
Antwort auf Beitrag Nr.: 31.750.000 von Birgit.Tersteegen am 26.09.07 15:37:39wir haben in den USA die $21,- Marke im normalen Handel überwunden (vorbörslich heute auch schon einmal, aber das zählt ja nicht so richtig).
Antwort auf Beitrag Nr.: 31.750.000 von Birgit.Tersteegen am 26.09.07 15:37:39ich wars nicht
Antwort auf Beitrag Nr.: 31.749.711 von bernie55 am 26.09.07 15:20:22..heute fallen die 21 USD !!!!
Last Price 21.00 USD
.....somit läuft alles nach Plan...
Last Price 21.00 USD
.....somit läuft alles nach Plan...
Antwort auf Beitrag Nr.: 31.757.539 von bernie55 am 27.09.07 07:56:48schöner Schlusskurs, bin gespannt was die Woche noch so bringt.
Goodbody
Genzyme moves Campath into Phase III trials against MS
Analyst: Ian Hunter
Of interest to Elan in the MS drug pipeline, Genzyme and its drug development partner Bayer Schering Pharma AG, yesterday announced that the first of two planned Phase III clinical trials with Campath (now referred to as Alemtuzumab) for the treatment of MS has treated its first patient. The first trial, using drug naïve patients, will compare an annual \"dose\" of Campath (an infusion of 12mg/day for five days followed twelve months later by 12mg/day infusions for three days) versus Rebif, administered by injection three times per week. The second trial will target patients experiencing breakthroughs, while currently on available disease-modifying therapies. The companies anticipate filing for marketing approval of Campath for the treatment of MS in 2011. It has already been approved in the US for the treatment of a specific type of leukaemia and in the EU for that leukaemia, only if the patient has failed alternative therapy. Campath\'s progression follows a Phase II trial which showed that the drug statistically reduced the sustained accumulation of disability and annualized relapse rates compared to patients on Rebif. We first noted, in September 2001 (MS - Review of disease course management), that it was in Phase II studies but it had been seen to induce an autoimmune response against the thyroid gland in MS patients. The approved product currently has boxed warnings on cytopenias (deficiencies in cellular elements in the blood), infusion reactions and infections. In October 2005 (Tysabri: judgement day approaching), we noted that Campath had completed Phase II studies but that there were side-effect issues that might have to be resolved. The drug\'s progress through clinical trials has been slow to date and, from earlier data, we do not believe that it will have the same impact on the MS market as Tysabri.
http://www.investorvillage.com/smbd.asp?mb=160&mn=154904&pt=…
Genzyme moves Campath into Phase III trials against MS
Analyst: Ian Hunter
Of interest to Elan in the MS drug pipeline, Genzyme and its drug development partner Bayer Schering Pharma AG, yesterday announced that the first of two planned Phase III clinical trials with Campath (now referred to as Alemtuzumab) for the treatment of MS has treated its first patient. The first trial, using drug naïve patients, will compare an annual \"dose\" of Campath (an infusion of 12mg/day for five days followed twelve months later by 12mg/day infusions for three days) versus Rebif, administered by injection three times per week. The second trial will target patients experiencing breakthroughs, while currently on available disease-modifying therapies. The companies anticipate filing for marketing approval of Campath for the treatment of MS in 2011. It has already been approved in the US for the treatment of a specific type of leukaemia and in the EU for that leukaemia, only if the patient has failed alternative therapy. Campath\'s progression follows a Phase II trial which showed that the drug statistically reduced the sustained accumulation of disability and annualized relapse rates compared to patients on Rebif. We first noted, in September 2001 (MS - Review of disease course management), that it was in Phase II studies but it had been seen to induce an autoimmune response against the thyroid gland in MS patients. The approved product currently has boxed warnings on cytopenias (deficiencies in cellular elements in the blood), infusion reactions and infections. In October 2005 (Tysabri: judgement day approaching), we noted that Campath had completed Phase II studies but that there were side-effect issues that might have to be resolved. The drug\'s progress through clinical trials has been slow to date and, from earlier data, we do not believe that it will have the same impact on the MS market as Tysabri.
http://www.investorvillage.com/smbd.asp?mb=160&mn=154904&pt=…
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