Elan: erst der Anfang! - 500 Beiträge pro Seite (Seite 2)

[bernie55]

...also Poppie, wenn " loseit " das sehen würde.....

[Birgit.Tersteegen]

.....dann garantieren wir ihm den 1000sten!

[Poppholz]

[posting]19.271.963 von Birgit.Tersteegen am 13.12.05 12:55:35[/posting]jetzt wirst Du aber großzügig.

Der sportliche Ehrgeiz sollte doch erhalten bleiben.

[Birgit.Tersteegen]

Poppi-für die allgemeine gute Laune an Bord muss man auch mal ein Geschenk machen können!

[bernie55]

dann garantieren wir ihm den 1000sten !!!

bei einem ELAN - Kurs von 30 USD....

[Cyberhexe]

das sieht auch heute wieder gut aus:


http://thomson.finance.lycos.com/lycos/iwatch/cgi-bin/iw_act…

PS: Leute macht mir doch den Gefallen und beschränkt Euch in diesem Thread auf Infoaustausch!

[jojobada]

[Cyberhexe]

nun scheint Bewegung in die Biotech-Szene zu kommen: die Übernahme von Abgenix durch Amgen kam nicht unerwartet. Mit der XenoMouse Technology von Abgenix erwirbt Amgen eine wertvolle Schlüsseltechnologie zur Identifikation von Antikörpern. Ein weiterer Überfnahmekandidat scheint mir deswegen Medarex zu sein, deren UltiMAB-Technologie zum Erforschen von Antikörpern ebenfalls Begehrlichkeiten bei den big playern auslösen sollte. Nichtsdestotrotz halte ich an meinem 110%-Investment an Elan fest, da mittelfristig mit den Alzheimer-Kandidaten ein Riesenpotential möglich ist und zudem eine für den Anleger eher unattraktive Übernahme durch verschiedene Abkommen (mit Biogen und Wyeth) sehr unwahrscheinlich ist.
ps: ich, bin davon überzeugt, dass die Abgenix-Aktionäre mittelfristig in der Selbständigkeit wesentlich mehr profitiert hätten, als von den gedealten, schnellen 50%.

[jojobada]

Warum ist unter der WKN 871331 Elan hier nicht mehr zu erreichen. Bitte um Antowrt!

Danke und Gruß www.jojobada.de

[Cyberhexe]

reges Interesse von institutionellen Anlegern:

http://thomson.finance.lycos.com/lycos/iwatch/cgi-bin/iw_tic…

[Cyberhexe]

...und das soll noch irgendjemand verstehen, welche Absicht mit solchen Analystenmeinungen verbunden sind: Elan für 2006 ein "top sell"....selten so gelacht!


http://www.forbes.com/2005/12/19/biotechnology-pharmaceutica…

Market Scan
Biotech Picks And Pans For 2006
Kate DuBose Tomassi, 12.19.05, 4:22 PM ET

The biotech sector "is likely to be volatile in 2006," said Merrill Lynch analyst Eric Ende in a report Friday. Stock picking and disease areas are probable focuses for investors, and mid- and small-caps "should outperform" large-cap biotech companies in 2006, the analyst said.

"The biotech group seems to have become a favored alternative investment to pharmaceuticals because growth is higher, generic risk is lower, and pharma companies are licensing biotech drugs and acquiring biotechs to foster growth," said Ende.

Specific disease areas that investors are likely to focus on in 2006 include cancer, Crohn`s disease, diabetes, hepatitis C and serious staph infections, said the analyst.

"With large-cap biotech stocks having outperformed mid- and small-caps by 30% and 40%, respectively, in 2005 we believe there is better relative value in the mid-cap/small-cap space," the analyst said. Also, "because large-caps are more subject to the potential adverse effect of option expensing and negative foreign-exchange effects, we believe investors may choose to hide in smaller biotechs, which are less exposed to these risks."

A risk to the sector is a "massive amount of potential equity financings," the analyst cautioned. "67% of biotech companies have less than two years of cash...In prior cycles, a large increase in the number of equity deals has tended to coincide with the end of the biotech bull cycle." According to the analyst, the sector is 2.8 years into the latest bull cycle and such cycles typically last two to three years.

For 2006, the analyst`s top large-cap pick is Amgen (nasdaq: AMGN - news - people ). The analyst`s top mid-cap picks are Protein Design Labs (nasdaq: PDLI - news - people ) and Cubist Pharmaceuticals (nasdaq: CBST - news - people ). Top small-cap picks are Theravance (nasdaq: THRX - news - people ), New River Pharmaceuticals (nasdaq: NRPH - news - people ), and Keryx Biopharmaceuticals (nasdaq: KERX - news - people ). Alkermes (nasdaq: ALKS - news - people ) is the top specialty biopharmaceutical pick.

The firm`s top European picks are Brussels-based UCB and Copenhagen-based GenMab.

Top "sells" cited by the analyst were ImClone Systems (nasdaq: IMCL - news - people ), Martek Biosciences (nasdaq: MATK - news - people ) and Elan (nyse: ELN - news - people ).

[moneyseeker]

[posting]19.348.483 von Cyberhexe am 20.12.05 12:08:23[/posting]Hi Cyberhexe und die anderen !

wie negativ könnte sowas wohl den Kurs betreffen ?

Gruß

[Cyberhexe]

@money

kurzfristig ist ein minimaler Effekt nicht auszuschliessen...aber mittel- bis langfristig wird sich der Kurs nicht an irgendeinem dilettantischem Anylystenurteil orientieren sondern an den Zahlen. Und die werden auch kurzfristig bereits davon abhängen, ob Tysabri zugelassen wird oder nicht. Und meines Erachtens spricht nicht mehr viel dagegen....und so wie es aussieht wird es ein "Come back" mit Blockbuster-Potential geben.

Also....keep coooool.

goodluck
ch

[welke91]

hallo ?

http://www.internalmedicinenews.com/article/PIIS109786900572…

grüße

[Cyberhexe]

http://www.marketocracy.com/media/pdf/researchreport/Elan_12…

Marketocracy Opinion:
When I fi rst recommended Elan Corporation (nyse: ELN) in an Advisor Soapbox at Forbes.com on June 17th, the
stock was trading below $7 and I said it would double. Since then the stock has doubled -- closing at $14.23 on
December 15th. Based on Marketocracy’s collaborative research process, I believe ELN could double again in the
next year or two.

[Cyberhexe]

Elan ist bereits in einigen Nanotechnologiefonds ein Schwergewicht. Warum? Hier ist die Begründung:


NanoCrystal Technology
Elan’s NanoCrystal technology to create nano-sized particles of drugs without changing their chemical properties
was actually developed by Kodak and is based on a simple idea. Smaller particles = more surface area = more
chemical reactions = better bioavailability. More of the drug is actually used by the body and less is available to
cause side effects. To see how this works, think of how long it takes for a piece of rock candy to dissolve in water.
The same quantity in table sugar form dissolves much faster because the particles are smaller. If you took the same
quantity and pulverized it into nano-sized sugar particles they would almost instantly dissolve.
Elan acquired the technology from Kodak in 1998 for $150 million; but then tried to sell the business in 2002 when
Elan was trying to reduce its debt. Fortunately, they were not successful because this technology is a hidden gem.
I think there is a huge opportunity for Elan’s NanoCrystal technology to improve the safety and efficacy of a wide
range of new and existing drugs. Alza never had anything like this.
So far, Elan has used this technology to partner with major drug companies to improve their partner’s existing drugs.
Elan typically earns royalties in the 5% - 8% range on these deals. But I think Elan should be able to do much
better. All that the partner brings to the table is a blockbuster drug with a soon to be expired patent. Elan brings the
technology to create an improved drug with renewed patent protection that can compete well against other generic
versions for years to come. Why should Elan settle for 5% - 8% of revenues? What’s to stop Elan from using this
technology to come out with their own generic versions of these blockbuster drugs after they go off-patent?
This is a much better way to build a stable of blockbuster drugs. Instead of funding R&D and working on pre-clinical
compounds that might take a decade to bring to market IF they prove to be effective Elan could be working on the
NanoCrystal versions of blockbuster drugs that will soon be off-patent. These are drugs that have already proven to
be a success. And the FDA approval process is streamlined: generic drug manufacturers need only show chemical
equivalence. That is much easier to prove than efficacy, helping make this a faster and more certain path to build
a big pharmaceutical company.

[Poppholz]

22 December 2005
Elan to Present at Healthcare Conferences in January 2006
DUBLIN, Ireland--(BUSINESS WIRE)--Dec. 22, 2005--Elan Corporation, plc announces that it will present at two healthcare conferences in January 2006.

On January 5, 2006, Elan will present at the Morgan Stanley Pharmaceutical CEO`s Unplugged Conference in New York at 8:00 a.m. Eastern Standard Time (EST), 1:00pm Greenwich Mean Time (GMT). On January 10, 2006, Elan will present at the JP Morgan 24th Annual Healthcare Conference in San Francisco at 3:00 p.m. Pacific Standard Time, 6:00 p.m. EST and 11:00 p.m. GMT.

Interested parties may access a live audio webcast of the presentations by visiting Elan`s website at www.elan.com and clicking on the Investor Relations section, then on the event icon. Following the live webcasts, an archived version of the presentations will be available at the same URL.

About Elan

Elan Corporation (NYSE: ELN), 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.


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
Click here for printable version

[Poppholz]

hier die News auch noch einmal auf Deutsch:


Business Wire

Elan gibt Präsentationen auf medizinischen Fachkonferenzen im Januar 2006

Freitag 23. Dezember 2005, 10:57 Uhr

DUBLIN, Irland 23. Dezember 2005 Die Elan Corporation, plc kündigt Präsentationen auf zwei medizinischen Fachkonferenzen im Januar 2006 an.
Elan wird am 5. Januar 2006 um 8 Uhr morgens Eastern Standard Time (EST) bzw. um 13 Uhr Greenwich Mean Time (GMT) eine Präsentation auf der Morgan Stanley Pharmaceutical CEO`s Unplugged Conference in New York, USA, geben. Am 10. Januar 2006 um 15 Uhr Pacific Standard Time bzw. 18 Uhr EST und 13 Uhr GMT findet dann eine Präsentation von Elan auf der JP Morgan 24th Annual Healthcare Conference in San Francisco statt.

Interessenten haben Zugang zu einem Live-Audiowebcast der Präsentationen über die Website von Elan unter www.elan.com auf den Seiten " Investor Relations" (Symbol " Events" klicken). Nach den Live-Webcasts wird an dieser Stelle auch eine Archivversion der Präsentationen zur Verfügung stehen.

Über Elan

Die Elan Corporation (NYSE: ELN), plc ist ein Biotechnologieunternehmen mit Schwerpunkt Neurowissenschaften. Das Ziel des Unternehmens ist es, das Leben von Patienten und ihren Familien zu erleichtern, indem es durch wissenschaftliche Innovationen signifikante und weltweit dringend benötigte medizinische Lösungen bereitstellt. Elans Aktien werden an den Wertpapierbörsen von New York, London und Dublin gehandelt. Mehr Informationen gibt es im Internet unter http://www.elan.com.

[Cyberhexe]

ML hat seit April ein “sell”-rating für Elan, akkumuliert jedoch seit einiger Zeit z.B. im letzen Quartal um über 1 Mio auf knapp 7 Mio Anteile...eigentlich ein Skandal!
Interessiert sich die Börsenaufsicht nicht für derartige Machenschaften...hier wird versucht die Kleinanleger über den Tisch zu ziehen:

http://holdings.nasdaq.com/asp/Institutional.asp?FormType=In…


http://finance.yahoo.com/q/ao?s=ELN

[curacanne]

na, das macht ml doch immer so;

[Poppholz]

[posting]19.414.957 von Cyberhexe am 27.12.05 11:32:54[/posting]wäre für uns (den Aktienverlauf) auf jeden Fall hilfreich, wenn die Börsenaufsicht sich hier einschalten würde.

Stellt Euch nur die Schlagzeile vor:

"ML gibt negative Analystenmeinung raus und deckt sich reichhaltig mit der Perle 2006 ein!"

[Cyberhexe]

...und noch ein "bullisher" Beitrag von heute:

http://www.masshightech.com/displayarticledetail.asp?art_id=…


Tysabri will be brought back onto the market.
The multiple-sclerosis drug is a potential blockbuster for Biogen Idec Inc., but the Cambridge company pulled it from the shelves in early 2005 after three deaths caused by a rare brain disease were linked to the compound.

The evidence that Tysabri was the direct cause is scant.

Subsequent tests by Biogen Idec have persuaded the U.S. Food and Drug Administration to re-investigate the data, and at some point in 2006 give it the green light.

One variable: MS patients want the drug, and they themselves are pressuring regulatory officials to help bring back the medication.

[Poppholz]

FREE 2006 Market Forecast by top market timer, Bernie Schaeffer.

Europe | Elan Corporation quote - chart - all headlines - analyst actions
Frankfurt: DRX.FSE at 5.20AM ET €11.40 -0.42 (-3.55%)

Elan "buy"

Wednesday, December 28, 2005 4:49:34 AM ET
Goodbody Stockbrokers

LONDON, December 28 (newratings.com) - Analyst Ian Hunter of Goodbody Stockbrokers maintains his "buy" rating on Elan Corp Plc (DRX.FSE).

In a research note published this morning, the analyst mentions that the decision on the return of Tysabri to the US market is expected during late March 2006, since the drug is on priority status for further review. Goodbody Stockbrokers believes that Elan`s stock would witness marginal weakness through January, after the company`s share price rose 38% during early December.

[Poppholz]

habe auch noch eine Kauf-Empfehlung vom 19.12.2005 gefunden. Mit Kursziel €26,80.Ist diese hier bereits eingestellt worden?

More Power. More Speed. More Accuracy. Still Just $7. Scottrade. GO

Europe | Elan Corporation quote - chart - all headlines - analyst actions
Frankfurt: DRX.FSE at 5.26AM ET €11.40 -0.42 (-3.55%)

Elan "buy"

Monday, December 19, 2005 11:31:22 AM ET
Goodbody Stockbrokers

LONDON, December 19 (newratings.com) – Analyst Ian Hunter of Goodbody Stockbrokers reiterates his "buy" rating on Elan Corp Plc (DRX.FSE). The target price is set to €26.80.

In a research note published this morning, the analyst mentions that Elan’s share price has appreciated by 32.2% since the beginning of this month on account of the significant volumes achieved by the company. The FDA is widely expected to refer the Tysabri sBLA to an advisory committee, which would then have to announce its decision by the end of March, the analyst says.

[Cyberhexe]

Biogen IDEC, Inc.

BIIB
Lazard Capital Markets Life
Sciences Conference Nov. 30, 2005

Company_ Ticker_ Event Type_ Date_

Breakout session Q & A transcript

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: We`re going to get started. We actually web cast our Q&A sessions, so in the future if you don`t get to the conference you can always listen to the Q&A on web cast as well to make sure everybody can hear whatever is going on. So I think we`re getting ready to start. Yes, go ahead.

Audience Member: []

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: No, the question can I comment on compassionate use to TYSABRI. We are not, no one is being dosed right now, so all dosing of the drug was suspended in February 28th. We`re currently in discussions with the FDA to restart dosing for the MS patients who`d been in the trials, and we would then move on to Crohn`s at some point after that, but at this point nobody`s receiving the drug until all of the safety work has been reviewed by the FDA, but that is an ongoing discussion. We would expect probably to have dosing started before we get through the full approval process.

Audience Member: When do you expect to hear whether or not you`ll be required to have a panel meeting?

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Yes, the question was when do we expect to hear about a panel meeting? We really think that`s any time now. It’s up to the FDA to let us know. On the time line we`re on they probably would let us know certainly this month, it wouldn`t let it drag into next year. Our expectations are that there would be a panel meeting, that`s just what we`ve been assuming.


Audience Member: [] December?

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Not a panel meeting in December, but we`d expect--

Audience Member: You`ll know in December.

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: But we`ll know in December, and we`re planning for it and assuming it will happen. Maybe it wouldn`t, but it would be our expectation it probably would. It`d be certainly understandable. It’s a drug that`s generated a lot of physician and patient interest and certainly the safety data`s new. There`s a discussion what the label should say and what kind of activity should be happening with the risk mapping. I think all of that would be kind of discussed before the FDA comes back.

Audience Member: []

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: [Much interesting] question, so the question was have we thought we PDL deal combining in combination therapy a M200 program with TYSABRI? That`s really beyond anything we`ve done at this point. At this point we`re kind of at the blocking tackling on M200. It’s an interesting idea and certainly the kind of the thing that we`d be kicking around. We love having the portfolio of products to work with, but at this point it’s probably too early.

Speaker 3: At this point actually given that the deal is relatively new, a lot of teams, both teams on both sides are kind of just getting together really re visiting the clinical development plans to kind of carve out a path forward for each of the programs.


Audience Member: Are you still pursuing TYSABRI in Crohn`s?

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Yes, the question is, are we still pursuing TYSABRI in Crohn`s? Yes we are, at this point that comes subsequent to the MS work at this point. So all the safety work has been done and submitted so the sBLA has all the safety profile for all the indications. Crohn`s would come probably after we get traction with MS both in the U.S. and Europe. So it would probably be delayed a bit, but it would certainly be something we`re still going to pursue, we`re impressed with the data.



Audience Member: []

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Regarding a panel meeting to the FDA, we`re just waiting to hear if there will be one at this point. We haven`t requested it, but it’s really entirely up to the FDA, however it’s been our expectations there likely would be one. If you consider the amount of interest that`s in TYSABRI and the amount of safety data we`ve accumulated and then what the label should read and what kind of risk mapping should be applied, I think it’s very logical that there will be a panel. So we expect it, we haven`t heard yet though anything from the FDA.

Audience Member: []


Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Right, they`ll come back to some point if they want to have a panel.


Audience Member: []

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Yes, the question has there been any dialogue relative to the sBLA and there`s always dialogue as you know, so we`re always, we`re talking from one topic to the next and going through everything. I`d say that some of the dialogue has been related to re dosing in the clinical setting in the short term and certainly they`re reviewing all of our data, it’s probably just fairly comprehensive.


Audience Member: []


Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Yes, right, re dosing of patients within our clinical trials, but nothing that we could really talk about it. It’s really just the normal process that you go through. There`s always dialogue and conversations but it would inappropriate to draw any conclusions from any of it.

Audience Member: []

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Yes.

Audience Member: []

Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Right, so the question was are there, we had a restructuring in 2005, are there any plans for that in or similar restructuring in 2006? No, definitely not. We took our time to really evaluate what capacity we needed in terms of manufacturing, but also just in terms of functional areas and we did it all at once. So it’s a one-time restructuring we don`t anticipate having anything like that in going forward. The restructuring was really a combination of different things actually, so it was both re gearing relative to what we had to quickly build because you may recall TYSABRI was accelerated by more than a year based on being reviewed for one-year data and getting accelerated review or prior review. Secondly we had to really build up our manufacturing capacity quickly based on not only the trajectory of what we thought TYSABRI sales might be, but also the accelerated start point.

So we were in the middle of building a plant in California that we had to really put the accelerator on because we suddenly needed that plant in a hurry. We were going to burn right through RTT. What the delay has done is it has one given us time to finish and get going up in Denmark as well, but two it`s allowed us to work on the [higher tire] manufacturing process which by multiples increases the yield out of the same manufacturing capacity. So at this point, while it’s not done, we`re very encouraged by what we`ve been able to do there. So we believe that number one, the delayed restart if you will or the restart in 2006, perhaps a different sales trajectory curve obviously with the experience of suspension, and then finally overtime the [higher tire] process kicking in, being able to use RTP in Denmark will be fine.



So a lot of it related to kind of re gearing around that, and then beyond that we also just went through and tried to re calibrate what we needed in different places and in some cases actually consolidated functionaries in either in San Diego or in Cambridge or in [RTT]. So it was just a lot of it was just kind of restructuring and making ourselves more efficient and obviously everybody in the biopharmas space is doing this to make sure they get the most R&D [] possible. We did have a goal though of carving out the space in our R&D and our operating expenses to allow us to really bring in a fairly healthy amount of external programs without having to sit there and every time we bring one in re jigger our operating budgets or whatever, so we really wanted to carve out that space up front which I think is a little bit unusual, but we wanted to have a significant space that we could step up our external growth activity.



Audience Member: []



Peter Kellogg, Executive Vice President, Finance and Chief Financial Officer Biogen: Yes we did, we announced that we would anticipate having about $200 million of operating expense next year related to external growth activity; and we actually in the guidance we`ve already given for operating expenses any piece of that $200 million is already assumed to be spent.

[Cyberhexe]

Tysabri ist mit Abstand das effektivste Medikament zur Behandlung von MS. Sollten nur 10% aller MS-Patienten in der EU und in den US sich dafür entscheiden - und das scheint wohl sehr konservativ - dann würde dies bedeuten, dass 80.000 Jahresdosen zu $23.500 einen Jahresumsatz von 1.88 Milliarden $ generieren würden. Bei einer Bruttomarge von 85% würden 1.6 Milliarden :2 (Elan:Biogen = 50:50, also 800 Mio$ dem Deckungsbeitrag beider Unternehmen zufliessen. Da Elan bereits ohne Tysabri in diesem Quartal EDBITDA positiv sein möchte, würde dies bedeuten, dass ein Jahresgewinn von mindestens 750 Mio$ oder knapp 2$/Aktie ausgewiesen werden könnte.
Wenn man berücksichtigt, dass eine Genentec mit einem KGV über 80 bewertet wird, dann kommt man mit vergleichbarem Massstab bei Elan bereits auf astronomische Kurse....und dies wohlgemerkt dann, wenn nur jeder 10. MS-Patient in den EU und US auf das wirkungsvollste Medikament zurückgreift. MorbusCrohn bleibt hierbei unberücksichtigt. Von Überraschungen der Alzheimer-Forschung und der Nanotechnologie ganz zu schweigen.
Also knappe 27$ auf Ende 2006 wären für mich eine Enttäuschung!

good luck
ch

[Cyberhexe]

[posting]19.433.869 von Cyberhexe am 28.12.05 17:32:24[/posting]deswegen mein Kursziel auf Ende 2006:

Elan > $40

[Cyberhexe]

zudem werden jährlich in den USA 40.000 MS-Neudiagnosen gestellt, welche keine immunsuppressive Vorgeschichte mitbringen...diese Patienten werden sich sehr wahrscheinlich überwiegend für die Behandlung mit dem effektivsten Wirkstoff entscheiden...so jedenfalls auch die Meinung von persönlich Betroffenen!

[Cyberhexe]

...und wieder interessantes von der Alzheimer-Front.
Das passive Vorgehen mit dem Antikörper erfordert angeblich eine möglichst frühe Medikation....
Wenn sich die Ergebnisse aus dem Tierversuch sowie aus Phase I in Phase II bestätigen sollten, dann wirds lustig!
Bekanntgabe der ersten Ergebnisse aus Phase II (AAB-001) im kommenden Sommer.


http://www.alzforum.org/new/detail.asp?id=1314

Passive Aggressive—Must Antibody Therapy Start Early to Be Effective?


27 December 2005. Ever since encephalitis halted development of Elan’s active vaccine for Alzheimer disease (see ARF related news story), researchers have been racing to find a better alternative. Passive immunotherapy, the administration of antibodies rather than antigens, is considered safer, and there is ample evidence to suggest that it could help clear amyloid-β (Aβ peptides from the brain (see ARF related news story, Wilcock et al., 2004, and ARF news story). But two recent reports indicate that antibody-mediated clearance of Aβ may be heavily influenced by age, at least in mice. The findings suggest that passive immunotherapy should be started early to be most effective, and that some antibodies might only work as prophylactics.
In the first paper, which appeared in the December 8 Journal of Clinical Investigation online, Todd Golde and colleagues at the Mayo Clinic College of Medicine, Jacksonville, Florida, report that some monoclonal antibodies to Aβ fail to attenuate deposition of the peptide in older mice. First author Yona Levites and colleagues tested three different monoclonal antibodies in prevention and therapeutic studies. One of the monoclonals, recognizing Aβ amino acids 1-16 as an epitope, bound Aβ1-40, Aβ1-42, and amyloid plaques. In addition to this “pan-Aβ” antibody, the authors tested two monoclonals that fail to bind plaques; these specifically recognize Aβ1-40 and Aβ1-42, respectively. Levites and colleagues found that the three monoclonals worked equally well when given to seven-month-old Tg2576 transgenic mice for four months. These animals express mutant human Aβ precursor protein (AβPP) harboring the Swedish mutations and begin to show behavioral deficits and plaque accumulation by about nine months. The authors found that at 11 months, mice treated with any of the antibodies had half the amount of SDS-soluble Aβ found in control animals. Plaque numbers were decreased by a similar amount.

But in mice already burdened with Aβ plaques, the antibodies did not work as well. When 11-month-old Tg2576 or three-month-old CRND8 mice were started on the Aβ1-40 or Aβ1-42 monoclonals, then the amount of Aβ in the brain four months later was not significantly different from that in controls. (CRND8 mice express human AβPP with Swedish and Indiana mutations, and already have detectable plaques by three months.) The pan-Aβ antibody fared slightly better, reducing SDS-soluble Aβ by about 40 percent in CRND8 animals and by about 60 percent when injected directly into the brains of 18-month-old Tg2576 mice. The Aβ1-40 and Aβ1-42 antibodies had no effect in this last experiment.

“We interpret our peripheral passive immunization data as being more consistent with preventing additional plaque deposition than with clearing existing plaques,” write the authors. What that means for human passive immunotherapy is a little hazy right now, especially given that other groups have found the technique does clear existing plaques. Dave Morgan and colleagues, for example, found that monoclonal antibodies against an Aβ28-40 antigen clears parenchymal plaques in mice that are even older (19-month-old Tg2576 animals), and it improves learning and memory (see Wilcock et al., 2004). Levites and colleagues suggest that the reason for the different findings might be related to the preponderance of diffuse plaques in some experimental models. In contrast to dense core plaques, diffuse plaques contain Aβ that many monoclonals recognize and perhaps clear. Whatever the reason, it is obvious from these experiments that not all antibodies are created equal. It will be interesting to see the outcome of the first human clinical trial AD passive immunotherapy (see Clinical Trials database).

In the meantime, the second paper, from Berislav Zlokovic and colleagues at the University of Rochester Medical Center in New York might shed some light on why the older mice do not respond as well to passive immunotherapy. Writing in the December 14 Journal of Neuroscience, they reveal that the mechanism for antibody-mediated efflux of Aβ across the blood-brain barrier (BBB) changes as mice get older.

First author Rashid Deane and colleagues report that in young mice, efflux of Aβ in complex with a monoclonal antibody (4G8, which recognizes an Aβ17-24 epitope) is mediated by either lipoprotein receptor-related protein (LRP) or the neonatal Fc receptor (FcRn). In aged mice, however, the LRP contribution is minimal, while FcRn-mediated efflux is increased. The authors found, for example, that 4G8-mediated clearance of endogenous Aβ from the brain of nine-month-old FcRn-negative mice was negligible. In normal mice, on the other hand, the passive antibody treatment halved the amount of Aβ in the cerebral cortex.

The loss of LRP-mediated efflux might explain why the authors detected increasing influx of Aβ into the brain of transgenic mice once they reached about 15-20 months. They also reported that this influx can be attenuated by passive immunotherapy with the 4G8 antibody. When APPSwe+/- mice were started on the treatment at 2-3 months, they had significantly lower influx of Aβ into the brain later in life.

Based on these findings, Deane and colleagues propose two ways to improve clearance of Aβ across the BBB—maintain or even increase the activity of the LRP pathway, and optimize the FcRn pathway. The latter may, in fact, happen naturally because the authors found that FcRn is elevated almost fourfold in brain samples from AD patients compared to controls. “Increased FcRn expression at the BBB in AD may likely be of a therapeutic value for Aβ immunotherapy,” the authors write.

Both papers also appear to agree that early is better for passive immunotherapy. That’s assuming, of course, that the passive approach is truly safer than other forms of immunization. Recent work from John Trojanowski’s lab challenges that view and shows that passive Aβ immunotherapy can, in fact, lead to encephalitis in mice (see Lee et al., 2005). If that finding repeats itself in the human trial, it would send efforts back to square one.—Tom Fagan.

[[KERN]Codex]

huhu


Splaylaywahtheepi pps outlook
by: Splaylaywahtheepi 01/01/06 03:56 pm
Msg: 866229 of 866259

donewithpunting:

Firstly, there is no "net profit" until revenues exceed expenses.

But, after that, how do you get to $75? I think you get most of the way there on real progress, on fundamentals, and the rest of the way on hope.

Fundamentals:

YE2006:
1. 60,000 patients on Tysabri for ~$1.5b run rate (most of revenue and half of revenue-COGS recorded by Elan.)

2. $220m nanotech/DD revenue

3. $300m ongoing revenue from existing drugs

4. $20m Prialt revenues (just wanted to line item this out and show my low hopes for this one.)

Hope:
1. aab-001 progress - 2006 peek may show plaque and tangle clearance like the AN1792 did (this is a 8m-10m insured US/EU market and if Elan gets only 20% and prices at modest $16K/yr then this is a $30b drug.) The peek will be enough to set expectations and $30/sh in earnings 2 years out is enough to light a fire under this stock.

2. acc-001 progress - immunoconjugate passing to P2 would be remarkable in that it would show that safety issues of the AN1792 immunoconjungate have been successfully addressed.

3. More nanotech deal announcements. Are there dozens pending? That was the plan. If the plan unfolds then hope will grow that Elan has a very successful plan in the works.

4. PD trial start. Born of the same parents as Antegren/Tysabri, confidence will be high that PD drug will deliver.

5. CT301 small molecule to hit same target at Tysabri. Wholly owned by Elan, supposedly, this will be a big bang and be oral treatment.

I can see $45 on fundamentals and another $40 on hope.

[[KERN]Codex]

http://www.nia.nih.gov/NewsAndEvents/PressReleases/PR2005122…

New Study Demonstrates Combined Techniques to Detect, Monitor Alzheimer`s Disease
[Embargoed by Annals of Neurology until Wednesday, December 21, 2005]

The search for new measures, or "biomarkers," to detect Alzheimer`s disease (AD) before signs of memory loss appear has advanced an important step in a study by researchers at Washington University in St. Louis, MO, and the University of Pittsburgh.

The researchers combined high-tech brain imaging with measurement of beta-amyloid protein fragments in cerebrospinal fluid (CSF). They found that greater amounts of beta-amyloid containing plaques in the brain were associated with lower levels of a specific protein fragment, amyloid-beta 1-42, in [spinal fluid]. Prior research indicates that amyloid-beta 1-42 is central to AD development. The fragment is a major component of amyloid plaques in the brain, which are believed to influence cell-to-cell communication and are considered a hallmark of the Alzheimer`s brain.

The study, published online December 21, 2005, by the Annals of Neurology, is the first to examine the relationship between levels of amyloid plaque deposits in the brain and different forms of beta-amyloid in CSF in living humans....

The method studied might one day help to more accurately diagnose AD, even before the appearance of cognitive symptoms, and to monitor disease progression. In the near term, the findings could be useful in a research context, allowing scientists to track the effects of potential beta-amyloid lowering treatments in clinical trials.
....
The study included 24 people ages 48 to 83 years who were cognitively normal or had very mild, mild, or moderate dementia. The researchers used positron emission tomography (PET), a brain imaging technique, with a tracing substance called Pittsburgh Compound B (PIB), to determine the amount of plaques in the participants` brains. PIB travels through the bloodstream into the brain and then binds to beta-amyloid containing plaques in the brain. PIB makes it possible to see on PET images any areas of the brain with high concentrations of plaques.

The researchers also analyzed samples of study participants` CSF and blood plasma for levels of specific protein fragments, including two forms of beta-amyloid and the protein tau.

The seven participants whose PET scans showed PIB binding -- and therefore deposits of beta-amyloid containing plaques in the brain -- had the lowest levels of amyloid-beta 1-42 in their CSF. Those without PIB binding had the highest levels of CSF amyloid-beta 1-42. No relationship was seen between PIB binding and the other CSF or blood-plasma biomarkers studied, including plasma amyloid-beta 1-42. As shown in previous studies of mice, decreases in CSF beta-amyloid may result from plaques acting as a "sink," hindering movement of soluble beta-amyloid between the brain and CSF, the researchers hypothesize.

Importantly, three of the participants had normal cognitive evaluations but had high PIB binding and low CSF amyloid-beta 1-42, suggesting the possibility that this combination of methods may be useful as "antecedent" biomarkers of AD, identifying the presence of AD amyloid pathology before the development of cognitive impairments.

[[KERN]Codex]

I`ve been very busy recently, but I don`t think I`ve seen this report before.

This is a critically important paper and the results are very enticing!!!

Let me lay it out for you non-physicians and non-scientists:

1. Elan has shown in several animal studies that amyloid and Alz are closely related...

2. Elan has results from Human trials Phase IIa and an abbrevated Phase IIb trial (AN-1792) which shows removal of plaque from autopsied brains with this approach...

3. STABILIZATION of "daily function" was seen in the "responders" of the AN-1792 trial 3 mos after vaccination...

4. Elan has tweaked the approach against Beta-amyloid and the results as seen in this study (http://www.nia.nih.gov/NewsAndEvents/PressReleases/PR2005122… are about one step short of PROOF OF CONCEPT!!!

I have the strong feeling the world is on the verge of some incredible earth-shattering results if the preliminary reports are validated over time....

We will know something..good or bad...in late 2006

Holding very tight....clutching my shares till my last dying gasp or until I know the results.

My shares are not for sale either (MSANFSe),
Creedster

[[KERN]Codex]

Re: PIB PET Scan..WHOA NELLY!!
by: winonefortheteam (40/M) 01/02/06 12:45 am
Msg: 866431 of 866460

Bchsp / wwilson / creed -- appreciate your analysis of this very important article. This layman very much appreciates the skills that you provide to the board.

It seems to me that there has been a tremendous increase in articles which support the beta amyloid thesis in the past year. It was not so long ago that the WSJ science beat writer had written articles noting the wide split in the scientific community about the cause of Alzheimer. Beta amyloid seemed to be one of many theories, all of which merited consideration.

The situation has changed dramatically. The following two sentences from the article strikes a blow to a bunch of competing theories while at the same time provides tremendous support to the approach taken by Elan/Wyeth: "No relation was observed between PIB binding and CSF A40, tau, phospho-tau181, plasma A40, or plasma A42.......These observations suggest that brain amyloid deposition results in low CSF A42, and that amyloid imaging and CSF A42 may potentially serve as antecedent biomarkers of (preclinical) AD."

I would also like to point out that all of the researchers in this article were unaffiliated with Elan or Wyeth.

The above is tremendously exciting news for families affected by Alzeimer`s (i.e. just about everyone). As investors, we should be realistic about time lines. Even if everything goes great, we won`t have a drug to sell for many years. However, there is NO WAY that Elan survives as an independent entity until 2009 if we continue to make progress in Alzeimers this year. Wyeth will buy out Elan in a friendly deal and the board would be smart to take it. The stock market is never going to value a Phase II research program very highly, whereas Wyeth will pay us well.

My theory is that Tysabri approval (and I believe Elmer will win his bet) brings us to high teens, and we will work our way to the $25 level during the year as the market grasps what a blockbuster Tysabri will be. Assuming continued progress on Alz (and this year will be hugely important), a buyout happens at $40 late in the year.

If Wyeth buys us at $40, you exchange relatively risky Elan shares for a growing pharmaceutical company which has multiple billion dollar revenue streams, a great pipeline, and an undervalued stock. And if the Alz treatment is successful for Wyeth, its stock price could potentially double in due course given the unbelievable huge market. So you do get $80 a share eventually, but in a much more secure manner.

[Poppholz]

Finanzen.net
Biogen Idec akkumulieren
Montag 2. Januar 2006, 13:46 Uhr

Die Wertpapierexperten von "pacconsec.de" stufen die Aktie von Biogen Idec (ISIN US09062X1037/ WKN 789617) mit "akkumulieren" ein.

Bereits Ende Oktober 2005 habe der amerikanische Biotechnologiekonzern seine Zahlen für das dritte Quartal 2005 veröffentlicht.

Wie das Unternehmen mitgeteilt habe, habe der Nettogewinn im Berichtszeitraum bei 27 Mio. Dollar bzw. 8 Cents je Aktie gelegen, nach einem Gewinn von 36,8 Mio. Dollar im Vorjahresquartal. Exklusive Sondereffekte habe sich aber ein EPS von 36 Cents ergeben. Analysten seien im Vorfeld von einem EPS von 42 Cents ausgegangen. Der Konzernumsatz sei im Vergleich zum Vorjahresquartal um 10% auf 596 Mio. Dollar geklettert, was unterhalb der Analystenschätzung von 620 Mio. Dollar gelegen habe. Für das laufende Quartal würden Analysten ein EPS von 48 Cents sowie einen Erlös von 638 Mio. Dollar prognostizieren.

Im September 2005 hätten Biogen Idec und der Partner Elan Pharmaceuticals einen Antrag auf Wiederzulassung ihres Multiple-Sklerose-Mittels Tysabri in den USA und Europa gestellt. Das Mittel hätte im Februar letzten Jahres wegen Sicherheitsbedenken vom Markt genommen werden müssen, nachdem in einer klinischen Studie drei Patienten an der hirnschädigenden und häufig tödlich verlaufenden Krankheit progressive multifokale Leukenzephalopathie (PML) erkrankt seien. Beide Aktien seien daraufhin deutlich eingebrochen, da dem Präparat Blockbuster-Potenzial zugesprochen worden sei. Der neue Antrag enthalte Vorschläge für eine revidierte Etikettierung sowie zusätzliche Informationen zur Risikovorsorge. Eine Entscheidung werde für Mitte 2006 erwartet. Man rechne damit, dass Tysabri die Zulassung erhalten aber vorerst keinen Blockbuster-Status erreichen werde, dennoch sollte Biogen Idec dadurch Umsatz und Gewinn merklich steigern können.

Derzeit würden bei Biogen Idec vierzehn neu entwickelte und zum Teil einlizenzierte Präparate in klinischen Studien getestet. Zusätzlich zum vielversprechenden Portfolio neuartiger Medikamente, die künftig zum Einsatz kommen sollten, verfüge der Konzern über Produktionsstätten für biotechnologisch hergestellte Proteine. Außerdem verfüge die US-Gesellschaft über drei Anlagen zur Großproduktion von Zellkulturen. Damit habe die Biotech-Gesellschaft genügend Produktionskapazitäten nicht nur für alle eigenen Entwicklungen, sondern auch für die von potenziellen Partnern.

Neben dem positiven Nachrichtenfluss Tysabri betreffend und der viel versprechenden Produktpipeline halte man es für erwähnenswert, dass vor Kurzem die Beteiligungsholding BB BIOTECH ihren Anteil an Biogen Idec erhöht habe. Nach Ansicht der Wertpapierexperten verfüge die Aktie von Biogen Idec über ein attraktives Chance/Risiko-Verhältnis und das Vertrauen in den Titel nehme nach dem Tysabri-Vorfall wieder zu. Der Wert habe am Freitag an der NASDAQ bei 45,28 USD geschlossen.

Die Wertpapierexperten von "pacconsec.de" empfehlen, die Aktie von Biogen Idec zu akkumulieren.
Analyse-Datum: 02.01.2006




Dann wollen wir doch mal sehen, wie sich unser Baby von der Empfehlung mitreißen läßt.

[Cyberhexe]

Anbei eine Zusammenfassung zur Doppelblindstudie mit AN-1792, dem Vorläufer des Immunokonjugates ACC-001, welches mittlerweile auch schon in der Klinik getestet wird (Phase I).

Risk factors associated with beta-amyloid(1-42) immunotherapy in preimmunization gene expression patterns of blood cells.

O`Toole M, Janszen DB, Slonim DK, Reddy PS, Ellis DK, Legault HM, Hill AA, Whitley MZ, Mounts WM, Zuberek K, Immermann FW, Black RS, Dorner AJ.

Biological Technologies, Wyeth Research, Cambridge, MA 02140, USA. [e-mail]

BACKGROUND: A phase 2a, double-blind, placebo-controlled, multicenter study was conducted to evaluate safety, tolerability, and pilot efficacy of immunization with beta-amyloid((1-42)) in patients with Alzheimer disease. Six immunizations were planned but were halted when meningoencephalitis was recognized as an adverse event in 6% of immunized patients. OBJECTIVE: To identify biomarkers associated with both the risk of meningoencephalitis and antibody responsiveness. PARTICIPANTS: One hundred fifty-three patients with mild to moderate Alzheimer disease.Main Outcome Measure Association between response to immunization and preimmunization expression levels of 8239 messenger RNA transcripts expressed in peripheral blood mononuclear cells that had been collected at the screening visit. RESULTS: Expression patterns of genes related to apoptosis and proinflammatory pathways (tumor necrosis factor pathway in particular) were identified as biomarkers of risk for the development of meningoencephalitis. Expression patterns of genes related to protein synthesis, protein trafficking, DNA recombination, DNA repair, and cell cycle were strongly associated with IgG response to immunization. CONCLUSIONS: Candidate biomarkers associated with risk of immunotherapy-related meningoencephalitis were detected in blood collected prior to treatment. In addition, a different set of biomarkers were identified that were associated with the desired outcome of IgG response.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&d…

[Poppholz]

Stock Of The Week
Loving Elan`s Latest Comeback

John Dobosz, 01.04.06, 9:00 AM ET


NEW YORK - Ken Kam, co-founder and chief executive officer of the amateur investor tracking and analysis service Marketocracy, recommends buying the American depositary receipts for shares of Irish biotechnology and drug delivery company Elan.

There are two ways to look at the performance of Elan’s ADRs in 2005: They were down 48.9% over the entire 12-month period, but they gained better than 365% off of their March 31 low of $3.00 per share. Elan (nyse: ELN - news - people ) closed Tuesday at $14.01.

Time to take your gains in Click Commerce or buy more? Click here to see what the best investors are doing now in Marketocracy Marketscope.
Elan lost nearly 90% of its value early in 2005 when it pulled multiple sclerosis treatment Tysabri off of the market in February after the deaths of two patients who had taken Tysabri in conjunction with another drug from Elan’s partner, Biogen Idec (nasdaq: BIIB - news - people ), and developed the rare but sometimes fatal brain disease, progressive multifocal leukoencephalopathy (PML).


Special Offer: Does Lufkin Industries have any fuel left in the tank? Click here for a full list of the new names the smart money is buying in 2006 in the Marketocracy Marketscope newsletter.
Even after Elan has more than quadrupled in value in the past nine months, Ken Kam believes it’s still a good buy since, he says, Tysabri is coming back. On Nov. 17, the U.S. Food and Drug Administration granted Tysabri "priority review" status, which means that a decision on the drug’s return will be rendered within six months instead of the usual ten months.

Kam, who has a background as an entrepreneur and manager in the medical products industry, says two factors that should help Tysabri are that no patients taking just Tysabri came down with PML, and that existing drugs to fight multiple sclerosis don’t work for 25% of MS patients. For those 100,000 or so patients in the U.S., Kam says Tysabri can greatly improve their quality of life.

These facts, according to Kam, mean that there is no good reason to withhold Tysabri from this group of patients. He says the U.S. Food and Drug Administration will use this as their justification for returning Tysabri to the market as a monotherapy with a big "black box" warning about the risk of PML on the label.

“Wall Street is beginning to agree that Tysabri will return, but Merril Lynch and Citibank both recently reiterated their sell recommendations, both citing their belief that Tysabri will be hard to sell to physicians and MS patients until the risks of PML are better understood,” says Kam, who views the pessimism as a buying opportunity, especially in light of heavy “tax-motivated” selling toward the end of last month by people who held it early in 2005 and have “huge losses.”

“Lets look at Tysabri from the perspective of MS patients,” says Kam. “For the 100,000 that are not on any MS medication right now, the choice boils down to this: Tysabri can cut your risk of relapse by 50% without making you feel as if you always have the flu. There is a 0.1% risk of contracting PML if you use Tysabri in combination with other immunosuppressive drugs, but so far, no cases of PML have turned up in patients who took Tysabri alone. To put this risk in perspective, a recent study showed that the mortality risk for aspirin is 0.2%. So an MS patient who is comfortable with the risks of taking aspirin, ought to be comfortable with the risk of taking Tysabri.


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“Wall Street expects that Tysabri sales to these patients will be a slow ramp, but, if only 25,000 of them start to use Tysabri, they would generate over $600 million a year of sales, 50% of which would go to Elan,” says Kam, who also sees potential for treating the other 300,000 MS patients in the U.S. with Tysabri.

“One of the common side effects of competing drugs is constant flu-like symptoms. If you caught the flu this winter, you know how miserable it can be. Imagine how it would affect your life if you had the flu all the time. That is what life is like for many of these 300,000 MS patients. An important fact I noted from the clinical trial data and interviews with MS patients is that Tysabri does not seem to give MS patients these same flu-like symptoms.

“For this reason, many of the other 300,000 MS patients who endure these flu-like symptoms may switch to Tysabri, even if it means they have to stop taking their current drugs. If 10% of these patients switch to Tysabri, it would mean an additional 30,000 MS patients that Wall Street is not counting on. So, the potential market for Tysabri may be more than twice as big as Wall Street is expecting,” says Kam, who adds that he is beginning to hear of MS patients on existing therapies who have stopped dosage to clear their bodies in time for Tysabri’s likely release date in the early spring.

“The FDA granted Tysabri a priority review, so a decision is due by March 26, 2006,” says Kam. “We`ll see soon enough whether Wall Street is right. If I`m right, Wall Street is in for a big upside surprise.”

Click here for more analysis and insights from Ken Kam and to learn more about subscribing to Marketocracy Marketscope.

The investment above was recommended in Forbes Newsletters’ free Stock of the Week e-mail. Click here to receive Stock of the Week next Monday morning instead of waiting until Wednesday.

Send comments and questions to [e-mail]

[Poppholz]

habe gesehen, dass ich noch zwei "Werbeblöcke" mit rein kopiert habe. Deshalb jetzt noch einmal die bereinigte Version, damit keine Missverständnisse entstehen.



Auf FORBES gefunden:

Stock Of The Week
Loving Elan`s Latest Comeback

John Dobosz, 01.04.06, 9:00 AM ET


NEW YORK - Ken Kam, co-founder and chief executive officer of the amateur investor tracking and analysis service Marketocracy, recommends buying the American depositary receipts for shares of Irish biotechnology and drug delivery company Elan.

There are two ways to look at the performance of Elan’s ADRs in 2005: They were down 48.9% over the entire 12-month period, but they gained better than 365% off of their March 31 low of $3.00 per share. Elan (nyse: ELN - news - people ) closed Tuesday at $14.01.

Time to take your gains in Click Commerce or buy more? Click here to see what the best investors are doing now in Marketocracy Marketscope.
Elan lost nearly 90% of its value early in 2005 when it pulled multiple sclerosis treatment Tysabri off of the market in February after the deaths of two patients who had taken Tysabri in conjunction with another drug from Elan’s partner, Biogen Idec (nasdaq: BIIB - news - people ), and developed the rare but sometimes fatal brain disease, progressive multifocal leukoencephalopathy (PML).

Even after Elan has more than quadrupled in value in the past nine months, Ken Kam believes it’s still a good buy since, he says, Tysabri is coming back. On Nov. 17, the U.S. Food and Drug Administration granted Tysabri "priority review" status, which means that a decision on the drug’s return will be rendered within six months instead of the usual ten months.

Kam, who has a background as an entrepreneur and manager in the medical products industry, says two factors that should help Tysabri are that no patients taking just Tysabri came down with PML, and that existing drugs to fight multiple sclerosis don’t work for 25% of MS patients. For those 100,000 or so patients in the U.S., Kam says Tysabri can greatly improve their quality of life.

These facts, according to Kam, mean that there is no good reason to withhold Tysabri from this group of patients. He says the U.S. Food and Drug Administration will use this as their justification for returning Tysabri to the market as a monotherapy with a big "black box" warning about the risk of PML on the label.

“Wall Street is beginning to agree that Tysabri will return, but Merril Lynch and Citibank both recently reiterated their sell recommendations, both citing their belief that Tysabri will be hard to sell to physicians and MS patients until the risks of PML are better understood,” says Kam, who views the pessimism as a buying opportunity, especially in light of heavy “tax-motivated” selling toward the end of last month by people who held it early in 2005 and have “huge losses.”

“Lets look at Tysabri from the perspective of MS patients,” says Kam. “For the 100,000 that are not on any MS medication right now, the choice boils down to this: Tysabri can cut your risk of relapse by 50% without making you feel as if you always have the flu. There is a 0.1% risk of contracting PML if you use Tysabri in combination with other immunosuppressive drugs, but so far, no cases of PML have turned up in patients who took Tysabri alone. To put this risk in perspective, a recent study showed that the mortality risk for aspirin is 0.2%. So an MS patient who is comfortable with the risks of taking aspirin, ought to be comfortable with the risk of taking Tysabri.

“Wall Street expects that Tysabri sales to these patients will be a slow ramp, but, if only 25,000 of them start to use Tysabri, they would generate over $600 million a year of sales, 50% of which would go to Elan,” says Kam, who also sees potential for treating the other 300,000 MS patients in the U.S. with Tysabri.

“One of the common side effects of competing drugs is constant flu-like symptoms. If you caught the flu this winter, you know how miserable it can be. Imagine how it would affect your life if you had the flu all the time. That is what life is like for many of these 300,000 MS patients. An important fact I noted from the clinical trial data and interviews with MS patients is that Tysabri does not seem to give MS patients these same flu-like symptoms.

“For this reason, many of the other 300,000 MS patients who endure these flu-like symptoms may switch to Tysabri, even if it means they have to stop taking their current drugs. If 10% of these patients switch to Tysabri, it would mean an additional 30,000 MS patients that Wall Street is not counting on. So, the potential market for Tysabri may be more than twice as big as Wall Street is expecting,” says Kam, who adds that he is beginning to hear of MS patients on existing therapies who have stopped dosage to clear their bodies in time for Tysabri’s likely release date in the early spring.

“The FDA granted Tysabri a priority review, so a decision is due by March 26, 2006,” says Kam. “We`ll see soon enough whether Wall Street is right. If I`m right, Wall Street is in for a big upside surprise.”

Click here for more analysis and insights from Ken Kam and to learn more about subscribing to Marketocracy Marketscope.

The investment above was recommended in Forbes Newsletters’ free Stock of the Week e-mail. Click here to receive Stock of the Week next Monday morning instead of waiting until Wednesday.

Send comments and questions to [e-mail]

[Cyberhexe]

Elan: Aktie der Woche bei Forbes. "Man solle nicht überrascht sein, wenn sich die Aktie 2006 verdoppelt."

Mich würde auch eine Verdreifachung nicht wundern.

http://www.forbes.com/video/?video_url=http://www.forbes.com…

[Cyberhexe]

Die Zusammenarbeit mit Roche und anderen Pharmagrössen mit Elans NanoChrystalTechnology ist allerdngs nichts Neues. Aufgrund der bereits bestehenden Übereinkünfte mit einigen Pharmariesen kann zukünftig mit Neuigkeiten gerechnet werden und zwar vor allem im Bereich von schlecht wasserlöslichen Aktivsubstanzen, die demnächst ihren Patentschutz verlieren. Durch Verwendung von Elans patentierter Technologie wird eine erhöhte Bioverfügbarkeit realisiert, wodurch die Möglichkeit besteht sich nach Ablauf des Patentschutzes von generischen Anbietern abzugrenzen.
Es wäre darüber hinaus noch spannend zu wissen, in welcher Höhe die Lizenzzahlungen vereinbart werden. Da nach Ablauf des Patentschutzes Elan durchaus auch ohne den eigentlichen Patentinhaber aktiv werden könnte, ist die Ausgangslage für Elan bei der Verhandlung der Lizenzzahlungen gar nicht so schlecht. Und es gilt zu beachten, dass derartige Lizenzzahlungen fast vollständig in den Deckungsbeitrag eingehen, da so gut wie keine Kosten anfallen.

nachfolgend die Pressemitteilungen zur Zusammenarbeit mit Roche:

21st April 2004
Elan Licenses Its NanoCrystal Technology to Roche
http://www.elan.com/News/2004/04-21-2004-eln_licenses.asp

7 January 2005
Elan and Roche Expand Nanocrystal Technology License
Proprietary Elan Technology Helps Improve Drug Delivery by Transforming Drugs into More Effective and "User Friendly" Dosage Forms to Increase Patient Convenience and Compliance

http://www.elan.com/News/full.asp?ID=660276


http://www.roche.com/de/sci_coll_phar_part

[Cyberhexe]

....und schon wieder eine bemerkenswerte Vereinbarung mit Elans patentierter Nanotechnologie....und das Potential ist riesig, da alle nicht wasserlöslichen Wirkstoffe als potenzielle Kandidaten in Frage kommen.



Elan and EntreMed Execute License Agreement for Proprietary NanoCrystal(R) Technology
Tuesday January 10, 2:30 am ET


DUBLIN, Ireland & ROCKVILLE, Md.--(BUSINESS WIRE)--Jan. 10, 2006--Elan Corporation, plc (NYSE: ELN - News) and EntreMed, Inc. (NASDAQ: ENMD - News) today announced that they have entered into a License Agreement in which EntreMed has been granted rights to utilize Elan`s proprietary NanoCrystal Technology to develop the oncology product candidate, Panzem® NCD (2ME2 or 2-methoxyestradiol). Under the terms of the License Agreement, Elan is eligible to receive payments upon the achievement of certain clinical, manufacturing, and regulatory milestones. Additionally, Elan will receive royalty payments based on sales of Panzem® NCD.



Under the License Agreement and corresponding Services Agreement, Elan will manufacture EntreMed`s Panzem® NCD, a NanoCrystal Technology formulation with improved bioavailability and absorption. Other marketed pharmaceutical products in the United States utilizing Elan`s NanoCrystal Technology include TriCor® (marketed by Abbott), Megace® ES (marketed by Par Pharmaceuticals), and Rapamune® (marketed by Wyeth). In 2004, the parties signed a Clinical Supply Agreement covering the supply of Panzem® NCD for Phase 1 trials. These Agreements extend the Panzem® NCD supply arrangement to Phase 2 and later trials. Panzem® NCD is currently in Phase 1b clinical studies in patients with advanced cancer. EntreMed expects to announce the commencement of multiple Phase 2 trials in early 2006.

Paul V. Breen, Executive Vice President, Elan Drug Technologies, said, "We are pleased to extend our relationship with EntreMed. We hope that these agreements will lead to the launch of a new product with unique benefits to cancer patients."

EntreMed President and Chief Executive Officer, James S. Burns commented, "These agreements continue our relationship with Elan for further development and manufacturing of Panzem® NCD, our lead clinical drug candidate. Interim results from our Phase 1b studies demonstrated that daily dosing with the Elan formulation maintains blood levels of 2ME2 within the desired therapeutic range, allowing us to move forward with Phase 2 clinical trials."

Mr. Burns further commented, "Expanding the Elan relationship is a logical next step for EntreMed that provides us with access to process improvements and continuity of supply for further scale-up and clinical development. We look forward to working closely with Elan to meet our development goals and move Panzem® NCD towards commercialization."




http://biz.yahoo.com/bw/060110/20060109006149.html?.v=1

[Cyberhexe]

Kommentar von NCB (10.1.2006)


Elan €12.02 BUY Licensing Deal/Progress Of Oral MS Product
• Elan announced this morning a license agreement in which EntreMed has been
granted rights to utilize Elan`s NanoCrystal technology to develop Panzem, an
oncology product in Phase 1b clinical studies. In addition to receiving potential
royalties based on product sales, Elan could also receive contract manufacturing fees
and milestone payments.
• Separately, a Phase II study with BiogenIdec/Fumapharm`s oral multiple sclerosis BG-
12 has met its primary endpoint of reducing the total number of gadolinium-enhancing
brain lesions (as measured by MRI) in patients with relapsing-remitting multiple
sclerosis (MS) following six-months of treatment. With only headline data available at
this point it is difficult to compare this oral product in the context of Tysabri or even
FTY720 (Novartis` oral product in Phase III studies which is expected to be filed with
the FDA in 2009).
• Both Tysabri and FTY720 show similar reduction in the frequency of relapses with both
exceeding the currently marketed products. More importantly, Tysabri shows a 42%
reduction in the frequency of disability progression which is the best improvement seen
to date for any drug. Tysabri`s updated label is expected to include this disability data.

[Cyberhexe]

Kommentar von Davy Stockbroker (10.1.2006)

Elan (ELN US)
Extends nanocrystal agreement with Entremed
Previous close: 1440c Target: 1300c (09/08/05; previously 870c, issued 26/05/05) Analyst: [e-mail]
In another illustration of the increased importance of Elan`s drug technology division, Elan and Entremed have extended their
development agreement to utilise nanocrystal delivery technology in oncology product candidate, Panzem NCD. The product
is currently in Phase 1b studies and will move into the next phase in early 2006. Elan had already been contracted to provide
trial supplies for the product during Phase 1.
This extension allows Elan to benefit from potential milestone fees and royalty payments should Panzem NCD successfully
progress through studies to commercialisation.
No financial details were disclosed.

[Poppholz]

Jetzt auch auf Deutsch:

Business Wire
Elan und EntreMed schließen Lizenzvereinbarung über die geschützte NanoCrystal(R)-Technologie
Dienstag 10. Januar 2006, 18:56 Uhr

DUBLIN, Irland & ROCKVILLE, Maryland 10. Januar 2006 Elan Corporation, plc (NYSE: ELN) und die EntreMed, Inc. (NASDAQ:ENMD) gaben heute bekannt, dass sie eine Lizenzvereinbarung geschlossen haben. Durch diesen Vertrag ist EntreMed berechtigt, die geschützte NanoCrystal-Technologie von Elan zur Entwicklung des onkologischen Wirkstoffkandidaten Panzem(R) NCD (2ME2 oder 2-Methoxyestradiol) einzusetzen. Der Vertrag sieht vor, dass Zahlungen an Elan zu leisten sind, sobald bestimmte Fortschritte bei der klinischen Forschung, der Herstellung und dem Zulassungsverfahren verzeichnet werden. Des Weiteren erhält Elan anteilig zu den Umsätzen ANZEIGE

mit Panzem(R) NCD Nutzungsgebühren.
In der Lizenzvereinbarung und der entsprechenden Leistungsvereinbarung wurden festgelegt, dass Elan den Wirkstoffkandidaten Panzem von EntreMed, eine Rezeptur, die auf der NanoCrystal basiert und eine bessere Bioverfügbarkeit und Resorption aufweist, produzieren kann. Weitere, in den USA vermarktete pharmazeutische Produkte, die auf der NanoCrystal-Technologie von Elan basieren, sind TriCor(R) (Vermarkter: Abbott), Megace(R) ES (Vermarkter: Par Pharmaceuticals) und Rapamune(R) (Vermarkter: Wyeth). In 2004 unterzeichneten die Parteien einen Liefervertrag für klinische Studien, der die Bereitstellung von Panzem(R) NCD für Phase I-Studien vorsah. Mit den aktuellen Verträgen werden die Liefervereinbarungen auf Phase II- und nachfolgende Studien ausgeweitet. Panzem(R) NCD wird derzeit in Phase Ib-Studien an Patienten mit fortgeschrittenem Krebs klinisch getestet. EntreMed rechnet damit, die Einleitung verschiedener Phase II-Studien Anfang 2006 bekannt geben zu können.

Paul V. Breen, Executive Vice President der Elan Drug Technologies, erklärte: "Wir freuen uns darauf, unsere Beziehungen mit EntreMed auszuweiten, und hoffen, dass diese Vereinbarungen zur Markteinführung eines neues Produktes führen, das sich für Krebspatienten als segensreich erweist".

James S. Burns, Vorsitzender des Vorstandes von EntreMed, kommentierte den Vertragsschluss wie folgt: "Durch diese Verträge werden unsere Geschäftsbeziehungen mit Elan mit dem Ziel fortgesetzt, unseren klinischen Wirkstoffkandidaten Panzem(R) NCD weiterzuentwickeln und herzustellen. Die vorläufigen Ergebnisse unserer Phase Ib-Studien zeigen, dass eine tägliche Gabe mit der Rezeptur von Elan den Pegel von 2-Methoxyestradiol im Blut auf dem therapeutisch gewünschten Niveau hält. Somit können wir jetzt mit den klinischen Phase II-Studien beginnen.

Burns sagte des Weiteren: "Die Ausweitung der Geschäftsbeziehungen mit Elan ist für EntreMed der nächste logische Schritt. Wir können auf diese Weise von Prozessverbesserungen und einer Lieferkontinuität profitieren, um eine weitere nachfolgende und klinische Entwicklung voranzutreiben. Wir freuen uns auf die enge Zusammenarbeit mit Elan, damit wir unsere Entwicklungsziele erreichen und Panzem(R) NCD der Vermarktung näher bringen können".

Über die NanoCrystal(R)-Technologie von Elan

Bei der NanoCrystal-Technologie von Elan handelt es sich um eine neuartige Technologie zur Freisetzung von Medikamenten, die in Kombination mit schwer wasserlöslichen Präparaten hervorragende Ergebnisse erzielt. Mehr und mehr Wirkstoffkandidaten, die jedes Jahr von pharmazeutischen Unternehmen synthetisch hergestellt werden, sind schwer wasserlöslich. Viele dieser möglicherweise innovativen Wirkstoffkandidaten werden oftmals aufgegeben, weil sie geringe pharmakokinetische Eigenschaften u. a. bei der Resorption, Verteilung, dem Stoffwechsel und der Ausscheidung aufweisen. Die NanoCrystal-Technologie könnte einen beträchtlichen Teil dieser chemischen Verbindungen retten.

Diese Technologie von Elan ist Teil einer Reihe von Technologien, die das Unternehmen dritten Parteien überlässt. Elan Drug Technologies stellt seine technologisch-basierten Lösungen der pharmazeutischen Industrie weltweit zur Verfügung. Mit mehr als 30 Produkten, die in 40 Ländern eingeführt wurden, hat das Unternehmen gezeigt, dass sich seine Technologien erfolgreich von Drittkunden vermarkten lassen. Weitere Informationen über das breite Spektrum der Technologien, den Bestand an Patenten und die Bandbreite der Dienstleistungen von Elan Drug Technologies sind unter www.elan.com/EDT abrufbar.

Über Elan

Elan ist ein im Bereich der Neurowissenschaft tätiges Biotechnologieunternehmen, das sich auf die Entdeckung, Entwicklung, Herstellung, den Verkauf und die Vermarktung hoch entwickelter Therapien für neurodegenerative Erkrankungen, Autoimmunerkrankungen sowie die Linderung großer Schmerzen spezialisiert hat. Die Aktien von Elan (NYSE:ELN) werden an den Börsen in New York, London und Dublin gehandelt.

Über Panzem(R) NCD

2-Methoxyestradiol ist ein oral aktives kleines Molekül, das mittels verschiedener Wirkungsmechanismen Tumorzellen angreift und die Entwicklung neuer Blutgefäße, die Tumorzellen mit verschiedenen Stoffen versorgen, behindert. Panzem(R) Nanocrystal Colloidal Dispersion (Panzem(R) NCD), eine flüssige, orale Rezeptur, hat in vorklinischen Studien ihr Potential, die Bioverfügbarkeit des Stoffes beträchtlich zu erhöhen, unter Beweis gestellt. Auf diese Weise wird der Pegel von 2ME2 im Blut der Patienten erhöht.

Über EntreMed

EntreMed, Inc. (NASDAQ: ENMD) ist ein Pharmazieunternehmen, das sich auf die klinische Forschung und Entwicklung von therapeutischen Wirkstoffkandidaten zur Behandlung von Krebs und Endzündungen spezialisiert hat. Panzem(R) (2-Methoxyestradiol oder 2ME2), ein Wirkstoffkandidat des Unternehmens, wird derzeit in klinischen Studien für die Behandlung von Krebs getestet. In der präklinischen Forschung und Entwicklung wird der Wirkstoff auch für weitere Indikationen geprüft. EntreMed gab kürzlich bekannt, dass es Miikana Therapeutics, Inc. übernehmen wird, ein auf die klinische Krebsforschung spezialisiertes Unternehmen mit Sitz in Fremont im US-Bundesstaat Kalifornien. Ziel von EntreMed ist, neue Verbindungen zu entwickeln und vermarkten. Ausgangspunkt dafür ist das Fachwissen seiner Forschungsabteilungen in den Bereichen Angiogenese, Steuerung des Zellzyklus und Entzündungen, die als Prozesse für die Behandlung von Krebs und anderen Krankheiten wie der rheumatoiden Arthritis von ausschlaggebender Bedeutung sind. Weitere Informationen über EntreMed sind auf der Website des Unternehmens unter www.entremed.com abrufbar oder können in den bei der US-Börsenaufsichtsbehörde verschiedentlich eingereichten Unterlagen eingesehen werden.

Die NanoCrystal(R)-Technologie ist eine eingetragene Handelsmarke und Eigentum der Elan Pharma International Limited Corporation aus Irland.

Panzem(R) ist eine eingetragene Handelsmarke und Eigentum der EntreMed, Inc.

TriCor(R) ist eine eingetragene Handelsmarke und Eigentum der Abbott Laboratories Corporation.

Megace(R) ist eine eingetragene Handelsmarke der Bristol-Myers Squibb Company. Lizenznehmer ist die Par Pharmaceutical, Inc.

Rapamune(R) ist eine eingetragene Handelsmarke und Eigentum der Wyeth Pharmaceuticals.

Vorausschauende Aussagen

Diese Pressemitteilung enthält vorausschauende Aussagen im Sinne des "Private Securities Litigation Reform Act", die sich auf die Realisierung zukünftiger finanzieller und geschäftlicher Ziele, Strategien, Erwartungen und Zielsetzungen beziehen. Vorausschauende Aussagen unterliegen zahlreichen Voraussetzungen, Risiken und Unwägbarkeiten, die sich kontinuierlich wandeln. Die vorausschauenden Aussagen beziehen sich nur auf den Zeitpunkt, an dem sie abgegeben werden. Es wird keine Verpflichtung zu ihrer Aktualisierung übernommen. Die tatsächlichen Ergebnisse können sich aufgrund zahlreicher Faktoren maßgeblich von den derzeit vorhergesagten Ergebnissen unterscheiden. Einige dieser Faktoren sind in den bei der US-Börsenaufsichtsbehörde "Securities and Exchange Commission" eingereichten Unterlagen unter der Bezeichnung "Risikofaktoren" aufgeführt. Andere Faktoren beziehen sich auf die Risiken in Verbindung mit dem Bedarf an zusätzlichem Kapital und die Unsicherheit in Verbindung mit einer zusätzlichen Kapitalausstattung, die Produkte, die sich in einem frühen Stadium der Entwicklung befinden, die Tatsache, dass präklinische Modellierungsergebnisse nicht unbedingt aussagekräftig sind in Bezug auf klinische Ergebnisse, die Unsicherheiten in Verbindung mit der präklinischen und klinischen Forschungsphase, den Erfolg bei der klinischen Entwicklung der Produkte, die Abhängigkeit von dritten Parteien, den zukünftigen Kapitalbedarf und schließlich die Risiken in Verbindung mit der Vermarktung der vorgestellten Produkte des Unternehmens, sollte diese realisiert werden (wie beispielsweise Unwägbarkeiten in Bezug auf Marketing, Sicherheit, Zulassung, Patente, Produkthaftung, Belieferung, Wettbewerb und andere Unwägbarkeiten).

Kontakt

Elan Corporation
Kapitalanleger:
Emer Reynolds, [phone]
800-252-3526
Chris Burns, 800-252-3526
ODER
Medien:
Davia Temin, [phone]
Elizabeth Headon, [phone]
ODER
EntreMed, Inc.
Communications/IR
Ginny Dunn, [phone]

[Cyberhexe]

interessante Dia-Show anlässlich der Analystenpräsentation


http://www.tixx.com/jpm2006/index.html

[Cyberhexe]

dieses Slide zeigt die derzeitigen Alzheimer-Aktivitäten


http://www.tixx.com/jpm2006/target24.html

[Cyberhexe]

eindrucksvoller "proof of concept" bei der Alzheimerstrategie:


http://www.elan.com/Images/FINAL%20Slide%20%233%20PDAPP%20Mo…

[Nostarowie]

Hexi, warum verlinkst Du deine urls eigentlich nicht, oder funktioniert das nur bei mir nicht.


(nicht falsch verstehen, ich bin nicht auf der Ebene dich zu Kritisieren)

[Poppholz]

10.01.2006 23:23
Biogen rechnet mit Tysabri-Rückkehr

Biogen Idec (Nachrichten/Aktienkurs) hat heute den Ausblick für das Jahr 2006 bekräftigt. Der Biotech-Konzern rechnet weiter mit einem Gewinn zwischen 1,95 und 2,10 Dollar je Aktie vor Sondereffekten.

Voraussetzung dafür sei allerdings auch die Rückkehr des umstrittenen Medikaments „Tysabri“. Dieses war im vergangenen Jahr wegen schwerwiegender Nebeneffekte vom Markt genommen worden. Wie das Unternehmen mitteilte, werde die US-Zulassungsbehörde FDA demnächst wohl ein Expertengremium bilden, das über die Zukunft des einstigen Hoffnungsträger-Präparats gegen Multiple Sklerose entscheiden werde. Hauptproblem seien dabei die Anweisungen an die verschreibenden Ärzte, die die Entwicklung von Nebenwirkungen sehr präzise und kenntnisreich beobachten müssten. Es sei aber damit zu rechnen, dass die Probleme lösbar seien und der Wirkstoff zur Jahresmitte zurückkehren werde.

An der Nasdaq konnten sich Biogen Idec heute um 0,86 Prozent auf 47,96 Dollar verbessern.

[Poppholz]

(AFX UK Focus) 2006-01-11 06:11 GMT:
Biogen: FDA to rule on Tysabri by end of March

Article layout: raw

SAN FRANCISCO (AFX) -- Executives for Biogen Idec said Tuesday that they expect the U.S. Food and Drug Administration to make a decision by the end of March to clear the market return of the company`s recalled drug, Tysabri.
In a presentation before investors at the annual J.P. Morgan Healthcare Conference, Biogen executives said that the FDA is scheduled to rule by March`s end on whether to approve new labeling for Tysabri that would warn the drug has been linked to an extremely rare but deadly brain disease called PML. Tysabri was approved in late November 2004 by the FDA for the treatment of multiple sclerosis.

Biogen and partner Elan Pharmaceuticals voluntarily pulled Tysabri from the market in February 2005 after three cases of PML were reported. Two of the patients died. About 3,000 patients had taken the drug before it was recalled. The drug`s recall surprised both medical experts and Wall Street analysts, many of whom had hailed Tysabri as a wonder drug in the treatment of MS. Industry watchers had predicted that Tysabri, which appeared to be more effective and better tolerated than existing MS treatments, would greatly expand the market for MS drugs. Currently, many MS sufferers eschew drug treatment due to the unpleasant side effects of the drugs. Since that time, Biogen and Elan have been conducting an exhaustive safety review of the drug to determine how the drug can be mostly safely prescribed to MS patients. The companies filed last fall to have the drug approved with a new label that discusses the risks of contracting PML, a disease that generally occurs in patients whose immune systems are severely compromised. According to Biogen Chief Executive Jim Mullen, the new label will dictate that Tysabri should only be used "with great caution" by people whose immune systems are already comprised, such as with immunosuppressant drugs. Mullen reiterated that the company expects to be able to have the drug back on the market by midyear. He added that Biogen was in discussions with health insurers about how the new labeling will affect coverage. Biogen`s executive president for development, Burt Adelman, added that the label also will contain information supporting Tysabri`s unusually high effectiveness in slowing down the progression of MS. In addition, Adelman noted that many of the leading drugs used to treat MS can also cause dangerous side effects. The one great exception, he said, is a group of drugs known as interferons, which includes Biogen`s widely prescribed Avonex. Tysabri had been considered to be superior to interferons because it did not cause the flu-like symptoms associated with those drugs and appeared to be far more effective. Mullen said that the company expects to have the FDA hold a special advisory-panel meeting on the matter. He added that a major topic of the meeting will likely be what sort of language should be included on the label about diagnosing and treating PML in its earliest stages. The FDA has not yet contacted Biogen about scheduling such a meeting, according to Mullen. Biogen`s chief financial officer, Peter Kellogg, declined to speculate on what sales of a newly-launched Tysabri might look like. "Until we all know the new label, we can`t estimate," he said. Prior to its recall, analysts had predicted that Tysabri could have peak sales upward of $2 billion a year. This story was supplied by MarketWatch. For further information see www.marketwatch.com.

[e-mail] jlw

[zenman]

für hexi

verlinken geht so

[.url.]...........[./url.]


die pkte in der klammer weglassen, lies sich andersa nich darstellen


is userfreundlicher

[Poppholz]

Elan Tysabri Could Hit $1.8B Sales
- NCB

Wednesday, January 11, 2006 9:29:09 AM ET
Dow Jones Newswires

1305 GMT [Dow Jones] NCB Stockbrokers says $1.6B in peak sales for suspended MS drug Tysabri are factored into the share price of over $14. It says $1.8B sales are achievable and gives a sum-of-the-parts valuation of up to $15.96. As Tysabri is under review by the FDA, NCB cautions, "The risk of negative commentary ahead of the (FDA) panel`s decision could generate negative sentiment." Maintains at buy. Elan +3.3% at EUR12.25. (QAF)

Contact us in London.
[phone]
[e-mail]

[Cyberhexe]

besten Dank zeni & russensocke...anbei mein 1.Versuch:

http://www.tixx.com/jpm2006/target8.html

und das ist ja wirklich ein visionärer Paukenschlag...Elan hat "kleine Moleküle" in der Pipeline für Arthritis und MS, und das ohne Kooperationspartner. Da wirds demnächst ein IND geben!

[Nostarowie]

Oooch Hexi wir hatten doch beim letzten gemeinsamen abendessen beschlossen die Kosenamen nicht zu veröffentlichen.....ts,ts..Frauen und erinnerung

[Cyberhexe]

Genentech hat für 2005 einen Gewinn je Aktie von $1.28 ausgeweisen...bei 1.05 Milliarden Aktien und einer Marktkapitalisierung von 94 Milliarden $ entspricht dies einem KGV von über 65.
Falls 100.000 Tysabri-Jahresdosen (MS+Crohn) abgesetzt werden, erhält Elan abzüglich Unkosten ca. 1 Milliarde$, welche vollständig in den Deckungsbeitrag einfliessen. Da bereits ohne Ty ein ausgeglichenes EBITDA prognostiziert wird, würde bei 100.000 Jahresdosen der Gewinn weit höher liegen als $1.28...
Bei einem derartigen Benchmarking kommt man gleich zu einem astronomischen Kurspotenzial....und 100.000 Jahresdosen sind sicherlich nicht unrealistisch...die Kapazität soll mit Hillerode/Dänemark auf mindestens das Dreifache erhöht werden.

[Poppholz]

Biogen erwartet Ende März erneute Marktzulassung von Tysabri

13.01.2006 - (dpa-AFX) Biogen Idec erwartet bis Ende März eine Entscheidung der US-Gesundheitsbehörde zur erneuten Markteinführung des Medikaments Tysabri. Während einer Präsentation vor Investoren am Rande der jährlichen JP-Morgan- Healthcare-Konferenz in San Francisco sagten führende Mitarbeiter, dass die Gesundheitsbehörde FDA über die erneute Zulassung von Tysabri auf der Grundlage einer neuen Produktinformation bis Ende März entscheiden werde. In der neuen Verpackung werde auf die Gefahr einer extrem seltenen und tödlichen Form der Hinhautentzündung hinweisen.

Im Februar 2005 hatte Biogen das Medikament Tysabri gemeinsam mit dem Partner Elan Pharmaceuticals vom Markt genommen. Damals gab es Berichte über zwei Todesfälle, die mit dem Mittel zur Behandlung von Multiple Sklerose in Verbindung gebracht wurden.

http://www.bionity.com/news/d/51574/1206C/-0123456789

[Poppholz]

habt Ihr das schon gesehen?

-ohne Worte-


Morningstar.com
The Market`s Most Overvalued Stocks
Friday January 13, 6:00 am ET
By Mitchell P. Corwin, CFA, CPA


Equity valuations as a whole barely budged in 2005, but the market remains a bit on the pricey side when compared to Morningstar`s collective fair value estimates (To see more on Morningstar`s perspective on market valuations, check out our Market Valuation Graph). The median stock in our coverage universe of 1,700 stocks is now trading at nearly a 10% premium to our estimate of its fair value. However, within our overall coverage universe, there remain plenty of stocks that are trading at significant discounts or premiums to our fair value estimates.
ADVERTISEMENT


For today`s Stock Strategist, we`ll take a look at some stocks at the high end of the range: those trading at prices more than 2 times our estimate of the company`s underlying fair value. Nearly 100 stocks were pricey enough to pass this screen as of Jan. 11, 2006. All of these stocks are expensive enough that we`d consider selling them, but we narrowed the list a bit further by screening for stocks lacking an economic moat and showing an above-average level of business risk.

A total of 80 stocks made the final cut. Over one fifth of those stocks were in the industrial materials sector and nearly another fifth are classified as energy firms. The common thread running through many of these high-priced stocks is the influence of high energy prices and insatiable demand by investors for anything remotely correlated with the booming price of gold.

In addition to energy and industrials, many other sectors are represented in this list, including business services, financial services, hardware, health care, and media. I thought I`d highlight a few of these larger companies that we think are overvalued for reasons other than having to do with the price of commodities:

Sirius Satellite Radio (NasdaqNM:SIRI - News)
Price/fair value ratio: 302%
From the Analyst Report: "With all of the substitutes to satellite radio available, each installed satellite radio unit will not translate into a self-paying subscriber. Not all consumers will want to spend $150 per year for satellite radio when terrestrial radio, still available through satellite radio hardware, costs nothing. In our opinion, digital music on MP3 players, wireless networks capable of streaming Internet radio into the car, and content through cell phones loom as potential threats, too."

US Airways Group (NYSE:LCC - News)
Price/fair value ratio: 330%
From the Analyst Report: "Let`s get one thing straight: Newlywed US Airways is not a low-cost carrier, no matter what its ticker suggests. Despite its newfound financial stability and some favorable near-term industry trends, US Airways cannot escape its poor business fundamentals. This is not a buy-and-hold stock."

MEMC Electronic Materials (NYSE:WFR - News)
Price/fair value ratio: 328%
From the Analyst Report: "MEMC Electronic Materials is one of many suppliers of silicon wafers, the disks on which semiconductors are fabricated. Despite the firm`s impressive comeback, the industry`s commodity nature and MEMC`s capital intensity still concern us."

LSI Logic (NYSE:LSI - News)
Price/fair value ratio: 204%
From the Analyst Report: "LSI has also struggled to keep pace within its own ASIC market. The firm has steadily been losing share, as its manufacturing capabilities have fallen behind those of rivals like IBM (NYSE:IBM - News). Larger ASIC suppliers, by streamlining their leading-edge manufacturing with the design process, offer a much higher value proposition to customers than LSI, in our view."

Elan ADR (NYSE:ELN - News)
Price/fair value ratio: 533%
From the Analyst Report: "Elan is a broken company desperately trying to fix itself. Its success requires Tysabri`s return to the market, but even then, the company faces an uphill path to become cash flow positive (let alone stay that way). We have incorporated some of the risks into our fair value estimate, but we would still require a hefty margin of safety before investing."

To see the results of this screen for yourself, click here: http://news.morningstar.com/article/article.asp?id=153588 . Note: The stocks mentioned above passed our screen as of Jan. 11. The results of the screen may change due to daily price fluctuations or other factors. After clicking, you can save the search to use later by clicking the "Save Criteria" button in the bottom right-hand corner of the screen. (You will need to be logged in as a Premium Member to view and save the complete screen.)

Get Morningstar`s portfolio tools, data, and editorial insight, plus Analyst Reports on 1,450 stocks and 2,000 funds. Start your free 14-day trial today.

http://biz.yahoo.com/ms/060113/153588.html?.v=1

[bernie55]

Elan Announces Webcast of Fourth Quarter and Full Year 2005 Financial Results

1/13/2006 1:00:01 PM

DUBLIN, Ireland, Jan 13, 2006 (BUSINESS WIRE) -- Elan Corporation, plc announced today that it will host a conference call on Tuesday, January 31 , 2006 at 8:30 a.m. Eastern Standard Time (EST), 1:30 p.m. Greenwich Mean Time (GMT) with the investment community to discuss Elan`s fourth quarter and full year 2005 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.

[Cyberhexe]

auch Goodbody Stockbrokers Analyst Ian Hunter vermutet, dass AAB-001 noch gegen Ende des Jahres in die klinische Phase III eintreten könnte...und bei Kooperationspartner Wyeth spricht man bereits davon den Wirkstoff 2009 zu vermarkten. Und falls der Wirkstoff tatsächlich den Verlauf von Alzheimer nachhaltig beeinflussen sollte, dann wird AAB-001 alles bisherige in den Schatten stellen.


http://www.rte.ie/business/2006/Morningrep/download/0113good…

[welke91]

hy Cyberhexe
WARUM gibs kein approval von der EMEA ?

Tysabri-Morbus Chron

ick flipp noch aus

Tysabri approval in MS kann ich ja noch verstehen aber in MC keine Chance,...

wenn Ty wieder zugelassen wird FDA,

steht unmittelbar danach

MS EMEA approval &
MC EMEA approval an.

und warum verkauft sich Piralt so schlecht?

müssen wir auf die army warten?

grüße welke

[Poppholz]

16.01.2006 11:08
Elan kündigt Webcast zur Diskussion der Bilanzen des vierten Quartals und des gesamten Jahres 2005 an

Die Elan Corporation plc kündigte heute für den 31. Januar 2006 um 8:30 Eastern Standard Time (EST) bzw. 13:30 Greenwich Mean Time (GMT) eine Konferenzschaltung mit der Investmentgemeinschaft an, um die Bilanzergebnisse von Elan im vierten Quartal sowie für das gesamte Jahr 2005 zu diskutieren; diese sollen noch vor Öffnung der Finanzmärkte in den USA und in Europa veröffentlicht werden.

Gleichzeitig wird über Internet eine Live-Audioübertragung der Konferenzschaltung für Investoren, Medienvertreter und die allgemeine Öffentlichkeit frei geschaltet.

Zugriff zu dieser Veranstaltung erhält man über die Website von Elan auf www.elan.com, Öffnen der Seiten "Investor Relations" und Anklicken des Veranstaltungssymbols. Im Anschluss an das Live-Webcast wird unter derselben URL eine Archivversion der Konferenzschaltung zur Verfügung gestellt.

Über Elan

Die Elan Corporation (NYSE: ELN), plc ist ein Biotechnologieunternehmen mit Schwerpunkt Neurowissenschaften. Das Ziel des Unternehmens ist es, das Leben von Patienten und ihren Familien zu erleichtern, indem es durch wissenschaftliche Innovationen signifikante und weltweit dringend benötigte medizinische Lösungen bereitstellt. Elans Aktien werden an den Wertpapierbörsen von New York, London und Dublin gehandelt. Mehr Informationen gibt es im Internet unter http://www.elan.com.

Quelle: Business Wire

[Poppholz]

und was soll das jetzt wieder?

Lehman Cuts Elan To Underweight From Equalweight

Thursday, January 19, 2006 7:11:43 AM ET
Dow Jones Newswires

NEW YORK (Dow Jones)--Lehman Brothers cut Irish biotech company Elan Corp. PLC (ELN) to underweight from equal weight, citing overextended valuation.

The broker told clients that based on the current share price, the market is already more the fully discounting a return to market of multiple sclerosis treatment Tysabri and robust product revenues going forward. Lehman said that assuming a return to market, it believes neurologists may be reluctant to broadly prescribe the drug due to the responsibility of the required strict patient monitoring.


Copyright (c) 2006 Dow Jones & Company, Inc.

[Cyberhexe]

...darf ich Euch daran erinnern, dass auch MorganStaley das Sell-Rating für Elan bestätigt hat und im vorletzten Quartal knapp 2 Mio Anteile zugekauft hat...also meine Meinung handelt es sich da lediglich um ein kurzes Störfeuer

keep cool...spätestens am 26. März sollte die Wiederzulassung von der FDA ausgesprochen sein und dann solltebn die 20$ fallen

Weshalb die EMEA sich nicht emanzipiert und unabhäöngig von der FDA entscheidet kann ich nicht beurteilen...habe keine Kontakte zur europäischen Arzneimittelzulassungsbehörde. Aber ärgerlich ist das allemal. Dass die europäischen MS-Patienten sich dies gefallen lassen!

[Poppholz]

das ist ja wie "Wasser predigen und Wein saufen".

Sollte mich nicht wundern, wenn die Jungs von Lehmann Brothers, Morgen Stanley und Merrill Lynch diesbezüglich noch einige Nachfragen bekommen werden.

[Poppholz]

Goodbody Holds Its Nerve On Elan`s Tysabri

Friday, January 20, 2006 9:12:15 AM ET
Dow Jones Newswires

1249 GMT [Dow Jones] Goodbody Stockbrokers sees "some nervousness at this late stage in the rehabilitation" of Elan`s (ELN) MS drug Tysabri until definite newsflow on the drug`s return to market, new labeling/conditions and visibility on its market potential. Keeps at add. Elan -5.4% at EUR11.50 ahead of the expected update by the FDA. (QAF)

Contact us in London.
[phone]
[e-mail]

[Cyberhexe]

...wurde nun ja auch Zeit, dass der Zeitpunkt des AC festgesetzt wurde: 7. März 2006
So viel ich weiss, sind derartige Sitzungen zumindest teilweise öffentlich. Auf den Kursverlauf im Monat März darf man/frau wirklich gespannt sein.
Ich konnte es natürlich nicht lassen, und habe gestern nochmal nachgelegt....bin nun unvernünftigerweise mit meinem Investitionsgrad wieder bei 110%...und zwar all-in-one...bzw. all-in-elan
Belehrungen diesbezüglich sind übrigens zwecklos, ich werde in meinem wissenden Bekanntenkreis bereits als unzurechnungsfähig erklärt

;-)

good luck
ch

ach ja Leute...die Planungen für die 13 Euronen-Party solltet ihr nicht unterbrechen...ich bin mir ziemlich sicher, dass es gegen Ende März noch mehr zu feiern geben wird

http://www.fda.gov/oc/advisory/accalendar/2006/cder12543d030…

[Cyberhexe]

das AC setzt sich aus folgenden Personen zusammen:

http://www.fda.gov/cder/audiences/acspage/peripheralroster1.…

[2CB_06]

... aus dem YMB. Ein interessanter Link zum Thema Alzheimer.

http://www.dradio.de/dlf/sendungen/forschak/461067/

[Cyberhexe]

http://biz.yahoo.com/bw/060123/20060122005072.html?.v=1

[Poppholz]

FDA Ruling On Elan`s Tyasbri Seen By March 26
Monday, January 23, 2006 7:12:13 AM ET
Dow Jones Newswires

1051 GMT [Dow Jones] The US FDA`s review of Elan (ELN) and Biogen Idec`s (BIIB) MS drug Tysabri, which will take place on March 7, will yield a decision on or before March 26, says Goodbody Stockbrokers. The review will discuss the efficacy of Tysabri, its proposed risk management plan and possible return to market. Maintains add. Elan trades -7.8% at EUR10.87 in an overall weak market. (QAF)

Contact us in London.
[phone]
[e-mail]

[Poppholz]

Elan Faces Further Risk Of Negative Sentiment

Monday, January 23, 2006 7:27:44 AM ET
Dow Jones Newswires

1103 GMT [Dow Jones] Risk of negative commentary ahead of the FDA`s decision on Elan`s (ELN) MS drug Tysabri could generate negative sentiment and a weak share price performance, says NCB Stockbrokers` Orla Hartford. But she still sees the relaunch of Tysabri by end-March with a revised label post-FDA review. Maintains at buy. Elan -8.5% at EUR10.80 in weak overall market. (QAF)

Contact us in London.
[phone]
[e-mail]

[Poppholz]

AP
Elan, Biogen Anticipate Regulators` Verdict
Monday January 23, 8:34 am ET
By Shawn Pogatchnik, Associated Press Writer
Elan, Biogen Expect U.S. Regulators` Verdict on Key Suspended Drug Tysabri in March

DUBLIN, Ireland (AP) -- Drug makers Elan Corp. PLC and Biogen Idec Inc. said Monday they expect U.S. regulators to decide in March whether their suspended multiple-sclerosis treatment Tysabri can return to the American market.

The joint makers of the drug said the U.S. Food and Drug Administration had told both companies that an advisory committee would discuss whether to permit Tysabri to return to the U.S. market on March 7 and would make a decision "by late March."

Elan, based in Dublin, and Biogen of Cambridge, Mass., withdrew Tysabri from sale in February 2005 after confirming that two multiple sclerosis sufferers using it had contracted a rare brain disease, one fatally. The companies later confirmed that another person taking Tysabri for treatment of Crohn`s disease, an intestinal disorder, had died of the same disease called PML, or progressive multifocal leukoencephalopathy.

The FDA launched an accelerated review of Tysabri`s risks in November after the two companies screened about 3,500 people, mostly in the United States, who had taken Tysabri in clinical trials and detected no new cases of PML.

Analysts said they expected U.S. regulators to permit Tysabri`s sale but with a range of new restrictions and warnings.

Elan shares fell in a broadly weak Dublin market, down 9.3 percent by midday to 10.70 euros ($13.15) -- about half their value when Tysabri was withdrawn. Elan`s market value is tied closely to the fortunes of Tysabri, its most high-profile drug in development.

The FDA had approved Tysabri for sale in November 2004 to the approximately 350,000 Americans who suffer from MS, a debilitating and incurable disease that can cause sudden partial paralysis. The drug was administered every four weeks by intravenous infusion.

The two companies say no case of PML has been confirmed among any of approximately 5,000 people, chiefly in the United States, who took Tysabri during the drug`s three-month availability on the U.S. market.

Biogen Idec, http://www.biogen.com
Elan, http://www.elan.com

[Poppholz]

die Meldung des gestrigen Tages in deutscher Sprache:


Business Wire
Biogen Idec und Elan melden Benachrichtigung über Sitzung des FDA Advisory Committee zur Prüfung von TYSABRI® zur Behandlung von multipler Sklerose
Montag 23. Januar 2006, 23:46 Uhr

Aktienkurse
Biogen Idec Inc
BIIB
44.84
-0.20%


Elan Corp
DRX.IR
11.53
-2.29%


CAMBRIDGE, Mass. und DUBLIN, Irland 23. Januar 2006 Biogen Idec (NASDAQ: BIIB) und die Elan Corporation, plc. (NYSE:ELN) meldeten heute, dass sie von der US-amerikanischen Food and Drug Administration (FDA) benachrichtigt worden sind, dass der Beratungsausschuss für Medikamente zur Behandlung des peripheren und zentralen Nervensystems (Peripheral and Central Nervous System Drugs Advisory Committee) am 7. März 2006 zusammenkommt, um TYSABRI® (Natalizumab) zur Behandlung von multipler Sklerose (MS) zu prüfen.
Am 26. September 2005 hatten die Unternehmen gemeldet, dass sie für TYSABRI bei der FDA einen ergänzenden Zulassungsantrag (Biologics License Application, sBLA) beantragt haben. Die FDA erhöhte später den Prioritätsstatus der Prüfung von TYSABRI. Bei der FDA wird der Status einer vorrangigen Bearbeitung und Prüfung ("Priority Review") Produkten gewährt, von denen angenommen wird, dass sie möglicherweise signifikante therapeutische Vorteile gegenüber bestehenden Therapien haben, die einen unerfüllten medizinischen Bedarf ansprechen. Ausgehend von der vorrangigen Einstufung des Antrags zur Zulassung von TYSABRI bei MS von Seiten der FDA rechnen die Unternehmen in etwa 6 Monaten ab dem Einreichungsdatum bzw. bis Ende März 2006 mit einer entsprechenden Antwort der Behörde.

Der sBLA-Antrag enthält Zwei-Jahres-Daten aus der Monotherapiestudie der Phase III, AFFIRM, sowie aus der Ergänzungsstudie SENTINEL mit AVONEX® (Interferon Beta-1a) bei MS, einen überarbeiteten Kennzeichnungs- und Risikomanagementplan und eine integrierte Beurteilung der Sicherheit von Patienten, die an klinischen Studien mit TYSABRI teilnehmen. Biogen Idec und Elan schlossen kürzlich eine umfassende Unbedenklichkeits- und Sicherheitsprüfung von über 3.000 mit TYSABRI behandelten Patienten in Zusammenarbeit mit führenden Experten für multifokale Leukoenzephalopathie (PML) und MS ab. Die Ergebnisse der Sicherheitsprüfung ergaben keine neuen bestätigten Fälle von PML außer den drei bereits gemeldeten.

Über Biogen Idec

Biogen Idec setzt neue Versorgungsstandards in der Onkologie und Immunologie. Als international führendes Unternehmen in der Entwicklung, Herstellung und Kommerzialisierung neuartiger Therapien setzt Biogen Idec wissenschaftliche Entdeckungen zu Fortschritten in der Gesundheitsversorgung des Menschen um. Pressemitteilungen, Fachinformationen zu Produkten und sonstige Informationen über das Unternehmen gibt es im Internet unter http://www.biogenidec.com.

Über Elan

Die Elan Corporation, plc, ist ein Biotechnologieunternehmen, das sich auf Neuroforschung spezialisiert hat. Das Unternehmen möchte die Lebensqualität von Patienten und ihren Familien verbessern, indem es innovative Forschung durchführt und damit bislang ungedeckten medizinischen Bedarf weltweit erfüllt. Die Aktien von Elan werden an den Börsen New York, London und Dublin gehandelt. Mehr Informationen über das Unternehmen gibt es im Internet unter http://www.elan.com.

Safe Harbour Erklärung / Zukunftsweisende Aussagen

Diese Pressemeldung enthält zukunftsweisende Aussagen über die mögliche und zulassungsorientierte Weiterentwicklung von TYSABRI. Das kommerzielle Potenzial und die zukünftige Zulassung von TYSABRI unterliegen einer Reihe von Risiken und Unwägbarkeiten. Faktoren, die dazu führen können, dass die tatsächlichen Ergebnisse wesentlich von den von Seiten der Unternehmen erwarteten abweichen, beinhalten das Risiko, dass sich aus den weiteren Daten oder Analysen Bedenken ergeben oder dass die Unternehmen anderen unerwarteten Verzögerungen oder Hürden begegnen. Es gibt ferner keine Gewährleistung, dass die Unternehmen die Vermarktung und den Verkauf von TYSABRI wieder aufnehmen können. Wirkstoffentwicklung und Kommerzialisierung sind mit hohen Risiken verbunden. Ausführlichere Informationen über die Risiken und Unwägbarkeiten in Verbindung mit der Arzneistoffentwicklung und anderen Aktivitäten der Unternehmen sind in den von Biogen Idec und der Elan regelmäßig bei der Börsenaufsichtsbehörde eingereichten Unterlagen enthalten. Die Unternehmen übernehmen keine Verpflichtung zur Aktualisierung zukunftsweisender Aussagen sei es als Ergebnis neuer Informationen, zukünftiger Ereignisse oder aus anderen Gründen.

Kontakt

ANSPRECHPARTNER FÜR MEDIEN
Biogen Idec
Amy Brockelman, [phone]
oder
Elan
Davia B. Temin, [phone]
oder
Elizabeth Headon, [phone]
oder
ANSPRECHPARTNER FÜR INVESTOREN
Biogen Idec
Oscar Velastegui, [phone]
oder
Elan
Emer Reynolds, [phone]
oder
Chris Burns, 800-252-3526

[Cyberhexe]

FDA Will Weigh
Return to Market
Of Drug for MS

By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
January 24, 2006; Page D6


http://online.wsj.com/article_email/SB113806193294154148-lMy…

[Cyberhexe]

Serono findet möglicherweise keinen Käufer - WSJ

http://www.faz.net/d/invest/meldung.aspx?id=18455119&news=un…


...nun das wundert mich nicht, da sich deren Blockbuster "Rebif" zur Behandlung von MS demnächst mit übermächtiger Konkurrenz auseinanderzusetzen hat.

[[KERN]Codex]

[bernie55]

@CYBERHEXE
Hat diese Info grundsätzlich eine Bedeutung für ELAN ???

Grüße bernie55


Roche plant Studie mit Alzheimer-Antikörper von Morphosys

MARTINSRIED (dpa-AFX) - Der Schweizer Pharmakonzern Roche plant eine Studie mit Alzheimer-Antikörpern von Morphosys . Dies teilte die Biotechfirma am Mittwoch in Martinsried mit. Finanzielle Einzelheiten wurden nicht genannt.

Roche habe alle notwendigen Anträge für den Start einer europäischen Phase-1-Studie mit einem HuCAL-basierten Antikörper zur Behandlung von Alzheimer eingereicht, teilte Morphosys weiter mit.

Der HuCAL-Antikörper soll anormale, für Alzheimer-Patienten typische Ansammlungen des Proteins Amyloid-beta im Gehirngewebe (so genannte Plaques) angreifen und diese auflösen helfen.
Durch den Antrag erhält MorphoSys eine Meilensteinzahlung von Roche.

MorphoSys beschäftigt sich mit der Entwicklung und Anwendung von Technologien zur Herstellung synthetischer Antikörper, die die Entdeckung neuer Medikamente beziehungsweise krankheitsassoziierter Zielmoleküle beschleunigen. Das Unternehmen verfügt über eine Reihe innovativer Technologien, allen voran HuCAL, die Humane Kombinatorische Antikörper-Bibliothek, die weltweit von Wissenschaftlern zur Herstellung von menschlichen Antikörpern genutzt wird./ne/she
Quelle: dpa-AFX

[Poppholz]

Bosten Globe:

Withdrawn Biogen drug to get FDA review soon
By Bloomberg News
January 24, 2006

Elan Corp., Ireland`s biggest drugmaker, and Biogen Idec Inc. said a US Food and Drug Administration advisory committee will review their multiple sclerosis treatment Tysabri on March 7.

The drug, which was withdrawn after two patients died of a rare nerve disease, will get a priority review, the companies said yesterday. Dublin-based Elan applied to the FDA in September to resume sales after studies found no new cases of the nerve disease.

Biogen chief executive James Mullen two weeks ago said the Cambridge-based company expects to reintroduce the product in the United States by midyear. Tysabri may generate annual sales of $1 billion by 2010, said JP Morgan analyst Ronald Renaud. Before the safety concerns, analysts had said the drug might bring in as much as $3 billion.

Elan shares fell 27 cents, or 2.3 percent, to 11.53 euros at the close of trading in Dublin. The stock has gained 24 percent since the FDA said Nov. 18 it would grant the drug priority review.

FDA advisers will focus in their meeting on whether neurologists can adequately monitor the nerve disease called progressive multifocal leukoencephalopathy, or PML, that led to Tysabri`s removal from the market, Mullen has said.

US regulators approved Tysabri in November 2004 under a fast-track program to speed promising medicines to patients with serious diseases. Tysabri was pulled from the market in just three months after reports of two cases of PML. A third case was later identified. Two patients died from the disorder.

© Copyright 2006 Globe Newspaper Company.

[Cyberhexe]

@bernie

fast alle Pharmariesen sind in der Alzheimer-Forschung tätig - selbstverständlich auch Roche-, da für diese degenerative Erkrankung des ZNS bisher keine wirkungsvollen Therapiemöglichkeiten zur Verfügung stehen. Und bei der zukünftigen demographischen Entwicklung muss man kein Prophet sein um vorherzusagen, dass die Zahl der Neuerkrankungen sehr wahrscheinlich dramatisch zunehmen wird.
Elan beschäftigt diesbezüglich eine Reihe von hochkarätigen Wissenschaftler - mich würde nicht wundern wenn Dale Schenk irgendwann einmal für seine wahrschheinlich bahnbrechenden Ergebnisse mit dem Nobel-Preis gewürdigt wird - und ist zusammen mit Kooperationspartner Wyeth mit 2 Wirkstoffen in der Klinik (ACC-001 in Ph.I und AAB-001 in Ph.II), deren Wirkungsmechanismus bereits in einer Vorgängerstudie (AN-1792) nachgewiesen wurde - diese Studie wurde allerdings wegen aufgetretenen Hirnhautentzündungen bei 6% der Studienteilnehmer in Phase II abgebrochen. Im nachhinein wurde jedoch festgestellt, dass die Plaquebildung im Gehirn als sichtbares Symptom des Fortschreitens der Alzheimer-Erkrankung sichtbar eingeschränkt ist - massiv sogar.
Wenn auch die Details nicht immer sehr leicht verständlich sind, so kann man doch feststellen, dass die Arbeitsgruppe um Dale Schenk der Konkurrenz nich nur eine Kurve voraus ist...das ist bereits eine ganze Runde. Und falls AAB-001 wirklich eine Chance darauf hat in 2009 zugelassen zu werden, dann ...ja dann...
Also bei Roche würde ich mich jetzt festlegen, dass die vor 2012 keine Chance haben eine wirkungsvolle Aktivsubstanz gegen Alzheimer am Markt zu platzieren.

[Poppholz]

Elan und Biogen erwarten Zulassungsentscheidung der FDA für Tysabri im März
25.01.2006 - (dpa-AFX) Das irische Biotechunternehmen Elan und der US-Konzern Biogen erwarten noch im März eine Entscheidung der US-Gesundheitsbehörde FDA zum gemeinsam entwickelten Nervenmittel Tysabri. Ein Prüfungsausschuss werde am 7. März über die erneute Marktzulassung beraten, teilten beide Unternehmen mit. In der Regel folgt die FDA den Empfehlungen der Ausschüsse.

Biogen hatte bereits vor einigen Wochen auf einer Health-Care-Konferenz Zuversicht für eine baldige Einführung von Tysabri geäußert. Das Mittel war Ende 2004 als neuartiges Medikament bei Multipler Sklerose (Muskelschwund) auf den Markt gebracht und bereits nach wenigen Monaten wieder zurückgezogen worden. Drei Todesfälle wurden mit der Einnahme von Tysabri in Verbindung gebracht. Elan und Biogen gehen nun davon aus, dass bei einer erneuten Zulassung das Medikament mit einem Warnhinweis ausgestattet wird.

http://www.bionity.com/news/d/51820/?pw=a&defop=and&wild=yes…

[bernie55]

[posting]19.868.743 von Cyberhexe am 25.01.06 11:39:18[/posting]...besten Dank für die Information...

Grüße bernie55

[2CB_06]

Hier ein interessanter Einblick zum Zulassungprozess in Europa (Stand 2003)
Das heißt doch, daß mit der EMEA Zulassung noch lange nicht die Zulassung in den einzelnen Ländern erfolgen kann, oder????
....
C o m p l e x R e g i s t r a t i o n P r o c e s s

Total harmonisation of pharmaceutical products in Europe has never quite been reached,
instead remaining in a midway position in which centralised and national authorisation
procedures co-exist. Because of this complex registration process, approval of a drug can be a
relatively long and drawn out process. When the benefits of being first to market are being
considered, it is important for a product to gain rapid market authorisation and establish the
product on the market prior to the arrival of direct competition.
In an attempt to make the European market a more attractive one and decrease the approval
time, the European Commission issued proposals to streamline the regulatory process and
introduce a US style `fast track` procedure for breakthrough medicines. Currently, the
average time taken for a drug to be approved in Europe is eighteen months, approximately
four months longer than in the US. Even after approval, companies still face significant
barriers, the main one being price control. Price and reimbursement is set on a national
rather than European level and this can further slow the time it takes a drug to reach the
market. On the most part, companies favour the US as the lead market for new product
introductions, with European launch occurring approximately twelve months later.
Even if a drug meets the primary endpoint and is filed for approval, there is no guarantee
that it will be reach the market. Regulatory hurdles may arise. This has aready been observed
in the case of two Mabs, Xolair and Raptiva. The former drug was filed for regulatory
approval in 2000, with an estimated launch date of early 2002. However, further clinical trial
data was requested by the regulatory authorities, thus drug approval has been severly
delayed. It is only now (January 2003) that Xolair is once again being considerd for approval
but this is currently only in the US, with European filing not expected until early 2004.
A similar delay in approval occurred with Raptiva. After submission of a BLA in 2001, the
FDA insisted that a third phase III trial was conducted due to pharmacokinetic study results
revealling that Genentech produced Raptiva contained slightly higher serum concentration
than that produced by Xoma. The newly submitted BLA containing the required additional
information is now being considered by the FDA.
Successful approval and launch of a product onto the European market can be difficult and
time consuming process, thus simplification and harmonisation would be welcomed.

... (Quelle: Marktanalyse zu Mab, Frost & Sullivan Ltd, 2003)

[2CB_06]

Für Crohn`s gibt zurückhaltende Meinungen über das Potential von Antegren (Tysabri)
Stand ist jedoch 2003. Gibt es neuere Erkenntnisse zur Wirksamkeit von Ty gegenüber den Konkurrenzprodukten bezüglich Crohn`s?

(Stand 2003 für alle Zitate!!!)
...Frost & Sullivan do not predict that success will be instantaneous. Significant barriers for
uptake already exist. The drug faces intense competition from other novel products in both
indications. When analysing the Crohn`s disease market, Mabs and other biologics will
already be well established, thus penetration of Antegren may be hindered. However, Antegren
may have the advantage by mediating its action in a different way to the competition. It
is a selective adhesion molecule inhibitor, whereas the majority of the others act as TNF
antagonists. Recently there has been concern of serious adverse events associated with these
drugs. This could work in Antegrens favour bolstering uptake.
.....

Konkurrenzprodukte sind neben Remicade noch weitere anti-TNF Mab`s


Celltech/Pharmacia: CDP 870
CAT/Abbott: Humara
Celltech/Biogen: Humicade


Celltech/Pharmacia: CDP 870
CDP 870 is a third generation, humanised antibody fragment, which binds with high affinity
to TNF-alpha. The compound is manufactured using Celltech`s proprietary bacterial fermentation
technology and is chemically modified, that is PEGylated, to provide long lasting half
life in patients. In March 2001, Celltech established a development and marketing agreement
with Pharmacia, in which Pharmacia hold the marketing rights for the drug in the rheumationd
arthritis indication, and Celltech retain the rights to the drug for Crohn`s disease...
...The drug is also in clinical development for Crohn`s disease. Outline results form Phase II
study were released in March 2002, with promising safety and efficacy data being seen.
Currently plans for phase III trials are being finalised, with trial commencement expected
sometime in 2003. It is estimated that the drug will reach the European market in late 2005
for RA, with the indication from Crohn`s the following year.

CAT/Abbott: Humara
Humara (adalimumab) developed by Cambridge Antibody Technology in collaboration with
Abbott, was the first fully human anti-TNF monoclonal antibody to enter Phase III trials for
treatment of rheumatoid arthritis. In RA, TNF accumulates in the joints and initiates an
inflammatory response which causes swelling, pain and joint damage. Studies show that
Humara selectively binds TNF in patients with rheumatoid arthritis and therefore switches
off this critical signal in the body`s inflammation process....
...The drug is also in phase II/III trials for Crohns and phase III
for juvenile rheumatoid arthritis.


Celltech/Biogen: Humicade
Humicade is a huminised IgG4 antibody which blocks the activity of tumour necrosis factor
alpha, a key mediator in the inflammatory response.
The drug was showing promise as a therapy for Crohn`s, however hopes were dashed in
August 2002, when Celltech announced results from two phase III trials conducted in
patients with moderate to severe Crohn`s disease. What the trial revealed was that although
Humicade proved to be an active drug and capable of producing positive response to a
certain degree, statistical significance was not shown and primary endpoints were not
achieved. The drug was however said to have an excellent safety profile.
Biogen are said to be currently analysing the data and will make a decision on whether to
continue the partnership with Celltech. It is widely expected that further studies would be
required with Humicade before consideration for approval and Celltech have know pinned
greater hopes on their other drug candidate, CDP 870 currently showing greater promise in
this area. Discussions regarding the initiation of phase III trials are underway.

.... und hier nochmal eine kruze Zusammenfassung zu Ty

Elan/Biogen: Antegren
Antegren (natalizumab), a humanised monoclonal antibody was discovered by Elan and is
the first in a new class of potential therapeutics known as alpha 4 integrin inhibitors.
Alpha 4 integrin inhibitors are designed to block immune cell adhesion to blood vessel walls
and subsequent migration of lymphocytes into tissue. Antegren binds to cell surface receptors
known as alpha-4-beta-1 (VLA-4) and alpha-4-beta-7. Presently, Antegren is being investigated
for use in the treatment of multiple sclerosis and Crohn`s disease, however it may have
wider indications in other inflammatory conditions. In August 2000, Biogen and Elan
announced a worldwide collaboration to develop, manufacture and commercialise the drug.
Biogen will be responsible for manufacture and are likely to be the key marketer of the drug,
certainly within the US.
The drug is now in Phase III trials for both indications after promising data from phase II
studies was obtained. In the case of Crohn`s disease, the first of two planned trials are fully
enrolled, comprising of 850 patients. ENACT-1 (Evaluation of Natalizumab in Actice
Crohn`s Disease Trial-1) will evaluate clinical response and ability to induce remission. The
second trial ENACT-2 (Evaluation of Natalizumab As Continuous Therapy-2) is designed to
evaluate duration of effect. It is expected that enrolment of the latter trial will be fully
enrolled in early 2003. Two MS trials are also being conducted, evaluating the drug in
patients with relapsing-remitting MS. AFFIRM will evaluate the ability of Antegren to slow
the rate of disability in MS and reduce the rate of clinical relapse. The second study,
SENTINEL (safety and efficacy of natalizumab in combination with Avonex) will evaluate
whether combination of the two drugs is more effective than Avonex alone, in slowing the
rate of disability and reducing rate of clinical relapses.

[Cyberhexe]

[posting]19.881.126 von 2CB_06 am 25.01.06 22:12:38[/posting]Die fehlende statistische Signifikanz bei den ersten Phase-III-Studien zu MorbusCrohn, den sogen. ENACT-Studien, wurde durch eine hohe, unübliche "Placebo-Wirksamkeit" verursacht. ENCORE und auch die weiteren Auswertungen zu ENACT haben jedoch nun die Wirksamkeit unter Beweis gestellt und dies bei geringeren Nebenwirkungen als beim derzeitigen Goldstandard (Remicade von J&J). Da Crohn-Patienten jedoch traditionell mit Cortison behandelt werden, also immunsupprimierenden Wirkstoffen, scheint die PML-Gefahr in Verbindung mit Natalizumab erhöht zu sein - man bedenke, dass nicht unbedingt eine parallele Einnahme erforderlich ist, da beispielsweise Azathioprin die Immunabwehr auch noch 2 Jahre nach Einnahme herabsetzt. Deswegen erwarte ich bei Crohn, dass lediglich neuerkrankte Patienten, die zuvor keine immunsupprimierenden Wirkstoffe eingenommen haben, mit Tysabri behandelt werden.


http://www.elan.com/news/full.asp?ID=725210

http://www.elan.com/News/2004/20040929.asp

http://www.fda.gov/cder/foi/label/2004/125104lbl.pdf

http://content.nejm.org/cgi/content/abstract/353/18/1912?hit…

[Cyberhexe]

http://www.tixx.com/ElanQ405NCB.pdf

[Poppholz]

[posting]19.929.232 von Cyberhexe am 28.01.06 20:12:58[/posting]dann gehen die Jungs von NCB auch in Q4 von einem negativen Ergebnis bei ELAN aus?

Bisher steht ja noch die Hoffnung, dass ELAN in Q4 die Gewinnschwelle erreicht hat.

Bin auf morgen gespannt, wenn die Zahlen von ELAN kommen.

[Cyberhexe]

@poppi

...du solltest da nichts verwechseln. Nicht die Gewinnschwelle steht zur Diskussion sondern ein positives EBITDA, also Earnings Before Interests Taxes Depreciation and Amortisation.
Aber ein +EBITDA wär natürlich auch schon ein Fingerzeig in die gewünschte Richtung und der Beweis, dass Elan die Kosten im Griff hat.

[Poppholz]

Die Zahlen von ELAN für das 4. Quartal und 2005 Gesamt:


http://www.elan.com/news/full.asp?ID=810372

[Poppholz]

Drug Maker Elan Reports Heavy 2005 Losses Tuesday January 31, 3:21 am ET
By Shawn Pogatchnik, Associated Press Writer

Drug Maker Elan Reports Heavy 2005 Losses, Pins Hopes on Tysabri Rebound


DUBLIN, Ireland (AP) -- Elan Corp. PLC, which is anxiously awaiting a verdict on a key suspended drug, reported heavy net losses Tuesday but expressed hopes of a rebound this year.

Ireland`s leading drug maker reported fourth-quarter losses, covering the October-December period, of US$58.3 million (euro48.2 million), substantially lower than the US$107.1 million net loss for the same quarter in 2004. Revenues rose to US$140.4 million (euro116 million) from US$123.8 million a year earlier.

For the full year, Elan said its net loss was US$383.6 million (euro317 million), marginally lower than 2004`s loss of US$394.7 million. Revenues grew to US$490.3 million (euro405.2 million) from US481.7 million in 2004.

Analysts say Elan`s fortunes heavily depend on whether the U.S. Food and Drug Administration permits the company`s key drug in development, Tysabri, to return to the American market. Elan`s top brass are publicly optimistic that will happen.

"We should know by the end of March how to relaunch the drug in the U.S. market," said Kelly Martin, Elan`s president and chief executive officer. He forecast that European regulators also would permit Tysabri`s sale in mid-2006.

Elan and its U.S. development partner, Biogen Idec Inc. of Cambridge, Massachusetts, withdrew Tysabri from sale in February 2005 over fears that the multiple sclerosis-fighting drug could be linked to a rare, usually fatal brain disease called PML.

At the time, Elan and Biogen Idec said two MS sufferers had contracted PML, one fatally, while a third Tysabri user who took the drug to treat Crohn`s disease, an intestinal disorder, also had died of PML. But both companies said a subsequent survey of approximately 3,500 clinical-trial users of Tysabri had failed to detect any new PML cases, opening the way for a fast-tracked FDA review.

"We are well positioned to re-market Tysabri, and the progress we have made in improving our operating leverage will accelerate our return to profitability," said Shane Cooke, Elan`s executive vice president and chief financial officer.

Kelly Martin, Elan`s president and chief executive officer, said the company was committed "to delivering tangible results through a relentless focus on the execution of our plans."

"For 2006, we will continue to focus on making measurable progress in our science, technology and commercial activities. Such focus, discipline and alignment will enable us to deliver benefits to patients, shareholders and our employees."

Elan`s shares -- which plummeted after Tysabri`s withdrawal -- have gained in recent months in expectation of an eventual return for Tysabri with new FDA-imposed warnings and restrictions.

"There will be some restrictions for the drug," Martin said, "but it`s very premature to say what those restrictions might be."

He said Tysabri represented "an important part of the short-term success of Elan," while Elan`s ongoing effort to develop a treatment for Alzheimer`s disease constituted the most important of several "long-term, big-growth business opportunities."

http://www.elan.com

[Poppholz]

NEWS SNAP:
Elan 4Q Net Loss Narrows, Hopeful On Tysabri


01-31-06 03:10 AM EST
DUBLIN -(Dow Jones)- Elan Corp. PLC (ELN) Tuesday reported a narrower fourth quarter net loss as it cut costs and improved revenues, but the key issue for the company remains the ongoing U.S. regulator`s review of its multiple sclerosis drug Tysabri.

Elan`s net loss narrowed 45.5% to $58.3 million from $107.1 million a year ago, while its basic and diluted loss per share narrowed to $0.14 from $0.27 a year ago.

Goodbody Stockbrokers Ian Hunter, who has a buy on Elan, said, "As with previous quarters, the ongoing business numbers are not the market`s prime focus."

He said everyone`s waiting to hear the outcome of the U.S. Food & Drug Administration`s advisory panel meeting on March 7, on Tysabri, which before its suspension last year was hoped would generate over $1 billion in annual sales.

Elan and joint partner Biogen Idec PLC (BIIB) suspended Tysabri in the U.S. on Feb. 28 after two patients using combination therapy contracted the rare neurological disease PML. A third case was confirmed later.

However, some analysts say Tysabri will need to create around $550 million each year in sales to offset Elan`s current spending, adding that the FDA will introduce some kind of restrictive labeling.

Chief Financial Officer Shane Cooke said, "We are well positioned to re-market Tysabri and the progress we have made in improving our operating leverage will accelerate our return to profitability."

The company said it remains "optimistic" about Tysabri`s return and plans to spend $150 million to $170 million on research & development, as well as selling and administrative expenses related to Tysabri in 2006.

These figures are based on the potential re-marketing of Tysabri in the U.S. in the second quarter of 2006 and its potential launch in Europe in the second half of 2006, Elan said.

In relation to the remaining business, excluding Tysabri, Elan expects total revenues in 2006 to exceed $500 million, with product revenue expected to account for in excess of 90% of the total.

Elan continues to focus on reducing costs, paying off debt and simplifying its business model and balance sheet, while focusing on its key drugs Tysabri and pain reliever Prialt, and its Alzheimer`s program.

Cash and cash equivalents stood at $1.081 billion at the end of the quarter, the company said.

At Monday`s close, Elan was up 5 cents at EUR11.90 on the Irish Stock Exchange in a tepid ISEQ Overall Index, after falling from around EUR20.30 when Tysabri was suspended in February.

"The fourth quarter numbers are significantly ahead of our forecasts, but there`s no pipeline news that we didn`t already know," said NCB Stockbrokers` Orla Hartford. She maintains a buy stance on the stock.

Hartford cautioned that the share price performance over the coming weeks is likely to be strongly influenced by the FDA decision on March 7 - although she expects the regulator to recommend a relaunch.

Elan`s Tysabri setback - on which it completed a safety review of 3,000 patients late last year - followed a long and arduous recovery for the company, beginning with a change of senior management in 2002, when Elan`s late former CEO and Chairman Donal Geaney resigned amid accounting troubles and falling share price.

Company website: http://www.elan.com

-By Quentin Fottrell, Dow Jones Newswires; [phone]; quentin.fottrell@ dowjones.com

(END) Dow Jones Newswires
01-31-06 0310ET
Copyright (c) 2006 Dow Jones & Company, Inc.

[Poppholz]

(AFX UK Focus) 2006-01-31 08:21 GMT:

Elan `optimistic` on Tysabri return, to spend 150-170 mln usd on relaunch

Article layout: raw
LONDON (AFX) - Ireland`s biggest drugmaker Elan Corporation PLC said it plans to spend 150-170 mln usd on the development and marketing of its multiple sclerosis drug Tysabri in 2006, which it expects to be able to relaunch later this year.

The product was withdrawn in February after being linked to a rare brain disease, from which two people died. Medicine regulators are due to decide whether to re-grant marketing approval in the next couple of months.

Elan said today it is "optimistic" about its return, and is working on a US launch in the second quarter of the year, and the second half for Europe.

While it is not yet forecasting potential Tysabri sales, other revenues this year are seen exceeding 500 mln usd, with income from its own drugs accounting for more than 90 pct of that.

Losses before interest, tax, depreciation and amortisation, excluding revenues related to Tysabri, are expected to fall between 150-175 mln usd in 2006, the company predicted.

For 2005, the drug maker reported an EBITDA loss of 176.9 mln usd, compared to 223.1 last time.

Revenues edged almost 2 pct higher to 490.3 mln usd, boosted by a 13 pct rise in product revenues, to 404.4 mln.

Loss per share narrowed to 0.93 usd from a loss of 1.01 usd last time.

Finance chief Shane Cooke said: "We are well positioned to re-market Tysabri and the progress we have made in improving our operating leverage will accelerate our return to profitability."

Elan shares closed at 11.82 eur yesterday. [e-mail] ab/bam

COPYRIGHT

Copyright AFX News Limited 2005. All rights reserved. The copying, republication or redistribution of AFX News Content,inculding by framing or similar means, is expressly prohibited without the prior written consent of AFX News.

AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited

[Poppholz]

Elan Stock Seen Influenced By Chat On FDA
Tuesday, January 31, 2006 4:23:28 AM ET
Dow Jones Newswires


0810 GMT [Dow Jones] Elan (ELN) shares expected to be "strongly influenced" by commentary surrounding the FDA`s meeting to review MS drug Tysabri on March 7, says NCB Stockbrokers` Orla Hartford. However, she sees the FDA recommending a relaunch. Maintains buy rating. Shares +0.8% at EUR11.99. (QAF)


Contact us in London
[phone]
[e-mail] .

[Poppholz]

31.01.2006 12:11
Elan reduziert Quartalsverlust

Der irische Pharmakonzern Elan Corp. plc (ISIN IE0003072950 (Nachrichten)/ WKN 903801) konnte seinen Verlust im Schlussquartal 2005 dank kräftig steigender Umsätze zurückfahren und gibt sich nun optimistisch, bald wieder profitabel zu sein.

Wie das Unternehmen am Dienstag verkündete, wuchsen die Umsatzerlöse auf 140,4 Mio. Dollar, nach 123,8 Mio. Dollar im Vorjahresquartal. Analysten hatten nur 127,0 Mio. Euro erwartet.

Gleichzeitig verringerte sich der Nettoverlust von 27 Cents je Aktie im vierten Quartal 2004 auf nun 14 Cents pro Aktie. Analysten hatten mit einem EPS von 19 Cents gerechnet.

Im Gesamtjahr erhöhten sich die Umsätze auf 490,3 Mio. Dollar, nachdem in 2004 481,7 Mio. Dollar verbucht werden konnten. Der Verlust ging von 1,01 Dollar auf 93 Cents zurück und lag damit unter der Analystenprognose von 99 Cents.

In London stiegen die Aktien bisher um 2,79 Prozent und stehen derzeit bei 12,15 Euro.

[Poppholz]

Goodbody To Up Elan Topline Forecasts

Tuesday, January 31, 2006 6:13:15 AM ET
Dow Jones Newswires


0958 GMT [Dow Jones] Goodbody Stockbrokers will up some of Elan`s (ELN) topline forecasts after 4Q results. Elan is guiding 06 revenue excluding MS drug Tysabri of $500M versus Goodbody`s previous forecast of $489.1M. "Guided costs, inclusive of Tysabri at $575M-$625M, are, however, ahead of our current projections of $483.9M," it adds. Maintains buy. Shares +1.6% at EUR12.09. (QAF)


Contact us in London
[phone]
[e-mail] .


Copyright (c) 2006 Dow Jones & Company, Inc.

[Poppholz]

31.01.2006 18:35 Elan Corp.: Verlust fast halbiert

Der Pharmakonzern Elan (Nachrichten) hat seinen Nettoverlust im abgelaufenen Quartal deutlich auf 58 Millionen Dollar oder 14 Cents je Aktie verringern können. Im Vorjahr hatte dieser bei 107 Millionen Dollar gelegen. Die Umsätze kletterten im gleichen Zeitraum um 13 Prozent auf 140,4 Millionen Dollar. Die Analystenerwartungen hatten laut Reuters Estimates bei einem Verlust von 18,5 Cents je Aktie und 127 Millionen Dollar Umsatz gelegen.

Das Unternehmen teilte zudem mit, weiterhin voll auf die Rückkehr seines Präparats „Tysabri“ zu setzen. Das Medikament gegen Multiple Sklerose war im vergangenen Markt wegen einiger Todesfälle vom Markt genommen worden; die Wiederzulassung unter verschärften Sicherheitsvorkehrungen wird derzeit aber von der FDA überprüft. Wie Elan erklärten, würden 2006 für die Wiedereinführung von Tysabri 150 bis 170 Millionen Dollar investiert. Diese Kosten würden sich bereits bezahlt machen, wenn etwa 20.000 Patienten das Präparat einnehmen würden. Elan wird Tysabri wieder zusammen mit Biogen Idec vertreiben.

An der Nasdaq legen Elan aktuell um 4,3 Prozent auf 15,28 Dollar zu.

(Quelle: Börse Go)

[Poppholz]

CATEGORY: SMALL CAPS NEWS
Elan narrows losses, looking to re-market Tysabri
Tue 31 Jan 2006

LONDON (SHARECAST) - Pharmaceutical group Elan halved its fourth quarter losses and said it was confident that suspended multiple sclerosis drug Tysabri would return to the market.

Losses for the fourth quarter fell to $59.8m from $103.6m in the same period last year, while losses for the year to 31 December 2005 narrowed to $385m compared with $414m last year.

Turnover in the fourth quarter was 13% higher at $140m and for the year as a whole it rose to $490m from $481m previously.

The group cut costs by withdrawing Tysabri in February after the death of a patient. It is looking to bring back the drug pending decisions from US regulators by the end of March and the EU in the middle of this year.

“We are well positioned to re-market Tysabri and the progress we have made in improving our operating leverage will accelerate our return to profitability,” said Elan chief financial officer Shane Cooke.

http://www.sharecast.com/cgi-bin/sharecast/story.cgi?story_i…

[Poppholz]

Elan`s Risks Are On Upside For Tysabri-Davy

Wednesday, February 01, 2006 10:44:26 AM ET
Dow Jones Newswires

1403 GMT [Dow Jones] The risk/benefit balance favors a return for Elan`s (ELN) MS drug Tysabri, "albeit with some label restrictions," says Davy Stockbrokers: "Our revenue-based sum-of-the-parts model, incorporating peak revenues for Tysabri of $1.6B and 30% approval probability on the Alzheimer`s Disease franchise, yields a price target of around $18." Davy has no rating on Elan shares. They trade +2.8% at EUR12.90. (QAF)

[Poppholz]

Market Scan
Elan Shares Discounting $1.2B Tysabri Sales Peter Kang, 02.01.06, 1:44 PM ET

Morgan Stanley maintained an "underweight" rating on Elan after the Irish specialty pharmaceutical company reported fourth-quarter results above Wall Street forecasts.

Elan (nyse: ELN - news - people ) reported quarterly revenue of $140.4 million and a loss of 14 cents per share, compared with analysts` consensus estimates of revenue $129 million and a loss of 19 cents per share. Elan attributed the earnings beat to better-than-expects sales of Maxipime and Azactam, along with lower research costs.

"It has been a difficult 2005, but we think management has done a great job running the business through this transition period," wrote analyst Marc Goodman. "The quarter was fine, but all eyes are clearly focused on the Tysabri FDA Advisory Panel on Mar. 7."

The analyst said the consensus sentiment is that Tysrabi, a multiple sclerosis treatment pulled from the market last year on safety concerns, will be re-launched in both the U.S. and Europe some time this year.

"Given the stock’s current valuation, we think not only the approval is an after-thought but also a certain level of sales," Goodman said.

The Morgan Stanley analyst said the stock is discounting $1.22 billion in sales for the product, assuming a price-to-sales multiple of 10 times and a $3 per-share valuation of Elan`s base business. Elan splits Tysabri profits with marketing partner Biogen Idec (nasdaq: BIIB - news - people ).

And while $1.22 billion in annual sales is achievable, Goodman noted, it "certainly should not be an after-thought."

Goodman noted investors should watch for the re-launch of Tysabri in the U.S. in the second quarter and in Europe in the second half of 2006.

[Poppholz]

Thursday tips round-up: Chemring, Wolfson, Elan
Thu 02 Feb 2006

LONDON (SHARECAST) - Defence firm Chemring`s shares have doubled in the last six months, on the back of the soaring US military budget. Chemring`s helicopter decoy flares have been in high demand of late, which explains yesterday`s annual figures of a 27pc rise in earnings, and a 66pc boost in orders.

The Independent notes that the news hasn`t been all good – Chemring`s marine electronics business lost £2.5m last year, but the division is earmarked for disposal, and the Independent sees continued gains for the stock in 2006.

The Times writes that the shares are no longer cheap, with a negligible 1pc yield, which may tempt investors to take profits. Nonetheless, The Times also feels that there could be more gains for patient investors.

Wolfson Microelectronics has been particularly grateful for the success of the iPod, which contains Wolfson`s chips, and has been at least partly responsible for the firm`s 156pc rise in full year profits.

Shares have soared accordingly, but are trading at a forward price-earnings multiple which compares favourably with it`s peers. The Independent says hold for further gains, but the Times worries that Wolfson is too dependent on Apple`s business, and says sell.

It`s been a rollercoaster ride for Elan`s investors, who`ve seen the stock crash and recover more than once. The most recent nosedive was brought on by regulatory problems with Tysabri, the company`s MS drug, but Tysabri may be back on the shelves soon, pending a review of new data by US regulators on March 7th. The Times says buy.

Please note: Digital Look provides a round-up of news, tips and information that is impacting share prices and the market. Digital Look cannot take any responsibility for information provided by third parties. This is for your general information only as not intended to be relied upon by users in making an investment decision or any other decision. Please obtain a copy of the relevant publication and carry out your own research before considering acting on any of this information.

[Poppholz]

Business Wire
Elan meldet Finanzergebnisse des vierten Quartals und des Gesamtjahres 2005
Montag 6. Februar 2006, 13:26 Uhr

DUBLIN, Irland 6. Februar 2006 Die Elan Corporation, plc gab heute ihre Finanzergebnisse des vierten Quartals und des Gesamtjahres 2005 bekannt sowie einen Ausblick auf die Finanzentwicklung 2006.
In einem Kommentar über die Geschäftstätigkeiten von Elan sagte Kelly Martin, Präsident und Unternehmenschef von Elan: 2005 war für uns ein Jahr, das unerwartete Herausforderungen aber auch geschäftliche Chancen und wissenschaftliche Fortschritte barg. Vernünftige betriebliche und finanzielle Vorgehensweisen in Kombination mit selektiven Investitionen in unsere Forschung und Technik haben es uns ermöglicht, in allen Unternehmensbereichen Fortschritte zu machen. Wir werden auch in Zukunft mit aller Kraft daran arbeiten, handfeste Ergebnisse zu produzieren, indem wir unermüdlich an der Umsetzung unserer Pläne arbeiten. Im letzten Jahr haben wir dies durch die Fortschritte in Bezug auf eine mögliche Wiedereinführung von Tysabri, der Weiterentwicklung des Alzheimer-Immuntherapieprogramms und das Wachstum unserer Geschäftssparte Drug Technology bewiesen."

Martin ergänzt: "Wir werden uns auch 2006 bemühen, messbare Erfolge in unseren wissenschaftlichen, technologischen und kommerziellen Aktivitäten zu erzielen. Von diesen Schwerpunkten, unserer Disziplin und gemeinsamer Ausrichtung werden die Patienten, unsere Aktionäre und unsere Mitarbeiter profitieren."

Shane Cooke, stellvertretender Vorstandschef und Geschäftsführer, erklärte in einem Kommentar zu den Finanzergebnissen Elans des vierten Quartals und des Gesamtjahres 2005: Im Februar 2005, als wir Tysabri freiwillig vom Markt nahmen, haben wir uns zum Ziel gesetzt, den Rest unseres Geschäfts bis Ende 2005 auf EBIDTA-Basis auszugleichen und dabei weder unser Einnahmenwachstum noch den Fortschritt der Weiterentwicklung unserer Pipeline bis in klinische Testphasen zu behindern. Wir sind stolz darauf, mitteilen zu können, dass wir dieses Ziel und damit einen wichtigen Schritt zurück zur Profitabilität unseres Unternehmens geschafft haben. Die Produkteinnahmen sind 2005 im Vergleich zum Vorjahr um 30% gestiegen. Geringere Kosten haben zu besseren Betriebsmargen und einer Senkung des Nettoverlustes um 46% auf 58,3 Mio USD geführt, während wir unseren Kassenbestand auf über 1 Mrd. USD halten konnten."

Cook fügt hinzu: Wir befinden uns in einer guten Position, Tysabri wieder auf den Markt zu bringen. Der Fortschritt, den wir bei der Verringerung unseres Kostenstrukturrisikos gemacht haben, wird unsere Rückkehr in die Gewinnzone beschleunigen."

Ungeprüfte zusammengefasste Einnahmen nach US-GAAP

Drei Monate Zwölf Monate
geendet am 31. geendet am 31.
Dezember Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
--------------- -------------------------------------- ---------------
Umsatzerlös (Siehe Seite 7)
102,3 132,7 Produktumsätze 404,4 458,1
21,5 7,7 Auftragsumsätze 77,3 32,2
------- ------- ------- -------
123,8 140,4 Gesamtumsatzerlös 481,7 490,3
------- ------- ------- -------

Betriebsausgaben(siehe Seite 11)
48,0 44,7 Umsatzkosten 170,4 191,6
71,4 52,8 Forschung und Entwicklung 257,3 233,3
107,7 86,5 Algemeine Betriebsaufwendungen 340,5 362,9
Reingewinn nach Veräußerung von
(1,7) (15,0) Geschäften (44,2) (103,4)
Sonstige signifikante Nettoeinnahmen/
(3,7) 2,1 Kosten 59,8 4,4
------- ------- ------- -------
221,7 171,1 Gesamte Betriebsausgaben 783,8 688,8
------- ------- ------- -------
(97,9) (30,7) Betriebsverlust (302,1) (198,5)
------- ------- ------- -------

Nettozinsen und Anlagegewinne
und -verluste (Siehe Seite 14)
37,5 28,2 Nettozinsbelastung 107,8 127,6
(55,6) (1,4) Nettoanlagegewinn (114,6) (16,3)
23,8 2,7 Anlageverluste 71,8 23,5
-- -- Verlust durch EPIL II-Garantie 47,1 --
Nettokosten der Rückzahlung von
-- (0,4) Verbindlichkeiten -- 51,8
------- ------- ------- -------
Nettozinsen und Anlagegewinne und
5,7 29,1 -verluste 112,1 186,6
------- ------- ------- -------

Nettoverluste aus laufenden
(103,6) (59,8) Geschäftstätigkeiten vor Steuern (414,2) (385,1)
Rückstellung für/(Anrechnung von)
4,6 (1,5) Einkommenssteuern (0,5) (0,9)
------- ------- ------- -------
Nettoverluste aus laufenden
(108,2) (58,3) Geschäftstätigkeiten (413,7) (384,2)
Nettoeinkommen aus nicht fortlaufenden
1,1 -- Geschäftstätigkeiten(siehe Anhang I) 19,0 0,6
------- ------- ------- -------
(107,1) (58,3) Reinverlust (394,7) (383,6)
======= ======= ======= =======

Basaler und verdünnter Nettoverlust je
(0,27) (0,14) Aktie (1,01) (0,93)
Gewichtete durchschnittliche Anzahl
393,1 427,0 umlaufender Aktien (in Mio) 390,1 413,5
Anzahl umlaufender Aktien
395,1 428,8 am 31. Dezember (in Mio) 395,1 428,8

Ungeprüfte Finanzdaten Nicht-GAAP - EBITDA

Drei Monate Finanzdaten Nicht-GAAP Zwölf Monate
geendet am Abstimmungsplan geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
--------------- -------------------------------------- ---------------
Nettoverluste aus fortlaufenden
(108,2) (58,3) Geschäftstätigkeiten (413,7) (384,2)
37,5 28,2 Nettozinsbelastung 107,8 127,6
Rückstellung für/(Anrechnung von)
4,6 (1,5) Einkommenssteuern (0,5) (0,9)
29,2 35,0 Abschreibungen und Amortisierungen 122,5 130,8
(15,7) (15,0) Gebührenabschreibungen (55,6) (57,8)
9,4 3,4 Ertragsabgrenzungen 16,4 7,6
------- ------- ------- -------
(43,2) (8,2) EBITDA (223,1) (176,9)
======= ======= ======= =======

Drei Monate Finanzdaten Non-GAAP Zwölf Monate
geendet am Abstimmungsplan geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
--------------- -------------------------------------- ---------------
(43,2) (8,2) EBITDA (223,1) (176,9)
Reingewinn nach Veräußerung
(1,7) (15,0) von Geschäften (44,2) (103,4)
Sonstige signifikante Nettoeinnahmen
(3,7) 2,1 /Kosten 59,8 4,4
-- -- Verlust durch EPIL II-Garantie 47,1 --
(31,8) 1,3 Nettoanlagegewinne/-verluste (42,8) 7,2
Nettobelastung aus Rückzahlung
-- (0,4) von Verbindlichkeiten -- 51,8
------- ------- ------- -------
(80,4) (20,2) Berichtigter EBITDA (203,2) (216,9)
======= ======= ======= =======

Zur Ergänzung seines konsolidierten Jahresabschlusses in der Darstellung nach US-GAAP stellt Elan den Lesern den EBITDA (Gewinn vor Zinsen, Steuern, Abschreibungen und Wertminderungen) und den berichtigten EBITDA zur Verfügung, das heißt Nicht-GAAP-Messgrößen der betrieblichen Ergebnisse. EBITDA ist definiert als der Nettoverlust aus fortbestehenden Tätigkeiten plus oder minus Abschreibungen und Wertminderungen von Kosten und Erträgen, Einkommensteuerrückstellungen und Nettozinsaufwand. Der berichtigte EBITDA ist definiert als EBITDA plus oder minus Nettogewinne oder -verluste aus Veräußerung von Geschäften, Sanierungsplan und anderen wesentlichen Belastungsposten, Nettoanlagegewinnen und -verlusten und Nettobelastung aus der Rückzahlung von Schuldverschreibungen. Weder EBITDA noch berichtigter EBITDA wird als alternative Messgröße der betrieblichen Ergebnisse, Mittelzufluss aus Tätigkeiten oder Reinverlust aus fortbestehenden Tätigkeiten dargestellt, wie in Übereinstimmung mit US-GAAP ermittelt. Die Geschäftsleitung von Elan verwendet EBITDA und berichtigten EBITDA zur Bewertung der betrieblichen Leistung von Elan und seinem Geschäft und diese Messgrößen gehören zu den Faktoren, die als Grundlage für die Planung und Prognose von Elan für zukünftige Zeiträume betrachtet werden. Nach Auffassung von Elan werden die Leistungsmessgrößen EBITDA und berichtigter EBITDA von manchen Investoren, Aktienanalysten und anderen verwendet, um sachkundige Anlageentscheidungen zu treffen. EBITDA und berichtigter EBITDA dienen als analytische Indikatoren für Erträge, die für den Schuldendienst und zur Finanzierung von Investitionen verwendet werden. In EBITDA und berichtigtem EBITDA sind keine liquiden Mittel berücksichtigt, die für Zinszahlungen für Schuldendienstanforderungen verwendet werden, und keine Mittel enthalten, die für Investitionen in das Geschäft von Elan oder für andere Ermessenszwecke zur Verfügung stehen. EBITDA und berichtigter EBITDA in der Definition von Elan und der Darstellung in dieser Pressemitteilung sind nicht mit Messgrößen mit ähnlichen Bezeichnungen vergleichbar, die von anderen Unternehmen gemeldet werden. Abstimmungen von EBITDA und berichtigtem EBITDA auf den Reinverlust aus fortbestehenden Tätigkeiten sind in den vorstehenden Tabellen mit der Bezeichnung Nicht-GAAP-Finanzdaten Abstimmungsplan" enthalten.

Ungeprüfte zusammengefasste Konzernbilanz nach US-GAAP

31. Dez. 30. Sept. 31. Dez.
2004 2005 2005
Mio USD Mio USD Mio USD
----------------------------------------------------------------------
Aktiva
Laufende Aktiva
Cash und Guthaben 1.347,6 1.130,7 1.080,7
Eingeschränkt verwendbares Cash 164,3 20,2 20,4
Börsenfähige Anlagepapiere 65,5 14,2 9,3
Vorausbezahlte und andere
Kurzfristige Vermögensgegenstände 152,5 118,5 131,0
--------- ---------- --------
Kurzfristige Vermögensgegenstände
gesamt 1.729,9 1.283,6 1.241,4

Langfristige Vermögensgegenstände
Besitz, Anlagen und Ausrüstung, netto 346,2 355,6 353,6
Immaterielle Anlagewerte, netto 764,0 698,9 675,8
Börsenfähige Anlagepapiere 39,0 18,6 13,8
Gebundene liquide Mittel 28,4 4,5 4,5
Sonstige Aktiva 68,4 54,4 51,8
--------- ---------- --------
Aktiva gesamt 2,975,9 2,415,6 2,340,9
========= ========== ========

Passiva und Eigenkapital
Verbindlichkeiten aus Lieferungen und
Leistungen und Rückstellungen 361,5 244,8 246,7
Transitorische Passiva 110,4 71,6 60,1
EPIL III-Notes vom März 2005 39,0 -- --
6,5%ige garantierte Wandelanleihen mit
Laufzeit bis 2008 460,0 254,0 254,0
7,25%ige Senior Notes mit Laufzeit
bis 2008 650,0 613,2 613,2
7,75%ige Senior Notes mit Laufzeit
bis 2011 850,0 850,0 850,0
Variabel verzinsliche Anleihen mit
Laufzeit bis 2011 300,0 300,0 300,0
Eigenkapital 205,0 82,0 16,9
--------- ---------- --------
Gesamte Passiva und
Eigenkapital 2.975,9 2.415,6 2.340,9
========= ========== ========

Eigenkapitalbilanz
Eröffnungssaldo 147,8 82,0
Reinverlust für den Zeitraum (67,1) (58,3)
Sonstige 1,3 (6,8)
---------- --------
Endsaldo 82,0 16,9
========== ========

Ungeprüfte zusammengefasste Cash-Flow-Daten nach US-GAAP
Drei Monate Zwölf Monate
Geendet am Geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
----------------------------------------------------------------------

Cash-Flow aus operativer
(63,1) (9,4) Tätigkeit (322,9) (178,0)
Änderungen bei Kreditzinsen und
(31,4) (47,7) Steuern (110,7) (159,4)
144,3 (9,5) Betriebsmittelveränderung (1) 245,5 (114,1)
Bilanz für Zahlungsmittel mit
(180,1) -- Verfügungsbeschränkung (159,8) 168,0
Nettokauf von materiellen und
(30,8) (8,0) immateriellen Anlagewerten (54,5) (50,2)
Reinerlös aus
24,3 3,3 Anlageverkäufen 254,1 62,3
Reinerlös aus
4,2 15,0 Geschäftsveräußerungen 274,6 108,8
Cash-Flow aus Finanzierungs-
809,1 6,3 maßnahmen 834,9 (65,3)
-- -- Rückzahlung von EPIL III Anleihen -- (39,0)
Cash-Zahlung nach EPIL II
-- -- Garantie (391,8) --
-------- -------- --------- --------
676,5 (50,0) Netto-Cash-Bilanz 569,4 (266,9)
Cash-Bilanz am Anfang des
671,1 1.130,7 Bilanzierungszeitraums 778,2 1.347,6
-------- -------- --------- --------
Cash und Guthaben
1.347,6 1.080,7 am Ende des
Bilanzierungszeitraums 1.347,6 1.080,7
======== ======== ========= ========

(1) Für die am 31. Dezember 2005 geendeten zwölf Monate umfasst die
Betriebskapitalbilanz eine Cash-Zahlung von 40,0 Mio USD für die
Belegung der Sammelklage aus dem Jahr 2002.

Die obige Analyse beruht auf den Einnahmen und Ausgaben aus laufenden Geschäftstätigkeiten nach US-GAAP.

Reinverlust

Der Reinverlust für das vierte Quartal 2005 belief sich auf 58,3 Mio USD, das entspricht einem Rückgang von 46% gegenüber den 107,1 Mio USD im selben Quartal 2004. Dieser Rückgang ist hauptsächlich auf das starke Wachstum der Produkteinnahmen und der Betriebsmargen im Kerngeschäft zurückzuführen. Diese Verbesserungen der Betriebsergebnisse wurden von rückläufigen Auftragseinnahmen und Gesamtgewinnen aus der Veräußerung von Geschäften und Anlagen ausgeglichen.

Der Reinverlust für das Gesamtjahr 2005 verringerte sich um 3% auf 383,6 Mio USD gegenüber 394,7 Mio USD im Jahr 2004 (wie auf Seite 2 aufgeführt). Die Produkteinnahmen aus den Kerngeschäften stiegen um 34%, was den Verlust der Gewinne durch Produkte, die 2004 ausgelagert wurden, und durch rückläufige Auftragseinnahmen mehr als kompensierte. Die Ausgaben für Forschung und Entwicklung sowie für Vertrieb und Verwaltung waren 2005 trotz gestiegener Investitionen in Tysabri und die Alzheime--Programme dank laufender Kostendämmungsinitiativen und Neuverteilung von Ressourcen weitgehend unverändert gegenüber dem Vorjahr.

Berichtigter EBITDA

Ein Abgleich des negativen berichtigten EBIDTA mit dem Reinverlust aus laufenden Geschäftstätigkeiten ist in der Tabelle mit der Überschrift Ungeprüfte Finanzdaten Non-GAAP - EBITDA" auf Seite 3 vorgelegt. Eine weitergehende Analyse des berichtigten EBIDTA zwischen Tysabri und dem Rest des Geschäftes befindet sich in Anhang II.

Der negative berichtigte EBIDTA belief sich im vierten Quartal 2005 auf 20,2 Mio USD im Vergleich zu 80,4 Mio USD im vierten Quartal 2004, was einer Verbesserung um 75% entspricht. Dabei ist auch der negative berichtigte EBIDTA von 28,9 Mio USD in Zusammenhang mit Tysabri berücksichtigt (2004: 49,3 Mio USD). Die Verbesserung des negativen berichtigten EBIDTA in Zusammenhang mit Tysabri spiegelt die ursprüngliche Markteinführung von Tysabri im vierten Quartal 2004 wider, die spätere freiwillige Rückziehung von Tysabri im ersten Quartal 2005 sowie die geringeren Ausgaben für Forschung und Entwicklung und kommerzielle Aktivitäten nach Abschluss einer Reihe klinischer Studien 2005. Der berichtigte EBIDTA für das übrige Geschäft, ausschließlich der Kosten in Verbindung mit Tysabri, lag im vierten Quartal 2005 mit 8,7 Mio USD im Plus (2004: 31,1 Mio USD im Minus). Die Verbesserung des berichtigten EBIDTA in den übrigen Geschäftssparten gibt das stabile Wachstum der Produktumsätze und Betriebmargen wider, die teilweise von den verringerten Auftragseinkünften ausgeglichen wurden.

Für das Gesamtjahr 2005 lag der berichtigte EBIDTA mit 216,9 Mio USD im Minus, was einer Verbesserung von 7% gegenüber 203,2 Mio USD im Jahr 2004 entspricht. Dabei ist ein negatives berichtigter EBIDTA von 163,9 Mio USD in Verbindung mit Tysabri berücksichtig (2004: 119,5 Mio USD). Der berichtigte EBIDTA für das übrige Geschäft, ausschließlich Tysabri, lag im Gesamtjahr 2005 mit 53,0 Mio USD im Minus, was einer Verbesserung von 32% gegenüber den im Vorjahr 2004 verzeichneten 83,7 Mio USD. Diese Zahlen sind auf die Steigerung der Produktumsätze und günstigere Betriebsmargen in den Kerngeschäften zurückzuführen, was den Verlust der Gewinne durch Produkte, die 2004 ausgelagert wurden, und durch rückläufige Auftragseinnahmen mehr als kompensierte.

Der negative berichtigte EBIDTA in Verbindung mit Tysabri erhöhte sich von 119,5 Mio USD im Gesamtjahr 2004 auf 163,9 Mio USD im Gesamtjahr 2005. Dies spiegelt die Kosten der ursprünglichen Markteinführung von Tysabri im vierten Quartal 2004 wider, die freiwillige Rückziehung von Tysabri im Februar 2005 und die anschließende Sicherheitsprüfung sowie die Kosten für den Erhalt der kommerziellen Infrastruktur im Hinblick auf eine mögliche Wiedereinführung von Tysabri 2006.

Umsatzerlös

Der Gesamtumsatzerlös erhöhte sich im vierten Quartal 2005 um 13% auf 140,4 Mio USD gegenüber 123,8 Mio USD im vierten Quartal 2004. Auf das Gesamtjahr berechnet erhöhte sich 2005 der Gesamtumsatzerlös um 2% auf 490,3 Mio USD gegenüber 481,7 Mio USD im Vorjahr. Der Umsatzerlös wird unten analysiert, wobei Produkteinkünfte aus den Kerngeschäften, Einkünfte aus Produkte, die ausgelagert wurden, sowie Einkünfte aus Verträgen berücksichtigt sind.

Drei Monate Zwölf Monate
Geendet am Geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
------- ------- -------------------------------------- ------- -------

Erlös aus vermarkteten Produkten
29,9 46,8 Maxipime(TM) 117,5 140,3
15,3 17,5 Azactam(TM) 50,6 57,7
6,4 (0,4) Tysabri 6,4 11,0
-- 2,0 Prialt(TM) -- 6,3
------- ------- ------- -------
Gesamtumsatzerlös aus vermarkteten
51,6 65,9 Produkten 174,5 215,3

Erlös aus Herstellungsverträgen
40,2 58,3 und Lizenzzahlungen (siehe Seite 10) 130,9 207,1

Abgeschriebene Erlöse -
8,5 8,5 Adalat(TM)/Avinza(TM) 34,0 34,0
------- ------- ------- -------
Gesamtumsatzerlös aus
100,3 132,7 Kerngeschäft 339,4 456,4

Umsatzerlös aus ausgelagerten Produkten
-- -- Europageschäft 10,5 --
-- -- Zonegran(TM) 41,2 --
2,0 -- Sonstige 13,3 1,7
------- ------- ------- -------
Gesamtumsatzerlös aus ausgelagerten
2,0 -- Produkten 65,0 1,7
------- ------- ------- -------

------- ------- ------- -------
102,3 132,7 Gesamtumsatzerlös aus Produktverkauf 404,4 458,1
------- ------- ------- -------

Auftragseinkünfte
6,2 2,9 Abgeschriebene Gebühren 17,6 16,4
15,3 4,8 Erlös aus Forschung und Meilensteinen 59,7 15,8
------- ------- ------- -------
21,5 7,7 Gesamtumsatzerlös aus Verträgen 77,3 32,2
------- ------- ------- -------

------- ------- ------- -------
123,8 140,4 Gesamtumsatzerlös 481,7 490,3
======= ======= ======= =======

Produkterlös

Der Gesamtprodukterlös belief sich im vierten Quartal 2005 auf 132,7 Mio USD, was einer Steigerung um 30% gegenüber den 102,3 Mio USD im vierten Quartal 2004 entspricht. Die Steigerung ist überwiegend auf höhere Einkünfte aus vermarkteten Produkten und aus Herstellungs- und Lizenzzahlungen zurückzuführen. Der Gesamtprodukterlös für das Jahr 2005 lag bei 458,1 Mio USD, d. h. 13% über den 404,4 Mio USD, die 2004 bilanziert wurden. Die Steigerung der Produkteinnahmen aus dem Kerngeschäft von 34% im Gesamtjahr 2005 liegt signifikant über den Verlusten durch Produkte, die 2004 ausgelagert wurden.

Einkünfte aus vermarkteten Produkten

Die Einkünfte aus vermarkteten Produkten lagen im vierten Quartal 2005 bei 65,9 Mio USD gegenüber 51,6 Mio USD im selben Zeitraum 2004. Dies entspricht einer Steigerung von 28%, welche hauptsächlich auf bessere Verkaufszahlen von Maxipime und Azactam sowie die Einnahmen aus dem Verkauf des 2005 eingeführten Prialt zurückzuführen ist und teilweise von einem Rückgang des Verkaufs von Tysabri ausgeglichen wird, welches im Februar 2005 freiwillig vom Markt genommen wurde. Im Gesamtjahr 2005 erhöhten sich die Einnahmen aus vermarkteten Produkten um 23% auf 215,3 Mio USD gegenüber 174,5 Mio USD im Jahr 2004 infolge der gestiegenen Verkaufszahlen von Maxipime und Azactam.

Die Einnahmen durch Verkauf von Maxipime erhöhten sich im vierten Quartal 2005 auf 46,8 Mio USD gegenüber 29,9 Mio USD im vierten Quartal des Vorjahres. Im Gesamtjahr lag der Erlös aus dem Verkauf von Maxipime bei 140,3 Mio USD, was einer Steigerung um 19% gegenüber den 2004 bilanzierten 117,5 Mio USD darstellt. Die Zahlen sind auf eine erhöhte Nachfrage, eine Preiserhöhung von 8% Ende 2004 und bessere Lieferbedingungen zurückzuführen.

Für Azactam ergab sich im Oktober und November 2004 ein Anstieg der Anzahl der Verschreibungen um 10% gegenüber demselben Zeitraum 2004, während sich die Einnahmen in diesem Quartal von 15,3 Mio USD um 14% auf 17,5 Mio USD erhöhten. Auch in den ersten elf Monaten des Jahres 2005 erhöhte sich die Anzahl der Verschreibungen von Azactam um 10% gegenüber dem Vorjahr, wodurch die Einnahmen im Gesamtjahr 2005 um 14% von 50,6 Mio USD im selben Zeitraum 2004 auf 57,7 Mio USD stiegen. Der Unterschied zwischen der Zunahme der Verschreibungen von Azactam und dem Einnahmenwachstum ist auf eine Veränderung der Bevorratung der Großhändler und Preiserhöhungen zurückzuführen. Der Patentschutz von Azactam lief im Oktober 2005 ab. Bislang wurde jedoch noch kein generisches Azactam-Produkt zugelassen.

Prialt, ein neues Medikament zur Behandlung chronischer Schmerzen, wurde im Dezember 2004 in den USA zugelassen. Die Einnahmen aus dem Verkauf von Prialt im vierten Quartal 2005 beliefen sich auf 2,0 Mio USD. Die Gesamteinnahmen 2005 für Prialt lagen bei 6,3 Mio USD (2004: keine Einnahmen).

Einkünfte aus Herstellungs- und Lizenzverträgen

Die Einkünfte aus Herstellungs- und Lizenzverträgen von Elans Geschäftssparte Drug Technology umfasst Einnahmen aus der Produktherstellung von externen Unternehmen und Lizenzzahlungen durch den Verkauf von Produkten durch externe Unternehmen, die Elans Technologien anwenden.

Die Einkünfte aus Herstellungs- und Lizenzverträgen beliefen sich im vierten Quartal 2005 auf 58,3 Mio USD, was einem Anstieg von 45% gegenüber den im vierten Quartal 2004 verzeichneten 40,2 Mio USD entspricht. Im Gesamtjahr 2005 lagen die Einkünfte aus Herstellungs- und Lizenzverträgen bei 207,1 Mio USD, also 58% über den 130,9 Mio USD im Jahr 2004. Der Anstieg der Einkünfte aus Herstellungs- und Lizenzverträgen ist auf einen Mehrverkauf von Produkten mit Elans Technologien von Seiten externer Unternehmen zurückzuführen, hauptsächlich Tricor(TM), sowie auf eine Steigerung der Produktionsaktivitäten externer Unternehmen.

Die Einkünfte aus Herstellungs- und Lizenzverträgen lassen sich wie folgt weiter analysieren:

Drei Monate Zwölf Monate
Geendet am Geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
----------------------------------------------------------------------
4,5 15,3 Tricor 4,5 45,4
8,7 7,8 Verelan(TM) 27,8 34,7
2,7 3,2 Skelaxin(TM) 12,2 17,9
3,5 2,7 Ritalin(TM) 11,8 13,8
4,9 4,3 Avinza(TM) 15,8 13,4
4,1 5,8 Diltiazem(TM) 19,3 18,6
- 4,0 Zanaflex(TM) - 11,1
11,8 15,2 Sonstige 39,5 52,2
------- ------- ------ ------
40,2 58,3 Gesamt 130,9 207,1
------- ------- ------ ------

Andere Produkte als die oben angegebenen trugen mit höchstens 10% zu den Gesamteinkünften aus Herstellungs- und Lizenzverträgen im vierten Quartal 2005 oder 2004 bei. Von dem Gesamtbetrag von 58,3 Mio USD an Einkünften aus Herstellungs- und Lizenzverträgen im vierten Quartal 2005 bestanden 35% aus Lizenzeinnahmen aus Produkten, die nicht von Elan selbst hergestellt werden; im gleichen Zeitraum 2004 waren es 26%. Im Gesamtjahr 2005 lag der Anteil der Lizenzeinnahmen aus Produkten, die nicht von Elan selbst hergestellt werden, bei 34% gegenüber 19% im Vorjahr 2004.

Abgeschriebene Umsatzerlöse

Die Ergebnisse für das vierte Quartal und das Gesamtjahr 2005 und 2004 umfassen 8,5 Mio USD bzw. 34,0 Mio USD an abgeschriebenen Erösen in Zusammenhang mit der Lizenzierung der Rechte an Elans generischer Form von Adalat CC und der Umstrukturierung von Elans Lizenzvertrag für Avinza mit Ligand Pharmaceuticals, Inc im Jahr 2002. Für die übrigen abgeschriebenen Umsatzerlöse mit diesen Produkten in Höhe von 35,2 Mio. USD, die in den transitorischen Passiva enthalten sind, erfolgt der Ertragsansatz bis zum Juni 2007 (Generikum Adalat CC) und November 2006 (Adalat), was Elans laufendes Engagement in der Fertigung dieser Produkte verdeutlicht.

Auftragseinkünfte

Die Auftragseinkünfte im vierten Quartal 2005 beliefen sich auf 7,7 Mio USD, was einem Anstieg von 64% ausgehend von den 21,5 Mio USD im vierten Quartal 2004 entspricht. Für das Gesamtjahr gingen die Auftragseinnahmen gegenüber 77,3 Mio USD im Jahr 2004 um 58% auf 32,2 Mio USD zurück. Dieser Rückgang ist hauptsächlich auf den Rückgang von Meilensteinzahlungen bzw. eine Verringerung der Einnahmen aus Forschung und Entwicklungsaktivitäten zurückzuführen, die Elan im Auftrag externer Unternehmen durchführt. Dies betrifft neben Meilensteinzahlungen auch den Abschluss vorübergehender Forschungs- und Entwicklungsaktivitäten in Bezug auf bestimmte ausgelagerte Produkte und die Aufhebung der Aktivitäten in Bezug auf Sonata.

Bruttogewinn

Die Bruttogewinnmarge der Produkterträge belief sich im vierten Quartal 2005 auf 66% gegenüber 53% im selben Zeitraum 2004. Der Anstieg lässt sich im Wesentlichen auf eine Änderung der Zusammensetzung der Produkteinkünfte zurückführen.

In den Jahren 2004 und 2005 lag die Bruttogewinnmarge der Produkterträge jeweils bei 58% und blieb damit unverändert. Gründe dafür sind die kompensatorischen Änderungen der Zusammensetzung der Produkteinkünfte, der Einfluss der freiwilligen Rückziehung von Tysabri und die Auslagerung von Produkten 2004.

Betriebsausgaben

Die Ausgaben für Forschung und Entwicklung (F&E) lagen im vierten Quartal 2005 bei 52,8 Mio USD gegenüber 71,4 Mio USD im selben Zeitraum 2004. Dieser Rückgang ist aufgrund der geringeren ausgaben in Verbindung mit Tysabri, Kostendämmung und der Neufokussierung von Forschungs- und Entwicklungsschwerpunkten im Rahmen der zentralen Alzheimer-Programme zurückzuführen. Die F&E-Ausgaben berücksichtigen auch Kosten von 10,6 Mio USD in Verbindung mit Tysabri (2004: 23,9 Mio USD), wobei der Rückgang im Wesentlichen durch den Abschluss klinischer Studien bedingt ist.

Insgesamt wurden im Jahr 2005 für F&E 233,3 Mio USD ausgegeben gegenüber 257,3 Mio USD im Jahr 2004. Dies entspricht einem Rückgang von 9%, einschließlich 66,9 Mio USD in Verbindung mit Tysabri (2004: 84,2 Mio USD). Der Rückgang der Jahresausgaben ist das Resultat von Kostendämmungsinitiativen, der Neufokussierung von Forschungs- und Entwicklungsschwerpunkten im Rahmen der zentralen Alzheimer-Programme und der geringeren Aufwendungen für Tysabri als Ergebnis des Abschlusses klinischer Studien. Dem gegenüber stehen den Kosten für die umfangreiche Sicherheitsprüfung von Tysabri.

Die allgemeinen Betriebsaufwendungen (SG&A) verringerten sich um 20% auf 86,5 Mio USD im vierten Quartal 2005 gegenüber 107,7 Mio USD im selben Quartal 2004 und lassen sich wie folgt analysieren.

Drei Monate Zwölf Monate
Geendet am Geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
-------------- ----------------------------------------- -------------
57,4 49,5 Übriges Geschäft 221,6 202,0
35,0 17,8 Tysabri 52,3 82,7
Abschreibung und Amortisierung
15,3 19,2 (hauptsächlich Maxipime und Azactam) 66,6 78,2
------- ------ ------ ------
107,7 86,5 Gesamt 340,5 362,9

Die auf das übrige Geschäft bezogenen allgemeinen Betriebsausgaben, ausschließlich Abschreibungen, gingen im vierten Quartal 2005 um 14% auf 49,5 Mio USD zurück und lagen im gleichen Quartal im Vorjahr bei 57,4 Mio USD. Die Gründe dafür liegen im Wesentlichen im anhaltenden aktiven Kostenmanagement des Unternehmens. Die allgemeinen Betriebsausgaben in Verbindung mit Tysabri, ausschließlich Abschreibungen, lagen im vierten Quartal 2005 bei 17,8 Mio USD, gegenüber 35,0 Mio USD im vierten Quartal 2004 als Tysabri eingeführt wurde.

Der Gesamtaufwand an allgemeinen Betriebsausgaben lag 2005 bei 362,9 Mio USD im Vergleich zu 340,5 Mio USD im Jahr 2004 und stieg damit um 7%. Dies reflektiert die Kosten der Aufrechterhaltung der kommerziellen Infrastruktur für Tysabri in Erwartung der möglichen Wiedereinführung, erhöhte Abschreibungen und die Kosten der Einführung von Prialt 2005. Dem gegenüber steht der geringere Aufwand für das sonstige Geschäft.

Reingewinn aus Veräußerung von Geschäftsbereichen

Der Reingewinn aus Veräußerung von Geschäftsbereichen für die am 31. Dezember 2005 und 2004 geendeten drei bzw. zwölf Monate war wie folgt:

Drei Monate Zwölf Monate
geendet am geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
-------------- ---------------------------------------- --------------

1,5 -- Zonegran 42,9 85,6
0,9 15,0 Europageschäft (2,9) 17,1
(0,7) -- Sonstige 4,2 0,7
------- ------ ------- ------
1,7 15,0 Gesamt 44,2 103,4
======= ====== ======= ======

Der Reingewinn im vierten Quartal 2005 besteht aus 15,0 Mio USD an nachträglichen Kaufpreisanpassungen in Verbindung mit dem Verkauf des Europageschäftes an Zeneus Pharma Ltd. im Jahr 2004.

Der Gesamtgewinn in Höhe von 103,4 Mio USD für das Jahr 2005 (2004: 44,2 Mio USD) berücksichtigt 85,6 Mio USD (2004: 42,9 Mio USD) in Bezug auf den Verkauf von Zonegran (Zonisamide) an Eisai Co. Ltd ("Eisai"). Im April 2004 hat das Unternehmen seine US- und Europa-Anteile an Zonegran für 113,5 Mio USD an Eisai verkauft und war nachträglich bis 1. Januar 2006 zu einer Kaufpreisanpassung in Höhe bis zu 110,0 Mio USD von Eisai berechtigt, primär abhängig von der Zulassung von generischem Zonegran im Dezember 2005. Der resultierende Reingewinn aus dem Verkauf von Zonegran belief sich daher auf 198,5 Mio USD und resultierte in einem kumulativen Reingewinn von 128,5 Mio USD.

Elan hat kürzlich vom US-amerikanischen Justizministerium und dem Gesundheitsamt eine Vorladung erhalten und soll dem Inspector General Unterlagen und Material in Verbindung mit seiner Vorgehensweise zur Vermarktung für Zonegran vorlegen. Wir werden mit den Behörden in dieser Sache zusammenarbeiten.

Sonstige erhebliche Nettokosten

Sonstige bilanzrelevante Nettokosten für die am 31. Dezember 2005 und 2004 geendeten drei bzw. zwölf Monate waren wie folgt:

Drei Monate Zwölf Monate
geendet am geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
-------------- ---------------------------------------- --------------

-- 9,7 Abfindungszahlungen und
Umstrukturierungskosten 3,0 14,4
SEC-Untersuchungen, Kosten der
Beilegung einer Sammelklage der
Aktionäre
(3,7) (7,6) und Sonstige 56,8 (10,0)
------- ------ ------ -------
(3,7) 2,1 Gesamt 59,8 4,4
======= ====== ====== =======

Der Posten von 2,1 Mio USD im vierten Quartal 2005 bestand im Wesentlichen aus Abfindungszahlungen und Umstrukturierungskosten in Höhe von 9,7 Mio USD, die von einem Kredit von 7,0 Mio USD in Verbindung mit der Beilegung einer Sammelklage ausgeglichen wurden.

Nettozinsen und Anlagegewinne bzw. -verluste

Nettozinsen und Anlagegewinne bzw. -verluste beliefen sich im vierten Quartal 2005 auf 29,1 Mio USD gegenüber einer Nettobelastung von 5,7 USD im selben Zeitraum 2004. Die Nettobelastung von 29,1 Mio USD im vierten Quartal 2005 setzte sich primär aus Nettozinsen in Höhe von 28,2 Mio USD zusammen; im vierten Quartal 2004 lag dieser Betrag bei 37,5 Mio USD. Der Rückgang der Nettozinsbelastung ist überwiegend das Ergebnis einer Rückzahlung der EPIL III Notes im vierten Quartal 2004, der Stilllegung von wandelbaren und vorrangigen Anleihen im Umfang von 242,8 Mio USD im zweiten Quartal 2005 und einer Zinseinnahme aus im Durchschnitt höheren Cashbilanzen, teilweise ausgeglichen durch die Zinsen für feste und freie vorrangige Anleihen in Höhe von 1,15 Mrd UDS, die im November 2004 ausgegeben wurden. Der Nettoposten von 5,7 Mio USD im vierten Quartal 2004 enthielt darüber hinaus einen Nettoanlagegewinn von 55,6 Mio USD (hauptsächlich durch unsere Veräußerung unserer Anteile an Warner Chilcott) und Anlageverluste von 23,8 Mio USD.

Die Nettozinsen und Anlagegewinne bzw. -verluste beliefen sich im Gesamtjahr 2005 auf eine Nettobelastung von 186,6 Mio USD gegenüber 112,1 Mio USD im Jahr 2004. Die Nettobelastung für das volle Jahr 2005 umfasst Nettozinsausgaben von 127,6 Mio USD, die im Vorjahr 2004 bei 107,8 Mio USD lagen. Dies spiegelt die Mehrbelastung an Zinszahlungen für die Ausgabe von festen und freien vorrangigen Anleihen im Volumen von 1,15 Mrd. USD im November 2004 wieder. Dem gegenüber steht die Rückzahlung der EPIL III Notes im November 2004, der vorzeitigen Rückzahlung von wandelbaren und vorrangigen Anleihen im Umfang von 242,8 Mio USD im zweiten Quartal 2005 und gestiegene Zinseinnahmen in Verbindung mit einer höheren Cashbilanz und Zinsraten. Die Nettobelastung für das Jahr 2005 umfasst auch eine Nettobelastung von 51,8 Mio USD in Verbindung mit der vorzeitigen Rückzahlung der 7,25% vorrangigen Anleihen, fällig 2008, in Höhe von 36,8 Mio USD (Athena Notes) und die vorzeitige Konversion von 6,5 % Convertible

Guaranteed Notes mit Laufzeit bis 2008 im Gesamtvolumen von 206,0 Mio USD. Dies verringerte unsere Verbindlichkeiten um 242,8 Mio USD und unsere jährlichen Zinsausgaben um etwa 16 Mio USD.

Ausblick auf 2006

Finanzausblick

Elan gibt einen Ausblick auf die möglichen Finanzergebnisse des Jahres 2006, ausschließlich der möglichen Umsätze durch Tysabri und dem Einfluss der aktienbasierten Kompensation. Elan geht von einer Rückkehr von Tysabri auf den Markt aus und plant für 2006 Ausgaben in Höhe von 150 bis 170 Mio USD für Forschung und Entwicklung und allgemeine Aufwendungen in Verbindung mit Tysabri. Das Unternehmen geht dabei von einer möglichen Wiedereinführung von Tysabri in den USA im zweiten Quartal 2006 und der möglichen Einführung von Tysabri in Europa im zweiten Halbjahr 2006 aus.

Was die übrigen Geschäftssparten anbelangt, erwartet Elan für 2006 einen Gesamtumsatzerlös von mehr als 500 Mio USD, davon insgesamt mehr als 90% durch Produktumsätze. Der Bruttogewinn aus Produktumsätzen, ohne Umsätze und Umsatzkosten für Tysabri und aktienbasierte Kompensation, wird auf 60% bis 65% geschätzt.

Elans Investition in F&E sowie die allgemeinen Betriebsaufwendungen für 2006 werden auf 575 Mio USD bis 625 Mio USD geschätzt, davon werden, wie oben erwähnt, etwa 150 Mio USD bis 170 Mio USD für Tysabri anfallen.

Der negative EBITDA für 2006 ohne Tysabri wird auf 150-175 Mio USD geschätzt und enthält den negativen EBIDTA für das restliche Geschäft, der voraussichtlich unter 25 Mio USD liegt.

Forschung und Entwicklung

Tysabri (Natalizumab)

Wie bereits gemeldet, wurde die ergänzende Biologics License

Application (sBLA) für Tysabri zur Behandlung von MS angenommen und derzeit von der US-amerikanischen Food and Drug

Administration (FDA) vorrangig begutachtet. Eine solche vorrangige Begutachtung (Priority Review) gewährt die FDA Produkten, die möglicherweise signifikante therapeutische Vorteile gegenüber bestehenden Therapien haben und einen bislang ungedeckten medizinischen Bedarf erfüllen.

Erwartete Hauptmeilensteine für Tysabri 2006

MS

-- Konferenz des Advisory Committee Panel am 7. März 2006

-- FDA-Entscheidung über den sBLA-Antrag für Tysabri

-- Klinische Neudosierung in den USA und international

-- Entscheidung der europäischen Zulassungsbehörden hinsichtlich einer möglichen Zulassung von Tysabri

-- Mögliche Wiedereinführung von Tysabri in in den USA und Europa

Morbus Crohn

-- Entscheidung der europäischen Zulassungsbehörden hinsichtlich einer möglichen Zulassung von Tysabri; richtet sich dem Zulassungsbescheid für Tysabri als Behandlung für MS

-- Einreichung eines BLA-Antrags für Tysabri als Behandlung gegen Morbus Crohn in den USA; richtet sich dem Zulassungsbescheid für Tysabri als Behandlung für MS

Alzheimer und andere neurodegenerative Erkrankungen

Elan konzentriert sich auf den Aufbau seiner Bahn brechenden Forschungs- und Entwicklungsarbeiten zum Morbus Alzheimer und untersucht derzeit weitere neurodegenerative Erkrankungen, beispielsweise die Parkinson-Krankheit.

Zwei unserer Verbindungen aus dem Alzheimer-Immuntherapieprogramm werden derzeit in Zusammenarbeit mit Wyeth klinisch geprüft.

Erwartete Hauptmeilensteine für das Alzheimer-Programm 2006

-- Zwischenanalyse der Phase-II-Daten mit AAB-001 (experimenteller monoklonaler Antikörper) zur Bestimmung des Zeitpunktes, an dem das Programm zur nächsten Phase der klinischen Studien übergeht.

-- Zwischenanalyse der Phase-I-Daten mit ACC-001 (aktives Abeta-Immuntherapiekonjugat) zur Bestimmung des Zeitpunktes, an dem dieses Programm zur Phase II der klinischen Studien übergeht.

-- Mögliche Beantragung von IND für AAB-002

Über Elan

Die Elan Corporation (NYSE:ELN), plc, ist ein Biotechnologieunternehmen, das sich auf Neuroforschung spezialisiert hat. Das Unternehmen möchte die Lebensqualität von Patienten und ihren Familien verbessern, indem es innovative Forschung durchführt und damit bislang ungedeckten medizinischen Bedarf auf der ganzen Welt erfüllt. Die Aktien von Elan werden an den Börsen New York, London und Dublin gehandelt. Weitere Informationen über die Gesellschaft finden Sie unter http://www.elan.com.

Zukunftsbezogene Aussagen

Dieses Dokument enthält zukunftsbezogene Aussagen über Finanzlage, Geschäftsergebnisse, Geschäftsaussichten und in der Forschung befindlicher Produkte von Elan. Diese Aussagen beinhalten beträchtliche Risiken und Unwägbarkeiten. Sie sind an der Verwendung von Wörtern wie "erwarten", "schätzen", "projizieren", "anstreben", "beabsichtigen", "planen", "annehmen" und anderer Wörter und Begriffe mit ähnlicher Bedeutung im Zusammenhang mit einer Diskussion der zukünftigen betrieblichen oder finanziellen Ergebnisse oder Ereignisse zu erkennen. Zu den Faktoren, die dazu führen können, dass die tatsächlichen Ergebnisse erheblich von den in diesem Dokument beschriebenen oder projizierten Ergebnissen abweichen, gehören folgende: ob und wann Elan die Vermarktung und Entwicklung von Tysabri wieder aufnehmen kann; selbst wenn Elan die Vermarktung und Entwicklung von Tysabri wieder aufnehmen kann, das Potenzial von Tysabri und das Potenzial zur erfolgreichen Entwicklung und Kommerzialisierung weiterer Produkte, darunter solcher, in denen Tysabri verwendet wird; das Potenzial der gegenwärtigen Produkte von Elan; Elans Möglichkeit zur Erhaltung ausreichender Barmittel, liquider Ressourcen und Anlagen und sonstigen Vermögenswerten, die zur Erfüllung seines Liquiditätsbedarfs monetisiert werden können; der Erfolg der Forschungs- und Entwicklungstätigkeiten und die Geschwindigkeit, mit der behördlichen Zulassungen und Produkteinführungen erzielt werden können; Wettbewerbsentwicklungen, die sich auf Elans Produkte auswirken; die Fähigkeit zur erfolgreichen Vermarktung von neuen und bestehenden Produkten; Schwierigkeiten oder Verzögerungen bei der Herstellung und Lieferung von Elans Produkten (einschließlich insbesondere Maxipime); Bezugsmuster im Handel; die Auswirkungen des Wettbewerbs bei Generika und Markenprodukten nach Ablauf der Patente von Elan, darunter der Auswirkungen des Generika-Wettbewerbs nach dem Verlust der Patentexklusivität von Azactam im Oktober 2005; ob beschränkende Bestimmungen bei den Schuldverpflichtungen von Elan nachteilige Auswirkungen auf Elan haben werden; der Trend zur Kostendämpfung in Pflege und Gesundheitswesen, darunter in Medicare und Medicaid; die potenziellen Auswirkungen des Medicare Prescription Drug, Improvement und Modernisation Act 2003; mögliche Gesetze mit Folgen für Preise und Erstattung von Arzneimitteln im In- und Ausland; Nichteinhaltung von Gesetzen über Bestechung und falschen Behauptungen, einschließlich in Verbindung mit dem früheren Marketing von Zonegran; Nichteinhaltung der Zahlungsverpflichtungen im Rahmen von Medicaid und anderen staatlichen Programmen; Produkthaftungsrisiko und andere Arten von Gerichtsverfahren und Rechtskosten und die Risiken nachteiliger Entscheidungen oder Vergleiche im Zusammenhang mit Produkthaftung, Patentschutz, staatlichen Ermittlungen und anderen juristischen Verfahren; Elans Möglichkeit zum Schutz seiner Patente und anderen geistigen Schutzrechte; Behauptungen und Bedenken, die sich bezüglich der Verträglichkeit oder Wirksamkeit von Produkten oder Produktkandidaten von Elan ergeben könnten; Zins- und Wechselkursschwankungen; staatliche Gesetze und Durchführungsbestimmungen über inländische und ausländische Tätigkeiten, darunter steuerliche Verpflichtungen; allgemeine Änderungen der Grundsätze ordnungsmäßiger Bilanzierung in den USA, international und in Irland; Steigerung von Kosten und Aufwendungen; Änderungen des Produktmix; und Auswirkungen von Übernahmen, Veräußerungen, Umstrukturierungen, Produktrücknahmen und anderen Einmalposten. Eine weitere Liste und Beschreibung dieser Risiken, Unwägbarkeiten und sonstiger Angelegenheiten ist in Elans Formular 20-F für das am 31. Dezember 2004 geendete Geschäftsjahr, wie ergänzt in Amendment Nr. 1 auf Formular 20-F/A, und in seinen Auslandsemittentenberichten auf Form 6-K zu finden, die bei der US-Börsenaufsichtsbehörde eingereicht wurden. Elan übernimmt keine Verpflichtung zur Aktualisierung zukunftsbezogener Aussagen, gleich ob auf Grund neuer Informationen, zukünftiger Ereignisse oder aus sonstigen Gründen.

Elan bewertet kontinuierlich seinen Liquiditätsbedarf, seinen Finanzbedarf und die Verfügbarkeit von Ressourcen unter anderem im Hinblick auf alternativen Einsatz von Kapital, Schuldendienstanforderungen, Kosten von Fremd- und Eigenkapital und den geschätzten zukünftigen Betriebs-Cash-Flow. Elan kann weiteres Kapital beschaffen, ungetilgte Verbindlichkeiten umschulden oder refinanzieren, ungetilgte Verbindlichkeiten in erheblicher Höhe zurücknehmen, den Verkauf von Produkten, Beteiligungen an Tochtergesellschaften, börsengängigen Wertpapieren oder anderen Vermögenswerten erwägen oder eine Kombination aus diesen Maßnahmen oder andere Schritte vornehmen, um seine Liquidität und seine Kapitalressourcen zu erhöhen oder zu managen. Alle diese Maßnahmen oder Schritte, darunter der Verkauf von Vermögenswerten oder die Rücknahme ungetilgter Verbindlichkeiten, können wesentlich sein. Im Rahmen der normalen Geschäftstätigkeit kann Elan zukünftige Unternehmens- oder Produktübernahmen, Investitionsausgaben, Kapitalanlagen und andere Geschäftschancen prüfen, bewerten, diskutieren und durchführen. Bei zukünftigen Übernahmen, Investitionsausgaben, Kapitalanlagen oder anderen Geschäftschancen kann Elan die Inanspruchnahme von verfügbaren liquiden Mitteln oder die Beschaffung von weiterem Kapital erwägen, darunter die Emission weiterer Schuldverschreibungen.

Finanzergebnisse von Elan im vierten Quartal und im Gesamtjahr 2005

Anhang I

In den bisherigen Quartalen und in Übereinstimmung mit SFAS Nr. 144 wies Elan die Ergebnisse sowie Gewinne und Verluste aus der Veräußerung seiner eingestellten Tätigkeiten, darunter Elan Transdermal Technologies, Athena Diagnostics, Elan Diagnostics, einer Fertigungsstätte in Italien, des Portfolios an Schmerzprodukten, Actiq(TM), des Portfolios an dermatologischen Produkten, Abelcet(TM) in den USA und Kanada, Frova(TM), Myobloc(TM) und zweier in Großbritannien und Irland vermarkteter Produkte unter den eingestellten Tätigkeiten in der Konzernergebnisrechnung aus. Eine Analyse der Ergebnisse der eingestellten Tätigkeiten ist nachstehend angegeben.

Elan hat außerdem eine Reihe anderer Vermögenswerte und Geschäfte verkauft (hauptsächlich das Primärpflegefranchise, das europäische Vertriebs- und Marketinggeschäft und Zonegran), die in Übereinstimmung mit SFAS No. 144, nicht in den eingestellten Tätigkeiten enthalten sind. Nach eigener Auffassung hat Elan eine erhebliche weitere Beteiligung an der Tätigkeit dieser Geschäfte, zum Beispiel durch laufende Liefervereinbarungen oder Formulierungstätigkeiten.

Drei Monate Eingestellte Tätigkeiten (ungeprüft) Zwölf Monate
geendet am geendet am
31. Dezember 31. Dezember
2004 2005 2004 2005
Mio USD Mio USD Mio USD Mio USD
----------------------------------------------------------------------
Umsatzerlös
(0,1) -- Produktumsätze 23,6 --
-- -- Auftragsumsätze 5,1 --
------- ------- ------ ------
(0,1) -- Gesamtumsatzerlös 28,7 --
------- ------- ------ ------
Betriebsausgaben
(0,1) -- Umsatzkosten 13,3 --
(1,6) -- Forschung und Entwicklung 3,3 (0,4)
0,2 -- Allgemeine Betriebsaufwendungen 4,5 0,3
(0,3) -- Reingewinn aus Veräußerung von
Geschäften (11,5) (0,5)
------- ------- ------ ------
(1,8) -- Gesamte Betriebsausgaben 9,6 (0,6)
------- ------- ------ ------

1,7 -- Betriebsmarge 19,1 0,6

0,4 -- Nettozinsaufwand 0,1 --
0,2 -- Nettoanlageverluste -- --
------- ------- ------ ------

Nettogewinn aus eingestellten Tätigkeiten
1,1 -- vor Steuern 19,0 0,6
-- -- Steuerrückstellungen -- --
------- ------- ------ ------
1,1 -- Nettoeinnahmen aus eingestellten
Tätigkeiten19,0 0,6
======= ======= ====== ======

Nicht-GAAP Finanzdaten
EBITDA
1,1 -- Nettoeinnahmen aus eingestellten
Tätigkeiten 19,0 0,6
0,4 -- Nettozinsaufwand 0,1 --
Im Betriebsgewinn enthaltene
Abschreibungen und
-- -- Amortisierungen 1,0 --
Im Gesamtumsatzerlös enthaltene
abgeschriebener
-- -- Umsatzerlös (4,6)
------- ------- ------ ------
1,5 -- EBITDA 15,5 0,6
------- ------- ------ ------

(0,3) -- Nettgewinn aus Veräußerung von
Geschäften (11,5) (0,5)
0,2 -- Nettoanlageverluste -- --
------- ------- ------ ------
1,4 -- Berichtigter EBITDA 4,0 0,1
======= ======= ====== ======

Anhang II

Drei Monate geendet am Zwölf Monate geendet am
31. Dezember 2005 31. Dezember 2005
Tysabri Restl. Geschäft, gesamt Tysabri Restl. Geschäft, gesamt
Mio USD Mio USD Mio USD Mio USD Mio USD Mio USD
------------------------- ------------------ -------------------------
Umsatzerlös
(0,4) 133,1 132,7 Produktumsätze (1) 11,0 447,1 458,1
1,5 6,2 7,7 Auftragsumsätze 10,8 21,4 32,2
-------- --------- ------ ------- --------- -------
1,1 139,3 140,4 Gesamterlös 21,8 468,5 490,3
-------- --------- ------ ------- --------- -------

Betriebsausgaben
0,2 44,5 44,7 Umsatzkosten(2) 5,4 166,2 191,6
Allgemeine Betriebs-
18,3 68,2 86,5 aufwendungen(3) 84,7 278,2 362,9
Forschung und
10,6 42,2 52,8 Entwicklung 66,9 166,4 233,3
Nettogewinn aus
Veräußerung von
-- (15,0) (15,0) Geschäften -- (103,4) (103,4)
Sonstige erhebliche
2,0 0,1 2,1 Nettobelastungen 2,3 2,1 4,4
-------- --------- ------ ------- --------- -------
Gesamte Betriebs-
31,1 140,0 171,1 ausgaben 179,3 509,5 688,8
-------- --------- ------ ------- --------- -------
(30,0) (0,7) (30,7) Betriebsverlust (157,5) (41,0) (198,5)

Abschreibungen und
0,5 34,5 35,0 Amortisierungen 2,0 128,8 130,8
(1,4) (13,6) (15,0) Gebührenabschreibungen(10,7) (47,1) (57,8)
Nettogewinn aus
Veräußerung von
-- (15,0) (15,0) Geschäften -- (103,4) (103,4)
-- 3,4 3,4 Ertragsabgrenzungen -- 7,6 7,6
Sonstige erhebliche
2,0 0,1 2,1 Belastungen 2,3 2,1 4,4
-------- --------- ------ ------- --------- -------
(28,9) 8,7 (20,2) Berichtigter EBITDA (163,9) (53,0) (216,9)
======== ========= ====== ======= ========= =======

(1) Der Umsatzerlös aus dem Tysabri-Absatz in den zwölf Monaten
bis 31. Dezember 2005 versteht sich abzüglich 15,4 Mio USD für
Absatzretouren auf Grund des Produktrückrufs.

(2) Die Umsatzkosten für Tysabri in den zwölf Monaten bis 31.
Dezember 2005 enthalten 14,0 Mio. USD Vorratsabschreibungen auf Grund
der freiwilligen Aussetzung der Vermarktung von Tysabri.

(3) Gemein- und Konzernkosten wurden Tysabri nicht zugewiesen.

Kontakt

Elan Corporation, plc
Investor Relations
Emer Reynolds, [phone]
oder
Chris Burns, [phone]
oder
Media Relations
Davia Temin, [phone]
oder
Elizabeth Headon, [phone]

[Poppholz]

# 600

Hier der Link zu vorgelagerten Bericht.

Die Zahlen sind über den Link doch ein wenig besser nachzuvollziehen.



http://de.biz.yahoo.com/06022006/240/elan-finanzergebnisse-v…

[bernie55]

1:57 AM

Elan to sell rights to Prialt in Europe to Eisai (ELN)

Co announces that it has agreed to sell the rights to Prialt in Europe to Eisai Co, while retaining the product rights in the US. Under the terms of the agreement, Elan may receive up to $100 mln in cash; $50 mln on the closing of the transaction, a further $10 mln on the earlier of two years from closing or launches of Prialt in key European markets, and an additional $40 mln contingent on Prialt achieving revenue related milestones in Europe. The closing of the transaction, which is expected to occur in the Q106, is subject to the receipt of relevant regulatory authority approvals and other customary closing conditions. Elan expects to record a gain on closing in excess of $40 mln.

[bernie55]

ERGÄNZUNG der News :


Kelly Martin, Elan`s President and CEO said, "Prialt is a highly innovative, approved, intrathecal analgesic for patients suffering from severe chronic pain. Patient need in this area remains significant given that there have not been any meaningful therapeutic advances in this area for more than two decades. We are delighted that this transaction will enable Eisai to offer this new therapy to patients throughout Europe."

Mr. Martin concluded, "Elan will continue to market Prialt in the US and we look forward to working closely with Eisai on providing patients with a unique and effective choice in the treatment of severe chronic pain."

About Prialt

In February 2005, the European Commission (EC) granted marketing approval for Prialt (ziconotide) for the treatment of severe, chronic pain in patients who require intrathecal (IT) analgesia. Prialt has been awarded orphan drug status in the European Union, which designates it as a product used for the diagnosis, prevention or treatment of life-threatening or very serious rare disorders or conditions.

Prialt, developed by scientists at Elan, is in a class of non-opioid analgesics known as N-type calcium channel blockers. Prialt is the synthetic equivalent of a naturally occurring conopeptide found in a marine snail known as Conus magus. Research suggests that the mechanism of action of Prialt works by targeting and blocking N-type calcium channels on nerves that transmit pain signals.

The approval of Prialt was based on three independent pivotal studies, each of which demonstrated significant improvement on the Visual Analog Scale of Pain Intensity, a well-accepted pain outcome measure.

Prialt is currently marketed by Elan in the US where it was launched in the first quarter of 2005. Prialt revenue for full-year 2005 was $6.3 million.

About Severe Chronic Pain

Severe chronic pain is defined as pain lasting longer than six months and has multiple causes, such as failed back surgery, injury, accident, cancer, AIDS, and other nervous system disorders.

[Poppholz]

Für die Englisch-Legasteniker (zu denen ich mich ebenfalls zähle):



Business Wire
Elan verkauft die Europa-Rechte für Prialt an Eisai
Donnerstag 9. Februar 2006, 12:03 Uhr

Aktienkurse
Elan Corp
DRX.IR
12.40
+4.20%

DUBLIN, Irland 9. Februar 2006 Die Elan Corporation, plc meldete heute eine Vereinbarung zum Verkauf der Europa-Rechte für Prialt(tm) (Ziconotide, opiatfreies Mittel zur Behandlung chronischer Schmerzen) an Eisai Co., Ltd (Eisai). Das Unternehmen behält weiterhin die Produktrechte in den USA.
Der Vertrag sieht vor, dass Elan bis zu 100 Mio USD in Bar erhält sowie 50 Mio USD bei Abschluss der Transaktion, weitere 10 Mio USD entweder zwei Jahre nach dem Verkauf oder der Einführung von Prialt in wichtige Europamärkte, je nachdem was früher eintritt, und nochmals 40 Mio USD nach Erreichen von umsatzrelevanten Meilensteinen mit Prialt in Europa. Der Abschluss der Transaktion ist für das erste Quartal 2006 geplant und unterliegt der Genehmigung der zuständigen Behörden und anderen von den Vertragspartnern festzulegenden Abschlusskonditionen. Elan erwartet bei Vertragsabschluss ein Einnahmenplus von über 40 Mio USD.

Kelly Martin, Präsident und CEO von Elan, sagte: "Prialt ist ein hoch innovatives, zugelassenes intrathekal zu verabreichendes Analgetikum für chronische Schmerzpatienten. Der Bedarf auf Seiten der Patienten in diesem Bereich ist signifikant, da es seit mehr als zwei Jahrzehnten keine wesentlichen Therapieneuerungen mehr gegeben hat. Wir freuen uns sehr, dass es diese Transaktion Eisai ermöglichen wird, diese neue Therapie Patienten in ganz Europa zur Verfügung zu stellen."

Martin bemerkt abschließen: "In den USA wird Prialt weiterhin von Elan vermarktet, und wir freuen uns auf die enge Zusammenarbeit mit Eisai, damit wir den Patienten diese einmalige und wirksame Behandlungsmöglichkeit ihrer schweren chronischen Schmerzen anbieten können."

Über Prialt

Im Februar 2005 hatte die Europäische Kommission (EC) die Marktzulassung für Prialt (Ziconotide) zur Behandlung schwerer, chronischer Schmerzen bei Patienten erteilt, die intrathekale (IT) Analgetika benötigen. Prialt erhielt in der Europäischen Union den Status "Orphan Drug", das heißt, es handelt sich dabei um ein Produkt zur Diagnose, Prävention oder Behandlung lebensbedrohlicher oder sehr schwerer seltener Erkrankungen oder Störungen.

Prialt wurde von Wissenschaftlern bei Elan entwickelt und gehört zu einer Klasse von opiatfreien Analgetika mit der Bezeichnung N-Typ-Kalziumkanalblocker. Prialt ist das synthetisch hergestellte Äquivalent eines natürlicherweise vorkommenden Conopeptids der im Meer lebenden Kegelschnecke Conus magus. Forschungsergebnisse lassen den Schluss zu, dass der Wirkmechanismus von Prialt auf einer spezifischen Blockade von Kalziumkanälen des N-Typs auf Nervenzellen beruht, die Schmerzsignale übermitteln.

Die Zulassung von Prialt basierte auf drei unabhängigen Pivotalstudien, die alle eine signifikante Verbesserung der Schmerzintensität auf der allgemein anerkannten visuellen Analogskala zur Einstufung des Schweregrades von Schmerzen zeigten.

Prialt wird von Elan derzeit in den USA vermarktet, wo es seit dem ersten Quartal 2005 auf dem Markt ist. Die Produktumsätze für Prialt im Jahr 2005 beliefen sich auf 6,3 Mio USD.

Über schwere chronische Schmerzen

Schwere chronische Schmerzen sind definiert als Schmerzen, die länger als sechs Monate anhalten. Die Ursachen sind vielfältig und umfassen Wirbelsäulenoperationen mit erfolglosem Ausgang, Verletzungen, Unfall, Krebs, AIDS und Erkrankungen des Nervensystems.

Über Elan

Die Elan Corporation (NYSE: ELN), plc ist ein Biotechnologieunternehmen mit Schwerpunkt Neurowissenschaften. Das Ziel des Unternehmens ist es, das Leben von Patienten und ihren Familien zu erleichtern, indem es durch wissenschaftliche Innovationen signifikante und weltweit dringend benötigte medizinische Lösungen bereitstellt. Elans Aktien werden an den Wertpapierbörsen von New York, London und Dublin gehandelt. Mehr Informationen gibt es im Internet unter http://www.elan.com.

Zukunftsweisende Aussagen

Diese Pressemeldung enthält zukunftsweisende Aussagen über den geplanten Verkauf der Europa-Rechte an Prialt. Der Abschluss der Verkaufstransaktion und der Erhalt der Bstätigung der Planung eines solchen Verkaufs durch Elan unterliegen einer Reihe von Risiken und Unwägbarkeiten. Beispielsweise könnte der geplante Verkauf der Europa-Rechte an Prialt an Eisai durch Elan nicht stattfinden, da die Vereinbarung zum Verkauf solcher Rechte vor dem Abschluss aufgelöst werden könnte, wenn die Abschlussbedingungen wie beispielsweise die Zustimmung des Kartellamtes oder eine Exportlizenz nicht erhalten werden oder wenn die Marktzulassung für Prialt entzogen wird oder wenn Prialt den Orphan-Drug-Status verliert. Darüber hinaus sind Erhalt und Zeitplanung meilensteinbasierter Zahlungen an Elan selbst bei Durchführung des geplanten Verkaufs ungewiss. Mehr Informationen zu den Risiken und Unwägbarkeiten, die Elan betreffen, sind in unserem Jahresbericht auf Formblatt 20-F in der überarbeiteten Version sowie auf Formblatt 6-K enthalten, die sämtlich bei der Börsenaufsicht eingereicht worden sind.

Elan übernimmt keine Verpflichtung zur Aktualisierung zukunftsweisender Aussagen, weder bei neuen Informationen, noch bei zukünftigen Ereignissen oder aus anderen Gründen.

Kontakt

Elan Corporation
Investoren:
Emer Reynolds, [phone]
oder
Chris Burns, [phone]
oder
Medien:
Davia Temin, [phone]
oder
Elizabeth Headon, [phone]

[Poppholz]

Killing Elan`s Pain
By Rich Duprey (TMF Cop)
February 13, 2006

Did Elan (NYSE: ELN) give away the medicine chest? Severe painkiller Prialt doesn`t yet have the same blockbuster potential that multiple-sclerosis drug Tysabri seemed to possess, but the deal the company struck with Japanese pharmaceutical Eisai for the drug may have given away too much.

On the surface, Elan did OK. It will receive as much as $100 million for the drug, for which it realized $6.3 million in revenues in 2005. That`s a purchase price equal to 15 times sales. When Elan and Eisai negotiated the sale of Zonegran in 2004, Eisai agreed to pay as much as $240 million for the antiepileptic, which had revenues of $80.7 million -- a purchase price equal to three times sales. So the Prialt deal is better, right?

Not necessarily. While Elan retains the North American rights, Eisai acquires the exclusive development, manufacturing, and distribution rights for Europe. Even though U.S. sales have amounted to less than $10 million thus far, Elan has estimated that peak sales could reach $250 million. To date, Zonegran has been achieving 30% annual sales growth for Eisai and recorded first-half 2005 sales of 7.6 billion yen, equivalent to $68 million at then-current exchange rates. Furthermore, the fundamental U.S. patent on Prialt expires in 2011, while extending as far out as 2016 in Europe. Equally important for Eisai, Prialt has been granted "orphan drug status" in Europe, which grants the company 10 years of marketing exclusivity, unless another drug comes along that can be proven to be "clinically superior." That`s a tough hurdle for competitors to overcome.

Prialt, derived from a tiny marine snail, is in a class of non-opioid analgesics. That`s an important distinction, because opioids like morphine and codeine, while superior at shutting down pain receptors in the brain, are also highly addictive. The COX-2 pain relievers that held a lot of promise, like Merck`s (NYSE: MRK) Vioxx and Pfizer`s (NYSE: PFE) Celebrex, attacked pain by blocking pain-causing enzymes around joints, but they ended up causing additional problems. Prialt shows no signs of being addictive, even though it`s considered far more potent at blocking pain than morphine. However, it also tends to be more toxic, which caused the FDA to limit its treatment to patients in the U.S. for whom morphine is no longer effective. That severely curtails Elan`s potential market.

It`s definitely not a win-lose situation. Eisai will pay Elan $50 million when the deal closes, which is anticipated to be in the first quarter of 2006. Elan then should receive another $10 million within two years` time, or when the product is launched in key markets -- whichever is sooner. A final payment of $40 million will be realized if Prialt achieves certain sales milestones, for a total of $100 million. Without similar orphan drug recognition here at home, and with a more limited U.S. market, competitors can move in on Elan`s turf a lot sooner. Even so, Prialt is earning money for Elan, while it has yet to launch in Europe.

It`s only one drug, and Elan is in need of revenues these days to shore up the loss of Tysabri, but it seems to this Fool that Eisai got the better side of the deal.

Pfizer is a Motley Fool Inside Value recommendation. Merck is an Income Investor recommendation. Try a 30-day free subscription to the newsletter that best fits your investing style.

Fool contributor Rich Duprey owns shares of Eisai and Merck, but does not own any of the other stocks mentioned in this article. The Motley Fool has an ironclad disclosure policy.

[RedLobster]

Was habt ihr eigentlich für ne Exit-Strategie?

ich werd mich wahrscheinlich nach dem 7.3. verdünnisieren, wenn der Kurs nach dem FDA-Meeting (hoffentlich) explodiert.

Als Langfristkauf seh ich den Laden gar nicht

[Cyberhexe]

[posting]20.221.263 von RedLobster am 15.02.06 17:28:44[/posting]@lobster
Alzheimer research is the reason for being

Und falls Elan zusammen mit Wyeth tatsächlich den ersten Nutzen bringenden Wirkstoff gegen ein Fortschreiten der Alzheimer-Erkrankung auf den Markt bringen sollte, dann, ja dann wirst du dich wundern!

good luck
ch

[2CB_06]

WASHINGTON, Feb 15 (Reuters) - U.S. regulators said on Wednesday they will allow Biogen Idec (BIIB.O: Quote, Profile, Research) and Elan Corp. (ELN.I: Quote, Profile, Research) to resume use of their multiple sclerosis drug Tysabri in patients who had previously been taking it as part of a study.

The Food and Drug Administration said it will decide in late March whether the companies can resume widespread sales of the drug, which were halted after reports of a serious brain ailment in a small number of patients.

http://yahoo.reuters.com/stocks/QuoteCompanyNewsArticle.aspx…

[tippse]

Questions and Answers on Tysabri (natalizumab)
Regarding Lifting of the Clinical Hold

1) Why is FDA lifting the clinical hold?

We received detailed information on the extensive re-examination that Biogen and Elan undertook on all patients who had received natalizumab in clinical studies under an IND. No additional cases of PML were identified. The better understanding of the actual occurrence of PML in these patients permitted better estimation of the potential risk of PML occurring in the future. In addition, Biogen has proposed a resumption of natalizumab administration under an IND study with very specific plans for close monitoring of patients.


2) Will Tysabri be available to all patients?

Biogen has proposed to FDA only to resume administration of natalizumab to patients who had previously been receiving the drug within an IND study at the time of the suspension of use in February 2005. Those patients would need to discuss with their Study physician the potential risks and potential benefits of resuming treatment with natalizumab, and will be able to make a decision after that discussion. Biogen has not proposed to administer the drug to anyone who had not previously been receiving it under an IND study. Biogen has submitted an application to FDA to resume marketing the drug for more widespread use. That application has a due date for a decision by FDA in late March 2006.

3) What happens to the other holds on similar products and what is our process for lifting these holds?

The lifting of the clinical hold on natalizumab may lead to requests from other product sponsors to begin or resume clinical studies for molecules that act in a similar manner. FDA will consider each of those proposals as they are received. An important aspect to consider is whether the potential risk of a specific product is reasonable in the setting of a specific disease, type of patient, and other currently available therapies for that type of patient.


4) Is there still a significant safety concern with the product, and if so, why did we lift this hold?

FDA remains very concerned about the potential for PML associated with natalizumab use. However, the currently available information are not adequate to clearly define the level of risk or the exact circumstances when this risk occurs. Furthermore, the existing efficacy data with natalizumab indicate this is a very effective product and multiple sclerosis is a devastating neurologic disease. Therefore, if a study is done in a manner that provides as much safety monitoring as feasible, it is reasonable to resume studying this product under IND to obtain more safety-related information that may permit us to begin to better understand how large or small the true risks associated with natalizumab are.

http://www.fda.gov/cder/drug/infopage/natalizumab/natazumab_…

... schwer zu interpretieren für mich. ich denke aber, dass wir uns bis zu einer offiziellen vermarktungsfreigabe wohl noch etwas gedulden werden müssen ...

[Poppholz]

Serono Hit By Tysabri Clinical Trial News

Thursday, February 16, 2006 6:59:32 AM ET
Dow Jones Newswires

1036 GMT [Dow Jones] Serono (SRA) -0.9% at CHF931 on news that the FDA has cleared the way for Elan (ELN) to begin an open-label, multi-center safety extension study of Rebif`s rival drug Tysabri. "The FDA approval of additional clinical trials may be an indication of comfort with the risks," on Tysabri, says Kepler Equities. Says Tysabri will return to the market, which could take market share from Rebif. Notes FDA deadline, March 26. Keeps reduce rating, CHF700 target. (SWZ)


Contact us in London.
[phone]
[e-mail]

[Birgit.Tersteegen]

...und was sagt unser Hexchen zu den neueren Entwicklungen??

[Poppholz]

Biogen and Elan to resume Tysabri trial
17th February 2006
By Staff Writer

The FDA has removed restrictions on the use of the multiple sclerosis drug Tysabri allowing Biogen Idec and Elan to begin new clinical trials into the safety of the treatment.

AdvertisementBiogen and Elan had voluntarily removed Tysabri from the US market and all ongoing clinical trials following reports of three patients developing a rare and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML).

Now that the hold on clinical trial dosing of Tysabri (natalizumab) in multiple sclerosis (MS) has been removed, the companies expect to begin a multi-center safety extension study of the drug as a monotherapy. Patients who previously participated in the phase III MS program are eligible for entry.

The companies completed a comprehensive safety evaluation of more than 3,000 Tysabri patients in collaboration with leading experts in PML and MS. The results of the safety evaluation yielded no new confirmed cases of PML beyond those three previously reported.

The FDA is due to make a decision on whether the drug can re-enter the market by March 2006.

http://www.pharmaceutical-business-review.com/article_news.a…

[Cyberhexe]

ohohoh...die wohl bemerkenswerteste Äusserung aus diesem Interview mit Forschungsleiter Lars Ekman, dass dieser von keinem anderen Forschungsprogramm, einschliesslich Tysabri, mehr fasziniert/interessiert war:

‘‘I have never been more intrigued by any programme I have been involved in, including Tysabri, over the last 25 years,” he said.

http://www.thepost.ie/post/pages/p/story.aspx-qqqt=MARKETS-q…

[Cyberhexe]

das liest sich sehr verheissungsvoll; sollte Elan zusammen mit Kooperationspartner Wyeth tatsächlich einen wirkungsvollen Alzheimer-Wirkstoff auf den Markt bringen, der nicht nur den Krankheitsverlauf verlangsamt sondern die kognitven Fähigkeiten gar verbessert, dann gibts nicht nur den Nobel-Preis, dann wird auch der Kurs in schwindelerregende dreistellige Höhen emporschnellen.
Und was man dabei nicht vergessen sollte, dass einer schrecklichen Krankheit der Stachel gezogen werden könnte.

Elan for ever!!

Vacine for Alzheimer`s Disease
The goal is to eliminate Beta Amloid in the brain, which is the toxic species that gives the symptoms of the disease. The antibody attacks the A-Beta 42. It extracts these peptides out of the plaques. The plaque disappears and we can hopefully then give the memory back to the patients.
Question: So, in effect you are administrating an artificial harmless form of this Beta Amloid into peoples bodies and hoping they will produce antibodies in response to it.
Answer: That is correct, that is the harmless species of A Beta. The form that you described have actually already been tested in man. We did two studies, one with 120 and one with 360 patients. That study revealed on the positive side we could improve memory function, we could improve executive functions and we could improve the quality of life of the patients. However that drug had side effects in some, in a few patients, a transient inflamation. So, we at that point decided to abandon the program. We identified what the problem was and we are now back into clinical programs with a product that do not give raise to these kind of problems

[Birgit.Tersteegen]

[posting]20.394.371 von Cyberhexe am 26.02.06 20:38:58[/posting]

[welke91]

[posting]20.394.371 von Cyberhexe am 26.02.06 20:38:58[/posting]So wie sich das anhört, einfach Klasse, eine Steigerung in der Merkfähigkeit und Probleme mit Nebenwirkungen (inflammatio (lat.) Entzündung die sie in Griff bekommen also wenn das nix is!

[welke91]

@ Cyber wie war das nochmal mit der Mrs. Smith?

wie kann so etwas passieren?

http://www.boston.com/business/technology/biotechnology/arti…

[Cyberhexe]

http://content.nejm.org/cgi/content/abstract/354/9/899?hits=…

[Cyberhexe]

...um noch einmal auf den Vergleich mit HIV zurückzukommen, anbei ein Auszug aus dem im NEJM veröffentlichten Artikel:

Infections were generally mild to moderate in severity and did not lead to drug discontinuation. The overall incidence of infection was 79 percent in each treatment group and occurred at a rate of 1 per patient-year in each group. When the rate was reanalyzed to include multiple occurrences of infection, it went up in each group, as expected. However, there remained no significant differences between the groups, with infections occurring at a rate of 1.52 per patient-year in the natalizumab group and 1.42 per patient-year in the placebo group (P=0.32).

Trotz einer Herabsetzung der Immunabwehr ist die Infektionsrate bei den mit Natalizumab behandelten Studienteilnehmern kaum höher als in der Plazebo-Gruppe.

Im EYMB hat einer der wissenschaftlichen Experten die Gleichsetzung von HIV mit Natalizumab verglichen mit einer Gleichsetzung von Helium und Wasserstoff auf Grund der Tatsache, dass beide Gase für den Auftrieb bei Luftballons sorgen.
Jeder der sich etwas mit Chemie beschäftigt weiss jedoch, dass Helium als Edelgas absolut reaktionsträge und deswegen ungefährlich ist, Wasserstoff hingegen in Verbindung mit Luftsauerstoff verheerende Explosionen verursachen kann.


http://content.nejm.org/cgi/content/full/354/9/899?excludefl…

[welke91]

ich begrüße diese DATEN sind verdammt stark!

Cyber es gab ein hold auf diese Trials inwiefern könnte das beeinträchtigt haben?
So um die 20%

P=0,001=geiles Ergebniss

freue mich für alle MS Patienten

[welke91]

Tysabri, a drug made by Biogen Idec and Elan Pharmaceuticals, significantly reduces the rate of disease progression in patients with relapsing multiple sclerosis (MS), according to the results of two trials reported in this week`s New England Journal of Medicine.

"The available drugs for MS, interferon and Copaxone, have been shown in trials to reduce relapse rate by one third," Dr. Richard A. Rudick, of the Cleveland Clinic Foundation in Ohio, told Reuters Health. The two current trials show that "the effectiveness of Tysabri was very excellent," far better than that of the other available drugs.

However, a review of more than 3000 patients treated with Tysabri (which is known as natalizumab, generically) in clinical trials revealed that the drug is associated with a small risk of a serious neurological disease called progressive multifocal leukoencephalopathy or PML.

@ Cyber hast du Zugang?

http://www.healthcareindustrytoday.com/
is ein interessanter Artikel über Elan CEO drinn....Alzheimer etc.

[Cyberhexe]

Ein Vertreter von MSAA hat sich vor dem „Advisory Committee“ dafür stark gemacht, dass vor der Widerzulassung von Tysabri neue Studien durchgeführt werden sollten. Anbei die Sponsorenliste von MSAA:

http://www.msaa.com/corporate.html

[eliasesteban]

moin,das wär aber nicht so toll,nicht nötig wie ich finde,genug studiert,auserdem wird an dem mittel ja ständig gearbeitet.

[Cyberhexe]

ungünstig ist die Tatsache, dass Biogen über das BLA verfügt und Elan somit keine Möglichkeit hat direkt in den Verlauf des AC einzugreifen
Die PML-Fälle werden deswegen lediglich mit Tysabri in Verbindung gebracht, jedoch kein Wort von Avonex bzw. dass in der Monotherapie bisher keine PML-Fälle aufgetreten sind (beim PML-Fall in der SENTINEL-Studie (MC) wurde zuvor mit Azathioprin immunsupprimiert).

[Cyberhexe]

...aber ich bin dennoch felsenfest davon überzeugt, dass die Zulassung empfohlen wird...
bin allerdings gespannt, welche Einschränkungen gemacht werden. Ich tippe auf ein "black box label" bezüglich PML!

[bernie55]

[posting]20.570.596 von Cyberhexe am 08.03.06 10:57:13[/posting]Glaubst du , Cyberhexe, dass die Experten bei der FDA nicht auch genau wissen, welche Rolle BIOGEN im Zusammenhang mit der Zulassung von Tysabri spielt ???

Wenn sie zumindest über dein fundiertes Fachwissen verfügen, werden sie auf jeden Fall die von dir erwähnten Aspekte mit in ihre Überlegungen einbeziehen, oder nicht ????

Grüße bernie55

[bernie55]

[posting]20.571.329 von Cyberhexe am 08.03.06 11:21:41[/posting]...nach Abwägen aller Informationen, die mir vorliegen bzw. die ich als " Laie " verstehe, kann es doch eigentlich nur eine Zulassung von Tysabri geben.......

Ich gehe auch davon aus, dass Einschränkungen gemacht werden - wie diese jedoch genau aussehen, entziehen sich meiner " laienhaften " Kenntnisse.....

Wie würde denn ein " Black Box Label " für PML aussehen ????

Würden genauste diagnostische Anforderungen an die verschreibende Ärzte gestellt werden ???

[Cyberhexe]

[posting]20.571.767 von bernie55 am 08.03.06 11:39:52[/posting]@bernie
ein "black box label" ist die grösste Warnung, welche von der FDA zu einem Medikament gegeben wird. Mit ihm wird in der Regel darauf hingewiesen, dass tödliche Nebenwirkungen nicht auszuschliessen sind.
Diese Warnung ist jedoch auf vielen Beipackzetteln von zugelassenen Medikamenten zu finden und soll nicht bedeuten, dass eine Anwendung nicht empfohlen wird.

[Cyberhexe]

Infliximab (brand name: Remicade) der bisherige Gold-Standard bei der behandlung von MorbusCrohn hat beispielsweise folgenden Hinweis:

"Tuberculosis…and other opportunistic infections…have been observed in patients receiving Remicade…Some of these infections may be fatal."

Etwas Analoges wird es wohl auch für Natalizumab geben.

[bernie55]

Thanks , Cyberhexe....

[Cyberhexe]

na also, exklusiv vom AC...keine weiteren Daten erforderlich

[Cyberhexe]

der "worst case" ist abgewendet, jetzt bin ich mal auf das Label gespannt...also Jungens und Mädels jetzt kanns losgehen!

[Birgit.Tersteegen]

SPANNEND!DANKE!GRUSS!

[bernie55]

der " worst case" ist abgewendet, jetzt bin ich mal auf das Label gespannt...also Jungens und Mädels jetzt kanns losgehen!

[Nostarowie]

SCHTRONG BAI

[Poppholz]

[posting]20.576.644 von Cyberhexe am 08.03.06 15:42:42[/posting]Danke für die INFO.

(Dein Wort hat doch ein wesentlich größeres Gewicht, als dass der Yahoo Board Teilnehmer)

[Cyberhexe]

"Time is brain" for MS patients ...wenn es so weiter geht, dann ist sogar eine Erstmedikation mit Ty wieder durchaus realistisch!

[Cyberhexe]

[posting]20.576.954 von Poppholz am 08.03.06 15:53:24[/posting]da muss ich dir aber widersprechen....im EYMB (ElanYahooMemberBoard) gibt es einige Experten (z.B. Pin, neuro, und natürlich peadar, der sich endlich auch wieder mal gemeldet hat), mit deren Fachwissen ich nicht mithalten kann und von denen ich jede Menge gelernt habe. Also deswegen...alle Komplimente gehen ans EYMB.

good luck
ch

[bernie55]

ACHTUNG !!!!! ACHTUNG !!!!! ACHTUNG !!!!! ACHTUNG !!!!!

LINK zur KONFERENZ:

http://wmslive.talkpoint.com/bear002_15147_150k.wmv


...mit Windows Media Player....

[Cyberhexe]

nachdem der Moderator die anwesenden Spezialisten gefragt hat, ob sie Tysabri als "first line treatment" verabreichen würden, hat sich die Mehrheit (7:5) dafür ausgesprochen

[Cyberhexe]

einig waren sich die Experten, dass die Anwendung nur auf RRMS (Relapsing-Remitting Multiple Sclerosis) beschränkt sein soll - dafür wurde Tysabri auch getestet...war also nicht anders zu erwarten, wobei ich mir vorstellen könnte, dass Natalizumab auch bei den anderen Formen (Sekundär progrediente MS, progredient schubförmige MS) wirksam sein könnte

[Cyberhexe]

alle bisherigen Abstimmungen:

1) Tysabri als Erstmedikation möglich
ja:7
nein:5

Kommentar: fantastisch

2) Medikation nur bei höheren EDSS-Werten (mit der Leistungsskalla "EDSS" werden neurologische Behinderungsgrade angegeben)
ja:1
Rest nein

Kommentar: fantastisch

3) Medikation ohne RRMS (also andere MS-Formen)
einstimmig nein

Kommentar: erwartet


4) Medikation in Kombi-Therapie
einstimmig nein

Kommentar: erwartet

[Cyberhexe]

es geht weiter!

[Cyberhexe]

12:0
für die Rückkehr Tysabris auf den Markt

[lonesome loser]

WASHINGTON -(Dow Jones)- A U.S. Food and Drug Administration panel said the multiple-sclerosis drug Tysabri could be given without restrictions, in a precursor vote to the question of whether the drug should be returned to the market.

The drug`s manufacturers, Biogen Idec Inc. (BIIB) (BIIB) and Elan Corp. (ELN) (ELN), pulled the drug in February 2005 after two patients developed a rare brain disorder, known as progressive multifocal leukoencephalopathy, or PML, and one died. A third patient was later discovered to have PML and also died.

The 12-member panel of outside medical experts voted 7 to 5 in favor of allowing doctors to use Tysabri as a first-line treatment, meaning that other MS drugs would not have to be tried first. The panel voted 11 to 1 against requiring that the drug be used in sicker MS patients.



The panel has not yet voted on whether it would allow Tysabri to return to the market. However, earlier the panel said the FDA should not require the companies to conduct additional studies before the drug should be put back on the market, suggesting the panel supports at least a limited return.

The FDA usually follows its panel`s advice, but is not required to. The agency is expected to make a final decision by the end of the month.

[Cyberhexe]

nun ist Mittagspause bis 19:30 (MEZ)

[Birgit.Tersteegen]

[posting]20.580.934 von Cyberhexe am 08.03.06 18:33:12[/posting]Ist jetzt die Empfehlung es zuzulassen klar und auch ohne gravierende Label?

[Cyberhexe]

es sollte jetzt nichts mehr schief gehen, da die FDA dem Vorschlag des AC normalerweise folgt

gerade hab ich im EYMB aufgeschnappt, dass Lars Ekman mit Eskorte eingetroffen ist und ausserdem ein Beobachter der europäischen Arzneimittelzulassungsbehörde EMEA anwesend sein soll - angeblich ein Mediziner aus Deutschland.

Die Zulassung in Europa sollte nun auch nicht mehr lange auf sich warten lassen.

deswegen nicht "mayday" sondern "payday"

good luck
ch

Birgit gibts auch eine 30$-Party ?

[Cyberhexe]

einen Hinweis analog demjenigen bei Remicade
wird es schon geben

" Tuberculosis…and other opportunistic infections…have been observed in patients receiving Remicade…Some of these infections may be fatal."

aber dieser sollte den Absatz nur geringfügig beeinflussen - wichtig erscheint mir die Tatsache, dass es als Erstmedikation zugelassen wird, dann scheint mir Blockbuster-Potential garantiert.

[Birgit.Tersteegen]

[posting]20.581.329 von Cyberhexe am 08.03.06 18:53:24[/posting]30$ Party a.d. Seychellen--Kommste denn dann auch?

[Cyberhexe]

Seychellen ...eigentlich nicht ganz so meine Richtung...aber spätestens auf der "triple digit party" bin ich dabei

[Birgit.Tersteegen]

die ist nur für Dich,Hexchen!

[Birgit.Tersteegen]

gehts jetzt um Fragebögen,die die Patienten bekommen wenn sie TY nehmen?

[Cyberhexe]

es geht grundsätzlich darum, wie man eine PML-Erkrankung erkennen kann (monitoring)...aber es ist schon sehr medizinisch...versteh auch nicht alles

[Cyberhexe]

nun wirds ja immer besser, fast schon unheimlich...angeblich soll eine Studie mit Tysabri bei progressiver MS modelliert werden

na dann Prost!

so mir reichts...besser wirds nimmer...keep cool stay long...mit viel Vorfreude auf Morgen grüsse ich alle germelans

;-))))

good luck
ch

[hechtbarsch]

danke für die Recherchen!

hb

[welke91]

grandios Hexe!

und die 2 year data ist auch grandioser als grandiose also grande grande am Rande alles supi Prost

Pinot Grigio musste sein...

[Birgit.Tersteegen]

Tomorrow`s Trading
by: fixer13605
Long-Term Sentiment: Strong Buy 03/09/06 12:20 am
Msg: 950452 of 950452

IMHO we can expect to finally see the retail sector really start to step in, I don`t think that even one percent of the trading that occurred today was retail.

Institutions already had their buy programs in place when the AC rendered it`s decision, the way the vote went IMHO only helped to create the mass hysteria buying that we saw in "ONE HALF HOUR" today.

Regarding short positions... the last short update showed that the smarter money was already positioning itself to be... covered on their existing short positions (remember 5 million shorts covered last month) and they`re poised to either re-short based upon a less than favorable decision or immediately go long this stock if the decision was favorable to Tysabri, remember they`ve had almost a month to cover their asses at our expense by controlling and dropping the price with phony trades. The furious half hour of trading that took place today was all about the BIG BOYS shoving their way to the front of the buffet line.

How many small retail investors do you think got their orders filled in what was probably a scene in the trading pits equivalent to the movie trading places when the orange juice report came out contrary to what they thought they knew was going to happen.

Tomorrow we can expect a real interesting day if there truly is a greater short position left than indicated, but we won`t be able to see the true number for a few more days.

There most likely will be squawking weasels yelling SELL SELL SELL and TIMBBRRRRRRRRRRRR, but we`ve truly weathered the worst of the storm, I held onto every share going into the AC on a very nervous stomach not because of a lack of faith in TY, but a lack of faith in peoples ability to do what is right, I hoped that the patients rights would weigh more than dollars, luckily I was right.

The worst is behind us, so cancel your stop losses, lighten your margins, these are tools that they will use against us, the future looks bright for both the shareholders and those that are afflicted with MS.

Keep the faith, hold on to your shares, you`ve got an E ticket on the best ride in the park, next stop... Alzheimer`s station!!!

GOOD LUCK TO US ALL!!!

[Cyberhexe]

nun erst mal tief durchatmen und dann über Strategien nachdenken, zuvor jedoch noch einmal die Fakten/Risiken ordnen:

- Tysabri wird diesen Monat noch vermarktet und zwar als "first line treatment", Erstmedikation also möglich
- EMEA wird Zulassung ebenfalls erteilen --> EU-Vermarktung ab 3.Q/06 (BLA bei Elan!)
- Bekanntgabe der ersten Studienergebnisse (Phase III) zu AAB noch in 2006
- Bekanntgabe weiterer Nanochrystal-Abkommen möglich
- Nachfrage nach Tysabri sehr wahrscheinlich über Prognosen

- derzeit keine Tysabri-Medikation, d.h. vorerst sind keine "fatalen Ereignisse" analog "Black Monday" (28.02.05) möglich


Conclusion: momentan ist ein Investment in Elan nicht so riskant wie auch schon; die positiven Nachrichten werden in den kommenden Monaten sehr wahrscheinlich eindeutig überwiegen und den Kurs nach oben treiben (falls erste Tysabri Zahlen überzeugen)
Zudem sind noch 27 Mio Aktien "short", die wohl vor Bekanntgabe der Alzheimer-Ergebnisse zum grössten Teil abgebaut werden, d.h. es wird auch von dieser Seite ein Nachfrageüberhang geben.
Also, jetzt zu verkaufen scheint mir eine vergebene Chance zu sein, trotz Investitionsgrad > 100%
Erst im Sommer wird das Risiko gestreut, so wie es sich für einen seriösen Investor auch gehört

;-))

keep cool, stay long
ch

[eliasesteban]

hallo hexe,wollt mich mal so nebebei bei dir für deine grossartige arbeit bedanken!

[Cyberhexe]

gelungene Zusammenfassung von der Analystenkonferenz aus dem EYMB:

CC Notes...............Pt 1
by: dallas769 03/09/06 12:47 pm
Msg: 952125 of 952141

Quick generalities and typing fast bearwthme...

Timeline for T:
-should T be made available to some subset of rrms..fda voted yes 12-0
-T should be made 1st line treatment---no boundries to edss scores upper and lower
-no combo-MONO
March 29th Pdufa date:
-T registry
-What types of patients(some or all)
-label finalizations
-RiskMAP guides etc...
AD:
-AAb-001 half way thru Phase 2 some data towards end of year.
-AAC-001 Phase 1 progressing from enrollment and processing point of view.
-3 immuno therapeutics for AD(10 times amount of patients)unmet medical need!
4.5 million patients--growing exponentially!!!
15-20 years of research on AD if no treatments some estimates of patients to be in the 35-40 million

Drug Delivery:
-4 Prod using Nanotechnology
each doing very well
Nano is positive going forward
- 5 or 6 expansions of business.....
Partnered compounds or solo applications pertaining to Nano
-70 compounds in pipeline...analyzing which of the 70 can we change/improve using the best technicals...and for many different therapies...cardiac(I think was mentioned) etc...

Q&A summary to follow------shortly!!!
sorry for any typos

[Cyberhexe]

ich denke, man sollte Forbes beim Wort nehmen:

* If you do not already own Elan, buy some at the current price.

* If you currently have a small position in Elan, add to your position.

* If Elan already represents more than 10% of your portfolio, you may have an opportunity to trim the position on this run-up.




http://www.forbes.com/2006/03/09/elan-tysabri-comeback-in_kk…

[Cyberhexe]

das Volumen mit 30 Mio Aktien in den US ist beeindruckend; allerdings ist es für mich nicht verständlich, dass derart viele Aktien zu solch niedrigen Kursen geradezu verschleudert werden.

Interessant in diesem Zusammenhang ist jedoch der Hinweis, den ich bereits mehrfach im EYMB aufgeschnappt habe: Angeblich ist es eine Strategie von shorties, weitere bei den Brokern geleaste Aktien am Markt zu platzieren, um so den Kurs niedrig zu halten. Deswegen wird empfohlen, bei den Depotbeständen utopische Verkaufsorder einzugeben, um eine Ausleihe zu verhindern.
Bei meinen US-Beständen hab ich das nun mal gemacht ($55).

[welke91]

[posting]20.604.255 von Cyberhexe am 09.03.06 20:24:45[/posting]wat utopisch Hexe utopisch 55 $ is net utopisch!

in wie fern könnte sich das Nanopotenzial noch entwickeln?

denke der Nanorun bleibt hier aussen vor aber sicher wird es medikamentöse behandlung geben die mit dem Nano von Elan besser anschlägt!

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4208-in…

grüße

[Cyberhexe]

[posting]20.607.968 von welke91 am 10.03.06 08:23:52[/posting]@welke
selbstverständlich kurzfristig utopisch
mittel-bis langfristig narürlich durchaus realistisch

[tippse]

der mann hat spaß bei seinem job ...


Elan exec makes €340,000 profit as FDA clears Tysabri
Sunday March 12th 2006

MARTIN FITZPATRICK

ELAN`S research and development director, Lars Ekman was one of the fastest into the market when the temporary suspension of the pharma group`s shares was over on Wednesday last.

Mr Ekman made a quick profit worth the equivalent of €342,000 when he exercised share options on 30,000 shares and sold the same number just as the share resumed its quotation after a two-day suspension to allow the advisory committee of the US Food and Drugs Administration (FDA) consider the future of the controversial drug Tysabri.

In the event the advisory panel`s finding were generally favourable. Mr Ekman who had exercised options on 30,000 shares at an option price of $2.11 per share immediately sold 30,000 shares at the unexpectedly high post suspension price of $15.70 per share.

It is reckoned that Tysabri could be back on the market by the middle of the year, but in a restricted way. Elan`s 50 per cent partner in producing Tysabri, Biogen has already proposed a plan that would call for the mandatory registration of all Tysabri users into a database that would track them for adverse reactions for several years.

The plan also calls for the drug to be administered only at registered infusion centres.

In addition, Biogen has proposed that Tysabri`s prescribing information carry a stern "black box" warning. The firm would also issue educational materials to both patients and doctors about the drug.

http://www.unison.ie/business/stories.php3?ca=80&si=1579569

[Cyberhexe]

ELN had a big week last week. It was announced that Tysabri will be re-launched in June. This was obviously big news for ELN, as Tysabri being pulled almost drove the stock to penny stock status. ELN bounced nicely off of the news, but now what? Where does the stock go to from here? Short-term, I believe that ELN will consolidate a bit this week in the low $14 range, before continuing higher over the next month or two. I believe that ELN, which is now trading at $14.56, will take out its 52 week high of $16.83 before the end of April. Although I don’t own shares, I like this company, and believe it goes higher, after consolidating a little bit.



http://www.flowtrader.net/2006/03/12/eln-the-week-ahead/


das glaub ich auch:
"...will take out its 52 week high of $16.83 before the end of April."

[Cyberhexe]

na also...auch BBBiotech glaubt an Elan:
im Februar 2006 wurde der Bestand von 2.4 Mio auf 2.7 Mio Aktien erhöht
http://www.bbbiotech.ch/index.php/bbbiotech_de/de/informatio…

[Cyberhexe]

dann sollte es bei der EMEA ja auch zügig voran gehen:

http://www.emea.eu.int/pdfs/general/direct/pr/9309006en.pdf

[Poppholz]

[posting]20.699.767 von Cyberhexe am 15.03.06 15:34:36[/posting]wahrscheinlich werden die aber noch da GO der FDA abwarten, oder meinst Du die EMEA wird der FDA die Show stehlen?

[Cyberhexe]

da wurde im Musterdepot sogar noch von Biogern nach Elan umgeschichtet:

http://www.marketocracy.com/media/pdf/marketscope/CurrentMar…

[Cyberhexe]

[posting]20.703.062 von Poppholz am 15.03.06 17:04:04[/posting]@poppi
die EMEA wird natürlich die FDA-Entscheidung abwarten, aber danach könnte es relativ schnell gehen.
Mein Tipp, vor den Sommerferien...im Juni

[Poppholz]

[posting]20.703.725 von Cyberhexe am 15.03.06 17:24:50[/posting]quartalsweise gute News würde unserem Kurs bestimmt nicht schaden.

[welke91]

http://www.aerzteblatt.de/v4/news/news.asp?id=23481

Todesfälle bei Alz-Tests mit Aricept&Reminyl®,...
grüße

[Poppholz]

@ Cyberhexe: Was hat das zu bedeuten?

Börse Go
FDA erweitert Zeitraum zu Tysabri-Prüfung
Mittwoch 22. März 2006, 08:51 Uhr

Die US-Gesundheitsbehörde FDA will ihre Überprüfungen zu dem vom Markt genommenen Multiple Sklerose-Präparat Tysabri um 90 Tage ausweiten. Dies gaben Biogen Idec (NASDAQ: BIIB - Nachrichten) und Elan am Mittwoch bekannt. Die Unternehmen gehen davon aus, dass die FDA bis zum 28. Juni eine Einschätzung über die Risiken von Tysabri und einen entsprechenden Managementplan zur Vorlage bringt.

[YoungRich]

Ja bravo .. hat jemand RT ?

Tx
Young

[YoungRich]

- 10% ...super ..

[YoungRich]

Hallo ...lebt Ihr noch ? :-)

[Poppholz]

[posting]20.903.528 von YoungRich am 22.03.06 10:33:55[/posting]der Thread von Cyberhexe "soll" hauptsächlich für Infos genutzt werden, hat sich in der Vergangenheit so ergeben.

(im anderen Thread ist allerdings auch nicht viel los)

[Cyberhexe]

Antwort auf Beitrag Nr.: 20.903.616 von Poppholz am 22.03.06 10:36:50

anbei die deutsche Übersetzung der Zusammenfassung aus dem "New England Journal opf Medicine" über die Wirksamkeit von Natalizumab

http://content.nejm.org/cgi/content/german_abstract/354/9/89…


Da ich in meinem Bekanntenkreis 2 Personen habe, die sehnlichst auf die Zulassung von Tysabri warten, habe ich folgende E-Mail an
den Beauftragten des dt. Instituts für Arzneimittel geschrieben:

---------------------------------
Sehr geehrter Herr Enzmann,
zu meinem engeren Bekanntenkreis gehören 2 an MS erkrankte Personen.
Da die am Markt eingeführten Medikamente (Avonex, Betaseron, Copaxone und Rebif) bei beiden den Krankheitsverlauf nicht wesentlich beeinflussen konnten, haben beide die Hoffnung, dass mit dem ersten alph4-Integrinantagonist (generic name: Natalizumab; brand name: Tysabri) ein massgeschneiderter Wirkstoff bereitgestellt wird, der den weiteren körperlichen Zerfall verhindern könnte.
Trotz der bekannten Probleme mit PML (allerdings nur in SENTINEL = Kombi-Therapie mit Avonex und bei ENACT bei einer stark immunsupprimierten Vorgeschichte; nicht jedoch in den Mono-Studien) ist und bleibt Natalizumab der einzige Hoffnungsschimmer für meine Bekannten.
Umso grösser ist nun die Enttäuschung, dass die FDA weitere 90 Tage benötigt, um eine endgültige Entscheidung über die Wiederzulassung zu treffen. Darüber hinaus stellt man sich die Frage, weshalb von der europäischen Zulassungsbehörde gar nichts vernommen wird, obschon der Antrag auf Zulassung bereits am 4. Juni 2004 gestellt wurde. Für meine Bekannten gilt „time is brain“, zumal der EDSS sich bei beiden in dieser Zeit massiv verschlechtert hat – bei beiden derzeit bei „5,5“.

Könnten Sie mir Auskunft geben, in wie weit die Beratungen der EMEA fortgeschritten sind und ob meine Bekannten noch in diesem Jahr mit der Verfügbarkeit von „Tysabri“ rechnen können.

Ich wäre Ihnen sehr dankbar, wenn Sie mir eine kurze Auskunft in dieser Angelegenheit geben könnten.
------------------------

--> anbei die Adressen der Ansprechpartner in den einzelnen Mitgliedstaaten der EMEA

http://www.emea.eu.int/htms/general/contacts/CHMP/CHMP_membe…

meiner Meinung nach sollten alle Betroffenen (also Patienten, nicht Investoren) sich entsprechend äussern, damit nicht unnötig Zeit verloren geht, denn "time is brain"

ch

[Cyberhexe]

Antwort auf Beitrag Nr.: 20.935.346 von Cyberhexe am 24.03.06 11:43:15

anbei eine 2. ins Deutsche übersetzte Zusammenfassung aus dem NEJM, und zwar zu PML

http://content.nejm.org/cgi/content/german_abstract/354/9/92…

[bernie55]

Was hälst du von diesem Statement, Cyberhexe ??

Es scheint wirklich nicht alles mit rechten Dingen zuzugehen....

FDA to ask for more safety data
by: wallstreetmaster9999
Long-Term Sentiment: Strong Sell 03/24/06 01:40 am
Msg: 969680 of 969715

Another horrific scenario that may happen is that the FDA will ask for 6-12 months more safety data PER BIOGEN's request. That would be the best scenario for Biogen and they have all the control with regards to marketing, how and when Tysabri will be introduced. You all think this is ridiculous and will never happen, but Elan is a ridiculous stock in the way it behaves. Tysabri should have been approved first time around and wasn't. Tysabri should have been approved second time around and is delayed. Tysabri should be approved after this delay, but FDA will ask for more data. That will send pps crashing back to the 3-4 range.

[bernie55]

Antwort auf Beitrag Nr.: 20.935.346 von Cyberhexe am 24.03.06 11:43:15

...well done, Cyberhexe....

[Cyberhexe]

Antwort auf Beitrag Nr.: 20.935.467 von bernie55 am 24.03.06 11:51:48

@bernie

natürlich könnte man Biogen ein Interesse unterstellen, die Zulassung eines Konkurrenzproduktes zu verzögern; allerdings glaube ich, dass mit einem 50%-Anteil an Tysabri mindestens genau so viel Umsatz zu generieren ist als mit 100% Avonex. Und da auch die Avonex-Umsätze nicht auf Null zurückgehen werden, wird auch Biogen von der Zulassung profitieren.

Plausibel scheint für mich die Erklärung, dass die FDA nicht darauf vorbereitet war, dass Tysabri als "first line treatment" empfohlen wird und deswegen der Risikoplan einen grössere Vorbereitung benötigt.

Allerdings bin ich der Meinung, dass diese Verzögerungen nicht verhältnismässig sind und zu Lasten der betroffenen Patienten gehen. Deswegen wird in den Staaten ein entsprechender Druck auf Politik und FDA aufgebaut , so dass das Prozedere vielleicht doch noch bescghleunigt wird.

Warum nicht auch in Europa? (siehe posting von 11:43h)


ch

[Cyberhexe]

anbei eine Zusammenfassung vom FDA-Panel zu Natalizumab:

http://www.stones.net/TysabriAC.pdf

[Cyberhexe]

nun ist der generic name von AAB-001 geboren:

BAPINEUZUMAB

etwas gewöhnungsbedürftig, aber verheissungsvoll - wird das der grosse Durchbruch?


http://www.ama-assn.org/ama1/pub/upload/mm/365/bapineuzumab.…

[lonesome loser]

Antwort auf Beitrag Nr.: 20.997.822 von Cyberhexe am 29.03.06 19:51:50

UPDATE: Biogen, Elan To Resume Tysabri Trials



Wednesday March 29, 5:08 PM EST


LOS ANGELES (Dow Jones) -- Biogen Idec Inc. (BIIB) and Elan Corp. Plc (ELN) said Wednesday they plan to resume clinical trials of their Tysabri multiple sclerosis drug after finding no new instances of a potentially fatal side effect in patients.

Biogen (BIIB) and Elan (ELN) ended trading up 3% just before the companies announced their plans to resume testing the drug that was pulled from the market more than a year ago.

The companies said they have enrolled and dosed the first patients in what they called a monotherapy safety extenstion study program. Sites in the U.S., Europe, Canada, Australia, New Zealand and Israel are included.

Biogen and Elan pulled Tysabri off the market in February 2005 after three patients taking the drug contracted a brain disease called progressive multifocal leukoencephalopathy, or PML. Two of them died.



The U.S. Food and Drug Administration was expected to rule by Wednesday on whether to allow Tysabri to return to the market, but then extended that review period to June 28.

Biogen and Elan said they conducted their own study of 3,000 Tysabri patients and used experts in PML and multiple sclerosis and found no new confirmed cases of PML.

The companies said in a press release that on March 8, an FDA advisory panel voted to reintroduce Tysabri to treat relapsing multiple sclerosis.

[lonesome loser]

Antwort auf Beitrag Nr.: 21.002.997 von lonesome loser am 30.03.06 07:40:02

Biogen, Elan Start Tysabri Study

By Althea Chang
TheStreet.com Staff Reporter
3/29/2006 5:59 PM EST
Click here for more stories by Althea Chang


Biogen Idec (BIIB:Nasdaq - commentary - research - Cramer's Take) and Elan (ELN:NYSE ADR - commentary - research - Cramer's Take) have started enrolling patients in a safety study of Tysabri, the multiple sclerosis drug that was pulled from the market last year after being linked to a rare brain disease.

The companies, seeking to return Tysabri to the market, said Wednesday that they have dosed the first patients in a safety extension study program. Biogen and Elan had previously pulled all clinical trials of Tysabri after the drug was linked to two cases of progressive multifocal leukoencephalopathy, a sometimes fatal brain disease. The companies conducted a safety review on more than 3,000 patients, and no additional cases of the disease were found.





1. 360 Degrees of JDSU
2. Lucent, Alcatel Talk Merger
3. Level 3 Raises Its Game
4. Three Low-Risk Stocks Even Bears Love
5. Hello, Goodbye at Rambus





The Food and Drug Administration is mulling whether to allow the drug back on the market based on its efficacy, which a number of patients attested to in an emotional public hearing at a meeting of an FDA advisory committee earlier this month.

According to some patients, after only one dose of Tysabri, they saw significant improvements in movement and ability to think. Multiple sclerosis is a degenerative disease of the central nervous system that causes loss of motor skills and cognition.

Following the hearing, the committee recommended that the drug be allowed to return to the market. The FDA is not required to follow advisory committee suggestions, but it often does.

Last week, the FDA said it wanted another 90 days to review Tysabri's return to the market. The agency is expected to decide on the matter by June 28.

Biogen shares dipped 10 cents in late trading after rising $1.36 to $47.22 during the regular session. Elan shares advanced 10 cents after hours, after trading up 49 cents to $14.59 during the day.

[Poppholz]

Antwort auf Beitrag Nr.: 21.003.008 von lonesome loser am 30.03.06 07:41:52

Business Wire
Biogen Idec und Elan kündigen Wiederaufnahme der Gabe von TYSABRI(R) zur MS-Behandlung im Rahmen von klinischen Studien an
Donnerstag 30. März 2006, 14:59 Uhr

CAMBRIDGE, US-Bundesstaat Massachusetts und DUBLIN, Irland 30. März 2006 Biogen Idec (NASDAQ: BIIB) und Elan Corporation, plc. (NYSE: ELN) gaben heute bekannt, dass die beiden Unternehmen die Rekrutierung und Gabe für die ersten Patienten im Rahmen der Sicherheitsanschlussstudie der TYSABRI(R)-Monotherapie (Natalizumab) zur MS-Behandlung (Multiple Sklerose) begonnen haben. Patienten, die am MS-Programm der Phase III und an der anschließenden Sicherheits- und Unbedenklichkeitsprüfung teilgenommen haben, sind zum Screening für die Aufnahme in diese offene multizentrische Studie zugelassen. Es werden Rekrutierungen von Patienten an Standorten in allen Teilen Europas, den Vereinigten Staaten, Kanada, Australien, Neuseeland und Israel erwartet. Diese Sicherheitsanschlussstudie wird im Rahmen des bei der US-Zulassungsbehörde FDA gestellten Antrags auf Zulassung als Studienmedikament (Investigational New Drug - IND) sowie weiterer in anderen Ländern gestellter derartiger Zulassungsanträge durchgeführt.

Biogen Idec und Elan hatten TYSABRI zuvor freiwillig vom US-Markt genommen und alle laufenden klinischen Studien basierend auf Berichten über progressive multifokale Leukoenzephalopathie (PML), eine seltene und potentiell tödlich verlaufende Entmarkungskrankheit des zentralen Nervensystems, unterbrochen. Biogen Idec und Elan haben nun in Zusammenarbeit mit führenden Experten für PML und MS eine umfassende Unbedenklichkeits- und Sicherheitsprüfung von über 3.000 mit TYSABRI behandelten Patienten durchgeführt. Diese Sicherheitsüberprüfung hat keine neuen bestätigten Fälle von PML ergeben, außer den drei bereits gemeldeten.

Am 8.3.2006 sprach sich der FDA-Beratungsausschuss für Medikamente zur Behandlung des peripheren und zentralen Nervensystems (Peripheral and Central Nervous System Drugs Advisory Committee) einstimmig für die Wiederaufnahme der Behandlung von wiederkehrenden Formen von MS mit TYSABRI aus.

Mit ihrem Schritt nehmen die Unternehmen eine Empfehlung der FDA zur Wiedereinführung von TYSABRI in den USA vorweg, die bis spätestens 28.6.2006 erfolgen wird. Der Antrag der Unternehmen auf Zulassung von TYSABRI zur MS-Behandlung ist auch bei den entsprechenden europäischen Behörden in Bearbeitung.

Informationen zu Biogen Idec

Biogen Idec setzt neue Behandlungsstandards in den Bereichen Onkologie, Neurologie und Immunologie. Als einer der weltweiten Marktführer bei der Entwicklung, Herstellung und Vermarktung neuer Therapien setzt Biogen Idec wissenschaftliche Erkenntnisse in innovative Produkte zur Gesundheitspflege um. Produktbeschreibungen, Pressemitteilungen und weitere Informationen sind auf der Website des Unternehmens unter http://www.biogenidec.com abrufbar.

Informationen zu Elan

Die Elan Corporation, plc ist ein Biotechnologie-Unternehmen mit neurowissenschaftlicher Ausrichtung und strebt danach, das Leben der Patienten und ihrer Familien zu verbessern. Das Unternehmen setzt sich dafür ein, wissenschaftliche Innovationen für ernsthafte, nicht gelöste medizinische Probleme nutzbar zu machen, da diese nach wie vor weltweit anzutreffen sind. Die Aktien von Elan werden an den Börsen in New York, London und Dublin gehandelt. Weitere Informationen über das Unternehmen sind unter http://www.elan.com abrufbar.

Safe Harbour-Erklärung/Vorausschauende Aussagen

Diese Pressemitteilung enthält vorausschauende Aussagen über das Potential und den zulassungsrechtlichen Weg von TYSABRI. Das kommerzielle Potential und der zulassungsrechtliche Weg von TYSABRI unterliegen einer Reihe von Risiken und Unwägbarkeiten. Zu den Faktoren, aufgrund deren die tatsächlichen Ergebnisse in starkem Maße von den derzeitigen Erwartungen des Unternehmens abweichen können, gehören das Risiko, dass wir nicht in der Lage sein könnten, während der zulassungsrechtlichen Verfahren adäquat auf die Bedenken oder Fragen der US-Zulassungsbehörde FDA oder der europäischen Zulassungsbehörden zu reagieren, dass sich aus den zusätzlichen Daten oder Analysen Bedenken ergeben könnten oder dass die Unternehmen mit anderen, unerwarteten Verzögerungen oder Hürden konfrontiert sind. Es gibt keine Garantie dafür, dass die Unternehmen in der Lage sein werden, den Vertrieb und den Verkauf von TYSABRI aufzunehmen. Die Entwicklung und die Vermarktung von Medikamenten beinhalten ein großes Risiko. Ausführlichere Informationen über die Risiken und Unwägbarkeiten in Verbindung mit der Medikamentenentwicklung und anderen Aktivitäten der Unternehmen sind in den Berichten enthalten, die die Biogen Idec und Elan regelmäßig bei der US-Börsenaufsichtsbehörde SEC (Securities and Exchange Commission) eingereicht haben. Die Unternehmen übernehmen keine Verpflichtung, vorausschauende Aussagen zu aktualisieren, sollten sich neue Informationen, Ereignisse o. ä. ergeben.

Kontakt

Für die Medien:
Biogen Idec
Amy Brockelman, +1 / 617 / 914 65 24
oder
Elan
Davia B. Temin, +1 / 212 / 407 57 40
oder
Elan
Elizabeth Headon, +1 / 353 / 1 / 498 03 00
oder
Für Anleger:
Biogen Idec
Oscar Velastegui, +1 / 617 / 679 28 12
oder
Elan
Emer Reynolds, +1 / 353 / 1 / 709 40 00
oder
Elan
Chris Burns, +1 / 800 / 252 35 26

[bernie55]

Elan Announces Filing of 20-F and Annual Report for Year Ended December 31, 2005

Friday March 31, 6:45 am ET

DUBLIN, Ireland--(BUSINESS WIRE)--March 31, 2006--Elan Corporation, plc today announced that it has filed with the Securities and Exchange Commission its Form 20-F for the fiscal year ended December 31, 2005 and has published its Annual Report for the fiscal year ended December 31, 2005. Both these documents are available on Elan's website at www.elan.com

[Cyberhexe]

anbei ein von der FDA publzierte Zusammenfassung zum AC von Tysabri:

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4208S1-Sl…

[Cyberhexe]

neu in der Pipeline: ELND-01 und 02 bei Autoimmunerkrankungen (ist das die galenische Natalizumab-Variante, die oral verabreichbar sein soll?) sowie AAB-002, ein Antikörper bei Alzheimer. Das sieht mittlerweile üppig aus!

http://www.elan.com/research_development/Pipeline_Products/


good luck
ch

[lonesome loser]

Antwort auf Beitrag Nr.: 21.083.752 von Cyberhexe am 05.04.06 12:49:37

Thursday April 6, 9:21 PM EDT


Dow Jones Newswires

Biogen Idec Inc. (BIIB) (BIIB) and Elan Corp. (ELN) (ELN) said late Thursday that, in Phase III multiple sclerosis studies, Tysabri showed "significant" effects on health- related quality of life measures.

The results showed a positive impact on disability progression, including visual and cognitive function, the companies said.

The data were presented this week at the annual meeting of the American Academy of Neurology in San Diego.

On March 8, a Food and Drug Administration committee voted to recommend reintroduction of Tysabri as a treatment for relapsing forms of MS.

-Gabriel Madway; 415-439-6400; [e-mail]

[Poppholz]

Antwort auf Beitrag Nr.: 21.113.578 von lonesome loser am 07.04.06 07:28:25

07.04.2006 09:13
Elan, Biogen say Tysabri trial showed significant quality of life improvements

LONDON (AFX) - Elan Corp (Nachrichten) and Biogen Idec (Nachrichten/Aktienkurs) said patients in a phase III trial of multiple sclerosis drug Tysabri showed significant improvements in quality of life.

The data follows previously reported improvements in measures of disability progression, relapse rate and an MRI scan.

The two companies have only just recommenced trials of Tysabri, after the drug was pulled from the market and studies halted early last year. Three cases of a rare brain disease emerged among patients, causing two deaths.

The results are being presented this week at a neurology conference in California.

Richard Rudick, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, who presented the findings at the meeting, said: 'We have never before observed positive findings on our quality of life measures in a Phase III MS study.

'The Tysabri study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging.'

Quality of life is assessed using three different measures.

In the Affirm study, using Tysabri on its own, two of the measures produced a statistically significant result.

Improvements in quality of life measures were also observed in the Sentinel study, in which the drug is added to another therapy, Avonex.

Elan and Biogen expect to hear by June 28 whether US medicine regulators will allow the drug back on the market.

Elan shares closed at 11.6 eur yesterday.

[e-mail]

ab/bam

Copyright AFX News Limited 2005. All rights reserved.

The copying, republication or redistribution of AFX News Content, including by framing or similar means, is expressly prohibited without the prior written consent of AFX News.

AFX News and AFX Financial News Logo are registered trademarks of AFX News Limited

[Poppholz]

Antwort auf Beitrag Nr.: 21.114.561 von Poppholz am 07.04.06 09:21:49

07.04.2006
Biogen u. Elan - positive Studien zu Tysabri

Bei Biogen Idec Inc. und Elan Corp. ergaben Phase III-Studien zu dem vom Markt genommenen Multiple Sklerose-Präparat Tysabri wesentliche Qualitätsverbesserungen für das Präparat. Wie beide Unternehmen am Donnerstag nach Börsenschluss weiter mitteilten, zeigten die Resultate positive Wirksamkeiten bei fortgeschrittener Invalidität inklusive des Auftretens von Wahrnehmungs bzw Empfindungsstörungen. Die Daten wurden diese Woche auf dem Jahrestreffen der American Academy of Neurology in San Diego präsentiert. Am 8. März votierte ein Ausschuß der FDA für eine Wiedereinführung von Tysabri zur Behandlung von Multiple Sklerose-Rückfällen.

http://www.wirtschaftsblatt.at/cgi-bin/page.pl?id=470219

[Poppholz]

Antwort auf Beitrag Nr.: 21.114.561 von Poppholz am 07.04.06 09:21:49

Tysabri trials cheer Elan
Fri 07 Apr 2006

LONDON (SHARECAST) - Irish biotech Elan said today that in Phase III multiple sclerosis studies Tysabri showed significant effects on pre-specified health-related quality of life measures.

“The Tysabri study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging,” said the group.

Data presented this week at the annual meeting of the American Academy of Neurology in San Diego also showed a “significant” impact on additional pre-specified measures of disability progression, including visual and cognitive function.

Patients treated with the drug had a reduction in the risk of visual decline, said Elan in conjunction with drug group Biogen Idec.

Biogen and Elan have previously voluntarily suspended Tysabri from the US market.

The companies anticipate action by the US Food and Drug Administration regarding the reintroduction for Tysabri in the US on or before 28 June.

http://www.sharecast.com/cgi-bin/sharecast/story.cgi?story_i…

[Cyberhexe]

Marketocracy "Best Ideas" Portfolio
Stock

Tesoro (nyse: TSO - news - people )
A refining capacity shortage drives earnings growth.

Chaparral Resources (otcbb: CHAR.OB - news - people )
Still recovering from the overreaction to the Jan. 24 CEO and drilling announcements.

Lufkin Industries (nasdaq: LUFK - news - people )
We sold some in January and February during the price run-up, but we still like the stock.

Agrium (nyse: AGU - news - people )
Negative news is hurting short-term revenue profits, but prospects remain high.

Elan (nyse: ELN - news - people )
An FDA Advisory Committee recommendation removes re-approval uncertainty and gives hope for more upside.

Biogen Idec (nasdaq: BIIB - news - people )
We sold some and shifted to ELN. But Biogen still has more upside.

Click Commerce (nasdaq: CKCM - news - people )
Its price drop is a buying opportunity, as CKCM continues to execute.

[Poppholz]

WirtschaftsWoche - Geld
Wall Street sollte freundlich eröffnen
Freitag 7. April 2006, 15:05 Uhr

Die US-amerikanischen Aktien werden am Freitag zu Handelsbeginn überwiegend freundlich erwartet. Die Arbeitsmarktdaten seien vorbörslich positiv aufgenommen worden, hieß es von Händlern.

Die US-amerikanischen Aktien werden am Freitag zu Handelsbeginn überwiegend freundlich erwartet. Die Arbeitsmarktdaten seien vorbörslich positiv aufgenommen worden, hieß es von Händlern.

Der Future auf den S & P-500-Index stieg gegen 14.50 Uhr um 0,43 Prozent auf 1323,10 Punkte. Am Vortag hatte der marktbreite Index 0,19 Prozent auf 1309,04 Zähler nachgegeben. Der Future auf den Nasdaq 100 (NASDAQ: Nachrichten) gewann 0,41 Prozent auf 1762,00 Punkte. Der technologielastige Auswahlindex war am Donnerstag um 0,37 Prozent auf 1739,20 Zähler vorgerückt.

Die US-Wirtschaft hat im März mehr neue Arbeitsplätze geschafften als erwartet. Die Zahl der Beschäftigten sei um 211.000 zum Vormonat gestiegen, teilte das US-Arbeitsministerium am Freitag mit. Von Marketwatch befragte Volkswirte hatten im Durchschnitt mit 187.000 neuen Jobs gerechnet. Die Arbeitslosenquote ist im März überraschend auf 4,7 Prozent gesunken. Von Market Watch befragte Volkswirte hatten mit 4,8 Prozent gerechnet. Die durchschnittlichen Stundenlöhne stiegen im März nicht so stark wie erwartet.

Aktien von Starbucks (NASDAQ: SBUX - Nachrichten) waren vorbörslich gefragt. Die Umsätze waren im März auf vergleichbarer Fläche um zehn Prozent gestiegen. Damit seien die bei einem Wachstum von 7,6 Prozent liegenden Prognosen übertroffen worden, kommentierten Händler.

Elan-Titel zeigten sich im vorbörslichen US-Handel ebenfalls stärker. Händler verwiesen auf positive Studienergebnisse zu dem gemeinsam mit Biogen Idec (NASDAQ: BIIB - Nachrichten) entwickelten Medikaments Tysabri. In einer Studie der Phase III hatte sich Tysabri bei Patienten mit Mutipler Sklerose (MS) als sehr wirksam bei der Verbesserung der Lebensqualität gezeigt.

Aktien von Research In Motion gerieten dagegen deutlich unter Druck. Der Hersteller des mobilen Taschencomputers Blackberry hatte im vierten Quartal den Umsatz deutlich gesteigert. Der Ausblick auf das erste Quartal falle jedoch schwächer aus als erwartet, hieß es von Händlern.

Ford könnten ebenfalls das Anlegerinteresse auf sich ziehen. Der Präsident des zweitgrößten US-amerikanischen Autobauers, Jim Padilla, geht in den Ruhestand. Nach 40 Jahren Tätigkeit für Ford verlasse Padilla das Unternehmen zum 1. Juli, teilte der Konzern am Freitag in Detroit mit.

http://de.biz.yahoo.com/07042006/318/wall-street-sollte-freu…

[Poppholz]

Antwort auf Beitrag Nr.: 21.122.232 von Poppholz am 07.04.06 16:03:32

auf Reuters:

Elan reports positive MS drug trial results
Fri Apr 7, 2006 4:50 AM ET
By Michael Smith


DUBLIN (Reuters) - Elan Corp. Plc said on Friday the latest trials of its multiple sclerosis drug Tysabri showed significant positive results in patients, sending its shares higher.

"The Tysabri study data show not only significant reductions in relapses and disability, but also suggest improved quality of life. This is very encouraging," the company said in a statement.

Elan and drugmaker Biogen Idec faced a fresh delay in getting Tysabri back to the market last month after U.S. regulators extended their review of the drug by three months, until June 28.

Tysabri was pulled abruptly last year following concerns about a link with a life-threatening side effect, but an independent advisory panel recommended that multiple sclerosis sufferers be allowed to take the drug, subject to certain risk controls.

Elan shares rose 4.0 percent to 12.06 euros by 0840 GMT after releasing the results of its Phase III trials of the drug, which were presented at the annual meeting of the American Academy of Neurology in San Diego. The DJ Stoxx European healthcare index was down 0.2 percent.

"These additional data further underpin Tysabri's superior efficacy profile to currently marketed MS drugs," Davy stockbrokers said in a note to clients.

Davy said its earnings forecasts for Elan assumed it would launch the drug by mid-2006.

Elan aims to launch the drug within weeks of FDA approval, which it expects to receive following the extended review.

PROGRESSIVE DISABILITY

Elan said this was the first time it had observed positive findings on so-called quality of life measures in a Phase III trial.

Multiple sclerosis causes progressive disability that can include blurred vision, weakness, poor muscle coordination and loss of memory and mental function as nerves lose their insulating sheath.

The company said patients treated with the drug had a reduction in the risk of visual decline and a reduction in the risk of the rate of disability.

Biogen and Elan suspended Tysabri sales in February 2005 after three patients developed an infection called progressive multifocal leukoencephalopathy, or PML. Two of them died.

But the advisory panel said that, despite potential risks, Tysabri should be available as an option for MS sufferers, many of whom they said did not find relief with current medicines.

(Additional reporting by Pete Harrison in London)

http://today.reuters.com/news/newsarticle.aspx?type=business…


(die NEWS laufen und werden auf wichtigen Seiten publiziert)

[Poppholz]

Study shows Tysabri may aid in quality of life
FDA is considering whether to let sales of MS drug resume
By Stephen Heuser, Globe Staff |
April 8, 2006

Patients taking the multiple sclerosis drug Tysabri showed improvement in several important quality-of-life measurements, according to the results of studies presented at a medical conference this week.

The findings, from two studies sponsored by the drug's makers, Biogen Idec Inc. of Cambridge and Elan Corp. of Ireland, provide new evidence of the effectiveness of a treatment that was pulled off the market last year after two patients taking it died of a rare brain infection.

The Food and Drug Administration is considering whether to allow Tysabri sales to resume.

The new report analyzed data from earlier Tysabri studies to see whether the drug could improve patients' lives and alleviate MS symptoms. It measured such factors as energy level, vision, bowel and bladder function, and mental health. It was presented on Thursday at the American Academy of Neurology meeting in San Diego by Richard Rudick of the Cleveland Clinic, the lead investigator of one of the studies.

In a statement, Rudick called the findings ''very encouraging."

According to a summary issued by the companies, patients using Tysabri showed ''a significant improvement" in standard measurements of both mental and physical health in one of the studies. Patients treated with a placebo, meanwhile, showed a decline.

In the second study, patients taking Tysabri in combination with Avonex, Biogen Idec's current MS drug, experienced physical improvements. Patients using Avonex alone did not see a significant change in their condition.

''I'm always glad to see a major clinical trial looking at quality of life, because that's very important," said Nicholas LaRocca, an executive of the National Multiple Sclerosis Society who has helped develop quality-of-life measurements for multiple sclerosis patients.

''I don't know if it's a huge difference or a modest difference, but even a modest difference is better than no difference," he said.

Multiple sclerosis is an incurable disease in which the body's own immune system attacks the tissue that surrounds and insulates nerves, causing tremors, vision problems, weakness, and progressively worsening disability.

Tysabri was approved by the FDA in November 2004 based on one year's data, rather than the customary two, after results showed it reduced flare-ups of MS symptoms twice as effectively as current treatments.

It was voluntarily pulled from the market by Biogen Idec and Elan in February 2005 after they learned of two cases of a rare brain disease in patients taking the drug. A third case was later confirmed, and two of the patients died. An extensive safety review by the companies did not uncover additional cases of the disease, called progressive multifocal leukoencephalopathy.

In February, the FDA allowed Biogen to continue giving the drug in a clinical trial, and last month an advisory panel recommended Tysabri return to market. The FDA is now reviewing the companies' plan to monitor patient safety and is expected to make a decision by June 28.

Stephen Heuser can be reached at [e-mail].

© Copyright 2006 Globe Newspaper Company.[/mail]

http://www.boston.com/business/globe/articles/2006/04/08/stu…

[Cyberhexe]

das Vertrauen in Natalizumab ist ungebrochen:
http://www.fdanews.com/dailies/drugdaily/2_325/news/54171-1.…

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.187.502 von Cyberhexe am 13.04.06 10:17:10

NEJM...zwar schon einige Wochen alt, aber extrem wichtig:
http://content.nejm.org/cgi/content/german_abstract/354/9/89…

[Poppholz]

ELAN wurde von der International Association of Nanotechnology zu einem der Top 100 Nanotechnologie-Unternehmen ernannt


http://www.ianano.org/Fortune-Nanotech.pdf

(der Artikel bezieht sich hauptsächlich auf MIV, aber ELAN ist eben mit in der Liste aufgeführt)

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.224.166 von Poppholz am 18.04.06 15:12:27

deutsche Übersetzung aus dem "New England Journal of Medicine" zur Wirksamkeit von Natalizumab:

http://content.nejm.org/cgi/content/german_abstract/354/9/92…

[Cyberhexe]

und hier die Zusammenfassung zur SENTINEL-Studie, das ist die Kombi-Therapie mit Avonex

http://content.nejm.org/cgi/content/german_abstract/354/9/91…

[Cyberhexe]

anbei Neuigkeiten vom Alzheimer-Sympossium in Genf

http://www.elan.com/InvestorRelations/events/International_G…

[bernie55]

Tysabri An Overhang On Biogen Idec's Q1
Peter Kang, 04.25.06, 3:31 PM ET


Wachovia Securities reiterated a "market perform" rating on Biogen Idec ahead of the biotech firm's first-quarter earnings report.

Analyst George Farmer expects results to fall slightly below Wall Street expectations. He forecasts a profit of 45 cents per share on sales of $610 million, compared with the First Call consensus estimate of 47 cents per share on sales of $634 million.

Farmer noted that marketing partner Genentech (nyse: DNA - news - people ) recently reported light sales of Rituxan, a cancer drug that was approved as a treatment of rheumatoid arthritis in late February.

"We believe that the recent approval of Rituxan for the treatment of moderate-to-severe RA will drive sales growth following a sluggish first quarter."

The analyst said Tysabri continues to be an "overhang" on the stock, which he values in a range of $48 to $52 per share. Still, he expects the U.S. Food and Drug Administration to allow the multiple sclerosis drug back on the market.


"We believe sales will begin slow and ramp gradually to about $243 million in 2010, catering largely to patients failing all approved regimens," he said.

In addition, Farmer said market opportunities for Avonex, Zevalin and other Biogen products "may have approached their peak, while the potential of its clinical pipeline remains too early-stage to adequately evaluate."

The FDA delayed a decision on Tysabri in March, following a unanimous recommendation by and FDA advisory panel to allow the halted multiple sclerosis treatment back on the market.

"Given this new timeline, we expect FDA action on or before June 28," he wrote in a client note Tuesday. "While we anticipate approval, we expect a slow ramp, as physicians and patients may await more experience to gain comfort with the drug’s safety profile."

Tysabri was pulled from the market by Elan (nyse: ELN - news - people ) and Biogen Idec (nasdaq: BIIB - news - people ) in early 2005 due to safety issues. Biogen Idec will announce quarterly results on Wednesday prior to the start of trading.

[Cyberhexe]

wie erwartet, auch die Exopertenkommission der EMEA gibt für Tysabri grünes Licht:
CHMP Issues Positive Opinion for TYSABRI(R) as a Treatment for Relapsing-Remitting Multiple Sclerosis
http://biz.yahoo.com/bw/060428/20060428005228.html?.v=1

übrigens in Deutschland ist das PEI (Paul-Ehrlich-Institut) für die Zulassung von Tysabri zuständig;
es gibt MS-Patienten, die für eine Beschleunigung des Verfahrens beim PEI vorsprechen bzw. sich via E-Mail über die verzögerte Bearbeitung beschweren;
sollte jemand ebenfalls an einer Kontaktaufnahme interessiert sein (jedoch nicht Investoren sondern nur MS-Patienten), dann sollte man sich mit Christian Schneider am PEI in Verbindung setzen und zwar über folgende email-Adresse:
[e-mail]

[Cyberhexe]

offizieller Text von der EMEA:

http://www.emea.eu.int/pdfs/human/opinion/9585406en.pdf


meiner Meinung nach wichtig ist die Option, bei schwerwiegendem Verlauf Tysabri zu verabreichen; dies ermöglicht den Ärzten auch eine Medikation als "first line treatment";
und zudem gibt es in den US und in der EU derzeit über 400.000 Patienten, die wegen fehlender Wirksamkeit der CRABs nicht medikamentös behandelt werden. Das Potential ist also enorm.


The approved indication is:
“TYSABRI is indicated as single disease modifying therapy in highly active relapsing remitting
multiple sclerosis for the following patient groups:
• Patients with high disease activity despite treatment with a beta-interferon
or
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis.”

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 21.362.377 von Cyberhexe am 28.04.06 12:49:15

[Cyberhexe]

aus aktuellem Anlass noch einmal die Zusammenfassung zum FDA-Panel:

http://www.stones.net/TysabriAC.pdf

man beachte das Nebenwirkungsprofil gegenüber Plazebo auf Seite 4 --> "FDA View of Tysabri Non-PML Safety"


overall infections:
Tysabri 73.7%
Placebo 73.9%

serious infections
Tysabri 2.4%
Placebo 2.3%

also Infektionskrankheiten im Plazebo-Bereich; bei der immunsupprimierenden Wirkungsweise mehr als erstaunlich und neben der Wirksamkeit ein weiterer entscheidender Vorteil gegebnüber den CRABs!

[Cyberhexe]

Wieder mal etwas Vielversprechendes aus der Alzheimer-Pipeline:

http://www.palmbeachpost.com/pbcsouth/content/local_news/epa…


The drug, called ACC-001, stimulates the body's immune system to attack beta-amyloid plaque — an abnormal protein that builds up in the brain's memory circuits and is a key factor in the development of Alzheimer's disease. ACC-001 is made by Elan Pharmaceuticals of Dublin, Ireland.
"There was an immediate and noticeable improvement within a week," said Kathy, whose 81-year-old father, Ben, of Highland Beach, received the one-time vaccine last month.

[Cyberhexe]

und hier noch etwas von der FDA zum Risikoplan von Tysabri:

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4208S1-01…

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 21.387.646 von Cyberhexe am 01.05.06 08:17:45

Himmel,der ist ja sehr umfangreich.....dürfen "normale"Neurologen Ty nicht geben,nur Infusionszentren?Ist dies der Vorschlag von Biogen an die FDA?

[Cyberhexe]

anbei die Antwort des PEI * (Paul-Ehrlich-Institut) auf meine Anfrage hinsichtlich Stand der Zulassung von Tysabri bei der EMEA:

zuständigkeitshalber beantworte ich gerne Ihre Anfrage bezüglich des Arzneimittels Tysabri (Natalizumab) zur Behandlung der Multiplen Sklerose. Der europäische Arzneimittelausschuss (CHMP) hat letzte Woche auf seiner Aprilsitzung eine so genannte "positive Opinion", d.h. die Zulassungsempfehlung ausgesprochen (siehe auch http://www.emea.eu.int/pdfs/human/press/pr/15260806en.pdf). Nun muss noch die Zulassung durch die Europäische Kommission erfolgen, die in der Regel ca. zwei Monate dauert. In der Regel folgt die Kommission der Empfehlung des CHMP, daher ist mit einer baldigen Zulassung zu rechnen. Die Zulassung erfolgte jedoch angesichts der potentiell fatalen Nebenwirkungen (PML) für eine eingeschränkte Patientengruppe. Eine ausführliche Konsultation bei einem spezialisierten Neurologen sollte daher erfolgen.

Mit freundlichen Grüßen
i.A.
C. Schneider



dies war meine Anfrage:

zu meinem engeren Bekanntenkreis gehören 2 an MS erkrankte Personen.
Da die am Markt eingeführten Medikamente (Avonex, Betaseron, Copaxone und Rebif) bei beiden den Krankheitsverlauf nicht wesentlich beeinflussen konnten, haben beide die Hoffnung, dass mit dem ersten alph4-Integrinantagonist (generic name: Natalizumab; brand name: Tysabri) ein massgeschneiderter Wirkstoff bereitgestellt wird, der den weiteren körperlichen Zerfall verhindern könnte. Trotz der bekannten Probleme mit PML (allerdings nur in SENTINEL = Kombi-Therapie mit Avonex und bei ENACT bei einer stark immunsupprimierten Vorgeschichte; nicht jedoch in den Mono-Studien) ist und bleibt Natalizumab, also Tysabri, der einzige Hoffnungsschimmer für meine Bekannten. Umso grösser ist nun die Enttäuschung, dass die FDA weitere 90 Tage benötigt, um eine endgültige Entscheidung über die Wiederzulassung zu treffen. Darüber hinaus stellt man sich die Frage, weshalb von der europäischen Zulassungsbehörde gar nichts vernommen wird, obschon der Antrag auf Zulassung bereits am 4. Juni 2004 gestellt wurde. Für meine Bekannten gilt "time is brain", zumal der EDSS sich bei beiden in dieser Zeit massiv verschlechtert hat - bei beiden derzeit bei "5,5".

Könnten Sie mir Auskunft geben, in wie weit die Beratungen der EMEA fortgeschritten sind und ob meine Bekannten noch in diesem Jahr mit der Verfügbarkeit von "Tysabri" rechnen können.



* Das im Oktober 2004 gestartete zentrale Zulassungverfahren zu Natalizumab wird entsprechend der Aufteilung der Zuständigkeit nicht vom BfArM sondern von den Kollegen und Kolleginnen am Paul-Ehrlich-Institut bearbeitet.

[Cyberhexe]

http://www.rte.ie/business/2006/Morningrep/download/0502davy…

Elan (ELN US)
Previous close: $14.80 Target: $18.00 (31/1/06; previously $13.00, issued 9/8/05) Analyst: [e-mail]
Tysabri gets positive EU recommendation
Tysabri has got a positive recommendation from CHMP, the scientific committee that advises as part of the European
regulatory process. In its Q1 conference call Biogen had highlighted that this would occur short term. The recommendation is
like an advisory panel recommendation in the US; full and final approval is to be confirmed by European agency EMEA
probably within 60 days.The CHMP recommendation is for use as therapy in patients who have failed with interferon beta or those with rapidly
evolving severe disease. The scope of use in the recommendation is more akin to second line therapy, although the
interpretation of “treatment failures” and “rapidly evolving severe disease” may be open to neurologists on a case by case
basis.
Full EMEA approval will be followed by separate pricing negotiations with the various EU member states. The timeline is in
line with Elan’s comments, i.e. EU newsflow in H1, launch in some EU territories in H2.
We remain comfortable with our Tysabri forecasts on the back of this positive announcement. Our $18 target is reiterated.
See our note “Crucial months ahead”, published April 27th.

[Cyberhexe]

anbei noch die Zusammenfassung von Davy, welche am 27.04.2006 veröffentlicht wurde:

http://www.davy.ie/other/email/elancr20060427.pdf

[Cyberhexe]

"The company is testing more than 70 compounds with nanotechnology, he said."


wowwwwwwwwwwwwwww....über 70 Aktivsubstanzen werden mit Elans NanoChrystal-Technologie getestet....hier kann man das Potential ja förmlich riechen!!!



http://www.marketwatch.com/News/Story/Story.aspx?guid={A393F…


Elan has had particular success using its NanoCrystal technology to reformulate drugs and make them easier for patients to take. For example, the company uses its nanotechnology in the antirejection agent Rapamune, which the body is better able to absorb than previous treatments, said Paul Breen, head of Elan's drug technologies in Dublin, Ireland.
"We eliminated the need to make a complicated mixture and the patient was able to take a tablet," Breen said.
The company is testing more than 70 compounds with nanotechnology, he said. "We make the particles so small that they easily cross over the biological barriers," Breen said. "Particles of that size tend to want to clump together to go back to bigger particles. Part of our technology is not only reducing the size to an extremely nanoscale, but also stabilizing them there so they can easily pass through the cell wall and into the bloodstream."

[Cyberhexe]

und noch ein Artikel zur Alzheimer-Phantasie:

http://www.bocaratonnews.com/index.php?src=news&prid=15090&c…

[Cyberhexe]

und noch was zu Alzheimer:

http://www.oxfordpress.com/news/content/shared/news/stories/…

[curio]

Antwort auf Beitrag Nr.: 21.404.320 von Cyberhexe am 02.05.06 16:42:43

Ahhh da ist sie ja, hab nur kurz den thread überflogen tolle Arbeit von dir gratuliere !!
Ist das dein einziges Investment ???

[Cyberhexe]

@curio

wieder jeder Börsenvernunft bin ich zu 120% (einschl. Wertpapierkredit) "all in one all in Elan!"

Versuch es nicht mir auszureden, ist völlig zwecklos und haben übrigens auch schon einige aus meinem persönlichen Umfeld probiert.
Natürlich kann man sich nie zu 100% sicher sein aber nach unten scheint mir der Wert momentan sehr gut abgesichert zu sein und das Potential nach oben ist sicherlich riesig.

good luck
ch

[curio]

Antwort auf Beitrag Nr.: 21.406.009 von Cyberhexe am 02.05.06 18:31:37

Jeder muß seine entscheidungen selbst treffen.
Verrätst du deinen KK.
Außerdem kommt es auf die Summe darauf an. Das Risiko erscheint mir jedoch sehr hoch.Ich persönlich konzentriere mich immer nur auf vier Aktien gleichzeitig, nicht mehr.

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.406.009 von Cyberhexe am 02.05.06 18:31:37

@curio

es gibt übrigens noch einen andere Thread über Elan, eröffnet von zenman, in welchem vor allem Birgit sehr gute Arbeit leistet - schau doch mal rein!

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.406.130 von curio am 02.05.06 18:42:24

@curio
das ist sicherlich vernünftiger...mein durchschnittlicher Kaufkurs ist im einstelligen $-Bereich...und die Summe ist ganz schön heftig. Aber wenns gut geht bin ich auf immer und ewig saniert....wenns schief geht, dann wars ein schöner Traum - die Rückzahlung des WP-Kredites wäre dann natürlich schmerzhaft, aber würde nicht die Existenz bedrohen.

[curio]

Antwort auf Beitrag Nr.: 21.406.231 von Cyberhexe am 02.05.06 18:49:23

Seit wann bist du denn investiert.Ist übrigens schade das es deine einzige ist sonst wäre ein austausch sicherlich interessant geworden.

[Nostarowie]

Antwort auf Beitrag Nr.: 21.406.422 von curio am 02.05.06 18:59:33

Was soll die Fragerei?
Die Frau ist verrückt, merkst Du das nicht?!

[Cyberhexe]

NCB

http://www.tixx.com/Elan%20Q12006.pdf

[Cyberhexe]

Goodbody Stockbrokers 2 may 2006

http://www.rte.ie/business/2006/Morningrep/download/0502good…

[Cyberhexe]

Davy 2 may 2006

http://www.rte.ie/business/2006/Morningrep/download/0502davy…

in meinen Augen ist Davy sehr konservativ:

"We remain comfortable with our Tysabri forecasts on the back of this positive announcement. Our $18 target is reiterated."

[Cyberhexe]

Diese Aussage von Davy in Übereinstimmung mit allen anderen Analysten ist für mich einfach schwer nachzuvollziehen:

"Our forecast calls for peak revenues of $1.6bn by 2009. This translates to approximately 80,000 patients
on therapy."

Ich kann einfach nicht glauben, dass bis 2009 nicht einmal 10% aller an MS-Erkrankten auf das mit Abstand wirkungsvollste Medikament zurükgreifen werden, zumal über 500.000 in den US und in der EU wegen fehlender Wirksamkeit der CRABs momentan überhaupt nicht therapiert werden. Ich selbst habe in meinem Bekanntenkreis eine Person mit RRMS, der mit allen Medikamenten abgesetzt hat, um nach der Zulassung schnellstmöglich Tysabri anzuwenden.

http://www.davy.ie/other/email/elancr20060427.pdf

[Cyberhexe]

und nochmal Davy...von heute:

http://www.davy.ie/other/pubarticles/eqbrief20060503.pdf


Elan (ELN US)
Previous close: $14.69 Target: $18.00 (31/01/06; previously $13.00, issued 09/08/05) Analyst: [e-mail]
Q1 results due May 4th
For Q1, we anticipate a strong year-on-year (yoy) increase in revenues and a sharp reduction in EBITDA losses. All forecasts
currently exclude share option expensing.
Revenues are forecast at $125.7m, up 22%. This comprises product (88%), contract (5%) and unamortised revenue
(Adalat/Avinza 7%) sources. We expect to see some quarter-on-quarter increase in operating expenses, although still down
yoy given that Tysabri was launched in the prior period. SG&A of $90m would represent a fall of 13%. R&D spending should
be flattish yoy and should stay in a similar range to recent quarters ($50–60m). EBITDA losses for Q1 are forecast at $37.8m,
and adjusted loss per share is forecast at 21c. We estimate that the Q1 burn will be in the region of $70m (EBITDA losses plus
interest charges).
Conference call at 13.30 (UK/Ireland) on May 4th; US participants dial 888 434 1984 and international participants dial +1
706 758 4972.

[Goldmariele]

Antwort auf Beitrag Nr.: 21.405.603 von curio am 02.05.06 18:04:37

Von sowas läßt du dich einwickeln, blenden und manipulieren, ich hoffe doch nicht für dich.
Das ist wirklich ehrlich gemeint Curio.

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 21.420.518 von Goldmariele am 03.05.06 18:45:48

Was willst Du mit diesem Beitrag sagen?

[lippi5]

Quartalsbericht!

http://www.finanznachrichten.de/nachrichten-2006-05/artikel-…

[bernie55]

Antwort auf Beitrag Nr.: 21.425.350 von lippi5 am 04.05.06 08:53:05

Danke, lippi5 für den Link.

http://www.finanznachrichten.de/nachrichten-2006-05/artikel-…

[curio]

Antwort auf Beitrag Nr.: 21.424.323 von Birgit.Tersteegen am 04.05.06 00:10:12

Vielleicht ist sie ja verliebt in mich.
So und jetzt ziehe ich mich wieder zurück aus diesem Thread, da mich Elan ja nicht wirklich interessiert obwohl ich davon überzeugt bin, daß die Story gut ist und Erfolg haben wird.
Somit wünsche ich euch alles Gute und viel Erfolg
lg
Curio

[Cyberhexe]

BBBiotech erhöht den Anteil von Elan im Portfolio sukzessive: immerfhin halten sIE seit März 2006 2.7 Mio Aktien. Im April konnte ich bisher keine konkreten Angaben über das Portfolio finden, allerdings soll der Anteil noch einmal aufgestockt worden sein (in einer Anzeige im Aktionaer stand neulich unter Kumulationen u.a. auch Elan)

http://bbbiotech.at/index.php/bbbiotech_de/de/informationspo…


Und der Aktionaer hat die mögliche Erfolgsgeschichte nun auch aufgegriffen. In Ausgabe 20/2006 auf Seite 21 ist nämlich zu lesen:

"...sollte die Zulassung wie erwartet erfolgen, hätte die Aktie deutliches Potenzial. Ein gewisses Restrisiko bleibt allerdings. Denn die Europäische Arzneimittelbehördekönnte sich auch gegen das Produjkt entscheiden..."

Aber auch die EMEA wird Tysabri ebenfalls zulassen, weil das CHMP diese bereits empfohlen hat. Und mir ist kein Entscheid gegen dieses Gremium bekannt.


http://www.elan.com/News/full.asp?ID=849173

[Cyberhexe]

Anbei eine Übersicht von der FDA über RRMS und die klinischen Studien zu Natalizumab:

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4208S1-01…

[Cyberhexe]

zu den Nebenwirkungen von Natalizumab:

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4208S1-01…


Der 2-Jahres-Überblick zu den Nebenwirkungen (Seite 4 von 39) ist sehr beeindruckend. SAE (seriuous adverse effects) bei Placebo (18.9%) höher als unter Tysabri (15.5%)!!!

[Cyberhexe]

anbei auch noch eine kleine Fundgrube:

http://www.biopractical.com/node/119#comment

[Cyberhexe]

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01340.html

"The agency is working intensively to complete review of this new information and will attempt to do so before the end of the 90 day extension period."

...dann wollen wir hoffen, dass dies auch stimmt!

[Cyberhexe]

in der Zusammenfassung noch einmal die Entscheidungen des Advisory Committee's, wobei Frage/Antwort 6a natürlich die spannendste war und bleibt. Wie wird die FDA dies umsetzen?

6.
If natalizumab returns to commercial distribution, are there specific subsets of the relapsing MS population for whom you would consider natalizumab use either reasonable or inappropriate? Please discuss, for example: a. Patients with MS who have not tried any of the other available first-line therapies (interferon beta or glatiramer acetate) After significant debate the chair polled the committee members on 4 questions. These were polls to see if the committee was at a consensus and was not an official vote. Should natalizumab be permitted as first line therapy? YES: 7 NO: 5

[Cyberhexe]

das Interesse ist beeindruckend:

http://thomson.finance.lycos.com/lycos/iwatch/cgi-bin/iw_tic…

[Cyberhexe]

anbei die Video-Botschaft einer Betroffenen anlässlich des AC

http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4208OPH1-…


ich denke die Zulassung steht kurz bevor...vielleicht schon Anfang nächster Woche, zumal die FDA versprochen hat, schnellstmöglich zu handeln: "...will attempt to do so before the end of the 90 day extension period.""

[Birgit.Tersteegen]

Prost Hexchen!

[Cyberhexe]

ich werde diesen Sommer noch mehrere Male Gelegenheit haben auf dich und unser "Baby" anzustossen....cheers!

http://www.kentucky.com/mld/kentucky/business/14581494.htm

About 350,000 people in the United States have MS, an incurable disease of the central nervous system. An estimated 200,000 people in America with MS currently use one of the four disease-modifying therapies: Avonex, Betaseron, Copaxone and Rebif.


...d.h.mehr als 150.000 Patienten in den USA nehmen derzeit kein Medikament wegen mangelnder Wirksamkeit. Selbst wenn Tysabri nur als "second line treatment" zugelassen würde - und ich glaube immer noch an "first line" (7:5 beim AC)-, wäre der potentielle Markt nur schon in den Staaten gigantisch. Und die EMEA wird auch nicht mehr lange auf sich warten lassen.

150.000 * 23500$/Jahr

[Cyberhexe]

Welche Faktoren beeinflussen unser Anlageverhalten?
In erster Linie, die Aussicht auf Gewinn, also die Chance, und zweitens das damit verbundene Risiko.

Nun bei unserem elanvollen Favoriten sind die Chancen nahezu gigantisch, denn sollte sich auf Ende Jahr beim Alzheimer-Projekt eine Phase III- Studie abzeichnen, sind steigende Kurse nicht nur in Cent-Beträgen vorprogrammiert.
Die kurzfristigen Schlagzeilen werden jedoch von der Tysabri-Wiederzulassung bestimmt. Sollte Tysabri kurzfristig (von den Analysten zumindest) unerwartete Marktanteile sichen - und davon gehe ich aus-, dann wird dies den Kurs ebenfalls beflügeln.
Verbunden mit der hochinteressanten Nanotechnolgie für wasserunlösliche Aktivsubstanzen - über 70 Wirkstoffe werden getestet, 5 sind bereits zugelassen, für welche Elan bereits Lizenzeinnahmen erhält (und dies ohne Kosten zu generieren!) - ergeben einen überaus interessante Kombination mit riesigem Kurspotential.

Nun, demgegenüber steht momentan ein, wie ich finde, relativ kleines Risiko.
Tysabri wurde in den letzten 15 Monaten nicht appliziert, weshalb von dieser Seite vorerst keine negativen Schlagzeilen zu erwarten sind.
Die in der Klinik getesteten Alzheimer-Aktivsubstanzen (AAB-001 und ACC-001) hatten bereits eine Vorläufer-Substanz (AN-1792), mit welcher der "proof-of-concept" bereits erbracht wurde.
Die bei AN-1792 aufgetretenen Nebenwirkungen (Hirnhautentzündung) sind jedoch zumindest bei AAB-001 nicht zu erwarten, da es sich hierbei nicht um eine aktive Immunisierung sondern um einen passiven Schutz durch Injektion des Antikörper handelt.
Und bei der Nanotechnologie ist sowieso jede weitere Zulassung ein Volltreffer, der nur Einnahmen und keine Kosten verursacht.

Das Chance/Risiko-Verhältnis scheint mir deswegen momentan einzigartig, weshalb man nicht ungeduldig werden sollte.

[Cyberhexe]

Studies bloom on Alzheimer's as Boomers age

http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2006/05/…

A therapy developed by the South San Francisco lab of Elan Pharmaceuticals that would vaccinate people against amyloid buildup has been redesigned and is once again in clinical trials. In 2003, Elan was forced to halt its study of an Alzheimer's vaccine after the tests caused serious brain inflammation in 15 patients.

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.598.703 von Cyberhexe am 16.05.06 00:49:02

...übrigens, hiermit ist das Vaccin in Phase 1 gemeint (ACC-001)

A therapy developed by the South San Francisco lab of Elan Pharmaceuticals that would vaccinate people against amyloid buildup has been redesigned and is once again in clinical trials.

http://www.elan.com/research_development/Pipeline_Products/

Der Antikörper, AAB-001, befindet sich bereits in Phase 2!

[Cyberhexe]

...und auf die Nacht noch etwas für die Charttechniker...aber nicht unbedingt informativ.

Options Update: Trading with Elan
http://www.schaeffersresearch.com/commentary/observations.as…

[Cyberhexe]

Anbei, näheres zur klinischen Phase 2 von AAB-001; diese dauert sehr lange, nämlich bis April 2008. Ist ja auch kein Wunder, da die Wirksamkeit bei einer degenerativen Krankheit wie Alzheimer nur über grössere Zeiträume zu erfassenn ist. Nichtsdestotrotz besteht die Möglichkeit direkt von Phase 2 in Phase 3 zu konvertieren, so dass hierdurch eine beschkleunigte Zulassung möglich wäre.

http://clinicaltrials.gov/ct/show/NCT00112073;jsessionid=131…

[Cyberhexe]

...wenn ich mich nicht irre (...Hi Sam!), dann müsste unter nachfolgendem Hyperlink die Wiederzulassung durch die FDA bekannt gemacht werden.
Wobei jedoch Biogen und Elan fast gleichzeitig entsprechende Pressemitteilungen herausgeben werden.

http://www.fda.gov/cder/whatsnew.htm

[Cyberhexe]

Diese Zeilen sind beeindruckend , und erinnern mich wieder daran, dass es hier nicht nur um (m)ein Investment geht, sondern für viele Tausende von existenzieller Bedeutung ist. Einer meiner Arbeitskollegen ist an MS gestorben (dies ist eigentlich das falsche Wort, es war viel schlimmer!), so dass es mir bewusst ist, welche Konsequenzen mit MS möglich sind.

http://www.mspatientsforchoice.org/


OPEN LETTER TO THE FDA

To the FDA,

When I left Washington with other team members of MSpatientsforchoice after testifying at the open hearing on March 7th, I was elated that we were going to see the return of Tysabri. The months since the recall of the drug have been difficult for all. For many in the MS community, the withdrawal of Tysabri has meant the advancement of disability. For many it has meant there are NO options against intolerable pain. Almost all who came to Washington, and the thousands they represent, have seen decline in their quality of life.


We had hoped with our very personal stories of what it's like to live with this horrendous disease, that it would be readily understood why we're ready to manage the risks associated with this drug. Enough reviews, surveys, and studies have been done on Tysabri. The risks are understood well enough that a percentage can even be attached to the risk. And over and over again individuals with MS are begging for this drug to be back as an option in their care. Tysabri is THE ONLY THING ON THE HORIZON THAT OFFERS A FUTURE FOR MANY WITH MS. It is unkind, unnecessary and intolerable to keep the drug away from the thousands of us with MS who are in such desperate need. Please remove this latest 90 day waiting period and begin making a positive change in the lives of so many with MS.

Sincerely yours,

MSpatientsforchoice

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 21.603.554 von Cyberhexe am 16.05.06 12:59:32

Da hast Du wirklich recht!

[Cyberhexe]

...Heute noch nicht:

http://www.fda.gov/cder/whatsnew.htm

[Cyberhexe]

Investmentfonds akkumulieren ebenfalls:


http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew…

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 21.621.042 von Cyberhexe am 17.05.06 13:42:16

genau,Fidelity hat 3 Mill. aufgestockt und:

JUST RELEASED!!!!
by: cg2003jan
Long-Term Sentiment: Strong Buy 05/17/06 07:28 am
Msg: 1009553 of 1009561

http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew… 36&source=RNS

note that the increase of the holdings is 3.126m shares

doesn't that explain the rise in the past few days??!!

[Cyberhexe]

...über die Wirkunsweise von Natalizumab:

http://www.ms-gateway.de/start.jsp?/resources/treatingms/new…

[Cyberhexe]

"Briefing Information" zu Natalizumab:

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4208-in…

[Cyberhexe]

Dennis Selkoe...ein zukünftiger Nobelpreisträger?
Ich würde eine kleine Wette darauf annehmen!


http://www.alzforum.org/new/detail.asp?id=1394

Selkoe
http://www.knaw.nl/cfdata/news/pressrelease_detail.cfm?nieuw…

Selkoe bei Elan
http://www.elan.com/governance/board_of_directors/full.asp?I…

[bernie55]

Elan Announces Resignation of Board Director


Thursday May 18, 2:30 pm ET


DUBLIN, Ireland--(BUSINESS WIRE)--May 18, 2006--Elan Corporation, today announces the resignation of Nancy Lurker as a non-executive director of the Company with effect from May 31, 2006. Ms Lurker has been a director of Elan since May 2005. Ms Lurker this week announced that she will be taking up the position of Chief Marketing Officer, Novartis Pharmaceuticals, US. To avoid the possibility of any conflict of interest in the future, both she and Elan agreed it was appropriate for her to step down from the board of Elan.
ADVERTISEMENT

Paying tribute to Ms Lurker, Kyran McLaughin, chairman thanked Nancy for her excellent contribution to the Board over the past year. "While we will miss Nancy on our board, we wish her well in her new challenging position", he added.

About Elan

Elan Corporation (NYSE: ELN - News), 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.



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

[bernie55]

Antwort auf Beitrag Nr.: 21.663.779 von bernie55 am 19.05.06 11:44:42

DIRECTOR WHO RESIGNED BOT 2,500 SHARES
by: hunglikeahorz (33/M/NC)
Long-Term Sentiment: Strong Buy 05/18/06 10:52 pm
Msg: 1011651 of 1011745

Lurker bought 2,500 at $14.80 before she resigned. Now that's a sign of how she puts her faith in ELN.

http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew… 67&source=RNS" target="_blank" rel="nofollow ugc noopener">http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew… 67&source=RNS

[Cyberhexe]

wow...Fidelity, ein riesiger Investmentfonnd mit Indikatorfunktion, hat er neut akkumuliert:

http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew…

[bernie55]

Antwort auf Beitrag Nr.: 21.668.630 von Cyberhexe am 19.05.06 14:19:06

My prediction about Fidelity was 100%
by: hunglikeahorz (33/M/NC)
Long-Term Sentiment: Strong Buy 05/19/06 07:32 am
Msg: 1011766 of 1011795

My prediction yesterday about Fidelity adding more was right on the money and 100% correct.
They added 3.5 million shares at $17+. Wow!

This means only one thing ---> they are supporting ELN to $25.00

[Cyberhexe]

Anbei das aktuelle Label der FDA zu Remicade vom 17. Mai 2006.
Remicade gilt momentan als das wirkungsvollste Medikament gegen MorbusCrohn und wird zukünftig in direkter Konkurrenz stehen zu Tysabri. Aber auch bei Remicade hat es bereits einige Todesfälle gegeben!

http://www.fda.gov/cder/foi/label/2006/103772s5138lbl.pdf

RISK OF INFECTIONS 8
9
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT 10
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER 11
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS 12
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL

[Birgit.Tersteegen]

18,45!Ich sag´s ja nur mal so ......Hexchen-wie heisst Dein Zaubertrunk?

[Nostarowie]

Antwort auf Beitrag Nr.: 21.741.508 von Cyberhexe am 22.05.06 16:27:40

Was könnte passieren, nur mal angenommen, es gibt wieder einen Todesfall-herbeigeführt nur durch einen Hauch mitbeeinflussung durch Tysabri....

...würde der Markt/Eln nicht hochsensibel reagieren?

Ich weis hätte, wäre, wenn nur so aus lauter ANGST.

Nun man könnte vielleicht dann alles riskieren bei einem zu erwartendem neuerlichen Absturz, da alles nur auf Ty abzielt.
Die relevanten Dinge in der entwicklung/erforschung des Konzerns werden nicht erfasst von der Allgemeinheit...

...man könnte aber auch gar nix machen und die Spekulation spekulation sein lassen....
Das hatten wir ja schon alles mal im Kursverlauf.

Worauf ich hinaus wollte...sollte sich Geschichte wiederholen,
ever and ever...?!

Schaut euch den Kurs an über die längst mögliche Zeit.
Das Unternehmen lebt davon, so hatts den anschein...



Oh bitte zerstreue meine Gedanken Cyberhexe...

[Cyberhexe]

@Russensocke

Nosta, ich hatte vor kurzem folgenden Beitrag ins Forum gestellt, der sich auch mit den Risiken eines elanvollen Investment auseinandersetzt. Hier nochmals der Beitrag:

#747 von Cyberhexe 15.05.06 16:55:08 Beitrag Nr.: 21.590.568
Dieses Posting: versenden | melden | drucken | Antwort schreiben ELAN CORP. PLC EO-


Welche Faktoren beeinflussen unser Anlageverhalten?
In erster Linie, die Aussicht auf Gewinn, also die Chance, und zweitens das damit verbundene Risiko.

Nun bei unserem elanvollen Favoriten sind die Chancen nahezu gigantisch, denn sollte sich auf Ende Jahr beim Alzheimer-Projekt eine Phase III- Studie abzeichnen, sind steigende Kurse nicht nur in Cent-Beträgen vorprogrammiert.
Die kurzfristigen Schlagzeilen werden jedoch von der Tysabri-Wiederzulassung bestimmt. Sollte Tysabri kurzfristig (von den Analysten zumindest) unerwartete Marktanteile sichen - und davon gehe ich aus-, dann wird dies den Kurs ebenfalls beflügeln.
Verbunden mit der hochinteressanten Nanotechnolgie für wasserunlösliche Aktivsubstanzen - über 70 Wirkstoffe werden getestet, 5 sind bereits zugelassen, für welche Elan bereits Lizenzeinnahmen erhält (und dies ohne Kosten zu generieren!) - ergeben einen überaus interessante Kombination mit riesigem Kurspotential.

Nun, demgegenüber steht momentan ein, wie ich finde, relativ kleines Risiko.
Tysabri wurde in den letzten 15 Monaten nicht appliziert, weshalb von dieser Seite vorerst keine negativen Schlagzeilen zu erwarten sind.Die in der Klinik getesteten Alzheimer-Aktivsubstanzen (AAB-001 und ACC-001) hatten bereits eine Vorläufer-Substanz (AN-1792), mit welcher der "proof-of-concept" bereits erbracht wurde.
Die bei AN-1792 aufgetretenen Nebenwirkungen (Hirnhautentzündung) sind jedoch zumindest bei AAB-001 nicht zu erwarten, da es sich hierbei nicht um eine aktive Immunisierung sondern um einen passiven Schutz durch Injektion des Antikörper handelt.
Und bei der Nanotechnologie ist sowieso jede weitere Zulassung ein Volltreffer, der nur Einnahmen und keine Kosten verursacht.

Das Chance/Risiko-Verhältnis scheint mir deswegen momentan einzigartig, weshalb man nicht ungeduldig werden sollte.




Sicherlichn, sobald die Wiederzulassung erteilt wurde und Natalizumab zigtausendfach über mehrere Monate appliziert wurde, wird sich das Risiko von Negativschlagzeilen massiv erhöhen. Spätestens bis dahin muss ich meinen Investitionsgrad auf ein vernünftiges Mass gesenkt haben. Allerdings wird Elan auch dann die stärkste Fraktion in meinem Portfolio stellen, da die Alzheimer-Geschichte, "the reason for our being", alles bisherige in den Schatten stellen könnte.

deswegen gilt noch immer,
all in one all in Elan
good luck
ch

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 21.747.461 von Cyberhexe am 22.05.06 21:59:27

Russensocke klingt süss!

Unser Babe wird steigen....!

[Nostarowie]

Antwort auf Beitrag Nr.: 21.747.923 von Birgit.Tersteegen am 22.05.06 22:27:03

Bibi Blocksberg aber auch.

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 21.751.501 von Nostarowie am 23.05.06 09:53:01

--wir dürfen hier aber nicht shakern--gibt Rüffel vom Hexchen....(Vielleicht erlaubt sie diese Ausnahme?)

[Cyberhexe]

keine Sorge Birgit, ich werde Euch deswegen nicht verhexen; obschon, ich finde es eigentlich ganz ok, wie derzeit die Elan-Aktivitäten im Forum gehandhabt werden:
ein Thread für Stimmungen
ein Thread für Fakten

good luck
ch


NCB Stockbrokers

Elan is to present detailed Phase III Crohn’s disease induction trial (ENCORE) data
with Tysabri at Digestive Disease Week (DDW) today. As announced last year, Tysabri
met the primary endpoint (a response to Tysabri at week 8 and week 12 as defined by
a 70-point drop in the Crohn's Disease Activity Index (CDAI)) and all of the secondary
endpoints in this Crohn's disease study including clinical remission (a CDAI score of
less than 150).
• The 509 patients that were enrolled in the study had moderate to severely active
Crohn's disease and the study was powered to only include patients with active
inflammation (as determined by elevated C-reactive protein (CRP) levels). Tysabri
induced response and remission by week 8 that was sustained through week 12.
Briefly, 48% of patients in the Tysabri treated group were in response at week 8 and
week 12 compared to 32% of placebo treated patients. In addition, remission was
achieved by 26% of Tysabri treated patients compared to 16% of placebo patients at
week 8 and week 12. Adverse events were similar between the two groups. Overall
response and remission rates for Tysabri in Crohn’s Disease were superior to placebo
at all timepoints tested.
• In addition to the ENCORE data a number of paper presentations around Tysabri are
also being presented at DDW including the safety findings obtained from the 3,500
patients that participated in the Tysabri safety evaluation following the drugs’
suspension. Currently, we have not factored in the use of Tysabri in Crohn's disease in
our forecasts. Once clarity is provided by the FDA on Tysabri in MS, the company plan
to submit a BLA for Tysabri for Crohn's disease. The European regulatory filing for
Crohn's disease continues to be reviewed by the EMEA.
• One other interesting product to emerge for the treatment of Crohn’s Disease is Cimzia
(anti-TNF; UCB), with Phase III data presented at DDW yesterday. As highlighted
previously Cimzia met Phase III endpoints and although the Phase III data with Cimzia
is not directly comparable to Tysabri, Cimzia is the third anti-TNF expected to be
approved for Crohn’s disease. Cimzia will likely have broader patient use than Tysabri
as Tysabri, if approved, is expected to be confined to Crohn's patients with active
disease (c.70% of Crohn's patients).

[Cyberhexe]

Gestern hat im Rahmen der Digestive Disease Week in Los Angeles eine von Elan und Biogen organisiertes Symposium stattgefunden.
Gab es da was Neues?

http://www.fissioned.com/BeyondTNF2006/

[Cyberhexe]

Natalizumab in Phase III bei MorbusCrohn:

http://www.ddw.org/wmspage.cfm?parm1=443


Natalizumab Induces Sustained Response and Remission in Patients with Active Crohn's Disease: Results from the ENCORE Trial [Abstract 747]

To counteract the chronic inflammation of Crohn's disease, recent research has focused on new therapies to induce a measurable and sustained response in patients with moderate to severe symptoms. In this phase III trial, researchers found successful results with the use of natalizumab therapy for up to eight weeks. Natalizumab (Tysabri®), is a monoclonal antibody, which interferes with the immune response that causes inflammation in Crohn's disease.

ENCORE (Efficacy of Natalizumab in Crohn's Disease Response and Remission) evaluated the effects of natalizumab in Crohn's patients with active inflammation (C-reactive protein [CRP] levels greater than the highest normal rating of 2.87 mg/L). More than 500 patients were randomized to receive natalizumab (n=259) or placebo (n=250) infusions at weeks 0, 4 and 8. The researchers measured efficacy and side effects after 4, 8 and 12 weeks, with the hope of achieving a sustained clinical response (≥ 70 point decrease in baseline CDAI score) or remission (CDAI < 150).

The team found promising results with the use of natalizumab. A significantly higher proportion of patients in the natalizumab group responded to therapy at weeks 8 and 12 compared to patients in the placebo group (48 percent vs. 32 percent). Half of patients receiving natalizumab responded after the first infusion (51 percent) compared to one-third (37 percent) in the placebo group, and the response rate in the treated group was sustained at all points during the trial. More than 25 percent of natalizumab patients achieved remission at weeks 8 and 12, compared to just 16 percent of the placebo group. Incidence and adverse events were similar between the groups.

"These results demonstrate that natalizumab induced early and sustained response and remission in patients with active Crohn’s disease," said Stephan Targan, M.D., of Cedars-Sinai Medical Center and lead study author. "We believe this trial confirms the benefit of this therapy along with its safe use as an induction therapy for Crohn’s patients, and may be a better option for treating moderate to severe symptoms."

A Safety Evaluation for Progressive Multifocal Leukoencephalopathy (PML) in Greater Than 3,500 Patients with Crohn’s Disease (CD), Multiple Sclerosis (MS), and Rheumatoid Arthritis (RA) Previously Treated with Natalizumab in Clinical Trials [Abstract 492]

Natalizumab, a humanized monoclonal antibody approved to treat multiple sclerosis (MS) in 2004, was in trials for the treatment of Crohn’s disease (CD) and rheumatoid arthritis (RA). Clinical trials for the product were suspended in February 2005 after two patients experienced PML (progressive multifocal leukoencephalopathy) while on combination therapy with natalizumab and β interferon. Subsequently, a third case was identified in a patient with Crohn’s disease who was receiving natalizumab and previously had received combination therapy with natalizumab and azathioprine. A safety evaluation was performed in all patients who had been recently treated with natalizumab to screen for PML and determine a more accurate estimate of the actual incidence of the event. PML is a rare disorder of the nervous system that affects individuals with suppressed immune systems and is caused by a JC virus (a brain infection damaging nerve cells and causing mental deterioration which may be fatal, named for a patient first diagnosed with the disease).

The evaluation included a physical exam, referral to a neurologist, brain MRI and analysis of cerebral spinal fluid (CSF) and serum for JC virus. An independent expert committee reviewed all suspected cases of PML and made final determinations of whether the patient had PML. In addition to patients from clinical trials, four post-marketing reports of suspected PML were also referred to the committee.

Enrollment in the safety evaluation was high, including 87 percent (1,275), 91 percent (2,248) and 92 percent (296) of all eligible study participants with Crohn's disease, multiple sclerosis and rheumatoid arthritis, respectively. CSF was analyzed for JC virus in 6 percent of CD, 16 percent of MS, and 4 percent of RA patients, and plasma in 88 percent of CD, 56 percent of MS, and 95 percent of RA patients. No additional cases were found to have PML, and the four post-marketing cases referred to the committee were also judged not to have PML.

"Results of this analysis suggest that the absolute risk of developing PML during therapy with natalizumab is very low," said William Sandborn, M.D., of the Mayo Clinic and lead study author. "We believe that natalizumab is still of great benefit to patients with moderate to severe Crohn’s disease, so that potential benefit in selected patients needs to be carefully weighed against the small risk of PML."

[Cyberhexe]

News from DDW 2006

http://www.ddw.org/wmspage.cfm?parm1=443

[Cyberhexe]

Goodbody Stockbrokers
über Natalizumab bei MorbusCrohn

Ich persönlich sehe die Chancen auf Marktanteile bei der Behandlung von MorbusCrohn mit Natalizumab begrenzt,
da 1.) Alternativen vorhanden sind (Remicade und Cimiza, welches in der Klinik in Phase 3 die Endpunkte ebenfalls erreicht hat)
und 2.) die PML-Gefahr in Verbindung mit anderen immunsupprimierenden Wirkstoffen erhöht ist und die meisten der Crohn-Patienten eine immunsupprimierte "Vorgeschichte" haben.

Nichtsdestotrotz!
all in one, all in Elan
good luck
ch


http://www.rte.ie/business/2006/Morningrep/download/0523good…

Elan (Add, Closing Price $17.37); Digestive Disease Week highlights Tysabri for Crohn’s.
Analyst: Ian Hunter T [phone] E [e-mail]
During Digestive Disease Week (DDW) this week in the US, there will be six presentations on the use of Tysabri for the treatment of
Crohn’s Disease. The use of the drug has also been highlighted by the conference organisers in their introductory press release. Papers
on previously reported results note that: (i) monthly infusions of Tysabri achieve sustained remission over 12 months with remission
“highly likely” to remain an additional 12 months; (ii) the drug is effective without the need for concomitant use of immunosuppressants:
(iii) the use of Tysabri improves a Crohn’s patients quality of life; (iv) the absolute risk of developing PML during therapy is low; and (v)
patients are willing to accept a defined risk of death or disability from PML in exchange for the clinical efficacy of the drug.

[bernie55]

Elan Holds Its AGM, All Resolutions Passed
Thursday May 25, 8:30 am ET


DUBLIN, Ireland--(BUSINESS WIRE)--May 25, 2006--Elan Corporation, plc today held its annual general meeting (AGM). All eighteen shareholder resolutions proposed to the meeting were passed by the shareholders.

The AGM was webcast and a replay of the event is available by visiting Elan's website at www.elan.com and clicking on the Investor Relations section, then on the event icon.

http://biz.yahoo.com/bw/060525/20060525005343.html?.v=1

[bernie55]

Elan-Biogen mull price rise for MS drug Tysabri
Thu May 25, 2006 9:17 AM ET

By Paul Hoskins

DUBLIN, May 25 (Reuters) - Biotech group Elan Corp. (ELN.I: Quote, Profile, Research) says there is scope to raise prices for suspended MS drug Tysabri and hopes along with U.S. partner Biogen to know more about the product's return to market before a June 28 deadline.

The Irish company (ELN.L: Quote, Profile, Research) and Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) would need to see the drug's final risk profile before setting a price, Elan Chief Executive Kelly Martin said on Thursday, citing price rises for rival multiple sclerosis treatments.

"Clearly there's headroom to raise the price," Martin told journalists after the company's annual shareholder meeting. "But we haven't finalised that."

Sales of Tysabri were suspended in February 2005 after three patients developed a rare brain infection, which led to two deaths. Elan (ELN.N: Quote, Profile, Research) has said it hopes to start relaunching the drug in the third quarter after receiving regulatory approval.

Elan stock was up 0.5 percent at 13.50 euros by 1230 GMT, slightly outperforming a flat Irish ISEQ index <.ISEQ>.

The shares soared in March after a panel of U.S. experts recommended Tysabri be allowed back onto the market subject to certain controls. The Food & Drug Administration (FDA) in the United States is currently considering the risk management plan for the drug and is due to reach a decision by June 28.

Martin said on Thursday he hoped there might be a judgment even before then given the pressure from doctors and patients wanting to use Tysabri.

"Elan and Biogen and the agency (the FDA) have indicated that if we can achieve clarity sooner than that we will do that," he said.

Tysabri is seen as key to Elan's future after a brush with bankruptcy in 2002. The company posted a smaller-than-expected net loss earlier this month and said it was confident that revenue from Tysabri would speed up a return to profitability.

"Elan's AGM message was optimistic on both timelines and pipelines," Jack Gorman, analyst at Davy stockbrokers, wrote in a research note. "Tysabri remains on course for US and EU launch in the second half of the year, with significant operating leverage as revenues expand."

In terms of Elan's pipeline of other potential new drugs, the company said it still hoped to reach a decision on whether to launch a final Phase III trial on the AAB-001 Alzheimer's drug, developed with Wyeth (WYE.N: Quote, Profile, Research), by the end of the year.

(Additional reporting by Claire Shoesmith)


http://yahoo.reuters.com/stocks/QuoteCompanyNewsArticle.aspx…

[Cyberhexe]

Fidelity (ein riesiger Investmentfonds) hat wiederum akkumuliert:
+ 4.44 Mio Anteile auf nunmehr knapp 35 Mio!


Total Shares Held 34,926,290
Current ownership 8.13%
percentage:
Shares in issue: 429,816,652
Change in holdings since +4,443,400 ordinary
last filling: shares



http://www.investegate.co.uk/Article.aspx?id=200605251237075…

[Cyberhexe]

kurz das Wichtigste from AGM, dem AnnualGeneralMeeting, also der Jahreshauptversammlung von Elan (Zusammenfassung aus mehreren Beiträgen aus dem YMB):

MS
Prävalenz (Anzahl Individuen, die an einer best. Krankheit erkrankt sind) weltweit 2.5Mio , 1Mio in US/EU

MorbusCrohn
1Mio US/EU

Alzheimer
weltweit derzeit 18Mio, mit Veränderung der Altersstruktur der Ges. wird ein Anstieg auf über 30 Mio erwartet

Tysabri
Zulassung von der FDA auf Ende Juni erwartet
EMEA im frühen Sommer

AAB-001, momentan in Ph2, Zwischenergebnisse auf Ende 2006, nach denen ein Übergehen in Ph3 durchaus möglich erscheint

ACC-001, momentan in Ph1, Phase 2 innerhalb von 12 Monaten realistisch

ACC-002, IND (Investigational New Drug) innerhalb von 12 Monaten (mit dem IND erteilt die FDA die Berechtigung klinische Studien zu modellieren)

Nano...nichts Neues, obschon einige Teilnehmer den Eindruck äusserten, dass die Formulierungen Rückschlüsse erlauben, dass zukünftig sehr viel zu erwarten ist...aber dies ist sehr spekulativ!

wow...folgendes hab ich nun zum ersten Mal gelesen....aus dem YMB allerdings, wobei der Absender der Info jedoch sehr zuverlässig und seriös eingeschätzt wird:
ElyLilly hat einen gamma-Secretase-Wirkstoff gegen Alz in Ph2, der demnächst in Ph3 gehen wird. Dieser Wirkstoff stammt aus derselben Forschung wie Elans Secretase-Programm, und Elan soll angeblich eine Option auf einen 50%-Anteil haben - diese Info jedoch mit Vorsicht geniessen, da offiziell bisher nicht bestätigt (ich werde diesbezüglich noch intensiver recherchieren; mal sehen, vielleicht sind da detaillierte Info verfügbar!)

einige aktive Teilnehmer des ymb haben zudem die Gelegenheit genutzt, sich im Rahmen des AGM mit Forschungsleiter Lars Ekman persönlich zu unterhalren. Anbei eine kurze Zusammenfassung der geschilderten Eindrücke:

1. I started by asking Lars whether Biogen had investigated whether the dodgy Avonex batches had been assessed for jcv contamination of hsa suspension by biogen. He confirmed that they did the assessment but found no virus. Fine.

Production: High titre process will be on stream before the Danish facility gains regulatory blessing.
der Produktions-Prozess mit der vierfachen Natalizumab-Ausbeute soll noch vor der Inbetriebnahme von Hillerode/Dänemark implementiert werden

I asked about the european salesforce for crohns and why there is little evidence of Elan hiring here. He seemed rather surprised by my question but after a pause suggested that there are ´many means´ of dealing with Crohns sales. Read into that what you will...I didnt press it further.

Diese Antwort auf die bisher bescheidene Anzahl der Pharmavertreter in der EU zu MC fiel zweideutig aus. Ich würde dies jedoch so deuten, dass die Verantwortlichen bei MC nicht den grossen Durchbruch sehen, zumal Ty bei der Wirksamkeit den anderen Wirkstoffen nicht derart überlegen ist wei bei MS.

On Tysabri, he suggested that we will look back in 2010 and realise that the everything that happened was worth it in the long run. He often used the term `gigantic` when referring to the future of Tysabri.


Bei MS scheint LE allerdings immer wieder Superlative zu verwenden ("gigantisch")

2. AAB-001. Great stuff here.

In the PI they were still seeing +ve effects of the drug AFTER A SINGLE DOSE, 1 YEAR LATER. That is startling in my mind.

Bereits nach einer Applikation AAB-001 wurden positive Effekte beobachtet!

AAB001 attacks both soluble and plaque based a-beta oligomers. One expects to see cognitive improvement rather rapidly due to removal of the soluble form. PET scans should reveal morphological changes due to plaque removal at a later stage. Lillys immunotherapeutic targets solely the soluble form.

Half-life of the drug is 3 months.

Chucky asked about fast tracking and the possibility of entering p3 while still in P2. Lars tried to hide his smile and responded that they were planning for success and that the phase3 study is already being designed. They want to be ready to go as soon as the data suggest they should. Interestingly, Lars indicated that given the data they already have at hand and the p2 data, a phase3 study could be considerably shorter than most anticipate...I read from that about 12 months or less (6?).

...Lars versuchte sein Lächeln zu unterdrücken und antwortete, auf Erfolg zu planen und dass die Ph3-Studie bereits in Vorbereitung sei!

In the present p2 they are assessing concentrations slightly above the 1.5mg and down below 0.5mg. The FDA is interested in identifying the concentration at which no effect is discernable.

In terms of body language Lars was clearly very charged about the AD program. He acknowledged that the past year has been the toughest in his career, but AD results seem to have made up for everyones stress over this time.

All in all, a great and very positive experience discussing with Lars. He is an extremely nice person and he left me very confident about the future of scientific innovation at Elan.

thats a quick wrap for those waiting. Illl take a bit more time next week when I return home to expand on some of the above.

best,
David

[Cyberhexe]

Goodbody Stockbrokers übers AGM:

http://www.rte.ie/business/2006/Morningrep/download/0526good…

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.804.756 von Cyberhexe am 26.05.06 09:40:37

Daten/Infosuche bzw. Verifizierung der Info aus dem ymb zum Secretase-Projekt von EliLilly:

wow...folgendes hab ich nun zum ersten Mal gelesen....aus dem YMB allerdings, wobei der Absender der Info jedoch sehr zuverlässig und seriös eingeschätzt wird:
ElyLilly hat einen gamma-Secretase-Wirkstoff gegen Alz in Ph2, der demnächst in Ph3 gehen wird. Dieser Wirkstoff stammt aus derselben Forschung wie Elans Secretase-Programm, und Elan soll angeblich eine Option auf einen 50%-Anteil haben - diese Info jedoch mit Vorsicht geniessen, da offiziell bisher nicht bestätigt (ich werde diesbezüglich noch intensiver recherchieren; mal sehen, vielleicht sind da detaillierte Info verfügbar!)


...also da scheint es tatsächlich eine Zusammenarbeit mit EliLilly zu geben:

Thursday: gamma-secretase inhibitors
Eli Lilly & Co is sponsoring a session on gamma-secretase inhibitors to wrap up the presentations from the Division of Medicinal Chemistry on the morning of the final day. Lilly has a program looking at gamma-secretase inhibitors for the potential treatment of Alzheimer's disease, in collaboration with Elan Pharmaceuticals Inc, which is included in Tuesday's David Robertson Memorial Symposium. In addition, there are offerings from Merck Sharp & Dohme Ltd, AZ and BMS. This session runs alongside the final general oral session.




http://scientific.thomson.com/free/meetingpreviews/2004/8242…

[Cyberhexe]

NCB aktuell über Elan:


http://www.rte.ie/business/2006/Morningrep/download/0526ncb.…

Elan held its AGM yesterday with all resolutions passed. Management continues to be
confident about Tysabri's return to the US market with a PDUFA date of 28th June.
The decision on Tysabri by the FDA is expected to coincide with the EMEA's review of
Tysabri. With competitor MS products witnessing significant price increases since
Tysabri's withdrawal in the US and with the two year Phase III data now available (this
shows that Tysabri is twice as efficacious as competing MS products in reducing the
rate of relapses), it seems likely that Tysabri's price will increase from the $23.5k
level set in November 2004. A 10% increase in Tysabri's price (c.30% premium to
Rebif) in the US would increase our SOTP by c.50c to $16.25-$19.29.
• The near-term pipeline remains focussed on Alzheimer's disease with interim
analyses of the Phase II data with AAB-001 (monoclonal antibody directed against
amyloid-beta) in H2 2006. A positive signal (meeting a cognitive endpoint along with
a improvement in a quality of life measure or a reduction in plaque formation (as
observed by PET scanning)) observed on interim analyses will trigger progression of
AAB-001 to Phase III studies. Alongside the completion of the Phase II trial, Elan is
working on a protocol for the Phase III study with patients potentially receiving AAB-
001 over a 18-month period. Interim analysis at 6 months and 12 months would be
incorporated into this protocol. Phase I data recently release with AAB-001 was
encouraging from a clinical and safety perspective with some very early signs of
efficacy observed at 4 months. We are currently factoring in $5.50 a share in our
sum-of-the-parts assessment for the Alzheimer's disease pipeline (this assumes a
25% probability of success). Should AAB-001 progress to Phase III the probability of
success of AAB-001 in our analysis would increase from 25% to 50% increasing our
SOTP value by an additional $5.50. In addition to AAB-001, Phase I trials of ACC-001
(A beta conjugate) are progressing with an interim analyses of this data later this year.
• Over the coming month we expect the FDA to finalise Tysabri's RiskMap and
label and for the product to be launched in the US 1-2 months later. European
approval is also expected around this time. With the FDA to recommend a “wash out”
period for patients on existing MS treatment or on immunosuppressants, we believe it
will be Q4 2006 before the initial uptake of the drug in the US becomes apparent. In
terms of Tysabri for Crohn's disease, the European regulatory filing for Crohn's
continues to be reviewed by the EMEA with a decision expected towards by the end of
2006. A BLA filing is planned in Crohn's disease once clarity is reached with the FDA
with Tysabri in MS.

[bernie55]

Fidelity now at 9.12%
by: huntsmann_ie 05/26/06 07:15 am
Msg: 1017921 of 1017925


Security: ELAN CORP PLC

Current ownership percentage: 9.12%
Total Shares Held 39,197,190
shares in issue: 492,816,652
Change in holdings since last filing +8,714,300 Ordinary Shares

MANAGEMENT
SHARES HELD COMPANY NOMINEE/REGISTERED NAME

26,968,820 FMRCO BROWN BROTHERS HARRIMAN AND CO
9,844,700 FMRCO JPMORGAN CHASE BANK
1,441,780 FMRCO STATE STREET BANK AND TR CO
612,000 FMRCO NORTHERN TRUST CO
120,800 FMRCO MELLON BANK N.A.
13,500 FMRCO FIRSTAR TRUST COMPANY
8,900 FMRCO BANK OF NEW YORK
126,700 FIL BROWN BROS HARRIMN LTD LUX
59,200 FIL JP MORGAN, BOURNEMOUTH
790 FIL BROWN BROS HARRIMN LTD LUX



This announcement has been issued through the Companies Announcement Servic of the Irish Stock Exchange.

This information is provided by RNS
The company news service from the London Stock Exchange


http://www.investegate.co.uk/Article.aspx?id=200605251531566…

[Cyberhexe]

Analyse von Davy:

From Davy's : AGM COMMENTARY HIGHLIGHTS OPERATING LEVERAGE ON TYSABRI AND
CONFIDENCE IN AD PROGRESS
By the end of June, Elan is on track to receive approval for
Tysabri in both the US and EU (preliminary approval has
already been granted for the latter). A decision on its
Crohn’s indication in Europe could also occur in the second
half of 2006. On AD, the company line remains that Phase
II data on AAB-001 will be available towards the end of the
year. A decision will also be made on Phase III at that time.
We still believe that interim analyses may allow Elan to
make this decision earlier.

Upbeat on prospects in AD
Management continues to demonstrate strong underlying confidence in the progress of its AD pipeline.
The company line remains that it will be the end of the year before Phase II data on lead product AAB-
001 (bapineuzumab) are available.
We continue to believe that interim analyses may allow Elan to interpret data earlier in 2006. There are
several endpoints being analyzed – cognition, memory, quality of life and imaging. Statistically significant
results are not required; strong signals will be sufficient for the product to progress to Phase III. Specific
patient subgroups are also being analyzed.
Although Phase III studies would most likely last 18 months, existing AD therapies have been approved
for symptomatic use on the basis of just six months of data. That Phase III on AAB-001 is also likely to
include interim analyses could provide Elan with the potential to accelerate development, even as a superior
symptomatic treatment in the first instance.
We were very encouraged by the recently released Phase I data on AAB-001. Although a small 30-patient
study, several dosage levels demonstrated absolute improvements in MMSE scores (a measure of language
and short-term memory used in AD trials).

A strong message was also given regarding intellectual property. With 40 issued patents in the AD
immunotherapy area already, Elan is likely to be in the enviable position of defending its IP rights rather
than infringing on the rights of others.

Newsflow on drug technology division in H2
Elan’s drug technology division remains focussed on developing internal and partnership projects for its
Nanosystems delivery technology. The division is currently preparing feasibility studies on 30 compounds
internally, and half a dozen discussions with prospective pharma partners are also ongoing. Newsflow
on some of these initiatives is expected in the second half of 2006.Elan is also exploring angles to co-promote products that use Nanosystems technology. This may be one
way of filling the potential gap in revenues that will be created by the genericisation of Maxipime and
Azactam.

Prialt
Slow, steady progress is being reported on Prialt as Elan focuses on increasing medical education on the
product. In particular, the company is targeting oncologists as an avenue for future revenue growth.

[Cyberhexe]

RTÉ Business...AGM
http://www.rte.ie/business/2006/0525/elan.html

[bernie55]

Elan Announces the Appointment of a New Board Director

Friday May 26, 1:00 pm ET


DUBLIN, Ireland--(BUSINESS WIRE)--May 26, 2006--Elan Corporation, plc today announced the appointment of Mr. William R. Rohn to the company's Board of Directors.
Elan's chairman, Kyran McLaughlin, said, "The Board is extremely pleased to announce the appointment of Bill. His extensive experience in the pharmaceutical and biotech industries, together with his personal qualities, will make him an excellent addition to the Board and we all look forward to working with him".

Kelly Martin, Elan's president and chief executive officer, added: "I look forward to working with Bill and benefiting from the experience he brings with him".

Mr. Rohn (62) is an experienced biotech and pharmaceutical industry executive. He is currently Vice Chairman of Raven Biotechnologies, Inc., and a Director of Metabasis Therapeutics, Inc., Cerus Corp and Pharmacyclics, Inc. Previously he was Chief Operating Officer of Biogen Idec until January 2005 and prior thereto President and Chief Operating Officer of Idec Pharmaceutical Corporation from 1993.

http://biz.yahoo.com/bw/060526/20060526005354.html?.v=1

[bernie55]

Antwort auf Beitrag Nr.: 21.825.650 von bernie55 am 26.05.06 21:09:31

William R. Rohn
CEO and Vice Chairman

Mr. Rohn has over 30 years of management experience in the biotechnology and pharmaceutical industry including more than 10 years in executive management positions at Idec Pharmaceuticals Inc. and, more recently, Biogen Idec where he served as Chief Operating Officer. He joined Idec in August 1993 as Senior Vice President, Commercial and Corporate Development, was appointed Senior Vice President, Commercial Operations in April 1996 and was promoted to Chief Operating Officer in May 1998. In January 2002, he became President, responsible for Sales, Marketing, Business Development, Manufacturing, Quality, Medical Affairs and CMC Regulatory Affairs. He was responsible for building Idec's initial commercial infrastructure to support the launch of Rituxan, the first monoclonal antibody approved in the United States for the treatment of cancer. Prior to joining Idec, Mr. Rohn held marketing and sales management positions at Adria Laboratories, now part of Pfizer, Abbott Laboratories, Warren-Teed Pharmaceuticals, Miles Laboratories and Mead Johnson Laboratories. Mr. Rohn serves on the Board of Directors of Pharmacyclics, Inc., Metabasis Therapeutics, Inc. and Cerus Corporation. Mr. Rohn received a B.A. in Marketing from Michigan State University. In late 2004 Mr. Rohn announced his retirement from Biogen Idec, effective January 31, 2005.

[Cyberhexe]

ENCORE = Studie zur Wirsamkeit von Natalizumab bei Morbus Crohn

http://www.elan.com/Images/targan_tcm3-13870.pdf

Conclusions: Natalizumab induced response and remission by week 8 that was sustained through week 12.
The response and remission rates for natalizumab were superior to placebo at all timepoints beginning at
week 4, thus confirming the efficacy of natalizumab as induction therapy. Natalizumab was well tolerated,
with adverse events not significantly different than pbo.

[Cyberhexe]

nochmal was zu Morbus Crohn:

http://www.elan.com/Images/feagan_tcm3-13866.pdf

[Cyberhexe]

Anbei die Ergebnisse der beiden ENACT-Studien (Natalizumab bei Morbus Crohn).
Die ENACT-2-Studie wurde nur mit Teilnehmer der ENACT-1-Studie durchgeführt, die auf Natalizumab angesprochen haben.

http://www.elan.com/Images/sandbornddw_tcm3-13869.pdf

Conclusions:
Natalizumab was significantly better than placebo at maintaining sustained response and remission
through 12 months, and the benefit was similar regardless of concomitant IMM use. The AE profiles
between these subgroups were also similar. The rate of persistent anti-natalizumab Abs in patients not
receiving concomitant IMM was relatively low and did not appear to significantly impact sustained
efficacy at 1 year.

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.848.450 von Cyberhexe am 28.05.06 14:49:03

bei Gelegenheit müsste man einmal die Phase3-Ergebnisse von Infliximab (brand: Remicade) zum "benchmarking" heranziehen

[wave]

an cyberhexe


Kannst du mir ein paar Fragen beantworten?

Warum ist die Aktien schon 2 x fast gestrandet:

2001 von über 60 EUR auf 2 EUR

2005 von 30 auf 4 EUR

(Kurzfassung)


Jetzt sieht es nach einer sehr schönen Erholung aus aber auch sehr schnell

12 Monate über 130 %

dieses Jahr schon über 30 %


Hast du ein paar Daten für 2006 für mich?

Geplanter Umsatz 2006
Gewinn oder Verlust 2006

Danke

[Cyberhexe]

@wave

2001 lebte der Kurs von der Phantasie des Alzheimer-Programms; nachdem bei dem weitesten entwickelten Wirkstoff, AN-1792, einem Vaccin, bei einigen Studienteilnehmern Hirnhautentuzündungen aufgetreten sind, wurden die klinischen Tests gestoppt.
Daraufhin ist der Kurs dramatisch eingebrochen.
Allerdings wurden die Studienteilnehmer mit AN-1792 auch nach Abbruch der Studie selbstverständlich weiter beobachtet. Bei jenen, die mittlerweile eines natürlichen Todes vertschieden sind, wurden Autopsien durchgeführt und der Nachweis erbracht, dass im Gegensatz zu normalen Alzhheimer-Patienten bei den Studienteilnehmern keine Plaquebildung im Gehirn festzustellen ist. Obschon der letzte Nachweis der Kausalität noch nicht erbracht wurde, geht man davon aus, dass die Plaquebildung ein Fortschreiten der Krankheit zumindest anzeigt.
Aus diesen Erkenntnissen wurden nun die weiter entwickelten Wirkstoffe AAB-001 (Phase 2 ), kein Vaccin sondern ein Antikörper (im Gegensatz zum Vaccin handelt es sich beim Antikörper um ein passives Vorgehen, so dass Überreaktionen wie bei AN-1792 nicht zu erwarten sind) und ACC-001 (Phase 1 ), ein weiter entwickeltes Vaccin, in die Klinik gebracht.

am 28.2.2005 (BlackMonday) wurde Tysabri (generic name: Natalizumab) freiweillig vom Markt genommen, nachdem im Zusammenhang mit der Applikation dieses Wirkstoffes 3 PML-Fälle, davon 2 fatal, aufgetreten sind. Daraufhin ist der Kurs ein 2.Mal eingebrochen.

Nachdem sich nun eine Wiederzulassung von Tysabri abzeichnet und auch das Alzheimer-Programm stetig vorwärts kommt, ist der Anstieg auf mittlerweile 18$ keine Überraschung.


Für 2006:
Beim EBITDA ist Elan bereits ausgeglichen: Der weitere Geschäftserfolg hängt nun davon ab, wie sich Tysabri am Markt behaupten wird. Ich denke, dass einige 10Tausende sehnlichst der Zulassung entgegenfiebern, da ein Grossteil der MS-Erkrankten aus Mangel an Wirksamkeit der am Markt platzierten Wirkstoffe überhaupt nicht behandelt wird. Und das Fortschreiten dieser Krankheit kann mehr als grausam sein!

Das Potential ist gewaltig:
MS
Prävalenz (Anzahl Individuen, die an einer best. Krankheit erkrankt sind) weltweit 2.5Mio , 1Mio in US/EU

MorbusCrohn
1Mio US/EU

Wenn nur 10% aller MS-Erkrankten mit dem wirkungsvollsten Medikament (doppelt so effizient als alle am Markt platziertebn Wirkstoffe) behandelt würden dann gebe sich momentan folgende Jahresrechnung für Elan (nur von Tysabri):

10% von 2,5 Mio Erkrankten =250.000 Behandelte
250.000 Jahresdosen x 23500$ (Preis soll jedoch erhöht werden!)
= Brutto-Umsatz kanpp 6 Milliarden$
gross profit 85%: ca. 5 Milliarden$
dividiert durch 2 (Biogen!): 2,5 Milliarden$, welche voll in den Deckungsbeitrag einfliessen
da EBITDA bereits ausgeglichen, wäre der Reingewinn > 2 Milliarden$

also ca. 5$ je Aktie

KGV in Biotechbranche: 30 ist nicht unüblich (Genentech hat zB eines über 60)

Das obige Rechenbeispiel soll lediglich verdeutlichen, welch riesiges Kurspotential vorhanden ist. Selbstverständlich scheint dieses Szenario für 2007 noch zu früh, aber mittelfristig ist es sicherlich nicht unrealistisch.

Und sollte das mit dem Alzheimer-Programm tatsächlich etwas werden, dann ist wirklich der Himmel die Grenze (the sky is the limit!)

[Poppholz]

Antwort auf Beitrag Nr.: 21.851.393 von Cyberhexe am 28.05.06 18:35:59

dpa-afx
Biogen Idec geht auf Einkaufstour - Budget von zwei Milliarden Dollar
Montag 29. Mai 2006, 09:13 Uhr

MÜNCHEN (dpa-AFX) - Das US-Biotechnologie-Unternehmen Biogen Idec will auf Einkaufstour gehen und dabei bis zu zwei Milliarden Dollar ausgeben. "Wir müssen uns breiter aufstellen", sagte Europachef Hans Peter Hasler der "Süddeutschen Zeitung" (Montag, SZ). So suche das Unternehmen intensiv nach Arzneimittelkandidaten oder Firmen, um diese zu kaufen. "Wir wollen uns in der Neurologie und der Onkologie verstärken", sagte Hasler.
Für diesen Zweck stünden im Unternehmen zwei Milliarden Dollar an kurzfristig verfügbaren Mitteln bereit. Zusätzlich könnte Biogen Aktien zum Tausch anbieten. Besonderes Interesse habe die Firma an Produkten in der späten klinischen Testphase am Menschen, die in wenigen Jahren auf den Markt kommen könnten.

RÜCKKEHR VON TYSABRI IM SOMMER?

Experten rechnen dem Bericht zufolge damit, dass schon im Sommer das zurückgezogene Multiple-Sklerose-Medikament Tysabri wieder auf den Markt gebracht werden kann. Ebenso wie die Biotechnologie-Wettbewerber Serono und Amgen (NASDAQ: AMGN - Nachrichten) sei Biogen auf nur wenige Medikamente angewiesen. Diese Abhängigkeit und der mit dem Tysabri-Rückzug verbundene Kurssturz - die Aktie fiel innerhalb von Stunden um 40 Prozent - haben ein Umdenken im Unternehmen eingeleitet, wie es hieß. Biogen muss sich laut Hasler durch Zukäufe breiter aufstellen.

Im Februar 2005 hatte sich die Biotechnologie-Firma entschlossen, das gerade erst eingeführte Tysabri vom Markt zu nehmen. Das Mittel zur Behandlung der unheilbaren Nervenkrankheit Multiple Sklerose hatte bei drei Patienten unerwartet schwere Nebenwirkungen ausgelöst, zwei von ihnen starben daran, wie es hieß.

Erst vor kurzem hatte ein Expertengremium der US-Gesundheitsbehörde FDA dennoch empfohlen, das Mittel in den USA wieder zuzulassen. "Wir hoffen auf eine positive Entscheidung bis Ende Juni", sagte Hasler, der für die internationalen Geschäfte von Biogen außerhalb der USA zuständig ist. Patientengruppen hatten sich für die Rückkehr von Tysabri eingesetzt, weil das Mittel trotz starker Nebenwirkungen in besonders schlimmen MS-Fällen besser helfen soll./sk/jb/sbi

[Cyberhexe]

aus dem dpa-Artikel:
...Patientengruppen hatten sich für die Rückkehr von Tysabri eingesetzt, weil das Mittel trotz starker Nebenwirkungen in besonders schlimmen MS-Fällen besser helfen soll./sk/jb/sbi

diese Aussage ist eigentlich zu pauschal! Betrachtet man die klinischen Studien, so fällt auf, dass Tysabri Nebenwirkungen hat im Plazebobereich.

siehe Seite 7 von 11 (Adverse Reactions)

http://www.fda.gov/cder/foi/label/2004/125104lbl.pdf

Da die 3 PML-Fälle bisher in Verbindung mit der Applikation anderer Wirkstoffe aufgetreten sind, ist es meines Erachtens nicht korrekt, wenn diese Aussage mit den schwerwiegenden starken Nebenwirkungen auch auf die Monotherapie bezogen wird.
Bei den 3 PML-Fällen gab es nämlich folgende Hintergründe:


2 Teilnehmer aus der SENTINEL-Studie, d.h. es wurde (natürlich auf Wunsch von Biogen!) eine Studie durchgeführt, in der Tysabri zusammen mit dem Interferon Avonex appliziert wurde; durch das Interferon erhöht sich die Halbwertszeit von Natalizumab (Halbwertszeit = die Zeit, in der die Hälfte der Substanz abgebaut wird), so dass sich über mehrere Monate bzw. 2 Jahre die Konzentration von Natalizumab im Organismus anreichert und so die
Immunabwehr mehr beeinträchtigt als erwünscht. Unter diesen Bedingungen besteht die Möglichkeit, dass das latent vorhandene JC-Virus ausser Kontrolle gerät und zu den schwerwiegenden Nebenwirkungen (PML) führt.

1 Teilnehmer aus ENACT (Studie zur Behandlung von MorbusCrohn)
Dieser Teilnehmer hatte eine extrem immunsupprimierte Vorgeschichte (wenn ich mich richtig erinnere über 2 Jahre mit Azathioprin, wewlches eine lange Halbwertszeit hat und somit bei der Tysabri-Applikation noch nicht vollständig eliminiert war). Anscheinend wurde ein kompletter "Arzneimittel-Cocktail" zuvor verabreicht, welcher in Verbindung mit der extrem schlechten Verfassung des Teilnehmers eine Teilnahme an der Studie normalerweise gar nicht zugelassen hätte.

Conclusion (persönliche Meinung, ich bin jedoch nicht Mediziner!):

Die sicherlich vorhandene PML-Gefahr bei der mehrjährigen Applikation von Tysabri müsste unter folgenden Voraussetzungen relativ klein sein:

- Verabreichung ausschliesslich in Monotherapie
- keine immunsupprimierte Vorgeschichte der Behandelten (vor allem bei MorbusCrohn, da dort oft immunsupprimierende Wirkstoffe zur Erstbehandlung eingesetzt werden)
- regelmässige Kontrolle der Immunabwehr von Langzeitbehandelten

[Poppholz]

29.05.2006 11:30
Biogen Idec schöpft neuen Mut

Was für ein Comeback. Biogen Idec will zwei Milliarden Dollar für Übernahmen ausgeben. Vor einem Jahr verlor die Aktie noch 40 Prozent, als der wichtigste Hoffnungsträger vom Markt genommen wurde.

Biogen Idec Zentrale, San Diego
Am 28. Februar 2005 war das Heulen und Zähneklappern groß beim US-Biotechnologiekonzern Biogen Idec. Das Multiple-Sklerose-Medikament Tysabri zeigte extreme Nebenwirkungen, zwei Menschen starben, Biogen nahm das Medikament vom Markt, der Aktienkurs fiel binnen eines Tages um 40 Prozent.

Multiple Sklerose ist wie viele chronische Krankheiten eine Goldgrube für Pharmakonzerne. Die Behandlung dauert im besten Fall bis zum Lebensende, ist extrem teuer und sichert den Unternehmen stabile Einnahmen. Die Behandlung von Multipler Sklerose schlägt pro Jahr mit rund 15.000 Dollar zu Buche: Biogen Idec macht mit Avonex mehr als die Hälfte des Gesamtumsatzes von 2,4 Milliarden Dollar im vergangenen Jahr.

Umso katastrophaler war der Rückzug von Tysabri. Der Blockbuster sollte bis zu 3 Milliarden Dollar pro Jahr einbringen. Statt dessen musste Biogen 670 Mitarbeiter entlassen und die Geschäftsprognose deutlich nach unten korrigieren.

Tysabri kommt wieder
Vor einem Monat hat die amerikanische Gesundheitsbehörde FDA nun empfohlen, Tysabri wieder zuzulassen. Zuvor hatten sich MS-Patientengruppen für Tysabri eingesetzt, da das Präparat trotz Nebenwirkungen gerade bei sehr schwerem Krankheitsverlauf gute Behandlungsergebnisse erziele.

Der Europachef von Biogen Idec, Hans Peter Hasler, hofft jetzt auf eine Entscheidung pro Tysabri. Das Medikament könnte sofort ausgeliefert werden. Investoren rechnen damit, dass Tysabri ab 2010 wieder einen stabilen Jahresumsatz von einer bis 1,5 Milliarden US-Dollar erzielen kann.

Die Lehre aus der Geschichte: Diversifizierung!
Der folgenreiche Rückzug von Tysabri samt Kurshalbierung und Umsatzeinbussen ist expemplarisch für das Risiko kleiner Biotechnologieunternehmen. Es winken Milliardenumsätze, wenn es gelingt, erfolgreiche Produkte zu entwickeln. Andererseits droht der Totalverlust, wenn der Blockbuster vom Markt muss. Zwar ist Biogen Idec kein kleines Unternehmen mehr, allerdings erwirtschaftet ein einziges Präparat die Hälfte des Umsatzes.

Biogen Idec kündigte am Montag an, man habe aus dem Tysabri-Fiasko gelernt und plane nun, das Geschäft zu diversifizieren. Europachef Hasler kündigte an, der Konzern wolle sich in den Bereichen Neurologie und Onkologie (Krebsforschung und –behandlung) verstärken. Dafür stünden kurzfristig 2 Milliarden Dollar zur Verfügung. Das besondere Interesse des Unternehmens gelte Produkten, die kurz vor der Marktzulassung stünden.

Die Aktie vollzieht die an sich positive Nachricht nicht nach. An der Frankfurter Börse bewegte sich Biogen Idec nach Börsenstart zielstrebig auf konstantem Seitwärtskurs.

kle

http://www.boerse.ard.de/content.jsp?key=dokument_166334

[loseit]

Antwort auf Beitrag Nr.: 21.857.334 von Cyberhexe am 29.05.06 12:20:09

Hi Cyberhexe,

Du rechnest in Deiner Antwort an wave mit 6 Mrd. Bruttoumsatz, in untenstehendem Artikel ist aber nur von einer bis 1,5 Mrd. die Rede.

Wenn dort nur Biogen gemeint sein sollte, liegst Du immer noch beim Doppelten.

Ist die Annahme von 10% zu optimistisch, oder Preis bzw. Dosis?
Oder sind die anderen zu pessimistisch?

Gruss Loseit

[Cyberhexe]

@loseit

ich habe dieses Rechenbeispiel nur angeführt, um auf das, so wie ich finde, riesige Potential von Tysabri hinzuweisen.
Diejenige Analysten, die Tysabri kein Blockbuster-Potential (= 1 Milliarde $ Jahresumsatz) zutrauen, halte ich eindeutig für zu konservativ.
So weit mir die Zahlen bekannt sind, gehe ich davon aus, dass innerhalb der EU und den US die Hälfte aller MS-Erkrankten derzeit nicht medikamentös behandelt werden, und zwar nicht weil MS so harmlos ist, sondern weil die CRABs (Copaxone, Rebif, Avonex und Betaseron) nicht gewirkt haben. Bei der Konsequenz von MS - ich hatte einen bekannten, der daran bzw. an den Sekundärfolgen gestorben ist - bin ich überzeugt , dass ein Grossteil dieser Untergruppe es mit Tysabri versuchen wird.
Ob die 6 Milliarden Jahresumsatz mit Tysabri realistisch sind oder nicht, das wird sich zeigen! Ich bin optimistisch...vielleicht jedoch zu optimistisch!

[Cyberhexe]

Antwort auf Beitrag Nr.: 21.861.168 von loseit am 29.05.06 16:24:35

@loseit

MS zu haben bedeutet zu beginn relativ geringe Einschränkungen; im Laufe der Jahre geht jedoch häufig die Mobilität verloren. Zuerst ist man nur auf eine Gehhilfe angewiesen, später dann auf einen Rollstuhl. Ein weiteres Fortschreiten der Krankheit kann zur vollständigen Immobilität und 100%igen Pflegebedürftigkeit führen.
Bei meinem Bekannten war dies zum Schluss derart ausgeprägt, dass er nicht einmal mehr in der Lage war, seinen Kehlkopf zu koordinieren. Die Folge davon war ein häufigs Verschlucken, verbunden mit entsprechenden Bronchialentzündungen. Zum Schluss hat er eine künstliche Ernährung strikte abgelehnt und hatte, davon bin ich überzeugt, nur noch ein Ziel, "es schnellstmöglich hinter sich zu bringen."
Alle seine Bekannten waren sich darüber einig, dass dies kein Sterben war, sondern viel, viel grausamer!

Ein 2.Bekannter leidet ebenfalls unter MS, momentan mit einem EDSS von 5,5 (mit EDSS wird der Grad der Behinderung angegeben: 0 = keine neurologischen Defizite; 10 = Tod infolge MS). Dies bedeutet, dass er mittlerweile auf eine Gehhilfe angewiesen ist. Die CRABs haben bei ihm, wie bei meinem 1. Bekannten auch, nicht gewirkt. Er klagt häufig über Müdigkeit und Kraftlosigkeit, so dass ihm bereits ein längeres Gespräch vollste Konzentration abfordert und ihn schnell ermüden lässt. Obwohl er noch keine 50 Jahre alt ist, ist er mittlerweile ebenfalls invalidisiert.


Die letzte Hoffnung meines 2. Bekannten ist Natalizumab, für den das PML-Risiko wirklich nur nebensächlich ist.
...und ich bin davon überzeugt, dass es noch viele andere gibt, die ähnlich denken.

[bernie55]

Antwort auf Beitrag Nr.: 21.861.878 von Cyberhexe am 29.05.06 17:02:10

Deine persönlichen Beiträge, liebe Cyberhexe, zeigen, wie die Realität wirklich aussieht.

Persönliche Schicksale beleuchten die Notwendigkeit von Tysabri nochmals unter einem ganz anderen Licht. Für uns nicht MSler sind der Krankheitsverlauf und die damit zusammenhängenden gesundheitlichen Probleme einfach zu weit weg und somit gar nicht richtig greifbar.

Deshalb vielen Dank für deine offenen Beiträge.

Mögen die Menschen, die von MS betroffen sind, so schnell wie möglich ihre Chance erhalten,auf Medikamente zurückzugreifen, die ihnen Verbesserung ihres gesundheitliche Allgemeinzustandes und zugleich neuen Lebensmut und Perspektiven geben können.

[loseit]

Antwort auf Beitrag Nr.: 21.862.210 von bernie55 am 29.05.06 17:20:20

Hi Cyberhexe,

danke für Deine Antwort.

Auch für mich ist es ein Unterschied, ob ich mein sauer verdientes Geld in eine Rüstungsfirma investiere oder in ein Unternehmen mit dem Ziel, Leben zu retten bzw. erträglicher zu machen.

Wenn die Wahrheit irgendwo in der Mitte liegt, dann sollte bei einem KGV von 30 immer noch ein langfristiges Kursziel von ca. 80 Euro erreichbar sein, Alzheimer und Crohn noch nicht mitgerechnet.

Gruss Loseit

[Cyberhexe]

Zweifel an der Widerzulassung von Tysabri gibt es meines Erachtens keine; kursrelevant ist jedoch die Entscheidung der FDA, ob Tysabri als "first line" oder nur als "second line treatment" zugelassen wird.
Bei einer uneingeschränkten Anwendung dürfte der "Hüpfer" grösser ausfallen!

[tippse]

erstmal lesen:

*******************************************************************

AVONEX(R), das weltweit meistverordnete Therapeutikum gegen Multiple Sklerose feiert seinen 10. Geburtstag
CAMBRIDGE, Mass.--(BUSINESS WIRE)--19. Mai 2006---19. Mai 2006--

Die Geburtstagsfeier umfasst feierliches NASDAQ Glockenläuten, Informationsveranstaltungen, Denkschriften und -videos

Biogen Idec (NASDAQ:BIIB) notierte heute den 10. Geburtstag des AVONEX(R) (Interferon beta-1a), des weltweit meistverordneten Therapeutikums gegen Multiple Sklerose (MS), als James Mullen, CEO des Unternehmens, die Eröffnungsglocke des NASDAQ Aktienmarkts läutete. AVONEX, das von Biogen Idec hergestellt wird, wurde am 17. Mai 1996 von der U.S. Food and Drug Administration (FDA) für rezidivierende Formen der MS zugelassen. Kurz nach seiner Einführung in den USA, wurde es die Nummer eins der zur Behandlung von MS verordneten Therapie. Heute entscheiden sich mehr als 130.000 Patienten weltweit für AVONEX, um ihre MS zu behandeln.

Biogen Idec begeht den Geburtstag von AVONEX mit der Veröffentlichung einer Denkschrift "Profiles of Inspiration" mit begleitendem Video. Buch und Video sind ein Schaukasten außerordentlicher Menschen, die an MS leiden und deren Leben durch AVONEX positiv beeinflusst wurde. Buch und Video werden bald unter www.AVONEX.com zu beziehen sein.

"Biogen Idec ist stolz, den 10. Geburtstag von AVONEX, der Nummer eins weltweit der verordneten MS-Therapie, zu begehen und dessen Einfluss auf das Leben von Patienten in der ganzen Welt anzuerkennen. Mit MS lebende Menschen inspirieren und motivieren jeden von uns täglich dazu, dass wir unsere Anstrengungen bei der Weiterentwicklung von Wissenschaft und Behandlung dieser behindernden Krankheit verdoppeln. Die Einführung von AVONEX war ein bedeutender Schritt für die Behandlung von MS, aber wir wissen, dass immer noch erheblicher unbefriedigter Bedarf besteht, weshalb wir unser unnachgiebiges Engagement fortsetzen werden, um den Patienten in ihrem Kampf gegen diese Krankheit Hoffnung zu machen," erklärte Mullen.

Der Geburtstag wird von MS Patienten, Ärzten und Pflegepersonen in einer Reihe von Veranstaltungen im ganzen Land gefeiert, in der Absicht, das Bewusstsein über MS zu wecken und die Rolle von AVONEX, die es zur Veränderung der MS Therapie gespielt hat, zu feiern.

"Der Auftrag der National Multiple Sclerosis Society besteht darin, den verheerenden Wirkungen von MS ein Ende zu setzen," meinte John Richert, MD, Vicepresident des Bereichs Forschung und klinische Programme der National Multiple Sclerosis Society. "Wir unterstützen die Bemühungen von Unternehmen, wie Biogen Idec, die sich für die Forschung und Entwicklung bahnbrechender Therapien einsetzen, die mit MS lebenden Menschen eine Hilfe sein können."

AVONEX bleibt die einzige, einmal in der Woche verabreichte, die Krankheit verändernde Therapie, die nachweislich sowohl das Fortschreiten der Ausfallerscheinungen verlangsamt als auch die Häufigkeit klinischer Rückfälle der MS, einer chronischen Krankheit des Zentralnervensystems, reduziert. Bei dem Versuch, der den Wendepunkt darstellte und zu seiner Zulassung in den USA führte, bewies AVONEX eine 37 %ige Reduzierung des Fortschreitens der Ausfallerscheinungen verglichen mit Placebo. Jüngst veröffentlichte Daten belegten, dass AVONEX das Risiko der Entwicklung der klinisch endgültigen MS für bis zu fünf Prozent der Patienten reduzierte, die mit der Behandlung unmittelbar nach ihrem ersten MS Schub begannen, verglichen mit Patienten, die die Behandlung hinauszögerten.

Informationen über AVONEX

AVONEX ist die meistverordnete Behandlung gegen rezidivierende Formen der MS. In den USA wurde es 1996 und danach in Europa auf den Markt gebracht, um rezidivierende Formen der MS zu behandeln, um das Fortschreiten der Behinderung zu verlangsamen und Rückfälle zu reduzieren. AVONEX wird international in mehr als 90 Ländern vermarktet. AVONEX war die erste Behandlung, die für MS Patienten, die ihren ersten klinischen MS Schub erleiden und einer NMR des Gehirns unterzogen werden, die auf MS schließt, zugelassen wurde; die Anwendung wurde in Europa im Jahr 2002 und in den USA im Jahr 2003 genehmigt.

Die am häufigsten in Verbindung mit der Behandlung mit AVONEX auftretenden Nebenwirkungen sind grippeähnliche Symptome einschließlich Muskelschmerzen, Fieber, Müdigkeit, Kopfschmerzen, Frösteln, Übelkeit, Erbrechen, Schmerzen und Asthenie.

AVONEX sollte bei unter Depression oder einer anderen Stimmungsstörung leidenden Patienten und bei Patienten mit Anfallsstörungen mit Vorsicht verordnet werden. AVONEX sollte von schwangeren Frauen nicht eingenommen werden. Patienten mit Herzleiden sollten streng beobachtet werden. Die Patienten sollten auch auf Zeichen eines Leberschadens hin beobachtet werden. Routinemäßig und regelmäßig durchgeführte chemische und hämatologische Bluttests sind während der Behandlung mit AVONEX empfohlen. Seltene Fälle einer Anaphylaxie wurden berichtet. Siehe hierzu die vollständige Verschreibungsinformation unter www.AVONEX.com.

http://home.businesswire.com/portal/site/google/index.jsp?nd…

*******************************************************************

hier sollte der tysabri insider-gemeinde doch einiges spontan dazu einfallen, oder?

(ich persönlich gehe mal locker von 100.000 tysabri-patienten aus (womit wir, nebenbeibemerkt, bei 40-45€ stehen sollten)

stay long

[Cyberhexe]

bewies AVONEX eine 37 %ige Reduzierung des Fortschreitens der Ausfallerscheinungen verglichen mit Placebo.

Avonex ist jedoch weit weniger wirksam als Tysabri.
siehe Seite 3

http://www.fda.gov/cder/foi/label/2004/125104lbl.pdf

66 % gegenüber 37% ...das sind Welten in der Arzneoimittelindustrie!!

[Cyberhexe]

jabbbaaadabbbaaaduuuuuuuuuuuuuuuuuuuuuuuuu

http://www.fda.gov/cder/drug/infopage/natalizumab/default.ht…

[Cyberhexe]

Tysabri is indicated for use as monotherapy, meaning it should not be used in combination with other immune system modifying drugs, and is for patients who have not responded adequately to, or cannot tolerate, other treatments for MS.


...also auch "first line treatment" möglich!
wowwww

[Birgit.Tersteegen]

VIDEOS zur ENTSCHEIDUNG


Checkout the video for todays news.
by: ulosecuziwin
Long-Term Sentiment: Strong Buy 06/05/06 04:14 pm
Msg: 1026127 of 1026128

link is
http://www.prnewswire.com/broadcast/24030/consumer.shtml

Very good video.

[Cyberhexe]

gigantische Aussichten:

DUBLIN (Dow Jones)--Elan Corp. PLC (ELN) on Monday remained hopeful that its multiple sclerosis drug Tysabri could take up to 60% of the MS market, despite the U.S. Food & Drug Administration's ruling restricting its use.

http://www.amtddj.inlumen.com/bin/djstory?StoryId=CrioSqaebq…


Forschungsleiter Lars Ekman, bisher eher zurückhaltend mit euphorischen Prognosen, ist der Meinung, dass Tysabri bei der Behandlung von MS bis zu 60% Marktanteil erzielen könnte.
Man bedenke, dass weltweit mehr als 2 Mio Menschen von dieser Krankheit betroffen sind. Eine Jahresdosis kostet derzeit noch 23500$, wobei jedoch eine Preiserhöhung bereits angekündigt wurde.
Das Potential erscheint gigantisch.

Bin nun gespannt, wie lange es dauern wird, bis die EMEA bzw. das PEI (Paul-Ehrlich-Institut) nun mit der Zulassung in Europa auf sich warten lässt. Ich rechne fest mit einer schnellen Zulassung!

Trotz des Rücksetzers ist heute ein sehr, sehr guter Tag...vor allem für MS-Patienten...aber auch für Investoren.

good luck
ch


mal sehen was mein Girokonto noch zulässt!

[Cyberhexe]

Lars Ekman sagte auch zu "first" bzw "second line treatment":


Although the FDA didn't return Tysabri to market as a first-line treatment, he said: "It's more complicated than that - it's not black and white. New MS patients also have a right to choose it together with their physician."

...-nicht schwarz oder weiss. Neu diagnostizierte MS-Patienten habe das Recht zusammen mit ihrem Arzt sich für Tysabri zu entscheiden!

[Cyberhexe]

...und bei Alzheimer häufen sich die positiven Nachrichten ebenfalls:


http://seattletimes.nwsource.com/html/health/2003040077_alzh…

Targeting protein

One of the drugs, sponsored by the biotech company Élan, of Dublin, Ireland, is targeted at beta-amyloid, a protein that forms a plaque. The plaque clogs spaces between brain cells, disturbing electrical impulses between the cells and impairing memory, reason and the ability to move and speak.

The drug, for now called AAB-001, uses monoclonal antibodies produced in the lab in hamster cells and sensitized only to beta-amyloid. After they are injected into the body, the antibodies bind only to beta-amyloid and remove it from the brain. The trial involves 240 patients, aged 50 to 85, in 30 medical centers across the country and will last 2 ½ years. UW researchers already have seven participants and are seeking several more.

Raskind said tests so far have found no serious side effects. He said small, temporary changes in MRI images of the brain were found in several patients, but only one had a symptom — temporary dizziness. If the drug proves safe and likely effective, it will move on to a large-scale tests of its effectiveness.
Researchers are especially wary of side effects of any drugs after tests of an experimental Alzheimer's vaccine made by Élan eliminated plaque but caused dangerous brain inflammation in 15 patients. The vaccine, which used the immune system to fight the plaque, was withdrawn from trials four years ago. Monoclonal antibodies used in the new drug do not involve the immune system, Peskind said

[Cyberhexe]

die betroffenen MS-Patienten, die beim AC angehört wurden, sollte man sich in Erinnerung rufen:

http://www.thisisms.com/article258.html

First Day of Tysabri AC Meeting Over

A passionate and emotional first day is now over for the Tysabri Advisory Committe meeting. Some preliminary highlights:

Testimony was heard from MS patients, many tearful, who made the general point that they would risk a potentially fatal side effect for the more certain chance at relief from MS symptoms. Some Examples:
]Heather Smith, a 36 year old mother said, "I know Tysabri worked for me when all other MS drugs failed. Each patient has the right to make their own choice," Smith said.

MS'er Marcy Canavan said "I have no treatment options left, and the way things are progressing, in a few years my life won't be worth living ... I want Tysabri badly,"

Marcy Canavan said.
A particularly poignant comment made by one of the MS patients testifying: "There is a one-in-1,000 chance of developing MS. After winning that lottery, I am fully willing to become one of the 999 who don't develop PML while taking Tysabri"

[Cyberhexe]

http://www.marketocracy.com/media/pdf/researchreport/Elan_06…

Recommendation: (based on your portfolio)
If you do not already own ELN: Buy some at the current price.
If you currently have a small position in ELN: Add to your position.
If ELN is already a big position: if ELN represents a lot more than 10% of your portfolio you may have an
opportunity to trim the position back on this run up.

[Cyberhexe]

Davys bzw. Jack Gormans Kommentar zu Elan von Heute:


http://www.rte.ie/business/2006/Morningrep/download/0606davy…

Elan (ELN US)
Previous close: $18.98 Target: $18.00 (31/01/06; previously $13.00, 09/08/05) Analyst: [e-mail]
Tysabri approved in US; favourable label: July launch
Tysabri has received marketing approval from the FDA a month ahead of schedule. The associated label, riskmap and launch
timing leaves us comfortable with our existing forecasts that Tysabri revenues (in MS alone) can reach $1.6bn by 2010.
The label allows that Tysabri is “generally recommended for patients who have had an inadequate response to, or are unable
to tolerate, alternate multiple sclerosis therapies”.
We believe this is a favourable label from an Elan perspective as:
(a) It leaves the interpretation of inadequate response to the neurologists on a case-by-case basis.
(b) It implicitly leaves open the option of Tysabri as a first-line therapy through the use of the broad term “generally
recommended”.
As such, the label is “somewhere between” first-line and second-line therapy. It also looks less prescriptive than its European
counterpart guided on May 2nd.
The riskmap also looks to be as complex and detailed as expected. It looks consistent with the findings and guidance from
the FDA advisory panel meetings last March.
Elan and BiogenIdec anticipate that the product will be available in July. We expect a pricing announcement in the coming
days – management has hinted previously that the US price may be higher than that at the original launch (i.e. $23,500).
The companies are hosting a conference call today at 13.00 Irish time. Participants please call [phone] (intl) or 877
650-1145 (US).

[Cyberhexe]

Der Zulassungsantrag bei der EMEA zur Behandlung von MS mit Natalizumab wurde bereits am 4. Juni 2004 eingereicht - damals noch unter dem ursprünglich vorgesehenen "brand name" Antegren; ich denke es ist an der Zeit, dass auch die EMEA bzw. das PEI (Paul-Ehrlich-Institut, welches für Deutschland die Zulassung bearbeitet) schnellstmöglich handelt!!

http://www.elan.com/News/2004/20040604.asp

[Cyberhexe]

bin gespannt, ob die EMEA demnächst ebenfalls entscheidet

http://www.emea.eu.int/calendar/Calendar%20of%20events.htm

[Cyberhexe]

die Negativpresse ist geradezu lächerlich --> Fett gedrucktes!
beispielsweise stand eine Kombi-Therapie mit Avonex natürlich nie mehr zur Diskussion, was im übrigen ja auch nur vorteilhaft ist für Elan, da man an den Avonex-Umsätzen eh nicht beteiligt ist!!

Elan Falls Over MS Drug Restrictions
Tuesday June 6, 12:48 pm ET
Elan Falls 18 Percent Over Restrictions on MS Drug, Leads Steep Irish Stock Drop


DUBLIN, Ireland (AP) -- Shares in Elan Corp. PLC, Ireland's leading drug maker, dropped more than 18 percent Tuesday after U.S. regulators approved a troubled multiple sclerosis drug but placed more restrictions on its use than many analysts expected.


Elan led the way as the Irish Stock Exchange suffered its worst one-day drop this year. The index lost 345 points, or 4.5 percent, to close at 7,334. The wider market was hit both by an unexpected drop in Irish consumer confidence in a report published Tuesday and a second day of steep declines on the New York indexes.

Elan lost 2.70 euros ($3.48), or 18.3 percent, to close at 12.06 euros ($15.56), but recovered some ground in after-hours trading in Dublin. The stock represents 4.6 percent of the value of the Irish stock market.

Elan and its U.S. partner, Biogen Idec, withdrew the MS drug Tysabri from the U.S. market in February 2005 after it was linked to a rare, often fatal disease. The U.S. Food and Drug Administration on Monday approved Tysabri's return to the market, where an estimated 350,000 people suffer from MS, an incurable neurological disorder that can cause sudden, partial paralysis.

But the FDA disappointed Elan investors by placing restrictions on Tysabri's use, and advising patients to use more established MS drugs first. An earlier FDA panel had recommended that Tysabri be used as a first-choice treatment.

The FDA also said Tysabri should be used alone and not with Avonex, another MS drug that Elan and Biogen Idec had used in combination in clinical trials. The agency said it would require all doctors who prescribe Tysabri and patients who take it to enroll in a monitoring program, while all would-be Tysabri users must first have an MRI scan.

Analysts said these requirements would mean fewer patients use Tysabri in the short term, although most expect the drug gradually to gain market share because of its exceptional ability to suppress MS symptoms versus other existing treatments.


http://biz.yahoo.com/ap/060606/ireland_elan.html?.v=2

[Birgit.Tersteegen]

Der Zulassungsbescheid im Wortlaut

http://www.fda.gov/cder/foi/appletter/2006/125104s015LTR.pdf

[Cyberhexe]

...die Preiserhöhung war bereits angekündigt und ist mit 4900$ auf 28400$ für die Jahresdosis recht üppig ausgefallen.
Bei 100.000 Jahresdosen sind das Brutto bereits knapp 3 Milliarden$ Umsatz.
Und ich bin davon überzeugt, dass nicht nur jeder 25. auf das mit Abstand wirkungsvollste Medikament zurückgreifen wird.


DUBLIN, June 9 (Reuters) - Irish drugs company Elan (ELN.I: Quote, Profile, Research) announced its pricing plan for multiple sclerosis drug Tysabri on Friday, raising the wholesale acquisition cost of the drug to $2,184.62 per vial, up 21 percent on its original launch price.

"Tysabri will be available upon the completion of key activities related to the risk management plan ... As such, Elan and Biogen Idec anticipate Tysabri will be available in July," Elan said in a statement published on its Web site www.elan.com.

U.S. health officials cleared the way on Monday for Tysabri, developed with Biogen Idec (BIIB.O: Quote, Profile, Research), to return to the market with restrictions, following its withdrawal last year when it was linked to a rare but potentially fatal brain disease.



"Based on a treatment plan of once every four weeks (13 times per year), we calculate the cost per annum to be $28,400," said Goodbody Stockbrokers' analyst Ian Hunter.

"This is $4,900 (21 percent) ahead of the $23,500 we have built into our numbers. This increase gives us further comfort in our numbers and we believe will act as a support to the share price at current levels."

Davy Stockbrokers' analyst Jack Gorman said the new price represented a 20.9 percent increase on the launch price in November 2004.

"The increase takes account of general price inflation in competing MS therapies in the intervening period, and also the additional costs associated with the risk-map," he said.

[Cyberhexe]

http://www.rte.ie/business/2006/Morningrep/download/0609good…

[Cyberhexe]

http://www.rte.ie/business/2006/Morningrep/download/0609ncb.…

[Cyberhexe]

interessante Stellenausschreibung von Biogen:

http://jobs.imdiversity.com/JobSeekerX/SearchJobs.asp?JobKey…

Norway
The work will be allocated to 70% Tysabri and 30% AVONEX. This person will have his/her own responsibility of a sales district of 4 University hospitals. Bergen, Ullevål, Akershus (the last two in Oslo area) and Molde covering both AVONEX and TYSABRI.
1. Ensure that all hospitals will be ready and prepared for Tysabri treatment in time of the launch...

oder


The Business Support Manager (BSM) is responsible for the implementation of the reimbursement and the logistical strategy for our new product Natalizumab (Tysabri). The BSM is responsible for removing (all the) barriers in order to make Tysabri available for hospitals in The Netherlands. Taking into account that all insurance companies and hospitals are the actual payers for the product the BSM is primarily responsible for these relationships. In this role it’s also important to support the Area Business Managers (ABMs) with activities towards all the DMU members (hospital pharmacists and pharmaco therapeutic committee members).

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 22.089.309 von Cyberhexe am 13.06.06 09:35:02

Hi Hexchen!
Tippst Du in einem Prager Internet-cafe´??

[Cyberhexe]

@birgit
bin seit gestern Abend wieder zurück aus dieser beeindruckenden Stadt

[Birgit.Tersteegen]

Hi Hexchen;Welcome back!Bin heute mit ordentlichem Verlust aus Einigem ausgestiegen und kann so bei Elan bei Bedarf aufstocken-Die Panikmache am Markt ist zum K- tzen --aber man weiss nicht wie weit sie`s noch so treiben....Elan sollte wegen der aktuellen Story glimpflicher davon kommen!

Gruss Birgit

[Cyberhexe]

Antwort auf Beitrag Nr.: 22.092.909 von Birgit.Tersteegen am 13.06.06 13:03:47

@birgit
ich seh es kommen, es dauert nicht mehr lange, dann stehst du neben mir...direkt an der Kante: all in one, all in Elan!!!
...aber die Chance/Risiko-Relation bei Elan scheint ja auch keine Alternative zuzulassen!!!
Uns und allen anderen elanvollen Investoren wird wohl ein spannender Sommer bevorstehen ...und ein heisser Herbst.

good luck
ch

[Cyberhexe]

hatte gerade die neuste Aktionärszeitschrift in den Fingern: dort wird Elan mit Kursziel 16€ empfohlen, jedoch eine Anwendung als "first line treatment" ausgeschlossen: dies ist allerdings eine Falschmeldung, da Tysabri unter gewissen Voraussetzungen durchaus auch als Erstmedikation appliziert werden kann.

...aber das passt ins derzeitige Bild der oberflächlichen Berichterstattung!!

[Poppholz]

Biogen Idec CFO Outlines Plans For Tysabri

06-14-06 03:36 PM EST
NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB) has a system in place to minimize potential neurological risks associated with its multiple sclerosis drug, Tysabri, as it puts the drug back on the market in July, according to Chief Financial Officer Peter Kellogg.

At the Goldman Sachs Global Healthcare Conference on Wednesday, which was Webcast, Kellogg said Tysabri's new improved risk profile reduces the risk of patients who use the drug from developing a neurological disease called progressive multifocal leukoencephalopathy, also known as PML, associated with Tysabri.

In February 2005, Tysabri was suspended in the U.S. after three patients on combination therapy including Tysabri contracted PML. Two of the patients died. The three PML cases were out of 3,000 patients who received Tysabri in a clinical trial.

Kellogg expects Tysabri's new "risk map" will help minimize risks associated with the drug because it involves patient screenings for PML and other symptoms. The company will also monitor patients who are taking the drug. The patients will be checked three and six months after receiving their first infusion.

Tysabri, which has been in development for 12 years, is being sold at a premium, according to Biogen.

"We do anticipate quite a response when we get the product back on the market, " Kellogg said. "MS is a market that has tremendous unmet need."

Biogen and its partner, Elan Corp. (ELN), co-own the drug and will share the profits 50-50.

Shares of Biogen Idec were recently trading at $46.41, up $1.01, or 2.2%.

-By Nicole Urbanowicz, Dow Jones Newswires; 201-938-5460; nicole.urbanowicz@ dowjones.com

Corrected June 14, 200616:56 ET (20:56 GMT)

Biogen Idec Inc.'s (BIIB) multiple sclerosis drug Tysabri is administered in a hospital, doctor's office or clinic as a monthly IV infusion.

(An item at 3:36 p.m. EDT incorrectly stated Tysabri patients will no longer be able to give self injections.)


(END) Dow Jones Newswires
06-14-06 1536ET
Copyright (c) 2006 Dow Jones & Company, Inc.


http://news.morningstar.com/news/DJ/M06/D14/200606141536DOWJ…

[Cyberhexe]

Möglicherweise wird diese Veranstaltung den Kurs bereits günstig beeinflussen. Nach der EMEA-Zulassung sollten dann die 20$ nachhaltig überschritten werden!!

http://biz.yahoo.com/prnews/060615/sfth015.html?.v=55

[Cyberhexe]

Ken Kam scheint von Elan überzeugt zu sein. Dies kann man bisher natürlich nicht von allen Analysten behaupten. Aber dennoch schätze ich, dass Kam den anderen eine Kurve voraus ist.

all in one, all in Elan


http://articles.moneycentral.msn.com/Investing/StrategyLab/R…

Earlier this month, Elan (ELN, news, msgs) got the go-ahead from the FDA to re-launch Tysabri. In clinical trials, Tysabri has proven to be twice as effective as any other drug at preventing relapses in patients with multiple sclerosis. The drug was first approved in late 2004, but was voluntarily withdrawn from the market in early 2005 after three patients experienced a potentially fatal complication called progressive multifocal leukoencephalopathy (PML). After an exhaustive review of all patients turned up no additional cases of PML, it turned out that all three cases of PML occurred in patients who had taken Tysabri in combination with another drug that compromised their immune systems. When the FDA re-approved Tysabri, it restricted its use to patients who are not on any of these other drugs. Wall Street didn't like the restrictions and sold the stock off.
I think this sell-off created a great buying opportunity. During the course of this round of Strategy Lab, Elan will re-launch Tysabri in the U.S. and possibly receive European approval. I think the response from MS patients will surprise Wall Street and drive this stock higher.

[Poppholz]

UPDATE: Biogen Exec: Industry Must Focus On Drug Safety

06-19-06 05:51 PM EST
BOSTON (Dow Jones) -- The drug industry must focus more on safety than it does on effectiveness when developing new drugs, Biogen Idec's executive vice president for development, Burt Adelman, told fellow researchers at a meeting in Boston Monday.

"I used to say 51% of drug development is safety," said Adelman, at a scientific meeting of the American Association of Pharmaceutical Scientists in Boston. "Now I say it should be 75%."

Adelman made his remarks while presenting an overview on Biogen's (BIIB) multiple sclerosis drug Tysabri. The drug was recalled in February 2005 after being linked to extremely rare but deadly brain disease known as PML even though previous data had shown the drug to be remarkably safe. Two of an estimated 3, 000 users died of PML before it was pulled.

In early June, the FDA gave Biogen and partner Elan (ELN) the green light to put Tysabri back on the market, albeit with restrictions. The drug, which was shown to be unusually effective in battling the progress of the highly debilitating disease, had been hailed by many medical experts and patient advocates as a breakthrough in the treatment of MS.

According to Adelman, Tysabri's tale is illustrative of how the drug industry must work to better anticipate negative side effects during the drug development process, especially in the pre-clinical stage, before they enter human clinical trials.

"We have to make sure we fully understand the mechanism of action that we're dealing with, and what the potential upsides and downsides of that mechanism are," said Adelman. "The industry tends to focus on the upsides."

Up to this point, said Adelman, the industry's emphasis has been designing studies that to prove the effectiveness of a drug, an approach that has been encouraged by the drug approval process itself, which heavily emphasizes efficacy.

Such an approach would likely call for more preclinical testing, but not necessarily for more human clinical trials, according to Adelman.

Human clinical trials tend to be vastly more expensive than pre-clinical studies, which generally involve small animals.

Adelman also said that the FDA, along with the greater medical community, needs to create a process that encourages more doctors to report any adverse drug side effects.

Because of its problems with Tysabri, Adelman said that Biogen plans to review its key drug development programs to see if there are any "signals" in the drug data so far that might indicate safety issues.

"We don't want to miss anything," said Adelman.


(END) Dow Jones Newswires
06-19-06 1751ET
Copyright (c) 2006 Dow Jones & Company, Inc.[/i

http://news.morningstar.com/news/DJ/M06/D19/200606191751DOW…

[Cyberhexe]

Die erweiterte Verfügbarkeit von Maxipime könnte sich in einem Umsatzzuwachs bemerkbar machen:

http://www.fda.gov/cder/drug/shortages/default.htm#Maxipime


...allerdings wird der Maxipime-Umsatz nicht entscheidend auf den Kurs Einfluss nehmen.

[tippse]

Anbei das von der fda in zusammenarbeit mit eln/biib entwickelte pml-risk monioring programm "TOUCH" (TYSABRI Outreach: Unified Commitment to Health)

gerade die nächsten zwei jahre werden wesentlich geprägt sein durch die "vertrauensfrage" in dieses medikament.

ebenso gilt es die z.t. falschen bzw. oberflächlichen berichterstattungen in den medien wieder zu korrigieren und last not least, unlautere attacken der mitbewerber zu entlarven ...

http://www.fda.gov/cder/drug/infopage/natalizumab/RiskMAP.pd…

auch zu beachten:
http://www.tysabri.com

[Cyberhexe]

http://www.emea.eu.int/calendar/Calendar%20of%20events.htm

Die Kommission, welche über die Zulassung von Tysabri entscheidet, tagt von Heute bis Donnerstag. Bin gespannt, ob bereits auf dieser Sitzung die Zulassung für den europ. Markt ausgesprochen wird.
Eigentlich ist seit der Antragsstellung (4.6.2004 ) genügend Zeit vergangen.


http://www.rte.ie/business/2006/Morningrep/download/0626ncb.…

European approval of Tysabri is expected over the coming weeks. An EMEA
meeting is scheduled this week which could see final approval of Tysabri in
Europe over the coming days. The CHMP (Committee for Medicinal Products
for Human Use) recommended marketing approval of Tysabri two months ago
for use in patients that (i) failed to respond to treatment with a beta-interferon
(so called second-line use) or (ii) have rapidly evolving severe relapsingremitting
MS (naive patients with severe disease). We would expect the
EMEA to endorse the CHMP recommendation.
• Once the EMEA issues a final recommendation on Tysabri, pricing
discussions can commence immediately with the individual member states
(this will lead to a country-by-country roll-out starting in Germany with the rollout
in other European markets in H1 2007). With the annual price of Tysabri
recently increased by almost 21% to $28.4k, we recently revised upwards our
US forecasts but have left our European/RoW forecasts unchanged given the
discount of MS products (and other products) in the European market relative
to the US. With the revised price of Tysabri our global peak sales forecasts
are $2bn (from $1.8bn) for Tysabri in MS.
Orla Hartford [phone]

[Cyberhexe]

die Info in #834 war nicht korrekt, da das CHMP ja bereits die Zulassung empfohlen hat, die Entscheidung letztlich jedoch von der "European Commission" getroffen wird (siehe Grafik Seite 11:
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/doc… )

Das CHMP hat seine Empfehlung bereits am 28. April ausgesprochen wurde: http://biz.yahoo.com/bw/060428/20060428005228.html?.v=1

[Cyberhexe]

...man glaubt es kaum, Förtschens "Aktionaer" über Tysabri und Elan Corp.:

http://www.deraktionaer.de/xist4c/web/Neue-Hoffnung-fuer-MS-…

[Poppholz]

Für den Bekanntheitsgrad unserer Aktie ist der Artikel auf jeden Fall gut. Wenn sich dann interessierte Investoren näher mit ELAN beschäftigen, werden wohl auch weitere Longies hier einsteigen.

Auch kurzfristig sollte es hier einen kleinen Schubs nach oben geben, dieser könnte sich allerdings in den nächsten Tagen wieder zurück kommen, je nachdem, wer aufgrund des aktionärs die "spekulativen" Aktien kauft.

In dem Artikel fehlt meiner Meinung noch der Hinweis, dass die FDA das Medikament Tysabri bereits wieder zugelassen hat.

[Cyberhexe]

Ty in EU von der EMEA zugelassen!!!!!!!!!!!

[Poppholz]

Antwort auf Beitrag Nr.: 22.332.819 von Cyberhexe am 29.06.06 10:03:08

UPDATE: Elan's Recovery Continues As EU Approves Tysabri
06-29-06 03:45 AM EST

DUBLIN -(Dow Jones)- Elan Corp. PLC's (ELN) multiple sclerosis drug Tysabri Thursday received long-awaited approval from the European Commission as a therapy for highly active relapsing remitting MS patients.

Analysts say Tysabri will be rolled out quicker than expected and could theoretically be used for both first-and second-line MS patients, but in the rare condition of severe relapsing remitting MS for first-line.

The European Medicines Agency's advisory committee in April recommended Tysabri be used in the E.U. for MS patients in relapse; the European Commission was always expected to follow the EMEA's decision.

Elan and copartner Biogen Idec (BIIB) suspended Tysabri in the U.S. in February 2005 after three patients on combination therapy - including Tysabri - contracted a rare neurological disease called progressive multifocal leukoencephalopathy or PML; two died.

At 0810 GMT Thursday, Elan was flat at EUR13.25 on the Irish Stock Exchange in a weak overall market. The stock remains volatile, but analysts see this latest news underpinning its gradual recovery.

Goodbody Stockbrokers' Ian Hunter, who maintains an add on Elan, said the European Commission's ruling is consistent with the EMEA's stance: "It's now up to Tysabri to continue to fulfill these expectations."

"Unlike the U.S., the E.U. has not specified a mandatory registry of Tysabri patients and physicians, but individual E.U. countries may yet stipulate this when they come to roll out the drug," Hunter added.

Elan and Biogen expect Tysabri to be available in Germany and Ireland in July with a rolling launch over the next few months throughout the E.U. with pricing talks currently taking place with individual countries.

Tysabri will be used as a monotherapy in both the U.S. and E.U. with labeling, and a risk management plan designed to inform physicians and patients of the benefits and risks of the would-be blockbuster drug.

Earlier this month, U.S. Food & Drug Administration said Tysabri could be returned to the U.S. market as a monotherapy and is "generally recommended" for MS patients who've had an "inadequate response" to other MS therapies.

In the U.S., Elan has said Tysabri could still be marketed to about 60% of the MS market, which equates to the percentage of those MS patients who have had an inadequate response to current therapies.

Goodbody Stockbrokers predicts peak Tysabri sales of $1.9 billion per year globally in 2009.

Company website: http://www.elan.com

-By Quentin Fottrell, Dow Jones Newswires; [phone]; quentin.fottrell&# 174;dowjones.com


(END) Dow Jones Newswires
06-29-06 0345ET
Copyright (c) 2006 Dow Jones & Company, Inc.

http://news.morningstar.com/news/DJ/M06/D29/200606290345DOWJ…

[Poppholz]

Elan Go-Ahead For Tysabri In Europe In-Line

Thursday, June 29, 2006 4:27:27 AM ET
Dow Jones Newswires

0711 GMT [Dow Jones] Elan's (ELN.DB) approval from European regulators to market its multiple sclerosis drug, Tysabri, had been expected says an analyst. Notes Elan has already received approval for the drug in the US and the Americas and says European approval was not a surprise. "This has already been priced into the shares," the analyst adds. Elan will be marketing the drug with Biogen Idec (BIIB). Elan shares have yet to trade from EUR13.25. (KHO)


Contact us in London.
[phone]
[e-mail]

http://www.newratings.com/analyst_news/article_1307758.html

[Poppholz]

Link zur ELAN Homepage:

Medikamenten Pipeline:

http://www.elan.com/research_development/Pipeline_Products/d…

[Poppholz]

Die Meldung von der Homepage von ELAN.COM

29 June 2006
TYSABRI® Receives Approval in European Union for the Treatment of Relapsing Remitting Forms of Multiple Sclerosis

ZUG, Switzerland & DUBLIN, Ireland--(BUSINESS WIRE)--June 29, 2006--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced that they received approval from the European Commission to market TYSABRI(R) (natalizumab) as a treatment for relapsing remitting multiple sclerosis (MS) to delay the progression of disability and reduce the frequency of relapses. TYSABRI is indicated as a single disease modifying therapy in highly active relapsing remitting MS for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing remitting MS.

The approval was based on a submission that included TYSABRI two-year Phase III clinical trial data, findings from the comprehensive safety evaluation, suggested labeling, and a risk management plan designed to inform physicians and patients of the benefits and risks of TYSABRI treatment and minimize the potential risk of progressive multifocal leukoencephalopathy (PML) and other opportunistic infections.

"Today marks an important step forward for the European MS patient community," said James C. Mullen, Chief Executive Officer, Biogen Idec. "TYSABRI represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice."

"This decision means that patients in Europe who are suffering from this chronic, debilitating disease now have an effective new treatment alternative," said Kelly Martin, President and Chief Executive Officer, Elan.

This action follows a recommendation made by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), which on April 28, 2006, issued a positive opinion recommending marketing authorization for TYSABRI.

For more information about TYSABRI please visit www.biogenidec.com or www.elan.com.

About Biogen Idec

Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. 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.


CONTACT: Media Contacts:
Biogen Idec
Katja Buller, [phone]
or
Amy Brockelman, [phone]
or
Elan
Davia B. Temin, [phone]
or
Elizabeth Headon, [phone]
or
Investor Contacts:
Biogen Idec
Elizabeth Woo, [phone]
or
Elan
Emer Reynolds, [phone]
or
Chris Burns, 800-252-3526

SOURCE: Biogen Idec and Elan Corporation, plc


http://www.elan.com/News/full.asp?ID=877416

[Cyberhexe]

Kommentar von Orla Hartford, NCB von Heute:

As expected Tysabri has received marketing approval in Europe for patients that (i)
have highly active relapsing remitting MS despite treatment with a beta-interferon (so
called second-line use) or (ii) have rapidly evolving severe relapsing-remitting MS
(naive patients with severe disease). Patients that have failed to respond to a betainterferon
should have at least one relapse in the previous year while on treatment
while naive patients with severe disease include those that have two or more relapses
within a year (with one of more gadolinum lesions on the brain or a significant increase
in T2 lesions (compared to a prior MRI)). Restricting use of Tysabri to naive patients
with severe disease or those that have failed interferon therapy is unlikely to limit
Tysabri's potential in the first few years post launch. We have not factored in Tysabri
use in naive patients in our forecasts. European approval is in-line with the
recommendations of the CHMP (Committee for Medicinal Products for Human Use)
made on 28th April 2006.
• A risk management plan has also been approved in Europe with the main components
of the program including prescribing guidelines for physicians and an alert card for
patients. On a European wide level no mandatory registry of patients is required
although individual countries may introduce one.
• Tysabri is expected to be marketed in Europe by BiogenIdec's sales force of 100-150
reps. Pricing discussions have commenced with the individual member states which
will lead to a country-by-country roll-out. Tysabri is expected to be available in July
2006 starting with a roll-out in Germany and Ireland.
• With the price of Tysabri recently increased by almost 21% to $28.4k, we revised our
US forecasts but left our European/RoW forecasts unchanged given the discount of MS
products in the European market relative to the US. With the revised price of Tysabri
our global peak sales forecasts are $2bn (from $1.8bn) for Tysabri in MS.

http://www.rte.ie/business/2006/Morningrep/download/0629ncb.…

[Cyberhexe]

...auch noch der heutige Kommentar von Davy:


Elan (ELN US)
Previous close: $16.33 Target:: $18.00 (31/01/06; previously $13.00, issued 09/08/05) Analyst: [e-mail]
Tysabri receives approval in European Union
Elan has announced (June 29th) that it has received approval from the European Commission to market Tysabri as a
treatment for patients with highly active relapsing remitting multiple sclerosis (MS) to prevent relapses and delay disease
progression. In May, Tysabri had received a positive recommendation from CMP, the scientific committee that advises the EU
regulatory process. Therefore, the approval was very much anticipated.
Elan expects Tysabri to be commercially available in July, starting with Germany and Ireland. It will be a rolling launch
throughout Europe.
Tysabri has been approved as a single disease-modifying therapy for use in patients with rapidly evolving severe relapsing
remitting MS or in patients with high disease activity despite treatment with a beta-interferon.
A risk management plan was also approved by the Commission which is intended to promote informed benefit-risk decisions
on Tysabri use in MS patients to minimize the risk of PML.
There is no mandatory registry for the EU, as in the US. However, Elan plans to enrol 2,000 European patients in an
observational study to assist with monitoring the safety of Tysabri in normal marketed use. In addition, registries may be
established in individual EU countries or hospitals to contribute further to accumulating the data used to assess safety
Elan is currently in discussions on price in each European market in which Tysabri is expected to be available. Biogen Idec will
market Tysabri in Europe, where it already has an infrastructure in place.
This is very good news, with the drug on track as per guidance. There is no change to our forecasts or the share price target


http://www.rte.ie/business/2006/Morningrep/download/0629davy…


...das sind wirklich einmal sehr erfreuliche Neuigkeiten...vor allem für die an MS Erkrankten.
Aber auch für die Investoren dürfte das 3. Quartal überaus erfreulich sein.

[Cyberhexe]

...und der Vollständigkeit wegen auch noch Goodbodys Stockbrokers Mitteilung:

http://www.rte.ie/business/2006/Morningrep/download/0629good…

[Poppholz]

die Meldung auch noch einmal auf Deutsch:

Business Wire
TYSABRI(R) erhält Zulassung in der Europäischen Union für die Behandlung rezidivierend-remittierender Formen multipler Sklerose
Donnerstag 29. Juni 2006, 22:50 Uhr


ZUG (Schweiz) und DUBLIN (Irland) 29. Juni 2006 Die Biogen Idec (NASDAQ: BIIB) und die Elan Corporation, plc (NYSE: ELN) gaben heute bekannt, von der Europäischen Kommission die Zulassung für die Markteinführung von TYSABRI(R) (Natalizumab) zur Behandlung rezidivierend-remittierender multipler Sklerose (MS) erhalten zu haben. Das Medikament dient zur Verzögerung des Fortschreitens der Behinderung und zur Verringerung der Rückfallhäufigkeit. TYSABRI ist als einfache krankheitsmodifizierende Therapie bei hochaktiver rezidivierend-remittierender MS bei Patienten mit trotz Beta-Interferon-Behandlung hoher Krankheitsaktivität oder bei Patienten mit sich schnell entwickelnder schwerer rezidivierend-remittierender MS indiziert.

Die Zulassung basierte auf einem Antrag, der die Daten der zweijährigen klinischen TYSABRI-Erprobung der Phase III, die Ergebnisse der umfassenden Sicherheitsbewertung, die vorgeschlagene Kennzeichnung und einen Risikomanagementplan beinhaltete. Letzterer ist dafür konzipiert, Ärzte und Patienten über den Nutzen und die Risiken der TYSABRI-Behandlung zu informieren und das potenzielle Risiko progressiver multifokaler Leukoenzephalopathie (PML) und anderer opportunistischer Infektionen zu minimieren.

"Der heutige Tag bedeutet für die europäischen MS-Patienten einen wichtigen Schritt nach vorn", erklärte James C. Mullen, Geschäftsführer der Biogen Idec. "TYSABRI stellt einen der wesentlichsten Fortschritte in der MS-Behandlung seit fast 10 Jahren dar und bietet Patienten, die mit dieser mit Behinderungen einhergehenden Krankheit leben, eine wichtige neue Therapiemöglichkeit."

"Die Entscheidung bedeutet, dass Patienten in Europa, die an dieser chronischen, schwächenden Krankheit leiden, nun über eine wirksame neue Behandlungsalternative verfügen", führte der ELAN-Präsident und -Geschäftsführer, Kelly Martin, aus.

Diese Maßnahme folgt einer Empfehlung des Ausschusses für Humanarzneimittel (CHMP), des wissenschaftlichen Ausschusses der Europäische Arzneimittelagentur (EMEA), der am 28. April 2006 eine positive Stellungnahme abgab und die Marktzulassung für TYSABRI empfahl.

Weitere Informationen über TYSABRI finden Sie unter www.biogenidec.com oder www.elan.com.

Über die Biogen Idec

Die Biogen Idec setzt neue Behandlungsstandards in den Bereichen Onkologie, Neurologie und Immunologie. Als einer der weltweiten Marktführer bei der Entwicklung, Herstellung und Vermarktung neuer Therapien setzt Biogen Idec neue wissenschaftliche Erkenntnisse in innovative Produkte zur Gesundheitspflege um. Produktkennzeichnungen, Pressemitteilungen und weitere Informationen sind auf der Website des Unternehmens unter www.biogenidec.com abrufbar.

Über Elan

Die Elan Corporation, plc ist ein Biotechnologie-Unternehmen mit neurowissenschaftlicher Ausrichtung und strebt danach, das Leben der Patienten und ihrer Familien zu verbessern. Das Unternehmen setzt sich dafür ein, wissenschaftliche Innovationen für ernste, nicht gelöste medizinische Probleme nutzbar zu machen, da diese nach wie vor weltweit anzutreffen sind. Die Aktien von Elan werden an den Börsen in New York, London und Dublin gehandelt. Weitere Informationen über das Unternehmen sind unter www.elan.com abrufbar.

Kontakt

KONTAKT:
Kontakte zu Medien:
Biogen Idec
Katja Buller, [phone]
oder
Amy Brockelman, [phone]
oder
Elan
Davia B. Temin, [phone]
oder
Elizabeth Headon, [phone]
oder
Kontakte zu Investoren:
Biogen Idec
Elizabeth Woo, [phone]
oder
Elan
Emer Reynolds, [phone]


http://de.biz.yahoo.com/29062006/240/tysabri-r-erhaelt-zulas…

[wave]

@cyberhexe

vielen Dank für deine wirklich guten Informationen. Ich bin ab heute auch bei ELAN eingestiegen.

wave

[Cyberhexe]

@wave
vielen Dank für die Blumen.

Ich denke, du wirst deinen Einstieg nicht bereuen!

ch

[hri]

test

[Cyberhexe]

aus der Süddeutschen Zeitung
vom 19.6.2006

Biogen Idec (Umsatz 2005: 2,4 Milliarden
Dollar) hat den Firmensitz in Cambridge,
der 50-prozentige Entwicklungspartner
für Tysabri, die Firma Elan, ist
in Irland ansässig. In Folge der Todesfalle
waren 2005 die Börsenkurse beider Firmen
abgestürzt. Biogen Idec musste 670
Mitarbeiter entlassen, vorrangig in Cambridge.
Heute beschäftigt das drittgroBtes
Bioteclmologie-Unternehmen weltweit
3400 Mitarbeiter und steilt wieder
ein. ,,Wir werden auf dem Niveau ankommen,
wo wir vor Ruckzug des Medikaments
waren", sagte Kellog. Analyst
Christian Lach von BB Biotech erwartet
für dieses Jahr Erlose für Tysabri von
100 Millionen Euro. ,,Mit diesem Ergebnis
wären wir sehr glucklich", sagte Kellog,
der die Umsatzerwartungen nicht beziffern
wollte. Das Mittel werde allen
vier Konkurrenzprodukten ,,in gleichem
Verhältnis" Marktanteile abnehmen


...bei 100 mio$ Umsatz mit Tysabri in 2006, werden ca. 40 Mio$ dem Deckungsbeitrag von Elan zufliessen. Vieleicht schreibt Elan bereits im 4. Quartal schwarze Zahlen? Das sind ja rosige Aussichten!

[Cyberhexe]

What to buy: Stocks that can double
I look for a diversified portfolio of stocks that can double over the next couple of years, driven by different factors. For most stocks, it boils down to just a handful of issues.
In the case of Elan (ELN : Elan Corporation, plc
News , chart, profile, more
Last: 16.70+0.21+1.27%

12:06am 07/03/2006

ELN16.70, +0.21, +1.3%) , now that the Food and Drug Administration has re-approved its multiple sclerosis drug, Tysabri, the issue is: how many patients will use Tysabri?
Our community-based research has shown that for most multiple-sclerosis patients, the current drugs (all of them blockbusters) have undesirable side effects or just don't work. Tysabri has had such miraculous results that MS patients are willing to give up all other drugs to be first in line to receive treatments when Tysabri returns to the market in July.
Our research convinces me that Tysabri will be a multibillion-dollar drug -- and interest rates, the price of oil, and the election will not affect an MS patient's decision to use Tysabri. So when Wall Street panics, as it did in January when ELN dropped 22% in two days or in June when ELN dropped 24% in two days, that's the time to buy a stock that can double over the next couple of years.


http://www.marketwatch.com/News/Story/Story.aspx?guid=%7BFD8…

[wave]

Elan Signs License Agreement with Abbott for Elan's Proprietary NanoCrystal(R) Technology
Thursday July 6, 2:30 am ET
To Develop a Single Fixed-Dose Combination of TriCor(R) and Crestor(R) for High Cholesterol Patients

DUBLIN, Ireland--(BUSINESS WIRE)--July 6, 2006--Elan Corporation, plc (NYSE:ELN - News) today announced that it has entered into a License Agreement with Abbott Pharmaceutical PR Ltd (NYSE:ABT - News) 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.

ADVERTISEMENT
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.

[wave]

Elan Announces Webcast of Second Quarter 2006 Financial Results
Wednesday July 5, 1:15 pm ET

DUBLIN, Ireland--(BUSINESS WIRE)--July 5, 2006--Elan Corporation, plc announced today that it will host a conference call on Tuesday, August 1, 2006 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 2006 financial results, which will be released before the U.S. and European financial markets open.

ADVERTISEMENT
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.

[Cyberhexe]

Davys Kommentar von Heute:

Previous close: $16.36 Target: $18.00 (31/01/06; previously $13.00, issued 09/08/05) Analyst: [e-mail]
Elan has signed a new licence agreement with Abbott Labs/AstraZeneca to develop a single-dose pill using its Nanosystems
delivery technology.
The fixed-dose product will be a combination of multi-billion-dollar products Tricor, a fibrate product, and Crestor, a statin.
Tricor already uses the Nanosystems technology.
Financial terms were not disclosed. However, the structure is similar to other licence arrangements in this area: Elan will
receive development and clinical milestones and ultimately a royalty rate on the end-user sales. We estimate that Elan
receives a mid-single-digit royalty on Tricor sales at present.
This is very positive news for Elan’s drug technology division and we believe it will the first of several new initiatives from that division during this year and next.


...da darf man ja noch einiges erwarten!

[Birgit.Tersteegen]

Yepp!Re: NANO significance
by: nsdrum (50/M)
Long-Term Sentiment: Buy 07/06/06 07:47 am
Msg: 1050641 of 1050641

This is the start of the 3rd quarter. First Nano News, then Ty infusion/patient uptake, and ALZ around the corner. Would be nice to see the PPS start back up on its way back up to $30.

[Cyberhexe]

http://www.rte.ie/business/2006/Morningrep/download/0707good…

Elan (Add, Closing Price $16.12); Tysabri - from promise to performance.
Analyst: Ian Hunter T [phone] E [e-mail]
With Tysabri now approved for the treatment of relapse remitting MS in both the US and Europe and the price, at least in the US, set,
we have increased our 2006 total Tysabri sales projections to $88.1m from $58.6m. The uptick reflects the inclusion of sales in Europe.
The subsequent 17%, 13% and 14% lift in FY07, FY08 and FY09 projections to $895.0m, $1448.1m and $2185.7m reflect the price
increase, tempered by reduced expectations from drug-naive European patients. For Elan, this equates to a 3.3%, 21.1% and 18.8%
uptick in FY06, FY07 and FY08 revenue to $612.1m, $1.2bn and $1.6bn respectively. Our forecast fully diluted losses per share for
FY06 decrease 3.0% to 73.5c. We have raised our forecast FY07 and FY08 fully diluted earnings by 59.8% and 24.4% to 17.1c and
44.3c respectively. On Tysabri for the treatment of MS, we believe that there will be a hiatus in newsflow for a couple of months after
launch in the US. The next European news will centre round pricing in Germany and Ireland. Our model assumes the full US price will
be achieved in Europe. Any dip will not materially affect our model but will be perceived by the market as a setback. Counter to this,
however, we do expect progress on the use of Tysabri for the treatment of Crohn’s. We are, therefore, tempering our enthusiasm for the
stock over the longer term (Tysabri sales could be greater than we currently forecast, the Alzheimer’s pipeline has potential for upside
surprise in late 2006 early 2007 and progress is flagged on Crohn’s) with concerns over short term sentiment. As such, we are retaining
our Add recommendation but with a price target of $18.50 (up from $16.50), at the upper end of our current valuation range.

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 22.451.649 von Cyberhexe am 07.07.06 14:55:37

....jetzt musst Du nur nochmal den Kurs etwas hochhexen....

[Cyberhexe]

"the reason for our being":

http://www.alzforum.org/drg/drc/detail.asp?id=101

...und es wurde bereits darauf hingewiesen, dass ein frühzeitiger Übergang in Phase3 möglich ist.

[Cyberhexe]

...und das Vaccin wird möglicherweise noch vor Jahreswechsel in Phase 2 konvertieren!

http://www.alzforum.org/drg/drc/detail.asp?id=102

[Cyberhexe]

...bin gespannt, wie lange es noch dauert bis aus dem Beta-Amyloid-Programm ein Wirkstoff in die Klinik geht. Elan scheint gemeinsam mit Wyeth bei den neurologischen Erkrankungen zum Platzhirsch aufzusteigen...und falls bei AD oder PD irgendetwas wirkungsvolles zur Marktreife gebracht wird, dürfte Dale Schenk erster Anwärter auf den Nobel-Preis sein!


http://www.alz.org/icad/satellite_ancillary_events_jul18.asp

[Cyberhexe]

...interessanter Link zu AD und Elans Kooperationspartner Wyeth

http://www.washingtonpost.com/wp-dyn/content/article/2006/06…


z.B. über den zukünftige wirtschaftliche Bedeutung:
Alzheimer's is expensive. It requires $19,000 a year in out-of-pocket costs for each caregiver family. Last year Medicare spent $91 billion for Alzheimer's. That figure will nearly double in just four years -- and keep soaring as 14 million cases are diagnosed in boomers' lifetimes.

...über AAB-001:
Another promising approach is an antibody directed against beta-amyloid. By removing these plaques, we hope to stop the disease from progressing.

[Cyberhexe]

Fidelity scheint von Elans Zukunft ebenfalls überzeugt zu sein und ist mit 54.9 Mio Aktien (entspricht 13.9%) der grösste Anteilseigner:
http://www.londonstockexchange.com/LSECWS/IFSPages/MarketNew…

[bernie55]

Antwort auf Beitrag Nr.: 22.501.576 von Cyberhexe am 10.07.06 13:50:00

..aus dem Yahoo Board:

10-Jul-06 01:44 am

Still can't believe that

1) Biogen has currently scaled to 100k(patients)/yr production for Tysabri...

2) Biogen has discussed openly that "3"X high titre (means "3" fold output for the non-bio board members, cells make more product, etc...) is complete...

3) Biogen is building a facility in denmark to make more Tysabri at the current approved production scale (100k(patients)/yr)...high titre will be "3"X this amount...

And some stupid analyst/shorty hedge fund says 200M in sales for Tysabri, tops...


Do the math [600k(max production capacity with out contracting production out) X 28k(*initial* launch price) = 16.8 Billion] like Fidelity has done and you will see why fido owns 13% (http://www.londonstockexchange.com/LSECW...
92&source=RNS) of Elan!

Lest we forget the 2 Alz Disease drugs in Phase 2, nor the Alz Disease Vaccine in Phase 1, or the Nano Formaulation programS (Quantity=30?) with Pharmas(JNJ, ABT, Aventis, Roche, etc)...

Elan is one of the best places in the financial world to set aside some cash for the FUTURE...


Elan Rocks!


http://messages.finance.yahoo.com/Healthcare/Biotechnology_a…

[Cyberhexe]

wohl nur der Anfang einer langen Liste von nanotechnologischen Erfolgsmeldungen. Mit Hilfe Elans Technologie haben die Pharmagrössen die Möglichkeit, ihre Erfolgsprodukte von generischen Anbietern abzugrenzen. Und dies gilt für alle wasserunlöslichen Wirkstoffe.

http://www.drugresearcher.com/news/ng.asp?n=68996-abbott-ela…

[surga]

Antwort auf Beitrag Nr.: 22.504.434 von Cyberhexe am 10.07.06 16:49:40

Hi Cyber,
dann verstehe ich nicht was 10k ASK zu 15,85$.
Ist es nur Angstmacherei?

[Cyberhexe]

Antwort auf Beitrag Nr.: 22.504.694 von surga am 10.07.06 17:01:13

es handelt sich bei Elan nicht um eine "Pennystockrakete", die sich in 4 Tagen verfünffacht! Für mittelfristig orientierte Anleger eröffnen sich jedoch mit den verschiedenen Projekten riesige Chancen:

Pipeline
http://www.elan.com/research%5Fdevelopment/Pipeline%5FProduc…

Nanotechnologie
bereits am Markt platziert und mit ständig steigenden Lizenzeinnahmen durch die Vermarktung von folgenden Produkten:

Avinza® – once-daily, novel dual release morphine sulphate
Emend® – oral table form of aprepitant, a poorly water soluble compound
Focalin® XR – once-daily Dexmethylphenidate marketed in US and other territories
Herbesser® R – once-daily, high-potency, sustained release diltiazem for Japanese and other Asian markets
Megace® ES – concentrated oral suspension utilizing NanoCrystal® Technology, marketed in the U.S.
Naprelan® - once-daily, sustained-release naproxen sodium
Rapamune® - oral tablet form of poorly water soluble compound
Ritalin® LA – once-daily, pulsatile release of methylphenidate
Theo-Dur® - twice-daily, sustained-release theophylline
TriCor® - new formulation of Abbott’s fenofibrate, which can be taken without regard to food, launched in the U.S.
Verelan® - once-daily, sustained-release verapamil
Verelan® PM – modified release, chronotherapeutic verapamil


...fast alle Pharmagrössen verwenden die patentierte Technologie:
http://www.elan.com/EDT/Announcements/

[surga]

Antwort auf Beitrag Nr.: 22.505.121 von Cyberhexe am 10.07.06 17:30:59

Danke für die Infos. Das sehe ich auch so.
Bin set Juni 2005 investiert und noch kein Stück verkauft.

[Poppholz]

13.07.2006 13:31
Archemix Announces Strategic Alliance With Elan to Discover and Develop Aptamer Therapeutics

CAMBRIDGE, Mass., July 13 /PRNewswire/ -- Archemix Corp. announced today a multi-year, multi-product alliance with Elan Corporation, (Nachrichten) plc focused on the discovery, development, and commercialization of first-in-class aptamer therapeutics to treat autoimmune disease. The companies will seek to develop aptamer therapeutics to IL-23, a cytokine that has emerged as a mediator in the chronic autoimmune inflammatory diseases, and additional protein targets. The collaboration combines Archemix's extensive expertise in aptamer therapeutics with Elan's experience and leadership in the development and commercialization of new therapies for autoimmune diseases.

Under the terms of the agreement, Archemix will receive an upfront payment of $7 million. Depending upon the number of products successfully commercialized under the collaboration, Archemix is eligible to receive development and sales milestones in excess of $350 million. Archemix is also entitled to receive a royalty on any marketed products developed under the collaboration. Other financial terms were not disclosed. Archemix also has an option to participate in the co-development of some products that may emerge from this collaboration.

"We selected Elan from a number of potential pharmaceutical partners because of its demonstrated expertise in the clinical and regulatory landscape of autoimmune disease," said Dr. Errol De Souza, President and Chief Executive Officer of Archemix. "Our robust intellectual property position in aptamer therapeutics uniquely positions Archemix to be a product development engine, developing a portfolio of aptamers for both acute and chronic disease. Aptamers are poised to become the next generation of therapeutics, and we are extremely pleased to be working with a company of Elan's caliber on their development."

G. Kelly Martin, Elan's President and Chief Executive Officer, commented, "We are pleased and enthusiastic about joining forces with Archemix to seek to further expand patient/physician treatment choice in autoimmune diseases. By combining our strengths, this collaboration can accelerate the development of new therapies for chronic, debilitating diseases with continued unmet medical needs."

About Interleukin 23

Interleukin 23, or IL-23, is a cytokine that has emerged as a mediator in chronic autoimmune inflammatory diseases such as Multiple Sclerosis, Crohn's Disease, Psoriasis, and Rheumatoid Arthritis. Preclinical results have demonstrated that IL-23 exerts its pro-inflammatory effects principally at the site of inflammation. It is hypothesized that specific blockade of IL-23 may control clinical symptoms at the level of the inflamed tissue without generally suppressing the patient's immune system, thus preserving the body's ability to fight infection. The current anti-cytokine treatments for autoimmune disorders have a number of disadvantages, including an increased risk of infection, increased chances of developing lymphoma, renal toxicity, and limited efficacy. Archemix's aptamers are first-in-class therapeutics for autoimmune diseases that exert their action by specifically inhibiting IL-23 in the target tissue.

About Aptamers

Aptamers are single-stranded nucleic acids that form well-defined three-dimensional shapes, allowing them to bind to target molecules in a manner that is conceptually similar to antibodies. Aptamers combine the optimal characteristics of small molecules and antibodies, including high specificity and affinity, chemical and biological stability, low immunogenicity, and the ability to target protein-protein interactions. In contrast to monoclonal antibodies, aptamers are chemically synthesized rather than biologically expressed, potentially offering a significant cost advantage. As therapeutic agents, aptamers have demonstrated clinical biological efficacy and typically have excellent, tunable pharmacokinetic properties.

About Archemix Corp.

Archemix Corp. is a privately-held biopharmaceutical company based in Cambridge, Massachusetts. The company's mission is to develop aptamers as a class of directed therapeutics for the prevention and treatment of human disease. Because of their unique properties and proven efficacy, aptamers are a superior alternative to biologics and small molecules and will be a major class of drugs for the treatment of unmet medical needs.

Archemix's aptamer expertise is complemented by a robust patent estate comprised of over 220 issued and 230 pending patents covering the identification, composition, and use of therapeutic aptamers. In addition to the company's core aptamer generation technology, Archemix possesses strong expertise in both preclinical and clinical drug development. Further information on Archemix can be found at http://www.archemix.com/.

For further information about the strategic alliance, Archemix, or aptamers, or to speak with Dr. Errol De Souza, please contact Davia Temin at 212-588-8788 or [e-mail]. For more information about Elan plc, please contact Anthony Silverman at 212-407-5740.

Quelle: PR Newswire

[Cyberhexe]

Davy zum Alchemix-Abkommen:

http://www.rte.ie/business/2006/Morningrep/download/0714davy…

Elan (ELN US)
Previous close: $15.29 Target: $18 (13/01/06; previously $13, issued 09/09/05) Analyst: [e-mail]
Outward looking
One of the most interesting aspects of Elan’s R&D collaboration with Alchemix is that it represents an outward investment by
the former. Such forays have been rare in recent times – no doubt as other internal issues took priority. We think it is
encouraging that Elan’s early stage autoimmune/inflammation R&D is being strengthened and it is likely that we will see
more deals like this in the future.
The deal itself involves early stage R&D and carries modest financial outlay in the near term - $7m upfront and close to $25m
over three years if certain milestones are met. The headline $350m payments mentioned in the Alchemix statement assume
everything goes perfectly right, but we assume in turn would translate to very substantial product opportunities for Elan.
The agreement covers three targets based on aptamers that bind to specific protein targets. The lead target is in preclinical
development.

[Cyberhexe]

http://www.rte.ie/business/2006/Morningrep/download/0717good…

Elan (Add, Closing Price $14.73); Focus on Alzheimer’s this week.
Analyst: Ian Hunter T [phone] E [e-mail]
The 10th International Conference on Alzheimer’s Disease and Related Disorders is now in session in Madrid, having officially opened
yesterday after pre-conference meetings on Saturday. The five day meeting of academics and researchers into Alzheimer’s will bring
the disease onto focus over the week. Elan, with its partner Wyeth has two candidate drugs in clinical trials for the treatment of the
disease. AAB-001 is in Phase II, with the possibility of it moving into Phase III in early 2007 should data prove favourable. ACC-001 is
in Phase I. At the conference, Elan researchers will give three oral and five poster presentations during the conference on various topics
(e.g. “Novel gamma secretase inhibitors showing potential for the treatment of Alzheimer’s Disease” and “Immunotherapy with
antibodies to N-terminal amyloid-beta peptides reduces cerebral amyloid angiopathy in PDAPP mice”) that add to the body of knowledge
on the development and treatment of the disease but are not new to the market



http://www.alz.org/icad/

[Cyberhexe]

Überblick über die Alzheimer-Forschung - Elan ist jedoch nicht speziell erwähnt - aber dennoch interessanter Link:

http://www.bloomberg.com/apps/news?pid=20601102&sid=a80v3BIS…

[Cyberhexe]

es werden zwar keine neuen Daten veröffentlicht, jedoch wird die Konferenz einen Einblick über die Forschungsprogramme geben...und so wie es aussieht, dürften Wyeth und Elan momentan nicht nur eine Nasellänge im Vorsprung sein!

http://www.rte.ie/business/2006/Morningrep/download/0718davy…

Previous close: $14.25 Target: $18.00 (31/01/06; previously $13.00, issued 09/08/05) Analyst:[e-mail]

Although Elan and Wyeth are not revealing any substantial new data at the Alzheimer Association's tenth ICAD conference in Madrid, the event is nonetheless providing valuable insights on the overall Alzheimers Disease (AD) research environment.
Attending the satellite symposium, hosted by Myriad Genetics, one was struck by the strong continuing support for the
amyloid hypothesis. Though by no means the only approach, it is the cornerstone for many of the later-stage therapies
currently in clinical development.
Various strategies are attempting to target the production, degradation and aggregation of the amyloid plaques associated
with AD. The symposium focused on emerging anti-amyloid therapies.
Sessions earlier in the day focussed on imaging technologies and secretase inhibition. Both have relevance for Elan. The
company is already using hi-tech imaging for its ongoing Phase II study.
There is a very large body of R&D work underway in enzyme inhibition; more than 100 patents have been published to date.
The broad sense from what we saw was that there are still more questions than answers in this area, especially from a safety
perspective.
Elan and Wyeth, gold sponsors at ICAD, are hosting a symposium this evening (July 18th). Guest speakers will present under
the theme "Current progress on the beta-amyloid peptide as a therapeutic agent in AD".
Previous close: 153.25p Target: 200p (13/07/06) Analyst: [e-mail]

[Cyberhexe]

...our biggest baby is launched!

http://www.nationalmssociety.org//tysabri_july18.asp

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 22.757.028 von Cyberhexe am 19.07.06 14:45:11

Aber was heisst das mit der Verzögerung----warum sagt Elan das nicht seinen Aktionären??????

[Birgit.Tersteegen]

angucken http://tysabri.com/

[Birgit.Tersteegen]

Für Dich Hexchen

Links
Treatment of Alzheimer's disease: the beginning of a new era.

* Schenk D.

Chief Scientific Officer, Elan Corporation, 800 Gateway Blvd., South San Francisco, CA 9480, USA. [e-mail].

Many of the challenges that we once faced of treating Alzheimer's disease are now understood because of the worldwide research efforts into this deadly disease. We now understand certain aspects of the pathology, genetics and neurotransmitter deficits of AD. This has resulted in two classes of drugs to partially remedy the underlying neurotransmitter abnormalities and more recently has launched an extensive clinical effort targeting beta amyloid peptide. We still, however, require broader therapeutic approaches to ultimately prevent and modify disease progression in AD, and we need concomitant advances in diagnostics to parallel this process in order to ultimately control the devastation that this disease extols on society. The classic clinical features of Alzheimer's disease include its insidious onset, slow progression, memory loss and loss of cognitive skills. The cognitive skills lost include language, visuospatial relations, planning and problem solving, calculations and behavior. The three consistent neuropathological hallmarks are amyloid-rich senile plaques, neurofibrillary tangles and neuronal degeneration. These neuropathological changes eventually lead to the clinical symptoms, but they likely begin to occur years before the onset of symptoms. Currently, much work is being done on the neuropathological aspect of the disease including research in the areas of inflammation, oxidative injury, neurotrophic factors, tau and tau kinases and Abeta. Inflammatory mediator levels have been shown by several research teams to be elevated in the diseased tissue, indicating that inflammation might be a key factor in AD. Similarly, oxidation has been shown to correlate with the progression of the disease. In addition to these two types of insults in the disease, changes in neu Because Abeta peptide formation is implicated in AD, both because of genetics and its obvious pathological accumulation, the Beta Amyloid Hypothesis that the peptide is causative of the disease has been proposed. This has led to ongoing extensive research into the secretases involved in its release. This pathway has led to several potential disease inhibitors such as beta-secretase inhibition, gamma-secretase inhibition and modulation as well as Abeta immunotherapy. The idea behind active Abeta immunotherapy is to introduce antibodies that prevent Abeta from forming plaques and also to promote plaque clearance from the brain. This idea has been tested in mice and shown to reduce plaque burden and improve behavioral outcomes. In humans, immunotherapy has been shown to reduce plaque burden, and limited clinical data with an active immunization approach (AN 1792) has demonstrated a benefit in neuropsychological test battery scores. Currently, phase 2 clinical studies are ongoing with a humanized anti-Abeta antibody to better understand its ultimate therapeutic potential for treatment of AD. Extensive clinical and research efforts are ongoing by many groups to fully explore the potential utility of Abeta immunotherapy for treatment and possible prevention of AD. Historically, diagnostic markers together with therapeutic agents must co-exist to have a meaningful effect on disease progression. Obvious examples of this are cardiovascular disease and many forms of cancer. For AD, such markers might ultimately include CSF Abeta and tau levels. To date, four acetylcholinesterase inhibitors and one NMDA antagonist have arisen to aid in the symptomatic treatment of AD. Research and clinical efforts are underway to assess the Beta Amyloid Hypothesis and numerous additional hypotheses have recently been proposed to combat AD by novel mechanisms. These are truly groundbreaking yet challenging times for future treatment opportunities for AD.

PMID: 16842091 [PubMed - in process]

[2CB_06]

Hier mal ein interessanter Link zum Thema Alzheimer

http://www.nature.com/news/2006/060529/pf/nbt0606-595_pf.htm…

Neben Elan git es noch eine Reihe weiterer Firmen, die versuchen monoklonale Antikörper gegen Alzheimer zu entwickeln.
So wie es aussieht erzeugt der Elan Antikörper Abnormalitäten bei hohen Dosen im Gehirn

"Elan generated a buzz in April when it released early clinical data from 30 patients receiving its monoclonal antibody bapineuzumab. The ten patients receiving the second of three doses showed statistically significant improvement in the mini-mental state examination 16 weeks after antibody injection. However, MRI scans of three of ten patients receiving the highest dose showed abnormalities that could indicate microhemorrhaging, says Dave Morgan, director of the Alzheimer research laboratory at the University of South Florida, Tampa.
Morgan, who has no financial stake in Rinat or any other company, was stunned when he saw Elan's data, because he had published several articles showing small brain bleeds in mice receiving Rinat's antibody. "The human data parallels the mouse data perfectly," he says. "When I first saw [microhemorrhaging] in my mice, I said, 'This is dead, this approach is over.' I was afraid Rinat was going to call me a lousy scientist. Instead, they wanted to see if they could correct it."

(bapineuzumab = AAB-001)

Die nicht glykolisierte Form des Antikörpers ist wohl besser verträglich.
Elan versucht nun eine deglykolisierte Form des Antikörpers herzustellen.

"Rinat cofounder and president, Arnon Ronsenthal, thought that a modified version of the antibody, one that didn't bind to glucose, might provide a cleaner safety profile. His team engineered such an antibody and shipped it to Morgan for mouse testing. In the May 17 issue of the Journal of Neuroscience (2006, 26 (20): 5340–5346), Morgan's team reports that the new, deglycosylated antibody clears beta-amyloid plaque as well as or better than the older antibody while causing less microhemorrhaging. The mice also performed better on a standard water-maze memory test."
Elan and others in the field are now eager to develop their own deglycosylated antibodies. But the standard method of deglycosylation uses a slow, expensive enzyme reaction. Here, Rinat has a head start—its latest antibody lacks the glucose-reaction site altogether. "They engineered it that way," says Morgan. Citing confidentiality concerns, Rosenthal would not confirm this, but he did say that Rinat's antibody is "specifically designed to minimize" microhemorrhaging.

Was das für die bestehende Phase II von AAB-001 bedeutet, kann ich jedoch nicht sagen. Vielleicht kann jemand mehr dazu sagen, ob eine Veränderung des Antikörpers eine Verzögerung der klinischen Studien zur Folge hätte.

Die Zeitschrift Nature Medicin hat eine Sonderausgabe zum Thema Alzheimer herausgegeben. Sind paar interessante Artikel dabei ...

http://www.nature.com/nm/focus/alzheimer/index.html

[welke91]

BACKGROUND: The pathogenesis of Crohn's disease involves migration of leukocytes into gut tissue and subsequent inflammation. Natalizumab (Tysabri(R), Elan Pharmaceuticals and Biogen Idec) a recombinant humanized IgG4 monoclonal antibody that blocks adhesion and subsequent migration of leukocytes into the gut by binding the alpha4 integrin is a member of a new class of molecules known as selective adhesion molecule (SAM) inhibitors. The results of animal studies suggest that alpha4 integrin blockade could be a useful therapy for inflammatory bowel disease. The results of randomized controlled trials suggest that natalizumab may be an effective therapy for active Crohn's disease. This systematic review summarizes the current evidence on the use of natalizumab for the induction of remission in Crohn's disease.

OBJECTIVES: To determine the efficacy and safety of natalizumab for induction of remission in Crohn's disease. SEARCH STRATEGY: A computer assisted search of the Cochrane Central Register of Controlled Trials, the Cochrane Inflammatory Bowel Disease and Functional Bowel Disorders Review Group Specialized Trials Register, MEDLINE and EMBASE was performed to identify relevant publications between 1966 and June 2005. The medical subject heading (MeSH) terms "Crohn disease" or "inflammatory bowel disease", "Natalizumab" or "Antegren" or "Tysabri" and "Antibodies, Monoclonal" were used to perform key word searches of each database. Manual searches of reference lists from potentially relevant papers were performed in order to identify additional studies that may have been missed using the computer-assisted search strategy. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. Personal contacts, leaders in the field, and the manufacturers were contacted to identify other studies which may not be published. SELECTION CRITERIA: We included only randomized controlled trials comparing natalizumab to a placebo or control therapy for the induction of remission in Crohn's disease. DATA COLLECTION AND ANALYSIS: Data were analyzed using Review Manager (RevMan 4.2.8). All data were analyzed on an intention-to-treat basis. For pooled data, summary test statistics were derived using the relative risk and 95% confidence intervals. Fixed and random effects models were used where appropriate. The definitions of treatment success, remission and clinical improvement were set by the authors of each paper, and the data were combined for analysis only if these definitions were sufficiently similar. MAIN RESULTS: Pooled data from the three included studies suggest that natalizumab (3 to 4 mg/kg) may be effective for induction of clinical response and remission in patients with moderately to severely active Crohn's disease. This benefit is statistically significant for one, two and three infusion treatments. There was a trend toward increased benefit with additional infusions of natalizumab. Natalizumab appears to provide greater benefit for patient subgroups characterized by objective confirmation of active inflammation or chronically active disease despite conventional therapies. These subgroup analyses demonstrated significantly greater clinical response and remission rates for natalizumab compared with placebo in patients with elevated C-reactive protein levels, active disease despite the use of immunosuppressants, or prior anti-tumor necrosis factor therapy. These benefits were apparent for both short term (one infusion) and longer term treatment (two or three infusions). Natalizumab was generally well tolerated and the safety profile observed in the three included studies was similar. Adverse events occurred infrequently and were experienced by a similar proportion of natalizumab and placebo treated patients. There were no statistically significant differences between natalizumab and placebo treated patients in the proportions of patients who withdrew due to adverse events or those who experienced serious adverse events. The included trials lacked adequate power to detect serious adverse events that occur infrequently. Recently, two patients with multiple sclerosis treated with natalizumab in combination with interferon beta-1a and one patient with Crohn's disease treated with natalizumab in combination with azathioprine developed progressive multifocal leukoencephalopathy (PML) resulting in two patient deaths. As a result all dosing in clinical trials and commercial use of natalizumab has been suspended. A retrospective investigation was conducted to assess the risk of PML in natalizumab treated patients and no new cases were identified. AUTHORS' CONCLUSIONS: Pooled data and the results of an ongoing study suggest that natalizumab may be effective for induction of clinical response and remission in patients with moderately to severely active Crohn's disease. The clinical benefit of induction therapy with natalizumab in Crohn's disease should be weighed against the potential risk of serious adverse events. Currently natalizumab is not available on the market for routine clinical use as a consequence of the unexpected association with PML. However, preliminary data from the retrospective investigation of adverse events associated with natalizumab suggest that it may be possible to identify patients at risk for PML by testing for the appearance of JC virus in plasma.

PMID: 16856112 [PubMed - in process]

[Cyberhexe]

back from the top of Gran Paradiso:
http://de.wikipedia.org/wiki/Gran_Paradiso


Biogen Idec and Elan Announce Availability of TYSABRI® for the Treatment of Relapsing Forms of Multiple Sclerosis

http://www.elan.com/research_development/Pipeline_Products/d…

http://www.elan.com/News/full.asp?ID=885261


sorry, hatte bisher noch keine Zeit, mich mit den interessanten Info von 2CB_06 (wellcome!) und welke auseinanderzusetzen.
Nichtsdestotrotz scheint mit der Heute beginnenden Vermarktung von Tysabri die Sommerdepression beendet.

good luck
ch

[Cyberhexe]

...so ähnlich wie Davy beurteile ich die momentane Situation
http://www.rte.ie/business/2006/Morningrep/download/0724davy…

Elan (ELN US)
Previous close: $13.31 Target: $18.00 (31/01/06; previously $13.00, issued 09/08/05) Analyst: [e-mail]
Weakness provides an opportunity
Based on Friday’s close, the Elan share price is now back at levels last seen just before the FDA Advisory Panel meeting in
early March. The stock is now in negative territory year-to-date.
In the interim period there have been very significant, positive developments for the stock:
• Tysabri received marketing approval as a MS treatment in the US.
• This was followed by similar approval in the EU.
• Elan reported encouraging Phase I data from its AAB-001 study, and all AD programmes remain on schedule.
• Q1 results also beat expectations.General market sentiment towards biotech has waned, and we think that this is a contributory factor to the Elan fall. The
Nasdaq Biotech Index is 20% off its 2006 highs, while Elan is currently 31% off its own 2006 high in early June.
The next expected newsflow is on August 1st, when the company reports its Q2 numbers. We feel the recent downturn is
overdone and provides an opportunity to increase weightings.

[Cyberhexe]

NCBs Kommentar von Heute:

http://www.rte.ie/business/2006/Morningrep/download/0724ncb.…

ELAN €13.31 BUY Tysabri launched in US and EU
• Tysabri is now commercially available in the US and in Europe (Germany, Ireland, UK
and Sweden) with dosing commenced in both the US and Europe. BiogenIdec and Elan
are currently involved in the training of sites and physicians and the ultimate focus of
the launch program in the US is on 2000 infusion sites and 2,500 physicians that
represent over 50% of MS treated patients.
• Launch activities include educating physicians on the benefits and risks of TYSABRI
and implementing the TOUCH precribing program as well as working with payers to
facilitate product access and reimbursement. With the TOUCH program, only
prescribers, infusion centres, and pharmacies associated with infusion centres
registered with the program are able to prescribe, infuse or distribute TYSABRI. For
distribution, Elan has contracted with ICS and 12 specialty pharmacies for distribution
to authorised infusion centres and pharmacies.
• Further details on the launch and dosing of patients are expected on Wednesday when
BiogenIdec report Q2 results. Elan report Q2 results on 1st August.

[Cyberhexe]

last but not least Ian Hunter von Goodbodys Stockbroker:

http://www.rte.ie/business/2006/Morningrep/download/0724good…

Elan (Add, Closing Price $13.31); Tysabri launched in the US and four European
countries.
Analyst: Ian Hunter T [phone] E [e-mail]
Elan and its partner Biogen Idec this morning announced that Tysabri is now commercially
available in the US and Europe. In the US, the drug was approved in late May with the proviso
that it could not be launched until the PML risk management programme was in place. The
renamed TOUCH Prescribing Program is now in place, designed to inform patients and
physicians of the benefits and risks of Tysabri and minimise potential risk of PML. Only
prescribers, infusion centres and pharmacies associated with infusion centres registered with the
TOUCH programme are able to prescribe, infuse or distribute Tysabri. On distribution, Elan has
contracted a single distributor and 12 speciality pharmacies to handle Tysabri. The training at MS
infusion sites for physicians and prescribers is on-going, we understand focussing on 2,000 sites
and 2,500 physicians and prescribers representing over 50% of treated MS patients. We also
understand that in Europe, Tysabri has been launched in Germany, Ireland, the UK and Sweden.
No details have been given on drug pricing in each of these countries. Elan and Biogen Idec had
flagged that Tysabri would be on the market by July and this deadline has been met. We now
await concrete prescription and uptake data (possibly in the coming two to three months), which
will give some indication of MS patient/physician appetite for the drug post-PML.

[Cyberhexe]

Das Potential von Tysabri ist riesig:


MS affects more than 350,000 people in the United States and 2.5 million worldwide. In the United States, prevalence estimates vary between 5 and 119 per 100,000 population.

http://www.clevelandclinicmeded.com/diseasemanagement/neurol…

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.034.060 von Cyberhexe am 25.07.06 09:25:55

Eigentlich eine grosse Chance dicke Gewinne eunzufahren wenn sich TY als Blockbuster erweist---wonach es von der Nachfrage her ja aussieht....

[Cyberhexe]

goodbody Stockbrokers über die Preisgestaltung von Tysabri in Europa:
http://www.rte.ie/business/2006/Morningrep/download/0725good…

Elan (Add, Closing Price $13.43); Pricing of Tysabri in Europe higher than expected.
Analyst: Ian Hunter T [phone] E [e-mail]
Subsequent to yesterday’s announcement of the launch of Tysabri into four European markets,
Elan has indicated that the prices per vial for Tysabri in Europe will be in the €1,130 to €1,815
range. When annualised and converted into US$, this is equivalent to $27,160 per annum in the
UK (4.4% discount to US price); $26,860 per annum in Ireland (5.4% discount); and $29,780 per
annum in Germany (a 4.8% premium). This pricing is better than we had envisaged (10%
discount across the board) and so gives us increased comfort in our current Tysabri projections
of total sales [Elan and Biogen Idec] of $88.1m in FY06 rising to $2.2bn in FY09.

[bernie55]

Antwort auf Beitrag Nr.: 23.036.210 von Cyberhexe am 25.07.06 11:28:17

Elan has indicated that the prices per vial for Tysabri in Europe will be in the €1,130 to €1,815
range.


Wie verfahren denn eigentlich die Krankenkassen in Deutschland mit der Verordnung von Tysabri???

Werden die Ärzte vielleicht dazu angehalten , " billigere " Medikamente zu verschreiben, ohne dass die " besseren " Behandlungserfolge bei Tysabri berücksichtigt werden ????

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.036.377 von bernie55 am 25.07.06 11:38:38

Ich glaube kaum ,dass sich die Leute mit weniger Effektivem abspeisen lassen wenn sich herumspricht,dass unter TY Viele ihren Rollstuhl verlassen können....

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.036.377 von bernie55 am 25.07.06 11:38:38

....Tysabri wurde ja erst zugelassen, weshalb natürlich noch keine generics angeboten werden.
Und da die Wirksamkeit der Interferone weitaus geringer ist, haben die Krankenkassen wohl keine andere Wahl, als die Kosten für das wirkungsvollste Medikament zur Behandlung von RRMS zu übernehmen.


PS
Bin allerdings kein Spezialist im bundesdeutschen Gesundheitsdschungel!

[bernie55]

Antwort auf Beitrag Nr.: 23.036.740 von Cyberhexe am 25.07.06 12:01:55

Bin allerdings kein Spezialist im bundesdeutschen Gesundheitsdschungel!

...aber auf jeden Fall eine Spezialistin im Biotechdschungel.....

Danke , Cyberhexe für die Info....

Grüße bernie55

[bernie55]

Antwort auf Beitrag Nr.: 23.036.727 von Birgit.Tersteegen am 25.07.06 12:01:11

...das wollen wir hoffen, Birgit...

[Birgit.Tersteegen]

Subject: Re: Ken Kam releases a new buy alert for elan today....just receivedan email this morning
Sentiment:
Posted as a reply to: msg 4903 by cwackman


We are issuing this alert because Élan Corporation, plc ADR (nyse: ELN) fell 5.4% last Friday when two competitors, Teva Pharmaceutical Industries Ltd. (nasdaq: TEVA) and Serono SA (nyse: SRA), joined forces and uncorked another shot below the belt.

In our March Marketscope (click here to read) I said that Élan's competitors would be pulling out all their guns to try to slow Tysabri. Last month the FDA re-approved Tysabri and today, it was re-released to the market. Now as the market is trying to figure out how profitable it will be, an Associated Press report touting a new therapy for multiple sclerosis patients combining Serono's Novantrone, a cancer drug, with Teva's Copaxone, hit the newswires on Friday. The media focused on the 90% reduction in relapse rate for patients in a clinical trial, lending support to Wall Street's doubts that Élan's newly re-approved MS drug, Tysabri, will ever generate significant sales. In an already weak market, the news helped push Élan's stock price down 5.4% in an already weak market to its lowest level in months.

Élan's stock price was already down, driven by a weak market, but the actions by competitors make Élan an even better opportunity to buy.

My Take

Beyond the headlines, however, the rest of the story leads to quite a different conclusion. It turns out that the clinical trial consisted of just 27 patients. Although some of the patients experienced an improvement, one developed acute leukemia. Everyone acknowledges that a lot more work needs to be done, and it's going to take time. A three-year study is just now being launched.

I don't think many MS patients are going to hold-off taking Tysabri, which reduces relapses by 68% and is available now, in the hope that in 3 years, the combination of Novantrone and Copaxone will turn out to be better. As a result, this news should have little impact on Tysabri's launch. But, it seems to have scared a lot of people into selling their stock in Élan just when Tysabri is finally coming to fruition.

Competitors React to Tysabri's Growing Momentum

One way to tell whether a new drug is going to be a success is to look at the reaction of its competitors. It's noteworthy that this story appears first in the AP newswire, not a respected medical journal. That's how you can tell that competitors, not scientists, are behind this story.

There is no doubt in my mind that both Serono and Teva are afraid of the impact Tysabri will have on their sales.

Serono generated $1.2 billion from the sales of MS drugs (primarily Rebif) almost 50% of their revenue in 2005. Copaxone generated almost $1.2 billion of revenue for Teva in 2005 -- about 25% of their total revenue and probably an even higher percentage of their profits.

But Rebif, and Copaxone are only about as effective as Tysabri in preventing relapses. Neither drug has been shown to slow the progression of multiple sclerosis much less an improvement in disability measures as has Tysabri.

Consequently, both companies have to be concerned that they may lose significant sales now that Tysabri is cleared for sale. From their perspective, the 16 months that Tysabri was off the market was a windfall that enabled them to maintain sales of their existing drugs longer than they expected. Now that Tysabri is back on the market, Serono and Teva are acting as though they are preparing for the worse.

Last year, Serono's board essentially decided to cash out before Tysabri could significantly impact their business. The company hired Goldman Sach's to help them explore "strategic options." Pfizer (nyse: PFE), GlaxoSmithKline (nyse: GSK) and Novartis AG (nyse: NVS) were rumored to be the likely acquirers. However, the Wall Street Journal reported that in spite of Goldman Sach's efforts, Serono had received no serious offers.

In January, Teva acquired generic drug manufacturer IVAX Pharmaceuticals, financing the big acquisition through a $1.25 Billion bond offering by Lehman Brothers and Citigroup during a time when Tysabri was off the market and not considered a threat to Teva's Copaxone. Since then Teva has acted more desperately, trying to reassure investors that Tysabri's growing momentum will not steam roll over Copaxone and affect their debt payments.

Teva seems to be willing to pull out the brass knuckles to maintain Copaxone's sales. On the eve of the FDA Advisory Committee meeting for Tysabri, Bloomberg reported that Teva paid a marketing agent to publicize an unpublished article comparing Tysabri's effect on the human immune system to AIDS. That is a ridiculous comparison. If the best way to protect Copaxone sales is to try to create fear of Tysabri by drawing a ridiculous comparison to AIDS, then Teva must be desperate.

Teva's investment bankers, Lehman Brothers and Citigroup, have also been active. Both firms published research reports citing the risk of PML as justification for their low expectations for Tysabri sales. Coming as it did on the day before the FDA Advisory Committee meeting, these two firms proved that their analysis was not going to change no matter what data was presented at the meeting.

I cannot think of a reason why an analyst making an honest assessment of Tysabri would not want to consider the data that was going to be presented the very next day. I can only surmise that the folks at Teva, and their investment bankers, must believe that Tysabri is a threat to Copaxone's sales. I agree with them.

Action to Take

Competitors often hit below the belt. Whenever a new product threatens to reorder a $5 billion/yr market, you can count on it. Watching Serono, Teva, and their investment bankers take increasingly desperate steps to slow down Tysabri only increases my conviction that Tysabri will be a home-run for Élan.

Although they succeeded in taking Élan's stock price down temporarily, if you have a two-year investment horizon, these shenanigans will not have any impact on your return. Take advantage of this opportunity to increase your position in Élan.

[Birgit.Tersteegen]

Press Release Source: Alzheimer's Drug Discovery Foundation

Alzheimer's Drug Discovery Foundation Invites Scientists to Apply for Grant Award Program
Tuesday July 25, 10:38 am ET

NEW YORK, NY--(MARKET WIRE)--Jul 25, 2006 -- The Alzheimer's Drug Discovery Foundation (ADDF) invites scientists from the biotechnology industry and academia to apply for a grant award program entitled "Novel Approaches to Drug Discovery for Alzheimer's Disease." The goal of the research program is to accelerate the discovery, development and clinical evaluation of effective therapies for Alzheimer's disease. This grant program is being made possible through a generous donation from Elan Pharmaceuticals, Inc.

The total pool of grant funds available for fiscal year 2007 is $535,000. Only research programs with lead compounds are eligible. Target discovery and validation programs will not be accepted. Funds may be used for advancing the development of lead compounds through pre-clinical in-vitro and in-vivo evaluation including pharmacology, toxicology, pharmacokinetics, formulation chemistry and the conduct of pre-clinical proof of concept studies. A funding priority is to support AD discovery in emerging biotechnology companies.

Applications are available at www.alzdiscovery.org. The submission deadline date is October 13, 2006. Applications will be reviewed by an independent Scientific Review Committee convened by ADDF and comprised of leading experts in the Alzheimer's drug discovery and development research field and biotechnology investment community. Selections will be made by December 29, 2006 and funding will be awarded in January 2007. Criteria for selection is based on the merit and feasibility of the proposed research and its relevance to drug discovery and development for the treatment of Alzheimer's disease, the qualifications of the scientific staff conducting the study, the excellence of the research environment including the availability of working with a multidisciplinary research team, and the likelihood of advancing the field.

For more information, contact ADDF Executive Director Howard Fillit, MD, at 212-935-2402 or [e-mail].

About the Alzheimer's Drug Discovery Foundation (ADDF)

The Alzheimer's Drug Discovery Foundation (ADDF) is a public charity established in 2004 to expand upon the programs initiated by the Institute for the Study of Aging (ISOA), a private foundation founded by the Lauder family in 1998. Our mission is to accelerate drug discovery research for Alzheimer's disease (AD) through venture philanthropy. To date, ADDF and ISOA have awarded $25 million for 155 research programs and conferences worldwide. For more information, visit the ADDF website at www.AlzDiscovery.org.

About Elan Pharmaceuticals, Inc. (NYSE:ELN - News)

Elan Pharmaceuticals, Inc. is a neuroscience-based biotechnology company. We are committed to making a difference in the lives of patients and their families by dedicating ourselves to bringing original approaches 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, visit the Elan website at www.elan.com.


Contact:

ADDF Contact:
Suzanne Grossberg
Director of External Affairs
[phone]
Email Contact

[Cyberhexe]

interessanter Artikel über Tysabri und Avonex; immer wieder auffallend ist der Hinweis auf die müde machenden Nebenwirkungen der Interferone. Im Gegensatz dazu sind diese die Lebensqualität stark nbeeinträchtigenden Nebenwirkungen bei Tysabri im Plazebobereich.

http://www.newsobserver.com/724/story/464359.html

Hoffman went back on Avonex, another Biogen MS drug, when Tysabri was pulled. But Avonex made her very tired and gave her flu-like aches and pains the day after each weekly injection, she said.




Es würde mich wundern, wenn Dr. U.Goetzel Recht behalten würde:

Dr. Ugo Goetzel of Millennium Neurology in Durham has whittled the number of patients who will receive Tysabri to a handful.

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.063.628 von Cyberhexe am 26.07.06 14:11:33

aus dem selben Artikel:

The 57-year-old Cary woman is fighting a losing battle with multiple sclerosis. The bracelet represents the promise of a powerful drug, Tysabri.

"It's the best thing that has come along for a long time," Hoffman said. "It keeps me from getting worse."

The possible risks and side effects spelled out in the Biogen e-mail gave her some pause, Hoffman said. "But I still want to get back on it," she said.

[Birgit.Tersteegen]

Conference Call von BIIB heute:

James Mullen, Biogen Idec’s Chief Executive Officer, commented, “The core businesses demonstrated double-digit growth in the second quarter, driven by strong AVONEX and RITUXAN performance. With TYSABRI recently approved in both the US and Europe, this important therapeutic option is now available to the multiple sclerosis community. We expect TYSABRI will enhance our neurology business and begin to accelerate top-line growth over the coming quarters. Additionally, we completed two acquisitions of private companies this quarter and continue to focus on business development opportunities.”
< EOM >

[Cyberhexe]

...diese wunderbaren Geschichten hat man nun schon vielfach gehört...und da diese, für mich mindestens, glaubwürdig sind, habe und werde ich keinen Augenblick daran zweifeln, dass Tysabri zum meist applizierten Medikament bei RRMS aufsteigen wird.

5669 of 5704 posted 7/26/2006 1:23:13 PM Recommend Hide Post Add to Favorites Report abuse
Author: stillholdun Send PM Ignore View Profile Recs: 58
Subject: Wow - you guys gotta hear this - serious stuff Sentiment: Strong Buy
To all my fellow ELN investors-

Just called the Metro Infusion Center near my home; one of 10 MIC offices in the Chicago market. They are among the "official" centers for Tysabri infustions in the Chicago area.

Had a chance to chat with the director there. Very sharp woman, very upbeat and knowledgeable. Herewith is some of the conversation as best I can recall.

Their centers infused Tysabri on the first go round; about 3-4 months before it was pulled from the market. She said they had about 70 patients. Most ALL of them derived TREMENDOUS results in just the 3-4 infusions they had. She mentioned a woman who had been wheelchair bound, and in three months painted 4 rooms in her house! Almost all patients benefitted from Tysabri - amazing results.

When she realized I was knowledgeable about the whole Tysabri saga, and the current status of what is going on, she opened up further. She indicated that most of her 70 patients were floored by having the drug pulled. Many told her they would go to Mexico, Canada, wherever - to get the drug.

Now that it is back on the market - most if not all of the 70 former patients are banging down the door - and many new ones as well. They all know the risk, she said, and feel very comfortable that the TOUCH program has been created to make it even more safe.

She said that MS patients are a very special breed; extremely well informed about their condition, and what is available to help. She is a huge believer in Tysabri, and suspects that their clinics here in the Chicago area are going to be very busy in the months and years ahead administering Tysabri.

Personally gang, I have derived so much knowledge about my investment from this board; but this 5 minute phone call to a hands-on Tysabri professional in my community has just DOUBLED my already strong conviction about my investment in ELN. I am psyched for me, I am psyched for my fellow ELN longs, and I am psyched for the MS patients.

This is NO bullshit - you may want to find an infusion center in your community and see what you can find out.

First new post here on the IV board. Best to all - let's rock 'n roll.
< EOM >

[loseit]

Antwort auf Beitrag Nr.: 23.039.127 von Birgit.Tersteegen am 25.07.06 14:31:29

Sehr guter Artikel von Ken Kam -
der übrigens eine hohe Reichweite in den Staaten hat.

Bleibt zu hoffen, dass die PR-Winkelzüge der verzweifelten Konkurrenz von der Masse der Anleger richtig interpretiert werden.

[Cyberhexe]

wir nehmen langsam Fahrt auf:
...In the EU, dosing is well underway in Germany. Launch has also occurred in Ireland, UK and Sweden. In Q3, the product will
be launched in five other countries - Netherlands, Denmark, Austria, Finland and Norway.

http://www.rte.ie/business/2006/Morningrep/download/0727davy…

Elan (ELN US)
Previous close: $14.72 Target: $18.00 (31/01/06; previously $13.00, issued 09/08/05) Analyst: [e-mail]
Positive signs on Tysabri from BIIB call
As the official commercial launch was earlier this week, it was wrong to anticipate hard data on Tysabri from the BIIB Q2
conference call (or indeed from Elan’s Q2 results next week). However, the commentary was positive and the rollout in US/EU
is very much up and running.
In the US, patient dosing has begun. Training has begun for physician practices, infusion centres and other partners on the
risk management plan. Over the next few months, 2000-2500 practices will be trained, representing the high prescribers and
more than 50% of all treated MS patients. Full rollout will take several months.
BIIB described physician interest as “high, and many have identified a list of patients that may be appropriate for Tysabri
treatment”. The commercial positioning seems to be that patients will start with Avonex and move to Tysabri when needed.
This is in line with our own thoughts on where the target market will be for Tysabri in the short term.
BIIB also reported that initial feedback indicates that health plans are likely to provide coverage. This is because it recognises
that the TOUCH program is designed to facilitate appropriate usage and that Tysabri offers significant clinical benefit. A few
payers have even commented that they may not require prior authorisation or a medical policy due to the comprehensive
aspects of the risk map.
In the EU, dosing is well underway in Germany. Launch has also occurred in Ireland, UK and Sweden. In Q3, the product will
be launched in five other countries - Netherlands, Denmark, Austria, Finland and Norway. Overall EU pricing is expected to be
similar to that of the US, which supports our own forecasts.

[Cyberhexe]

Goodbody Stockbrokers von Heute:





Elan (Add, Closing Price $14.72); Q2’06 preview - Tysabri hiatus.
Analyst: Ian Hunter T [phone] E [e-mail]
Yet again, Elan approaches a quarterly reporting date when more focus will be on future potential
(Tysabri now back on the market plus two compounds in clinical trials for the treatment of
Alzheimer’s Disease) rather than current performance. That said, we forecast that when the
company reports its Q2’06 results next Tuesday, 01 August, it will record a 38.8% decrease in
fully diluted losses per share to $0.22 from a 14.2% increase in revenue to $135.4m. We are
looking for Maxipime to be the single biggest contributor to revenue at $45.0m, followed by
Azactam at $19.5m. With Tysabri now on the market in the US, Germany, the UK, Sweden and
Ireland, the current widely varying assessments on Tysabri’s potential can only be resolved with
concrete market data. This, however, will only be forthcoming over the next two to three months.
On the pipeline, we are expecting some update on the filing of Tysabri in the US for the treatment
of Crohn’s and an updated timeline on the Phase II (AAB-001) and Phase I (ACC-001) trails in
Alzheimer’s. Elan’s share price has been under pressure over the past two months, falling back
from a high of $19.21 on 01 June to current levels. We believe there could be continued weakness over the coming weeks given the potential hiatus in Tysabri newsflow. We do, however, remain confident that Tysabri can hit our projections (peak sales of $2.2bn in 2009) and that when prescription data start to back this forecast, the price will regain lost ground. We are, therefore, retaining our Add recommendation until there is greater visibility on the performance of the drug both in the US and European markets.
Biogen Idec, Elan’s partner in the development and commercialisation of Tysabri reported a very strong set of Q2’06 results yesterday with earnings of $0.57 versus consensus of $0.49. The improvement was driven by better than
expected Avonex and Rituxan sales coupled with lower SG&A and R&D costs. Management had little to add to the Tysabri story other
than patients in the US and Germany have already received infusions.

[Cyberhexe]

neben der doppelten Wirksamkeit sind es die anscheined nebensächlichen Dinge, die den Erfolg von Tysabri ausmachen werden.
Beispielhaft ein Beitrag einer Betroffenen:

"I can't help but be reminded of what MS patients are having to do in order to fight their MS with injections and their horrible side effects:

Avonex - loooong needle, once a week i.m. injection, horrendous flu-like symptoms that can keep a patient down for up to 3 days, and depression from the IFN.

Betaseron - subq injection every other day, similar s.e.'s from IFN.

Copaxone - subq injection daily with horrible injection site reaction (severe welts) and racing heart rate for some, etc.

Rebif - subq injection every 3 days with all the s.e.'s of the INF's, including severe "burn" of the med after injection.

Then there is TYSABRI, a once a month infusion (convenient for the patient, less side effects, and very low risk), with proven safety in monotherapy non-immune compromised MS patients, superior efficacy, improvement in symptoms, and offering a better QoL to the patient, which none of the others above can claim....
sooo Tysabri......or one of the ABCR's for your fight against MS???

Simple, very simple.

Lauren"

[Birgit.Tersteegen]

Keiner kann später sagen er hätte es nicht wissen können....

All-Star Team / Ken Kam7/27/2006 12:00 AM ET
Tysabri is back, but Elan is down -- time to buy

* Buy 100 shares of Elan (ELN, news, msgs) at the open.

In our March issue of Marketscope (Subscribers) (Free Trial), I said that Elan's (ELN, news, msgs) competitors would be pulling out all their guns to try to slow Tysabri. Last month, the FDA re-approved Tysabri and on Monday, it was re-released to the market. Now as the market is trying to figure out how profitable it will be, two competitors; Teva Pharmaceutical (TEVA, news, msgs) and Serono (SRA, news, msgs), joined forces and uncorked another shot below the belt.

A report touting a new therapy for multiple sclerosis patients combining Novantrone, a cancer drug, with Copaxone, hit the newswires on Friday. The media focused on the 90% reduction in relapse rate for patients in a clinical trial, lending support to Wall Street's doubts that Elan's newly re-approved MS drug, Tysabri, will ever generate significant sales. In an already weak market, the news helped push Elan's stock price down 5.4% in an already weak market to its lowest level in months.

Beyond the headlines, however, the rest of the story leads to quite a different conclusion. It turns out that the clinical trial consisted of just 27 patients. Although some of the patients experienced an improvement, one developed acute leukemia. Everyone acknowledges that a lot more work needs to be done, and it's going to take time. A three-year study is just now being launched.

I don't think many MS patients are going to hold-off taking Tysabri, which reduces relapses by 68% and is available now, in the hope that in three years, the combination of Novantrone and Copaxone will turn out to be better. As a result, this news should have little impact on Tysabri's launch. But it seems to have scared a lot of people into selling their stock in Elan just when Tysabri is finally coming to fruition.
Competitors react to Tysabri's growing momentum
One way to tell whether a new drug is going to be a success is to look at the reaction of its competitors. It's noteworthy that this story appears first on the newswires, not a respected medical journal. That's how you can tell that competitors, not scientists, are behind this story.

There is no doubt in my mind that both Serono and Teva are afraid of the impact Tysabri will have on their sales.

Serono generated $1.2 billion from the sales of MS drugs (primarily Rebif) almost 50% of their revenue in 2005. Copaxone generated almost $1.2 billion of revenue for Teva in 2005 -- about 25% of their total revenue and probably an even higher percentage of their profits.

But Rebif, and Copaxone are only about half as effective as Tysabri in preventing relapses. Neither drug has been shown to slow the progression of multiple sclerosis, much less an improvement in disability measures, as has Tysabri.

Consequently, both companies have to be concerned that they may lose significant sales now that Tysabri is cleared for sale. From their perspective, the 16 months that Tysabri was off the market was a windfall that enabled them to maintain sales of their existing drugs longer than they expected. Now that Tysabri is back on the market, Serono and Teva are acting as though they are preparing for the worse.

Last year, Serono's board essentially decided to cash out before Tysabri could significantly impact their business. The company hired Goldman Sachs (GS, news, msgs)to help them explore "strategic options." Pfizer (PFE, news, msgs), GlaxoSmithKline (GSK, news, msgs) and Novartis AG (NVS, news, msgs) were rumored to be the likely acquirers. However, the Wall Street Journal reported that in spite of Goldman Sach's efforts, Serono had received no serious offers.

In January, Teva acquired generic drug manufacturer IVAX Pharmaceuticals, financing the big acquisition through a $1.25 billion bond offering by Lehman Brothers (LEH, news, msgs) and Citigroup (C, news, msgs) during a time when Tysabri was off the market and not considered a threat to Teva's Copaxone. Since then, Teva has acted more desperately, trying to reassure investors that Tysabri's growing momentum will not steam roll over Copaxone and affect their debt payments.

Teva seems to be willing to pull out the brass knuckles to maintain Copaxone's sales. On the eve of the FDA Advisory Committee meeting for Tysabri, Bloomberg reported that Teva paid a marketing agent to publicize an unpublished article comparing Tysabri's effect on the human immune system to AIDS. That is a ridiculous comparison. If the best way to protect Copaxone sales is to try to create fear of Tysabri by drawing a ridiculous comparison to AIDS, then Teva must be desperate.

Teva's investment bankers, Lehman Brothers and Citigroup, have also been active. Both firms published research reports citing the risk of PML (Progressive multifocal leukoencephalopathy is an opportunistic infection associated with AIDS and certain cancers) as justification for their low expectations for Tysabri sales. Coming as it did on the day before the FDA Advisory Committee meeting, these two firms proved that their analysis was not going to change no matter what data was presented at the meeting.

I cannot think of a reason why an analyst making an honest assessment of Tysabri would not want to consider the data that was going to be presented the very next day. I can only surmise that the folks at Teva, and their investment bankers, must believe that Tysabri is a threat to Copaxone's sales. I agree with them.
Time to buy
Competitors often hit below the belt. Whenever a new product threatens to reorder a $5 billion-a-year market you can count on it. Watching Serono, Teva and their investment bankers take increasingly desperate steps to slow down Tysabri only increases my conviction that Tysabri will be a homerun for Elan.

Although they succeeded in taking Elan's stock price down, if you can hold onto this stock for the next two years, these shenanigans will not have any impact on your return. I'm taking advantage of this opportunity to increase my position.

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.069.652 von Cyberhexe am 26.07.06 20:05:13

...anbei noch eine weitere Geschichte, Heute gefunden in einem MS Forum:

" Dear Folks:

I am currently taking Copaxone, was on Novantrone for the full three years (finished two years ago); and I also was on Tysabri alone for two months before it was pulled.

I have been calling my neuro office to get info, and evidently the nurses and others in the office were trained on the protocol just two days ago. They will start infusing again very soon! I am on the list...

Meanwhile, the Copaxone pep club ("Shared Solutions") called me last week to make sure I was aware of the "good news" about Copaxone! They are very nice and thoughtful and helpful, you know.

I agree, the fact that I personally know others who were on the Tysabri for several months longer than I who had dramatic positive results, and the fact that I myself felt that I was doing better after just two infusions, does influence my decision to pursue this course more strongly than any of the statistics the pharmeceutical companies deign to feed me. While I was in the Tysabri regimen, I was more stable, had better balance, my eyesight improved, and I had more energy. I want to feel that way again.
I hope I haven't hurt the feelings of the pleasant people working the phones at Shared Solutions.

And, don't let me interrupt the scrapping around. Conflict promotes change, which is important for progress, right? "

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.069.652 von Cyberhexe am 26.07.06 20:05:13

...anbei noch eine weitere Geschichte, Heute gefunden in einem MS Forum:

" Dear Folks:

I am currently taking Copaxone, was on Novantrone for the full three years (finished two years ago); and I also was on Tysabri alone for two months before it was pulled.

I have been calling my neuro office to get info, and evidently the nurses and others in the office were trained on the protocol just two days ago. They will start infusing again very soon! I am on the list...

Meanwhile, the Copaxone pep club ("Shared Solutions") called me last week to make sure I was aware of the "good news" about Copaxone! They are very nice and thoughtful and helpful, you know.

I agree, the fact that I personally know others who were on the Tysabri for several months longer than I who had dramatic positive results, and the fact that I myself felt that I was doing better after just two infusions, does influence my decision to pursue this course more strongly than any of the statistics the pharmeceutical companies deign to feed me. While I was in the Tysabri regimen, I was more stable, had better balance, my eyesight improved, and I had more energy. I want to feel that way again.
I hope I haven't hurt the feelings of the pleasant people working the phones at Shared Solutions.

And, don't let me interrupt the scrapping around. Conflict promotes change, which is important for progress, right? "

[Cyberhexe]

...Tysabri, so scheint es, wird von der Konkurrenz gefürchtet!

http://www.fool.com/News/mft/2006/mft06072714.htm?logvisit=y…

It's always good to see sales for your company's lead product growing, but Rebif sales growth is starting to abate (see below), and with the market debut in the past week of Biogen Idec (Nasdaq: BIIB) and Elan's (Nasdaq: ELN) rival MS drug, Tysabri, competition in this space is only going to heat up.

[Cyberhexe]

Elans Forschungsleiter Lars Ekman: "this is the reason for our being"...und er hat damit Elans Alzheimer-Forschung gemeint.


One way to do so might be to develop a vaccine that stimulates antibodies against amyloid beta-peptide 42. That is the path being pursued by Elan Pharmaceuticals and Wyeth Research. In 2000, these two firms began a clinical trial of such a vaccine. Unfortunately, they had to halt it when 18 of the 300 patients involved developed severe inflammation of the brain. In the time that the trial had run, however, the researchers noticed that those patients who had reacted to the vaccine, but whose brains had not swollen up, showed a marked slowing of cognitive decline. This suggested they were on the right track, and the companies are now testing what they hope is a less toxic vaccine.

http://www.economist.com/science/displaystory.cfm?story_id=7…

[Cyberhexe]

...und wieder eine dieser beeindruckenden Geschichten:

http://www.sltrib.com/ci_4104441?source=rss

Utah man among the first in line as controversial MS drug returns
By Carey Hamilton
The Salt Lake Tribune

Jay Gurmankin, an attorney in Salt Lake City, works in his office in the Wells Fargo building. On July 22, 2006 he began taking the MS drug Tysabri even though it had been pulled from the market because of deaths. (Steve Griffin/The Salt Lake Tribune)

Jay Gurmankin was delighted last year when he climbed and walked back down a flight of stairs. It might seem like a small feat - but not for someone who suffers from multiple sclerosis and was using a scooter and cane to get around.
The Salt Lake City lawyer credits his temporary recovery to Tysabri, a drug taken off the market last year when it was linked to a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML.
The drug's manufacturers, Biogen Idec Inc. and Elan Corp. PLC, voluntarily pulled it from the market in February 2005, after two patients in clinical trials involving 7,000 people died of PML. The drug had been sold for just four months.
Multiple sclerosis patients lobbied for its return, arguing they should be able to make their decision about the risks and benefits. In June, the Food and Drug Administration approved the drug's return to the market, with restrictions.
Tysabri became available again in July, with its use carefully monitored by the FDA.
On July 22, Gurmankin became the first patient of Salt Lake City neurologist John Foley to receive an intravenous infusion of Tysabri. He was upset when Tysabri was taken off the market, and he's not worried about possible side effects.
"It's possible I will get complications," he said. "But when you balance that against the potentially improved quality of life, it's a no-brainer. I already have so many complications from MS."
FDA officials have said that one in every 1,000 patients may get the often-fatal virus believed to cause PML.
In Utah, an estimated 10,000 residents have the disease. When Tysabri became unavailable, Foley was treating about 80 patients who had been using it.
"The bulk of them had significant clinical improvement in one of several areas," Foley said. "Some got stronger; some were walking better. A lot of people have been waiting for this drug." Patients have to enroll in an FDA-approved program and must be accepted into it by the drug companies. They are told of all the possible side effects and must sign a release meant to prevent them from suing the company.
"We are going to monitor them very closely," Foley said. "The study data is very positive. We think that this is a major improvement in MS therapeutics." Gurmankin said he probably won't feel the effects of the medicine until his second dose in late August. That was how long it took last time.
"I would have been happy if I didn't miss 17 months of it because I've declined," he said. "I'm probably in a small minority, but I think they (the companies) overreacted to what happened. Just tell me what the risk is and I'll decide if I want to take it."

[Cyberhexe]

...und noch eine weitere "Lebensgeschichte", geschildert vor dem ADVISORY COMMITTEE im Holiday Inn in Gaithersburg, Maryland, am Dienstag, 7.März 2006:


Thank you for listening to my personal experience with Tysabri. My name is Pamela Clark, and I have had MS for 10 years. I have progressed from relapsing-remitting to secondary progressive.
My mother and I traveled here from Phoenix and Salt Lake City respectively. We paid for our own ticket, and we are not sponsored by any organization. It was important that my mom be here, because she has two daughters with multiple sclerosis, and she was the one who held my hand during my first Tysabri infusion. In the weeks after the infusion, she witnessed the improvement in my gait and my energy level. We were ecstatic and we were filled with hope.
You see, she fought her own battle with cancer 15 years ago, using then risky and then experimental drugs. Today, she is cancer-free and those experimental drugs are widely used by people with cancer every day. As a family, we understand the risks of using experimental drugs, but we also understand the risk of doing nothing. The risk of doing nothing for me is too great. The risk of doing nothing, which for me means continuing to take ineffective drugs, is too high for me to ignore. I must fight for the right to have the opportunity to live life to its fullest. I owe it to myself and I owe it to my family.
I attend a MS physical therapy group three days a week. It is comforting to be among people who have the same affliction, and they understand my struggles completely. It is not comforting, however, to watch my friend's health falter and fail. It is not mforting, however, to watch my friend, who walked in on a cane last year, roll in in a wheelchair.
This disease and its symptoms are progressive and they will not wait for anyone's approval. The drug they take do not stop or even slow the progression of MS. Finding an effective treatment seemed hopeless. That was I felt hopeless until I found Tysabri last January or January of 2005. In January of 2005, I had two infusions of Tysabri and I got better, not miraculous jump up and run a race better, but I did walk to the duck pond with my two, five-year-old boys. I did stand up and cook dinner, stand up long enough to cook dinner, and I did smile more often. That is what hope does. That is what Tysabri did for me.On the issue of risk management that you have been talking about this morning with Tysabri, I received monthly Solu-Medrol infusions at the infusion clinic in my neurologist's office, and there, Julie and Martha, who I know from being there monthly, every month, they sit down with me, and they have a questionnaire already, and they say, "What are your symptoms like? What have changed?" This new reporting mechanism will be no different for them, and I know that they will gladly do it.
The cost of getting here is high for me, both the cost of our travel expenses and the cost to my health.

[Cyberhexe]

...und noch eine weitere eindrucksvolle Schilderung einer Betroffenen vor dem Advisory Committee in Gaithersburg am 7.3.2006.
Erst durch solche Berichte kann man als Nichtbetroffener etwas nachfühlen, welche Bedeutung wirkungsvolle Medikamente und deren Zulassung haben können. Deswegen gilt in erster Linie meine Freude den MS-Patienten, denen mit Tysabri eine wirkungsvolle Alternative zur Behandlung ihrer Krankheit zur Verfügung steht.



Good afternoon, ladies and gentlemen.
Thank you for allowing my videotaped testimony today. I had planned on being there in person, however, due to a recent exacerbation of my MS symptoms, I am no longer able to travel, and for the same reason, please excuse my slurred speech. My name is Lauren Roberts. I am 51 and I live in California. I have been living with MS for 30 years. As a long-time MS patient, I can tell you that there is a tremendous unmet medical need when it comes to MS therapies, because what is available to us today is ineffective for a large population of people with MS like me. My MS started out 30 years ago being fairly mild with only numb hands and a slight drop foot on the right, and I was able to remain a productive member of society working as a certified paralegal for 26 years. I enjoyed hiking, camping, dancing, swimming, et cetera.
However, in 2001, I had to retire due toe worsening of my cognitive problems, and in the past two years, my disability has progressed very rapidly. MS has taken away my ability to work, destroyed my finances, destroyed my health, and is rapidly destroying my ability to remain independent. Since the worsening of my MS, I have been on Avonex, Copaxone, oral and I.V. steroids. Novantrone was not an option for various reasons. I actually got worse on these therapies. None of them stopped my attacks, and now I have an overall decline in strength and coordination. Only Tysabri stopped my attacks and gave me hope with the improvement in my symptoms. The issue here is having the option of a choice, which we currently do not have without Tysabri. The FDA's over-caution is not warranted here. It is only hindering our hopes of a recovery and a future. Regarding PML, most well-informed patients know that Tysabri is safe as a monoclonal therapy, and we have taken steps to clear our bodies of medications in anticipation of Tysabri's return.
As a Tysabri patient, I would be more than willing to undergo regular medical testing including MRIs and a regular blood test to minimize any possible risk of PML. These are our bodies and our lives, and the unmet medical needs of the MS patients are staggering. There is a much greater risk presented by not having Tysabri available to us as a choice. Give us back the right to make our own fully informed choice and give us back the tools to do so. Put Tysabri back in the arsenal of therapies to choose from.
I gratefully thank you for this opportunity to address the AC panel. I pray that you never have to experience this dreadful debilitating disease called multiple sclerosis. Do the right thing and give us Tysabri back now until something better comes along.

[Cyberhexe]

...da könnten, sogar rückwirkend, weitere Lizenzeinnahmen für Elans patentierte Nanotechnologie fällig werden. Letztes Jahr berugen dei Verkaufserlöse für Abraxane 134 mio$, wofür normalerweise zwischen 5 und 10% an Lizenzgebühren zu zahlen sind. Das wären immerfhin ca. 10 Mio$/Jahr, die ohne einen Aufwand zu generieren voll in den Deckungsbeitrag von Elan eingehen würden.
Mit fast allen Grossen der Pharmabranche bestehen bereits entsprechende Abkommen, so dass das zukünftige Potential Riesiges verspricht.


Tiny Particles Cause a Big Storm for Abraxis
Friday July 28, 2:07 pm ET
By Jack Uldrich


The news of yet another lawsuit being filed in Delaware is easy to overlook, especially in today's society, where such filings are about as common -- and, I would argue, bothersome -- as pigeon droppings.
ADVERTISEMENT


Yet Elan's (NYSE: ELN - News) decision last week to sue Abraxis Bioscience (Nasdaq: ABBI - News) -- over claims that Abraxis had infringed on its patent for nanoparticle formulation by selling the breast cancer treatment, Abraxane -- could have serious long-term implications for Abraxis.

Abraxane isn't just any new drug. In January 2005, it became the first drug using nanoparticles to receive FDA approval. Due to their small size, the nanoparticles have a number of unique attributes. Specifically, they helped improve the effectiveness of Taxol (the active molecule in Abraxane is the same as in Taxol) by lowering toxicity and opening up the possibility that the drug could be used by some patients for whom Taxol had lost its efficacy.

As a result of the FDA approval, the company's stock soared in early 2005. Much of the run-up was not directly attributable to Abraxane -- even though the drug recorded $134 million in sales in the past year and Abraxis agreed to a partnership with AstraZeneca (NYSE: AZN - News) to co-promote the drug. Instead, many investors -- myself included -- were excited about the company's ability to apply the nanoparticle formulation to improve and rejuvenate its long list of generic drugs.

And it is here that the Elan lawsuit could have the most chilling affect on Abraxis' long-term prospects. Until the legal issues are resolved, a dark, menacing cloud will linger over the company's head.

Abraxis' stock, which has fallen nearly 60% from its 52-week high, might make a compelling buy for more risk-tolerant investors, but my personal recommendation is to stay indoors and take a wait-and-see approach.

This is not because I have any unique knowledge of the patent in question. Rather, it is because if Abraxis Biosciences is found guilty, the company may well have to pay sizeable retributions to Elan. Moreover, the future value of its other drugs may also be greatly reduced. On the other hand, if it is found innocent, it simply has Elan's lawyers off its back. It must still seek FDA approval for those other applications in which it hopes to use the nanoparticle formulation -- and this can often be a long process.

To put it another way, my forecast for Abraxis reads like a cautious weather report. "A cool front appears to have settled in for the foreseeable future, bringing with it cloudy skies and a good chance of rain."

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.196.077 von Cyberhexe am 29.07.06 08:49:21

---Den Artikel fand ich auch Klasse--der Autor ist ja auch Aktionär von Elan.....

Hexchen---Dir ein schönes Wochenende!

[Birgit.Tersteegen]

Subject: Lehman's Tysabri research
Sentiment:

Thanks Dallas great info here. For those who couldn't get the link that Dallas posted on IV, here is a taste of what Lehman thinks of Tysabri for Crohn's.

Tysabri: Crohn’s Disease
We think there is a clear opportunity in Crohn’s Disease for Tysabri; Tysabri has similar efficacy to the anti-TNFs as a maintenance regimen following induction and in a subset of patients with elevated CRP Tysabri is clearly effective as an induction agent.

• Monotherapy is as efficacious as immunosuppressive agent combinations, likely perceived as reducing the risk of PML and other immunosuppression-related AEs
• Can maintain remission in >80% of patients for at least 2 years
• Safe and very well tolerated in clinical studies, antibodies to Tysabri rare with no impact on either efficacy or safety.
---
The antibody profile to Tysabri is very different to Remicade and a clear differentiating factor in favor of Tysabri.

Comparison with Remicade: Tysabri is very competitive: equal efficacy, better safety and monotherapy.
Remicade is currently the only biologic approved for the treatment of Crohn’s disease though an approval for UCB’s Cimzia is expected
before year end; Abbott will file an sBLA for Humira before year-end. ------------------ Data presented at the recent DDW meeting showed that neither response nor remission was influenced by the use of concomitant medications suggesting that Tysabri can be used as a monotherapy, a critical observation given the degree of suspicion surrounding the role of immunosuppression in PML, especially the case occurring in the CD patient who had prior exposure to both Remicade and immunotherapy.

Also at the recent DDW meeting data from a 1 year open label extension of this study were presented for 142 patients in remission at month 12 showing that after an additional 6 and 12 months of Tysabri 89% and 84% remained in remission, an impressive result that strongly suggests that Tysabri has long-term efficacy that could be considered disease modifying; currently there is no equivalent of the Sharp
Score, used in RA as a measure of disease modification.

[Birgit.Tersteegen]

Moin Hexchen

Dies schrieb unser Welke im anderen Thread--" FD720 neuer Novartiskandidat bei MS und wie es aussieht besser als Tysabri "--ich drohte an es Dir zu petzen---Was sagst Du dazu???Thanks!

[lippi5]

Antwort auf Beitrag Nr.: 23.243.222 von Birgit.Tersteegen am 30.07.06 21:16:16

News von der Alzheimer - Front
http://www.alzforum.org/new/detail.asp?id=1435

[lippi5]

http://www.finanznachrichten.de/nachrichten-2006-08/artikel-…

[wave]

Woher kommt der Einbruch bei zanaflex. Kann mir das jemand sagen. Danke


Six Months
Ended June 30

2005 2006
US$m US$m
Tricor(TM) 19.0 - 22.7
Skelaxin(TM) 8.2 - 14.4
Verelan(TM) 16.3 - 20.0
Diltiazem(TM) 9.1 - 9.9
Avinza(TM) 4.9 - 6.3
Ritalin(TM) 5.7 - 5.4
Zanaflex(TM) 5.2 - 1.7
Other 24.0 - 29.0
---------- ----------
Total 92.4 - 109.4

[Cyberhexe]

...zurück vom Bieler See in die Welt der Quartalszahlen.
Zahlen sind auf den ersten Blick ok! Bisher nichts Auffälliges entdeckt.
Lizenzzahlungen steigend, lediglich bei Zanaflex
- ARCODA Therapeutics hat im Juli 2004 die kompletten Vermarktungsrechte für Zanaflex von Elan übernommen -
scheinen die Umsätze zurück zu gehen oder aber bei dem Abkommen wurden rückläufige Lizenzzahlungen vereinbart (das müsste mal jemand bei Arcoda nachsehen - hab grad keine Zeit/Lust).

CC hab ich noch nicht angehört.

[Cyberhexe]

...ich könnte mir noch vorstellen, dass das absolute PML-Risiko in Monotherapie sowie bei nicht immunsupprimierter Vorgeschichte wesentlich geringer ist als 0.1%.
Für MorbusCrohn bin ich jedoch aufgrund der medikamentösen Vorgeschichten der meisten Crohn-Patienten etwas skeptischer als bei MS.

http://www.internalmedicinenews.com/article/PIIS109786900673…

Suspected cases of PML were reviewed by an independent expert committee. Four postmarketing reports of suspected cases that were not included in the original trials were included in the safety evaluation. No additional cases were found to have the JC virus, which has been associated with PML, according to the researchers. They found that the absolute risk of developing PML after taking natalizumab was about 0.1%.

[Cyberhexe]

...da sind keine ASchaumschläger am Werk:

Elan CEO Kelly Martin told a news conference that the company was "very pleased with what we have seen in the first few weeks" of Tysabri sales. But he said Elan wouldn't announce any sales figures until the third-quarter results.

[Cyberhexe]

Davys Kommentar zu Elan von Heute:

http://www.rte.ie/business/2006/Morningrep/download/0802davy…

Previous close: $15.00 Target: $18.00 (31/01/06; previously $13.00, issued 09/08/05) Analyst: [e-mail]

Good news for Tysabri’s prospects in the Crohn’s Disease market: Leukine, Schering’s late-stage biologic, reported mixed
results on its Phase III studies this week.
Headline data from two studies were published. In the 288-patient induction trial, Leukine was demonstrated a treatment
benefit but this was not statistically significant in its two primary endpoints (response and remission).
Leukine did meet its endpoints in a smaller more specific 129-patient study that investigated induction of steroid-free
remission in previously steroid-dependent patients.
Schering noted that “at this time the development programme continues to move forward”, though it is clear that either
additional studies or a significant switch in emphasis may now be required. This may delay its timeline to approval and in turn
provide an opportunity for the competition, including Tysabri.
The Crohn’s indication for Tysabri should return to a more definitive timeline in the short term. In the US, filing discussions
are ongoing with the FDA and an update will be provided within the next quarter. The product has already been filed in the
EU and we await a decision in late 2006/early 2007.

[Cyberhexe]

...und auch noch der obligate Ausblick von Goodbody Stockbroker von Heute:

Elan (Add, Closing Price $15.00); Raising forecasts - awaiting performance.
Analyst: Ian Hunter T [phone] E [e-mail]
Elan reported a solid set of Q2’06 numbers yesterday, broadly in line with our and the market’s expectations. Fully diluted losses per share of 21.0c were only 2.8% ahead of our forecast on a tax benefit. Losses before tax of $92.9m were 0.4% greater than forecast on sales of $136.4m, 0.7% ahead of forecast. Running these results and subsequent guidance from the conference call through our model, changes in cost assumptions sees a 1.0% increase in revenue projections for FY’06 translate into a 2.4% reduction in forecast fully diluted losses per share to 71.7c. These adjustments run through to a 4.7% and 1.1% increase in FY’07 and FY’08 forecast earnings
per share to 17.9c and 44.8c respectively. As expected, little guidance could be given on Tysabri as it has only been back on the market a couple of weeks. The company did indicate that training and initial administration associated with the TOUCH programme in the US could pull back significant ramp up into the fourth quarter. For the treatment of Crohn’s, we understand that the drug is still on track for a regulatory decision from the EU during H2’06. In the US, the company indicated that it is in discussions with the FDA and, along with
its partner Biogen Idec, expect to file shortly. The Alzheimer’s pipeline is on track with Elan and its partner Wyeth planning to assess interim data from Phase II (AAB-001) and Phase I (ACC-001) trials before the end of the year. If the latter shows promise, the companies plan to move it into a Phase III trial in early 2007. We do not expect, however, any data from either trial to be forthcoming at least until early 2007. Despite the upgrade in numbers and our longer term confidence in the Elan model, we are retaining our Add recommendation with an unchanged price target of $16.50 until visibility improves and the newsflow hiatus is near an end.

[Cyberhexe]

...der Forschungsleiter hat seine Portokasse gefülltz. Das liest man eigentlich nicht so gerne:

Lars Ekman, Executive Vice President and President R&D of Elan, has excercised
30,000 options (at $2.11) and sold 30,000 shares (at $15).

http://www.rte.ie/business/2006/Morningrep/download/0803ncb.…

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.296.491 von Cyberhexe am 03.08.06 12:07:10

War aber ein "geplanter"Verkauf--bzw.Einlösung von Optionen----97% seiner Aktien/Optionen hat er ja noch.....ich glaube das dies nichts bedeutet.

[Cyberhexe]

Fidelity International Limited glaubt ebenfalls an unser "Baby"

Change in holdings since last filing +2,541,668 Ordinary Shares
http://www.investegate.co.uk/Article.aspx?id=200608031431462…

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.326.192 von Cyberhexe am 05.08.06 01:23:52

Dir ein schönes Wochenende,Hexchen.....

[Cyberhexe]

http://www.bizjournals.com/masshightech/stories/2006/08/07/s…

Archemix Corp. of Cambridge, meanwhile, signed a partnership with Elan Corp. to treat psoriasis, multiple sclerosis and rheumatoid arthritis. That deal could be worth more than $350 million. Elan, a global pharmaceutical company based in Ireland, is interested in Archemix's aptamer science. Aptamers represent a new direction in therapeutics in which compounds as effective as antibodies could be developed more quickly.

[Cyberhexe]

BBBiotech hat den Anteil an Elan.-Aktien im Portfolio 2006 kontinuierlich erhöht:

Elan 2 850 000 Anteile zum 30.6.2006
+ 450 000 seit 31.12.2005

http://www.bbbiotech.com/index.php/bbbiotech_de/de/informati…

[Birgit.Tersteegen]

guckt mal http://www.pharma24.de/medikamente/TYSABRI-300-mg-20-mg-ml-I…

[Birgit.Tersteegen]

aus dem Investorvillage-Board

I just got off the phone with my wifes' infusion specialist.She said that we will have to come back in to see the Neuro again (we were just there 3 weeks ago). We need to sign 4 pages of "disclaimers",agreeing to the risk of Ty. After we do that the forms will be sent in to Biogen along with the Neuros info. on the recent MRI ( must be within 3 months), and that we have tried other treatments (CRABS).The best guess the infusion specialist had on eta of first infusion was 1 month ( if the insurance issues were ironed out). Frustrating to the max for us !----------- ---------------------------------------------------

Wieso ist das bloss alles so kompliziert?????????????????????????????

Für mich sieht es so ein bisschen nach Verhinderungsstrategie aus????

Was meinst Du Hexchen??

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.357.828 von Birgit.Tersteegen am 08.08.06 18:29:28

das seh ich leider auch so...kann sein, dass Biogen noch immer wenig Interesse hat an der Tysabri-Vermarktung.
Wahrscheinlich wird sich der Absatz erst nach den ersten Erfolgsmeldungen von Betroffenen beschleunigen.

Insgesamt doch eher ernüchternd, dass dem wirkungsvollsten Medikament derart viele bürokratischen Hürden aufgebaut werden, andere Medikamente, mit möglicherweise fataleren Nebenwirkungen, jedoch nahezu frei über den Ladentisch zu haben sind.

[wave]

Warum sollte Biogen wenig Interesse an der Abgabe haben???

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.358.529 von wave am 08.08.06 19:27:04

....wegen ihrem Avonex vielleicht....

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.358.679 von Birgit.Tersteegen am 08.08.06 19:37:28

allerdings ist mittlerweile die Hälfte einer Tysabri-Anwendung für Biogen genauso umsatzträchtig wie eine 4-wöchige Avonex-Therapie.

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.358.853 von Cyberhexe am 08.08.06 19:48:07

vielleicht sind die Jungs einfach nicht so wahnsinnig kompetent---diese Vertriebler aller couleur sind meistens etwas "schlicht".....

[Cyberhexe]

Ich befürchte, unsere Geduldsnerven werden weiterhin auf die Probe gestellt, denn die Ergebnisse des 4.Quartals werden erst im Februar 2007 veröffentlicht.
Nun ja, vielleicht sind vorher noch positive Neuigkeiten von der Alzheimer-Front zu erwarten.


Sent an e-mail yesterday asking when we might get numbers on rollout. Here is the reply. Although it is not as soon as I hoped I was impressed with the quick response.

Thanks you for your recent email. On our recent quarterly results conference call, our CFO and CEO covered this topic in detail. I would encourage you to listen to the webcast by accessing it on our website. On the call, Mr Cooke stated that we are focused on the roll out of the TOUCH program in the US and launching in the various EU countries. In the US we and Biogen Idec are focused on training and authorizing the doctors and infusion sites so that Tysabri can become available as soon as possible to the appropriate MS patients. Patients have been dosed in the US and Europe but it is too early in the roll-out for any of the data to be of any real value. The roll-out will continue throughout the third quarter and the take up should ramp up in the fourth quarter of this year. We will likely give some metrics on the launch when we report our Q3 results but it is likely to be the fourth quarter when the revenue starts ramping up.

Kind Regards

Emer Reynolds

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.371.231 von Cyberhexe am 09.08.06 16:53:11

.....hoffe,wir werden schon vorher massenhafte Patientenberichte hören....--GUTE,natürlich!!

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.358.853 von Cyberhexe am 08.08.06 19:48:07

Auch unglaublich--oder?------investorvillage

Subject: Would you like to get REAL angry this morning?


Just for the heck of it, I just called BIIB in Cambridge.
I got connected to a Patient support person.
I told her that a friend had MS and I wanted to know where, after her doctor prescribed Tysabri, she could get an infusion of Tysabri in Massachusetts.
I told her I wanted to know the nearest location so I wouldn't have to drive longer than necessary.Her response: That information is not available.
I said, let me get this straight. You sell T but will not tell me where I can get it infused in the local area where you are located?
She danced as quickly as she could but she couldn't answer where they are giving infusions!!!!!!!
Our partner? Yeh, right!
Thank God, I don't have MS...

[Birgit.Tersteegen]

Scheinbar gehts voran.....(will ja nicht nur meckern.....)



Author: goodtoreadthis Send PM Ignore View Profile Recs: 55
Subject: Good news
Sentiment:

My business partner just called. He has been pre-qualified for T. Fallon Health Care - who had been fighting him since Nov 04 - stopped fighting. They are paying for his and others T.

He has his MRI this Saturday. He expects infusion in Oct ( due largely to neuro vacation schedules) .

Worcester has an MS Center - specifically built for T infusions. He spoke wih Doc familiar with that MS Center - "business is going strong. They expect lots of use of infusion center. They have 10 chairs at Center. They are infusing currently."

[Cyberhexe]

interessante Zusammenstellung über die Therapiemöglichkeiten bei MS:

http://www.klinikum-ingolstadt.de/www/downloads/multiple_skl…

[Birgit.Tersteegen]

Hexchen--der Song für Dich zum WE...

Subject: A song - TYSABRI'S BACK
Sentiment:

Tysabri’s Back
(sung to the tune of "My Boyfriend's Back" by the Angels)

Tysabri’s back – the competition’s in trouble
(Hey la hey la Tysabri’s back)
Patients are lining up to get Tysabri on the double
(Hey la hey la Tysabri’s back)
Teva spread some lies that we knew was untrue
(Hey la hey la Tysabri’s back)
So look out now because Copaxone is through
(Hey la hey la Tysabri’s back)

Yeah Krasner has been trying
But we know he has been lying

Ty’s been gone for such a long time
(Hey la hey la Tysabri’s back)
That it was gone at all was an awful crime
(Hey la hey la Tysabri’s back)
The current medications are all kinda shoddy
(Hey la hey la Tysabri’s back)
Not nearly as good as our monoclonal antibody
(Hey la hey la Tysabri’s back)

Hey Ernesto’s turning pale
That’s why he tried to bail

What made you think that Tysabri was dead
(Wah-ooo Wah-ooo)
It will now take over the MS market instead
(Wah-ooo)
Wait and see


Tyabri’s great – why can’t Piper Jaffray see?
(Hey la hey la Tysabri’s back)
The patients all do, as did the advisory committee!
(Hey la hey la Tysabri’s back)

Yeah Serono’s sales are fleeting
Yeah Rebif will take a beating
Wait and see

Yeah Tysabri’s back
Yeah yeah Tysabri’s back

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.404.617 von Birgit.Tersteegen am 11.08.06 19:31:44

[Birgit.Tersteegen]

Moin Elanies-----VORTEIL ELAN!

Subject: Advantage Elan
Sentiment: Strong Buy

Overproduction of amyloid beta is at fault in inherited forms of Alzheimer disease. But in sporadic Alzheimer’s, even the most basic knowledge of amyloid beta dynamics has been lacking.

Recently however, a research team led by Dr. Randal J. Bateman at Washington University in St. Louis, has developed a test that can monitor the protein production and clearance rates. Surprisingly, his research team has found amyloid beta to have the second-fastest production rate of any protein that has been measured before.

http://mednews.wustl.edu/news/page/normal/7348.html

Additionally, his research team has measured production and clearance rates in humans of amyloid beta. This is important for several reasons.

First, there has been a long unanswered question about the origins of Alzheimer’s disease. Do Alzheimer’s patients have high levels of amyloid beta because they make too much or is it because they can’t clear it from their brains quickly enough?

Secondly, measuring production and clearance rates in humans, may lead to simple diagnostic tests to determine whether someone is/has developing/developed Alzheimer’s.

Third, this new test could let researchers directly monitor patients in clinical trials to see if the drug is really doing what it is expected to do in terms of amyloid beta metabolism. It could be very valuable for determining which drugs go forward in clinical trials and at what doses.

Combined with Dr. Bateman’s work, a recent article published Thursday by the journal Science, seems to indicate that sporadic Alzheimer’s is the result of "molecular janitors" failing to clear away amyloid beta. They appear to get old and simply stop sweeping up amyloid beta leading to a cascade of neurolopathological events. “As the affected individual [ages] the clearance machineries fail to degrade the continually forming toxic aggregates and the disease emerges.

http://www.salk.edu/news/releases/details_20060810a.php

Adding these 2 separate research pieces together seems to validate Elan's alzheimer's program. Elan seems to be building a very strong alzheimer's portfolio. A passive immunotherapy (aab-001) approach, a vaccine (acc-001) and Eli Lilly's gamma seratease inhibitor (LY450139), that inhibits the production of amyloid beta leading to a cascading sequence of neuropathological events, and aab-002.

Advantage Elan

[Birgit.Tersteegen]

Subject: TY presentations at ECTRIMS 2006 - list
Sentiment:

22nd Congress of the European Committee for the Treatment and Research in Multiple Sclerosis
27.09.2006 - 30.09.2006
********************************************
Thursday, September 28, 2006
15:30 - 17:00 Immunomodulation - Part I
Natalizumab alters transcriptional expression profiles in peripheral blood of multiple sclerosis patients
R.L.P. Lindberg, L. Achtnichts, J. Kuhle, F. Hoffmann, L. Kappos (Basel, CH)

15:30 - 17:00 Immunomodulation - Part I
The effects of natalizumab on brain atrophy and cognitive function: results from the AFFIRM study
E. Fisher, P.W. O'Connor, E. Havrdova, M. Hutchinson, L. Kappos, D.H. Miller, J.T. Phillips, C.H. Polman, F.D. Lublin, G. Giovannoni, A. Wajgt, R.A. Rudick, F. Lynn, M.A. Panzara, A.W. Sandrock for the AFFIRM and SENTINEL Investigators

19:15 - 19:35 A new era in the treatment of relapsing-remitting MS (Room A)
General overview of natalizumab efficacy
F. Fazekas (Graz, A)

19:35 - 19:55 A new era in the treatment of relapsing-remitting MS (Room A)
Selecting patients for natalizumab therapy
H. Rossman (Farmington Hills, USA)

19:55 - 20:15 A new era in the treatment of relapsing-remitting MS (Room A)
Considerations for management of natalizumab patients
O. Fernández (Málaga, E)

Friday, September 29, 2006
15:00 - 15:12
Results of clinical and magnetic resonance imaging analyses following cessation of natalizumab dosing in patients with multiple sclerosis
P.W. O'Connor, A. Goodman, L. Kappos, F.D. Lublin, D.H. Miller, C.H. Polman, R.A. Rudick, F. Lynn, M.A. Panzara, A.W. Sandrock for the AFFIRM and SENTINEL Investigators

15:12 - 15:24
Natalizumab in relapsing multiple sclerosis: appropriate patient selection, management guidelines, and a diagnostic algorithm for the differential diagnosis of new neurologic signs or symptoms
L. Kappos, C.H. Polman, D. Bates, J. King, P.W. O’Connor, R.A. Rudick, H.L. Weiner, S.L. Hauser, T.A. Yousry, E.W. Radue, D. Clifford (Basel, CH; Amsterdam, NL; Newcastle-upon-Tyne, UK; Melbourne, AUS; Toronto, CAN; Cleveland, Boston, San Francisco, USA; London, UK; St. Louis, USA)

15:30 - 17:00 Immunosuppression
Twelve months after suspension of natalizumab: experience at our multiple sclerosis centre
E. Moral, O. Carmona, V. Casado, L. Romero-Pinel, L. Gubieras, J. Niubó, C. Polo, S. Martínez-Yélamos, T. Arbizu (Hospitalet de Llobregat, E)

[Cyberhexe]

Fidelity hat ja mächtig akkumuliert:

Fidelity Management & Research 60,797,645 +37,063,645 08-09-06

http://www.adrbny.com/dr_ownership.jsp?cusip=284131208&LSP=2…

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.433.996 von Cyberhexe am 14.08.06 01:16:50

[Poppholz]

Antwort auf Beitrag Nr.: 23.433.996 von Cyberhexe am 14.08.06 01:16:50

wahrscheinlich hat der Händler eine Kauffreigabe bis €13,- und kauft zu den jetzigen Kursen ständig große Positionen nach.

[Cyberhexe]

Was sind die Analystenhäuser doch verlogen.
Obwohl man im letzten Quartal massiv Aktien eingesammelt hat, wurde nun ein "Wreduce rating" publiziert, ohne dass sich fundamental irgendetwas verschlechtert hätte:

http://finance.yahoo.com/q/ud?s=ELN

http://www.nasdaq.com/asp/Holdings.asp?mode=&page=&symbol=EL…

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.442.280 von Cyberhexe am 14.08.06 18:34:08

...ach ja, die UBS findet man auf Seite 3, und diese hat den Bestand von 10.000 Elan-Aktien auf über 740.000 Aktien erhöht:

http://www.nasdaq.com/asp/Holdings.asp?mode=&page=&symbol=EL…

[Birgit.Tersteegen]

Na Ja----sie wollen das volle Potential noch nicht sehen,diese Analysten---wahrscheinlich erst,wenn wir ÜBER 30$stehen....




Market Features
To Win With Elan, Counter Fidelity
By Marc Lichtenfeld
Senior Columnist
8/14/2006 2:25 PM EDT
URL: http://www.thestreet.com/markets/marketfeatures/10303522.htm…

If you've spent any time on Lower Grand Canal Street in Dublin this past year, you're probably wondering what that incessant beeping is.

Turns out Fidelity Investments has been backing up the truck to Elan's (ELN) doors and loading up on the Irish drugmaker's shares. In January, Fidelity already owned more than 20 million shares -- a greater than 5% stake. Then, sometime in February or early March, the fund giant began to build on its holdings.

Eventually, Fidelity had accumulated nearly 61 million shares, or 14% of the company, as of Aug. 4, according to regulatory filings.

That's a far cry from early 2005, when Fidelity, like so many others, fled Elan after its multiple sclerosis therapy Tysabri was pulled from the market in February of that year. Elan had been trading in the mid-$20s at the time, but after the Tysabri withdrawal, the stock quickly fell below $9 and ultimately dropped to around $3.

During that time, Fidelity dumped about 16 million shares, leaving it with about 20 million, and that's where it stayed until the beginning of this year. The problem isn't with Fidelity's faith in Elan in and of itself but with the timing of its buying and selling.

Source: Investegate

Fidelity doesn't have a great track record in the stock. The asset manager got burned last year by the Tysabri debacle after loading up on Elan. As the price recovered from the single digits, Fidelity sat tight. Not until the stock hit the mid-teens does it appear that Fidelity became more involved. A similar pattern played out in 2002, when Elan shares cratered and Fidelity sold on the way down and picked up shares well after the recovery was under way.

History could be repeating itself. Mike Hurley, chief technical strategist at M.S. Howells & Co., says Elan is headed lower.

"The stock has been in an uptrend since April of 2005," he says. However, "the uptrend looks like it's starting to break." For the intermediate term, Hurley says the chart looks neutral to bearish, but for the short term it's decidedly bearish, with the stock making lower highs and lower lows for the past few months. The fact that the stock failed at resistance and at its 50-day moving average in the mid-$15s is meaningful, according to Hurley.

Elan trades on emotion, and that's what worries me about the stock. I don't doubt the efficacy of Tysabri, and after speaking with many people in the industry I suspect it's safer than some people fear.

Elan, along with partner Biogen Idec (BIIB) , took Tysabri off the market after its use was linked to a potentially fatal disease called PML, an infection of the brain. The companies revisited their clinical data on 3,000 patients, and all told, three cases of PML were found; this led to the nonscientific estimate that the risk was roughly 1 in 1,000. After the MS drug was unavailable for more than a year, the Food and Drug Administration reapproved it in June.

Patients who came down with PML were taking Tysabri along with other medications for MS. Additionally, doctors didn't realize the symptoms were related to PML, so patients continued to receive Tysabri. Now, Tysabri is used as a monotherapy, and physicians are on alert to look for signs of PML. Theoretically at least, patients showing signs of the infection would immediately stop taking the medication.

Keep in mind that the FDA is unlikely to take action even if new cases of PML are reported, provided the rate of infection is less than 1 in 1,000. One hedge fund manager, whose fund owns a significant chunk of Elan's stock, says the PML "incidents will be less than expected."

The fund manager, who didn't want his name used, well may be right. Still, if another case linking Tysabri to PML is suspected, I believe you'll see Elan's shares implode again. Investors who know the stock's track record will shoot first and ask questions later.

That's just fine with the fund manager, who is a long-term holder. "After one or two years, if PML incidents are fewer than expected, the drug has a 'hockey stick' projection," he declares.

He also says that the company's therapies for Alzheimer's disease, being developed in collaboration with Wyeth (WYE) , could be worth more than Tysabri, should they become marketable drugs. The manager says the potential success of treating Alzheimer's isn't even priced into Elan's stock at current levels.

For investors who have the ability to put Elan away and not look at it for a few years, I suspect they will be rewarded if the fund manager's prognostications come true. However, with the emotion and risk involved in the stock, don't be surprised if the stock suffers serious damage at some point along the way.

And considering its track record in the stock, the axiom "buy when there's blood in the streets" may be especially true when it's Fidelity's blood that's spilled.

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.445.276 von Birgit.Tersteegen am 14.08.06 20:49:29

ABERie Sicherheit von Ty heute und die Tatsache, dass die Alzheimer Forschungnicht eingepreist ist kann er sehen---ansonsten ist es ein Versuch Fidelity zu diskreditieren....

[Cyberhexe]

Sehr interessant, die ersten Marktbeobachter scheinen nicht nur von der Effizienz von Natalizumab überzeugt zu sein, sondern auch von einem geringeren PML-Risiko als 1:1000 auszugehen:

"I don't doubt the efficacy of Tysabri, and after speaking with many people in the industry I suspect it's safer than some people fear."


Und auch die Alzheimer-Pipeline findet langsam grössere Beachtung:

"He also says that the company's therapies for Alzheimer's disease, being developed in collaboration with Wyeth (WYE - commentary - Cramer's Take), could be worth more than Tysabri, should they become marketable drugs. The manager says the potential success of treating Alzheimer's isn't even priced into Elan's stock at current levels."

http://www.thestreet.com/_yahoo/markets/marketfeatures/10303…

[Birgit.Tersteegen]

Zur Info

Finding may lead to skin test for Alzheimer's

Mon Aug 14, 9:52 PM ET

The discovery of enzymes that react abnormally in the skin of patients with Alzheimer's disease could lead to quick, painless test for the disease, U.S. researchers said on Monday.

It could not only quick and easy, but it would be the first accurate test for diagnosing Alzheimer's disease, which can now only be diagnosed by careful psychiatric assessments and by examining the brain after death.

Tapan Khan and Daniel Alkon at the Blanchette Rockefeller Neurosciences Institute in Rockville, Maryland said their test distinguished Alzheimer's from other brain-damaging diseases such as Parkinson's.

Writing the Proceedings of the National Academy of Sciences, they said it might even be used to find Alzheimer's, the most common cause of dementia, early on, when drugs may do the most good.

"When it begins, Alzheimer's disease is often difficult to distinguish from other dementias or mild cognitive impairment," Alkon said in a statement.

"Potential treatments of Alzheimer's, however, are likely to have their greatest efficacy before the devastating and widespread impairment of brain function that inevitably develops after four or more years."

Alzheimer's disease is marked by inflammation, which in turn is caused by a variety of compounds in the body.

Alzheimer's specifically stimulates a change in an enzyme called MAP Kinase Erk 1/2, Alkon and Khan found.

They tested this on various tissue samples taken from people who had died of known causes, including people who had died with Alzheimer's.

When they tested skin cells with bradykinin, a common inflammatory signal, the Erk 1/2 response in Alzheimer's patients was different from that seen in tissues taken from other people.

That included patients with dementia caused by Parkinson's disease, multiple infarct dementia and Huntington's chorea.

More than 4.5 million people have Alzheimer's disease in the United States alone and 12 million worldwide. There is no cure.

[Birgit.Tersteegen]

Hi Hexchen

Was genau meint Elmer -- you know it?

Author: elmer92692 Send PM Ignore View Profile Recs: 12
Subject: This Is What I'm Hearing.......
Sentiment: Strong Buy

AAB-001 is working. The phrase used to describe AAB-001 is "it's a miracle drug". For the Elan longs, that will sound familiar, it was the exact phrase used to describe Tysabri.
I'm sharing with you, not so you'll up your position in Elan, but so you'll know what is happening. I'm trusting all Elan longs took their positions long ago. It wouldn't surprise me if the institutions are hearing the same thing. I think the institutions are still accumulating.
Please do your own DD. Never rely on a single poster.
That having been said, we're going higher. Much higher.cheers

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.499.859 von Birgit.Tersteegen am 18.08.06 17:56:56

ahoi birgit

"Alzheimer disease is the real reason for our being"

...diese Erklärung wurde von Lars Ekman, dem Forschungsleiter von Elan, schon einge Male zitiert. Und in Anbetracht dessen, dass es bisher noch nichts Vernünftiges bei Alzheimer gibt, scheint das Potential riesig zu sein. Und Elan ist zusammen mit Wyeth allen anderen Pharmagrössen mindestens eine Kurve voraus - dies wird auch aus meinem beruflichen Umfeld immer wieder bestätigt.
Falls Bapineuzumab (dies ist der "generic name" für AAB-001) frühzeitig von Phase 2 in Phase 3 konvertieren sollte, dann....ja dann werden wir unsere Freude haben.

good luck + schönes WE
ch

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 23.500.325 von Cyberhexe am 18.08.06 18:23:01

danke!

[Birgit.Tersteegen]

Vortag über Alzheimer

http://www.nyas.org/ebriefreps/ebrief/000546/presentations/s…

[Cyberhexe]

Bleibt zu hoffen, dass die positiven Schlagzeilen um Tysabri häufiger werden:

Coram, Inc. Infusion Suites Now Providing Tysabri Infusions

DENVER, Aug 23, 2006 (PRIMEZONE via COMTEX) -- Coram, Inc., a leading national provider of specialty home infusion and specialty pharmaceutical distribution services, has announced that it has been approved to provide Tysabri(r) (natalizumab), the monotherapy treatment for relapsing forms of multiple sclerosis (MS). Coram treated its first Tysabri patient at its Boise, Idaho branch on August 14, 2006. Currently, Tysabri is offered at select Coram Infusion Suites throughout the country; it is anticipated the treatment will be available through all Coram suites by the end of September, 2006.
"We are pleased to add Tysabri to the extensive list of treatments available at our infusion suites," said John J. Arlotta, Coram's Chairman and CEO. "Coram's 25-year history as a provider of specialty infusion services makes us the perfect choice for the administration of Tysabri, and our nationwide network of infusion suites provides patients with a safe, convenient environment in which to receive these treatments."


http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B3E2…

[Birgit.Tersteegen]

EntreMed gets patent for chemical in cancer drug
Baltimore Business Journal - 4:24 PM EDT Thursday
by Vandana Sinha
Contributor

EntreMed has been granted a patent for the chemical source of its lead cancer-fighting drug.

The patent, which lasts until 2022, covers methods of using the compound 2-methoxyestradiol, or 2ME2, for treatments related to abnormal cell division in cancer and non-cancer diseases, including rheumatoid arthritis.

It also covers the formulation of the compound, first developed at Children's Hospital Boston and later licensed to Rockville-based EntreMed.

The company is testing Panzem, an oral drug based on that 2ME2 compound, in Phase II trials for cancer and in preclinical trials for rheumatoid arthritis.

Earlier this month, EntreMed was awarded a patent covering the composition of highly purified 2ME2, as well as the method of obtaining that compound.

In January, the company signed an agreement with Elan to license the Irish biotech company's nano-crystal technology and incorporate it into Panzem to create the liquid form Panzem NCD. The local company has sent Elan milestone payments based on Panzem NCD's Phase II trials for brain cancer, and Elan will ultimately manufacture the drug under the agreement.

So far this year, EntreMed (NASDAQ: ENMD) has spent $422,000 on patent costs, according to a recent regulatory filing.

[Birgit.Tersteegen]

Author: markettwain Send PM Ignore View Profile Recs: 27
Subject: Alzheimer's rediscovered led by Wyeth/Elan's MAb therapeutic vaccines - Cowen///per briefing.com
Sentiment:

09:08

Alzheimer's rediscovered led by Wyeth/Elan's MAb therapeutic vaccines - Cowen



Yesterday Cowen held a conference call with two leading Alzheimer's disease specialists to discuss the outlook for new therapies. Following the setback for Wyeth (WYE)/Elan's (ELN) AN-1792 four years ago, disease modifying agents for Alzheimer's disease finally are back on the radar screen, led by Wyeth (WYE)/Elan's (ELN) MAb therapeutic vaccines, Neurochem's (NRMX) Alzhemed, and Myriad Genetics' (MYGN) Flurizan. Firm says more than 40 compounds are in clinical trials for Alzheimer's disease: nearly half are potentially disease modifying agents. Firm believes Alzheimer's disease treatments will be an important investment theme for the next several years, as successful agents could gain broad combination use and drive a $10-15 bln market by 2015. Yesterday's discussion focused on Wyeth (WYE)/Elan's (ELN) AAB-001 and ACC-001, LLY's M266, NRMX's Alzhemed, MYGN's Flurizan, and GSK's Avandia, as well as other earlier-stage programs.

[Cyberhexe]

OMAHA, Neb. -- A new drug to help slow the progression of multiple sclerosis is being studied in Omaha.

The University of Nebraska Medical Center is the first site in the state to treat MS patients with the drug Tysabri. Patients will get monthly infusions of the drug, which was developed by a European drug company. It is designed to slow the progression of MS by 60 to 80 percent.

http://www.ketv.com/health/9757195/detail.html

[Cyberhexe]

Die Mitteilung im NEJM liest sich schon extrem gut, so dass ich mir kaum vorstellen kann/möchte, dass dieser mit Abstand effektivste Wirkstoff zur Behandlung der MS nicht angenommen wird:

http://content.nejm.org/cgi/content/german_abstract/354/9/89…

[Cyberhexe]

Antwort auf Beitrag Nr.: 23.718.272 von Cyberhexe am 01.09.06 13:21:27

man beachte, dass Natalizumab zudem der einzige Wirkstoff ist, der gezielt in den Entzündungsprozess eingreift, mindestens doppelt so wirksam ist als alle anderen Medikamente, ein Nebenwirkungsprofil im Plazebobereich hat und bei der Anwendung durch die einmalige Infusion in 4 Wochen von den meisten Anwendern gegenüber der lästigen fast täglichen Spritzerei bevorzugt würde.
Ich bin mir nur nicht sicher, in wiefern die Konkurrenten da "gegensteuern" können. Man liest da ja unglaubliche Geschichten.


Ergebnisse Natalizumab verringerte das Risiko für eine anhaltende Progression der Behinderung um 42% über zwei Jahre (Hazard Ratio 0,58; 95%-Konfidenzintervall 0,43 bis 0,77; p<0,001). Die kumulative Wahrscheinlichkeit einer Progression (auf der Basis von Kaplan–Meier-Analysen) betrug 17% in der Natalizumab-Gruppe und 29% in der Placebogruppe. Natalizumab verringerte die Rate der klinischen Schübe nach einem Jahr um 68% (p<0,001) und führte zu einer 83%igen Reduktion der Akkumulation von neuen oder vergrößerten hyperintensen Läsionen, gemessen durch eine T2-gewichtete Magnetresonanztomographie (MRT), über zwei Jahre (mittlere Anzahl an Läsionen: 1,9 mit Natalizumab und 11,0 mit Placebo; p<0,001). In der Natalizumab-Gruppe wurden sowohl nach einem als auch nach zwei Jahren 92% weniger Läsionen (nachgewiesen mit gadoliniumverstärktem MRT) verzeichnet als in der Placebogruppe (p<0,001). Die unerwünschten Ereignisse, die in der Natalizumab-Gruppe signifikant häufiger auftraten als in der Placebogruppe, waren Müdigkeit (27% vs. 21%, p=0,048) und allergische Reaktionen (9% vs. 4%, p=0,012). Überempfindlichkeitsreaktionen irgendeiner Art traten bei 25 Patienten unter Natalizumab (4%) auf, und schwere Überempfindlichkeitsreaktionen traten bei 8 Patienten (1%) auf.

Schlussfolgerungen Natalizumab verringerte das Risiko einer anhaltenden Progression der Behinderung und die Rate der klinischen Schübe bei Patienten mit schubförmiger multipler Sklerose. Adhäsionsmolekül-Inhibitoren versprechen eine wirksame Behandlung bei schubförmiger multipler Sklerose. (ClinicalTrials.gov, Studiennummer NCT00027300 [ClinicalTrials.gov] .)

[Cyberhexe]

aus den Zulassungsunterlagen zu Tysabri:
auf Seite 41 sind 2 Studien tabellarisch aufgeführt, 1801 (Tysabri=Natalizumab vs. Plazebo) und 1802 (Avonex+Plazebo vs. Avonex+Tysabri). Die Wirksamkeit von Tysabri in diesen beiden Studie ist beeindruckend. Interessanterweise ist im Quervergleich Avonex+Plazebo vs. Plazebo die jährliche Schubrate fast identisch.

Auf Grund dieser Ergebnisse fällt es mir schwer zu glauben, dass Tysabri erst dann verschrieben wird, wenn sämtliche Interferone durchgetestet sind.
Time is brain!


http://www.fda.gov/cder/foi/nda/2004/125104s000_Natalizumab_…

komplette Zulassung:
http://www.fda.gov/cder/foi/nda/2004/125104s000_Natalizumab.

[Cyberhexe]

interessante ppt-Präsentation zu Tysabri von Biogen
http://www.fda.gov/OHRMS/DOCKETS/ac/06/slides/2006-4208S1-01…

[Birgit.Tersteegen]

wie Du schon vermutet hast,Hexchen......

Author: ridge303 Send PM Ignore View Profile Recs: 17
Subject: From a doctors` journal
Sentiment:

:


Well said !

"Auch bei bisher unbehandelten Patienten mit schon zu Beginn hoher Krankheitsaktivität
und rascher Progression könnte mit Natalizumab therapiert werden, so Gold.
Denn die Substanz, die einmal im Monat als Infusion appliziert wird, könne das Fortschreiten
der Behinderung stärker bremsen als andere Präparate."

Dr. Gold says: " untreated patients with disease activity already high at the beginning
and a rapid progression ,
could be treated with Natalizumab.
Because the substance, which is applied once a month as an infusion,
can brake the progression of the handicap more strongly than other medications.

" target="_blank" rel="nofollow ugc noopener">http://www.aerztezeitung.de/docs/2006/08/29/151a1109.asp?cat=

[Birgit.Tersteegen]

Élan---für die Neuen in Elanville

From Wikipedia, the free encyclopedia
Jump to: navigation, search

For other uses, see Elan.

Élan Corporation plc is a neuroscience-based biotechnology company that is focused on discovering, developing, manufacturing and marketing advanced therapies in neurology, autoimmune diseases, and severe pain.
Type: Public
Founded: Athlone, County Westmeath, Ireland (1969)
Headquarters: Dublin 2, Dublin, Ireland
Key people: Kelly Martin, President & CEO
Paul Breen, Global Services & Operations
Richard T. Collier, General Counsel
Shane Cooke, Chief Financial Officer
William Daniel, Company Secretary
Lars Ekman, Global R&D and Corporate Strategy
Jack Laflin, Global Core Services
Ivan Lieberburg, Chief Medical Officer
Industry: Biotechnology
Products: PRIALT (ziconotide)
NANOCRYSTAL™ technology
In pipeline:
TYSABRI (natalizumab)
AZACTAM™ (aztreonam for injection, USP)
MAXIPIME™ (cefepime hydrochloride) for Injection
Revenue: $464.0 million USD (2004)
Employees: 2,000 (2004)
Website: www.elan.com

Élan Corporation plc (NYSE: ELN, LSE: ELA) is a major drugs firm based in Athlone, County Westmeath, Ireland.It also has Major interests in the U.S. It works with some of the biggest pharmaceutical companies in the world and is a leader in the fight against Alzheimer's disease. In the late 1990's its value as a PLC on the Irish Stock Exchange reached over €20bn. It has secondary listings on the London Stock Exchange and the New York Stock Exchange. It was one of Ireland's major business success stories. However in the early years of 2000's an accounting scandal and investor reactions to the global slump, caused a major devaluation resulting in a share price slump of over 90%. Since then the company has regained its growth path under the reign of a new American CEO Kelly Martin.

Today, Élan still employs over 2,000 people worldwide. It is listed on the New York Stock Exchange as ELN, the Irish Stock Exchange as ELN.I, and the London Stock Exchange as ELN.L.

Élan is currently focusing its research on a ground-breaking drug for Alzheimer's disease.

On 28th February 2005, Élan announced that it was withdrawing its Tysabri drug, after reports that a patient died after usage. This led to its share price dropping by 70%.


3/8/2006 FDA Advisory Committee Unanimously Recommends Reintroduction of TYSABRI® for the Treatment of Relapsing Forms of Multiple Sclerosis

The crash in the company led to a number of senior executives leaving the company over the period 2000-2004 led to a number of smaller pharmaceutical companies being set up. One of these is Amarin Corp PLC, a small drug company listed on Ireland's IEX(Irish Enterprise Exchange).

'Tysabri' Returned to the market On June 5, 2006, after reviewing two years of safety and efficacy data and an Advisory Committee hearing ending in a unanimous recommendation for reapproval, FDA re-approved it for patients


Contents
[hide]

* 1 See also
* 2 LOWSOCS SAY'S ELAN'S SHARE PRICE IS GOING TO DA MOON
* 3 Elan leading the fight against Alzheimer’s disease
* 4 Natalizumab Tysabri
* 5 Link on all that's happening with Elan updated very regularly
* 6 Links to video on Tysabri
* 7 Well worth a listen
* 8 External links

[edit]

See also
[edit]

LOWSOCS SAY'S ELAN'S SHARE PRICE IS GOING TO DA MOON

For people that have an interest in following news flow on this stock. I have a link which may help in your investment decision . This site has not been recommended by Lowsocs one of the better option players. Also you may follow Littleshinstars a poster whom has called the closing price correctly on so many days it's uncanny . I'll leave it up to you to work out the better posters . Fred is Fred enough said.

http://www1.investorvillage.com/smbd.asp?mb=160&clear=1&pt=m
[edit]

Elan leading the fight against Alzheimer’s disease

Products in Development

In neurology, Elan, in collaboration with Wyeth, initiated a Phase II clinical trial for an experimental humanized monoclonal antibody with a targeted indication of immunotherapeutic treatment of mild to moderate Alzheimer’s disease (AD). The humanized monoclonal antibody is designed and engineered to clear the neurotoxic beta-amyloid peptide that accumulates in the brains of patients with AD. In autoimmune diseases, Elan’s primary emphasis is studying and developing ways to provide disease-modifying therapies for a wide range of diseases.

Elan’s discovery research efforts are centered on bringing science and innovation to patients in its core therapeutic focus areas of neurology, autoimmune diseases and severe pain.

In neurology, Elan is focused on building upon its breakthrough research and extensive experience in the area of neuropathology-related disorders such as Alzheimer’s disease, where the company’s efforts include programs focused on small molecule inhibitors of beta secretase and gamma secretase, enzymes whose actions are thought to affect the accumulation of the amyloid plaques found in the brains of patients with Alzheimer’s disease. Elan is also studying other neurodegenerative diseases, such as Parkinson's disease.

In autoimmune diseases, Elan’s primary emphasis is studying cell trafficking to discover ways to provide disease-modifying therapies for autoimmune diseases such as rheumatoid arthritis, multiple sclerosis and inflammatory bowel disease; and in severe pain, research efforts focus on inflammatory and neuropathic pain.

Elan will know very soon how it's drug aab-001 is doing in the trials as the first results are due Q3 2006. This drug is considered by many to be the leading contender in the fight against Alzheimer's Disease.

javascript:openWin('http://www.nyas.org/ebriefreps/ebrief/000546/presentations/s…
[edit]

Natalizumab Tysabri

Natalizumab is a drug co-marketed by Biogen Idec and Élan as Tysabri. It was previously named Antegren.

Contents

1 Description

2 Mechanism of action

3 Link to PML

4 Return to the market

5 Marketing issues

6 External links





Description Tysabri is a monoclonal antibody that has proven efficacy in the treatment of two serious autoimmune disorders: multiple sclerosis (MS) and Crohn's disease (CD). In MS, Tysabri was shown to reduce relapses by 67% vs. a placebo. It slowed the progression of disability (as measured by EDSS) by 42%. While it is impossible to compare results across different clinical trials, the older generation drugs, interferons and Copaxone, are generally acknowledged as demonstrating about a 30-35% decrease in relapse rate vs. placebo; and only two drugs have been shown to decrease the progression of disability, but again only by around 20-40%.


Mechanism of action The mechanism of action of Tysabri is believed to involve the inhibition of immune cells from crossing blood vessel walls to reach various tissues, including the brain.


Link to PML While the drug was shown to be powerfully effective for preventing relapses of MS, just three months after Tysabri was initially approved for MS by the FDA, the companies announced on February 28, 2005 that one fatal and one non-fatal case of a rare, often lethal brain disease known as progressive multifocal leukoencephalopathy (PML) were found in patients given Tysabri in combination with Avonex over a two year period. Tysabri was voluntarily withdrawn from the market that day, after the first two confirmed cases, so that an intensive safety evaluation could be conducted to determine the prevalence of PML and what actions might be taken to minimize the likelihood of PML. During the safety review, a second PML death was attributed to Tysabri in March of 2005, in a CD patient who had died in December 2003 from what was thought at that time to be a brain tumor, but the diagnosis was subsequently re-evaluated as having been PML. The CD patient who had received eight doses of Tysabri over an 18-month period had a prior medication history which included multiple courses of immunosuppressant agents, which are thought to have contributed significantly to the PML.

During the summer of 2005, the drug and the two companies garnered a lot of media attention. This included reports of two additional alleged PML cases, which were later discredited (one woman who had reportedly died of PML received the report of her death while she was out shopping).

Biogen Idec lost about $8 billion in market capitalization the day the withdrawal announcement was made. Elan's stock, which had risen like a Phoenix on positive Tysabri data, also collapsed. Natalizumab had promised to be a major earner for both companies. Tysabri became part of a broader drug safety story in 2005 in the context of Merck's withdrawal of Vioxx, a widely-used anti-inflammatory drug that was associated with an increased risk of heart attacks.

The companies announced in the fall of 2005 that they had resubmitted it to the US Food and Drug Administration (FDA) and were also resubmitting to the EMEA, for approval in Europe. The FDA again granted Tysabri "Priority Review" status, a designation granted to products considered to be potentially significant advancements over existing therapies. Under this designation, the FDA commits to render a decision within six months of submission rather than the standard ten months.


Return to the market On June 5, 2006, after reviewing two years of safety and efficacy data and an Advisory Committee hearing ending in a unanimous recommendation for reapproval, FDA re-approved it for patients with relapsing forms of MS under certain conditions (the FDA Advisory Committee recommended the return of the treatment as a first line therapy but the FDA did not follow completely the recommendation).

They also included a special restricted distribution program known as the TOUCH Prescribing Program ("TOUCH" stands for "Tysabri Outreach: Unified Commitment to Health"). Under this program, only prescribers, infusion centers, and specialty pharmacies trained and enrolled in the TOUCH program can prescribe and administer Tysabri. Additionally, patients must also be enrolled in the TOUCH program, so that they may be educated on Tysabri as well as periodically evaluated while being treated with Tysabri.

In April of 2006 the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion recommending marketing authorization for Tysabri as a treatment for relapsing-remitting multiple sclerosis. Several weeks later on June 29, the EMEA also approved Tysabri in the European Union for relapsing forms of MS, but not subject to the TOUCH restrictions.


Marketing issues TYSABRI® Pricing: The wholesale acquisition cost is $2184.62 per vial. Given that Tysabri is generally administered 13 times a year, the annual costs for Tysabri is approximately $28,400 (not including costs associated with infusion services), priced at a premium to the older generation drugs.

Elan and Biogen Idec are committed to making TYSABRI accessible to appropriate patients who may benefit from therapy. To achieve this goal, programs have been developed to assist patients who are uninsured or who require financial assistance. Patients who require financial assistance can receive more information by calling MS ActiveSource at 1-800-456-2255. Information on TOUCH-enrolled neurologists and infusion centers, and other information Tysabri may be found at the non-profit MS patient information website, www.MSPatientsForChoice.org, or by calling MS ActiveSource.

http://mspatientsforchoice.org/

http://www.tysabri.com/

http://www.elan.com/Products/united_states/tysabri_informati…

http://www.biogenidec.com/site/019_2.html

http://www.thisisms.com/

http://doodah95.blogspot.com/

http://www.aei.org/publications/filter.all,pubID.24299/pub_d…
[edit]

Link on all that's happening with Elan updated very regularly

http://www.tixx.com/elan.htm
[edit]

Links to video on Tysabri

http://xgen.vitalstream.com/mcasx.asx?media=1882728&package=…

http://homepage.mac.com/vincentmacaluso/Dr.Macaluso'sSite/F…

http://mspatientsforchoice.org/l_rob.wmv

mms://wm.world.mii-streaming.net/media/whdh/windowsmedia/features/3/060301_managing_ms.wmv

http://www.wndu.com/news/032006/news_48379.php


[edit]

Well worth a listen

http://www.healthtalk.com/multiplesclerosis/programs/10_585/…




* List of Irish companies

[edit]

External links

* Information about Élan
* Wikinews report of Tysabri withdrawal
* Élan stock on the Irish Stock Exchange

[Cyberhexe]

Tysabri hat immer noch nicht die beste "Presse":

"Tysabri (brand name for natalizumab) will not make a big difference for most MS patients - at least, not right away - because the FDA reapproval carries a variety of restrictions. And the drug's link to that deadly side effect, a rare brain infection called progressive multifocal leukoencephalopathy, means that physicians will likely consider Tysabri mainly for aggressive or unresponsive cases."

http://www.newsday.com/news/health/ny-hsedge4887055sep12,0,8…


....obschon, wenn ich mir die Ergebnisse der SENTINEL-Studie (Tysabri+Avonex vs. Plazebo+Avonex) in Erinnerung rufe, dann fällt es mir schwer zu glauben, dass Ty gegenüber den Interferonen sich nicht durchsetzen sollte - vorausgesetzt das PML-Risiko verschlechtert sich nicht gegenüber den bisherigen Prognosen (1:1000).

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 24.001.573 von Cyberhexe am 17.09.06 18:45:31

Hi Hexchen!

Schön mal wieder von Dir zu hören...!

uthor: elmer92692 Recs: 0
Subject: It Makes You Wonder......
Sentiment: Strong Buy

Erica Whittaker is ML's analyst for Elan. She has a "sell" on our stock, with a $5.50 valuation. Hmmmm.
However, after reading her latest analysis I came away with an overwhelming desire to buy more Elan stock. Her reasoning is extremely bullish.
Get this. Erica says the chance of AAB-001 going into Phase 3 is 60%. She says, if we go into Phase 3, the chance of FDA approval is 50%. Now I ask you, where can you buy a stock with little downside risk and huge upside potential with the odds she, herself, has assigned?
If I may, let me give my analysis. After talking with knowledgeable friends, I believe the odds of going into Phase 3 is 100%. I'll go with Wyeth's odds of getting a drug approved (from Phase 3). Those odds are 90%.
When the CEO, Bob Essner, tells the TV viewing audience his best drug in the pipeline is a Phase 2 AD drug [AAB-001], you should listen. Furthermore, he said approval would "transform Wyeth and the healthcare industry".
Here's a little known secret. Most Elan longs know we're going up big-time from these levels (even Fred), the only real question is, how soon.
Investing is about risk/reward. You'll look a long time before you'll find an opportunity like this. cheers

[Cyberhexe]

...es gibt jedoch auch Positves zu vermelden:

"TYSABRI NOW BEING ADMINISTERED AT MULTIPLE SCLEROSIS CENTER OF ATLANTA"

http://atlanta.dbusinessnews.com/shownews.php?newsid=91780&t…

[Birgit.Tersteegen]

Annals of the New York Academy of Sciences 939:425-435 (2001)
© 2001 New York Academy of Sciences

Antihistamine Agent Dimebon As a Novel Neuroprotector and a Cognition Enhancer


S. BACHURIN, E. BUKATINA, N. LERMONTOVA, S. TKACHENKO, A. AFANASIEV, V. GRIGORIEV, I. GRIGORIEVA, YU. IVANOV, S. SABLINa,b AND N. ZEFIROV

Institute of Physiologically Active Compounds, 142432, Chernogolovka, Moscow Region, Russia
aSelena Pharmaceuticals, Inc., San Francisco, California, U.S.A.
bDepartment of Biochemistry and Biophysics, University of California, San Francisco, U.S.A.

Address for correspondence: Sergey O. Sablin, Ph.D., Selena Pharmaceuticals, Inc., 167 Skyview Way, San Francisco, CA 94131, U.S.A. Voice: 415-990-4761; fax: [phone].
[e-mail]

Dimebon, launched earlier in Russia as an antihistamine drug, was evaluated as a representative of a new generation of anti-Alzheimer's drugs that have two beneficial actions: (1) to alleviate symptoms, and (2) to prevent progression of the disease. The drug demonstrated cognition and memory-enhancing properties in the active avoidance test in rats treated with the neurotoxin AF64A, which selectively destroys cholinergic neurons. Dimebon protected neurons in the cerebellum cell culture against the neurotoxic action of ß-amyloid fragment (Aß25-35, EC50 = 25 µM). In vitro, Dimebon displayed Ca2+-blocking properties (IC50 = 57 µM, on isolated rat ileum intestine) and pronounced anticholinesterase activity (IC50 = 7.9 µM and 42 µM for butyrylcholine esterase and acetylcholine esterase, respectively). It also exhibited strong anti-NMDA activity in the prevention of NMDA-induced seizures in mice (EC50 = 42 ± 6 mg/kg i.p.). A beneficial effect of Dimebon in the therapy of Alzheimer's disease was demonstrated in a pilot clinical trial performed in the Moscow Center of Gerontology. Fourteen patients who participated in the trial were evaluated for their state of personality and for the severity of the disease. The evaluation included orientation (space, place, time, and patient personality), memory for the past and present, life in present, speech, irritability, and so forth. During and after the eight-week therapy with Dimebon, cognitive and self-service functions of patients improved significantly, and psychopathic symptoms, anxiety, depression, tearfulness, and headache were substantially diminished. The results of these studies suggest Dimebon as a new candidate for the therapy of Alzheimer's-like disorders.

Key Words: Alzheimer's disease • Dimebon • Neuroprotector • Cognition enhancer

-------------------------------------------------------------
Hexchen,
wie schätzt Du dies im Verhältnis zu Elan`s ALzheimer Forschung ein??
--------------------------------------------------------------------

SAN FRANCISCO, Sep 21, 2006 (BUSINESS WIRE) -- Medivation, Inc. (MDV : medivation inc com
News , chart, profile, more
Last: 7.87+1.85+30.73%

11:11am 09/21/2006

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Sponsored by:
MDV7.87, +1.85, +30.7%) today announced that its proprietary drug Dimebon(TM) met all five efficacy endpoints in a six-month randomized, double-blinded, placebo-controlled Phase 2 clinical study of 183 patients with mild to moderate Alzheimer's disease conducted at 11 sites in Russia. Compared with patients receiving placebo, patients treated with Dimebon demonstrated highly statistically significant improvement on the study's primary efficacy endpoint, the Alzheimer's Disease Assessment Scale-cognition (ADAS-cog; 4.0 point improvement in the mean change from baseline to week 26 as compared to placebo; p less than 0.0001), and on the key secondary efficacy endpoint, the Clinical Global Impression of Change (CGIC; 0.6 point improvement in the mean change from baseline to week 26 as compared to placebo; p less than 0.0001). Dimebon-treated patients also achieved statistically significant improvement (p less than 0.01) compared with placebo patients on all three of the other secondary efficacy endpoints - the Activities of Daily Living, the Neuropsychiatric Inventory and the Mini Mental State Examination.
In addition to these improvements in comparison to placebo, Dimebon-treated patients also showed statistically significant improvement over baseline on all five efficacy endpoints used in this study (p less than 0.05). By contrast, placebo-treated patients deteriorated from baseline on all five endpoints.
Dimebon was well tolerated in this study. There were fewer serious adverse events in Dimebon-treated patients than in placebo-treated patients. No gastrointestinal side effects occurred in more than 3% of the Dimebon-treated patients except for dry mouth, which occurred in 13.5% of the Dimebon-treated patients. A higher percentage of Dimebon-treated patients than placebo-treated patients completed the trial (87.6% and 81.9%, respectively), for an overall trial completion rate of 84.7%.
Rachelle Doody, MD, PhD, Effie Marie Cain Chair, Director of the Alzheimer's Disease and Memory Disorders Center at Baylor College of Medicine, and a member of Medivation's Clinical and Scientific Advisory Board, observed: "From my review of these rigorously collected data, I believe the results are striking. It is very rare for a Phase 2 Alzheimer's disease study to demonstrate significance on all of the primary and secondary endpoints, five in this case, and with strong statistical significance. I look forward to continued collaboration with the Medivation team to further develop Dimebon as a potential new therapy for Alzheimer's disease."
"We believe that these results are important, in part because the primary and key secondary efficacy endpoints used in this trial are accepted by the FDA for registration of drugs to treat mild to moderate Alzheimer's disease," stated David Hung, MD, President and Chief Executive Officer of Medivation. "In a meta-analysis of 10 randomized, double-blinded, placebo-controlled trials of approved Alzheimer's disease drugs, published in 2006(1), treatment with these drugs produced an average ADAS-cog improvement over placebo of 2.7 points. We thus believe that our results support continued, aggressive pursuit of the further studies required to assess Dimebon's potential safety and efficacy in treating Alzheimer's disease."
As the first step in its subsequent development plans, Medivation today also announced that in the second quarter of 2006 it initiated a double-blinded extension study which allows patients from the Phase 2 study to continue treatment for up to a total of 12 months in the same treatment group to which they originally were randomized. Enrollment in the extension study was 86% of eligible patients, and study results are expected in the second quarter of 2007. Plans for further Alzheimer's disease studies with Dimebon will be disclosed as they are finalized.
"Given the encouraging results from the six-month trial, we are delighted that such a large number of patients have elected to continue treatment," noted Lynn Seely, MD, Chief Medical Officer of Medivation. "The extension study will give us a unique opportunity to investigate the effects of Dimebon compared with placebo at 12 months, and also will provide longer term safety information to assist in addressing regulatory requirements."
Dr. Hung concluded: "The Phase 2 data that we are announcing today are an important step in validating Medivation's business model. We secured our first equity financing less than two years ago, and to date have used less than $20 million in funding our operations. With that investment of time and cash, we have not only generated positive results in a large Phase 2 Alzheimer's disease trial, but also initiated new development programs in Huntington's disease and hormone-refractory prostate cancer, both of which are scheduled to enter the clinic in the next three quarters. We also remain committed to finding new technologies to reach our targeted portfolio of four to six programs."

http://www.marketwatch.com/News/Story/Story.aspx?guid=%7B21E…

[bernie55]

KEN KAM gibt auch noch einmal ein Statement in Marketocracy über ELAN ab:

Er verweist auf Oktober 2006 , wo die Geschäftszahlen und auch die ersten TYSABRI-Verkaufszahlen bekanntgegeben werden.
Weiterhin kommentiert er die Alsheimer Forschung, die seiner Meinung nach bisher noch keine nenneswerte Ergebnisse geliefert hat. Auch wenn die Erfolgsstory beim Alsheimer Projekt Wyeth und Elan nicht fruchten sollte, scheint in seinen Augen die Story um Tysabri bzgl. MS und Crohn`s Disease den aktuellen Wert von ELN zu rechtfertigen.

In diesem Zusammenhang nennt er die Presentation von Wyeth im November mit dem Titel:
Aß Immunotherapie prevents Alsheimer`s Disease Neuropathologie

http://www.marketocracy.com/media/pdf/marketscope/CurrentMar…

[bernie55]

..hier ein Bericht über die Verwendung von ELANs Nanotechnologie.

http://www.investorvillage.com/smbd.asp?mb=160&mn=24011&pt=m…
Author: Creedster_99
Subject: JNJ buys Alza for $16B but uses ELAN's NANO technology for their $3.4B dollar drug for schizophrenia???

Elan Corp.’s (elan.com) proprietary NanoCrystal technology is being used by Johnson & Johnson Pharmaceutical Research & Development in a Phase III clinical trial of a long-acting injectable formulation of its paliperidone palmitate in patients with schizophrenia



Research and development expense as a percent of sales for the Pharmaceutical segment was 16.4% for 2004, 16.4% for 2003, and 15.7% for 2002. Combined, the Consumer and the Medical Devices and Diagnostics segments averaged 6.2% in 2004, 6.7% in 2003, and 6.6% in 2002. Significant research activities continued in the Pharmaceutical segment, increasing to $3.6 billion, or 13.6% compared with 2003. The compound annual growth rate was about 15.5% for the five-year period since 1999. Johnson & Johnson Pharmaceutical Research & Development (jnjpharmarnd.com), Centocor Inc. (centocor.com), Alza Corp. (alza.com), Tibotec-Virco NV (tibotec.com), and Scios Inc. (sciosinc.com) are primary research centers for the company.

http://www.pharmalive.com/magazines/medad/view.cfm?articleID…" target="_blank" rel="nofollow ugc noopener">http://www.pharmalive.com/magazines/medad/view.cfm?articleID…

[bernie55]

Author: chiefypadl

Subject: Article of the Year Confirming Elan's Alzheimer Target & Research


I do expect to see an article to Elan's approach to Alzheimer as this study confirms Elan's approach as the Holy Grail. Elan has to be in the Black-Out period(No News on Alzheimer) due to Human Clinical Trials. That is why Elan uses the mouse model and or AN-1792 as follow-thru news...However,this study wasn't done by Elan as has been made public and the connection is in High definition(Crystal Clear). Wonder No More !

http://www.newscientist.com/article/dn10134-alzheimers-may-s…" target="_blank" rel="nofollow ugc noopener">http://www.newscientist.com/article/dn10134-alzheimers-may-s…

[bernie55]

..ein Fachartikel für Dich, Cyberhexe....

Researchers Discover New Key Function Of An Enzyme In The Nervous System - Impact On Drug Development Against Alzheimer`s Disease

Main Category: Alzheimer's / Dementia News
Article Date: 24 Sep 2006 - 0:00am (PDT)



"Ever since scientists first elucidated the molecular mechanisms underlying the pathology and loss of nerve cells in Alzheimer's disease, drug companies have been working to develop drugs which will inhibit the outbreak of this severe form of dementia. Now researchers in Munich and Berlin (Germany) have discovered that an enyzme which has a central causal role in Alzheimer's disease happens also to have a key function in the normal development of the nervous system. This enzyme, beta-secretase or BACE1, ensures that nerve fibers (axons) are adequately isolated with sheaths of myelin, enabling rapid conduction of electrical impulses, as well as preventing short-circuits, akin to plastic insulation on electrical wires..."

http://www.medicalnewstoday.com/medicalnews.php?newsid=52554…" target="_blank" rel="nofollow ugc noopener">http://www.medicalnewstoday.com/medicalnews.php?newsid=52554…

[bernie55]

Biogen Idec Plots its Positioning of Avonex and Tysabri to Maximize Revenues and Capture Patient Share from Competitors



WALTHAM, Mass. and TORONTO, Sept. 25 /PRNewswire/ -- Decision Resources
and Millennium Research Group find that Biogen Idec must carefully position
its two multiple sclerosis drugs, Avonex and Tysabri, to maximize the
patient share of both drugs. According to the new report entitled Brands &
Strategies: Multiple Sclerosis, Tysabri is expected to be used almost
exclusively as a second-line or later treatment option due to its new
labeling, which recommends the drug only for patients who have failed to
respond to at least one other multiple sclerosis therapy. In order to
maximize the sales potential of Tysabri, it will be important for Biogen
Idec to position the drug as the first alternative should a patient fail to
respond to their initial multiple sclerosis treatment. This would allow
Biogen Idec to start patients on Tysabri much sooner than if those patients
were to first try switching between various interferon-beta brands and Teva
Pharmaceuticals' Copaxone before considering Tysabri.
"Biogen Idec will continue positioning Avonex as the first choice for
multiple sclerosis therapy and make Tysabri the first alternative, rather
than a high-dose interferon or Teva's Copaxone, should patients fail while
taking Avonex," said Craig Speziali, analyst at Millennium Research Group.
"This strategy should be effective in maximizing revenues from Biogen
Idec's entire multiple sclerosis franchise while potentially capturing
patient share away from competitors."

The new report is the first in a series from Decision Resources and
Millennium Research Group that reveals critical commercial and competitive
analysis at the market, brand, and company level. It is the first
initiative between the two companies since Decision Resources bought
Millennium Research Group in February of 2006. Brands & Strategies:
Multiple Sclerosis covers:
* How leading competitors have positioned their brands for success
* Which multiple sclerosis drugs will continue to succeed in the market
* The launch and level of uptake of biosimilar interferon-beta in the
major markets and which branded drugs will be most affected
* Tysabri's impact on the market and the effect safety concerns have on
its commercial success
* New drugs entering the market between 2005 and 2010 and products being
developed in the major multiple sclerosis competitors' pipelines


About Brands & Strategies
Brands & Strategies is the first and only report series to bring
together all the competitive information elements biopharmaceutical
companies need to make informed decisions about their own products and
next-steps. Each report includes:
* Brand-specific, event-driven, five-year annualized market forecast
* Country-specific market share projections by brand and impacts of future
events
* Drug class sales by country
* Brand sales by region
* Projected price for all drugs for five years
* Generic pricing impact on all drugs
* Prevalence and diagnosis rates by country
* Promotional spend for each product
* Pipeline analysis by company within a specific disease
* SWOT analysis on each brand
* Clinical trial reviews and clinical trial competitive analysis
* Detailed brand strategy and how it relates to clinical trial results
* Impact of Medicare
* Selling strategies based on clinical trials
About Millennium Research Group


Millennium Research Group (http://www.MRG.net) is a leading provider of
strategic information to the healthcare sector. Focused on the medical
device, pharmaceutical, and biotechnology industries, the Company provides
its clients with the benefits of its specialized industry expertise through
published reports and customized consulting services.

About Decision Resources
Decision Resources, Inc., (http://www.DecisionResources.com) is a world
leader in healthcare market research publications, advisory services, and
consulting designed to help clients shape strategy, allocate resources, and
master their chosen markets.
All company, brand, or product names contained in this document may be
trademarks or registered trademarks of their respective holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
[e-mail]

SOURCE Decision Resources, Inc.



http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=…

[bernie55]

...eine Meldung von Acorda Therapeutics...


Acorda Therapeutics Announces Positive Results of Phase 3 Study of Fampridine-SR on Walking in People with Multiple Sclerosis

Monday September 25, 6:00 am ET

Statistical Significance Achieved on All Three Efficacy Criteria Set Forth in Spa
Conference Call and Webcast at 8:30 am ET on September 25, 2006


HAWTHORNE, N.Y.--(BUSINESS WIRE)--Acorda Therapeutics, Inc. (Nasdaq: ACOR - News) today announced positive results from its Phase 3 clinical trial of Fampridine-SR on walking in people with multiple sclerosis (MS). Statistical significance was achieved on all three efficacy criteria defined in the Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). A significantly greater proportion of people taking Fampridine-SR had a consistent improvement in walking speed, the study's primary outcome, compared to people taking placebo (34.8 percent vs. 8.3 percent) as measured by the Timed 25-Foot Walk (p less than 0.001). In addition, the effect was maintained in this study throughout the 14-week treatment period (p less than 0.001) and there was a statistically significant improvement in the 12-Item MS Walking Scale (MSWS-12) for walking responders vs. non-responders (p less than 0.001).
ADVERTISEMENT


The average increase in walking speed over the treatment period compared to baseline was 25.2 percent for the drug group vs. 4.7 percent for the placebo group. Increased response rate on the Timed 25-Foot Walk was seen across all four major types of MS. In addition, statistically significant increases in leg strength were seen in both the Fampridine-SR Timed Walk responders (p less than 0.001) and the Fampridine-SR Timed Walk non-responders (p=0.046) compared to placebo. The Company intends to present comprehensive data at an upcoming medical meeting.

"We are delighted with the results from this trial, which are consistent with Acorda's prior Phase 2 study in people with MS. We will request a meeting with the FDA as soon as possible to discuss next steps for the Fampridine-SR program," said Ron Cohen, M.D., President and CEO. "Acorda is committed to the development of therapies that will improve the function and lives of people with MS, and we wish to thank the physicians and people with MS who participated in this trial."

"Many people with MS experience nerve damage that eventually impairs walking. Currently, no therapies are indicated to improve neurological function, such as loss of mobility, in MS," said Andrew Goodman, M.D., Director of the Multiple Sclerosis Center at the University of Rochester. "Based on the results of this trial, Fampridine-SR could represent a new way to treat people with MS. In this study, a significantly higher proportion of subjects experienced a consistent improvement in walking speed with Fampridine-SR than with placebo, and this was accompanied by a reduction in the degree of disability that the subjects reported in their daily activities related to mobility."

Special Protocol Assessment (SPA)

This clinical trial was conducted under an SPA from the FDA. The efficacy criteria set forth in the SPA included three elements:

To show that there were significantly more responders in the Fampridine-SR treated group than in the placebo group, as measured by the Timed 25-Foot Walk, a standard neurological test. A responder was defined as someone whose walking speed on the Timed 25-Foot Walk was consistently greater during at least three of four on-drug visits than the person's fastest speed on any of the five off-drug visits.
To demonstrate statistically significant improvement in walking speed on the last on-drug visit for the Fampridine-SR-treated responders compared to the placebo group.
To show that responders reported a significantly greater improvement than non-responders on the MSWS-12, a self-rated assessment of walking disability. This step was meant to validate the clinical meaningfulness of consistent improvement on the Timed 25-Foot Walk.
Study Design

The double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of Fampridine-SR in improving walking ability in people with MS. The trial, which enrolled 301 individuals at 33 MS centers in the United States and Canada, recruited patients between 18 and 70 years old with a definite diagnosis of MS and some degree of walking disability. The study was open to people with all types of MS, including primary-progressive, secondary-progressive, relapsing-remitting and progressive-relapsing. Participants were permitted to remain on a stable regimen of their current medications, including interferons. Secondary endpoints for the trial included measurements of leg strength. Subjects were randomized to 14 weeks of treatment with Fampridine-SR (n=229) or placebo (n=72), a 3:1 ratio of drug to placebo.

Safety Statement

In this study, adverse events were largely consistent with the safety profile observed in previous studies of Fampridine-SR in people with MS, including an increased risk of seizures that appears to be dose related. Following is a list of the most common adverse events reported in the study, with percentages representing the Fampridine-SR treatment group vs. the placebo group: falls (15.8 percent vs.15.3 percent), urinary tract infection (13.6 percent vs.13.9 percent), dizziness (8.3 percent vs. 5.6 percent), insomnia (8.3 percent vs. 4.2 percent), fatigue (6.1 percent vs. 2.8 percent), nausea (6.1 percent vs. 4.2 percent), upper respiratory tract infection (6.1 percent vs. 9.7 percent), asthenia (5.7 percent vs. 6.9 percent), back pain (5.7 percent vs. 0 percent), balance disorder (5.7 percent vs. 2.8 percent) and headache (5.7 percent vs. 5.6 percent).

Two serious adverse events that were judged potentially related to treatment and led to discontinuation were anxiety in one subject and a seizure in another subject that was observed during an occurrence of sepsis associated with a urinary tract infection. No deaths occurred during the study. One death was reported for a subject five weeks after the last on-drug study visit. This death occurred outside of the protocol time window for reporting adverse reactions and the cause of death is not known at this time.

About MS

Multiple sclerosis is a chronic, usually progressive disease of the central nervous system in which the immune system attacks and destroys the structure, and therefore degrades the function, of nerve cells. Approximately 400,000 Americans have MS, and every week about 200 people are newly diagnosed. Most are between the ages of 20 and 50, and women are affected two to three times as much as men. Worldwide, MS may affect 2.5 million individuals.

According to the National Multiple Sclerosis Society (NMSS), the direct costs of medical care for MS patients in the United States exceed $6 billion annually. Additionally, a recent NMSS analysis estimated the total cost of MS, including medical and non-medical care, production losses, and informal care, at more than $47,000 per U.S. patient per year. Complications from MS may make it harder for people to work and may interfere with their ability to perform common, daily activities.

For most people with MS, the disease slowly progresses with a series of unpredictable flare-ups, also called relapses or exacerbations. But for some, the progression of the disease is rapid. Each relapse tends to lead to increasing disabilities such as walking impairment, muscle weakness or speech or vision impairments. Approximately 80 percent of people with MS experience some form of walking disability. Within 15 years of an MS diagnosis, 50 percent of patients often require assistance walking and in later stages, about a third of patients are unable to walk.

About Fampridine-SR

Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine, or 4-AP). Data collected in laboratory studies found that fampridine can improve the communication between damaged nerves, which may result in increased neurological function.

Fampridine-SR Mechanism of Action

A nerve cell has one extension, called an axon, which it uses to communicate via electrical signals to other nerve cells. All but the smallest axons have a special covering of a fatty substance called myelin that acts as insulation to preserve and speed these nerve signals, much like the insulating cover of an electrical cord helps preserve the transmission of electricity.

In MS, the myelin becomes damaged and the axon cannot effectively transmit electrical impulses. Specifically, the damaged myelin exposes channels in the membrane of the axon, which allow potassium ions to leak from the axon, dissipating the electrical current. Fampridine-SR blocks these exposed channels, and helps the electrical signals to pass through areas of damage.

Conference Call and Webcast

Acorda will hold a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the top-line results from the trial. To access the call, please dial 866-510-0704 (domestic) or 617-597-5362 (international) five minutes prior to the start time, and provide the access code 20529997. A replay of the call will be available from 10:30 a.m. Eastern Time on September 25, 2006 until 11:59 p.m. Eastern Time on October 25, 2006. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international), and provide the access code 88067926. An audio webcast of the call can also be accessed from the Company's website, at http://www.acorda.com, for the next 30 days.

Patient Information Line

Patients with questions regarding the results of this study, or, who want to join Acorda's mailing list to be kept informed of future company news, may call 877-223-5212, toll-free, weekdays from 10:00am to 5:00pm ET.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug indicated for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.



Contact:
Media:
Acorda Therapeutics
Erica Wishner, 914-347-4300 ext. 162
Cell: 914-282-0836
[e-mail]
or
Porter Novelli
Marion E. Glick, 212-601-8273
Cell: 917-301-4206
[e-mail]
or
Investors:
Stern Investor Relations
Sarah Lux, 212-362-1200
[e-mail]

--------------------------------------------------------------------------------
Source: Acorda Therapeutics, Inc.

[bernie55]

Newsday Staff Writer
BY JAMIE TALAN


September 26, 2006


An experimental drug for multiple sclerosis is helping some patients walk better, results from a new study show.


Scientists at Acorda Therapeutics, in Hawthorne, announced their results yesterday after finishing analysis of the study over the weekend. Patients on the medicine were walking consistently faster over a 14-week period than those on a placebo. Their leg muscles also seemed stronger.

This is a great drug and a great story," said Dr. Lauren Krupp, director of the pediatric MS center at Stony Brook University Hospital and co-director of the adult center. She treated 16 of her patients with Acorda's experimental drug. "We had great results," she said. "Our goal is to keep patients out of a wheelchair." Multiple sclerosis is an autoimmune disease that affects the central nervous system.Krupp said she first heard about the substance, now called Fampridine-SR, more than 20 years ago. The chemical was synthesized from coal tar in the 1890s. It took almost 100 years for scientists to discover its biological properties. It improves impulse conduction along nerve fibers.

Earlier versions of the medicine in the 1990s proved too toxic to test in humans. But its potential led Dr. Ron Cohen, president, chief executive and founder of Acorda, to take up the challenge. Elan Corp.,Acorda's research partner, created a safer, slow-release version.

Cohen's company has been testing it in humans for several years. The drug is in its final stages of clinical testing. It is also being tested as a treatment for spinal cord injuries.

Fampridine-SR doesn't prevent damage of the myelin sheath around the axons of nerves, which is the mark of MS. But it does increase the electrical signal along damaged fibers, allowing the proper messages to get through.

Patients recruited for the multicenter study had noticeable walking problems. Many already were using walkers or canes. At the end of three months, a third of the patients on the drug showed improvement in walking compared to 8.3 percent who were not taking it. The average increase in walking speed was 25 percent in those on the experimental drug compared with 4.7 percent of those on placebo.

http://www.newsday.com/news/health/ny-hsms264906761sep26,0,5…

[bernie55]

In fact, not only will he show you what to look for, he’ll even give you the names of six companies that fit the mold and are poised to make major gains for you.

And best of all, they’re companies you can invest in immediately.

Don’t wait another minute to learn how to create the wealth you’ve always dreamed of!


My Biotech Fantasy Team

By Brian Lawler
September 25, 2006


...neben AMGEN , GENENTECH , BIOGEN, GENZYME und VERTEX natürlich ELAN


Elan is best known for the trials and tribulations that the company has gone through with its multiple sclerosis drug Tysabri. Even though Tysabri is now on the market, the company is still going to need to grab another touchdown if it wants to escape from its $2 billion mountain of debt. Fortunately, Elan is at the forefront of Alzheimer's research and has a novel drug, AAB-001, in phase II trials. The company expects to announce results from a moderately sized phase II trial later this year. If successful, this will give the company the points it needs to win the biotech game.



http://www.fool.com/news/commentary/2006/commentary06092514.…

[bernie55]

Analyst Worries About Tysabri

By Althea Chang
TheStreet.com Staff Reporter
9/26/2006 11:40 AM EDT


Tysabri, the multiple sclerosis treatment from Elan (ELN - commentary - Cramer's Take) and Biogen Idec (BIIB - commentary - Cramer's Take), appears to be getting hit by the strict safety rules that accompanied the drug's reapproval by regulators, according to one analyst.
Deborah Knobelman of the research firm Piper Jaffray slashed her estimate for worldwide Tysabri sales to $21 million for this year, down from her previous $123 million expectation. According to her feedback from doctors, physicians' adoption rates of the drug were slower than she had anticipated in the U.S. because of safety concerns, reimbursement procedures and patient-monitoring requirements.

Tysabri was recleared by the Food and Drug Administration earlier this year after being taken off the market for fear it could be linked to a potentially fatal brain illness. Before the drug could again go on sale, its makers had to agree to meet a number of criteria dealing with safety monitoring for side effects.

"The current, and in our view, overvalued, [Elan] stock price is not reflective of our new 2006 Tysabri estimates," Knobelman wrote in a research report. "Even if Tysabri revenues reach $1 billion (our peak sales assumption), the stock's current valuation reflects almost double Tysabri's peak potential. We believe [Elan's] Q3 report will reflect our lowered estimates, which might close the stock price's valuation disconnect."

Knobelman maintained an underperform rating on Elan's shares, with a price target of $10. The stock was trading down 14 cents, or 0.9%, at $15.73 Tuesday. Biogen Idec's shares fell 7 cents, or 0.2%, to $44.64.


http://www.thestreet.com/_yahoo/newsanalysis/biotech/1031121…

...also, Knobelman, ich würde sagen, warten wir mal bis November, dann werden wir sehen, was Sache ist.....

[bernie55]

Elan and Transition Therapeutics Inc. Announce Global Collaboration to Develop and Commercialize Alzheimer's Disease Drug AZD-103


Wednesday September 27, 2:30 am ET


DUBLIN, Ireland & TORONTO--(BUSINESS WIRE)--Elan Corporation, plc ("Elan") (NYSE:ELN - News) and Transition Therapeutics Inc. ("Transition") (TSX: TTH - News), today announced an exclusive, worldwide collaboration agreement for the joint development and commercialization of a novel therapeutic agent, AZD-103, for the treatment of Alzheimer's disease. AZD-103 is a small molecule compound in Phase I clinical development that acts by breaking down and preventing the assembly of beta amlyoid fibrils, a hallmark pathology of Alzheimer's disease.



Under the terms of the agreement, Transition will receive upfront payments of US$15 million: US$7.5 million in 2006 and the remaining US$7.5 million in 2007. In addition, dependant upon the successful development, regulatory approval and commercialization of AZD-103, Transition will be eligible to receive milestone payments of up to US$185 million. Elan and Transition will share the costs and operating profits of AZD-103 if successfully developed and commercialized. Each party's cost share and ownership interest may vary throughout the term of the Agreement dependant on certain elections that may be made during the development of AZD-103.

"We are delighted to have this opportunity to work closely with Dr. Cruz and his team at Transition. The opportunity to advance this program to provide much needed therapeutic choice in the treatment of Alzheimer's will be a strategic priority and focus for all of us here at Elan. By joining forces, we increase our probability of success. The AZD-103 program represents a significant addition to our scientific portfolio and continues to reinforce our commitment and leadership in bringing more therapeutic choice to patients and their caregivers suffering from Alzheimer's around the world," said Kelly Martin, Chief Executive Officer and President of Elan.

"We are extremely pleased to have Elan as our collaborator in developing AZD-103. Elan shares our vision and commitment to develop an effective Alzheimer's disease therapy. We are confident this collaboration will allow us to fully achieve the potential of the disease-modifying compound AZD-103 and help make a difference in the lives of millions of Alzheimer's disease patients and their loved ones," said Dr. Tony Cruz, Chairman and Chief Executive Officer of Transition.

Conference Call

Transition will hold a conference call at 11:00am Eastern time on Wednesday, September 27th, 2006 to discuss today's news in more detail. This call is open to the public and can be accessed live either over the Internet from the company's website www.transitiontherapeutics.com or by dialling 1(888) 633-8341 or [phone].

About the AZD-103 Drug

AZD-103 is a novel therapeutic agent in Phase 1 clinical development for the treatment of Alzheimer's disease that has the potential to both reduce disease progression and improve symptoms such as cognitive function. As reported recently in a Nature Medicine publication, oral treatment with AZD-103 reduced accumulation of amyloid beta and amyloid beta plaques in the brain, and reduced or eliminated learning deficits in a leading transgenic mouse model of Alzheimer's disease. In addition, AZD-103 is well positioned as a potential Alzheimer's therapy as it is a small molecule, crosses the blood brain barrier and has exhibited a favorable safety profile.

About Alzheimer's disease

Alzheimer's disease is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. The disease affects more than 4 million Americans and approximately 20 million people worldwide, and with an aging population incidence of Alzheimer's disease is expected to double over the next 20 years. Currently approved Alzheimer's therapies treat some disease symptoms but do not reverse or slow down disease progression. These products have worldwide annual sales of US$3.1 billion; however, the Alzheimer's pharmaceutical market is expected to grow significantly with the arrival of products that have the potential to alter disease progression.

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.

About Transition

Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include regenerative therapies E1-I.N.T.(TM) and GLP1-I.N.T.(TM) for the treatment of diabetes, AZD-103 for the treatment of Alzheimer's disease, and HCV-I.E.T. for the treatment of hepatitis C. Transition has a strong pipeline of preclinical drug candidates developed using its proprietary drug discovery engine. Transition's shares are listed on the Toronto Stock Exchange under the symbol "TTH". For additional information about the company, please visit www.transitiontherapeutics.com.

Forward Looking Statement

This press release contains forward-looking statements regarding the collaboration agreement between Elan and Transition. These statements are based on Elan's and Transition's current beliefs and expectations. AZD-103 may not be successfully developed or commercialized under the collaboration agreement. Factors which could cause actual results to differ materially from Elan's and Transition's current expectations include the risks that clinical development of AZD-103 fails due to safety or efficacy issues, the results from preclinical testing of AZD-103 are not predictive of results obtained in clinical trials, that any patents will issue with respect to AZD-103 or that, even if issued, whether such patents would provide substantial protection or commercial benefit, the development and commercialization of competitive therapies, the collaboration agreement is terminated early or Elan and Transition 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. For more detailed information on the risks and uncertainties associated with Transition's drug development and other activities, see the risk factors and other cautionary statements discussed in Transition's quarterly and annual filings with the Canadian commissions. Elan and Transition assume 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
or
Transition Therapeutics
Dr. Tony Cruz, 416-260-7770, x.223
or
Mr. Elie Farah, 416-260-7770, x.203

--------------------------------------------------------------------------------
Source: Elan Corporation, plc and Transition Therapeutics Inc.

[bernie55]

This is report of one of several PhI trials. It mentions a recent Nature medicine publication which would be interesting......;



Aug 08, 2006

Transition Therapeutics Reports Results from Canadian Phase I Clinical Trial of Alzheimer's Disease Drug Product AZD-103


TORONTO, ON - Transition Therapeutics Inc. ("Transition") (TSX: TTH), announced today the results from a phase I clinical trial of its lead Alzheimer's disease drug product AZD-103. Thirteen healthy volunteers were dosed in the study to evaluate the pharmacokinetics, safety and tolerability of a single ascending dose of AZD-103. The study showed that AZD-103 has a favourable pharmacokinetic profile that supports the targeted therapeutic dosing levels for AZD-103. The safety data indicated that AZD-103 was well tolerated by all subjects. No safety concerns or significant adverse events were observed in the study.

The Phase I clinical development program for AZD-103 consists of a series of Phase I studies to establish the safety, tolerability and pharmacokinetic profile for AZD-103. Building on the results reported today, Transition has received FDA clearance and will commence a Phase I study to examine higher doses of AZD-103 (previously announced August 1, 2006). These and subsequent studies will position Transition to submit an application for a Phase II trial in Alzheimer's disease patients in early 2007.

About the AZD-103 Drug

The lead compound AZD-103 is part of an emerging class of disease-modifying drugs that have the potential to both reduce disease progression and improve symptoms such as cognitive function. As reported recently in a Nature Medicine publication, oral treatment of AZD-103 reduces accumulation of amyloid beta and amyloid beta plaques in the brain, as well as reduces or eliminates learning deficits in a leading transgenic mouse model of Alzheimer's disease. In addition, AZD-103 is well positioned as a potential Alzheimer's therapy as it can be taken orally, crosses the blood brain barrier and has a favorable safety profile.

[bernie55]

from NCB
http://ftp.ncb.ie/equities/092806.pdf

Novartis is presenting 2 year data (18-month extension of a 6 month study) with
FTY720, an oral treatment for relapsing multiple sclerosis, at ECTRIMS today. While
FTY720 is of relevance in the context of Tysabri, the design of the FTY720 extension
study leaves it difficult to compare the headline data announced this morning for
FTY720 with that available for Tysabri at 24 months.
• 24-month data for FTY720 does not include reduction in relapse rate although the data
did show that up to 77% of patients taking FTY720 remained free of relapses over two
years. With Tysabri 67% of patients remained relapse free after 2 years of treatment.
• Data previously presented with FTY720 showed that the c.55% reduction in relapse
rate which was achieved at 6 months was broadly maintained at 12-months. The data
reported at 6 months with FTY720 is comparable to the c.55% reduction in relapse rate
seen with Tysabri at 6-months in Phase II trials (the reduction in relapse rate for Tysabri
at 12 and 24 months was c.67%). Annualised reduction in relapse rates for the
interferon products is c.30%.
• Phase III trials with FTY720 for MS have started and is expected to enrol over 3,000
patients. As the long-term safety profile of FTY720 is currently unknown, the entire twoyear
data will be required by the FDA/EMEA for approval.
• Novartis has noted that FTY720 is associated with decreases in heart rate and an
elevation of a liver enzyme. Phase III studies are expected to further characterise the
safety profile of FTY720.

At best, the Phase III studies could see a launch of FTY720
for MS in H2 2009/H1 2010.
•

[bernie55]

New Data on TYSABRI(R) Presented at ECTRIMS Congress Demonstrate Significant Improvement in Cognitive Function in Patients with Multiple Sclerosis


Thursday September 28, 9:30 am ET

ZUG, Switzerland & DUBLIN, Ireland--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that data from the Phase III AFFIRM monotherapy study demonstrated that treatment with TYSABRI® (natalizumab) significantly reduced the proportion of multiple sclerosis (MS) patients with worsening cognitive function as measured by the 3-second Paced Auditory Serial Addition Test (PASAT 3). These data, presented at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, contribute to existing data which demonstrate the overall therapeutic benefits of TYSABRI, including its significant impact on relapse reduction, disability progression and MRI measures. TYSABRI has demonstrated a 68% relative reduction in the annualized relapse rate compared to placebo and a 42% reduction in the relative risk of disability progression, as published in the New England Journal of Medicine.

ADVERTISEMENT
Cognitive deficits are under-recognized and often misdiagnosed as depression, stress or other personality disorders. Studies have shown that approximately 43% to 65% of MS patients show measurable cognitive impairment in formal testing.(1) Cognitive dysfunction can occur early in MS and in patients with relatively mild physical disability. These deficits have a substantial effect on the daily functioning of patients. Areas impacted by cognitive dysfunction include memory, ability to process information and learning. (1),(2)

The AFFIRM study was a two-year, randomized, multi-center, placebo-controlled, double-blind study of 942 patients conducted in 99 sites worldwide, evaluating the effect of TYSABRI on the progression of disability and the rate of clinical relapses. Evaluating the effect of TYSABRI on cognitive function was a pre-specified endpoint of the AFFIRM study. Cognitive function was assessed using the 3-second Paced Auditory Serial Addition Test (PASAT 3), a test of auditory information processing. The study showed that treatment with TYSABRI reduced the risk of sustained cognitive worsening by 43% (p=0.013) when compared to placebo.

These cognitive function data complement the previously presented results of the AFFIRM study, which demonstrated a significant effect of TYSABRI on two-widely accepted health-related quality of life measures, the Short Form-36 Health Survey and the Visual Analogue Scale.

"Neuropsychological dysfunction significantly diminishes quality of life in many patients with multiple sclerosis, impacting everything from employment to social interaction. It is responsible for much hardship experienced by MS patients. The important positive effects of TYSABRI on cognitive functioning and quality of life add to the important benefits already reported on progression of disability and relapses. This provides strong evidence that observed neurologic benefits translate into important improvements as perceived by the patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic.

About TYSABRI

In the US, TYSABRI is approved as a monotherapy treatment for relapsing forms of MS. TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Patients should be monitored at regular intervals for any new or worsening signs or symptoms suggestive of PML. Because of the increased risk of PML, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternate MS therapies. It is available in the US only through a restricted distribution program called the TOUCH Prescribing Program. According to product labeling, after two years, TYSABRI treatment led to a 67% relative reduction (p<0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42% (p<0.001). TYSABRI treatment also resulted in sustained and statistically significant reductions in brain lesion activity as measured by MRI. Changes in MRI findings often do not correlate with changes in the clinical status of patients (e.g., disability progression). The prognostic significance of the MRI findings in these studies has not been evaluated.

In the European Union, TYSABRI is indicated as a single disease-modifying therapy in highly active relapsing-remitting MS patients. Because of the increased risk of PML, it is for patients with high disease activity despite treatment with a beta-interferon or in patients with rapidly evolving severe relapsing-remitting MS. According to product labeling in the EU, 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).

Serious adverse events that occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. 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. Herpes infections were slightly more common in patients treated with TYSABRI. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. 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.

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 oncology, neurology and immunology. As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. 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.

[Poppholz]

und hier die deutsche Übersetzung:



Business Wire
Neue Daten belegen auf dem MS-Kongress ECTRIMS bedeutende Verbesserungen der kognitiven Fähigkeiten bei Patienten mit Multipler Sklerose
Freitag 29. September 2006, 02:44 Uhr

ZUG, Schweiz & DUBLIN, Irland Wie Biogen Idec (NASDAQ: BIIB) und die Elan Corporation, plc (NYSE: ELN) heute bekannt gaben, zeigen die Daten der Monotherapiestudie PHASE III AFFIRM, dass die Behandlung mit TYSABRI(R) (Natalizumab) den Anteil der Multiple-Sklerose-Patienten mit eingeschränkten kognitiven Fähigkeiten, die mit dem Progressiven Auditiven Seriellen Additions-Test (PASAT 3) gemessen wurden, erheblich verringert hat. Diese neuen Daten, die auf dem 22. Kongress des Europäischen Komitees für die Behandlung und Erforschung der Multiplen Sklerose (ECTRIMS) in Madrid (Spanien) ANZEIGE

vorgestellt wurden, ergänzen zuvor erhobenes Datenmaterial, das bereits die therapeutische Wirksamkeit von TYSABRI insgesamt belegen konnte, einschließlich der deutlichen positiven Beeinflussung der Häufigkeit klinischer Schübe, der Progression der Behinderung und von MRT-ermittelten Veränderungen. TYSABRI zeigte laut New England Journal of Medicine eine relative Reduktion der Häufigkeit von klinischen Schüben auf Jahresbasis um 68% im Vergleich zu Placebo sowie eine Reduktion um 42% des relativen Risikos eines progressiven Behinderungsverlaufs. Defizite im kognitiven Bereich werden allgemein unterschätzt und häufig als Depression, Stress oder Persönlichkeitsstörungen fehldiagnostiziert. In Studien wurde nachgewiesen, dass etwa 43% bis 65% der MS-Patienten in formalen Tests messbare Beeinträchtigungen ihrer kognitiven Funktionen aufweisen.(1) Kognitive Dysfunktion kann im frühen Stadium der MS auftreten sowie bei Patienten mit relativ leichten körperlichen Behinderungen. Solche Einschränkungen haben substanzielle Folgen für den Alltag des Patienten. Eine kognitive Dysfunktion kann das Gedächtnis, die Fähigkeit zur Verarbeitung von Informationen oder die Lernfähigkeit betreffen. (1),(2) Die AFFIRM-Studie wurde als zweijährige, randomisierte, multizentrische, placebo-kontrollierte Doppelblindstudie mit 942 Probanten an 99 verschiedenen Orten weltweit durchgeführt, um die Wirkung von TYSABRI auf die Evolution der Behinderung und auf die Häufigkeit von klinischen Schüben zu untersuchen. Die Bestimmung des Einflusses von TYSABRI auf die kognitiven Funktionen wurde bereits vor Beginn der Studie als Ziel festgelegt. Die kognitiven Fähigkeiten wurden mithilfe des Progressiven Auditiven Seriellen 3-Sekunden-Additions-Test (PASAT 3)gemessen, der auf der Verarbeitung von auditiven Informationen basiert. Die Studie ergab, dass durch die Behandlung mit TYSABRI das Risiko einer anhaltenden Verschlechterung der kognitiven Funktionen im Vergleich zu Placebo um 43% (p=0,013) gesenkt wird. Die Daten der kognitiven Funktionen ergänzen die zuvor veröffentlichten Daten der AFFIRM-Studie, die eine erhebliche Wirkung von TYSABRI durch zwei in der Medizin anerkannte Methoden zur Bewertung der Lebensqualität nachweisen konnte: der Patientenfragebogen Short Form-36 Health Survey sowie die Visual Analogue Scale. "Eine neuropsychologische Dysfunktion verschlechtert dramatisch die Lebensqualität vieler MS-Patienten und beeinträchtigt unterschiedliche Lebensbereiche von der Erwerbstätigkeit bis hin zum gesellschaftlichen Leben. Sie ist daher für einen Großteil der Folgen verantwortlich, die Patienten mit Multipler Sklerose ertragen müssen. Die deutlichen positiven Wirkungen von TYSABRI auf die kognitiven Fähigkeiten und die Lebensqualität ergänzen die bereits bekannten Vorteile im Hinblick auf das Fortschreiten der Behinderung und das Auftreten klinischer Schübe. Damit ist nunmehr zweifelsfrei nachgewiesen, dass die beobachteten neurologischen Effekte durch den Patienten als spürbare Verbesserungen wahrgenommen werden", erklärte Richard Rudick, Doktor der Medizin und Leiter des Mellen Center for Multiple Sclerosis Treatment and Research an der Cleveland Clinic. Über TYSABRI In den USA ist TYSABRI zur monotherapeutischen Behandlung von klinischen Schüben der MS zugelassen. TYSABRI erhöht das Risiko einer progressiven, multifokalen Leukenzephalopathie (PML), einer opportunistischen Virusinfektion des Gehirns, die im Allgemeinen zum Tod oder zu schweren Behinderungen führt. Patienten sollten in regelmäßigen Abständen auf neue oder sich verstärkende Anzeichen und Symptome hin untersucht werden, die einen Verdacht auf PML begründen können. Aufgrund des erhöhten Risikos von PML ist TYSABRI grundsätzlich für Patienten geeignet, die unzureichend auf andere MS-Therapien ansprechen oder diese nicht vertragen. TYSABRI ist in den USA über ein eingeschränktes Vertriebsprogramm (das so genannte TOUCH-Verschreibungsprogramm) erhältlich. Laut der Produktinformation bewirkt TYSABRI auf Jahresbasis umgerechnet eine relative Reduktion der Häufigkeit klinischer Schübe um 67% (p<0,001) im Vergleich zu Placebo sowie eine Reduktion um 42% (p<0,001) des relativen Risikos eines progressiven Behinderungsverlaufs. Die Behandlung mit TYSABRI führt weiterhin zu einer nachhaltigen und statistisch relevanten Verringerung von MRT-ermittelten Hirnläsionen. Durch die MRT erfasste Veränderungen stimmen häufig nicht mit der Entwicklung des klinischen Zustands des Patienten überein (z.B. mit einem zunehmenden Behinderungsgrad). Die prognostische Signifikanz der MRT-Befunde wurde im Rahmen dieser Studien nicht untersucht. Innerhalb der Europäischen Union wird TYSABRI Patienten mit häufigen klinischen Schüben als einzelnes, den Krankheitsverlauf beeinflussendes Therapeutikum verabreicht. Wegen des erhöhten Risikos von PML ist TYSABRI für Patienten angezeigt, die trotz Betainterferon-Behandlung starke Symptome aufweisen, oder für Patienten mit schweren, stark progressiven klinischen Schüben. Laut der Produktinformation in der EU bewirkt TYSABRI auf Jahresbasis umgerechnet eine relative Reduktion um 68% (p<0,001) der Häufigkeit klinischer Schübe im Vergleich zu Placebo sowie eine Reduktion um 42-54% (p<0.001) des relativen Risikos eines progressiven Behinderungsverlaufs. Zu den wesentlichen nachteiligen Vorfällen, die bei Patienten während der TYSABRI-Therapie beobachtet wurden, zählen hypersensible Reaktionen (z.B. Anaphylaxie), Infektionen, Depression und Gallensteine. In MS-Versuchen waren das Auftreten und die Häufigkeit von anderen schweren nachteiligen Nebenwirkungen einschließlich der Gesamtzahl und die Häufigkeit von Infektionen unter den verschiedenen Behandlungsgruppen ausgeglichen. Herpes-Infektionen traten geringfügig häufiger bei Patienten auf, die mit TYSABRI behandelt wurden. Schwere opportunistische und andere atypische Infektionen wurden bei TYSABRI-behandelten Patienten beobachtet, wobei einigen von ihnen gleichzeitig Immunsuppressiva verabreicht wurden. Zu den häufigen unerwünschten Nebenwirkungen, die bei TYSABRI-behandelten Patienten auftraten, zählen Kopfschmerzen, Erschöpfung, Infusionsreaktionen, Harnwegsinfektionen, Gelenk- und Gliederschmerzen, Infektionen der unteren Atemwege, Hautausschläge, Magen-Darm-Entzündungen, Unterleibsbeschwerden, Vaginitis und Durchfall. Weitere Informationen sind im Internet auf www.tysabri.com , www.biogenidec.com oder www.elan.com erhältlich sowie telefonisch unter [phone]. Über die Biogen Idec Die Biogen Idec setzt neue Behandlungsstandards in den Bereichen Onkologie, Neurologie und Immunologie. Als einer der weltweiten Marktführer bei der Entwicklung, Herstellung und Vermarktung neuer Therapien setzt Biogen Idec neue wissenschaftliche Erkenntnisse in innovative Produkte zur Gesundheitspflege um. Produktkennzeichnungen, Pressemitteilungen und weitere Informationen sind auf der Website des Unternehmens unter http://www.biogenidec.com abrufbar. Über Elan Die Elan Corporation, plc ist ein Biotechnologie-Unternehmen mit neurowissenschaftlicher Ausrichtung und strebt danach, das Leben der Patienten und ihrer Familien zu verbessern. Das Unternehmen setzt sich dafür ein, wissenschaftliche Innovationen für ernste, nicht gelöste medizinische Probleme nutzbar zu machen, da diese nach wie vor weltweit anzutreffen sind. Die Aktien von Elan werden an den Börsen in New York, London und Dublin gehandelt. Weitere Informationen über das Unternehmen sind unter www.elan.com abrufbar. Safe Harbor-Erklärung/Vorausschauende Aussagen Diese Pressemitteilung enthält vorausschauende Aussagen über TYSABRI. Diese Aussagen stützen sich auf gegenwärtige Erwartungen und Annahmen des Unternehmens. Das kommerzielle Potenzial von TYSABRI unterliegt einer Reihe von Risiken und Unwägbarkeiten. Zu den Faktoren, aufgrund derer die tatsächlichen Ergebnisse in starkem Maße von den derzeitigen Erwartungen des Unternehmens abweichen können, gehören das Risiko, dass wir nicht in der Lage sein könnten, während der zulassungsrechtlichen Verfahren adäquat auf die Bedenken oder Fragen der FDA oder der europäischen Zulassungsbehörden zu reagieren, dass sich aus den zusätzlichen Daten oder Analysen Bedenken ergeben könnten, dass die Häufigkeit von PML oder opportunistischen Infektionen von TYSABRI-behandelten Patienten die in den klinischen Studien beobachteten Werte übersteigt oder dass die Unternehmen mit anderen, unerwarteten Verzögerungen oder Hürden konfrontiert werden. Die Entwicklung und die Vermarktung von Medikamenten beinhalten ein großes Risiko. Ausführlichere Informationen über die Risiken und Unwägbarkeiten in Verbindung mit der Medikamentenentwicklung und anderen Aktivitäten der Unternehmen sind in den Berichten enthalten, die Biogen Idec und Elan regelmäßig bei der US-Börsenaufsichtsbehörde Securities and Exchange Commission" eingereicht haben. Die Unternehmen übernehmen keine Verpflichtung, vorausschauende Aussagen zu aktualisieren, sollten sich neue Informationen, Ereignisse o. ä. ergeben. (1) Rao SM, et al. Neurology. 1991;41:685-691 (2) Amato MP, et al. Arch Neurol. 1995;52:168-172
Kontakt

Für Medienvertreter: Biogen Idec Amy Brockelman, Tel.:
[phone] oder Katja Buller, Tel.: [phone] oder Elan Davia
B. Temin, Tel.: [phone] oder Elizabeth Headon, Tel.:
[phone] oder Für Investoren: Biogen Idec Eric
Hoffman, Tel.: [phone] oder Elan Emer Reynolds,
Tel.: [phone] oder Chris Burns, Tel.: [phone]


http://de.biz.yahoo.com/29092006/240/daten-belegen-ms-kongre…

[bernie55]

@Cyberhexe

Was hälst du von dieser Studie bzw Ergebnissen ???
Ist die Indikation für eine Behandlung mit Tysabri in irgendeiner Form davon betroffen ???
Wird mit COPAXONE eine andere Patientengruppe behandelt ????


Study Showed Significant and Sustained Efficacy Of COPAXONE(R) Alone Following Short-Term Combination Therapy With IV Steroids in Multiple Sclerosis Patients
Friday September 29, 1:00 am ET

New Data on COPAXONE(R) in Combination Use Presented as Late-Breaking News at ECTRIMS

http://biz.yahoo.com/bw/060929/20060928005593.html?.v=1


JERUSALEM--(BUSINESS WIRE)--A new study showed that continuing treatment with COPAXONE® (glatiramer acetate injection) alone, produced pronounced, early and sustained effects on disease activity, following 6 months combination therapy with IV steroids. Multiple sclerosis (MS) patients (n=89) with very active disease, having an average of 5.4 gadolinium (T(1)-W Gd) enhancing lesions at entry as measured by magnetic resonance imaging (MRI) experienced a 65% reduction (p less than 0.0001) in lesions during treatment with COPAXONE® and IV steroids in the first six months of the study. This reduction was sustained for an additional six month period when patients received COPAXONE® alone.
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These data were presented yesterday as late-breaking news at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), in Madrid, Spain.

Patients in this study also experienced a reduction in mean annualized relapse rate (ARR) from the pre-study baseline of 1.65 +/- 0.74 down to 0.55 and 0.45 during the first and the second study periods, respectively. Results also showed that patients who completed the study experienced a significant decrease in mean converted Kurtzke Expanded Disability Status Scale (EDSS) score as measured after 12 months of treatment as compared to baseline (-0.15, 95 percent CI, -0.13, p=.0323).

"In this patient population with highly active disease as shown by baseline MRI scans, the rapid and significant reduction of brain lesions achieved with COPAXONE® combined with short-term IV steroid was sustained for an additional six months with COPAXONE® alone," said Clive Hawkins, D.M., F.R.C.P., Professor of Clinical Neurology, Keele University, Consultant Neurologist to the Regional Neuroscience Centre, Stoke-on-Trent, UK and the lead investigator in this study. "These data may be important for physicians making decisions on how to treat patients with very active disease as characterized by frequent or disabling relapses, or those who do not respond optimally to traditional first-line therapies." added Hawkins.

About the Study

This open-label, one-arm study examined short-term combination therapy of COPAXONE® and the IV steroid methylprednisolone (IVMP), followed by ongoing treatment with COPAXONE® alone. Patients with at least two T(1)-weighted gadolinium (T(1)-W Gd) enhancing lesions and an EDSS score of less than or equal to 4.0 at the time of screening received COPAXONE® (glatiramer acetate injection) 20mg once daily along with monthly 1g IVMP for six months. After six months, patients continued to receive COPAXONE® alone for an additional six months.

Disease activity assessed by MRI scans in the first six month period demonstrated a 65 percent reduction (p less than 0.0001) in the number of T(1)-W Gd-enhancing lesions from baseline. This reduction was sustained in the second six month period and showed no statistical difference from the change achieved in the first six months (ratio 0.75) as shown by a non-inferiority analysis for the change.

Adverse events throughout the 12-month study period were similar to the safety profile of COPAXONE® alone.

Teva will be issuing a press release regarding additional data presented at ECTRIMS on the efficacy and safety of COPAXONE® treatment after induction therapy with mitoxantrone, which will be posted at www.tevapharm.com.

About COPAXONE®

Current data suggest COPAXONE® (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONE® is indicated for the reduction of the frequency of relapses in RRMS. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.

COPAXONE® is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONE® is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONE® is marketed by Teva Neuroscience, Inc.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva`s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic products, the impact of competition from brand-name companies that sell or license their own brand products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic product, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the reintroduction of Tysabri® into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

[bernie55]

ein Artikel von NBC:

http://www.rte.ie/business/2006/Morningrep/download/0929ncb.…


Tysabri data presented yesterday at ECTRIMS from the Phase III monotherapy
AFFIRM study showed that treatment with the drug reduced the proportion of MS
patients with worsening cognitive function (as measured by the 3-second Paced
Auditory Serial Addition Test). Evaluating the effect of Tysabri on cognitive function was a pre-specified endpoint of the monotherapy study. Specially, this study showed that treatment with Tysabri reduced the risk of cognitive function worsening by 43% when compared to placebo. The cognitive function data complements the previously presented quality of life measures adds to the relapse and progression of disability data.

• An update is expected on the rollout of Tysabri later next month. With considerable administrative detail behind the TOUCH prescribing program in the US, we expect use of Tysabri to be limited until at least Q4 2006 and for the rollout to be considerably slower than was seen following its initial approval in November 2004. The rollout of Tysabri is been phased with the ultimate focus of the launch program on 2000 infusion sites and 2,500 physicians that represent over 50% of MS treated patients.

To date over 600 infusion centres have been registered in the US. In Europe, Tysabri has been launched in Germany, UK, Ireland, Denmark, Sweden, the Netherlands, Austria, Finland and Norway.

[Cyberhexe]

http://www.bbbiotech.com/index.php/bbbiotech_de/content/down…

[Cyberhexe]

Antwort auf Beitrag Nr.: 24.490.177 von Cyberhexe am 08.10.06 14:00:59

Optics tests for early Alzheimer's diagnosis make significant advances



http://www.eurekalert.org/pub_releases/2006-10/osoa-otf10030…

[Cyberhexe]

Antwort auf Beitrag Nr.: 24.490.177 von Cyberhexe am 08.10.06 14:00:59

http://www.mult-sclerosis.org/prev_tab.html

[Cyberhexe]

...allerdings auch dieses:


Davy Cuts Elan Tysabri 06 Rev Forecast


http://www.newratings.com/analyst_news/article_1381624.html

[Cyberhexe]

Smaller is Better


Oct 1, 2006
By: Jason McKinnie
Pharmaceutical Executive





Pages | 1 | 2



Nanobiotechnology Manufacturing Techniques

Elan Corporation is one of the most successful nanobiotechnology integrators, with four partnered drugs on the market. Elan's proprietary NanoCrystal technology utilizes a wet-milling technique to reduce the drug crystal size to 1,000 nanometers. At this small size, the greater surface area of the crystals increases the solubility of the drug. The latest company to adopt Elan's technology is Abbott Laboratories, which uses it for TriCor (fenofibrate), a cholesterol-lowering drug. Previously, TriCor had to be taken with food at a higher dose, but this third-generation TriCor allows the patient to take a lower dose at a convenient time. This strategy not only has the potential to improve patient compliance, it has fended off potential generic manufacturers. Generic drug makers can reproduce the active ingredient, but they are not allowed to copy the enhanced nanobiotechnology delivery system. Elan also helped transform Rapamune (sirolimus), a Wyeth drug used to counteract organ rejection, from an oral suspension to a simple pill.


http://www.pharmexec.com/pharmexec/article/articleDetail.jsp…

[Cyberhexe]

Antwort auf Beitrag Nr.: 24.553.416 von Cyberhexe am 11.10.06 10:36:59

goodbody
...we have pulled back our FY06
and FY07 revenue estimates to $25.7m and $664.7m from $88.2m and $895.0m respectively.


...ich kann das einfach nicht glauben, dass das wirkungsvollste aller MS-Medikamente sich nicht besser am Markt behaupten soll.
Aber wahrscheinlich bin ich halt doch meistens zu optimistisch!!

[Cyberhexe]

664.7 Mill $ in 2007 entsprechen ca. 23500 Jahresdosen

Dies würde bedeuten, dass bei weltweit über 1 Mio MS-Erkrankten nicht einmal jeder 40 mit dem mit Abstand wirkungsvollsten aller zur Verfügung stehenden Medikamente behandelt werden würde.
Kaum zu glauben!

[bernie55]

Antwort auf Beitrag Nr.: 24.558.475 von Cyberhexe am 11.10.06 14:34:15

664.7 Mill $ in 2007 entsprechen ca. 23500 Jahresdosen

..das sind doch erst mal Prognosen....die MS Betroffenen werden schon aktiv .......


aus MSPatientsForChoice.org


MS is a devastating disease that affects up to two million people worldwide.

• Effective MS treatment options are limited.

• We deserve the right to have the choice whether to take drugs to treat our disease or not to take drugs to treat our disease.

• If we choose drugs to treat our disease, then we want the right to choose which drugs to take.

• It is extremely important for patients to be fully informed as to the pros and cons of each treatment option.

• We all have an obligation to ourselves and our families to ensure that we are properly and fully informed.

• Many of us have injected ourselves with interferons or Copaxone®, and some of us have even had to resort to chemotherapy.

• Despite evidence that these treatments provide marginal benefit and have significant side effects, our governments have given us the option to choose these treatments.

• When an effective new drug exists that appears to be reasonably safe, we as patients would like that drug to be available as an option for our treatment.

• Tysabri appears to be the most effective treatment option for MS, based on two years of clinical data, and we want the ability to choose Tysabri as our treatment option.

• There is overwhelming evidence that Tysabri is extremely safe and effective.

• We feel that a reasonably safe and effective treatment option should not be blocked or delayed by the FDA or the competing companies in the pharmaceutical industry that market the less effective and older treatment alternatives.

• We feel the decision for our treatment should be ours, after fully informing ourselves and consulting with our physicians.

• The pharmaceutical industry, the medical establishment and government regulators must give us the tools to decide on our treatment options, so we can build a future with hope.

• We feel MS sufferers are being denied access to one of the most effective treatments for multiple sclerosis.

• What we insist on is the right to choose to be treated with Tysabri as soon as the current review can be completed.

• MS sufferers deserve choice.

http://www.mspatientsforchoice.org/opinion.htm" target="_blank" rel="nofollow ugc noopener">http://www.mspatientsforchoice.org/opinion.htm

[Cyberhexe]

Wide Receivers: Vertex and Elan
The final important position on any fantasy football team is wide receiver. Wide receivers are fast and athletic players. They don't get the ball as often as running backs, but they always have the potential to score a touchdown on a big play. This analogy aptly describes the prospects for biotech firms Vertex Pharmaceuticals (Nasdaq: VRTX) and Elan (NYSE: ELN).

Elan is best known for the trials and tribulations that the company has gone through with its multiple sclerosis drug Tysabri. Even though Tysabri is now on the market, the company is still going to need to grab another touchdown if it wants to escape from its $2 billion mountain of debt. Fortunately, Elan is at the forefront of Alzheimer's research and has a novel drug, AAB-001, in phase II trials. The company expects to announce results from a moderately sized phase II trial later this year. If successful, this will give the company the points it needs to win the biotech game.

http://www.fool.com/news/commentary/2006/commentary06092514.…

[Cyberhexe]

Eine weitere Einnahmequelle könnten Lizenzzahlungen für Abraxane sein. Elan hat Abraxis auf Lizenzzahlungen für die Inanspruchnahnme deren patentierter Nanotechnologie bei der Formulierung von Abraxane verklagt. Abraxane soll in 2006 über 600 Mio $ Umsatz generieren , wofür bei einem für Elan positiven Entscheid Lizenzgebühren zwischen 5 bis 10% fällig werden. Mit den Umsätzen aus 2005 und den zukünftigen Umsätzen mit extrem steigender Tendenz sind die möglichen Lizenzzahlungen nicht nur Peanuts.
Und in der Nanotech-Pipeline sind so um die 30 Wirkstoffe, teils in eigener Entwicklung teilweise in Kooperation, wodurch eine kleine "cash cow" zu gedeihen scheint:

http://www.elan.com/EDT/Announcements/



Elan Sues Abraxis Over Drug Patent
Thursday July 20, 5:25 pm ET
Elan Sues Abraxis Bioscience for Patent Infringement on Cancer Drug


WILMINGTON, Del. (AP) -- Irish drug maker Elan Corp. has accused rival Abraxis Bioscience Inc. of infringing its patents by selling the breast cancer treatment Abraxane.
A lawsuit filed Wednesday in a Delaware federal court says Abraxane, a nano-particle formulation of paclitaxel, trespasses on two patents issued in the 1990s that cover methods of formulating anticancer drugs.

Abraxis is a Los Angeles-based biopharmaceutical company formed by the merger of American Pharmaceutical Partners and American BioScience. It recorded $134 million in Abraxane sales in 2005, the first year the drug was approved as a treatment for metastatic breast cancer.

A spokeswoman for Abraxis wasn't immediately available to comment on Elan's lawsuit.

In April, British drug company AstraZeneca announced it would co-promote the drug Abraxane, which is designed to maximize the delivery of cancer-fighting compounds while minimizing toxicity.



erwarteter Umsatz mit Abraxane in 2006:

While APP had a fairly strong business making generic drugs before, analysts expect Abraxane to push revenues up 50%, to $609 million, this year.

[Nostarowie]

...tschuldigung

[bernie55]

from Goodbody


Elan - Collaborating with Michael J Fox Foundation on
Parkinson’s.

Analyst: Ian Hunter T [phone] E [e-mail]

The Michael J Fox Foundation for Parkinson’s Research (MJFF) yesterday announced it was
committing $2m for research projects to drive the development of disease-modifying therapies
for Parkinson’s Disease. Its new initiative - “Novel Approaches to Drug Discovery for Parkinson’s
Disease” - is being backed by Elan, who has committed to work with MJFF grant recipients in
carrying their work forward as quickly as possible through follow-on funding and partnership of
promising programmes. Elan has been committed to the development of drugs for the treatment
of Parkinson’s for some years and the collaboration with this leading Foundation illustrates its
continued commitment to developing therapies in an indication other than MS and Alzheimer’s.

http://www.rte.ie/business/2006/Morningrep/download/1012good…

[bernie55]

...alles wie gehabt...Seitwärtsbewegung

Abschlusskurs: 15,61 USD
+0,06
+0,39 %

[tippse]

Die aktuelle Ausgabe von "FOCUS-Money" (Ausgabe 42/2006) widmet ihre Titelstory den Biotechs ("Der neue Biotech-Boom"). Hier ist auf Seite 30 folgendes (indirekt) über Elan zu lesen:

" Bei Erkrankungen des zentralen Nervensystems tut sich ebenfalls einiges - Biotech sei Dank. Ganz groß im Geschäft ist Biogen Idec. Das Unternehmen bekam im Sommer die Zulassung für das Multiple-Sklerose-Mittel Tysabri. Spätestens 2009 dürfte das Medikament zum Blockbuster aufsteigen, also Jahresumsätze von mehr als einer Milliarde Dollar erwirtschaften..."

So langsam zeichnet sich also hier und da in der Medienwelt wieder ab, dass mit Tysabri ernsthaftes Umsatzpotenzial zu erwarten ist.

Bei einer Umsatz-Miliiarde ($) in 2009 komme ich auf ca. 35.000 Patienten weltweit. Dies dürfte m.E. immer noch ziemlich konservativ sein.

[Birgit.Tersteegen]

Antwort auf Beitrag Nr.: 24.642.123 von tippse am 15.10.06 19:13:10

Hi Tippse!

Klasse Fund! Gruss und Welcome in Elanville Birgit