Elan nach positiver Tysabri-Studie +22% - 500 Beiträge pro Seite

[GlobalFinanz]

13.04.2005 09:20
Elan nach positiver Tysabri-Studie +22%

Die beiden Biotechnologiepartner Biogen Idec und Elan Corp. (Nachrichten) präsentierten am Dienstag nach Börsenschluss vor dem American Academy of Neurology Phase III-Daten, wonach deren vom Markt genommenes Multiple Sklerose-Präparat Tysabri das Fortschreiten des Kranhkeitsverlaufes deutlich bremst.

Elan konnten infolge jener Meldung nachbörslich um 22,02% auf 4,60 USD durch die Decke gehen. Biogen legten nachbörslich um 1,5% auf 37,25 USD zu

In Frankfurt steht Elan auch schon wieder mit mehr als 20 % im Plus.

Ich sehe hier gute Chancen auf eine Wiederzulassung des Medikaments durch die FDA.

Zudem dürfte Elan bei vielen Shorties noch ganz oben auf der Lsite stehen. Dies dürfte für weiteren Antrieb sorgen.

[LuisDega]

Kursziel 5 Euro in den nächsten Tagen.

[calibra21]

WKN???

[GlobalFinanz]

[posting]16.362.905 von calibra21 am 13.04.05 11:41:31[/posting]Klick doch einfach mal oben rechts auf ELAN Corp.

903801

RT 3,53

[GlobalFinanz]

Dow Jones/vwd
Elan/Biogen Idec legen positive Zweijahresstudie zu Tysabri vor
Mittwoch 13. April 2005, 08:47 Uhr


DUBLIN (Dow Jones-VWD)--Die Elan Corp plc, Dublin, und die Biogen Idec Inc, Cambridge, haben am Dienstag eine zweijährige Studie vorgestellt, nach der ihr umstrittenes Medikament " Tysabri" das Fortschreiten vom Multipler Sklerose (MS) deutlich bremsen soll. Analysten sind sich jedoch uneins, ob das kürzlich vom Markt genommene MS-Medikament wieder verkauft werden wird. Laut einer Präsentation vor dem American Academy of Neurology hemmte die Behandlung mit Tysabri in 42% der Fälle das Anzeige

Fortschreiten der Krankheit im Gegensatz zu den Patienten, die ein Placebo genommen hatten. Zudem habe es nur wenige Fälle von Immunität gegeben.

Als Nebenwirkungen benannten die Unternehmen Kopfschmerzen, Müdigkeit, Harnwegsinfektionen, Depressionen, Infektionen der Atemwege und Gliederschmerzen. Laut Goodbody-Strockbrokers-Analyst Ian Hunter werden die jüngsten Daten jedoch von dem Rückzug des Medikamentes überschattet. Elan und Biogen Idec hatten Ende Februar das Medikament vom Markt genommen, nachdem Fälle einer seltenen neurologischen Krankheit bekannt geworden waren, die im Zusammenhang mit der Einnahme des Präparats stehen sollen. Tysabri war erst im vergangenen November von der FDA auf Basis einer einjährigen Studie gegen MS zugelassen worden.

David Marshall, Analyst von NCB Stockbrokers, schätzt hingegen, dass Tysabri durchaus noch eine kommerzielle Zukunft hat. Der für die Entwicklung zuständige Executive Vice President von Biogen Idec, Burt Adelman, ist sich weiterhin sicher, dass Tysabri einen " erheblichen therapeutischen Vorteil" für MS-Kranke bringt. -Von Quentin Fottrell, Dow Jones Newswires; [phone], [e-mail] (ENDE) Dow Jones Newswires/13.4.2005/DJN/nas/rio


David Marshall, Analyst von NCB Stockbrokers, schätzt hingegen, dass Tysabri durchaus noch eine kommerzielle Zukunft hat. Der für die Entwicklung zuständige Executive Vice President von Biogen Idec, Burt Adelman, ist sich weiterhin sicher, dass Tysabri einen " erheblichen therapeutischen Vorteil" für MS-Kranke bringt.

Bei einem RT von 3,53 heißt es daher KAUFEN!!

[calibra21]

und was ist mit dieser WKN???: WKN:871331 ist die falsch?

[Cyberhexe]

positiv ist vor allem, dass bereits von 1500 Studienteilnehmen (= ca. 50%) MRIs aufgenommen worden sind ohne auf weitere PML-Verdachtsmomente aufmerksam zu werden; sollte sich dies bestätigen und das Auftreten von PML auf Effekte im Zusammenhang mit CRABs, Steroiden oder anderen Immunsuppressiva (Azathioprin) reduzieren lassen, dann wird das zukünftige Potenzial von Tysabri enorm sein. Denn bei der Wirksamkeit ist Natalizumab den bisherigen Medikamenten (CRAB) um den Faktor 2 überlegen.

Ich wünsche dies nicht zuletzt auch den vielen MS-Erkrankten!

[calibra21]

und was ist mit dieser WKN???: WKN:871331 ist die falsch?

[zenman]

871331 sin die in amiland handelbaren shares

903801 sin in dublin und london handelbar

[BrauchGeld]

Hi

Ich würde mit dem kaufen noch warten ,so wie es aussieht wird Tysabri nicht so schnell auf den Markt kommen.


UPDATE 2-Elan leaps, but no early return seen for MS drug
Wed Apr 13, 2005 06:57 AM ET
(Adds analyst`s comment, updates share price)
By Paul Hoskins

DUBLIN, April 13 (Reuters) - Ireland-based Elan Corp`s (ELN.I: Quote, Profile, Research) battered shares leapt over 20 percent on Wednesday after a clinical trial confirmed the effectiveness of its suspended Tysabri multiple sclerosis drug, reviving hopes it may return to the market.

But industry analysts said the news did not address the safety problems that had led to its withdrawal and an early comeback looked unlikely.

"This confirms Tysabri`s significant benefit for patients," said Richard Parkes of ING Financial Markets. "But it doesn`t change the fact that we have now seen three cases of a potentially fatal side effect.

"The risk-benefit profile at the moment looks unattractive," added Parkes, who rates the stock a "sell".

Elan shares, which slumped 90 percent in the wake of the drug`s withdrawal in February after a patient died, were up 18 percent at 3.48 euros in Dublin by 1037 GMT and 19.3 percent stronger at 3.46 euros in London, following an earlier high of 3.82.

Elan (ELN.L: Quote, Profile, Research) , which nearly collapsed three years ago, has staked much of its revival hopes on Tysabri.

Elan and its U.S. partner Biogen Idec (BIIB.O: Quote, Profile, Research) said late on Tuesday that a two-year trial of 942 patients found that Tysabri reduced by 42 percent the risk of greater disability compared with a placebo. The drug also cut relapse rates by 67 percent.

After two years 29 percent of placebo-treated patients saw their disability worsen, compared with 17 percent of Tysabri-treated patients, according to the study presented at a meeting of the American Academy of Neurology in Miami.


TOO RISKY?

Analysts said Elan and Biogen still faced a tough uphill battle, however, to persuade the U.S. Food and Drug Administration that any risks associated with Tysabri could be outweighed by the benefits.

"Patients will only be willing to try it, and importantly doctors will only be willing to prescribe it, if this risk can be defined," Jack Gorman, analyst at Davy Stockbrokers in Dublin, wrote in a research note.

Having only been launched late last year, Tysabri was suspended from the market and from clinical trials at the end of February after a patient died from the rare brain infection progressive multifocal leukoencephalopathy.

A second patient was later determined to have died from the same infection while a third was diagnosed with it but lived.

The companies said their evaluation of Tysabri continued and repeated that they were working with the FDA to determine the drug`s future.

In terms of safety, Tuesday`s trial results showed side effects to be limited, with serious infections in 3.2 percent of patients versus 2.6 percent of placebo patients. Hypersensitivity occurred in less than one percent of patients.

But even if Tysabri does make a comeback, the drug looks to have lost its blockbuster potential for good, analysts said.

"The best case is probably that this drug gets back to the market at some point and is restricted to those patients that aren`t responding to other therapies," said ING`s Parkes.

"In that case it could be a $500 million drug -- but we would view that as quite unlikely," he said of a treatment once tipped as a product that could sell more than $2 billion a year.

Stock in Switzerland`s Serono SA (SEO.VX: Quote, Profile, Research) , which makes rival drug Rebif, was down 0.7 percent at 845.50 Swiss Francs while Schering (SCHG.DE: Quote, Profile, Research) , the German maker of MS treatment Betaseron, fell 0.2 percent to 52.65 euros.

[calibra21]

Danke. Ich habe mir nämlich die WKN 971331 ins Depot gelegt. Habe sie aber in Deutschland gekauft. Ist aber kein Problem oder?

[zenman]

die 971331 is schon en problem

[calibra21]

Das Elan heute 30-40% Plus macht ist doch klar. Die Meldung sorgt für Kursfantasie.

[calibra21]

@zenman. Und warum ist die 971331 ein Problem?

[zenman]

gibs mal ein
dann siehstes

[calibra21]

Ich sehe kein Problem. Sag´s mir halt einfach!


http://www.finanztreff.de/ftreff/kurse_einzelkurs_uebersicht…

[Leono01]

Ich hab mir gerade ein Paar zu 3,38€ ins Depot gelegt, denke war kein Fehler..;-)

Mein Ausgang ist bei 3,20€, da Gier schneller greift als Angst durften wir Heute ne schöne Performance hinlegen in Amiland, oder? :-)

Übrigens Zeni, Neid und Spott muss man sich erarbeiten!
Schwamm über deinen Trade von Gestern!!!

Grüße
Leono

[zenman]

ich helf dir
also
gib ein
9
7
1
3
3
1

nu guck was raus kommt

[calibra21]

*g* sorry. Hättest mich ja gleich drauf bringen können. Ich dacht schon

[zenman]

blödeln muss sein

[GlobalFinanz]

RT vorbörslich in US 4,50

RT in D 3,44

Kurs zieht mit US Vorgaben wieder gut an. TT 3,30

[walterdergenaue]

Meldung bei Consors 16,35 Uhr Elan veröffentlichte eine Studie , welche das Multiple-Sklerose-Medikament als wirksam einstuft.

Gute Geschäfte für alle Walter

[Marktinsider]

So, ich habe soeben meine 500 Stück Elan (ELN.NYS / 2307237 / US2841312083) verkauft und bin der Meinung, dass dies eine gute Entscheidung war. Immerhin bin ich seit 3.10 USD dabei, was einem Gewinn von 500 USD oder über 30% exkl. Kommissionsgebühren bedeutet. Damit bin ich zufrieden. Viele Leute vergessen, Gewinne zu realisieren. Werdet nicht zu gierig! In meiner Vergangenheit war meine Gier zu gross und ich vergass, meine Gewinne mitzunehmen. So wurden aus +60% schon wieder einmal +10%.

Also: Rechtzeitig verkaufen! Allen investierten Leuten trotzdme weiterhin schöne Gewinne. Doch der Kurs entwickelt sich sehr langsam jetzt. Das gefällt mir jetzt nicht.

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Elan shares leap as investors take bet on MS drug

Fri Apr 29, 2005 11:55 AM ET

DUBLIN, April 29 (Reuters) - Shares in Elan Corp (ELN.I: Quote, Profile, Research) jumped 19 percent on Friday as traders said investors with high-risk appetites were betting that its suspended Tysabri multiple sclerosis drug could ultimately make a comeback. "There`s no specific news but it looks like people are betting on the possibility it will return to the market," said one Dublin-based trader. "You can very easily have a $8 share price if you put some Tysabri sales back into the models."

Shares in Ireland-based Elan (ELN.N: Quote, Profile, Research) were up 18 percent at 4.20 euros ($5.43) in Dublin by 1536 GMT, outperforming a 0.4 percent higher Irish market index but 80 percent below their 2005 high, having collapsed following Tysabri`s withdrawal.

Elan (ELN.N: Quote, Profile, Research) halted sales of Tysabri on February 28 after a patient died from a rare brain infection. The company is currently conducting safety studies to establish whether there is a connection.

Davy analyst Jack Gorman, whose company acts as a stockbroker for Elan, said in a research note that both Elan and its U.S. partner Biogen Idec (BIIB.O: Quote, Profile, Research) sounded confident this week that Tysabri could find its way back onto the market.

"Our view is still that the Elan share price is assuming little or no chance of a return for Tysabri, and that a trading opportunity is thus available despite the limited near-term visibility on the product`s fate."

Gorman said that while the risks were high, giving the drug a 10 to 50 percent chance of returning to the market with peak annual sales of $400 million to $1.6 billion would add as much as $5 to his $3.82 per share sum-of-the-parts valuation.

The stock was 14.9 percent higher at $5.39 in New York.

Posting first-quarter results on Thursday, Elan Chief Executive Kelly Martin told Reuters in an interview that he believed the treatment would ultimately return.

"I certainly believe that, given the unmet medical need and given the efficacy of Tysabri, that this will ultimately be back in the hands of patients and their doctors."

But analysts believe it could be months before Tysabri`s fate becomes clearer with safety studies due to conclude in late summer at which point Elan will begin discussions with the Food and Drug Administration in the U.S. to determine its future.

"You`ve got to have a high-risk appetite but obviously if Tysabri comes back to the market there`s still a lot of upside for the shares," said another Dublin-based analyst. "Both Elan and Biogen management have certainly sounded pretty upbeat."

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[welke91]

BOSTON (MarketWatch) -- It`s been nearly three months since Biogen Idec Inc. voluntarily pulled its multiple sclerosis drug Tysabri from the market over safety concerns, but the company holds out hope the treatment will make a comeback.




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Not only does Cambridge, Mass.-based Biogen continue to maintain inventories of the drug, it also has retained its nearly 100 Tysabri salespeople along with its marketing team.

And at least for now, Biogen (BIIB: news, chart, profile) still produces Tysabri, albeit at a lower rate. Biogen co-markets Tysabri with Irish drugmaker Elan Corp. Plc. (ELN: news, chart, profile)

"We have a pretty good feeling that it will go back on the market," said Peter Kellogg, Biogen`s chief financial officer. "We had a lot of people lining up for the drug [before the recall] and they`re still inquiring."

While Biogen management continues to be hopeful, one question continues to vex biotechnology investors and medical professionals alike: Can Tysabri, once hailed as a wonder treatment for multiple sclerosis, really make it back to the market?

Tysabri was recalled by Biogen and Elan on Feb. 28 after two members of an MS clinical trial were discovered to have developed progressive multifocal leukoencephalopathy, or PML, an extremely rare but deadly brain infection seen mostly in AIDS patients. One patient died.

A subsequent review of Tysabri patient records revealed a third user also had died of PML, during a clinical trial for the treatment of Crohn`s disease.

As a result, Biogen and Elan have suspended all clinical trials of the drug until it figures out what triggered the PML cases. The companies are engaged in a review of all Tysabri patient files in an effort to solve the puzzle and plan to discuss the results with the Food and Drug Administration later this summer.

Skepticism

Biogen and Elan are trying to get Tysabri back on the market to treat MS as soon as possible, but it`s likely to be greeted with a good measure of skepticism, analysts say.

"Confidence in the drug has been damaged," says Deutsche Bank analyst Jennifer Chao. "It will take time for physicians to regain confidence in the drug."

"I think there`s a high possibility that Tysabri will be relaunched onto the market, but with significant labeling," said Chao, who doesn`t see Tysabri back on the market before 2006. "I think the FDA will likely insist upon long-term, post-marketing clinical trials. They may allow a relaunch contingent upon finishing those trials."



Biogen has continued to make Tysabri largely to keep up its inventories of the drug, which takes months to produce, in case of a relaunch down the road.

The company plans to destroy all returned quantities of the drug, out of safety concerns. Biogen will make a decision as to whether to keep producing the drug sometime next quarter, when it expects the results of its safety review to be completed.

Based on the antibody natalizumab, Tysabri originally was developed by Elan, which saw its potential in treating such autoimmune disorders as MS and Crohn`s disease.

MS, a progressive disease where the immune system attacks the body`s central nervous system, is characterized by lesions on the brain and bouts of physical debilitation. About 400,000 Americans have from the illness.

Biogen buys in

The drug eventually captured the attention of Biogen, which also markets the popular MS therapy Avonex. Together, the companies moved to develop Tysabri first for the MS market, then for Crohn`s.

Clinical data showed the drug to be so effective in treating MS, some hailed Tysabri as a medical breakthrough.

Biogen and Elan won accelerated FDA approval for Tysabri on Nov. 23. Just three months later, it was yanked from the market after the first two PML cases were reported.






PML is fatal in 70% of cases, according to Biogen, and there is no treatment for the disease. So far, only three cases of PML have been reported out of the estimated 5,000 patients who took the drug. Two of those three PML patients have died.

Several shareholder suits have been filed against the company alleging its officers did not properly disclose the PML problem. But Kellogg says no personal injury or product liability cases have been filed to date.



Since the Tysabri recall, Biogen and Elan have reviewed the medical records of Tysabri patients, looking for clues as to why some patients contracted PML. Biogen has been splitting costs of the medical review with Elan, Kellogg said.

The goal is produce a more accurate risk profile of the drug. The companies then hope to hold discussion with the FDA on new labeling and monitoring mechanisms needed to put the drug back on the market.

"I don`t think we can find a way to reduce the risk to zero," said Burt Adelman, Biogen`s executive vice president for development. "But we can find a way to screen to minimize the risk."

The companies should have their review completed by the end of the summer, at which point they would then begin talks with the FDA, who will have final say as to whether the drug should go back onto the market.

Niche drug?

The consensus, however, is that if Tysabri does come back on the market, it would be as a niche drug, at least until enough long-term data can be assembled to prove that the risk of developing PML is highly remote.

"We`re talking about it being looked at as a `salvage` therapy," says Deutsche Bank`s Chao. "Tysabri is a bird that`s had its wings clipped."

One major question is whether physicians would prescribe Tysabri if it were put back on the market. Most analysts and doctors agree the FDA will likely require the product to carry a "black box" warning, the sternest label a drug can carry and still remain on the U.S. market.

"Let`s assume there are no further cases of PML, especially among the monotherapy patients -- then there`s a potential for Tysabri, with proper patient warnings and monitoring," said Dr. Aaron Miller, director of the Corinne Goldsmith Dickinson Center for MS at Mount Sinai Medical School in New York. "The problem is we don`t know the risk of PML with a longer duration of therapy."

"My guess is that a prudent neurologist would only reserve the drug for patients that have failed in other therapies," Miller added. "But before, Tysabri would`ve been the first drug we could`ve gone for."

While neurologists appear to be at least open to the idea of prescribing the drug, most market analysts still believe the drug`s future is gloomy.

Seen as drug of choice

Indeed, the idea of Tysabri being a niche drug was almost unthinkable last November. At that time, market analysts predicted Tysabri would become the drug of choice for MS sufferers, as it didn`t cause the flu-like symptoms associated with Avonex or other leading MS drugs Rebif and Betaseron, all based on the protein interferon.

"Certainly, people with MS are desperate for therapies," says Dr. Patricia O`Looney, director of biomedical research for the National Multiple Sclerosis Society. "There was so much disappointment from people with MS [from the recall]."

As opposed to other medications injected at least once a week, Tysabri was administered just once a month.

"The first-year data for Tysabri showed a stupendous degree of suppression of relapse and [brain] lesions," said David Margolin, an MS specialist at Massachusetts General Hospital. Margolin is also helping to develop a rival MS therapy, currently in Phase II clinical testing, for Genzyme Corp. (GENZ: news, chart, profile)

"The safety data looked pristine," Margolin said.

Not only was Tysabri expected to take market share away from other drugs, many saw it expanding the market nearly 30% by appealing to MS patients who have avoided drug therapy. Some analysts forecasted Tysabri could end up with first-year sales of $400 million and peak sales of $4 billion by the end of the decade.

Some neurologists now think the drug would be prescribed only to patients who are deteriorating and not responding to other drug regimens, such as interferons or Copaxone.

Mt. Sinai`s Miller, for example, says only 5% to 10% of the nation`s estimated 400,000 MS patients would be considered candidates for Tysabri, given the apparent risks.

Deutsche Bank`s Chao says the population is slightly higher, about 10% to 20%, with potential peak sales of about $200 million, four to five years after a relaunch. She adds that despite Tysabri`s woes, Biogen and Elan likely won`t drop the price of the drug, which can cost a patient up to $25,000 a year.

Clearance needed

But for the drug to make it back to the market, it needs FDA clearance.

What`s harder to predict is whether patients are willing to take the risk of developing PML, even if it is remote. While MS can lead to paralysis or blindness in some severe cases, patients generally live normal life spans.

"There are some people who won`t get past that there were people who took the drug and died," said Massachusetts General`s Margolin. "Then there`ll be patients who look at the numbers and want to take the risk anyway."

One reason patients may opt to take the risk is the alternatives for failing patients are also risky. Patients who cannot tolerate or fail to respond to interferons or Copaxone sometimes resort to taking chemotherapy drugs.

"The reason why I think it [Tysabri] will come back is because if you don`t respond to interferon or Copaxone therapy, the alternatives are also very toxic," Margolin said. "When the alternative is chemotherapy or Tysabri, people will probably choose Tysabri."

Meanwhile, because of its strong efficacy in helping slow the progression of the disease, the MS community appears to be receptive of a comeback.

"The MS Society is certainly in favor of new treatments. If the FDA allows Tysabri back on the market, even with a black box, certainly we`d be in favor of it. It would be another option for patients," O`Looney said.


Bla Bla platz für Spekulationen,

hier verkennt man die positiven eigenschaften von dem Medikament.
Klar nach der Erneuerung, auf Medikamenten ein Black Label aufzudrucken kommt man nicht mehr herum, aber schwere Krankheiten erfordern agressive Medikamente.
Auf jeder Schachtel Zigaretten steht ein Hinweis, dass das oder jenes eintreten könnte, jedoch rauchen alle wie zuvor weiter.

Bei einer Krankheit wo es keine Alternativen gibt, nimmt man das doch in Kauf oder?

Pfitzer hat auch solche Medikamente wo ein Black Box Zeichen geklebt werden muss.Das sind die Neuen Sicherheitsbestimmungen man kommt da nicht mehr drum herum.
Elan auch euch...

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7,76$ AH -0,03

[[KERN]Codex]

Elan ist auf diesen Niveau ein klarer Kauf





1) $1.4 Billion cash - no further debt due until 2008.
2) Tysabri was voluntarily withdrwn by BIIB & ELN. Two MS patients on Tysabri/Avonex combo for 2 years developed PML. However, both patients were immune compromised. ALSO ONE PATIENT ON MONOTHERAPY FOR CROHN`S BUT WITH CLEAR HISTORY OF TAKING OTHER IMMUNOSUPPRESSANTS WHICH MAY CAUSE PML IN AND OF THEMSELVES. HOWEVER, two year Mono therapy with Tysabri (Affirm Phase III study) no PML. Apparently PML is present & many adults & becomes a problem when immune system is compromised.3)Tysabri will be back on the market MS patients are clamoring for it - it works better than alternatives.
4) CLINICAL TRIALS SHOULD RESUME EVENTUALLY to use Tysabri in MS, Crohn`s & rheumatoid arthritis
5)Pain drug Prialt on the market & several others. NOT THAT PRIALT HAS MADE A BIG IMPACT YET.
6) BIIB insiders are in deep trouble for insider trading before Tysabri withdraw NOT ELN.
7) ACC-001 (SON OF AN1792 AS amyloid-beta ACTIVE immunotherapy) for Alzheimers disease is back on track AND WILL ENTER PHASE I CLINICAL TRIALS IN THE NEAR FUTURE. AAB-001, AN ENTIRELY NEW ENTITY FOR PASSIVE IMMUNOzation TO BETA AMYLOID, IS NOW IN PHASE II CLINICAL TRIALS. BOTH THERAPIES inhibits build up of plaque in the brain
8) ELN will break even BY EBITDA in 2005 even if Tysabri doesn`t come back to market.
9) Shareholders to vote on a 15% share buyback
10) THE NEW CHAIRMAN OF THE BOARD recently (last or so) bought 90,000 shares TO AVERAGE DOWN FROM WHAT HE ALREADY OWNS (BUT STILL ENCOURAGING)
11) Nanocrystal drug delivery
12) Stock was 28 before Tysabri withdraw & MAY be near that when it comes back IF THERE ISN`T A TAKEOVER (TAKEUNDER) FIRST. 13) I`ve now got 3600 shares ELN in cash (no margin)



Will Tysabri make it back to market?
Biogen continues to make drug, in hopes of return
By Val Brickates Kennedy, MarketWatch
Last Update: 7:24 PM ET May 12, 2005

=>http://www.marketwatch.com/news/story.asp?guid={33214CB0-F92…

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