Elan: erst der Anfang! - 500 Beiträge pro Seite

[Cyberhexe]

Dies ist eine relativ freie Übersetzung eines amerik. Neurologen zu Elan:

Obschon der derzeitge Aufwärtstrend bei Elan nett ist, notiert die Aktie immer noch tiefer als vor der Bekanntgabe des 3.Patienten, welcher jedoch gemäss den Aussagen von CEO Mullen und MD Adelmann auf der ConferenceCall von Biogen nicht als PML-Fall in Verbindung mit Tysabri angesehen werden kann, da dieser lange und schwerwiegend mit immunsuppressiven Medikamenten behandelt wurde: über 6 Jahre mit Azathioprin, einem Medikament zur Verhinderung der Organabstossung in der Transplantationsmedizin, bei welchem schon mehrere PML-Fälle aufgetreten sind sowie 2 Jahre mit Remicade, dem derzeitigen Goldstandard zur Behandlung von MorbusCrohn. Auch unter Remicade sind schon mehrfach PML-Fälle aufgetreten.
[Anm: Der 3.Patient ist ein Studienteilnehmer der ENACT2-Studie = Natalizumab zur Behandlung von MorbusCrohn, welcher 2003 verstarb und dessen ehemalige Todesursache Hirntumor mit Bekanntgabe vom 31.3.05 auf PML abgeändert wurde]

Auch wurden bei diesem Patienten eine permanent niedrige Anzahl an Blutzellen festgestellt, welche sehr wahrscheinlich durch Knochenmarkdefekte verursacht wurden.

Der derzeitige Aufwärtstrend von Elan ist deshalb lediglich ein zurück zu dem Punkt, als ob die Krankengeschichte dieses Patienten von Anfang an richtig gedeutet wurde.

Nachdem der Review der MRIs zumindest der Studienteilnehmer abgeschlossen scheint und Mullen (CEO von Biogen) öffentlich gesagt hat, dass es keine weiteren PML-Fälle gibt, wird es wohl noch einige Zeit dauern, bis man Tysabri wieder Blockbuster-Status zugestehen wird.
Jedoch scheint es klar zu sein, dass die FDA die klinischen Versuche wieder sehr schnell zulassen wird und nach dem Treffen im Sommer mit Biogen und Elan die Vermarktung von Tysabri ebenfalls, zumal viele MS-Patienten Druck zum Teil über Kongressabgeordnete auf die FDA ausüben.

[Cyberhexe]

es gibt natürlich auch Analysten, die sehen die Elan-Geschichte völlig anders wie zB Goodbody Stockbrokers, ein irisches Analystenhaus mit Analyst Ian Hunter.

Zu dieser negativen Analystenmeinung muss man zwar sagen, dass Ian Hunter von Goodbody seit ich Elan verfolge...also seit fast 2 Jahren...immer dem Kurs hinterhergerannt ist. Ich bin überzeugt davon, dass Hunter bei einem zukünftigen Kurs von $30 sein sell-rating mit Kursziel von ca. $20 angeben wird.

Obschon ich von Elan überzeugt bin, auch davon dass die alten Kurse mittelfristig wieder erreicht werden, möchte ich Euch diese Meinung zum Zweck der Ausgewogenheit nicht vorenthalten. Es sind nicht alle so bullisch in diesem Board.

Anbei die heutige Bewertung:

Elan(Reduce, Current Price $6,71); Recent price surge valuing Tysabri at $2.8bn.
Based on our valuation of Elans core business, the latest surge in share price now has the market valuing Elans share of Tysabri at $1.4bn, giving a total value for the drug of $2.8bn. Elans current core business consists of (i) three drugs (Azactam coming off patent this year - $8.4m revenue in Q1`05; Maxipime coming off patent in 2007 - $19.8m in Q1`05; and Prialt with a poorer than expected launch - $1.0m in Q1`05; (ii) a drug delivery business ($7.3m in Q1`05); and (iii) a contract manufacturing business ($43.5m inQ1`05). We believe this is worth $2.28 to $4.02 (average $3.15). This includes a $0.50 to $1.00 per share value for the Alzheimers pipeline, which it is hoped will have its first drug on the market in 2009. We, therefore, believe that, on currently available information on the progress of the Tysabri review and uncertainty on the timing and level of its return to market, the valuation is streched.

[Cyberhexe]

...und hier noch was absolut positives von der Alzheimerfront, und zwar geht es um den wissenschaftlichen Beweis der von Wyeth und Elan aufgestellten Theorien zur Plaquebildung im Gehirn bei Alzheimer-Patienten. In den Erkenntnissen zu AN-1792 und den daraus abgeleiteten Entwicklungen AAB-001 (der Antikörper in Phase II) sowie ACC-001 (das Vaccin in der Präklinik, aber IND wird dieses Jahr noch erwartet) ist die anerkannte Leaderrolle von WYE/ELN begründet. Mit dem proof-of-concept erhöhen sich wohl auch die Erfolgsaussichten der klinischen Studien.

all in one!!

Primary News: Immunotherapy Protects against Synaptic Effects of Soluble Amyloid-β Oligomers

Comment by: William Klein, Grant Krafft
Submitted 30 April 2005 Posted 30 April 2005


This study represents an important advance in establishing solid in vivo proof-of-concept for eventual human therapeutics directed toward soluble, neurotoxic Aβ oligomers, also known as ADDLs. This study confirms results from other studies that passive immunization with anti-Aβ antibodies can reverse memory deficits, and it lends further support for the idea that functional deficits stem from synaptic failure and signaling malfunction, rather than nerve cell death. This study nicely demonstrates that symptomatic efficacy can be achieved by active vaccination with Aβ oligomers, but these results also suggest that alternate strategies that use more sophisticated immunogens will be required to generate a robust and sustained ADDL-neutralizing immune response.
This study builds very nicely on concepts and in vitro experiments that we published in 2001, establishing the idea that ADDL-directed immunotherapy for AD could effectively reverse memory deficits, and demonstrating that ADDL-selective polyclonal antibodies were highly effective at blocking ADDL... Read more

[Cyberhexe]

wow ...noch eine megastarke Neuigkeit.....gemäss Pflichtmitteilung der Irish Stock Exchange hat KyranMcLaughlin, Chairman von Elan, am 29.4.05 90.000 (Neunzigtausend) Aktien von Elan zum Preis von ca. $5,14 gekauft.


RNS Number:7782L Elan Corporation PLC 03 May 2005

SCHEDULE 11

NOTIFICATION OF INTERESTS OF DIRECTORS AND CONNECTED PERSONS

1. Name of company

Elan Corporation, plc

2. Name of director

Kyran McLaughlin

3. Please state whether notification indicates that it is in respect of holding of the shareholder named in 2 above or in respect of a non-beneficial interest or in the case of an individual holder if it is a holding of that person`s spouse or children under the age of 18 or in respect of a non-beneficial interest

(2) above

4. Name of the registered holder(s) and, if more than one holder, the number of shares held by each of them (if notified)

Kyran Mclaughlin

5. Please state whether notification relates to a person(s) connected with the director named in 2 above and identify the connected person(s)

n/a

6. Please state the nature of the transaction. For PEP transactions please indicate whether general/single co PEP and if discretionary/non discretionary

7. Number of shares / amount of stock acquired

90,000

...

[GlobalFinanz]

Dem ist nichts mehr hinzuzufügen.

Danke für die ausgewogene Recherche.

Jedem hier sollten die Risiken und Chancen bewußt sein.

[mmeureka2164]

elan macht- werde ich gerne zehen-10$.am donnerstag gibt neue nachrichten.bis dann

[[KERN]Codex]

Elan CEO Confident on Tysabri`s Future

By TSC Staff
5/26/2005 10:46 AM EDT


Elan`s (ELN:NYSE ADR - commentary - research) chief executive said he believes the multiple sclerosis drug Tysabri, whose sales were suspended after a patient died while taking it, will again be given the green light by regulators.

According to published reports, Kelly Martin said he expects Tysabri to return to the market. Reuters reported that Martin said a safety investigation of the drug should end by mid-to-late summer, after which talks with the Food and Drug Administration could start.


Martin spoke to reporters after Elan`s annual shareholder meeting in Dublin, the report said.

Elan and partner Biogen Idec (BIIB:Nasdaq - commentary - research) pulled the drug in February after two people taking the drug contracted a brain disease called progressive multifocal leukoencephalopathy. One died. Tysabri was cleared for marketing by the FDA late last year.

Shares of Elan were gaining 96 cents, or 13%, to $8.17. Biogen Idec was up 62 cents to $38.61.



8,2/8,22$ (sehr stark!)

[CBBBeobachter]

Elan CEO Confident auf Tysabri `s Zukunft Durch den TSC-Personal am 5/26/2005 10 Uhr 46 EDT Elan (ELN:NYSE ADR - Kommentar - Forschung) sagte leitender Angestellter, dass er glaubt, dass die multiple Sklerose Tysabri betäubt, dessen Verkäufe aufgehoben wurden, nachdem ein Patient starb, indem er es nehmen wird, wird wieder das grüne Licht durch Gangregler gegeben. Gemäß veröffentlichten Berichten sagte Kelly Martin, dass er annimmt, dass Tysabri zum Markt zurückkehrt. Reuters berichteten, dass Martin sagte, dass eine Sicherheitsuntersuchung des Rauschgifts durch die Mitte-zu-spät Sommer enden sollte, nachdem welcher mit der Nahrungsmittel- und Rauschgift-Verwaltung spricht, konnte anfangen. Martin sprach mit Reportern, nachdem Elan jährlicher Aktionär, der sich in Dublin trifft, der Bericht sagte. Elan und Partner Biogen Idec (BIIB:Nasdaq - Kommentar - Forschung) zogen das Rauschgift im Februar, nachdem sich zwei Menschen, die das Rauschgift nehmen, zusammenzogen, nannte eine Gehirnkrankheit progressiven im Brennpunkt multistehenden leukoencephalopathy. Ein starb. Tysabri wurde für das Marketing durch den FDA gegen Ende letzten Jahres geklärt. Anteile des Elans gewannen 96 Cent, oder 13 % zu 8.17 $. Biogen Idec war um 62 Cent zu 38.61 $. 8,2/8,22$ (sehr völlig!)

[CBBBeobachter]

Na also,

auf auf

[Cyberhexe]

Kelly Martin`s 3 statements today;

1. not if, but when, t comes back.

2. Tysabri can stop the progression of MS, and no other therapy can do that;

3. With approval to go forward, we can get it back to the market the next day.



wow....Ty kann ein Fortschreiten von MS verhindern....wow

[Elmshorner]

Hier kann es bald über 10 Dollar gehen

[CBBBeobachter]

Nicht kann, wird

Ist nur ein Frage der Zeit.

ELAN ist zu unrecht abgestraft worden, soviel ist nun klar

[Elmshorner]

CBBBeobachter , mit kann habe ich in kürzester Zeit gemeint. Ich sehe es wie Du, daß der Kurs bald über 10 Dollar und höher gehen wird.

[[KERN]Codex]

FDA Grants Approval to Market Focalin XR(TM) for the Treatment of ADHD in Adults, Adolescents and Children
Friday May 27, 7:00 am ET


EAST HANOVER, N.J., May 27 /PRNewswire/ -- Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Focalin XR(TM) (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.

" Focalin XR provides a new treatment option for adults, adolescents and children to address the many difficult symptoms of ADHD," said Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital. " Focalin XR provides patients with a treatment that starts working quickly to alleviate symptoms with the advantage of a once-daily dose."

In adults and children, the core symptoms of ADHD are inattention, impulsivity and hyperactivity; however, in adults symptoms of hyperactivity often subside with maturity or may manifest differently. ADHD is one of the most common psychiatric disorders of childhood and is estimated to affect five to seven percent of children. Many children with ADHD will continue to experience symptoms into adulthood. ADHD is estimated to affect approximately four percent of the adult population.

" We are pleased to introduce Focalin XR as a valuable treatment to help adults, adolescents and children effectively manage their symptoms of ADHD," said Paulo Costa, head of Pharma Americas and CEO, Novartis Pharmaceuticals Corporation. " Novartis has been a leader in helping ADHD patients since we first introduced Ritalin® in the 1960s. The addition of Focalin XR further emphasizes this commitment as it provides a new treatment option to address the many difficult symptoms of ADHD."

Focalin XR was generally well tolerated. There were no significant changes in patient weight or vital signs, such as sitting pulse or sitting blood pressure, in adults or children. The most common side effects in adults and children include decreased appetite, headache, dyspepsia, anxiety, insomnia, feeling jittery and anorexia.

The approval of Focalin XR for the treatment of ADHD was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents and children diagnosed with ADHD.

Adult Study

A 5-week, double-blind, placebo-controlled study involving 221 men and women with ADHD aged 18 to 60, demonstrated Focalin XR to be safe and effective in treating ADHD symptoms in adults. Patients received Focalin XR or placebo once daily. Results indicated that Focalin XR was statistically superior to placebo, based on changes in the Diagnostic and Statistical Manual-IV (DSM-IV) ADHD Rating Scale, a standard assessment tool used in ADHD. Secondary measures included evaluations rated by patients, clinicians and observers.

Following the completion of the 5-week double-blind clinical trial, 170 patients continued into a 6-month open-label extension phase. Patients who switched from placebo to Focalin XR showed significant clinical improvement and patients continuing treatment with Focalin XR continued to show increasing benefits over six months, based on changes in the DSM-IV ADHD Rating Scale.

Focalin XR was generally well tolerated. The most frequently reported adverse events included headache, insomnia and decreased appetite.

Pediatric Studies

The efficacy and tolerability of Focalin XR for the treatment of ADHD in children was demonstrated in a pivotal clinical trial of children and adolescents aged 6 to 17 years diagnosed with ADHD.

In this trial, 103 ADHD patients aged 6 to 17 years received Focalin XR or placebo once daily for seven weeks. Results indicated that Focalin XR was statistically superior to placebo, based on the Conners` ADHD/DSM-IV Scales for Teachers (CADS-T). The CADS-T Rating Scale is a tool used in clinical trials to assess attention and behavior.

In an additional trial of 54 pediatric patients aged 6 to 12 years, investigators evaluated the efficacy of Focalin XR 20 mg/day at various points throughout the day. Focalin XR was found to be significantly more effective than placebo in treating ADHD symptoms after just one hour, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale. The SKAMP Rating Scale evaluates attention and behavior in clinical trials.

In these studies, Focalin XR was generally well tolerated. The most frequently reported adverse events included decreased appetite, headache, dyspepsia, upset stomach and anxiety.

About Focalin XR

Focalin XR is an extended-release form of Focalin(TM) (dexmethylphenidate HCl). Focalin is an advance in single-isomer technology and is formulated by isolating the active d-isomer of methylphenidate. Data suggest that the d- isomer is responsible for the effective management of the symptoms of ADHD. Focalin XR is available in 5, 10 and 20 mg capsules for oral administration.

Like most drugs approved for the treatment of ADHD, Focalin XR is contraindicated in patients known to be hypersensitive to the drug or to methylphenidate, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette`s syndrome. It is also contraindicated during treatment with monoamine oxidase inhibitors and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result). In addition, like most drugs approved for the treatment of ADHD, Focalin XR is a schedule II drug and should be given cautiously to patients with a history of drug dependence or alcoholism.

For further information about Focalin XR, visit www.FocalinXR.com.

About ADHD

ADHD is a neurobiologic disorder that interferes with an individual`s ability to regulate activity level and behavior, and sustain focus in developmentally appropriate ways. In adults, it is associated with poor functioning in educational and occupational environments, as well as emotional, social and economic problems. For further information, visit www.ADHDInfo.com.

About Novartis ADHD Treatments

The Novartis ADHD product portfolio includes Ritalin (methylphenidate HCl) tablets, Ritalin-SR® (methylphenidate HCl) sustained-release tablets, Ritalin LA® (methylphenidate HCl) extended-release capsules, Focalin (dexmethylphenidate) tablets, and Focalin XR extended-release capsules. These products are classified as schedule II drugs.

Celgene Corporation (Nasdaq: CELG - News) of Summit, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Ritalin LA, Focalin and Focalin XR. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets Focalin in the U.S.

Ritalin LA and Focalin XR were developed with SODAS® technology (spheroidal oral drug absorption system), a multiparticulate drug delivery system of Elan Corporation, plc (NYSE: ELN - News). Focalin XR is being supplied to Novartis under an exclusive worldwide (except Canada) royalty and manufacturing agreement between Elan Corporation, plc, and Novartis Pharma AG. Novartis Pharmaceuticals Corporation has commercialization rights to Ritalin LA and Focalin XR in the U.S.

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology such as, " to address," " introduce" or similar expressions, or by express or implied statements regarding potential future approvals of, or potential future revenues from Focalin XR. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Focalin XR will reach any particular sales levels. In particular, management`s expectation regarding the commercial success of Focalin XR could be affected by among other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company`s mission is to improve people`s lives by pioneering novel healthcare solutions.

Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer`s disease, Parkinson`s disease, Attention-Deficit/Hyperactivity Disorder, epilepsy, schizophrenia and migraine, many of which continue to be regarded as " gold standards" to this day. Novartis Neuroscience continues to be at the forefront of research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS - News) -- a world leader in pharmaceuticals and consumer health. In 2004, the Group`s businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 81,400 people and operate in over 140 countries around the world. For further information please consult www.novartis.com.

[CBBBeobachter]

Na ?

Wo geht die Reise nächste Woche hin ?

Gruß

[CBBBeobachter]

Aha, nirgendwo hin

[Birgit.Tersteegen]

Alle sind in der Sonne und können sich darauf verlassen ,dass Elan ihren Weg gen Norden auch ohne unsere ständige Kursbeobachtung macht.....Die Newslage ist eindeutig!

[Cyberhexe]

interessanter Link:

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

[CBBBeobachter]

Danke Dir,

sehe ich genauso

Schönen Sonntag

[Cyberhexe]

Gerade gehört von der Hauptversammlung unter...

hxxp://www.elan.com/investorrelations/events/webcast_details.asp?eventID=1051649

In der Aufzeichnung ab 1h 08 Minuten sagt Kelly Martin beispielsweise: "We knew, because we could see the demand for the drug, where it was going to be very shortly...If we projected out 3 more months, we may have had another 25,000 to 30,000 patients on the drug..."

[Cyberhexe]

zwar schon etwas älter dieser Artikel , jedoch aktueller denn je; Elan hält etliche Patente in der Nanotechnologie

http://www.drugresearcher.com/news/news-ng.asp?n=58109-big-p…

Big pharma missing the nanotechnology boat?

[CBBBeobachter]

Guten Morgen

Ich schätze das noch diese Woche der erste Angriff auf die 10 $ erfolgen wird.

Alles spricht dafür

Gruß

[Cyberhexe]

http://biz.yahoo.com/bw/050531/305082.html?.v=1

Elan Announces the Appointment of New Board Directors
Tuesday May 31, 2:30 am ET


DUBLIN, Ireland--(BUSINESS WIRE)--May 31, 2005--Elan Corporation, plc announced today the appointment of five new members to the company`s Board of Directors. The three new non-executive board members are Goran Ando MD, Gary Kennedy and Nancy Lurker and the two new executive board members are Shane Cooke and Lars Ekman MD, PhD.

[CBBBeobachter]

Chart sieht sehr gut aus

Gruß

[[KERN]Codex]

Elan: FDA will be under pressure to resume sale of MS drug Tysabri

29 May 2005
The way Elan tells it, by the end of this summer the safety panel of the US Food and Drug Administrat ion (FDA) will be under immense pressure to let the sale resume of Tysabri.

The multiple sclerosis (MS) drug was withdrawn late last February, with dramatic consequences tohopes of sufferers of MS and Crohn`s and to the shareholders of Elan and its partner Biogen. Three thousand patients trialled Tysabri in combination with other autoimmune-suppressant drugs. Three of these contracted a rare brain disease, progressive multifocal leukoencephalopathy (PML).

Two of those who contracted the brain disease died, and one survived. Details of the surviving patient have not been released.

The renewed confidence that the drug will be relaunched, which sent Elan shares climbing 14 per cent last week, is not misplaced, according to the person with the closest knowledge of the Tysabri drug, Lars Ekman, Elan`s head of global research and development.

Ekman has overseen the development of the drug, seen as the breakthrough treatment for MS and Crohn`s before the FDA ordered that its sales be ‘paused` three months ago. The growing confidence within the company is palpable. It is based on the belief that the PML cases were not, as feared, the tip of an iceberg, and that the FDA will allow the drug`s return, with revised patient packaging and warnings.

By this summer, the review of the case histories of the 3,000 patients will be completed and after seven weeks of statistical research, an FDA safety committee will be ready to review the drug. Speaking last week to The Sunday Business Post, Ekman said that his confidence was based not on the fact that more patients have not contracted PML, but that he now understood more about the nature of PML.

[Cyberhexe]

CEO Kelly Martin sagte folgendes bei der Hauptversammlung am 26.5.2005 in Dublin:

"We have multiple things that we are focused on with Tysabri. We are very, very focused on its return to the marketplace in the US for MS patients. We are as focused on its continued regulatory advancement in Europe for both Crohn’s and Multiple Sclerosis. We are focused on its regulatory advancement in the US for Crohn’s. And in addition to those specific therapeutic areas, we are also continuing to Tysabri’s use in other autoimmune diseases such as ulcerative colitis, asthma, organ transplant, and others."

Das liest sich sehr zuversichtlich, so dass man auf die Entwicklung bis zum Jahresende gespannt sein darf. Falls Ty wieder vermarktet wird (MS in US) und die Zulassung in Europa erteilt wird (MC und MS) sowie diejenige für MC in US, dann ...ja dann, scheint mir ein Kurs gröseer 30$ sehr wahrscheinlich.

[Cyberhexe]

Kelly Martin, CEO von Elan, sagte ausserdem auf dem AGM am 26.5.05 in Dublin:


We need to advance, continue to advance our development pipeline. I’ll specifically talk here about a Phase II Alzheimer’s program that we have that started dosing patients about six weeks ago. It is a disease-modifying program and one that we are extremely excited about in a disease area at which there are currently no disease-modifying therapies globally. Secondly we are very focused on the Prialt launch in the US. Prialt was our second innovative drug that we got approved last year in both the US and Europe. We’re working every week to add the number of doctors using the drug, add the number of patients, and build the foundation for a very successful business over time.

The third short term focus…third area is our drug technologies business. Our drug technologies business, to define that more fully for you is our nanotechnology business which is in King of Prussia, Pennsylvania, our Athlone manufacturing plant in Ireland, and our Gainesville manufacturing plant in Georgia in the US. Historically Élan had a contract manufacturing business. The drug technologies business is not a contract manufacturing business. We are now using our nanotechnology business which has got a very wide and deep patent-protected IP to work with the marketplace on changing existing drugs from a life cycle planning point of view. In the last two years we’ve doubled the net income of that business each year, and from the seat that I sit in I would say that the business prospects for that business are extremely, extremely bright over the coming years.

[Cyberhexe]

und noch einmal K.Martin zu Elans Nanotechnologie, deren Entwicklung sehr vielversprechend ist; mit den patentgeschützten Verfahren verfügt Elan über eine Schlüsseltechnologie in der pharmazeutischen Industrie, die jetzt schon pro Quartal über 40 Mio$ Lizenzzahlungen einbringt, und zu fast 100% als Deckungsbeitrag verbucht wird. Und dies mit stark steigender Tendenz. Dies ist die Wachstumsgeschichte schlechthin: Ein biotechnologisches Unternehmen mit patentgeschützer Schlüsseltechnologie im Nanotechnologiebereich. Dazu Blockbusterpotenzial bei der Behandlung von schwerwiegenden Krankheiten, zu welchen bisher keine befriedigenden therapeutischen Ansätze existieren (MS, MC, Parkinson, Alzheimer)

The other business to highlight from an innovative business model is the drug technologies business which I mentioned previously. To repeat, the drug technologies business is not a contract manufacturing business. The drug technologies business is a business that will allow us to build up a primary care pharmaceutical company without the infrastructure of the commercial organizations globally. So we will use our patent and technology and our manufacturing base to work with large pharmaceutical companies in the world to change their business, to change their specific molecules, take a royalty on that, and put it through our business. Paul Breen and his team have done a great job in transforming that business in its early days. There will be a lot more to come there and I think that the prospects again for that business are quite significant.

[[KERN]Codex]

27 May 2005

Article by Mary C. Till*, Michele M. Simkin** and Stephen Maebius***

Abstract

Introduction

In order to market and sell a pharmaceutical product, the crucial hurdle is approval by the FDA, the agency which regulates all pharmaceutical products in the United States. Until recently, the FDA had never faced the question of whether to approve a drug based on nanotechnology. That all changed when Wyeth, Merck and Abbott all developed nanoparticulate drugs using technology developed by Elan Drug Delivery ("Elan") and obtained FDA approval for the new drugs.

Merck utilized technology licensed from Elan to successfully develop and obtain approval to market their nanoparticulate drug, aprepitant. Commercially marketed as Emend®, aprepitant is the first FDA approved drug for treatment that prevents the delayed nausea and vomiting symptoms that many cancer patients experience greater than twenty-four hours after receiving chemotherapy.

Wyeth brought their drug sirolimus to Elan for development of a nanoparticulate formulation of sirolimus (Rapamune®). Wyeth applied for and successfully obtained approval to market Elan’s nanoparticulate formulation of sirolimus, making this the first commercial launch of a nanoparticulate drug.

Abbott came to Elan seeking to formulate their micronized TriCor® commercial drug into a nanoparticulate formulation. Not only was Elan able to reformulate TriCor® to require a smaller dose, the formulation developed also eliminated the variability observed upon administration of TriCor® in fasted and fed patients.

With the exception of Emend®, a new chemical entity, Elan’s licensees and collaborators set their sights on existing drugs that suffered from several problems and converted them into nanoparticulate forms. Not only did this transformation result in new drugs with better performance characteristics, but it led to new exclusivities and extensions of patent term, generating tremendous value from what had been under-performing drugs. This article will discuss the key issues faced during FDA regulatory review and highlight some surprising new benefits for patients and market exclusivities that resulted during the approval of the first series of nanotech based drugs developed by and under license from Elan.

I. General Overview Of FDA Approval Process For New Drugs

In a multi-step process, a developer of a new drug must submit studies to the FDA in order for the FDA to evaluate the information contained in the studies to determine whether the drug is safe and effective.

[Cyberhexe]

die Hauptversammlung hat den Antrag der Geschäftsleitung angenommen, im Bedarfsfall bis zu 15% der Aktien (also knapp 40 Mio Anteile) zurück zu kaufen; dies bedeutet, dass die Aktien derzeit nach unten relativ gut abgesichert sind. Dazu noch die ca. 20 Mio Aktien, welche geshortet sind...als ehemaliger WallStreet-Experte (bei ML ?) dürfte Kelly Martin gerade der richtige sein, um die Hedge Fonds auszubremsen.
Als "shorty" wäre mir dies Pulverfässchen zu ungemütlich...let`s go Elan

[[KERN]Codex]

Let´s go

[Cyberhexe]

interessanter link:

http://www.thisisms.com/


Tysabri: Not IF but WHEN

Remarks made by the CEO of Elan today were remarkably positive regarding the company`s Tysabri treatment for Multiple Sclerosis. Tysabri represents a great advancement in MS therapies, and not to be underestimated-- a great deal of hope inherent in a new therapeutic option. We are very happy to see that it seems that Tysabri`s safety review has apparently uncovered (at least to this point) nothing further of serious concern where FDA reapproval would be highly uncertain from the company`s perspective.
"It`s a question of when [the drug returns] and what path that takes, not a question of if," [Kelly] Martin [CEO of Elan].

"I think the demand side of the curve is a given. What I can`t predict, with the risk benefit discretions and based on individual patients or doctors, is what the uptake will be versus what it was," he said.

"(But) there`s no reason over time why Tysabri would not be a very substantial drug in MS."

Martin reiterated that the safety analysis into Tysabri was scheduled to conclude by late summer, and then discussions with the U.S. Food and Drug Administration (FDA) would start. Martin thought the talks would move quickly. If an FDA approval was granted, Tysabri could be on the market "the next day."

Please click "read more" for the link to some of the better articles covering today`s news.

[Cyberhexe]

Mitschrift: Fragen und Antworten bei der Hauptversammlung von Elan in Dublin am 26.5.2005

Q: (Unknown speaker) Excuse me. Can you tell me if Biogen-Idec narrowed production or are they still on full scale production? And the second one, can you tell me the position is with the European Medical Authority with the application for Tysabri? Is it derailed? In my mind it would seem to be in limbo until this, uh, trials has restarted.

A: (Kelly Martin) Uh… Thank you for the question. The, the… Biogen-Idec is not producing at full scale right now. Um… uh… We spent… Shane Cooke and Lars Ekman and Paul Breen and Allison Hulme, who is accountable for Tysabri… we spent much of the fall, through the winter, into the early part of this year working with Biogen to make sure the production capability. uh… was big enough for what we thought the demand would be. Um…one of the solutions to that is a manufacturing process called the “high titer” process. So, what Biogen has done is they are continuing to produce Tysabri with the current process that was in place in a part of their plant in North Carolina. And with another part of their plant, they’ve actually put this different process in place. So we have actually used this pause and they have used this pause to change the engineering processes around the manufacturing of Tysabri, which, when Tysabri comes back to the market, is going to be exactly what we need from a productivity point of view.

[**It sounded like someone asked specifically at this point about Oceanside]
(Kelly Martin) Oceanside is not manufacturing yet. Oceanside was going through the regulatory time line to get a final approval from the FDA so it could produce, and it’s still… still on that time line. And I’m sorry, your second question was?

***
Q: (Unknown speaker-same one) The application for Tysabri in Europe where is it--in limbo until tests are analyzed?

A: (Kelly Martin) I’ll… is it OK… I’ll have Dr. Ekman… What… I’ll preface his comments with, just to remind the shareholders that in the US there was accelerated approval. Europe’s process didn’t have an accelerated approval, so they were on a two-year approval. So the time frames were actually slightly different. But I’ll let Dr. Ekman comment further.

A: (Dr. Lars Ekman) For MS in Europe the European Authority permitted us to file with one year data, which was exceptional. As Kelly mentioned, there is no process, not for Tysabri or for any other drug to get accelerated approval. To some extent, that is now working to our advantage, because now the European Authority can look at the PML cases and the totality of the safety data, which is very good, and the efficacy data, and do a balanced review. We do think that the PML situation will delay the process a number of months, but it’s otherwise on speed. With regards to Crohn’s Disease, we did file last fall. That process is on track, the Europeans will obviously be updated when we finish our last trial, but that is not mandatory for the process in Europe.
***

[Cyberhexe]

interessanter link

The Sunday Business Post
Artikel vom 29.5.2005 (nur in Englisch)

http://archives.tcm.ie/businesspost/2005/05/29/story5160.asp…

[Cyberhexe]

Neuigkeiten:
Elan Retires over $240 Million of 2008 Debt


http://www.elan.com/News/full.asp?ID=715429

[welke91]

Guten Morgen..

3:32am 06/01/05
Elan higher on debt retirement (UK:ELA, ELN) By Steve Goldstein
LONDON (MarketWatch) -- Elan Corp. (ELN) (UK:ELA) , the Irish pharmaceutical, rose 3.7% after saying it has retired $211.8 million in outstanding debt and has agreed to retire another $31 million in a few days. Its cash balance will be more than $1.3 billion, it said, and the payments will reduce annual interest rate payments by $16 million. Elan will record a net charge of approximately $53 million in the second quarter of 2005, of which approximately $48 million will be cash and approximately $5 million will be non-cash unamortized financing costs.

[Cyberhexe]

irisches Analystenhaus zu Elan (am 1.6.2005)
Elan kaufen bei $7,90
nur in Englisch




NCB equity research morning news & views
June 1, 2005

Elan $7.90 BUY

Elan has retired $211.8m of its 2008 debt and has agreed to retire a further $31m over
the coming days. The cash balances at end of March 2005 will be reduced $80m
following the transactions. The transactions will reduce the annual interest charge by
c.$16m.
• The company purchased $175m of the 6.5% convertible notes and agreed to purchase
a further $31m, through issuing 27.7m shares (an additional 7% increase to the free
float) and $49.1m of cash and interest of $0.7m. The total consideration for the
convertibles was $255m which was a c.4% premium to their market price at the time of
repurchase. Approximately 45% of the outstanding convertible bonds were retired and
the number of shares issued were the same as would have been issued upon
conversion of the notes.
• Elan also purchased $36.8m of the 7.25% senior notes (Athena notes due 2008) for
$33.3m plus accrued interest of $0.6m.
• In Q2, 2005 Elan will record a net charge of approximately $53m as a result of these
transactions, of which approximately $48m will be cash and approximately $5m will be
non-cash. Shareholders’ equity at March 31, 2005 would have increased by
approximately $153m and the annual interest charge will be reduced by approximately
$16m.
• Overall these transactions reduce the company`s convertible debt by $206m and
annual interest charge by $16m and confirm management`s confidence with the
liquidity and capital structure.
Orla Hartford +353

[Cyberhexe]

der Ausgewogenheit wegen:
Ian Hunter von Goodbody Stockbrokers
Elan reduzieren

Goodbody Stockbrokers am 1.Juni 2005
Elan (Reduce, Current Price $ 7,90); Over 240m of 2008 debt retired

Die Fakten werden ähnlich dargestellt als bei den anderen irischen Analysten. Ian Hunter bleibt jedoch bei seinem "reduce" rating. Obschon man hierzu sagen muss, dass Hunter seit Jahren der Kursentwicklung 1/2 Jahr hinterherhinkt. Er wird sein reduce rating auch aufrecht erhalten, wenn Elan wieder auf 30$ gestiegen istg. Hunter wird dann lediglich das Kursziel auf 20$ erhöhen...also wie gesagt der Ausgewogenheit wegen auch Goodbody Stockbrokers...es sind halt nicht alle bullisch

[Cyberhexe]

sehr interessant
aus us Forum (ymb) zum Rückkauf der Wandelanleihe:

The debt buyback is a good movement by management but not earth shattering great news. Disclosure: I am long 30,000 shares. I use to be a high yield debt analyst at Northern Trust(now full time private investor) when this convertible deal came to market. We wanted to buy some but could not, because the deal was not registered in the U.S. This deal was sold overnight in the European market and was an immediate hit and the price skyrocketed. This deal helped cement the restructuring of the company and contributed to the recovery of the stock price. I have been out of the high yield market since February of 2004 but I thought I remembered the price of the convert in excess of $150 on a $100 par value. I am sure it went much higher than that with the movement in Elan stock price. Management has two primary motives in buying back the convertible debt and a small amount of the 7.25% Notes. Buying back the convert is a prudent thing to do in case Elan stock price comes under severe pressure at time of maturity, saving the company a large, potential cash outflow during a time of stress. More important, the move is designed to build confidence in the company since all of the equity analysts (who know nothing about credit analysis) and the hedge funds can now see more clearly that there is likely to be no cash crunch in 2008. The company built equity by $153 million while reducing debt by $240 million and only used up $80 million of its $1.3 billion cash hoard. I like that math. Cash that can be used to fund higher returning investment in Tysabri, the Alzheimer`s program etc. Why did the company pay a small premium? Because it had to. A premium of only 4% to the market price is reasonable. The company could do this because the notes are likely held in large dollar amounts by a limited number of European investors. If Elan offered the market price, why should anyone sell to them? If they start buying back at the market, the size of the buying would drive up the price of the bonds and maket it more expensive to get done. I have no concerns about Elan`s balance sheet. (I did when we were buying discounted Elan bonds for our high yield portfolio back in 2003). The ultimate performance of Elan will depend on the resolution of Tysabri and the success of the company`s Alzheimer`s program. Other posters have a better feel for that than me, though none of us should kid ourselvess as to how much we know. I know I felt pain on Black Monday when I was holding 6500 shares. I feel the risk/return trade-off is favorable with the knockdown of the price and I increased my holdings to 30,000. It would be painful to me if Elan fell sharply again, but it would be a tolerable level. However, I believe ultimately the downside is limited due to the reasons cited by others and as you can see by today`s news, the company can handle its obligations and will not be filing for bankruptcy even if Tysabri does not return.

[Nostarowie]

Mal ne Frage,

wie is denn das mit ner Übernahme; bei dem geringen Kurswert?
Da ja nun Ty zurückkommt und dazu noch etliche Patente in dem Laden schlummern?
Elan Corp müsste doch ein Schnäppchen sein.

in liebe, Nosta

[Cyberhexe]

Das Management hat da schon vorgesorgt, dass eine Übernahme wenig attraktiv ist. Und zwar...

...existiert mit Biogen ein Stillhalteabkommen, ich glaube bis 2011

...bei einer Übernahme von Elan hat Biogen die Möglichkeit die Rechte von Tysabri voll zu übernehmen

...bei einer Übernahme von Elan hat Wyeth die Möglichkeit das Alzheimer-Programm voll und ganz zu übernehmen

Darüber hinaus gibt es auch noch finanztechnische Schikanen, welche ich jedoch nicht ganz kapiert habe (da nicht mein business und zudem in engl)...aber auch diese sollen eine Übernahme angeblich erschweren

Meiner Einschätzung nach geschickte Manöver, die eine feindliche Übernahme uninteressant machen.

[Nostarowie]

Aha,

obwohl das ja eigentlich auch irrelevant ist ob der Kurs durch Übernahme oder so steigt, denke ich.

Thanks, Nosta

[[KERN]Codex]

nostarowie,

das ganzen nennt man dann "poison pill"

[Nostarowie]

Achsoachso

so, ich möchte aber nicht zum schwatzen verleiten sonst kommen ja hier keine sinnvollen beiträge mehr zustande die ich lesen kann und muß auch noch selbst nach infos suchen.

Alles wird gut, Nosta

[Cyberhexe]

interessanter Kommentar/Vermutung zum bevorstehenden AGM von Biogen am kommenden Freitag (aus ymb):

I think that BIIB will be very positive on tysabri this friday just as they were after the last CC. I think JM knows that he needs to get tysabri back on the market as soon as possible and get his stock price up or he is going to be gone - there is also a sizeable amount of potential news that will be occurring within a month - depending on which rumors you listen too it is possible that JM could allude to any of the following
1. completion of safety review
2. no PML cases in safety review
3. minimal SAEs found in all arms of ty trials
4. timeframe for european approval for crohns or MS
5. restart of clinical trials and FDA dropping tysabri clinical trial moratorium (huge psychological boost because it means the FDA has seen the data and is happy with the risk profile)
6. time frame FDA review - or if a formal safety review will be performed or whether they can just take the drug back to market
7. production plans for tysabri (a ramp up means that BIIB knows when to expect it back on the market)
8. crohns and RA phase III data time frame
9. he will most certainly start beating the drum for how much better tysabri is for MS patients, and that patient demand is still very high
10. it might be early but he could also make statements similar to KM about tysabri`s return

I could go on and on - but I am quite sure of one thing - JM is still going to glowing about tysabri the way they did after the april CC - but know they have a ton more data and potentially market moving data

but in the end it doesn`t matter - seems all of these events occur before october and those that are interested in ELN and tysabri can just buy in at higher prices as they understand the situation better

[CBBBeobachter]

Was ist denn mit ELAN los ?

Gruß

[Bernd13090]

WKN 903801 ... steht alles drin,...

[CBBBeobachter]

Wenn sich zwei Medikamente nicht vertragen, dann gibt es keinen Grund für diesen Kursabschlag.

Gruß

[Cyberhexe]

der 4. PML-Fall beunruhigt die schwachen Gemüter...dabei bestätigt dieser lediglich die bisher aufgestellte Theorie, dass nur bei immunsupprimierten Patienten eine PML-Gefahr existiert.
Die betroffene Patientin hat an der SENTINEL-Studie (Tysabri+Avonex) teilgenommen...dies wäre nun der 3. PML Fall in SENTINEL, hingegen 0 Fälle in AFFIRM (Tysabri-Mono), obschon die AFFIRM-Studie von der Anzahl der Studienteilnehmer wesentlich grösser war...

Conclusion: Tysabri-Monotherapie ist sicher (bisher keine PML-Fälle bei über 2000 (?) Studienteilnehmern, hingegen ist in Kombination mit Immunsuppressiva (Avonex) ein signifikantes PML-Risiko vorhanden (3 Fälle bei wesentlich weniger Teilnehmern...die genaue Zahl hab ich nicht mehr im Gedächtnis, ich weiss lediglich noch dass es viel wenigger waren als bei AFFIRM


also, aus einer wissenschaftlichen Sicht steht der Wiedereinführung der Monotherapie nichtes mehr im Wege...ich hab nochmal 300 Stück zu 5,15 nachgekauft

[CBBBeobachter]

Sehe ich genauso wie Du Cyberhexe.

Stay long

Ich sehe einfach nicht hin

Gruß

[Cyberhexe]

der Vollständigkeit wegen...

...falls dieser Fall nun bestätigt wird, gibt es insgesamt 4 PML-Fälle; diese verteilen sich auf folgende Studien:


3 Fälle in SENTINEL (Tysabri+Avonex zur Behandlung von MS)
0 Fälle in AFFIRM (Tysabri zur Behandlung von MS)
1 Fall in ENACT (Tysabri zur Behandlung von Morbus Crohn)

Zum ENACT-Fall ist jedoch zu sagen, dass dieser Patient über 6 Jahre Azathioprin (ein starkes Immunsuppressiva zur Verhinderung der Organabstossung nach Transplantationen) sowie 2 Jahre Remicade (ein Immunsuppressiva zur Behandlung von MC) erhalten hat. Seine allgemeine Verfassung war zudem vor Studieeintritt derart schlecht (Blutbild weist auf Knochenmarksdefekte hin), so dass meines Erachtens diese Person eigentlich an einer derartigen Studie nicht hätte teilnehmen können.

Obschon ich die genauen Zahlen über die Grösse der Studien nicht mehr präsent habe, kann ich dennoch bestätigen, dass AFFIRM wesentlich umfangreicher war als die beiden anderen Studien und somit die Wahrscheinlichkeit bzw. das PML-Risiko bei der Monotherapie gering zu sein scheint. Jeder weitere Fall aus SENTINEL stützt diese These!

[CBBBeobachter]

Habe gerade auch noch einmal nachgelegt

[CBBBeobachter]

@Cyberhexe

Wie genau geht es mit ELAN nun weiter ?

Wie lange dauern die Studien noch ?

Fasse Deine Einschätzung bitte noch einmal kurz zusammen.

Gruß

[Cyberhexe]

CBB

die Studien sind längst abgeschlossen und bis auf ENACT sind auch alle Daten publiziert.

AFFIRM dauerte 2 Jahre und hat gezeigt, dass Tysabri doppelt so wirksam ist als alle anderen auf dem Markt angebotenen Wirkstoffe (Avonex, Betaseron, Rebif = alles Interferone mit enormen Nebenwirkungen ...sowie Copaxone = Glatramaracetat von Teva, dessen Nebenwirkungen nicht ganz so heftig sein sollen) und die Zahl der Verschlechterungen bzw. das Fortschreiten der Degenerierung wesentlich einschränkt. Und dies bei einem Nebenwirkungsprofil im Placebo-Bereich. Also meiner Meinung nach sprechen die Daten für sich...und wenn das Risiko kalkulierbar ist, dann wird Tysabri Goldstandard-Status zur Behandlung der MS erhalten...natürlich mit Blockbuster-Potenzial

[CBBBeobachter]

Danke Dir Cyberhexe,

und wann könnte es Deiner Meinung nach so weit sein ?

Wer oder welche Behörde muß nun das entsprechende Machtwort sprechen ?

Gruß

[Cyberhexe]

wie Kelly Martin, CEO, bereits am AGM (Elans Hauptversammlung vom letzten Donnerstag) ausführlich geschildert hat sieht der Weg folgendermassen aus:

Abschluss der Untersuchung (MRI) aller Studienteilnehmer Anfang Sommer

Auswertung der Daten und Treffen mit der FDA Mitte bis Ende Sommer

so dass Anfang Herbst die Vermarktung fortgesetzt werden könnte, sofern die Daten überzeugend sind...und davon gehe ich aus, da Elans Magmt eher zurückhaltend ist mit Prognosen, die Äusserungen zu Tysabri jedoch sehr positiv sind

[Cyberhexe]

mit Untersuchung meine ich natürlich den medizinischen Check, ob irgendwelche PML-Symptome vorliegen. Hierzu werden neue MRIs gemacht und ausgewertet, jedoch auch die bereits angefertigten MRIs noch einmal begutachtet.
Bei 3000 Studienteilnehmern sowie den 5000 "kommerziellen Konsumenten" eine logistische Herausforderung, welche eben diese Zeit beansprucht

[CBBBeobachter]

Danke für Deine Ausführlichen Infos Cyberhexe

Ich bleibe dabei

Gruß

[leiro1]

Cyberhexe: Woher hast Du die Info, daß dieser Todesfall nicht die Monotherapie von Tysabri betrifft?

Leiro

[Cyberhexe]

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


The possible fourth PML patient is a 48-year-old woman who was taking Tysabri along with Avonex, another multiple sclerosis drug sold by Biogen Idec.

[Cyberhexe]

falls der US-Kurs massiv nachgibt, könnte ich mir vorstellen, dass Elan mit dem Aktienrückkauf beginnt - 15% also ca. 60 Mio Stück wurden von der Hauptversammlung letzten Donnerstag genehmigt

eigentlich sollte man hoffen, dass der Kurs massiv nachgibt, denn das wäre "das" Geschäft für Elan und würde hinterher umso mehr auf die andere Seite ausschlagen

[[KERN]Codex]

by: goodtoreadthis (59/M/Boston, MA) 05/06/05 12:19 pm
Msg: 645001 of 672805

The other day at the tail end of the commentary with Bloomberg, Km was reputed to have said " It would not be accurate to assume that these are the only cases of PML that arose" or some such words as those.

At AAN they talked about a 4th case of PML. As I understand the facts, the person had PML, it was misdiagnosed as an MS exacerbation, and Tysabri was mistakenly added to the potpouri of stuff the person was taking.

About 8% of all MSers are reputed to develop PML without a causative relation to meds, rather to the disease and it`s development.

During the middle of the current situation a 44 year old woman with MS checked herself into a Pa hospital, becuase she suddenly felt sick, and died the next day. The cause was ruled to be the disease. She was on no MS meds of any kind.

My thought today is that the alarm that neuro111 sounded and the quality of this drug might lead the FDA to immediately allow mono re-use as soon as the package is presented in July. Neuro`s post needs to get to the FDA.

by: pinvestment 05/06/05 01:19 pm
Msg: 645045 of 672805

I would not be surprised at all if you took the time and went back through the previous MS cases where patients died from "MS" weren`t PML in the first place - an immune suppressive mutation of CCR5 is associated with a risk of much earlier death from MS - it is in the literature as part of a large MS autopsy review

I am just surprised that so many people can`t get there hands around the idea the tysabri does not cause PML - at most it could lead to some additional immune suppression in concert with other drugs - and that can be monitored

by: winonefortheteam (40/M)

GoodToReadThis, you are confusing the audience.

The JCV virus is what causes PML, just as HIV is the virus that causes AIDS. Just because you have HIV, it does not necessarily mean that you will develop AIDS; just because you have the JCV virus, it does not necessarily mean that you have PML.

The similarity ends there however. On a percentage basis, the presence of HIV in the population is very small. However, a majority of people have a latent form of the JCV virus, but it generally resides in the kidneys and does not enter the brain where it can do significant harm.

The 8% figure you are quoting relates to JCV virus being present in the cerebrospinal fluid of people with multiple sclerosis. (The correct figure is actually 9%.) What is interesting however, is that 0% of the non-MS population had JCV virus present in their cerebrospinal fluid. Why such a difference between MS and non-MS populations? No one knows, just speculation on possibilities.

JCV virus is only deadly when it gets to the brain. It is not a stretch to think that MS patients who have JCV in their cerebrospinal fluid are more susceptible to having the JCV get into their brains if they are severely immunosuppressed.

Hence, there are two protocol possibilities for Tysabri re-introduction. You screen initially (and periodically) for MS patients with JCV in their cerebrospinal fluid. Or you reduce the amount of immunosuppression by prohibiting the combination of Tysabri with a beta interferon and you monitor the level of immunosuppression of the patient.

In the pre-Tysabri past, is it possible that a small percentage of MS patients who died actually have PML (with meds playing no role)? It is possible that PML is widely under-diagnosed, but it is speculation at this point.

The link to the relevant study is as follows:

http://www.ingentaconnect.com/content/arn/ms/1998/00000004/0…

All of the above has previously been pointed out by Pinvestment.


..habe leider kein Geld um nachzukaufen

[Bernd13090]

was sagt der bericht aus ???

positiv oder negativ

[Cyberhexe]

das sin Beiträge aus dem ymb (yahoo member board)

pinvestment ist einer der informativsten Teilnehmer, der ein erstaunliche Fachlompetenz unter Beweis stellt

darüberhinaus hat er auch eine eigene webpage und ist Elan gegenüber sehr bullisch eingestellt

also kein Grund zur Sorge

[Bernd13090]

wollen wir es hoffen, kostet heute schon einiges an nerven

[Cyberhexe]

@ Bernd...
ich beschäftige mich seit 2 Jahren mit der Geschichte und bin felsenfest davon überzeugt, dass ein weiterer Fall aus der Kombi-Studie für die Monotherapie nur gut sein kann...und zudem die Kombi-Studie hat meiner Meinung nach eh noch nie Sinn gemacht...da ging es lediglich darum, Biogens Avonex am Leben zu erhalten...aus medizinischer Sicht [Disclaimer: bin kein Mediziner], scheint mir die Kombi-Therapie nicht sinnvoll zu sein

[Bernd13090]

hoffe, das du recht hast, das problem ist im moment nur, das die Meldung ein blutbad beim kurs anrichtet

[[KERN]Codex]

LONDON (AFX) - Biogen Idec Inc has told the US Food and Drug Administration that a fourth patient may have contracted a potentially deadly brain disease after being treated with the company`s multiple sclerosis drug Tysabri, developed jointly with Elan Corp PLC, according to a report in The Boston Globe.

Biogen Idec and Elan in February suspended sale of the drug and halted clinical trials after revealing one patient died of a brain disease known as PML (progressive multifocal leukoencephalopathy), and that another was believed to have it.

A third case of the disease was identified in March.

The newspaper said that if the case is confirmed it would deal another blow to hopes that the treatment might be made available again by making it more difficult for the companies to convince the FDA that Tysabri is safe.

It added that because PML is so rare, each additional confirmed case magnifies the drug`s potential risks.

The first two cases of the disease surfaced three months after the drug went on sale.

The newspaper said it obtained the report of the new unconfirmed case under the US Freedom of Information Act.

The possible fourth PML patient is a 48-year-old woman who was taking Tysabri along with Avonex, another multiple sclerosis drug sold by Biogen Idec.

The report said Biogen spokesman Tim Hunt declined to comment on the possible new case.

`We`re in the middle of our ongoing safety evaluation of Tysabri,` he was cited as saying. `We hope to have our findings by the end of the summer. Beyond that we`re not commenting on the particulars of our ongoing safety review.`

And Elan spokesman, Brian McGlynn, was cited as saying the company would not comment `on individual cases until the safety evaluation is completed.`

The newspaper said shares of both Elan and Biogen Idec have risen in the wake of comments from Elan chief executive Kelly Martin last week at the Irish group`s annual meeting.

According to the report, last Thursday, Martin said he was optimistic about Tysabri`s eventual revival, saying: `It would be inconceivable to me that the drug wouldn`t be available.`

[[KERN]Codex]

Blutbad ist gut,

knapp 30% MINUS Frage mich ab wann ELAN Aktien zurückkauft..

und ich frae mich auch welche Auswirkungen dieser Fall auf den CC von BIIB am Fr hat..

Wenn alle Medien draufgehauen haben dürfte es eigentlich rasant nach oben gehen, wie seht ihr das?

gruß codex

[Fuerte100]

Tja wie sagt man so schön. Man solle nie ins fallende Messer greifen. Ich würde allerdings gerne zugreifen!!! Aber wann?
Wie stark wird Sie noch fallen, und vorallem wie verhält sich der Kurs im Amiland? Tja wenn man für diese Fragen Antworten hätte.

[[KERN]Codex]

Fuerte,

warte die eröffnung ab,

eben ist der kurs schlagartig von 5,65 auf knapp 6 gestiegen, aktuell 5,95/6

der rutsch scheint wirklich etwas übertrieben, könnte sein wir pendeln uns im laufe des tages bei 6$ ein!

gruß codex

[[KERN]Codex]

6,2$

[Birgit.Tersteegen]

Ich habe die Hälfte nachgekauft,wenn`s noch weiter nach Süden
geht,tue ich es noch einmal.

Keine Panik auf der Titanic!!

[[KERN]Codex]

by: tekn0wizz (38/M/NL)
Long-Term Sentiment: Strong Buy 06/02/05 08:52 am
Msg: 673320 of 673380

This looks too much like the 47 year old woman that died in the Avonex ONLY arm of 1802, as I reported earlier in msg 634079.
[ http://finance.messages.yahoo.com/bbs?.mm=FN&board=7076797&t… ction=m&mid=634079 ]

A quote from that:

"Two deaths in the Avonex only arm of the MS trials were reported in the FDA approval documents [125104s000_Natalizumab_Medr_P2.pdf, page 55].

"...
Three subjects receiving placebo in MS trials
1. 66 year-old woman - pleural carcinomatosis by hemothrax and myocardial infarction, Study 231
2. 47 year-old woman - sudden death, presumed cardiac arrhythmia, Study 1802
3. 23 year-old women - sudden death, unexplained, Study 1802
...."

So nummber 2 & 3 were deaths in people on placebo & Avonex in the Sentinel trial.
No Tysabri came ever near them (just to be clear on this).
"


Read what the article in the Boston Globe actually says:

[http://www.boston.com/business/globe/articles/2005/06/02/a_f… ied_to_biogens_ms_drug/]
...
FDA spokeswoman Lenore Gelb said the agency is ``in communications with [Biogen Idec] on this case, as well as on the ongoing safety review."
...

Now what if this reporter got it wrong and is reporting on the 2 `sudden deaths` that I reported on occured in the Avonex ONLY arm of study 1802?

BIIB may indeed be communicating with the FDA on these cases.
They have nothing to do with Tysabri, as they occured in the Avonex ONLY arm of study 1802 (Tysabri+Avonex versus Avonex+placebo).
I know they are testing people now for Thyroid function (Avonex, Interferon-beta side-effect).
That is a rare but known problem with interferons.


[http://www.boston.com/business/globe/articles/2005/06/02/a_f… ied_to_biogens_ms_drug/]
"...
After being provided a copy of the report by the Globe, Dr. Patricia K. Coyle, an MS specialist and acting chairwoman of the Department of Neurology at the State University of New York at Stony Brook, said she thinks the FDA should investigate the new report ``quite vigorously."
..."


So the first expert got a copy of the article ("a copy of the report by the Globe", not "a copy of the filing with the FDA") & commented on it.

"...
Dr. Douglas R. Jeffery, a neurologist at Wake Forest University School of Medicine in North Carolina, said the patient`s symptoms would be ``quite rare" for multiple sclerosis, supporting the physician`s diagnosis of PML. ``It sure sounds convincing to me," Jeffery said.
..."

The second expert comments on undisclosed symptoms, that he says do not look like MS.
That it supports the reporters conclusion that it may be PML seems to be his conclusion.
And no `sudden death` does not look like MS, but it does not look like PML either!
And in the two deaths in the Avonex + placebo arm they CAN`T be related to Tysabri simply because those patients were not on that drug...!


And even IF this report is correct, than this person was on COMBO, which we already know can (probably) cause PML.

[Bernd13090]

[posting]16.779.443 von [KERN]Codex am 02.06.05 15:06:31[/posting]was sagt der Artikel aus ????

[Mr Ti]

das heißt, irgendein nachrichtenkrieg ist hier in gange, der kurs bewußt nach oben oder unten bewegen will.
wir können hier nur vermutlich aufs richtige pferd setzen und dass heißt gemütlicher trab nach oben, meine persönliche glaubensrichtung.
interessant ist doch die ganze geschichte, die mir noch kein mesch beantworten konnte: warum kackt der kurs nicht zum börsenstart ab, wenn die geschicht um 08.32 in den äther kommt? warum erst so spät, wer wollte/wer hat die lawine losgetreten??? wer profitiert davon: die shortys is klar.

[[KERN]Codex]

was verstehst du da nicht?

[[KERN]Codex]

Fakt is

tysabri mono = 0 deahts

[bernie55]

..die Leute begreifen es langsam....

6,86 $

[Cyberhexe]

genau Cody

und zudem sagte Kelly Martin letzten Donnerstag zu den Relaunch-Aussichten:

...not if but when

also, für den sonst eher zurückhaltenden CEO ist es lediglich eine Frage der Zeit, wann Tysabri wieder vermarktet wird...ich bin sehr zuversichtlich, dass das PML-Risiko in der Monotherapie sehr klein, wenn überhaupt nachweisbar, ist, zumal in der umfangreichen AFFIRM-Studie über 2 Jahre bisher keine PML-Fälle aufgetreten sind...und dies bei Nebenwirkungen im Plazebobereich und einer doppelten Wirkung...unglaublich!

und wenn die bishereige These mit dem zusätzlichen Fall wissenschaftlich abgestützt wird, um so besser für die Monotherapie

[Cyberhexe]

Kelly Martin sagte am 16.3.05 an der Analystenkonferenz bei SG Gowen folgendes:


<A – Kelly Martin>: “The first question was, did either patient have neutralizing antibodies and the
answer to that is no. Second question, with regard to if we find JC virus, what does that tell us in
terms of where we find it, in terms of what kind of patients, you know, we have, if those patients are
a combination patients that tells us probably a lot. If those patients are R.A. patients, it doesn’t tell
us as much and would probably be a bit perplexing. And gain that’s why we are going through this
process – to be has throw and exhaustive as possible, to make sure that we – both companies
understand all there is to know with regard to what happened.
Largest [ph] went through a hypothesis of what a fair amount of folks think might have happened.
But I think it will depend very much on which patients we have found anything in and what that
would give us. Just to hypothesize, if we found three more patients that all were from the
combination trial, that would statistically, clearly give us a zone that we would do extensive – more
extensive work and with regard to various DCs on what is occurring here between the combination
of the products. Yeah, up in the back there.”

[Mr Ti]

das ist ja alles richtig, sonst wäre ich ja nicht drinne, doch ist hier "bloss" ne lawine durch "lois lane" vom bosten xy losgetreten worden? auf elan haben andere kräfte ihr auge geworfen, die versuchen draufzuprügeln um wieder einzusteigen. hedgefonds vielleicht? hier sehen sie potenzial nach oben, das es mitzunehmen gilt.
denn wie schnell kann man seine meinung so derart an einem tage in frage stellen?
also logger bleiben und im zug sitzen bleiben.

[[KERN]Codex]

Hm in den Medien wird fast nur Tysabri die Schuld in die Schuhe geschoben, hoffentlich gibt es Morgen eine Korrektur, aber BIIB macht mir ein bissel Sorgen, die schieben sich doch nicht den schwarzen Peter zu, oder?

[Nostarowie]

Die sitzen doch sowieso im selben Boot von daher ists eigentlich egal wer die A..-Karte hat.Wichtig ist doch nur das in Zukunft die "Monokur" zugelassen wird.

(die hinundher Klickerei bei den haufen Elantraeds macht mich noch ganz wirr im Kopf)

[[KERN]Codex]

zenmans thread = kurskommentare
cyberexes thread = fundierte diskusionen

..oder meinst du das yahoo board?

[Cyberhexe]

nur wenn die Immunabwehr unterdrückt wird, kann es durch den JCVirus zum Ausbruch von PML kommen

PML ist relativ häufig bei HIV-infizierten Menschen...aber auch bei anderen die Immunabwehr unterdrückenden Wirkstoffen (wie zB Infliximab oder Azathioprin) ist PML ein Thema.
Die Tatsache, dass in der Monotherapie bisher keine PML-Fälle aufgetreten sind, spricht für ein sehr kleines, wenn überhaupt, PML-Risiko bei der Monotherapie.
Und die Kombi-Therapie (Ty+Avonex), bei der neben der immunsupprimierenden Wirkung von Avonex auch noch die Eliminationshalbwertzeit von Natalizumab eingeschränkt ist, d.h. sich der Wirkstoff über die Zeit akkumuliert, liefert kaum bessere Ergebnisse als die Monotherapie.
Deswegen... Tysabri wird zum Goldstandard zur Behandlung von MS (in Monotherapie). Und da Remicade ein ungünstiges Nebenwirkungsprofil hat, bin ich davon überzeugt, dass Ty auch bei MC eine gewichtige Rolle spielen wird. Bei RA (Polyarthritis) hingegen bin ich mir nicht so sicher. Allerdings sind dort die Cox-2-Hemmer mit schwerwiegenden Nebenwirkungen auch im Gerede, so dass ein wirkungsvolles Medikament mit Nebenwirkungen im Plazebo-Bereich auch auf diesem Indikationsfeld aussichtsreich erscheint.
Ich bin gespannt wie es weitergeht.

[Cyberhexe]

und zudem muss folgendes festgestellt werden...
es gibt bisher erst 2 bestätigte Todesfälle

einer der PML-Erkrankten ist wieder genesen, nachdem man rechtzeitig die richtige Diagnose gestellt hat und sämtliche immunsupprimierenden Wirkstoffe abgesetzt hat.
Also, auch wenn ein PML-Restrisiko vorhanden sein sollte, mit den richtigen Entscheidungen und Therapieansätzen muss PML nicht fatal enden!

[Nostarowie]

@ Codex,So isses

[Cyberhexe]

ach übrigens... Boston hat den Artikel nun korrigiert...es wird nicht mehr vom 4.Todesfall sondern von der 4. Erkrankung geschrieben...so ists richtig!


A fourth illness may be tied to Biogen`s MS drug
Finding could be blow to marketplace hopes
By Jeffrey Krasner, Globe Staff | June 2, 2005

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

[[KERN]Codex]

boston,

dieses drückerblatt

[Nostarowie]

Das bestätigt mich in meiner Meinung das dies ein Schachzug
ist; von wem ? das is hier die Frage ?!

Aber was solls ich geh jetzt Radeln.

[[KERN]Codex]

Vielleicht wollte BIIB ein Teil seiner wahrscheinlichen Combo Therapie Verluste durch einen höheren Anteil an ELN shares teilweise kompensieren

[[KERN]Codex]

Elan, Biogen fall on Tysabri report
Biogen reports fourth suspected case of PML to FDA
By Val Brickates Kennedy, MarketWatch
Last Update: 12:34 PM ET June 2, 2005


BOSTON (MarketWatch) -- Shares of both Elan Corp. and Biogen Idec Inc. took significant hits Thursday morning on the heels of news that a fourth suspected case of a deadly brain infection in a former user of the companies` now-withdrawn drug Tysabri has been reported to the Food and Drug Administration.

Shares of Elan (ELN: news, chart, profile) and Biogen Idec (BIIB: news, chart, profile) had come back from February lows on hopes that Tysabri could return to the market. By midmorning, Elan had tumbled 18% to $6.54 and Biogen had shed 4% to $38.04.

Recent stock gains

Elan shares have been stoked in recent days by remarks made May 26 by the company`s chief executive officer, Kelly Martin, at the Elan annual meeting. He`s said at that Dublin, Ireland, gathering that he was confident Tysabri would return to the market in some capacity.

The companies suspended all sales and clinical trials of Tysabri on Feb. 28 over fears that two users had contracted an extremely rare brain infection called progressive multifocal leukoencephalopathy, or PML. A third case of PML was reported in March.

On Thursday morning, the Boston Globe reported that FDA documents revealed Biogen had reported a fourth suspected case of PML to the agency. The Globe also reported that all four PML patients had died.

The FDA confirmed Thursday that a fourth suspected case of PML had been reported to the agency but said that the diagnosis had not been confirmed.

Biogen rebuttal

Biogen rebutted the Globe report early Thursday, stating that only two PML patients had died, while the third victim had survived. The company would not comment on the specifics of the fourth case in question, stating only that the patient was alive.

"The patient that the Globe referenced is definitely alive," said Biogen spokeswoman Amy Brockelman. "We`re not commenting on any of the other specifics in the article."

"We`re continuing to review any and all suspected cases," Brockelman added, saying that Biogen still hoped to have the review completed by the end of the summer.

Biogen has said that it plans to meet with the FDA as to the advisability of putting Tysabri back on the market after the medical review is complete.

Under review

Since Tysabri`s withdrawal, Biogen and Elan have been conducting an exhaustive review of all the medical files of the estimated 5,000 MS patients who took Tysabri, including 3,000 clinical-trial participants. As part of the review, Tysabri patients have been asked to submit to extensive physical examinations, including brain scans. Tyabri was approved by the FDA in late November 2004.

In recent interviews with MarketWatch, Biogen officials emphasized it was possible that more PML cases could be discovered during the course of the medical review.

An Elan spokesman, Brian McGlynn, told the Boston Globe that the company wouldn`t comment on individual cases "until the safety evaluation is completed."

The Globe also reported that the most recent PML victim was taking Tysabri in combination with another Biogen MS drug Avonex. Two of the previous PML cases were also taking both drugs, while a third had only been on Tysabri.

MS is a disease where the body`s own immune system attacks the central nervous system. Tysabri, which is based on an antibody, had been considered a breakthrough in MS treatment as it helped thwart those immunological attacks.

However, some medical experts now suspect that Tysabri may trigger PML, which is latent in almost 80% of all people, by lowering the body`s immune defenses against the disease. When used with Avonex, that effect may be enhanced, they posit.

Meanwhile, the path is still open for a return to the market of the Tysabri if the Boston Globe report is correct in saying the fourth case of PML was tied to the drug`s use in combination with Avonex, said Orla Hartford, an analyst at NCB Stockbrokers.

"Should it be confirmed, the path remains open for its use as a monotherapy," Hartford said.

Other analysts were less optimistic.

"Netting out our views, as we have said before, we would put the probability of return before mid-2008 (after robust safety trials) as quite remote," wrote William Blair analyst Winton Gibbons in a Thursday note.

http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yh…

[CBBBeobachter]

Na also,

das sieht doch gar nicht mal soooo schlecht aus. Ich denke das wir morgen über 7 Dollar schließen werden

Da wurden heute einige Stops ausgelöst

Stay long and strongc

[[KERN]Codex]

MS Drug Gets Another Possible Setback
Thursday June 2, 6:14 pm ET
Biogen Reports Fourth Possible Case of Rare Disease in Patient Who Took Multiple Sclerosis Drug


BOSTON (AP) -- Biogen Idec Inc. told the Food and Drug Administration that a fourth patient may have contracted a rare and potentially fatal brain disease after being treated with the company`s multiple sclerosis drug Tysabri, The Boston Globe reported Thursday.

Cambridge-based Biogen Idec and its development partner, the Irish drug manufacturer Elan Corp. PLC, hope to return Tysabri to the market, but if a fourth case is confirmed, it would be another setback.

Shares of Biogen Idec dropped fell $1.70, or 4.3 percent, to close at $38.07 in Thursday trading on the Nasdaq Stock Market where the stock has traded in a 52-week range of $33.85 to $70.00.

Elan`s U.S. shares tumbled fell $1.14, or 14 percent, to close at $6.85 on the New York Stock Exchange. The U.S. shares have traded in a 52-week range of $3 to $30.45.

Biogen and Elan suspended the drug Feb. 28 after two MS patients using Tysabri contracted a potentially fatal brain disease. One died. A third patient who had been taking Tysabri for treatment of Crohn`s, a bowel disease, later was confirmed to have died from the same rare condition, called progressive multifocal leukoencephalopathy, or PML.

The Globe said it obtained the report of the unconfirmed fourth case under the Freedom of Information Act. FDA spokeswoman Lenore Gelb said the agency is "in communications with (Biogen Idec) on this case, as well as on the ongoing safety review."

The possible fourth PML patient is a 48-year-old woman who was taking Tysabri and Avonex, another MS drug sold by Biogen.

Biogen spokeswoman Amy Brockelman told The Associated Press on Thursday that the patient is alive, but she declined to offer further details on the case.

"We`re reviewing any and all suspected cases as part of our safety evaluation," Brockelman said. "We hope to have our evaluations done by the end of the summer."

The FDA, after reviewing one year of data from planned two-year trials, in November approved Tysabri for sale to the 350,000 American sufferers of multiple sclerosis, a debilitating and incurable disease that can cause sudden partial paralysis. The drug has been shown effective in reducing relapses among MS patients.

Elan spokeswoman Emer Reynolds declined to comment on the Globe report.

"We don`t comment on rumors or individual cases going through the safety evaluation process," she said in Dublin on Thursday.

Biogen shares plunged more than 42 percent the day the drug was withdrawn and the company disclosed the drug may heighten the risk of contracting a rare disease of the central nervous system.

One week ago, addressing investors at the company`s annual meeting in Dublin, Elan Chief Executive Kelly Martin said he`s optimistic Tysabri would go back on the market. He said officials from both companies would meet U.S. regulators to discuss the "path forward for Tysabri" once their internal review was complete by late summer.

"It`s a question of when and what path that takes, not a question of if," he said on May 26.


http://biz.yahoo.com/ap/050602/ms_drug.html?.v=1

[CBBBeobachter]

Guten Morgen,

also wenn ich alles richtig verstanden habe sieht es folgendermaßen aus.

TYSABRI ist das am besten wirkende Medikament gegen MS.

TYSABRI ist solange es nicht in Kombination mit anderen Medikamenten verabreicht wirkt mit einem geringen Restrisiko ungefährlich.

Also ?

Auf steigende Kurse

Oder habe ich etwas vergessen ?

Gruß

[Cyberhexe]

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


das ist ja spannend:

The patient was not involved in a clinical trial of Tysabri, according to Brian McGlynn, an Elan spokesman. She had been treated with Tysabri during the roughly three-month period it was available commercially and given to about 5,000 patients. She received between one and three monthly infusions of the drug, McGlynn said, and according to FDA documents was also taking Avonex, an older Biogen Idec treatment for MS.

conclusion:
Die Betroffene hat nicht an einer Studie teilgenommen, sondern Tysabri auf kommerziellem Wege nach der Markteinführung erhalten. Dies bedeutet, dass maximal 3 Infusionen Tysabri verabreicht wurden. Interessant scheint mir zudem, dass auch noch immunsupprimiert wurde (Avonex). Es ist mehr als unwahrscheinlich, PML auf die Verabreichung von max. 3 Dosen Tysabri zurückzuführen.

Folgende Fragen stellt man sich unwillkürlich:

Wie lange zuvor wurde Avonex verabreicht?
Gab es bereits PML-Symptome vor der ersten Tysabri-Infusion?
Bedeutet dies vielleicht, dass Avonex-Mono ebenfalls ein PML-Risiko beinhaltet?

Diese und weitere Fragen könnten den Biogen-Verantwortlichen sehr unangenehm sein.

Für Tysabri scheint dies alles andere als negativ zu sein...im Gegenteil.

Ich bin mittlerweile bullischer denn je.

good luck to all longs!

[CBBBeobachter]

Persönliche Nachricht Cyberhexe

[Cyberhexe]

irisches Analystenhaus von heute (Davys Stockbrokers)

Elan (ELN US)
Previous close: 685c
Fourth PML case suspected
[e-mail]
• Though we understand that the case is suspected rather than confirmed, the emergence of another possible PML case has
weighed heavily on the Elan share price. Further media reports today suggest that the patient is still alive, was taking other
MS drugs in addition to Tysabri/Avonex, and had multiple illnesses.
• The company has maintained air silence on the basis that it will only comment on material developments during its Tysabri
patients` review. We assume that a confirmed case would be material and thus would require an announcement.
• But separate to the handling of such news (be it suspected or confirmed) is the significance of the news itself. Any other
PML cases that emerge (at any time) must also be assessed in the context of the three cases that have already been
confirmed, and a judgement must be made of their incremental scientific significance. This patient case involves combination
therapy (Tysabri + Avonex, plus perhaps other MS drugs) and may not be hugely different from the profile of the existing
three confirmed cases. As such, this would not alter Elan`s task to define the risk/benefit profile to the FDA.
• In this light, the scale of the price decline yesterday is overdone; but we would acknowledge the high volatility in the shares
at present and the fact that it had been running at the top end of its recent $5–8 range (boosted last week by the positive
AGM comments). The stock will remain volatile until there is more Tysabri visibility.

[Cyberhexe]

und hier eine wetere Analystenmeinung vom Tage, und zwar von Dolmen - ebenfalls ein irisches Analystenhaus:



Today’s Recommendations
Elan ($6.80) 4th PML case reported Stuart Draper
4th case : It has been reported that Biogen has informed the
FDA that a fourth patient taking Tysabri may have contracted
PML. The fact that the report has not been denied by Elan,
despite the more than 15% fall in its share price, indicates
that the report is likely to be true.
Not denied : Elan had previously stated that even if further
PML cases were discovered over the summer, the public would
not be told until “mid-to-late summer”, when the safety
probe into Tysabri is expected to be completed. The FDA also
confirmed that it is evaluating a possible 4th case of PML in a
patient who had taken Tysabri.
Cash burn : Following the suspension of Tysabri, Elan recently
took action to reduce its operating cash burn by $100m to c.
$250m in 2005. It is now targeting break-even on an EBITDA
basis by the end of 2005. However, despite Tysabri’s continued
strong efficacy data, until the very serious PML safety
concerns are clearly defined, there remains a significant risk
that the drug will not be commercially viable.
Disability progression : The drug’s recent efficacy results have
been very strong. The 2 year data showed a 42% reduction in
disability progression compared with placebo. Only 17% of Tysabri
patients progressed versus 29% for placebo. The best reduction
in disability progression previously achieved by a competitor
product was Avonex’s 37%.
Relapse rate : At the two year stage, Tysabri also showed a
67% reduction in the rate of clinical relapses relative to placebo,
consistent with its one–year data, rather than falling as
noted in trials of other MS drugs.
Commercial viability : However, the drug’s future commercial
viability remains in doubt and even if it does return to the
market, as claimed at last week’s AGM, there is a high risk of
it not generating the $1 bn + of sales implicit in the company’s
current valuation. There is also a high risk that even if the
drug does return to the market, that the regulatory approval
process now takes much longer than currently expected.
Net debt : The consensus fair value estimate for Elan without
Tysabri is c.$4 per share. However, such valuation support
could be undermined by further liquidity concerns if Tysabri
turns out to have no commercial future as Elan has debt of
$1.1 bn due to be repaid in 2008. Therefore, our current NEUTRAL
recommendation remains in place until the review of
the Tysabri clinical trial patients for PML is completed.

[Mr Ti]

cyberhexe nicht vergessen.
davy stockbrokers, wer ist dort der chef: unser elanchef ;-)

[Cyberhexe]

stimmt Mr Ti, daran hatte ich gar nicht gedacht!
vD

[Cyberhexe]

ich fass es nicht....Ian Hunter von Goodbody Stockbrokers (irisches Analystenhaus) empfiehlt Elan zum Kauf...verrückte Welt...eigentlich ein Kontraindikator...oder scheint IH die story nun begriffen zu haben

Einschätzung vom 3.6.2005

Elan(Buy, Current Price $6.85); What is material to Tysabri`s progress?
Ian Hunter T [phone] E [e-mail]
After a day with no communication on speculation around Tysabri, a spokesperson for the FDA now appear to have confirmed that Elan and Biogen Idec have received a report of a suspected case of PML. Given the lack of response from both Elan and Biogen Idec, we infer that the case referred to has been deemed by all parties involved not to be material to the progress of Tysabri through the approval process...


es handelt sich hier also um ein nicht relevantes Ereignis...

[Nostarowie]

Kontra könnte bei dem auch bedeuten das das Teil nun Fällt.

Das durcheinander ist nun Perfekt.

[[KERN]Codex]

The patient was not involved in a clinical trial of Tysabri, according to Brian McGlynn, an Elan spokesman.

..genau das habe ich bereits gestern gelesen, das ist wirklich heftig was boston da abgezogen hat!

[Cyberhexe]

ich gebe im allgemeinen wenig auf derartige Analystenkommentare, da diese in der Recherche oft sehr unpräzise sind

Ian Hunter bzw. dessen Einschätzung zu Elan verfolge ich bereits seit 2 Jahren, in denen er mit seinen ratings eigentlich immer den Kursen hinterhergelaufen ist...

überrascht bin ich deswegen...
vorgestern (also am 1.6.05) hat IH empfohlen, Elan zu verkaufen (Reduce, Current Price $7.90)...nachdem der Rückkauf der Wandelanleihe bekanntgegeben wurde

und heute empfiehlt er Elan zum Kauf
Elan (Buy, Current Price $6.85) und das nach den gestrigen Meldungen

Welchen Schluss zieht man daraus:
vielleicht hat er nun wirklich begriffen, dass Tysabri auf den Markt zurückkommen wird!

[[KERN]Codex]

Vielleicht wußte er vom Boston Bericht?

[Mr Ti]

hier ist jedem alles zuzutrauen, also ohne witz. wer von wem, wie und wann wußte und diese kursbewegungen. irgendeiner wollte noch billig rein, hats geschafft und wir haben hoffentlich unsere "ruhe" und das ding geht mit der weiteren positiven story seinen "gemütlichen gang" nach oben.

man kann doch nicht während der arbeit nur als g.netzer spielen.

man muss doch auch mal die sonne geniessen können und langsam das we einleuten, oder?

[Cyberhexe]

veröffentlicht auf thisisms.com am 1.4.2005

3rd Patient had History of Severe Immunosuppression
Previous therapy linked directly to PML

A firestorm has erupted with the revelation on March 29, 2005 that a 3rd patient dosed with Tysabri had been discovered to have Progressive multifocal leukoencephalopathy (PML). PML is a demyelinating disease of the brain caused by the JC virus. This patient had 8 doses of Tysabri over the course of 18 months during a clinical trial for Crohn`s disease, an autoimmune disorder that strikes the bowels. The doses were spaced out as follows: 3 months Tysabri, 9 months placebo, then 5 months Tysabri. The patient passed away in December of 2003, with his death originally attributed to a fatal brain tumor.

The recent revelation of 2 cases of PML found in extended combination therapy of Avonex and Tysabri prompted a reinvestigation of this death. The new conclusion was that the patient had actually died of PML, not a brain tumor. This has been viewed by many as devastating the chances of Tysabri ever returning to market, given that it seems on the surface that Tysabri can cause PML even when used alone (monotherapy).

However, This is MS became suspicious of the link between Tysabri and PML in this case, particularly given the low number of Tysabri doses that the patient had been exposed to, the spacing of those doses, and the mysterious mention of a past history of severe immunosuppresion. If PML were so "easy" to contract when exposed to Tysabri, why would we not see higher numbers of incidents in the multiple sclerosis Tysabri groups, who are more frequently dosed (monthly) over longer periods of time (over three years for the extended trial participants) with higher Tysabri circulation (when combined with Avonex, Tysabri clearance is reduced by ~30%). Something is clearly amiss...

The investigation is enlightening, and we believe, shows that Tysabri cannot easily be considered the critical factor for this case of PML. As you will see, it is not a foregone conclusion that this patient could be considered to have been on Tysabri monotherapy, given the long-term effects of his previous therapies. To preface this article, note that this is an opinion piece based upon information in the public domain and written by non-medical personnel, so all conclusions are meant to serve as discussion points and not definitive answers.

That being said, Elan disclosed the list of medications Patient #3 was treated with:


Steroids No surprise here, and this relatively weak immunosuppressant is used commonly with most MSers.

Remicade, which is a powerful drug used to treat Crohn`s disease. Now things get more interesting. A *partial* list of warnings for Remicade: "Many people with heart failure should not take REMICADE...There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. ...REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away...There have been rare cases of serious liver injury in people taking REMICADE, some fatal...Blood disorders have been reported, some fatal...Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE. Reports of lymphoma (a type of cancer) in patients on REMICADE and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer." (Source).
Clearly, Remicade is not a treatment to be undertaken lightly and has a number of ways of causing fatalities.


Azathioprine (aka Imuran) -- This is where things get extremely interesting. The patient was treated for approximately five years (!) with this powerful drug commonly used for preventing the rejection of organ transplants (!) and in lower doses, rheumatoid arthritis and other inflammatory diseases such as Crohn`s. Quoting Medline: "[Azathioprine] works by weakening the body`s immune system so it will not attack the transplanted organ or the joints." It is not clear for what indication this patient took this drug, but it was likely taken off-label for what would obviously have to be a severe case of Crohn`s disease. Let us examine this drug`s mode of action and safety profile:
"Imuran [is] used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months..." Note that Imuran is commonly prescribed in combination with another immunosuppressant AND the effect of the drug-- severe immunosuppression-- is often delayed.

Continuing on with the litany of grave warnings:

"Severe leukopenia [an abnormal decrease of white blood cells] and/or thrombocytopenia [abnormal decrease of blood platelets] may occur in patients on azathioprine. Macrocytic anemia and severe bone marrow depression may also occur...Delayed hematologic suppression may occur. Prompt reduction in dosage or temporary withdrawal of the drug may be necessary if there is a rapid fall in, or persistently low leukocyte count or other evidence of bone marrow depression [Tysabri works by preventing leukocytes from crossing the Blood-Brain-Barrier, so if they are already severely reduced...]...Serious infections are a constant hazard for patients on chronic immunosuppression...Fungal, viral, bacterial and protozoal infections may be fatal and should be treated vigorously...Azathioprine is mutagenic [causes mutations] in animals and humans, carcinogenic [causes cancer] in animals, and may increase the patient`s risk of neoplasia [pre-cancerous cell growth]...acute myelogenous leukemia as well as solid tumors have been reported in patients...who have received azathioprine." (Source).

Let us recap: Azathrioprine can be incredibly toxic, can decimate the immune system long after its dosing, and leaves the patient susceptible to potentially fatal infection. Could Imuran still have been exerting its effects during the Tysabri infusions? We don`t have an answer to that, but if so, let us explore "the smoking gun":

While looking at the reported adverse reactions for Azathioprine, we found this:

"A case of progressive leukencephalopathy (PML) after a four year azathioprine therapy...was reported (Schnider,1991)." (Source). That`s right-- a case of PML linked directly with long-term administration of azathioprine. Patient #3 was actually on azathioprine for one year longer than this PML-azathioprine case. This is not the only case, here`s another:

"A 71-year-old woman receiving azathioprine and glucocorticoid therapy experienced onset of right-sided hemiplegia within a few days, became comatose, and died within a few days...postmortem examination showed PML." (Source).

Simply put, we are aghast that this ravaged individual, exposed to years of dosing with a cocktail of potentially lethal drugs-- that among other things, can cause delayed immunosuppression, cancer, and even PML itself(!), was participating in a clinical trial with another experimental immunosuppresant. Maybe his case was so bad, he had no other hope, but in such an extreme situation, the fault of his death cannot be placed squarely on Tysabri. That he died is of course tragic, but quite frankly, a serious adverse event is not entirely surprising given his cumulative medical history.

To conclude that Tysabri is the key factor for his contraction of PML and ultimate death, based on the post-mortem analysis of a patient that clearly was severely ill (a gross understatement!) is to us, simply preposterous. While we are not doctors and so our opinion is purely non-medical, this situation cannot reasonably be viewed as akin to an otherwise healthy individual contracting PML after exposure to Tysabri monotherapy. In fact, given the latent effects of the Imuran treatment, without further information as to treatment start and stop dates, it cannot even be said definitively that this patient was on Tysabri monotherapy, as after five years of treatment, Imuran could still have been exerting its effects without being actively dosed.

The contraindications for prescribing Tysabri are becoming clear, and coupled with the increased vigilance for PML that would be sure to accompany any Tysabri prescription, the risk factor would seem to be acceptable for many MSers anxious for a new treatment option. The fact that toxic drugs like Remicade and Imuran are tolerated but Tysabri would not be is at the very least extremely puzzling. Tysabri is extremely effective at what it does, and because of that potency, cannot be coupled with drugs that cause, or people who have, a history of immunosuppression, cancer and serious infections.

[[KERN]Codex]

Da gibt es doch tatsächlich jemanden der immernoch es hätte einen 4. Todesfall gegeben, guckt mal in zens thread

[Cyberhexe]

cody nichts durcheinanderbringen...folgende 4 Fälle sind bisher aufgetreten:

2 Fälle in SENTINEL (TY+Avonex), davon einer fatal
1 Fall in ENACT (Ty zur Behandlung von MC), fatal, allerdings sehr stark immunsupprimiert mit Azathioprin während 6 Jahren (das hält dann noch ziemlich lange an) sowie 2 Jahre mit Remicade

sowie derletzte Fall, wobei es sich hier nicht um eine Studienteilnehmerin handelt, sondern um eine kommerzielle Verabreichung nach Markteinführung, d.h. es sind also maximal 3 im Extremfall 4 Dosen möglich (29.11.04 bis 28.2.05/Infusion im Abstand von 4 Wochen), nicht fatal

[[KERN]Codex]

ne ne,

das einzige was ich durcheinander bringe ist meine satzstellung

so wünsche allen ein schönes wochenende,

ELAN macht das schon,

gruß codex

[[KERN]Codex]

by: chucky_r_law (41/M/Dublin, ie)
Long-Term Sentiment: Strong Buy 06/03/05 09:35 am
Msg: 676804 of 677244

David

The full text article is in German.
I am emailing it to you.

This is the summary
Blocking adhesion molecules with natalizumab in multiple sclerosis
Summary Natalizumab is a humanized, monoclonal antibody, that inhibits adhesion molecules (4-integrins) on the surface of immune cells. These adhesion molecules are important for binding of lymphocytes to endothelial cells of blood vessels and infiltration of inflammatory cells into tissues. Natalizumab is currently being tested in large clinical trials for the treatment of multiple sclerosis (MS) and other autoimmune diseases (inflammatory bowel diseases, rheumatoid arthritis). After demonstrating the safety and potential effectiveness of natalizumab in MS therapy during shorter treatment periods (6 months) in clinical phase I and II studies, two ongoing large, double-blinded, placebo-controlled phase III trials (named AFFIRM and SENTINEL) are evaluating its efficacy for patients with relapsing-remitting MS in respect to primary clinical endpoints (relapse rate, disease progression). Based a 1-year interim analysis of these studies, natalizumab was recently authorized by the U.S. Food and Drug Administration for treatment in reducing the frequency of clinical surges in multiple sclerosis, and an application was also made for its use in Europe. After more than 2 years of combined natalizumab (Tysabri) and interferon beta-1a (Avonex) therapy in the so-called Sentinel Study, there was one unexpected death and one appearance of progressive multifocal leukoencephalopathy. As a result, in February 2005 the manufacturers (Biogen/Elan) stopped all running studies of natalizumab and removed the drug from the market. New studies are underway to gain more understanding and especially to determine the risk to patients treated in the Sentinel Study. This article summarizes and updates the results of previous and ongoing natalizumab trials in the context of MS.

GLTAL

G

[[KERN]Codex]

by: dunkey21 06/03/05 11:47 am
Msg: 677239 of 677255

I`m an MSer. I can tell you who will avoid it. Initially, it will be anyone who has taken steroids in the last several months as they will be afraid of the immunosuppression issue and will likely be unable to get a script from a neuro for at least 3 months post-steroids.

Those who take steroids regularly (meaning a couple times a year) might hesitate to get on the drug as it means they won`t be able to take the steroids if they have an acute exacerbation. Thats a tough one as the steroids usually do a good job of putting out the fire ASAP which is important.

Others will be slow to come to the table until more data is released regarding its saftey. They feel like lab rats and don`t trust Elan/Biogen due to their less than timely reports.

Others will flock to it as they either took it before with success, are in bad enough shape to ignore the risk and non-existent long-term data, or just believe that its a better treatment worthy of any risk (and some will believe that there is no risk unless immunocompromised).

The real spike in usage would come 2-4 years from re-introduction when additional long-term data is revealed.



..so ich bin offline

[Cyberhexe]

und hier noch ein interessanter Link aus dem ymb zur Alzheimer-Geschichte

http://pn.psychiatryonline.org/cgi/content/full/40/11/1

schönes we wünscht
ch

[Cyberhexe]

Jungs...Ohren steif halten...freu mich auf Montag...das wird für alle Elanians ein spannendes Jahr

also dann bis Montag...und prügelt nicht so sehr auf dem rotie rum

[CBBBeobachter]

Kursziel bei Wiedereinführung ?


Gruß

[invest2002]

.

[[KERN]Codex]

Tysabri dominates Biogen Idec meeting
By Jeffrey Krasner, Globe Staff | June 4, 2005

At Biogen Idec`s annual meeting of shareholders yesterday, executive chairman William H. Rastetter did not make bullish predictions about when the Cambridge firm`s troubled multiple sclerosis drug Tysabri might become available.

The closest he came was a reference to it as a drug, ``which we hope will return to the market."

Yet Tysabri dominated the 90-minute meeting at the Royal Sonesta Hotel in Cambridge. Company officials stressed the medical need for Tysabri by reading the quotes of MS patients who described it as a ``last hope."

Biogen Idec and its partner in Tysabri, Elan Pharmaceuticals Corp. of Ireland, in February pulled the drug from the market and discontinued clinical trials after a trial patient died of a rare brain disease. A second suspected case was confirmed; that man is still alive. A third case of PML -- resulting in a second PML-related death -- was reported in March. On Thursday, the Globe reported a suspected fourth case in a woman who took Tysabri for about three months when it was briefly available commercially, in combination with Avonex, another Biogen Idec MS drug. She also is alive.

On Thursday, Biogen Idec shares fell 4 percent and Elan shares were off 14 percent. Yesterday, Biogen Idec dropped $1.67, or 4.4 percent, to $36.40. Elan gained 18 cents, or 2.6 percent, to close at $7.03.

James C. Mullen, the firm`s chief executive, said the review of Tysabri is focused on identifying which patients are at risk for PML and finding ways to reduce the chances they could contract the brain disease. He also tried to change the perception that the disease, whose full name is multifocal progressive leukoencephalopathy, always results in death.

``It can be fatal, but if detected early it can be treated, and patients do fairly well," Mullen said. ``We need to look at which populations should be considered for therapy [with Tysabri] and which should be contraindicated."

Biogen Idec plans to meet with regulators in late summer. Mullen said he and Rastetter are ``blinded" to the ongoing inquiry of PML cases, and will not be told the full results until they are complete.

Jeffrey Krasner can be reached at [e-mail].

© Copyright 2005 Globe Newspaper Company.


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

[[KERN]Codex]

Biogen Idec Says What`s Known Is Known

By Althea Chang
TheStreet.com Staff Reporter
6/3/2005 4:53 PM EDT
Click here for more stories by Althea Chang


As Biogen Idec (BIIB:Nasdaq - commentary - research) executives started the company`s annual shareholder meeting Friday, there was little doubt that much of the talk would focus on Tysabri, the now-withdrawn multiple sclerosis drug that might be linked to a handful of cases of a brain disease.

Chairman Bill Rastetter and CEO Jim Mullen addressed concerns about the drug with investors, but said they had nothing new to report. "Jim and I are blinded. We know exactly what you know, and we know nothing more," said Rastetter, who asked shareholders not to approach the meeting looking for "nuance."

Rastetter spent part of the meeting using the emotional approach to the Tysabri discussion by reading aloud quotes from patients who considered the drug their "last hope," and he touted the treatment as a "much heralded, much desired" treatment for MS.

Biogen Idec and marketing partner Elan (ELN:NYSE ADR - commentary - research) said in February that they were suspending sales of Tysabri after clinical trials revealed that two patients had contracted the brain disease PML, or progressive multifocal leukoencephalopathy.

The first two cases were found in patients who were taking Tysabri and Avonex, another MS drug. A review of trial records later revealed a third patient. Two of the patients died. On Thursday, The Boston Globe reported that a fourth case of PML might be related to Tysabri.

Though little is known about the sometimes fatal brain disease, experts do know PML is extremely rare in the generally healthy population, but it has been known to occur in patients with impaired immune systems, like those with HIV or on drugs that suppress the immune system. PML is not a death sentence if it`s discovered early, the company said after consulting with specialists. It could even be controlled by stopping immunosuppressive therapy, Mullen said.

The questions now, Mullen said, are: "What can we do to educate people, who should be considered for therapy, and should not, and how to mitigate the risk."

[[KERN]Codex]

Heute geht die Reise weiter

[Cyberhexe]

etwas ältere aber immer noch akteuelle Info zur Alzheimer-Phantasie

Alzheimer`s Vaccine Shows Promise

July 21, 2004


The vaccine was intended not to prevent Alzheimer`s, but to treat it. The experiment was halted in early 2002 after 18 of 300 participants developed brain inflammation.

(AP) An experimental vaccine for Alzheimer`s disease slowed memory decline somewhat even though the research was stopped before the full treatment could be administered, a study suggests.

There`s no indication that the effect made any noticeable difference in the patients` day-to-day functioning. The study wasn`t set up to look for that.

But the memory result was surprising and encouraging for the general idea of using the immune system to attack Alzheimer`s, said researcher Sid Gilman.

"I think there`s a positive signal here," said Gilman, a professor of neurology at the University of Michigan.

The vaccine was intended not to prevent Alzheimer`s, but to treat it. The experiment was halted in early 2002 after 18 of 300 participants developed brain inflammation. The vaccine formulation has been abandoned, but the general immune-system strategy is still being pursued.

Gilman spoke in a telephone interview before presenting the vaccine results Wednesday at the International Conference on Alzheimer`s Disease and Related Disorders in Philadelphia. The study was sponsored by Elan Corp., based in Dublin, Ireland, and Wyeth Pharmaceuticals of Collegeville, Pa., which are collaborating on the idea of treating Alzheimer`s through the immune system.

People with Alzheimer`s have amyloid plaque clumps in their brains, and the vaccine was designed to develop blood proteins call antibodies to attack the plaque. Autopsy studies of three people who had received the experimental vaccine show that the plaque clumps had been cleared from areas of the brain, Gilman said.

Originally, study participants, who had mild to moderate Alzheimer`s, were to get six injections over 12 months. But because of the brain inflammation, nobody got more than three and most got only two. The new research looked at psychological tests done 12 months after the first injection.

The study compared test results from patients who had a certain level of antibodies in response to the vaccine versus patients who were given inert injections for comparison purposes.

Not all patients completed each psychological test. Among those who responded to the vaccine, the various tests were completed by 34 to 41 patients; the range for the inert-injection group was 45 to 52.

Results showed no performance difference between the groups in several tests, including two standard ones used for tracking treatment effects. That was no surprise, since the treatment had been interrupted, Gilman said.

But researchers found that the treated group did better than the other group in tests that measure ability to retain memory up to a half-hour. They also found that higher levels of antibody were associated with better scores on the memory tests, further suggesting an effect of the vaccine.

"I think it`s a very interesting preliminary finding," commented Bradley Axelrod, a neuropsychologist at the Veterans Affairs Medical Center in Detroit, who didn`t participate in the study.

It will take more research to see whether similar therapies can also create detectable differences in mental functioning, and to see precisely what aspects of mental ability they improve, he said.

Elan and Wyeth have started early human studies of infusing antibodies into Alzheimer`s patients rather than spurring the immune system to create antibodies.

Dr. Sam Gandy, an Alzheimer`s Association spokesman and researcher at Thomas Jefferson University, said human studies of therapies that attack the amyloid clumps are the only way to end the long-standing debate over whether that plaque really causes symptoms of the disease.

Even if they do, scientists will have to figure out how early such treatment is needed to slow the effects of the devastating disease. Gandy said an amyloid-attack treatment might prove effective in preventing the disease rather than stopping it.

[[KERN]Codex]

Last Thursday, June 2, The Boston Globe ran a story relating to a potential fourth case of PML in a Tysabri-treated patient.

The Boston Globe obtained the case report form (CRF) from the FDA under the Freedom of Information Act. We have not been able

to obtain the CRF but have requested it from the FDA. However, late last week, we spoke to Dr Patricia Coyle (Professor of

Neurology, the School of Medicine, Stony Brook, New York) who was quoted in The Boston Globe article after the newspaper had

shared the details of the report with her. Based on Dr. Coyle’s insights and statements made by Elan and Biogen Idec over the

last two days, we have been able to put together the following facts:

(1) The case report form was filed with the FDA in April by a community-based clinician – it did not come from Biogen or

Elan.

(2) The report relates to a 48-year old woman with MS who was given the drug post-approval. She was not in the MS trials. She

had had three or four infusions (one per month) of Tysabri at most between approval (late November) and being taken off drug

(January/February).

(3) The woman was taken off drug because of her worsening condition prior to the general withdrawal of Tysabri (on February

25)

(4) The case is not yet confirmed which is why Biogen and Elan have not issued a press release. However, according to Dr

Coyle, the symptoms are consistent with PML and are severe: loss of cognitive function, aphasia (problems with language), and

dementia, among others. The reasons for the delay in confirming PML were not clear to Dr Coyle.

(5) The patient has not died as far as Dr Coyle is aware (but she has limited information). However, this is consistent with

statements from Biogen and Elan.

(6) At Friday`s annual shareholder meeting Biogen management was unwilling to comment on this potential fourth case given that the case has yet to be confirmed as PML.






MPLICATIONS OF THE POTENTIAL “FOURTH CASE” - As outlined in a conference call that we hosted with our Biotech colleagues Craig Parker, Nick Abbott, and Sam Williams on May 13th, we have previously suggested that the reason for Biogen and Elan`s recent optimism regarding Tysabri`s potential re-launch may stem from the results of an ongoing analysis of frozen blood samples and data from patients involved in the MS and Crohn`s studies. We surmised that it is possible that Biogen has identified a correlation between the presence of a `neurotrophic` strain of the JC virus and the subsequent onset of PML. Biogen & Elan expect to submit the result of their findings to the FDA in mid-to-late summer. We also surmised that Biogen would use this analysis to try and persuade the FDA to allow Tysabri back onto the market with monthly blood monitoring to identify at-risk patients. We also noted that we were unsure of the FDA`s likely approach to such an analysis and that it might require a further prospectively defined clinical study to provide further proof of the value of monthly screening
for risk factors as a way of avoiding further cases of PML. If confirmed, we think that this ‘fourth case’ of PML complicates the re-launch process given its apparent differences. If these differences cannot be satisfactorily resolved then we think it would significantly reduce the chances of the FDA allowing market re-launch without data from a further study (if at all).
Recall that the previous three cases of confirmed PML had occurred in patients from the clinical trials and after some time on the drug. For example, the two MS patients had been on drug for 24 and 27 months, respectively. We understand that the Crohn’s patient had had at least eight doses of drug (three in the induction phase of the study and five in the open-label phase). The potential fourth case suggests that PML can come on very quickly following the onset of therapy. Therefore, even if Biogen were able to show that all four patients had the neurotrophic virus in their blood one or two months prior to developing PML, there is no guarantee that withdrawing Tysabri following a positive blood test will be sufficient to prevent the onset of PML. While it may be sufficient to prevent death, we think the FDA`s primary goal will be to prevent the onset of PML altogether, given its debilitating effects.

However, it may be that Biogen is also able to identify PML risk factors that are present prior to starting Tysabri therapy and that are common to all four PML patients. Such risk factors could be used to prevent at-risk patients from starting Tysabri therapy in the first place. In this situation the ‘fourth case’ may not detract from Biogen`s argument (and could strengthen its case). However, this thesis remains highly speculative, particularly as we don`t know the results of Biogen`s data review. The most conservative way to view this newest development is to assume that it damages Tysabri`s chances of re-launch, in our opinion.

[[KERN]Codex]

by: tekn0wizz (38/M/NL)
Long-Term Sentiment: Strong Buy 06/06/05 07:30 am
Msg: 679463 of 679465

Bend_over_shortie, these documents are known and have been discussed before.
Of these 9 deaths only 1 was possibly related to Tysabri and it is the well known case of the CD patient with PML (patient#3).


[ 125104s000_Natalizumab_Medr_P2.pdf, page 55 ]

"Three subjects receiving placebo in MS trials
1. 66 year-old woman - pleural carcinomatosis complicated by hemothorax and myocardial infarction, study 231
2. 47 year-old woman - sudden death, presumed cardiac arrythmia, Study 1802
3. 23 year-old woman - sudden death, unexplained, Study 1802
"

Clearly none of these are Tysabri related.

I already discussed #2 & #3 (from 1802 Sentinel, the combo trial), who where on Avonex ONLY, see msg 634079.
[ http://finance.messages.yahoo.com/bbs?.mm=FN&board=7076797&t… ction=m&mid=634079 ]
These `sudden deaths` are both suspect and not explained; these may be a statistical glitch, they may also be really related to Avonex.
One of the known side-effects of interferon-beta treatment (that could possibly explain this) are thyroid problems; in some (fairly extreme & rare) cases these can lead to cardiac problems and `sudden death` even in young adults.
For more details read my earlier posts on this.


[ 125104s000_Natalizumab_Medr_P2.pdf, page 55 - continued ]

"Two subjects receiving natalizumab in MS trials
1. 49 year-old woman - violant death (homicide or suicide; police investigation in progress), Study 1801
2. 5 year-old girls - respiratory distress secondary to progressive MS, Study 1804;"

From what I know #1 was indeed a homicide.
The 5 year old girl we have been talking about; this was a rescue attempt that failed. She was put on Tysabri when er symptoms where already very progressed and there was little hope left. They tried to safe her by putting her on Tysabri (as well). That attempt failed.

Summary MS trials: 5 deaths of which 3 in placebo, 1 homicide and 1 not because of the drug (Tysabri) but from the disease(s) she was treated for.


[ 125104s000_Natalizumab_Medr_P2.pdf, page 55 - continued ]

"Four subjects receiving natalizumab in CD trials
1 . 42 year-old man - carbon monoxide poisoning, described by the applicant as "work-related ... [and] accidental," Study 301
2. 49 year-old woman - progression of CD and nephrotic syndrome, complicated by peritonitis and spesis, Study 301
3. 60 year-old man - malignant astrocytoma, Study 351
4. 73 year-old man - perforated duodenal ulcer with peritonitis and pulmonary aspergillosis, Study 351"

So here we have #1 accidental death, #2 and #4 died of (complications of) their disease (CD) and finaly #3 is our well known patient #3, who died of a malignant astrocytoma (malignant brain tumor), but who`s diagnosis was later `re-assessed` as PML.

Summary of the CD trails: 4 deaths, 1 accidental, 2 not because of the drug (Tysabri) but from the disease(s) they were treated for and 1 where Tysabri may have played a role.
However the patient was on both a heavy cytotoxic immunosuppressant (Azathioprine) which by itself can cause various opportunistic infections (a.o. JCV and as a result PML) and on anti-TNF drug (Remicade / infliximab) that is by itself also associated with PML.

In total 1 death of the 9 is possibly Tysabri related and it is the now (in)famous case of patient #3.

[CBBBeobachter]

Und ?

Wie sieht es aus ?

[[KERN]Codex]

Hier ein Link zu Zens neuem Thread:

http://www.wallstreet-online.de/ws/community/board/thread.ph…

Thread: ELAN - 1.000 % for the LONG-time

gruß codex

[Cyberhexe]

jetzt wirds langsam lächerlich....Morningstar bewertet Elan derzeit mit 0.00$...also für mich ist das alles nichr ganz durchschaubar...wer mit wem und weshalb und warum?
Derzeit sind 38 Mio Aktien short! Ich frag mich deswegen...sind die voll daneben oder bin ich es???
Auf alle Fälle lass ich mich nicht beirren...hab gestern meine letzten Kröten zusammengekratzt und bin nun zu 100% Elan long!


Elan ELN
Fair Value Estimate: $0.00
Morningstar Rating: 1 Star
Economic Moat: None
Business Risk: Speculative
From the Analyst Report: "Unless Elan and partner Biogen IDEC BIIB can find a speedy way to resume marketing Tysabri, Elan`s ability to remain a viable business is significantly diminished, especially since the firm shed most of its noncore assets already during its recent restructuring; there`s not much left to aid it through this setback."


http://news.morningstar.com/doc/article/0,,135899,OO.html

[Birgit.Tersteegen]

Da wollen wir doch mal hoffen dass viele Investoren ihren eigenen Kopf einschalten und aus Erfahrung mittlerweile wissen,dass Analystenhäuser ihre eigenen Ineressen verfolgen.....

[Cyberhexe]

6/6/05 MS Outreach Effort
by: lovesjohndory
Stealthisalias and a couple of other MS patients plan to be in Washington, DC on July 6, 7 and 8 to meet with officials at the FDA, on Capitol Hill and with the media to communicate their views on Tysabri risk/reward and patient choice. Steal and the others plan to return to DC should FDA schedule an advisory committee meeting so they can testify before the committee.

Anyone wishing to assist this effort might contact your local chapter of the National Multiple Sclerosis Society or other MS organization, to advise them of this Tysabri MS Outreach effort, and see if anyone in that area has an interest in participating. You can then put them in contact with me to coordinate. My email is in my profile.

[[KERN]Codex]

Danke für die Info

[[KERN]Codex]

by: pinvestment 06/07/05 10:02 am
Msg: 681211 of 681367

I wonder if krasner would like to correct his story to say that the real report that he saw had 20 different potential diagnoses (guesses) on it. So he just cherry picked PML out of a whole laundry list of potential diagnoses and carefully crafted a story around it. I wonder why he didn`t say that the adverse reaction form had 20 potential diagnoses on them. If you went to your doctor and he/she said that you could have one of 20 potential diagnoses I think you would look at them a little cross-eyed - but this is in fact what krasner did - he saw something he liked and made it sound like another case - while the FDA probably looked at the laundry list of potential diagnoses and had a bit of skepticism about it - and remember there are more than one report on this patient - if the CSF test for PCR was performed and was negative then the later reports would have omitted the PML diagnosis and the case would have been dead at that point - so as you might expect I am waiting to get those reports also to expose this write up of this non-case

Brian McGlynn, a spokesman for Elan, said it was "absolute speculation" to conclude that a fourth person had the infection. Elan and Biogen are co-developers of Tysabri
Mr. McGlynn said the patient had NOT participated in the Tysari clinical trials-- as the other three confirmed PML patients had done. That means this patient could have received only 3 or 4 doses of Tysabri, at maximum, given the drug was introduced at the end of November 2004 and pulled just months later.
The report made to the FDA is light on details. It lists more than 20 symptoms and conditions of the patient, including PML, without stating how the diagnoses were made. This paucity in detail seems strange given the seriousness of the matter...
The patient had been taking Tysabri (the question of when her last dose was is not answered), Avonex, and "two other multiple sclerosis drugs" (unnamed)
The FDA received the report on April 18th.


6,62/6,64

[[KERN]Codex]

by: pinvestment 06/07/05 10:24 am
Msg: 681249 of 681382

on the adverse event report - and this patient was on two other MS drugs before getting between one and three doses of tysabri

so krasner just pulls the diagnosis out that he wants and creates a smear campaign - his article wouldn`t have sounded nearly as good if he had originally said that the adverse event report had 20 diagnoses on it - and that the patient may have only gotten one dose of tysabri and that is may have occurred after this patients adverse event - so there should be the same info on the same patient under a search for the two other MS drugs (probably rebif, avonex, novantrone, copaxone or azathioprine)

but then you have people like lehman who fell for this hook, line, and sinker - just amazing

also I have heard that there are several reports on this patient over time - if the CSF was tested and was negative then it would have been excluded from the long list of potential diagnoses and that krasner would have known this prior to writing his article

so in those reports may lie the information that dismissed the potential PML diagnosis in the first place

[[KERN]Codex]

Antipsychotic Drugs Stop Fatal Viral Infection in Brain Cells

PROVIDENCE, R.I. — Generic antipsychotic drugs can protect brain cells from a virus that causes a fatal nervous system disorder, according to research conducted at Brown University and Case Western Reserve University.

The disorder, called progressive multifocal leukoencephalopathy or PML, affects hundreds of Americans with suppressed immune systems, including kidney transplant recipients, cancer patients undergoing chemotherapy and an estimated 4 percent of people with AIDS.

PML is caused by the JC virus, which destroys the cells that produce the fatty sheath that covers nerve cells. This causes dementia, vision loss, movement and speech impairment, paralysis and coma. The disorder is fast moving and fatal; Many patients die within four months after onset. PML is also on the rise. Due to the AIDS pandemic, incidence of the disorder rose 20-fold in the United States between 1979 and 1994, according to a study conducted by federal researchers....

weiter gehts hier:

http://www.brown.edu/Administration/News_Bureau/2004-05/04-0…

[Cyberhexe]

Elan Completes Retirement of over $240 Million of 2008 Debt
Wednesday June 8, 2:30 am ET


DUBLIN, Ireland--(BUSINESS WIRE)--June 8, 2005--Elan Corporation, plc today announced that it has completed the retirement of $242.8 million of its 2008 outstanding debt. As previously announced, Elan has purchased $206.0 million in aggregate principal amount of 6.5% Convertible Guaranteed Notes due 2008 issued by Elan Capital Corp (Guaranteed Convertible Notes) and has purchased $36.8 million in aggregate principal amount of 7.25% senior notes due 2008 issued by Athena Neurosciences Finance, LLC (Athena Notes). Elan Capital Corp. and Athena Neurosciences Finance, LLC are wholly-owned subsidiaries of Elan. The terms of these repurchases were detailed in Elan`s June 1, 2005 press release.
In addition, the $206.0 million in aggregate principal amount of the Guaranteed Convertible Notes, which are listed on the Official List of the Irish Stock Exchange and the Official List of the United Kingdom Listing Authority and admitted to trading on the respective main markets for listed securities of the Irish Stock Exchange and the London Stock Exchange, has been cancelled with effect from June 7, 2005. Following this cancellation, $254.0 million in aggregate principal amount of the Guaranteed Convertible Notes remain outstanding. The $36.8 million in aggregate principal amount of Athena Notes purchased by Elan are held by a subsidiary of Elan and are expected to remain outstanding.

[Cyberhexe]

nachzulesen unter

http://www.elan.com/News/full.asp?ID=718167

[Cyberhexe]

Goodbodys

Elan (Buy, Current Price $6.77)
Completes retirement of 2008 debt
This morning Elan announced that it had completed the retirement of the remaining $31.0m of its 2008 outstanding debt. On June-1 Elan announced that it was to retire $242.8m of its 2008 debt, $211.8m of which it had already retired. The reduction in debt will lead to annual interest costs savings of c.$16m.

[Cyberhexe]

für mich ist peadar_og "der" Autor, neben pin und neuro, im ymb; ihn solltet ihr im Auge behalten, da seine Beiträge immer sehr informativ sind:

Elan
by: peadar_og 06/08/05 06:49 am
Msg: 682362 of 682471

Retiring almost half of the outstanding convertible debt is a major coup for us long term holders. I’m delighted! That debt issue was a steal in the first place. Talk about claiming something positive from the jaws of despair. This could work out nicely assuming Tysabri comes back to the market – and I feel very strongly that it will.

I also still believe that Tysabri can become the treatment most commonly used by MS sufferers. There seems to be more MS sufferers not on existing old treatments than there are currently on them. Shlt, even by limiting T usage to a debatable 20% or so humans not vulnerable to PML, i.e. no virus present, you still have a potential market of several billion notes. Somehow I feel that T will not be so limited.

From the bright side of the road,
Peadar ‘Og

[Cyberhexe]

1.PML Fall: bestätigt

We have the following information based on reports from the treating neurologist.

A 46-year-old female MS subject with a past medical history of depression and migraines received 37 doses of TYSABRI in combination with AVONEX as part of company-sponsored clinical trials. Her last dose of TYSABRI was on 18 Jan 05.
In Dec 04, the subject experienced right-sided weakness and aphasia, which was initially considered a MS relapse. A MRI revealed a left-sided 2 cm non-enhancing tumor like lesion. She was treated with two courses of steroids, one dose in Dec 04 and the other in Jan 05. Her symptoms continued to worsen with altered mental status and increased spasticity. She was hospitalized on 12 Feb 05. Neurological examination showed a non-responsive subject with right gaze preference, decorticate posturing, upgoing toes and no gag reflex. A MRI showed “deep white matter, small vessel ischemic changes within the centrum semiovale periventricular regions, high signal throughout portions of the left temporal and left parietal lobes extending across the corpus callosum into the right frontal lobe.” This MRI appearance suggested a differential diagnosis that included PML. Complete blood count was significant for a WBC of 14,000 and 29,000 cells/µL on 12 February and 15 February 2005, respectively (normal range 3,500-10,600 cells/µl). A lumbar puncture revealed glucose of 53 mg/dL (normal range 15-45) and protein of 90 mg/dL (normal range 40-70). Viral PCR testing of the cerebral spinal fluid (CSF) was positive for JC virus. HIV testing via Elisa was negative. The subject was treated with intravenous methylprednisolone but her condition continued to decline and she was transferred to a hospice. The subject died on 24 February 2005. AVONEX neutralizing antibody status and TYSABRI antibody status were negative at baseline and weeks 24, 48 and 72.

Concomitant medications at the time of the event included vitamins, ranitidine, donepezil, tizanidine, zolpidem, and ibuprofen.

[Cyberhexe]

2.PML-Fall bestätigt

We have the following information based on reports from the treating neurologist.
A 46-year-old male MS subject with a history of melanoma, allergies and Bell’s Palsy received 28 doses of TYSABRI in combination with AVONEX as part of a company-sponsored clinical trial. His last dose of TYSABRI was on 13 Dec 04.

In December 04, the subject developed slow thinking, slurred speech and cognitive dysfunction, and a left hemiparesis, which later progressed to include left-sided sensory impairment in early Jan 05. An MRI scan in Jan 05 showed a right frontal lesion with no Gd enhancement, some degree of gray matter involvement, with the lesion extending beyond the right frontal lobe, also juxtacortical in the insular regions right and left, with no mass effect or edema. He underwent an extensive work-up that included chest X-ray, chest and pelvic CT, PET scan and CSF analysis. The CT scans showed no malignancy. In addition, the subject tested HIV negative via Elisa. The subject underwent a brain biopsy on 16 February 2005. Preliminary results of the biopsy on 24 Feb 05 showed a demyelinating process, no vasculitis, no lymphoma, and no evidence of infection or malignancy. Viral PCR testing of the CSF for JC virus is pending. As of 25 February 2005, the subject was clinically worsening.

AVONEX neutralizing antibody status and titer levels are as follows: Baseline level=15, Week 24 was negative, Week 48 level=27, Week 72 level=30, Week 96 and Week 120 are pending. TYSABRI antibody status was negative at Weeks 12, 24, 36, 48, 60 and 72.

Concomitant medications at the time of this event included Levitra, Claritin-D, Benadryl, and Nasarel.

As of 25 Feb 05, the subject was clinically worsening. Given the appearance of the current and past MRIs and the subject’s clinical course, the investigator believes that this may be PML and is possibly related to TYSABRI.

[Cyberhexe]

3.PML-Fall


That being said, Elan disclosed the list of medications Patient #3 was treated with:


Steroids No surprise here, and this relatively weak immunosuppressant is used commonly with most MSers.

Remicade, which is a powerful drug used to treat Crohn`s disease. Now things get more interesting. A *partial* list of warnings for Remicade: "Many people with heart failure should not take REMICADE...There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. ...REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away...There have been rare cases of serious liver injury in people taking REMICADE, some fatal...Blood disorders have been reported, some fatal...Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE. Reports of lymphoma (a type of cancer) in patients on REMICADE and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer." (Source).
Clearly, Remicade is not a treatment to be undertaken lightly and has a number of ways of causing fatalities.


Azathioprine (aka Imuran) -- This is where things get extremely interesting. The patient was treated for approximately five years (!) with this powerful drug commonly used for preventing the rejection of organ transplants (!) and in lower doses, rheumatoid arthritis and other inflammatory diseases such as Crohn`s. Quoting Medline: "[Azathioprine] works by weakening the body`s immune system so it will not attack the transplanted organ or the joints." It is not clear for what indication this patient took this drug, but it was likely taken off-label for what would obviously have to be a severe case of Crohn`s disease. Let us examine this drug`s mode of action and safety profile:
"Imuran [is] used as an immunosuppressant antimetabolite either alone or, more commonly, in combination with other agents (usually corticosteroids) and procedures which influence the immune response. Therapeutic effect may be evident only after weeks or months..." Note that Imuran is commonly prescribed in combination with another immunosuppressant AND the effect of the drug-- severe immunosuppression-- is often delayed.

Continuing on with the litany of grave warnings:

"Severe leukopenia [an abnormal decrease of white blood cells] and/or thrombocytopenia [abnormal decrease of blood platelets] may occur in patients on azathioprine. Macrocytic anemia and severe bone marrow depression may also occur...Delayed hematologic suppression may occur. Prompt reduction in dosage or temporary withdrawal of the drug may be necessary if there is a rapid fall in, or persistently low leukocyte count or other evidence of bone marrow depression [Tysabri works by preventing leukocytes from crossing the Blood-Brain-Barrier, so if they are already severely reduced...]...Serious infections are a constant hazard for patients on chronic immunosuppression...Fungal, viral, bacterial and protozoal infections may be fatal and should be treated vigorously...Azathioprine is mutagenic [causes mutations] in animals and humans, carcinogenic [causes cancer] in animals, and may increase the patient`s risk of neoplasia [pre-cancerous cell growth]...acute myelogenous leukemia as well as solid tumors have been reported in patients...who have received azathioprine." (Source).

Let us recap: Azathrioprine can be incredibly toxic, can decimate the immune system long after its dosing, and leaves the patient susceptible to potentially fatal infection. Could Imuran still have been exerting its effects during the Tysabri infusions? We don`t have an answer to that, but if so, let us explore "the smoking gun":

While looking at the reported adverse reactions for Azathioprine, we found this:

"A case of progressive leukencephalopathy (PML) after a four year azathioprine therapy...was reported (Schnider,1991)." (Source). That`s right-- a case of PML linked directly with long-term administration of azathioprine. Patient #3 was actually on azathioprine for one year longer than this PML-azathioprine case. This is not the only case, here`s another:

"A 71-year-old woman receiving azathioprine and glucocorticoid therapy experienced onset of right-sided hemiplegia within a few days, became comatose, and died within a few days...postmortem examination showed PML." (Source).

Simply put, we are aghast that this ravaged individual, exposed to years of dosing with a cocktail of potentially lethal drugs-- that among other things, can cause delayed immunosuppression, cancer, and even PML itself(!), was participating in a clinical trial with another experimental immunosuppresant. Maybe his case was so bad, he had no other hope, but in such an extreme situation, the fault of his death cannot be placed squarely on Tysabri. That he died is of course tragic, but quite frankly, a serious adverse event is not entirely surprising given his cumulative medical history.

To conclude that Tysabri is the key factor for his contraction of PML and ultimate death, based on the post-mortem analysis of a patient that clearly was severely ill (a gross understatement!) is to us, simply preposterous. While we are not doctors and so our opinion is purely non-medical, this situation cannot reasonably be viewed as akin to an otherwise healthy individual contracting PML after exposure to Tysabri monotherapy. In fact, given the latent effects of the Imuran treatment, without further information as to treatment start and stop dates, it cannot even be said definitively that this patient was on Tysabri monotherapy, as after five years of treatment, Imuran could still have been exerting its effects without being actively dosed.

The contraindications for prescribing Tysabri are becoming clear, and coupled with the increased vigilance for PML that would be sure to accompany any Tysabri prescription, the risk factor would seem to be acceptable for many MSers anxious for a new treatment option. The fact that toxic drugs like Remicade and Imuran are tolerated but Tysabri would not be is at the very least extremely puzzling. Tysabri is extremely effective at what it does, and because of that potency, cannot be coupled with drugs that cause, or people who have, a history of immunosuppression, cancer and serious infections.

Again, the above is a non-medical opinion and you are urged to form your own opinions. We hope this has been helpful to you.

Note: Biogen stated today, April 1st, that this 3rd patient not only had a history of severe immunosuppression as stated within this article, but was actually taking the other immunosuppressive(s) while receiving the first series of Tysabri doses. This again casts serious doubt on Tysabri`s role in the causation of PML in this case.

[Cyberhexe]

jetzt gehts ab...fasten your seat bells

Forbes:
The journal reports provide "two major pieces of information we have not had before," Richert said. "One is that in one case, when they looked at blood samples that were serially obtained during the trial [of the drug], the JC virus that causes PML was detected in the blood serum before the onset of symptoms. That raises the possibility that diagnosis of this infection may be possible much earlier than we have thought in people at risk."

[Cyberhexe]

pin ist einfach grossartig...ebenfalls neuro und peadar
...das Elan ymb scheint mir das informativste und beste zu sein im ganzen Cyberspace...ich müsste es ja wissen
ch
;-))


patient 3 was lymphopenic since 1996
by: pinvestment 06/09/05 01:33 pm
Msg: 684688 of 684824

on a intermittent basis , 28 year history of treated crohns and was given AZA while lymphopenic while being given remicade - as expected I think this patients PML risk was very evident long before receiving tysabri

even in patients that are not lymphopenic AZA and remicade has been shown to make them very immune suppressed and subject to diseases normally only seen in aids patients

[Cyberhexe]

Roche, mein Brötchen..., hält grosse Stücke auf Elans Nanotechnologie...

http://www.elan.com/DrugDelivery/Announcements/

Announcements
12 January 2005 Elan`s Proprietary NanoCrystal® Technology is Used by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&J PRD) in Phase III Clinical Trial of Paliperidone Palmitate
7 January 2005 Elan and Roche Expand Nanocrystal Technology License
14 June 2004 Announcement on the establishment of new Sterile Biopharmaceuticals Plant at its Athlone, Ireland facility
10 June 2004 Elan Announces Manufacturing Agreement with Lilly
21 April 2004 Elan NanoSystems licenses NanoCrystal™ technology to Roche
20 Jan 2004 Elan NanoSystems licenses NanoCrystal™ technology to Aventis
13 Oct 2003 Elan`s NanoSystems licenses NanoCrystal® to Janssen
30 Sep 2003 Elan`s NanoSystems and Bristol-Myers Squibb sign license
20 May 2003 Merck and Elan Announce NanoCrystal® Technology is Formulation for Merck’s Emend® (aprepitant)
30 Aug 2000 Elan announces first U.S. approval for its NanoCrystal™ technology




Press Release Source: Elan Pharma International Ltd.
Elan Licenses Its NanoCrystal Technology to Roche
Wednesday April 21, 1:30 am ET
Proprietary Elan technology helps improve drug delivery by transforming drugs into more effective and "user friendly" dosage forms to increase patient convenience and compliance.

Relatedly from Davy`s: Roche has signed a technology access agreement with Elan to use its Nanosystems drug delivery technology for one of its products in clinical trials. Terms were not disclosed but similar deals have comprised milestone payments, research revenues and single-digit royalties on any client products that eventually reach the market. Jack Gorman

[Cyberhexe]

also noch einmal...erste Anzeichen von PML sind in Blutuntersuchungen festzustellen, so dass rechtzeitig reagiert werden kann (Tysabri und Immunsuppressiva absetzen, so dass die körpereigene Immunabwehr den Virus kontrollieren kann)...und zudem bisher kein PML-Fall in der Monotherapie, so dass das Risiko diesbezüglich sehr klein sein sollte; in Kombination mit periodischen Blutuntersuchungen sollte die Ty-Monotherapie zum Gold-Standard bei der Behandlung von MS (vielleicht auch bei MC) aufsteigen...also ich bin mir nun ziemlich sicher, dass Tysabri Blockbuster-Status erreichen wird.

110% in Elan
Grüsse
ch

Goodbody: Analystenkommentar vom 10.6.2005

Elan (Buy, Current Price $7,37); Tysabri victim showed previous signs of disease

Reports in the New England Journal of Medicine, released yesterday, stated that a patient who died after taking Tysabri, Elan and Biogen, Idec`s drug, showed signs of the fatal infection, PML, in blood samples taken months earlier. The consequence of this is that if doctors can monitor the progress of patients being treated with Tysabri they can spot the early signs of the fatal sisease and intervene and remove patients from the drug before they ars harmed. Shares in Elan closed at 7,37$ yesterday, up 12% on the back of the news.

[Cyberhexe]

anbei auch noch j.gormans (Davy) Analystenkommentar


Elan (ELN US)
Previous close: 737c
NEJM sheds some more light on Tysabri and PML
[e-mail]
That the New England Journal of Medicine (NEJM) brought forward the publication of patient case detail is a reflection of the
importance and impact of Tysabri in the MS and overall medical community. NEJM published three brief reports on the confirmed PML cases, an editorial and related correspondence from the head of R&D at Biogen Idec, Burt Adelman.
Further detail was provided on each of the three confirmed PML cases. These highlighted the other medications that these patients were on and the complex nature of each of the three specific cases.
Aside from the scientific detail, Biogen Idec`s correspondence (also carried in the NEJM release) highlights two observations:
that the JC virus may be detectable in the bloodstream before clinical PML occurs, and that PML is not universally fatal. These could be vital components in Elan/BIIB`s presentation of its ultimate findings to the FDA, with the observations lending
credence to the fact that, if diagnosed early enough, there is a chance of recovery for PML sufferers.
The early NEJM release is on balance positive for sentiment in that it offers some more insight on how Elan/Biogen is building its case for Tysabri`s path forward. It supports our overall view that defining the risk/benefit profile remains the key element
of a prospective Tysabri return. The release also highlights that this is a difficult task—and additional PML cases can complicate this if the scientific profile is markedly different to the existing cases.

[Cyberhexe]

http://www.nytimes.com/2005/06/10/business/10biogen.html


Doubt Cast on 4th Case of Illness on M.S. Drug

By ANDREW POLLACK
Published: June 10, 2005
A Biogen Idec official has sent an e-mail message to neurologists suggesting that a suspected fourth case of a brain infection in a patient taking the drug Tysabri was a false alarm, according to two doctors who received the message. The e-mail message said the patient was shopping when she heard news reports last week that she had the potentially fatal infection.

Word of the e-mail message emerged on the same day The New England Journal of Medicine released several papers on the three people who contracted the rare but deadly viral infection after taking Tysabri, a multiple sclerosis drug.

The papers suggested, at least to Biogen, that it might be possible to detect the virus in blood early enough to avert serious consequences of the infection. If that were the case, it might be possible for the drug to return to the market. Biogen`s interpretation was presented in a letter that will be published with the documents released today in the July 28 issue of the journal.

On news of the journal material, the company`s stock rose $1.78, or 5 percent, to close at $35.13. yesterday. The American depository receipts of Elan, an Irish company that is co-developer of Tysabri, climbed 77 cents, or 12 percent, to $7.37.

The companies pulled Tysabri from the market in February after two people contracted a rare infection, called progressive multifocal leukoencephalopathy or P.M.L., and one of them died. A third case was later found in a patient whose death was initially attributed to another cause.

The possibility of a fourth case, first reported by The Boston Globe last week, was based on a report made by a health professional to the Food and Drug Administration.

This week, though, Dr. Michael A. Panzara, a medical official at Biogen, sent an e-mail message to some neurologists casting doubts on the report. Dr. Norman Kachuck of the University of Southern California, one of those who received the e-mail message, said it quoted from a message sent by the doctor treating that fourth suspected patient.

"I just spoke to my patient`s daughter, 11:50 a.m., and she is alive and out shopping," the treating doctor wrote, according to Dr. Kachuck. Dr. Kachuck said he thought the patient had had another type of inflammation.

Dr. Douglas R. Jeffery, who runs the multiple sclerosis clinic at Wake Forest University, said he had also received the e-mail message, but still had concerns. "It`s fishy," he said, "because if that`s the case, why didn`t they say that to The Boston Globe right upfront?"

A spokeswoman for Biogen Idec declined to confirm the existence of the e-mail and said the company would not comment on individual patient cases. She said experts were examining the records of all patients who took the drug and would compile a complete report, which might be ready by the end of summer.

The journal`s papers provided details on the first three patients. Doctors in Belgium looked at stored blood samples taken over time from one patient who died from P.M.L.

P.M.L. is caused by the JC virus, which is present in most people but lies dormant in the kidneys or lymph nodes. It is thought that Tysabri weakens the immune system, which, allows the virus to become active.

The Belgian researchers found that the JC virus was present in the blood, perhaps a precursor to entering the brain, two months before the patient was admitted to the hospital with symptoms of the disease.

A second paper, by doctors at Stanford and the University of California, San Francisco, reported on a patient who now appears to be recovering from P.M.L.

Biogen executives said in a letter to the medical journal that, taken together, those observations suggested it might be possible to monitor patients closely and then stop the drug if the virus is detected in the blood in time to avert serious consequences. Biogen is analyzing blood samples from the other patients to see if they, too, had JC virus in their blood well before the onset of P.M.L. symptoms.

But Dr. Joseph R. Berger of the University of Kentucky, the co-author of an editorial in the medical journal, said, "We don`t know if simply stopping the drug once the virus is observed is going to prevent development of the disease."

Dr. Berger, a consultant to Biogen and many of its competitors, said evidence from the papers suggested that the drug continues to have an effect up to three months after the last dose. Moreover, he said, there is no good treatment for P.M.L. Even if the disease is not fatal, patients can be left with problems. The patient in California is now at a rehabilitation center but still cannot walk, said Dr. Annette Langer-Gould of Stanford, an author of the paper.

Moreover, when Tysabri wore off three months after the last dose, the patient`s immune system went into overdrive, causing severe inflammation that nearly killed him.

[Cyberhexe]

Zusammenfassung....die neusten headlines zu Tysabri und PML



6/9/05 Med journal fans hopes for Tysabri MarketWatch -
..edition of the New England Journal of Medicine, several medical experts say that while they see a
link between the use of the recalled drug Tysabri and ...



6/9/05 WSJ Biogen Idec Says Early Testing May Halt Deaths Tied to Tysabri

6/10/05 Doubt Cast on 4th Case of Illness on MS Drug New York Times, NY -
... official has sent an e-mail message to neurologists suggesting that a suspected fourth case
of a brain infection in a patient taking the drug Tysabri was a ...

6/9/05 Multiple sclerosis drug Tysabri could be back on the market later this year
News-Medical.net, World -
The drug Tysabri which was approved by the Food and Drug Administration (FDA) for the treatment of
multiple sclerosis in November 2004, was taken off the ...

[Cyberhexe]

und noch eine Analystenmeinung von heute, 10.6.2005: NCB (irisches Analystenhaus)


Elan $7.37 BUY Tysabri PML case studies suggest early detection is a possibility
• Yesterday the New England Journal of Medicine published extensive details on the
three patients that developed PML in Tysabri clinical studies. Details on the three case
studies were also accompanied by an editorial. From the patient reviews, the key
finding is that in two of the three patients assessed for the presence of the JC virus in
the blood, the virus was found to be present in both patients. In one of the patients (the
Crohn’s disease patient that subsequently died) the virus was detected in the blood
before the symptoms of PML developed but in the second patient (the MS patient that
survived) the JC virus was only detected post the development of the initial PML
symptoms. However, in this latter patient the first PML lesion was visible on MRI two
months before neurological symptoms developed.
• The screening of blood for the presence of the JC virus is suggested in the editorial as
a possible assay for PML in Tysabri patients along with the termination of treatment
should JC virus DNA appear in the blood. A similar strategy has been used
successfully for the prevention of a nephropathy caused by a JC-related virus. That
said, the predictive value of detecting JC virus in blood needs to be further established.
In addition, more frequent MRI monitoring of patients who receive treatment could be
warranted.
• One PML patient continues to recover after termination of combination treatment and
after treatment with Cytarabine. This may be a future treatment option for PML. In the
two patients that died from PML, the disease appears to have been too advanced by
the time Tysabri was withdrawn.
• The screening procedures that we believe the FDA may require for identifying and
monitoring at risk individuals include (i) assaying for lymphocyte counts prior to
treatment (low lymphocyte counts are suggestive of an immunocompromised
condition), (ii) screening the blood and possibly the cerebrospinal fluid prior to
treatment or during treatment should suspicions of PML exist (this could confirm if the
JC virus is present), (iii) periodically assaying for the saturation of the alpha-4 receptor
during Tysabri treatment (high saturation of the alpha-4 integrin receptor is likely to be
a risk factor in PML) and/or (iv) MRIs prior to and at routine intervals during treatment
for monitoring purposes. Should patients develop PML, the early detection followed by
withdrawal of therapy could significantly improve the survival rate. Recent publications
support this view and suggest that withdrawal from immunosuppressive treatment in
transplant patients suffering PML leads to significantly improved survival rates.
• Over and above the findings in these papers, we are surprised that the effect that
AVONEX has on the increased accumulation and reduced clearance rates of Tysabri
was not highlighted as a possible factor for PML development in two of the three
cases.
David Odlum [phone] [e-mail]
John Cantwell [phone] [e-mail]

[Cyberhexe]

die Stimmung scheint sich nun zu bessern...


Tysabri News Seen `Incrementally Positive` For Biogen, Elan
06.10.05, 1:18 PM ET


Tear Sheet | Chart | News



Piper Jaffray maintained a "market perform" rating on Biogen Idec (nasdaq: BIIB - news - people ) after the New England Journal of Medicine published articles and editorials discussing the three cases of multifocal leukoencephalopathy (PML) confirmed by Biogen and partner Elan (nyse: ELN - news - people ). "The details are encouraging in regard to gaining a better understanding of the link between Tysabri and PML, and we view this information as incrementally positive regarding Tysabri`s eventual return to the marketplace--but we still believe questions remain regarding Tysabri`s risk profile with respect to PML," said Piper Jaffray. "We expect Biogen shares to be volatile through the second half of 2005." The research firm reiterated a $42 price target on the stock. "It is likely that if Biogen is cleared to resume marketing Tysabri a significant number of trials will need to be performed in order to monitor and better understand the PML risk--the major outstanding question is if the FDA will allow these studies to be done prior to resumption of Tysabri marketing, or in conjunction with resumption of marketing," said Piper Jaffray. "Regardless, we believe Tysabri`s market is smaller than originally expected."

[Cyberhexe]

scheint so, als ob am 4.August bei der FDA eine Zusammenkunft geplant ist, bei welcher Natalizumab ein Thema sein könnte:

Peripheral and Central Nervous System Drugs
August 4 3014512543



CENTER FOR DRUG EVALUATION AND RESEARCH
Anesthetic and Life Support Drugs Advisory Committee

November 9-10
3014512529
Anti-Infective Drugs Advisory Committee

To be announced as needed
3014512530
Antiviral Drugs Advisory Committee To be announced as needed
3014512531
Arthritis Advisory Committee September 6
3014512532
Cardiovascular and Renal Drugs Advisory Committee September 29
November 16-17

3014512533
Dermatologic and Ophthalmic Drugs Advisory Committee October 20-21
November 3-4
3014512534
Drug Safety and Risk Management Advisory Committee

October 26-27
November 3-4
December 8-9
3014512535
Endocrinologic and Metabolic Drugs Advisory Committee September 8-9
December 13-14
3014512536
Gastrointestinal Drugs Advisory Committee October (Day to be announced)
3014512538
Nonprescription Drugs Advisory Committee To be announced as needed
3014512541
Oncologic Drugs Advisory Committee September 13-14
December 7-8
3014512542
Peripheral and Central Nervous System Drugs

August 4 3014512543

[Cyberhexe]

sorry...hab vergessen den link zu posten

http://www.fda.gov/oc/advisory/accalendar/2005/2005TentMtgSc…

[Birgit.Tersteegen]

Looks like Aug. 4 is FDA meeting
by: ipar4s2
Long-Term Sentiment: Strong Buy 06/10/05 01:36 pm
Msg: 687094 of 687127

time for Tysabri.

http://www.fda.gov/oc/advisory/accalendar/2005/2005TentMtgSc…

The return appears close at hand.

yahoo-board

[welke91]

hy Cyberhexe,

der zenman hat gemeint, ich solle es mal bei dir versuchen wenn es um Zulassungen bzgl. Elan geht.
Da war doch im letzten Jahr ein Antrag über Morbus Chron bei der European Medicines Agency.

Heute hast du MC erwähnt.

Was ist da dran, ich habe im Netz auf einer führenden Seite über Morbus Chron gelesen, dass die Zulassung abgelehnt wurde.

Oder ist sie momentan durch den Stop einfach nur ausgesetzt?

weisst du mehr?

[Cyberhexe]

Hi welke,
ich will dich nicht erschlagen mit Informationen...nur vielleicht soviel...
...Elan hat am 29.9.04 bei der EMEA, das ist die europ. Zulassungsbehörde für Arzneimittel die Zulassung von Natalizumab (also Tysabri) zur Behandlung von Morbus Crohn beantragt. Es ist jedoch nichts aussergewöhnliches, dass einer Zulassung eine zeitintensive (9 Monate ?) Prüfung der Zulassungsunterlagen, also der statistischen Auswertung der klinischen Tests, vorausgeht. Die Bekanntgabe der 2-Jahresergebnisse von ENACT-2 (so heisst die klinische Phase-III-Studie, die dem Antrag auf Zulassung zugrunde liegt) wird in einigen Wochen erwartet. So viel ich weiss läuft ENACT-2 bis Ende Juli. Die 12-Monats-Ergebnisse und auch die Kommentare des sonst eher zurückhaltenden Mgmts lassen vermuten, dass die endgültigen Ergebnisse sehr vielversprechned sind. Bisher ist Infliximab (Remicade) von J&J das Mass aller Dinge zur Behandlung von Morbus Crohn. Nachdem ich jedoch dessen Packungsbeilage einmal intensiver studiert habe....also ich möchte mich nicht weiter dazu äussern, vielleicht nur so viel...falls die PML-Probleme bei Tysabri kalkulierbar werden bzw. sogar ein entsprechendes Monitoring mit Therapiemöglichkeiten aufgezeigt werden, dann könnte ich mir vorstellen, dass das Nebenwirkungsprofil von Tysabri (im Plazebobereich) die Vorherrschaft von Infliximab bei der Behandlung von MC in Frage stellen wird.

Ich bin mir jedoch ziemlich sicher, dass die EMEA die Zulassung erst dann erteilen wird bzw. eine Entscheidung treffen wird, wenn die Theorien um PML aus einer wissenschaftlichen Sicht plausibel sind.

Anbei einige Links...jedoch lediglich in english:


Elans Pipeline:

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

interessanter Artikel über den Durchbruch der Behandlung von Morbus Crohn:
http://www.wnbc.com/drmaxgomez/4186643/detail.html

New Drug Shows Breakthrough In Treating Crohn`s Disease


Bekanntgabe der Antragstellung:
http://www.elan.com/News/full.asp?ID=620045

29 September 2004
Elan and Biogen Idec Submit Application to the European Medicines Agency for Approval of ANTEGREN for Crohn`s Disease
Application includes 12-month data from Phase III Maintenance Trial showing sustained response, remission, and withdrawal from corticosteroids in a significant number of patients
DUBLIN, Ireland & CAMBRIDGE, Mass. & SAN DIEGO, Sep 29, 2004 (BUSINESS WIRE) -- Elan Corporation, plc and Biogen Idec today announced that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency for the approval of ANTEGREN(R) (natalizumab) as a treatment for Crohn`s disease. Additionally, the companies presented new 12-month data from the Phase III maintenance trial, ENACT-2 (Evaluation of Natalizumab As Continuous Therapy-2), today at the United European Gastroenterology Week meeting in Prague, Czech Republic, and these data were included in the filing.

Data from ENACT-2 showed a sustained and clinically significant response throughout 12 months of extended natalizumab infusion therapy, confirming findings in patients who had previously shown a sustained response throughout six months (data presented at Digestive Disease Week in May, 2004). Maintenance of response was defined by a Crohn`s Disease Activity Index (CDAI) score of less than 220, and less than 70-point increase from baseline, in the absence of rescue intervention throughout the study. Response was maintained by 54 percent (90/168) of patients treated with natalizumab compared to 20 percent (34/170) of those treated with placebo. In addition, 39 percent (51/130) of patients on natalizumab maintained clinical remission during the study period, versus 15 percent (18/120) of those on placebo.

By the end of month 12, 49 percent (33/67) of natalizumab-treated patients who had previously been treated with corticosteroids were able to withdraw from steroid therapy compared to 20 percent (15/76) of placebo-treated patients. No notable difference in the overall rates of side effects between natalizumab and placebo treatment groups was observed through month 12. The safety profile seen in this trial was similar to that seen in previous natalizumab trials. The most frequently reported adverse events were headache, nasopharyngitis, nausea and abdominal pain.

"This filing and the presentation of 12-month data from the ENACT-2 study represent important milestones in our development of natalizumab as a treatment for Crohn`s disease, and we are committed to working closely with the European regulators to facilitate a thorough review of our submission and the supporting data," said Lars Ekman, MD, executive vice president and president, Research and Development, Elan. "We believe natalizumab can be an important therapy in this underserved patient population."

"These findings suggest that natalizumab may sustain a significant level of efficacy and safety in the treatment of Crohn`s disease," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "These data also reinforce natalizumab`s potential across a range of immune-mediated diseases."

ENACT-2 Study Findings

This Phase III, double-blind, placebo-controlled, international maintenance trial of natalizumab in Crohn`s disease enrolled responders from ENACT-1 (a three-month double-blind, placebo-controlled study in patients with moderately to severely active Crohn`s disease). Natalizumab responders from ENACT-1 (339 patients) were re-randomized after the three-month study to one of two double-blind treatment groups: natalizumab (300 mg) or placebo, both administered monthly for a total of 12 months. The primary endpoint of ENACT-2 was sustained maintenance of response throughout the first six months of treatment.

Findings from the initial six-months of ENACT-2 showed:

-- 61 percent (103/168) of natalizumab-treated patients exhibited
sustained significant clinical response versus 28 percent
(48/170) of patients re-randomized to receive placebo.

-- Clinical remission at six months was maintained by 44 percent
(57/130) of patients receiving natalizumab versus 26 percent
(31/120) of placebo patients.

[Cyberhexe]

anbei noch was zu Nebenwirkungen von Remicade, publiziert vom Multiple Sclerosis Resource Centre

hier der link:
http://www.msrc.co.uk/index.cfm?fuseaction=show&pageid=1007



Remicade, which is a powerful drug used to treat Crohn`s disease. Now things get more interesting. A *partial* list of warnings for Remicade: "Many people with heart failure should not take REMICADE...There are reports of serious infections, including tuberculosis (TB), sepsis and pneumonia. Some of these infections have been fatal. ...REMICADE can lower your ability to fight infections, so if you are prone to or have a history of infections, or develop any signs of an infection such as fever, fatigue, cough, or the flu while taking REMICADE, tell your doctor right away...There have been rare cases of serious liver injury in people taking REMICADE, some fatal...Blood disorders have been reported, some fatal...Nervous system disorders have also been reported. Tell your doctor if you have or have had a disease that affects the nervous system, or if you experience any numbness, weakness, tingling, or visual disturbances while taking REMICADE. Reports of lymphoma (a type of cancer) in patients on REMICADE and other TNF blockers are rare but occur more often than in the general population. Tell your doctor if you have or have had cancer." (Source).
Clearly, Remicade is not a treatment to be undertaken lightly and has a number of ways of causing fatalities.

[Cyberhexe]

und noch ein interessanter Artikel, in welchem die Vermutung aufgestellt wurde, dass Natalizumab gegenüber Infliximab (Remicade) sicherer sein soll...dies war allerdings vor der Bekanntgabe der PML-Fälle!



http://www.macleans.ca/topstories/health/article.jsp?content…


Multiple sclerosis drug treats Crohn`s disease

Natalizumab offers an alternative to the current last-resort treatment
...
The study also suggests natalizumab is safer than infliximab, which has been associated with an increased incidence of infections and lymphoma, a form of cancer. "Several experts in the field suggest that it may be a safer alternative for patients who would otherwise require infliximab," Panaccione says.

[welke91]

man cyberhexe das ist ja Wahnsinn wenn es so kommen sollte, ja dann, dann blühe ich auf



Vielen Dank für die ausführliche Antwort werde sie jetzt eingehend studieren.

gruß

[Cyberhexe]

dieser pinvestment ist einfach grandios...vor allem aus wissenschaftlicher Sicht und zwar derart, dass dieser auch schon von Forschungsleiter Lars Ekman bei einer Analystenkonferenz lobend erwähnt wurde verbunden mit dem Verweis, dass verschiedene Beiträge im ymb (vor allem diejenigen von pin und neuro) von bemerkenswerter wissenschaftlicher Qualität seien

anbei die neusten pininfos


a big week coming up
by: pinvestment 06/12/05 11:30 am
Msg: 688175 of 688242

BIIB talks on wednesday - ENS meeting with 8 tysabri abstracts, talks, and posters - breakdown of the tysabri AFFIRM trial info should show that for a rather large subgroup of paitent treatment with tysabri reverses MS disabilities which is just HUGE

as for the safety review - I have always thought that BIIB was much farther ahead than what they were saying and despite ideas that the FDA is not up to data on the data as it has been formed I think that is a silly notion also - BIIB is just trying to keep the day to day focus from the FDA by setting a time point for completion that is much later than is really happening

see this message from yesterday morning from elmer92692

**** it has come to pass. Safety review is done. No more PML. No JC in CSF. Data will be submitted in 2 weeks. Full data compilation is almost complete. BIIB/ELN will formally ask for a safety panel review. Tysabri will be back on the market between Aug.-Oct. EDSS scores will show Tysabri reverses damage. All in my humble opinion....cheers *****

I think this is very possible time -wise and should support the rampant rumors of a re-start of the clinical trials at the end of this month or next

but either way it is going to happen (reivew completed and sent to FDA) and the gears will be motion

from seeing the AFFIRM two year data I am very confident there is no PML in it and given the efficacy tysabri will be back on the market in a few short months

maybe by then a few more analysts will have figured it out - the disconnect between wall street and what is really happening should provide a very rapid rise for price of ELN as it will be a large surprise

and for the record - I think no black box - just a label change and that demand will soar because of the reporting ofthe reversal of MS disability from tysabri use and its superior efficacy

[Cyberhexe]

übrigens pinvestment hat auch eine eigene Homepage...dort gibt es auch noch eine Menge Info zum Thema...allerdings nur in engl


http://www.biopractical.com/

[Bernd13090]

was ist denn jetzt schon wieder ((( ELAN kostet sehr viel nerven

[Cyberhexe]

ruhig bleiben Bernd...da wird von einem möglichen 5. PML-Fall berichtet...allerdings würde dieser lediglich die bisherige Theorie bestätigen...Tysabri+Avonex+CellCept

CellCept ist ein Medikament, welches nach Transplantationen zur Verhinderung der Organabstossung verabreicht wird d.h. nichts anderes als dass die eigene Immunabwehr unterdrückt wird...und immunsupprimierte Konditionen sind die Vorraussetzung für ein PML-Szenario...also kein Grund zur Panik


Entwarnung Jungs...Tysabri + Avonex + CellCept, welches zur Verhinderung einer Abstossungsreaktion nach Transplantationen eingesetzt wird...also auch wieder immunsupprimierte Konditionen...die bisherige Theorie scheint sich zu verdichten...also nur positiv....also ruhig bleiben und entspannen!!


The fifth possible case was reported by an unnamed health professional and concerns a female patient whose age is undisclosed. The report lists PML as one of the suspected reactions to Tysabri and Avonex, another MS drug made by Biogen. In two of the three confirmed PML cases, the patients were part of a clinical trial testing a combination of Tysabri and Avonex.

The report indicates the patient has been hospitalized, but gives no other indication of her condition. The report says the patient was also taking four other drugs, but they aren`t listed as being suspect in the adverse reactions. However, one of the other drugs taken by the patient, called Cellcept, is commonly given to transplant recipients, who are known to be more susceptible to PML.

[Bernd13090]

danke für die info,

hoffe für mich und uns, das es nicht ein großer flop wird...

[Cyberhexe]

NCB Stockbrokers: Morning Notes
irisches Analystenhaus zu Elan am 14.6.05

Elan $6.78 BUY Unconfirmed Reports Of Another PML Case/Legal Action Settled
• The Wall Street Journal reported yesterday that another possible PML case has been detected in a patient on Tysabri in combination with four other drugs (including
CellCept, an immunosuppressant). This case was apparently reported to the FDA on 16th May through the Adverse Event Reporting System and we would expect, if positive, that this would be confirmed by now.
• Cellcept is an immunsuppressant approved for use in kidney, heart and liver transplants. It was previously indicated on the Tysabri label that patients receiving
immunosuppressive agents should not receive concurrent therapy with Tysabri because of the possibility of increased risk of infections. Transplant patients are at
increased risk of developing PML because of their immunocompromised state. In any future use of Tysabri, it is accepted that a combination of immunosuppressive drugs or immunomodulators (e.g. Avonex) will be avoided.
• If this patient highlighted in the WSJ is confirmed in combination with drugs that lead to immunosuppression, we continue to believe that Tysabri will return to the market as a monotherapy in multiple sclerosis. To date, two confirmed cases of PML have been in combination use and one case was reported when Tysabri was taken in combination with Azathioprine while been very immunosuppressed. A fourth possible case was
highlighted almost two weeks ago which has not been confirmed.
• Elan and BiogenIdec continue to methodically review the patients in the Tysabri clinical trials and we expect the review to be completed over the coming weeks. Post
completing the review Elan and BiogenIdec will meet the FDA with an FDA advisory meeting expected in late Q3/early Q4. As previously highlighted it is impossible to
predict the outcome of the review and any advisory panel discussions, as further cases of PML may be uncovered although we would expect any confirmed cases of PML in
patients to have been disclosed at this point.
• Separately, Elan has settled an action with Donal Geaney, former chairman and CEO,
for €3.5m plus costs relating to the timing for the exercise of share options.
Orla Hartford [phone] [e-mail]

[Cyberhexe]

http://www.thisisms.com/

Rumors of a 5th Tysabri PML Case... And Thoughts on the "Cases" yet to Come

In a trend we expect to continue over the next many weeks, another "possible" case of PML in a former Tysabri patient has been published in the press. This patient was supposedly on Tysabri + Avonex, and four other MS drugs, one of which is the powerful immuno-suppressant CellCept. No confirmation of this case actually being PML has come from Biogen, Elan, or the FDA.


As with the "4th case" (where the woman who had apparently died found about her own death while out shopping), one should pay no serious heed to these rumors until confirmation comes from either the companies or the FDA.


Note that all neurologists should now be extremely wary about the Tysabri-PML link, and will likely consider PML initially whenever a Tysabri-dosed patient comes in with neurological complaints. If this suspicion is put on paper, it will ultimately end up in the press via the Freedom of Information Act (or FOiA, which mostly occurs via keyword searches on the keywords "PML" and "Tysabri") and become the "Xth Possible Case of PML." Let`s be clear: We are not saying that this particular situation is not a "real" case of PML-- just that there is no confirmation and it is probably not worth taking seriously until word, if any, comes from an official source. Given that this information is likely a month old (if obtained via FoIA), and there is no comment from the primary sources, one might conjecture in the interim that this very well might be another false call.


We will report the significant rumors only to share what information is KNOWN, in hopes of calming any unsubstantiated fear. Any confirmed reports will of course receive all due respect and coverage.

[Cyberhexe]

http://www.biogen.com/news/biibnejmletter.pdf

The
new england journal
of medicine

Natalizumab and Progressive Multifocal Leukoencephalopathy

[Cyberhexe]

bin gespannt, ob Biogen heute wirklich etwas zu sagen hat:

http://phx.corporate-ir.net/phoenix.zhtml?c=148682&p=IROL-in…

[Cyberhexe]

hier das Ergebnis von AFFIRM (1801), also Tysabri bzw. Natalizumab in der Monotherapie, nach 1 Jahr

Table 1.
13-Month Clinical and 1-Year MRI Endpoints in Study 1 (Monotherapy Study)

TYSABRI® Placebo
n=627 n=315

Clinical Endpoints
Annualized relapse rate

0.25 0.74

Relative reduction (percentage)
66%

Percentage of patients remaining relapse-free
76% 53%

MRI Endpoints New or newly enlarging T2-hyperintense lesions Median Percentage of patients with:
0 lesions 60% vs. 22%
1 lesion 18% vs. 13%
2 lesions 6% vs. 7%
3 or more lesions 16% vs. 58%


Gd-enhancing lesions

0 lesions 96% vs. 68%
1 lesion 3% vs. 13%
2 or more lesions 1% vs. 19%


also die Zahlen sind statistisch derart beeindrucken, dass ich an der Weitervermarktung nicht zweifeln kann

vergleicht man dazu die Ergebnisse von SENTINEL (Avonex+Tysabri), dann fragt man sich, wieso überhaupt noch über die Kombi-Therapie geredet wird

Fortsetzung (SENTINEL-Daten) folgt

[Cyberhexe]

Table 2. 13-Month Clinical and 1-Year MRI Endpoints in Study 2 (Add-On Study)
TYSABRI®+Avonex vs. Placebo+Avonex
n=589 n=582

Clinical Endpoints
Annualized relapse rate 0.36 vs. 0.78
Relative reduction (percentage) 54%
Percentage of patients remaining relapse-free 67% vs. 46%

MRI Endpoints
New or newly enlarging T2-hyperintense lesions Percentage of patients with:
0 lesions 67% vs. 40%
1 lesion 26% vs. 29%
2 lesions 4% vs. 10%
3 or more lesions 3% vs. 21%

Gd-enhancing lesions
Percentage of patients with:
0 lesions 96% vs. 76%
1 lesion 3% vs. 12%
2 or more lesions 1% vs. 12%

[Cyberhexe]

vergleicht man nun die beiden Studien --> AFFIRM (Tysabri Mono) mit SENTINEL (Tysabri+Avonex), dann wird folgendes deutlich:
- Avonex alleine hat eine Wirkung im Plazebobereich
- die Ergebnisse der Monostudie sind besser als in der Kombistudie

wieso dann überhaupt die Kombitherapie? Ach ja, Biogen fürchtet um die Avonex-Umsätze, welche zu 100% verbucht werden...bei Tysabri muss geteilt werden


noch Fragen?
die Zahlen sprechen eigentlich für sich!

[Cyberhexe]

und zudem ...keine PML-Fälle in AFFIRM, lediglich in Verbindung mit dem Immunmodulator (Avonex)...und dazu noch die schlechteren Ergebnisse!

Tysabri-Monotherapie scheint sicher zu sein und dies bei einer Erniedrigung der Schubrate von 66% (bei SENTINEL lediglich 54%)...also für mich eine klare Sache...Tysabri wird zurückkommen!

[bernie55]

...also, das heisst, heute nochmal nachkaufen, bevor die Amis aufwachen......wenn man schaut, aus welchen " nördlichen " Regionen ELAN gekommen ist, dann ist der Einkauf dieser Aktie doch ein absolutes MUSS.....

[Cyberhexe]

da scheint auf der Parkinson-Schiene etwas in die Pipeline zu kommen...also wenn das mit Tysabri klappen sollte und Elan da eine cash cow zur Verfügung hat, dann steht auch die Finanzierung der hoffnungsvollen Alzheimer und Parkinson-Ansätze nichts mehr im Wege...und wenn dort der Durchbruch gelingen sollte, dann ist eine 2. Genentech geboren. Anbei Goodbody`s Kommentar von heute zum Parkinson-Ansatz:


Elan (Buy, Current Price $7.09); Positive signs for Parkinson`s vaccine.
It has been reported that a vaccine being developed by Elan for the treatment of Parkinson`s disease has been proven effective in mice, an important stage in the pre-clinical development of any drug. We believe results from the animal studies conducted at the University of California will be published in the neurological journal Neuron later this month. The candidate vaccine uses a similar approach to controlling Parkinson`s as the withdrawn candidate drug AN-1792 did in controlling Alzheimer`s. A protein
(alpha-synuclein) that normally accumulates in the brain of Parkinson`s patients was injected into the mice to elicit an immune response. These results are positive in the overall development of Elan`s pipeline for candidate drugs. However, as the scientists conducting the trial indicate that the vaccine will probably have to be modified before being tested in humans (injecting antibodies rather than the protein to reduce side-effects), the time to clinical trial is still uncertain.

[Cyberhexe]

anbei auch noch der Kommentar von davy stockbrokers

Thursday June 16 2005

Elan (ELN US)
Positive news for a Parkinson vaccine being developed by Elan
Previous close: 709c Price target: 650c Analyst: [e-mail]
According to an article in the Financial Times, researchers at the University of California, who conducted trials in mice said a
vaccine being developed for Parkinson’s has worked well in mice trials and that the vaccine could also work for Alzheimers.
The vaccine use an approach of injecting the alpha-synuclein protein that abnormally accumulates in the brain of Parkinson`s
patients to encourage an immune response.

[Cyberhexe]

in Hillerød entsteht Biogen`s 3.Fabrik zur Herstellung von monoklonalen AK, mit einem jeweiligen Fassungsvermögen von 90000 l...so weit ich das in Erinnerung habe, könnte pro Einheit/Fabrik der Bedarf von 75.000 Jahresdosen Tysabri fermentiert werden - die in Aussicht gestellten Verfahrensoptimierungen unberücksichtigt.


“With its 90,000 litre production capacity, the plant in Hillerød will be the same size as our factory in North Carolina and the one in San Diego due for completion in 2006. It gives us production planning flexibility. In 2008, the Hillerød plant will have a workforce of 200 people, of whom some will come from the US in connection with technology transfer necessary for the start-up phase. In the long term there will be an opportunity to exchange experience and staff between the three plants.”



http://www.um.dk/Publikationer/Eksportraadgivning/FocusDenma…

[Cyberhexe]

http://www.newsday.com/news/health/ny-hspark164306142jun16,0…

Parkinson`s vaccine hopes
BY JAMIE TALAN
STAFF WRITER
June 16, 2005

Scientists have developed the first vaccine, tested only in animals so far, that clears away a brain protein that accumulates in some cases of Parkinson`s disease.

So far, it`s been tested only in mice bred to develop the same plaque deposits as seen in humans, but its potential has some doctors hopeful. About 30 to 40 percent of the mice responded to the vaccine. Of those, 50 percent had less damage than mice with no exposure to the treatment. The study appears today in the journal Neuron.

"It is an exciting study," said Dr. Ole Isacson, a professor of neurology and neuroscience at Harvard Medical School, but he cautioned that the findings are very preliminary. The disease affects more than a million Americans, who suffer damage to brain cells that control movement.

Dale Schenk, chief scientific officer at Elan Pharmaceuticals in South San Francisco, teamed up with Eliezer Masliah of the University of California, San Diego, to develop the vaccine.

Schenk`s group also developed an experimental vaccine for Alzheimer`s that introduced a snippet of abnormal protein, called beta amyloid, that caused the immune system to make antibodies that reduced levels of the abnormal protein in the brain. When the Alzheimer`s vaccine was tested in humans, 18 of 300 patients developed brain swelling and the trial was halted. Investigators have started new tests using a new procedure, bypassing the immune system.

Parkinson`s may be more complicated because it involves many abnormal proteins that can damage cells. Several Parkinson`s genes have been discovered. One makes a protein called alpha-synuclein, and like beta amyloid in Alzheimer`s it accumulates as a plaque in the brain.

So it was with great excitement that the team delivered a vaccine that contains a small bit of alpha-synuclein and found that the body waged an antibody response against it. The antibody migrated into the brain and actually sat on the surface of cells. It was then taken into the cell, and began destroying the abnormal protein. "It has long-term implications for Parkinson`s patients," said Schenk.
Copyright 2005 Newsday Inc.

[Cyberhexe]

dieser Dale Schenk könnte eines Tages den Nobelpreis erhalten...faszinierend, mit welch bahnbrechenden Erfolgen die auf sich aufmerksam machen!

[Cyberhexe]

Nebenwirkungen bei der Monotherapie im Plazebobereich

Table 3. Adverse Reactions in Study 1 (AFFIRM)
Adverse Events (Preferred Term)

TYSABRI® n=627 Studienteilnehmer vs. Plazebo n=312

Kopfschmerzen 35% bei Tysabri vs. 30% bei Plazebo
Müdigkeit 24% vs. 18%
Gelenkschmerzen 15% vs. 11%
allergische Reaktionen 7% vs. 3%
Harndrang 7% vs. 5%
Brustbeschwerden 4% vs. 2%
lokale Blutungen 3% vs. 1%
Rigors 3% vs. 1%
Ohnmacht 2% vs. 1%

[Cyberhexe]

...also ganz ehrlich....dass Biogen Oceanside an meinen Brötchengeber verkauft, damit habe ich nicht gerechnet...dies bedeutet, dass die erwartete biotechnologische Kapazität um 1/3 schrumpft:

Research Triangle Parc in North Carolina mit 90.000 l
sowie Hillerode in Dänemark mit ebenfalls 90.000 l (ab 2008)

die 90.000 l in Oceanside werden jedoch nun für die Produktion von Bevacizumab (Avastin) und nicht für Natalizumab (Tysabri) verwendet...für mich ein lachendes und ein weinendes Auge


...obschon immer wieder zu hören ist, dass die Ausbeute des bestehenden Prozesses bei der Natalizumab-Produktion um den Faktor 4 erhöht werden soll, ist der Verkauf von Oceanside für mich eine eindeutige Euphoriebremse

Hexi be careful...ich werde deswegen heute noch meinen Wertpapierkredit durch den Verkauf von einigen Elan liquidieren

allerdings bin ich dann immer noch zu 100% in Elan

[Cyberhexe]

gefunden im ymb zu Biogen...ich bin allerdings da eher skeptisch; eine Ausbeuteerhöhung um den Faktor 5-10...das ist fast zu schön um wahr zu sein.

Wenn ich mich richtig erinnere, sind mit dem bisherigen Prozess in RTP bei 90.000 l Fermentationsvolumen ca. 75.000 Jahresdosen herstellbar. Eine Ausbeuteerhöhung um den Faktor 5 wäre natürlich phantastisch, das würde ca. 350-400.000 Jahresdosen entsprechen. Dann wären die Kapazitätsprobleme auch im best-case Szenario mit einem Schlag gelöst. Aber wie gesagt, da bin ich nicht ganz so zuversichtlich.


RTP Improved Yields - Excess Capacity
by: kaisertomasi 06/16/05 05:53 pm
Msg: 38323 of 38359

Yesterday Biogen Idec at the Goldman Sachs conference announced they were finishing up a campaign of Tysabri at RTP in N. Carolina at the end of the month. They would stop making Tysabri since they would have plenty for the forseeable future at relaunch.

As I recall from the Elan annual meeting, Elan noted that the N. Carolina RTP facility was testing out a "high titer" process. I gather from this statement that they`ll be able to increase their yields of Tysbri 5-10 fold or so. So pretty soon, what would take 5 large facilities to make could easily be made in 1 facility.

So, as Corchess noted, this is merely an excess capacity issue, not any diminuation in confidence in Tysabri. Certainly no hidden messages here.

[Cyberhexe]

NCB, das irische Analstenhaus hat soeben folgenden Kommentar herausgegeben:

Elan €7.02 BUY Oceanside Sale-Implications For Tysabri
• BiogenIdec has agreed to sell its Oceanside (California) biologics manufacturing plant
to Genentech. At this stage both parties have signed a purchase and sale agreement
and the sale is expected to close as early as 23rd June 2005. Originally Oceanside (in
addition to RTP (North Carolina)) was to be used for the production of Tysabri.
• Before the withdrawal of Tysabri, the production process at RTP was expected to yield
sufficient drug to meet the demand of c.70,000 patients. We understand that this
production process is been optimised to increase the yield of Tysabri approximately 4-
fold (i.e. sufficient production to meet demand from c.280,000 patients). Elan indicated
that good progress has been made in improving production yields.
• Given that our peak forecasts assume c.50,000 patients a year on Tysabri, the level of
production at RTP is expected to be several fold in excess of the demand of our current
estimates. In addition, the Denmark facility which is currently under construction and is
expected to be available from 2008, could be used for Tysabri production.
• Post the withdrawal of Tysabri, BiogenIdec continued to manufacture the drug albeit at
a slower rate and at the end of this month will complete the current Tysabri production
cycle. They will then await the results of the safety review before determining the next
manufacturing steps. Should Tysabri be re-launched, we expect that sufficient drug has
been produced to meet the near-to-medium term demand.
Orla Hartford [phone] orla.

...anscheined kann man sich auf die Fortschritte bei der Ausbeuterehöhung verlassen. Falls Faktor 4 zutrifft, dann könnte man alleine in RTP 4 x 70.000 Jahresdosen produzieren (x 23500$/Jahresdosis), dies entspräche dann einem Umsatzpotenzial an der Kapazitätsgrenze von immerhin 6 Milliarden$ und ab 2008 soll dann ja Hillerode in Dänemark produktionsbereit sein. Also, ist der Verkauf von Oceanside doch nicht so dramatisch.

[Birgit.Tersteegen]

Cyberhexi,

Danke für Deine Arbeit die Du hier leistest!!!!!!!!
Einfach Klasse.

[Nostarowie]

So bin auch wieder wach,

schließe mich der Birgit mal an.
Auch ich vertrau der Frau blind wie,n Kind

seit nunmehr fast zwei Jahren.

[Cyberhexe]

und hier noch etwas zu den Nebenwirkungen....hinsichtlich der Infektionen im Plazebobereich
Also gegenüber den CRABs ist Natalizumab doppelt so wirksam und hat ein ungleich günstigeres Nebenwirkungsprofil. Auch die Applikationsweise (1x i.v. in 4 Wochen) ist vielen angenehmer als das fast tägliche Spritzen, verbunden mit den auftretenden Müdigkeitserscheinungen



Infections In Studies 1 and 2, the rate of infection was approximately 1 per patient-year in both TYSABRI®-treated patients and placebo-treated patients. The infections were predominately upper respiratory tract infections, influenza, and urinary tract infections. Most patients did not interrupt treatment with TYSABRI® during the infection. In Study 1, the incidence of serious infection was 2.1% in TYSABRI®-treated patients versus 1.3% in placebo-treated patients. No difference was seen between treatment groups in Study 2.

[lonesome loser]

Betting On Elan`s Second Resurrection


http://www.forbes.com/2005/06/17/elan-biogen-wyeth-cx_kk_061…

[whyso]

Yep-Forbes ist schon eine Macht im Amiland-und der goldene Schlußssatz regt wirklich zum nackdenken an:

"It`s not often you get the opportunity to invest in a drug after clinical trials have already proven its efficacy and a company with a great pipeline without having to pay a large premium. In our opinion, the combination of significant upside potential and good downside protection makes for great investments."

Is this a once in a lifetime Gelegenheit???-Die 400Mio$ Gewinn berühigt irgedwie sehr
Schönen Sonntag noch allerseits,
Whyso

[[KERN]Codex]

hallo whyso

der satz trifft die spekulation auf ELAN ziemlich gut

[welke91]

Morgen am 22. Juni werden nochmal Sicherheiten und Erfolge einzelner Tysabristudien erläutert.

Hintergrund ist die ENS(Fifteenth Meeting of the
European Neurological Society)hier wird über Tysabri folgendes kommen:

The efficacy of natalizumab add-on therapy in patients with relapsing multiple sclerosis: subgroup analyses of SENTINEL,

The effect of natalizumab on brain atrophy in patients with relapsing multiple sclerosis: 2-year results from the AFFIRM study,

The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM und

The effect of natalizumab on brain atrophy in patients with relapsing multiple sclerosis: 2-year results from the AFFIRM study

[Cyberhexe]

Goodbodys Analystenkommentar von heute

Elan (Buy, Current Price $6.98)
Tysabri trial data revisited at ENS meeting.

Yesterday afternoon (17:00 to 18:30 Dublin time), two Tysabri-related papers (one on the two-year data from the monotherapy AFFIRM clinical trial and one on the dual therapy SENTINEL trial with Avonex) were presented at a satellite symposium at the European Neurological Society meeting in Vienna, Austria. Nothing new was revealed on the drug`s efficacy given that initial data from the monotherapy trial were released to the market on 17 February and discussed at the American Academy of Neurology meeting on 12 April.

Further data from the clinical trials will be presented in papers at the ENS meeting on Wednesday 22 June and in poster sessions on both Tuesday 21 June and Wednesday 22 June. Such academic meetings help re-iterate the efficacy of Tysabri in the treatment of MS. However, what is of paramount importance to Elan now is the outcome of the patient review (scheduled for completion by the end of June/beginning of July) and subsequent discussions with the FDA on if, when and under what conditions the drug can return to the market.
There was no additional information on the on-going screening of the 3,000 patients that received Tysabri during clinical trials.
However, from information currently available, we still believe the drug will return to the market, possibly in early to mid 2006.

[Cyberhexe]

zu FTY720, orale Applikation bei MS von Novartis

...die Phase-II-Daten erreichen nicht das Niveau der Tysabri-Ergebnisse. Ich glaube nicht, dass die einmalige (in 4 Wochen) Infusion gegenüber einer oralen Verabreichung ein ganz grosses Handycap darstellt. Wenn die Effektivität gegeben ist, dann wird sich eine Mehrheit für die Infusion entscheiden.
Und zudem...Start von Phase III erst im 4. Quartal...d.h. vor Ende 2008 wäre nicht mit einer Zulassung zu rechnen


Novartis MS pill data promising but Phase III delayed
21 Jun 2005 14:45:41 GMT

Source: Reuters

By Tom Armitage

ZURICH, June 21 (Reuters) - Swiss drugmaker Novartis AG <NOVN.VX> has pushed back the start of a late-stage trial of its FTY720 pill for multiple sclerosis (MS) after U.S. regulators asked for a safety analysis of the drug`s use in transplant patients.

Investors and analysts have been watching the experimental drug`s progress carefully, believing it could be a potential blockbuster seller for Novartis, as well as being one contender in the race to bring the first pill for treating MS to the market.

Over 2 million people worldwide are thought to have MS, a disabling disorder of the central nervous system in which the immune system is thought to attack healthy nerve tissue.

Symptoms include slurred speech, numbness, pain, poor balance and blurred vision. Most MS patients have a relapsing form of the disease, meaning symptoms come and go, and most current treatments are injected.

Novartis said on Tuesday that Phase II data on FTY720 in MS was promising but the Phase III trial would now start in the fourth quarter of 2005, rather than mid-2005 as previously announced.

Details of the six-month, Phase II study released on Tuesday in Vienna were promising, Novartis said, showing a more than 50 percent reduction in relapses and up to an 80 percent reduction relative to placebo in terms of brain lesions seen in scans.

However, Novartis said that the U.S. Food and Drug Administration had asked the firm to conduct a safety analysis of data from Phase III trials of the drug`s use as a treatment to prevent organ rejection in kidney transplant patients.

Some cases of macular edema, or swelling in the eye, had been observed in the transplant trial but not in the MS trial, a Novartis spokesman said, adding that the transplant trial had used higher dosages of FTY720 than the MS trial.

"As a result, the Phase III programme in MS is expected to be launched in the fourth quarter of 2005 involving centres in North America and Europe," Novartis said.

PROMISING DATA

The Phase II trial, involving daily 1.25 mg or 5 mg doses of FTY720, showed the drug was well-tolerated with 92 percent of patients completing the six-month trial. The most frequent side effects included headaches, respiratory problems and diarrhoea.

"There was no real drop-out rate and a clear-cut, highly statistically significant advantage of the drug over placebo at both doses," Ludwig Kappos, chief investigator of the trial, told Reuters.

"There was a tendency as you would expect in a drug that acts on the immune system towards a somewhat higher rate of infection especially with a higher dose but not serious infection," he said.

Swiss biotech company Serono SA <SEO.VX> is also working on a pill to treat MS, dubbed Mylinax, while British-based GlaxoSmithKline Plc <GSK.L> plans to file a competitor for regulatory approval in 2008.

Patients with MS were dealt a blow earlier this year when Elan Corp <ELN.I> and Biogen Idec`s <BIIB.O> Tysabri, which had been expected to revolutionise MS treatment, was pulled after it was linked to a rare brain infection.

Serono hopes its Rebif drug, co-marketed with Pfizer <PFE.N> in the United States, will become the number one MS treatment in time, despite competition from rivals made by Germany`s Schering AG <SCHG.DE> and Biogen.

[Cyberhexe]

...sogar Goodbody hat erkannt, dass von FTY720 die nächsten 4 Jahre keine Konkurrenz zu erwarten ist...und die Ergebnisse von Tysabri nach 2 Jahren sind immer noch das Mass aller Dinge. Also Leute...warum denn nervös werden, weil einige unqualifizierten Analysten den Teufel an die Wand malen. Ich bin mir fast zu 100% sicher - sagen wir mal zu 97%-, dass Tysabri auf den markt zurückkommen wird und zwar mit Blockbuster-Potenzial.

Elan (Buy, Current Price $6.99)
Novartis oral MS drug - safety review could slow progress.
Novartis yesterday reported Phase II results for its experimental drug FTY720 for treatment of MS at the European Neurological Society meeting in Vienna. Data showed that the drug reduced the rate of clinical relapses by 53% to 55% compared to placebo and disease activity as measured by MRI scans by 80% over 6 months. This compares favourably with existing medications, which reduced relapse rates by 30% to 40%. It is, however, less effective than Tysabri, which reduces relapse rates by 67%. Its one advantage over all existing medications is that it is an oral formulation as opposed to formulations requiring injection or infusion. There were no material side effects noted in the 281 patients over the six months of the trial. The drug (which is in advanced trials for the treatment of organ transplant rejection) will now progress into larger Phase III trials against MS to test for sustained improvement in a larger patient population. Novartis plans to launch such trials in the US and Europe in Q4`05. However, the US FDA has requested a safety review of 2,000 patients currently on a clinical trial using FTY720 to counteract renal transplant rejection. This could delay progress of the drug into Phase III. If not, the two-year trial (Novartis yesterday stated that there would be no interim, 1-year, data analysis) should be completed in Q4`07/ Q1`08 at the earliest. Subsequent data collation and submission to the authorities, followed by review and decision, could see a drug on the market by late 2008 or early 2009. Even prior to its market withdrawal, our Tysabri model had sales peaking in 2009 - reflecting the ever-narrowing window of opportunity afforded to new drugs in today`s competitive and innovative market place. The on-going development of FTY720 justifies such caution.

[Cyberhexe]

NCB Stockbrokers hat sich heute auch zu den Ergebnissen von FTY720 geäussert...auf alle Fälle sind sich die irischen Analystenhäuser in Bezug auf Elan nun einig...BUY...das war nicht immer so!


Elan $6.99 BUY Comparison of Novartis` MS product with Tysabri
• Novartis presented Phase II (six-month data) data yesterday on FTY720, an oral
immunomodulator for relapsing multiple sclerosis, at the European Neurological
Society. While the data is encouraging and shows the potential of FTY720 as an
efficacious treatment for multiple sclerosis with the benefit of once daily oral
administration, there are several key points in the context of Tysabri worth highlighting.
• This six-month study with FTY720 showed a 55% reduction in relapse rate which is
directly 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%.
• The main efficacy difference between FTY720 and Tysabri was seen on MRI
measures with new lesion formation reduced by more than 66% with FTY720
compared to a reduction in new lesion formation of c. 90% in Tysabri treated patients.
Effects on relapses and MRI were seen as soon as two months with FTY720 and
continued to increase over the 6 month period. In clinical trials with Tysabri the effect
was seen as early as one month and was sustained throughout the 6-month period. In
addition, there are differences in the patient population between the two studies with
patients in the FTY720 less severe MS patients (with an average EDSS score of 2.5
compared to an average EDSS score of 4.3 in the Tysabri treated population (higher
EDSS scores indicate more severe disease)).
• Overall while FTY720 and Tysabri show similar reduction in the frequency of relapses
with both exceeding the currently marketed products, the main divergence on efficacy
between the two products relates to the greater effect that Tysabri has on the reduction
in the formation of new lesions.
• The Phase III trials with FTY720 for MS (FTY720 is also in Phase III trials for the
prevention of organ rejection in transplant patients) have been delayed from mid-year
to Q4, 2005 as Novartis review, at the request of the FDA, the transplant safety
database (for infection risk as well as pulmonary and other risks). As the long-term
safety profile of FTY720 is currently unknown, the entire two-year data will be required
by the FDA/EMEA for approval. At best, this could see a launch of FTY720 for MS in
mid-to-late 2009. Importantly, FTY720 is an oral product which gives it an
administration advantage over currently available therapies and Tysabri.

[Cyberhexe]

beim Neurologentreffen in Wien stan heute MS und dabei auch Natalizumab auf der Agenda...weiss jemand etwas näheres? Von 10:15 bis 11:15h war Natalizumab das Thema

June 18-22, 2005
Vienna, Austria
Fifteenth Meeting of the
European Neurological Society



Wednesday, June 22, 2005
09:30 - 11:15
Room K
Oral Session 25
Multiple sclerosis 5
Chair: K. Toyka (Wurzburg, D)
A. Steck (Basle, CH)



09:30 - 09:45 A comparative study of interferon-beta products for relapsing-remitting multiple sclerosis: QUASIMS results from Italy O 154
A. Lugaresi on behalf of the Italian QUASIMS Study Group

09:45 - 10:00 QUASIMS comparative study of interferon-beta products for relapsing multiple sclerosis: results from Belgium, Netherlands, and Luxembourg O 155
G. Nagels, J. Debruyne, E. Sanders, S. Yang, J. Tinbergen, V. Limmroth (Antwerp, Ghent, B; Breda, Lijnden, NL; Essen, D)

10:00 - 10:15 The OPTIMS study. I. Looking for a treatment response marker O 156
L. Durelli, E. Verdun, P. Barbero, M. Clerico, B. Ferrero, E. Versino, G. Giuliani, E. Montanari and the OPTIMS Study group

10:15 - 10:30 Defining beta-interferon failure in multiple sclerosis: impaired relapse rate reduction predicts progressive disability O 157
K. O`Rourke, M. Hutchinson (Dublin, IRL)

10:30 - 10:45 The effect of oral temsirolimus on new magnetic resonance imaging scan lesions, brain atrophy, and the number of relapses in multiple sclerosis: results from a randomised, controlled clinical trial O 158
L. Kappos, F. Barkhof, A. Desmet, G. Tremblay, Y. Brault, G. Edan, X. Montalban, C. Polman, C. Pozzilli (Basle, CH; Amsterdam, NL; Paris, F; Collegeville, USA; Rennes, F; Barcelona, E; Rome, I)

10:45 - 11:00 The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM O 159
E. Havrdova, P. O`Connor, M. Hutchinson, L. Kappos, D. Miller, J.T. Phillips, C. Polman, F. Lublin, G. Giovannoni, A. Wajgt, F. Lynn, M. Toal, M. Panzara, A. Sandrock for the AFFIRM Investigators

11:00 - 11:15 Magnetic resonance imaging results from AFFIRM: a randomised controlled trial of natalizumab in patients with relapsing multiple sclerosis O 160
D. Miller, P. O`Connor, E. Havrdova, M. Hutchinson, L. Kappos, J.T. Phillips, C. Polman, F. Lublin, G. Giovannoni, A. Wajgt, F. Lynn, M. Toal, M. Panzara, A. Sandrock for the AFFIRM Investigators

[Cyberhexe]

A Vaccine Approach to Treating Parkinson`s Disease
Libraries
Medical News Keywords
VACCINE PARKINSONS MICE PROTEIN SYNUCLEIN
Contact Information

Available for logged-in reporters only
Description

Researchers UCSD School of Medicine working with scientists at Elan Pharmaceuticals, have reported promising results in mice of a vaccine approach to treating Parkinson’s and similar diseases.



Newswise — Researchers at the University of California, San Diego (UCSD) School of Medicine working with scientists at Elan Pharmaceuticals, have reported promising results in mice of a vaccine approach to treating Parkinson’s and similar diseases. These results appear in the June edition of the journal Neuron.

Eliezer Masliah, M.D., Professor of Neurosciences and Pathology at UCSD, and colleagues at UCSD and Elan Pharmaceuticals in San Francisco, vaccinated mice using a a combination of the protein that abnormally accumulates in the brains of Parkinson’s (called human alpha-synuclein) and an adjuvant. This approach resulted in the generation of anti-alpha synuclein antibodies in mice that are specially bred by Masliah’s team to simulate Parkinson’s disease, resulting in reduced build-up of abnormal alpha-synuclein. The accumulation of abnormal alpha-synuclein is associated with degeneration of nerve cells and interference with normal inter-cellular communication, leading to Parkinson’s disease and dementia.

The work marks the first time a vaccine for this family of diseases has been found effective in animal studies. Scientists at Elan Pharmaceuticals have been working for the past few years in a vaccine for Alzheimer’s Disease.

The researchers focused on a spectrum of neurological disorders called Lewy body disease, which include Parkinson’s and Alzheimer’s. These disorders are marked by the presence of Lewy bodies -- abnormal clumps of alpha-synuclein -- in the brain. Normally, alpha-synuclein proteins support communications between brain cells, or neurons. However, when abnormal proteins clump together in the neurons, a build-up of synuclein can cut off neuron activity, blocking normal signaling between brain cells and ultimately choking the cells to death.

“We found that the antibodies produced by the vaccinated mice recognized and reduced only the abnormal form of alpha-synuclein, since the protein’s normal form is in a cellular compartment where antibodies can’t reach it,” said Masliah. “Abnormal alpha-synuclein finds its way to the cell membrane, where antibodies can recognize it.”

Masliah stressed that the team’s experimental active immunization, while effective in mice, may not be as useful in humans. “We would not want to actively immunize humans in this way by triggering antibody development, because one could create harmful inflammation,” he cautioned. “However, it might be feasible to inject antibodies directly, as if the patient were creating his or her own.”

The team, the first to identify the presence of these proteins in the human brain, originally thought the protein played an important role in the development of Alzheimer’s disease. Then, an explosion of research linked Lewy bodies and their constituent proteins to both Alzheimer’s and Parkinson’s. The team spent four years clarifying alpha-synuclein’s role in Parkinson’s, developing a mouse model that contained the faulty and normal genes for alpha-synuclein, and conducting the experiments that led to their current findings.

With evidence that this approach could be effective in treating Lewy Body disease, the UCSD researchers are now working with Elan Pharmaceuticals to develop alternative ways to produce alpha-synuclein antibodies, with the goal of making a vaccine that is safe and effective in humans. While this research could take many years and holds no promise of prevention or cure, the researchers are hopeful that the mouse studies are a step in the right direction.

“This shows the first demonstration of a vaccine for this family of disease,” Masliah said.

[Cyberhexe]

anbei zur Info, alle von der FDA zugelassenen Arzneimittel zur Behandlung von Multiple Sclerosis

Brand Name / Generic Name / Verabreichungshäufigkeit

Betaseron / Interferon beta-1b / jeden 2.Tag
Avonex / Interferon beta-1a / einmal pro Woche
Copaxone / Glatiramer-acetat / täglich
Novantrone / Mitoxantrone / 4 x pro Jahr
Rebif / Interferon beta-1a / 3 x pro Woche
Tysabri / Natalizumab / 1 x in 4 Wochen

Novantrone wird beim Übergang von relapsing-remitting MS zu progressive-relapsing oder secondary-progressive MS verabreicht. Alle anderen Arzneimittel sind lediglich für RRMS zugelassen.

[UserX5]

CH..., Heute sieht auch nicht gut aus !!?

[Cyberhexe]

was sieht nicht gut aus?

Natalizumab ist mit Abstand das Wirkungsvollste zur Behandlung von MS und wird, da bin ich mir ziemlich sicher, wieder auf den Markt zurückkommen - mit Blockbusterpotenzial versteht sich.
Ich rechne ebenfalls mit einer Zulassung für die Behandlung von MC. Bei Arthritis bin ich mir nicht sicher, ob hier eine Phase III-Studie initialisiert wird - die Phase II-Daten sind jedoch sehr vielversprechend und die Probleme bei den Cox-2-Hemmern sind ja auch nicht unbedeutend.
Dazu hat Elan vermeldet, auch ohne Ty bis zum Ende des Jahres EBITDA positiv zu sein. Die Patente zur Formulierung von Medikamenten (Nanotechnologie) scheinen mittlerweile Früchte zu tragen; die Lizenzeinnahmen im letzten Quartal haben um 30% auf über 43 Mio$ zugenommen bei stark steigender Tendenz.

Wenn dann an einem Sommertag wie heute nichts Neues bekannt wird und der Kurs vor sich herdümpelt...dann ist dies für mich kein Grund mein Investment zu hinterfragen. Denn keine Neuigkeiten sind in diesem Falle gute Neuigkeiten. Falls weitere PML-Fälle aufgetreten wären, hätte man diese wohl veröffentlicht.

[Cyberhexe]

Anbei ein Artikel über das Schmerzmittel Prialt
erschienen unter kansas.com
Mit Prialt ist seit langem wieder ein Medikament zugelassen worden, welches über medizinische Dosierpumpen injiziert wird. Angeblich arbeitet Elan mit den herstellern eng zusammen, damit über eine verbesserte Technik der Pumpen das Indikationsfeld für Prialt erweitert werden kann, weswegen Optimisten auch für Prialt Blockbuster-Potenzial voraussagen. Man bedenke, dass die Wirksamkeit von ziconotide etwa 1000 x grösser ist als die der Morphine und bei chronischen Schmerzen sehr gute Ergebnisse zeigt.

http://www.kansas.com/mld/kansas/news/nation/11965631.htm

Posted on Thu, Jun. 23, 2005

From depths of the ocean, bright hope for medicines

BY TOM AVRIL

Knight Ridder Newspapers


PHILADELPHIA - (KRT) - The pain in Tom McAuliffe`s back was so bad that he had to sleep standing up, propped against a couch. His body racked by colorectal cancer, the 57-year-old worried he wouldn`t make it to his daughter`s wedding in July.

Now he can rest easier, thanks to a new pain medicine derived from an unlikely source: the venom of a snail from a coral reef off the Philippines.

When the drug received clearance from the Food and Drug Administration in December, it was believed to be the first time the agency has approved a medicine that is an exact copy of a chemical found in the ocean. Called Prialt, it is used for patients with severe, chronic pain that isn`t alleviated by other treatment.

The compound was first isolated by a University of Utah scientist who, as a boy in the Philippines, had been warned to be careful of swimming near the venomous snail.

"I was blown away" to learn the drug`s origin, said McAuliffe, a former executive in the arcade-game industry.

Scientists say the ocean is a largely untapped reservoir of possible medicines, with at least as much potential as the rain forests that have been popular pharmaceutical hunting grounds. And environmentalists are encouraged, hoping that drug companies will be allies in the quest to prevent the destruction of corals and sponges by fishing trawlers.

Oceana, a nonprofit group based in Washington, expects word this month on its federal petition to stop trawling in unexplored waters. The group`s primary goal is to preserve fish habitat, but officials say the promise of the ocean as medicine cabinet is an added bonus.

George Miljanich, a research fellow at Elan Corp., the Irish firm that makes Prialt, agreed.

"We need to preserve these habitats so that we have the time to find the next great drug," said Miljanich.

Although the deep reaches of the ocean are largely unexplored, making medicines from so-called natural products is not new. Plants and their extracts have been used to treat ailments for many thousands of years, almost as long as people have been getting sick, said Frank Koehn, director of natural-products discovery for Wyeth Pharmaceuticals.

In the modern era, perhaps the most famous "natural" medicine is Alexander Fleming`s accidental discovery, in 1928, of the bacteria-fighting mold that he named penicillin. And in the 1950s, drug makers modified compounds found in sea sponges to create antiviral medicines.

Almost half of the drugs on the market today trace their origin to a compound found in nature, Koehn said.

But some large drug companies have turned away from nature`s chemical storehouse in recent years, favoring instead the use of computers to try millions of combinations of chemical building blocks in hopes of synthesizing the next blockbuster.

That approach is a faster way of creating chemical candidates, but it has had mixed success in creating actual medicines. Some critics urge a return to nature, which has the advantage of "bioactive" chemical diversity that has evolved over eons.

"Mother Nature was there first and has structures and molecules that we`ve never seen," said David J. Newman, acting chief of the natural-products branch at the National Cancer Institute in Frederick, Md.

Wyeth, along with Bayer and Novartis, is among the few large drug companies with big natural-products programs, focusing its efforts on microbes both from the soil and the sea. Wyeth said it had more than 20 scientists working in the field but declined to disclose its spending.

Most natural-product discovery and testing is handled by smaller firms and by academic institutions, such as the Scripps Institution of Oceanography in California, which then license their discoveries to companies.

About 15 drug candidates derived from marine organisms are in various stages of clinical trials for cancer, Newman said. Another half-dozen trials are underway for other diseases. One compound, derived from a creature called the sea squirt, is being tested on cancer at Fox Chase Cancer Center.

Supporters caution against the idea that every plant or animal is brimming with potential medicines. Wyeth`s Koehn estimated that of the thousands of microbial strains in the company`s library, fewer than 1 percent score a "hit" - some type of biological response that is worth pursuing - when tested in the lab on a particular enzyme or cell.

But the odds are good enough, said Newman - especially in the ocean. We share common ancestors with marine life, and so it is not surprising that marine-based compounds could provoke various impacts in humans, he said.

"The odds are better for natural products" than for the man-made variety, Newman said. "Mother Nature has designed them to do things."

And because sea creatures live in the water, any compounds that they secrete are likely to be potent because they must overcome the dilution effect, he said.

The snail toxin now being injected into Tom McAuliffe`s spine, for example, is 1,000 times as potent as morphine. He needs just a few micrograms a day to ease the pain that he likened to being jammed with "an electric prod."

Prialt`s road from ocean to doctor`s office was a long one.

Although scientists have since learned how to make the drug in the lab, the compound initially was extracted from a cone snail - one of several hundred such species that possess a startling method of catching their prey.

The animal injects venom into passing fish through its tubular tongue, and then swallows its catch with a stomachlike appendage.

Baldomero Olivera, the scientist who learned of the snail as a boy in the Philippines, published a paper in 1985 about toxins in the animal`s venom after one of his students isolated them.

One toxin was discovered to block calcium channels that are the key to transmitting impulses from pain nerves to the spinal cord. Morphine has a similar effect, albeit indirectly, and Miljanich, then at the University of California, decided to test it as a medication.

Though more powerful than morphine, Prialt is not addictive, and users do not build up tolerance to it, Miljanich said. But there can be serious side effects, including dizziness, nausea and confusion, and it is reserved for those with severe, chronic pain.

McAuliffe, for one, said he could live with some mental "fogginess" in exchange for being able to sleep at night.

Two days after starting the drug, the excruciating waves of nerve pain were mostly gone, McAuliffe said recently while waiting for his doctor, pain-relief specialist Philip Kim, to adjust his dose.

As for his daughter`s wedding next month, he said: "My job is to be there for it."

With a little snail toxin, he thinks he`ll make it.

[Cyberhexe]

auch BB Biotech glaubt an die Rückkehr von Tysabri...siehe letzter Absatz



Vertrauen in Tysabri
Im ersten Quartal hat BB Biotech vor allem unter der Rücknahme des Medikaments
Tysabri von Biogen gelitten. Bislang wurde die Position nicht reduziert. Dies dürfte wohl auch so
bleiben. BB Biotech glaube daran, dass Tysabri wieder auf den Markt komme. Zudem sei die Aktie
nach dem Kurssturz unterbewertet, so Müller

http://media.bbbiotech.ch/docs/swisscontent_BIOdenPharmafirm…

[Cyberhexe]

das Alzheimer-Projekt von Elan und Wyeth ist eine sehr spannende Geschichte...allerdings dauert die Phase II-Studie bis April 2008...ungewöhnlich lange, jedoch bei einer Krankheit mit schleichendem Fortschritt ist ein kurzfristiger Vergleich wenig sinnvoll. Für mich persönlich bedeutet die, dass ich die Hälfte meiner umfangreichen Elan-Position kurz-bis mittelfristig verkaufen werde (allerdings nicht unter 20€), die andere Hälfte jedoch als langfristiges Investment betrachte...falls AAB-001 marktreif werden würde, bzw. die Phase-II-Ergebnisse den Nachweis auf einen postiven Einfluss auf den Krankheitsverlauf erbringen würden, dann geht das Ding durch die Decke...

UNIVERSITY OF PITTSBURGH RESEARCHERS TO TEST INVESTIGATIONAL TREATMENT FOR ALZHEIMER’S DISEASE

PITTSBURGH, June 24, 2004 – The Alzheimer’s Disease Research Center (ADRC) at the University of Pittsburgh has been chosen as a research site to participate in the first human clinical trials of an investigational treatment for Alzheimer’s disease (AD).

The investigational drug known as AAB-001, a specific antibody to beta-amyloid, is thought to work by removing a protein called beta-amyloid, which is present only in small amounts in the normal brain but is greatly increased in the brains of AD patients. Researchers believe the amyloid plaques result from unknown genetic and environmental miscues that cause the brain to produce and deposit it in clumps. The accumulation of amyloid plaque is believed to cause the death of neurons, in part by stimulating another abnormal protein metabolism known as neurofibriallary tangles in neurons, resulting in memory loss. As the disease progresses, more and more plaques accumulate and patients suffer greater cognitive impairments.

“Working with AAB-001 gives us an exciting opportunity to continue our Alzheimer’s disease research,” said Steven T. DeKosky, M.D., professor of neurology, psychiatry, neurobiology and human genetics at the University of Pittsburgh School of Medicine and director of the ADRC. “If the safety data from these initial clinical tests are positive, larger clinical trials may be initiated to determine whether AAB-001 can be a potential treatment breakthrough.”

The drug, AAB-001, is the first of its kind to emerge for testing since trials of an anti-amyloid vaccine were suspended two years ago due to medical complications. AAB-001 is a novel monoclonal antibody, using synthetically engineered antibodies directed to seek out and reduce amyloid. The monoclonal antibody is intended to provide the patient’s immune system with the capability to respond to the amyloid, a key difference from the earlier vaccine strategy. In that study, the vaccine, AN-1792, stimulated the patient to mount their own immune response, that is, produce their own antibodies.

The primary purpose of this study is to evaluate the safety of AAB-001 and how well increasing doses of AAB-001 (in successive groups of subjects) are tolerated. A secondary purpose of the study is to measure the amount of AAB-001 in the blood, and how long it remains in the blood over time.

AAB-001 is an investigational drug and is not currently approved for commercial use by the U.S. Food and Drug Administration. In this study, AAB-001 is being given to humans for the first time. The study is sponsored by Wyeth Research, and is an initiative of the Elan/Wyeth Alzheimer’s Immunotherapy Program.

The study has so far enrolled three patients in Pittsburgh and will eventually include approximately eight. Participants must meet criteria outlined in the study protocol.

About the University of Pittsburgh Medical Center

The University of Pittsburgh Medical Center is a non-profit, comprehensive academic health care system affiliated with the University of Pittsburgh Schools of the Health Sciences. Their combined mission is to provide quality patient care, educate the next generation of health care professionals and advance biomedical knowledge through basic and clinical research.

The ADRC at the University of Pittsburgh was established in 1985 by a grant from the National Institute on Aging as a mechanism for integrating, coordinating and supporting new and ongoing research in Alzheimer’s and aging.

[zenman]

so ähnlich werd ich das wohl auch händeln

[Cyberhexe]

anbei die FDA-Seite, auf welcher die Phase-II-Studie zu AAB-001 beschrieben ist

http://www.clinicaltrials.gov/ct/show/NCT00112073

[UserX5]

na toll ELN wieder unter 6.70$ ich denke das wir
demnächt die 5$ erreichen werden...wen keine neue
news komen...!!!

[Birgit.Tersteegen]

nicht jammern!

[Bernd13090]

sieht ja heute nicht so gut aus (( , hoffe, das bald positive news kommen

[mmeureka2164]

ich denke das WIR die 2.5$ erreichen werden...
VIEL SPASS DAMIT!!!:O:O:O:O:O:O:O:O:O:O:O

[[KERN]Codex]

Dies ist ein Faktenthread, ich bitte dies zu bedenken

[Bernd13090]

im Forum ist es sehr ruhig geworden,... gibts zur Zeit keine News ???

[bernie55]

Was seid ihr eigentlich so nervös ??????

Das, was wir zur Zeit sehen, ist die Ruhe vor dem Sturm !!!!!!

Grüße bernie55

[Birgit.Tersteegen]

Bernie:Genau;will noch zu 5,20E aufstocken.

[bernie55]

...tja, wenn unser Elan- Baby noch so tief gehen sollte......warum nicht, Birgit.........just do it......

[[KERN]Codex]

Ist doch alles

[bernie55]

#209



Frankfurt 28.06.05

15:45:50

5,20 € 600 Stk.

..hast du also doch noch zugeschlagen, Birgit ????


Grüße, bernie

[Birgit.Tersteegen]

nee,ist leider bei mir nichts ausgeführt worden.

[Cyberhexe]

..und wieder ein Analystenkommentar...von Goodbodys Stockbroker...aber nichts bewegendes, die Diskussion mit der FDA um die Weitervermarktung von Tysabri wird auf Ende Q3 bzw. Anfang Q4 erwartet.

Elan (Buy, Current Price $6.43)

Debt due to Elan repaid early but at a discount.

Depomed yesterday announced that it has paid Elan $9.1m to retire debt it owed the company. The loan was repaid early, which was due in January 2006, at which time the projected balance was $11.3m. Depomed originally borrowed $7.8m from Elan in January 2000 under a convertible note. A joint venture between both companies was formed in 1999 to use Depomed`s gastro-retention oral drug delivery technology in the reformulation of three undisclosed compounds. This repayment continues the administrative tidying up of financial and technical agreements established during the development of Elan`s numerous (55) joint ventures. A small boost to the coffers, it does not deflect from the core issue for Elan at present, namely the Tysabri patient review, which if on schedule, should be nearing completion. Data collation and analysis will be top priority for Elan and Biogen Idec, with subsequent presentation to and discussion with the FDA due in late Q3`05/early Q4`05.

[Cyberhexe]

und noch ein Kommentar eines irischen Analystenhauses: Davy schreibt heute...

Elan (ELN US)
IND for potential MS rival does not change our Tysabri view; balance sheet boosted by early
Depomed cash

Previous close: 646c Price target: 650c Analyst: [e-mail]

Our view on Tysabri is unchanged following news that Teva and its partner Active Biotech AB have submitted an
investigational new drug application (IND) to the Food and Drug Administration to initiate a US clinical trial for oral drug
Laquinimod. This submission was expected, but with a phase-III trial planned for 2006, its prospective market impact is likely
to be beyond any prospective Tysabri return.
It follows on with our view that Elan retains a window of opportunity for Tysabri in the MS market before any significant
increase in competition from new entrants towards the end of the decade.

[Birgit.Tersteegen]

Bernie,für 5,15 E hats heute geklappt!

[bernie55]

Wo hast du denn gekauft ???

..sehe nirgendwo Tief - Kurse von 5,15 € .....

Grüße bernie55

[Birgit.Tersteegen]

Frankfurt.

[Poppholz]

kleine Hilfestellung:

Birgit hat gekauft: WKN 903801

Bernie hat geschaut: WKN 871331

Gruß
Poppholz

[Birgit.Tersteegen]

genau!

[Birgit.Tersteegen]

....und Glückwunsch zu Deinem ersten Posting!

[Poppholz]

Danke Birgit.

Habe mich bisher nur als LESER auf WO herumgetrieben.

[bernie55]

.....alles klar.....

Grüße, bernie

[[KERN]Codex]

ELAN

[lonesome loser]

Elan, Biogen plan Tysabri safety look by end summer


3:05:00 AM ET 6/30/2005

LONDON (MarketWatch) -- Irish pharmaceuticals firm Elan Corp. (ELN)(UK:ELA) and its U.S. partner Biogen Idec, Inc. (BIIB) on Thursday said safety evaluations of their pulled multiple sclerosis treatment Tysabri were ongoing. In February, Elan and Biogen pulled Tysabri from the U.S. market after there were several reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal brain disease, in patients who had been taking Tysabri. The two firms said they hope the safety evaluation would be concluded by the end of the summer. In addition, the two companies said ENCORE, the second phase III induction trial of Tysabri for the treatment of Crohn`s disease, was positive, meeting all primary and secondary endpoints. There were no notable differences in the overall rates of adverse events or serious adverse events between the Tysabri and placebo treatment groups, the companies said.

[Cyberhexe]

...nun ja, das Ergebnis von ENCORE (ENCORE met all of its secondary endpoints) habe ich genau so erwartet. Muss mal sehen, ob es Vergleichsdaten zu Remicade gibt, dem derzeitigen Goldstandard bei der Behandlung von MC.



TYSABRI(R) Phase III Induction Trial in Crohn`s Disease Meets Primary Endpoint
Thursday June 30, 2:30 am ET
TYSABRI Induced Statistically Significant Response and Remission in Patients with Active Disease


DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--June 30, 2005--
Study Showed Reduction in Signs and Symptoms of Crohn`s Disease;

Ongoing Safety Evaluation Remains on Track

Elan Corporation, plc and Biogen Idec announced today that ENCORE, the second Phase III induction trial of TYSABRI® (natalizumab) for the treatment of moderately to severely active Crohn`s disease (CD) in patients with evidence of active inflammation, met the primary endpoint of clinical response as defined by a 70 point decrease in baseline Crohn`s Disease Activity Index (CDAI) score at both weeks 8 and 12.

In addition, ENCORE met all of its secondary endpoints including clinical remission at both weeks 8 and 12. Clinical remission was defined as achieving a CDAI score of equal to or less than 150 at both weeks 8 and 12.

There were no notable differences in the overall rates of adverse events or serious adverse events between the TYSABRI and placebo treatment groups. The most common adverse events seen in the trial were headache, nausea, abdominal pain and nasopharyngitis.

On February 28, 2005, Elan Corporation, plc and Biogen Idec announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials. This decision was based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Elan and Biogen Idec`s comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. At the time of the dosing suspension, all ENCORE study patients had completed dosing based on the study protocol and collection and analysis of data followed.

The full data from ENCORE, including further sub-analysis of response and remission rates as well as clinical effect at other time points, effect on inflammatory markers and quality of life data will be presented at an upcoming medical meeting.

"The results of the ENCORE study are encouraging because patients treated with TYSABRI achieved a significant improvement in symptoms of this devastating, chronic immune disease," said Lars Ekman, MD, executive vice president and president, Research and Development, Elan. "Patient safety remains our top priority. We plan to share the data from ENCORE and our other Phase III TYSABRI Crohn`s studies with the FDA and other regulatory agencies to determine the appropriate path forward for TYSABRI as a potential new treatment option for this underserved patient population."

"These data provide further evidence of the benefit of TYSABRI in treating immune-mediated diseases. We are committed to a thorough safety evaluation so we can better define the benefit-risk profile of TYSABRI. We hope to have findings from the evaluation by the end of the summer," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.

The ENCORE Study

ENCORE was a Phase III, international, double-blind, placebo-controlled study of 510 patients at 114 sites to evaluate the safety and efficacy of intravenous TYSABRI in patients with moderately to severely active Crohn`s disease (based on a confirmed diagnosis of CD and a CDAI score of greater than or equal to 220 and less than or equal to 450) and evidence of active inflammation (as evidenced by elevated C-reactive protein (CRP) levels of CRP greater than 2.87 mg/l, the upper limit of normal). Patients were randomized 1:1 to treatment with TYSABRI (300mg) or placebo infusions at weeks 0, 4, and 8. Efficacy and safety assessments were performed at weeks 4, 8 and 12, and the study remains ongoing for safety follow-up.

[frauholl]

Das sind gute Neuigkeiten.

[Cyberhexe]

Remicade® (infliximab) scheint enorme Nebenwirkungen zu haben. Anbei eine von der FDA veröffentlichte Warnung:

October 18, 2001
IMPORTANT DRUG WARNING
Dear Healthcare Professional:
Centocor, Inc. would like to inform you of important new safety information for
REMICADE® (infliximab). Upon review of preliminary results of its ongoing phase 2 trial in
150 patients with moderate to severe (NYHA class III-IV) congestive heart failure (CHF), higher
incidences of mortality and hospitalization for worsening heart failure were seen in patients
treated with REMICADE, especially those treated with the higher dose of 10 mg/kg. Seven of
101 patients treated with REMICADE died compared to no deaths among the 49 patients on
placebo.
In this trial, stable but symptomatic patients with NYHA Class

[Cyberhexe]

Remicade, also Infliximab, ist von den Nebenwirkungen her problematisch. Falls das PML-Risiko in der Natalizumab-Monotherapie tatsächlich sehr, sehr gering sein sollte, dann dürfte Remicade durch die Zulassung von Tysabri zur Behandlung von Morbus Crohn ernsthafte Konkurrenz bekommen.

"...some of these infections have been fatal."


http://www.fda.gov/medwatch/SAFETY/2004/Remicade_12-22-04_PI…

REMICADE.
(infliximab)
for IV Injection
WARNING

RISK OF INFECTIONS

TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT
CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER
OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS
RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE WARNINGS).

PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION
WITH A TUBERCULIN SKIN TEST.1 TREATMENT OF LATENT TUBERCULOSIS
INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH REMICADE.

[Cyberhexe]

...bin gespannt, wie die Daten im Vergleich zu Remicade im einzelnen ausfallen werden. Die genauen Zahlen von ENCORE werden erst zu einem späteren zeitpunkt veröffentlicht


Active Crohn’s Disease
The safety and efficacy of REMICADE were assessed in a randomized, double-blind, placebocontrolled
dose ranging study of 108 patients with moderate to severe active Crohn’s disease

Concurrent use of stable dose regimens of corticosteroids, ASA, MP and/or AZA was
permitted and 92% of patients continued to receive at least one of these medications.
The study was divided into three phases. In the first phase, patients were randomized to receive a
single intravenous (IV) dose of placebo, 5, 10 or 20 mg/kg of REMICADE. The primary endpoint
was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI
by 70 points from baseline at the 4-week evaluation and without an increase in Crohn’s disease
medications or surgery for Crohn’s disease. Patients who responded at week 4 were followed to
week 12. Secondary endpoints included the proportion of patients who were in clinical remission
at week 4 (CDAI <150), and clinical response over time.
At week 4, four of twenty-five (16%) of the placebo patients achieved a clinical response vs.
twenty-two of twenty-seven (82%) of the patients receiving 5 mg/kg REMICADE (p < 0.001, twosided,
Fisher’s Exact test). One of twenty-five (4%) placebo patients and thirteen of twenty-seven
(48%) patients receiving 5 mg/kg REMICADE achieved a CDAI <150 at week 4. The maximum
response to any dose of REMICADE was observed within 2 to 4 weeks. The proportion of patients
responding gradually diminished over the 12 weeks of the evaluation period. There was no
evidence of a dose response; doses higher than 5 mg/kg did not result in a greater proportion of
responders. Results are shown in Figure 2.
Figure 2. Response (70 point decrease in CDAI) to a Single IV REMICADE or Placebo
Dose.
During the 12-week period following infusion, patients treated with REMICADE compared to
placebo demonstrated improvement in outcomes measured by the Inflammatory Bowel Disease
Questionnaire.
In the second phase, 29 patients who did not respond to the single dose of 5, 10 or 20 mg/kg of
REMICADE entered the open label phase and received a single 10 mg/kg dose of REMICADE 4
weeks after the initial dose. Ten of twenty-nine (34%) patients experienced a response 4 weeks
after receiving the second dose.

[Birgit.Tersteegen]

Sieht doch bisher so aus,als seien wir auf der richtigen Spur.Dass versucht wird den Kurs zu drücken mit allen Mitteln,scheint bei der Konkurrenz die durch die Wiedereinführung von TY für andere Präparate entstehen würde,sehr verständlich...

[Cyberhexe]

da wird es für Remicade wohl zukünftig eine Alternative geben, die ein Nebenwirkungsprofil im Plazebobereich hat. Alle primären und sekundären Ziele wurden in ENCORE erreicht, also die erhoffte Wirksamkeit konnte nachgewiesen werden.
Jetzt bleibt letztlich nur noch das PML-Risiko. Falls der nachweis gelingen sollte, dass das Risiko in der Monotherapie verschwindend klein sein sollte, dann sind die Aussichten wirklich hervorragend.


In addition, ENCORE met all of its secondary endpoints including clinical remission at both weeks 8 and 12. Clinical remission was defined as achieving a CDAI score of equal to or less than 150 at both weeks 8 and 12.
There were no notable differences in the overall rates of adverse events or serious adverse events between the TYSABRI and placebo treatment groups. The most common adverse events seen in the trial were headache, nausea, abdominal pain and nasopharyngitis.

[Cyberhexe]

pinvestment hat folgendes im ymb geschrieben:

while patients on remicade have about a 1% death rate and a 5% serious adverse events rate
do you think JNJ can let ty get to market and absolutely gut their drug - just something to think about

Man bedenke, dass in der Monotherapie bei Tysabri bisher keine PML-Fälle aufgetreten sind...und schwerwiegende Nebenwirkungen gab es bisher ledoglich im Plazebobereich

[[KERN]Codex]

With Reports of Death, FDA Warns Multiple Sclerosis (MS) Patients Against Pharmaceutical Drug Tysabri


Campaign Launched to Rally Multiple Sclerosis Patients in Potential Class Action Lawsuit Against the Manufacturer of Pharmaceutical Drugs Tysabri and Avonex

WILMINGTON, N.C., June 30, 2005 /PRNewswire/ -- Greg Jones and Associates, a North Carolina-based law firm, in association with

www.lawyersandsettlements.com, launches a marketing campaign to increase awareness of the Multiple Sclerosis drug, Tysabri. Makers of Tysabri, Biogen Idec Inc. and Elan Pharmaceuticals Inc., have recently taken the drug off the market and sent out warnings to doctors.
In November 2004, Biogen Idec and Elan Corporation received approval from the FDA to market and distribute Tysabri (natalizumab). Only four months later, February 2005, the drug was quickly removed from the market after the FDA received several reports of severe illness and death in patients prescribed Tysabri and Avonex. In several cases, the patient or corpse was diagnosed with Progressive Multifocal Leukoencephalopathy (PML), a rare brain infection that directly affects the central nervous system. Symptoms of PML are similar to a stroke: headaches, memory loss, speech and vision difficulties, limb weakness, and partial paralysis; the disease leads to coma then to death.

To date, approximately 3,000 patients have been involved in clinical trials or prescribed Tysabri for multiple sclerosis, Crohn`s disease and rheumatoid arthritis. Biogen Idec and Elan Pharmaceuticals hope to redistribute the drug after extensive evaluations of Tysabri and the possible link to PML.

Biogen merged with IDEC Pharmaceuticals in 2003, creating the billion- dollar company, Biogen Idec, which is based in Cambridge, Massachusetts. Biogen Idec also has another MS drug in the news: the bread-winning drug, Avonex, the most widely prescribed Multiple Sclerosis drug in the world with revenues of $1.4 billion in 2004 has recently been linked to increased risk of liver damage and liver failure.

Greg Jones and Associates is urging patients that have had adverse side effects with the prescription drugs Tysabri or Avonex, to have their case reviewed at www.lawyersandsettlements.com; each case will be evaluated by a lawyer at no charge.

For more details about this product recall and potential class action lawsuit, visit https://www.lawyersandsettlements.com/case/tysabri .

About Online Legal Services Ltd (OLS) and www.lawyersandsettlements.com

OLS is a privately held Internet marketing company that specializes in joint advertising campaigns for lawyers and law firms. Lawyersandsettlements.com offers a comprehensive website with up-to-date information on legal news, class action lawsuits, personal injury cases, settlement details, product recalls, and more. Consumers can complete free case evaluations and subscribe to free newsletters.

Visit us at: http://www.lawyersandsettlements.com/

Contact us at:
604-608-3435

About www.lawyersandsettlements.com

About Online Legal Services Ltd (OLS) and www.lawyersandsettlements.com OLS is a privately held internet marketing company that specializes in joint advertising campaigns for lawyers and law firms. Lawyersandsettlements.com offers a comprehensive website with up-to-date information on legal news, class action lawsuits, personal injury cases, settlement details, product recalls, and more. Consumers can complete free case evaluations and subscribe to free newsletters.

This press release has been submitted on behalf of http://24-7pressrelease.com .

CONTACT: Tracy Laxdal, Marketing Manager of Lawyersandsettlements.com,[phone], or [e-mail]

Web site: http://www.Lawyersandsettlements.com/



http://www.pharmalive.com/news/index.cfm?articleID=252757&ca…

[[KERN]Codex]

TYSABRI Phase III Induction Trial in Crohn`s Disease Meets Primary Endpoint; TYSABRI Induced Statistically Significant Response and Remission in Patients with Active Disease


- Study Showed Reduction in Signs and Symptoms of Crohn`s Disease; Ongoing Safety Evaluation Remains on Track

DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun 30, 2005--Elan Corporation, plc and Biogen Idec announced today that ENCORE, the second Phase III induction trial of TYSABRI(R) (natalizumab) for the treatment of moderately to severely active Crohn`s disease (CD) in patients with evidence of active inflammation, met the primary endpoint of clinical response as defined by a 70 point decrease in baseline Crohn`s Disease Activity Index (CDAI) score at both weeks 8 and 12.

In addition, ENCORE met all of its secondary endpoints including clinical remission at both weeks 8 and 12. Clinical remission was defined as achieving a CDAI score of equal to or less than 150 at both weeks 8 and 12.

There were no notable differences in the overall rates of adverse events or serious adverse events between the TYSABRI and placebo treatment groups. The most common adverse events seen in the trial were headache, nausea, abdominal pain and nasopharyngitis.

On February 28, 2005, Elan Corporation, plc and Biogen Idec announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials. This decision was based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. Elan and Biogen Idec`s comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. At the time of the dosing suspension, all ENCORE study patients had completed dosing based on the study protocol and collection and analysis of data followed.

The full data from ENCORE, including further sub-analysis of response and remission rates as well as clinical effect at other time points, effect on inflammatory markers and quality of life data will be presented at an upcoming medical meeting.

"The results of the ENCORE study are encouraging because patients treated with TYSABRI achieved a significant improvement in symptoms of this devastating, chronic immune disease," said Lars Ekman, MD, executive vice president and president, Research and Development, Elan. "Patient safety remains our top priority. We plan to share the data from ENCORE and our other Phase III TYSABRI Crohn`s studies with the FDA and other regulatory agencies to determine the appropriate path forward for TYSABRI as a potential new treatment option for this underserved patient population."

"These data provide further evidence of the benefit of TYSABRI in treating immune-mediated diseases. We are committed to a thorough safety evaluation so we can better define the benefit-risk profile of TYSABRI. We hope to have findings from the evaluation by the end of the summer," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.

The ENCORE Study

ENCORE was a Phase III, international, double-blind, placebo-controlled study of 510 patients at 114 sites to evaluate the safety and efficacy of intravenous TYSABRI in patients with moderately to severely active Crohn`s disease (based on a confirmed diagnosis of CD and a CDAI score of greater than or equal to 220 and less than or equal to 450) and evidence of active inflammation (as evidenced by elevated C-reactive protein (CRP) levels of CRP greater than 2.87 mg/l, the upper limit of normal). Patients were randomized 1:1 to treatment with TYSABRI (300mg) or placebo infusions at weeks 0, 4, and 8. Efficacy and safety assessments were performed at weeks 4, 8 and 12, and the study remains ongoing for safety follow-up.

About TYSABRI

Elan and Biogen Idec are collaborating equally on the development of TYSABRI in MS, Crohn`s disease, and rheumatoid arthritis. On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials. Worldwide regulatory agencies are being kept informed of developments related to TYSABRI.

About Crohn`s Disease

Approximately one million people worldwide have Crohn`s disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women. The disease usually causes diarrhea and crampy abdominal pain, often fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), malnutrition and decreased growth rate in children.

About Elan

Elan Corporation (NYSE: ELN), plc 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 innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

About Biogen Idec

Biogen Idec (NASDAQ: BIIB) 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 http://www.biogenidec.com.

Safe Harbor/Forward Looking Statements

This press release contains forward-looking statements regarding the potential for TYSABRI. These statements are based on the companies` current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. There is no assurance, for example, that all experiences with TYSABRI will be the same or that the potential for TYSABRI will not be affected by unexpected new data or technical issues. The is no assurance that PML is not caused by TYSABRI, that there are not or will not be more PML cases or other serious adverse events associated with TYSABRI or that we will be able to gain sufficient information to fully understand the risks associated with TYSABRI. There is also no assurance that the companies will be able to resume marketing and sales of TYSABRI in any indication. For more detailed information on the risks and uncertainties associated with TYSABRI and the companies` drug development and other activities, see the periodic and other reports of Biogen Idec Inc. and Elan Corporation, plc filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Media Contacts: Elan Davia B. Temin or Brian McGlynn, 212-407-5740 Jim Milton, 353-1-498-0300 or Biogen Idec Amy Brockelman, 617-914-6524 or Investor Contacts: Elan Emer Reynolds, 353-1-709-4000 800-252-3526 or Biogen Idec Oscar Velastegui, 617-679-2812


http://www.pharmalive.com/news/index.cfm?articleID=252723&ca…

[Cyberhexe]

die Berichterstattung über Tysabri und dessen Marktchancen ist nun sogar bei Jeffrey Krasner wieder moderater...gegenüber der vergangenen Schwarzmalerei und den falschen Interpretationen - um nicht von Lügen zu sprechen- liest sich der heute veröffentlichte Artikel viel freundlicher.

Tysabri shows promise in Crohn`s trial
Biogen Idec: Test suggests besieged drug can be used for ills beyond MS
By Jeffrey Krasner, Globe Staff | July 1, 2005

Biogen Idec Inc. of Cambridge and Elan Corp. of Ireland yesterday said a late-stage trial of their drug Tysabri showed that it was safe and effective against Crohn`s disease, a chronic inflammation of the bowel.

News Alerts The release of part of the trial results underscores the potential effectiveness of Tysabri in autoimmune diseases beyond multiple sclerosis, the condition for which it was approved in November by the Food and Drug Administration. But it doesn`t remove the uncertainty about the drug`s prospects.

The companies voluntarily suspended sales and trials of the drug in February after a multiple sclerosis patient in a long-term trial of Tysabri died of a rare brain disease and another patient was suspected of having the condition. The second case was later confirmed, though that patient survived, and a third patient who took Tysabri in a trial for Crohn`s disease was posthumously diagnosed as having died of the disease.

In the latest Crohn`s trial, a statistically significant number of patients who had active inflammation showed improvement in their Crohn`s symptoms after taking Tysabri for periods of eight and 12 weeks. Detailed results will be released later.

``The results announced today reinforce the benefit of Tysabri in chronic immune diseases," said Amy Brockelman, a Biogen Idec spokeswoman. ``That`s why we`re committed to a thorough safety evaluation so we can better define the benefit-risk profile of Tysabri and determine the path forward." Biogen Idec and Elan have applied for approval to sell Tysabri to treat Crohn`s disease in Europe, but haven`t yet sought approval from US regulators.

The companies are conducting a detailed safety review of Tysabri and plan to meet with regulators by the end of the summer. It is unclear whether regulators will permit Tysabri to return to the market. The drug, which had been expected to generate more than $1 billion in annual revenue, is crucial to Biogen Idec`s continued growth and Elan`s survival.

[Birgit.Tersteegen]

wirklich schade,dass man/frau nicht hinter die Kulissen schauen kann;meiner Ansicht nach müsste der Kurs mittlerweile
schon ganz woanders stehen! ....Irgend jemand drückt!

[invest2002]

na da war doch gewaltiges kaufinteresse in usa bei fast 9 mio umsatz

invest2002

[francisvincent]

Liebe Leute,

Das einzige was zählt ist, ob Tysabri wieder zugelassen
wird,in welcher Form auch immer.Da muss man sich bis
zum Spätsommer gedulden.Entweder geht die Aktie dann
ab wie eine Rakete oder es gibt ein Desaster.Dazwischen
gibt es nichts.

[Birgit.Tersteegen]

Genau:Sekt oder Sekt--ist doch eigentlich einfach,oder???

[moneyseeker]

Hallo Birgit,

eine kleine Frage:

kommt bei Dir zuerst der Text und dann der (tolle) Smilie oder anders`rum ?

Gruß

[Birgit.Tersteegen]

Ehrlich gesagt,mal so-mal so!!

[bernie55]

...mal eine nicht " elanmäßige " Frage ..

..auf welcher Webseite findest du denn deine " laufenden Bilderchen " ??

Grüße bernie

[eliasesteban]

www.mainzelahr.de,www.my-smileys.de

[Birgit.Tersteegen]

sind doch nett,oder? www.cheesebuerger.de

[Gndlf]

vom yahoo-board geklaut:
xxxxxxxxxxxxxxxxxxxxxxxx

by: pinvestment 07/05/05 09:24 am
Msg: 707143 of 707143

my previous post described why people quit beta inf and copaxone - namely side effects and lack of efficacy - and from the affirm trial and crohns trials we know that ty monotherapy efficacy is fantastic while the side effects are not indistinguishable form placebo treated patients - so ty is far superior in terms of efficacy and side effects - the last step in the FDA move to put tysabri back on the market is risk tolerance by the FDA

hhttp://www.yellowcard.gov.uk/daps.html

use think link and search the UK drug safety data from infliximab - it is really quite stunning - that data and the data I posted last week from a mayo clinic studies of infliximab (remicade) show that the risk of death on remicade is about 1% in US stuides and much higher in the UK and the UK data includes 4 cases of paralysis (possible PML)

and then remember that I found an avonex SAE report form canada that described a woman that died from meningitis and encephalitis while taking avonex - probably just the tip of the iceberg in previously overlooked PML cases on beta interferon alone - this is important because it shows that beta inf can be the risk factor for avonex - not only ty used in combination

but with no immune suppression in ty mono seen in immune competent patients in phase II`s , affirm one and two year nad nothing in the post-marketing / medwatch FDA database means that almost no risk of PML from ty mono use

so put the efficacy and side effects of tysabri mono together with the current FDA risk tolerance for remicade (very high) , liklihood that no PML from ty mono, and the fact that 25-40% of patients on beta inf and copax quit

so what you get is a an easy slam dunk for the FDA to put tysabri mono back on the market and then because of the high level of severe side effects of beta inf and copax coupled with the low efficacy levels shows you that ty mono can just eat up the MS market and do the same in crohns because its side effects are much better than remicade

it looks, sounds , and smells like a blockbuster - will only take a little bit of time

[Cyberhexe]

anbei eine aktuelle Einschätzung von NCB Stockbrokers, einem irischen Analystenhaus
Die Studie hat insgesamt 29 Seiten, anbei erst einmal die Zusammenfassung. Alles zu PML sind eigentlich bekannte Fakten, aber dennoch gut zu wissen, dass diese mittlerweile auch bei den Analysten angekommen sind.


5.7.2005
Elan Corporation Buy
(unchanged)

Does AVONEX lead to TYSABRI “overdosing”?
• We have reviewed the data available in Tysabri’s Biological License Application (BLA) in an attempt
to understand why PML developed in two multiple sclerosis patients on Tysabri and AVONEX
combination treatment. This analysis revealed that after a relatively short period of combination
treatment that AVONEX had a significant effect on the accumulation, clearance and half-life of
Tysabri and essentially leads to almost double the intended Tysabri concentration after only 20
weeks of treatment. Patients on Tysabri alone did not accumulate the drug. This suggests to us that
over a sustained period of Tysabri and AVONEX treatment, the trends of accumulation and reduced
clearance of Tysabri leads to an “overdosing” of patients with Tysabri.
• Given Tysabri’s mechanism of action, we suggest a possible explanation for the occurrence of PML
in patients on combination treatment. The absence of confirmed cases in the monotherapy group
(without a complicating factor) gives us comfort in our thesis.
• We believe that the potential oversuppression of the immune system in patients on Tysabri and
AVONEX combination treatment will form a central plank of the case made to the FDA for the relaunch
of Tysabri (as a monotherapy). The efficacy of Tysabri in treating multiple sclerosis is
undeniable and we continue to believe that Tysabri will return to the market as a significant therapy.
We are assuming a re-launch in 2006 with the product achieving 10% market penetration in the
multiple sclerosis market in the US and in Europe by 2009. This level of market penetration can
support a revenue potential of c.$1bn for use in multiple sclerosis alone implying a sum-of-the-parts
value of $9.74-$11.95. At the current price of $6.77 (€5.44), the stock is trading 44% below the
bottom of our SOTP range. The stock remains high risk and speculative. We maintain our Buy
recommendation.

[Cyberhexe]

das ist ja wirklich lustig...
NCB Stockbrokers schätzt den Marktanteil von Tysabri auf 10% im Jahr 2009 (im Bericht auf Seite 20 "Valuation"):

We are assuming a re-launch in 2006 with the product achieving 10% market penetration in the multiple sclerosis market in the US and in Europe by 2009

Wenn man bedenkt, dass 25-30% der MS-Patienten derzeit nicht in Therapie sind, also keine Medikamente nehmen, da die CRABs nicht die erhoffte Wirkung gebracht haben, dann halte ich eine derartige Prognose (10% Marktanteil für das nachgewiesen wirksamste Medikament) für mehr als lächerlich.
Wobei, man bedenke, 10% von 1.5 Mio Erkrankten (USA+EU) sind immer noch 150.000 Patienten. Und bei 23500$/Jahr/Patient wären dies auch immerhin über 3 Milliarden $ Umsatz.
Davon 85% Gross profit, davon wiederum die Hälfte für Elan ergibt einen Deckungsbeitrag (Gewinn aus Tysabri) jenseits der Milliarden$-Grenze...und 10% für 2009 sind wirklich sehr konservativ. Und in dieser Rechnung sind die MC-Patienten gar nicht berücksichtigt.

[Cyberhexe]

da hat Davy Stockbroker ja still und heimlich (für mich jedenfalls) deren Kursziel für Elan erhöht --> price Target 870 cent. Letzte Woche lag dies noch bei 650 cent.
Ansonsten wird festgestellt, dass der Absatz an MS-Medikamenten insgesamt zugenommen hat und das Nichtinterferon Copaxone den grössten Marktanteil hat, nämlich 32.5%


Elan (ELN US)
Prescriptions in MS market show strong growth in 2005
Previous close: 682c Price target: 870c Analyst: [e-mail]
Our prescription tracker (from IMS data) provides some interesting insights into recent trends in the MS market in the US. We
track the weekly movements of the four main treatments for MS currently on the market: Copaxone, Avonex, Rebif and
Betaseron.
Weekly total prescriptions (TRx) have grown strongly in 2005. The four-week moving average is up 11% year to date, and
would suggest an increased take-up of MS treatments, most notably since the start of March.
The latest (June) figures for TRx show that non-interferon Copaxone has the strongest market share, at 32.5%.
Of the three interferon treatments, Avonex has the largest market share.
Across TRx and, more markedly, in new weekly prescriptions (NRx), Avonex’s market share of new prescriptions has suffered
since Tysabri`s withdrawal in February. Rebif looks to have been the main beneficiary.
It still looks like late-summer at best before the next material newsflow on Tysabri’s timeline.

[Cyberhexe]

und wieder eine überaus positive Nachricht:

Par Pharmaceutical Announces FDA Approval of Megace(R) ES for Anorexia, Cachexia, or an Unexplained, Significant Weight Loss in Patients With a Diagnosis of AIDS
.....
Megace ES utilizes Elan`s NanoCrystal® Technology delivery system* to improve the rate of dissolution and bioavailability of the original megestrol acetate oral suspension.

Das wird die Lizenzzahlungen weiter steigen lassen.
Elan wird sich zu einer "cash cow" entwickeln!


http://biz.yahoo.com/prnews/050706/nyw060.html?.v=16

[Birgit.Tersteegen]

Je näher der mögliche Zulassungstermin, desto höher werden die Kursziele...Uns soll´s recht sein!

[Cyberhexe]

Die Umsätze zu Megace sind bei Par Pharmaceutical dramatisch eingebrochen; im letzten Quartal von 18.7 Mio$ (Q104) auf 8.6 Mio$ (Q105). Mit der neuen Formulierung wird der Marktanteil sehr wahrscheinlich wieder steigen und dementsprechend auch die Umsätze. Falls pro Quartal 20 Mio$ umgesetzt würden, könnte Elan immerhin pro Quartal zusätzlich ca. 1 Mio$ an Lizenzzahlungen verbuchen. Ist zwar nicht die Welt, aber Kleinvieh macht auch Mist, zumal damit keine Kosten verbunden sind und 100% in den Deckungsbeitrag fliessen.

For the first quarter, sales of paroxetine hydrochloride (HCl).... Sales of megestrol acetate oral suspension, the generic form of Megace®, were $8.6 million and sales of fluoxetine, the generic version of Prozac®, were $6.1 million in the quarter. This is compared, respectively, with sales of $18.7 million and $14.9 million in the same period a year ago. The lower sales of these three products reflect the impact of increased generic competition and its corresponding effect on pricing and market share.

[bernie55]

6,95 Dollar vorbörslich....

[bernie55]

6,99 ......

[Cyberhexe]

Elans Vereinbarungen mit der patentierten NanoChrystal® Technology mit fast allen Platzhirschen lesen sich fast schon wie das "who is who" in der Pharmabranche. Mittelfristig könnte das ein Riesengeschäft werden.

http://www.elan.com/EDT/Announcements/

[Cyberhexe]

anbei eine Aufstellung von den Produkten, die mit Elans NanoChrystal Technology bereits vermarktet werden

Avinza® - once-daily, novel dual release morphine sulphate (Ligand Pharma)
Cardizem® SR – twice-daily, sustained-release diltiazem (Biovail Pharma)
Cardizem® CD – once-daily, sustained-release diltiazem (Biovail Pharma)
Emend® – oral table form of aprepitant, a poorly water soluble compound (Merck)
Focalin XR(TM) - extended-release capsules for (ADHD) (Novartis)
Megace ES - oral suspension for the treatment of anorexia, cachexia and weight loss (Par Pharma)
Naprelan® - once-daily, sustained-release naproxen sodium (Wyeth-Ayerst Lab)
Rapamune® - oral tablet form of poorly water soluble compound (Wyeth-Ayerst Lab)
Ritalin® LA – once-daily, pulsatile release of methylphenidate (Novartis)
Theo-Dur® - twice-daily, sustained-release theophylline (Schering)
TriCor – (Abbott Lab)
Verelan® - once-daily, sustained-release verapamil (Schwarz Pharma)
Verelan® PM – modified release, chronotherapeutic verapamil (Schwarz Pharma)

zusätzlich existieren Abkommen mit weiteren Grössen der Branche:

Aventis Pharma S.A., a subsidiary of Aventis S.A.
Bristol-Myers Squibb Company (NYSE: BMY)
Janssen Pharmaceutica N.V. (Janssen)
Johnson & Johnson – Paliperidone Palmitate P3
Roche

Da dürfte zukünftig noch einiges zu erwarten sein, da mit neuen Formulierungen und Spezialitäten die Möglichkeit besteht, sich von den Nachahmern fernzuhalten!

[Cyberhexe]

NCB -irisches Analystenhaus schreibt am 7.7.05
dass Elan für die Zulassung von Megace ES eine einmalige Zahlung sowie eine Umsatzvergütung im mittleren einstellige Prozentbereich geben wird - ich habe meiner Modellrechnung von gestern 5% angenommen; dies würde der Vermutung von NCB entsprechen. Wenn der Umsatz pro Quartal 20Mio$ betragen würde, wären dies 1Mio$ Lizenzengebühr/Quartal. Allerdings könnten die Umsätze durch die verbesserten Produkteigenschaften sowie die günstigere Darreichungsform (wässrig anstatt viskos) besser ausfallen als erwartet.
Für 2005 werden Lizenzzahlungen in Höhe von 186Mio$ erwartet.Tendenz stark steigend....das könnte eine cash cow werden


Elan $7.12 BUY Approval of product using NanoCrystal technology
• Par Pharmaceutical`s yesterday announced the approval of Megace ES, a new
formulation of a drug used in the treatment of anorexia and weight loss associated with
AIDs. The product utilizes Elan`s nanocrystal drug delivery technology. We expect Elan
to receive a milestone payment from Par on the approval and a mid-single digit royalty
from sales of Megace ES.
• Elan have a strong pipeline of products licensing the nanocrystal technology which are
expected to sustain growth momentum in the drug delivery business. The royalty
revenue from nanocrystal is recorded under contract manufacturing revenue. We are
forecasting $186m of contract revenue in 2005, a 42% increase y-o-y.

[Cyberhexe]

gefunden auf Bloomberg...

...die wahrscheinlich richtige Erklärung der PML-Erkrankung in der Kombitherapie (Ty+Avonex):

Durch das Interferon (Avonex) wird die Eliminationshalbwertszeit von Natalizumab erhöht, wodurch dessen Konzentration von Infusion zu Infusion ansteigt. Dies wiederum führt über die Zeit zu einer vollständigen Absättigung der Rezeptoren an den T-Zellen mit Natalizumab, so dass keine T-Zellen die Blut-Hirnschranke passieren können. Dieser Zustand erst ermöglicht eine Aktivität des JC-Virus im Nervengewebe.
Ohne Interferone erfolgt keine Akkumulation von natalizumab, so dass immer noch genügend T-Zellen die Blut-Hirnschranke durchqueren um die Aktivität des Virus unter Kontrolle zu halten.



http://www.bloomberg.com/apps/news?pid=10000102&sid=axINd0.X…


Elan`s Tysabri Link to Death May Be From `Overdosing` (Update5)
July 6 (Bloomberg) -- Elan Corp. and Biogen Idec Inc.`s multiple sclerosis drug Tysabri may have killed patients because interaction with another Biogen product, Avonex, led to a build- up and overdose of the medicine, an NCB Stockbrokers analyst said.

An interaction of Tysabri, recalled Feb. 28, and Avonex, an older MS drug sold by Biogen ``essentially leads to almost double the intended Tysabri concentration after only 20 weeks,`` NCB analyst Orla Hartford said today in a note to investors. ``Patients on Tysabri alone did not accumulate the drug.``

The effect Avonex has on Tysabri will likely ``form a central part of the case made to the FDA for Tysabri`s relaunch,`` she said. Hartford, who analyzed data submitted to the U.S. Food and Drug Administration during the approval process, expects the treatment to be reintroduced in 2006.

``Elan`s continuing with the review, which is on track, and will comment when it has been completed,`` Elizabeth Headon, a spokeswoman for Elan at Murray Consultants said in an interview.

Tysabri was withdrawn after being linked to progressive multifocal leukoencephalopathy, a rare neurological disease, in two patients, both of whom were taking a combination of the two drugs. Elan and Biogen Idec are reviewing medical records of patients who have taken the drug, and have said they expect to complete the review at the end of June or July. The companies will meet with the FDA to determine whether the drug can be sold again.

``The efficacy of Tysabri in treating multiple sclerosis is undeniable and we continue to believe that Tysabri will return to the market as a significant therapy,`` Hartford said.

Elan shares rose 42 cents, or 7.5 percent, to 6 euros at the close of trading in Dublin. They`ve dropped 69 percent since the start of the year.

Tysabri is the cornerstone of Elan Chief Executive Kelly Martin`s plan to reach profitability and repay debt due in 2008 and 2011. He said in May he`s confident the drug will return to the market.

Hartford said that over a sustained period of time, Tysabri accumulated in the system partially because the body is less able to process it, which leads to an ``overdosing,`` she said.

The Tysabri accumulation may have led to a suppressed local immune system in the brain and may have been a key pre-disposing factor in the two-cases of PML seen in combination therapy, Hartford said.

A third patient, identified in March, wasn`t taking Avonex, but was on azathioprine, another immunosuppressive drug. Other possible cases have been reported to the FDA. They haven`t been confirmed.

Hartford said a combination of Tysabri with any other immunosuppressive drug may ``have to be avoided.``

[Poppholz]

Elan Announces Webcast of Second Quarter 2005 Financial Results
Thursday July 14, 9:00 am ET


DUBLIN, Ireland--(BUSINESS WIRE)--July 14, 2005--Elan Corporation, plc announced today that it will host a conference call on Thursday, July 28, 2005 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 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.

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.

About Elan

Elan Corporation (NYSE: ELN - News), plc 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 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.

[Poppholz]

Kurs in USA

$ 7,30

[Poppholz]

Kurs USA

$ 7,43

Bei uns noch relativ ruhig, mal sehen wie lange noch

[Poppholz]

und hier sind die News:

Two-Year Sentinel Data Evaluating TYSABRI(R) in Addition to AVONEX(R) Reinforce Efficacy in Multiple Sclerosis
Monday July 18, 4:16 pm ET


CAMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--July 18, 2005--
Compared to AVONEX Alone, Data Show 24% Reduction in the Risk of
Disability Progression and Sustained 56% Reduction in Relapse
Rate

Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that SENTINEL, the Phase III TYSABRI® (natalizumab) add-on trial with AVONEX® (Interferon beta-1a), achieved the two-year primary endpoint of slowing the progression of disability in patients with relapsing forms of multiple sclerosis (MS). The addition of TYSABRI to AVONEX resulted in a 24 percent reduction in the risk of disability progression compared to the effect provided by AVONEX alone. Data from SENTINEL also demonstrated that the addition of TYSABRI to AVONEX led to a 56 percent relative reduction in the rate of clinical relapses compared to that provided by AVONEX alone. The reduction in relapse rate was statistically significant and sustained over the entire two-year study period.

Other efficacy data from SENTINEL at two years, including MRI measures and immunogenicity, were similar to previously reported one-year results.

Common adverse events included headache, nasopharyngitis, limb pain, depression, flu-like symptoms, diarrhea, insomnia, sinusitis, influenza, nausea, muscle pain, anxiety and cough. The rate of infection was 1.6 per patient-year in both AVONEX plus TYSABRI-treated patients and AVONEX plus placebo-treated patients. Serious infections occurred in 2.9 percent of AVONEX plus placebo-treated patients and 2.7 percent of AVONEX plus TYSABRI-treated patients. TYSABRI has been associated with hypersensitivity reactions, including serious systemic reactions which occurred at an incidence of less than 1 percent of patients.

On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system. The companies have previously reported three confirmed cases of PML, two of which were fatal. Two of the patients with confirmed PML had received AVONEX plus TYSABRI for over two years as part of the SENTINEL trial. Biogen Idec and Elan`s comprehensive safety evaluation concerning TYSABRI and any possible link to PML is ongoing. The results of this safety evaluation will be discussed with regulatory agencies to determine the appropriate path forward for TYSABRI.

"These data demonstrate the effect of TYSABRI on disability progression and clinical relapses. We continue to believe in the therapeutic benefit of TYSABRI in MS, a disease with significant unmet medical need," said Burt Adelman, MD, executive vice president, Development, Biogen Idec. "Our extensive safety evaluation, in collaboration with leading experts and regulatory agencies, is on track and we hope to have findings by the end of the summer. As always, our primary commitment is to improving the lives of people with MS."

"TYSABRI continues to show benefit in the treatment of immune-mediated diseases," said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan. "Patient safety is our top priority. We remain strongly committed to defining TYSABRI`s benefit-risk profile and determining the appropriate path forward."

SENTINEL is a two-year, randomized, multi-center, placebo-controlled, double-blind study of 1,171 AVONEX-treated patients in 123 clinical trial sites worldwide. In the trial, AVONEX-treated patients who continued to experience disease activity were randomized to add TYSABRI (n=589) or placebo (n=582) to their standard regimen.

The companies anticipate that two-year data from SENTINEL will be presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Thessaloniki, Greece, which begins September 28, 2005.

About TYSABRI

Biogen Idec and Elan are collaborating equally on the development of TYSABRI in MS, Crohn`s disease, and rheumatoid arthritis. On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials. Worldwide regulatory agencies are being kept informed of developments related to TYSABRI.

Information about TYSABRI, including the voluntary suspension of marketing and US prescribing information, is available at 1-800-456-2255 and www.TYSABRI.com.

About Multiple Sclerosis

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and more than one million people worldwide. It is a disease that affects more women than men, with onset typically occurring between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

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 http://www.biogenidec.com.

About Elan

Elan Corporation, plc 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 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.


Bei der Meldung habe ich einfach mal den gesamten Text reinkopiert.

Schönen Abend noch

[Cyberhexe]

interessanter link:

http://www.davy.ie/other/email/elancr20050718.pdf

[Cyberhexe]

Davy sagt unter anderem folgendes zur Entwicklung des Geschäftes mit der patentierten Nanotec sowie zu Alzheimer:

...R&D developments: Alzheimers, drug technology division. The phase II
Alzheimers’ studies are ongoing, covering 210 patients in total and of 18-
months duration. Three dosage levels are being investigated, the lowest being
equivalent to the levels generated independently by patients in the AN-1792
trial. The companies (Elan, Wyeth) will take an interim look at the data after 12
months (implying H2 2006).
The drug technology division is doing well at present, evidenced by recent
product approvals using Nanosystems technology (e.g. Megace ES from Par
Pharmaceuticals) and the impressive Q2 out-turn from Abbott’s Tricor drug,
which uses Elan technology in its next-generation product.

[frauholl]

Gute Neuigkeiten!!


--------------------------------------------------------------------------------

E-mail | Comments | E-Mail Newsletters | RSS


AFX News Limited
Elan, Biogen Idec say adding Tysabri to Avonex slows progress, relapses of MS
07.19.2005, 03:53 AM

LONDON (AFX) - Elan Corporation PLC and Biogen Idec said trials have shown that adding Tysabri to Avonex slows the progression of disability in patients with relapsing forms of multiple sclerosis (MS).

The addition of Tysabri to Avonex resulted in a 24 pct reduction in the risk of disability progression compared to the effect provided by Avonex alone, the groups said.

Data from Sentinel also demonstrated that the addition of Tysabri to Avonex led to a 56 pct relative reduction in the rate of clinical relapses compared to that provided by Avonex alone. The groups said the reduction in relapse rate was statistically significant and sustained over the entire two-year study period.

Biogen and Elan also updated on the suspension of Tysabri in February this year from the US market and all ongoing clinical trials, based on reports of progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal, demyelinating disease of the central nervous system.

The companies have previously reported three confirmed cases of PML, two of which were fatal.

Two of the patients with confirmed PML had received Avonex plus Tysabri for over two years as part of the Sentinel trial. Biogen Idec and Elan`s safety evaluation concerning Tysabri and any possible link to PML is ongoing. They said the results of this safety evaluation will be discussed with regulatory agencies to determine the appropriate path forward for Tysabri.

`These data demonstrate the effect of Tysabri on disability progression and

clinical relapses. We continue to believe in the therapeutic benefit of Tysabri

in MS, a disease with significant unmet medical need,` said Burt Adelman, MD,

executive vice president, Development, Biogen Idec.

`Our extensive safety evaluation, in collaboration with leading experts and regulatory agencies, is on track and we hope to have findings by the end of the summer,` he added.

[e-mail]

slm/



COPYRIGHT



Copyright AFX News Limited 2005. All rights reserved

[Cyberhexe]

interessanter Artikel...allerdings nur in english


http://www.techcentralstation.com/072005G.html

Should the FDA Always `Err on the Side of Safety`?
By Henry I. Miller Published 07/20/2005

These are turbulent times for the FDA. The almost daily barrage of negative headlines questioning the safety of marketed drugs is likely depleting regulators` individual stocks of aspirin and antacids. But as they try to soothe their own pain, regulators must not forget their mission -- to ease the plight of patients who need new medicines.

Past criticism of FDA mostly concentrated on what arguably remains the agency`s most important shortcoming: the delays and escalating expense of getting drugs through the development pipeline and into the marketplace. Lately, however, events have shifted the focus to issues of safety. First there were claims that the labeling of certain antidepressants failed to warn doctors that the drugs caused some adolescents to commit suicide. Then the agency was blind-sided by contamination that made half the nation`s flu vaccine supply unavailable. Finally, there were revelations about previously unknown side effects of several widely prescribed anti-inflammatory analgesic drugs.

Regulators` increasing sensitivity to safety concerns may have become contagious: Drug manufacturers, too, seem to have begun to "err on the side of safety" to a degree that causes safe and effective drugs to be taken off the market voluntarily.

Consider Tysabri, only the sixth medication approved -- and the first in several years -- for the treatment of Multiple Sclerosis (MS), a debilitating autoimmune disease that affects the central nervous system. The stunning results of the drug`s testing in clinical trials -- the frequency of clinical relapses was cut by more than half -- induced FDA to grant accelerated approval last fall. MS patients eagerly put their names on waiting lists to get the medicine.

But this ray of hope for MS sufferers was short-lived. By the time that several thousand patients were being treated with Tysabri, three confirmed cases of a rare neurological disorder caused by a virus were reported. (Because the drug suppresses certain aspects of the immune response, regulators, clinicians and the drug`s developers had from the beginning been sensitive to the possibility of infections as a side effect.)

Immediately -- some would say prematurely -- the manufacturers of the medicine voluntarily halted production and distribution and withdrew Tysabri from the market. MS victims and many neurologists were bitterly disappointed. Now they can only hope that a comprehensive review that is under way of all the clinical data -- including the results of new diagnostic tests being conducted on Tysabri recipients -- will permit a return of the drug to the market.

The "safety" of a drug is a relative thing. Safety and efficacy, the two criteria required for marketing approval of a drug, are inextricably linked. Regulators` judgments require a global and often difficult calculation of risk and benefit, including consideration of what alternative therapies are available. We would tolerate greater uncertainty and more severe side effects for a potential cure for pancreatic cancer or AIDS, for example, than for treating heartburn. When FDA grants marketing approval, the drug is deemed to be safe and effective for the conditions on the label.

In the current climate of litigiousness and antipathy to big companies, one can understand the haste to withdraw Tysabri voluntarily from the market. What is also understandable (and lamentable) is the chattering classes` hyping of the drug`s health concerns and of the stock market impacts of the withdrawal, while ignoring that real people who were able to lead more normal lives with Tysabri are now prevented from obtaining it.

Another casualty of the withdrawal is the ability of patients, after consultation with their health care providers, to make informed decisions about possible treatment options. That fundamental right should not be usurped by risk-averse, publicity-shy bureaucrats, anti-FDA healthcare activists, or members of Congress.

As more breakthrough drugs come before FDA for approval, the agency must curb its paternalistic instincts and find a way to balance more sensibly the assurance of safety with patients` right to assume responsibility for their own medical decisions. This would be a sea change for FDA, which in many areas -- "off-label" prescribing, and dissemination of new information about drug therapy, among others -- has sought repeatedly to limit the discretion of physicians and patients to make treatment decisions.

To this point, FDA has been even-handed in its treatment of Tysabri. The clinical data justified the accelerated approval; the ongoing analysis of safety data is a responsible action; and if the data support it, FDA should work with Tysabri`s producers to move rapidly toward reintroduction of the drug. Labeling restrictions, such as a prominent "black box" warning or strict limitations on which patients can receive a drug, are "risk-management" options within FDA`s purview. In any case, the agency`s actions must be driven by the data.

The notion that FDA should "err on the side of safety" must be qualified for patients with incurable or poorly treatable diseases: For them, there is no safety in the status quo, and we only damage them further with paternalistic public policy that prevents individuals from exercising their own judgment about risks and benefits. If FDA must err, it should be on the side of patients` freedom to choose.

[Cyberhexe]

wann gehts los??

....bin gespannt, was Biogen nach Börsenschluss zu berichten hat. Auch die Tatsache, dass Elan erst in 2 Tagen das Quartalsergebnis bekannt gibt, ist neu. Normalerweise haben die beiden Firmen immer zum selben Zeitpunkt (also Biogen nach Börsenschluss und Elan vor Börsenöffnung am folgenden Tag) berichtet. Es scheint mir, als wolle Elan eine zusätzliche Möglichkeit nutzen, auf sich aufmerksam zu machen.

Jungs und Mädels...ich würde mich schon mal anschnallen...denn in den nächsten 8 Wochen rechne ich mit signifikanten Kursbewegungen...es könnte morgen schon losgehen! Die Richtung scheint für mich klar.

good luck
ch

anbei Davys Analystenkommentar von heute...jedoch nichts Besonderes:


Elan (ELN ID)
Biogen Idec to report Q2 results this evening
Previous close: 785c Price target: 870c Analyst: [e-mail]
Biogen Idec is scheduled to report its Q2 results and hold a conference call after close of US trading this evening. Consensus
estimates call for EPS (pre-exceptionals) of 36c, up from 34c last year.
Of interest to Elan investors will be BIIB`s comments regarding Tysabri timelines (we expect existing timelines to be reiterated)
and whether Avonex has lost revenue market share in the global MS market during the quarter.
Elan reports its own Q2 results on the morning of July 28th.

[Poppholz]

Die Info, dass Elan die Zahlen für das zweite Quartal bekannt gibt, ist seit dem 14. Juli bekannt.

Elan Announces Webcast of Second Quarter 2005 Financial Results DUBLIN, Ireland--(BUSINESS WIRE)--July 14, 2005--Elan Corporation, plc announced today that it will host a conference call on Thursday, July 28, 2005 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 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.
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.

[bernie55]

.....Jungs und Mädels...ich würde mich schon mal anschnallen

tja, was soll ich dazu sagen ..... ich bin schon die ganze Zeit fest angeschnallt....

Grüße, bernie55



PS:...schön, dass du wieder im Lande bist....da kannst du mit allen anderen " Elannies " schon in einigen Tagen vielleicht gemeinsam feiern....

..und ich mit euch vor meinem Urlaub.....

[[KERN]Codex]

Hab mich fest angeschnallt

[Poppholz]

Hier noch die Einschätzung eines Analysten zu den bevorstehenden Zahlen:

BOSTON (MarketWatch) -- Health-care conglomerate Bristol-Myers Squibb will be unveiling its quarterly earnings next week, along with high-profile biotechnology players Biogen Idec, Chiron and Elan.

Biogen Idec rolling out July 26
Biogen Idec (BIIB: news, chart, profile) will be rolling out their quarterly earnings on Tuesday. The biotechnology giant has been under considerable pressure since it and partner Elan (ELN: news, chart, profile) recalled their multiple-sclerosis drug, Tysabri, from the market last winter after it was suspected of triggering a rare but deadly brain infection.
A poll of analysts by Thomson First Call estimates Biogen report net income of 36 cents a share, on revenue of $599 million, compared with 34 cents last year.
Investors on the company`s quarterly conference call will be keenly listening for any update on its ongoing safety review of Tysabri, which Biogen has said should be completed by the end of the summer.
Biogen and Elan have been combing through the medical records of more than 3,000 former Tysabri users to see if they have been stricken with a brain infection known as progressive multifocal leukoencephalopathy, or PML.
After the review is completed, the companies plan to consult with the U.S. Food and Drug Administration as to the advisability of putting Tysabri back on the market.

Bristol-Myers, Elan and Millennium weigh in July 28
Industry heavyweight Bristol-Myers Squibb (BMY: news, chart, profile) will unveil its results on Thursday morning.
A poll of analysts by Thomson First Call forecasts Bristol-Myers will show significantly lowered earnings of 36 cents a share, on lowered revenue of $4.8 billion. The company posted a profit of 46 cents a share last year.
Bristol-Myers` top line has been dragged down lately by generic competition for many of its best-selling drugs.
Earlier this month, Bristol-Myers announced it was selling its consumer-drug division -- which markets such popular products as Excedrin, Bufferin and Comtrex--- to Novartis for $660 million.
According to analysts, Bristol-Myers watchers will be hoping for an update on the company`s ongoing battle to protect its best-selling drug Plavix from generic competition. They`ll also be looking for clues on Plavix`s growth potential.
Plavix, which is used to prevent blood clots, had sales of $5 billion in 2004, according to IMS Health.
Tysabri co-developer Elan will also be checking in on Thursday.
Wall Street analysts are forecasting the Irish drugmaker will have a loss of 26 cents, on revenue of $123 million, compared with a loss of 30 cents last year.
Tysabri will undoubtedly be paramount on the minds of Elan investors, with any mention of its future prospects likely being a significant mover of the stock.

[bernie55]

Institute for the Study of Aging Receives Generous Donation From Elan Pharmaceuticals to Create a New Alzheimer`s Disease Research Program


NEW YORK CITY, NY -- (MARKET WIRE) -- 07/26/05 -- The Institute for the Study of Aging (ISOA), Ltd., a public charity founded by the Lauder family, is pleased to announce the creation of a new research award program entitled Novel Approaches to Drug Discovery for Alzheimer`s Disease that is being made possible through a donation from Elan Pharmaceuticals, Inc., a neuroscience-based biotechnology company, and funds from ISOA. The goal of this three-year program is to catalyze and fund academic and biotechnology industry scientists worldwide to conduct research leading to the discovery of effective therapies for Alzheimer`s disease.

Approximately 12 scientists will be awarded one-year research grants over the three-year program. ISOA will be the sole administrator of the program supported by a scientific advisory committee. Scientists will be invited to apply through an online application process available at ISOA`s website: www.aging-institute.org. The deadline for the first-year grant submission is October 14, 2005, and funding will be awarded in January 2006.

"We are grateful for Elan`s commitment to advancing the discovery and development of new treatments for Alzheimer`s disease, " remarked ISOA Executive Director Howard Fillit, MD, who will lead this effort. "Their foresight and generosity enables the ISOA to expand its program, fund more scientists, and make an even greater contribution to bridging the global funding gap for drug discovery research that will ultimately improve the lives of millions of people."
"Disease-modifying treatments that can potentially halt or reverse Alzheimer`s disease are essential if we are to address an impending crisis in our society," said Dale Schenk, Chief Scientific Officer, Elan Pharmaceuticals, Inc. "Elan is pleased to work with the ISOA, a leader in accelerating the development of therapies that will eventually make a tremendous difference in the lives of Alzheimer`s patients and their families. Our goal in establishing this important research program is to continue to encourage all efforts to accelerate the development of disease modifying treatments for this devastating disease."
About Alzheimer`s Disease

Over 16 million Americans suffer with Alzheimer`s disease, mild cognitive impairment, and age-related cognitive decline. Alzheimer`s disease alone costs U.S. society over $100 billion annually, making it the third most costly disease after heart disease and cancer. As the baby boomers retire, the number of people with Alzheimer`s disease is expected to increase from 4.8 million to 14 million by 2050. Four drugs are currently in the market that relieve patients of symptoms suffered from Alzheimer`s. No drugs are available to address the underlying degenerative process.

About the Institute for the Study of Aging (ISOA)

The Institute for the Study of Aging (ISOA) is a biomedical venture philanthropy whose sole mission is to accelerate the discovery and development of new drugs to prevent, treat and cure Alzheimer`s disease and related dementias. Since its founding as a private foundation by the Lauder family in 1998, ISOA has awarded $22.7 million for 133 research programs and conferences at leading academic institutions and biotechnology companies worldwide. In 2004, the Lauder family established a public charity, ISOA, Ltd., to enable individuals, foundations and corporations to partner with the Institute in an effort to raise additional funds and award more grants. For more information, visit http://www.aging-institute.org, or call Howard Fillit, MD (Executive Director) or Suzanne Grossberg (Director of Development) at 212 935 2402.

About Elan Pharmaceuticals, Inc.

Elan Pharmaceuticals, Inc. is a wholly owned subsidiary of Elan Corporation, plc (NYSE: ELN). Elan 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 innovations in science to fill significant unmet medical needs that continue to exist around the world. We continue to be dedicated to developing treatment alternatives for patients and caregivers suffering from Alzheimer`s disease. Currently our research programs include four approaches to modifying or halting the progression of the disease. Two of these programs are in collaboration with Wyeth, focused on immunologic approaches to treating the disease. One of the programs that focuses on halting the progression of the disease through humanized monoclonal antibodies is in Phase II clinical trials. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit http://www.elan.com, or call Davia Temin at 212 588 8788.

[[KERN]Codex]

Avonex, Rituxan Power Biogen

By Althea Chang
TheStreet.com Staff Reporter
7/26/2005 6:27 PM EDT


Updated from 5:01 p.m. EDT
Excluding Tysabri expenses and merger-related costs, Biogen Idec (BIIB:Nasdaq - commentary - research) beat Wall Street`s earnings estimates for the latest quarter and reported better-than-expected sales of its top two drugs.

The Cambridge, Mass., biotech company said Tuesday it earned $35 million, or 10 cents a share, in the second quarter.



Before a charge of $20 million, or 4 cents a share, from Tysabri inventories written off during the quarter, merger-related accounting expenses of $86 million, and $78 million in charges related to the sale of a manufacturing facility, earnings were $149 million, or 43 cents a share. Analysts expected a profit of 36 cents a share.

During the first quarter, Biogen pulled its multiple sclerosis drug Tysabri from the market after cases of a rare brain disease were linked to its use. The company recorded charges of about $36 million from the withdrawal in that quarter.

Thanks to sales of Avonex, which is also for multiple sclerosis, and Rituxan for B-cell non-Hodgkin`s lymphoma, Biogen`s revenue rose 12% to $606 million from $539 million last year. The consensus estimate was $599.3 million for the quarter.

Avonex, now the leading MS drug worldwide, brought in sales of $382 million, up 10% from a year earlier, and Rituxan revenue totaled $185 million, up 22%. Biogen co-promotes Rituxan with Genentech (DNA:NYSE - commentary - research).

"Impressive results from Avonex and Rituxan, coupled with operational discipline and effective cost management, drove an increase of more than 20% in earnings," said James Mullen, Biogen Idec`s chief executive, in a press release. "We have also maintained our strong commitment to the MS community by conducting an extensive safety evaluation of Tysabri which is ongoing. We look forward to the expected completion of the evaluation by the end of the summer and to further discussions with the regulatory authorities regarding the path forward for Tysabri."

During its conference call, Biogen declined to issue guidance for the year. The company also wouldn`t comment on the number of PML cases discovered in Tysabri users or the results of safety evaluations of the drug. The company did say that the evaluations are going well and that it expects the drug to return to the market.

Shares of Biogen were down 38 cents to $38.44 after hours Tuesday.

[[KERN]Codex]

GOODBODY "BUY"

Elan (Buy, Current Price $7.94)

Q2`05 - Biogen Idec results yesterday, Elan due tomorrow.

As we flagged last week, Elan will report its Q2`05 results tomorrow. Although secondary to Tysabri`s progress through the review process, we forecast a fully diluted loss per share of $0.33 from revenue of $116.5m. This includes a flagged net charge of $53m in relation to the debt retired on 01 June. Given that Biogen Idec`s results and subsequent conference call revealed nothing new on the progress of Tysabri (see below), we believe the Elan results will focus purely on the on-going business with, perhaps an update on its Alzheimer`s disease pipeline. On the latter, one drug has currently moved into Phase II and we are expecting the submission of an IND filing with the FDA to start a Phase I trial with a second drug candidate. In the on-going business, all product and manufacturing lines will have to perform ahead of expectations this quarter if the company is to retain its $500m revenue guidance for the year. We currently have FY05 revenue running at $468.3m and so would view a pull back, if any, as irrelevant to the bigger picture. What is required, however, is evidence of cost cutting - we have SG&A tracking at just under 72% of revenue and R&D costs, likewise, down to 41.6% of revenue.

Specifically on Tysabri, Biogen Idec yesterday confirmed that the safety evaluation of the 3,000 patients was on time and scheduled to be completed by the end of summer (mid-September). The company and Elan would then present the data to the FDA for discussion on how best to bring the drug back to market. The company also indicated that it is starting preparatory work for re-commencing trials. The ones currently under consideration are not large Phase II and III studies but smaller trials to better understand the drug after it has returned to the market.

[[KERN]Codex]

Elan €7.94 BUY BiogenIdec Continue to Remain Positive

• Several positives can be taken from BiogenIdec’s Q2 results conference call last night.
Firstly, management continue to remain positive on the return of Tysabri to the market.
The safety review is reported to be on-track and is expected to be completed at the end
of the summer (21st September 2005) at the latest and will be followed by regulatory
discussions on how to bring Tysabri back to the market (e.g. risk management
program, revised label etc). During the quarter BiogenIdec recorded a $20m charge to
cover the cost of Tysabri production and the development cost of a high-titre production
process for Tysabri.
• Secondly, BiogenIdec and Elan are currently taking steps to resume dosing of patients
who had been on Tysabri in MS clinical trials and to begin clinical trials. It is
BiogenIdec’s view that these trials are not required for the re-commercialisation of
Tysabri. In Phase II studies as patients withdrew from Tysabri treatment relapses
recurred (after 6 months) although there was no rebound above the level seen in
placebo patients. The FDA will therefore be conscious that the MS patients in trials
before Tysabri’s suspension may be at risk of relapsing after a 6-month period without
Tysabri. Resumption of Tysabri for patients who were in clinical trials may therefore be
possible by late August 2005. The re-opening of Tysabri’s IND and the subsequent restart
to clinical studies was noted as an easier process than the comprehensive
analysis required to bring Tysabri back to the market.
• Overall we see it as positive that BiogenIdec continue to talk confidently about
Tysabri’s return. We continue to believe that Tysabri as a monotherapy will be relaunched
as a treatment option for MS patients.

Orla Hartford Ph.D [phone] [e-mail]

[Poppholz]

MAP Pharmaceuticals Announces Expanded Development Agreement with Elan Drug Technologies

MOUNTAIN VIEW, Calif., July 27 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. announced today that MAP and Elan Corporation, plc (NYSE: ELN - News) have agreed to amend their previous agreement, signed in 2004, to seek to apply Elan`s proprietary NanoCrystal® technology to defined inhalation therapies. MAP has been collaborating with Elan to develop a nebulized form of budesonide for the treatment of asthma. The agreement provides additional rights to MAP for the use of NanoCrystal technology for the treatment of multiple respiratory diseases, including asthma.
This agreement covers nebulized delivery of budesonide and combinations of budesonide with beta agonists. Budesonide is an anti-inflammatory corticosteroid indicated for the maintenance treatment of asthma as well as prophylactic therapy for this condition. In all delivery forms, including nebulized delivery, budesonide sales exceeded US$1bn worldwide in 2004. Asthma affects approximately 17 million Americans, 5 million of whom are children. The nebulized portion of the asthma market is the fastest growing segment, largely due to the increasingly high diagnosis rates for asthma in the pediatric population.
Timothy Nelson, CEO of MAP Pharmaceuticals said, "We are pleased to expand our collaboration with Elan Drug Technologies. As an emerging specialty pharmaceutical company focused on becoming a leader in the inhaled drug delivery and respiratory disease sector, these expanded rights allow us to more fully serve our physician and patient customers in the treatment of asthma and other respiratory diseases. The growth of nebulized steroids over the past few years has demonstrated a need among physicians and patients for this type of therapy for the treatment of asthma. We believe the potential to deliver nebulized budesonide to the patient faster and more efficiently will serve MAP and our customers well in the years to come."
The NanoCrystal technology to be used in the development of the new formulation of budesonide is a proprietary Elan innovation for poorly water soluble compounds. NanoCrystal technology is designed to enhance the clinical performance of poorly water-soluble drugs by transforming them into nanometer- sized particles. It is anticipated that the budesonide formulation utilizing this technology may result in a product that will have a superior pharmaceutical delivery and clinical profile when administered via nebulizer.
Paul Breen, Executive Vice President, Elan Drug Technologies said, "We are very pleased to expand this development program with MAP Pharmaceuticals. This program, which will involve the application of the technology into a nebulized form, highlights the flexibility of the technology. We look forward to working closely with MAP in applying our technology to new dosage forms in the inhalation area."

[Poppholz]

Auf Reuters ist zu lesen:

Drug maker Elan posts Q2 net loss of $0.35/share
Do Jul 28, 2005 8:49 MESZ
DUBLIN, July 28 (Reuters) - Elan Corp. <ELN.I> posted a slightly better than expected second-quarter net loss per share of $0.35 cents on Thursday and said it was sticking to its forecasts for the full year.

"We are cautiously optimistic that, with continued strong revenue growth and careful and disciplined cost management, this business, excluding Tysabri, will get to our target of break-even on an EBITDA basis by the end of 2005," the company said in a statement.

Elan said it continued to invest prudently in its suspended Tysabri multiple sclerosis drug and remained committed to reintroducing it as a treatment.

[Poppholz]

UPDATE 1-Elan sticks to goals despite bigger Q2 loss
Do Jul 28, 2005 9:23 MESZ
(Adds details, background)

DUBLIN, July 28 (Reuters) - Elan Corp. <ELN.I> stuck to its full-year goals on Thursday and said it continued to invest cautiously in its suspended Tysabri drug after posting a second quarter loss that was close to what the market had expected.

"We are cautiously optimistic that, with continued strong revenue growth and careful and disciplined cost management, this business, excluding Tysabri, will get to our target of break-even on an EBITDA basis by the end of 2005," the company said in a statement.

Elan <ELN.L> said it continued to invest prudently in its Tysabri multiple sclerosis drug and remained committed to reintroducing the treatment after it was suspended in February following the death of a patient.

The company posted a net loss for the three months to the end of June of $0.35 per share, worse than the $0.30 loss in the same period last year but slightly better than the median forecast of a Reuters poll for a $0.37 loss.

At $118.6 million, revenues were also close to the $117.5 million predicted by analysts who had said, however, that given the uncertainties over Tysabri they would pay closest attention to cost-cutting measures at Elan.

The company, which during the first quarter spent more on selling, general and administrative costs than it received in revenues, said that in the three months that followed the costs came in at $91.4 million, or 77 percent of sales.

Shares in Elan have slumped almost 90 percent in the wake of Tysabri`s withdrawal but have since recovered some ground thanks to management`s confidence the drug will make a comeback. The shares were up 1.5 percent at 6.75 euros in Dublin by 0708 GMT.

[Cyberhexe]

zum Quartalsergebnis von Elan:

Neuigkeiten zu Tysabri sind erst gegen Ende des Sommers zu erwarten, so dass die fundamentale Sicht sich nur unwesentlich verändert hat. Positiv ist jedoch das "Drug Delivery Business" mit einer Umsatzzunahme von 67% im Jahresvergleich sowie die 50%ige Zunahme bei den Lizenzeinnahmen für die patentierte Nanotechnologie. Diese Patente haben das Potenzial einer Geldmachine, da sie fast zu 100% in den deckungsbeitrag einfliessen. Dazu Tysabri und Alzheimer...also wer mindestens mittelfristig plant....good luck
ch

[Poppholz]

UPDATE 2-Elan trims sales target but earnings goals intact
Thu Jul 28, 2005 05:21 AM ET
(Adds details, analyst comment, updates shares)
By Paul Hoskins

DUBLIN, July 28 (Reuters) - Elan Corp. (ELN.I: Quote, Profile, Research) tweaked its full-year sales goal on Thursday but stuck to its earnings targets and said it continued to invest in its suspended Tysabri drug after posting a second-quarter loss in line with forecasts.

Following supply problems in the early part of the year, Elan (ELN.L: Quote, Profile, Research) said it now saw 2005 sales of $460 million to $500 million -- as many analysts had expected.

"Top-line numbers were broadly in line with our forecast and at first glance, despite the pull back in revenue guidance, any changes to our revenue model will be minimal," Goodbody analyst Ian Hunter wrote in a research note.

Elan`s earlier forecast was for 2005 sales of $500 million.

However, the company said in a statement that by keeping a lid on costs it remained "cautiously optimistic" it would meet its target of break-even earnings before interest, tax depreciation and amortisation by the end of 2005 once the costs associated with Tysabri had been excluded.

Elan said it continued to invest prudently in its Tysabri multiple sclerosis drug and that, with U.S. partner Biogen Idec (BIIB.O: Quote, Profile, Research) , it remained committed to reintroducing the treatment after halting sales in February following a patient`s death.

The company posted a net loss for the three months to the end of June of $0.35 per share, worse than the $0.30 loss in the same period last year but slightly better than the median forecast of a Reuters poll for a $0.37 loss.

At $118.6 million, revenues were also close to the $117.5 million predicted by analysts. However, analysts said that given the uncertainties over Tysabri, they would pay closest attention to cost-cutting measures at Elan (ELN.N: Quote, Profile, Research) .


COSTS UNDER CONTROL

The company said costs in the second quarter came in at $91.4 million, or 77 percent of sales, an improvement on the first quarter, where the company spent more on selling, general and administrative costs than it received in revenues.

"Costs were well controlled in the second quarter," said Davy analyst Jack Gorman. "Though we will make minor changes to our forecast model, we are not changing our view that Tysabri is the key catalyst for a break out from the $6 to $8 range in which the share has traded in recent months".

Elan shares slid almost 90 percent in the wake of Tysabri`s withdrawal but have since recovered some ground thanks to management confidence the drug will make a comeback. The shares were down 2.3 percent at 6.50 euros in Dublin by 0855 GMT. Its U.S.-listed shares (ELN.N: Quote, Profile, Research) closed at $7.99 on Wednesday.

Dublin-based Elan said sales of its new Prialt painkiller picked up to $1.8 million in the second-quarter versus $1 million in the first three months of the year.

Overall, product revenues rose to $111.6 million versus $93.4 million in the same period last year as its Maxipime treatment recovered from supply shortages.

In terms of the cash Elan has to tide it over while it awaits the results of a U.S. probe into Tysabri`s safety, the company said it had $1.158 billion on its balance sheet at the end of June, down about $200 million over the last three months.

[Poppholz]

Elan`s Loss Gets Wider

By Robert Steyer
TheStreet.com Staff Reporter
7/28/2005 3:48 PM EDT

Updated from 1:33 p.m. EDT
Elan (ELN:NYSE ADR - commentary - research) issued second-quarter financial results on Thursday, prompting several analysts to issue the oft-repeated refrain that the company offers little promise without the multiple sclerosis drug Tysabri.

"Without Tysabri as a blockbuster product, we remain concerned that, unless there is a severe restructuring, Elan will have difficult repaying the $2 billion debt obligations in 2008 and 2011," said Erica Whittaker, of Merrill Lynch, in a Thursday research report, using the same words she offered in a first-quarter report. She also repeated a sell recommendation.

Elan`s shares were off 46 cents, or 5.8%, to $7.53 in afternoon trading.

Kelly Martin, Elan`s chief executive, tried to remain upbeat, telling investors and analysts in a prepared statement that the company and its partner Biogen Idec (BIIB:Nasdaq - commentary - research) continue to meet with regulatory agencies to assess the circumstances for Tysabri`s return to the market.

"We are advancing on multiple fronts, committed to pursuing a disciplined approach to managing costs and realizing revenue in our business," Martin added.

Biogen Idec and Elan pulled the MS drug in late February after reports that two patients who took Tysabri and Avonex, an MS drug from Biogen Idec, contracted a rare, often fatal brain diseases.

Second-quarter numbers without Tysabri look like this: Elan lost $142.6 million, or 35 cents a share, on revenue of $118.6 million on a GAAP basis for the three months ended June 30. For the same period last year, Elan lost $117.6 million, or 30 cents a share, on revenue of $108.4 million.

The wider losses were primarily a result of costs associated with Tysabri and a charge for early debt retirement, said Shane Cooke, the chief financial officer, in a prepared statement. "We continue to prudently invest in Tysabri and remain capable and committed to reintroducing it as a therapeutic option for patients, should it be appropriate," Cooke said.

Biogen Idec, which is much bigger than Elan and can better absorb the Tysabri setback, issued second-quarter financial results earlier this week, beating Wall Street`s estimates.

Elan and Biogen Idec hope to complete their review of patients` records and clinical trial results by the end of the summer.

Merrill Lynch`s Whittaker predicts Tysabri could return to the market in early 2006 "only in a limited clinical setting," in which it`s given to patients who have no other treatment options. Peak yearly sales could be $500 million at best, says Whittaker, who doesn`t own shares. Her firm is a market maker in Elan`s stock, and it also has a noninvestment-banking relationship.

Strong backing is in short supply from the analysts who cover Elan`s stock. According to Thomson First Call data, Wall Street has six sell ratings, three holds and only two analysts calling the shares a buy.

Another of the sell recommendations comes from Andrew Swanson of Citigroup Smith Barney, who writes in a Thursday research report that sales of the company`s new pain drug, Prialt, are "off to a slow start" and that the company lowered its full-year revenue guidance from "exceeding $500 million" to a range of $460 million to $500 million.

"We believe Elan`s current share price implies that Tysabri returns as the market leader in multiple sclerosis -- an optimistic scenario in our view," says Swanson, who doesn`t own shares and whose firm is a market maker in the stock. He believes it`s unlikely that Tysabri will return to the market.

Das größte Problem für uns sind die Analytiker.

[Cyberhexe]

http://fyms.blogspot.com

...Elan und Wyeth beabsichtigen eine Erweiterung der Fabrikationsstätten in Athlone. Dies deutet wohl darauf hin, dass mit einem positiven Studienverlauf bei den Alzheimer-Kandidaten (AAB-001 --> Phase II; ACC-001 (Vaccin) --> kurz vor der Klinik) gerechnet wird.
Mit der NanoChrystal Technology werden für 2005 Lizenzeinnahmen um die 140 Mio$ prognostiziert mit stark ansteigender Tendenz.
Die Fortführung der klinischen Tysabri-Studien (1808) kann jederzeit erfolgen und die Auswertung aller bisher therapierten Patienten und Studienteilnehmer soll bis spätestens 21.9.05 abgeschlossen sein.
Dazu hat Shane Cook, CFO bestätigt, dass Elan unabhängig von Tysabri zum Ende des Jahres EBITDA positiv sein will. Also wenn das keine guten Nachrichten sind.
Da muss ich doch glatt mein Urlaubsgeld einsparen (Mittelmeer) und mir dafür im Winter eine Südamerika-Reise leisten zu können.
good luck
ch



Quick Update of the cc

...that Elan and Wyeth may be looking to expand the drug manufacturing facility in Athlone. elan and wyeth have been in the news for their alzheimer`s drug AAB-001 which just recently entered phase2 FDA trials, so we should expect to hear some developments on that as well.


...finally, ever since Q1, ELN has been in the news for its nanocrystal deals with other pharma companies. i expect to hear updates on that area as well, but of course, whats ultimately going to move ELN`s stock tomorrow is tysabri progress and updates from shane cooke on their break-even EBITDA guidance.

i was really disappointed with ELN`s selloff this morning. it really could have gone either way i think.. traders like me had unreasonable expectations going into the earnings call, and we were presented with good but not extraordinary news. i wouldn`t be surprised if there were a lot of new traders wondering "so... is this good news or bad news?". .

[Nostarowie]

Südamerika ?



-mit,nem Besen-



alle Achtung Cybi

[Cyberhexe]

Turbobesen...allerdings nur für eine Hexe zugelassen!

[Cyberhexe]

interessanter Artikel, bsonders der letzte Abschnitt:

"...diese Gelegenheit in ein Medikament zu investieren, dessen Wirksamkeit bereits in der Klinik nachgewiesen wurde, gibt es nicht oft... dazu ein Unternehmen mit einer vielversprechenden Pipeline, ohne einen grossen Aufschlag zu bezahlen...es ist eine gute Zeit, Elan zu kaufen"



http://www.moneyshowdigest.com/Digest/article.asp?aid=msd072…

Elan: "A Wild Ride"

Ken Kam monitors some 60,000 virtual portfolios to find the top performers. For his latest featured stock, he turns to Marketocracy member Gary Franklin, whose virtual portfolio has gained 331% since inception in 2002 vs. a 42% gain in the S&P 500.

"Shareholders at Elan (ELN NYSE) have had a wild ride this year. The stock, which hovered near $28 at the beginning of the year plummeted to below $6 when Elan and its partner Biogen voluntarily withdrew its multiple sclerosis drug, Tysabri, from the market in late February when two patients from long-term clinical trials developed a rare and often fatal brain infection. After bottoming at about $3 in March, the stock has recently been trading between $6 and $8. Is this a good time to buy Elan or is it time to sell into the bounce?

"Multiple sclerosis is believed to be an autoimmune disease where the immune system attacks the insulation of nerve fibers in the central nervous system of the brain. While it is not fatal, it significantly impacts the lives of patients and can lead to paralysis. About 400,000 people in the US (2.5 million worldwide) have multiple sclerosis, and according to the Elan, existing drugs do not work for about 25% of them. After one year of Phase III clinical trials, Tysabri treated patients had an annualized relapse rate of .25 compared to .74 in the placebo group. That equates to a 66% relative reduction rate and a significant improvement in patient lives.

"On the basis of such strong clinical trial results and unmet medical need, Tysabri was given FDA fast track approval in November of 2004. Unfortunately, after the drug was approved, two cases of PML in patients from the long-term clinical trials were confirmed in February 2005, and the drug was voluntarily taken off the market to protect patients and gather more information. Elan and Biogen are reviewing every patient that has taken Tysabri to try to establish the risk/benefit profile for the FDA. This review is almost complete.

"Meanwhile, Tysabri could still become a significant MS therapy with its proven efficacy, well-tolerated monotherapy side effects, and convenient monthly injections/infusions instead of daily or weekly injections. Tysabri, in the largest MS clinical trial ever undertaken with 942 relapsing patients, reduced the relapse rate by 67% compared to placebo. Furthermore, Tysabri has proven to reduce the risk of disability progression by 54 percent compared to placebo. In late June, news showing the effectiveness of Tysabri in treating Crohn’s disease was released.

"Even without Tysabri, Elan is a strong company. Elan has annual revenues of about $400 million and could be at breakeven EBITDA by end of year according to the Company’s CFO. Elan also has other assets with good potential over the next several years in the areas of drug delivery and Alzheimer’s research. Their Alzheimer’s research, in collaboration with Wyeth, is a second-generation effort, currently in Phase II, which attempts to use the patient’s own immune system to remove beta amyloid plaque. It’s not often you get the opportunity to invest in a drug after clinical trials have already proven its efficacy and a company with a great pipeline without having to pay a large premium. The combination of significant upside potential and good downside protection makes for great investments. It’s a good time to buy Elan."

[[KERN]Codex]

#282

Elan und Wyeth beabsichtigen eine Erweiterung der Fabrikationsstätten in Athlone. Dies deutet wohl darauf hin, dass mit einem positiven Studienverlauf bei den Alzheimer-Kandidaten (AAB-001 --> Phase II; ACC-001 (Vaccin) --> kurz vor der Klinik) gerechnet wird.



#285

It’s not often you get the opportunity to invest in a drug after clinical trials have already proven its efficacy and a company with a great pipeline without having to pay a large premium. The combination of significant upside potential and good downside protection makes for great investments. It’s a good time to buy Elan.

=> Sagt eigentlich alles! Ich bin guter Dinger in Sachen ELAN

[welke91]

Mann ey, wird ziemlich kniffelig diese Sache.

Salve Cyberhexe wie siehst du das?
Weil, wenn Tysabri zurückkehrt dann, wird es schwer in Morbus Chron eine Zulassung zu erhalten.

28.07.05 New England Journal
PML in a Patient with Crohn`s Disease
In a man with Crohn`s disease who was treated with natalizumab and subsequently died, reexamination showed that the fatal lesion was progressive multifocal leukoencephalopathy.

[Cyberhexe]

der bisherige Goldstandard bei MC Remicade (Infliximab) hat ein sehr bedenkliches Nebenwirkungsprofil...Tysabri mit einem Nebenwirkungsprofil im Plazebobereich scheint da wesentlich günstiger zu sein, wenn da, und da geb ich dir recht, das PML-Risiko nicht wäre.
Da in der Monotherapie bisher keine PML-Fälle aufgetreten sind, ist für alle neuen MC-Patienten, die bisher noch nicht mit Interferonen oder anderen Immunsuppresiva behandelt wurden mehr als eine Alternative. Bei den schon mit Immunsuppressiva behandelten MC-Patienten muss man abwarten, wie die letztendlich wissenschaftliche Erklärung des PML-Szenario aussehen wird und wie die statistischen Häufigkeiten sind...letztendlich ist bei jedem Medikament eine Nutzen-Risiko-Abwägung erforderlich...und das Risiko bei Remicade ist sicherlich nicht vernachlässigbar!

[jobl]

Hi Cyberhexe,

ansich verfolge ich ganz interessiert dieses Forum.
Über Deine letzte Aussage bin ich allerdings gestolpert:

"´...ist für alle neuen MC-Patienten, die bisher noch nicht mit Interferonen... behandelt wurden mehr als eine Alternative"

Wenn man diese Aussage auf MS überträgt, dann dürfte auch niemand mehr der "alten MS-Fälle" zukünftig mit MS mit Tysabi behandelt werden, da ja doch eine Vielzahl bereits mit Interferonen, usw. vorher behandelt wurden? Oder interpretiere ich Deine Aussage falsch? Ist ja nicht eine unbeutende Patientengruppe.

Ist dieser Fall aus dem New England Journal "offiziell". Ist ja doch ne "erschreckende" Neuigkeit, wenn PML auch in der Monotherapie von Tysabi auftritt. Gerade das ist doch eine große Hoffnung. Wiedereinführung von Tysabi in der Monotherapie? Oder verstehe ich den Sachverhalt falsch, d.h. der Patient hat als MC-Patient ebenfalls parallel Interferone erhalten?

Viele Grüße
Jochen

[Cyberhexe]

@jobl
...obschon ich beruflich mit klinischen Studien zu tun habe, möchte ich betonen, dass ich weder Neurologe noch Arzt bin, und somit lediglich widergeben kann, was ich zum Thema in Erfahrung bringen konnte; ich selbst habe jedoch nicht die Fähigkeiten, mich wirklich wissenschaftlich mit diesen Aussagen auseinanderzusetzen.

Aber lasst uns dennoch einmal die PML-Fälle rekonstruieren:
der PML-Fall (verstorben 2003, ursprüngliche Todesursache Hirntumor) in ENACT-2, also der MC-Studie, hatte eine Vorgeschichte und zwar, wenn ich mich recht erinnere, in etwa so...Behandlung über 6 Jahre mit Azathioprin, einem Medikament zur Verhinderung der Organabstossung in der Transplantationsmedizin sowie 2 Jahre mit Remicade, dem derzeitigen Goldstandard zur Behandlung von MorbusCrohn.
Darüberhinaus wurde bei diesem Patienten eine permanent niedrige Anzahl an Blutzellen festgestellt, welche sehr wahrscheinlich durch Knochenmarkdefekte verursacht wurden.

Die anderen beiden PML-Fälle sind in SENTINEL (Tysabri+Avonex) aufgetreten, davon einer fatal
Folgende Erklärung wird derzeit zu den SENTINEL-Fällen gegeben:
Durch das Interferon (Avonex) erhöht sich die Halbwertszeit von Natalizumab, so dass über die Zeit eine Konzentrationmszunahme bzw. Überdosierung von Natalizumab stattfindet. Dies hat zur Folge, dass die Rezeptoren an den T-Zellen abgesättigt werden, so dass keine T-Zellen die Blut-Hirnschranke durchqueren können. Hierdurch kann der JCVirus eine "ungestörte" Aktivität im Nervengewebe entwickeln. Dies erscheint für mich, mit meinen allerdings bescheidenen Kenntnissen, durchaus eine logische Erklärung zu sein.

Bei dem ENACT2-Fall ist die Vorgeschichte wesentlich komplexer, zumal sowohl bei der Behandlung mit Azathioprin als auch mit Remicade bereits PML-Fälle aufgetreten sind.
Mitunter haben diese Substanzen, vor allem Azathioprin, sehr grosse Halbwertszeiten, so dass eine Herabsetzung der Immunaktivität über längere Zeit anhält. So lange der Zusammenhang nicht eindeutig geklärt ist, gehe ich deswegen davon aus, dass die FDA eine Warnung aussprechen wird, Tysabri in Verbindung mit immunsupprimierenden Wirkstoffen zu verabreichen bzw. auch immunsupprimierte Patienten von der Behandlung mit Natalizumab auszuschliessen. Entscheidend wird wohl sein, wie lange die immunsupprimierende Wirkung anhält bzw. wie lange die empfohlene Wartezeit sein wird.

Man darf auf alle Fälle auf die genauen Zahlen der MC-Studien gespannt sein, so dass ein direkter Vergleich mit der Effektivität von Remicade gegeben ist.

[Cyberhexe]

@jobl
bedenke, viele der RRMS-Patienten werden derzeit gar nicht medikamentös therapiert (in US und EU mehr als 30% von insgesamt 800.000 Patienten), da die am Markt eingeführten Wirkstoffe bei diesen Patienten keinen Nutzen erbracht haben. Gerade aus diesem Klientel werden sehr wahrscheinlich sehr viele eine Therapie mit Tysabri in Erwägung ziehen. Ich denke Elan und Biogen werden vorsichtig sein, da ein PML-Risiko in Verbindung mit Immunsuppressiva statistisch nachweisbar ist. Dagegen scheint das PML-Risiko in der Monotherapie bei nicht supprimiertem Immunsystem verschwindend klein zu sein (bisher 0 Fälle). Hinzu kommen die jährlich neu diagnostizierten MS-Patienten (ca. 35000 in US und EU), die ja bisher auch noch nicht behandelt wurden. Dieser Kreis würde durchaus genügen, um eine Blokckbuster-Nachfrage nach Tysabri zu generieren.

[welke91]

hy Cyberhexe
jetzt gehts langsam los!!!!

http://biogen.com/site/019_0.html?pr_id=../news/BiogenIDECPR…

[UserX5]

Goodbody Sees Elan`s Tysabri Back In 2006
Friday, August 05, 2005 4:22:19 AM ET


0812 GMT [Dow Jones] Elan (ELN) and Biogen Idec`s (BIIB) review of suspended MS drug Tysabri is more advanced than previously thought, says Goodbody Stockbrokers` Ian Hunter, citing Elan/Biogen`s review and discussions with the FDA. Sees Tysabri returning in early 2006 with $239M sales that year and $1.77B peak sales in 2009. Maintains buy. Elan flat at EUR6.30. (QAF)

[welke91]

HA Hey X 5 nächstes Jahr vergiss es

never.....

Warum sollte sich Biogen einen neuen Partner in der Behandlung von Avonex holen.
Protein Design Labs, Inc. announced a broad collaboration for the joint development, manufacture and commercialization of three Phase II antibody!!!! products.
The agreement provides for shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases, and for shared development and commercialization of M200 (volociximab) and HuZAF(TM) (fontolizumab) in all indications.
Warum fällt der Kurs von Biogen????
740000 Shares????
Biogen bekommt mächtig Hosenbluten....

Shares of the Year ELAN!

[[KERN]Codex]

Ich sach nur

Tysabri Monotherapie

Schönen Samstag noch..

[Cyberhexe]

@welke

PDL ist ein höchst interessantes Unternehmen...eine regelrechte MAB-Schmiede. Auch Natalizumab wurde von denen entwickelt, so dass ca. 5% vom Umsatz direkt an PDL abzuführen sind. Ich hatte ursprünglich einmal gehofft, dass bei einer erfolgreichen Markteinführung von Tysabri mit entsprechenden Umsätzen und der daraus resultierenden Marktkapitalisierung, Elan eine derartige Kooperation mit PDL eingehen würde...das ist für BiogenIdec sicherlich kein schlechter Deal.

[Cyberhexe]

man bedenke, wo eine Roche heute stehen würde, wenn man Genentec nicht übernommen hätte...unter ferner...

[welke91]

Hy Cyberhexe,
sicher ist es das Beste was Biogen machen konnte.
Combo Avonex-Tysabri hat sich wohl erledigt.

Tysabri - Can Efficacy of VLA-4 Mechanism Overcome Safety Concerns?
Published: 5 Aug 2005, Publisher: Datamonitor

Introduction
Tysabri was voluntarily withdrawn from the multiple sclerosis market in February 2005 following two cases of multifocal leukoencephalopathy (PML) resulting in fatality. However, recently published data indicates that PML is only linked to patients also taking Avonex or recent immunosuppressive therapy. Datamonitor expects that Tysabri will be relaunched as a monotherapy in late 2005/early 2006.

Scope
Overview of Tysabri`s product history from development to approval and launch, and subsequent withdrawal from the market
Viewpoints from key opinion leaders on the withdrawal and potential relaunch of Tysabri
Biogen-Idec and Elan`s options and potential strategies for the relaunch of Tysabri
Assessment of the future product positioning and life-cycle management strategies open to Tysabri

Highlights
Strong evidence suggests that Tysabri used in conjunction with Avonex, increases the concentration of Tysabri in the body, while also decreasing the clearance rate of the drug, resulting in immune suppression. In contrast, the concentration and clearance of Tysabri when used in monotherapy remains within acceptable, safe levels.

At present, the future for Tysabri is still uncertain, although Datamonitor forecasts that Tysabri will be relaunched as a monotherapy in the US in late 2005 or early 2006, with a subsequent launch in EU countries.
!!!!

Datamonitor expects that Tysabri`s labeling will certainly feature a black box warning against the use of the drug in combination with Avonex and will also give strong warnings against the use of Tysabri in conjunction with all beta interferons, and the use of medication in immunosuppressed patients.
!!!!!!
Deswegen musste Biogen handeln um ein tragfähiges Produkt gegenüber Tysabri zu stellen.Oder??

Fakt ist das Biogen am Umsatz beteiligt ist, nur müssen sie avonex, doch auch in Zukunft gut verkaufen.

Sorry viel Text....

Eight-year immunogenicity and safety of interferon beta-1a-Avonex treatment in patients with multiple sclerosis.

August 2005
University of Mississippi, VA Medical Center, Jackson, MS 39216, USA. [e-mail]

An open-label extension study of the phase III trial of intramuscular interferon beta-1a (IFNbeta-1a-Avonex) was conducted to evaluate the immunogenicity and safety of IFNbeta-1a-Avonex over six years in patients with relapsing multiple sclerosis (MS).

Patients who participated in the pivotal phase III study were offered enrolment; entry was also open to patients who had not participated. All patients received IFNbeta-1a-Avonex 30 microg intramuscularly once weekly for six years, for a treatment duration of up to eight years in patients who received IFNbeta-1a-Avonex in the phase III trial.

Serum levels of IFNbeta antibodies were measured every six months using a screening enzyme-linked immunosorbent assay (ELISA) followed by an antiviral cytopathic effect assay to detect neutralizing antibodies (NAbs) in serum samples positive on ELISA.

The incidence of adverse events and laboratory test results assessed safety. Of 382 total patients, 218 had participated in the phase III study (103 placebo, 115 IFNbeta-1a-Avonex) and 164 had not participated; 24 of the 164 were IFNbeta-naive.

At baseline, 281 patients were negative for IFNbeta antibodies (NAb-). NAbs (titre > or = 20) developed at any time over six years in 5% of these patients. Of 140 patients who had been on IFNbeta-1b-Betaseron, 49 were positive for NAbs (NAb+) at baseline; 11 of 115 who had been on IFNbeta-1a-Avonex were NAb+ at baseline. Thirty-nine of 49 patients who had been on Betaseron and were NAb+ had titres < 100; 36 of these 39 seroconverted to NAb- while on IFNbeta-1a-Avonex, with a median time of approximately six months. Ten patients who had been on Betaseron had NAb titres > or = 100; five remained NAb+ during six years on IFNbeta-1a-Avonex and five seroconverted to NAb-, but only after at least two years.

Five patients who had been on IFNbeta-1a-Avonex during the clinical trial were NAb+ with titres < 100 at baseline; four seroconverted to NAb-, with a median time of two to three years. Six patients who had been on IFNbeta-1a-Avonex had NAb titres > or = 100; five of these remained NAb+ at six years. No patient with a NAb titre > 1000 seroconverted to NAb-, whether initially treated with IFNbeta-1a-Avonex or -Betaseron. Adverse events were similar to those observed in the pivotal phase III trial. Results from this trial indicated that IFNbeta-1a-Avonex was associated with a low incidence of NAbs and was well tolerated for up to eight years. Further, the results indicate that persistence of NAbs is dependent on titre and IFNbeta product.

Soweit zu Avonex und Biogen

Elan-is aufgepasst!!!

on friday, i jumped back into ELN with a purely speculative position because of some new information that i picked up.

i came across several posts on the yahoo msg board stating that tysabri patients are known to relapse 6 months after treatment is halted. i verified this information by searching through ThisIsMS, a multiple sclerosis community which is pretty unbiased.

in this article, the author states that: "Previous studies (Phase II) showed that patients who were taken off of Tysabri treatment had relapses begin recurring after about 6 months– though there was no rebound above the level seen in the placebo patients. Therefore, the FDA will theoretically be aware that MS patients in the Tysabri trials before the marketing suspension are reaching the point where they should begin relapsing. As such, there is a sliver of hope that re-dosing of former Tysabri clinical trial patients could begin by early September 2005. To be clear– This is SPECULATION. However, note that it is easier to restart clinical trials then it is to re-introduce the drug to the general market."

Tysabri wird bald als Monotherapie zurückkommen.

Biogen, -deswegen mein Einwurf Post292- arbeitet mit Hochdruck nun an Avonex weiter!!!Bei Biogen geht man davon aus, Tysabri is back in 2005!!!
Man will ja auch seine eigenen Produkte vermarkten oder???
Grüße
welke

[welke91]

ach noch was Cyberhexe...

Therapeutic targeting of alpha4-integrins in chronic inflammatory diseases: tipping the scales of risk towards benefit?
mmmhhh was meinen die?

Theodor Kocher Institute, University of Bern, CH-3012 Bern, Switzerland.

Inhibition of leukocyte trafficking via alpha4-integrin antibody blockade has recently become a validated therapeutic approach for several inflammatory diseases, including multiple sclerosis, ulcerative colitis and Crohn`s disease. In the midst of this recent success, 3 patients receiving chronic treatment with the anti-alpha4 antagonist natalizumab (Tysabri) for the treatment of multiple sclerosis or Crohn`s disease,

developed JC-virus related progressive multifocal leukoencephalopathy (PML)
These unforeseen consequences suggest that long term blockade of alpha4-integrins might prevent trafficking of non-pathogenic lymphocytes that are essential for viral immunosurveillance.
In the current issue of the European Journal of Immunology Bjursten and colleagues report that long term treatment with anti-alpha4-integrin antibodies results in exacerbation of the murine model of colitis induced by the targeted deletion of the heterotrimeric G protein subunit Galphai2.
In order to properly evaluate the efficacy and safety of anti-alpha4-integrin therapy, the relationship between these observations in an immunologically altered animal model and human clinical disease needs to be carefully measure

noch was

ATL1102 is designed to target the same immune system protein (VLA-4) as Tysabri.

Antisense Therapeutics Limited (ANP.AX) is an Australian publicly listed biopharmaceutical company.
ANP`s major shareholder is Isis Pharmaceuticals (ISIS).
Antisense blockade of the VLA-4 receptor produces probably less sideeffects than the blockade of the receptor by an antibody (Tysabri).blick nicht durch

[welke91]

AMBRIDGE, Mass. and DUBLIN, Ireland--(BUSINESS WIRE)--Aug. 9, 2005--Biogen Idec (NASDAQ: BIIB - News) and Elan Corporation, plc (NYSE: ELN - News) announced today that findings from their safety evaluation of TYSABRI® (natalizumab) in patients with multiple sclerosis (MS) resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously reported three confirmed cases of PML, two of which were fatal. The ongoing safety evaluation in Crohn`s disease and rheumatoid arthritis is on track to be completed by the end of the summer. The companies anticipate making submissions to regulatory authorities in early fall of 2005. The companies are taking preliminary steps to restart clinical trials in MS.

ADVERTISEMENT

More than 2,000 MS patients from clinical trials were eligible for the safety evaluation. To date, 91% of these MS patients participated in the safety evaluation. The remaining 9% of patients did not participate in the safety review. A total of 99% of patients participating in the evaluation visited their treating physician and had a neurological exam. In addition, 98% of participants had an MRI exam. The safety evaluation also included the review of any reports of potential PML in patients receiving TYSABRI in the commercial setting.

"Our ongoing TYSABRI safety evaluation is a rigorous medical and scientific undertaking that has been led by some of the world`s leading experts in neurology and neuroradiology," said Whaijen Soo, MD, PhD, senior vice president, Medical Research, Biogen Idec. "Given the high unmet medical need in MS and the therapeutic benefit we have seen with TYSABRI, we are encouraged by these safety findings."

"The findings announced today are an important milestone in understanding the appropriate benefit-risk profile for TYSABRI.

Patient safety remains our top priority.

We are committed to finalizing the safety evaluation for Crohn`s disease and rheumatoid arthritis, which is progressing well and on track to be completed by the end of the summer.

We look forward to working with regulatory authorities to determine the path forward for TYSABRI," said Lars Ekman, MD, PhD, executive vice president and president, Research and Development, Elan.

[tippse]

es gibt auch eine (kultivierte) übersetzung der meldung:

***********************************************************
August 09, 2005 02:30 AM US Eastern Timezone

Biogen Idec und Elan veröffentlichen aktualisierte Daten über die Sicherheit von TYSABRI®

Redaktion Pharmazeutik/Wirtschaft/Gesundheit/Medizin/Biotech


CAMBRIDGE, Mass. und DUBLIN, Irland--(BUSINESS WIRE)-9. Aug. 2005--Biogen Idec (NASDAQ: BIIB) und Elan Corporation, plc (NYSE: ELN) meldeten heute, dass die Ergebnisse ihrer Sicherheitsprüfung von TYSABRI® (Natalizumab) bei Patienten mit multipler Sklerose (MS) keine neuen bestätigten Fälle von progressiver multifokaler Leukoenzephalopathie (PML) ergeben hat. Die Unternehmen hatten zuvor drei bestätigte Fälle von PML gemeldet, von denen zwei tödlich verlaufen waren. Derzeit findet eine Sicherheitsprüfung bei Morbus Crohn und bei rheumatoider Arthritis statt, die bis Ende des Sommers abgeschlossen sein soll. Die Unternehmen wollen die Daten Anfang Herbst 2005 bei den Zulassungsbehörden einreichen und planen derzeit den Neustart der klinischen Studien bei MS. Für die Teilnahme an der Sicherheitsprüfung kamen über 2.000 MS-Patienten aus klinischen Studien infrage, von denen bislang 91% an der Studie teilgenommen haben. Die verbleibenden 9% der Patienten nahmen nicht an der Sicherheitsprüfung teil. Insgesamt wurde bei 99% der an dieser Sicherheitsstudie teilnehmenden Patienten eine neurologische Untersuchung und bei 98% dieser Patienten eine Kernspintomographie durchgeführt. Zu der Sicherheitsprüfung gehörte auch die Durchsicht etwaiger Berichte einer möglichen PML bei Patienten, die TYSABRI außerhalb einer klinischen Studie als Handelsprodukt erhalten hatten. "Unsere derzeitige Sicherheitsüberprüfung von TYSABRI findet nach strengen medizinischen und wissenschaftlichen Kriterien statt und steht unter der Leitung einiger der weltweit führenden Experten auf den Gebieten der Neurologie und Neuroradiologie", so Whaijen Soo, MD, PhD, Senior Vice President, Medical Research, Biogen Idec. "In Anbetracht des bislang ungedeckten Bedarfs bei MS und der therapeutischen Vorteile, die wir bei TYSABRI festgestellt haben, werten wir diese positiven Sicherheitsdaten als sehr ermutigend." "Die heute veröffentlichten Befunde sind ein wichtiger Meilenstein zum Verständnis des angemessenen Nutzen-Risiko-Profils von TYSABRI. Die Sicherheit der Patienten ist und bleibt unsere oberste Priorität. Wir konzentrieren uns derzeit auf den Abschluss der Sicherheitstests für Morbus Crohn und rheumatoide Arthritis, die gute Fortschritte machen und voraussichtlich planmäßig bis zum Ende des Sommers beendet sein werden. Wir freuen uns auf die Zusammenarbeit mit den Zulassungsbehörden, wenn wir den weiteren Weg für TYSABRI festlegen", erklärt Lars Ekman, MD, PhD, Executive Vice President und Präsident, Research and Development, Elan. Am 28. Februar 2005 hatten Biogen Idec und Elan den freiwilligen Rückzug von TYSABRI vom Markt in den USA und den Stopp aller laufenden klinischen Studien gemeldet und damit auf Berichte über das Auftreten von PML, einer seltenen und potenziell tödlichen Demyelinisierungskrankheit des Zentralnervensystems, reagiert. Die umfassende Sicherheitsprüfung von TYSABRI und einer möglichen Verbindung zu PML durch Biogen Idec und Elan ist noch nicht abgeschlossen. Die Ergebnisse dieser Prüfung werden mit den Zulassungsbehörden erörtert, um die nächsten Schritte bezüglich TYSABRI festzulegen. Biogen Idec und Elan werden heute um 8:30 EST ein Webcast für die Medien und für die Investoren abhalten, um die neuen Daten zum Sicherheitsprofil von TYSABRI zu diskutieren. Der Zugang zu diesem Webcast erfolgt über die Seiten "Investor Relations" auf den Websites der Unternehmen.

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

Elan Corporation, plc ist ein im Bereich der Neurowissenschaften arbeitender Biotech-Konzern, der es sich zum Ziel gesetzt hat, das Leben von Patienten und ihren Familien zu verbessern, indem wissenschaftliche Innovation zur Deckung medizinischer Notstände weltweit umgesetzt werden. Elan wird an den Börsen New York, London und Dublin gehandelt. Weitere Informationen gibt es im Internet unter http://www.elan.com.

Safe Harbour Erklärung / Zukunftsweisende Aussagen Diese Pressemeldung enthält zukunftsweisende Aussagen über das Potenzial von TYSABRI, die zukünftige Zulassung, den Neustart der klinischen MS-Studien und die Sicherheitsprüfung von TYSABRI. Das Potenzial von TYSABRI, die zukünftige Zulassung und der Neustart der klinischen Studien mit TYSABRI unterliegen einer Reihe von Risiken und Unwägbarkeiten. Zu den Faktoren, die dazu führen können, dass die tatsächlichen Ergebnisse wesentlich von den derzeitigen Erwartungen der Unternehmen abweichen können, gehört beispielsweise das Risiko, das sich aus den Zusatzdaten oder Zusatzanalysen, einschließlich der derzeitigen Sicherheitsprüfung, Bedenken ergibt, oder dass die Unternehmen anderen unerwarteten Verzögerungen oder Problemen begegnen. Es gibt außerdem keine Gewährleistung, dass die Unternehmen ausreichende Informationen erhalten, um die Risiken in Verbindung mit TYSABRI hinreichend zu verstehen, oder dass die Unternehmen die Vermarktung und den Verkauf von TYSABRI wieder aufnehmen können. Der Abschluss der Sicherheitsprüfung unterliegt einer Reihe von Risiken und Unwägbarkeiten, darunter der Schwierigkeit der Analyse komplexer Daten und Ergebnisse und nicht vorhersehbarer logistischer Schwierigkeiten. Arzneistoffentwicklung und Kommerzialisierung sind mit einem hohen Risiko verbunden. Ausführlichere Informationen über die Risiken und Unwägbarkeiten in Verbindung mit der Arzneistoffentwicklung und anderen Aktivitäten der Unternehmen sind in den von Biogen Idec Inc. und der Elan Corporation, plc, 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.

Contacts


Ansprechpartner für Medien:
Biogen Idec
Amy Brockelman, [phone]
oder
Elan
Davia B. Temin, [phone]
oder
Elizabeth Headon, [phone]
oder
Ansprechpartner für Investoren:
Biogen Idec
Elizabeth Woo, [phone]
oder
Elan
Emer Reynolds, [phone]
oder
Chris Burns, [phone]

***************************************************************************

darüberhinaus gilt mein dank und meine anerkennung an "cyberhexe" - für einen der sachlichsten und informativsten threads, die w;o zur zeit hat.

tippse

[Cyberhexe]

...um 13.30 also 14.30 MESZ soll es angeblich eine Pressekonferenz geben...
anbei Davys Kommentar von Heute

Elan (ELN US)
Safety evaluation update—MS review complete, no additional PML cases found
Previous close: 800c Price target: 870c Analyst: [e-mail]
Elan and Biogen Idec have updated the market with a first update on its safety evaluation, specifically regarding MS patients
on Tysabri. The review has completed and no new cases of PML have been identified. 91% of trial patients participated in the
evaluation—99% of these had a neurological exam and 98% had an MRI exam. This is positive news for the product as Elan
positions it for re-entry to the market. The announcement is a clear signal to patients (and the FDA) of the companies` belief
that Tysabri can make it back to the market. As ever, the ultimate decision will rest with the FDA.
The evaluation of Crohns/RA patients remains ongoing and is on track to complete by end-summer. Though the MS
commercial pathway is more important, the safety profile of the other patients is as important for Tysabri in MS as it is in the
other indications.
The companies anticipate making regulatory submissions in early autumn, which we take to be formal presentations of data
and risk management programmes to the FDA. This is in line with our view that a possible regulatory decision on Tysabri
could be made around the end of 2005. Our forecasts still call for a mid-2006 launch which still looks eminently achievable.
This newsflow makes us more confident that Tysabri is being positioned for commercial re-launch. Our SOTP model implies
that a successful launch that meets our peak $1.6bn target would result in a share price return to mid-teen levels.
A conference call at 13.30 today will outline further detail.

[[KERN]Codex]

http://www.marketwatch.com/news/yhoo/story.asp?source=blq/yh…

BOSTON (MarketWatch) -- Elan Corp. shares rocketed Tuesday after the Irish pharmaceutical firm and U.S. partner Biogen Idec said a safety review of multiple sclerosis patients who took Tysabri revealed no new confirmed cases of a rare but fatal brain disease.



Elan (UK:ELA: news, chart, profile) (ELN: news, chart, profile) and Biogen (BIIB: news, chart, profile) have been conducting an exhaustive review of former Tysabri users to see if any have developed the brain disease PML, or progressive multifocal leukoencephalopathy. The companies said that an additional review of Tysabri patients who took the drug to treat Crohn`s disease or rheumatoid arthritis is expected to be completed by the end of the summer.

Elan soared 16% to $9.31, while Biogen spiked 6% to $40.73 in early trade.

To date, the companies have confirmed three cases of PML, two of which were fatal. Tuesday`s news discounts recent media reports that additional cases of PML had recently been discovered among former Tysabri users.

The companies withdrew Tysabri from the market and halted all clinical trials of the drug in February after detecting the presence of PML in two Tysabri users. The Food and Drug Administration approved Tysabri for the treatment of multiple sclerosis in November 2004.

Elan and Biogen said they are now taking preliminary steps to restart clinical trials in MS and will make submissions to regulators in the early fall. The companies also plan to meet later this fall with regulators to discuss the feasibility of putting Tysabri back on the market.

"I think it`s positive news for the stock of course, but it`s also a clear message to patients with multiple sclerosis that the companies are preparing to submit applications for the return of the drug to market," said Jack Gorman, an analyst with Davy Stockbrokers.

Gorman believes the earliest Tysabri could make a comeback would be early 2006.

"Confidence has increased that a return to market is possible," he said.

What is particularly good news, according to Olga Hartford, an analyst with NCB Stockbrokers, is that the announcement confirms there are no new cases in monotherapy treatment, meaning when Tysabri is used alone rather than in combination with another drug like Avonex.

Ian Hunter, of Ireland`s Goodbody Stockbrokers, said the news gives Elan and Biogen a much stronger position to take to the U.S. Food and Drug Administration.

"It also shows that the companies are now quite advanced in their capacity to diagnose PML," he said.

Multiple sclerosis is a chronic disease of the central nervous system that affects more than a million people worldwide. Symptoms may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

After the drug was withdrawn, shares of Biogen and Elan plummeted and Wall Street largely wrote off a comeback for Tysabri.

Three of the existing MS therapies are part of a class of drugs known as beta-interferons that require injections at least once a week.

[Cyberhexe]

Ich kann nicht glauben, dass Ty erst 2006 wieder am Markt sein soll...NCB schreibt heute folgendes:
We continue to believe that Tysabri as a monotherapy will be re-launched as a
treatment option for MS patients. We are assuming a re-launch in 2006. The key
catalyst from here is a positive outcome to the upcoming discussions with the FDA with
Tysabri returning to the market. Later on today (8.30 EST/1.30 BST) both companies
host a conference call/webcast to discuss the safety data from the Tysabri review. The
stock is high risk and speculative. We maintain our Buy recommendation

[Mr Ti]

hi cyberhexe,

aber kommt es auf ein paar monate an? die 4 monate machen es doch nicht, wenns passiert passierts. spekufrist noch gar nicht eingerechnet.
hauptsache ty kommt, dann ist mehr zeit um kursphantasien zu spinnen. und dann noch der rest aus der pipeline.

gruss der wartende ti-man

[Cyberhexe]

Hi Mister...natürlich hast du nicht unrecht....jedoch je schneller Elan die Kassen füllen kann, je eher wird das Unternehmen in der Lage sein, strategisch am Markt aktiv zu werden....denn derzeit ist das Personal, welches sich um die klinischen Studien kümmert wohl nicht ausgelastet und da KM 2004 angekündigt hatte, dass man dieses Defizit mit Einlizenzierungen oder Übernahmen kompensieren möchte/würde, ist eine schnelle Wiedereinführung von Tysabri natürlich willkommen...zudem je länger Tysabri konkurrenzlos am Markt etabliert ist, um so grösser ist der Erfolg...und die derzeitigen Wirkstoffe scheinen nicht ebenbürtig zu sein...in 4 bis 5 Jahren wird sich dies sicherlich geändert haben...

zudem kann ich mir nicht vorstellen, dass man noch 5 Monate benötigt, um Ty wieder zuzulassen...was soll sich in dieser Zeit ändern?
Der Review ist nun fast abgeschlossen und die Fakten sollten auf dem Tisch liegen. Und die MS-Patientenschar beginnt so langsam Druck auszuüben auf die FDA (über Kongress- und Senatsabgeordnete)...siehe folgender Aufruf-->

8/7/05

Tysabri Talking Points and Contact Information

The following Senators and Representatives have either co-sponsored drug safety legislation or otherwise expressed concern about FDA permitting unsafe drugs to remain on the market. I am particularly concerned that these individuals are largely the reason the FDA may act slowly in reviewing and resolving the Tysabri issues. If enough people can write these Senators and Congressmen to educate them on the Tysabri issue, and ask them to contact the FDA to urge the expeditious review of Tysabri, it might cut a few weeks or even months off the FDA review.

The following talking points which can be used as a starting point to draft letters to each of these individuals, but feel free to draft your own form letter, making it as individualistic as possible, then send it to everyone on this list, as well as your own two senators and congressman.

I suggest you fax your letters, if possible, as mail is usually delayed due to security issues (I do not have all the fax numbers, but will try to get them tomorrow and post this list again). Also, you might send an email or use the email web forms provided.

Important: Please get your friends and family members to send their own letters, even if you have to take care of faxing them or typing the envelopes. If each of us is responsible for getting ten others to do this, we could generate hundreds of letters.

You can get the names and addresses of your own Senators and Representatives at:

www.senate.gov

www.house.gov

Senator Chuck Grassley
135 Hart Senate Office Building
Washington, DC 20510-1501
[phone]
Web Form: grassley.senate.gov/webform.htm

Cosponsor of S.930 (see below)

Senator Christopher J. Dodd
448 Russell Senate Building
Washington, DC 20510
Fax [phone]
Web Form: dodd.senate.gov/webmail/
Cosponsor of S.930

Senator Jeff Bingaman (NM)
703 Hart Senate Office Building
Washington, DC 20510
Fax [phone]
E-mail: [e-mail]

Cosponsor of S.930

Senator Lincoln Chafee (RI)
|141A Russell Senate Office Building
Washington, DC 20510
202.224.2921
Web Form: chafee.senate.gov/webform.htm

Cosponsor of S.930

Senator Thad Cochran (MS)
113 Dirksen Senate Office Building
Washington, DC 20510
202.224.5054
Web Form: cochran.senate.gov/contact.htm

Cosponsor of S.930

Office of Senator Michael B. Enzi (WY)
379A Senate Russell Office Building
Washington, DC 20510
Toll Free Phone: [phone]
Phone: [phone]
Fax: [phone]
Web Form: enzi.senate.gov/email.htm

Office of Rep. Maurice Hinchey
2431 Rayburn H.O.B.
Washington, DC 20515
Phone: [phone]
Fax: [phone]
Web Form: http://www.house.gov/hinchey/contact/

Sponsor of H.R. 2090, FDA Improvement Act of 2005 (see below)

Office of Rep. Edward J. Markey (MA)
2108 Rayburn House Office Building
Washington, DC 20515
Fax [phone]
etc.etc.

[UserX5]

Goodbody Ups Elan Shr Price Target To $11.15

Stockbrokers ups Elan`s (ELN) share price target to $11.15 from $10.00 after it said Tuesday it`ll submit data and filings to the FDA in early fall/late summer. However, Goodbody cautions the stock is still a high risk, speculative play until Tysabri completes the FDA review process and the FDA rules on its progress. Maintains buy.

[Cyberhexe]

Davy Stockbrokers: Starting Points

Elan (ELN US)
Increased visibility on Tysabri safety evaluation; what we have seen to date makes us more
confident that it can return to market
Previous close: 909c Price target: 870c Analyst: [e-mail]
Increased visibility on the Tysabri safety evaluation has emerged and what we have seen to date makes us more confident
that Tysabri can return to market. Increasingly, the question now is what commercial impact such a return could generate.
Our revenue-based SOTP model implies that a successful launch, which meets our existing target of $1.6bn in peak revenues,
results in a share price target of just over $13 per share. The share price at the time of writing ($9.35) implies peak revenue
potential of just under $1bn per annum, again based on our SOTP methodology.
The revenue potential of Tysabri will depend to some extent on the label restrictions that may be agreed with the FDA.
However, that is not the only factor: the availability of credible alternative therapies is another key issue and plays on the
theme of patient choice.
For further detail, see our research note issued August 9th.

[Cyberhexe]

es gibt doch auch Journalisten, die langsam begreifen welch Potenzial in diesem Unternehmen schlummert...J.Uldrich bspw. hat begriffen, dass die patentierte NanoChrystal Technology von Elan eine Geldmaschine sein wird...


Does NanoCrystal Ball See All?
By Jack Uldrich
August 10, 2005

Shares of Elan (NYSE: ELN) and Motley Fool Stock Advisor recommendation Biogen Idec (Nasdaq: BIIB) jumped 14% and 7%, respectively, on yesterday`s news that a recent Elan study found no new confirmed cases of the brain disease
.....

But in spite of these things, I am long on Elan. In fact, I own shares of the company. It has little to do with Tysabri, though. What I really like about the company is its NanoCrystal Technology, which takes advantage of the unique properties of nanoparticles to help improve the bioavailability of any number of drugs.

http://www.fool.com/news/commentary/2005/commentary05081014.…

[Cyberhexe]

anbei noch die Korrektur von J.Uldrich zu seinem veröffentlichten Artikel in TMF, in welchem er ursprünglich von 3 PML-Todesfällen berichtet hat...

Wednesday, August 10, 2005
Important Correction Re: Elan
In today`s Motley Fool, I had an article discussing Elan. In the body of the article, I made one serious mistake (I have already asked TMF to issue a correction) and a second issue should have been elaborated on.

The mistake is regarding the number of patients who have died from Tysabri. I said the number was three, but it should have two ... and, quite possibly, even one.

The second PML case was diagnosed on a Crohn`s patient, who already passed away but whose death was initially misdiagnosed and attributed to Tysabri. The person is now believed to have died of another illness.

In each case, it is also important to note that the PML was complicated by the fact that all 3 patients were either on AVONEX or some other immunosuppressive therapy. That is ... they were taking other drugs in addition to Tysabri.

When used as a monotherapy, the number of PML cases or deaths attributed to Tysabri is zero.

I still stand by stock recommendations ... but these facts could easily lead investors to a conclusion other that which I reached.

The second point I want clarify in the article relates to this sentence: "Yesterday`s increase seems to reflect a more balanced and appropriate response. This is because if and when Tysabri receives new FDA approval, its use will be limited to those MS suffers who have no alternative treatment."

I should have said "its use will probably be limited." The comment was based on my belief that the FDA tends to be fairly conservative with drugs when there is a known alternative and, as such, will likely limit its use to those MS suffers for whom there is no other alternative.

It is important to note that this is my opinion and does not reflect a definitive statement ... although it reads like one ... and, for that, I apologize.

As always, I encourage my readers to do their own due diligence ... and this article aptly demonstrates why!

Related Links:
Nanotech Investors: Keep Your Eye on the Prize
Starpharma "Nano" star on the rise?
Elan Good News for Nanotech Investors?
pSivida: Down Under Comapny has Big Upside Potential
Sincerely,

Jack Uldrich
posted by Jack Uldrich at 7:19 PM 0 comments

[loseit]

Hi cyberhexe,

siehst du irgendeinen sachlichen Grund für den andauernden Sinkflug? Dass Elan sein eigenes Medikament für sicher hält, war sicher keine 20% wert, und die gehen jetzt auch flöten.
Aber jetzt muesste doch mal gut sein, wenn sich nix geändert hat??
Gruss Loseit!

[Cyberhexe]

ich bin mir ziemlich sicher, dass da einige Grössen noch nicht vollständig eingedeckt sind und mit ihrer Marktmacht den Kurs unten halten...so hat kürzlich ML angeblich ...wieviel waren das nochmal...5Mio Aktien gekauft, obschon Elan derzeit mit einem sell rating bedacht ist. Zudem bin ich mindestens mittelfristig orientiert, so dass ich kurzfristige Schwankungen ignoriere, zumal wenn diese fundamental unbegründet erscheinen.

Aber wir könnten ja eine Spielerei starten und für Elan
den Jahresschlusskurs in NY vorhersagen...also ich wage mich mal aus dem Fenster...
Elans Jahresschlusskurs (2005) in NY... $ 17.90

[welke91]

was ist der Einsatz???

wenn ich verliere sollte, Spende ich für den Niger.
Wenn ich gewinnen sollte, Spende ich für Liberia.Im August, nach dem Rücktritt von Liberias Präsident Charles Taylor, unterzeichneten die kriegführenden Parteien ein Friedensabkommen, das zu einer Übergangsregierung und Entwaffnung führte.
ÄRZTE OHNE GRENZEN konnte in verschiedenen Teilen des zerstörten Landes die Arbeit in Krankenhäusern und Gesundheitszentren wieder aufnehmen.

Mein Tipp 30 Dez. 05 24,89 99 $$$$$
30 Dez. handel die doch noch oder???

[[KERN]Codex]

Ich tippe auf 16,45$

[Cyberhexe]

...was ist der Einsatz?....wie immer....10% für karitative Zwecke

good luck
ch

[Cyberhexe]

...Forbes geht davon aus, dass Tysabri kein Blockbuster-Potenzial erreicht


Tysabri Is No Blockbuster
Matthew Herper, 08.09.05, 2:17 PM ET

NEW YORK - Shares of Biogen Idec and Elan soared on Tuesday as the companies said they had completed part of a safety review of their multiple sclerosis drug Tysabri--a medicine that has been demanded by some patients since it was pulled by the companies in February.

But some doctors and analysts still say it is important to be cautious about the meaning of the safety review--especially since scientists are still combing through data testing Tysabri in Crohn`s disease, a gastrointestinal disorder, and rheumatoid arthritis.

Biogen (nasdaq: BGEN - news - people ) and Elan (nyse: ELN - news - people ) have finished the safety review of the drug they began when they pulled it from the market on Feb. 28, after it was linked to a rare brain disorder. They`ve found no new cases of progressive multifocal leukoencephalopathy. In all, they say, there have been three confirmed cases of PML in Tysabri patients, two of them in subjects with multiple sclerosis and one in a subject with Crohn`s disease. In all, 2,000 multiple sclerosis patients were included in the review.

"It`s good news that there are no new cases," says Igor J. Koralnik, director of the HIV/Neurology Center at Harvard`s Beth Israel Deaconess Medical Center and an expert on PML. "But it`s not surprising because the medicine had been stopped."

As a scientist and a physician, Koralnik says, he would like to see all the data before drawing any conclusions about Tysabri`s risks.

Two cases of PML that were reported in the press were not confirmed in the final review. Says Alex Hittle, an analyst at A.G. Edwards: "It`s really a case of `no news is good news.`"

Especially important is the fact that all three patients who had contracted PML were on other drugs aside from Tysabri. PML seems to occur when a dormant virus--called the JC virus--takes advantage of a weakened immune system. Tysabri is linked to the PML cases, but the MS patients were also taking Avonex, another Biogen drug. The PML patient with Crohn`s had taken other drugs that suppress the immune system.

"I think the odds of it getting back to market are looking better and better," says Hittle. "It seems that it`s a side effect that`s associated with some additional impairment to the immune system," he says.However, earlier this year, many analysts expected Tysabri would take over the MS market, effectively sidelining competition from Teva (nasdaq: TEVA - news - people ) and Serono (nyse: SRA - news - people ). That, Hittle says, is unlikely to happen. The PML issue could make it, "a real medicine of last resort."

Biogen and Elan say that they are taking preliminary steps to restart clinical trials of Tysabri in MS, which could help further define the drug`s benefits and risks. Executives on a conference call were optimistic that Tysabri might return to the market for some patients. "We`re encouraged that it will be coming back to the market," said James Mullen, chief executive of Biogen Idec.

Despite Mullen`s optimism, there is still room for doubt on Tysabri. On a conference call with analysts at Sanford C. Bernstein last week, Daniel Wynn, a multiple sclerosis investigator, said that most patients being evaluated for safety were not given spinal taps--the most conclusive test for PML and the virus that causes it. Based on today`s conference call with the companies, Wynn appears to have been correct.

"I think they are being very cautious on their language," says Geoffrey Porges, the biotech analyst at Bernstein. "The companies have said that there are `no new confirmed cases`, not `no new potential cases.`"

Porges says he would still like to know how many patients who did not have spinal taps had suspected cases of PML. "I think we are still several steps away from a final decision," Porges says, "but this is now set up for a showdown with the regulatory agencies with patients and the companies on one side and safety oversight and caution on the other side."

[Cyberhexe]

MSAA ist eine nicht kommerzielle nationale Organisation (NGO), die MS-Patienten zu den Problemen des täglichen Leben kompetente Informationen zur Verfügung stellt.
Gestern nun hat diese Organisation auf ihrer Homepage einen Tysabri update präsentiert, der die jüngsten Ergebnisse bei der PML-Problematik richtigstellt. So langsam scheint die Info auch an der Basis anzukommen.


http://www.msaa.com/articles/article34.htm

RevisedTysabri Update: No New Cases of PML; Re-release Possible; Potential Risks Still a Concern
August 18,2005

Good News for Patients Previously on Tysabri… No new cases of PML

Biogen Idec and Elan Corporation, makers of Tysabri® (natalizumab), have conducted a safety evaluation of patients who previously took Tysabri. Any unusual responses to the drug are being investigated and reported to the FDA. Three cases of progressive multifocal leukoencephalopathy (PML) have resulted in two deaths so far in patients on Tysabri. PML is an often-fatal brain disorder thought to be caused by the activation of a virus known as the “JC Virus.”

According to a press release from Biogen Idec and Elan, dated August 9, 2005, no new confirmed cases of PML have been discovered. Almost 2,000 MS patients from clinical trials participated in the safety evaluation. With no additional cases of PML among patients exposed to Tysabri, Biogen Idec and Elan are taking preliminary steps to restart clinical trials in MS.

[Cyberhexe]

interessant...CEO Kelly Martin hat sich seine Bedingungen im falle eines unfreiwilligen Ausstieges verbessern lassen...das riecht nach einer möglichen Übernahme

http://www.ireland.com/cgi-bin/dialogserver


The chief executive of struggling biotech firm Elan has negotiated improved severance terms with the company in the event of a takeover.

Any change of control at the helm of the Irish drugs company that leads to Kelly Martin`s dismissal as chief executive will cost the company almost $5 million (€4.11 million).

Under his initial contract, Mr Martin was entitled to severance payments amounting to two times his salary and bonus in the event of his "involuntary dismissal". However, a new agreement filed with the US Securities and Exchange Commission (SEC) this week has extended the period of severance payments to three years.

The deal, signed only last week, amends Mr Martin`s position in the event of a "change in control" at the company. It will be triggered should Mr Martin`s employment be terminated following such a move.

The improved terms will also be activated should the company enter an agreement up to 90 days after his removal from office that leads to a change of control of the company.

Speculation about Elan`s future mounted after the company`s decision - taken jointly with its partner Biogen in February - to suspend sales of Tysabri, the multiple sclerosis (MS) treatment on which the company had pinned its future.

Mr Martin has consistently stated his intention to remain at the helm of the company.

He has also repeatedly expressed his confidence that Tysabri, which had shown itself to be far more effective than previous treatments for MS, would return to the market.

Elan and Biogen have recently concluded a review of data on more than 2,000 multiple sclerosis patients after three patients taking part in trials of Tysabri contracted a rare and generally fatal neurological condition - progressive multifocal leukoencephalopathy (PML).

The companies expect to meet officials from the regulator, the Food and Drug Administration, in the next month to determine the prospects for a resumption of sales of the drug. Both groups have taken steps to prepare for a resumption of patient trials of the drug, which were also suspended in February.

Mr Martin was appointed in January 2003 as Elan recovered from an earlier stock market collapse triggered by concerns over its accounting, which themselves raised concerns about the company`s future independence.

The agreement filed this week contains a new provision covering the payment of legal fees in the event of a dispute over the severance terms.

It also modifies certain other elements of Mr Martin`s pay package.

The Elan chief will retain rights to benefits under the company`s health and medical plans for the full severance period or until such time as he takes up other employment.

He will be able to exercise any outstanding share options immediately upon "involuntary termination" of his contract and for two years thereafter.

The agreement provides that Elan will have to continue paying his severance benefits to his estate in the event of his death within the three-year period following any dismissal as a result of a change in control at the company.
© The Irish Times

[Cyberhexe]

auch NCB berichtet heute von den Änderungen in den Vertragsbedingungen von Elans CEO...diese Übereinkunft erhöht die Wahrscheinlichkeit einer Übernahme in den nächsten Jahren...


Chief Executive Agrees New Severance Package in Event of a Takeover
• Press reports today indicate that the chief executive of Elan, Kelly Martin, has
negotiated improved severance terms with the company in the event of a takeover.
• Under his initial contract, in the event of his "involuntary dismissal, Mr Martin would
receive a severance payment of two times his salary and bonus. However, a new
agreement filed with the SEC this week has increased this to three years.
• The deal, signed only last week, amends Mr Martin`s position in the event of a "change
in control" at the company. It will be triggered should Mr Martin`s employment be
terminated following such a move.
• The agreement also contains a new provision covering the payment of legal fees in the
event of a dispute over the severance terms. In addition, Mr Martin, will retain rights to
benefits under the company`s health and medical plans for the full severance period or
until such time as he takes up other employment and he will be able to exercise any
outstanding share options immediately upon "involuntary termination" of his contract
and for two years thereafter.
• This agreement seems to lay to rest any recent speculation of the future of Kelly Martin
as CEO, it may also lead the market to put a higher probability on a takeover of the
Group over the next couple of years.
Orla Hartford [phone] [e-mail]

[Cyberhexe]

für ein mögliches Übernahmeszenario kommen meines Erachtens lediglich die beiden Kooperationspartner Biogen (Tysabri) und Wyeth (Alzheimer-Projekt) in Frage, da bei einer Übernahme durch ein 3.Unternehmen die jeweiligen Projekte von den Kooperationspartner vollständig übernommen werden...dann blieben lediglich die anderen eingeführten Produkte (Prialt, Azactam und Maxipime) das "Drug Delivery"-Geschäft sowie die patentierte NanoChrystal Technology...obschon diese Geschäftsteile hoch profitabel sind, glaube ich nicht, dass deswegen eine Übernahme geplant werden dürfte...
ich hoffe jedoch, dass Elan mindestens so lange die Selbständigkeit bewahren kann, bis sich zumindest ein Teil dieser vielversprechenden Aktiva im Börsenkurs manifestiert hat

good luck
ch

[Cyberhexe]

...na...wenn an diesem Gerücht wirklich etwas Wahres dran ist, dann wirds bald losgehen...

good luck
ch

fasten your seat belts!


http://www.thebulltrader.com/2005/08/06/speculating-on-tysab…

Speculating on Tysabri Trials

on friday, i jumped back into ELN with a purely speculative position because of some new information that i picked up. i came across several posts on the yahoo msg board stating that tysabri patients are known to relapse 6 months after treatment is halted. i verified this information by searching through ThisIsMS, a multiple sclerosis community which is pretty unbiased.

in this article, the author states that: "Previous studies (Phase II) showed that patients who were taken off of Tysabri treatment had relapses begin recurring after about 6 months– though there was no rebound above the level seen in the placebo patients. Therefore, the FDA will theoretically be aware that MS patients in the Tysabri trials before the marketing suspension are reaching the point where they should begin relapsing. As such, there is a sliver of hope that re-dosing of former Tysabri clinical trial patients could begin by early September 2005. To be clear– This is SPECULATION. However, note that it is easier to restart clinical trials then it is to re-introduce the drug to the general market."

this is interesting. the 1808 trials were suspended around february 28th. today is august 6th, a little bit more than 5 months since tysabri was pulled. august 28 will mark 6 months since tysabri infusions were halted.

both elan and biogen made it very clear in the Q2 conference calls that they plan to resume clinical trials for patients who are at high risk. therefore, if the FDA’s interest is to put patients first, there is a chance that they will try to resume trials before the august 28th. the reasoning is that the FDA will be criticized if they delay the resumption of trials if patients in the 1808 study relapse since the FDA (according to ThisIsMs) is aware of the 6-month relapse statistic.

of course, like i said, this is highly speculative, but according to elan/biogen, its really just a matter of weeks before trials resume. i’m not sure if trials will just restart all of a sudden, or if eln/biogen will need to submit any formal requests/data before the FDA gives an OK.

i was burned by this stock last week when i was speculating on their Q2 CCs, so i’ll be speculating carefully. good luck.

[Cyberhexe]

..aber dennoch stimmt es mich nachdenklich, dass GA 200.000 Stück gerade jetzt verkauft hat....wenn die Zulassung so kurz bevor stünde, dann hätte der doch zugewartet...naja

[welke91]

Hy Cyberhexe, keep cool "GA`r" hat noch genügend Aktien auf der Tasche.

Former Elan chairman sells 200,000 shares
Elan’s former chairman, Garo Armen, sold off 200,000 shares on
Monday at a price of $8.25 after exercising 200,000 options. The
transaction leaves Armen with 270,000 shares left in the company
and also has options over a further 875,000 shares.

Der braucht sicher ein neues SUV, oder muss seiner Schwiegertochter ein dickes Hochzeitgeschenk machen.

Übrigens Zen ist in den Flitterwochen

grüße

[Cyberhexe]

...dieser Bericht ist zwar schon etwas älter (5.August 2005)...jedoch werden einige Journalisten und auch Analysten so langsam auf das Nanotech-Potenzial bei Elan aufmerksam!


http://www.physorg.com/news5646.html


"More pharma giants will seek such capabilities as the impact of initial successes like American Pharmaceutical Partners` Abraxane kicks in and as reformulators like Elan deliver more winning products," Lackner added. "Companies that enter this underserved field with low-cost deals to prove their worth will transform themselves into long-term partners deserving premium prices."

[Cyberhexe]

na endlich...Neuigkeiten von der Alzheimer-Front...das Vaccin ACC-001 soll im September in die Klinik gehen (Phase I)



http://www.palmbeachpost.com/business/content/business/epape…


Delray neurologist to test Alzheimer`s vaccine
By Stephanie Horvath

Palm Beach Post Staff Writer

Monday, August 22, 2005

A Delray Beach neurologist is one of five doctors in the country testing a new Alzheimer`s vaccine in a clinical trial.

The vaccine, made by Elan Pharmaceuticals in Dublin, Ireland, should prompt the body to produce antibodies that will attack plaque that forms in the brain of Alzheimer`s patients. Dr. Mark Brody, a principal investigator, said no one is certain that the plaque is the primary cause of the memory loss and mental degeneration, but it forms where memory is stored and processed.

More business news
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Starting in September, Brody and his staff at Brain Matters Research will inject the vaccine into 12 patients with mild to moderate Alzheimer`s in the first phase of the clinical trial. New drugs go through three phases of trials before makers seek Food and Drug Administration approval.

Brody said the trial will last two years, during which he`ll evaluate patients with medical scans and exams as well as tests that assess memory, processing speed and judgment.

"Eventually, if we show a treatment is effective in people who have the disease, eventually we will start to treat people with pre-Alzheimer`s," Brody said.

[Cyberhexe]

...nichts neues, aber die Schar der Journalisten fischt halt immer noch im Trüben bzw. denen fehlt der Blick in die Zukunft...the troubled Irish drug company




Elan chief in line for £7m payoff

Heather Tomlinson


Friday August 26, 2005
The Guardian


A leading shareholder group has criticised the troubled Irish drugs company Elan for increasing the amount its chief executive could receive in a takeover bid to some $13m (£7m).
Elan has changed the contract of its boss, Kelly Martin, to pay him three years` salary and bonuses if the company is taken over.

City investors dislike such large multiples because it can lead to "payment for failure" if a company is bought at a cheap price when distressed.


http://www.guardian.co.uk/business/story/0,3604,1556688,00.h…

[Cyberhexe]

die alles beherrschenden Überschriften zu TYSABRI seit Black Monday im Zeitraffer:



I. Black Monday (28.2.2005 Tysabri wurde freiwillig vom Markt genommen)

a. One PML patient and one suspected PML patient later to be confirmed
b. 36 and 28 months of combo therapy
c. failed avonex treatment
d. steroids were used
e. months of steroids for patient that died, not for survivor
f. clinical suspicion for PML aroused
g. Tysabri mono and combo therapy pulled from market
h. Tysabri trials suspended
i. Why the new drug suspension reaction?
j. Implications

II. March 31
a. Third PML patient – Crohn’s disease trial
b. Died in 2003, was diagnosed as astrocytoma
c. Transient immune suppression since 1996 – PML risk
d. Remicade for 18 months – PML risk
e. AZA for 6 years – PML risk
f. How long was patient treated for Crohn’s
g. Previous treatments – cause for bone marrow weakness/failure?
h. Implications

III. AAN – AFFIRM (Phase III-Studie zu Natalizumab-Mono)
a. Continuation of 1 year exceptional efficacy results
b. No more PML cases
c. No signs of immune suppression
d. Excellent side effect profile
e. Anecdotal reversal of MS disabilities

IV. June 30 – Crohns induction trial
a. Success as an induction agent
b. Very safe
c. Side effects similar to placebo
d. Previous efficacy as a maintenance therapy for Crohns

V. July 18 – SENTINEL (Ph-III Kombi-Studie mit Avonex)
a. Affirmed efficacy of Tysabri
b. What do the results mean- avonex a help or a hinderance?
c. Immune suppression noted?

VI. August 9 – MS safety review
a. No more PML cases

VII. Mono versus Combo Tysabri
a. Tysbari monotherapy
i. Excellent efficacy
ii. Side effects like placebo – much better than others
iii. Reversal of disability
iv. No more fatigue, itching, and spasms
v. What does quality of life mean
b. Avonex causes Tysabri overdosing
c. Avonex and Tysabri synergies – may layers of overlap
i. Avonex reduces VCAM-1
ii. Avonex reduces VLA-4 expression
iii. Avonex increases sVCAM-1
iv. Avonex causes reduction of Tysabri clearance
v. Avonex causes increases of Tysabri half-life
vi. Avonex reduces LFA-1 expression
vii. Avonex causes Th2 to Th1 T helper cell shift
viii. Beta interferon causes lymphopenia (2%)
d. Why immune suppression so rare

VIII. The competitors
a. Beta interferons
i. Does it work long term?
ii. Why so many quit
iii. The debilitating side effects
iv. Liver
v. Depression suicide
vi. Rare events
Is there PML in the past? Did anyone look?
b. Copaxone
i. Injection side necrosis
ii. Flu-like side effects
iii. Lymph node enlargement
iv. Rare events
c. Novantrone
i. Malignancy and death
ii. PML?
d. Cellcept
i. Infections
ii. PML?
e. Enbrel
i. Infections and deaths
ii. Demyelinating events
iii. Heart failure
iv. Malignancy
f. Remicade
i. Infections and deaths
ii. Demyelinating events
iii. Heart failure
iv. Malignancy

IX. The MS patients

X. The “fake” PML cases
a. Krasner – cooked from a adverse event report
b. Reuters #5 – another cook job
c. The new #4 – unconfirmed and one dose of tysabri
d. Tysabri use and an asteroid hitting the earth

XI. PML
a. Before AIDS – long term and severe immune suppression
i. Lupus
ii. CLL – B cell
iii. Transplant
iv. Immune suppression
v. Chemotherapy
vi.
b. HIV/AIDS
i. Only 5% and only when T cell are very low
ii. Deaths from other causes
iii. T cells are protective
iv. Strain differences
v. Antibodies
c. Recent
i. Tysabri combo cases
ii. Hypogammaglobulinemia
iii. Complement Deficiency
iv. Hyper-IgM syndrome
v. Combined variable immune deficiency
vi. Antibodies

XII. The future
a. Efficacy versus risk
i. Remicade – a poster child for biologics
ii. How much risk can the FDA bear
iii. Tysabri unmet medical need, fantastic efficacy, no risk, what?
b. Is combo risk really monotherapy risk?
i. Drug adverse interaction is not risk of the single drug
c. Reducing the risk or wasting money
i. Testing CSF is somewhat diagnostic, not predictive
ii. Testing blood for JC virus – why and why not
iii. PML needs immune suppression, obvious?
d. The resolution

[Cyberhexe]

Mitoxandron ist ein Zytostatikum von Serono, welches sowohl bei relapsing/remitting MS als auch bei Sekundär-progressiver MS verabreicht wird. Die Nebenwirkungen sind bei solchen Zytostatika natürlich beträchtlich. Unter anderem ist Leukämie eine möglicher Nebeneffekt

Arq Neuropsiquiatr. 2005 Jun;63(2A):327-9. Related Articles, Links

Acute myeloid leukaemia induced by mitoxantrone: case report.

Arruda WO, Montu MB, de Oliveira Mde S, Ramina R.

Instituto de Neurologia de Curitiba, Curitiba PR, Brasil. [e-mail]

Mitoxantrone (MX) is an immunosupressant drug used in secondarily progressive multiple sclerosis (SPMS) and in relapsing-remitting multiple sclerosis (RRMS). It has a leukemogenesis potential induced by cytogenetic abnormalities, though with a low incidence. Promyelocitic leukaemia (type M3) and other forms of acute myeloblastic leukaemias (M4 and M5) have been described in a few MS patients who received MX during their treatment. We describe a white female patient, 47 year-old, with SPMS (EDSS = 4) with 14 years of disease. She received MX during her disease and developed acute promyelocytic leukaemia (M3), with severe thrombocytopenia 30 months later. She ultimately died due to intracerebral hemorrhage. Other cases of treatment related to AML are reviewed and discussed.

[moneyseeker]

Ach so !

[Cyberhexe]

...hoch interessant,was man auf dem EYMB so alles findet:

da hat jemand die FDA-Datebank gescannt, in welcher die Arzneimittel-Todesfälle gespeichert werden. Unter der #5756178 ist u.a. folgender Eintrag zu finden:

FDA AERS Case #5756178
======================

Reaction - Preferred Term: JC VIRUS INFECTION
Outcome: Death
Reported by: Consumer

Drug: Avonex [Primary Suspected]
Other Drugs: None reported

Gender: Female
Age: Not reported

Event Date: 2004-01-19
Death Date: 2004-04-30
Report Date: 2005-03-01
FDA Date: 2005-03-02

Indication & Therapy not supplied

Image of ISR for FOIA: 4599260-6

Ein PML-Fall bei einer Avonex-Monotherapie und dieser wurde der FDA erst am 1.3.2005 mitgeteilt!
Es sei daran erinnert, dass in der Natalizumab-Monotherapie bisher keine PML-Fälle aufgetreten sind und in Anbetracht dessen, dass Natalizumab mit Abstand am meisten Remissionen über die Zeit ermöglicht, sollte eine Entscheidung nicht noch viele Monate dauern. Also ich bin zuversichtlich, dass Ty spätestens Ende Oktober wieder am Markt ist.

[Cyberhexe]

Das könnte ja langsam zu einem Wirtschaftskrimi ausarten.
Ein PML-Fall nach der Behandlung mit Avonex in Monotherapie wurde bereits gemeldet...allerdings erst 13 Monate danach. Es wird natürlich nun vermutet, dass es noch weitaus mehr PML-Fälle gegeben hat...
Die Problematik der nebenwirkunegen bei der Behandlung mit Interferonen ist zudem schon länger bekannt. Im beigefügten Artikel vom 19.12.2003 werden u.a. schwere Leberschäden diskutiert. Ich kann mir nun wirklich nicht vorstellen, dass das wirkungsvollste Präparat mit einem Nebenwirkungsprofil im Plazebobereich und "Null" PML-Fälle in Monotherapie nicht wieder auf den Markt zurückkommen soll. Die Interferon-Hersteller scheinen jedoch nichts unversucht zu lassen....(da halt ich mich mal zurück; den satz kann jeder für sich zu Ende bringen; vielleicht könnte man dabei das Eingangsvokabular unterbringen!).


Health Canada issues warning of MS therapy


TORONTO — Health Canada is warning health-care professionals of the risks of using beta-interferon therapy for the treatment of multiple sclerosis.

Serious liver injury such as hepatitis has been linked to beta-interferon therapy, including three cases of liver failure that required liver transplantation, the department said in a release. Serious liver injury is considered rare, with cases mostly occurring in the early months of therapy but also in patients on therapy beyond one year, it noted.

The department reminded treating physicians they should perform periodic liver function tests, particularly in the early months of therapy, and patients receiving beta-interferon products should be aware of the signs and symptoms of liver injury.

Those symptoms include yellowing of the skin or eyes (jaundice), nausea and vomiting, easy bruising of the skin, diffuse itching and abdominal pain.

Beta-interferon is one several treatments some people with multiple sclerosis take to try to reduce the frequency and severity of MS attacks.

The beta-interferon treatments are marketed under the names Avonex, made by Biogen Idec Canada; Betaseron, made by Berlex Canada and Rebif, made by Serono Canada.

A spokeswoman for the Multiple Sclerosis Society of Canada said specialists and the patients they treat have likely been aware of these risks.

"Yes, it certainly is known. But whether or not a GP (general practitioner) would have that top of mind, that`s something I would not be able to answer," Deanna Groetzinger said.

"It`s a simple thing to monitor, but you have to do it."

Health Canada said MS patients receiving beta-interferon therapy who experience any of the above symptoms should contact their doctors immediately.

http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/10718412…

[Cyberhexe]

übrigens AERS = "Adverse Effect Repoorting System", es handelt sich hierbei um eine Datenbank der FDA, in welcher alle bekannten Fälle mit Nebenwirkungen von Medikamenten hinterlegt sind. Einer vom EYMB (Elan Yahoo Member Board) hat diese Datenbank in mühevoller Kleinarbeit durchforstet und hat den unten geschilderten PML-Fall (#330) bei einer mit Avonex therapierten Patientin entdeckt. Berichtet wurde darüber am 1.3.05 (Todestag war der 30.4.04), also genau 1 Tag nach Black Monday! Allerdings war dieser Fall nicht in den Schlagzeilen.



http://www.fda.gov/cder/aers/default.htm

[Cyberhexe]

Am 6.10.05 hält Elans Nobelpreis verdächtiger Alzheimer-Experte Dale Schenk einen Vortrag mit dem Thema: "Behandlung von Alzheimer - der Beginn eines neuen Zeitalters"
Zuvor wird im September das Vaccin ACC-001 in die Klinik gehen (Phase I). Der Antikörper AAB-001 befindet sich zudem bereits in Phase II, wobei erste Ergebnisse jedoch nicht vor Ende 2006 zu erwarten sind. Da jedoch die Theorie (Verhinderung der Plaquebildung im Gehirn) bereits durch den Vorgänger von ACC-001, nämlich AN-1792, unter Beweis gestellt wurde, könnten sowohl mit dem Antikörper als auch dem modifizierten Vaccin spektakuläre Erfolge möglich sein.

http://www.aging-institute.org/i/isoa/c20051006_agenda.pdf

Institute for the Study of Aging (ISOA)
6th annual Alzheimer’s Disease Drug Discovery
Conference
Preliminary Agenda
DAY 1 – Thursday, October 6th, 2005
7:30-8:00 am Registration & Coffee
8:00-8:10 am Welcome & Opening Remarks
Howard Fillit, MD, Executive Director, ISOA
8:10-8:40 am Plenary Speaker 1
Dale Schenk, PhD
Elan Pharmaceuticals
"Treatment of Alzheimers Disease: The beginning of a new era"

[Cyberhexe]

momentan gibts jede Menge Störfeuer; Bostons Jeffrey Krasner hat sich heute auch wieder zu Wort gemeldet...und der negative Tenor ist immer derselbe...obschon sogar die Miesmacher nun nicht mehr an der Rückkehr von Tysabri zweifeln

MS drug`s predicted sales are lowered
By Jeffrey Krasner, Globe Staff | August 30, 2005

Even if Biogen Idec Inc. is able to win regulatory approval to sell its multiple sclerosis drug Tysabri, sales probably will not be enough to have a significant impact on the Cambridge company, according to a report by a Wall Street analyst.

Steven Harr of Morgan Stanley said that instead of the $3 billion in annual sales once predicted by some analysts, Tysabri would likely become a ``niche" drug with yearly sales of about $500 million.

der vollständige Artikel kann hier eingesehen werden:

http://www.boston.com/business/globe/articles/2005/08/30/ms_…

[Cyberhexe]

Krasner geht bei Tysabri von einem maximalen Jahresumsatz von $ 500 Mio aus; dies würde bedeuten, dass lediglich 21.300 Patienten eine Behandlung mit Tysabri in Anspruch nehmen...da lachen ja die Hühner. Die Interferone mit ihren problematischen Nebenwirkungen und der weitaus geringeren Wirkung werden 300.000 Patienten verabreicht, eine halbe Million wird gar nicht behandelt, weil denen die Interferone nichts gebracht haben und das wirkungsvollste Präparat mit Nebenwirkungen im Plazebobereich soll gerade einmal bei 2% der MS-Patienten appliziert werden (in der industrialisierten Welt haben ca. 1,5 Mio Menschen MS; MorbusCrohn bleibt hierbei unberücksichtigt)...hahaha

[Cyberhexe]

Im Artikel von Boston.com von Jeffrey Krasner wird Steven Harr, ein Analyst von Morgan Stanley, zitiert, der bereits am Freitag mächtig unter die Gürtellinie gegriffen hat...(man beachte MS hat intensive Geschäftsbeziehungen zu Serono, die mit Rebif, ein Interferon, eines der Konkzrrenzprodukte von Tysabri am Markt platzieren)...dieser berichtet von unüblichen Infektionen bei der Medikation von Tysabri.
Anbei die Original-Textstelle in engl.:


Harr also highlighted a broad range of complications experienced by multiple sclerosis patients taking the drug during clinical trials. He said those adverse events, including unusual infections, will play a role when Biogen Idec and Elan Corp. of Ireland, its partner in Tysabri, meet this year with Food and Drug Administration officials to discuss reintroducing the drug.

Dazu sollte man sich die offiziellen Unterlagen der FDA ansehen (--> Link zur FDA am Ende des Beitrags). In diesen kann man nachlesen, dass hinsichtlich der Infektionen kaum ein Unterschied von Tysabri zur kontrollgruppe besteht...da müssten sich eigentlich sämtliche Balken biegen!!!


Infections In Studies 1 and 2, the rate of infection was approximately 1 per patient-year in both TYSABRI®-treated patients and placebo-treated patients. The infections were predominately upper respiratory tract infections, influenza, and urinary tract infections. Most patients did not interrupt treatment with TYSABRI® during the infection. In Study 1, the incidence of serious infection was 2.1% in TYSABRI®-treated patients versus 1.3% in placebo-treated patients. No difference was seen between treatment groups in Study 2.


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

[Cyberhexe]

Bin mal gespannt, wie sich der EDSS-Score unter der Behandlung von Natalizumab entwickelt


http://www.akm.ch/ectrims2005/


September 28 – October 1, 2005
Thessaloniki, Greece


Friday, September 30, 2005
15:30 - 17:00
Therapy - immunomodulation - Part II
Poster topic 21

(P 580) "The effects of natalizumab on disability progression in the AFFIRM study: correlation between changes in Multiple Sclerosis Functional Composite and Expanded Disability Status Scale [EDSS] scores"
F.D. Lublin, P.W. O`Connor, E. Havrdova, M. Hutchinson, L. Kappos, D.H. Miller, J.T. Phillips, C.H. Polman, G. Giovannoni, A. Wajgt, F. Lynn, M.A. Panzara, A.W. Sandrock for the AFFIRM Investigators

[zenman]

krasners umsatzschätzung is der absolute, unrealistische
WORST CASE

genaugenommen is jede solche rechnung fiktion
viel zu viele unbekannte variablen
also
wird er wohl was bezwecken wollen damit
planmä#ssige miesmache

professionelles BASHING

DAS nenn ich missbrauch der medien

[[KERN]Codex]

alle wollen über eine lange zeit günstig akkumulieren

[zenman]

SK 8,64
+ 0,5 %

[Cyberhexe]

Kommentar zu Elan von Davy Stockbroker (1.9.05)

A media interview carried with Biogen Idec`s CEO, Jim Mullen, indicates that Biogen and Elan will suggest a number of
revisions to the Tysabri label when it submits its findings from the safety review. Specific warnings about the three PML cases
are likely to be included, as is a warning concerning risks for patients with weak immune systems. We feel that these
suggested revisions would have been standard in light of what happened with the drug.
The FDA has never explicitly specified the criteria for black box warnings. But a survey (Food & Drug Law Journal, 1998) of
375 separate black box warnings, conducted in 1995 across 206 separate drugs, sheds some light. The two most cited
warnings were for patient subsets which were at higher risk, and for potential dosing/drug interaction risks. It would seem
that Tysabri could potentially fit into both categories, if the risks are sufficiently well-defined for the agency to analyse.
On timelines, the CEO is also quoted as saying it is "highly unlikely" the FDA will complete its own review by year-end. We
believed that a result by end-2005 could be possible, but any slippage into early 2006 would still leave us comfortable with
our mid-2006 re-launch forecast for the drug.
According to the CEO interview, the companies` safety evaluation should be submitted by the end of September.

[Cyberhexe]

Kommentar zu Elan von Davy Stockbroker (1.9.05)

A media interview carried with Biogen Idec`s CEO, Jim Mullen, indicates that Biogen and Elan will suggest a number of
revisions to the Tysabri label when it submits its findings from the safety review. Specific warnings about the three PML cases
are likely to be included, as is a warning concerning risks for patients with weak immune systems. We feel that these
suggested revisions would have been standard in light of what happened with the drug.
The FDA has never explicitly specified the criteria for black box warnings. But a survey (Food & Drug Law Journal, 1998) of
375 separate black box warnings, conducted in 1995 across 206 separate drugs, sheds some light. The two most cited
warnings were for patient subsets which were at higher risk, and for potential dosing/drug interaction risks. It would seem
that Tysabri could potentially fit into both categories, if the risks are sufficiently well-defined for the agency to analyse.
On timelines, the CEO is also quoted as saying it is "highly unlikely" the FDA will complete its own review by year-end. We
believed that a result by end-2005 could be possible, but any slippage into early 2006 would still leave us comfortable with
our mid-2006 re-launch forecast for the drug.
According to the CEO interview, the companies` safety evaluation should be submitted by the end of September.

[Cyberhexe]

abc news, ein prominenter Nachrichtensender, hat soeben folgende Nachricht veröffentlicht:

http://abcnews.go.com/Health/Business/wireStory?id=1085999&C…

Biogen Idec Aims to Resume Sale of MS DrugBiogen Idec Seeks to Resume Sale of MS Drug With Additional Warning Label, CEO Tells AP
By MARK JEWELL
The Associated Press

CAMBRIDGE, Mass. Sep 1, 2005 — Biogen Idec Inc. will ask federal regulators to allow it to resume sales of a multiple sclerosis drug linked to a brain disease with additional warning labels, the company`s CEO said in an interview.

James Mullen said Wednesday that Biogen Idec will likely recommend that Tysabri include warnings about three cases of an often-fatal brain disease that were confirmed after clinical trials of the drug, which was withdrawn from the market Feb. 28 despite hopes that it would become an important new tool in treating MS.

Mullen said the revised label that the company will propose to the U.S. Food and Drug Administration also will warn about risks for patients who have weak immune systems and therefore could be more susceptible to contracting the disease, called progressive multifocal leukoencephalopathy, or PML.


Health Threats Grow in New Orleans
FDA Approves Drug for Short Children
Why Do Some Stay, Despite Evacuation Orders?

However, Mullen said the label language his company will suggest to FDA when it seeks permission to resume marketing Tysabri will acknowledge that scientists don`t yet understand precisely how the bioengineered drug put the three patients who contracted PML at risk of contracting the rare disease. Two of those patients died.

"I think it`s important for us to not overstate what we know," Mullen, Biogen Idec`s chief executive and president, said in an interview with The Associated Press at the company`s Cambridge headquarters. "We want to be concrete about what we know and what we don`t know."

Mullen said Biogen Idec and its Irish partner on Tysabri, Elan Corp., plan to submit findings from their review of the drug`s safety to the FDA by the end of September.

The companies had previously said the report would be submitted sometime in the fall so the FDA could review whether Tysabri can safely return to the market. Some industry analysts have said strong warnings on Tysabri`s label could ruin the drug`s chances of becoming a commercial success.

Mullen said it is "highly unlikely" the FDA will complete its own review by year`s end, but he said the regulators are "interested in a thorough but expeditious review of determining whether this can brought back to the market in the near future or not."

[[KERN]Codex]

jeah

[Cyberhexe]

interessanter Artikel über die Nanotechnologie in der Pharma-Industrie:


In order to market and sell a pharmaceutical product, the crucial hurdle is approval by the FDA, the
agency which regulates all pharmaceutical products in the United States. Until recently, the FDA
had never faced the question of whether to approve a drug based on nanotechnology. That all
changed when Wyeth, Merck and Abbott all developed nanoparticulate drugs using technology
developed by Elan Drug Delivery (“Elan”) and obtained FDA approval for the new drugs.
Merck utilized technology licensed from Elan to successfully develop and obtain approval to market
their nanoparticulate drug, aprepitant. Commercially marketed as Emend®, aprepitant is the first FDA

http://www.foley.com/files/tbl_s31Publications/FileUpload137…

[jojobada]

[moneyshow]

es kommen gute nachrichten

[[KERN]Codex]

Sehr gute Nachrichten!

[[KERN]Codex]

Und wie man sieht geht es konstant aufwärts

[moneyshow]

und dann im lift bis 20.

[loseit]

Hallo Kern,

was meinst Du für Nachrichten

[bernie55]

....bestimmt die News von der Zulassung von Tysabri.....

[tomtop]

Du kannst nicht einfach Gerüchte verbreiten.Dass ist so dumm.

[moneyshow]

[posting]17.818.032 von tomtop am 07.09.05 17:14:10[/posting]welche gerüchte sollen das sein ?????

[[KERN]Codex]

loseit,

ja ich meine dass tysabri re released wird und nat. ALZ Phase 2

[Cyberhexe]

Wyeth hat in Irland eine biotechnologische Produktionsstätte eröffnet...also falls AAB-001 zur Marktreife gelangt, und die Chancen hierfür scheinen nicht schlecht zu sein (proof of concept mit AN-1792, und da es sich nicht um das Vaccin sondern um den Antikörper handelt, sollten keine Hirnhautentzündungen auftreten), dann sollte die Produktionskapazität für den Blockbuster schlechthin geschaffen sein.

http://phx.corporate-ir.net/phoenix.zhtml?c=78193&p=irol-new…

Wyeth Opens World`s Largest Integrated Biotech Production Facility
- Ireland Plant centerpiece of Wyeth`s growing investment in biotech processes
and products -
MADISON, N.J., Sept. 8 /PRNewswire-FirstCall/ -- Wyeth (NYSE: WYE) today formally opened its Grange Castle biotech production facility in South County Dublin, Ireland. The new 1.2 million square foot campus is one of the largest integrated biotech manufacturing facilities in the world and is expected to produce some of the Company`s most innovative products.

[eliasesteban]

gibt es hier eigentlich auch investierte MS betroffene in dem tread??

[[KERN]Codex]

Bist du betroffen?

[Cyberhexe]

interessantes Interview mit Robert Essner, CEO von Wyeth, vom 1.5.2005; zur Erinnerung, Wyeth ist der Kooperationspartner von Elan im Alzheimer-Programm


http://www.usatoday.com/money/companies/management/2005-05-0…

Insana: Do you have other promising vaccines?

Essner: One really interesting one we have right now is in Alzheimer`s. We have one of the most extensive Alzheimer`s disease development programs. We have a vaccine approach where we`ve created a way of modifying the immune system so that it can rid the body of this beta-amyloid plaque that most people feel is an important component in developing Alzheimer`s.

[Poppholz]

ganz unangenehme Info:

Dow Jones/vwd
Biogen Idec streicht 17% der Stellen (zwei)
Freitag 9. September 2005, 07:50 Uhr

CAMBRIDGE (Dow Jones)--Die Biogen Idec Inc, Cambridge, will weltweit 650 Stellen streichen. Dies entspräche einer Reduzierung der Belegschaft um etwa 17%, teilte das Biotechnologieunternehmen am späten Donnerstag mit. Der Stellenabbau soll zum größten Teil bis zum Jahresende erfolgen. Biogen plane zudem den Verkauf von Randaktivitäten. Die Maßnahmen sollen dazu beitragen, die Kosten um jährlich 200 Mio bis 300 Mio USD zu senken. Im Zuge der Verringerung der Belegschaft und der Neuordnung falle im dritten Quartal eine Vorsteuerbelastung von 30 Mio bis 40 Mio USD an, teilte Biogen weiter mit.

Von Analysten wurde die Ankündigung des Unternehmens dahingehend interpretiert, dass Biogen Idec nicht mehr mit einer Wiedereinführung ihres Medikaments "Tysabri" rechne. Das Unternehmen hatte das Multiple-Sklerose-Mittel Ende Februar wegen Sicherheitsbedenken vom Markt genommen. Allerdings hatten seinerzeit einige Investoren noch damit gerechnet, dass das Produkt doch wieder verkauft werden könne. Analyst Adam Walsh von Jefferies & Co bewertete die Einsparungen dank des Stellenabbau als positiv für die Finanzlage des Unternehmens. Die Restrukturierung sei aber, was "Tysabri" betreffe, ein Zeichen der Niederlage, sagte er. In einer separaten Mitteilung kündigte Biogen am Donnerstag zudem an, dass Michael Gilman, Executive Vice President of Research, das Unternehmen zum 8. November verlassen werde. Eine Begründung für diesen Schritt nannte der Konzern nicht.
Biogen und Elan Corp, die an der Entwicklung von "Tysabri" mitgearbeitet hat, prüfen derzeit die Sicherheit des Mittels und wollen den zuständigen Behörden im Herbst ihren Bericht vorlegen. Die US-Gesundheitsbehörde FDA hatte das Medikament im November 2004 zugelassen.

-Von Heather Draper, Dow Jones Newswires; [phone], [e-mail]

DJG/DJN/bam/cbr




Ist natürlich nur wieder eine Analystenmeinung. Ich gehe nach wie vor davon aus, das Tysabri wieder an den Markt kommt.

Hat von Euch ansonsten jemand etwas gehört?

[Cyberhexe]

da bin ich aber ganz anderer Meinung:
Die von Biogen favorisierte Kombi-Therapie (Tysabri+Avonex) wird sich nicht durchsetzen, zumal in SENTINEL die PML-Fälle aufgetreten sind. Die FDA wird sehr wahrscheinlich das Label für Tysabri derart gestalten, dass davor gewarnt wird Tysabri zusammen mit Interferonen einzunehmen. Dies wird m.E. jedoch nicht die Chancen von Tysabri reduzieren, sondern die der Interferone, da die Effektivität von Natalizumab bei weitem günstiger ist.
Diese Interpretationen der Analysten scheinen wiederum der gleichen Presse zu entstammen, die bereits seit Monaten versucht Tysabri zu disqualifizieren...koste es was es wolle !!!!!
Also Poppholz und alle anderen zittrigen Hände...keep cool!

[Nostarowie]

Hmm,

ich habe den Verdacht das Biogen immer mehr als Konkurrent
zu Elan steht. (Avonex)
Biogen rechnet, vielleicht ist hier der Wunsch Vater des Gedanken, nicht mehr mit einer einführung!
Die Luft wird wahrscheinlich dünn in bezug auf die vermarktung herkömmlicher MS-Drogen ?!

Was meint unser Fräulein vom Fach dazu? Cybi?

[Nostarowie]

Oh verdammt Sie war schneller.

[Poppholz]

Hallo Cyberhexe (und alle anderen Elan-Interssierten Leser),
ich bin auch ganz entspannt bei diesem Thema, da Elan ja bereits im Vorfeld angekündigt hat, auch ohne Tysabri dieses Jahr in die Gewinnzone zu gelangen. Somit können wir ja gar nichts verlieren.



In der Meldung wird bezüglich der "nicht wieder Einführung" auch kein Analyst namentlich erwähnt. Der Name von Adam Walsh fällt erst bei der Einschätzung, dass die Kostensenkung positiv für die Finanzlage zu sehen ist.

Es ist trotzdem erschreckend, wie immer wieder versucht wird mit solchen "Andeutungen" Unruhe bei den Investierten zu schaffen.

Ich bleibe investiert und das noch eine sehr lange Zeit.

[welke91]

hy nosta, guten morgen allerseits...

deine Vermutung ist gar nicht so falsch....

Cambridge, Mass. and Fremont, Calif., August 2, 2005 - Biogen Idec (Nasdaq: BIIB) and Protein Design Labs, Inc. (PDL) (Nasdaq: PDLI) today announced a broad collaboration for the joint development, manufacture and commercialization of three Phase II antibody products.


The agreement provides for shared development and commercialization of daclizumab in multiple sclerosis and indications other than transplant and respiratory diseases, and for shared development and commercialization of M200 (volociximab) and HuZAFTM (fontolizumab) in all indications.

nicht wahr wie gesagt Biogen bekommt bächtiges hosenbluten......
Natürlich ist die Zusammenarbeit mit PDL nicht nur darauf hin gerichtet!!!
Aber ein Kriterium das man begutachten sollte.
Die wollen schließlich auch nur Geld verdienen und Avonex an den Mann/Frau bringen.

[Nostarowie]

Gruß welke,

wolln mer ma dran glauben das es so ist wie es ist.

[welke91]

Abeta42 immunization in Alzheimer`s disease generates Abeta N-terminal antibodies.


Elan Pharmaceuticals, Inc., So. San Francisco.

Serum samples from Alzheimer`s disease (AD) patients immunized with Abeta42 (AN1792) were analyzed to determine the induced antibody properties including precise amyloid-beta peptide (Abeta) epitopes and amyloid plaque-binding characteristics. The predominant response in these patients is independent of whether or not meningoencephalitis developed and is against the free amino terminus of Abeta. The immunostaining of amyloid plaques in brain tissue by patient sera is adsorbable by a linear Abeta1-8 peptide, demonstrating that the antibodies are directed predominantly to this epitope and not dependent on Abeta conformations or aggregates specific to plaques. Furthermore, the antibodies are not capable of binding amyloid precursor protein and would be predicted to be competent in facilitating clearance of amyloid plaques in AD brains.
Cyber?

[Cyberhexe]

@welke

könntest du zukünftig den Link mit angeben, da es mitunter schon noch wichtig ist, aus welchem Kontext derartige Zitate stammen.

Bei dem Statement geht es um den Versuch mit dem Vaccin AN-1792. Zum Verständnis muss ich vielleicht ein wenig weiter ausholen:
Ein Vaccin ist ein biologisch oder gentechnisch hergestellter Impfstoff, bei welchem das Immunsystem aktiv angeregt wird Antikörper zu produzieren. Normalerweise handelt es sich hierbei um Eiweissbruchstücke oder Teile der Erbsubstanz der Fremdeiweissstoffe (Antigene), oder aber um abgetötete oder abgeschwächte Erreger selbst.
AN-1792 war nun eine synthetische Form des natürlich vorkommenden Beta-Amyloid-Eiweiss, das mitunter verantwortlich gemacht wird für die Plaquebildung im Gehirn der Alzheimer-Erkrankten. Man geht davon aus, dass diese Plaque die Funktionalität von Nervenzellen stört und deren Absterben verursacht.
Die Impfung mit AN-1792 hat nun zu einer Immunreaktion geführt, welche die Entfernung von der Plaque aus dem Gehirn fördert. Im Verlauf der Immunantwort bilden sich nämlich Antikörper, welche sich an die Proteine der Plaque binden. Gleichzeitig werden Zellen aktiviert, die ebenfalls Teil der Immunantwort im Gehirn sind, welche beginnen, die Amyloid-Plaque einzuhüllen.
Im klinischen Versuch sind jedoch ca. 6 % der mit AN-1792 geimpften Studienteilnehmer an Hirnhautentzündung erkrankt(auf Grund einer Überreaktion der Immunabwehr), weshalb der Versuch sofort gestoppt wurde. Die Studienteilnehmer wurden jedoch weiterhin betreut und untersucht. Bei den Studienteilnehmern, die in der Zwischenzeit eines natürlichen Todes verstorben sind, wurden Autopsien durchgeführt. Hierbei wurde festgestellt, dass im Gegegensatz zu normalen unbehandelten Alzheimer-Patienten keine bis fast keine Plaque im Gehirn vorhanden war.

AAB-001, derzeit in Phase II, ist nun kein Vaccin sondern der Antikörper selbst, so dass bei diesem keine Überreaktion der Immunabwehr auftreten sollte.
ACC-001, das weiterentwickelte Vaccin, soll diesen Monat noch in die Klinik gehen. Von ihm erhofft man sich eine kontrolliertere Immunantwort, so dass keine Entzündungen der Hirnhaut auftreten.

Bei dem Artikel wird lediglich festgestellt, dass unabhängig von der Hirnhautentzündung eine Wirkung festgestellt wurde.

Nebenbei: ich bin kein Mediziner. Es kann durchaus sein, dass im Detail nicht alles 100% richtig erklärt ist.....aber ich gebe mir Mühe, nicht zu viel Unsinn zu erzählen.

good luck
ch

Anbei noch ein paar interessante, weiterführende Links zu diesem Thema (allerdings alles in englisch):

http://www.foxnews.com/story/0,2933,156108,00.html

http://i-newswire.com/pr19426.html

http://www.wcax.com/Global/story.asp?S=3296076&nav=4QcRZPmS

http://www.newswise.com/articles/view/511571/

http://www.physorg.com/news4033.html

[welke91]

Großer Dank!!

hier der Link:

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

und noch einer, der sich gut anhört:

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

[Cyberhexe]

8..7..Der Countdown läuft..6..5..4..

When a trial drug is withdrawn patients can pay a high price
Strict rules govern how firms test new treatments but withdrawing a drug can have adverse effects for patients trialing them, writes Dominic Coyle

Clinical trials are always a risk, both for patients and for the companies trying to prove the efficacy of their products.

From the company`s perspective, trials can throw up all sorts of unexpected results despite the best research and preparation. Adverse results can be catastrophic for businesses whose shareholders and other financial backers invest largely on the basis of drug pipelines and the prospects of future sales success.

For the patient, the situation is even more critical. Most are seriously unwell in the first place, sick enough to take the risk of being dosed with an experimental drug that may prove beneficial but, then again, might not.

Ann (not her real name) has been battling with multiple sclerosis (MS) since her early 30s. As the condition progressed, she found her declining mobility made her more dependent on her husband and family. Worse still, for a woman who worked with her hands, she found herself suffering from diminishing sensation in her hands and feet.

When Elan Pharmaceuticals and Biogen Idec began clinical trials for Tysabri, then called Antegren, her neurologist put her name forward. Apart from the MS, Ann was young, healthy and had a clean medical history in that she had not been taking a series of medicines that might contaminate the trial.

"I enrolled in trials because I thought it mattered a lot, I thought, maybe, one person might not have to wake up every day, lying very still, taking mental inventory of fingers and toes before daring to move as a result of the decisions of myself and others to take part in the trial and that would have made it all worthwhile."

Ann was lucky initially. The experimental drug was designed to slow down the progression of her disease, not reverse its physical symptoms.

"I certainly did not expect to find a miracle, just a small step to help those walking behind me would have been enough. I`d have been happy with that. But it was a miracle, from my point of view, I was so alive. I was healthy and strong and so happy."

From a position where her mobility was borderline, Ann had almost fully recovered from the physical symptoms of her condition.

Ann spent three years on the trials and, as a result of her positive experience and that of the trial patients in general, Tysabri won fast-track approval from the US regulator, the Food and Drug Administration (FDA), for sale on the open market late last year.

[Poppholz]

@ cyberhexe:

gibt es Neuigkeiten?

Der Kurs in den USA bricht zum Teil auf $ 8,30 weg.

[Birgit.Tersteegen]

Schon wieder 8,50$

[Cyberhexe]

no news
aber schau dir doch mal das an:

http://finance.yahoo.com/q/hp?s=ELN&a=00&b=10&c=2004&d=03&e=…


Februar 2004 und September 2005....da gibts doch gewisse Ähnlichkeiten
good luck
ch

[Cyberhexe]

neue Unternehmensanalyse zu Elan von Davy (14.09.2005)

Prescription trends in the MS market remain of interest as we await further
visibility on the fate of Tysabri. Latest data indicates the following:
• First-half revenues for the four main products grew by 15.7% globally; the
winners were Copaxone and Rebif. Avonex demonstrated the lowest growth
rate.
• Underlying pharmacy TRx growth in the US, as measured by progression in
the rolling four-week moving average data, is approximately up 8.5% since
the start of the year.
• Adjusted for increased distribution via the mail service segment, Avonex’s TRx
share in the US remains close to 40% of the overall MS market.
September is an important month for Tysabri. We expect to see the headline
results from the safety evaluation on Crohn’s/RA patients, and anticipate that
the full dataset will also be submitted to the FDA and EMEA by the end of the
month.
The annual ECTRIMS conference – being held from September 28th to October
1st in Thessaloniki, Greece – will include abstracts on the SENTINEL two-year
data and on the lab evaluation for JC virus in MS patients. The latter could
provide more colour on the MS safety evaluation work that has already been
carried out.
Beyond the submission of the filings, the FDA’s internal evaluation and decision
is of uncertain duration. Fundamentally this analysis will centre on the definition
and ongoing monitoring of the risk/benefit profile. Though a result by end-2005
is possible, any slippage into early 2006 is still in line with our mid-2006 relaunch
forecast for the drug.
We acknowledge that high product risk remains. Our revenue-based SOTP
model implies that a successful launch that meets our existing target of $1.6bn
in peak revenues, results in a share price of just over $13. Excluding Tysabri
altogether, the SOTP model generates a share price of just under $4.

[frauholl]

Wird dem Kurs sicher keine "Flügel" verleihen.

[tippse]

Schering mit Rückschlag
Am Nachmittag rückte Schering in den Mittelpunkt. Der Berliner Pharmakonzern hat in einer Studie schwere Nebenwirkungen bei seinem Medikament Campath festgestellt. Der Wirkstoff zur Behandlung von Multiple-Sklerose wurde deshalb in der Studie ausgesetzt. Die Nebenwirkungen führten in der Studie zum Tod eines Patienten. Der Wirkstoff habe ansonsten eine starke therapeutische Wirkung im Einsatz gegen Multiple Sklerose gezeigt, sagte ein Schering-Sprecher. In Absprache mit der US-Gesundheitsbehörde FDA soll die Studie fortgesetzt werden.

Analysten sagten, nach dem Verkaufsstopp für das Konkurrenzprodukt Tysabri von Biogen/Idec dürfte die FDA eher vorsichtig sein beim weiteren Vorgehen bei Campath. Das Medikament sei noch Jahre von einer möglichen Zulassung entfernt. Schering-Aktien rutschten nach der Nachricht zeitweise ins Minus.

http://boerse.ard.de/content.jsp?key=dokument_122604

[[KERN]Codex]

Tysabri wird zurückkommen, was sollen sonst die MS Kranken machen???!!

[[KERN]Codex]

Elan and Biogen Idec Provide an Update on TYSABRI(R)
Tuesday September 20, 4:05 pm ET


DUBLIN, Ireland & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 20, 2005--Elan Corporation, plc (NYSE: ELN - News) and Biogen Idec (NASDAQ: BIIB - News) announced today that in the coming weeks they expect the safety evaluation of TYSABRI® (natalizumab) in Crohn`s disease and rheumatoid arthritis will be completed, and that they will submit a supplemental Biologics License Application for TYSABRI in multiple sclerosis (MS) to the U.S. Food and Drug Administration.

On August 9, 2005, the companies announced the completion of the safety evaluation of TYSABRI in MS, which resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously reported three confirmed cases of PML, two of which were fatal.

On February 28, 2005, Biogen Idec and Elan announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of PML, a rare and potentially fatal, demyelinating disease of the central nervous system.

[Cyberhexe]

Das kann (will) ich nicht glauben...Davy Stockbrokers Analyst Jack Gorman rechnet mit einer erneuten Markteinführung von Tysabri Mitte des nächsten Jahres. Weshalb will man den MS-Patienten derart lange den effektivsten Wirkstoff vorenthalten...zumal die "shelf life" von der Anfang des Jahres produzierten Menge bis dahin ablaufen würde.
Also für mich ist das nicht nachvollziehbar...aber den Analysten trau ich schon lange nicht mehr über den Weg!

Elan (ELN US)
On track to complete safety evaluation in coming weeks - will then submit all data under a
supplemental BLA – mid-2006 relaunch still looks appropriate
Previous close: 831c Price target: 1300c Analyst: [e-mail]

Elan and Biogen Idec will complete the Crohn`s/RA safety evaluation in the coming weeks, slightly behind the September 21st
schedule but still broadly in line with timing guidance.
The companies confirmed that the full safety evaluation and two-year AFFIRM/SENTINEL data will be submitted to the FDA
under a supplemental BLA (biologics licence application). This puts a formal process on the submission, a decision which we
presume is in consultation with the agency itself. Our mid-2006 forecast for re-launch still looks appropriate in this light,
though a more definitive view on timing still depends on the response of the FDA. Note the FDA granted accelerated
approval status for the original BLA for Tysabri.

[Cyberhexe]

Ian Hunter von Goodbodys Stockbroker schreibt heute, dass er mit der Einführung zu Beginn des nächsten Jahres rechnet.

[Poppholz]

hatte ich bereits im Nachbarthread geposted, aber hier ist ja der "Info-Thread":

Dow Jones/vwd Biogen/Elan planen Wiederzulassung von Tysabri
Mittwoch 21. September 2005, 09:29 Uhr

CAMBRIDGE (Dow Jones)--Biogen Idec Inc und Elan Corp wollen die Wiederzulassung ihres Multiple-Sklerose-Medikaments Tysabri beantragen. Das teilten die Unternehmen am Dienstag mit. Sie hatten das Medikament im Februar des laufenden Jahres vom Markt genommen. In einer klinischen Studie waren drei Patienten an der hirnschädigenden und häufig tödlich verlaufenden Krankheit progressive multifokale Leukenzephalopathie (PML) erkrankt.

Im vergangenen Monat hatten die Unternehmen eine Sicherheitsstudie abgeschlossen, nach der keine weiteren Fälle von PML-Erkrankungen aufgetreten waren. Wie die Unternehmen am Dienstag außerdem erklärten, wird eine weitere Sicherheitsstudie über die Anwendung von Tysabri bei den Krankheiten Morbus Crohn und rheumatischer Arthritis in den " kommenden Wochen" abgeschlossen.

- Von Geoffrey Rogow; Dow Jones Newswires; +49 (0) 69 - 29725 - 111, [e-mail]

DJG/DJN/abe/nas

[Cyberhexe]

auf die Info hab ich gewartet:
“At this point, we do not expect we will need to conduct additional multiple sclerosis trials to return Tysabri to market,” Brockelman said.

...es sind keine neuen klinischen Studien erforderlich bei Multipler Sklerose. Mit anderen Worten...nach dem Review der Daten durch die FDA und bei entsprchender Zustimmung kann die Vermarktung von Ty sofort wieder aufgenommen werden!!



http://www.thebulltrader.com/2005/09/20/eln-supplemental-bla…

ELN and BIIB have followed through with their promised press release today. Apparently ELN and BIIB will be seeking to file a supplemental BLA (Biologics License Application) with the FDA in a few weeks.

Biogen Idec spokeswoman Amy Brockelman on Tuesday said the drug “never lost” its original approval from the U.S. Food and Drug Administration, although it was withdrawn from the market.

She said her company and Elan now plan to submit the updated safety information on Tysabri to the FDA, as a possible prelude to re-launching the drug for treating multiple sclerosis. The data involves more than 3,000 patients with multiple sclerosis, Crohn’s disease and rheumatoid arthritis that have taken Tysabri in past trials.

“At this point, we do not expect we will need to conduct additional multiple sclerosis trials to return Tysabri to market,” Brockelman said.

I’m glad that Biogen has assured that additional trials will not be needed to return Tysabri to the market. Some bearish analysts have been trying to argue that the FDA would require new trials before reinstating the drug. Nice call, losers.

The press release had no mention on the restart of the 1808 Phase IV clinical trials, though. With the MS portion of the safety reviews finished, I really expect that a move to restart the trials will take place before filing of the supplemental BLA.

The next date to look toward for possible Tysabri developments is September 28 (next week) at the ECTRIMS conference where data regarding Tysabri efficacy and safety are expected to be discussed.

[Poppholz]

dpa-afx
ANALYSE: Piper Jaffray bestätigt Biogen Idec mit `Market Perform`
Mittwoch 21. September 2005, 15:04 Uhr

FRANKFURT (dpa-AFX) - Die Analysten von Piper Jaffray haben ihre Anlageempfehlung für Biogen Idec (NASDAQ: BIIB - Nachrichten) nach Bekanntgabe eines neuen Anlaufes für die Zulassung von Tysabri mit "Market Perform" bestätigt. Das Kursziel betrage 43 Dollar, hieß es in der Studie vom Mittwoch.
Der US-Biotechnologiekonzern Biogen Idec und der irische Partner Elan Pharmaceuticals hatten am Dienstagabend bekanntgegeben, einen neuen Anlauf für die Zulassung ihres wegen zwei Todesfällen vom Markt genommenen Multiple-Sklerose-Medikaments Tysabri unternehmen zu wollen.

Die Experten halten eine neuerliche Zulassung durch die zuständige US-Gesundheitsbehörde FDA ohne weitere klinische Testreihen für wenig wahrscheinlich. Auch wenn es zu einer sofortigen Zulassung käme, sei eine deutliche Zurückhaltung der Ärzte bei Verschreibungen zu rechnen. Piper Jaffray berücksichtigt Umsätze mit Tysabri daher zunächst nicht in ihren Ergebnisschätzungen und sieht die Aktie gegenwärtig als fair bewertet.


Eingestuft mit "Market Perform" geht Piper Jaffray davon aus, dass sich die Aktie in den nächsten zwölf Monaten im Einklang mit dem S&P-500-Index oder dem Russell (NYSE: RML - Nachrichten) -2000-Index entwickeln wird./ag/tw

Analysierendes Institut Piper Jaffray.




Jetzt müßte Elan nur noch einmal expliziet erwähnt werden.

[Poppholz]

von einer "deutlichen Zurückhaltung der Ärzte bei Verschreibungen" gehe ich nicht aus.

Sobald das Medikament wieder am Markt zugelassen ist, wird dieses auch verschrieben werden, da die Nachfrage entsprechend vorhanden ist.

[Cyberhexe]

Unternehmensanalyse von NCB

http://www2.ncbdirect.com/EquityBook/HTML/ELN.htm

[tippse]

emotionaler artikel:

Time to Bring Back a Miracle Drug
Michael Fumento (archive)


September 22, 2005

The makers of the multiple sclerosis drug Tysabri have just announced they will seek Food and Drug Administration approval to resume sales of the drug. I don’t have MS, but I couldn’t be happier.

Since April, when I wrote about the biotech drug’s sudden withdrawal two months earlier, I’ve been deluged with heart-rending e-mails from people begging me to do more to help bring it back. Despite readily qualifying as a “miracle drug,” it got the yank (possibly under FDA pressure) because three users had developed an often-fatal neurological condition.

“Please see what you can do to persuade the FDA to do something for Tysabri`s speedy return,” pleaded one. “I don`t think I can hold out much longer. Nothing else is stopping my attacks, or the progression of my MS. Haven`t I suffered long enough (29 years)?”

Said another, “For those who suffer from MS [the drug’s withdrawal] is more then a travesty, it is the abduction of hope itself. My niece, age 25 has MS. She had hoped Tysabri would give her life back. That she might marry, have a family, and be happy. Her story is duplicated 400,000 times.” That’s about the number of Americans with MS.

Tysabri, jointly produced by Biogen Idec and Elan Pharmaceuticals, is incredibly effective against MS, a disease that attacks both the brain and spinal cord and can cause a host of symptoms including paralysis, blindness, fatigue, and sometimes death. There are other MS drugs, but none appear to be nearly as powerful or as well-tolerated as Tysabri. Results from two years of clinical trials showed a stunning 42% reduction in the risk of disability progression and an even more striking 67% reduction in clinical relapses.

In late clinical trials Tysabri has also apparently been extremely effective against Crohn`s disease, a severe bowel disorder, and it was in human testing for rheumatoid arthritis. But these trials were also halted. Doctors told me their patients loved Tysabri not just because it was so effective but because the side effects were so mild. So it came as a stunning blow to the approximately 8,000 using the drug, as well as a long list of persons waiting to get prescriptions, when the axe fell.

The neurological disorder linked to Tysabri, progressive multifocal leukoencephalopathy (PML), is caused by a common virus that the immune system usually keeps under lock and key. But in all three known cases among Tysabri users it was being tested in combination with another drug. Both are immunosupressants and apparently the combination allowed the virus to flourish. Nevertheless, there are NO known cases of PML in patients using only Tysabri, according to the FDA.

Tysabri’s makers have now screened the entire database of more than 2,000 MS patients and are finishing a similar review of about 1,500 people from the Crohn’s and arthritis trials. They’ve found no new PML cases.

It appears Tysabri would simply be on the huge list of both prescription and over-the-counter (OTC) drugs that have serious interactions with other drugs. The FDA also allows continued sale of countless drugs that when used alone kill thousands of Americans each year, such as aspirin and Tylenol. Why? Because the benefits are so huge. For that matter, there’s been no withdrawal of an MS called Novantrone that causes such serious side effects as fatal congestive heart failure and leukemia.

Likewise, all the drugs that slow the development of rheumatoid arthritis carry FDA warning labels and some may cause death. Yet arthritis sufferers practically worship them.

There’s a simple way of dealing with vital drugs that nonetheless may cause serious harm. It’s a warning label made especially conspicuous by placing it inside a “black box.” Tysabri’s makers have already said that if the drug is reintroduced they want it black-boxed.

I use a black-boxed drug (implicated in liver failure deaths) and thank God it just tagged rather than being yanked as a “consumer protection” group had demanded. (It falsely claimed other drugs were just as effective and well-tolerated.) Otherwise I might be as desperate as those poor MS sufferers who were shown a glimpse of normal life only to have it brutally ripped away. They, too, deserve access to the best medicine available.

Michael Fumento ( mfumento at pobox.com ) is a senior fellow at Hudson Institute in Washington, D.C. and a science and health columnist for Scripps Howard News Service.

http://www.townhall.com/columnists/GuestColumns/Fumento20050…

[jojobada]

Makers of MS drug seek to resume sales with revised label

BOSTON, Sep 26, 2005 (AP WorldStream via COMTEX) -- The makers of a multiple sclerosis drug withdrawn from the market in February because of safety concerns applied to resume selling the medication with a revised label and a plan to address patient risks.
U.S.-based Biogen Idec Inc. and Ireland-based Elan Corp. said Monday they requested a priority review of their drug Tysabri that could result in action by the U.S. Food and Drug Administration in about six months, rather than the standard 10-month review.

The application supplements the filing the companies made before the FDA initially approved Tysabri last November. Information in the new application also is being sent to European regulators as part of an ongoing review on whether the companies can begin sales of Tysabri there.

Biogen Idec spokeswoman Amy Brockelman declined to discuss the changes the companies are recommending for the drug`s label, saying such comment would be premature before the regulatory review.

But the company`s chief executive, James Mullen, said in an Aug. 31 interview with The Associated Press that the application would likely recommend warnings about three cases of an often-fatal brain disease that were confirmed after clinical trials of the drug. Two of those patients died.

Mullen said the revised label likely would warn about risks for patients who have weak immune systems and therefore could be more susceptible to contracting the disease, called progressive multifocal leukoencephalopathy, or PML.

Brockelman said the application submitted Monday includes a risk management plan that would include the creation of a registry of all patients who take Tysabri.

The drug was withdrawn from the market Feb. 28 despite hopes that it would become an important new tool in treating MS, a debilitating and incurable disease in which the body`s immune system attacks, inflames and damages its own nerve tissue.

Biogen Idec shares plunged more than 42 percent the day the drug was withdrawn, while Elan`s stock fell 70 percent.

Some industry analysts have said strong warnings on Tysabri`s label could ruin the drug`s chances of becoming a commercial success.

The application submitted Monday includes data from a safety review the drug`s makers completed early last month on more than 2,000 MS patients who took the drug in clinical trials. The companies say no new cases of PML were discovered in the review.

The companies are close to finishing a similar review of about 1,500 people who took Tysabri in trials to test its effectiveness in treating Crohn`s disease and rheumatoid arthritis.

Monday`s announcement came after Biogen shares closed down 10 cents at $38.46 on the Nasdaq Stock Market. Shares of Elan closed up 5 cents on the New York Stock Exchange at $8.

---

On the Net:

[Cyberhexe]

Davy Stockbrokers Analystenkommentar zum Zusatz-Filing:


Elan (ELN US)
Submits sBLA for Tysabri - clock starts ticking
Previous close: 800c Price target: 1300c Analyst: [e-mail]
The submission of the sBLA for Tysabri to the FDA lends more visibility to the timeline for potential re-launch of the drug in
the US. Elan/Biogen Idec will know within 30 days whether standard (10 months) or priority (6 months) review status will be
granted—the latter was granted for the original sBLA for Tysabri. An advisory panel meeting, if deemed necessary by the
agency, would occur within this time period.
Given these timelines we still believe that our mid-2006 forecast for launch is appropriate, with a priority review possibly
allowing a launch a month or two earlier.
The sBLA comprises the full two-year data from AFFIRM and SENTINEL, the MS safety evaluation data and a revised label and
risk management plan. The evaluation of Crohn`s/RA patients will be completed in the coming weeks and will then be added
to the file. We understand that the risk management plan will include a patient registry though the final shape of this plan
will be very dependent on discussions with the FDA. A similar package will be submitted to EMEA in Europe in the coming
weeks, though the timeline is harder to judge here as there are no priority/standard review procedures.

[bernie55]

Mono-Therapy Will Double Elan
Ken Kam; Marketocracy Marketscope , 09.28.05, 6:00 AM ET

NEW YORK - The single biggest issue that is significant enough to drive a double in Elan over the next two to three years is this: Will the FDA approve Tysabri for use in mono-therapy after Elan pulled it from the market?

The FDA: For the U.S. Food and Drug Administration, the question of whether to allow Tysabri back on the market is one of benefits and risks. The main benefit is that two-year clinical studies have shown Tysabri, when used alone, is twice as effective as any other approved drug in preventing relapses. People who have used Tysabri have actually got out of their wheelchairs.

The main risk is that three patients have come down with a potentially fatal complication called progressive multifocal leukoencephalopathy, or PML--two have died. That`s a complication rate of 0.1% out of 3,500 patients. All three cases involve patients taking Tysabri in combination with Avonex from Biogen (nasdaq: BGEN - news - people ). Since the three PML cases were discovered, 91% of the patients in Multiple Sclerosis clinical trials that took Tysabri have been screened for PML, and no additional patients have showed signs of contracting it. There has not been a single case of PML when Tysabri was used alone, but Elan voluntarily took it off the market.

The bottom line is the drug sets the gold standard for efficacy in a disease that is very nasty. Patients want this drug available because it is effective. I expect the FDA will decide that its benefits offset its risks--especially for patients for whom all existing drugs have failed.

Patients, Doctors and Caregivers: MS patients and the people who care for them understand that treating powerful diseases requires commensurately powerful drugs, and they understand that, because of potency, the drugs have potentially fatal consequences for some at-risk patients.

For almost 25% of MS patients, existing drugs have failed to be effective, so many have stopped taking any MS drug at all. Tysabri could be their best option. Most of the remaining MS patients report that the drugs they take do not work well. At best, they slow the progression of the disease, but there is a high relapse rate and many side effects.

So, given the almost 100% certainty of the progressive debilitating effects of the disease, most patients would opt for the rare possibility of PML if they could halt the progress of MS and improve the quality of their lives. A particularly poignant response I received was: " I participated in the AFFIRM trials and had Tysabri for nearly three years. I forgot what it was like to be an " MSer." Since Feb. 28, nearly all of my most annoying symptoms (itching, fatigue, brain fog) have returned, and I have had my first relapse in about four years."

Biogen: Biogen, the U.S. distributor for Tysabri, also owns a best-selling MS drug called Avonex. Typically, a drug has to be proved effective as mono-therapy before it is approved for combination therapy. Biogen pushed Tysabri`s use in combination with Avonex, hoping to convince doctors to prescribe two drugs instead of one. Taking on Biogen as a partner created a conflict of interest.

With FDA approval of Tysabri in combination with Avonex looking remote, Biogen`s next-best alternative is to return Tysabri to the market as quickly as possible. As a result, Biogen`s interests are now much more aligned with Elan`s.

Approval by the FDA of Tysabri for use in mono-therapy by the 20% to 25% of MS patients that have already given up on all other drugs would drive a double in Elan`s stock price. Based on the feedback we`ve received from the people who are in the best position to judge, we believe that will happen. And if any of the remaining MS patients decide to give up on the less-effective drugs they are currently using to try Tysabri then Elan will do even better.

[Cyberhexe]

man darf wirklich gespannt sein, ob heute auf ECTRIMS etwas neues berichtet wird. Neuigkeiten zu Natalizumab, vor allem eine Vernbesserung des EDSS (Erklärung siehe unten) unter der Behandlung von Natalizumab würden den Kurs massiv beflügeln, zumal die bisher am Markt zugelassenen Wirkstoffe den schleichenden Zerfall wenn überhaupt lediglich verlangsamen können. Man hört, allerdings aus bisher unsicheren Quiellen, dass sich bei verschiedenen Studienteilnehmer in AFFIRM der EDSS verbessert haben soll. Ich bin wirklich gespannt, ob heute darüber auf ECTRIMS etwas berichtet wird, und zwar ab 19:20h:

Thursday, September 29, 2005
19:15 - 20:15
Main Hall
Biogen Idec / Elan Symposium
A new approach to MS therapy
Chair: K. Karageorgiou (Athens, GR)
R. Rudick (Cleveland, USA)

19:15 - 19:20
Welcome and introduction
K. Karageorgiou (Athens, GR)

19:20 - 19:40 The AFFIRM study: natalizumab as monotherapy 46
M. Hutchinson (Dublin, IRL)

19:40 - 20:05 Overview of natalizumab safety 47
T. Olsson (Stockholm, S)

20:05 - 20:15
Question and answer session

http://www.akm.ch/ectrims2005/


Die "EDSS" ist eine Leistungsskala nach Kurzke J.F. (expanded disability status scale) und gibt Auskunft über den Grad der Behinderung eines MS-Patienten. Sie reicht von 0,0 (keine neurologischen Defizite) bis 10 (Tod
infolge MS). Die Angaben der Grade (von 0-10) in der EDSS beziehen sich auf die Untersuchung der Funktionellen Systeme (FS), durch den behandelnden Arzt.

[jobl]

Hallo Cyberhexe,

erst mal vielen Dank - ich bin ein sehr interessierter Leser Deiner Beiträge.

Was mich bei Tysabri noch interessieren würde. In wie weit hat denn Biogen Rechte an Tysabri.

Bei treten meist zusammen auf und man denkt bei Biogen an Ihr Produkt Avonex (o.ä.) - oder ist die Verbindung tiefer - hat Biogen Rechte an Tysabri?

Viele Grüße
jobl

[Cyberhexe]

Hat jemand etwas von der gestrigen Veranstaltung vernommen? DAVY Stockbrokers hat heute nichts vermeldet(siehe unten), so dass ich davon ausgehe, dass nichts Neues zum EDSS ausgesagt wurde!

Morgen ist auf ECTRIMS noch einmal eine Veranstaltung, welche Tysabri tangiert.

Late breaking news
Saturday, October 01, 2005, 09:00 - 09:15
The laboratory evaluation for JC Virus DNA in cerebrospinal fluid and plasma from multiple sclerosis patients participating in the phase III clinical trials of natalizumab
E.O. Major, C. Ryschkewitsch, G. Fahle, S. Fischer, J. Hou, B. Curfman, D. Clifford, T. Yoursy (Bethesda, St. Louis, USA; London, UK)

--------------------------------------------------------------------------------
Background: During the course of the dosing trial of natalizumab (TYSABRI), the humanized monoclonal antibody to alpha 4 integrin, three patients developed the JC Virus induced demyelinating disease, progressive multifocal leukoencephalopathy (PML). The global trials, with 2249 MS patients, were sponsored and conducted by Biogen IDEC and ELAN. Clinical description and pathology of PML in 3 patients were published by site investigators; N Eng J Med 2005; 353.
Objective: To evaluate the JC virological status of all patients who received Tysabri alone or in combination with Avonex, an independent, comprehensive laboratory evaluation was conducted at two NIH laboratories using CLIA certified and validated quantitative PCR assays for JCV DNA.
Methods: Sensitivity of the Q-PCR assays ranged from 10 and 100 copies of viral DNA per 200 µl of sample. Over 300 CSF and 1700 plasma samples from Tysabri treated patients were evaluated. Furthermore, 200 CSF samples and 193 matched plasma samples from non-treated MS patients, provided by the Karolinska Institute, Stockholm, Sweden, were tested as controls.
Results: Over 99% of participating patients completed neurological examinations and brain MRI scanning, however many patients declined additional CSF collection. There was no evidence of PML found in any of these cases. Detailed analysis of the laboratory results with emphasis on the PCR assays on the CSF samples will be presented with additional data from the 3 previously reported confirmed PML cases.
Conclusions: PML is a rare disease caused by lytic infection of oligodendrocytes occurring almost exclusively in immune compromised individuals. The occurrence of PML in patients treated with TYSABRI warrants further investigation to determine if there is a specific link between the mechanism of action of this drug and PML.

--------------------------------------------------------------------------------
Davy Stockbroker aktuell (30.9.2005)
Elan (ELN US)
ECTRIMS presentations to shed some more light on Tysabri
Previous close: 881c Price target: 1300c Analyst: [e-mail]
The annual ECTRIMS conference being held from September 28th to October 1st in Thessaloniki, Greece, will include
abstracts from Elan`s AFFIRM (monotherapy) and SENTINEL (combination therapy) two-year data which has just been
submitted to the FDA as part of the sBLA on Tysabri. A specific presentation on the lab evaluation for JC virus in MS patients
could provide more colour on the MS safety evaluation work which has already been carried out on the drug.
Regarding AFFIRM, a general overview of Tysabri as a monotherapy and a specific project correlating disability progression
with the MS Functional Composite (a scale measuring MS progression), will be presented. The main two-year results from the
SENTINEL study will be presented, as well as separate abstracts on how Tysabri+Avonex reduces lesion formation, and on the
safety and tolerability findings from the study.
On October 1st, in the conference programme called "late breaking news", an abstract will be presented on the lab
evaluation for JC virus in MS patients. Detailed analysis of the lab results will focus on the cerebro-spinal fluid samples, with
additional data from the three previously confirmed PML cases. We would expect several other companies to highlight
developments in their own MS products during the conference as well.
Separately, Elan announced its interim results prepared under IFRS. As quarterly results and forecasts are presented under US
GAAP accounting, the IFRS reconciliation is of passing relevance. The single greatest difference between IFRS and US GAAP
lies with the treatment of convertible notes.

[Cyberhexe]

@jobl

BiogenIdec und Elan haben eine 50:50 Kooperation für Tysabri, wobei Biogen alleiniger Inhaber des BLA (biologics license application) für MS in den Staaten (FDA) ist - eine Zulassung kann immer nur ein Unternehmen erhalten. In Europa gegenüber der EMEA wird Elan verantwortlich sein. Der Gewinn (also Umsatz - Produktionskosten) wird 1:1 geteilt.
Ansonsten existieren keine Verflechtungen, lediglich die Vereinbarung, dass Biogen ein Vorkaufsrecht für Tysabri hat, falls Elan feindlich übernommen wird.

[Cyberhexe]

Vorkaufsrecht meint, dass BiogenIdec Elans Rechte an Tysabri übernehmen kann. Dies ist gleichzeitig auch für Elan ein ÜBERNAHMESCHUTZ!

[Poppholz]

[posting]18.096.214 von Cyberhexe am 30.09.05 15:41:41[/posting]hallo Cyberhexe,

habe auch nichts gehört.

Kursentwicklung ist aber für alle sehr erfreulich.

[Cyberhexe]

das ist ja eine Sensation...und keine PR von Elan oder BiogenIdec?...oder vielleicht kommt die erst am Montag 2.30 a.m.

Und zwar hat NCBI (Natioanl Library of Medicine) den unten zitierten, fast schon sensationellen Abstract veröffentlicht.
Die Sensation ist, dass bei der Hemmung von Alpha-4-Integrinen im Tierversuch eine Remyelinisierung der geschädigten Nervenzellen stattgefunden hat, verbunden mit einem Wiedergewinn von verlorenen motorischen Funktionalitäten. Und Natalizumab ist ein gegen Alpha-4-Integrin gerichteter Antikörper. Der Antikörper bindet an die Integrine, das sind Rezeptoren an der Oberfläche der Lymphozyten, und verhindert dadurch dass diese in ein Gewebe (z.B. Nervengewebe) eindringen. Es wird somit ein Ansammeln von Lymphozyten im Gewebe verhindert, was normalerweise ein wichtiges Kennzeichen einer Entzündungsreaktion ist.
Wenn nun im Tierversuch die Remyelinisierung stattfindet, spricht nichts dagegen, dass dies auch beim Menschen möglich istgb.
Ich bin mal gespannt, ob demnächst eine Aussage gemacht wird, wie sich der EDSS bei den Phase III- Studienteilnehmern entwickelt hat. Also wenn da tatsächlich eine Verbesserung zumindest bei einem Teil der Studienteilnehmer festgestellt wurde, dann können die anderen Anbieter von MS-Wirksttoffen ihre Produktion herunterfahren.

Neuroimmunol. 2005 Oct;167(1-2):53-63. Related Articles, Links
Spontaneous remyelination following prolonged inhibition of alpha(4) integrin in chronic EAE.

Piraino PS, Yednock TA, Messersmith EK, Pleiss MA, Freedman SB, Hammond RR, Karlik SJ.

Department of Physiology and Pharmacology, University of Western Ontario, Medical Sciences Building, Room 223, London, ON, Canada N6A 5C1.

Inhibition of alpha(4)beta(1) integrin blocks immune cell influx into the CNS providing benefit to patients with multiple sclerosis and in animal model systems. We have used this mechanism to examine whether the presence of inflammatory cells suppresses spontaneous myelin repair in experimental autoimmune encephalomyelitis. We observed (1) 87% of plaques showed remyelination after 40 days of treatment; (2) myelin repair occurred in half of the total lesion area; (3) half of the animals regained motor function. There was no significant repair or gain of motor function in vehicle-treated animals. Therefore, prolonged inhibition of CNS inflammation, in the absence of targeted myelin repair, facilitates mechanisms of spontaneous remyelination.

PMID: 16095724 [PubMed - in process]

[Cyberhexe]

so weit ich das beurteilen kann, ist die Nachricht über die Remyelinisierung bei Behandlung mit Hemmern der Alpha-4-Integrine sensationell (siehe #396).
Ich frage mich nun, wie weit fortgeschritten der weiterentwickelte Produktionsprozess (high titer process) ist, mit welchem die Ausbeute mit der vorhandenen Kapazität um bis das Vierfache erhöht werden soll.
Die Spannung steigt, und steigt....
Ich denke die Kurse werden ähnlich verlaufen.

good luck
ch

[hechtbarsch]

naja heute erst mal in den süden.

die 9 USD waren wohl erstmal nicht so leicht zu knacken. Vielleicht in ein paar Tagen.

cu hb

[bernie55]

#396 von Cyberhexe

Ich habe einen sehr guten Freund, der im Biotechsektor arbeitet...ich habe ihm den amerikanischen Text per E Mail zukommen lassen....sein Kommentar dazu :

....das paper klingt sehr erfolversprechend. Eine grosse Frage ist, wie reproduzierbar dies alles beim Menschen ist. Nicht alles was im Tierversuch geht, funktioniert später auch beim Menschen. Grund zur Hoffnung macht dies paper aber......

Grüße bernie55

[Cyberhexe]

@bernie
die Aussage deines Freundes ist sicher richtig, eine Extrapolation vom Tierversuch auf den Menschen beinhaltet viele Unsicherheiten.
Spannend ist dennoch, dass überhaupt eine Remyelinisierung stattgefunden hat und zum anderen, dass die Hemmung der Intergrine an diesem Prozess beteiligt ist.
Da die Integrine im allgemeinen eine wichtige Rolle bei Entzündungsreaktionen übernehmen, besteht da einige Hoffnung...

Bernie...immer Kontakt halten zu derart kompetenten Leuten. Es wäre natürlich von Vorteil, wenn sich diese Leute interaktiv am Board beteiligen würden. Da könnten durchaus alle profitieren...ansonsten wünsche ich dir gute Geschäfte

good luck
ch

[bernie55]

Hallo Cyberhexe,

mein Freund ist Leiter einer Stammzellenforschungsabteilung, deshalb wird er keine Zeit haben, sich hier im WO rumzutreiben......ich werde ihn sicherlich bei News weiterhin informieren und seine Statements, soweit er sich zu bestimmten Themen äußern kann, hier reinstellen....

Grüße bernie55

[hechtbarsch]

October 4, 2005 - 1:30 PM EDT
ELN 8.43 0.01

Today 5d 1m 3m 1y 5y 10y



Elan Announces Webcast of Third Quarter 2005 Financial Results
Elan Corporation, plc announced today that it will host a conference call on Thursday, October 27, 2005 at 8:30 a.m. Eastern Time (ET), 1:30 p.m. British Summer Time (BST) with the investment community to discuss Elan`s third quarter 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.

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.

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.


Elan Corporation
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: Business Wire (October 4, 2005 - 1:30 PM EDT)

News by QuoteMedia
www.quotemedia.com

[Cyberhexe]

BB Biotech hat im Laufe des Sommers die Elan-Position von 2.0 auf 2.4 Mio Anteile erhöht.
Die scheinen ebenfalls an die `story` zu glauben.


http://www.bbbiotech.at/index.php/bbbiotech_de/de/informatio…

[bernie55]

@ alle

Ich bin durch Zufall auf untenstehende Webseite gestoßen. Vielleicht hat der/die eine oder andere ja Interesse, die
kostenpflichtigen " VIEW ABSTRACTS " von ELAN zu lesen.


http://screen.yahoo.com/d?tk=eln&src=&aut=&month=&day=&year=…

Grüße bernie55

[hechtbarsch]

weiß jemand wie die Flüsterschätzungen für die Zahlen am 27.10.05 sind?

cu hb

[Cyberhexe]

@bernie
ich denke, diese Ausgaben kann man/frau sich sparen.
Alle veröffentlichten Zahlen, Informationen sind bekannt und stehen im web kosttenlos zur Verfügung...und die Analystenkommentare sind eh mit Vorsicht zu geniessen, da diese nicht immer die Interessen der Kleinanleger "bedienen".

@hechtbarsch
natürlich ist das Ergebnis von Interesse - besonders die Entwicklung der Nanotech- und DD-Einnahmen.
Aber massiv kursbewegend wird sich das Ergebnis nicht auswirken, zumal keine enormen Abweichungen von den Prognosen zu erwarten sind (dies war in der Vergangenheit zumindest immer so).
Kursbewegend wird auf alle Fälle die Entscheidung der FDA sein, ob dem Review des sBLA zu Tysabri "fast track"-Status gewährt wird. Diese Entscheidung müsste bis spätestens 26.10. gefallen sein. Wenn fast track, dann doch hoffentlich ein Kursplus von mindestens 30%. Wenn negativ entschieden wird, in die andere Richtung.

[bernie55]

Danke für die Info, Cyberhexe...

Grüße bernie

[hechtbarsch]

danke sehr @cyberhexe

also erstmal abwarten bis zum 26.10.05.

cu hb

[zenman]

in den letzten Q-zahlen war ein 80 mio aufwand
für rückkauf verbindlichkeiten enthalten
allein deshalb wird Q3 um mind. 80 mio besser

und da break-even operativ für Q4 angesacht wurde
müsste Q3 dem schon mal nahe kommen

ich bin also optimistisch gestimmt

[zenman]

Monday October 17, 07:30 AM
Elan and Biogen Idec Announce TYSABRI(R) Safety Evaluation Findings in Crohn`s Disease and Rheumatoid Arthritis Patients; TYSABRI Safety Evaluation Co
By Business Wire

DUBLIN, Ireland & CAMBRIDGE, Mass. Oct. 17, 2005 Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB - news) (NASDAQ: BIIB) announced
today that findings from their safety evaluation of TYSABRI(R) (natalizumab) in patients with Crohn`s disease (CD) and rheumatoid arthritis (RA) resulted in no new confirmed cases of progressive multifocal leukoencephalopathy (PML). The companies have previously reported that findings from their safety evaluation of TYSABRI in patients with multiple sclerosis (MS) resulted in no new confirmed cases of PML. Three confirmed cases of PML were previously reported, two of which were fatal. The TYSABRI safety evaluation is now complete.
On September 26, 2005 the companies announced that they submitted a supplemental Biologics License Application for TYSABRI to the U.S. Food and Drug Administration (FDA) for the treatment of MS. The companies also recently submitted a similar data package to the European Medicines Agency.
More than 1,500 CD and RA patients from clinical trials were eligible for the safety evaluation. A total of 88% of these patients participated in the safety evaluation. In total, 98% of the patients participating in the evaluation had a neurological exam by a consultant neurologist and an MRI exam.
On February 28, 2005, Biogen Idec and Elan (Dublin: DRX.IR - news) announced that they voluntarily suspended TYSABRI from the U.S. market and all ongoing clinical trials based on reports of PML, a rare and potentially fatal, demyelinating disease of the central nervous system.



darf hier nich fehlen

nu sin die zeiten UNTER 10 $ schnell vorbei

[zenman]

hexi
wassn los ?

biste in urlaub ?

[Cyberhexe]

...nur noch 6 Tage...die Vorentscheidung rückt näher!

Ian Hunter von Goodbody Stockbrokers am 20.10.2005

Pipeline newsflow will be of a paramount importance to Elan when it reports Q305
...die Neuigkeiten zum Produkteportfolio wird bei der Bekanntgabe des Ergebnis zum 3.Quartal von überragender Wichtigkeit sein

...on 26 September, Elan and BiogenIdec announced that they had submitted a supplementary sBLA including a request for a priority review for Tysabri against MS, to the FDA
...Elan und BiogenIdec haben am 26.September bei der FDA ergänzende Notifizierungsunterlagen für Tysabri zur Behandlung von MS eingereicht einschliesslich einem Antrag auf bevorzugte Bearbeitung


...A respone is therefore expected on or before 26 October. Priority review acceptance would imply that the FDA is satisfied by the quality of submitted data
...eine Antwort wird deshalb bis spätestens 26 Okt. erwartet. Falls die bevorzugte Bearbeitung der Notifizierungsunterlagen Zustimmung finden würde, würde dies für die Qualität der eingereichten Daten sprechen

[welke91]

Die Zulassung in Europa (Morbus Chron)geht die jetzt zeitgemäß weiter oder wird es sich dort auch noch verspäten?

http://www.boston.com/business/healthcare/articles/2005/10/2…

[welke91]

http://www.infrastructure.ie/events/consultation/nanoireland…

grüsse

[welke91]

BERLIN (dpa-AFX) -
Der Pharmakonzern Schering muss nach jüngsten Enttäuschungen bei der Zulassung neuer Medikamente erneut einen Rückschlag verkraften. Deutschlands drittgrößter Pharmakonzern wird die Zulassung für seinen Medikamentenkandidaten Sargramostim zur Behandlung von Morbus Crohn später als geplant beantragen.

Einreichung gegen Ende 2007.

Viel Zeit für Tysabri ...

[Cyberhexe]

nun habens die Analysten bei ncb verstanden: Die Entscheidung über das beschleunigte Zulassungsverfahren muss innerhalb 60 Kalendertagen gefällt werden, also spätestens bis zum 25.November. Beim bevorzugten Zulassungsverfahren muss innerhalb von 6 Monaten eine Entscheidung fallen, also spätestens zum 26.März 06. Falls dem beschleunigten Verfahren nicht zugestimmt wird, ist die Entscheidung innerhalb 10 Monaten fällig, also allerspätestens zum 26.Juli 06.

Also, die Dauer zur Bekanntgabe der "fast track"-Entscheidung hat auf die Dauer der Gesamtprozedur keinen Einfluss - entscheidend ist, ob dem Antrag auf "fast track" zugestimmt wird oder nicht (Konsequenz...6 oder 10 Monate bis zur endgültigen Entscheidung)

Elan $8.12 BUY Clarification On Priority Review Timeline for Tysabri
• One note of clarification on the priority review timeline for Tysabri. It was previously
understood that the FDA would respond to BiogenIdec/Elan`s request for priority
review within a 30-day period.
• We now understand that the FDA has up to 60-days from the date of submission to
respond to this request (a decision is now expected by 25th November).
• The timing of the priority review decision will not impact the time the FDA will take to
review the sBLA file (6 months from the date of submission for a priority review or 10
months from submission for a standard review).

[Cyberhexe]

...aber wer weiss, vielleicht kann sich die EMEA "frei schwimmen" und ist bei der Zulassung "schneller" als die FDA...das wäre ein Paukenschlag!


Die Zulassungen bei der EMEA wurden eingereicht am...

...29.9.04 für Morbus Crohn
http://www.elan.com/News/full.asp?ID=620045


...4.6.04 für MS
http://www.elan.com/News/full.asp?ID=578660

[Poppholz]

[posting]18.429.541 von Cyberhexe am 25.10.05 11:42:30[/posting]wie lange braucht die EMEA (normalerweise) für die Zulassung eines Produktes bzw. um einen Termin für die Zulassung festzulegen?

Die beiden Anträge sind ja nun auch schon vor über einem Jahr gestellt worden.

[welke91]

Hey Poppholz, liest du den Thread nicht???

Halte dich fest .....denn jetzt kommts ich gebe dir, die Hexe moment,.... jetzt...

ich will dich nicht erschlagen mit Informationen...nur vielleicht soviel...
...Elan hat am 29.9.04 bei der EMEA, das ist die europ. Zulassungsbehörde für Arzneimittel die Zulassung von Natalizumab (also Tysabri) zur Behandlung von Morbus Crohn beantragt. Es ist jedoch nichts aussergewöhnliches, dass einer Zulassung eine zeitintensive (9 Monate ?) Prüfung der Zulassungsunterlagen, also der statistischen Auswertung der klinischen Tests, vorausgeht. Die Bekanntgabe der 2-Jahresergebnisse von ENACT-2 (so heisst die klinische Phase-III-Studie, die dem Antrag auf Zulassung zugrunde liegt) wird in einigen Wochen erwartet. So viel ich weiss läuft ENACT-2 bis Ende Juli. Die 12-Monats-Ergebnisse und auch die Kommentare des sonst eher zurückhaltenden Mgmts lassen vermuten, dass die endgültigen Ergebnisse sehr vielversprechned sind. Bisher ist Infliximab (Remicade) von J&J das Mass aller Dinge zur Behandlung von Morbus Crohn. Nachdem ich jedoch dessen Packungsbeilage einmal intensiver studiert habe....also ich möchte mich nicht weiter dazu äussern, vielleicht nur so viel...falls die PML-Probleme bei Tysabri kalkulierbar werden bzw. sogar ein entsprechendes Monitoring mit Therapiemöglichkeiten aufgezeigt werden, dann könnte ich mir vorstellen, dass das Nebenwirkungsprofil von Tysabri (im Plazebobereich) die Vorherrschaft von Infliximab bei der Behandlung von MC in Frage stellen wird.

Ich bin mir jedoch ziemlich sicher, dass die EMEA die Zulassung erst dann erteilen wird bzw. eine Entscheidung treffen wird, wenn die Theorien um PML aus einer wissenschaftlichen Sicht plausibel sind.

[Poppholz]

natürlich lese ich den Thread, aber es gibt bei besonders bei den "Prüfungszeiträumen" so viele unterschiedliche Angaben, dass es schwer fällt hier den Überblick zu behalten.

Der Antrag für die Zulassung von Tysabri zur Behandlung von Morbus Crohn liegt jetzt ja auch immerhin schon 13 Monate zurück.

Somit wäre es schon gut, wenn hier demnächst eine News kommt.

[Cyberhexe]

...so langsam werden auch die anderen Aktiva von Elan verstanden!

PowerShares Introduces World`s First Nanotech ETF
ETF Designed to Track Lux Nanotech Index
CHICAGO, IL -- (MARKET WIRE) -- 10/21/2005 -- PowerShares continues to "Lead the Intelligent ETF Revolution" with the introduction of the PowerShares Lux Nanotech Portfolio. The trading symbol for the PowerShares Lux Nanotech Portfolio will be (AMEX: PXN) and is anticipated to begin trading October 26, 2005 on the American Stock Exchange.


Largest Components of Index as of 06/30/05

Lux Nanotech Index Ticker Weight
------------------ ------ ------
Elan Corp Plc -ADR ELN 6.10%
Headwaters Inc HW 5.10%
American Pharma Inc APPX 5.00%
Westaim Corp WEDX 5.00%
Accelrys Inc ACCL 4.90%
Veeco Instruments Inc VECO 4.90%
Skyepharma Plc -ADR SKYE 4.60%
Biosante Pharmaceuticals Inc BPA 4.50%
Symyx Technologies Inc SMMX 4.50%
Altair Nanotechnologies Inc ALTI 4.50%
Harris & Harris Group TINY 4.10%
Nanophase Technologies NANX 3.90%
NVE Corp NVEC 3.90%
Cambridge Display Tech OLED 3.80%
Flamel Technologies SA -ADR FLML 3.80%
FEI Co FEIC 3.70%
Hewlett-Packard Co HPQ 3.20%
BASF AG -ADR BF 3.00%
Intl Business Machines Corp IBM 2.90%
Immunicon Corp/De IMMC 2.90%
NEC Corp. -ADR NIPNY 2.70%
General Electric Co GE 2.60%
General Motors Corp GM 2.60%
3M Co MMM 2.60%
Air Products & Chemicals Inc APD 2.50%
Du Pont ( E I) De Nemours DD 2.40%


kompletter Artikel unter:
http://www.marketwire.com/mw/release_html_b1?release_id=9880…

[Cyberhexe]

das Ergebnis erfüllt meine Erwartungen:

Positiv ist,...

...dass die Lizenzeinnahmen auf $ 57.8 (immer in Mio) um 99% gestiegen sind (yoy) bzw. 21.7% (qtq)

...dass man mit ACC-001, dem Immunokonjugat zur Vaccinierung von Alzheimerpatienten in die Klinik eingetreten ist (Phase 1: Studie über 12 Monate)

... dass das negative abgestimmte EBITDA, ohne Tysabri, im 3.Q auf $5.4 zurückgegangen ist (2.Q 2005 noch $20.5 )

...dass sowohl die FDA als auch die EMEA mit zusätzlichen Informationen zu Tysabri bedient wurden

...dass erst 2008 die nächsten Anleihen in Höhe von $613 fällig werden und dann Ruhe ist bis 2011


die einzige Enttäuschung sind wohl die Verkaufserlöse von Prialt (1.5 gegenüber 1.8 qtq); substanzielle Verkäufe werden wohl erst möglich sein, wenn von Seiten der Pumpenhersteller (medtronic etc.) ein Innovationsschub erfolgt

[Cyberhexe]

auch wenn derartige Rechnungen "vom Schiff" immer sehr gewagt sind, so offenbaren sie doch zumindest das mögliche Potential:

Annahme
Ende 2006 wird einer von 25 MS-Patienten in Nordamerika und Europa mit dem wirkunsvollsten Medikament gegen MS (Tysabri) behandelt. Im Durchschnitt übers Jahr würde also jeder 50. Tysabri einnehmen. Dies würde ca. 30.000 Jahresdosen entsprechen.

30.000 x $23.500 = $705 Mio
$705 Mio x 0.85 = $599.25 Mio (85% Bruttomarge)
geteilt durch 2 (Biogen:Elan=50:50) =
$299.6 Mio Deckungsbeitrag

Da EBITDA bis dort positiv, wäre der Reingewinnn wohl jenseits 200 Mio $/a


Und ich kann mir nicht vorsstellen, dass mittelfristig nur ein Patient von 25 mit dem wirkungsvollsten Medikament behandelt wird. Da ist wesentlich mehr drin. Und wenn dann die Alzheimeroptionen ihren vielversprechenden Ansatz halten, dann sind Kurse über 50 $ keine Utopie


good luck
ch

[Cyberhexe]

Bloxham sieht das allerdings ganz anders:

"Therefore Elan`s current valuation remains unattractive on a risk-reward basis."

Die halten das Verfhältnis von Chance und Risiko für unattraktiv.

[Cyberhexe]

Aus dem Artikel in der Irish Times geht das enorme Potential von Elan hervor:

Das "drug technology business", welches auch Elans patentierte Nanotechnologie umfasst, hat die Umsätze auf Jahresbasis fast verdoppelt (99%). Dies ist jedoch erst die Spitze des Eisbergs, da momentan erst für 6 Formulierungen Lizenzeinnahmen generiert werden, jedoch mit fast allen Grössen der Branche entsprechende Entwicklungen vereinbart wurden. Aktuell betrifft dies 24 weitere Formulierungen. Da in den nächsten 4 Jahren der Patentschutz von Wirkstoffen abläuft, die Umsätze über 50 Milliarden $ generieren, wird der Bedarf nach entsprechenden Neuformulierungen enorm wachsen. Mit Neuformulierungen, gerade mit den Möglichkeiten der Nanotechnologie, eröffnet sich die Möglichkeit die Bioverfügbarkeit und dergleichen zu verbessern, so dass über eine veränderte Produkteigenschaft eine Erweiterung des Patentschutzes bzw. eine Differenzierung von generischen Herstellern erzielt werden kann. Dies könnte für Elan eine Geldmaschine werden, da bei der Markteinfführung der neuformulierten Produkte Elans Aufwand gegen Null geht, jedoch jeder $ Umsatz den die neu formulierten Produkte generieren ca. 5 Cent an Lizenzgebühren fällig werden - 5 % ist so viel ich weiss die derzeitige Marge, teilweise konnten jedoch auch schon Lizenzgebühren im zweistelligen Prozentbereich ausgehandelt werden.

Zum Alzheimer-Projekt äussert sich Kelly Martin ebenfalls optimistisch, da die Neurologen in den Studienzentren zu AAB-001 (klinische Phase II) ausserordentlich positives über den Verlauf der Studie vermelden. Ergebnisse werden in der 2.Jahreshälfte 06 veröffentlicht. K.Martin weist darauf hin, dass Alzheimer die am weitesten verbreitete Krankheit ist, für die es keine Therapiemöglichkeit gibt und dies bei Zuwachsraten über 10%.

Und schliesslich sagt er zu Tysabri das wirklich Sensationelle:
"Since the drug was pulled off the market, we now have the two- year data and it tells us the drug is better than earlier data on which the initial approval was based - in terms of safety, efficacy and EDSS quality of life scores.

"Over 50 per cent of the patients on the drug for more than six months show complete stoppage of signs of progression of MS."

Und zum Schluss wird er noch mit den Worten zitiert, "...dass es aus medizinischer Sicht keinen Grund gibt, warum Ty nicht die dominierennde Therapiemöglichkeit bei MS werden sollte so lange es keine bessere gibt."

Ich bin optimistischer denn je... aber ich werde die Geduldsprobe auf mich nehmen!





The Irish Times
October 28, 2005
by Dominic Coyle

Biotech group Elan still has high hopes for its breakthrough multiple sclerosis (MS) drug Tysabri but it`s not waiting around for it to deliver.

The Irish group has been through a torrid time in the months since it withdrew the drug from the market after two patients fell ill with a generally fatal brain disease.

At the time, Elan was looking forward to a period of stability after more than two years of turmoil driven by a failed Alzheimer`s programme, a Securities and Exchange Commission (SEC) inquiry into accounting practices, wholesale management changes and a drastic rescue programme that saw it sell assets worth $2.7 billion (EUR 2.2 billion) in an effort to stay afloat long enough to profit from what was seen as a "blockbuster" MS drug.

Tysabri had only been on the shelves a few months after winning fast-track approval from the US regulator, the Food and Drugs Administration (FDA), on the basis of just one-year`s data.

Elan is still bullish about the prospects for the drug. Speaking to The Irish Times this week, chief executive Kelly Martin said the experience of the drug in the short time it was available was that it had attracted heavier demand than even the most optimistic analysts had projected.

In the meantime though, it is concentrating on developing other sides of the business. In particular, it is working to expand both the drug technology business run from Athlone by Paul Breen and the specialty business in the US that is built around selling Elan and other products into 900 hospitals around the United States - over 600 of them university or teaching hospitals.

These businesses are growing strongly, notably the drug technology side which recorded 99 per cent year-on-year growth in the third quarter and is now the largest operating unit in Elan.

"You have over $50 billion of drug revenue that is going to go off patent in the next four years," says Martin, "and that is our market.

"We can take existing drugs and change the chemical composition to improve efficacy and safety or to alter dosage levels, regularity of dosage or how they are taken. These are not our drugs but those of other companies."

Martin characterises the business as a technology operation rather than a contract manufacturing unit.

And he has switched its revenue model from one where it operated as a service to other companies for a fee to one where it is a partner in modifying drugs to improve them and/or extend their lifetime under patent in return for royalty fees.

"The way to think of our drug technology business is like Intel - they have technology (the chips) and they put it into hardware," says Martin. "They don`t care whose hardware."

"Elan drug technology is like `Intel Inside`. We can use our technology to change and improve a product. It is good for patients, and the potential partner."

Already, six products from the drug technology pipeline have been launched in the United States and the company is currently in discussions in relation to around two dozen others.
Elan reckons the drug technology programme indirectly touches between two and 2.5 million patients.

Martin uses Elan`s experience with a drug used to treat psychiatric patients, who have schizophrenia, as an example of what Elan`s drug technology can do.

Compliance is an obvious and serious problem for schizophrenic patients and the requirement to take this particular drug once a day means that up to 80 per cent of patients abandon their therapy. Elan is reformulating the drug so that it need only be taken four times a year, allowing it to be administered to patients during visits to doctors.

"If you can get compliance to go from 20 per cent to 90-plus per cent, that`s an incredible change."

The business, together with the specialty hospital sales operation, has the added advantage of giving Elan a better balance, offsetting some of the higher risk intrinsic in the biotechnology operations for which it is better known.

Back on the biotech side, the company has high hopes for its Alzheimer`s programme - from which Tysabri first emerged - and which is being developed with Wyeth. The company currently has one programme in Phase II trials and another entering Phase I.

"The neurologists in the centres we are using in the Phase II trial are exceptionally positive about progressing and we will have data from that in the second half of next year," says Martin.

"There is no therapy doing what we are trying to do. Alzheimer`s is probably the biggest disease with no therapy in the world and it is growing at double-digit rates."

Martin says the past three years have been a steep learning curve for someone who moved to the group from bankers Merrill Lynch, but some things don`t change from sector to sector. "Our job is to reduce risk and increase shareholder value and, as a company we spend a lot of time looking at our strategic future."

However, the sector in which Elan operates does provide its own unique challenges. "The objective of biotech companies is to be innovative - we want to find, discover, develop and then make available to patients drugs or therapies that are fundamentally going to stop the progression of the disease. That`s the Holy Grail. If you can do that, it`s an enormous win for the patients, it`s an enormous win for the company and it`s an enormous win over time for the shareholders. That`s what we try to do."

Elan says it has exceptionally good dialogue with the FDA before and since the removal of Tysabri. "It`s fair to say the agency is being as responsive and flexible and thorough as they can be with us to work through the Tysabri opportunity for patients, that what we do," says Martin.

"Since the drug was pulled off the market, we now have the two- year data and it tells us the drug is better than earlier data on which the initial approval was based - in terms of safety, efficacy and EDSS quality of life scores.

"Over 50 per cent of the patients on the drug for more than six months show complete stoppage of signs of progression of MS.

The company accepts that it is going to be a monotherapy drug but, as Elan research chief Lars Eckman noted yesterday, investigation since the suspension of Tysabri indicates that it is only a minority of MS patients that will be at risk to the neurological disease that led to the drug`s suspension.

"At the end of the day, it is going to be a patient demand product. I believe patient demand is as high or higher than it was a year ago. I also think Tysabri now, perversely, is now the best understood drug in the history of the pharmaceutical business. So I see no reason from a medical point of view why Tysabri won`t be the dominant MS therapy until there is one that is better than it."

[welke91]

Hallo Cyberhexe,

deinen Thread zu finden wird immer schwieriger.

Vielleicht mal bei der DRX einen neuen anlegen?

Unter der WKN 871331 gibt es bei WO keinen Eintrag mehr?!

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

The role of alpha-4 integrin in the aetiology of multiple sclerosis.
Habe mir erlaubt aus diesem Thrad etwas in ZEN-Thrad zu kopieren um diesen posimist das Potenzial von Elan zu zeigen.
Außerdem:

http://www.die-forschenden-pharma-unternehmen.de/krankheitsb… keine Tysabriinfo!

[Cyberhexe]

Das Interesse der Institutionellen an Elan ist mittlerweile stark angewachsen:

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

Bin gespannt, um wieviel "bucks" der Kurs bei einer bevorzugten Bearbeitung durch die FDA - ich kann mir nur schwer vorstellen, dass "fast track" nicht gewährt wird - steigen wird. Ebenso gespannt darf man auf die Dauer sein, welche die FDA für den Review benötigt. da sich an der ursprünglichen Datenlage tatsächlich wenig verändert hat, und zudem von Patientenorganisationen Druck gemacht wird. Eine derartige Entscheidung mit den vorausgehenden Studien der Unterlagen müsste in weniger als 6 Monaten (fast track) zu machen sein...wenn dies gewollt ist!

[Cyberhexe]

Der bisherige Goldstandard bei Morbus Crohn "Infliximab" (brand name: Remicade) hat auch seine Schwierigkeiten:

http://www.fda.gov/medwatch/SAFETY/2005/MAY_PI/Remicade_May0…

[Cyberhexe]

Im "NEJM" (The New England Journal of Medicine) vom 3.11.2005 werden die Ergebnisse von ENACT-1 und ENACT-2 (Natalizumab-Studien bei MC) diskutiert:
Während bei ENACT-1 nach 12 Wochen die Endpunkte nicht signifikant erreicht wurden, konnten bei der länger dauernden ENACT-2-Studie alle Endpunkte signifikant erreicht werden. Es handelt sich hierbei um eine plazebokontrollierte Doppelblind-Studie an Studienteilnehmern, bei denen in ENACT-1 eine Reaktion nachgewiesen wurde.

http://content.nejm.org/content/vol353/issue18/images/large/…

[Cyberhexe]

interessant sind natürlich die Verkaufsabsichten der Bertarelli-Familie:
Fakt ist, dass Serono über 50% des Umsatzes mit Rebif generiert. Falls Tysabri nun zugelassen wird, dann würde sich eine Ernst zu nehmende Konkurrenz zu Seronos Blockbuster am Markt etablieren. Dies könnte massive Kursverluste zur Folge haben.
Seronos CEO Ernesto Bertarelli hat bisher auch keine Gelegenheit ausgelassen, um die Wirksamkeit und Sicherheit von Natalizumab in Frage zu stellen. Dessen Verkaufsabsichten interpretiere ich als ein überaus positives Signal. Allerdings kann ich mir nicht vorszellen, dass sich derzeit jemand findet, der für diese "dünne" Pipeline und das Rebif-lastige etablierte Geschäft 15 Milliarden $ hinblättert . Da gibt es weitaus interessantere und elanvollere Unternehmen, die derzeit nicht einmal zu einem Viertel dessen bewertet sind.

Let`s go.
Good luck.
ch

[Cyberhexe]

übrigens...falls Elan ähnlich hoch bewertet würde wie Serono, dann hätten wir einen Kurs um ca. 37$

...und Elan hat das DD-Geschäft einschl. Nanotechnologie
Tysabri
Alzheimer-Kandidaten
Prialt (bisher allerdings eine Enttäuschung)
...

[welke91]

Ist schwer dich zu finden;-)

Das mit Serono ist schon ein Ding.
Eine Frage wenn du erlaubst?
Ich meine im Schreiben von 26.09.05 The companies have requested Priority Review status for the sBLA which, if granted, would result in action by the FDA approximately six months from the submission date, rather than 10 months for a standard review.

Das bezieht sich doch nur auf die MONO!!! Combo hat doch eine Zulassung(sBLA)!!!ODER???

Die NDA brauchen die ja nicht mehr!Nur noch das FDA-OK!

Kann mir nicht vorstellen das ein Medikament zugelassen wird und nach einen Jahr nochmals den Prozess durchläuft nur um festzustellen das Ty sicher ist.

Unter den Umständen, die man kontrollieren kann.

Eine neue Lizenz brauchen die nur für die MONO!
Verweise hier auf VIOXX-Geschichte!
Da hat die FDA sogar empfohlen VIOXX wieder zu bringen!

[Cyberhexe]

hi welke

da es sich bei Natalizumab um einen monoklonalen Antikörper handelt, wird nicht ein NDA sondern ein BLA (Biologic License Applikation) fällig, welches von der FDA BiogenIdec, dem Antragssteller in den Staaten, zugesprochen wurde. Das BLA ist bisher nicht auf eine Anwendung (Mono oder Kombi) beschränkt. Die Kombi-Therapie hatte meines Erachtens aber noch nie eine grosse Chance , weil einerseits die Ergebnisse mit Mono genau so gut sind und zudem die Kombitherapie (Ty+Avonex) noch einmal mehr als die Hälfte teurer ist. Hinzu kommen dann noch die möglichen Interaktionen zwischen den Wirkstoffen. Die Interessen von BiogenIdec, die Avonex-Umsätze nicht vollständig zu kannibalisieren, haben jedoch dazu geführt, die Kombi am Leben zu erhalten.
Obschon dies natürlich diese Verzögerung verursacht hat, kann man der Sache positiv abgewinnen, dass über Natalizumab und dessen Wirkmechanismus nun wesentlich mehr Info zur Verfügung stehen.
Bei der Neuzulassung wird es wohl ein Label geben, das auf die mögliche PML-Gefahr bei supprimierten Immunsystemen hinweisen wird , also auch bei der gemeinsamen Therapie mit Interferonen - ich geh davon aus, dass die Kombi-Therapie dann "gestorben" ist (gut für Elan, schlecht für BiogenIdec!).

Bei der Dauer des Reviews gebe ich dir vollständig recht. Ich kann mir auch nicht vorstellen, dass man 6 Monate für die Durchsicht der neuen Unterlagen benötigt.
Warten wirs ab!

[Birgit.Tersteegen]

...."die Umsätze nicht vollständig zu kannabilisieren"-nett ausgedrückt!

[Gndlf]

09.11.2005 22:02
The National MS Society, Biogen Idec, Elan, and MSWorld Recognize MS Leaders of Hope(SM) Award Winners


Seven Winners Honored at the National MS Society Conference in Atlanta, Georgia

The National Multiple Sclerosis Society, Biogen Idec (Nachrichten), (NASDAQ: BIIB), Elan Corporation (Nachrichten), plc (NYSE: ELN) and MSWorld(R) announced today the winners of the MS Leaders of Hope award, which recognizes people with multiple sclerosis (MS) and their caregivers who have demonstrated ways of managing the challenges of their disease that uniquely inspire others.

This year, over 2,000 entries were submitted from the United States and Canada. Entries were submitted in seven categories representing areas of life that are often challenged by MS: mobility, relationship, time management, employment/workplace, memory, caregiver, and youth. Nearly 29,000 votes were cast for 21 finalists over a one-month period. The seven winners received their awards today, including a $1,000 cash prize, at the National MS Society Annual Conference in Atlanta, Georgia.

"We would like to thank all those who submitted their inspiring stories and creative solutions to the MS Leaders of Hope awards. The MS community continues to amaze us with its passion, spirit and eagerness to share ways to improve the lives of others," said Joyce Nelson, president and chief executive officer, National MS Society.

The following winners` stories can be found on www.msleadersofhope.com:

-- Mobility - Sarah Hunter, South Jordan, UT: At age 16, Sarah, an avid basketball player and fan, was diagnosed with MS. She had such difficulty walking that she told her team she was going to quit basketball. At her team`s urging, Sarah resolved to continue to play. Her senior year, she made the team and even played in a few games. She became an inspiration to her teammates and others.

-- Relationship - Jennifer Leone, Fresno, CA: To give her friends and family a sense of some of the physical limitations of a person with MS, she hosted a party where all attendees had to bind their feet together with rope, put five-to-10-pound weights on their arms, wrap elastic bands around their fingers, and then perform simple tasks such as buttoning a shirt or writing a note. For many of her friends it was the first time they truly understood what it was like to live with MS.

-- Time Management - Donna Goldman, Buffalo, IL: Juggling a busy schedule of family and work proved to be a challenge for Donna, and her MS made it difficult for her to remember to bring many things she would need throughout the day. To help remedy this, Donna began to use her car as an extension of her home, keeping coupons, gift certificates, an extra change of clothing, bottled water and snacks in a backpack in the trunk. This helped her prepare for many MS-related challenges and manage her time more effectively.

-- Employment/Workplace - Joy Gravely, Greenwood, SC: One year after her diagnosis, Joy found that she had to give up what she had loved doing for 22 years - teaching. She began tutoring local children at home, and subsequently opened Hopewood Academy for 25 students, which increased to 90 over three years. Joy and her staff ensured that students not only learned about core subjects but also about having special needs such as MS.

-- Memory - Buddy Hayes, Chesapeake, VA: Because of her MS, Buddy had problems remembering directions when driving to doctors` appointments or running errands. In order to solve the problem, she bought a small photo album, printed directions in large font, along with phone numbers, and organized them in alphabetical order. Buddy`s "How Do I Get There?" book has made trips easier for her and for others she knows.

-- Caregiving - Jody Roberts, San Diego, CA: Before Jody went to college, she wanted to find a way to keep her father`s memory strong and his outlook positive rather than focused on the challenges of his MS. She decided to buy a personalized page-a-day calendar and write a favorite memory or dream of the two of them. The calendar turned out to be her father`s most prized possession. Her dad passed away two weeks before she started her senior year in college, however, Jody has remained active in the MS community, including participating in numerous fundraising activities the last five years.

-- Youth - Brandhi Russo, West Chester, OH: Brandhi was diagnosed with MS at the age of 13, and, as a result, faced a unique set of challenges. Brandhi started the MSKidsConnection, which promotes a better understanding of pediatric MS and provides support and resources to children and families. They host seminars at local schools, including the first regional College and Career Day for young MS patients, featuring successful professionals with MS.

"The MS Leaders of Hope winners have demonstrated exemplary courage and innovation in dealing with the challenges that come with living with this difficult disease. They, and many others, inspire us at Biogen Idec to extend our leadership in providing support and developing new therapies that can help serve the significant unmet need that exists for people with MS," said James C. Mullen, chief executive officer, Biogen Idec.

"The MS Leaders of Hope program has successfully showcased the lives of many inspirational individuals in the MS community. Patients helping patients is what MSWorld is all about, and these individuals will help and inspire so many to improve the quality of their lives." said Kathleen Wilson MA, MFA, president and founder of MSWorld. "The categories of this competition reflect the complexity of the challenges facing people with MS. Creativity is definitely part of the solution when it comes to managing each day with multiple sclerosis."

"Elan is proud to be a part of the MS Leaders of Hope. The strength and spirit of these winners, and of all MS patients around the world, continues to motivate us as we work to make a positive difference in the lives of these patients and their loved ones," said Kelly Martin, president and chief executive officer, Elan.

Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, unpredictable disease of the central nervous system that, according to the National MS Society, affects approximately 400,000 people in the United States and approximately 2.5 million people worldwide. It is a disease typically of young adults, mostly women, with onset typically between 20 and 50 years of age. Each hour someone is newly diagnosed. MS symptoms may include vision problems, loss of balance, numbness, difficulty walking and even complete paralysis.

About The National MS Society

The National Multiple Sclerosis Society, founded in 1946, supports more MS research, offers more services to people with MS, provides more professional education programs, and advances more MS advocacy efforts than any other MS organization in the world.

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 http://www.elan.com.


About MSWorld

Inspired by Christopher Reeve nine years ago, MSWorld began with a single chat room and has evolved into a comprehensive on-line self-help site for everyone coping with MS. All of the staff at MSWorld are diagnosed with MS and volunteer their time and talents to help others. MSWorld is committed to helping people attain an unparalleled level of independence by providing a safe place on-line to meet for support and to gather information. "Our Motto at MSWorld is Wellness is a State of Mind. When you are well within your mind your life has its greatest potential," Kathleen Wilson MA, MFA, President&Founder, www.msworld.org.

[Cyberhexe]

wow...die Umsätze von King Pharmaceuticals Skelaxin (metaxalone) haben yoy um 92% auf 115.9 mio$ zugenommen. Die Lizenzeinnahmen für Elan betragen derzeit noch 5%, erhöhen sich jedoch zu beginn des kommenden Jahres auf 10%. Da sind ja jährlich über 50 mio$ an Lizenzeinnahmen möglich. Also kein Wunder, hat KM das Ziel vorgegeben vor Abschreibungen und Steuern für das nächste Jahr ein positives Ergebnis vorzulegen.

Deswegen...Elanvoll Spass haben!
good luck
ch

Birgit, dein Kannabili gefällt mir auch!

http://biz.yahoo.com/prnews/051109/nyw069.html?.v=48

[Birgit.Tersteegen]

oh je-Stimmt....klingt beides ziemlich abgefahren (v.a. in diesem Zusammenhang!)Hexchen : Danke nochmal für Deine kompetente Unterstützung in diesem Thread!Grüsse!

[welke91]

Ja supi dass es dich gibt.

Habe noch nie jemanden getroffen, der von einer Aktie so überzeugt ist und dennoch sachlich bleibt.

Also ein BLA wird von der FDA ausgesprochen, wogegen die NDA ein eigenes Institut ist.AAHH!!

Prüft die FDA die Unterlagen denn selber? Ein BLA gilt nur für das was "biologisch hergestellt werden kann",wie z.b. monoklonale Antikörper?
Dann wurde in dem Schreiben bekannt gegeben, dass ein sBLA für die MONO zum Antrag steht. Sehe ich das richtig?

Weil sie in der ersten zeit mit der Kombi arbeiten wollen.
Also 05 noch;-).
Will euch nicht verrückt machen aber:muss sein..


Aber Cyberhexe Du hast Recht warten wir es ab.

[jojobada]

Guten morgen@all.

Einen schönen Tag Tag noch!

Gruß jojobada

[lonesome loser]

Irish drug company Elan (ELN:NYSE ADR - commentary - research - Cramer`s Take) was upgraded to hold from sell at A.G. Edwards, whose analysts believe that chances are the multiple sclerosis drug Tysabri will return to the market.

The product, which Elan markets with Biogen Idec (BIIB:Nasdaq - commentary - research - Cramer`s Take), was pulled earlier this year after being linked to a serious and potentially fatal brain disease.




By factoring Tysabri back into Elan`s results for next year, A.G. Edwards expects the company to lose 54 cents a share, compared with its previous estimate of 59 cents.

Assuming that by 2009 the drug has about 7% of the U.S. multiple sclerosis market and 6% of the European Union market, it would generate revenue of $1 billion, A.G. Edwards says.

"We believe this level of success for Tysabri is already factored into the [Elan] share price, however, as the stock is volatile, we would not want to be selling the shares in the event Tysabri is allowed back on the market," the firm says in a research report dated Nov. 11.

Elan was trading up 35 cents, or 4%, to $9.20. Biogen was gaining 13 cents, or 0.3%, to $44.11.

[Jogybroker]

14.11.2005 - 08:36 Uhr
Elan Upgrade
Rating-Update:

Die Analysten von A.G. Edwards & Sons stufen die Aktie von Elan (ISIN US2841312083/ WKN 871331) von "sell" auf "hold" hoch. Die Nachrichten von Tysabri und den Alzheimer-Programmen könnten den Aktienkurs beflügeln. Analyse-Datum: 14.11.2005


Quelle: Finanzen.net



Gruß Jörg

[eliasesteban]

erst sellen und dann holden,die sind ja gut

[hastrubal]

@eliasesteban
?????????????????????????????????????
????????????????????????????????????

[Poppholz]

aus dem Nachbarthread:

aus :thebulltrader.com

ELN Breakout Watch

I’m bullish on the whole Tysabri news, but I totally didn’t expect this breakout. This is the highest ELN has ever traded since Feburary 28 when Tysabri was pulled. I had personally expected ELN to see resistance at the downward sloping trendline, but two upgrades from brokerage houses gave ELN the momentum to plow right through both extremely strong resistances. Because the stock gapped down so brutally on Feburary 28, there is no resistance above until around $28.

I’m not sure what will happen now. I’ve traded ELN many times in the past, both successfully and unsuccessfully. From my experience with this stock, I have good reason to suspect that this stock is highly manipulated on the street. If you thoroughly investigate the connections between ELN, brokerage houses, hedge funds, and the media, I totally wouldn’t be surprised if you discovered some fishy business. So be careful with this stock.

I’ve been out of the loop on ELN for awhile, but there are rumors floating on message boards that the FDA is soon going to rule on whether or not to grant the Tysabri sBLA a priority review or not.

My speculation is that the FDA will grant the Tysabri sBLA a priority review, but that’s just my opinion. I probably won’t be trading this stock at the moment, but feel free to leave any comments on what you think of the whole Tysabri situation.
By JWU on November 15, 2005: Charts
2 Responses to “ELN Breakout Watch”

1. Anonymous Says:
November 15th, 2005 at 1:25 am

10$ and congrats to all
by: pinvestment 11/14/05 02:54 pm
Msg: 819242 of 819877

but this is still an unfolding story - many still have to come to realize where tysabri is headed into the future - and the real news really isn’t out yet

be patient and prosper

but if ty does get the 30-40% of the MS market i think it can - that is 6-8 billion of revenue from the MS market alone

a nice story can play out while the data from the aab-001 trial comes along

nobody talking about it - but where is the trial restart - IRB and protocol OK should have been completed

[bernie55]

.....there is no resistance above until around $28....

[Cyberhexe]

Es gibt immer noch Analysten, die mitreden ohne die Hintergründe zu kennen. Hier ein erneuter Beweis: Der Experte bei Biotech... kann sich nicht vorstellen, aus welchem Grund sich Wyeth für Elan interessieren könnte. Ich kann hierzu lediglich sagen...Hausaufgaben nicht gemacht. Note 6. Setzen!
...bzw. zukünftig vollständig ignorieren.

http://biotechstockblog.com/article/4283

Rumor Du Jour: Wyeth Looking at Acquiring Elan (WYE, ELN)
Only one word comes to mind to describe this rumor: Absurd. I cannot see why any company would acquire Elan (ticker: ELN) at its current stock price. As of today’s close, Elan had a $4.4 billion market capitalization, which represents a $5.2 billion enterprise value. Based on its reported third quarter revenue, Elan is trading at 10x annualized revenue. Moreover, the valuation implies a significant contribution from Tysabri in the future, a level which I believe is irrational.

« Any opinions expressed on the Seeking Alpha sites are those of the individual authors and do not necessarily represent the opinion of SeekingAlpha or its management. »

[Cyberhexe]

...thestreet bzw. Cramer ist und bleibt Elan gegenüber negativ eingestellt. Welche Strategie wohl dahinter verborgen ist?

http://www.thestreet.com/_yahoo/funds/lightninground/1025330…

Elan (ELN:NYSE ADR - commentary - research - Cramer`s Take): "I do not think that Elan is a buy here."

[bernie55]

Welche Strategie wohl dahinter verborgen ist?

Wir können es nur erahnen ..

... ich habe heute morgen auf jeden Fall nochmals mein Depot zugunsten von ELAN umgeschichtet.....



...ich sage nur eins....TIME WILL TELL....

[Cyberhexe]

@bernie
es scheint mir, dass ich nicht mehr so einsam bin im "Tal der Unvernünftigen"

all in & long
good luck
ch

[Birgit.Tersteegen]

Cramer kann nicht mehr anders;er hat in den vergangenen Monaten schon zu viel Politik mit Falschaussagen betrieben.Ich hoffe,dass ein "Karriereknick" bei ihm die Folge sein wird

Fest steht:Auch er wird Elan nicht aufhalten können!!

[bernie55]

...sind wir nicht alle ein wenig " im Tal der Unvernünftigen "....

all in & long
good luck

[bernie55]

...not " all in " but - a lot -...

[bernie55]

...auf jeden Fall - long -

[bernie55]

..und good luck...

[Birgit.Tersteegen]

[Poppholz]

hier seit Ihr alle.



(manchmal muss man auch mal was "unvernünftiges" machen)

[posimist]

Cyberhexe,ich hoffe nicht,daß du wieder "auf Pump" gekauft hast?!
posimist

[Cyberhexe]

@posimist

ich bin immer noch zu 110% in Elan investiert...und daran wird sich kurzfristig nicht viel ändern.

good luck
ch

[Poppholz]

[posting]18.850.157 von posimist am 17.11.05 11:10:58[/posting]seit der Äußerung von Cyberhexe, dass Sie auf "Pump" gekauft hat, ist der Kurs um die 50% nach oben gegangen und dieses über einen Zeitraum von ca. 6 Monaten.

Wenn Cyberhexe sich nicht bei den falschen Leuten die Kohle geliehen hat, sollte alles im grünen Bereich sein.

[welke91]

Hey Cramer hab dich gewarnt!!!

Ein hoffnungsloser Fall ist dass!!!

[posimist]

Also Cyberhexe bist du 110% sicher,dass Ty alsbald zugelassen wird?!
POSIMIST

[Birgit.Tersteegen]

Als posimist kann man das doch nicht wirklich fragen.....

[Poppholz]

ich glaube hier ist keine(r), der (die) nicht meint, dass Tysabri wieder an den Markt kommt.

[Poppholz]

und so wie sich der Kurs in den letzten Tagen entwickelt hat, sind wir nicht alleine.

[posimist]

Poppholz...alsbald... .
Im Prinzip hast du Recht,Birgit.
posimist

[Cyberhexe]

[posting]18.851.007 von posimist am 17.11.05 12:14:29[/posting]@posimist

ich könnte allerhöchstens zu 100% sicher sein...aber eine 100%ige Sicherheit gibts am Kapitalmarkt nur in seltenen Fällen (100%ige Sicherheit gibts tatsächlich z.B. bei Arbitrage-Geschäften oder dergleichen.
Aber bei Elan scheint mir das Risiko in Relation zu den Erfolgsaussichten sehr interessant zu sein. Und zu Tysabri...ich bin mir ziemlich sicher , dass die FDA "Fast track"-Status zugestehen wird. Einerseits besteht für diese Indikation ein immenser Bedarf an wirklich wirksamen Medikamenten und zum anderen hat die FDA schon beim BLA eine bevorzugte Bearbeitung zugestanden. Weshalb sollte sie diese dann beim sBLA verweigern.

[Poppholz]

dpa-afx
FDA nimmt Lizenzantrag von Elan und Biogen für Tysabri an
Freitag 18. November 2005, 10:33 Uhr


BOSTON/CAMBRIDGE (dpa-AFX) - Die US-Arzneimittelbehörde Food and Drug Administration (FDA) hat einen Antrag des US-Biotechnologieunternehmens Biogen Idec und seines irischen Partners Elan auf Zulassung ihrer Version von Tysabri angenommen. Der Antrag sei für eine ergänzende biologische Lizenz des Multiple-Sklerose-Medikaments gestellt worden, teilten die Unternehmen am Freitag in Boston und Cambridge mit.
Die Behörde habe Tysabri als MS-Medikament Prioritäten-Status eingeräumt. Die Unternehmen versprechen sich davon eine Verkürzung der Prüfungsphase der Behörde auf sechs statt regulär zehn Monate. Der Status werde Medikamenten zuerkannt, ANZEIGE

die möglicherweise einen signifikanten therapeutischen Fortschritt gegenüber bestehenden Therapien böten.

Elan (Dublin: DRX.IR - Nachrichten) und Biogen hatten Tysabri im Februar nach zwei schwerwiegenden Vorfällen, bei denen das Mittel zusammen mit einem anderen Präparat verwendet wurde, vom Markt genommen. Die FDA hatte es im November 2004 in den USA zugelassen. Tysabri ist ein Konkurrenzmedikament zu dem Multiple-Sklerose-Mittel Rebif, das vom Schweizer Biotechkonzerns Serono hergestellt wird. Auch der Berliner Pharmakonzern Schering ist mit seinem umsatzstärksten Medikament Betaferon auf dem Markt für Multiple-Sklerose -Produkte vertreten./FX/cm/ep

[Poppholz]

[posting]18.852.815 von Cyberhexe am 17.11.05 14:37:36[/posting]sehr schöne Vorhersage, und das auf Tagessicht.



Bitte nicht aufhören, Deine Meinung zu äußern.



(allen ein erfolgreiches ELAN Jahr)

[Poppholz]

ddp
US-Behörde nimmt Zulassungsantrag für Schering-Konkurrenzprodukt an
Freitag 18. November 2005, 12:23 Uhr


Berlin/Washington (ddp.vwd). Die US-Zulassungsbehörde FDA hat einen Zulassungsantrag für das Multiple-Sklerose-Medikament «Tysabri» angenommen. Diesem sei ein bevorzugter Zulassungsstatus erteilt worden, gaben die US-Unternehmen Biogen Idec und Elan (Dublin: DRX.IR - Nachrichten) in der Nacht zum Freitag bekannt. Das Medikament gilt als Hauptkonkurrent für «Betaferon», das umsatzstärkste Mittel des Berliner Pharmakonzerns Schering.

Analysten zufolge ist ein Comeback des Konkurrenzprodukts ANZEIGE

nun etwas wahrscheinlicher. Die Schering-Wettbewerber hatten «Tysabri» im Februar vom Markt genommen, nachdem vereinzelt schwere Nebenwirkungen aufgetreten waren. Sie wollen es nun neu einführen.

Die Bedeutung von «Tysabri» sei für Schering aber beschränkt, sagte Alexander Groschke von der Landesbank Rheinland-Pfalz. Weil Patente für das Schering-Mittel gegen das Voranschreiten der Nervenkrankheit Multiple Sklerose 2007 und 2008 ausliefen, sei die dann drohende Generika-Konkurrenz größer.

Auch Schering selbst rechnet nicht mehr mit entscheidender Konkurrenz durch «Tysabri». Auch wenn das Mittel wieder auf den Markt gelange, werde es wohl nur für eine kleine Gruppe von Patienten zugelassen, sagte ein Sprecherin auf Anfrage.

ddp.vwd/hpn/pon

[Birgit.Tersteegen]

Letzteres hätte Schering wohl gerne....

[Poppholz]

Business Wire
Biogen Idec und Elan melden Annahme eines zusätzlichen BLA-Zulassungsgesuchs und vorrangige Bearbeitung des Antrags für TYSABRI(R) bei Multipler Skler
Freitag 18. November 2005, 13:12 Uhr

Aktienkurse
Biogen Idec Inc
BIIB
44.81
0.00


Elan Corp
DRX.IR
9.30
+0.45


CAMBRIDGE, Mass. und DUBLIN, Irland 18. November 2005 Biogen Idec (NASDAQ: BIIB) und die Elan Corporation, plc (NYSE: ELN) meldeten heute, dass ihr zusätzliches Zulassungsgesuch als "Supplemental Biologic" (sBLA) für TYSABRI(R) (Natalizumab) zur Behandlung von Multipler Sklerose von der U.S. Food and Drug Administration (FDA) angenommen und dort im Rahmen einer vorrangigen Prüfung bearbeitet wird.
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, ANZEIGE

die einen unerfüllten medizinischen Bedarf ansprechen. Ausgehend von der vorrangigen Einstufung des TYSABRI-Antrags von Seiten der FDA rechnen die Unternehmen in etwa 6 Monaten ab dem Einreichungsdatum mit einer entsprechenden Antwort der Behörde; bei einem Standardprüfverfahren dauert dieser Prozess etwa 10 Monate. Am 26. September 2005 hatten die Unternehmen die Einreichung des sBLA-Antrags für die Neueinführung von TYSABRI für MS und die Beantragung des Prioritätsstatus gemeldet.

Der sBLA-Antrag für TYSABRI enthält:

-- Abschließende Zwei-Jahres-Daten aus der Phase-III-Monotherapiestudie AFFIRM und der Nachfolgestudie SENTINEL mit AVONEX(R) (Interferon beta-1a) bei MS;

-- Integrierte Sicherheitsbeurteilung von Patienten, die in den klinischen Studien mit TYSABRI behandelt worden sind, und

-- Einen überarbeiteten Kennzeichnungs- und Risikomanagementplan.

"Wir freuen uns, dass TYSABRI eine Einstufung zur vorrangigen Prüfung erhalten hat, was unserer Meinung nach zeigt, welcher Bedarf bei der Behandlung von MS besteht", so Burt Adelman, MD, stellvertretender Vorstandsvorsitzender, Entwicklung, Biogen Idec. "Wir freuen uns auch auf die Zusammenarbeit mit der FDA bei dieser Prüfung und gehen davon aus, dass wir den Menschen, die mit MS leben müssen, TYSABRI bald wieder zur Verfügung stellen werden können."

"Wir sind überzeugt, dass die Annahme des sBLA-Zulassungsatrags auf vorrangige Bearbeitung ein weiterer Schritt auf unserem Weg ist, TYSABRI als Behandlungsoption für MS-Patienten anzubieten", so Lars Ekman, MD, stellvertretender Vorstandsvorsitzender und Präsident, Forschung & Entwicklung, Elan. "Wir werden weiterhin eng mit der FDA zusammenarbeiten, während unser Antrag dort bearbeitet wird, so dass TYSABRI schließlich ein angemessenes Nutzen-Risiko-Profil aufweist."

Am 28. Februar 2005 hatten Biogen Idec und Elan den freiwilligen Rückzug TYSABRIs vom Markt in den USA und den Stopp aller laufenden klinischen Studien gemeldet. Diese Entscheidung beruhte auf Berichten einer progressiven multifokalen Leukoenzephalopathie (PML), einer seltenen und potenziell tödlich verlaufenden Demyelinisierungserkrankung des Zentralnervensystems. 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 PML und Neurologie ab. Die Ergebnisse der Sicherheitsprüfung ergab 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 auf der ganzen Welt 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 Vorgehensweise zur Zulassung von TYSABRI. Die Vorgehensweise zur Zulassung von TYSABRI unterliegt 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]
Elizabeth Headon, [phone]
oder
Ansprechpartner für Investoren:
Biogen Idec
Rob Jacobson, [phone]
oder
Elan
Emer Reynolds, [phone]
Chris Burns, [phone]

[Poppholz]

CATEGORY: NEWS AND ANNOUNCEMENTS
Elan up on FDA priority review
Fri 18 Nov 2005

ELA - Elan

Latest Prices
Name Price %
Elan € 9.26 +6.38%

techMARK 1,281 +0.72%
techMARK 100 1,336 +0.99%

LONDON (SHARECAST) - Irish biotech Elan hit its highest level since April as the US Food and Drug Administration gave priority status to a renewed licence application for troubled multiple sclerosis treatment, Tysabri.

Elan, and partner Biogen Idec, said the FDA has designated Priority Review for Tysabri in MS and, on this basis, the companies anticipate a decision on approval in approximately six months from the submission date, rather than 10 months under a standard review.

Tysabri was suspended from sale in February after three patients contracted the rare brain disease PML, though subsequent safety trials in 3,000 patients revealed no new cases of the illness.

`We believe that the acceptance of the sBLA for Priority Review is another step in our ongoing commitment to provide Tysabri as a treatment option for MS patients in need,` said Lars Ekman, Elan`s managing director.

[Poppholz]

soll das eine Kaufempfehlung sein?

NCB Sees Elan`s Tysabri Hitting $1B Sales

Friday, November 18, 2005 7:08:30 AM ET
Dow Jones Newswires

1057 GMT [Dow Jones] Elan +5.2% at EUR9.31 after the US FDA designated MS drug Tysabri for priority review. NCB Stockbrokers sees Tysabri relaunch approved by March `06; it has a $9.70-$11.90 sum-of-the-parts range on Tysabri with $1B in peak worldwide annual sales due to its efficacy. Maintains buy. (QAF)


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

[Cyberhexe]

die Institutionellen sind kräftig am einsammeln:

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

[Cyberhexe]

Forbes berichtet heute...dass Tysabri in der zweiten Hälfte des kommenden Jahres wieder auf den Markt zurückkommen könnte!
Ich frage mich nun, sind diese wiederholten Falschmeldungen Strategie oder tatsächlich nur Ausdruck eines erschreckenden Dilettantismus.


Biogen Idec (nasdaq: BIIB - news - people ) and Elan (nyse: ELN - news - people ) announced Thursday the U.S. Food and Drug Administration granted priority review status of Tysabri. The companies are confident the multiple sclerosis drug, pulled from the market last February, can return to the market by the second half of 2006. On Friday, Bear Stearns said while further tests of Tysabri showed no new cases of PML, or progressive multifocal leukoencephalopathy, the larger issue of predicting the rare brain disorder remains. "Biogen acknowledged that they do not have a viable method to screen for at-risk Tysabri patients," the firm said. "We believe this is a major concern for the FDA and one that Biogen must clearly address." Bear Stearns maintained an "underperform" rating on the stock. "We still harbor concerns that the market is modestly overvaluing the company`s base business (Avonex and Rituxan)," it said.

[Cyberhexe]

und wieder ...Beispiel nehmen an den Institutionellen, die akkumulieren.
Vorsicht mit "stop loss"!!

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

good luck
ch

[Cyberhexe]

Elans` Alzheimer-Projekt wird mittlerweile immer öfter zitiert:

Posted 11/21/2005 3:21 PM

Riskier work urged as `safe` Alzheimer`s tests fall short
WASHINGTON (AP) — A fog is slowly creeping over Dr. William Deutsch`s brain. He`d try ...
Consider Elan Corp.`s 2002 vaccine, ultimately found to slow memory decline somewhat and clear out some plaque, even though the experiment was halted before participants received a full dose. It took FDA more than three years to allow Elan to study a potentially safer version.


http://www.usatoday.com/news/health/2005-11-21-dementia-test…

Man darf gespannt sein auf die ersten Ergebnisse aus Phase II (AAB-001 = Antikörper-Studie) bzw. Phase I (ACC-001 = Vaccinierung).

[Cyberhexe]

Die Short-Positionen wurden auf Ende November um über 2.2 Mio Aktien abgebaut...die riechen den Braten!

ELAN CORPORATION
Ende Nov.: 29,510,061
Ende Okt.: 31,714,351

http://www.nyse.com/pdfs/sitable.pdf

[bernie55]

" Man darf gespannt sein auf die ersten Ergebnisse aus Phase II (AAB-001 = Antikörper-Studie) bzw. Phase I (ACC-001 = Vaccinierung)."

Sind das die Testphasen, bei denen die Ergebnisse ca. Anfang 2008 erwartet werden, Cyberhexe ??????

Grüße bernie55

[Cyberhexe]

[posting]18.932.743 von bernie55 am 22.11.05 08:33:35[/posting]@bernie

AAB-001 ist eine Doppelblindstudie mit dem Antikörper. Die Studie dauert bis 2008, erste Ergebnisse sind jedoch auf Mitte des nächsten Jahres angekündigt. Normalerweise dauern Phase-II-Studien nicht so lange, da jedoch die Wirkung bei Alzheimer-Patienten nur über grössere Zeiträume objektiv beurteilt werden kann, wurde die Studiendauer entsprechend lange gewählt. Falls die ersten Ergebnisse jedoch auch im kognitiven Bereich einen günstigeren Krankheitsverlauf zeigen, könnte die Phase-II auf eine Phase-III-Studie erweitert werden.

Official Title: A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients with Mild to Moderate AD

Further Study Details:
Primary Outcomes: safety assessments
Secondary Outcomes: blood levels of administered study drug; cognitive and functional assessments
Expected Total Enrollment: 180
Study start: April 2005; Expected completion: April 2008


The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods.

This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient`s participation will last approximately 2 years.


Bei ACC-001 handelt es sich um die Weiterentwicklung von AN-1792, mit welchem die ersten Immunisierungsversuche durchgeführt wurden.
ACC-001 soll im Gegensatz zu AN-1792 das Risiko an Hirnhautentzündung zu erkranken erheblich verringern. Das Vaccin wurde jedoch erst unlängst in die Klinik eingeführt, befindet sich also erst in Phase I.

[bernie55]

......supergroßes Dankeschön für die Info......

[Cyberhexe]

Angeblich sind mehrere Neurologen der Meinung, dass dem einen fatalen PML-Fall eine Fehldiagnose vorausgegangen sei. Die 4 Neurologen sind der Meinung, dass es sich um eine nicht tödlich verlaufende PML-Erkrankung gehandelt haben könnte, welche zu einem früheren Zeitpunkt als MS diagnostiziert wurde. Mehrere Indizien würden eindeutig darauf hinweisen, dass ein MS-Krankheitsbild nicht vorgelegen hat.
Dies hat natürlich enorme Auswirkungen auf die Riskoabschätzung.

http://www.bostoncure.org:8080/article.pl?sid=05/10/27/1241240&mode=nocomment

Though we are not as exposed to Elan/Biogen as we were in the past, we feel compelled to provide a quick update on Biogen Idec and Elan given two articles published yesterday in the New England Journal of Medicine. In July, three different case study articles were published in the New England Journal of Medicine on the patients (2- Multiple Sclerosis and 1- Crohn`s) presumed to have succumbed to Tysabri induced Progressive Multifocal Leukoenchephalopathy (PML). Please recall that one of the Multiple Sclerosis (MS) patients (from Colorado) reportedly died from the PML infection. In response to these articles, four neurologists drafted letters to the authors and the resulting correspondence was published yesterday in the New England Journal of Medicine.

Interestingly, all four neurologists noted that the Multiple Sclerosis patient who died from PML, likely did not have Multiple Sclerosis. These neurologists state that after reviewing the Colorado patients history, medical records etc.. that this patient did not have MS because: 1) no oligoclonal bands were detected in two separate examinations of the cerebrospinal fluid, 2) several Magnetic Resonance Imaging (MRI) scans obtained over many years never showed enhancing lesions and 3) neuropathology unequivocally proves that no MS lesions were ever detected (the presence of these lesions are the key hallmark of the disease). Based on this, the neurologists believe that this patient from Colorado may have had a subclinical nonfatal case of PML, which was misdiagnosed as MS. Strikingly, one of the original authors of the New England Journal of Medicine case study articles concurs with the potential misdiagnosis. Thus, this patient, likely should have never been enrolled in the MS study evaluating the use of Tysabri along with Avonex. These findings also bring into question the diagnosis/underlying condition of the other patients presumed to have developed PML due to treatment with Tysabri.

The suspension of Tysabri on February 28 was a prudent measure by both Biogen Idec and Elan to fully assess the situation and define the risk of PML to MS patients. However, these recent findings show the inherent variability/occasional errors that occur in the diagnosis and treatment of patients. If Biogen Idec and Elan can prove that this patient was misdiagnosed (which may be highly unlikely at this point) it could significantly change the risk profile of Tysabri. In the analysis we forwarded in early March, we cited the potential for misdiagnoses based on the strong safety data seen at two years in the monotherapy study and the known MS-like effects of PML in the brain.

It is astonishing how the public markets can jump to conclusions and formulate opinions, which at times are just not based on hard evidence. It does not matter now since the damage has been done, but we remain hopeful that Tysabri becomes available to the patients who desperately need it and that over time these issues around PML are resolved. We fully understand that being intellectually right; yet losing money is a bad outcome. However, our investment process has not and will not change.

Thanks again for your support.

Best,

Will Muggia and Matt Strobeck

William A. Muggia
President & Chief Investment Officer
Westfield Capital Management Company, LLC
One Financial Center, 24thFloor
Boston, MA 02111"

[Poppholz]

[posting]18.949.080 von Cyberhexe am 23.11.05 11:23:49[/posting]dies wäre natürlich der Hammer.

Eine solche Vermutung müßte doch eine entsprechende Untersuchung nach sich ziehen, oder ist diese Untersuchung bereits durchgeführt worden und das Beschriebene ist das Ergebnis?

Wenn wirklich ein Todesfall nicht auf das Konto der Kombi-Therapie geht, müßte diese Info doch auch von Elan und BIIB publiziert werden, oder nicht?

[loseit]

Das glaube ich nicht; hiermit würde Druck auf die FDA ausgeübt werden; selbst wenn es stimmen würde, wird dies sicher im laufenden Verfahren zwischen Elan/Biogen/FDA vertraulich besprochen -

und dann erst zum erfolgreichen Abschluss des Verfahrens publiziert werden!

Es ist m.E. erstaunlich und wahrscheinlich gar nicht im Interesse von Elan, dass die Ärzte in einer Fachzeitschrift an die Öffentlichkeit gegangen sind. Ich glaube, Elan wird hierzu auch keine Stellungnahme abgeben.

Trotzdem: gut zu wissen, denn wenn dies letztendlich stimmt, ist es natürlich ein Hammer!

[welke91]

Hey Cyberhexe, was soll ich sagen bussi.

[Cyberhexe]

...die "big player" sind am zukaufen - ein weiteres Indiz dafür, dass sich demnächst etwas bewegen wird!



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

[Birgit.Tersteegen]

Tja,die Klugen kaufen JETZT!Gute Einstiegskurse und gefüllte News-Pipeline!

[Cyberhexe]

Tixx ist wieder mal allererste Sahne...über BiogenIdec, Elans Kooperationspartner bei Natalizumab. Interessant ist, dass Fortschritte erzielt wurden bei der biotechnologischen Herstellung von Natalizumab. Bei dem "High titre process" soll die 4-fache Ausbeute möglich sein, so dass ReseargchTriangleParc bis zu 300.000 Jahresdosen produzieren sollte. Mit Hillerode in Dänemark wird dann ab 2008 die Kapazität extrem ausgebaut:

So the time line for TYSABRI includes all kinds of others things relative to manufacturing. We have
been very successful with the high tire [ph] process that`s significantly increased the yields, that`s
one of the reasons why we didn`t need as much manufacturing capacity quite frankly as we`re
getting much more out of the same plants as we would have a year ago.

http://www.tixx.com/biogennov2005.pdf

[Cyberhexe]

...falls irgendwann einmal tatsächlich 300.000 Jahresdosen verkauft würden, entspräche dies einem Umsatz von 7 Milliarden $

Bei einer Bruttomarge von 85% und halbiert auf die beiden Kooperationspartner würde Elan 3 Milliarden$ zustehen

[Cyberhexe]

ich kann nicht nachvollziehen, weshalb eine Entscheiudung der EMEA über die Zulassung von Ty erst Mitte 2006 erwartet wird. Die ursprüngliche Zulassung für die Indikationen MS (4.6.2004) und MC (29.9.2004) wurde bereits vor mehr als einem Jahr eingereicht. Die ergänzenden Daten des sBLA wurden wahrscheinlich zeitgleich mit dem Antrag bei der FDA Ende September 2005 (FDA am 26.9.2005) eingereicht. Ich kann nun nicht nachvollziehen, weshalb nun fast ein weiteres Jahr für eine Entscheidung nötig sein soll. In der Zwischenzeit werden viele Patienten eine wesentliche Verschlechterung ihres Gesundheitszustandes hinnehmen müssen. Hierdurch wird den Medizinern die Möglichkeit vorenthalten, gegen diese fatale Krankheit mit dem wirkungsvollsten aller Medikamente anzugehen. Und ich weiss wovon ich rede...MS ist keine Bagadell-Erkrankung.

http://business.timesonline.co.uk/article/0,,9068-1910578,00…


Elan keeps chief on board with improved contract
By Richard Irving

THE board of Elan, the Irish drugs maker, is to approve a new open-ended contract today for Kelly Martin, the chief executive.
The new agreement will tie the former investment banker to the company ahead of the expected relaunch of Tysabri, its multiple sclerosis treatment, next April. It will replace a three-year fixed contract that expires at the end of the month.



According to the latest report and accounts, Mr Martin earned just over $834,000 (£478,000) in salary last year. He also received 200,000 stock options with a weighted strike price of $7.47 in lieu of an annual cash bonus, which he waived.

Under the new deal, Mr Martin’s basic pay and benefits package is understood to be broadly in line with current levels. However, the new contract will include more performance-related share options, reflecting the board’s determination to ensure that Mr Martin oversees the relaunch of the firm’s most promising drug.

The company pulled Tysabri from pharmacy shelves in late February amid fears that the drug might be linked to progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain disease.

Elan has since reviewed the case studies of three patients who appeared to contract PML while taking Tysabri, as well as additional data on more than 3,500 patients who had participated in trials of the treatment.

The information, which has since been lodged with the US drug regulator, appears to strengthen claims by the company that Tysabri is the most effective treatment available for multiple sclerosis.

Scientists have collated clinical trials over two years showing that 67 per cent of patients taking Tysabri experienced a reduction in debilitating relapses. The results are slightly better than Elan’s initial tests, which covered one year and considerably better than some analysts had hoped for.

The US watchdog has vowed to give Tysabri a priority review and a decision on its future is due next March.

It is expected that, because the latest data is better than that supporting Tysabri’s initial filing for approval, regulators will be minded to approve the medicine.

Current talks between regulators and Elan are understood to be focusing on what the company must do to ensure that doctors prescribing the treatment recognise immediately any symptoms that might suggest the early onset of PML.

Kelly Martin said yesterday that it was inconceivable that the drug would not be reapproved. He expected more than 25,000 patients who had pre-registered their intention to switch to Tysabri at the time of its launch in November 2004 to make the switch immediately the drug becomes available, despite the bad publicity.

The company expects to break even on Tysabri, which will sell for $23,000 per person per year, once it has signed up 20,000 patients.

Mr Martin added that a decision from European regulators was expected next June or July.

[Poppholz]

[posting]19.184.384 von Cyberhexe am 07.12.05 11:57:22[/posting]wahrscheinlich haben die von der EMEA nicht genug Mumm, die Entscheidung über die Zulassung vor der FDA zu fällen.

Weiß jemand genaueres über die Verbinung zwischen den beiden Instituten?

Weiterhin wird ELAN die FDA nicht unter Druck setzen indem eine Entscheidung der EMEA zu einem früheren Zeitpunkt als März 2006 angekündigt wird.

[Cyberhexe]

aber poppi, Elan hat weder bei der FDA noch bei der EMEA die "Fäden" in der Hand.
Falls die EMEA jedoch die Zulassung für Tysabri erteilen würde, dann würde die FDA ganz klar unter Zugzwang kommen - und zwar wegen der MS-Lobby innerhalb den Vereinigten Staaten.
Elan selbst hat kaum die Möglichkeit diesen Prozess zu beeinflussen. Die geübte Zurückhaltung in der Öffentlichkeit und die Kooperation mit der Behörde (FDA) werden allgemein als vorbildlich beurteilt.
Meine persönliche Meinung ist jedoch, dass die EMEA einer Entscheidung der FDA nicht vorgreifen wird, da es sich bei der EMEA wohl nicht um eine emanzipierte Behörde handelt. Die Entscheidungsgewalt und Kompetenz in der zentralisierten amerikanischen Behörde scheint gegenüber den dezentralen Strukturen in Europa (trotz EMEA mit Sitz in London) zu übermächtig

[eliasesteban]

hallo cyberhexchen,ich hatte mal gefragt woher dein interesse an Elan und der researchperfektionysmus kommen-deine ausdrucksweise und dein sachverstand haben die frage aufkommen lassen!die antwort vom metzger und bäcker ........fand ich gut.weshalb weisst du von was du redestdas ist keine bakatelle,ich weiss das auch!
EE

[welke91]

ganz einfach:

cyber ist der Elan Checker!

[Birgit.Tersteegen]

stimmt! Danke dafür!

[Poppholz]

[posting]19.189.499 von Cyberhexe am 07.12.05 16:57:39[/posting]habe mich wohl nicht so ganz deutlich ausgedrückt.

"Weiß jemand genaueres über die Verbinung zwischen den beiden Instituten?"

hiermit meinte ich EMEA und FDA. Elan hat natürlich keinerlei Möglichkeiten bzw. Beziehung zu diesen Instituten. Elan wird weiterhin stark darauf achten, bei keinem der Institute Druck zu erzeugen.

Mit der Frage wollte ich wissen, ob die FDA und die EMEA eher "gut miteinander" können, oder es hier auch zu "Wettbewerb" kommen kann. Hierauf bist Du in Deiner Antwort ja auch eingegangen. Dies deckt sich auch mit meiner Auffassung.

[Lanzalover]

lesezeichen

[Lanzalover]

hallo alle beinander

als neu-interesierter hätte ich damal eine frage

also, im anderem thread habe ich folgendes posting gefunden, was sagt denn ihr dazu;


Allerdings wundert mich bei den vielversprechenden Aussichten das Insiderverhalten - kein einziger Kauf, sondern nur Verkäufe:

also, ich fand da keine verkäufe . . .

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



könnt ihr mich aufklären? betreffs tatsächlicher insider-deal? danke im voraus


mit freundlichen grüßen,

lanzalover

[Cyberhexe]

Die Institutionellen akkumulieren massiv, und zwar schon seit einiger Zeit:

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


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

[Poppholz]

die #500