ELAN - 1.000 % for the LONG-time - 500 Beiträge pro Seite (Seite 45)

[bernie55]

Antwort auf Beitrag Nr.: 38.161.021 von Schero am 12.10.09 18:02:57

Was meint Ihr wann eine Besserung des Kurses zu sehen sein wird??

...das Spielchen wird sich leider noch eine ganze Weile hinziehen..


....bei guten BAPI Daten in 2010 hingegen...

könnten ?
sollten ?
müssten ?

wir den Hype von DNDN sehen...

[Poppholz]

Die Übernahme von Wyeth durch Pfizer ist somit durch. Dann wollen wir doch mal schauen, in wie weit dies jetzt für unsere ELAN "positive" Nebenwirkungen haben wird.


14.10.2009 19:42

Pfizer macht US-Wettbewerbsbehörde Zugeständnisse bei Wyeth-Übernahme

Der US-Pharmakonzern Pfizer <PFE.NYS> <PFE.FSE> kann den Konkurrenten Wyeth <WYE.NYS> <AHP.FSE> übernehmen. Die US-Wettbewerbsbehörde erteilte am Mittwochabend die Genehmigung unter der Bedingung, dass sich Pfizer von Teilen seines Tiermedizingeschäfts trennt. Den Angaben der Behörde zufolge übernimmt Boehringer Ingelheim sowohl von Wyeth als auch Pfizer Geschäftsfelder, um eine Vormachtstellung bei Tiermedikamenten und -impfstoffen zu verhindern.

Auch die europäische Kartellbehörde hatte bei ihrer Genehmigung Mitte Juli ein Monopol auf dem Markt für Tierimpfungen befürchtet und auf den Verkauf von Geschäftsfeldern gedrängt. Die kanadische Wettbewerbsbehörde gab nach den Zugeständnissen von Pfizer ebenfalls ihre Zustimmung, wie Phizer am Mittwoch in New York mitteilte. Die Wyeth-Aktionäre hatten sich schon Mitte Juli für die 63 Milliarden Dollar schwere Übernahme ausgesprochen. Pfizer will die Transaktion den Angaben zufolge an diesem Donnerstag (15. Oktober) abschließen./dct/ck

ISIN US9830241009 US7170811035

AXC0203 2009-10-14/19:42

© 2009 dpa-AFX

[Poppholz]

Analyst Blog
Subpoena for Elan
October 13, 2009

Elan Corporation (ELN - Snapshot Report) recently received a subpoena from the US Securities and Exchange Commission (SEC) regarding the company’s disclosure of two brain disorder cases (in July 2008), often fatal, tied to the use of its drug Tysabri for the treatment of multiple sclerosis.

Elan has a marketing agreement with Biogen Idec (BIIB - Analyst Report) for Tysabri. In addition, the subpoena asked for detailed information regarding clinical trial data on bapineuzumab, a drug for the treatment of Alzheimer's disease. Recently, Johnson & Johnson (JNJ - Analyst Report) paid $885 million for an 18.4% stake in Elan in addition to $500 million for a majority stake in the company’s Alzheimer's disease pipeline.

As a reminder, in July last year, both Elan and Biogen announced the occurrence of two cases of brain infection, progressive multifocal leukoencephalopathy (PML), in patients taking the drug. Meanwhile, 11 such cases have been reported by the companies through July 2009. Since then, the companies stopped informing public about the infection. The drug was withdrawn from US markets in 2005 due to the PML concern but was reintroduced after one year with a strict warning regarding the occurrence of PML.

The occurrence of this infection is believed to be related to the prolonged usage of the therapy (in the last reported case, the patient took 29 doses of the drug). The break in therapy, if advocated by doctors, would hamper sales of the drug, hitting the company’s financials.

Despite this, the drug continues to post strong sales. Total Tysabri sales increased by a healthy 27% to $254 million during the second quarter of 2009 compared to $200 million in the year-ago period. For 2009, we see total worldwide sales of more than $1 billion.

Initially, Biogen predicted about 100,000 patients would be taking the drug by 2010. But the current level of 43,300 at the end of June is way below the mark. Though the company is hopeful of achieving its target in due course (not within the 2010 timeframe) we think the PML incidence will be a major roadblock. Physicians and patients continue to have faith in the drug even with the risk of PML due to its effectiveness. We maintain our Neutral recommendation on Biogen.

http://www.zacks.com/stock/news/25868/Subpoena+for+Elan

[Schero]

Hallo an alle.

Verstehe ich es richtig, dass das Alzheimer Medikament erst 2014 auf dem Markt kommen soll oder kommen kann???

LG

Schero


Further study details as provided by Wyeth:


Primary Outcome Measures:
Incidence and severity of treatment emergent adverse events, clinically important changes in vital signs, weight, ECG, laboratory determinations, brain magnetic resonance imaging (MRI), physical and neurological examinations and infusion site assessments [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]



Secondary Outcome Measures:
Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Disability Assessment for Dementia [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Neuropsychiatric Inventory [ Time Frame: 2 years ] [ Designated as safety issue: No ]


Estimated Enrollment: 1000
Study Start Date: December 2009
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

[Poppholz]

19.10.2009 22:17
REG-Elan Corporation PLC Elan to Highlight Tysabri Data in Crohn’s Disease at the American College of Gastroenterology Annual Scientific Meeting

Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDQ: BIIB) today announced multiple presentations at the American College of Gastroenterology (ACG) Annual Scientific Meeting, taking place October 23-28 in San Diego.

The posters and presentations during ACG will highlight TYSABRI® (natalizumab) data in treating Crohn’s Disease. During a plenary session on inflammatory bowel disease (IBD), an oral presentation will focus on a retrospective subset analysis of two registrational Phase 3 trials (ENACT-2 [Evaluation of Natalizumab as Continuous Therapy] and ENCORE [Efficacy of Natalizumab in Crohn’s Disease Response and Remission]) and one open-label study (ENABLE). Corey A. Siegel, MD, director of the Inflammatory Bowel Disease (IBD) Center at Dartmouth-Hitchcock Medical Center will give the presentation. In addition, representatives from Elan and investigators will present four posters that analyze patient reported outcomes from the TOUCH study, and one poster reporting the utilization and safety results from the TOUCH™ prescribing and surveillance program.

Details of the presentations at ACG are as follows:

* Note: All times are listed in Pacific Time

Sunday, October 25:

Poster session: TOUCH™ Study Patient Outcomes: The Impact of Natalizumab on Crohn’s Disease Severity
Abstract P270: 3:30 - 7:00 PM

Poster session: TOUCH™ Study Patient Outcomes: Workforce Participation, Productivity and the Impact of Natalizumab
Abstract P271: 3:30 - 7:00 PM

Monday, October 26:

Poster session: Natalizumab Use in Patients with Crohn’s Disease and Relapsing Multiple Sclerosis: Updated Utilization and Safety Results from the TOUCH™ Prescribing Program, the Pregnancy Registry, and the INFORM and TYGRIS Studies
Abstract P724: 12:15 - 2:00 PM

Tuesday, October 27:

Poster session: TOUCH™ Study Patient Outcomes: The Impact of Natalizumab on Common Measures of Quality of Life in CD patients
Abstract P1100: 12:15 - 2:00 PM

Poster session: TOUCH™ Study Patient Outcomes: The Impact of Natalizumab on Utilization of Healthcare Resources by the Patients and Their Associated Treatment Satisfaction
Abstract P1104: 12:15 - 2:00 PM

Podium Presentation: Natalizumab Reduces the Rate of Hospitalization in Moderate to Severe Crohn’s Patients: Data from the ENACT and ENCORE Trials
Abstract 41: 2:45 - 4:15 PM

About Crohn's Disease

An estimated 500,000 people in the United States have Crohn's disease, a chronic and progressive inflammatory disease of the gastrointestinal tract, which commonly affects both men and women.

The disease usually causes diarrhea and crampy abdominal pain, often associated with fever, and at times rectal bleeding. Loss of appetite and weight loss also may occur. Complications include narrowing of the intestine, obstruction, abscesses, and fistulas (abnormal channels connecting the intestine and other organs, including the skin), and malnutrition. Most patients eventually require surgery, which has both risks and potential short- and long-term complications.

Crohn's disease can have a devastating impact on the lifestyle of patients, many of whom are young and active. Currently there is no medical or surgical cure for Crohn's disease. Many patients fail to respond to current therapies, including biological therapies such as agents that inhibit tumor necrosis factor alpha (TNF-alpha). Due to this failure of current therapies in CD, therapies that have alternate biological targets may provide patients and physicians with other therapeutic options.

About TYSABRI® (natalizumab)

In early 2008, TYSABRI was approved in the U.S. to induce and maintain clinical response and remission in adult patients with moderately to severely active Crohn's disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-alpha. According to the U.S. full prescribing information, among patients who responded to TYSABRI in a clinical trial, 54 percent sustained their response through the one year visit compared to 20 percent of patients receiving placebo (p<0.001), for a treatment difference of 34 percent.

In the U.S., TYSABRI is approved for relapsing forms of multiple sclerosis (MS) and in the European Union for relapsing-remitting MS. TYSABRI is approved for MS in more than 40 countries. According to data from the Phase III AFFIRM trial published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate, when compared with placebo, and reduced the relative risk of disability progression by 42-54 percent (p<0.001).

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Pharmaceuticals, Inc. For more information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

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 bringing innovations in science to fill significant unmet medical needs. Elan shares trade on the New York, London and Dublin Stock Exchanges. For additional information about the company, please visit www.elan.com.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements regarding TYSABRI. These statements are based on the companies' current beliefs and expectations. The commercial potential of TYSABRI is subject to a number of risks and uncertainties. Factors which could cause actual results to differ materially from the companies' current expectations include the risk that we may be unable to adequately address concerns or questions raised by the FDA or other regulatory authorities, that concerns may arise from additional data, that the incidence and/or risk of PML or other opportunistic infections in patients treated with TYSABRI may be higher than observed in clinical trials, that the companies may encounter other unexpected hurdles, or that new therapies for MS with better efficacy or safety profiles or more convenient methods of administration are introduced into the market. Drug development and commercialization involves a high degree of risk.

For more detailed information on the risks and uncertainties associated with the companies' drug development and other activities, see the periodic and current reports that Elan has 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.




Contacts:

INVESTOR:
Elan
Chris Burns, 800-252-3526
David Marshall, 353-1-709-4444
Biogen Idec
Eric Hoffman, 617-679-2812
MEDIA:
Elan
Miriam Mason, 650-278-7113
or
Mary Stutts, 650-823-5255
Biogen Idec
Jennifer Neiman, 617-914-1201

© 2009 Business Wire

http://www.reuters.com/article/pressRelease/idUS50448+20-Oct…

[Poppholz]

PetMed Express Inc. Meets Analyst Expectations; PETS, HSP, ELN
Monday, 19 October 2009 05:43

Analysts were expecting PetMed Express Inc. (PETS) [Chart - News - Analysis] to report earnings of $0.28 for last quarter, and PETS met expectations with actual earnings of $0.28---in line the consensus estimate.

If you compare last quarter's earnings to the $0.25 the company made per share during the same quarter a year ago, you can see that PETS’s earnings are up this year.

Be sure to check out our free report: 5 Stocks to Pick for 5 Different Reasons

Also, if you compare PETS's 14.75% projected earnings-per-share (EPS) growth rate for the next five years with the projected EPS growth rate of 14.95% for the Drug Delivery industry as a whole during that same time frame, you can see that analysts expect PETS to underperform the industry in the future---which is a bad sign for the stock.

Drilling down a little deeper into the Drug Delivery industry, you can see how analysts believe PETS will stack up against some of the other stocks in the industry, like Hospira Inc. (HSP) [Chart - News - Analysis] and Elan Corp. plc (ELN) [Chart - News - Analysis], in the future. Analysts believe HSP's earnings are going to grow at a rate of 14.31% while ELN's earnings are going to grow at a rate of 15.00%.

Earnings season can be a volatile time in the stock market. Check out these videos and articles to be better prepared to take advantage of the large price moves that tend to accompany earnings announcements.


http://www.learningmarkets.com/index.php/200910196053/News-F…

[bernie55]

Biogen Reports Higher Q3 Profit



AUSZUG:


Worldwide sales of the multiple sclerosis drug Tysabri totaled $279 million in the third quarter, ahead of the consensus estimate of $273 million.

The company said 46,200 patients were being treated with Tysabri at the end of September, up from 43,000 patients treated at the end of the June quarter. But that translates into a decline in the number of new patient starting on Tysabri, with 223 new patients adds per week in the third quarter, down from 262 new patient adds per week in

http://www.thestreet.com/_yahoo/story/10613831/1/biogen-repo…

[leiro1]

Antwort auf Beitrag Nr.: 38.213.491 von bernie55 am 20.10.09 14:28:22

... auch auf Deutsch:

Biogen Idec steigert Umsatz und Gewinn


Dienstag, 20. Oktober 2009, um 14:19 CEST
Cambridge (aktiencheck.de AG) - Der US-Biotechnologiekonzern Biogen Idec Inc. (ISIN US09062X1037/ WKN 789617) wies im dritten Quartal 2009 dank höherer Umsätze bei seinem MS-Medikament Tysabri einen Anstieg bei Umsatz und Ergebnis aus.

Wie das Unternehmen am Dienstag mitteilte, wuchsen die Umsatzerlöse um 3 Prozent auf 1,12 Mrd. Dollar. Im Vorjahresquartal haben sich die Umsätze auf 1,09 Mrd. Dollar belaufen.

Zudem kletterte der Nettogewinn um 34 Prozent von 206,8 Mio. Dollar oder 70 Cents je Aktie auf nun 277,6 Mio. Dollar bzw. 95 Cents pro Aktie. Bereinigt um Sondereffekte belief sich das EPS sogar auf 1,12 (Vorjahr: 0,98) Dollar und überstieg damit die Analystenprognose von 1,04 Dollar.

Für das Gesamtjahr 2009 rechnen Analysten mit einem Gewinn pro Aktie von 3,91 Cents bei Umsätzen in Höhe von 4,38 Mrd. Dollar. Das Unternehmen selbst geht von einem EPS von über 3,85 Dollar aus.

Gestern stiegen die Biogen-Aktien um 0,39 Prozent auf 49,39 Dollar. (20.10.2009/ac/n/a)

Soeben gelesen auf yahoo.de


LG LEIRO1

[Tebi]

Elan Reports Third Quarter 2009 Financial Results

* Press Release
* Source: Elan Corporation, plc
* On 2:00 am EDT, Wednesday October 21, 2009



DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc today reported its third quarter 2009 financial results.
Related Quotes
Symbol Price Change
ELN 6.46 0.00
Chart for ELAN CP PLC ADR


Elan CEO Kelly Martin said, “The third quarter of 2009 proved to be a time of significant transformation for Elan. Completion of the Johnson & Johnson transaction and the subsequent refinancing of our balance sheet provide strategic flexibility and financial stability for the company.” He added, “We are now afforded the opportunity to focus on growing Tysabri and EDT businesses, advancing our bioneurology pipeline and investing in unique science while having fundamentally reduced business risk across the enterprise.”

Commenting on the third quarter results, Elan executive vice president and chief financial officer, Shane Cooke said, “We are delighted with our progress this quarter, which reflect a substantial improvement in our liquidity and net debt position, as well as a continued strengthening in our operating performance. We reported net income of $52.3 million compared to a loss of $83.5 million last year. This turnaround was as a result of a net gain related to closing the Johnson & Johnson transaction and an improvement in operating performance which saw revenues grow, but operating expenses decline. Tysabri continued to show solid growth with a 19% increase in worldwide sales over last year. After the quarter-end, we further strengthened our financial position through a tender offer and new bond issue which extended the average maturity of our debt by approximately 70% and staggers it over the next 7 years.”

Mr. Cooke added that for the full year Elan remains on track to record double digit revenue growth and now expects Adjusted EBITDA of around $75 million, better than previously expected.

[Tebi]

[u]Elan turns to profit...
http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1&Id=10… &Category


Elan Corp Turns To Profit In Q3 - Quick Facts
10/21/2009 2:13 AM ET




(RTTNews) - Elan Corporation, plc (ELN: News ) reported third quarter net profit of $52.3 million or $0.11 per share, compared to net loss of $83.5 million or $0.18 per share last year.

On average, 5 analysts polled by Thomson Reuters expected the company to report loss of $0.13 per share. Analysts' estimates typically exclude special items.

Total revenue grew to $287.0 million from $270.1 million in the prior year quarter. Five analysts estimated revenues of $285.18 million.
[/u]

[leiro1]

Schön wenn sich positive Zahlen gut auf die Kursentwicklung auswirken....

ist doch phänomenal oder?

Ich versteh es (noch) nicht...?
Sell on good news?

GLG LEIRO!

[Tebi]

Antwort auf Beitrag Nr.: 38.219.755 von leiro1 am 21.10.09 09:53:29

tja----:O

[Tebi]

Conference Call war gut + ermutigend....was,wie wir wissen,für den kurzfristigen Kurs nichts zu sagen hat....

[Poppholz]

Antwort auf Beitrag Nr.: 38.219.755 von leiro1 am 21.10.09 09:53:29

GOOD NEWS sind noch nie gut für den ELAN-Kurs gewesen.

Das ist auch der Grund, warum der Kurs da steht wo er steht.

"Eigentlich" ist alles im grünen Bereich und wir müßten eher bei $67,- als bei $6,70 stehen.

Aber was soll man machen. Wenn ich die Kohle hätte, dann würde ich den Laden übernehmen.

Wie sieht eigentlich die Beteiligung der PBBS-Group aus? Können wir hier bald einen Sqeeze-Out starten?

[Poppholz]

Elan kann Gewinn ausweisen

Mittwoch, 21. Oktober 2009, um 10:15 CEST

Dublin (aktiencheck.de AG) - Der irische Pharmakonzern Elan Corp. plc (ISIN IE0003072950/ WKN 903801) meldete am Mittwoch, dass er im dritten Quartal einen Gewinn erzielt hat, was mit höheren Umsätzen und einer stärkeren Nachfrage nach dem MS-Medikament Tysabri zusammenhängt.

Demnach belief sich der Nettogewinn auf 52,3 Mio. Dollar bzw. 11 Cents pro Aktie, gegenüber einem Minus von 83,5 Mio. Dollar bzw. 18 Cents pro Aktie im Vorjahr. Das operative Ergebnis verbesserte sich von -39,3 Mio. Dollar auf 102,8 Mio. Dollar, während das bereinigte EBITDA von -1,6 Mio. Dollar auf 23,8 Mio. Dollar zulegen konnte. Der Umsatz nahm indes um 6,3 Prozent auf 287 Mio. Dollar zu.

Analysten waren im Vorfeld von einem Verlust von 13 Cents pro Aktie und einem Umsatz von 285,2 Mio. Dollar ausgegangen. Für das laufende Quartal sehen sie ein EPS-Ergebnis von -10 Cents bei Erlösen von 302,1 Mio. Dollar.

Für das Gesamtjahr rechnet der Konzern weiterhin mit einem zweistelligen Umsatzwachstum und sieht nun auf Basis des bereinigten EBITDA einen Gewinn von rund 75 Mio. Dollar. Analysten sehen hier Erlöse von 1,13 Mrd. Dollar.

Die Aktie von Elan (Dublin: DRX.IR - Nachrichten) gewinnt zurzeit 0,36 Prozent auf 4,51 Euro. (21.10.2009/ac/n/a)

http://de.finance.yahoo.com/nachrichten/elan-kann-gewinn-aus…

[Tebi]

Msg 388307 of 388344 at 10/22/2009 11:31:29 AM by

srsmgja

Why I'm Still a Shareholder
My reasons:

1. Sentiment - Ususally a good contrary indicator. I've never seen sentiment as poor as it is today.

2. Balance sheet - The best its been in years. 1.7Billion in net now down to 600 million in net debt. Majority of debt exending out 5-7 years.

3. P &L - The best its been in years. The days of large quarterly cash losses are over. The only reason holding up profitability until late next year are expected loss of Azactam (15M of EBIDTA) starting in 1Q, loss of Skelaxin (10 million in EBITDA) sometime witihn the next few months to year) and the gradual erosion of Tricor (15 million of EBITDA) from Triplex. The signifiacnt revenue offset from JNJ's and ACORDA's product won't start ramping up until 1 year or so from now. That being said, the CASH losses will be very small over the next few quarters.

4. Tysabri - Despite the worst press imaginable over the last few years, Tysabri sales continue to grow. The efficacy is just too good and there is no other place to go for most of its users.

I posted the good and bad issues yeasterday. I might add that Dr. Paya indicated in his remarks that there were NO other significant safety issues arising in a closely monitored database of tens of thousands of patients. If we can solve or better handle the PML risk, Tysabri sales will see much more significant growth.

One last point. Dr. Paya also referenced the 'competition' from orals. He alluded to cancer and infection risk with these new agents. His comments mirror what I have been saying.......

Cladribine - High cancer risk in its only phase 3 trial. Also 20+% of patients experience lymphopenia (SEE PML). Drug is not reversible, can't use PLEX. If you get PML, you are cooked! Remember, the FDA just denied Rituxin for RA due to a 3:100,000 PML risk. Why? Not reversible, and no great unmet medical need in the RA space. L:astly, the drug causes birth defects..... Do I really need to say more? Its unbelievable that many in the investment world think that Cladribine will get past this FDA.

FTY-720- Only one completed 2 year phase 3 trial NOT done in US. Safety signals conflict with previous 1 year phase 3 trial. Another ongoing phase 3 trial (in US) scheduled for read out in 2Q'10. The FDA will wait for this safety data. It would be idiotic not to wait. That puts any decision of FTY-720 well into 2012 ( 2 1/2 years away), as a BEST CASE SENARIO.

5. AD - The clock is ticking. In answer to a question on a previous conference call, KM indicated that the trial read out on the CARRIER US trial should be available in the 3Q of next year. Now as everyone knows, the street has low expectations for the carriers based on the phase 2 results. I happen to think the street is wrong, again. WHile I expect better results from the non-carriers, I still believe (and so do the 200 Million of RD money) that the carrier trial has an even chance of success. If that trial shows positive reults, the market for BAP expands immediately, AIP is validated, and values will be placed on the vaccine and the SubQ candidiates. Elan's PPS will substantially rise (even with only 25% share) of a potential 10's billion dollar market.

Sometime around the summer, Elan PPS will begin to rise in anticiapation of that read out. I'm expecting a 5-7 point rise based on this factor alone, added to any other underlying fundamentals of the company. Essenetially, one should be able to sell Elan at 12-15 PPS 6-9 months from today, if one is so inclined. Why sell today?


The risk - large, massive new PML cases. Frankly, I don't see that happening.
But that is the risk.

[noogmann]

Antwort auf Beitrag Nr.: 38.235.726 von Tebi am 22.10.09 20:41:29

Mann was ist denn jetzt wieder Los
Wie billig wird den das teil noch?


Gruß Noogmann

[HeinzBork]

Antwort auf Beitrag Nr.: 38.241.890 von noogmann am 23.10.09 16:30:17

Elan (ELN) and Biogen (BIIB) Weak On Jump In Tysabri PML Cases

Shares of Elan (NYSE: ELN) and partner Biogen Idec Inc. (Nasdaq: BIIB) are under pressure today after there was a meaningful jump in cases of a fatal brain disease, PML, related to the companies MS drug Tysabri. There are now 23 cases, versus 16 prior cases.

In a statement today, the European Medicines Agency said they will review "any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment."

Analyst at R.W. Baird said the jump in cases is not surprising. The firm said, "at worst, we anticipate CHMP may recommend a drug holiday after an extended period on therapy, but is unlikely to suspend Tysabri's marketing authorization." The firm is maintaining their Neutral rating on share of Biogen Idec.

Shares of Biogen Idec are down 6 percent and shares of Elan are down 21 percent in early trading.

[Tebi]

EMEA Hyperlink
page 2 of 3


http://www.emea.europa.eu/pdfs/human/press/pr/67119009en.pdf

Review of benefits and risks for Tysabri started
The Committee started a review of the benefits and risks of Tysabri, in view of reports of 23 cases of progressive multifocal leukoencephalopathy (PML) worldwide since Tysabri has been on the market. This review is initiated to discuss any additional measures necessary to ensure the safe use of Tysabri and how to balance the risks to the patients against the benefits of the treatment. Tysabri is indicated for patients suffering from highly active relapsing remitting multiple sclerosis with high disease activity despite treatment with a beta-interferon and for patients with rapidly evolving severe relapsing-remitting multiple sclerosis.

[quickclick]

Antwort auf Beitrag Nr.: 38.242.101 von Tebi am 23.10.09 16:49:38

Wer hat den da in den USA 460 Stk. zu einem solchen Preis verkauft....

[Tebi]

Antwort auf Beitrag Nr.: 38.242.794 von quickclick am 23.10.09 17:59:36

...idiots:O

[quickclick]

Antwort auf Beitrag Nr.: 38.242.826 von Tebi am 23.10.09 18:02:04

Hi TEBI,

Du meinst doch nicht mich
Gruß
qq

[Tebi]

Antwort auf Beitrag Nr.: 38.243.168 von quickclick am 23.10.09 18:36:56

Nein!

....kann´s nicht lassen...310 Stück sind zusätzlich meine...bin bald "Grossaktionär"

[Tebi]

Habe mal an die IR-Abtg von Elan geschrieben...rein "symbolisch"...vielleicht macht Ihr das auch mal??

"Our mission is to translate science from the lab to the clinic to the market."--and WHY didnt we shareholder hear anything from you today??????
Do you really know that we exist??How many more schocks will you realize for us??
I would be glad to hear an answer.
Best regards
Birgit Tersteegen

[mikel_ann]

Hallo, das macht echt keinen Spass ...

[Tebi]

Antwort der IR

Dear Ms. .............,



Thank you for your email. We had stated on our Third Quarter Results call earlier in the week that we are continuously in discussions with regulators about our drugs and current patient data. It is no different for Tysabri. As we capture more clinical data regarding patient outcomes, we have ongoing discussions with global regulators to determine the best usage and positioning of the drug for patients. We cannot speculate or comment on these discussions or potential outcomes.



We continue to work hard at Elan to drive our science and deliver novel therapeutics to patients.



Thank you for your support.



Regards,



Elan Investor Relations

[quickclick]

Hi Tebi,

kannst Du mir sagen, worin der Unterschied der beiden ELAN Aktien liegt bzw. welche maßgebend für die Kursentwicklung ist?

903801 Elan Shares Kurs 6,85 USD
871331 Elan Shares (ADR)Kurs 5,31 USD

Gruß
qq

[prebroker]

Antwort auf Beitrag Nr.: 38.245.106 von quickclick am 23.10.09 23:40:56

Hi,
ich bin zwar nicht Tebi, aber ich versuche dir mal zu helfen:

ADR= American Depository Receipt sind Hinterlegungsscheine (Zertifikate), um die Börsenzulassung den in USA zu vereinfachen. Hier werden also keine strengen Auflagen vorgenommen, wie in etwa zum Dow Jones Index. Die Shares (903801) sind die Originalaktien, die an der Heimatbörse notiert sind. Man kann also auch, wenn man ADRs besitz, diese in Originalaktien umtauschen. Dabei gibts es ein bestimmtes Umtauschverhältnis. In diesem Fall wäre es 1:1.
Maßgebend für die Kursentwicklung ist da wo der meiste Umsatz stattfindet, hier also in den USA.

Hoffe ich konnte dir weiterhelfen.

Viel Glück und gute Nerven wünsche ich allen Beteiligten.

Gruß

Prebroker

[Tebi]

...Alle entlassen°


Elan's response to today's news
Sorry if it has already been posted.

http://www.elan.com/news_events/news_features/tysabri_review…


Tysabri Review

The Committee for Medicinal Products for Human Use (CHMP) announced today, October 23, 2009, that it had started a review of the benefits and risks of Tysabri. The purpose of this review is to consider whether any additional measures might be needed to make sure that the product is used safely in the European Union, and that any potential risks are balanced against the benefits of the treatment. Tysabri is approved for use in the EU in a specific population of MS patients suffering from high disease activity despite treatment with a beta-interferon and for patients with rapidly evolving severe relapsing-remitting multiple sclerosis.

The CHMP is a committee of the European Medicines Agency and is responsible for the scientific evaluation of medicinal products for human use.

Elan as Marketing Authorisation Holder for Tysabri in the EU is committed to co-operating fully with the agency in the course of this review and is working in collaboration with Biogen Idec to inform the agency on progress made with risk minimization.

[surga]

Antwort auf Beitrag Nr.: 38.245.430 von Tebi am 24.10.09 08:31:43

Hi Tebi
Ich kann nur schreiben: Ach je, schon wieder
Weg mit KM
Gruß aus der Ferne

[Tebi]

Antwort auf Beitrag Nr.: 38.245.535 von surga am 24.10.09 09:47:27

Gruss an Dich in die Ferne!!Kelly Martin ist ein Dauer-Looser---soetwas 2 Tage nach dem conference Call.....

Mach´s gut!!

[surga]

Antwort auf Beitrag Nr.: 38.247.108 von Tebi am 24.10.09 20:28:53

Danke! Gruß auch an Bernie und Poppi

[quickclick]

Antwort auf Beitrag Nr.: 38.245.237 von prebroker am 24.10.09 01:01:44

Hi,

danke für Die INFO!

Das mit den ADR`s war mir eigentlich klar ich habe mich nur über die beiden verschiedenen Kurse in USD gewundert.....


Ist hier der Boden gefunden oder werden wir hier noch weit niedrigere Kurse sehen?


Danke für euere Einschätzung.

Gruß
qq

[welke91]

Antwort auf Beitrag Nr.: 38.245.535 von surga am 24.10.09 09:47:27

hi,

ich weiß nicht was los ist aber der deal ist ja wohl enormous.

nun ich habe gesagt, als johnson eingestiegen ist, wird es schwer werden für elan. die fantasie ist weg.

aber mullen hat in meinen augen einen riesigen deal gelandet.

erst wollte johnson elan ganz nun haben die aber alzheimer bekommen und können wahrscheinlich eine wirkungslose droge an die menschen verkaufen.

wie das geht?

es geht! glaubt mir.

bei meinen genta versuch habe ich so einiges erfahren wie das alles so miteinander funktioniert.

ich habe auch vor einem jahr euch gewarnt, dass ihr eure kinder von gardasil fern halten sollt.

ich habe recht behalten aus drei toten wurden 21 stand: 08/2008

mit mehr als 90.000 high side effects and so fort.

das nun Tysabri einer erneuten kontrolle sich unterziehen muss ist nicht ungewöhnliches.

schließlich macht ja elan nicht umsonst diese follow up studie.

diese daten werden nun offiziell ausgewertet und bestimmt.

und man wird tysabri als effectiv darstellen and the benefits outweight the risks!

so läuft das. diese reaction ist mehr als doubtful.

zumal sich biogen nun einen kandidaten kaufen könnte, der seine schulden durch den johnson deal verringert hat und profitabel arbeitet und ein so cyberhexe exellentes Forscherteam hat.

wer da nein sagt ist selber schuld.

aber
der chart ist nun mal nicht auf elans seite:



deshalb rate ich vorerst weiter zur vorsicht.

bis sich abzeichnen wird, wie die EMEA etc. sich entscheiden werden.
wie eben beim letzten mal.

grüße

[Poppholz]

26.10.2009

Biogen Idec: Schärfere Auflagen für Tysabri?
Frank Phillipps

Scheinbar hat die Zahl gefährlicher Hirninfektionen, die durch Biogen Idecs Medikament Tysabri ausgelöst wurden, stärker zugenommen als erwartet. Analysten sorgen sich daher um die Wachstumsperspektiven für den Biotech-Konzern. Die Aktie kommt unter Druck.

Offenbar sind mehr Patienten, die mit dem Multiple-Sklerose-Mittel Tysabri behandelt wurden, an einer gefährlichen Hirninfektion erkrankt, als bisher bekannt war. Die europäische Gesundheitsbehörde meldete zuletzt 23 Fälle von progressiver multifokaler Leukenzephalopathie (PML), die mit der Einnahme von Tysabri in Verbindung gebracht werden. Die Zahl wurde inzwischen auch von der US-Arzneimittelbehörde FDA bestätigt. Letztmalig waren die Zahlen im September dieses Jahres veröffentlich worden. Damals waren nur 13 Fälle der lebensbedrohlichen Krankheit gemeldet worden.

Sorge ums Wachstum

Die jüngsten PML-Zahlen sorgten auf dem Parkett für Alarmstimmung. Tysabri gilt als wichtigster Wachstumstreiber für den amerikanischen Biotech-Konzern Biogen Idec und dessen Partner Elan. Allein im dritten Quartal hatte das Multiple-Sklerose-Medikament Biogen Idec Umsätze von 207 Millionen Dollar beschert.

Das Präparat war 2005 schon einmal wegen Sicherheitsbedenken vom Markt genommen und 2006 unter strengen Auflagen wieder eingeführt worden. Experten befürchten nun, dass die Gesundheitsbehörden diese Auflagen noch einmal verschärfen wird, zumal sich der Verdacht zu erhärten scheint, dass die Gefahr einer PML-Infektion mit der zunehmenden Dauer der Behandlung steigt.

Stoppkurs ausgelöst

Der jüngste Kursrutsch hat die Aktie von Biogen Idec unter den Stoppkurs von 30,50 Euro gedrückt. Nach der ohnehin negativen Performance der letzten Wochen wird hier die Reißleine gezogen, um den Verlust zu begrenzen. Das Papier wird mit einem Minus von zwölf Prozent verkauft. Vorerst ist kein Neueinstieg geplant.

http://www.deraktionaer.de/xist4c/web/Biogen-Idec--Schaerfer…

[Poppholz]

Biogen's Tysabri Disclosure Policies Raise Questions
10-26-09 2:55 PM EDT

NEW YORK -(Dow Jones)- Biogen Idec Inc.'s (BIIB) refusal to disclose new cases of a severe brain infection among multiple-sclerosis patients taking its Tysabri drug has raised questions about its disclosure policies.

The Cambridge, Mass., biotech company believes those developments aren't material news because the risk profile for developing progressive multifocal leukoencephalopathy, or PML, is well defined, and providing such information isn't beneficial for patients, physicians or investors unless that profile changes. As the company notes, the drug's label implies a risk rate of one in every thousand patients.

However, knowing the risk rate didn't prevent Biogen shares Friday from dropping more than 7% and shares of Elan Plc (ELN) – the drug's co- marketer – from falling almost 18% when the number of confirmed PML cases since its 2006 relaunch jumped to 23 from 13.

Some investors and analysts argue that Tysabri's significant role as the key growth driver for the companies makes any such developments vital in making a decision in investing in either company, and should be disclosed accordingly.

"It is hard to understand how they wouldn't have deemed it necessary to communicate such material information as soon as it was available to them," Geoffrey Porges, analyst with Sanford Bernstein, said. "I think the company will have to revisit its disclosure policies in light of this."

News of the sharp increase in PML cases didn't come from Biogen or Elan, neither of which have commented on the figure, but rather from U.S. and European regulators.

Although the companies consult with each other, Biogen takes the lead on releasing information on Tysabri related to MS. Elan's stock is more sensitive to related news because the drug is its biggest seller.

Biogen was keeping Wall Street updated on new cases until July, the third anniversary of Tysabri's relaunch, when it believed the risk profile would be clearer. It hasn't provided any information since that time.

"We are confident we are in full compliance with all disclosure requirements," Biogen spokeswoman Naomi Aoki said.

Tysabri was pulled from the market for 18 months beginning in 2005 because of PML risk, but patients and physicians pushed for its return citing its effectiveness in treating the debilitating disease.

That potency makes it unlikely to be pulled from the market again, but regulators could recommend that physicians take patients off the drug after a certain period, potentially hurting sales. Last week, Biogen revealed that it is in talks with regulators to amend Tysabri's label to reflect that PML risk increases with duration of use.

The number of PML cases and the potential label changes could further hurt the already damaged sales trajectory of the drug, along with the stock prices of Biogen and Elan.

Public companies are typically required to disclose any material information to investors through a filing with the Securities and Exchange Commission. Officials from the agency didn't respond to requests for comment.

By definition, material information is that which a reasonable investor would find important in deciding on how to invest or vote on shareholder matters, said Charles Elson, director of the Weinberg Center for Corporate Governance at the University of Delaware.

While that leaves room for interpretation, Elson noted that stock movement can help determine whether information is material

"In an efficient market, the stock price is driven by news, and 7% is a very large move for one day," said Alex Edmans, professor at the Wharton School of Business and a former Morgan Stanley investment banker. "I think it would be hard for someone to argue that it isn't material."

While the company contends that the PML-related information doesn't help physicians or patients, Morgan Stanley analyst Steven Harr notes that Biogen's decision to stop reporting cases, just as evidence of accelerating risk was developing, may in fact cause increased concern.

In addition, other analysts are challenging Biogen's assertion that the PML rate remains "well within" the risk rate implied by the label. Barclays Capital analyst Jim Birchenough said the new cases could push the rate as high as 1-in- 700 patients among those patients on the drug for more than two years. Bernstein's Porges estimates the risk jumps to 1-in-400 patients after three years of use.

Aoki said the company uses "statistically acceptable measurement of risk" that incorporates the number of patients exposed along with their duration of use.

On a conference call last week, Biogen executives defended the rate, which " even in that third year beyond 24 months, is within the currently implied risk in the label"


-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; [e-mail]

(END) Dow Jones Newswires 10-26-091455ET Copyright (c) 2009 Dow Jones & Company, Inc.

http://news.morningstar.com/newsnet/ViewNews.aspx?article=/D…

[Poppholz]

Source: InvestorSoup
Trading Outlook for Elan Corp. Plc. Issued by InvestorSoup.com
DALLAS, Oct. 27, 2009 (GLOBE NEWSWIRE) --

InvestorSoup.com announces an investment report featuring Elan Corp. Plc. (NYSE:ELN). The report includes financial, comparative and investment analyses, and pertinent industry information you need to know to make an educated investment decision.

The investment report on Elan Corp. Plc. (NYSE:ELN) should be of particular interest to other biotechnology and drug companies: Gilead Sciences Inc. (Nasdaq:GILD), Biogen Idec Inc. (Nasdaq:BIIB), Genzyme Corp. (Nasdaq:GENZ) and Life Technologies Corp. (Nasdaq:LIFE).

It is available at: http://www.investorsoup.com/lp/ELN

Get our alerts BEFORE the rest of the market. Follow us on Twitter: www.twitter.com/investorsoup

Elan Corporation plc (ELN) is a neuroscience-based biotechnology company. Its principal research and development, manufacturing and marketing facilities are located in Ireland and the United States. ELN's operations are organized into two business units: Biopharmaceuticals and Elan Drug Technologies (EDT). Biopharmaceuticals engages in research, development and commercial activities primarily in neuroscience, autoimmune and severe chronic pain.

Message Board Search for ELN: http://www.boardcentral.com/boards/ELN

In the report, the analyst notes:

"A European panel has started a review of controversial Multiple Sclerosis drug Tysabri, sold by Biogen Idec Inc. and ELN, citing a much higher number of rare brain infections than previously disclosed. The European Medicines Agency's Committee for Medicinal Products for Human Use, commonly called CHMP, reported that there are 23 cases of progressive multifocal leukoencephalopathy, or PML, since the drug's launch. Previously, there had only been 13 confirmed cases of the infection since the drug re-entered the market in 2006, following an 18-month removal that was prompted by a link to three previous cases of PML. The drug is key to the growth of both companies, and this recent news had Biogen shares recently trading down 5.8% to $44.49, while ELN's American depository receipts fell 20% to $5.17.

"For the second quarter of 2009, Tysabri in-market net sales increased by 27% to $253.8 million, up from $200.0 million for the same period of 2008. The increase reflects strong patient demand across global markets."

To read the entire report visit: http://www.investorsoup.com/lp/ELN

See what investors say about these stocks at: http://www.stockhideout.com/

InvestorSoup.com is a small-cap research and investment commentary provider. InvestorSoup.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on InvestorSoup.com, please visit http://www.InvestorSoup.com

InvestorSoup.com Disclosure

InvestorSoup.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. InvestorSoup.com is a Web site wholly owned by BlueWave Advisors, LLC. Please read our report and visit our Web site, InvestorSoup.com, for complete risks and disclosures.

CONTACT: InvestorSoup.com
Jeffrey Brown, Editor
(469)-252-3505
[e-mail]


http://www.globenewswire.com/newsroom/news.html?ref=rss&&…

[Poppholz]

http://investorsoup.com/2009/10/technical-trading-overview-f…

[welke91]

Antwort auf Beitrag Nr.: 38.251.361 von welke91 am 26.10.09 11:49:06

good is bad and bad is nothing too know what is behind us!

http://www.youtube.com/watch?v=jmt16WC_mqo&feature=player_em…

[GuHu1]

http://industry.bnet.com/pharma/10005010/biogen-idecs-tysab…

[Tebi]

Press Release
Source: Elan Corporation plc / Biogen Idec
On 5:45 pm EDT, Tuesday October 27, 2009
Companies:Biogen Idec Inc.Elan Corp. Plc
DUBLIN & SAN DIEGO--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) and Biogen Idec (NASDAQ: BIIB - News) today announced data showing that treatment with TYSABRI® (natalizumab) significantly reduced the rate of hospitalization compared with placebo in patients with moderate–to–severe Crohn’s disease during both induction and maintenance treatment. These results were obtained from retrospective subset analyses of three registrational Phase 3 trials (ENACT-1 [Efficacy of Natalizumab as Active Crohn’s Therapy]), (ENACT-2 [Evaluation of Natalizumab as Continuous Therapy] and ENCORE [Efficacy of Natalizumab in Crohn’s Disease Response and Remission]), and one open-label study (ENABLE [Evaluation of the Natalizumab Antibody for Long-term Efficacy]). The data were presented for the first time in an oral session at the American College of Gastroenterology Annual Scientific Meeting in San Diego.

[Poppholz]

es ist unbegreiflich.

Die Unternehmensleitung von ELAN ist absolut unfähig.

[bingohopper]

Die haben doch einen Nettogewinn( net income ) von 52 Millonen
gemacht. Warum fällt die Aktie.

[Poppholz]

Antwort auf Beitrag Nr.: 38.280.418 von bingohopper am 29.10.09 14:57:28

lies die letzten Artikel, da steht alles drin.

[Tebi]

Antwort auf Beitrag Nr.: 38.280.261 von Poppholz am 29.10.09 14:43:56

Ja!Ich bin auch wirklich geschockt...WAS machen die den ganzen Tag????:O

[Poppholz]

Antwort auf Beitrag Nr.: 38.280.853 von Tebi am 29.10.09 15:32:32

ich hoffe nur, dass wir heute den Tiefststand gesehen haben.

Nachgekauft habe ich aber nicht mehr, keine Kohle und auch kein Bock noch mehr Kohle in den Sand zu setzen.

Meine LONG-Positionen bleiben liegen, und wenn es noch drei weitere Jahre dauert, bis der Kurs endlich bei 20,- Euro liegt.

[Tebi]

Antwort auf Beitrag Nr.: 38.281.142 von Poppholz am 29.10.09 15:54:58

....genau Poppi----Bernie,Surga ,Du und ich werden mit unseren Elan-Aktien gemeinsam alt....und dann,irgendwann im Heim ,träumen wir von der aufregenden Zeit als Elan am Höchstpunkt stand und wir uns schon richtig reich fühlten....

Was macht Mini Nr.2??????? lg

[surga]

Antwort auf Beitrag Nr.: 38.282.602 von Tebi am 29.10.09 17:57:24

ELN-Investition ist doch als unser Rente gedacht!!
Lassen wir doch ELN liegen, bis wir auf dem Rentenalter kommen, dann steigt hoffentlich ELN wieder auf 20 EURO.
Und ich hoffe, bis dahin muss ich den Namen KM nicht mehr lesen

[somart1]

Kursziel 0€, haha. Alles steigt, nur euer Dreck nicht.

[Poppholz]

Antwort auf Beitrag Nr.: 38.285.709 von somart1 am 30.10.09 06:22:43

nun ja, gestern immerhin 17% gestiegen.

Aber vielen Dank für Deine Meinung.

[Poppholz]

Antwort auf Beitrag Nr.: 38.282.602 von Tebi am 29.10.09 17:57:24

alles gut.

[Tebi]

Antwort auf Beitrag Nr.: 38.286.678 von Poppholz am 30.10.09 09:38:50

! Verteile 2 !

Und Surga: Du hast Recht.....wir nehmen Elan als Rente....ich kriege staatlicherseits eh nur 150€--das reicht nur für den Wein im Monat....

[surga]

Antwort auf Beitrag Nr.: 38.286.875 von Tebi am 30.10.09 09:56:12

Na ja, wenn wir auf Insel Bali leben,
brauchen wir ehe nicht so viel wie in Deutschland.
Dazu noch immer sonnig
Also immer cool bleiben

[Tebi]

Antwort auf Beitrag Nr.: 38.288.445 von surga am 30.10.09 12:43:17

OK.bitte suche etwas schönes!!!

[Poppholz]

Antwort auf Beitrag Nr.: 38.286.875 von Tebi am 30.10.09 09:56:12

ich bekomme immerhin 238,- Euro.

Habe gerade vor ein paar Tagen Bescheid bekommen.

[GuHu1]

Breakthrough in Alzheimer’s disease may lie with new research drug

Article Body
Alzheimer’s disease is a neurodegenerative disorder that affects more than 5.3 million families in the United States each year and unleashes a path of emotional and financial heartache for patients and their families.

Cleveland Kinney is researching an experimental drug known as bapineuzumab. UAB is participating in national and international Phase III Alzheimer’s clinical trials in which they administer the drug to patients, and there is real hope that bapineuzumab will change the underlying pathology of the disease, ultimately eradicating it from the body.
The disease carries an annual societal price tag of $148 million, according to the Alzheimer’s Association. It destroys brain cells, which causes memory loss and problems with thinking, and the behavior of patients with the disease can deteriorate to the point that it affects work, lifelong hobbies and social function. Alzheimer’s gets progressively worse, and it is fatal.

But an experimental drug known as bapineuzumab could change all that.

UAB researchers are participating in national and international Phase III Alzheimer’s clinical trials in which they administer the drug to patients every 13 weeks for 18 months, and there is real hope that bapineuzumab will change the underlying pathology of the disease, ultimately eradicating it from the body.

“There has been much effort and money put into this research, and there is real hope for Alzheimer’s patients,” says Cleveland Kinney, M.D., Ph.D., professor of psychiatry and behavioral neurobiology. “What’s so exciting about these new studies and this new drug in particular is the possibility of changing the pathology of the illness. I don’t know if we’ll ever cure it, but I think it will be managed by a cocktail of medicines and patients will be able to live a normal life.”

Bapineuzumab appears to undermine the grip the disease-causing proteins has on the brain, and that is the reason there is promise in the drug’s efficacy.

Current Alzheimer’s medications, including Aricept, Exelon and Razadyne — the three most popular cholinesterase inhibitors used to treat patients — act as managers of the disease. They maximize the remaining brain activity and slow the disease.

Bapineuzumab uses an antibody not commonly found in the patient’s blood to treat Alzheimer’s. It is designed to bind to a particular protein called beta amyloid protein, which accumulates in the brain and forms plaques related to the progression of the disease. It is hoped that bapineuzumab will attach to the beta amyloid protein in the brain and help the body remove it. Researchers also believe the drug will prevent the build up of beta amyloid protein.

“It’s particularly fascinating that as the study progresses and the plaques are dissolved, the brain shrinks because it’s getting rid of space-occupying lesions,” Kinney says. “But the patients theoretically do better over time, which means they are re-establishing connections in the brain they had lost because the plaques were there.

“If you get rid of the plaques the patients do better; the brain shrinks and the connections are re-made,” he says. “If that’s the case, that means the brain is far more plastic than anyone ever thought possible. That’s what we think is going to happen.”

The studies look at two different patient populations — those carrying what is known as apolipoprotein ε4 gene (APO ε4) alleles and those who do not. APOE contains the instructions needed to make a protein that helps carry cholesterol in the bloodstream and comes in several different forms. Three of those alleles occur more frequently than others. Dozens of studies have confirmed that the allele identified as APOE ε4 increases the risk of developing Alzheimer’s, but the way that happens is not yet understood.

Administered through infusions
Patients in the trials undergo an infusion of bapineuzumab every 13 weeks in addition to several MRI scans and neuropsychological testing. More than 100 sites in the United States are participating in the randomized study funded by Elan, but UAB is the only participating site in Alabama. Numerous sites around the world are participating in an identical study funded by Wyeth. UAB is enrolling participants in both studies.

The studies are double-blind and placebo-controlled. Sixty percent of patients enrolled in the studies will receive the drug, and 40 percent will not. Participants will be given the opportunity to receive the study drug in an extension study after the 18-month study has been completed.

UAB is in the top 25 percent in the country for enrolling participants in the studies, and more are being sought. Potential participants can call the Office of Psychiatric Research at 934-2484 to be screened. Patients currently taking Aricept, Exelon, Razadyne or other Alzheimer’s drugs will continue to take their existing medications in addition to the trial medication.

Those who are eligible to participate in the study must be between ages 50 and 88, have a diagnosis of probable Alzheimer’s disease, and have a caregiver who is willing to be involved in the study.

“Something will come out in the not too distant future that I think will be pretty miraculous,” Kinney says. “If it weren’t promising, we wouldn’t be participating in the study.”

http://main.uab.edu/Sites/reporter/articles/70605/

[posimist]

Ich bin drauf und dran,
nochmal nachzukaufen,
denn ich bin ziemlich sicher,
Tysabri wird weiter verkauft,
die Alzheimerpillen werden kommen,
der Verein macht Plus.
posimist

[Poppholz]

Antwort auf Beitrag Nr.: 38.333.869 von posimist am 06.11.09 11:09:15

aus diesen Gründen halte ich meine Aktien ja weiter.

Alles wird gut.

[Poppholz]

Antwort auf Beitrag Nr.: 38.333.877 von Poppholz am 06.11.09 11:09:58

hatte in der Vergangenheit bei "Kurstiefstständen" immer wieder nach gekauft.

Vor einigen Wochen einige für eine ALLOS Investition verkauft.

Nunja, war auch nicht der große Bringer.

Der Rest wird wohl noch Jahre im Depot bleiben und dann (zum Großteil) steuerfrei veräußert werden.

[leiro1]

Antwort auf Beitrag Nr.: 38.333.893 von Poppholz am 06.11.09 11:11:58

... da tut sich was...

sehe auf der elan-homepage daß es news gibt und der Kurs steigt:

11/06/2009: Elan and Biogen Idec Announce an Update to Tysabri Prescribing Information and Medication Guide

Ich kann diese aber nicht öffnen? Die vom 29.10 jedoch schon??


LG LEIRO1

[GuHu1]

Antwort auf Beitrag Nr.: 38.339.209 von leiro1 am 06.11.09 21:36:46

http://www.investorvillage.com/smbd.asp?mb=160&mn=390781&pt=…

New FDA Tysabri Labeling is out

Go to www.Tysabri.com, and click on Prescriber Information:
5 WARNINGS AND PRECAUTIONS
5.1 Progressive Multifocal Leukoencephalopathy (PML)

Progressive multifocal leukoencephalopathy, an opportunistic infection caused by the JC
virus that typically only occurs in patients who are immunocompromised, developed in three patients
who received TYSABRI in clinical trials [see Boxed Warning]. Two cases of PML were observed
among 1869 patients with multiple sclerosis treated for a median of 120 weeks. The third case
occurred among 1043 patients with Crohn’s disease after the patient received eight doses. Both
multiple sclerosis patients were receiving concomitant immunomodulatory therapy and the Crohn’s
disease patient had been treated in the past with immunosuppressive therapy.
In the postmarketing setting, additional cases of PML have been reported in multiple
sclerosis patients who were receiving no concomitant immunomodulatory therapy. In patients
treated with TYSABRI, the risk of developing PML increases with longer treatment duration, and for
patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials. There is
limited experience beyond 3 years of treatment. There are no known interventions that can reliably
prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML
and discontinuation of TYSABRI will mitigate the disease.
Ordinarily, patients receiving chronic immunosuppressant or immunomodulatory therapy or
who have systemic medical conditions resulting in significantly compromised immune system
function should not be treated with TYSABRI.


http://www.investorvillage.com/smbd.asp?mb=160&mn=390789&pt=…

Re: New FDA Tysabri Labeling is out
Additional new information in label:
For diagnosis of PML, an evaluation including a gadolinium-enhanced MRI scan of the
brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA are recommended.
There are no known interventions that can adequately treat PML if it occurs. Three sessions of
plasma exchange over 5 to 8 days were shown to accelerate TYSABRI clearance in a study of 12
patients with MS who did not have PML, although in the majority of patients alpha-4 integrin
receptor binding remained high. Adverse events which may occur during plasma exchange
include clearance of other medications and volume shifts, which have the potential to lead to
hypotension or pulmonary edema. Although plasma exchange has not been studied in
TYSABRI treated patients with PML, it has been used in such patients in the postmarketing
setting to remove TYSABRI more quickly from the circulation.
Immune reconstitution inflammatory syndrome (IRIS) has been reported in TYSABRI
treated patients who developed PML and subsequently discontinued TYSABRI. In almost all
cases, IRIS occurred after plasma exchange was used to eliminate circulating TYSABRI. It
presents as an unanticipated clinical decline in the patient’s condition after return of immune
function (and in some cases after apparent clinical improvement) and, in the case of PML, is
often followed by characteristic changes in the MRI. TYSABRI has not been associated with
IRIS in patients discontinuing treatment with TYSABRI for reasons unrelated to PML. In
TYSABRI treated patients with PML, IRIS has been reported within days to several weeks after
plasma exchange. Monitoring for development of IRIS and appropriate treatment of the
associated inflammation during recovery from PML should be undertaken.

[Poppholz]

'Benign' label change for Elan/Biogen’s Tysabri
09 November 2009

Elan Corp and partner Biogen Idec have made changes to the label on Tysabri to reflect the increased risk of a rare and potentially fatal brain disease when the multiple sclerosis blockbuster is taken over a longer period of time.

The companies said that effective immediately, they are updating the label on Tysabri (natalizumab) following consultation with the US Food and Drug Administration. Specifically it notes that the “risk of developing progressive multifocal leukoencephalopathy increases with longer treatment duration, and for patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials. There is limited experience beyond three years of treatment”.

Ian Hunter, an analyst at Irish broker Goodbody said that from a regulatory point of view, “this is a fairly benign label update for the drug as it does not change the risk rate (one in 1,000), apply a quantitative time-based weighting to the risk of PML or require/suggest that patients should take a drug holiday after a certain period”.

The changes comes just a couple of weeks after the European Medicines Agency’s Committee for Medicinal Products for Human Use announced that it has begun a review of the benefits and risks of Tysabri in view of reports of 23 cases of progressive multifocal leukoencephalopathy worldwide since the drug was reintroduced in July 2006. Mr Hunter added that “it has still to be seen, however, if the sudden increase in PML cases will drive the EMEA or individual authorities within the European Union to make changes to their prescribing and use requirements for the drug”.

He went on to say that the commercial impact of the label change will only be quantified in the next results releases from Elan and Biogen, which are not due until February 2010. As when the first cases of PML appeared last year, “we believe the current ramp up in cases could see Tysabri progress slowed as patients/physicians new to the drug take a more cautious approach to initiating treatment,” Mr Hunter concluded.

By Kevin Grogan

http://www.pharmatimes.com/WorldNews/article.aspx?id=16874

[Poppholz]

Biogen Idec's Social Media Ties Save Tysabri Again; FDA Watching

By David Phillips | Nov 12, 2009

On November 2, Biogen Idec updated the prescribing label for its blockbuster multiple sclerosis drug Tysabri (natalizumab) after consultation with the FDA. Aside from acknowledging that the risk of developing progressive multifocal leukoencephalopathy (PML), an often fatal brain infection, increases with longer duration of treatment, no other revisions concerning the risk of PML were required. The fact that this biologic remains a cornerstone treatment for adult patients with relapsing forms of MS — only the second drug to ever return to U.S. pharmacy shelves after having been withdrawn — speaks volumes to the growing influence of the Web.



The Internet has radically changed pharmaceutical marketing and sales. No longer do drug companies need legions of attractive and personable salespeople to “detail” physicians on the efficacy and patient benefits of their choice drugs. With an average annual spend of $150,000 per primary care sales representative and $300,000 per specialty rep, leveraging the Internet is a more cost-effective proxy by which to disseminate educational (meant to persuade) information to doctors, medical staffs, health care administrators, and patients. Scrip tracking (sales lingo for how much — and what — drugs a physician is prescribing), free sample requests, and patient educational brochures — all can be handled by one techie sitting in a cubicle these days. A two-day FDA-sponsored public hearing on heretofore unregulated use of web-enabled social media tools used to promote prescription drugs to consumers is getting underway in Washington DC.

Biogen does utilize a drug-specific salesforce (90+) for Avonex and another 90+ reps to exclusively market Tysabri — plus a small neuroscience group (of about 200) selling both MS drugs — to select opinion leaders and high-value (volume prescribing) physicians. Nonetheless, the company was ahead of the pack in recognizing the value an online media presence adds to product marketing and brand awareness. In the battle for market share and sales, the company has successfully conveyed the Tysabri message to providers and potential customers alike through popular social media websites like YouTube, where the Tysabri Recovery Series recounts personal testimonials from MS patients on how the biologic has helped them lead normal lives. Branded promotions and drug/ disease updates can be found on a plethora of websites, from Facebook and MySpace, to the latest fad, Twitter.

That the Internet is both a powerful tool for finding information quickly on MS and an effective means by which the more than 400,000 Americans living with MS can connect and chat with others through online MS communities has not been lost on Biogen management. In addition to mandatory patient enrollment in the Tysabri Touch Prescribing Program, Biogen offers MS patients who are thinking about — or have chosen — Tysabri therapy a number of options to get more involved in their treatment decisions: programs ranging from the TYSABRI Mentor Program to a Webinar Series that lets the patient dial in on the phone to hear a healthcare professional discuss treatment information. There are a number of third-party informative, patient-centric services available to MS patients online, too, such as the National Multiple Sclerosis Society. As mentioned, Biogen’s Internet investments yielded unprecedented dividends when the FDA reintroduced Tysabri back onto the U.S. market after PML safety concerns forced its initial withdrawal.



Despite the increasing amount of PML cases that have been diagnosed since Tysabri was re-introduced to the U.S. market in July 2006, Tysabri’s benefit-risk profile remain favorable, as confirmed by the 69 percent of surveyed doctors (see Figure 1 to the right; click for a larger version). And, the message that “Tysabri’s benefits outweigh the risk it poses to MS patients” is seen in the upward trending of monthly tracking data — up 18 percent in one 12-month period (see Figure 2, below, and click for a larger version).



A legitimate concern raised by drug safety watchdogs, like The Health Research Group, a DC-based nonprofit of the advocacy group Public Citizen (founded by well-known corporate gadfly Ralph Nader), is whether or not the ethical line has been blurred between company-sponsored web portals (profit-driven) and unbranded, patient-driven websites (representing the public’s health interests). Does anyone really know how much money Biogen has donated to MS advocacy groups, including the National MS Society? Or, what incentives have been provided to nonprofits to communicate positive clinical trial data to their constituents?

Although I’m not a conspiracy theorist, one might speculate that the invisible finger of Biogen was behind the explosive online propaganda campaign (emphasizing the drug’s benefits) that erupted following the 23rd and 24th confirmed cases of PML in patients taking Tysabri (in October - early November).

At the very least, any resultant FDA initiative from this week’s public forum should focus on the need for increased transparency due to the entangled interests that have arisen between industry and “independent” patient-centric advocacy groups. By the way, I was just informed that PML-patient # 14 passed earlier this week. Funny thing — her death didn’t make headlines — anywhere. If confirmed as the fifth PML fatality related to drug therapy, how ironic that patient empowerment has already been betrayed by its chosen medium.

http://industry.bnet.com/pharma/10005261/fda-looking-to-regu…

[Poppholz]

2nd UPDATE: Biogen, Elan, Roche In Brain Infection Consortium
11-11-09 6:16 PM EST

(Adds additional details, comments from Roche in the ninth paragraph)

By Thomas Gryta

Of DOW JONES NEWSWIRES

NEW YORK -(Dow Jones)- Biogen Idec Inc. (BIIB), Elan Corp. Plc (ELN) and Roche Holding AG (RHHBY) are planning to form a research consortium dedicated to a rare brain infection that has emerged in patients taking a number of their drugs.

The move comes as cases of progressive multifocal leukoencephalopathy, or PML, have risen sharply in patients taking multiple sclerosis treatment Tysabri, sold by Biogen and Elan, prompting a panel of European regulators to review the drug. The infection, also found in users of several other immune system-suppressing therapies, is often deadly, and its emergence has perplexed physicians and researchers as they balance the risk and reward of these drugs.

Mariska Kooijmans-Coutinho, Biogen's senior director of clinical trial safety and risk management, detailed the plans for the consortium at a meeting covering various aspects of the infection at the New York Academy of Sciences on Tuesday.

The group plans to pool resources related to PML, including the formation of a global database of cases in an effort to predict, prevent and treat the condition, she said.

The effort will also include non-profit organizations and academic institutions, and she invited other drug companies to join the effort. She noted that the consortium will seek financial and time commitments from companies to ensure stability in the group.

PML is caused when JC virus, which most people carry, attacks the central nervous system in people with weakened immune systems, often leading to an irreversible decline in neurologic function and death.

It has appeared in patients taking some drugs used after organ transplants, as well as rheumatoid arthritis and cancer treatment Rituxan, sold by Biogen and Roche, and Raptiva, a psoriasis drug that Roche'sGenentech unit pulled from the market earlier this year because of the issue.

Before these drugs, the condition hadn't shown up in patients with MS, or psoriasis, and was most common in patients with AIDS.

PML has been previously reported in patients with rheumatoid arthritis, according to Roche spokeswoman Nikki Levi, who declined to provide additional details about the consortium because formal agreements haven't been signed.

There have been 24 confirmed cases of PML in users of Tysabri for MS since its re-launch in 2006, which is generally consistent with the 1-in-1,000 patient rate implied by its label. The drug is subject to a rigorous risk management plan and the companies have been researching PML since its emergence in 2005, which led to Tysabri's temporary withdrawal from the market.

There have been three confirmed cases of PML in patients on Rituxan when treated for rheumatoid arthritis, but a study released earlier this year linked Rituxan to 57 cases of PML since 1997. The drug is also approved to treat non- Hodgkin's lymphoma, a type of blood cancer.

Levy acknowledged that other PML cases have occurred when Rituxan is used to treat lymphoma, as well as in patients treated with Rituxan in ways not approved by regulators.

The PML risk is difficult to evaluate in those patients, because they are already at increased risk of the infection, Levy said. Information suggests that rheumatoid arthritis patients on the drug have an increased risk of the infection.

Although PML is often fatal, a higher number of Tysabri-linked PML patients have survived, with only four dying since 2006, because of close patient monitoring and quick removal of the drug from the body. Regardless, the infection's nature often leaves survivors with varying degrees of disability.

Eugene Major, who runs the Laboratory of Molecular Medicine and Neuroscience at the National Institutes of Health, believes that the risk of PML in Tysabri is generally known, but he warns that the condition may be more common than thought in areas not related to Tysabri.

"It is pretty clear that it is underreported," Major said, noting that the NIH and Centers for Disease Control are forming a collaboration to increase the monitoring of PML in the broader population with the hope of gaining a better understanding of its scope.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; [e-mail]

(END) Dow Jones Newswires 11-11-091816ET Copyright (c) 2009 Dow Jones & Company, Inc.

http://news.morningstar.com/newsnet/ViewNews.aspx?article=/D…

[bernie55]

Elan to Present at Lazard Capital Markets 6th Annual Healthcare Conference



....................... at the Lazard Capital Markets 6th Annual Healthcare Conference,

on Tuesday, November 17, 2009 at; 9:55 a.m. Eastern Time and 2:55 p.m. GMT.


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


http://finance.yahoo.com/news/Elan-to-Present-at-Lazard-bw-4…

[bernie55]

Antwort auf Beitrag Nr.: 38.396.758 von bernie55 am 16.11.09 18:05:32

2:55 p.m. GMT

= 15.55 MEZ .

[Poppholz]

Antwort auf Beitrag Nr.: 38.396.758 von bernie55 am 16.11.09 18:05:32

heute sind einige unserer Firmen am presentieren.

http://www.reuters.com/article/earningsSeason/idUSL297030962…

[DonServante]

Ausgerechnet Reuters - da gab es doch schon mal was und das war nicht so glücklich oder täusche ich mich?

[Poppholz]

Antwort auf Beitrag Nr.: 38.404.789 von DonServante am 17.11.09 18:17:13

Reuters kann da aber wohl nicht für.

[Poppholz]

http://www.investegate.co.uk/Article.aspx?id=200911181631187…

[Poppholz]

Biotech, Multiple Sclerosis, Drugs
Tysabri, the MS Drug Haunted by Deadly Side Effect, Doesn’t Look So Deadly Anymore
Luke Timmerman 11/19/09

Few doctors knew much about a rare brain infection called PML back in 2005, when two patients on a hot new multiple sclerosis drug from Biogen Idec and Elan died from the side effect. The infection, at the time, was generally considered a death sentence. But now with three years of data from more than 60,000 patients worldwide who have taken natalizumab (Tysabri) under strict monitoring by physicians, a new picture is emerging that shows PML is still very much a serious threat, but that it isn’t nearly as deadly as first feared.

While each and every confirmed case of PML, known formally as progressive multifocal encephalopathy, scares investors in Cambridge, MA-based Biogen (NASDAQ: BIIB) and Ireland-based Elan (NYSE: ELN), I sought to assemble a big picture view of exactly how deadly PML really is when I interviewed Al Sandrock last week. He’s the senior vice president of neurology R&D at Biogen, and an assistant clinical professor of neurology at Harvard Medical School.

Before diving too far into the numbers about the risk of Tysabri, a little background is required. This drug, an antibody treatment designed to block certain white blood cells that cause MS when they attack nerves, has a history of also making patients vulnerable to infection. Biogen and Elan yanked it off the market in February 2005 after two cases of the brain disease were confirmed among patients taking the drug; a month later, a third case was confirmed. But legions of patients still demanded the drug, considered to be the most effective medicine on the market at reducing the disabling nerve damage from multiple sclerosis flare-ups. The FDA allowed the drug to return to the market in July 2006 after determining its benefits outweighed the risks, but it also forced doctors into a strict monitoring program to keep an eye out for the early signs of PML.

This matters not just for doctors and patients, but for Biogen’s and Elan’s financial futures. The drug, Biogen’s fastest-growing product, generated $560 million in sales in the first nine months of this year. (The importance of this drug is one reason why investors get so ticked at Biogen when it isn’t exactly forthcoming about every newly diagnosed case, but that’s a bone to pick another day.)

When the drug came back on the market, its FDA-approved prescribing information contained a prominent warning that about 1 out of every 1,000 patients on the drug were likely to get PML. But that was really just a forecast, and the actual risk-benefit balance for this drug is really a moving target that shifts over time when a new case is confirmed. So I sought to build a simple chart when I spoke to Sandrock that provides a snapshot of PML cases in February 2005, when the drug was pulled off the market because of the PML risk, versus those confirmed as of yesterday. Here’s what I gathered:


Number of patients
who have taken Tysabri...........Number of PML cases........Deaths
February 2005....3,000...........................3..............2
Nov. 18, 2009...63,000..........................27..............5

The February 2005 figures came from clinical trial data and formed the foundation for the FDA-required warning of the 1-in-1,000 chance of getting PML. The more recent figures include all the experience of patients who have gotten the drug since it was returned to the market in July 2006. The thing that jumped out at me was the fact that only five of the 27 confirmed patients with PML have died—meaning that the current survival rate stands at over 80 percent.

That curious fact has been buried under a rash of scary headlines this fall, in which the number of cases of PML appears to have gone through a sharp increase. There were 13 cases confirmed in an FDA notice on September 17, and the number climbed to 23 when European regulators issued an update on October 23. The latest tally now stands at 27, Sandrock said in a Nov. 11 interview (and which was confirmed again yesterday by company spokeswoman Naomi Aoki). Based on this evolving body of evidence, the FDA updated the Tysabri prescribing information earlier this month to say that the risk appears to increase as patients stay on the drug for longer periods of time.

But even as more cases get diagnosed, I wanted to know why there hasn’t been a corresponding increase in the number of deaths. The chart shows more than 80 percent of patients diagnosed with PML since the drug came back on the market in July 2006 are still alive. Lots of doctors also want to know what’s happening to those patients who get PML, but still live. Biogen isn’t releasing a patient-by-patient breakdown of what is happening to them all, but its medical affairs staff is answering those questions from physicians, Aoki says.

Some of the patients are severely disabled, Sandrock says, but a few—he wouldn’t say exactly how many of the 27 cases—have recovered and even feel strong enough to return to work. The New England Journal of Medicine recently published an article about one case of PML in which a patient became critically ill with PML, but recovered.

“Back when I trained as resident, we didn’t know much about it, but it was assumed that PML was almost always fatal,” Sandrock says. “But the survival rates appear to have changed. The outcome from PML is not certain death. Some have done well, and others, not so well.”

Of course, this isn’t the only way to look at the PML risk. The drug’s makers and regulators are looking at databases that factor in different variables, like the number of patients who have been on the drug for more than a year, more than two years, more than three years, and so forth. Those figures are what led regulators to add new language to the label that says the risk increases over time. Sandrock emphasized that even though the risk does increase, it’s still within the 1-in-1,000 rate that patients were warned about back in July 2006, even for patients who have been on the drug since shortly after it was brought back to the market. The degree of statistical confidence in the PML risk figure declines over time, because there are fewer patients who have been on the drug for two and three years, Aoki says.

So while the incidence appears to be rising, what has changed that’s keeping PML patients alive? One of the big reasons is the strict monitoring program insisted upon by regulators, Sandrock says.

Now that every physician who treats MS has heard a lot about PML, they are trained to look for telltale signs like changes in cognition, changes in personality, or seizures that are not typical symptoms of an MS patient, Sandrock says. Doctors watch for those signs every time a patient comes in for their monthly IV infusion of the drug. If the side effect is suspected, the doctor will withhold the drug and run an MRI test to look for signs that the cause of PML, the JC virus, has entered the brain. If the MRI shows the virus is there, the doctor then does a spinal tap that can confirm the presence of the virus.

“We think we’re catching the virus early now,” Sandrock says, noting that some cases have been detected with extremely low concentrates of virus in the spinal fluid that only a specialty lab at the National Institutes of Health can detect.

Once the virus is detected, doctors do what is called a “plasma exchange,” which basically means that whatever amount of drug is still circulating in the bloodstream gets washed out through a filtering procedure. Doctors then reconstitute the patients’ immune system, which “clears the virus out,” Sandrock says.

So while early detection has helped lower the risk of death, I wanted to know what else Biogen and Elan think holds promise to bring the fatality rate down even further. Analysts suggested earlier this month that regulators might impose a drug “holiday” for patients who stay on Tysabri for long-periods of time. Sandrock didn’t like the sound of this idea, saying there isn’t data to support the notion that such a step will help lower the risk, while it essentially guarantees that a patient’s disabling MS symptoms will come back. But he did note that the company is looking to conduct a clinical trial to test the idea.

Biogen says it is more interested in developing a blood test that might offer doctors clues as to which individual patients have an elevated risk of getting PML from the start, and which ones are less likely to become infected. The key to determining this could lie in a relatively common lab technology, known as Elisa, that can detect whether a patient has antibodies in the blood made to fight the JC virus that can awaken from a dormant state to cause PML in Tysabri patients. About half of adults are estimated to have these antibodies, which suggest that JC virus is lurking in the body with the potential to become an opportunistic infection in at least some Tysabri patients. The remaining patients are thought to have no JC virus in their systems, and therefore would be considered less likely to get PML, Sandrock says.

Biogen also has a lot of other strategies for minimizing the risk of PML. It is forming a consortium with the makers of other drugs that have been linked to the side effect, such as rituximab (Rituxan), efalizumab (Raptiva), alemtuzumab (Campath), and mycophenolate (Cellcept), Sandrock says. The idea is that accumulating more data in a global database will help each company deal with the issue, Sandrock says.

There are other ideas in the works as well, such as a vaccine to protect against PML—”we’re very excited about that,” Sandrock says—and a potential anti-PML treatment called mephaquin, which is commonly used to treat malaria. A Biogen collaboration with Cambridge, MA-based Alnylam Pharmaceuticals to develop an RNA interference-based treatment for PML has stopped, Sandrock says.

Pressure to show progress with innovative new treatments, vaccines, or drug holidays will surely intensify if the incidence of PML keeps climbing past that 1-in-1,000 benchmark rate as patients stay on the treatment for years. The pressure to figure out how to best manage PML will come from investors, regulators, and from the patients themselves, who want to make sure that they can still get the drug.

“Not a week goes by around here that we don’t hear a story from a patient who has had their life transformed by this treatment,” Sandrock says. “The benefit has been confirmed, by real life stories. And we’ve made a lot of progress at mitigating the risk.”

Luke Timmerman is the National Biotechnology Editor for Xconomy. You can e-mail him at [e-mail], call 206-624-2374, or follow him on Twitter at http://twitter.com/ldtimmerman.

http://www.xconomy.com/boston/2009/11/19/tysabri-the-ms-drug…

[Tebi]

Msg 392171 of 392179 at 11/19/2009 4:24:58 PM by

nangasimon

trial paper quick opinion
I have been snowed under today, some of you may know why! Id like to give some brief opinions as I did have 20mins to give the paper and editorial a read this morning.

First of all I am disappointed this trial is published in Neurology. Neurology is a second tier neurology journal. Probably ranks fourth in neurology (after Lancet Neurology, Annals, and Brain). The papers are relatively short. Remember an autopsy study of a phase I/II trial (the Holmes/Nicoll paper) was published in Lancet (impact 4x that of Neurology) seems crazy to me, but Nicoll not to blame!

One thing that was good was that scales data shown were shown over the duration of the trial rather than just the difference at the end. This gave a good indication of the separation of the curves (fairly gradual for ADAScog in completers) and the degree of non-linearity (rather minor I thought).

There was not much info on the magnitude of VE related cogntive change and how this might have impacted the overall result. That I thought was a shame, even if this effect was trivial, which I doubt, it was an important potential confounding influence that should have been quanitified in some way.

Re the model used and the debate we have had on the board about baseline differences, from my quick read I believe the methods supports my position that the exploratory analyses incorporated baseline differences in the model and adjusted the actual scores accordingly. This is because they again clarify that baseline was a factor in the model in the methods and refer to model adjusted scores, or a similar phrase, in the illustrations.

There was little focus on the E4 stratiifcation, no figures, but maybe its all there in text when I go through again sometime soon. This was surprising given the emphasis of the editorial and the phase III design, probably related to the brevity of the journal format.

There was little on the NTB vs. ADAScog, which was another debate but not that important.

I was surprised that the competer placebos deteriorated so fast on the ADAScog I would have thought less than the MITT model, I dont yet understand how this happened, because frail patients should drop out...maybe have missed something here

So there we are, the trials roll on, I remain optimistic on the chances of success. Feel some opportunities were missed here. But the company prob doesnt really care much, as it isnt their drug anymore.

[GuHu1]

Best news I have seen a long time. Response from IR

Thank you for your email. Together with Biogen Idec, we believe that we have a validated assay to detect JCV antibodies in patients. We believe that patients who do not have JCV antibodies are at low risk to get PML. We are working with leading physicians in MS to best understand how to utilize the assay to ensure that patients receive the most benefit from the test. We are working with regulators and we believe it is possible the JCV assay could be available in the first part of next year.

Thank you for your interest in Elan.

Regards,

Elan Investor Relations

http://www.investorvillage.com/smbd.asp?mb=160&mn=392558&pt=…

[leiro1]

Antwort auf Beitrag Nr.: 38.457.860 von GuHu1 am 26.11.09 00:05:12

LEVERKUSEN (dpa-AFX) - Die chinesische Arzneimittelzulassungsbehörde hat das Multiple-Sklerose (MS)-Medikament Betaferon des Leverkusener Pharma- und Chemiekonzern Bayer zugelassen. Bayer (Xetra: 575200 - Nachrichten) will das Medikament ab Mitte 2010 in China vertreiben, teilte die im Dax (Xetra: Nachrichten) notierte Gesellschaft am Dienstag in Leverkusen mit. Das Konkurrenzprodukt Betaferon zu Rebif von der deutschen Merck (MERK.JK - Nachrichten) ist den Angaben zufolge bereits in mehr als 100 Ländern erhältlich. Multiple-Sklerose ist eine chronische, fortschreitende Krankheit des zentralen Nervensystems. Mit zunehmender Dauer der Erkrankung steigt die Wahrscheinlichkeit von Behinderungen./ne/wiz

[Poppholz]

The Michael J. Fox Foundation Announces $1.5 Million in Funding to Advance Development of Drug Targets for Disease-Modifying Parkinson's Disease Treatments

NEW YORK, Nov. 30 /PRNewswire-USNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) today announced $1.5 million in total awards to six research teams working to develop potentially disease-modifying therapies for Parkinson's disease. The funding was awarded under the Novel Approaches to Drug Discovery for Parkinson's Disease program, made possible by funding from Elan Corporation, plc (NYSE: ELN), a neuroscience-based biotechnology company.

The Novel Approaches program is an important component of MJFF's overall strategy of providing critical resources to under-funded areas of the drug development pipeline. Novel Approaches seeks to advance the development of therapeutic targets that already have some promising initial data, while engaging industry partner Elan as a potential follow-on funder for those projects with the greatest potential to bring new, transformative treatments to people living with PD.

Awardees under Novel Approaches include both academic and industry scientists. Of the six awardees, two will target the protein alpha-synuclein, whose clumping is a hallmark of PD pathology. The remaining teams are developing technologies to prevent the degeneration of dopaminergic neurons, the main type of cell affected in PD, by focusing on the reduction of oxidative stress and the inhibition of JNK, a protein associated with cell death.

Projects selected for funding are listed below. Grant abstracts and researcher bios are also available on the Foundation's Web site, www.michaeljfox.org. The selection of awardees was made exclusively by the Foundation via its standard peer-review process.

Inhibition of brain-dependent nitric oxide (NO) over-production by isoform-selective NO synthase (NOS) inhibitors

John Andrews, PhD, NeurAxon, Toronto, Ontario, Canada

Development of HSF1 effectors as Parkinson's disease therapeutics

William Janzen, PhD, and Maria Sippola-Thiele, PhD, Chaperone Therapeutics, Durham, North Carolina

Optimizing metalloporphryins for clinical development

Manish Patel, PhD, University of Colorado, Denver, Colorado

Optimization of alpha synuclein 5'UTR directed translation blockers as novel drugs for Parkinson's disease

Jack Rogers, PhD, Mental Health Research Institute of Victoria, Melbourne, Australia

Cerium oxide nanoparticles in treatment of Parkinson's disease

Beverly Rzigalinski, PhD, Virginia College of Osteopathic Medicine, Blacksburg, Virginia

Novel JNK inhibitors as therapeutic agents for Parkinson's disease

Bobby Thomas, PhD, Weill Medical College of Cornell University, New York, New York and Maurizio Pellecchia, PhD, Burnham Institute for Medical Research, La Jolla, California

About The Michael J. Fox Foundation

The Michael J. Fox Foundation is dedicated to ensuring the development of better treatments, and ultimately a cure, for Parkinson's disease through an aggressively funded research agenda. MJFF has funded over $158 million in research to date.

About Elan

Elan Corporation, plc (NYSE: ELN) is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York and Irish Stock Exchanges. For additional information about the company, please visit www.elan.com.


SOURCE The Michael J. Fox Foundation for Parkinson's Research

http://www.prnewswire.com/news-releases/the-michael-j-fox-fo…

[Poppholz]

market pulse
Dec. 7, 2009, 2:25 a.m. EST

Elan: J&J unit seeks Europe schizophrenia-drug OK

By Robert Daniel

TEL AVIV (MarketWatch) -- Elan Corp., the Dublin drugmaker, said on Monday that Janssen-Cilag submitted a marketing-authorization application to the European Medicines Agency for paliperidone palmitate, a once-monthly injection treatment for schizophrenia. The U.S. Food and Drug Administration cleared the drug earlier this year, Elan said in a statement. The drug from Janssen-Cilag, a subsidiary of Johnson & Johnson, the New Brunswick, N.J., health-care giant, uses Elan's NanoCrystal technology, Elan said.

http://www.marketwatch.com/story/elan-jj-unit-seeks-europe-s…

[Tebi]

Antwort auf Beitrag Nr.: 38.526.394 von Poppholz am 08.12.09 11:14:11

grüsse!

[Poppholz]

Antwort auf Beitrag Nr.: 38.527.297 von Tebi am 08.12.09 13:05:53

ebenfalls.

ist halt ein wenig ruhig hier geworden.

Aber wir haben ja Zeit, soll ja für die Rente sein.

[Tebi]

Antwort auf Beitrag Nr.: 38.527.894 von Poppholz am 08.12.09 14:19:39

.....so ist es....

[bernie55]

Elan Drug Technologies Announces First Japanese Approval of Product Using Its NanoCrystal(R) Technology)

DUBLIN, Dec 14, 2009 (BUSINESS WIRE) -- Elan Drug Technologies, a business unit
of Elan Corporation, plc (NYSE: ELN) announces the approval by the Japanese
Ministry of Health, Labour and Welfare of EMEND(R) (aprepitant) for the
treatment of cancer chemotherapy-induced nausea and vomiting. EMEND(R), which
was developed by a subsidiary of Merck & Co Inc., Whitehouse Station, N.J., USA
and licensed to Ono Pharmaceuticals Co., Ltd. for the Japanese market, is the
first licensed product approved in Japan that incorporates Elan Drug
Technologies' NanoCrystal(R) technology.

NanoCrystal(R) technology, enables formulation of poorly water soluble compounds
for all routes of administration. For EMEND(R), this technology advance
eliminates a food requirement and improves bioavailability by 600%. EMEND(R) was
confirmed to be effective for both acute and delayed phases of nausea and
vomiting in Japanese clinical trials, and becomes the first therapy approved for
treatment of delayed phase nausea and vomiting (24 hours or later after start of
cancer chemotherapy) in Japan.

"The approval of EMEND(R) is a significant achievement for our NanoCrystal(R)
technology, as it marks th e first Japanese approval of a product incorporating
this technology in this very important market," said Shane Cooke, Executive Vice
President and Head of Elan Drug Technologies. "We hope this is the first of many
products using our NanoCrystal(R) technology to be launched in Japan."

NanoCrystal(R) technology is a proprietary technology developed by Elan Drug
Technologies through Elan Pharma International Limited and other Elan
affiliates. Five licensed products have now been approved using the
NanoCrystal(R) technology by various health authorities including the US Food
and Drug Administration (FDA). Products incorporating the NanoCrystal(R)
technology are sold in markets worldwide.

About Elan Drug Technologies and NanoCrystal(R) Technology

Elan Drug Technologies (EDT), one of the world's leading drug delivery
businesses, is a business unit of Elan Corporation plc. As a fully integrated
drug delivery business, Elan Drug Technologies delivers clinically meaningful
benefits to patients, by using its extensive experience and proprietary delivery
technologies in collaboration with pharmaceutical companies. For 40 years, Elan
Drug Technologies has been, and continues to be, a drug delivery provider of
choice for a broad range of pharmaceutical companies, including many of the
world's leading pharmaceutical companies. Elan Drug Technologies offer clients
drug delivery expertise with a suite of commercially launched, proprietary,
technology-driven solutions, from NanoCrystal(R) technology for poorly water
soluble compounds, to customised oral controlled release drug technologies.
Products enabled by its technologies are used by millions of patients each day.
For more information go to www.elandrugtechnologies.com

NanoCrystal(R) is a registered trademark of Elan Pharma International Limited,
Ireland, a subsidiary of Elan Corporation plc.

EMEND(R) is a registered trademark of Merck & Co Inc.

Safe Harbour/Forward-Loo king Statements

The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. A further list
and description of the risks, uncertainties and other matters that confront us
can be found in our Annual Report on Form 20-F for the fiscal year ended
December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with
the U.S. Securities and Exchange Commission. We assume no obligation to update
any forward-looking statements, whether as a result of new information, future
events or otherwise.

SOURCE: Elan Corporation, plc




CONTACT:
Elan Corporation, plc
Media:
Mary Stutts, 650-794-4403
Niamh Lyons, 353-1-663-3602
or
Investors:
Chris Burns, 800-252-3526
David Marshall, 353 1 709 4444

http://www.investorvillage.com/smbd.asp?mb=160&mn=394461&pt=…

[bernie55]

....und noch Grüße in die Runde...

[Tebi]

Antwort auf Beitrag Nr.: 38.560.474 von bernie55 am 14.12.09 08:16:45

Grüsse zurück!

[Poppholz]

wünsche allen LONGIES eine schöne Weihnachtszeit.

[surga]

Antwort auf Beitrag Nr.: 38.561.004 von Poppholz am 14.12.09 09:50:33

Danke, ebenso Poppi

[surga]

Antwort auf Beitrag Nr.: 38.560.474 von bernie55 am 14.12.09 08:16:45

Hi Bernie,
Grüsse zurück!

[Poppholz]

December 15, 2009 02:00 AM Eastern Time
Elan and Transition Therapeutics Announce Modifications to ELND005 Phase II Clinical Trials in Alzheimer’s Disease
Two Highest Doses Removed from Phase II Trial, Lowest Dose Continues as Planned

DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc and Transition Therapeutics, Inc. today notified clinical investigators of modifications to the Phase II study AD201 and open label extension study AD251 for ELND005, a compound being developed for the potential treatment of Alzheimer’s disease. The AD201 study is evaluating three dose levels of ELND005 compared to placebo in 353 patients.

Patients will be withdrawn immediately from the study in the two higher dose groups (1000mg and 2000mg dosed twice daily). The study will continue unchanged for patients who are assigned to the lower dose (250mg dosed twice daily) and placebo groups. The AD251 study will be modified to dose patients only at 250mg twice daily.

The decision by the companies to take these actions was made in concurrence with the Independent Safety Monitoring Committee (ISMC) following a review of the ongoing ELND005-AD201 study. Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established.

The ISMC and both companies concur that the tolerability and safety data are acceptable among patients receiving the 250mg dose and that the blinded study should continue for this dose and the placebo group.

“Today’s decision speaks to our strong commitment to patient safety while allowing for the continued evaluation of ELND005 at the 250mg dose, twice daily,” said Menghis Bairu, M.D., EVP, Chief Medical Officer and Head of Global Development at Elan. “We continue to expect the ongoing study to provide important data to guide the next steps in the development of ELND005 for the potential treatment Alzheimer’s disease.”

About ELND005 (AZD-103)

ELND005 is an orally-administered therapeutic agent that has received fast track designation from the U.S. Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer's disease. Fast track designation can facilitate development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions.

ELND005 is currently in a Phase 2 clinical study, which completed enrollment in October 2008. The study is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study in approximately 353 patients with mild to moderate Alzheimer's disease. The planned treatment period for each patient is approximately 18 months.

About Alzheimer's disease

Alzheimer's disease, a leading cause of dementia, is a progressive brain disorder that gradually destroys a person's memory and ability to learn reason, make judgments, communicate and carry out daily activities. Alzheimer's disease may result from the build-up of toxic beta-amyloid peptides in the brain. As Alzheimer's disease progresses, individuals may also experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. It is currently estimated that more than 5 million Americans have Alzheimer's disease and more than 24 million people worldwide over the age of 60 have some form of dementia (Source: Alzheimer's Association and Alzheimer's Disease International).

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 and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

About Transition

Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include ELND005 for the treatment of Alzheimer's disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates acquired externally and developed internally using its proprietary drug discovery engine. Transition's shares are listed on the NASDAQ under the symbol "TTHI" and the Toronto Stock Exchange under the symbol "TTH". For additional information about the Company, please visit www.transitiontherapeutics.com.

Safe Harbor/Forward-Looking Statements

This press release contains forward-looking statements regarding the development of scyllo-inositol (ELND005) under the collaboration agreement between Elan and Transition. These statements are based on Elan's and Transition's current beliefs and expectations. ELND005 may not be successfully developed or commercialized under the collaboration agreement. Factors which could cause actual results to differ materially from Elan's and Transition's current expectations include the risks that clinical development of ELND005 fails due to safety or efficacy issues, the results from Phase 1 clinical trials and preclinical testing of ELND005 are not predictive of results to be obtained in Phase 2 or later clinical trials, the patent issued with respect to ELND005 may not provide substantial protection or commercial benefit, the development and commercialization of competitive therapies, the collaboration agreement is terminated early or Elan and Transition encounter other unexpected delays or hurdles. Drug development and commercialization involves a high degree of risk.

For more detailed information on the risks and uncertainties associated with Elan and Transition's drug development and other activities, see the periodic and current reports that Elan has filed with the Securities and Exchange Commission and that Transition has filed with the Securities and Exchange Commission and the Ontario Securities Commission. Elan and Transition assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6120846&lang…

http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[Poppholz]

December 14, 2009 02:00 AM Eastern Time
Elan Drug Technologies Announces First Japanese Approval of Product Using Its NanoCrystal® Technology

DUBLIN--(BUSINESS WIRE)--Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) announces the approval by the Japanese Ministry of Health, Labour and Welfare of EMEND® (aprepitant) for the treatment of cancer chemotherapy-induced nausea and vomiting. EMEND®, which was developed by a subsidiary of Merck & Co Inc., Whitehouse Station, N.J., USA and licensed to Ono Pharmaceuticals Co., Ltd. for the Japanese market, is the first licensed product approved in Japan that incorporates Elan Drug Technologies’ NanoCrystal® technology.

NanoCrystal® technology, enables formulation of poorly water soluble compounds for all routes of administration. For EMEND®, this technology advance eliminates a food requirement and improves bioavailability by 600%. EMEND® was confirmed to be effective for both acute and delayed phases of nausea and vomiting in Japanese clinical trials, and becomes the first therapy approved for treatment of delayed phase nausea and vomiting (24 hours or later after start of cancer chemotherapy) in Japan.

“The approval of EMEND® is a significant achievement for our NanoCrystal® technology, as it marks the first Japanese approval of a product incorporating this technology in this very important market,” said Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. “We hope this is the first of many products using our NanoCrystal® technology to be launched in Japan.”

NanoCrystal® technology is a proprietary technology developed by Elan Drug Technologies through Elan Pharma International Limited and other Elan affiliates. Five licensed products have now been approved using the NanoCrystal® technology by various health authorities including the US Food and Drug Administration (FDA). Products incorporating the NanoCrystal® technology are sold in markets worldwide.

About Elan Drug Technologies and NanoCrystal® Technology

Elan Drug Technologies (EDT), one of the world’s leading drug delivery businesses, is a business unit of Elan Corporation plc. As a fully integrated drug delivery business, Elan Drug Technologies delivers clinically meaningful benefits to patients, by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. For 40 years, Elan Drug Technologies has been, and continues to be, a drug delivery provider of choice for a broad range of pharmaceutical companies, including many of the world’s leading pharmaceutical companies. Elan Drug Technologies offer clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. Products enabled by its technologies are used by millions of patients each day. For more information go to www.elandrugtechnologies.com

NanoCrystal® is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc.

EMEND® is a registered trademark of Merck & Co Inc.

Safe Harbour/Forward-Looking Statements

The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of the risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[Tebi]

Antwort auf Beitrag Nr.: 38.561.004 von Poppholz am 14.12.09 09:50:33

Poppi,Bernie + Surga---von mir auch ALLES Liebe!!

[surga]

Antwort auf Beitrag Nr.: 38.574.292 von Tebi am 15.12.09 23:28:39

[Poppholz]

die gute alte PBBS-Truppe

[surga]

Antwort auf Beitrag Nr.: 38.586.709 von Poppholz am 17.12.09 13:44:49

[Tebi]

Frohes Neues Ihr Lieben!

....auf dass sich unser Schätzchen in diesem Jahr zu ungeahnten Höhen aufschwingt.....

aus dem Investorvillage

Msg 396298 of 396306 at 1/1/2010 3:59:29 PM by

ridge303




A recap of some honest scientific articles about the M.S. drug Tysabri /repost
I thought it wouldn`t harm to read this again - Let us start the New Year on a positive note

PROHOST IMPRESSION ON BIOTECH FIRMS
While enjoying the aroma and taste of our in-house fresh coffee, we will discuss recent interesting biotechnology news and some biotechnology companies that have solid fundamentals. To our breakfast guests, we stress the fact that “solid fundamentals” should not be considered a guarantee for a successful outcome of the firm’s endeavors. Tom, we know you have to be in the airport at 11. So, we start with you. Tom:

"“I want to thank you people for inviting me to your lovely “Morning Coffee”. I came to give a recap of some honest scientific articles about the M.S. drug Tysabri (natalizumab) developed by Elan (ELN) and Biogen Idec (BIIB).

I totally agree with your frustration about Wall Street’s bad treatment of this drug, which demonstrate an unparalleled efficacy on M.S. and could do the same for many other intractable diseases. ELAN (ELN) AND TYSABRI. “The fact that M.S. is a chronic progressive crippling and sometimes, life-threatening disease makes us feel bad for the large number of M.S. victims who refused to take the drug after reading the numerous negative unscientific articles about it. These negative articles, which meant in the first place to deter investors from buying Elan’sstock succeeded in their task, but caused many patients to refuse taking Tysabri, hence, depriving themselves from bring back the hope that disappeared when progression of symptoms and disability accelerates other treatments fail to help.”

“As a matter of fact, Tysabri is approved for use when other treatments fail. If not for the PML story, there is no doubt that Tysabri would have had much more efficacy results than all available products used as first line treatments. This also means that when the efforts made to avoid the infection, which I will talk about later, Tysabri’s use will be multiplied several folds and the drug sales would reach several billion dollars a year”


“Tysabri has been proven to positively affect key components of MS, including: - Slowing the progression of disability. In a 2 year study, 83% of people taking Tysabri had no disability progression compared with 71% of people taking placebo. - Reducing the number of brain lesions seen on an MRI, which are observed as areas of badly damaged nerves. - ReducIng the number of new lesions. Results from the 2-year study, 9 out of 10 patients taking Tysabri had no new lesions that show new disease activity.”

“Over a 2-year period, 36.7% of people taking Tysabri had NO flare-ups, NO disease progression, and, NO new or newly active MRI lesions. This means that more than 1 out of 3 people taking Tysabri were considered to be free from disease activity. (compared to 7.2%, or 1 out of 13 people on placebo). This meand that 5 times more people taking Tysabri lived free from MS disease activity compared with people who received placebo. Tysabri has also caused improvement in cognitive function, in mental disability, and physical disability – all known to be caused by M.S.”


“Bottom line, sincere researchers and analysts expressed their beliefs that, since the PML story started in 2005, until now, negative analysts have been busy sending their subliminal negative messages that hurt the patients, the medical profession, and the firms that developed Tysabri, especially Elan. They know, like everybody involved, that immunosuppressive drugs, including biological products and chemotherapeutics – all could cause PML. Yet, not every PML case caused by chemo is published inviting all the negative analysts to post their repeated negative articles. Those researchers are questioning the reason for the abnormal and unusual treatment of Tysabri and of Elan.”

“Since the reinstatement of Tysabri on the market until now more than 60,000 patients have taken the drug. Only 27 cases of PML have been detected. Many of these patients survived, which must have downgraded PML from a sure killer, to a serious side effect. It did not happen, as Elan’s critics cared only about profits. They are still repeating the PML story and still publishing more and more frightening articles about what they still label, “the deadly” PML.”


“We have to remind you that it was Biogen Idec’s decision to recall the drug, not the FDA. The FDA was, and is still, convinced that Tysabri’s benefits outweighed the risks and approved new prescribing information that includes a warning that about 1 out of every 1,000 patients on the drug were likely to get PML.”


“The hope of preventing PML is increasing as many processes and ideas are on the table. As a matter of fact,since July 2006, more than 80 percent of patients diagnosed with PML are still alive. The reason? The new monitoring process. Every time a patient comes for the treatment, physicians look for early signs and symptoms that are not typical of MS. If the virus is suspected, physicians would withhold the drug and run an MRI test to look for signs for the presence of JC virus, which causes PML. Once detected, doctors wash any remaining drug in the bloodstream and reconstitute the patients’ immune system to clear the virus.”


“More procedures and diagnostic tests are about to be installed, probably including a blood test that pinpoints the patients who have an elevated risk of getting PML and those that are less likely to become infected. This is possible through detecting the presence of antibody against the virus. Many patients are estimated to have the antibody, suggesting that JC might be turning to become an opportunistic infection in some patients taking Tysabri or other immunocompromized patients. The drugs are expected to be safe given to patients who have no JC virus in their systems.”

“We also might have a new vaccine to protect against PML.”
“ There is reason to believe that Mephaquin, a drug used to treat malaria may be effective against the virus.”
Tom abruptly ended his lecture, saying, “I thank you all and I think I should leave now.” He did.

What are our expectations? We all agree that the processes and suggestions that tom mentioned will definitely render Tysabri safer. The good news is expected to surprise many investors, as they have been hearing nothing in the past four years but exaggerated pessimism. The good news, when in, could cause a tremendous boost to ELN. It would open the door wide for Tysabri to become a blockbuster, probably a three billion dollar product. ---------------------------------------

[surga]

Antwort auf Beitrag Nr.: 38.654.422 von Tebi am 02.01.10 13:39:25

an alle ELANIS, alles Gute zum neuen Jahr 2010

[Poppholz]

Antwort auf Beitrag Nr.: 38.658.472 von surga am 04.01.10 09:49:58

dem schließe ich mich an.

[surga]

Halli Hallo, wo seid Ihr?

[Tebi]

Hi Surga, HIIIIIIIIIIIIIIIIIIIIIIIIER!!!!!!

Übrigens:Jim Mullen von Biogen geht zum April nächsten Jahres!

[surga]

Antwort auf Beitrag Nr.: 38.669.079 von Tebi am 05.01.10 16:48:56

und KM? Wird er auch rausgeschmiessen?
Wird aber Zeit

[Tebi]

Antwort auf Beitrag Nr.: 38.669.477 von surga am 05.01.10 17:27:09

.....D A S wäre schön....!!!!Lieben Gruss! Birgit

[posimist]

Möge das Jahr 2010 für uns "alte" Elanier endlich und natürlich auch für die Frischlinge das Jahr des Durchbruchs in der Alzheimer - Entwicklung geben, mit den endsprechenden Erfolgen hinsichtlich des Aktienkurses.

Noch im alten Jahr stand im Beiblatt des Kölner StA ein bewegender Artikel über eine Frau, die dank Tysabri wieder ein fast normales Leben führen kann. Seit dem fällt sie halt nicht mehr auf dem Klo sitzend einfach um, sie kann inzwischen sogar wieder auf hohen Absätzen laufen. Sie weiß um die Gefahren und läßt sich deshalb regelmäßig untersuchen, würde allerding nie mehr auf das Medikament verzichten wollen.

posimist

[surga]

Antwort auf Beitrag Nr.: 38.674.552 von posimist am 06.01.10 12:59:39

na dann....auf ein NEUES für ELAN

[surga]

Antwort auf Beitrag Nr.: 38.671.610 von Tebi am 05.01.10 21:51:12

sage mal TEBI. ELN steigt und steigt. Was ist los?
KM wird entlassen?

[GuHu1]

Antwort auf Beitrag Nr.: 38.674.552 von posimist am 06.01.10 12:59:39

http://www.ksta.de/html/artikel/1260194914170.shtml

Multiple Sklerose
Gefährlicher Lichtblick für MS-Patienten
Von Susanne Rohlfing, 21.12.09, 23:07h

Ein umstrittenes Medikament verhilft Multiple-Sklerose-Erkrankten zu neuer Lebensqualität. Die Nebenwirkungen allerdings können tödlich sein. Trotzdem ist es für viele Betroffene die letzte Hoffnung.

Der Rollstuhl steht im Arbeitszimmer, gemütlich ausgepolstert mit einem Fell und an den Rädern mit Schonscheiben versehen. Modell: „Drache mit blauen Rosen.“ Er wirkt fast einladend. Doch er dient nur noch als Schreibtischstuhl. Und als Erinnerung an ein anderes Leben. An Unbeholfenheit. An Frust. An Einschränkung. In der Garderobe beweist ein Paar brauner Lederstiefel mit mittelhohem Absatz, dass dieses Leben Vergangenheit ist. Zumindest im Moment. Viel weiter kann Silke Bauer (Name geändert) nicht planen, denn ihr Glück ist anfällig. Es ist den Tücken der Multiplen Sklerose (MS) ausgeliefert.
Heute geht es ihr dank eines Medikamentes, das wegen möglicherweise tödlichen Nebenwirkungen beinahe nicht auf dem Markt zugelassen worden wäre, so gut wie in den knapp 14 Jahren seit der MS-Diagnose nicht mehr. Tysabri (Wirkstoff: Natalizumab) blockiert den Eintritt von weißen Blutkörperchen (Leukozyten) ins Gehirn und verhindert bei MS-Patienten, dass diese Wächterzellen fälschlicherweise die Schutzhüllen der eigenen Nervenzellen angreifen. Krankheitsschübe werden so eingedämmt. „Leider haben die Leukozyten aber auch wichtige Aufgaben“, erklärt Michael Schroeter, Oberarzt und Leiter des MS-Schwerpunktes der Neurologie an der Uniklinik Köln. „Sie halten zum Beispiel Viren in Schach.“ Etwa den JC-Virus, mit dem rund 80 Prozent der Deutschen latent infiziert sind, ohne je an der von ihm ausgelösten progressiven multifokalen Leukenzephalopathie (PML), einer Infektion des Gehirns, zu erkranken.

Nachdem Tysabri 2005 in den USA zugelassen worden war, wurde allerdings bei drei der Patienten eine PML festgestellt, in zwei Fällen führte sie zum Tod. Die Wächterzellen dieser Patienten ließen nicht nur die Nervenhüllen im Gehirn in Ruhe, sondern auch den JC-Virus.

Anwendung nur im Ausnahmefall
Tysabri wurde daraufhin vom Markt genommen und erst Mitte 2006 unter verschärften Sicherheitsauflagen wieder zugelassen. Nur besonders schwere Fälle der schubförmigen MS dürfen behandelt werden und die Patienten müssen genau überwacht werden. Dennoch sind bis heute weltweit 27 der mit Tysabri behandelten Patienten an PML erkrankt. Die Hirninfektion kann glimpflich ausgehen, vor allem dann, wenn sie frühzeitig erkannt und behandelt wird. Sie kann aber auch zu schweren Schäden bis hin zum Tod führen.

Silke Bauer besaß vor drei Jahren keine Schuhe mit Absätzen. Die heute 32-Jährige hätte nicht darauf laufen können. Sie konnte ja schon ohne zusätzliche Herausforderungen kaum laufen. Ihre linke Körperseite war gelähmt. Bauer stolperte ständig oder kippte um. Die Wohnung konnte sie nur im Rollstuhl verlassen. Die Kölner Haie waren Bauers Medizin. „Seit 1996 habe ich immer dann eine Dauerkarte, wenn es mir richtig scheiße geht“, sagt sie. Vor drei Jahren war das so. Eishockey zu gucken war eine Flucht aus der Krankheit. Die Haie boten Freiheit, Geselligkeit, Ablenkung.

Dann, an einem Dienstag im Winter 2006, kam ein Anruf von Bauers behandelndem Arzt. Es gebe da ein neues Medikament, sagte er und fragte, ob Bauer in den nächsten Tagen vorbei kommen könne. „Eine Stunde später war ich in der Praxis“, erzählt Bauer. Und noch in der selben Woche bekam sie ihre erste der seither monatlichen Tysabri-Infusionen.

Gesundheitliche Verbesserung rechtfertigt das Risiko
Das Risiko war Bauer bekannt. Damals wie heute liegt es bei 1:1000. Einer von 1000 mit Tysabri behandelten Patienten erkrankt an einer PML. Weltweit 46.200 Menschen bekommen das Medikament inzwischen. „Bei Frau Bauer brachten alle anderen Behandlungsoptionen keinen Erfolg mehr“, erklärt ihr Arzt. „In regelmäßigen Schüben ging es immer weiter den Berg runter.“ Natürlich beunruhigten ihn die PML-Fälle. Doch die gesundheitlichen Verbesserungen rechtfertigten das Risiko.

Der Fortschritt begann in der Nacht von Bauers dreißigstem Geburtstag am 22. Januar 2007: „Ich stand im Schlafzimmer und zog mir den Pulli über den Kopf“, erzählt sie. Eine banale Alltagshandlung. Doch Bauer erschrak und dachte: „Verdammt, Silke, das ist keine gute Idee.“ Seit ihrem 19. Geburtstag konnte sie sich nicht mehr im Stehen einen Pullover über den Kopf ziehen, ohne dabei umzufallen. Diesmal klappte es. Bauer blieb stehen.

Nichts zu verlieren

Das war der Beginn vieler positiver Veränderungen. Gerade laufen, rückwärts gehen, mit beiden Händen Haare waschen und dabei die Augen schließen, eingehakt bei der Mutter wieder auf den eigenen Füßen gehen, Auto fahren, Schuhe mit Absatz tragen - all das kann Bauer inzwischen wieder. Sie muss nicht mehr ständig auf allen Vieren krabbeln, sie zerdeppert kein Geschirr mehr, und sie kippt nicht mehr seitlich von der Toilette. Silke Bauer will sich gar nicht vorstellen, dass Tysabri wieder vom Markt genommen werden könnte. „27 PML-Fälle sind mir nicht genug, um auf Tysabri zu verzichten“, sagt sie, „ich habe ja nichts zu verlieren“.

Außer ihrem Leben. Aber so sieht Bauer das nicht. „Das war kein Leben mehr“, sagt sie. Auch heute ist sie weit davon entfernt, gesund zu sein. Sie wird schnell müde, steht keine größeren körperlichen Anstrengungen durch. Ihren Beruf als Vermessungstechnikerin kann sie nicht ausüben, sie bekommt eine kleine Rente. Alltägliche Dinge wie Kochen oder mit ihrem Hund Spazierengehen brauchen viel Zeit. Aber sie kann laufen, allein, sogar auf Absätzen. 1996, nach ihrem ersten schweren MS-Schub, hatten die Ärzte ihr prophezeit, dass sie den Rollstuhl wohl nie wieder würde verlassen können. Beruf, Ehemann, Kinder, diese Dinge, von denen junge Frauen gemeinhin träumen - Bauer sollte sie sich abschminken. Heute sagt ihr Neurologe: „Wir machen durchgehend gute Erfahrungen mit Tysabri, die Krankheitsschübe flauen ab, aber der Erfolg bei Frau Bauer ist ganz ungewöhnlich.“

Sollte das Medikament eines Tages doch verboten werden, weil das Risiko, an einer PML zu erkranken, möglicherweise mit der Behandlungsdauer steigt, wäre das eine Katastrophe für die Kölnerin. Ebenso wie - allerdings aus ganz anderen Gründen - für den Hersteller Biogen-Idec. Das amerikanische Biotech-Unternehmen erzielte mit Tysabri allein im ersten Quartal 2009 einen Erlös von 227 Millionen Dollar (umgerechnet rund 152 Millionen Euro). Eine monatliche Infusion kostet gut 2300 Euro. Natürlich drängt sich da die Befürchtung auf, das Unternehmen könnte die möglichen Nebenwirkungen runterspielen oder PML-Fälle vertuschen.

Keine Alternativen

„Ein Pharmaunternehmen hat immer ökonomische Interessen, das lässt sich nicht wegdiskutieren“, sagt Neurologe Michael Schroeter von der Uniklinik Köln. Es sei aber allgemein unstrittig, dass es zur Zeit abgesehen von den Interferonen kein stärker wirksames Medikament als Tysabri zur Behandlung der schubförmigen Multiplen Sklerose gibt. Damit komme das Medikament zwar nur für eine Minderzahl der Patienten in Frage, so Schroeter, bei anderen Unterformen der Erkrankung sei es unwirksam. Dennoch steht für ihn fest: „Tysabri ist ein Medikament, auf das wir alle sehnlichst gewartet haben. Gerade Patienten, die zuvor durch viele Krankheitsschübe besonders stark beeinträchtigt waren, erleben tolle Therapieerfolge.“

Bei anderen Medikamenten, die in den letzten Jahren wegen gefährlicher Nebenwirkungen vom Markt genommen wurden, habe es Alternativen gegeben. Der Fettsenker Lipobay zum Beispiel sei nur einer von vielen gewesen und wurde deshalb 2001 wegen Nebenwirkungen vom Markt genommen, die meist beherrschbar waren und nur selten auftraten. 2004 traf es das Schmerzmittel Vioxx und anschließend weitere Präparate mit Wirkstoffen aus der Gruppe der Cox-2-Hemmer, weil der Verdacht bestand, dass sie das Herzinfarktrisiko erhöhen. „“Bei diesen Medikamenten gab es viele Alternativen mit ähnlicher Wirkung“, erklärt Schroeter.

Zu Tysabri gibt es bislang keine Alternativen. Für Silke Bauer ist es die Chance auf mehr Lebensqualität. Ungeschicklichkeit, Lähmungen, Sehstörungen oder Persönlichkeitsveränderungen können Indizien für eine PML sein. Tysabri-Patienten dürfen neue Symptome nicht ignorieren, sie dürfen nicht davon ausgehen, dass diese zur MS gehören. „Es ist eine große Aufmerksamkeit von Arzt und Patient nötig“, betont Schroeter.

Wenn Silke Bauer etwas komisch vorkommt, ruft sie sofort bei ihrem Arzt an. Bei Verdacht auf PML kann diese durch eine Kernspintomographie und eine Untersuchung des Nervenwassers diagnostiziert werden. „Lieber frage ich einmal zu viel nach, als dass ich mir irgendwann die Radieschen von unten ansehe“, sagt Bauer. Die Multiple Sklerose hat ihr viel genommen. Aber ihr Leben, zumal dieses neue, will sie behalten. „Ich glaube nicht an das Wunder, dass jetzt nie wieder etwas passiert“, sagt sie. „Aber dann fangen wir halt wieder von vorn an.“

[Fire2]

surga
alles klaro

[bernie55]

Hallo Birgit, Zul , Poppie, Cyberhexe, posimist, GuHu 1,

hallo Elanites und Elanics,

allen ein schönes neues Jahr mit allen nur erdenklich positiven und guten Wünschen für das Jahr 2010.

Ich war lange nicht mehr im Board gewesen - aber wie immer habe ich so nebenbei „ ein bisschen „ gearbeitet und wie immer war ich so nebenbei „ ein bisschen on the road „ gewesen.

Gelegentlich habe ich schon mal reingeschaut und immer wieder die kleinen statements gelesen –

Ich hoffe, dass das Jahr 2010 die BAP Resultate bringt, die die Wissenschaft sich in der Alzheimer Forschung erhofft, nämlich einen ersten Meilenstein in der Behandlung der Alzheimer Krankheit zu finden.

Schöne Grüße
bernie55

[bernie55]

Four More PML cases reported in November by Biogen

* Total PML cases at 28 as of Nov. 30, 2009 - Biogen

* Total at end of October was 24

* December figure to be released in week or two

BOSTON, Jan. 6 (Reuters) - Biogen Idec Inc (BIIB.O) said on Wednesday that four more patients taking its multiple sclerosis drug Tysabri had developed a potentially deadly brain infection known as PML in November, bringing the total to 28.

The biotech company said it will release the number for December within a week or two.

Cambridge, Massachusetts-based Biogen makes Tysabri, its biggest driver of growth, in partnership with Elan Corp Plc (ELN.I) of Ireland.

Tysabri was temporarily withdrawn from the market in 2005 after being linked with progressive multifocal leukoencephalopathy, or PML. It was reintroduced in July 2006 with stricter safety warnings.

The risk rate is still within the rate of 1/1000 listed in the drug's package insert, Naomi Aoki, a spokeswoman for Biogen, said .

"While I understand this interest in counting the cases, one case does not make any impact on the rate at all," she said. (Reporting by Toni Clarke; Editing by Gary Hill)

http://www.reuters.com/article/idCNN0615861020100106?rpc=44

[Tebi]

Antwort auf Beitrag Nr.: 38.676.075 von surga am 06.01.10 16:01:33

....wer weiss--vielleicht hat ihn Biogen abgeworben(,,,,als Ersatz für Jim..)

...sind aber wieder 5 neue PML-Fälle von Biogen bekanntgegeben ---aber vielleicht ist das nicht mehr so bedrohlich weil es besser gemanaged wird...

Gut´s Nächtle---bin krank + hatte einen SCH.....-Tag...!:O

[surga]

Antwort auf Beitrag Nr.: 38.679.823 von Tebi am 06.01.10 23:15:22

gute Besserung

[Tebi]

Antwort auf Beitrag Nr.: 38.680.289 von surga am 07.01.10 07:48:14

danke!!

[Poppholz]

Technical Analysis

Uptrend Spotted in Shares of Elan (ELN) -
1/6/2010 11:18:28 AM
By Chip Brian, SmarTrend Analytics Team

SmarTrend identified an Uptrend for Elan (NYSE:ELN) on November 09, 2009 at $6.39. In approximately 2 months, Elan has returned 11.7% as of today's recent price of $7.14.

Elan is currently above its 50-day moving average of $6.26 and above its 200-day moving average of $6.83. Look for these moving averages to climb to confirm the company's upward momentum.

SmarTrend will continue to scan these moving averages and a number of other proprietary indicators for any shifts in the trajectory of Elan shares.

http://www.mysmartrend.com/sl/22901

[Poppholz]

Antwort auf Beitrag Nr.: 38.679.823 von Tebi am 06.01.10 23:15:22

auch von mir gute Besserung.

[bernie55]

von bernie55 am 06.01.10 23:07:37 :

Hallo Birgit, Zul , Poppie, Cyberhexe, posimist, GuHu 1, Küsschen
hallo Elanites und Elanics,

allen ein schönes neues Jahr mit allen nur erdenklich positiven und guten Wünschen für das Jahr 2010.

Ich war lange nicht mehr im Board gewesen - aber wie immer habe ich so nebenbei „ ein bisschen „ gearbeitet Zwinkern und wie immer war ich so nebenbei „ ein bisschen on the road „ gewesen. Zwinkern

Gelegentlich habe ich schon mal reingeschaut breites Grinsen und immer wieder die kleinen statements gelesen –

Ich hoffe, dass das Jahr 2010 die BAP Resultate bringt, die die Wissenschaft sich in der Alzheimer Forschung erhofft, nämlich einen ersten Meilenstein in der Behandlung der Alzheimer Krankheit zu finden.

Schöne Grüße
bernie55


Da bin ich mal wieder im Board, wünsche allen alles Gute und dann hats " unsere " tebi gesundheitlich erwischt....

....von mir an dieser Stelle ebenfalls die besten Genesungswünsche..

Liebe Grüße
bernie55

[surga]

Antwort auf Beitrag Nr.: 38.681.085 von bernie55 am 07.01.10 10:07:10

[Tebi]

Danke schön für die lieben Genesungswünsche---hat echt gewirkt--mir gehts schon wieder deutlich besser!

[surga]

Antwort auf Beitrag Nr.: 38.682.936 von Tebi am 07.01.10 13:18:56

wenn kursmäßig so weiter läuft, sehen wir bald 10$

[Poppholz]

Antwort auf Beitrag Nr.: 38.684.437 von surga am 07.01.10 15:49:31

wir können ja mal ein Lineal anlegen und den Kurs für 2011 ablesen.

[Poppholz]

Antwort auf Beitrag Nr.: 38.684.528 von Poppholz am 07.01.10 15:56:56

dann wären wir auch bald wieder da, wo wir hingehören.

[surga]

Antwort auf Beitrag Nr.: 38.684.528 von Poppholz am 07.01.10 15:56:56

[Fire2]

Antwort auf Beitrag Nr.: 38.684.578 von Poppholz am 07.01.10 16:01:15

dausend

[Poppholz]

Antwort auf Beitrag Nr.: 38.684.619 von Fire2 am 07.01.10 16:05:07

das nun nicht gerade, aber ein Wert von $30,- ist nicht unrealistisch, zumal wir dort schon angekommen waren.

[Fire2]

ich weiss
bin schon lange dabei
war nur spass


surga,gehst du diesmal mit zum essen??

[surga]

Antwort auf Beitrag Nr.: 38.684.751 von Fire2 am 07.01.10 16:15:27

gern, wan und wo? Bei Tebi?

[bernie55]

Antwort auf Beitrag Nr.: 38.684.528 von Poppholz am 07.01.10 15:56:56

dann wären wir auch bald wieder da, wo wir hingehören


.....nämlich langsam und stetig voranschreitend > im hohen Norden...

[Fire2]

ihr wisst wer es ist





ich habe so großes netzwerk,da komm ich sonst nie zur ruhe vor telefonieren,e-mail ,bm usw

dieses jahr starte ich als el bundy auf ariva in allen börsenspielen
ziel,überall unter ersten 10
mal sehen ob es das netzwerk bringt

[surga]

Antwort auf Beitrag Nr.: 38.684.807 von bernie55 am 07.01.10 16:18:19

ow weia. Bist Du das Bernie

[Fire2]

Antwort auf Beitrag Nr.: 38.684.794 von surga am 07.01.10 16:17:50

kenn ich nicht
aber user schakal

da waren wir mit melzer auch das letzte mal

[Fire2]

Antwort auf Beitrag Nr.: 38.684.832 von surga am 07.01.10 16:19:46

das iss er

[Bachalor]

surga,bernie,birgit usw

ich sage immer privates netzwerk ist besser wie jeder bb

schaut mal den user el bundy in beiden ariva börsenspiele an

[Tebi]

Antwort auf Beitrag Nr.: 38.706.512 von Bachalor am 11.01.10 11:33:40

HEYYY--hier kehrt bja wieder Leben ein---GENAU,die 22€ wollen wir wieder sehen!!!!!

[surga]

Antwort auf Beitrag Nr.: 38.707.606 von Tebi am 11.01.10 13:36:29

ba ja, bis zu Rente haben wir ja noch Zeit

[Poppholz]

Antwort auf Beitrag Nr.: 38.708.505 von surga am 11.01.10 15:20:10

bis zur "Rente ab 40" sind es bei mir nicht mehr viele Jahre.

[bernie55]

Antwort auf Beitrag Nr.: 38.709.024 von Poppholz am 11.01.10 15:53:26

....dann mal ran an die Rentenperformance....

Elan to Present at the 2010 J.P. Morgan Healthcare Conference

DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that it will present at the 28th Annual J.P. Morgan Healthcare Conference,

on Wednesday, January 13, 2010, at 9:00 a.m. Pacific Time,

noon Eastern Time and 5:00 p.m. GMT.

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

[Tebi]

Wir wollen eben glückliche Frrührentner sein...

[bernie55]

World-Renowned Yogi Baron Baptiste Unveils New Program to Help People with Multiple Sclerosis

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Baron Baptiste, bestselling author and founder of Baptiste Power Vinyasa Yoga, and Dr. Elliot Frohman, one of the world’s leading authorities on multiple sclerosis (MS), have teamed up to develop My MS Yoga, a new program created especially for people with multiple sclerosis. My MS Yoga is an at-home exercise program that can be tailored to meet MS patients’ needs depending on how they are feeling on any given day.

“We designed My MS Yoga to make the many benefits of yoga available to most people with multiple sclerosis through a free DVD,” said Baron Baptiste. “A key part of the My MS Yoga program is the emphasis on accessibility with modifications. It encourages people with multiple sclerosis to begin at a comfortable level and advance at their own pace, allowing them to modify the poses based on how they feel.”

My MS Yoga is designed for people with multiple sclerosis of varying levels of ability, offering modified yoga poses to help decrease muscle weakness and stiffness; reduce spasticity and other common multiple sclerosis symptoms, and enhance strength, balance, flexibility and coordination. The goal of the program is to help people with multiple sclerosis stay physically active so they can do simple things most people take for granted, such as walking, grocery shopping or helping their child get ready for school.

“The medical community has long acknowledged that effective treatments are key to managing disease progression and alleviating the physical and mental symptoms of MS,” said Elliot Frohman, M.D., Ph.D., FAAN, director of the Multiple Sclerosis Program and Clinical Center at the University of Texas Southwestern Medical Center at Dallas. “What’s been under-recognized is the importance of overall wellness, including exercise, a positive attitude and healthy lifestyle. Because yoga focuses on so many specific areas and symptoms that affect people with multiple sclerosis, I believe it’s an ideal form of exercise.”

Every week, about 200 people are diagnosed with multiple sclerosis, one of the most common neurological disorders affecting more than 400,000 people nationally. More than half of the approximately 16 million adults in the United States who practice yoga are between 20 and 50 years old – the same age at which many people with multiple sclerosis first experience symptoms of the disease. My MS Yoga brings the MS community a modern and relevant exercise regimen to incorporate into their fitness routine. As always, people should consult with their physicians before beginning any new exercise program.

“My MS Yoga has been great for me because it shows me modified poses so I can adjust as needed, and the focus on stretching is really important for my MS,” said Kendall Freeman, a busy 24-year-old mom with multiple sclerosis. “Finding the right treatment regimen with TYSABRI has enabled me to manage my MS so I can do everyday activities, including my favorite exercise, yoga. Now I can keep up with my two young daughters and be active again.”

In the coming months, Baptiste will be personally teaching My MS Yoga to people with multiple sclerosis in several U.S. cities. Additional information about the program and how to order a free copy of the DVD is available at www.MyMSYoga.com.

Baron Baptiste and Dr. Elliot Frohman were contracted to help develop the My MS Yoga program by Biogen Idec (NASDAQ: BIIB - News) and Elan Pharmaceuticals, Inc. (NYSE: ELN - News), sponsors of this important initiative for people with multiple sclerosis. Kendall Freeman, a patient with multiple sclerosis, is a volunteer whose appearance on the My MS Yoga DVD was made possible by Biogen Idec and Elan.

http://finance.yahoo.com/news/WorldRenowned-Yogi-Baron-bw-39…

[bernie55]

..aus dem Investor Village Board..ein Update von UBS.....

wichtige Infos zu PML/ Ty und Fampridine nochmals schön zusammmengefasst...


UBS ups targetprice 27% today
Elan Corp. Rating: Neutral Target: €5.50 Price: €5.10 RIC: ELN.I
Prior: Unchanged Prior: €4.30 Mkt Cap: €2.42bn BBG: ELN ID
Pharmaceuticals Analyst: Guillaume van Renterghem Tel: [phone]

Maintain Neutral - PML cases moderating
�� 4/5 new PML cases and one more death since October 23rd 2009 BIIB reported a total of 28 PML cases with Tysabri as of end Dec. 09 that could have become 29 by now, and BIIB Head of Neurology said that 5 patients died of PML (up from 4 as of Oct 09). All of the c. 25% of PML patients who had been tested for JC virus were positive. Management also announced a 5% price increase for Tysabri in the US in December 2009.

�� JC Virus test could come to market in 2010 BIIB and Elan hope to bring a JC virus test to the market in H1 2010 that could discriminate the 40% MS patients JC virus negative, which the companies believe have very little risk of developing PML. These patients would be ideal candidates to Tysabri which remains the most efficacious MS treatment and offers the best safety profile, excluding PML risk.Tysabri could therefore become market leader in 400,000 JCV neg. MS patient pool.
Assuming 50% penetration rate would yield 5 times more patients than currently.

�� Approval of Fampridine SR in the US could add €0.4/share to valuation Fampridine-SR has PDUFA date of Jan. 22nd 2010. Elan is entitled toreceive royalties on global sales equating to 16% net. While not included in our model, this revenue stream could add €0.4 per share to our pricetarget.



�� Valuation – Increasing PT to €5.5 We value Elan using a SOTP probability weighted DCF-based model. Introducing a 5% price increase to Tysabri
and assuming only 25% chance of the introduction of a therapeutic window yields our increased €5.5 PT (from €4.3).
�� Notes

http://www.investorvillage.com/smbd.asp?mb=160&mn=397501&pt=…

[bernie55]

Biogen Says Tysabri Patient Additions Slow

SAN FRANCISCO (TheStreet) -- Biogen Idec(BIIB Quote) said Tuesday that sales of its multiple sclerosis drug Tysabri surpassed $1 billion in 2009, but the number of new patients starting treatment on the drug in the fourth quarter appears on the low end of Street expectations.

In advance of an afternoon presentation at the J.P. Morgan Healthcare Conference here, Biogen said that 48,800 patients were being treated with Tysabri worldwide as of the end of December.

That works out to 2,600 new patients added to Tysabri's treatment role in the fourth quarter, or 200 new net patients per week.

In a research note Monday, Deutsche Bank biotech analyst Mark Schoenebaum estimated that there would be 200 to 250 new Tysabri patients added per week in the fourth quarter.

In a note issued last week previewing his bank's healthcare conference, J.P. Morgan analyst Geoffrey Meacham said he was looking for 250 new Tysabri patients per week in the fourth quarter.

Biogen shares Tysabri revenue with Irish drugmaker Elan(ELN Quote).

The $1 billion in Tysabri global sales for 2009 were in-line with Street expectations.

Biogen shares were down 15 cents to $53.75 in early Tuesday trading.

In other news, Biogen and Acorda Therapeutics(ACOR Quote) announced the approval filing in Europe for fampridine, a drug to improve the walking ability of multiple sclerosis patients. The U.S. Food and Drug Administration is currently reviewing fampridine for approval.

-- Reported by Adam Feuerstein in San Francisco.


http://www.thestreet.com/_yahoo/story/10659772/1/biogen-says…

[bernie55]

Antwort auf Beitrag Nr.: 38.725.467 von bernie55 am 13.01.10 12:11:25

Number of patients on Tysabri

Q1 2009 > 40,000

Q2 2009 > 43,300

Q3 2009 > 46,200

Q4 2009 > 48,800


Quarter-over-quarter increase

Q1 2009 > 6.4%

Q2 2009 > 8.2%

Q3 2009 > 6.7%

Q4 2009 > 5.6%

[kaktus7]

Bin neu hier.

Welche anderen Produkte hat Elan denn noch?
Und wie laufen die?

[bernie55]

Antwort auf Beitrag Nr.: 38.725.467 von bernie55 am 13.01.10 12:11:25

Goodbodys,
Fampridine on schedule
FY09 Tysabri numbers in line with expectations

Biogen Idec yesterday announced that Tysabri has achieved "blockbuster" status in 2009 by recording worldwide sales of over $1bn in the year. It also noted that at the end of the year, there were approximately 48,200 MS patients on commercial therapy. This is in line with our forecasts, where we were expecting c.48,100 patients on the drug and sales of $1.1bn for the year. No update was given on the number of PML cases, although management previously indicated there were 28 cases at the end of 2009. We have built in a PML-case driven reduction in prescription growth from Q409 through to the end of 2010 and currently anticipate that by the end of this year there will be c.57,150 patients on the drug, generating $1.4bn in worldwide revenue.

Fampridine submitted on schedule for approval in the EU
Biogen Idec also announced that it has submitted a marketing authorisation application to the European Medicines Agency for the approval of Fampridine-PR tablets, a novel oral therapy for the improvement of walking ability in adult patients with MS. The company acquired the ex-US rights to the drug from Acorda Therapeutics in July 2009 for $110m upfront, with a potential $400m in milestones and royalties down the line. Acorda is awaiting an imminent FDA decision on approval for the US market (PDUFA [action] date 22 January). The drug incorporates Elan Drug Technologies' IXDAS drug delivery technology and is manufactured by the company, implying a potential royalty/manufacturing rate of c.17% revenue. As such, we have $12m and $42m pencilled in for FY10 and FY11 revenue, assuming approval in the US later this month and EU approval in early 2011. Yesterday's announcement gives us comfort that the EU approval process remains on schedule.


http://www.investorvillage.com/smbd.asp?mb=160&mn=397689&pt=…

[bernie55]

Antwort auf Beitrag Nr.: 38.726.232 von kaktus7 am 13.01.10 13:33:59

Hallo kaktus7,

schau mal auf die Webseite von ELAN, da wirst du viele Informationen bekommen.

http://www.elan.com/

Grüße
Bernie55

[Tebi]

Msg 397770 of 397844 at 1/13/2010 12:54:34 PM by

JBWIN Investorvillage


Unfiltered Notes ELN JPM Q&A

* Q1: Question, about EDT up for sale over a yr ago, would do it again?
* A1: SC, CFO and CEO of EDT, 18m ago in light of fin sitn, debt o/s, NT maturities, EDT tech driven, lower risk, funding a lot of R&D. Felt strat might be better on own, underinvested in last few yrs, that drove decision. Today, due to J&J t/a last yr, not under same fin pressure, capacity to invest more given growth prospects. W/bioneuro and EDT provides balance. In MT, not rule out again, but not no.
* Q2: Ask CP to answer, assay reg pathway?
* A2: CP, assay huge pillar to make T succ, in midst of disc, 1st create solid test, was not there for yrs unfort, disc w/FDA, could be inv re TOUCH program, next steps, formal approval as commercial test, anyone can access w/ or w/o TOUCH, may req formal study. Could be sequential or in parallel. 1st get tool for docs, make rt decisions for patients re T.
* Q3:
* A3: Under disc, but look at infectious diseases, test inv at least 6M for antibody test. If want to be sure, could test every 3 or 6 months.
* Q4:
* A4: Like any other viral infection, factor of time/age. Get exposed to virus. MS usually 22-40 yrs old, MS JC virus home brew pos 45-55%, similar to our findings. Look betw 25 and 40. Doing prospective study could be useful. Very little circum from neg to pos, and see no pos to neg.
* Q5: What about immuno-assay?
* A5: Key question need to answer. Can we define who has virus. If have virus, 50% of pop, then risk 1 in 500. Why only 1 dev PML? That is Q. How determine is key Q. Compared to viral test, assays less clear as serology. Fight hard what 1 in 500 dev PML.
* Q6:
* A6: Question is D5 TTHI molecule what like to see to move forward? D5 has a number of biomarkers. ADNI, ELN inv, at forefront, why array of biomarkers, huge amt of info which imp for efficacy and predicting of progr. Not disc which ones there. KM , it is small trial, understand tech, lots of ELN data re cascade, own theses what drives what. Collective decision w/TTHI, enough efficacy results that is consistent, like to move tech forward, very imp, which patients. 50-60 trials today in mild to mod, but disease starts earlier. Can we start earlier in trial. Want to be in mult pts of cascade, not just mild to mod. Look forward to data.
* Q7: Does PFE have rt to particp in that molecule?
* A7: With J&J, AIP partmered w/PFE via WYE. TTHI D5 nothing to do w/J&J or PFE.
* Q8:
* A8: CP, like any safe P II, any P II, doses chosen yrs back based on earlier data. Goal whether any dose gets into BBB. P I showed get into CSF. Outcome, # of deaths in 2 highest dose arms of P II, not linked dir to D5, but ethical goal, put patients first, understand why it is. Already fragile pop, due to imbal in highest dose arms, why stopped them. DSMB strongly supported continuing lower dose arm. KM, make decision after lots of thought, from tech persp, best way to explore, low dose provides adeq penetration, efficacy, risk manage tech thru complex Tx area. Lower risk, incr prob of succ. Challenge in AD trials, older folks, when mid-60 to low 80s, not built to last forever. Don’t overinterpret our decision, risk manage to next step.
* Q9:
* A9: Forr est of AD pipeline what get inv commercially? Devil in the detail. Small molecules w/primary care need not something we should do. Like to have forward integration into neurology ww. Links into all our clinical work, learning process, patients, research, clin to patients. Make sure commercial investment not out of ctl. Have identifiable slice of neuro mkt w/assets unenc, then partner other pieces, broad obj.
* Q10:
* A10: How ELN sees entry of oral agents MS? Cladrabine and FTY 720, pan immunosuppr, systemically, Safety profile probably show that. I predict they are 3rd line or late stage after ABCR, T. W/PML assay may see Tysabri earlier in course. When 20K, 100K patients, better understand their risk/efficacy balance.
* Q11:
* A11: Wheteher expect reg changes in US/EU, esp EU? I think this is positive. Fight hard why single patient dev PML. Any info gather, more cases imp to sitn. Duration largest risk factor re 1 in 1000, at 24m, longing to have that type of info. Any new info add to label. Toying around re label re prev immunsuppr exposure. I perceive EU rge disc parallel FDA. EMEA disc under Article 20, we will be inv, predict duration comes up. Pockets of info re C by C in EU. Any new info, ongoing disc for yrs to come, as have test.
* Q12:
* A12: KM, question re J&J Biogen topic. Wasn’t main part of T/A, J&J owns 18.4%, imp pt as investor for them. We thought reasonable thing to do, does not affect Biogen rel, not major part of rel, does not alter change of control for either of us. Focus is how build out asset, if either of us have t/a, deal as see fit.

[Tebi]

Msg 398269 of 398307 at 1/18/2010 10:41:31 AM by

kcchris



2010 highlights
Feb – first results that show cash flow positive. Cash balances will grow every quarter from here forward.
Feb/Mar – Assay and immune testing starts with Tysabri. Could change Tysabri forever. Less PML and more patients.
Summer/Fall – MM trial results in Tysabri. I don’t anticipate a lot but who knows.
Summer – Results from the 005 trial. Not sure what they are going to reveal but just another shot on goal. If successful the stock moves higher.
Fall/Winter – results from BAP trial are done. Debatable if we see them but the company will know the result and hopefully we see the results as well.
Fall – Profits for the first time in about a decade. The profits in the 90s and early 2000s were not real. So this is the first real profit at ELN.


Everything is on track. For the first time in a long time I feel very confident in Tysabri. Thank god the assay is on the way. I am more excited about the immune system test. The combo of the 2 mean only a few are at risk of PML and those at greatest risk will not take Tysabri. Probably 5-10% of the potential patients. Opens up the market for MS and Crohns. Wall street will definitely begin buying prior to AD results. If successful the company will be huge. I would imagine everything should lead to consistent buying throughout 2010. We will likely be out of the single digits in Feb/Mar time frame and stay over $10 forever. If we get potential buyouts it will happen in the fall or later. Hopefully any buyout happens well over $20. My personal opinion is we don’t get a buyout at all.

[bernie55]

Stock Strategist Industry Reports

The 2010 Outlook for Big Pharma Stocks

Winners

................ >


Losers

..............>

Wild Cards

Alzheimer's drugs bapineuzumab and dimebon represent the real wild cards for 2010. Strong Phase III data in Alzheimer's disease would likely translate into mega-blockbuster sales at a rapid rate, as current treatment options fail to halt progression of the disease.

Wyeth and J&J (bapineuzumab).

Wyeth shares rights to bapineuzumab with J&J and Elan
We project a 50% chance of success for bapineuzumab. While Phase II data showed strong performance for bapineuzumab relative to placebo, the lower-than-normal performance of the placebo group may have accounted for the portion of bapineuzumab's success. Also, Phase II data analysis was done retrospectively, making positive statistical results less conclusive. We expect we could see the first Phase III data for this drug candidate in late 2010.

Pfizer (dimebon). Studies in Russia showed positive results from treating Alzheimer's patients with dimebon. Given Pfizer's $225 million payment to Medivation and commitments of close to $1 billion related to the success of the drug, the company clearly believes in dimebon's early-stage data. However, we remain skeptical and project only a 30% chance of approval for the drug, based on incomplete early-stage data and Pfizer's poor track record of partnerships.

http://news.morningstar.com/articlenet/article.aspx?id=32225…

[bernie55]

DAVY -

EMEA review of Tysabri much as anticipated


The EMEA review of Tysabri's risk/benefit profile has been concluded and has been
incorporated into the EU package insert for the drug. The agency has reiterated
that the benefits of Tysabri continue to outweigh its risks, although it has
recommended that a number of measures be put in place to ensure adequate
monitoring and vigilance for any signs of PML in patients.
In the EU, prescribing and monitoring standards differ across member states. It is
estimated that circa two-thirds of patients are on some sort of registry in Europe
compared with 100% in the US via the TOUCH programme. It is also believed that
many patients with prior immunosuppressant treatment, a potential risk factor for
PML, have had access to Tysabri in Europe. This may have contributed to what is a
disproportionately high number of PML cases in Europe compared with the US to
date.
The EU label language and outlined initiatives aim to increase vigilance and impose
comparable access to that available in the US. None of this is draconian in our
view. The principal label changes and initiatives include:
• increased risk of PML with increasing Tysabri treatment duration, up to three
years;
• requirement to re-inform patients of the risk of PML after two years on therapy;
• treating Tysabri patients as part of a national registry, where possible;
• recommendations regarding MRI at baseline and on an annual basis to reset MRI
baseline as treatment proceeds;
• recommendations on monitoring and managing IRIS; and
• revisions to the indication statement to reflect current prescribing practice.
In summary, the revised US and EU labels show that regulatory authorities will
regularly inform patients and physicians of changes in the product's risk/benefit
profile. They also remain supportive of that risk/benefit balance. This, combined
with the advancing risk mitigation efforts and the robust growth of the drug in
what was a very difficult 2009, gives us more confidence that our Tysabri forecasts
have upside and that the product may have a longer tail to its growth than is
currently forecast.

http://www.investorvillage.com/smbd.asp?mb=160&mn=398664&pt=…

[bernie55]

FDA approves Ampyra as first drug to aid walking in multiple sclerosis patients


WASHINGTON (AP) -- Federal health regulators have approved an Acorda Therapeutics pill to improve walking in patients multiple sclerosis, an often disabling disease that affects the nervous system.

The Food and Drug Administration said Friday Ampyra is the first drug approved to help multiple sclerosis patients walk.

About 400,000 patients in the U.S. have the disease, which affects the brain and nervous system, causing loss of balance, muscle spasms and other movement problems.

Between 260,000 and 340,000 of those patients have difficulty walking, and could be eligible for the new drug, according to company officials.

Acorda, based in Hawthorne, N.Y., conducted two trials tracking patients' ability to complete a 25-foot walking exercise. Both studies showed improvements in time needed to complete the exercise. While those gains were often just a fraction of a second, Acorda CEO Ron Cohen said that on average, patients' times improved by 25 percent after taking Ampyra.

Cohen said the company will launch Ampyra in the U.S. in March. He added that the pill could be combined with older medications designed to slow the progression of multiple sclerosis.

Ampyra will be manufactured under a license with Irish drugmaker Elan Corp., which developed the extended-release formulation for the pill. Acorda will market and distribute the drug in the U.S.

Company shares jumped $2.50, or 9.8 percent, to close at $28.12 Friday, adding 13 cents in after-hours trading.

In its announcement posted online, the FDA warned that Ampyra can cause seizures when given at higher-than-recommended doses -- anything over 10 mg. Company studies showed that doses above 10 mg increased seizure risk but did not increase the drug's effectiveness.

The FDA said the drug should also not be given to patients with moderate to severe kidney disease, as they are at greater risk of seizures.

Other side effects reported in clinical trials included: insomnia, urinary tract infections, dizziness, headache, nausea and throat pain, according to the FDA.

http://finance.yahoo.com/news/FDA-clears-Acorda-drug-for-apf…

[bernie55]

Antwort auf Beitrag Nr.: 38.797.958 von bernie55 am 23.01.10 16:31:02

�� Approval of Fampridine SR in the US

Fampridine-SR has PDUFA date of Jan. 22nd 2010.

Elan is entitled to receive royalties on global sales equating to 16% net.

http://www1.investorvillage.com/smbd.asp?mb=160&mn=397639&pt…

[Poppholz]

25.01.2010 08:01
Elan Drug Technologies Welcomes the NDA Approval of MS Drug AMPYRA™ (Dalfampridine) Extended Release Tablets

AMPYRA™ APPROVED USING ELAN'S PROPRIETARY MXDAS™ (MATRIX DRUG ABSORPTION SYSTEM) DRUG DELIVERY TECHNOLOGY

Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE: ELN) today issued the following statement regarding the U.S. Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA™ will be marketed in the U.S. by Acorda Therapeutics (NASDAQ:ACOR).

Using Elan Drug Technologies MXDAS™ technology, AMPYRA™ was developed using a hydrophilic matrix, which controlled the rate of release of dalfampridine through a process of diffusion and erosion in the gastrointestinal tract. Using this technology, consistent therapeutic blood levels can be achieved throughout the dosing period and side effects associated with the immediate release formulations of the drug are potentially reduced. AMPYRA™ is the first New Drug Application (NDA) approved by the FDA for a product using the MXDAS™ technology.

"We wish to congratulate Acorda Therapeutics on the approval of AMPYRA™, which will bring a very important and much needed therapy to the market for MS sufferers," announced Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "This is the second product on which we have worked with Acorda and represents another significant milestone in our successful collaboration with them. It also marks the second product approved by the FDA in the last six months incorporating our technologies and reinforces our position of leadership in drug delivery."

This is the first medicine approved by the FDA indicated to improve walking speed in people with MS. The approval and subsequent launch of AMPYRA™ therefore may represent an important new addition to MS therapy. Approximately 400,000-500,000 people in the United States have MS, and recent studies indicate that between 64-85% of people with MS have walking disability. Some 70% of people with MS who have walking disability report it to be the most challenging aspect of their disease.

"We are very proud to announce the approval of AMPYRA™ and we thank Elan for their collaboration throughout the development program for this drug. Elan's expertise in formulation development, which resulted in this extended-release tablet, was a critical component of the AMPYRA™ clinical program," stated Ron Cohen, MD., President and CEO of Acorda. "Elan has shared our commitment to bringing important new therapies to the market to improve the lives of people with MS throughout the decade we have worked together and we look forward to continuing to find opportunities to work together in the future."

AMPYRA™ will be manufactured by Elan at its Athlone, Ireland facility, based on an existing supply agreement with Acorda.

About AMPYRA™

AMPYRA™ is a potassium channel blocker approved for the improvement of walking in people with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. AMPYRA™, was previously referred to as Fampridine-SR, is an extended release tablet formulation of dalfampridine (4-aminopyridine or 4-AP), which was previously called fampridine. In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. AMPYRA™ was developed using Elan Drug Technologies Oral Controlled Release MXDAS™(MatriX Drug Absorption System) technology and will be marketed in the United States by Acorda Therapeutics and by Biogen Idec in markets outside the U.S. AMPYRA™ is manufactured globally by Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc at its Athlone, Ireland facility.

About Elan Drug Technologies

Elan Drug Technologies (EDT) a leading drug delivery company is a business unit of Elan Corporation, plc. EDT developed the sustained release formulation of dalfampridine, using one of its Oral Controlled Release Technologies, the MXDAS™ (MatriX Drug Absorption System) technology. Elan Drug Technologies offers clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. EDT aims to deliver clinically meaningful benefits to patients by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. Products enabled by EDT technologies are used by millions of patients each day. More information is available at www.elandrugtechnologies.com

About Acorda Therapeutics

Acorda Therapeutics is a biotechnology company developing therapies for multiple sclerosis, spinal cord injury and related nervous system disorders. The Company's products include AMPYRA™ (dalfampridine), a potassium channel blocker approved for the improvement of walking in adults with multiple sclerosis (MS), this was demonstrated by an improvement in walking speed; and ZANAFLEX CAPSULES® (tizanidine hydrochloride), a short-acting drug for the management of spasticity. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.

AMPYRA™ and Zanaflex Capsules® are trademarks of Acorda Therapeutics Inc

MXDAS™ and NanoCrystal® are trademarks of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation, plc.

Safe Harbour/Forward-Looking Statements

The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and description of risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2008, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Elan
MEDIA:
Mary Stutts, 650-794-4403
Niamh Lyons, 353-1-663-3602
or
INVESTORS:
Chris Burns, 800-252-3526
David Marshall, 353 1 709 4444



© 2010 Business Wire

[bernie55]

Goodbody
Late Friday night, Acorda announced that the FDA had approved Fampridine-SR (now
branded Ampyra) for use in improving the walking in patients with multiple sclerosis. This is the
first drug on the market to address this disabling condition in MS sufferers. It will be marketed
in the US by Acorda. Biogen Idec bought the ex-US marketing rights in July 2009 for $110m up
front and potential $400m in milestone and royalty payments. It submitted the drug for
approval in the EU on 12 January, which would imply launch in early 2011. The drug is
expected to be launched in the US in March. Elan originally developed the extended release
formulation using Elan Drug Technologies’ MXDAS delivery platform. Having licenced it out to
Acorda, it not only has a royalty agreement in place but will also manufacture the drug. As
such, it should command a return for Elan of c.17% of revenue. We currently have the drug
generating revenue of $70m and $248m in FY10 and FY11, respectively, which implies Elan
revenue of $12m and $42m. This approval was expected and gives comfort that the drug will
be contributing to Elan’s revenue stream, as already pencilled in.
Monthly updates to be provided on Tysabri
In separate news, it was reported over the weekend that Biogen Idec plans to provide a
monthly update to physicians on new cases of PML associated with patients using Tysabri.
The data are expected to be released mid-month on a web site. There was no indication of the
level of detail to be given (e.g. patient location, length of time on the drug, current condition),
but we presume it will be similar to the weekly updates that were proved until the end of July
2009. Given the undoubted efficacy of Tysabri, improved visibility on the only major side effect
from the drug can only be positive.


http://www.investorvillage.com/smbd.asp?mb=160&mn=398986&pt=…

[bernie55]

Elan Announces Webcast of Fourth Quarter and Full Year 2009 Financial Results

DUBLIN, Jan 27, 2010 (BUSINESS WIRE) -- Elan Corporation, plc (NYSE: ELN) announced today that it will host a conference call on Wednesday, February 10, at 8:30 a.m. Eastern Time (ET), 1:30 p.m. GMT with the investment community to discuss Elan's fourth quarter and full year 2009 financial results, which will be released before the European and U.S. financial markets open.

Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to investors, members of the news media and the general public.

This event can be accessed by visiting Elan's website at www.elan.com and clicking on the Investor Relations section, then on the event icon. Following the live webcast, an archived version of the call will be available at the same URL.

http://www.investorvillage.com/smbd.asp?mb=160&mn=399506&pt=…

[bernie55]

Elan Pharmaceuticals To Implement Infosys' Co-creation Model

Published: 01-Feb-2010

Infosys Technologies will design and implement the Research Informatics System (RISe) at Elan Pharmaceuticals, to accelerate discovery research using a co-creation engagement model that leverages Infosys’ existing intellectual property in this field.

Infosys said that Elan and its research partners could realize gains in research productivity by focused and efficient selection of candidate drugs or biologics with the new RISe. Linking silos of heterogeneous data will not only contribute to a more effective selection process of biologics but could also reduce time to validate them clinically. Furthermore, the new system will reduce time spent on registering and experimenting with bio-entities, increase collaboration, and reduce chances of downstream failure.

Future versions of the software may enable integration of RISe with electronic lab notebook and analytical dashboards, which will enable more efficient research knowledge management, claims Infosys.

The co-creation engagement model enables Infosys to retain ownership of co-developed IP, as part of the implementation. Relevant components of this reference implementation can be reused or repurposed by Infosys to deliver faster business benefits at other Life Sciences organizations.

Arun Kumar, head of global life sciences practice at Infosys Technologies, said: "Elan’s vision to create a scalable research informatics system for scientists to collaborate better, dovetails perfectly with our investments in solutions that improve scientific innovation and our efforts to streamline discovery research."

Ajay Shah, director of research informatics at Elan Pharmaceuticals, said: “We are confident that partnering and collaborating with Infosys will create a comprehensive informatics platform for our discovery research needs.

“We selected Infosys after a competitive Proof-of-Concept phase during which they fully established their credentials and investments in this changing field of discovery research, and demonstrated flexibility and maturity in terms of rapid application development using Agile and Scrum methodologies.

With Infosys’ solution and engagement model, Elan will be able to lower costs for scientific operation and facilitate innovation.”


http://itsoftware.pharmaceutical-business-review.com/news/el…

[tnickel_de]

Antwort auf Beitrag Nr.: 38.706.512 von Bachalor am 11.01.10 11:33:40

Hi Bachalor,
jau platz 14/1682 als investor2010.
Mal schauen wie es weitergeht.

http://www.ariva.de/profil/el%20bundy

Investor 2010 Platz : 14 / 1682
Trader 2010 Platz : 1261 / 1287
Investor 2009 Platz : 987 / 3939
Trader 2009 Platz : 2080 / 3557
Investor 2007 Platz : 950 / 2507

thomas

[Poppholz]

irishtimes.com - Last Updated: Friday, February 5, 2010, 16:49
Elan shares fall on new Tysabri alert

The risk of a potentially fatal brain disorder with Elan's multiple sclerosis drug Tysabri increases as patients receive more infusions, US health officials warned today.

The prescribing instructions for Tysabri, co-marketed by Biogen and Elan, will be updated to warn about the higher risk over time, the Food and Drug Administration said.

The FDA said the warning is based on 31 confirmed cases of progressive multifocal leukoencephalopathy (PML), a brain infection that can be fatal.

Spokespeople for Biogen and Elan were not immediately available for comment.

Shares of Elan fell 31 cents to €5.05 today on the Dublin market.

http://www.irishtimes.com/newspaper/breaking/2010/0205/break…

[Poppholz]

Source: > 08 February 2010 (E-Business)

Company Financials: Elan Corporation, plc - Aarkstore Enterprise market reserach report.
Aarkstore announce a new report "Company Financials: Elan Corporation, plc" through its vast collection of market reserach report.


Introduction

The Company Financials offers insights into the financial performance of the company over last five years for about 1000 leading global companies. The datapack covers wealth of financial information relating to income statement, balance sheet, and cash flow statements. THIS PRODUCT HAS BEEN DESIGNED FOR DELIVERY IN A DATAPACK FORMAT (.XLS). PLEASE SELECT THE DATAPACK OPTION FROM THE DOWNLOAD MENU.

Scope

*Contains five years data on income statement, balance sheet, cash flows and other financials in the reported currency and its US Dollar translation

*Provides key ratios

*Includes information on revenue distribution by business segments and geographies

Highlights

Elan is a neuroscience based biotechnology company focused on discovering, developing, manufacturing and marketing therapies in neurology, autoimmune diseases, and severe pain. Elan's flagship product, Tysabri (natalizumab), is being marketed in collaboration with Biogen Idec for the treatment of multiple sclerosis and Crohn's disease.

Reasons to Purchase

*Access important financial information and analysis on the company in a single datapack

*Understand the financial evolution of the company over the last five years

*Build the periodic assessment of the company's performance for five year adjusted financial data along with key ratios and market capitalization

For more information, please visit :

http://www.aarkstore.com/reports/Company-Financials-Elan-Cor…
Visit

http://www.prminds.com/pressrelease.php?id=38515

[Tebi]

Hi Ihr Lieben,

sitze in Bangkok im Hippen Strassencafe Greenhouse bei 32Grad + lasse es mir gutgehen.....gestern sind wir angekommen....zu unserer Begrüssung haben gleich 50 Mönche in unserem Lieblingstempel gesungen...echt nett hier.....abends in der Nähe der Khao San road jeder 2 Laden mit guter life Musik und leckeren Cocktail....LANGER REDE KURZER SINN:Elan sollte steigen!!Heute ist doch Conference Call zu den ergebnissen---hört jemand von Euch
zu? Nette Sommergrüsse! (...ich weiss,das ist jetzt gemein... Birgit

[bernie55]

Elan Reports Fourth Quarter and Full-Year 2009 Financial Results

Press Release Source: Elan Corporation, plc On Wednesday February 10, 2010, 2:00 am EST

DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc today reported its fourth quarter and full-year 2009 financial results and provides financial guidance for 2010.

Elan CEO Kelly Martin said, “during 2009, as the biotechnology industry continued to change significantly, we advanced our multi-year strategy for evolving the company. Our strategic transaction with Johnson & Johnson, now our largest shareholder, accelerated our positioning as a company that vigorously invests in science, technology and people while reducing inherent risks. In 2010, we will remain focused on building out Elan’s unique mixture of science and technology while continuing to reduce risk and infrastructure so that we produce long term benefits for patients and provide a compelling investment thesis for shareholders.”

Commenting on the results, Elan EVP and CFO, Shane Cooke said, “the Company was pleased to have met or exceeded all of its financial guidance for 2009, which reflected a particularly strong financial performance from the Biopharmaceuticals business and a significant improvement in the Company’s liquidity and capital structure. Revenues grew by 11% to $1.1 billion, led by a 30% increase in revenues from Tysabri. This increase, combined with a 9% decrease in operating expenses, before other charges and gains, led to a significant improvement in Adjusted EBITDA to $96.3 million, well ahead of the previously guided $75.0 million and the $4.3 million we reported in 2008. We also completed a strategic review which resulted in the completion of a $1.4 billion transaction with Johnson & Johnson. This transaction and subsequent debt refinancing strengthened our liquidity, reduced our debt and extended its maturity.

The net loss before tax for the year decreased by 56% from $297.3 million to $129.8 million mainly as a result of the improved operating performance and a net gain associated with the Johnson & Johnson transaction.

For 2010, we expect to report operating profits before other charges or gains for the first time in several years, driven by our continued growth in revenue and reduced operating expenses.”

http://finance.yahoo.com/news/Elan-Reports-Fourth-Quarter-bw…

[bernie55]

Antwort auf Beitrag Nr.: 38.915.526 von Tebi am 10.02.10 08:42:28

Hi Birgit,

thx für die Sommergrüße...

.... dafür natürlich ein paar Wintergrüße aus D ...

LG bernie55

[bernie55]

Antwort auf Beitrag Nr.: 38.915.844 von bernie55 am 10.02.10 09:34:46

Elan muss Verlust ausweisen, positiver Ausblick
Dublin (aktiencheck.de AG)


Wie aus einer am Mittwoch veröffentlichten Pressemitteilung hervorgeht, erhöhten sich die Umsatzerlöse im Berichtszeitraum auf 300 Mio. Dollar, nach 269,8 Mio. Dollar im Vorjahreszeitraum. Unter dem Strich wurde jedoch ein Nettoverlust von 57,7 Mio. Dollar bzw. 10 Cents je Aktie verzeichnet, nachdem man im Vorjahreszeitraum noch einen Nettogewinn von 169,5 Mio. Dollar bzw. 36 Cents je Aktie ausgewiesen hatte.

Für das laufende Fiskaljahr erwartet der Konzern erstmals nach mehreren Jahren wieder einen bereinigten operativen Gewinn, wozu vor allem höhere Umsatzerlöse sowie Kostensenkungen beitragen sollen.

Die Aktie von Elan notiert aktuell mit einem Plus von 0,57 Prozent bei 5,25 Euro. (10.02.2010/ac/n/a)

http://www.wallstreet-online.de/nachrichten/nachricht/289261…

[bernie55]

Blockbuster in Hand, It's Time to Show a Profit

By Brian Orelli, Ph.D.
February 11, 2010 | Comments (1)

ELN
Elan Corp, plc (ADR)



Operating profits. Positive earnings before interest and taxes. The anti-GM. No matter what you call it, that's what Elan (NYSE: ELN) is predicting this year -- the first time since 2001.

There are two ways to increase profits: increase revenue or keep costs in check. Elan is doing both.

The company's multiple sclerosis drug, Tysabri, continues to grow, albeit at a slower rate. Revenue from sales of Tysabri, which Elan sells with Biogen Idec (Nasdaq: BIIB), increased 30% last year, compared to a 140% increase from 2007 to 2008. Some of the slowdown was to be expected -- you can't double sales every year forever -- but the increasing number of cases of potentially deadly progressive multifocal leukoencephalopathy (PML) has a lot to do with the current sale trajectory.

In order to reaccelerate growth, Elan and Biogen need to convince doctors and patients that the side effects do not outweigh the benefit of Tysabri over other multiple sclerosis drugs like Teva Pharmaceutical's (Nasdaq: TEVA) Copaxone, Novartis' (NYSE: NVS) Extavia, and Rebif from Pfizer (NYSE: PFE) and EMD Serono. To that end, they're planning on running a trial to see if switching from Rebif or Copaxone will decrease symptoms.

While sales of Tysabri will have the biggest affect on the future of Elan, the company has its hand in a few other potential big sellers. The Food and Drug Administration recently approved Acorda Therapeutics' (Nasdaq: ACOR) Ampyra, which Elan manufactures and gets royalties from. Elan also gets royalties from Johnson & Johnson's (NYSE: JNJ) Invega Sustenna, which was developed using its nanocrystal technology.

On the expenses side, Elan has lowered its SG&A expenses slightly and decreased R&D expenses considerably after partnering with Johnson & Johnson on its late-stage Alzheimer's disease program. Elan and Johnson & Johnson set up a joint venture with Elan's half of the program -- Pfizer owns the other half -- but Elan isn't responsible for paying half of the expenses until they hit $500 million.

It will nice to see Elan showing an operating profit, and it'll be even better if Elan can hit its goal of being cash-flow positive by the end of the year. Now all investors need is net profits and a few advancements in the pipeline.

Only then will the drugmaker get close to the list of stocks to never sell.

http://www.fool.com/investing/high-growth/2010/02/11/blockbu…

[Tebi]

Antwort auf Beitrag Nr.: 38.915.866 von bernie55 am 10.02.10 09:37:57

...hier ist es soooooooooooooooowarm----aber sehr nett!lg in die Runde!!B.

[Poppholz]

Feb. 25, 2010, 7:03 p.m. EST
Elan Announces Filing of Annual Report on Form 20-F for Year Ended December 31, 2009

DUBLIN, Feb 25, 2010 (BUSINESS WIRE) -- Elan Corporation, plc /quotes/comstock/13*!eln/quotes/nls/eln (ELN 6.75, -0.05, -0.74%) today announced the filing of its Annual Report on Form 20-F for the fiscal year ended December 31, 2009. The Form 20-F is available on Elan's website at www.elan.com. Elan will provide to all holders of Elan securities, upon request and free of charge, a hard copy of our complete audited financial statements included in our Form 20-F.

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 and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

SOURCE: Elan Corporation, plc

Elan Corporation, plc
MEDIA:
Mary Stutts, 650 794 4403
Niamh Lyons, 353-1-663-3602
or
INVESTORS:
Chris Burns, 800 252 3526
David Marshall, 353 1 709 4444



http://www.marketwatch.com/story/elan-announces-filing-of-an…

[bernie55]

Brain images suggest Alzheimer's drug is working
Sun Feb 28, 2010 7:01pm EST

* Bapineuzumab cuts amyloid plaque by 25 pct in small study

* Encouraging result after clinical trial setback in 2008

* Drug being developed by Pfizer, Elan and Johnson & Johnson

By Ben Hirschler

LONDON, March 1 (Reuters) - New imaging technology suggests an experimental drug for Alzheimer's reduces clumps of plaque in the brain by around 25 percent, lifting hopes for a medicine that disappointed in clinical tests two years ago.

Bapineuzumab -- being developed by Pfizer Inc (PFE.N), Irish drugmaker Elan Corp (ELN.I) and Johnson & Johnson (JNJ.N) -- is a potential game-changer because it could be the first drug to treat the underlying cause of the degenerative brain disease.

Investor confidence in the antibody medicine, however, took a big hit in July 2008 when it failed to meet its main goal in a mid-stage trial and caused brain swelling at higher doses. The new study, which only involved 28 patients, is modest fillip.

"It demonstrated that the drug has an effect on the pathological hallmark of Alzheimer's disease," lead researcher Juha Rinne from Finland's University of Turku told Reuters.

Rinne and colleagues used a novel imaging substance called carbon-11-labelled Pittsburgh compound B, which sticks to areas of the brain where there is a lot of beta amyloid plaque.

After 78 weeks, they found that patients given bapineuzumab had about a 25 percent reduction in plaque compared with those on placebo. The effect was similar with three different doses of the drug, they reported in the journal Lancet Neurology.

The treatment was generally well tolerated, although two patients on the highest dose had transient brain swelling. The drug's developers have since dropped the top dose from large ongoing Phase III trials.

Commenting on the results, Sam Gandy from New York's Mount Sinai School of Medicine said it was too early to say effective disease-modifying drugs were at hand, but the ability to measure plaque in living subjects was "something of a breakthrough".

Experts are divided on the root cause of Alzheimer's and hence the best way to tackle it.

Most advanced drugs, like bapineuzumab, have focused on removing clumps of amyloid plaques, which are thought to stop brain cells from functioning properly. But a rival school blames toxic tangles caused by an abnormal build-up of the protein tau.

Rinne's imaging study was funded by Elan and Wyeth, which is now part of Pfizer. (Editing by Jon Loades-Carter)

http://www.reuters.com/article/idCNLDE61P17120100301?rpc=44

[bernie55]

Antwort auf Beitrag Nr.: 39.031.389 von bernie55 am 01.03.10 11:09:54

Neuroimaging Technique Supports Reduction in Amyloid-Beta in Brains of Patients Suffering from Alzheimer's Disease Treated with Bapineuzumab

Phase II Study Published Online in Lancet Neurology


Press Release Source: Elan Corporation, plc On Sunday February 28, 2010, 7:00 pm EST

DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN - News) today announced that findings from a Phase II study which suggested bapineuzumab reduced amyloid-beta deposits in the brains of Alzheimer’s disease patients as measured using a neuroimaging technique known as [11C]PiB PET, were published in the February 28, 2010 online edition of Lancet Neurology. Bapineuzumab is a compound under development by Pfizer and Janssen Alzheimer Immunotherapy, a Johnson & Johnson subsidiary in which Elan holds a minority equity interest.

The findings of the study further suggest that it may be possible to assess and monitor the effects of potential therapeutic agents on amyloid-beta deposits in patients with Alzheimer’s disease using this neuroimaging technique.

Patients in the study were randomized to either bapineuzumab treatment or placebo groups. Estimated mean [11C]PiB retention ratio change from baseline to week 78 was -0.09 in the bapineuzumab group and +0.15 in the placebo group. The estimated mean difference in [11C]PiB retention ratio change from baseline to week 78 between the bapineuzumab group and the placebo group was -0.24. Differences between the bapineuzumab group and the placebo group in the individual regions of interest were similar to the overall mean difference.

“We are encouraged by the findings of this study,” said Dr. Menghis Bairu, Chief Medical Officer for Elan. “The potential to use [11C]PiB PET imaging to monitor the effectiveness of potential therapeutics on amyloid beta load during treatment could play a major role in Alzheimer’s research and future clinical trial designs.”

About the Study

The study, conducted in patients with mild to moderate Alzheimer’s disease was a Phase II multi-center, double-blind, placebo-controlled multiple ascending dose study. Twenty-eight patients were randomized to receive one of three dose levels of bapineuzumab in a 1-hour IV infusion every 13 weeks for up to 6 infusions (a total of 78 weeks) or placebo. Each patient underwent [11C]PiB PET, [18F] FDG PET, clinical assessments of cognition function, CSF sampling for amyloid-beta and tau, volumetric and safety MRIs, and safety evaluations. The study was powered to detect a treatment difference in [11C]PiB PET retention between bapineuzumab and placebo treated patients from baseline to study end. The study was not powered to evaluate efficacy on clinical or other biomarker outcomes. Adverse events were typically mild to moderate in severity and transient. Two patients in the 2.0mg/kg bapineuzumab group had transient cerebral vasogenic edema.

While the study was partially funded by Elan Pharmaceuticals in 2008, on September 17, 2009, Elan completed a definitive transaction with Johnson & Johnson whereby Johnson & Johnson acquired substantially all of the assets and rights of Elan related to the Alzheimer’s Immunotherapy Program (AIP), through a newly formed Johnson & Johnson subsidiary, Janssen Alzheimer Immunotherapy. In consideration for the transfer of its AIP rights and assets, Elan received a 49.9% equity interest in Janssen AI. The AIP clinical programs include bapineuzumab IV and Sub-cutaneous formulations, ACC-001 and backup compounds. All future updates regarding Elan’s interest in bapineuzumab and other compounds in the AIP will be provided by Janssen Alzheimer Immunotherapy

http://finance.yahoo.com/news/Neuroimaging-Technique-bw-3076…" target="_blank" rel="nofollow ugc noopener">
http://finance.yahoo.com/news/Neuroimaging-Technique-bw-3076…

[GuHu1]

http://www.cnbc.com/id/35640705

[bernie55]

ZUR INFO:

Medivation, Inc.
(NasdaqGM: MDVN)

Pre-market Real-Time: 13.04 Down 27.21

(67.60%)

9:07am ET


Pfizer, Medivation Alzheimer's Drug Fails

http://blogs.forbes.com/sciencebiz/2010/03/pfizer-medivation…


Medivation Alzheimer's Drug Fails Pivotal Study

http://www.thestreet.com/_yahoo/story/10693881/1/medivation-…

[Tebi]

Antwort auf Beitrag Nr.: 39.050.224 von bernie55 am 03.03.10 15:10:33

Hi Bernie

...nicht schlecht---AUS für die Konkurrenz!

Bin wieder im Lande + versuche mich zurechtzufinden!

Grüsse in die Runde!
Birgit

[Poppholz]

Antwort auf Beitrag Nr.: 39.050.224 von bernie55 am 03.03.10 15:10:33

"des einen Tod ist des anderen Brot"

dann wollen wir mal sehen wann die Kursdrücker wieder zurück kommen.

Nicht das wir in drei Jahren schon in Rente gehen können.

[bernie55]

Davy
Elan Corp (USc)

ELN US

Dimebon fails to meet endpoints in Phase III trial - an indirect positive for Elan

Jack Gorman


Price $7.50 Rating: Outperform 30/06/09

--------------------------------------------------------------------------------

Medivation’s shares dropped 67% yesterday (March 3rd) as its lead Alzheimer's Disease (AD) candidate, Dimebon, failed to show any efficacy signals in the first of its Phase III trials. Medivation reported that in its 598-patient study that Dimebon failed to meet any of its primary or secondary endpoints, spanning several cognitive and functional measures.

It represents an indirect positive for Elan for a number of reasons:
a) It removes some potential AD competition in that Dimebon was being primed for a launch sometime in 2011, ahead of Bapineuzumab (although in reality the treatments may have been as much complementary as competitive).
b) It dampens one of the anti-amyloid theories. Medivation had speculated previously that Dimebon may increase amyloid burden – so if it had been successful, it would have been contrary to the hypothesis shared by Elan that amyloid increase is somehow involved in AD development.
c) To the extent that Pfizer is partner to both Dimebon and Bapineuzumab, the latter moves up its commercial priority list in AD.
The trial result also highlights again the complexity and difficulty in bringing AD treatments through to commercialisation. Hurdle rates remain high for a disease for which the industry continues to have very imperfect knowledge.

http://www.investorvillage.com/smbd.asp?mb=160&mn=404533&pt=…

[bernie55]

Antwort auf Beitrag Nr.: 39.050.263 von Tebi am 03.03.10 15:14:12

@Birgit+@Poppie+@Surga+ @ alle

Uns allen muss klar sein, dass der Erfolg der Amyloid Theorie durch den missglückten Versuch von Dimeabon noch nicht bestätig ist.

Bei dem Medikament Dimeabon ging man davon aus, dass das Entstehen von Amyloid begünstigt bzw. sich Amoloid erhöht. Wenn die Wirkung des Medikaments positive Ergebnisse gezeigt hätte, wäre hinter der Amyloid Theorie ein großes Fragezeichen gestanden.

Das ist an diesem „ TRIAL ERROR“ jetzt vorerst das Positive für BAP.

[bernie55]

Betr: REMBER - vielversprechendes Medikament in der Alzheimer-Forschung

Neues Medikament für Alzheimer-Patienten

vom 18. September 2008

Die Firma TauRx Therapeutics hat angeblich ein Medikamente hergestellt, das dem Fortschreiten von Alzheimer entgegenwirken kann. Eine erste Studie hat erstaunliche Ergebnisse gezeigt. Im kommenden Jahr sollen zunächst weltweite Tests folgen, erst in einigen Jahren gibt es dann grünes Licht für eine Markteinführung. Das Internet-Gesundheitsportal www.imedo.de berichtet.

Die Firma TauRx Therapeutics, eine Ausgründung der Universität Aberdeen und der Charité Berlin, hat einen großen Erfolg in der Alzheimer-Forschung erzielt. Tests mit dem Mittel Rember an 321 Patienten reduzierten das Fortschreiten der Erkrankung um 81 Prozent. Das Medikament zielt auf die Ansammlung des Proteins namens Tau im Gehirn ab.

Studie über Demenz

Patienten mit einer leichten oder gemäßigten Form der Erkrankung erhielten entweder 30, 60 oder 100 Milligramm Rember oder ein Blindpräparat. Bei 60 Milligramm war die Wirkung am deutlichsten. In einem Zeitraum von 50 Wochen konnte ein Unterschied von sieben Punkten auf einer Skala zur Messung der Schwere der Demenz erzielt werden. Nach 19 Monaten konnte kein signifikanter Verfall der geistigen Funktionen mehr festgestellt werden. Bildgebende Daten legen laut BBC ebenfalls nahe, dass das Medikament in jenen Teilen des Gehirns seine größte Wirkung entfaltet, die für das Gedächtnis verantwortlich sind.

Wirkung auf Alzheimer zufällig entdeckt

Der Zusammenhang zwischen den Proteinablagerungen im Inneren der Nervenzellen des Gehirns und Alzheimer wurde vor mehr als 100 Jahren hergestellt. Sie bestehen, wie später nachgewiesen wurde, aus dem Protein Tau. Die Ablagerungen bilden sich in den Zellen, die direkt mit der Gedächtnisleistung in Verbindung stehen. Sie werden durch die Ablagerungen immer weiter zerstört. Rember oder Methylthioniniumchlorid, kurz MTC, ist das erste Medikament, das spezifisch auf die Tau-Ablagerungen abzielt. Bisher konzentrierten sich die meisten Medikamente mit beta-Amyloid auf ein Protein, das harte Ablagerungen bildet. Die aktuellen Forschungsergebnisse legen nahe, dass bei Tau die besseren Ergebnisse erzielt werden könnten. Methylthioniniumchlorid wird normalerweise eher als blaue Farbe bei Laborexperimenten eingesetzt.

Wischik entdeckte seine Wirkung zufällig vor rund 20 Jahren, als ein Tropfen Methylthioniniumchlorid zum Verschwinden eines Tau-Proteins in einem Teströhrchen führte. „Wir haben erstmals nachgewiesen, dass es möglich sein kann, das Fortschreiten dieser Krankheit durch das Abzielen auf jene Ablagerungen zum Stehen zu bringen, die in direktem Zusammenhang mit der Krankheit stehen. Wir haben das Ausmaß der Wirkung nach 24 und nach 50 Wochen mit der Wirkung bestehender Medikamente verglichen und ein rund zweieinhalb Mal besseres Ergebnis erzielt“, erklärt Wischik. Größere Tests sollen 2009 beginnen. Auf dem Alzheimer Kongress in Chicago hielt es der leitende Wissenschaftler Claude Wischik für denkbar, dass Rember bis 2012 auf dem Markt sein kann.

Bis dahin müssen aber weitere großangelegte Tests weltweit stattfinden. Derzeit untersuchen die Wissenschaftler, ob das Medikament auch zur Prävention eingesetzt werden kann.

http://gesundheitsnews.imedo.de/news/102769-neues-medikament…

[bernie55]

@Birgit

...halt dir diesen Termin schon einmal frei....Ohren aufgestellt am 10.2.10...

....nach dem schönen Urlaub, ein hoffentlicher unterstützend positiver Einstieg in die westliche Welt.....



Elan to Present at the Cowen and Company Healthcare Conference


DUBLIN, Mar 03, 2010 (BUSINESS WIRE) -- Elan Corporation, plc (NYSE: ELN) today announced that it will present at the Cowen and Company Healthcare Conference on Wednesday, March 10, 2010, at 8:45 a.m. Eastern Time and 1:45 p.m. GMT.

Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at http://www.elan.com, then clicking on the event icon. Following the live webcast, an archived version of the presentation will be available at the same URL.

[Poppholz]

Option Activity Alert: Calls Gain Popularity on Elan Corporation, plc
Optimistic option volume has ramped up on this sluggish drug stock
by Elizabeth Harrow ([e-mail]) 3/3/2010 12:32 PM

Keywords: ELNstocksoptions

Calls have been the options of choice on Elan Corporation, plc (ELN) lately. During the past five days, traders on the International Securities Exchange (ISE) have bought to open 4,284 calls on the Irish drugmaker, compared to just 44 puts. In other words, speculators have scooped up 97.36 times more bullish bets than bearish during the past week.

In fact, ELN's 10-day ISE call/put volume ratio now stands at 29.03, which ranks higher than 90% of other such readings taken during the previous year. This elevated percentile rank indicates that traders have purchased calls over puts at a faster pace just 10% of the time.



However, the equity's bullish bandwagon is far from overcrowded. ELN's Schaeffer's put/call open interest ratio (SOIR) weighs in at 0.69, in the 96th annual percentile. Despite the predominance of calls among options set to expire within three months, this lofty rank suggests that short-term option players have rarely been more skeptical of the stock's prospects.

The bearish tide could be turning, though, as traders have consistently flocked to calls over puts in recent sessions. On Tuesday alone, call volume on ELN ballooned to eight times the usual level, with roughly 18,000 contracts crossing the tape. The March 8 call saw 10,362 contracts change hands, and open interest at this strike rose overnight by 3,772 contracts -- confirming that new positions were opened here yesterday.

In fact, the March 8 strike is now home to peak call open interest of 4,671 contracts. By contrast, the most heavily populated front-month put is ELN's 7 strike, with just 1,468 contracts in residence.



Elsewhere on Wall Street, a generally skeptical attitude prevails toward the pharmaceutical firm. Short interest rose by 16.7% during the past month, and now accounts for 2.8% of the stock's float. Meanwhile, Zacks reports that six out of seven analysts maintain a "hold" or "strong sell" rating on ELN.

If the mood among option traders seems decidedly mixed, it's probably because ELN's price action has been rather uninspiring of late. Since October 2008, the shares have bounced between support near the $5 level and resistance in the $9 area. More recently, this sideways channel seems to have narrowed, with ELN oscillating between the $6 and $8 levels since November 2009.



In fact, ELN hasn't notched a single monthly close above $8 per share since September 2008 -- which makes the preponderance of calls at the March 8 strike somewhat troubling. During the near term, this accumulation of overhead calls could exacerbate ELN's existing issues in this area.

The shares have also been stymied by technical resistance at their 20-month moving average, which hasn't been bested on a monthly closing basis since June 2008. ELN is currently hovering just above this trendline, but the security will likely need to manage a convincing monthly close above this resistance level before winning over new buyers.



After considering the stock's technical performance, it seems possible that short sellers are picking up 8-strike calls in order to hedge against a possible breakout from ELN. By aligning their purchased calls with the site of long-term technical resistance, short sellers can comfortably let their bearish bets run, while simultaneously limiting their upside risk in the event of a rally.

http://www.schaeffersresearch.com/commentary/observations.as…

[Poppholz]

Daily Options Trading for Elan Corporation, (ELN)
Posted on 03/04/2010

ELN options saw interesting call activity today. A total of 168 put and 2,983 call contracts were traded raising a low Put/Call volume alert. Today's traded Put/Call ratio is 0.06. There were 17.76 calls traded for each put contract.

A significant increase in the trading volume of a stock's option often is a precursor of movement by the underlying stock. In such instances, Put/Call Ratio can be used as an investor sentiment indicator, where a high ratio implies that the overall investor sentiment is bearish and a low Put/Call ratio implies that the overall sentiment is bullish.

Shares of Elan Corporation, closed at $7.50 in the previous trading session and opened today at $7.48. ELN is currently trading at $7.24, down $0.26 (-3.47%) in today's trading session. The shares of the stock are trading between $7.14 and $7.58. Today's volume of 2,440,047 shares is greater than the average volume of 2,405,890 shares. ELN is trading above the 50 day moving average and higher than the 200 day moving average. The stock's 52 week low is $4.61 and 52 week high is $8.59.

Sasha Gelf
Options Analytics Group
[e-mail]

http://www.marketintellisearch.com/articles/1004308.html

[Tebi]

Msg 405396 of 405470 at 3/10/2010 10:03:40 AM by

Multiplural


Transcript from Elan´s Cowen presentation


Elan Corp. Presentation Teleconference ELN ID 2010-03-10 14:34:12.49 GMT

Event Date: 03/10/2010
Company Name: Elan Corp.
Event Description:Cowen & Company Health Care Conference
Source: Elan Corp.
For more event information and transcripts, visit <a href="bloomberg:EVTS /D:F-1892884">EVTS</a>
Cowen & Company Health Care Conference

MANAGEMENT DISCUSSION SECTION

Ian Sanderson, Analyst, Cowen & Company:
...scientific management of Elan this mornings. And this is a very
interesting program for those of you who listen to the Alzheimer's panel
yesterday. I think there is this sort of rebuilding enthusiasm for the
bapineuzumab program given that nothing else seems to work right now and
also. I think that Kelly will have some interesting talk about what they're
doing on the TYSABRI front.
So with that I'll turn it over to Kelly Martin, CEO.

Kelly Martin, Chief Executive Officer:
Thanks, Ian. Appreciate Cowen including us in this healthcare conference. We
think it great, so appreciate everyone's time this morning. I'm going to walk
through a number of slides both financial and a little bit on our pipeline as
Ian said I'll touch upon TYSABRI. I believe Biogen just spoke and I'm sure
they reviewed TYSABRI fairly thoroughly. And then I believe there is a
breakout session after this.
Safe harbor statement, I won't read it all but obviously we'll be talking
about some things prospectively. Oops, where are we? Just start off with some
basics, a lot as to - two businesses, by in large, are bioneurology business
based on the science that's been going on for the last 15 or 20 years and our
technology business which has proprietary technology.
We run these businesses quite separately. There is some common
infrastructure. There is some common resources. The drug delivery business is
run by Shane Cooke and the bioneurology business is run by Dr. Carlos Paya.
Over the last number of years from a performance point of view as it relates
to financials. Our revenue has grown 20% on a compounded basis a lot of this
has been driven by TYSABRI and the re-launch of TYSABRI some number of years
ago.
Expenses, we've done a lot at the company in the last number of years from an
expense point of view, I think what's important here is if you look at SG&A
we are down roughly $100 million from where we were in 2006. However, we
still continue to invest in the research and development side of the business
and that will continue and that will especially continue as I walk you
through the pipeline and talk about some things that are coming forward from
both the discovery side and the early clinical side of the company.
From adjusted EBITDA point of view again longer-term recovery of the company
from a P&L point of view, we've had good, good steady progress finishing up
last year with a $96 million positive adjusted EBITDA. Guidance for this year
is to continue to improve upon that and we have our first quarter earnings
update some time in middle to end of April.
TYSABRI and again I know Paul Clancy probably just went through this. TYSABRI
in 2009 despite all the challenges of PML and various issues, the drug
continue to grow year-over-year improvements as far as patient numbers, 30%
more patients around the drug at the end of 2009 and in the beginning. And
from a revenue point of view, rough increase of about 30% from a revenue
perspective.
We are spending enormous amount of time right now between the Elan and Biogen
on investing in these assets. We think that there is more to do with this
asset and there is more to invest in. I'll just briefly talk about the number
of things, first and foremost risk stratification, with regard to PML and
potentially constructing a segment approach to the marketplace, we are in the
process of rolling out with both regulator in the U.S. and in Europe and
antibody assay that will allow people and doctor in particular to begin
segmenting their clients who is more at risk of PML and who is much less
risk, and there is more to do on that. We think that's a very important tool
that we'd like to provide both to patients and the doctors as we move
forward.
And we also with Biogen, looking at starting some clinical studies, both
against existing therapy singly and in combination and that's something that
you hear more about as we move forward through the spring. We also are
looking at expanding the indications to both SPMS and CIS, CIS is the early
part of MS and all of those things are currently on going and being looked at
between Biogen and Elan from an investment point of view.
And lastly, commercially, there are geographic areas, which in 2010 we will
begin to look at and rollout commercially the asset across this different
countries, which again just expands the footprint of the marketplace.
From a pipeline point of view, a lot of people ask us at Elan post to J&J
transaction and since you have TYSABRI and that's partnered with Biogen what
else do you have in the company? And we have a lot of things that are all
science driven on the BioNeurology side and technology driven on the EDT
side.
So I'm going to spend a few minutes just educating people about what else is
the company from a pipeline point of view. So EDT, again run by Shane Cooke,
out of Ireland. EDT has 14 products in clinical development. Most
importantly, we've had two approvals over the last six to nine months. First
of all, the J&J [indiscernible] antipsychotic, drug was approved is in the
process of launching or has launched; and MS drug which was approved and in
the process of just launching, are important parts of that portfolio.
As you can see however the rest of the portfolio is moving along. This is a
similar business to any other pharmaceutical biotech business. So there is a
pipeline, the pipeline is treated from stages. Again, we apply technology,
some of this pipeline is proprietary, you see after Merck we have three
different proprietary products. Those are products that Elan owns or Elan has
all the rights to and we're moving those things forward.
Morphine product is in the process of being filed in Europe, [indiscernible]
in Europe is in late stage Phase III and Elan has the rights to that outside
of States; and a pain product which is in Phase II and then we have other
things that are earlier stage phase II and many ,many Phase Is and this is
pipeline that we continue to grow. So the EDT business continuous to work
both proprietarily and with partners as far as extending this pipeline and
news over time on the pipeline as far as advancements will be embedded in
both earnings call and investor updates.
The different business model here from a quarter, for instance, which we work
very well with Ron Cohen and this team. We manufacture that asset and we get
a royalty structure, we have no infrastructure involved other than technical
infrastructure and technical assistance as the same with J&J and the
proprietary pieces we have options, we can take the products forward
ourselves, we can partner them out at a much later stage, so there is
different parts of that puzzle that we continue to work with and we view this
as a very good business, it's diversified in risk, it's diversified in
assets, and it's diversified geographically and in therapeutic areas.
By a neurology pipeline, again we are quite busy from the science forward
into clinical assets. And all the while as we went through in the first few
slides the financial progress of the company in the last four of five years
we're also making progress from the science and technology point of view as
it relates to bio neurology. Multiple sclerosis, the first piece of the
pipeline TYSABRI obviously everybody knows about it, its in the market and
we're working very hard to continue to advance that asset.
Elan D002 is in Phase I, that is the Phase II, late Phase I early Phase II
decision to be made this year on that, that's for MS there is different ways
we can move that molecule forward, it's a small molecule out before, it's not
partnered and it's a technology obviously [ph] that we know quite well. Our
p75 is something that we end licensed last year. p75 you know it has
applications across MS, it has applications into Alzheimer's and to
Parkinson's and perhaps other CNS related diseases. We're moving that asset
forward quite quickly doing a lot of work on it. It's a small molecule,
ligand and it's - it focuses on neuro-protective aspects of neurology. We're
very excited about this asset and the potential ability to move that forward
in multiple indications.
And then at MS there is two other things we've just listed as Program A,
Program B. The things that we have listed without names are either targets,
new targets or technologies against existing targets, and as we get those
things farther along and we make sure that we have the intellectual property
managed correctly we'll begin to let people know what those targets are, what
that technology is. But we have two other things in MS that we're very
excited about, that are making rapid progress and overtime we'll be able to
talk about those things publicly.
Parkinson's is earlier on a very complex disease. We have an enormous amount
of resources in research and very early clinical working on Parkinson's. It's
a very, very large unmet medical need and we have a lot of things going on
there. Obviously, p75 as I mentioned beforehand has applications into
Parkinson's and different aspects of Parkinson's and we have four other
programs or targets that we're looking at all related to Parkinson's. Again
it's very complex but we have our biggest current research investment in the
company around Parkinson's and how we can move that forward and attack that
disease.
Alzheimer's, we've broken into two large buckets. First and foremost
everything in blue are things that are non-AIP. I think there is perception
from some of that when we did the transaction with J&J. All of our
Alzheimer's activity was somehow transferred to J&J which is clearly not the
point. But let me just go down through this programs. The first is Lilly's,
Lilly's gamma program is in Phase III. We have an opportunity to opt into
that commercially. We do not have any influence or endpoint into the
development or clinical journey. However, again if they are successful, we
can opt into that in the U.S. for commercial participation, so we view that
as part of our Alzheimer's business.
ELND005 in partnership with Transition Therapeutics is in late Phase II.
There is a Phase III decision on that asset in the third quarter of this
year, small molecule we think that has applications in mild or early AD, and
obviously if we can move that forward based on the data we'd be extremely
excited about that.
The [indiscernible] gamma secretase molecules, all alliance none of them are
partnered. They are all slightly different from a PK point of view. They all
have slightly different aspects to them. We are currently taking all of them
forward. We think the gamma space is quite interesting. It's obviously got
some challenges to it like everything else, but it's something that we are
going to keep moving forward.
p75 again has application in AD that was the primary reasons we in license
this technology was for AD we're now applying in across other neurogenerative
[ph] and CNS areas. We still work on base; again it's a very complex target.
We have enormous experience in base and we are making progress there, and
with a little bit more progress some block and some more technical insight,
we potentially could add base to our clinical assets.
And then we have two other programs different targets and different
technology that compliment the beta amyloid thesis and theory that we are
extremely excited about. But at their early days but we will be moving those
forward in with significant investment over the course of the next year or
so. So our AD portfolio away from AIP is full. I think on the beta amyloid
thesis we have surrounded it with every technology we can think of in pathway
and now we are adding other things starting with p75 that we will move
forward over the coming months and year.
In addition to all of that, we did the transaction with Johnson & Johnson
last year which was we think a great opportunity for us to invest in further
research around AD, PD and MS because it took the operational burden if you
will away from us. The AAB001 is in Phase III, the ACC the vaccine is in
Phase II, the subcutaneous version of bapi is in late Phase I, early Phase II
and there are back ups AAB002 there's ACC002.
We are no longer involved with the operational aspects of this that's run by
Johnson & Johnson and Pfizer. We do have some involvement from the scientific
point of view and an overall strategy point of view. And obviously from a
shareholder point of view and a financial point of view we have a big
participation in this whole technology. We own roughly half of the JAAI
Company and we will receive about 25% of the profitability of that whole
technology plus the opportunity to get some royalties over and above that. So
if you look at our AD activity across Beta Amyloid related technologies and
others plus the whole AIP platform, I think its clear that our investment in
and around AD has never been bigger and will most likely grow in the coming
year or two.
And just to show its slightly differently again, so people fully understand
our approach to AD. We have seven different initiatives in AD. One of them
which is very, very significant, obviously, is the AIP technology, which
again we're delighted with the structure that we have with Johnson & Johnson.
We think that they are fantastic partner for us globally given their
infrastructure, given the people they have and given their commitment to AD.
So we couldn't be happier having somebody of their caliber help to take this
technology forward to the marketplace.
And the other things ELND005, gamma secretase, p75 beta secretase and the
other two programs and/or targets I think that we as Elan can continue to
work on with full resources and full use of our talents, our IP knowledge,
our biology knowledge, and our clinical knowledge. And you will see us move
that portfolio as quickly as the data will allow us to move forward against
this very, very important and very large financial and market and patient
opportunity.
Lastly, from an AD perspective again, in the blue are all the Elan's specific
programs, in the green is what we have partnered out with Johnson & Johnson.
You can see that from a beta point of view that we have different approaches
that we are involved with either directly or indirectly. The elimination of
beta amyloid is obviously the immunotherapeutic approach. The prevention of
the aggregation of beta amyloid is D5, prevention of the production are the
secret [ph] both Gama and Beta some of which - most of which we are owning
completely and last but not least, we are starting to look at the neuron and
neurotoxicity aspects of AD and the first public program that we have is the
p75 ligands and there are others that we are looking at and working on with
quite interesting preliminary results and we will move those things forward
as we go.
So with that I am happy to take a few questions here from you all or go to
the breakout session and Ian I will take your lead if you have thoughts,
questions or anything you want to address here or I can go to the breakout
session.

Q&A

<Q - Ian Sanderson, Analyst, Cowen & Company>:

<A - Kelly Martin, Chief Executive Officer>: I will repeat the question that
was one of my jobs. So the question for everyone on the phone is if we have
an agent that blocks A beta or eliminates, would there be a need for
something that also gets involved with the neurotoxide of things and Dale
Schenk, our Chief Scientific Officer is going to give some comment on that.

<A - Dale Schenk>: So I think I mean, we will take our queue [ph] from other
diseases where we have diabetes or heart disease of what have you and while
data is - I think we have the initiator, we still got neuron but after
recovery right. So overtime there are no, probably left alone but as you can
see that along with different approaches it can be by example that it does. I
think there is a simple way of describing the two great examples.

<A>: So the goal here would be a recovery [indiscernible].

<A>: Well, yes, it would appear somewhat. It's an imaginable symptomatic and
[indiscernible].

<A>: Yeah, Bill.

<Q>: ?

<A>: Yes.

<Q>: ?

<A>: Well, our - from a financial - so the question is with the R&D pipeline,
how do you manage the cash need, capital need and the cash flow in the P&L,
which - its not easy.
First and foremost, we're committed to continuing to improve from a P&L point
of view of this company to get to an EPS point of view with all of the
various pieces that we went through. Secondly, the reason that we were so
excited about the J&J transaction is, there is a couple of things that we
look at, first of all size of market, so the size of market in Alzheimer's is
so big and is so global that for us to build the infrastructure to do that
commercially, operationally, manufacturing wise would be probably beyond what
we can do from a capital point of view and it would suck out all of the
opportunity that have to do earlier - early stage stuff, which I think is
from Elan point of view one of our sweet spots.
So what we will continue to do is as things progress, we would look to
partner certain things with certain indications. So AD, if we have other AD
opportunities, the same things hold, where the markets huge, the
infrastructure is going to be huge, and we would look to partner those things
out for commercial aspects. There is a point where Elan would like to have
some small sleeve of commercial. We would like to be able to talk in
particular, those doctors that are involved with trials; those doctors that
are pretty thoughtful on the science; those doctors who can help sort of
iterate your science into clinical things.
But I think that we - you haven't seen the last structure from us, I think
that as our science progresses we'll make decision about the risk/reward for
us as single entity and the size of market, size of opportunity and how much
capital, you need to do this.
So AD space is huge, Parkinson's is the next size space. People say there is
1.5 million to 2 million Parkinson's patients, we think that's small. It is
actually more than that. So we would want to do some of the Parkinson's
commercial, but not all of it. So we would look to have partnerships in
Parkinson's.
MS is small, we already have a MS partnership, MS is a very defined market of
4, 5000 patients, 2000 doctors in the U.S. prescribe 85% of the business. If
we had other things in MS that we want to do on our own, it would be
relatively simply for us to do. And then you go smaller neurodegenerative
diseases, Huntington's, ALS, restless leg syndrome, there is some interesting
neuropsychiatry things across these different things. And as you get into
smaller and smaller markets those are things that we think we can do on our
own. So I think you will see us move the science forward and the clinical
stuff forward as far as we can and then bigger the opportunity commercially
as far as size of market, the more apt we are to have structures that look
like this, the more define the commercial opportunity the more apt we ought
to take it all the way but all of the while improving the P&L so you get to
an earning situation. And we think we are making good progress on that.

<Q>: ?

<A>: Well, the beauty of the J&J transaction is that when we did the forward
calculation for capital need requirements for that - for this technology -
sorry - when we did the forward calculation for AAB001 Phase III, ACC001
potential Phase III, subcutaneous potential Phase III and the backups and
then you have mile to moderate AD, mild AD, early AD, and you have the
different regulatory bodies around the world. The amount of money that is
going to have to go into that is in the multi billions. So the transaction
with J&J is because of sub-partnered asset, partnered technology for the next
$2 billion of investment in AIP along we'll put in 250 million. So whatever
that is 12 or 13%. I think you will see research tick up slightly Phil, and I
think you will see a development tick up slightly but it's not going to
explode. We're going to manage it in a way that can accomplish getting us to
earnings increasing the pipeline and doing what we think are smart structural
transaction on the mature end of things specifically commercial. And that's
why - because we did the AIP trade is why we could add in AD Program G,
Program H and why we can't add in MS Program A and Program B because we have
capacity to do it from a capital point of view. And obviously the earlier you
are the farther way you are but the less expensive it is.
So we're very mindful of getting to earnings, we're very - also very mindful
of creating value, shareholder wise from a currency point of view. Yeah.

<Q>: Could you comment on the expected impact [indiscernible] timing of MS ?

<A>: TYSABRI spend. Let me get it. So the question is what's the impact of
oral is going to be on TYSABRI. I think the impact of orals; it will impact
all MS therapies including TYSABRI. I think orals as a - when you look at
orals versus biologics just kind of generally they always have an impact.
They're easier.
I'd say MS is a slightly different disease because it's also going to have to
do with efficacy and safety, so just because something is in oral isn't
necessarily mean that a doc or a patient is going to opt to it because it's
more convenient. I think it's going to have to do with efficacy, so the
efficacy of TYSABRI versus alternatives is ultimately going to be as big a
factor as it's a biologic versus an oral, at least from the feedback we've
gotten from patients.
And therefore, I think that orals will have an impact on the entire MS
business. I don't think it will have a disproportionate impact at TYSABRI
versus the other therapies. Ian?

<Q - Ian Sanderson, Analyst, Cowen & Company>:

<A - Kelly Martin, Chief Executive Officer>: We have some - so the question
is the early switch study with TYSABRI versus Copaxone and what we are
targeting? We have doctors Ian out there who used TYSABRI early - they use it
early because of the inflammatory process and I think others potentially
would like to use it early but they would like to see some data on that. So
that goal, particularly if you took about risk stratification if you are JC
virus negative and - so your risk of PML is extremely low - negligible.
And the question is if you have [ph] efficacy and that [ph] you reduce the
risk dramatically why wouldn't you use - why wouldn't you use TYSABRI much,
much earlier in a treatment protocol and again doctors have to decide that
but the best way to give them the impetus to the side that is to give them
the data and so that's - that's the intent of that trial.
TYSABRI launched number one without PML, everybody was shifting to TYSABRI
because there wasn't a risk and the efficacy of TYSABRI is pretty powerful
but we've never done a head to head and this is an opportunity to do that
because again if you could risk stratify the patient population and give the
docs and the patients the data of what happens to patients who perhaps use
TYSABRI earlier on, we think that's a good life cycle investment in the
asset. I think it's a very good lifecycle investment in the asset. And to the
previous questions about Orals, the Orals are going to have to compare
ultimate efficacy anyway. So I think that's a great investment and we've been
working with fib on doing that for sometime. I think this is an important
part of the future of TYSABRI.

<Q>: ?

<A>: Yes. So the question is for patients who come off TYSABRI for holidays,
is there a thought about doing a study around that? And the answer is, yes.
We get ask a lot of questions particularly by investors about patient
holidays and drug holidays and when we actually don't have any data, where we
do have data which shows people what happens if you take patients off
TYSABRI, because when the drug was pulled the first time that with this data
we have about what happens to patients and its not a good thing.
So we are working on ways to do that. What would the drug holiday look like,
is it a total drug holiday, you go from 100% to 0% you titrate down and then
stop and then titrate back up. And so we are going to work on that, we are
going to do that, we are going to have that investments as well because the
doctors definitely want that.
And you can tell from the patient data and week-over-week, month-over-month
you can see, what we see is net patient adds and that's divided into those
patients who have discontinued and those patients who've now come back on the
drug.
So you can see that there are people who perhaps have been off the drug for
three months, or two months, or six months and they are coming back because
they are sort of cycling back in, and it will be great again in this asset to
give the doctors the information how do you do that.
In the regulatory discussions we have in both the U.S. and Europe, both
regulators in the absence of any data they are not particularly positive on
drug holidays because they don't have any data which says that's what people
should do, however the reality is that with the 24 month sort of time period,
there are doctors who are doing that on their own, they are doing it a little
bit blindly, so if we can give them the data I think that's good. Yeah.

<Q>:

<A>: That appears to be the...

<Q>:

<A>: No antibodies, to set the latter. And the sort of the biology behind
that is you got to have the JC virus as a precursor to the PML virus
spreading and they are also going to get into the brands. So that's the
fairly simple theory. There is a lot of data that we have based on all the
patient data that we have that would support that. So I think getting an
assay into the hands of doctors and getting more data I think would only help
with that theory and the biological understanding of that, which is also
still - is still very new stuff. The biology around this is not, it's not
text book stuff that you just open up, so I think the more patient data that
we have the better off we'll be and the better off the doctors and the
patients will be.

<Q>:

<A>: It's about 50-50. Yeah.

<Q>: ?

<A>: The question is would we seek a label change, if patients who are JC
negative are - to use as first line therapy?
I think our first focus is, is get this assay in the hands of the clinicians,
embed that assay for instance in a couple of the study. So you actually have
studies going on and we'll give you clinical data that's useful and you'll
get more experience with the assay in real patients about real results. So
that's the first initiative.
I think where that goes beyond that as far as anything - any adjustments to
the label we'll have to tackle down the road, but that's not the first
objective. The first objective is if we can get this on the hands of the key
neurologist we think that that will bode well for the asset, the
understanding of the asset, the biology understanding and the discussion that
they can have with their patients.
All right. So with that thank you very much. I appreciate your time and I
look forward to everyone at the - whoever wants to join the breakout session.
Thank you.

This transcript may not be 100 percent accurate and may contain misspellings and other inaccuracies. This transcript is provided "as is", without express or implied warranties of any kind. Bloomberg retains all rights to this transcript and provides it solely for your personal, non-commercial use. Bloomberg, its suppliers and third-party agents shall have no liability for errors in this transcript or for lost profits, losses, or direct, indirect, incidental, consequential, special or punitive damages in connection with the furnishing, performance or use of such transcript. Neither the information nor any opinion expressed in this transcript constitutes a solicitation of the purchase or sale of securities or commodities. Any opinion expressed in the transcript does not necessarily reflect the views of Bloomberg LP

[Tebi]

WAS BEDEUTET DAS NUN SCHON WIEDER???????????????

Elan quietly gives J&J option on Alzheimer drug
Toni Clarke
BOSTON
Fri Mar 12, 2010 5:19pm EST

BOSTON (Reuters) - Irish drugmaker Elan Corp Plc (ELN.I) has quietly given Johnson & Johnson (JNJ.N) the right to acquire its 49.9 percent stake in their joint Alzheimer's disease venture -- a move that could deter potential bidders for Elan.



The agreement, buried in Elan's recently filed annual report, is part of a broader transaction announced last July in which J&J agreed to pay $1 billion for 18.4 percent of Elan and take a 50.1 percent stake in a new company working on Elan's most advanced experimental Alzheimer's drugs.

The terms of that deal were revised downwards after it emerged Elan and J&J had come to a secret -- and improper -- agreement under which J&J could gain a half share in the blockbuster multiple sclerosis drug, Tysabri, which Elan markets in a 50-50 partnership with U.S. biotech company Biogen Idec Inc (BIIB.O).

Now, it emerges Elan not only gave J&J an option on Tysabri, it also gave the company an option to acquire its 49.9 percent stake in Janssen Alzheimer Immunotherapy, the subsidiary formed by J&J to acquire Elan's Alzheimer's Immunotherapy Program (AIP). The unit includes bapineuzumab, Elan's most advanced experimental Alzheimer's drug.

"Many large shareholders are up in arms about this," said Larry Feinberg, who runs Oracle Investment Management and holds 5 million Elan shares. "Elan has one of the best neuroscience businesses in the world, but now Biogen has right of first refusal on Tysabri and J&J has right of first refusal on bapineuzumab. It's something that will get in the way of a potential acquirer."

Discussion of a possible buyer for Elan is far from academic. The company is one of research firm Morningstar's top 10 likely acquisition targets.

Biogen, whose standstill agreement with Elan expires in June, has long been considered the most logical suitor for Elan as the relationship between them -- each has the right to acquire the other's share of Tysabri should there be a change of control at either company -- represents a hurdle to potential third-party acquirer .

But Elan concedes its agreement with J&J on bapineuzumab could have a similarly chilling effect.

"We are party to agreements that may discourage a takeover attempt that might be viewed as beneficial to our shareholders," the company said in its annual report, listing as examples its Tysabri agreement and the newly revealed Alzheimer's drug agreement with J&J.

Elan did not directly respond to an email asking why it did not disclose the matter when the transaction was announced. Bob Purcell, a company spokesman, said only that "change of control clauses are a standard part of any asset transaction within the pharmaceutical industry."

A potential Elan acquirer would get either a non-controlling financial interest in Janssen AI or the cash equivalent to its fair value, he said.

Karen Andersen, an analyst at Morningstar, said the agreement should have been reported at the time.

"I think this is material information," she said. "I think this should have been volunteered and discussed when they had their conference calls to discuss the deal, rather than putting us in a position of digging for it later."

Bapineuzumab is being developed in conjunction with Pfizer Inc (PFE.N), which took the drug over when it acquired Wyeth. Pfizer currently has a 50 percent stake in the partnership, while J&J and Elan have roughly 25 percent each. If J&J exercises its option -- which would kick in if Elan were to be acquired -- it would gain Elan's share.

Some investors have written off bapineuzumab because it showed mixed results in a mid-stage clinical trial. But Alzheimer's disease, a degenerative condition that robs victims of memory, afflicts 26 million people worldwide and, if bapineuzumab turns out to be successful, it could generate billions of dollars in revenue.

The company's delay in disclosing the Alzheimer's option is particularly galling to investors, given its side agreement with J&J on Tysabri last year landed Elan in court.

In that case, a U.S. federal court judge ruled Elan breached its contract with Biogen, prompting Elan to withdraw the Tysabri option from its deal with J&J. J&J, in response, cut the amount it would pay for its Elan stake by $115 million to $885 million.

Elan's shares have fallen 13 percent to $7.45 from a 12-month high of $8.58 at the time the original transaction was announced on July 2.

(Reporting by Toni Clarke; editing by Andre Grenon)

[Poppholz]

Antwort auf Beitrag Nr.: 39.136.895 von Tebi am 14.03.10 21:13:33

keine Ahnung was die da schon wieder verhandeln.

Positiv könnte man annehmen, dass dieses Verhalten eine feindliche Übernahme durch einen "Dritten" verhindern soll. Für uns Aktionäre kurzfristig natürlich nicht so prickelnd. Langfristig könnten aber die "Gewinne" in der Zukunft den Kurs nach oben befördern.

Problematisch ist aber erneut die Art und Weise, wie diese Informationen nach außen gelangen und wie ELAN damit umgeht. Das kann nur zu Kursrückgängen führen.

[Tebi]

Antwort auf Beitrag Nr.: 39.139.026 von Poppholz am 15.03.10 11:24:35

....genauso sehe ich das auch!

Ich finde,wir Aktionäre hätten mehr Transparenz verdient....!

Netten Gruss!

[Poppholz]

Antwort auf Beitrag Nr.: 39.139.815 von Tebi am 15.03.10 12:56:45

das habe ich bei ELAN schon aufgegeben.

Eine strukturierte Arbeitsweise (in Bezug auf das Interesse der Aktionäre) ist hier nicht zu erkennen.

[bernie55]

Antwort auf Beitrag Nr.: 39.140.260 von Poppholz am 15.03.10 13:51:11

das habe ich bei ELAN schon aufgegeben.

Eine strukturierte Arbeitsweise (in Bezug auf das Interesse der Aktionäre) ist hier nicht zu erkennen.

..wie wahr...

...wenn unter dem Strich das rauskommt, was wir uns wünschen..

..dann könnten wir doch damit leben...

LG bernie55

[bernie55]

Azur acquires rights to Elan chronic pain drug Prialt

The Associated Press, On Thursday March 11, 2010, 1:04 pm EST

Azur Pharma Ltd. said Thursday that it has agreed to buy the chronic-pain drug Prialt from fellow Irish drugmaker Elan Pharmaceuticals.

Terms of the deal were not disclosed.

Azur said it acquired worldwide rights other than in Europe. The drug generated about $20 million in U.S. sales last year.

Patents covering Prialt expire in December 2016, and Azur said in a statement it believes the drug will grow "with continued investment."

Elan Pharmaceuticals Inc. is a subsidiary of Elan Corp. Plc. Shares of Elan rose 8 cents to $7.33 in Thursday afternoon trading.


http://finance.yahoo.com/news/Azur-acquires-rights-to-Elan-a…

[Tebi]

Antwort auf Beitrag Nr.: 39.145.943 von bernie55 am 16.03.10 08:08:08

Moin Du treulose Tomate,auch mal wieder zu sehen....

[Tebi]

NanoCrystal Wins Technology Innovation Award
Drug Discovery & Development - March 22, 2010

Elan Drug Technologies, a business unit of Elan Corporation, plc received the top award for Technology Innovation at the Drug Delivery Partnership (DDP) meeting for its NanoCrystal technology, which was voted as the most successful drug delivery technology innovation. The technology was designed to overcome issues associated with poor water solubility. Ten years since its first filing with the FDA, products using this technology are now marketed in over 100 territories worldwide and have achieved product in-market sales of more than $7.5B.

“We are delighted to accept this award, as voted by our peers, for our NanoCrystal technology platform,” announced Shane Cooke, executive vice president and head of Elan Drug Technologies. “This technology continues to be a major commercial success for our licensees. We strive to continue developing technologies and products that are innovative, unique and market relevant so as to provide true patient benefit to our clients.”

The award was presented by DDP co-chairman Peter Kramer, executive director for Technology Transactions at BMS, to Dr Gary Liversidge, Elan Drug Technologies’ chief technology officer and one of the key inventors of the NanoCrystal technology platform. This meeting is a leading worldwide event for personnel engaged in leading pipeline expansion through drug delivery innovation.

[Poppholz]

Unusual Trading Activity for Elan Corporation, (ELN)
Posted on 03/22/2010

ELN options saw interesting call activity today. A total of 476 put and 2,425 call contracts were traded raising a low Put/Call volume alert. Today's traded Put/Call ratio is 0.20. There were 5.09 calls traded for each put contract.

A significant increase in the trading volume of a stock's option often is a precursor of movement by the underlying stock. In such instances, Put/Call Ratio can be used as an investor sentiment indicator, where a high ratio implies that the overall investor sentiment is bearish and a low Put/Call ratio implies that the overall sentiment is bullish.

Elan Corporation, closed at $7.33 in the last trading session and opened today at $7.30. The stock price rose $0.26 (+3.55%) to $7.59 in today's trading session. ELN is trading between the range of $7.25 - $7.59. Volume is 2,839,515 in relation to the three month average volume of 2,332,750 shares. ELN is trading above the 50 day moving average and higher than the 200 day moving average. The stock's 52 week low is $4.61 and 52 week high is $8.59.

by Leo Goldman
Options Analytics Group
[e-mail]

http://www.marketintellisearch.com/articles/1006482.html

[bernie55]

.......dann tu ich auch mal wieder was für das ELAN Board.....


Davy
Elan Corp (USc)

ELN US

Icahn's influence increases at BiogenIdec

Jack Gorman


Activist investor Carl Icahn has increased his influence at BIIB with another of his nominees being appointed to the board. This compromise was accepted by the company in return for Icahn withdrawing his threat of a proxy fight — for additional board members — at the upcoming general meeting.
The investor now has three nominees on the board of 12 — though it will be 13 for a short period. Over time, this increases the pressure on BIIB to perform in terms of earnings and share price, as Icahn has indicated previously his interest in selling or splitting the company to generate shareholder value.
Either through improved performance or M&A, this is likely to involve Tysabri and to this extent it would be a potentially positive development for Elan.

http://www.investorvillage.com/smbd.asp?mb=160&mn=407528&pt=…

[posimist]

Die Jungs sollen in Sachen Alzheimer mal Gas geben,
dass ich meinen Einstandskurs von gut 6 Euro
endlich wieder von der anderen Seite sehen kann.

posimist

[Poppholz]

March 25, 2010 03:30 AM Eastern Daylight Time
Biogen Idec and Elan Enroll First Patient in Large, Well-Controlled Head-to-Head Study of Multiple Sclerosis Treatments

– Study Aims to Inform Treatment Decisions and Improve Patient Outcomes by Directly Comparing TYSABRI to Copaxone and Rebif –

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced enrollment of the first patient in a global Phase IIIb, randomized, rater-blinded, active-controlled study designed to evaluate switching to TYSABRI® (natalizumab) from Copaxone® (glatiramer acetate) or Rebif® (interferon beta-1a) in patients with relapsing remitting multiple sclerosis (RRMS). The study, called SURPASS, is expected to enroll 1,800 patients in 27 countries and provide direct comparative data of different treatment options for RRMS patients who experience breakthrough disease activity.

“Despite being on therapy, many MS patients still experience disease progression, resulting in loss of physical abilities and permanent damage to the central nervous system,” said Richard Rudick, M.D., chair of the SURPASS trial advisory committee and director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic. “Currently, there is limited data to inform decisions about how to switch in patients who have disease activity while on therapy. The goal of the SURPASS study is to provide that data so physicians can improve treatment decisions and outcomes for their MS patients.”

A significant number of MS patients continue to experience clinical relapses and disease progression despite treatment with disease-modifying therapies such as Copaxone and Rebif. The SURPASS study, a large, well-controlled comparative trial of MS treatments, will evaluate switching to TYSABRI versus staying on or switching between Copaxone and Rebif and determine whether early use of TYSABRI in the treatment algorithm ultimately leads to better outcomes.

“TYSABRI is a compelling treatment option that is bringing hope to many MS patients,” said Alfred Sandrock, M.D., M.P.H., senior vice president of neurology research and development at Biogen Idec. “By evaluating TYSABRI against other MS treatments, our goal is to provide the data needed to make better treatment decisions and improve patients’ lives.”

“We believe the SURPASS study has the potential to improve the way MS is treated,” said Carlos Paya, M.D., Ph.D., president at Elan. “Despite significant advances in treatment, the unmet medical need for many MS patients remains great and this study supports our commitment to continuing to advance the standard of care in MS.”

About SURPASS

SURPASS is a global, Phase IIIb, multicenter, randomized, rater-blinded, parallel-group, active-controlled trial designed to provide direct comparative data to inform patients and physicians of the relative benefits of different treatment options when faced with breakthrough disease activity. The large, well-controlled comparative study assessing TYSABRI, Copaxone and Rebif is expected to enroll 1,800 patients with RRMS, ages 18 to 60 years old, with a baseline Expanded Disability Status Scale (EDSS) score from 0.0 to 5.5. Patients must have been treated with a stable regimen of either Copaxone or Rebif as their principal first therapy for MS for six to 18 months prior to randomization. Patients must also have had disease activity within 12 months prior to screening defined as one or more clinical relapses or two or more new MRI lesions (Gd+ and/or T2 hyperintense lesions).

The primary endpoint of the study is the annualized relapse rate. Secondary endpoints include the change from baseline to 48 weeks in T2 lesion volume and the proportion of subjects who remain free of disease activity – defined as no clinical relapses, no new Gd+ lesions, no new or newly-enlarging T2 lesions, and no sustained progression on EDSS. Additional study objectives will evaluate the safety and tolerability of switching to TYSABRI.

Participants will be randomized in a 2:1:1 ratio to one of the following groups:

* Group 1: 900 patients will receive TYSABRI 300 mg intravenous (IV) every four weeks;
* Group 2: 450 patients will receive interferon beta-1a 44 mcg subcutaneous (SC) three times per week; and
* Group 3: 450 patients will receive glatiramer acetate 20 mg SC once daily.

Patients interested in learning more about the SURPASS trial may speak with their physician or e-mail [e-mail].

Dr. Richard Rudick is a paid consultant and speaker for Biogen Idec.

About TYSABRI

TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS.

Data from the Phase III AFFIRM trial highlights TYSABRI’s powerful efficacy. According to that data, which was published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001). In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSABRI-treated patients remained free of their MS activity, based on MRI and clinical measures, compared to 7 percent of placebo-treated patients.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Pharmaceuticals, Inc. For more information about TYSABRI, please visit www.tysabri.com, http://www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Pharmaceuticals, Inc., 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 are listed on the New York and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.
Contacts

MEDIA CONTACTS:
Biogen Idec
Kate Weiss, 617-914-6524
or
Elan
Mary Stutts, 650-794-4403
or
Miriam Mason, 650-877-7616
or
INVESTOR CONTACTS:
Biogen Idec
John Applegate, 617-679-2812
or
Kia Khaleghpour, 617-679-2812
or
Elan
Chris Burns, [phone] or 800-252-3526
or
David Marshall, [phone]

http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[Tebi]

Hi Aktionäre,

es gibt einen neuen Versuch seitens einiger Aktionäre,einen Wechsel im Management von Elan zu erwirken....Ihr könnt Euch beteiligen,indem Ihr auf Investorvillage.com dem User SPLAY per Bordmail Eure Anzahl der Aktien mailt + sagt dass Ihr die Aktion unterstützt.(Ich habs gemacht....weiss aber auch nicht mehr....kann ja allerdings nur besser werden...) lg

Msg 408000 of 408067 at 3/26/2010 7:56:34 AM by

splaylaywahtheepi

OKZ - shares to support change
You already know that Martin has lost institutional backing. Another poster has pointed out that your posts reflect your knowing that Martin has lost this important support AND the support of much of the internal company. You like to talk up Martin while implying or explicitly saying that everyone else is letting him down. This is probably a natural emotional attachment to a relative, and we all understand that.

As you know, at least at some level, selling assets and borrowing money is not that hard - but turning capital into more capital is hard. This is called operations. Piles of money do not merely multiply. People have to be organized along processes to produce something that is more valuable than the money you started with. Management. Martin doesn't care about operations and Elan desperately needs someone to drive the bus in a truly interested and committed manner.

Even publicity averse institutions are fed up with the seemingly endless line of bad choices made by the C-level officers and BOD at Elan. Doubtless, these officers and the BOD will fight tooth and nail to retain access to their ATM. But, this time we have a real chance to get a real management team that will be focused on delivering value to patients, shareholders and partners.

[Tebi]

Moin!

Msg 409715 of 409832 at 4/9/2010 7:51:42 AM by

godivatruffles6


Businessweek/Bloomberg: Biogen Races to Create Test for Brain Disease Linked to MS Drug


http://www.businessweek.com/news/2010-04-09/biogen-races-to-…

Click here to find out more!

Bloomberg
Biogen Races to Create Test for Brain Disease Linked to MS Drug
April 09, 2010, 6:20 AM EDT
More From Businessweek

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By Elizabeth Lopatto

April 9 (Bloomberg) -- Biogen Idec Inc. wants to take the fear out of prescribing its multiple sclerosis treatment Tysabri with a test that can tell patients their odds of getting a deadly brain illness from the drug.

The screening tool could be marketed as early as 2011 if clinical trials involving 9,000 people, set to start this year, show a low rate of false findings, said Naomi Aoki, a spokeswoman for the Cambridge, Massachusetts-based biotechnology company. The test is designed to detect the JC virus that causes progressive multifocal leukoencephalopathy, or PML, a brain-cell destroyer that can lead to disability and death.

Tysabri, which generated $1.1 billion in sales in 2009, has been linked to 42 PML cases, the company has reported. While it’s approved for use only after other drugs fail, 61 percent of 285 neurologists surveyed by RBC Capital Markets in San Francisco said Tysabri’s ability to slow MS progression would make it their first choice if they could assess the risk of PML.

If the test works, it is “absolutely a game changer,” said Patricia O’Looney, vice president of biomedical research at the New York-based National Multiple Sclerosis Society, in a telephone interview. “If Biogen can validate it, that takes out the guessing game.”

Tysabri was removed from the market on Feb. 28, 2005, after three patients developed PML, and two died. A year later, the U.S. Food and Drug Administration allowed Biogen and Dublin- based Elan Corp., its marketing partner, to resume selling the treatment after an advisory panel determined it was twice as effective as other drugs in slowing MS progression.

‘Longer-Term Positive’

It’s too early to set a dollar amount on the potential gain in drug sales based on such a test until the clinical trials are completed said Geoffrey Meacham, an analyst for J.P. Morgan in New York, in a telephone interview. A successful test that determines Tysabri is safe to use in some patients would be “a longer-term positive” for the company, he said.

Biogen’s shares, which sold for $67.28 on the last trading day before Tysabri was removed from the market, plunged 43 percent on the withdrawal. Shares have fallen 16 percent since Feb. 27, 2005, closing at $56.43 in Nasdaq Stock Exchange composite trading yesterday.

Biogen first tested their assay using blood samples taken from 11 patients who later developed PML, said Al Sandrock, senior vice president of neurology research and development. The findings from that study and research on the prevalence of JC virus will be presented next week at the American Academy of Neurology meeting in Toronto.

Behind Goal

Since the therapy returned to the market in 2006, the company hasn’t reached its goal to have 100,000 patients use it by the end of 2010. Tysabri is used by about 48,800 patients as of the end of 2009, according to Biogen. The company backed away from the goal last year, after a fifth patient developed PML.

About 200 new cases of multiple sclerosis are diagnosed weekly in the U.S., according to the National Institutes of Health. Patients, at first diagnosis, typically are prescribed Biogen’s Avonex; Rebif, made by Darmstadt, Germany-based Merck KGaA; Betaferon, made by Bayer AG, of Leverkusen, German; and Copaxone, by Israel-based Teva Pharmaceutical Industries Ltd.

While less effective than Tysabri, these drugs all carry fewer side-effects, Meacham said.

Biogen plans two clinical trials to determine the rates of false positives and false negatives. For patients who test positive, the risk of PML will be about 1 in 500, said Robert Fox, a neurologist at the Cleveland Clinic in Ohio. For those who test negative, though, the risk is “quite low,” Biogen’s Sandrock said.

MS Millions

About 400,000 Americans and 2.5 million people worldwide have multiple sclerosis, according to the National Multiple Sclerosis Society, a patient group.

The disease destroys neurons, leading to blurred vision, poor balance and coordination, problems with speaking, tremors, fatigue and paralysis. The malady is caused when the immune system mistakenly attacks myelin, a protective coating on nerve fibers, disrupting the brain’s communication with the body.

PML occurs when a common germ, called JC virus, mutates, then evades the body’s immune defenses and penetrates the brain, causing irreversible damage. Researchers theorize that Tysabri may subdue defenses meant to keep the virus out of the brain.

In February, the FDA updated Tysabri’s labeling to clarify its risks. The number of infections and deaths from PML remains about 1 in 1,000 overall. The rate is higher outside the U.S., with 2 of every 1,000 patients contracting the illness. The reason for the difference is unknown, the FDA said.

Antibody Presence

The test is designed to detect the presence of an antibody to the JC virus in the blood of patients, signaling that the patient has been infected.

With a false-negative rate of 2 percent, patients who are free of the virus would lower their risk of getting the brain disorder PML to 1 in 25,000 for the first three years of their Tysabri therapy, wrote analyst Joshua Schimmer of Leerink Swann, in a March 25 note to investors.

Since a patient may become infected with the JC virus at any time (it is passed through the air), part of Biogen’s task in its clinical trials is to determine how many patients become infected over time. This determination changes the odds that any one patient may get the disease.

Probably about 1 to 2 percent of patients will be infected yearly, Sandrock said.

Antibody Reliability

Eugene Major, a researcher at the National Institutes of Health in Bethesda, Maryland, said that when the NIH and others tested for the presence of the virus, rather than antibodies, they found that at least 70 percent of the population probably is infected. The company, based on antibody testing, has put that number at 50 percent.

“They’re underestimating the number of people who’ve been exposed,” Major said in a telephone interview. “We have strong evidence that the overwhelming majority, especially after the third and fourth decade, have been exposed.”

Biogen is looking at other biological signs of PML risk that may be incorporated to improve the test, Sandrock said. In those who test positive, Biogen is testing for markers to further determine which patients are at high risk, Sandrock said. Those markers may include certain genes that increase the risk of a brain infection, or viral mutation that allows JC virus to live in brain tissue.

“We know a lot about the benefits of Tysabri, and we know something about the risk,” said Sandrock. “If we can be specific about an individual’s risk versus an individual’s benefit, that would help patients make better-informed treatment decisions. Patients want to know, ‘what’s my risk?’”

--Editors: Angela Zimm, Lisa Rapaport

To contact the reporter on this story: Elizabeth Lopatto in New York at [e-mail].

To contact the editor responsible for this story: Reg Gale at [e-mail].

[GuHu1]

Antwort auf Beitrag Nr.: 39.305.637 von Tebi am 09.04.10 19:32:14

“absolutely a game changer,”
ich liebe diese aussage, wird aber langsam zeit das sich bei eln etwas positives tut.

[Poppholz]

Antwort auf Beitrag Nr.: 39.305.637 von Tebi am 09.04.10 19:32:14

Oh Oh.

Positive News.

Ich habe Angst.

[Tebi]

Antwort auf Beitrag Nr.: 39.306.387 von Poppholz am 09.04.10 21:57:41

...ich VERSTEHE Dich............... !!!

[welke91]

moin ihr alten haudegen,

jetzt kann man(n) bei elan mal wieder etwas wagen.

buy sentiment von welke!

grüße

[Tebi]

Antwort auf Beitrag Nr.: 39.307.489 von welke91 am 10.04.10 10:46:58

Schön von Dir zu hören!!!!!!!!!!!!!!!!!!!!!!

Fahren die Züge noch in die richtige Richtung...????

Steig ruhig bei uns wieder ein----Ziel :Altes HOCH....

[GuHu1]

Antwort auf Beitrag Nr.: 39.311.401 von Tebi am 11.04.10 21:26:57

Ziel :Altes HOCH....
na dann, wolln wir mal schauen ob sich geduld auszahlt....

[Tebi]

Antwort auf Beitrag Nr.: 39.319.746 von GuHu1 am 12.04.10 23:06:38

klar!

[welke91]

Antwort auf Beitrag Nr.: 39.320.398 von Tebi am 13.04.10 08:07:56

logisch!

so habe meine baby's sicher....

jetzt kann es starten!!! mal sehen wie der markt das aufnimmt:

AAN platform presentation shows MS patients treated with TYSABRI experienced no substantial changes in the presence of JCV DNA, and second platform shows that patients who developed progressive multifocal leukoencephalopathy (PML) had evidence of antibodies to JCV that suggests prior infection

One platform presents data suggesting that treatment with TYSABRI does not have a substantial effect on the presence of JCV DNA in MS patients. In the Dose Suspension Safety Assessment (n=1397) and STRATA (n=1094), JCV DNA was detected in less than 1 percent of all patients, approximately 50 percent of whom were TYSABRI naïve.

The second platform presents data indicating that patients who developed PML had evidence of prior infection with JCV, as measured by the presence of anti-JCV antibodies. Investigators evaluated serum samples from TYSABRI patients who developed PML where blood samples had been collected at least one year prior to the diagnosis of PML. Most of these samples were collected prior to beginning treatment with TYSABRI. In all of these patients, serum samples were positive for JCV antibodies prior to onset of PML, suggesting pre-existing JCV infection in these patients. Additional analyses are needed to determine whether anti-JCV antibodies are useful in stratifying for PML risk.



wells fargo hat gleich mal upperfom eingegeben!!!

[welke91]

Antwort auf Beitrag Nr.: 39.320.750 von welke91 am 13.04.10 09:06:08

hier noch mal damit ihr seht, dass es ernst wird....

zum ersten mal seit dem grauenvollen absturz konnte, eln einen 5er impuls EW nach oben vollenden.

Elliot wellen theorie...über die zeiten mal ein wenig verfolgt.

das muster hier unten lässt dies so nicht erkennen fand es aber sehr gut!



grüße

[Poppholz]

Antwort auf Beitrag Nr.: 39.319.746 von GuHu1 am 12.04.10 23:06:38

wenn es einige Personen verdient haben, dann ja wohl die ELANIES

[Poppholz]

April 13, 2010 02:30 AM Eastern Daylight Time
Large Body of Data on TYSABRI® to Be Presented at Annual Meeting of the American Academy of Neurology

– Data suggests improvement across broad range of functional and quality of life measures –

TORONTO--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced 15 company-sponsored platform and poster presentations at the American Academy of Neurology’s (AAN) 62nd Annual Meeting in Toronto, April 10 – 17, 2010. The AAN Annual Meeting is the world’s largest gathering of neurologists. The presented data, based on post-hoc analyses and patient-reported outcomes studies, highlights the ability of TYSABRI (natalizumab), in some multiple sclerosis (MS) patients, to improve sustained visual function, disability, overall quality of life (QoL), cognition and fatigue.

“TYSABRI continues to change the way neurologists and patients define success in the treatment of MS,” said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. “The data presented at AAN contribute to the growing body of scientific evidence supporting TYSABRI’s strong efficacy profile.”

Multiple sclerosis is one of the most common neurological disorders, affecting more than 400,000 people in the United States each year. Physical disabilities such as the loss of vision and difficulty walking are among the common symptoms associated with the disease and can have a devastating impact on quality of life for many MS patients. TYSABRI’s strong efficacy profile in treating MS demonstrated in clinical trials continues to be enhanced further with data such as those being presented at AAN.

Data from the 15 company-sponsored presentations at the conference show that TYSABRI, in some patients, improves sustained visual function, disability, overall QoL, cognition and fatigue. The presentations also include results from two studies related to the JC virus (JCV) and a follow-up study in pregnant women.

TYSABRI associated with sustained visual function improvement

Results of a post-hoc analysis of Phase III AFFIRM data demonstrated that TYSABRI is associated with sustained visual function improvement in some patients with MS. Vision impairment is one of the first symptoms experienced by many people with MS and can have a significant impact on daily life.

“Visual problems are often the first symptom of MS, and for many patients, the knowledge that vision may be compromised adds a level of anxiety about future quality of life and activities of daily living,” said Steven L. Galetta, M.D., University of Pennsylvania School of Medicine and an author on the study. “Fortunately, we have the suggestion from this study that natalizumab treatment may be associated with sustained improvement in visual function in some patients.”

In this post-hoc analysis, investigators examined whether TYSABRI caused improvement in visual function, as well as the capacity of low-contrast letter acuity (LCA), gray letters against a white background, and high-contrast letter acuity (HCA), standard black-on-white vision testing, to detect treatment-related improvement in visual function.

Visual improvement was measured by the number of letters a patient identified correctly at each visit. Cumulative probability of visual function improvement sustained over 12 weeks was determined for increases in score by seven letters, as well as by five letters and 10 letters.

Results showed that visual improvement, defined as ≥7-letter score increase from baseline, sustained for 12 weeks, was greater for TYSABRI (n=627) vs. placebo (n=314). This result was observed for LCA, where improvement in visual function at the 2.5 percent and 1.25 percent contrast levels was 57 percent (21.1% vs. 13.4%; HR=1.6, p=0.012) and 39 percent (31.6% vs. 23.9%; HR=1.4, p=0.014, Cox proportional hazards models), respectively. There were no significant differences between the treatment groups at the five-letter and 10-letter thresholds or the HCA.

The poster, Low-Contrast Letter Acuity Detects Visual Function Improvement in Phase 3 Relapsing MS Trials of Natalizumab (P05.060), will be available for viewing on April 15 from 7:30 a.m. - 12 p.m. EDT.

Dr. Galetta serves as a paid consultant for Biogen Idec.

Sustained improvement in physical function, as measured on the EDSS scale, was associated with improved quality of life for patients with relapsing MS taking TYSABRI

This study evaluated the relationship between sustained changes in disability, as measured by the Expanded Disability Status Scale (EDSS), and changes in patient-reported quality of life in TYSABRI patients. Disability improvement may be associated with improvements in patient-reported outcomes.

This analysis showed that sustained improvement in physician-rated EDSS scores was associated with sustained improvement in patient-reported QoL, including physical and mental components of QoL (as measured by Physical Component Summary, PCS, [p<0.0001] and Mental Component Summary, MCS, [p=0.0250] scores) and overall well-being (as measured by Visual Analogue Scale, VAS, [p<0.0001]). The association between sustained improvement in physician-measured EDSS and patient-reported measures of QoL suggests that EDSS is a meaningful outcome for assessing the impact of MS therapies on patients.

The poster, Improvement in EDSS Corresponds with Improvement in Quality of Life in Patients with Multiple Sclerosis (P02.169), will be available for viewing on April 13 from 3 - 7:30 p.m. EDT.

MS patients report improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI

In this ongoing one-year longitudinal study, patients with MS were asked to assess their outcomes using validated patient-reported outcome measures prior to treatment initiation and after the third, sixth and 12th infusions with TYSABRI. The posters presented at AAN show that patients reported significant improvements in quality of life, including physical and psychological well-being, as well as reduced fatigue and improved cognitive function after one year of treatment with TYSABRI.

One of the posters on this study, Effect of Natalizumab on Disease-Specific Quality of Life after One Year of Natalizumab Treatment (P02.164), will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. Another titled Improvement in Health-Related Quality of Life in Multiple Sclerosis Patients Receiving Natalizumab in the United States (P02.166) will be available for viewing on April 13 from 3 - 7:30 p.m. EDT. A third titled Improvement in Patient-Reported Fatigue and Cognitive Function over Time with Natalizumab Treatment (P06.167) will be available for viewing on April 15 from 3 - 7:30 p.m. EDT.


AAN platform presentation shows MS patients treated with TYSABRI experienced no substantial changes in the presence of JCV DNA, and second platform shows that patients who developed progressive multifocal leukoencephalopathy (PML) had evidence of antibodies to JCV that suggests prior infection

One platform presents data suggesting that treatment with TYSABRI does not have a substantial effect on the presence of JCV DNA in MS patients. In the Dose Suspension Safety Assessment (n=1397) and STRATA (n=1094), JCV DNA was detected in less than 1 percent of all patients, approximately 50 percent of whom were TYSABRI naïve.

The second platform presents data indicating that patients who developed PML had evidence of prior infection with JCV, as measured by the presence of anti-JCV antibodies. Investigators evaluated serum samples from TYSABRI patients who developed PML where blood samples had been collected at least one year prior to the diagnosis of PML. Most of these samples were collected prior to beginning treatment with TYSABRI. In all of these patients, serum samples were positive for JCV antibodies prior to onset of PML, suggesting pre-existing JCV infection in these patients. Additional analyses are needed to determine whether anti-JCV antibodies are useful in stratifying for PML risk.

The first platform presentation, Effects of Natalizumab Treatment on the Presence of JC Virus DNA in Blood or Urine in Multiple Sclerosis Patients (S31.002), is on April 14 during the session from 4:15 - 5:30 p.m. EDT, and the second, Evaluation of the Incidence of Anti-JCV Antibodies in a Cohort of Natalizumab-Treated MS Patients (S31.003), is on April 14 during the session from 4:15 - 5:30 p.m. EDT.

Preliminary pregnancy outcomes among women exposed to TYSABRI

The TYSABRI Pregnancy Exposure Registry (TPER) is an observational, exposure-registration, follow-up study of pregnant women with MS or Crohn’s disease who were exposed to TYSABRI within three months prior to conception or at any time during pregnancy. The study is being conducted in the United States, Canada and the rest of the world. Information on TYSABRI exposure, potential confounding factors and pregnancy outcomes is being collected. Enrollment in the TPER is ongoing.

The poster, Preliminary Evaluation of Pregnancy Outcomes from the TYSABRI® (Natalizumab) Pregnancy Exposure Registry (P01.185), will be available for viewing on April 13 from 7:30 a.m. - 12 p.m. EDT.

About TYSABRI

TYSABRI is approved in more than 45 countries. In the U.S., it is approved for relapsing forms of MS and in the European Union for relapsing-remitting MS.

Data from the Phase III AFFIRM trial highlights TYSABRI’s powerful efficacy. According to that data, which was published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68 percent relative reduction (p<0.001) in the annualized relapse rate when compared with placebo and reduced the relative risk of disability progression by 42-54 percent (p<0.001). In post-hoc analyses of the Phase III AFFIRM trial and as published in The Lancet Neurology, 37 percent of TYSABRI-treated patients remained free of their MS activity, based on MRI and clinical measures, compared to seven percent of placebo-treated patients.

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain. The risk of PML increases with increasing duration of use. Other serious adverse events that have occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g., anaphylaxis) and infections, including opportunistic and other atypical infections. Clinically significant liver injury has been reported in patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain and rash.

TYSABRI is co-marketed by Biogen Idec Inc. and Elan Pharmaceuticals, Inc. For more information about TYSABRI, please visit www.tysabri.com, www.biogenidec.com or www.elan.com, or call 1-800-456-2255.

About Biogen Idec

Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients worldwide benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.

About Elan

Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares are listed on the New York and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[GuHu1]

Antwort auf Beitrag Nr.: 39.322.015 von Poppholz am 13.04.10 11:19:11

ich hoffe du hast mich nicht falsch verstanden, jeder longie der aus überzeugung in ein unternehmen investiert hat es verdient am ende auch belohnt zu werden.

bin im übrigen auch investiert und das nicht seit gestern.

[Tebi]

http://www.dr-hankel.de/brief-an-die-bundesregierung/" target="_blank" rel="nofollow ugc noopener">http://www.dr-hankel.de/brief-an-die-bundesregierung/
ich hab´s unterschrieben---<<<<<<<Ihr vielleicht auch?? Lieben Gruss (Kampagne für Gold,Elan und die DM2)

[Poppholz]

Antwort auf Beitrag Nr.: 39.327.303 von GuHu1 am 13.04.10 20:38:00

alles gut

[welke91]

Antwort auf Beitrag Nr.: 39.328.858 von Tebi am 14.04.10 00:51:35

hi tebi,

habe auch unterschrieben.

paar Namen hinter dir.

Na da warst du aber auch noch lange wach gestern.

Ich finde es lohnt sich allemal den Prof. Hankel zu unterstützen.

Werde auch noch ein wenig spenden. www.pro-europa-ev.de

Warum nimmt der Markt die News nicht auf?

Ich meine da wird veröffentlicht, dass PML nicht in Verbindung mit Tysabri gebracht werden kann. Sondern vorher schon Antikörper ausgebildet wurden.

Das heißt, dass es schon eine orginäre Infektion vor der Infektion gab.

Aber nothing keine reaktion. Das sind wir ja gewöhnt.

Charttechnisch sollt es noch nach oben gehen sehe momentan keine besorgnis!

Heute wird ja die PML-Sache veröffentlich mal sehen ob das etwas bringt.

grüße

[Tebi]

Antwort auf Beitrag Nr.: 39.331.743 von welke91 am 14.04.10 12:52:07

...fein! lg Birgit

[welke91]

und tschüss..

wieder pml fälle und wieder keine puste mehr....



wird mal zeit, dass der pml-test läuft...

sonst säuft die kiste ab.

[bernie55]

Antwort auf Beitrag Nr.: 39.348.514 von welke91 am 16.04.10 11:34:57

The latest monthly safety update on Tysabri reveals that there have been four more cases of PML confirmed in patients over the course of the last month (to April 6th), bringing the total to date to 46.

The rate of new cases is lower than March and is more in line with previous months (i.e. circa one per week). PML has proved fatal in 11 (24%) of the cases.

Observing the data by treatment epoch is perhaps the most useful method as it clearly calculates the number of PML cases, per 1,000 patients, for each period. As the only incidence rate to change significantly month-on-month (mom) is the 37-48 month period, the recent cases must have occurred in patients with that duration of treatment.

The overall incidence rate is 0.67 (all data per 1,000 patients).

For 1-12 months, the rate is 0.01 – suggesting little or no PML.

For 13-24 months, the rate is stable at 0.33.

25-36 months incidence actually fell slightly mom to 1.33.

The incidence rate for 37-48 months rose from 0.62 to 0.89 mom, a large percentage increase but low in absolute terms (as only four new cases were reported overall).

Notably, Elan/BIIB also provide estimates (to 95% confidence levels) of what the upper and lower bounds of incidence may be for each of the treatment periods. As one would expect, the upper bounds are highest in the periods of longer duration (25-36 months, 37-48 months) – they are both approximately 2.0 per 1,000. Although statistics are notoriously dangerous to rely upon, the upper bounds have not moved beyond this level for some months and would have been around the levels observed by FDA/EMEA when they conducted their risk/benefit analyses.

http://www.investorvillage.com/smbd.asp?mb=160&mn=410864&pt=…

[bernie55]

...... schöne Grüße in die Runde......

[bernie55]

Antwort auf Beitrag Nr.: 39.348.820 von bernie55 am 16.04.10 12:00:49

..sorry, hatte vergessen, eine weitere wichtige Passage zu kennzeichnen...

......the upper bounds are highest in the periods of longer duration (25-36 months, 37-48 months) – they are both approximately 2.0 per 1,000

[Tebi]

Elan Announces Exploration Of EDT Separation And Board Changes

Elan Drug Technologies

businesswire

*
Companies:
o Elan Corp. plc

Press Release Source: Elan Corporation, plc On Monday April 19, 2010, 2:00 am EDT

DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc has decided to explore the possibility of a separation of its Elan Drug Technologies (EDT) business. If executed, any transaction would create two distinct publicly listed companies: Elan BioNeurology and EDT, with each entity being a leader in its field of expertise. The purpose of this exploration is to accurately assess the opportunity and impact on shareholder value.

On an operating basis, both EDT and BioNeurology are now profitable. Each represents vastly different investment propositions, and each generates distinct and on-going capital requirements for utilization against a broad array of potential opportunities.

The company’s review will include detailed assessment of the possible separation, including timing, market conditions and the impact on all of its key constituencies. The Company expects to make a decision whether to proceed in the coming months. No specific timetable has been set for completion of the review and there can be no assurances that such a transaction will take place.

Board changes

Separately, Kyran McLaughlin, the Chairman of the Board has informed the Board of his intention to retire as Chairman. The Board has authorized a search for a new Chairman and has appointed Dr. Dennis Selkoe – a founder of Athena Neurosciences - to oversee the search process in conjunction with the Nominating and Governance Committee. Mr. McLaughlin will continue to serve as Chairman until a successor is appointed.

Under Mr. McLaughlin’s exceptional leadership, Elan has made significant and fundamental business strides and has emerged a stronger company. The company has greatly reshaped its balance sheet, simplified its operations, and aligned its resources. Elan now has an industry leading drug delivery business as well as a leading neurology - based biotechnology company. In addition, Mr. McLaughlin provided invaluable leadership during the company’s strategic review that ultimately culminated with the September 2009 Johnson & Johnson transaction, which IN VIVO has hailed as a “Deal of the Year” for 2009.

Lead Director Kieran McGowan commented, “On behalf of the entire Elan Board of Directors, we thank Kyran for his leadership and commitment to Elan over the past five years as Chairman, and are greatly indebted to him for providing the guidance necessary to advance the business and the company overall.”

The company also announced the resignation of Bill Rohn from the Board. Chairman Kyran McLaughlin thanks Bill for his nearly four years of dedicated service to the company and wishes him well in all of his future endeavors.

The company does not plan to make further announcements on either the possible separation of EDT, or the new Chairman search process, until a final decision by the Board has been made in each case.

About Elan

Elan Corporation, plc (NYSE: ELN - News) is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Elan shares trade on the New York and Irish Stock Exchanges. For additional information about the company, please visit www.elan.com.

[Tebi]

By QUENTIN FOTTRELL

DUBLIN—Elan Corp. reported a much narrower first-quarter net loss and forecast an operating profit for the full current year, reassuring investors that its balance sheet is being repaired and that Elan's two core business divisions can stand on their own independently.

The Ireland-based drug maker, which reports in dollars, posted a first-quarter net loss of $2 million, dramatically smaller than the $102.6 million net loss a year earlier.

Elan's chief financial officer, Shane Cooke, predicted the improving trend will generate full-year revenue growth and adjusted earnings before interest, tax, depreciation and amortization of more than $150 million.

The improved results shed light on Elan announcement's Monday that it is again exploring the possibility of spinning off Elan Drug Technologies, or EDT, into a separate publicly listed company. Chief Executive Kelly Martin said the company will explore whether it can grow each business faster and bigger as separate entities.

Analysts note Elan has been through many potentially transformative events: the relaunch of multiple sclerosis drug Tysabri in 2006, last year's strategic investment by Johnson & Johnson, the proposed separation of Elan BioNeurology from its drug-delivery business Elan Drug Technologies, and now a return to underlying operating profit.

A crucial event occurred last year when Johnson & Johnson paid $885 million for an 18.4% stake in Elan and acquired rights to advanced research into drugs for Alzheimer's disease, representing most of the value credited to the Elan Alzheimer's pipeline at the time. The move helped the Irish company shore up its balance sheet.

Still, prospects for Tysabri's future rate of growth remain unclear to some analysts.

Revenue in the first quarter rose 27% to $310.5 million, helped by increased sales of Tysabri and by contract manufacturing revenues. Elan booked $198.8 million in Tysabri sales—but that was 10% below Goodbody Stockbrokers' expectations of $221 million.

Elan and its joint venture partner on Tysabri, U.S.-based Biogen Idec Inc., suspended Tysabri in the U.S. in 2005 after two patients using combination therapy contracted a rare brain infection, progressive multifocal leukoencephalopathy or PML. Tysabri was approved in the U.S. and EU primarily as a monotherapy a year later.

On Tuesday, Biogen reported Tysabri's first-quarter sales were slower than market expectations due to patient concerns about the risk of PML.

Davy Research Wednesday said Tysabri's risk/benefit profile is "complicating the near-term picture." Still, the broker said the 190 net new Tysabri patients per week in March was promising. "This may indicate that the market is digesting the label changes implemented in the U.S. and EU around year-end," it said. Davy has an outperform on the stock.

CEO Martin said that "ultimately, you could have an EDT business that is cash-flow positive with some debt on its balance sheet." That would allow Elan BioNeurology to open up resources to add to its assets and invest more in Tysabri clincial research, the company said.

Martin said the primary focus for EDT will be an IPO on the stock exchange--but he added that doesn't preclude a possible private equity option or trade sale.

It is Elan's second attempt to divest itself of EDT—in 2008 it failed to find a buyer for EDT due to the global financial crisis, analysts say.

Elan had $1.54 billion in long-term debt at end-March 2010, unchanged from its position at end-December 2009.

Write to Quentin Fottrell at [e-mail]

[Tebi]

Supernova for Elan
Will the Drugs Ever Work for Elan?


By Quentin Fottrell

Is this a new dawn for Elan? Has the Irish pharmaceutical company finally turned that corner? It has claimed to have done so several times in the past and then — bam! — another unforeseen event came out of nowhere.

Elan reported a much narrower first-quarter net loss year-on-year earlier Wednesday and forecast an underlying operating profit for the full current year–the first time it has made such a prediction in several years. [Read our coverage here.]

Shareholders have seen Elan through accounting difficulties that slammed the share price, rejoiced when multiple sclerosis drug Tysabri was launched and gasped when it was withdrawn from the market in 2005.

Five years is a long time for Elan. It re-launched Tysabri in 2006, got a new CEO in the guise of straight-talking and capable Kelly Martin, and sealed an $885 million strategic investment by Johnson & Johnson last year.

In return, J&J received an 18.4% stake in Elan and also acquired rights to advanced research into drugs for Alzheimer’s disease, representing most of the value credited to the Elan Alzheimer’s pipeline at the time. [Read the press release here.]

Now the company wants to separate Elan BioNeurology–which owns its precious blockbuster drug Tysabri and its remaining Alzheimer’s pipeline program–from its drug-delivery business Elan Drug Technologies.

The future looks bright. But some analysts like Goodbody Stockbrokers’ Ian Hunter remain cautious. He has a “sell” rating on the stock. Others, like Davy Research’s Jack Gorman, maintain an “outperform” rating.

So … what could go wrong? Tysabri is the most effective MS drug on the market. There’s no doubt Tysabri has been a Heaven-sent for MS sufferers. But Elan is still highly dependent on it–and it does not come without risks.

While they make up the bulk of revenue for Elan, Tysabri sales have been slower than expected due to the risk of a rare brain disease called progressive multifocal leukoencephalopathy or PML. It’s as scary as it sounds.

Biogen Idec–Elan’s joint venture partner on Tysabri–said about 50,300 patients were using Tysabri at end-March or net additions of around 1,500 patients on the previous quarter. Some analysts expected 2,000 new patients.

Then there is the shadow of PML: Biogen Idec last week disclosed four more cases of PML, bringing the total number of cases to 46 as of April 6. It also reported two more deaths in PML patients, bringing total fatalities to 11.

Elan’s stock has never been for the faint-hearted. Elan’s share price fell from its 2002 high of €50.27 due to the revelation of now-resolved accounting troubles in 2002, and the aforementioned temporary suspension of Tysabri.

That temporary setback followed a long and arduous recovery for Elan, beginning with a change of senior management in 2002 when its former CEO and Chairman, the late Donal Geaney, resigned amid accounting troubles.

And now? It’s all to play for. It still has long-term debt of $1.54 billion so it needs Tysabri, the superdrug that reversed its fortunes. Elan’s shares are down 65% in two years, but rose over 30% in the last 12 months.
Elan hopes that its pipeline Alzheimer’s drug Bapineuzumab will have supernova potential. But, with just one blockbuster drug on the market, this is only the end of one chapter for Elan–and the beginning of another.

http://blogs.wsj.com/source/2010/04/21/will-the-drugs-ever-w…

[posimist]

Antwort auf Beitrag Nr.: 39.381.357 von Tebi am 22.04.10 10:32:09

TEBI,wenn es mir nach geht,
kann die Supernova alsbald kommen.
posimist

[Tebi]

Antwort auf Beitrag Nr.: 39.400.206 von posimist am 26.04.10 12:21:52

...stimmt!

[welke91]

Antwort auf Beitrag Nr.: 39.400.325 von Tebi am 26.04.10 12:40:14

mmmh leute schaut nicht doll aus...

wenn 6,84$ bzw. 6,6 $ nicht halten sollten sehe ich keinen grund warum das baby hier sich nicht auf den hintern setzt!

ziel wären dann 4,50 $!

allgemein sieht die lage eher schlecht aus.

Goldman Sachs ist gestern unter eine wichtige unterstützung gerutscht.

denke, dass die indizes folgen werden!

damit ist das umfeld mehr als schlecht...

man sollte über shorts nachdenken....

keine sorge, hechtbarsch wird dies bestätigen das sage ich schon über einen halben jahr!

aber irgendwann muss es doch mal...

grüße und viel glück

[welke91]

schon mitgezeichnet?

https://epetitionen.bundestag.de/index.php?action=petition;s…

Tippe Dax in nächster Zeit 5300 -5200 Punkte.

Zu weit aus dem Fenster?

Nun ich glaube dran.

und wenns weiter runter geht gilt ne andre zählung.

dann gute nacht!

Gruß

[Tebi]

Antwort auf Beitrag Nr.: 39.408.358 von welke91 am 27.04.10 14:11:59

...bin schon länger short(Dax)....war bisher teuer....aber astrologisch soll es Ende April + Mai runtergehen...sieht für mich auch im Moment so aus...lg Birgit

[surga]

Antwort auf Beitrag Nr.: 39.409.474 von Tebi am 27.04.10 16:18:25

Leute, was ist los mit ELAN?

[welke91]

Antwort auf Beitrag Nr.: 39.418.283 von surga am 28.04.10 15:42:34

hi leute

elan testet unterstützung,...6,6 wenn da durch wird es sehr eng...

shortsignal beim dax noch nicht bestätigt...

aber denke es geht nochmal runter! dann wird es sich entscheiden wie man zählen muss!

schon unterschrieben?

https://epetitionen.bundestag.de/index.php?action=petition;s…

Ich hoffe Birgit dass ihr am 09.05 etwas bewegen könnt!

Die sind doch irre in Berlin. Haben jeglichen Kontakt verloren!

120 Mrd. sind es jetzt schon allein für dieses Jahr die refinanziert werden müssen!

Birgit deine Theorie zur astronomischen Bestimmung interessiert mich. Gern per BM.

grüße

[Tebi]

Originally published May 10 2010
Alzheimer's drug clinical trial halted after nine deaths
by David Gutierrez, staff writer

(NaturalNews) Elan Corp. and Transition Pharmaceuticals have called a premature halt on trials on the two highest doses of their experimental Alzheimer's drug ELND005 after the deaths of nine study participants.

"Greater rates of serious adverse events, including nine deaths, were observed among patients receiving the two highest doses. A direct relationship between ELND005 and these deaths has not been established," the companies said.

The announcement was greeted as particularly bad news for Elan, which recently had to update the safety label of its multiple sclerosis drug Tysabri after studies showed a heightened risk of death among patients taking it.

Elan and Transition had already completed a successful Phase I trial of the new drug, which showed that it built up in high concentrations in the brain and appeared to preserve higher levels of a key nerve-protecting enzyme. In the Phase II trial, the companies had been testing 353 people with either 250 milligram, 1,000 milligram or 2,000 milligram doses of the drug.

The decision to halt the two higher-dose trials was made in consultation with the study's Independent Safety Monitoring Committee. As no deaths were seen in the 250 milligram group, those tests will continue.

Although there was little effect on the companies' stock prices, analysts predicted an uphill battle for approval of the experimental drug.

"This is a considerable blow for the progress of the drug," Ian Hunter of Goodbody said.

"At the very least, efficacy at the lower dose will need to be compelling to justify development and ultimate approval," said Jack Gorman of Davy Stockbrokers.

Elan is also developing another Alzheimer's drug, this one in partnership with Johnson & Johnson, but progress on that product is not nearly as advanced.

Alzheimer's disease is the most common form of dementia, affecting more than five million people in the United States alone. The disease is characterized by a progressive loss of cognitive function, and is currently incurable. An Alzheimer's drug has been called the "holy grail" for pharmaceutical companies, but so far no effective cures seem forthcoming.

Sources for this story include: www.reuters.com; www.irishtimes.com.
Share Buzz up!

[Tebi]

Antwort auf Beitrag Nr.: 39.493.263 von Tebi am 10.05.10 16:55:45

Sorry,scheint eine alte Meldung zu sein,die nur neu aufgekocht wird----also nix beunruhigendes...

[posimist]

Antwort auf Beitrag Nr.: 39.493.312 von Tebi am 10.05.10 17:01:40

Phase 2 der Alzheimerstudie sollte im Mai 2010 abgeschlossen werden.Das weiß auch der Typ, der die alten Kamellen nochmal ausgepackt hat.
Die Ergebnisse werden sicher nicht uninteressant sein, nicht zuletzt für die Richtung des Aktienkurses.
Tebi,
wann rechnest du mit der Veröffentlichung des Ergebnisse?
posimist

[Tebi]

Antwort auf Beitrag Nr.: 39.507.647 von posimist am 12.05.10 14:32:20

...leider weiss ich das auch nicht---frage mal im Investor-board + melde mich wenn ich was weiss......lieben Gruss in die Runde

[Tebi]

Antwort auf Beitrag Nr.: 39.507.675 von Tebi am 12.05.10 14:35:36

Offiziell 2012;inoffiziell schon 2011....im Juli entscheidet sich wohl ob Phase3 von ELND gestartet wird----alles Infos von "Ridge" aus dem IV-Board. Gruss!

[surga]

Antwort auf Beitrag Nr.: 39.516.797 von Tebi am 13.05.10 20:21:35

von Popholz habe ich schon lange nicht mehr gelesen

[Tebi]

Antwort auf Beitrag Nr.: 39.583.487 von surga am 26.05.10 09:33:06

tja,was soll man bei dieser bescheidenen Performance auch schreiben? Wir warten Alle auf bessere "Elan-Zeiten"....Lieben Gruss!

[surga]

http://online.wsj.com/article/BT-CO-20100527-703775.html?mod…

Hat er erst jetzt erkann?

Elan CEO: Share Price Shows "Disconnect From Fundamentals"

DUBLIN (Dow Jones)--Irish drug maker Elan Corp. PLC's (ELN) share price shows a "disconnect from the fundamentals" of the business, Chief Executive Officer Kelly Martin said Thursday, but he said he was pleased with progress made in the group's drug pipleine.

At the group's annual general meeting, Martin told shareholders, "You've been exceptionally supportive and patient," though some shareholders expressed dismay about the share price.

The company said it expects to break-even on a cash flow basis this year.

Martin said Elan is exploring the possibility of spinning off its drug-delivery business Elan Drug Technologies into a separate publicly-listed company. The company said it was "early days" regarding initial discussions with debt and equity investors.

At 0930 GMT, Elan was up 1.7% at EUR4.27 in a flat overall market. The stock rose 23% in the eight weeks to early April, but has since fallen around 35% to a seven-month low due to the risk associated with its pipeline, analysts say.

Last year, Johnson & Johnson (JNJ) paid $885 million for an 18.4% stake in Elan and acquired rights to much of Elan's research into drugs for Alzheimer's disease. Phase III of Alzheimer's treatment Bapineuzumab was extended, the company said, because J&J has resources and the scale to pursue approval for the best label and product--not the fastest.

Elan and its joint venture partner on multiple sclerosis drug Tysabri, Biogen Idec Inc. (BIIB), suspended Tysabri in the U.S. in 2005 after two patients using combination therapy contracted a rare brain infection, progressive multifocal leukoencephalopathy or PML. Tysabri was approved in the U.S. and European Union primarily as a monotherapy a year later.



-By Quentin Fottrell, Dow Jones Newswires; [phone]; [e-mail]

[surga]

hat doch was geholfen

[Tebi]

Antwort auf Beitrag Nr.: 39.596.213 von surga am 27.05.10 21:29:34

ein bisschen...

[bernie55]

Antwort auf Beitrag Nr.: 39.596.301 von Tebi am 27.05.10 21:48:03

..zuerst mal liebe Grüße in die Runde....

...hier einige Auszüge aus folgendem Artikel....


Blockbuster Drugs Aimed at Busting MS

By Brian Orelli, Ph.D.
May 26, 2010 | Comments (0)



Today is the second annual World Multiple Sclerosis (MS) Day. Seems like a good day, I think, to take a good look at the current offerings and up-and-coming treatments for the debilitating disease.

Copaxone > Teva Pharmaceuticals (Nasdaq: TEVA)

Rebif > Merck KGaA and Pfizer

Betaseron > Bayer

Avonex > Biogen Idec

Tysabri > Biogen Idec and Elan

Each and every one of them is a blockbuster and a couple -- Copaxone and Tysabri -- are still growing like gangbusters.

Top selling Copaxone got a boost from a label change that said it could be used at the earliest possible time after just one multiple sclerosis attack. Whether it can keep up that growth remains to be seen.

New patients going onto Tysabri have actually slowed down recently as the number of cases of progressive multifocal leukoencephalopathy (PML), a potentially deadly brain infection, has increased.

Elan and Biogen have a three-pronged approach to reaccelerating sales:

* Develop a test for the virus that causes PML in combination with Tysabri to help patients determine their risk of getting PML.
* Develop a treatment for patients that develop PML.
* Test Tysabri against other multiple sclerosis drugs -- Rebif and Copaxone -- to show that treatment with Tysabri early in the disease progression is helpful.

All three will take awhile to develop because clinical trials are involved. That leaves Tysabri in somewhat of a holding pattern waiting for its chance to catch up to the top-selling drugs.



http://www.fool.com/investing/general/2010/05/26/blockbuster…

[surga]

Antwort auf Beitrag Nr.: 39.596.301 von Tebi am 27.05.10 21:48:03

klein Vieh macht auch Mist

[bernie55]

Irish drugmaker Elan says CEO to quit in 2012
Irish drugmaker Elan says CEO to quit in 2012
Irish drugmaker Elan says CEO to quit in 2012
Irish drugmaker Elan says CEO to quit in 2012


Thu Jun 3, 2010 2:46am EDT

* Change to fixed-term contract; to leave all duties in 2013

* CEO, chairman had rows with shareholders....u.a. mit TEBI und CO....


DUBLIN, June 3 (Reuters) - Kelly Martin will quit as chief executive of Elan Corp (ELN.I) in 2012 and from all duties at the Irish drugmaker a year later, the company said in a move that could help resolve rows between its board and shareholders.

Elan said it had changed Martin's contract from open-ended to a fixed term to "provide clarity and continuity on the executive leadership of the company".

"Mr. Martin and the executive team continue to be dedicated and focused on key drivers of growth and value for Elan and its pipeline, as well as its strong relationships with its collaborators and partners," Elan said in a statement.

Elan shareholders have voiced disapproval of the board in the past and director Jack Schuler, a former Abbott Laboratories (ABT.N) executive, called for Martin to resign before he was appointed to the board last year. [ID:nN11520690]

Elan announced in April that Kyran McLaughlin would retire as chairman with a replacement to be chosen by September or October.

McLaughlin had to put himself forward for re-election at a shareholder meeting last month and -- along with another director -- was opposed by an unusually large 28 percent of shareholders.

[ID:nLDE64Q1C4] (Reporting by Andras Gergely; Editing by Hans Peters)


http://www.reuters.com/article/idCNLDE65205V20100603?rpc=44

[bernie55]

Antwort auf Beitrag Nr.: 39.625.635 von bernie55 am 03.06.10 11:02:46

Davys morning wrap
Price $5.72 Rating: Outperform Issued: 30/06/09
Through a change in its CEO's employment contract, Elan has effectively
announced that Kelly Martin will step down from his role on May 1st, 2012, or
almost two years from now.
This amends the open-ended employment agreement that had been in place since
he assumed the role in 2003. The new contract allows Martin to stay on as an
executive advisor to the board until the end of January, 2013.
The announcement adds to the many organisational and structural changes that
have occurred at Elan over the last 12 months. Principal among these are the J&J
transaction, the subsequent debt refinancing, the phasing-out of its minor
products (Prialt, Maxipime and Azactam), the retirement of the chairman and the
exploration of a potential separation of the group into its bio-neurology and EDT
components.

http://www.investorvillage.com/smbd.asp?mb=160&mn=417232&pt=…

[surga]

Antwort auf Beitrag Nr.: 39.625.635 von bernie55 am 03.06.10 11:02:46

endlich,
ist aber noch lange hin.
Er kann noch viel kaputt machen

[Tebi]

Antwort auf Beitrag Nr.: 39.627.990 von surga am 03.06.10 16:45:35

stimmt!:O

[Tebi]

Article in WSJ yesterday havent seen this posted.

08:17 03Jun10 DJN-WSJ UPDATE: Elan CEO Martin To Step Down In 2012<ELN.I><ELN.N>
WSJ UPDATE: Elan CEO Martin To Step Down In 2012<ELN.I><ELN.N>

By Jeanne Whalen
Of THE WALL STREET JOURNAL

Irish biotechnology company Elan Corp. (ELN), facing long-running shareholder
dissatisfaction over company management, said Chief Executive Kelly Martin will
step down in 2012.
The news comes about six weeks after Elan said its chairman, Kyran
McLaughlin, would retire.
Martin was hired in 2003 to turn Elan around after an accounting scandal, and
was initially credited with improving the company's fortunes. But shareholder
discontent with his performance has mounted in recent years.
(This story and related background material will be available on The Wall
Street Journal Web site, WSJ.com.)
Some shareholders began pressuring for Martin's ouster in 2008, saying he had
botched the marketing of the company's most important drug--Tysabri for multiple
sclerosis--and wasted company money on private jets and an excessive number of
offices. They also lobbied for changes at the board level. Martin and McLaughlin
defended their record but made some changes, promising to close some offices and
cut other costs.
Some large shareholders later accused Martin and the board of mishandling a
deal with Johnson & Johnson (JNJ) involving Elan's experimental drugs for
Alzheimer's, and failing to publicly disclose certain elements of the deal. In
recent weeks, some shareholders have written to Elan's board expressing concern
over management's exploration of a spin-off of its drug-delivery business, Elan
Drug Technologies.
Martin and McLaughlin weren't immediately available to comment Thursday.
Elan said in a statement that Martin would serve as chief executive officer
and board member until May 1, 2012, "with a provision to then serve the board as
executive adviser through Jan. 31, 2013."
"The adopted timeframe enables Kelly and the board of directors to conduct a
comprehensive succession process," the statement said. "Elan's board recognizes
the significant contribution Kelly has made to the company since 2003 and looks
forward to the company benefiting from Kelly's continued leadership and direction
in the coming years."
Elan's stock price plummeted by more than 70% in late July and early August
of 2008 after disappointing news about Tysabri and a key Alzheimer's drug, and
has languished since then. The stock's current price on the New York Stock
Exchange of about $6 a share is roughly equal to where the shares traded five
years ago.
Elan's sale of 18.4% of the company to Johnson & Johnson last year did little
to improve Elan's stock price. Johnson & Johnson initially agreed to pay $1.5
billion for the stake and for partial control of Elan's experimental Alzheimer's
drugs.
A federal judge in the U.S. later ruled that an initially undisclosed clause
of the deal breached a partnership agreement between Elan and Biogen Idec Inc.
(BIIB), which jointly market Tysabri. That clause would have given J&J a lever of
control over Biogen--the ability to purchase Biogen's stake in Tysabri if Biogen
were ever acquired.
Johnson & Johnson and Elan were forced to remove that clause from their deal,
prompting J&J to knock $115 million off the deal price.

-By Jeanne Whalen, The Wall Street Journal; [e-mail]

(END) Dow Jones Newswires

[Tebi]

...tja--hier sieht frau was GUTES Marketing ist----ein Medikament (Pille!) gegen MS bekommt vom advisory committee first-line Empfehlung,obwohl ACHT Prozent der Patienten schwere Nebenwirkungen gezeigt haben...
Bloomberg's Take: Novartis MS Pill Can Be Used Safely, FDA Panel Says (Update1):
Link; http://www.bloomberg.com/apps/news?pid=20601087&sid=a5EVuMqi…

Novartis MS Pill Can Be Used Safely, FDA Panel Says (Update1)
Share Business ExchangeTwitterFacebook| Email | Print | A A A
By Catherine Larkin

June 10 (Bloomberg) -- Novartis AG’s Gilenia, the first pill to treat multiple sclerosis, can be used safely under certain conditions, a U.S. panel said.

The safety of the Swiss drugmaker’s product at a daily dose of 0.5 milligrams was backed by outside advisers to the Food and Drug Administration in a 25-0 vote today in Silver Spring, Maryland, after a positive recommendation on the drug’s effectiveness. They will discuss later today if Gilenia should be restricted to certain patients.

Novartis is racing German drugmaker Merck KGaA to sell the first pill to delay progression of MS, a neurological disease that affects 2.5 million people worldwide. Potential lung and heart risks seen in studies of the proposed dose of Gilenia aren’t as critical as the need for alternatives to current injectable therapies led by Biogen Idec Inc.’s Avonex and Teva Pharmaceutical Industries Ltd.’s Copaxone, the panel said.

“This is an enormously effective drug,” said Cynthia Sitcov, the panel’s patient representative. “I hope the agency approves it at the current dose.”

The panel voted 20-5 in favor of a new study testing a 0.25 milligram Gilenia pill once a day, which the FDA suggested may be “much safer” than the proposed dose. The panel voted unanimously that the study can wait until after the drug is on the market. Novartis said testing a lower dose would take 2,000 patients and five to six years.

Shares Rise

American depositary receipts of Novartis, each representing one ordinary share, rose $1.52, or 3.3 percent, to $47.45 at 4 p.m. in New York Stock Exchange composite trading. Novartis, based in Basel, Switzerland, declined 13 percent so far this year in New York trading.

The FDA usually follows its panels’ recommendations, though the agency isn’t required to do so. The agency is scheduled to decide whether to approve Gilenia by September. The review, initially set for six months, was delayed three months when Novartis said May 25 that the agency had requested additional analysis of current data.

The advisers also recommended that the first dose of the drug be taken under a doctor’s supervision to identify heart rhythm changes and other side effects linked to starting treatment. This requirement may be eased over time when people learn more about the drug, the panel said.

Les Funtleyder, a health-care strategist at Miller Tabak & Co. in New York, said he expects the drug will be used as an initial treatment in people with MS, also called first-line therapy, with peak sales topping $1 billion a year.

‘Big Advance’

“This will be used in first line eventually,” he said yesterday in a telephone interview. “Maybe not right out of the gate, but it’s such a big advance to go to oral from injectable.”

Merck, of Darmstadt, Germany, said this week that it had resubmitted its application to sell cladribine tablets as a treatment for MS. The FDA initially rejected Merck’s submission in November, saying it was incomplete.

Multiple sclerosis affects about 2.5 million people, according to the National Multiple Sclerosis Society, causing the body to attack itself through the immune system. The U.S. organization has about 370,000 members with the disease.

“Many doctors find it hard to convince their patients to get on and stay on a therapy that typically doesn’t make them feel better now but rather serves as an insurance policy against an uncertain future,” Patricia O’Looney, the society’s vice president of biomedical research, told the panel. “This is compounded by the fact that current therapies are injected or infused and may not be convenient.”

Gilenia and cladribine blunt the immune system’s attack on nerve cells. The drugs target certain white blood cells that harm the protective coating of nerve cells during MS. Cladribine was approved more than a decade ago to fight leukemia.

Mitsubishi Tanabe Pharma Corp., of Osaka, sold rights to Gilenia to Novartis in 1997 and will help the company develop the drug in Japan.

To contact the reporter on this story: Catherine Larkin in Silver Spring, Maryland, at [e-mail].

Last Updated: June 10, 2010 16:22 EDT

[Tebi]

Msg 418436 of 418466 at 6/10/2010 5:25:51 PM by

splaylaywahtheepi


FTY-720 is not as good as Tysabri - the problem is operations not FTY-720
Tysabri is superb. The most efficacious and safe drug on the market. FTY-720 is easy to take - but it is less safe. This will sort itself out with good marketing. But, I must admit that I am shocked that the FDA "experts" are so blase about FTY's side effects - they are far worse than Tysabri's...

In the meantime, operations at Elan sucks. 750 people in EDT do what? 600 people in Elan pharma do what? Elan makes virtually nothing, sells nothing, distributes nothing, and the pipeline outside of JNJ's AIP division and Transition Therapeutics has not moved even a little in years. Elan should have $50m lower expenses and should be profitable. It isn't - and there is not satisfactory explanation why this is the case.

Will Martin really stay around for 2 more years just to bury Elan? I hope not.

[surga]

Antwort auf Beitrag Nr.: 39.666.647 von Tebi am 11.06.10 01:40:35

Will Martin really stay around for 2 more years just to bury Elan? I hope not.

ich hoffe auch nicht, daß er solange bleibt

[Poppholz]

Antwort auf Beitrag Nr.: 39.666.975 von surga am 11.06.10 08:31:39

sollte er einen vorzeitigen Abgang bekanntgeben, dann wäre das auf jeden Fall gut für den Kurs.

[Tebi]

Antwort auf Beitrag Nr.: 39.668.853 von Poppholz am 11.06.10 12:39:00

Hi...schön dass Du noch da bist...ist schon ziemlich einsam hier...

[surga]

Antwort auf Beitrag Nr.: 39.668.853 von Poppholz am 11.06.10 12:39:00

H Poppi, schön von Dir zu lesen

[Poppholz]

Antwort auf Beitrag Nr.: 39.668.965 von Tebi am 11.06.10 12:57:22

bin natürlich noch dabei und habe auch ewig nichts verkauft.

(leider)

Viel zu tun momentan und somit kaum Zeit mich um die Aktien zu kümmern. Naja, es werden auch wieder bessere Zeiten kommen (auf den Kurs bezogen).

Wünsche allen alles Gute.

[surga]

Antwort auf Beitrag Nr.: 39.666.647 von Tebi am 11.06.10 01:40:35

geht ELN bald pleite, oder was ist los mit dem Kurs:O

[Tebi]

Antwort auf Beitrag Nr.: 39.700.122 von surga am 17.06.10 17:56:04

...absolut irre.....ob Biogen billig übernehmen will...ich habe keine Ahnung....im IV-Board ist auch nur Frust....:O

[bernie55]

Antwort auf Beitrag Nr.: 39.700.147 von Tebi am 17.06.10 17:59:20

..Grüße in die Runde...

.....vielleicht trägt diese News wieder dazu bei......


Biogen reports six new PML cases with Tysabri

Thu Jun 17, 2010 4:12pm EDT

* Says 6 new PML cases as of June 7th

* Total PML cases stand at 55, up from 49 as of May 6th

BOSTON, June 17 (Reuters) - Six more patients taking Biogen Idec Inc's (BIIB.O) multiple sclerosis drug Tysabri have developed a potentially deadly brain infection known as PML, the company said.

The Cambridge, Massachusetts-based biotechnology company said in its latest monthly update that as of June 7th, there were 55 confirmed cases of progressive multifocal leukoencephalopathy, or PML, up from 49 as of May 6th.

Biogen, which markets the drug with partner Elan Corp Plc (ELN.I), said the number of deaths from PML remained at 11.

Sales of Tysabri, the most important growth driver for both Elan and Biogen, have been crimped by concerns over PML as investors and physicians try to gauge how great the risk the risk of contracting the disease might be over time.

Last week, a panel of advisers to the U.S. Food and Drug Administration recommended the agency approve a rival product from Novartis AG (NOVN.VX) called Gilenia, potentially hurting Tysabri even further.

Tysabri was temporarily withdrawn from the market in 2005 after being linked with PML, but reintroduced in 2006 with stricter safety warnings.

The rate of PML increases with the length of time a patient remains on the drug. The incidence of PML in patients taking Tysabri for roughly a year is 0.01 per 1,000 patients. That rate rises to 0.35 cases per 1,000 in patients taking the drug for between one and two years, and to 1.47 cases for patients taking it between two and three years.

The company says the rate of PML is still within the 1 in 1,000 level seen in its clinical trials and noted on the drug's label.

The May 6th figure of 49 represented an increase of three new cases compared with the 46 cases reported as of April 6th. That in turn represented an increase of four from March 10th, when there were 42 cases.

(Reporting by Toni Clarke; Editing by Bernard Orr)

..ich weiß auch nicht, was aktuell läuft bzw. nicht läuft....

...TIME WILL TELL...


http://www.reuters.com/article/idCNN1725307720100617?rpc=44

[Tebi]

.....und dabei haben WIR mal gedacht,unsere Renten sind (hier)sicher.... nichts da :Wasser + Brotsuppe und Brennesselgemüse und Girschkartoffeln wirds geben...:O

Surga,Poppi + Berni---Ihr müsst dann später ins Karneol ziehen....da gibts nämlich auch noch Tomaten + Bohnen (aus dem neuen Gemüsegarten...)dazu...

[welke91]

Antwort auf Beitrag Nr.: 39.408.358 von welke91 am 27.04.10 14:11:59

Hi Leute es tut mir Leid!

Folgende Antwort bezieht sich auf Beitrag Nr.: 39.400.325 von Tebi am 26.04.10 12:40:14
mmmh leute schaut nicht doll aus...
wenn 6,84$ bzw. 6,6 $ nicht halten sollten sehe ich keinen grund warum das baby hier sich nicht auf den hintern setzt!
ziel wären dann 4,50 $!
allgemein sieht die lage eher schlecht aus.

Wenn das nicht stimmen sollte gehts auf 3,90 runter!

Es ist nicht plausibel warum er es nicht tun sollte! Leider



alles Gute

[surga]

Antwort auf Beitrag Nr.: 39.704.864 von Tebi am 18.06.10 14:06:21

hi Birgit, gern, jederzeit

[surga]

Antwort auf Beitrag Nr.: 39.705.148 von welke91 am 18.06.10 15:03:38

Hi Welke, schön daß Du hier wieder schreibst.
Es wird dann wieder (wenn nicht pleite geht )!
Du schreibst auch viel in DLG, bist Du auch dort investiert?

[Tebi]

Antwort auf Beitrag Nr.: 39.707.518 von surga am 18.06.10 22:12:49

Welke ist natürlich AUCH eingeladen...

Humor ist wenn mantrotzdem lacht---wir werden´s bald wissen was der Grund ist...

[welke91]

Antwort auf Beitrag Nr.: 39.707.563 von Tebi am 18.06.10 22:34:58

hi Leute,

vielen Dank, dass -wenn die Welt untergeht-ich bei euch mitmachen darf!

Ich bin gut in Gartenpflege -handwerklich ein wenig ungschickt- kann aber anpacken auch kochen und übe mich im survival

Es ist einfach wahnsinn in welcher Zeit wir leben!

Bei Dialog war ich nur kurz! Dachte die 9,76 kommen schneller bin aber bei 9 raus! Da hat der Kurs und die Indizes ja rumgesponnen!

Momentan sieht ja wieder alles in Butter aus aber ABER nich mehr lange!

In Wahrheit erschaffen wir nichts. Wir plagiieren lediglich die Natur.
Jean Baitaillon

So ist es auch bei den Kursen an der Börse aber wenn ein Kurs nicht der Natur gehörig ist wird er in eine Nische verbannt oder gar Darwins Auslese unterworfen!

Was ich sagen möchte:

Habe grad mit einem großen EW-Spezialisten gesprochen dem meine Hochachtung gebührt!

Aber er selbst versuchte es gar nicht mir den Kurs von Elan zu erklären! Er sagte lediglich "Wenn ein Kurs bei 5% seines historischen Hochs momentan liegt ist etwas Faul"!

Alles lief gut bei elan man konnte es prima zählen und der goldene Schnitt passte wie angegossen!

Jedoch was sich hier nun abspielt ist odiös!

Keine Richtung keine genauen Muster ja leblos würde ich sagen!

Und das alles kann man auch diesem CEO vorwerfen!

Wie kann man diese Firma mit diesen exzellenten Team so vor die Hunde gehen lassen!

Wollte man die Sterne und bekommt nun das schwarze Loch?

Herz sagte einmal:

Das wichtigste Problem, zu dessen Lösung uns unser bewußtes Wissen befähigen sollte, ist die Vorwegnahme künftiger Ereignisse, so daß wir unsere gegenwärtigen Angelegenheiten in Übereinstimmung mit dieser Vorwegnahme regeln können!

Wenn einer etwas weiß, warum Elan wieder steigen sollte bleibt drinn.

Sorry ein Mehr an Konstruktives kann ich nicht beitragen!



Und hier Langfristchart mit Unterstützung!
Gebrochen


Der absolute BODEN ist 3,25 $!!! Dann ist Ende!!!

Viel Mut und alles Gute!

welke

[Der.Eroberer]

Hallo ELAN-Experten!

Würdet Ihr auf diesem Niveau einen Einstieg in ELAN wagen? Ich kann
mir nicht erklären warum ELAN so günstig bewertet ist. Kann das alles
am CEO liegen?

[Tebi]

Antwort auf Beitrag Nr.: 39.708.904 von Der.Eroberer am 19.06.10 16:16:55

zu beiden Fragen :YEPP!(gleich JA....)

[welke91]

Antwort auf Beitrag Nr.: 39.709.690 von Tebi am 20.06.10 00:14:35

hi leute,

möchte euch nur noch mitteilen, bevor morgen alle verkaufen !

In Anbertacht der Tatsache, was Elan(Alzheimer, Medi gegen PML) noch bevorsteht kann dies aber ein Reset des Kurses sein!

Aber halten diese Marken nicht wird es ziemlich brenzlig.

Also zuerst die 4.5 $ hält die nicht 3.9 ziemlich fast und Bottom 3.25 $

Dann wären alle Chancen wieder offen!

Man könnte meinen, dann wäre auf langer Ebene ein Weg wieder in schwindlerregender Höhe gegeben!

So long! und alles Gute!


welke

[Der.Eroberer]

Bin heute auch an Bord gekommen. Das kann doch nicht der wahre Wert von Elan sein!?

[Tebi]

Antwort auf Beitrag Nr.: 39.716.602 von Der.Eroberer am 21.06.10 21:14:01

Nein,ist er nicht....irgendwas läuft im Hintergrund...wir werden es bald wissen... JEDENFALLS WILLKOMMEN IM CLUB!!

[surga]

Antwort auf Beitrag Nr.: 39.716.602 von Der.Eroberer am 21.06.10 21:14:01

Welcome aboard

[Tebi]

6/24/2010 2:55:07 PM by

doodah95

TOP TEN Ways Elan Investors Are Trying To Keep Their Spirits Up In Light of the Low Stock Price
From the Home Office where the stock price is crapola, here are the TOP TEN Ways Elan Investors Are Trying To Keep Their Spirits Up In Light of the Low Stock Price


10. Laugh at the investment choices made by Fidelity and Wellington in the recent decade.

9. Patiently await the upcoming transformational and seminal event that will finally turn Elan into the jewel we always expected it to be. Then after KM departs, we can also await BAP phase 3 trial results.

8. Watch a bit of Wimbledon tennis and perhaps a match with a few extra tie-break sets might come along.

7. Make a glass of lemonade costing 10 cents then sell for 20 cents – just to remind ourselves what a profit looks like.

6. Look at Elan’s chart over the past two months to remind ourselves how much fun we’ll have skiing next winter.

5. Compose a strongly-worded letter demanding better and more proactive IR/PR action in the future. Send letter to Mary Stutts and her department heads Groucho, Harpo, and Chico.

4. Hey, at least odds are good the stock can’t fall another 5 bucks.

3. Be thankful we at least have potential blockbuster Prialt in our portfolio (oh wait…).

2. Have a nice party with plenty of food, wine, and that stuff okz45 is smoking.

And the Number One way Elan investors are trying to keep their spirits up....

1. Maybe Landon Donovan will come and save Elan at the last minute.

[Poppholz]

nun mach doch mal jemand etwas.

Kann ja nicht angehen, wie der Kurs seit April (und überhaupt) am abrauschen ist.

[Tebi]

Antwort auf Beitrag Nr.: 39.737.871 von Poppholz am 25.06.10 14:37:47

Wir sollten die Konzernzentrale besetzen + Kelly zum arbeiten zwingen!

Hatten die nicht auch mal eine PR-Abteilung??????????????????????????????

[welke91]

Antwort auf Beitrag Nr.: 39.737.871 von Poppholz am 25.06.10 14:37:47

Hi Leute jetzt gilt es bei Eln,
1. Versuch eines Impulses!



Widerstände 4,80 - 5,10 kleines Kaufsignal generiert!



Und damit ihr mal seht, wie das ausgehen könnt:

Aber die Zählung ist überaus unplausible wie gesagt der Kurs ist schon überdimensional gefallen!

Nichts ist unmöglich!!!

Ob sich Elan von der Börse (AB)-koppeln kann, bleibt abzuwarten! Denn die Indizes werden demnächst straucheln!



beste Grüße

[Poppholz]

Antwort auf Beitrag Nr.: 39.744.251 von welke91 am 28.06.10 09:44:38

da sich Elan ja in der Vergangenheit "erfolgreich" vom Verlauf der Indizies abgekoppelt hat, brauchen die jetzt nicht meinen, bei einem entsprechend negativen Verlauf hier wieder dabei sein zu wollen.

Steigende Kurse sollten bei diesem Niveau der einzige Weg sein, aber wem sage ich das.

[welke91]

Antwort auf Beitrag Nr.: 39.744.251 von welke91 am 28.06.10 09:44:38

Das war nix...die Bären sind wieder am Zug.

4.51 $ und die Aussicht das diese Marke hält ist eher gering!

Dann wird es wohl ziemlich schnell gehen!

Das Ziel seht ihr ja! Höchstens 3.25 $

Grüße

[Tebi]

Antwort auf Beitrag Nr.: 39.749.884 von welke91 am 29.06.10 10:32:06

DANN KAUFEN W I R DIE FIRMA KOMPLETT!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

[surga]

Antwort auf Beitrag Nr.: 39.753.254 von Tebi am 29.06.10 19:02:34

genau

[Poppholz]

Antwort auf Beitrag Nr.: 39.753.254 von Tebi am 29.06.10 19:02:34

ich habe auch schon die ersten Ideen bezüglich der "Personalumgestaltung"

[Tebi]

Antwort auf Beitrag Nr.: 39.756.562 von Poppholz am 30.06.10 12:08:25

.....ich habe gerae meinen Hausmeister entlassen---dann krieg´ich das mit Kelly-Mausi auch noch hin....!

[Poppholz]

July 06, 2010 02:00 AM Eastern Daylight Time
Eliseo O. Salinas, MD, MSc Joins Elan as Executive Vice President and Chief Medical Officer

DUBLIN--(BUSINESS WIRE)--Elan Corporation, plc (NYSE: ELN) today announced that Eliseo Oreste Salinas, MD, MSc, has joined the company as Executive Vice President and Chief Medical Officer effective immediately, with responsibility for leading the company's global development, clinical and medical initiatives. Dr. Salinas will be based at Elan’s South San Francisco campus, will be a member of the company’s executive leadership team, and will report to Elan President Carlos Paya, MD, PhD. As the company’s Chief Medical Officer, he will also retain specific accountabilities to Elan CEO Kelly Martin relating to patient safety.

Commenting on Dr. Salinas’ 20 years of experience in the industry, Lars Ekman, MD, PhD, member of the Elan Board of Directors and chair of the Science and Technology Committee said, "During his career, Dr. Salinas has overseen 8 successful New Drug Applications (NDAs), 7 approved Supplemental NDAs, and 4 approved European submissions. He has a proven track record in the US and internationally and the leadership capability to advance Elan’s robust biotechnology pipeline and clinical portfolio through development toward those with unmet medical needs.”

Elan CEO Kelly Martin noted that the company's hiring of Dr. Salinas reflects Elan's highest priority: to become a world-class leader in novel therapeutics for patients who are afflicted with serious neurodegenerative diseases. “To do so successfully, we need significant expertise in clinical, regulatory and leadership development, along with a deep knowledge of CNS (central nervous system) science. Dr. Salinas brings demonstrated strengths in all these areas.”

Dr. Paya added, “During his career, Dr. Salinas has provided scientific oversight in therapeutic areas including CNS, Alzheimer’s disease, multiple sclerosis, Parkinson’s disease, autoimmune and other diseases, overseeing clinical trials in Eastern and Western Europe and North and South America. His expertise in regulatory interactions includes the FDA, the European Medicines Agency and authorities in Japan, Australia, North and South America. His experience and strategic perspective precisely meet Elan’s needs today and moving forward.”

Dr. Salinas joins the company from Adolor Corporation, where he was Senior Vice President of Research and Development and Chief Medical Officer, responsible for 90 scientists and clinicians in discovery, clinical research and development, pharmacovigilance, regulatory affairs and medical affairs. Previously, he served at Shire, Inc., as Chief Scientific Officer and Executive Vice President of Global Pharmaceutical Research and Development, where he managed R&D strategy and more than 400 employees, achieving six major drug submissions in four years. Dr. Salinas spent 11 years at Wyeth-Ayerst in progressive leadership positions including Head of Worldwide CNS, and as such is very familiar with Elan’s discovery role and progress in Alzheimer’s immunotherapy. He also served as International Project Leader, CNS at Synthelabo.

He is a member of the Society for Neuroscience, the American College of Neuropsychopharmacology, the American Academy of Pharmaceutical Physicians & Investigators, the American Society for Experimental NeuroTherapeutics and other professional and academic organizations; and, he has published and presented extensively in academic journals and forums. Educated in Argentina and France, Dr. Salinas practiced and served as a lecturer in clinical psychiatry in Paris.

Elan’s Chief Medical Officer and Head of Development, Menghis Bairu, MD, will resume his primary responsibility as Executive Vice President and General Manager of Tysabri, overseeing this critical part of Elan’s portfolio and leading integration of medical affairs, commercial, regulatory, global markets, clinical and safety assessment, life cycle and phase IV investments, as well as partnering with Biogen Idec to maximize the potential of this therapy for the benefit of patients globally.

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 and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.


http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[Poppholz]

Sanofi said to be planning $20bn acquisition in US
By Gareth Macdonald, 05-Jul-2010

Related topics: Mergers and acquisitions, Industry Drivers

Rumour has it that French drug giant Sanofi Aventis is planning to make a $20bn (€16bn) acquisition in the US with speculation that biotechs like Allergan, Biogen Idec and Genzyme are among the targets.

The speculation was sparked by a Bloomberg report late last week which stated that, according to unnamed sources, Sanofi’s board has met to consider a potential billion dollar US takeover.

While Sanofi has not commented, most observers agree that such an acquisition would be in keeping with the strategy CEO Christopher Viehbacher has employed since his appointment in 2008, which has seen the firm spend $17bn on 25 acquisitions.

In the last few weeks for example Sanofi bought US biopharmaceutical company Targegen, which is a developer of small molecule kinase inhibitors. And, while the Targegen deal's $560m value would be dwarfed by the rumoured takover, it does indicate that Sanofi is still looking to grow through acquisitions.

In addition, a large-scale acquisition would also fit with the general trend that has seen a number of Sanofi’s Big Pharma peers spend on M&A to replenish revenue from patent threatened products.

Perhaps the move would offset some of the losses the firm incurred with the launch of generic versions of Eloxatin (oxaliplatin) and Plavix (clopidogrel) and help protect the drugmaker against future generic competition for some of its leading products.

Biotech?

Miller Tabak & Co analyst Les Funtleyder was one observer who suggested a biotech firm like Allergan, Biogen Idec or Genzyme could be a likely target.

He told Reuters that such a deal would be in keeping with Sanofi’s development of late, adding that the firm “has been moving away from its pure play pharma model.”

This idea was supported by UBS analyst Fabian Wenner who told the newswire that Sanofi needs to boost its antibody offering and that this puts both Biogen and Allergan in the frame as possible takeover candidates.


http://www.in-pharmatechnologist.com/Industry-Drivers/Sanofi…


Also ich würde bei den Kursen ja eher in ELAN investieren.
Aber egal, wenn sich hier etwas in Richtung BIOGEN tun sollte, würde dies auf jeden Fall Bewegung in den ELAN-Kurs bringen.
(Die Richtung ist natürlich bei unserem Baby nie vorhersehbar)

[bernie55]

Tuesday, July 13, 2010

One Small Biomarker Step for Bapineuzumab

Our boss wouldn't sign off on a business trip to Hawaii, even to cover the International Conference on Alzheimer's Disease in Honolulu. Something about not letting us leave our brains on the beach.

Instead we've been neural surfing from the IVB HQ this week. We spent time on the phone with a couple clinical execs to discuss Johnson & Johnson and Pfizer's release of biomarker data Tuesday, which the firms say is evidence the drug bapineuzumab is having an effect on the underlying processes of Alzheimer's.

The news is not the answer to the $64 million (or several-billion-dollar?) question whether the drug is slowing or reversing cognitive decline through disease modification. No drug has shown that yet, and until one does the frustration that's come with several Phase III setbacks will continue. (We'll have to wait until at least 2012 to know the answer about bapineuzumab.)

But the new bapi data underscores the importance developers are placing on biomarkers to help understand disease progression and guide clinical trial practice in the Alzheimer's field. The Phase III bapi trials are underway and can't be modified, but the data could affect future studies. (We'll examine the effects of biomarker development and the clinical setbacks on Alzheimer's-focused startups in the upcoming issue of START-UP.)

Pfizer and J&J were quick to caution that the data are also preliminary. Taken from Phase II trials that ended in 2008, they need to be confirmed in the global Phase III program that Pfizer and J&J's Janssen Alzheimer Immunotherapy division are running. Company officials said Tuesday that bapi seems to lower the amount of a variant of the protein tau in spinal fluid (CSF) that has been linked to neurodegeneration. (Data are at the end of this post.)

Bapineuzumab itself does not target tau. The CSF measurements are a "downstream" biomarker rather than direct effect, Ron Black, Pfizer's assistant vice president of clinical R&D, told the IN VIVO Blog.



A humanized monoclonal antibody, bapineuzumab is designed to prevent the beta-amyloid plaques that accumulate in patients' brains. But the tau biomarker study, which measured "phospho" tau, or P-tau, shows bapi is also having some effect on a second Alzheimer's pathology. "Recent scientific data suggests both [Aβ and tau] processes might be important," Janssen Alzheimer Immunotherapy's head of clinical development Eric Yuen told IN VIVO Blog. "The initial step may be overproduction or underclearance of toxic Aβ...that aggregate and become more toxic. The increase in P-tau subsequently produces more toxicity to neurons. It's a long process."

Another study released Tuesday showed the predecessor to bapineuzumab, AN1792, also made statistically significant reductions in tau (as well as Aβ). Development of AN1792 was halted after Phase II trials in 2002 when patients were struck with brain inflammation. Researchers continued to follow the patients, however. "The findings give us more basic information about the interaction between beta amyloid and tau in Alzheimer's and may clarify how the disease progresses in the brain," researcher Delphine Boche of the University of Southampton's School of Medicine said in a statement.

When neurons die, the tau from the microtubules inside the neurons is released into the spinal fluid. With less P-tau in the spinal fluid, it's more evidence to suggest bapineuzumab is preventing neuronal death. (The statistically significant data came from 46 patients in two Phase II studies; 27 got bapineuzumab, 19 received placebo.)

But that's a long way from showing positive clinical outcomes. The main Phase II tests for bapineuzumab, run by J&J and Pfizer's predecessors Elan and Wyeth, showed that only patients who did not carry the ApoE4 allele had statistically significant cognitive and functional improvement. That's crucial, because in Alzheimer's trials only such "real-world" measurements, can lead to a drug's approval. It's one reason why the so-called amyloid hypothesis, which holds that to cure Alzheimer's you have to curtail Aβ, is in question these days: There's little evidence so far that fighting Aβ leads to a functional difference to patients.

That's another reason to study biomarkers: the more data researchers gather about the underlying molecular biology of Alzheimer's, the more chance to correlate changes in the biology to improved cognition and function if and when those improvements carry the day in a late-stage trial.

Elan's rights went to J&J in a far-reaching deal last year, and Pfizer got partial rights when it bought Wyeth. Janssen's data are due in 2012 and Pfizer's in 2014.

The top-line data from the Phase II CSF tau study pooled two patient populations. They showed a statistically significant decrease (p=0.0270) in P-tau in bapineuzumab treated patients (9.49±2.74 pg/mL) compared with placebo-treated patients (-0.51±3.26 pg/mL). Although not statistically significant, the analysis also showed a trend (p=0.0856) for a decrease in T-tau in bapineuzumab-treated patients (-73.31±32.73 pg/mL) compared to placebo (+9.79±38.95 pg/mL) in the change from baseline to month 12 values.

http://invivoblog.blogspot.com/2010/07/one-small-biomarker-s…" target="_blank" rel="nofollow ugc noopener">
http://invivoblog.blogspot.com/2010/07/one-small-biomarker-s…

[bernie55]

Bapineuzumab may cut 2nd Alzheimer's protein-study


Tue Jul 13, 2010 3:56pm EDT

* Drug being developed by Pfizer, Elan, Johnson & Johnson

* Effect on dementia still not clear


By Julie Steenhuysen

HONOLULU, July 13 (Reuters) - An experimental Alzheimer's drug designed to reduce clumps of the toxic protein amyloid in the brain also seems to lower levels of tau, a toxic protein that causes brain tangles, researchers said on Tuesday.

The findings offer a bit of evidence that the drug, bapineuzumab, which is being developed jointly by Pfizer Inc (PFE.N), Irish drugmaker Elan Corp (ELN.I) and Johnson & Johnson (JNJ.N), is having an effect.

But it is still unclear whether lowering levels of tau will improve symptoms of Alzheimer's disease, said the researchers, who found the changes in tau when testing the spinal fluid of patients.

"We think this is a new and important finding," Dr. Kaj Blennow of the University of Gothenburg in Sweden told reporters at the Alzheimer's Association scientific meeting in Honolulu.

Current Alzheimer's drugs only treat symptoms, but none change the course of the mind-robbing form of dementia that affects more than 26 million people globally.

Amyloid has long been the main focus of Alzheimer's drug research, but scientists have also been looking at tau.

Scientists think amyloid may be one of the earliest Alzheimer's disease-related changes, while tau may have a more direct effect on brain function.

"If you lower tau levels, it's logical to assume that this will have an effect on cognition," Blennow told the briefing, but said that still needs to be proven. Blennow has spoken at engagements on behalf of the companies.

For the study, Blennow and colleagues analyzed results from two phase 2 clinical trials in which spinal fluid was collected at the start of the study and two weeks after treatment.

They saw an effect in one of the studies, but not the other. But when they combined both studies, they saw a statistically significant drop in an abnormal form of tau in patients given bapineuzumab compared with people who got a placebo.

"It's one piece of the puzzle," Dr. Eric Yuen, head of clinical development at J&J's Janssen Alzheimer Immunotherapy said in an interview.

In April, a small imaging study in Lancet Neurology showed that bapineuzumab cut amyloid in the brain by 25 percent.

"When you take together all the data we have from phase 2, I think it's encouraging and it supported going forward into phase 3," Yuen said.

The drug had been seen as a front-runner in the race for a therapy that can disrupt the course of Alzheimer's disease, but a midstage study in 2008 found the drug caused brain swelling in people who have a variant of a gene called APOE that increases Alzheimer's risk.

The companies have had trouble getting patients to volunteer for its four phase 3 studies.

"Enrollment is slower than what we had expected. We're expecting that the two trials that are primarily North American will close in mid-2012," Yuan said.

Dr. Ron Black, assistant vice president of clinical research and development at Pfizer, said he is encouraged by the studies. But he acknowledged that they will mean nothing if the drug does not improve memory and thinking problems in patients. Black said the phase 3 studies are big enough to answer that question.

"Were plugging away at it. We want to get definitive results and get something to patients," he said. (Editing by Maggie Fox and Richard Chang)

http://www.reuters.com/article/idCNN1326474820100713?rpc=44

[Poppholz]

press release
July 15, 2010, 5:30 p.m. EDT

Elan Corporation, plc Reaches Agreement in Principle for Settlement of Investigation of Past Zonegran Sales and Marketing Activities
Elan establishes $206.3 million reserve for expected settlement

DUBLIN, Jul 15, 2010 (BUSINESS WIRE) -- Elan Corporation, plc /quotes/comstock/13*!eln/quotes/nls/eln (ELN 5.08, -0.21, -3.97%) today announced that it has reached an agreement in principle with the United States Attorney's Office for the District of Massachusetts with respect to the previously disclosed U.S. Department of Justice's investigation of sales and marketing practices for Zonegran (zonisamide), an antiepileptic prescription medicine that Elan divested in 2004.

If the agreement in principle is finalized, Elan expects to pay $203.5 million as part of a comprehensive settlement for all U.S. federal and related state Medicaid claims. Elan has established a reserve of $206.3 million for this expected settlement and related costs.

As part of this agreement in principle, Elan Pharmaceuticals, Inc., a U.S. subsidiary of Elan Corporation, plc, expects to plead guilty to a misdemeanor violation of the U.S. Federal Food, Drug and Cosmetic Act and to enter into a Corporate Integrity Agreement with the Office of Inspector General of the United States Department of Health and Human Services.

While Elan expects to negotiate and enter into final settlement and Corporate Integrity Agreements, there can be no assurance as to when or if any settlement will be finalized or, if a settlement is finalized, what the final terms of the settlement might be. Additionally, the proposed resolution of the Zonegran investigation could give rise to other litigation by state government entities or private parties.

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 and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

Forward Looking Statement

The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A list and description of some of the risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2009, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as otherwise required by law.

SOURCE: Elan Corporation, plc


Elan Corporation, plc
MEDIA CONTACT:
Bob Purcell
Ph: 866 964 8256
Paul McSharry
Ph: 353 1 663 3600
INVESTOR CONTACTS:
Chris Burns
Ph: 800 252 3526
David Marshall
Ph: 353 1 709 4444

http://www.marketwatch.com/story/elan-corporation-plc-reache…

[Poppholz]

JULY 15, 2010, 4:44 P.M. ET
Biogen: 3 More Brain Infections, 1 More Death In Tysabri Users

By Thomas Gryta Of DOW JONES NEWSWIRES

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) disclosed three more cases of a rare brain infection in multiple sclerosis patients on Tysabri, which it sells with Elan Corp. (ELN), bringing the total number of cases to 58 as of July 2.

The Cambridge, Mass., biotech company reported an additional death among patients that have developed progressive multifocal leukoencephalopathy, or PML, bringing the total to 12.

Tysabri is considered a highly effective therapy for MS, and its growth is important to the future of both Elan and Biogen. But its sales have been slower than originally hoped due to concerns about the risk of PML that led to its temporary withdrawal beginning in 2005. The infection re-emerged in mid-2008, and Biogen provides regular updates about the number cases.

The overall global PML rate is about 0.80 per 1,000 patients, the company said, which falls within the 1-in-1,000 rate previously seen in clinical trials and implied on the drug's label.

Shares of Biogen closed up 46 cents to $53.43, while Elan's American depositary shares dropped 4% to $5.08.

Of the total cases, 22 were in the U.S., 32 were in the European Union and four were in other areas.

The number of cases is important because if the infection rate climbs too high, sales of the drug may drop. A patient's risk of getting PML increases with the number of monthly infusions that he or she receives.

The most recent update translates to a rate of 1.27 cases per 1,000 for patients on the drug for a year or longer, but rises to 1.71 per 1,000 for those on the drug for two years or longer.

Looked at another way, the rate is about 1.42 cases per 1,000 patients on the drug for between two and three years. The incidence is about 0.37 case per 1,000 patients in those using it for one to two years, and it is almost nonexistent in patients using it for less than a year.

Elan sets the drug's price, which rose 18.7% in the U.S. on June 30, marking the most aggressive move since the drug's approval in 2004. There have only been two prior price increases: 1.5% a year ago and 8% last December. The price currently stands at $39,988 a year in the U.S.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; [e-mail]

http://online.wsj.com/article/BT-CO-20100715-713415.html

[Poppholz]

das wird ja wieder ein Wochenausklang bei Elan.

[Poppholz]

die Zahlen sind da:

http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[Tebi]

Antwort auf Beitrag Nr.: 39.858.875 von Poppholz am 22.07.10 08:52:56

Sie sind m.A.n. "na ja..."

Bloxham
Elan - Q2 results show strong Tysabri sales and a positive outlook
• Elan today released Q2 results with revenues of $264.5m down 2% on Q1 largely due to a
weaker than expected performance from the EDT division. Elan reported a net loss of
$213.1m in the quarter as it set aside $206.3m to settle US government charges for the sale
and marketing of Zonegran. Stripping out these costs the net loss would have been $6.8m
compared with a los of $68.2m a year earlier

Revenues were driven by a 22% increase in Tysabri sales along with boost from recently
launched Ampyra. Tysabri numbers were inline with 52,700 patients now on treatment
(+6.5% on Q2 09) producing revenue of $297m. Revenue from the EDT division was $56m,
a 29% drop YoY and $10m less than market expectations. Elan also commented that it
continues to explore the possibility of separating the EDT business and a decision will be
announced in the next couple of months.

• For the remainder of 2010 the group expects to achieve revenue growth and generate
EBITDA of greater than $150m. With the market looking for $122m and flat revenues YoY,
this will be seen as a positive. However concerns will be reaised about the slowdown in sales
across the EDT division. Despite this strong Tysabri sales and falling costs mean todays
results should be taken as broadly positive.

http://www.rte.ie/business/2010/morningrep/download/0722blox…

[Poppholz]

Elan's Net Loss Widens on Legal Charge
By QUENTIN FOTTRELL and STEN STOVALL

Drug maker Elan Corp. PLC reported a wider second-quarter net loss on Thursday, due to a legal charge, but reiterated its full-year operating profit outlook after the latest performance was boosted by cost cutting and patient enrollments for its key multiple-sclerosis drug Tysabri.

The Ireland-based drug maker, which reports in dollars, posted a second-quarter net loss of $213.1 million, more than triple the $68.2 million net deficit registered a year earlier.

Revenue fell 4% to $268.9 million, as a 29% fall in sales at its Elan Drug Technologies business offset a 19% rise in Tysabri sales to $207.4 million and a boost from the launch of multiple-sclerosis drug Ampyra earlier in the year.

The latest results include a $206.3 million charge related to the expected settlement with the U.S. Attorney's Office for the District of Massachusetts regarding a previously disclosed U.S. Department of Justice's probe into the drug maker's sales and marketing practices for Zonegran, an antiepileptic prescription medicine.

Elan sold the drug in 2004 to the Japanese group Eisai Co. for $130 million, with the potential for further earnings of $110 million on the sale. However, two years later, Elan received a subpoena from the Department of Justice, and an investigation was launched into the company for marketing the drug before the divestment as a therapy for conditions for which it hadn't been approved.

Elan hasn't disclosed what the nature of this marketing activity was, or what the unapproved conditions for which the drug was marketed were.

"Our second-quarter results demonstrate continued progress across our major areas of focus," Elan's Chief Financial Officer Shane Cooke said in a statement.

Mr. Cooke also confirmed that for the full-year 2010, Elan remains on target to record revenue growth, adjusted earnings before interest, taxes, depreciation and amortization of more than $150 million and operating profits before other charges or gains. He said the company generated almost $50 million in cash from operations in the first half of the year, including $23.7 million generated in the second-quarter, and was on track to be cash flow positive before other charges for the full-year.

Elan had $1.54 billion in long-term debt at the end of June.

Write to Quentin Fottrell at [e-mail] and Sten Stovall at [e-mail]


http://online.wsj.com/article/SB1000142405274870346730457538…

[Tebi]

http://www.saveelan.com/blog/

[bernie55]

Antwort auf Beitrag Nr.: 39.876.637 von Tebi am 26.07.10 15:21:00

Hi "Tebi"

...ich habe dich gerade leider telefonisch nicht erreichen können..

...somit erst mal auf diesem Weg alles Gute und Liebe zum..




bernie55

[posimist]

Antwort auf Beitrag Nr.: 39.876.637 von Tebi am 26.07.10 15:21:00

[posimist]

Antwort auf Beitrag Nr.: 39.876.637 von Tebi am 26.07.10 15:21:00

Da kann man nur hoffen, dass Mr. Martin endlich seinen Hut nimmt!
Erst dann würde ich mich mit dem Thema "nachkaufen" auseinander setzten.
posimist

[Poppholz]

Antwort auf Beitrag Nr.: 39.877.451 von bernie55 am 26.07.10 16:58:42

von mir natürlich auch die herzlichsten Glückwünsche.

[surga]

Antwort auf Beitrag Nr.: 39.876.637 von Tebi am 26.07.10 15:21:00

na dann, alles Gute nachträglich zum Geburtstag

[Tebi]

D A N K E S C H Ö N I H R L I E B E N

....ja,so werden wir miteinander und unserer Elan-Ration alt....


Entweder später bei Brotsuppe oder bei Kaviar-Häppchen

Liebe Grüsse in die Runde!!

[Poppholz]

Total Voting Rights
DUBLIN--(BUSINESS WIRE)--

ELAN CORPORATION, PLC

TOTAL VOTING RIGHTS

In conformity with Regulation 20 of the Transparency (Directive 2004/109/EC) Regulations 2007, Elan Corporation, plc announces that:

Elan Corporation, plc’s issued share capital as at 30 July 2010 consists of 585,059,560 Ordinary Shares of nominal value €0.05 each with voting rights. Elan Corporation, plc holds no Ordinary Shares in treasury, therefore, the total number of voting rights in Elan Corporation, plc is 585,059,560.

The above figure may be used by shareholders as a denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Elan Corporation, plc under the Transparency (Directive 2004/109/EC) Regulations 2007 and the Transparency Rules of the Financial Regulator.

CONTACTS:

William F. Daniel
EVP & Company Secretary


Short Name: Elan Corporation plc
Category Code: TVR
Sequence Number: 233994
Time of Receipt (offset from UTC): 20100730T110412+0100

http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[GuHu1]

http://www.fool.com/investing/high-growth/2010/08/04/one-bio…

One Biotech Stock Ready to Rebound?
By Mac Greer | More Articles
August 4, 2010 | Comments (0)

Irish-based drugmaker Elan (Nasdaq: ELN) recently reported a second-quarter loss of around $213 million after the company set aside around $206 million to settle a U.S. government investigation into Elan's marketing of the epilepsy drug Zonegran. Elan is one of the industry leaders in Alzheimer's research. Motley Fool Associate Advisor Charly Travers is bullish on the company despite the stock's recent poor performance. I recently asked him about the future of Elan.

Mac Greer: Charly, the stock has lost ground over the past one, three and five years, and yet I know that you are a fan of Elan. Why the attraction to this stock?

Charly Travers: Well before I get into the attraction, I will say the recent problems are perpetually recent problems stretching back over most of the last decade. I think you have to point to management at some point. This is a company that at one point had huge debt problems and then they had the Tysabri problems, which were pretty well-known. But that drug has come back, and right now they have been rumbling about spinning off their drug delivery segment. It's just one thing after another with this company over the years, and I think they have a credibility problem. But that said, they have some really attractive R&D, and with the stock where it is at, if you are interested in biotech, this is a company to look at right now.

Greer: And going forward, what do you see as their greatest opportunity and what is the greatest threat?

Travers: I would say the greatest opportunity is their world-class Alzheimer's research. So the likelihood of a person getting Alzheimer's disease goes up dramatically as you age, and by the time somebody is 85 years old, you have got about a 50-50 chance of having Alzheimer's. With people living longer and the baby boomers aging, this is going to be one of the big medical markets. It is already huge. It is going to get even bigger. So most of the current treatments are basically stopgap measures that don't really hit at the mechanism of the disease. They just basically slow down the decline, and so you want a company doing cutting-edge research in this area, and that would be Elan.

They have one of the top Alzheimer's pipelines in the industry. I think that tends to get a little overlooked with some of the missteps the company has made, but if you look deep in the early stage pipeline, they have several really interesting compounds.

Greer: And they have partnered with Johnson & Johnson (NYSE: JNJ) on some of these?

Travers: Yes. It is a three-way partnership with Johnson & Johnson and originally with Wyeth, which was recently acquired by Pfizer (NYSE: PFE). Elan has about a 25% interest in the immunotherapy-based Alzheimer's drugs, which you would see in the popular media as an Alzheimer's vaccine-kind of situation where the dangerous proteins in the brain will be cleared up by your immune system.

Greer: What is the biggest challenge for Elan?

Travers: Typically, I would say just the drug development risk in general. Alzheimer's disease is notoriously hard to attack. For a long time, the mechanisms of how the disease worked weren't really understood, and to create a drug against something you don't understand is nearly impossible, but the science has come a long way in the last decade. But to get a drug into the brain and have an effect is incredibly difficult. So while they do have a number of interesting products, this is a high failure rate research area.

Greer: And does Elan need to have success with these Alzheimer's treatments in order to be successful, or are they diversified enough outside of that?

Travers: They are diversified enough outside of that. They do have the multiple sclerosis drug Tysabri, which is partnered essentially 50-50 with Biogen Idec (Nasdaq: BIIB). Elan is going to do over a billion in revenue this year, and they have been cash flow positive through the first half of this year. If you think about biotechs just incinerating money and always having to issue shares to raise more money, Elan is not quite in that boat because of their Tysabri stake and their drug delivery business that is bringing in substantial revenue. They are in pretty good shape to ride these Alzheimer's products out to the goal that they hopefully hit.

Greer: Let's talk risk. On a scale of 1 to 10, with 1 being low risk like a Johnson & Johnson, and 10 being very high risk, where do you see Elan?

Travers: Ten is like a software company in some guy's basement.

Greer: Exactly.

Travers: I would put them at a 7. For one reason, the stock is already beaten up. It's at a five-year low. Biotech stocks have been pretty beaten up this year, and Elan has been crushed. So if you are going to look at [Elan], look at it when it is at a five-year low. That cuts some of your risk. And compared to other biotechs, which I would consider higher risk and grade a 9 or a 10, the fact that Elan already has an approved blockbuster drug and a lot of revenue brings its risk down.

Greer: And what one or two numbers will you look at to gauge Elan's success?

Travers: I think people underestimate the importance of a strong balance sheet for a biotech company. Drug development is incredibly expensive, and Elan has made a lot of progress shoring up the balance sheet to have nearly $900 million in cash. And since they are cash flow positive, that is a pretty substantial war chest, so I would look for them to keep those strong.

Greer: Three years from now, is Elan still a stand-alone public company or has it been acquired?

Travers: Yeah, I think [acquisition] is inevitable. If you're a shareholder, you want them to hold out as long as possible and get people thinking that one of these Alzheimer's drugs is going to be a $4 [billion] or $5 billion compound, which a truly successful Alzheimer's drug could hit those kinds of sales, really ramp up that share price and then get taken out for a nice premium. And then you go take your wife out to a nice dinner

[Tebi]

Antwort auf Beitrag Nr.: 39.938.428 von GuHu1 am 05.08.10 22:23:00

...danke!

[Tebi]

Gudrun Heyn, Berlin / Bei den therapeutischen Strategien gegen Alzheimer ist viel in Bewegung. Künftige Therapieoptionen zielen auf ein direktes Eingreifen in die Pathophysiologie der Erkrankung ab und bieten somit neue Perspektiven in der Behandlung. Mit dem Antikörper Bapineuzumab könnte zukünftig eine kausale Therapieoption zur Verfügung stehen.


Morbus Alzheimer stellt angesichts der demographischen Entwicklung eine der größten medizinischen Herausforderungen dar: Rund 700 000 Menschen leiden allein in Deutschland an der neurodegenerativen Erkrankung, die bis heute unheilbar ist. Bisherige Antidementiva wie Cholinesterase-Hemmer und der NMDA-Rezeptor-Antagonist Memantin wirken vor allem symptomatisch.


Die nächste Generation von Antidementiva soll jedoch gezielt in die Alzheimer-Patho­genese eingreifen. Dreh- und Angelpunkt dabei ist das β-Amyloid-Peptid, das sich in den Gehirnen Alzheimerkranker ablagert. »Noch ist allerdings ungeklärt, ob die β-Amyloid-Plaques im Gehirn der Betroffenen ursächlich für die Entstehung von Morbus Alzheimer verantwortlich sind, oder nur eine Begleiterscheinung der Erkrankung darstel­len«, gab Privatdozent Dr. Peter-Andreas Löschmann von Wyeth Pharma auf einem gemeinsamen Symposium mit der Berliner Charité und des Verbandes Forschender Arzneimittelhersteller (vfa) zu bedenken. Dennoch lassen erste Ergebnisse von Studien mit Arzneistoffen, die diesen Ansatz verfolgen, hoffen. Einer davon ist der Antikörper Bapi­neuzumab, der sich zurzeit in Phase III der klinischen Prüfung befindet.

Phase III: erste Ergebnisse 2014

http://www.pharmazeutische-zeitung.de/index.php?id=33787&typ…

[welke91]

Antwort auf Beitrag Nr.: 39.947.440 von Tebi am 07.08.10 21:47:20

Hi Birgit,

viel Gesundheit und nen guten weinkeller.

http://www.project-syndicate.org/commentary/jhunter1/German

Open-Source-Medikamente?
Jackie Hunter

Erschreckend ehrlich

charttechnisch noch langeweile!!! aber 4,50 $ war so denke ich reset!

grüße

[Tebi]

Antwort auf Beitrag Nr.: 39.948.663 von welke91 am 08.08.10 18:27:41

Hi Welke

Gesundheit (oder die passenden Pillen....),gefüllter Weinkeller und Bio-Anbei im Garten ist doch schonmal eine Grundlage...lieben Gruss an Dich!

[Tebi]

Dear fellow Elan shareholders and interested parties,

With today’s announcement that EDT is no longer for sale, common sense has finally prevailed. The board should never have allowed the CEO to make the reckless announcement three months ago to begin a process to sell EDT. Now the company is embarrassingly pulling this idea back. They should have thought this through before making the decision to go public. This is another example of current management's lack of experience. This is the second time the company made a similar announcement (January, 2009) to only find out that they could not get the value.

Large shareholders were against the timing of this sale, despite management claims of their full support.

It is likely that significant costs were incurred since the spin out was announced, both directly due to paying bankers and advisors, but also much higher indirect costs as the management team at EDT were defocused, concentrating on the sale of the business, versus building value.

I hope this is a sign that our Board of Directors is beginning to increase oversight of the current inexperienced CEO and that better times are ahead with a more experienced board. Please stay tuned.

Best regards,

Ib Sonderby

[Poppholz]

Antwort auf Beitrag Nr.: 39.956.087 von Tebi am 10.08.10 08:11:19

wie?

darf unser TOP-MANAGEMENT etwa nicht so agieren wie es möchte?

Warum denn plötzlich nicht mehr?

[Poppholz]

Antwort auf Beitrag Nr.: 39.956.101 von Poppholz am 10.08.10 08:14:38

hatte in den vergangenen Wochen und Monaten nicht den Eindruck, dass sich irgendjemand (außer uns) daran gestört hätte.

Vielleicht ist bei einigen Entscheidern das Verhalten des CEO jetzt doch ein wenig zu unprofessionel vorgekommen.

Besser spät als nie.

ich bin gespannt wie viele an der Seitenlinie stehen und nur auf eine solche Entscheidung gewartet haben.

[Tebi]

Antwort auf Beitrag Nr.: 39.956.117 von Poppholz am 10.08.10 08:16:55

Es gab wohl Ärger mit den Hauptaktionären---der Typ von dem ich die Mail habe ist einer davon---

[Tebi]

Davi´s

ANALYSIS: There are three main messages contained in the company's statement. The first concerns Elan's balance sheet. The company expects to retire c.$500m of gross debt (due 2011 and 2013) through the use of cash and a contemplated re-financing. We were already aware that some $190m of cash would be used to re-pay debt this year, associated with an asset sale proceeds offer following the J&J agreement - this will be used to reduce 2013 debt. The $300m or so of November 2011 debt will also be retired. Given the guidance on gross cash provided in the statement, we infer that some $200m of the latter may be in the form of a debt re-financing.

Secondly, Elan has also completed its evaluation of the possible separation of EDT. Although it is seen to make strategic sense, it is not thought that an appropriate valuation would be achievable in current market conditions. As such, the company will not pursue a separation at this time.

Thirdly, Elan has reiterated its 2010 P&L guidance, the only adjustment being that gross cash/investments will approach $400m by year-end (approaching $500m previously). It has also outlined that opex will remain broadly flat in 2011, i.e. within a $475-525m range.
DAVY VIEW: Faced with a discussion with debt-holders on the repayment of $190m as part of the asset sale proceeds offer, Elan now plans to further extend its debt maturity profile. That is no bad thing in current markets. A conclusion to the EDT evaluation is also welcome though market conditions look to be the only stumbling block here - and plainly a considerable one.



FACTS: Oral AD candidate ELND005 will be moved into Phase III trials after its Phase II data was considered sufficient by both internal and external parties to move forward.

ANALYSIS: Phase II data from this product were not powered to reveal efficacy on a statistically significant basis - though this was indeed what occurred. Elan previously indicated that safety, biomarker data and consistent efficacy signals would all be considered as part of any decision to move into Phase III. In the event, the 250mg dose was seen to be safe and tolerable, it demonstrated a biological effect on amyloid-beta protein in the CSF of a sub-group of patients, and some effects on clinical end-points were also seen.

In December 2009, Elan changed the design of its Phase II trials after a greater rate of serious adverse events, including nine deaths, was seen in the two higher-dosage groups. Although the deaths have not been linked directly to the drug, Elan and the independent safety monitoring committee decided to modify the trial. The two higher-dosage groups (1000mg and 2000mg taken twice daily) were stopped at that point, leaving the lower dose 250mg (twice daily).

Elan and its partner Transition will now finalise study design for Phase III with regulatory authorities. The statement also infers that an additional partner may be brought in to fund the Phase III programme, a pathway that had been hinted at previously given the scale of Phase III funding and the potential for ELND005 to be explored in other, earlier-stage indications for AD. Transition will receive a $25m milestone payment upon commencement of Phase III trials.

ELND005 is a small molecule (i.e. oral) drug designed to break down and prevent the aggregation of beta amyloid. Its mechanism of action is not linked to that of Bapineuzumab or any of Elan's biologic approaches, though there is a shared ultimate goal to remove amyloid.

DAVY VIEW: Elan's original outlay on ELND005 was modest ($15m). It now stands on the cusp of Phase III development. The prospect of further risk-sharing in Phase III is a strategy that makes sense to us, given Elan's balance sheet and its key skills in discovery and early research.

[Poppholz]

August 11, 2010 02:00 AM Eastern Daylight Time
Elan Corporation Plc Announces Intent to Offer US$200m in Aggregate Principal Amount of 8.75% Senior Notes Due 2016
DUBLIN--(BUSINESS WIRE)--

ELAN CORPORATION PLC ANNOUNCES INTENT TO OFFER US$200M IN AGGREGATE PRINCIPAL AMOUNT OF 8.75% SENIOR NOTES DUE 2016

DUBLIN, IRELAND -- August 11, 2010 – Elan Corporation, plc (“Elan”) (NYSE: ELN) today announced that its wholly-owned subsidiaries, Elan Finance public limited company (“Elan Finance”) and Elan Finance Corp. (“Elan Corp” and together with Elan Finance, the “Issuers”), intend to offer, subject to market conditions, US$200 million in aggregate principal amount of 8.75% senior notes due 2016 (the “New Notes”). The New Notes will be offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”), and to non-U.S. persons in accordance with Regulation S under the Securities Act. The New Notes will be fully and unconditionally guaranteed by Elan and certain of its subsidiaries. Proceeds from the New Notes, together with available cash on hand, will be used to redeem all of the Issuers’ outstanding Floating Rate Notes due 2011 (the “Redemption”), to pay fees and expenses incurred in connection with the offering and the Redemption and for general corporate purposes. This release does not constitute a notice of redemption. Any such notice, if issued, shall be issued pursuant to the terms of the indenture governing the Floating Rate Notes due 2011.

The New Notes have not been registered under the Securities Act, or any state securities laws and may not be offered or sold in the United States or to U.S. persons absent registration under, or an applicable exemption from, the registration requirements of the Securities Act and applicable state securities laws.

About Elan Corporation, plc

Elan Corporation, plc is a neuroscience-based biotechnology company focused on discovering and developing advanced therapies in neurodegeneration, autoimmune diseases and severe pain, and realizing the potential of its scientific discoveries to benefit patients and shareholders. The company has two business units: BioNeurology, focused on Alzheimer’s and Parkinson’s diseases and multiple sclerosis; and Elan Drug Technologies (EDT), a leading drug delivery business, which has over a dozen programs in late-stage development. Elan’s marketed products include TYSABRI®, a treatment for multiple sclerosis and Crohn’s disease marketed in collaboration Biogen Idec, which has over $1 billion in global sales annually. Elan shares trade on the New York and Irish Stock Exchanges. For additional information about the company, please visit http://www.elan.com.

Safe Harbor/Forward-Looking Statements

This press release does not constitute an offer to sell or the solicitation of an offer to buy the New Notes or any other security and shall not constitute an offer, solicitation or sale in any jurisdiction in which, or to any persons to whom, such offering, solicitation or sale would be unlawful. Any offers of the New Notes will be made only by means of a private offering memorandum.

The information contained in this press release is not for publication or distribution in Canada, Australia or Japan and does not constitute an offer of securities for sale in Canada, Australia or Japan.

In the United Kingdom, this press release is directed only at (i) Persons who have professional experience in matters relating to investments falling within Article 19(1) of The Financial Services And Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") and (ii) High Net Worth Entities falling within Article 49(2) of The Order and (iii) persons to whom it would otherwise be lawful to distribute it (all such persons together being referred to as "Relevant Persons").

In addition, if and to the extent that this press release is communicated in, or the offer of securities to which it relates is made in, any EEA member state that has implemented Directive 2003/71/EC (together with any applicable implementing measures in any member state, the “Prospectus Directive”), this press release and the offering of any securities described herein are only addressed to and directed at persons in that member state who are qualified investors within the meaning of the Prospectus Directive (or who are other persons to whom the offer may lawfully be addressed) and must not be acted on or relied on by other persons in that member state. This press release does not constitute a prospectus within the meaning of the Prospectus Directive. This press release constitutes an advertisement for the purposes of the Irish Prospectus (Directive 2003/71/EC) Regulations 2005. Investors are referred to the offering memorandum issued by Elan in connection with the offering of the New Notes, copies of which are available, in electronic form, on Elan’s website at www.elan.com.

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, regarding, among other things, the completion of the offering and the expected application of the net proceeds of the offering. You can identify these statements by the fact that they use words such as “expect”, “estimate”, and “intend” and other words and terms of similar meaning in connection with any discussion of future events. Factors that could affect whether the offering is completed and the proceeds are applied as expected include, among other things, uncertainties related to corporate debt securities generally, the securities of biotechnology companies generally and for Elan’s debt securities in particular. A further list and description of risks, uncertainties and other matters can be found in Elan’s Annual Report on Form 20-F for the fiscal year ended December 31, 2009, and in its Reports of Foreign Issuer on Form 6-K filed with the SEC. Elan assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc

INVESTOR CONTACT: MEDIA CONTACT:
Chris Burns Paul McSharry
Ph: 800-252-3526 Ph: 353-1-663-3600
David Marshall Mary Stutts
Ph: 353-1-709-4444 Ph: 650-794-4403


Short Name: Elan Corporation PLC
Category Code: MSC
Sequence Number: 235518

http://www.businesswire.com/portal/site/home/permalink/?ndmV…

[Poppholz]

Elan's Alternative to Strategic Alternatives
By Brian Orelli | More Articles
August 10, 2010 | Comments (0)

Elan (NYSE: ELN) has decided to do nothing with its Elan Drug Technologies (EDT) unit. Again.

Back in 2008, the company put EDT, which helps drugmakers develop extended-release drugs, up for sale. But apparently no one was willing to pay what Elan thought it was worth. The credit crunch certainly didn't help.

Then earlier this year, the company decided to explore the idea of spinning off EDT into its own publicly listed company. After finishing the review, the company decided it was a good idea. Just not right now.

Considering the current market conditions for new IPOs, waiting seems like a good idea. After being shut for so long, the biotech IPO window opened, but seems to have given investors a bit of a chill. Last week, Trius Therapeutics slashed its IPO price to $5 from the initial $12 to $14 it was hoping for and NuPathe (Nasdaq: PATH) cut its $14 to $16 expected range down to just $10 per share.

For now, Elan is content collecting the royalty checks on sales of drugs that EDT helped develop, such as Johnson & Johnson's (NYSE: JNJ) Invega Sustenna and Acorda Therapeutics' (Nasdaq: ACOR) Ampyra.

It looks like Elan can afford to wait out the market downturn. The company is in a much better financial place after its deal with Johnson & Johnson to license half its half of Alzheimer's drug bapineuzumab (Pfizer (NYSE: PFE) owns the other half). The company was able to retire some near-term debt and thinks it'll be able to refinance additional debt soon. The decreased interest payments and increasing sales of multiple sclerosis drug Tysabri, which it sells with Biogen Idec (Nasdaq: BIIB), should help the company be cash flow positive next year.

At some point investors will likely get a chance to own EDT separately, but for now, if you want a piece of the drug technology business, you'll have to be willing to own the neurology side, too.

http://www.fool.com/investing/high-growth/2010/08/10/elans-a…

[Tebi]

Antwort auf Beitrag Nr.: 39.963.276 von Poppholz am 11.08.10 08:41:32

Sie geben jetzt wohl eine Anleihe aus...nier die Google Übersetzung


ELAN CORPORATION Plc Intent-To-ANGEBOT 200 Mio. US $ im Gesamtnennbetrag von 8,75% Senior Notes mit Fälligkeit 2016




Dublin, Irland - 11. August 2010 - Elan Corporation, plc ("Elan") (NYSE: ELN) gaben heute bekannt, dass seine hundertprozentige Tochtergesellschaften, Elan Finance Aktiengesellschaft ("Elan Finance") und die Elan Finance Corp ( "Elan Corp" und zusammen mit Elan Finanzen, die "Emittentinnen") anbieten möchten, abhängig von den Marktbedingungen, US $ 200.000.000 im Gesamtnennbetrag von 8,75% Senior Notes mit Fälligkeit 2016 (die "New Notes"). Die neuen Anleihen werden an qualifizierte institutionelle Käufer angeboten werden, um gemäß Rule 144A des Securities Act von 1933 in geänderter Fassung (der "Securities Act") und Nicht-US-Personen gemäß Regulation S unter dem Securities Act. Die neuen Anleihen werden in vollem Umfang und vorbehaltlos von Elan und einige ihrer Tochtergesellschaften garantiert. Erlös aus der New Notes zusammen mit den verfügbaren Kassenbestände, wird verwendet, um alle ausstehenden Floating des Emittenten Rate Notes mit Fälligkeit 2011 (die zu erlösen "Redemption"), die Gebühren und Auslagen im Zusammenhang mit dem Angebot und der Rückzahlung aufzuerlegen und für allgemeine unternehmerische Zwecke. Diese Pressemitteilung stellt keine Kündigung. Jede derartige Mitteilung, falls ausgestellt, erteilt gemäß den Bestimmungen des Anleihevertrags über die Floating Rate Notes mit Fälligkeit 2011.

[Tebi]

http://www.saveelan.com/blog/index.php/2010/08/11/important-…

[Tebi]

finde ich auch! Aber :WAS TUN??

"Msg 427558 of 427694 at 8/13/2010 11:46:29 AM by

strunsi

Enough is Enough
It is amazing that this management team and BOD has been allowed to continue on in their positions based on two areas...one being performance or better put, lack of performance and the second is the constant perception of boarderline or flat out ethical lapses. At one time I thought KM and team were just too far over their skiis...not unethical but just out of their league. But now I am not so sure based on what we have recently learned coupled with what we already knew. A few examples as follows.

The recent semi insider dealing of the Prialt sale. Why would this team even consider this deal and then try to hide the facts giving the impression that there was something not quite right with the process.

The Amarin deal with Shane Cookes brother where we receive $192,000 and then buy it back for $700,000. Here again why would Elan be in bed with what could only be perceived as a conflict.

The Zonegram settlement that was so out of line with historical settlements that it makes one wonder what else was there that made this so startling and withheld from the public.

The idiodic pre ICAD e mail to a poster from KM that stated "TSRRW." Why the F**k would a CEO even come close to making a statement such as this and then being stupid enough to send it in an e mail. Poor decision or ethical laps?

KM being involved in a Hedge fund. Nothing illegal with this but since Hedge funds use Elan as their "bitch" why on earth would KM put himself and his company in a position where the perception of him being a partner causes people to question his decision making process. Does he need the extra income that badly and does he have that much spare time on his hands?

Some of the examples above could be put to bed if Elan would make a statement of clarification...kind of like the "Transparent company" we have been told that they are. But alas nothing.

We have given this group too much time and excuses over the years...enough is enough. "

[Tebi]

To Elan shareholders and interested parties,

As required, last week Elan finally disclosed the details of CEO Kelly Martin’s new two year employment agreement that was originally announced on June 2, 2010.

In this filing it was revealed that Kelly Martin’s base salary will increase 25% to $1M. In addition, the board also agreed to pay Kelly $750K a year as an advisor if he leaves the company on his own. During the period of time that Kelly will advise the company he will also be reimbursed for legal fees, financial planning and tax support, a provision never given to departing CEOs.

Why did the board feel they needed to give Kelly Martin a firm two year employment contract? Given the fact that the stock price has dropped from $37 to $5 over the last two years, did the board feel that some other company would hire him away? Why offer him a $750K advisor fee after he is terminated for cause?

The CEO’s latest salary increase is shocking. How could an outgoing Chairman as well as the existing Board approve this increase? Did the board thoroughly review whether this pay is aligned with his performance?

To examine this further I consulted with a biotechnology compensation consultant at one of the top firms to analyze Elan’s pay for performance. Specifically, we reviewed 1) how has the company performed versus its peer group, 2) how much pay has been delivered and 3) are pay and performance matched.

The results of my analysis revealed that Elan was in the lowest percentile on performance over a two and three year basis, while the rate of compensation increase was in the top percentile. This massive disconnect between pay and performance suggests that the compensation committee failed to perform this analysis.

In fact, the consultant could not find any company where the CEO had been on the job for more than three years and had received more than an 8% increase in salary. This recent 25% salary increase is on top of yearly bonuses and option grants, which last year was over $3M in the aggregate. How could this happen while the company is laying-off research scientists key to developing the company’s developmental therapies.

Why has the company not performed this pay for performance analysis? How could they continue to increase the CEO’s salary and give him a golden parachute while the company is in dire straits?

US companies are required by the SEC to extensively describe the rationale for CEO pay through the Compensation and Discussion Analysis section in a company’s filings as well as justification for salary increases. The company claims to follow top international standards of corporate governance, but has not provided any justification for this latest salary raise. Thus, I am asking the board to explain to shareholders the rationale behind this latest increase in CEO compensation.

Ib Sonderby

[Tebi]

Elan Shareholder Blasts CEO Martin's `Shocking' 25% Pay Increase in Letter
By Trista Kelley - Aug 16, 2010 3:27 PM GMT+0200


Elan Corp. Chief Executive Officer Kelly Martin’s 25 percent pay increase is "shocking" because the Irish drugmaker is losing money and the share price has dropped, a shareholder said in a letter to the company’s board.

Ib Sonderby, a Danish investor who owns 2 million shares, said there is a “massive disconnect” between pay and performance. As of June 1, Martin’s base annual salary rose 25 percent to $1 million, and will drop to $750,000 in May 2012 when he becomes a company adviser until January 2013, according to an Aug. 10 regulatory filing.

Elan last month reported that its second-quarter net loss widened to $213.1 million from $68.2 million after the company set aside $206.3 million to settle U.S. government charges linked to the sale and marketing of the Zonegran epilepsy treatment. Revenue fell 4.1 percent. The shares have declined 8.3 percent this year. Sonderby said he got advice from a biotechnology compensation consultant.

“The CEO’s latest salary increase is shocking,” Sonderby wrote in the letter, posted on an activist investor website. “Why has the company not performed this pay for performance analysis? How could they continue to increase the CEO’s salary and give him a golden parachute while the company is in dire straits?”

If Martin is fired or if he resigns, he can still cash in stock options until January 2015, according to the filing. In either event, or if the contract expires, he is eligible for severance pay, the company said.

2009 Bonuses

Martin, who began his role as CEO in 2003, received $800,000 in bonuses in 2009 after waiving his 2008 bonus amid a stock plunge of 73 percent that year. The stock has fallen 15 percent from the beginning of 2009 until the close of Dublin trading on Aug. 13.

Sonderby also wrote to the board last month, complaining about its oversight of Martin and pledging to “restore good governance” to Ireland’s biggest drugmaker.

"Mr. Sonderby has never shown any real interest in a dialogue with the company," Paul McSharry, an Elan spokesman, said today in an e-mail.

Martin’s pay is less that that of leaders of larger, more profitable U.K. drugmakers. Andrew Witty, CEO of GlaxoSmithKline Plc, earned 948,000 pounds ($1.48 million) last year with a 2 million-pound bonus. AstraZeneca Plc’s David Brennan earned 973,000 pounds in 2009, with a bonus of 1.17 million pounds. The salaries don’t include stock options.

In his letter, Sonderby said his analysis showed Elan to be in the lowest percentile for performance over two to three years, while the CEO compensation increase was in the top percentile.

“I am asking the board to explain to shareholders the rationale behind this latest increase in CEO compensation,” Sonderby said.

To contact the reporter on this story: Trista Kelley in London at [e-mail].

[Tebi]

Msg 427880 of 427886 at 8/16/2010 12:20:06 PM by

THEJARK




BAPI WORKS - MKT MISSING IT
http://www.oregonlive.com/opinion/index.ssf/2010/08/testing_…

Dr. Joseph Quinn, a neurologist at Oregon Heatlh & Science University, recently reported success in slowing the brain atrophy and mental decline of Alzheimer's patients receiving the experimental drug Bapineuzumab.

[Poppholz]

Elan To Move ELND005 To Phase III
By Zacks Investment Research on August 16, 2010

Elan Corporation Plc. (ELN: 4.92 0.00 0.00%) and partner Transition Therapeutics Inc. (TTHI: 4.1701 0.00 0.00%) recently announced their plans to move their Alzheimer’s disease pipeline candidate ELND005 into late stage trails. The companies also reported data from a mid-stage trial on ELND005. The companies presented positive safety and tolerability data on ELND005 taken twice-daily, for about 18 months. However, the trial’s cognitive and functional co-primary endpoints failed to achieve statistical significance.

The trial (AD201) initially enrolled 351 patients with mild-to-moderate Alzheimer’s disease at about 65 sites in the US. The study included four treatment arms: placebo, 250 mg BID, 1000 mg BID and 2000 mg BID. The 1000 mg BID and 2000 mg BID trials were discontinued in December last year due to serious adverse events, including mortality.

Based on these results, Elan and Transition Therapeutics plan to move ELND005 into phase III trials, the details of which are not currently available. We believe the companies will seek to enter into a partnership deal before commencing phase III studies. The signing of a lucrative deal would bring in additional funds, which would help finance the advanced stage development of the candidate.

Potential for ELND005

ELND005 received fast track designation from the US Food and Drug Administration (FDA) in 2007 for the treatment of Alzheimer’s disease. According to the Alzheimer’s Association and Alzheimer’s Disease International, more than five million Americans have Alzheimer’s disease while more than 26 million people worldwide suffer from some form of dementia.

The Alzheimer’s disease market consists of players like Pfizer Inc. (PFE: 16.03 0.00 0.00%), Novartis AG (NVS: 50.59 0.00 0.00%), Johnson & Johnson (JNJ: 58.01 0.00 0.00%) and Forest Laboratories, Inc. (FRX: 27.69 0.00 0.00%). It is estimated that the market is currently worth more than $5 billion.

Our View

We currently have a Neutral recommendation on Elan Corporation, which is supported by a Zacks #3 Rank (’Hold’). We are encouraged with the company’s decision to move ELND005 into advanced stages of clinical development.

Elan Corporation is currently highly dependent on Tysabri (multiple sclerosis and Crohn’s disease) for revenue generation. We remain concerned that an increase in the number of progressive multifocal leukoencephalopathy (PML) cases associated with the use of Tysabri could lead to a slowdown in the sales of the drug going forward.

http://www.dailymarkets.com/stock/2010/08/16/elan-to-move-el…

[Poppholz]

Elan Shareholder Blasts CEO Martin's `Shocking' 25% Pay Increase in Letter
By Trista Kelley - Aug 16, 2010 3:27 PM GMT+0200

Elan Corp. Chief Executive Officer Kelly Martin’s 25 percent pay increase is "shocking" because the Irish drugmaker is losing money and the share price has dropped, a shareholder said in a letter to the company’s board.

Ib Sonderby, a Danish investor who owns 2 million shares, said there is a “massive disconnect” between pay and performance. As of June 1, Martin’s base annual salary rose 25 percent to $1 million, and will drop to $750,000 in May 2012 when he becomes a company adviser until January 2013, according to an Aug. 10 regulatory filing.

Elan last month reported that its second-quarter net loss widened to $213.1 million from $68.2 million after the company set aside $206.3 million to settle U.S. government charges linked to the sale and marketing of the Zonegran epilepsy treatment. Revenue fell 4.1 percent. The shares have declined 8.3 percent this year. Sonderby said he got advice from a biotechnology compensation consultant.

“The CEO’s latest salary increase is shocking,” Sonderby wrote in the letter, posted on an activist investor website. “Why has the company not performed this pay for performance analysis? How could they continue to increase the CEO’s salary and give him a golden parachute while the company is in dire straits?”

If Martin is fired or if he resigns, he can still cash in stock options until January 2015, according to the filing. In either event, or if the contract expires, he is eligible for severance pay, the company said.

2009 Bonuses

Martin, who began his role as CEO in 2003, received $800,000 in bonuses in 2009 after waiving his 2008 bonus amid a stock plunge of 73 percent that year. The stock has fallen 15 percent from the beginning of 2009 until the close of Dublin trading on Aug. 13.

Sonderby also wrote to the board last month, complaining about its oversight of Martin and pledging to “restore good governance” to Ireland’s biggest drugmaker.

"Mr. Sonderby has never shown any real interest in a dialogue with the company," Paul McSharry, an Elan spokesman, said today in an e-mail.

Martin’s pay is less that that of leaders of larger, more profitable U.K. drugmakers. Andrew Witty, CEO of GlaxoSmithKline Plc, earned 948,000 pounds ($1.48 million) last year with a 2 million-pound bonus. AstraZeneca Plc’s David Brennan earned 973,000 pounds in 2009, with a bonus of 1.17 million pounds. The salaries don’t include stock options.

In his letter, Sonderby said his analysis showed Elan to be in the lowest percentile for performance over two to three years, while the CEO compensation increase was in the top percentile.

“I am asking the board to explain to shareholders the rationale behind this latest increase in CEO compensation,” Sonderby said.

To contact the reporter on this story: Trista Kelley in London at [e-mail].

http://www.bloomberg.com/news/2010-08-16/elan-shareholder-bl…

[Poppholz]

Antwort auf Beitrag Nr.: 39.997.148 von Poppholz am 17.08.10 13:58:18

Da bin ich aber auch geschockt.

[Tebi]

ALLES ECHT UNGLAUBLICH....

To Elan shareholders and interested parties,

A number of shareholders have pointed me toward a recent disclosure from Amarin Corporation regarding a transaction that occurred between Elan and Amarin in 2009. I was unaware of either the transaction or the disclosure, and was therefore troubled to learn that this was yet another example of a conflict of interests at Elan.

In July of 2010, Amarin, a biotechnology company based in Ireland , disclosed that Elan had paid it $700K to regain control of a product which Elan had out-licensed to Amarin for free. Until 2009 the former Vice Chairman of Elan Mr. Thomas Lynch was Chairman and CEO of Amarin. The timeline of this transaction is as follows:

* March 6th 2007, Amarin licenses nasal Lorazepam from Elan. There is no initial license payment to Elan;

* January 9th 2008, Amarin announces a positive result from a pre-clinical trial testing the absorption of Lorazepam in animals;

* December 31st 2008, Amarin pays Elan $192K;

* July 22, 2009, Elan pays Amarin $700K to repurchase all Lorazepam rights.

It is surprising to see that Elan gave away a product prior to conducting standard preclinical studies, only to repurchase it less than a year after these studies were completed for over three times what it received in payment. Elan’s rationale for doing this remains a mystery, since the Company has made no public statements about its intentions to develop Lorazepam. These events would simply reflect a series of poor decisions by Elan’s management were it not for Amarin’s insistence, in their recent disclosure, on highlighting that Elan’s Chief Financial Officer, Shane Cooke, is the brother of Amarin’s then Chief Operating Officer, Alan Cooke.

A transaction involving familial conflict of interests at public companies, where one party is so clearly favored over the other, is both unusual and troubling in the current environment. If Amarin was compelled to make this disclosure, why wasn’t Elan? That the dollar figures involved are not material does not supersede the fact that two brothers at two public companies were involved in a transaction which resulted in a sweetheart deal for the one.

All US companies, regardless of their size, are required to report insider dealings and conflicts of interest at an officer or director level, especially where family members are involved. Elan claims to practice a high level of corporate governance, yet its Management and, presumably, the Board kept this conflict from investors. What justifies this? What is the Company’s threshold for disclosing deals with family members? How many similar conflicts of interest remain undisclosed? Did Amarin’s auditors force them to disclose the conflict? If so, do Elan’s auditors know this conflict existed? I would like for the CFO and the board to help me understand the basis for this transaction and for why Elan never publicly disclosed this conflict.

Ib Sonderby

[surga]

Antwort auf Beitrag Nr.: 40.008.754 von Tebi am 18.08.10 21:58:21

geht ELN pleite
10 Tageschart

[Tebi]

Antwort auf Beitrag Nr.: 40.043.925 von surga am 25.08.10 16:41:57

nee,dafür verdienen sie zuviel........reiner Galgenhumor

Alles wird gut....

Aug. 25 2010 - 7:57 am |
Elan Defends Alzheimer’s Science
By ROBERT LANGRETH

Elan shares have plummeted in the last two years amidst safety problems for the multiple sclerosis drug it sells with BiogenIdec and concern that its Alzheimer’s drugs in trials may not work. Its shares trade around $4.50, down from a peak near $35 in 2008.

News last week that a competing Eli Lilly Alzheimer’s drug worsened the disease renewed the furious debate over what causes the disease. Most drugs in testing at Elan and elsewhere hit amyloid, protein fragments that clutter the brains of afflicted patients. A vocal minority argues that the concept is flawed, and that hitting amyloid will do nothing or make the disease worse.
Enzymes act on the APP (Amyloid precursor prot...

Image via Wikipedia

But Elan chief scientific officer Dale Schenk staunchly defends the company’s approach to treating Alzheimer’s Disease. In a long interview, he calmly brushed off critics who say that the drug industry has taken the wrong approach to treating Alzheimer’s disease and predicted that targeting amyloid will eventually pay off.

“I believe they will work,” says Schenk, who has been working on Alzheimer’s disease since the 1980s. The amyloid theory “is the simplest possible explanation for the combined weight of the genetics and pathological data.” Three genes that cause early onset Alzheimer’s disease appear to raise levels of certain amyloid fragments.

Elan’s most advanced drug, an antibody called bapinezumab, is in final stage testing with its partners Pfizer and Johnson & Johnson. It did not reach its main efficacy goal in a second-trial trial, but did help a subset of patients without a certain gene mutation. Elan has another Alzheimer’s drug nearing final trials that blocks amyloid fragments from clumping together, while a third drug in early trials, blocks amyloid production in a similar fashion to the failed Eli Lilly drug. Elan also is testing drugs for multiple sclerosis and Parkinson’s disease, with roughly one-third of its researchers devoted to each of the three diseases.

Commenting on the Eli Lilly trial, Schenk argues “it is unlikely it has anything to do with amyloid” as other amyloid-blocking drugs have not shown similar toxic effects. The drug might have “off target’” side effects. Or it might be hitting its proper target (the enzyme gamma secretase) but in too blunt a fashion. The compound may have interfered with other essential functions of gamma secretase that have nothing to do with amyloid. Elan’s gamma secretase inhibitor is more selective.

One problem with testing Alzheimer’s disease drugs is that researchers have no way of testing whether they prevent neuron damage in the short term. All they can measure is long-term changes in cognition that occur years later. ”It is like giving patients anti-cholesterol or anti-hypertensive drugs and then giving then a treadmill test and deciding whether high blood pressure or high cholesterol is important,” he says. Worse, the cognition changes are measured through crude doctor-patient questionnaires that fluctuate wildly from person to person and even day to day, making interpretation of small changes difficult.

Critics of the amyloid theory have to come up with convoluted arguments to account for all the genetic evidence in favor of amyloid, Schenk says. One theory from Harvard researcher Jie Shen holds mutations in genes called presenilin cause Alzheimer’s disease because they lose their proper function. But that doesn’t explain why patients who still have one functioning copy of presenilin still get the disease, Schenk says. He believes that the standard theory--that the mutant presenilin makes too much amyloid– is a much more likely explanation.

Schenk also dismissed the theory from Case Western Reserve Researcher Mark Smith that amyloid is protective and involved in wound healing. This is like arguing that plaque inside the arteries of heart patients is protective because it holds the vessel wall together, Schenk says. ”It is extraordinarily difficult to believe that [amyloid] has a positive role,” Schenk insists.

Schenk has been doing Alzheimer’s research for almost a quarter century now, and admits it has proven far harder than he initially expected. He appears most excited by the possibility that new brain scans and other tests will help researchers detect early signs of the disease, so companies can test their drugs in patients at risk of the disease years before dementia develops. Preventing dementia may prove far more tractable than treating patients who are already well into cognitive decline. Another possibility is to test drugs in the small subset of patients with genetic mutations that make them almost certain to get early-onset Alzheimer’s disease.

Such Alzheimer’s prevention trials could take years and years to perform. They are certain to generate waves of controversy along the way. Will Elan’s investors hold out that long?

[welke91]

Antwort auf Beitrag Nr.: 40.043.925 von surga am 25.08.10 16:41:57

hi surga nicht die kurze sicht der dinge ist entscheident sondern immer noch bei diesen Bewegungen der ganze wahnsinnige Zeitraum!



Houi Birgit ich hoffe dir gehts gut und du musst dein Haus nicht trocken legen?

War ja ziemlich viel Wasser bei euch unterwegs ?

Soll ich helfen kommen?

welke ;-)

[surga]

Antwort auf Beitrag Nr.: 40.061.916 von welke91 am 28.08.10 19:19:03

wenn bis zu unserem Renten ELN nicht steigt, dann kommen wir alle zu TEBI die Äcker bearbeiten

[Tebi]

Antwort auf Beitrag Nr.: 40.061.916 von welke91 am 28.08.10 19:19:03

Hi Ihr Süssen,

ja,war echt Land unter bei uns----aus den Dächern liefs und in die Gebäude wollte es auch von unten---aber heroische Elan-Kämpfer geben ja bekanntlich so schnell nicht auf und wir haben so mit Decken,Handtüchern und Laken uns zur wehr gesetzt....

[Tebi]

Antwort auf Beitrag Nr.: 40.064.170 von Tebi am 29.08.10 21:49:41

....und die Äcker--also unsere Kartoffeln und Tomaten--werden laufend geerntet--und--IHR SEID JEDERZEIT HERZLICH WILLKOMMEN...

[Tebi]

press release

Sept. 1, 2010, 4:24 p.m.
Elan Shareholder to Host Conference Call on September 8, 2010 at 10:00 AM EDT to Introduce Potential Board Members

COPENHAGEN, DENMARK, Sep 01, 2010 (MARKETWIRE via COMTEX) -- Ib Sonderby, CEO of Zoar Invest and a stockholder of Elan Corporation, plc /quotes/comstock/13*!eln/quotes/nls/eln (ELN 4.44, +0.06, +1.37%) , today announced that a conference call will be hosted on September 8, 2010 at 10:00 a.m. Eastern Daylight Time to introduce four potential Directors for the Elan Board and to discuss the current state of the Company. The call will be accompanied by a slide-show presentation, which will be available for download 15 minutes prior to the start of the call at www.SaveElan.com. A brief Q&A session will follow the prepared remarks.

Elan shareholders and other interested parties are invited to participate in the conference call by dialing [phone] (U.S.) or [phone] (International). The conference I.D. is 98514600. After the call, a replay will be available at www.SaveElan.com.

About SaveElan.com SaveElan.com was launched by Ib Sonderby in July as a forum to gather and educate concerned shareholders regarding the issues currently facing Elan and its Management. Mr. Sonderby presently serves as CEO of Zoar Invest, a private investment firm which holds long-term investments in both start-ups and mature companies. He currently sits on the board as chairman or non-executive director of 10 companies. Mr. Sonderby, with companies for whom he is a director, holds a total of 2,050,000 shares of Elan Corporation, plc, and has been investing in the company for more than 6 years.

Media Contact Information
Ib Sønderby
www.SaveElan.comEmail Contact

[Tebi]

Antwort auf Beitrag Nr.: 40.085.671 von Tebi am 01.09.10 23:20:14

UND NUN UNSER VORSITZENDER.....


Kelly Martin's Letter sent out to shareholders tonight (from Elan website)







September 6, 2010

Dear Shareholder:

The past few years have been active and positive ones for Elan Corporation plc on multiple fronts as they relate to our science, business and financial position. In more recent months we have continued to move a number of initiatives forward and I wanted to take this opportunity to summarize them for you so that you may have a full understanding and appreciation for where we are today, as well as our goals, objectives and focus as we move forward as a company.

As we have communicated in the past, all of our effort, focus and activity has been aimed at advancing our unique and innovative science against difficult neurodegenerative diseases while, at the same time, reducing enterprise wide risk and continuously improving the financial performance of the company. We have maintained a multi-year objective to become a profitable, sustainable and self–funding biotechnology company by 2011 – a goal we are well on target to achieve and which is a rarity in our industry globally. 2

Significantly Improved Operating Results

As a point of reference, Elan has gone from a 2005 full year operating loss before other items of $297.5 million to a 2010 first six months operating profit before other items of $34.0 million. This has occurred as a result of growing top line revenue by more than 15 percent on average each year while simultaneously reducing operating expenditure (R&D and SG&A) by more than 12 percent.1

1 Our 2005 operating loss before other items of $297.5 million comprises our operating loss under GAAP of $198.5 million, as adjusted to exclude the net gain on sale of businesses of $103.4 million and the other significant net charges of $4.4 million. Our first half of 2010 operating profit before other items of $34.0 million comprises our operating loss under GAAP of $177.2 million, as adjusted to exclude the settlement reserve charge of $206.3 million, and other net charges of $5.1 million.

With the currently available information and plans that have been developed within the company and with our collaborators, we anticipate that these positive financial trends and momentum will carry through into 2011. Continued revenue growth, coupled with cost and investment discipline, will drive further improvement from an operating profit point of view.

Dramatically Improved Balance Sheet

From a balance sheet point of view, we have made continuous progress over the past number of years in reducing our leverage. Since 2002, we have reduced our debt obligations by over 70% (nearly $3.25 billion) while, 3

importantly, maintaining relatively high cash balances to fund our long term commitment to our science.

Over the past year, we have raised over $2 billion in debt, equity and R+D funding while only incurring 18.4 % equity dilution to our existing shareholder base.

It is important to note that, while achieving these financial results, we continue to make prudent and precise investments in our science, drug technology and combined pipeline and products. Financial strength is a pre-requisite for long term success and growth and we continuously balance our focus on the financial picture with that of the longer term cycles of our science.

Our Collaborative Strategy Is Working

How have we been able to advance our business model over the past few years? Our strength has been, and will continue to be, the uniqueness of our science (in the BioNeurology business) and our technology (in the EDT business). These are our competitive advantages and we have demonstrated repeated successes in what is a highly competitive and challenging industry. Our business model has been and will continue to be characterized by the following core principles and themes: 4

 Within the BioNeurology business, we are a science based company, with biology and proprietary animal models at our core. Our clinical expertise is second to none in our areas of focus.

 Within the EDT business, we are the leading drug technology based company in the industry.

 We selectively acquire assets using proprietary science and technology screens and assessments.

 Talent and appropriate continuity at all levels and in all functions is key to our success.

 Our goals for collaborations / partnerships are centered upon clarity, accountability and expertise.

 We have a broad, deep and on-going investment in intellectual property across both of our businesses.

 We are risk taking early in the science life cycle (Phases 0, I, II) and risk sharing later in the science life cycle (Phase III). We measure risk as the sum of financial, clinical, science and commercial variables.

 Risk assessment is dynamic for both individual assets and within the portfolio overall.

 Our purposefully designed small infrastructure business model increases operating leverage.

 We maintain more than adequate cash on our balance sheet in order to advance our pipelines, and we are rapidly de-leverging the balance sheet to industry norm.

5

 Our Irish domicile provides an advantageous tax structure and is a strategic asset.

 We seek strong revenue growth to deliver after tax earnings.

UPDATE ON ELND-005 (SCYLLO-INOSITOL)

Consistent with our proven business model and approach, Elan and Transition Therapeutics have agreed to work together to explore strategic, operational and global options for ELND-005 with the intent of maximizing the value of this innovative potential therapeutic. As you know, on August 9th, Elan and Transition Therapeutics announced that we intend to advance ELND-005 into Phase 3.

By advancing ELND-005, Elan may benefit, either directly or indirectly, from several late stage Alzheimer’s programs: JAI AAB–001/Bapi (Phase 3); ELND-005 (to commence Phase 3); JAI ACC–001/Vaccine (Phase 2); JAI AAB–001 Sub q (Phase 2). In addition, we continue to advance our own gamma secretase with ELND-006 nearing Phase1 completion and ELND-007 having just entered Phase 1.

By almost any measure (development stage, mechanism of action, targets), Elan’s Alzheimer’s portfolio is the leader against any competitor in the field of Alzheimer’s. 6

Further potential advancements of some of our pre-clinical programs will only add to our leadership in terms of the scientific and clinical expertise, intellectual property and disease understanding required for the development of successful Alzheimer’s therapies.

COMPLETION OF EDT REVIEW

On August 9th, we also announced the completion of the strategic review of our EDT business, concluding that, while a separation makes sense at some point, it could not be done now at an appropriate valuation given current market conditions in terms of market multiples. That said, the outlook for EDT remains positive. EDT is the leading drug delivery business globally and has produced consistent results and cash flows while expanding its late stage pipeline. Within the last year, two products that incorporate EDT's technologies have been approved in the U.S. and have significant potential: Ampyra, marketed by Acorda; and Invega Sustenna, marketed by Johnson & Johnson. EDT's prospects in the medium term are very attractive with solid revenues coming from the existing broad portfolio of products and growth driven by recently launched products, four later-stage pipeline products and the anticipated approval of Ampyra and Invega Sustenna in European Union and other markets. 7

CONTINUED BALANCE SHEET IMPROVEMENT

As I noted earlier, we have significantly strengthened our balance sheet in recent years. In August, we announced initiatives that will:

 Extend maturity of our debt so there are no principal payments due until November 2013,

 Reduce our annual interest rate costs by up to $10 million, and

 Retain significant cash balances of approximately $400 million.

In accordance with this announcement, we have begun the repurchase of up to $186,000,000 of our 8 7/8% Senior Fixed Rate Notes due 2013 and Floating Rate Notes Due 2013, and the redemption of $300 million of Senior Floating Rate Notes due 2011.

Our progress was noted recently by Moody’s, which said in a recent report that: "Elan’s key credit metrics have steadily improved, mostly attributable to the solid growth of Tysabri since the re-launch in 2006. More recently, the $885 million investment by Johnson & Johnson in Elan’s Alzheimer’s Immunotherapy Program ("AIP") improved Elan’s cash and investment balances. In addition, as R&D is now funded through the AIP collaboration, Elan has realized significant cost savings, with combined SG&A and R&D expenses in the first half of 2010 ($258 8

million) having declined by approximately 14% relative to the first half of 2009." (Moody’s Credit Rating Report, July 2010)

UPDATE ON TYSABRI

The outlook for Tysabri, our leading MS drug that is co-marketed with Biogen Idec, also remains strong. On August 24, in conjunction with Biogen Idec, we announced progress in the development of a potential risk stratification plan that could further mitigate the rare risk of PML in Tysabri-treated patients. In the meantime, Tysabri continues to perform well. Tysabri revenues have increased almost 50% in the last two years, reflecting the important benefits of this product and the rapid growth in the overall MS market.

***

Despite our significant progress, one detractor in particular, Mr. Ib Sonderby, has received recently a fair amount of press for his personal attacks on executive management and Elan’s board. While he has never met at any time with management -- despite repeated offers from us to meet with him -- he has continued deliberately to spread misinformation and recycle issues that have been previously addressed. A number of 9

shareholders have asked me to set the record straight and I want to take this opportunity to do so.

In the last eight weeks, Mr. Sonderby has made false allegations about: the sale of Prialt and licensing Agreement with Amarin; my role with Kinsale Capital Management; provisions in our agreement with Johnson & Johnson for the development of bapineuzumab; the Zonegran settlement; among other false claims. Let me address each of these issues succinctly.

Allegations of Conflict on the Prialt Sale: In 2010, we sold the U.S. Prialt business to Azur Pharma Ltd. Ib Sonderby says we sold it for too little to a group controlled by our directors. Not true. There was a rigorous sale process and Azur is not controlled by our directors. On the sales process, some 36 companies, mostly well-known biotechnology /pharma companies, were contacted with the help of legal and financial advisors. This group was whittled down to three serious bidders and our Board selected Azur Pharma Ltd as the winning bidder based on price and terms that were favorable to Elan. Three of our directors collectively own significantly less than one percent of Azur and all positions and relationships were fully disclosed at the time of the sale in accordance with all applicable laws and regulation. These directors recused themselves fully 10

from any substantive Board discussions or decisions on Prialt.

The suggestion that Kyran McLaughlin, our Chairman, has a conflict because he is deputy chairman of J&E Davy, is equally mistaken. J&E Davy, Ireland’s leading provider of stockbroking, wealth management and financial advisory services, operates a nominee company called Davycrest for its clients, including over 200 private individuals who happen to own shares in Azur. Neither J&E Davy nor Davycrest, as a nominee, actually own shares in Azur, and Mr. McLaughlin has no role in the management of Davycrest, nor does he influence the investment decisions of the individuals in it.

It is important also to note that the Prialt sale had significant benefits for Elan. We achieved an accretive transaction by selling a loss making business in a non-core, sub-scale therapeutic area and accelerated our move to a cash flow positive operating business. And we retained the ability to receive future payments from milestones and royalties.

False Allegations Regarding Licensing Agreement with Amarin: Similarly, Mr. Sonderby has made false claims regarding a small licensing agreement with Amarin for the development of Lorazapam, a treatment for acute 11

seizures, claiming a conflict of interest with our CFO, Shane Cooke, and that Amarin received a "sweetheart" deal because Mr. Cooke’s brother works at Amarin. The facts are that Mr. Cooke was not involved in the transaction and was completely removed from all discussions regarding Amarin.

In 2007, Elan licensed its Nanocrystal technology to Amarin who wanted to develop a formulation of Lorazapam for nasal delivery to treat acute seizures, a formulation which is thought to have significant market potential. Under the license, Elan could receive fees and milestones for services provided and could ultimately receive royalties on any product developed. After developing the product for two years, in 2009 Amarin changed its strategic focus and consequently was no longer in a position to fund the development of Lorazepam. With positive pre-clinical data, EDT saw this as an attractive pipeline asset and agreed to purchase all of Amarin’s rights for $700,000. Consistent with its business model, EDT intends to develop Lorazepam beyond proof of concept in man and then out-license it to a partner who would fund late stage development and commercialize it. This is expected to occur around 2012.

Insinuations About Kinsale Capital Management: In a recent public letter, our detractor has questioned my 12

involvement with Kinsale Capital Management. The facts are these: Approximately six years ago I gave some limited assistance to a former colleague in setting up Kinsale. I served as a non-executive director of Kinsale until March of this year and Kinsale agreed not to invest in Elan securities while I was a director. I had no day-to-day involvement in the fund nor the running of the company and received no fees of any kind from Kinsale; I am not an equity holder in the fund. Further, I no longer have any affiliation, association or involvement with Kinsale in any way, shape or form.

Claims regarding change of control provisions in the Johnson & Johnson transaction: First, it is important to remember that this was an excellent transaction that significantly reduced our science, financial and execution risk around the immunotherapeutic approach to Alzheimer’s as well as allowing for the acceleration of the development of this technology and approach to the treatment of patients, while at the same time enabling shareholders to participate in the potential for substantial longer term value creation. I noted the positive comments from Moody’s earlier. The highly respected IN VIVO Blog also named it the 2009 M&A/Alliance deal of the year. 13

Change of control provisions, like the ones cited by Mr. Sonderby, are included in just about all collaborative transactions in our industry and were disclosed properly. In terms of the provision allowing Johnson & Johnson to acquire Elan’s interest in the collaboration at fair value if there is a change of control at Elan, the bottom line is that it’s likely and understandable that Johnson & Johnson would not have done the deal without this provision to protect themselves. This is a hollow issue, and anyone familiar with our industry recognizes it as such. Biogen Idec objected to a separate change of control provision, which was also disclosed in the agreement, and we resolved this issue.

Falsehoods regarding the Zonegran Settlement: As you know, we had been cooperating with the U.S. government with respect to the Zonegran investigation for more than four years, and reached the preliminary agreement that we announced in July in order to resolve this matter and move forward. Contrary to Mr. Sonderby’s allegation that the settlement is "the largest fine in history relative to sales," there have been other settlements with a larger ratio of settlement amount to sales revenue, including Serono’s settlement for alleged off-label promotion of Serostim in 2005. It also is important to realize that the Zonegran agreement in 14

principle is a misdemeanor instead of a felony. The distinction is important given that a felony plea requires mandatory exclusion from the federal Medicare and Medicaid programs. Further, as has been amply demonstrated in recent years, the U.S. government has aggressively been pursuing a variety of alleged marketing claims against most of the world’s leading biopharma companies. Elan is not alone in having recently settled these longstanding investigations into marketing practices dating back a decade.

That being said, we understand the importance of a strong compliance program to ensure that this situation, which resulted from practices that occurred more than six years ago, is not repeated. Elan has implemented a strong compliance program based upon best practices and guidance from the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers. Further, Elan recently hired a new Senior Vice-President to oversee compliance. Fabiana Lacerca-Allen, who joined Elan in June has more than 18 years of compliance and legal experience at Fortune 500 companies and law firms, including at Mylan Laboratories and Bristol-Myers Squibb.

***

Mr. Sonderby is likely to continue making or repeating false and misleading claims about the company in the 15

coming weeks. We presume that Mr. Sonderby is mostly concerned about the price of the stock as would be his right as a shareholder. While we cannot directly control the price of the stock, we do remain resolutely focused on the fundamentals and improving them every week, quarter and year. By doing so, the marketplace will ultimately assess the proper short, intermediate and long term value of the equity vs. competitors within our industry, and our stock price will accurately reflect the markets view.

In the meantime, we will stay focused on improving the fundamentals across the board and will not hesitate to continue to set the record straight when necessary as it relates to false allegations, and take appropriate steps to protect the company.

Finally, two of Elan’s directors who joined the board last July as part of a settlement agreement, notified us over the Labor Day weekend in the U.S. that they planned to file a lawsuit against Elan on Tuesday, September 7 unless certain conditions were met. The statements made by legal counsel for these two Board members are false, and are an attempt to circumvent previously approved Board policies and an independent review by outside counsel. Today, we filed a proceeding in response and with the goal of enabling the independent review -- conducted by a former President of the 16

American Bar Association -- to proceed unimpeded. The Court has granted all of our requests including injunctive relief. The need to take this action is regrettable but we will not allow the two directors to hijack the independent review before its scheduled presentation to the full Board.

We will keep you updated on developments and the real progress the company is making as we enhance financial performance, further develop our science and pipeline, and ensure that we continue to retain the best scientific talent in our industry.

The bottom line is that Elan remains well positioned to maintain growth, achieve profitability, advance both our science and technology and provide continuous innovation across both of our key businesses. We believe that we present a highly unique and compelling investment thesis to those interested in investing in the biotechnology industry.

Please feel free to contact me directly if you have any concerns, suggestions or comments or would like to discuss any of the above.

Most Sincerely,

G. Kelly Martin

Chief Executive Officer, Elan 17

[Tebi]

Und zudem scheinen 2 Vosrstandsmitglieder sich auch mit dem Rest zu streiten----echt was los on board..

from the Financial Times "Elan’s board spat hits Dublin High Court"

http://www.ft.com/cms/s/0/01e14c92-ba0c-11df-8804-00144feabd…


Elan’s board spat hits Dublin High Court

By Andrew Jack in London

Published: September 7 2010 01:21 | Last updated: September 7 2010 01:21

Elan, the Irish-based pharmaceutical group, has taken out an injunction against two of its own directors in an intensification of a boardroom row over corporate governance.

The Irish High Court in Dublin on Monday granted a temporary restraining order against Vaughn Bryson and Jack Schuler, two US-based independent directors who were appointed after a campaign criticising the company.

The men claim Elan failed to provide full disclosure to the board on aspects of a $1.5bn recapitalisation concluded with Johnson & Johnson last year.

In the filing, which has been obtained by the Financial Times, Gary Kennedy, an Elan director and chairman of its audit committee, seeks to prevent the two men from breaching corporate governance guidelines and seeking to hire a consultant to examine the issue and other concerns raised recently by the shareholders.

The highly unusual high-level spat comes as Elan investors led by Ib Sonderby, a Danish shareholder, have escalated their own attacks on the company’s management concerning a range of alleged conflicts of interest.

Mr Sonderby is planning on Wednesday to announce three candidates he wants to place on the board.

The Irish filing says that Mr Bryson and Mr Schuler requested without authority an audit on behalf of the company from Bird Marella, a Californian law firm, which has in turn threatened to begin rival legal action in the US on Tuesday if Elan refuses to co-operate.

Elan says the investigation would undermine a separate examination of corporate governance criticisms that its audit committee had already authorised from McKenna Long & Aldridge, another US firm.

The court filings say the two directors “made allegations in respect of a major transaction entered into by [Elan] with J&J” and sought an independent audit, while rejecting the company’s own proposed audit by McKenna.

A spokesman for Elan said the transaction related to the right of J&J to acquire Elan’s interest in the experimental Alzheimer’s drug bapineuzumab at fair value in the event of a change of control, and claimed that it was a standard clause that had been disclosed to the board.

The US directors and Mr Sonderby have in the past criticised the Irish directors of Elan including Kelly Martin, its chief executive.

Mr Martin agreed over the summer to step down in two years’ time.

Mr Sonderby expressed surprise on Monday night that shareholders had not been made aware of the McKenna investigation.

Copyright The Financial Times Limited 2010. Print a single copy of this article for personal use. Contact us if you wish to print more to distribute to others.

[Tebi]

Tue Sep 7, 2010 10:25am EDT

* Elan shareholders vote in Ib Sonderby director poll

* Identify directors they most would like to see removed

* Name Kyran McLaughlin, Kieran McGowan, Gary Kennedy

By Toni Clarke

BOSTON, Sept. 7 (Reuters) - Shareholders of Irish drugmaker Elan Corp (ELN.I) (ELN.N) want to see at least three directors booted off its board, according to a poll of 298 shareholders conducted by activist shareholder Ib Sonderby.

In answer to the question: "Which three directors would you like to see removed?" 93 percent said Kyran McLaughlin; 69 percent said Kieran McGowan; and 44 percent said Gary Kennedy.

Sonderby, who controls more than 2 million Elan shares between his own holdings and those of Danish companies on whose boards he sits, has been launching a vigorous campaign aimed at exposing what he and numerous other shareholders consider serious breaches of corporate governance.

On Tuesday, Elan revealed that it has itself commissioned an independent review of its corporate governance, which is due to be presented to the company's board at its next meeting scheduled for Sept. 15. The company commissioned the report in May, according to company spokesman Paul McSharry.

But two Elan directors, Jack Schuler and Vaughn Bryson do not trust that the investigation is truly independent and were planning a parallel probe into corporate governance issues. On Tuesday Elan said it had been granted an Irish High Court injunction to prevent the directors from launching their probe. [nLDE68609R]

Neither Schuler nor Bryson could be reached for comment.

On Wednesday, Sonderby will hold a conference call at which point he will reveal a slate of four alternative directors to the board. [ID:nN18210938]. The call-in details are published on Sonderby's website.

McLaughlin was appointed director of Elan in January 1998 and chairman in 2005. He is deputy chairman at Davy Stockbrokers, Ireland's largest stockbroking firm. He is also a director of Ryanair Holdings Plc (RYA.I) and director of a number of private companies.

Kieran McGowan was appointed a director of Elan in December 1998. From 1990 until his retirement in December 1998 he was chief executive of the Industrial Development Authority of Ireland. He is chairman of CRH Plc and a director of United Drug Plc

Gary Kennedy was appointed a director of Elan in May 2005. He served on the board of the Industrial Development Authority of Ireland for 10 years until he retired in December 2005. From May 1997 to December 2005, he was Group Director, Finance & Enterprise Technology at Allied Irish Banks Plc. (Additional reporting by Carmel Crimmins and Padraic Halpin) (Reporting by Toni Clarke, editing by Dave Zimmerman)

[Tebi]

Elan CEO Kelly Martin Ought to Resign, But He Won’t
By Jim Edwards | September 8, 2010

Now that the civil war inside Elan (ELN) has broken out into the open, it is time for CEO Kelly Martin to resign. Never heard of Elan? You’re not alone, but it’s an important company. It markets Tysabri for multiple sclerosis and is developing a promising new Alzheimer’s disease therapy, bapineuzumab. A lot of very sick people need this company to succeed.

But Martin and his management are a slapstick comedy act. Elan’s top brass once claimed that their Irishness qualified them for tax breaks, for instance. Elan’s stock once traded above $35; it now oscillates miserably around the $5 mark.

Yesterday, Martin and his gang sued two of their own board members and successfully won an injunction preventing them from hiring an independent law fim to investigate Martin’s alleged conflicts of interest. Martin wants the law firm he hired to do that probe.

The day before, Martin wrote an 18-page letter to his shareholders defending his record. It reads more like a resignation letter. Even if you give Martin the benefit of the doubt, it still confirms that Martin is too conflicted, and has made too many enemies, to remain in charge of the company. Among the controversies that Martin’s letter actually confirms are:

* Three Elan directors own stock in Azur Pharma, the company that bought Prialt, a painkiller, from Elan. Martin says Azur was ” the winning bidder based on price” but the terms of the deal are undisclosed.
* Elan chairman Kyran McLaughlin is also the deputy chairman of J&E Davy, the brokerage that handled the Prialt deal. Martin also confirms that J&E Davy “operates a nominee company called Davycrest” which has “200 private individuals who happen to own shares in Azur” as its clients.
* Elan CFO Shane Cooke’s brother works at Amarin, a company to which Elan gave a licensing agreement for the anti-seizure drug Lorazapam.
* Martin did assist with the founding of Kinsale Capital Management six years ago and he served as a non-executive director of Kinsale until March of 2010. Martin denies he was distracted from his main job by his Kinsale duties.

That’s not even half the reasons that three of Martin’s directors — former Eli Lilly (LLY) CEO Vaughn Bryson, former Abbott Labs (ABT) COO Jack Schuler, and investor Ib Sonderby — want adult supervision of Elan. You can read more about Elan’s tangled skein of friends-and-family deals here; and about how Martin managed to install an anti-takeover “poison pill” controlled by Johnson & Johnson (JNJ) without telling his investors here. Retail investors are openly calling for Martin’s head.

Of course, Martin won’t go. If he believed he couldn’t win he would have gone last year, when this battle first started. Rather, Martin will hang on despite being an international laughing-stock because he has so riddled his company with kill-switches — both Elan’s development partners, J&J and Biogen (BIIB), have the option to walk away with its most valuable drug assets in the event of a change of control. If anyone tries to sell its assets in order to realize their true value, or to take over the company and eject Martin, then the whole company basically implodes. It’s an astonishing situation: Executive leadership based on a suicide pact.

[surga]

Antwort auf Beitrag Nr.: 40.125.129 von Tebi am 09.09.10 13:47:16

warum sollte er wollen
Es ist ja nicht sein Geld, was er verbrennt.
Dafür bekommt er auch viel Geld:O

[Tebi]

Antwort auf Beitrag Nr.: 40.142.158 von surga am 13.09.10 16:11:19

er will sicher nicht---aber vielleicht MUSS er.....

[welke91]

Antwort auf Beitrag Nr.: 40.142.709 von Tebi am 13.09.10 17:31:22

chart sagt ein bissl geht noch.

beobachte das mal.

muss über 5,5 $ um nachhaltig zu sein!

in den nächsten tagen aufwärts. aber mit kleinen GANZ kleinen Schritten!

viel glück!!!

[bernie55]

Biogen to Present at the 2010 UBS Global Life Sciences Conference on Sept. 21, 2010 at 8:30 a.m. EDT


September 15, 2010 04:00 PM Eastern Daylight Time

Biogen Idec to Present at the 2010 UBS Global Life Sciences Conference

WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec Inc. (NASDAQ: BIIB) announced today that its presentation at the 2010 UBS Global Life Sciences Conference will be webcast live on Tuesday, September 21, 2010 at 8:30 a.m. EDT. To access the live webcast, please visit Biogen Idec’s Investor Relations section (investor.biogenidec.com). An archived version of the webcast will be available for 14 days following the presentation.

http://www.businesswire.com/news/home/20100915006518/en

[bernie55]

Antwort auf Beitrag Nr.: 40.162.375 von bernie55 am 16.09.10 15:36:44

..vielleicht wird auf o.g Konferenz etwas zum Thema über JC Virus und PML berichtet...


Paul Clancy CFO Biogen - Today at Stifel Nicolas Healthcare Conference - Explains the significance of 19 out of 19

Paul Clancy CFO Biogen was speaking today at Stifel Nicolaus Healthcare Conference. Here he is explaining the significance of 17 out of 17 going to 19 out of 19. "Let me explain, When we have PML cases, we do look to see if there was a blow draw on those patients before, if they got PML, and Of the PML cases, what we have now is 19 cases where they actually have determined whether or not they were JCvirus positive or JCvirus negative prior to going on therapy or well prior to getting PML. In 19 out of 19 cases now, they were JCvirus positive. So it really is beginning to be continued evidence of the potential of the risk stratification efforts that we have underway in the company."

http://www.investorvillage.com/smbd.asp?mb=160&mn=433394&pt=…

[Tebi]

aha---die Jungs auch mal wieder hier....??

Intern gehts ja ganz schön rund bei Elan...ich hoffe,die GUTEN setzen sich mal durch....Grüsse Birgit

[bernie55]

Antwort auf Beitrag Nr.: 40.163.345 von Tebi am 16.09.10 17:33:42

aha---die Jungs auch mal wieder hier....??

..wir müssen die Männerquote , statistisch gesehen, mal wieder nach oben bringen....

Liebe Grüße
bernie55

[Tebi]

Antwort auf Beitrag Nr.: 40.166.541 von bernie55 am 17.09.10 09:45:49

stimmt! Ausserdem VEREINSAME ich sonst! lg B.

[bernie55]

Antwort auf Beitrag Nr.: 40.162.375 von bernie55 am 16.09.10 15:36:44

Biogen to Present at the 2010 UBS Global Life Sciences Conference on Sept. 21, 2010 at 8:30 a.m. EDT


http://www.biogenidec.com/EVENTS_AND_WEBCASTS.aspx?ID=6017

[bernie55]

Novartis' Multiple Sclerosis Drug Gilenia Poised for Approval

Novartis' Multiple Sclerosis Drug Gilenia Poised for Approval
By Lisa LaMotta Sep 20, 2010 3:30 pm

A panel of experts voted in June to recommend approval of the drug despite some small safety concerns, and the FDA will likely follow the decision.
On Tuesday, the landscape of the multiple sclerosis treatment sector is going to change dramatically -- at least in theory.

The FDA is set to make a decision on the approval of Novartis’ (NVS) oral MS drug Gilenia by Tuesday, and in all likelihood, the drug will be approved. A panel of experts voted in June to recommend approval of the drug, despite some small safety concerns. While the FDA isn't required to follow the decisions of its panels, it often does (especially when the decision is unanimous).

Novartis is set to take a large chunk of the $11 billion multiple sclerosis market that already exists. (Analysts predict Gilenia could have sales of over $2 billion almost immediately, without any expansion to the current market.) If approved, Gilenia will be the first oral treatment for the disease that affects 2.5 million people worldwide. It will contend with injectibles from Biogen Idec (BIIB), Bayer, Merck KGaA, and Teva Pharmaceuticals (TEVA).

The one thing the Novartis drug has on its side is convenience. An oral drug would save MS patients a lot of unneeded pain and suffering caused by a daily injectible. Yet, convenience isn't enough. The drug has been proven to be more effective than a placebo, but has yet to go up against the tried and true treatments for the disease that are already on the market -- this will be a big issue if the drug is to actually capture that $2 billion-worth of patients; it’s likely that Gilenia will have a slow time penetrating the market as physicians see how effective it is compared with the injectible drugs already on the market -- like market leader Copaxone, made by Teva and Sanofi-Aventis (SNY).

Oppenheimer analysts expect that Copaxone will maintain its 40% market share and remarked in a recent investor note that Gilenia will likely be a second- or even third-line treatment as physicians assess possible side effects.

Novartis doesn’t have long to put its mark on the oral MS market. The Swiss drugmaker has been battling with German pharmaceutical company Merck KGaA to get the first oral treatment to the masses and Merck isn’t far behind.

In November, the FDA asked for more information from Merck KGaA regarding its MS pill cladribine. The German pharmaceutical company resubmitted the drug’s application for approval with the FDA in early June. Both Gilenia and cladribine function in the same way to suppress immune system attacks on the body’s own nervous system cells. If both drugs are approved, Gilenia would likely make it to market by the third quarter, while a priority review for Merck’s drug would allow it to potentially come to market by the end of the year -- giving Gilenia only about three months to prove it's the superior treatment.

Novartis’ challenge won’t end there though. Multiple-sclerosis treatments have been notorious for setbacks after launch -- just ask Biogen Idec. The company produces two of the best-selling MS drugs, but one of its treatments, Tysabri, has been plagued by the fact that on occasion, it has caused a rare brain disease. Tysabri was considered one of the most effect treatments to date, but shortly after its launch the serious side effect became known. The company reported in August that there have been a total of 63 cases of the brain disease worldwide, including 12 fatalities. Due to this serious issue, sales of Tysabri have always been disappointing.

http://www.minyanville.com/businessmarkets/articles/ms-multi…

[surga]

Antwort auf Beitrag Nr.: 40.182.460 von bernie55 am 21.09.10 08:27:59

Hi Bernie,
anscheinend ist unser Baby aus dem Tiefschlaf erwacht

[Poppholz]

Antwort auf Beitrag Nr.: 40.185.734 von surga am 21.09.10 16:04:25

gab es Rücktritte im Vorstand?

Würde den Kursverlauf erklären.

[bernie55]

Antwort auf Beitrag Nr.: 40.186.126 von Poppholz am 21.09.10 16:50:05

Es kursieren Gerüchte, dass Lundbeck ELAN übernehmen will....

....dann wollen wir aber mal ein ordentliches Angebot nicht unter XX $$ !!!!!


...mal im Ernst.....wer blickt denn aktuell überhaupt noch durch.......

...Gerüchte........Machtkämpfe in der Vorstandsetage......ewige Stille a la KM....


TIME WILL TELL

[Poppholz]

Antwort auf Beitrag Nr.: 40.186.269 von bernie55 am 21.09.10 17:03:45

ich glaube mein höchster Nachkaufkurs lag bei 12,xx Euro.

Die sollten schon wieder drin sein.

[surga]

Antwort auf Beitrag Nr.: 40.186.391 von Poppholz am 21.09.10 17:16:25

dann könnten wir doch verbilligen, oder?

[Tebi]

hi Jungs---aber wir wollen doch R E I C H im Alter werden (wegen der feudalen Altersresidenz)....das klappt bei 8$ irgendwie nicht...

nene,30 $ müssen es schon werden.....


Msg 434185 of 434217 at 9/21/2010 10:41:38 AM by

Creedster_99

Possible explainations for today's move...
1. Games played by WS re Galenia outcome. Buy 1M shares at $5 in a hurry and make people think there will be some pretty strong requirements for galenia coming from the FDA...

2. Article on EDT today making people realize that EDT CAN have real value if managed properly...

3. D5 being shopped around and those who have looked at the data think it's worth something...

4. Now that Schuller and Vaughn have seen the inner sanctum of Elan's board and are leaving they are planning something to "increase Elan's share price" as they said when joining...

5. BIIB starting to make a bid for Elan shares...

6. Lundbeck to buy Elan for $8...

7. More WS games to get the price up so that they can sell covered calls at a nice premium (usually happens monthly just to get everyone excited)...reference Lucy and Charlie Brown saga...

8. Elan's BOD realize that Elan's shareprice is too low so they are each buying $1M worth...

9. Hell has actually frozen over...

[Poppholz]

Antwort auf Beitrag Nr.: 40.186.667 von Tebi am 21.09.10 17:49:55

Lundberg kommt bestimmt mit so einer fadenscheinlichen Berechnung von wegen 50% Aufschlag auf den Durchschnittskurs der letzten drei Monate, ...

Da wird mit wenig Geld der Kurs unten gehalten und dann billig übernommen.

Alles gemeine Menschen an der Börse.

[Tebi]

Antwort auf Beitrag Nr.: 40.186.702 von Poppholz am 21.09.10 17:54:18

.....und W I R mittendrin

[Tebi]

Msg 434252 of 434281 at 9/21/2010 3:25:54 PM by

snugpharma

Andrew Hirsch of Biogen Idec ; Today at UBS Global Life Sciences Conference - JC Virus antibody test remarks
Andrew Hirsch, Vice President, Strategic Planning & Investor Relations, in the Breakout Session answered questions on JC Virus antibody test. snug

Question: When is the earliest that we can have a commercial JC Virus test on the marketplace.

Answer: Again, we're in discussion with the regulators right now on the path forward, and when we have something concrete to share, we will share it. At this point, we are still working through that. Our goal is to get it on the market as soon as we can.

Question: Is this test available in off-label setting.

Answer: The test is available only through Stratify 1 and Stratify 2. The entry criteria for Stratify 2 are patients considering Tysabri and patients currently on Tysabri. So if someone is considering Tysabri they can enter into Stratify 1 or Stratify 2

[Poppholz]

Antwort auf Beitrag Nr.: 40.187.043 von Tebi am 21.09.10 18:42:11

aber wir sind die GUTEN.

[Tebi]

Antwort auf Beitrag Nr.: 40.189.846 von Poppholz am 22.09.10 09:15:57

stimmt....!

[bernie55]

Antwort auf Beitrag Nr.: 40.189.846 von Poppholz am 22.09.10 09:15:57

aber wir sind die GUTEN.

..aber so was von GUT...

....da kannste wirklich einen drauf lassen...

[Tebi]

Antwort auf Beitrag Nr.: 40.191.260 von bernie55 am 22.09.10 12:03:08

na , ob DU auch gemeint bist bei den Guten......

[Poppholz]

Antwort auf Beitrag Nr.: 40.194.300 von Tebi am 22.09.10 19:28:59

doch, bernie ist auch dabei.

[Tebi]

Antwort auf Beitrag Nr.: 40.198.287 von Poppholz am 23.09.10 13:27:42

soso-Männersolidarität also hier....

[welke91]

Antwort auf Beitrag Nr.: 40.198.904 von Tebi am 23.09.10 15:05:00

Hi ihr lieben,

wünsche es euch so...

aber die indizes sprechen eine andere Sprache man muss sehen und hoffen


grüße

[Tebi]

Antwort auf Beitrag Nr.: 40.202.725 von welke91 am 24.09.10 08:16:54

hi welke,Du Lieber---wie geht es?? Gerne BM ...lg Birgit

[welke91]

Antwort auf Beitrag Nr.: 40.202.809 von Tebi am 24.09.10 08:35:19

ROUNDUP: Merck KGaA erleidet Rückschlag bei Cladribin - Kurs bricht ein

Der Pharma- und Chemiekonzern Merck KGaA hat einen Rückschlag im Zulassungsprozess seines Multiple-Sklerose-Mittel Cladribin erlitten. Der Ausschuss für Humanarzneimittel (CHMP) der europäischen Arzneimittelbehörde EMA habe eine negative Stellungnahme für Cladribin-Tabletten als Therapie der schubförmigen MS abgegeben, teilte Merck am Freitag mit. Der Ausschuss sei der Ansicht, dass aufgrund der derzeit vorliegenden Daten die Vorteile des Medikaments die Risiken nicht aufwiegen.

Auch in Europa!!!

http://www.mainpost.de/nachrichten/wirtschaft/branchen/pharm…

[Poppholz]

Antwort auf Beitrag Nr.: 40.202.725 von welke91 am 24.09.10 08:16:54

hallo welke,

das liegt nur daran, dass der Chart einen zu kurzen Zeitraum betrachtet:



Wir stehen jetzt an der gleichen Stelle wie Ende 2002 und Mitte 2005.

[Poppholz]

Antwort auf Beitrag Nr.: 40.202.725 von welke91 am 24.09.10 08:16:54

bei genauerer Betrachtung sieht Dein Chart ja auch steigende Kurs bei Elan und die INDIZES ärgern.

(habe eben ein wenig schnell geantwortet)

[bernie55]

Press Release


Elan to Present at the Jefferies 2010 Global SpecPharma and European Healthcare Conference

DUBLIN, Sep 29, 2010 -- Elan Corporation, plc (NYSE: ELN) today announced that it will present at the Jefferies 2010 Global SpecPharma and European Healthcare Conference on Wednesday, October 6, 2010, at 2:00 p.m. GMT, 9:00 a.m. Eastern Time.

Interested parties may access a live audio web cast of the presentation by visiting the Investor Relations section of the Elan website at http://www.elan.com, then clicking on the event icon. Following the live webcast, an archived version of the presentation will be available at the same URL.

http://newsroom.elan.com/phoenix.zhtml?c=88326&p=irol-pressr…

[bernie55]

....vielleicht kommt jetzt doch mal wieder ein bisschen Bewegung rein in Richtung XXX USD

Elan Corporation, plc ADR
(NYSE: ELN)

30.09.10. > Last Trade: 5.75 USD


Change: + 0.33 (6.09%)

[Tebi]

Antwort auf Beitrag Nr.: 40.245.663 von bernie55 am 01.10.10 08:18:18

....brauchen wir ja auch für unsere Rente-----wir armen Selbsständigen landen sonst auch noch bei Harz4 oder Leyen 1.....:O

[bernie55]

Antwort auf Beitrag Nr.: 40.246.621 von Tebi am 01.10.10 10:24:52

......wir armen Selbsständigen landen sonst auch noch bei Harz4 oder Leyen 1

......aber dann wenigstens mit einer HARz4LEYen1, Tebi-Baby

LG bernie55

[Tebi]

Antwort auf Beitrag Nr.: 40.247.400 von bernie55 am 01.10.10 11:53:56

....wie--muss ich auf Rente dann auch noch Motorrad fahren lernen?.... ---und das Alles weil ich mal Elan-Aktien gekooft habe....---na,das hält bestimmt jung...

[bernie55]

Elan Announces Official Launch of Manufacturing Services Business at CPhI World Meeting on October 5 in Paris and the Appointment of Philip Pratten as VP Manufacturing Services Operations.

Press Release Source: Elan Corporation, plc On Monday October 4, 2010, 2:00 am EDT

ATHLONE, Ireland--(BUSINESS WIRE)-- Elan Drug Technologies, a business unit of Elan Corporation, plc (NYSE:ELN - News) announces plans to officially launch its Manufacturing Services business at the CPhI world event in Paris on October 5.

At booth #5D63, Elan Drug Technologies will be highlighting the complete range of services it provides to pharmaceutical companies, including drug product optimisation, scale-up and commercial scale manufacturing of solid oral dosage forms.

"We are very excited to be launching our Manufacturing Services business at this world wide event where up to 25,000 pharmaceutical peers meet. For over forty years, Elan Drug Technologies has been a leading provider of drug delivery technologies and dosage form development for the pharmaceutical market,” said Shane Cooke, Executive Vice President and Head of Elan Drug Technologies. "We look forward to expanding our services in commercial scale-up and manufacturing, where we can offer a broad range of manufacturing solutions for our clients from our facilities in Europe and the US.”

Elan’s Manufacturing Services offers a significant advantage in outsourcing, including a broad range of services and expertise integrated to one company that is based in the US and Europe. Building on its over forty years of experience in drug delivery, Elan provides pharmaceutical clients with process design and development expertise, process improvements as well as improved production methods in scale-up and commercial manufacturing. Elan’s outstanding quality compliance, together with its excellent track record in product optimisation, have made EDT the supplier of choice for an impressive number of pharmaceutical companies including seven of the world’s leading pharmaceutical companies.

To support the launch of its Manufacturing Services business, Philip Pratten joins the Elan team as Vice President, Manufacturing Services Operations, having worked in Catalent Pharma Solutions and previously with Cardinal Health, GlaxoWellcome and the Wellcome Foundation. He has almost thirty years of broad based experience in the pharma industry and graduated with a degree in Biophysical Science from North East London Polytechnic (now University of East London).

To organise a meeting with Elan, e-mail [e-mail] or visit booth 5D63 in Hall 5 at CPhI.

http://finance.yahoo.com/news/Elan-Announces-Official-bw-147…

[bernie55]

Antwort auf Beitrag Nr.: 40.245.643 von bernie55 am 01.10.10 08:14:37

Elan to Present at the Jefferies 2010 Global SpecPharma and European Healthcare Conference


Title Elan Corporation, plc at Jefferies & Co. Biopharma Conference
Date and Time Wednesday, October 6, 2010 9:00 a.m. ET / 2:00 p.m. UKT
Duration 1 Hour
Location London GB


http://newsroom.elan.com/phoenix.zhtml?c=88326&p=irol-pressE…

[bernie55]

Antwort auf Beitrag Nr.: 40.274.768 von bernie55 am 06.10.10 15:40:13

Elan's CC yesterday was good - Tysabri related comments

aus dem IV Board > Msg 436566 of 436568
at 10/7/2010 8:34:51 AM by peadar_og


I see a little action pre-market and wonder if it's related.
Comments in brackets are mine. The rest came from Elan yesterday.
MS market had 560k patients in '09 and is adding 8% a year. (Although heavily criticised I was eerily right with my estimates, There will be 605k MS patients on therapy by the end of 2010. Suspect that G will increase that 8% rate too)

MS market has added 100k patients on therapy since 2006.

PML is the only safety signal of note for Tysabri.

50% of MS patients are JCV negative.

You need JCV to get PML.

G entering the market will change the dynamics in favour of Tysabri (not my comment).

(In case you don't get the significance. With the assay, Tysabri will be the most effective and the safest MS therapy on the market for 50% of patients. By far in both cases! In fact I would argue that it will also be the most convenient option for most - and perhaps by a mile also.

34k patients signed up for T during 10 weeks in 2004 before PML but with an unknown safety profile. Today there are 300k JCV negative patients in the market. That will rise to 400k in two or three years.)

Every 10k patients generates $100m profit for Elan (I think it's 20% higher now).

http://www.investorvillage.com/smbd.asp?mb=160&mn=436566&pt=…

[bernie55]

Elan Corporation, plc Earnings Conference Call (Q3 2010)

Scheduled to start Wed, Oct 27, 2010, 8:30 am Eastern

http://biz.yahoo.com/cc/5/117385.html

[bernie55]

Data Further Supporting Anti-JC Virus Antibody Assay

Data Further Supporting Anti-JC Virus Antibody Assay Presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis

Studies support potential of assay to stratify risk of PML in TYSABRI-treated patients -


Press Release Source: Biogen Idec and Elan Corporation, plc On Saturday October 16, 2010, 3:06 am EDT

GOTHENBURG, Sweden--(BUSINESS WIRE)-- Biogen Idec (NASDAQ:BIIB - News) and Elan Corporation, plc (NYSE:ELN - News) today announced data further supporting the potential clinical utility of an investigational assay that detects anti-JC virus (JCV) antibodies in human plasma or serum. The detection of anti-JCV antibodies may provide a means to segment, or stratify, multiple sclerosis (MS) patients considering or receiving treatment with TYSABRI® (natalizumab) and assess their risk for developing progressive multifocal leukoencephalopathy (PML), a rare, but serious, brain infection. These data have been presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden.

This two-step, analytically-validated, enzyme-linked immunosorbant assay (ELISA) to detect anti-JCV antibodies is currently being evaluated in large-scale, prospective clinical studies (>10,000 patients) to determine the utility of the assay in stratifying the risk of PML in TYSABRI-treated patients. Infection with JCV is one of a number of factors required for the development of PML. Detection of anti-JCV antibodies may be a useful tool to identify prior or ongoing JCV infection, helping physicians better assess a patient’s potential risk for developing PML.

“When treating a debilitating, chronic disease such as MS, patient safety is of the utmost importance. At Biogen Idec, we are committed to improving the lives of people with MS. Understanding and mitigating potential treatment risk factors further support our commitment,” said Alfred Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and Development at Biogen Idec. "We are committed to better understanding PML and have embarked on a number of risk mitigation efforts. The anti-JCV antibody assay is one of our most advanced initiatives and has the potential to provide physicians a tool to help them assess patients’ risk for developing PML."


Overview of Data

Late Breaking News – Factors associated with anti-JCV antibody prevalence in a large cohort of natalizumab-treated MS patients – Platform Presentation 138

The two-step ELISA was used to detect anti-JCV antibodies in blood from patients enrolled in the TYSABRI Global Observation Study (TYGRIS), Safety of TYSABRI Re-dosing and Treatment (STRATA) study, and JCV Antibody Program in Patients with Relapsing Multiple Sclerosis Receiving or Considering Treatment with TYSABRI (STRATIFY-1) study. A chi-square test was used to assess associations between factors and prevalence of anti-JCV antibodies. Together, these data represent one of the largest cohorts of MS patients evaluated for the presence of anti-JCV antibodies, demonstrating an overall prevalence of anti-JCV antibodies of approximately 50 to 60 percent and delineating the prevalence by factors such as age and gender. There was an increasing prevalence of anti-JCV antibodies in men compared to women. There was also an increasing prevalence with age, regardless of gender. TYSABRI use and prior treatment with immunosuppressants did not appear to affect the prevalence of anti-JCV antibodies in this cohort.

Assessment of the incidence of anti-JCV antibodies in a cohort of natalizumab-treated patients with multiple sclerosis – Poster P873

This study, which used the ELISA to evaluate more than 800 serum samples, was designed to assess the prevalence of anti-JCV antibodies in TYSABRI-treated MS patients and evaluate the possible utility of anti-JCV antibodies as a means to segment, or stratify, MS patients and assess their risk for developing PML. Of the more than 800 patients evaluated, 54 percent tested positive for anti-JCV antibodies.

Additionally, anti-JCV antibodies were detected in 20 out of 20 (100 percent) of TYSABRI-treated PML patients at least six months prior to the diagnosis of PML.
Further clinical studies are being conducted to determine whether the presence or absence of anti-JCV antibodies may be useful to stratify PML risk.

Late Breaking News – Multi-site cross-validation of the assay to detect anti-JCV antibodies in human serum and plasma – Poster P992

In this study, cross-validation of the ELISA was performed by three laboratories (Focus Diagnostics, Quintiles Laboratories, and Biogen Idec) by evaluating intra- and inter-assay precision, including specificity, sensitivity, selectivity and matrix interference, robustness, and reagent stability. A panel of 100 serum and plasma samples was evaluated at each laboratory. The ability of the ELISA to detect anti-JCV antibodies in human serum and plasma was robust and cross-validated by all three laboratories. The assay is now being used in two global clinical trials to evaluate the potential clinical utility of anti-JCV antibody status for stratifying PML risk.

Late Breaking News – Anti-JCV antibody prevalence in a Swedish cohort of MS patients and non-MS controls – Poster P983

In this study from Sweden, the ELISA was used to detect anti-JCV antibodies in plasma from 2772 untreated or treated MS patients, as well as non-MS controls. A chi-square test was used to assess the association between demographic factors and prevalence of anti-JCV antibodies. Based on the data analyzed to date, it is estimated that the prevalence of anti-JCV antibodies in the Swedish MS population to be 61 percent, which is lower than the prevalence observed in the non-MS control population (67 percent) in the study.

http://www.investorvillage.com/smbd.asp?mb=160&mn=437708&pt=…

[Tebi]

Antwort auf Beitrag Nr.: 40.337.706 von bernie55 am 17.10.10 16:23:38

Gut!

...und eine Freundin von mir arbeitet auf einer Station,wo demnächst auch MS Patienten die mit Tysabrei behandelt werden,aufgenommen werden...ich werde berichten...netten Gruss in die Runde!

[Tebi]

New Test Assessing PML Risk With Natalizumab Targeted for Early 2011."...said her team is preparing for an onslaught of requests."


From Medscape Medical News

New Test Assessing PML Risk With Natalizumab Targeted for Early 2011
Allison Gandey

October 18, 2010 (Gothenburg, Sweden) — A new assay measuring JC virus antibodies is in development and could be available as early as January. Biogen Idec and Elan Corporation are racing to bring a new tool to market that they hope will boost confidence in natalizumab (Tysabri) for multiple sclerosis (MS).

Large-scale, prospective clinical studies are currently under way to determine whether a new JC virus assay will help clinicians predict which patients are most at risk for progressive multifocal leukoencephalopathy (PML).

Presenting here at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, Al Sandrock, MD, Biogen's senior vice president of neurology research and development in Cambridge, Massachusetts, described the project.
Antibodies consistent across studies.

The 2-step enzyme-linked immunosorbent assay screens and confirms the presence of JC virus antibodies. So far, the test has been evaluated in more than 5000 patients.

Most of the people are from 4 large natalizumab studies. AFFIRM is a phase 3 multicenter international trial. TYGRIS is a US and Canadian observational study. STRATIFY-1 was launched as an anti–JC virus antibody study for patients receiving or considering natalizumab. And the final study uses data from a Swedish MS registry.

Dr. Sandrock reports the incidence of PML is lower in anti–JC virus–negative compared with anti–JC virus–positive patients. The prevalence of antibodies against JC virus was consistent across studies and ranged from 48% to 61%.
Dr. Sandrock suggests a PML global incidence of 1.63 per 1000 patients treated with natalizumab for at least 18 months. He says the prevalence of antibodies was not affected by prior immunosuppressant use. The virus was less often found in women, but the likelihood of testing positive seemed to increase with age.

False Negatives
Dr. Al Sandrock, Biogen

The false-negative rate for the new test is about 2.5%. The spontaneous seroconversion rate of negative-testing patients is estimated at about 2% per year. Both suggest that periodical testing might be warranted in patients taking natalizumab in clinical routine.

"With this assay, approximately 50% of tested individuals were positive and approximately 50% negative," Mathias Buttmann, MD, from Julius Maximilian University in Würzburg, Germany, pointed out in a recent Expert Review of Neurotherapeutics. This is a lower rate of positive-testing individuals than in some, but not all, published cohorts tested with other assays, where the rate of subjects testing positive was up to 90%, he notes.

"Higher JC virus specificity of this assay and/or testing of a younger cohort might possibly explain the rather low rate of positive-testing individuals," he explained.

Dr. Buttmann cautions that the lack of long-term safety data on the use of natalizumab in MS patients should be kept in mind when considering the drug for patients who test negative.

Trials are ongoing, but the companies say first tests could be available in certain laboratories in early 2011. Tatiana Plavina, PhD, a biochemist at Biogen, said her team is preparing for an onslaught of requests. "We think it's possible we'll have 50,000 new samples to analyze next year."

At a news conference here at the meeting, panelists agreed plans for the new assay are "very exciting". Jon Lycke, MD, from Sahlgrenska University in Sweden, Michel Clanet, MD, from Hôpital Purpan in France, and Ludwig Kappos, MD, from University Hospital in Basel, Switzerland, all nodded in agreement.

In the United States, many neurologists have also been looking forward to such a test. "It would be great to be able to preemptively stratify risk up front," Timothy West, MD, from the University of California at San Francisco, said during an interview at the recent American Neurological Association annual meeting.

Dr. West has been questioning whether planned natalizumab suspensions, proposed as a way to restore immunologic function, actually work. Dosage interruption is commonly used in clinical practice, but Dr. West has observed recurrence of clinically significant MS disease activity in 10% of patients.Dr. Buttmann pointed out to Medscape Medical News that cases of PML still occurred in the STRATA trial. This trial investigates the safety and efficacy of natalizumab after a treatment gap of at least 1 year. Four of 1094 patients developed PML, which he suggests could call into question the appropriateness of drug holidays to reduce the risk for PML. Three of the 4 patients had immunosuppressive pretreatment, which increases the risk for PML about 4-fold over patients without immunosuppressive treatment.

Earlier this year, the US Food and Drug Administration (FDA) notified healthcare professionals and patients that the risk of developing PML increases with the number of natalizumab infusions.

Natalizumab is a humanized monoclonal antibody against α4-integrin that decreases lymphocyte traffic across the blood brain barrier. PML continues to be the main concern with natalizumab.

The condition is a rare but serious and often fatal adverse effect of the drug and is characterized by progressive damage or inflammation of the white matter of the brain at multiple locations. It is caused by the JC virus, which is normally present and kept under control by the immune system. Immunosuppressive drugs prevent the immune system from controlling the virus.

Biogen Idec reports 68 cases of natalizumab-associated PML. Of these, 14 people died. Data from preliminary analyses of the new assay were released online August 24 in the Annals of Neurology and appear in the journal's September issue.

The FDA reports it is also monitoring for herpesvirus infections with natalizumab and cases of pericarditis.

Dr. Sandrock is an employee of Biogen Idec.
26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS): Parallel Session 10: Abstract 138. Presented October 16, 2010

[Tebi]

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NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.
UPDATE 1-Elan Corp sees yearly earnings topping $150 million

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Wed Oct 27, 2010 2:33am EDT

* Q3 revenue $281.4 mln vs f'cst $287 mln

* EBITDA up 61 percent to $38.2 million

(Adds detail)

DUBLIN, Oct 27 (Reuters) - Irish drugmaker Elan Corp Plc (ELN.I) said on Wednesday it expected to make underlying earnings before interest, tax, depreciation and amortisation (EBITDA) of over $150 million in the current year.

Elan said adjusted EBITDA for the third quarter increased by 61 percent to $38.2 million as its blockbuster multiple sclerosis drug Tysabri increased sales.

Total revenue in the third quarter fell 2 percent to $281.4 million, compared with an average forecast of $287 million from a Reuters poll of four analysts. Sales of Tysabri rose by 13 percent to $215.9 million.

The company said it expected to end 2010 with about $400 million in cash and to be cash-flow positive in 2011.

"The third quarter results highlight our ability to simultaneously improve our operating results, de-lever our balance sheet and advance our pipeline," said Chief Executive Kelly Martin.

Shares in Elan closed on Tuesday at 4.05 euros, valuing the business at over 2.4 billion euros ($3.4 billion). (Reporting by Matt Scuffham) ($1=.7166 Euro)

[Tebi]

Elan Reports Third Quarter 2010 Financial Results
businesswire

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Chart for Elan Corporation, plc ADR
{"s" : "eln","k" : "a00,a50,b00,b60,c10,g00,h00,l10,p20,t10,v00","o" : "","j" : ""}
Press Release Source: Elan Corporation, plc On Wednesday October 27, 2010, 2:00 am

DUBLIN--(BUSINESS WIRE)-- Elan Corporation, plc today reported its third quarter and first nine months 2010 financial results.

Elan CEO Kelly Martin commented, “We continue to advance the Company and achieve substantive progress in both our BioNeurology and EDT businesses. The third quarter results highlight our ability to simultaneously improve our operating results, de-lever our balance sheet and advance our pipeline. We continue to construct an operating model which allows us to leverage our core strengths while collaborating on many other components within the business.” Mr. Martin added, “We are excited about the potential clinical utility of an investigational JCV antibody assay to help physicians stratify risk among their Tysabri patients. The recent data presented at ECTRIMS encourages further exploration of this potential risk stratification tool.”

Commenting on the third quarter results, Elan chief financial officer, Shane Cooke said, “We are very pleased with the outcome of this quarter, which reflects continued improvements in our operating performance and our capital structure. Adjusted EBITDA for the third quarter increased by 61% to $38.2 million and the business generated cash flow from operating activities for the third quarter in a row. We recorded a net loss of $43.6 million in the third quarter of this year, compared to net income of $52.3 million in the same period last year, due to the inclusion of a $107.7 million net gain related to the Johnson & Johnson transaction in 2009. This improvement in the operating performance resulted from the continued growth in Tysabri, revenues from the launch of Ampyra and a reduction in operating expenses, which more than offset the impact of reduced revenues from a number of legacy products. We also made further progress in improving our balance sheet this quarter, repaying debt that was due in 2011 and 2013 and issuing a 2016 bond. Over the last year, we have repaid or refinanced $1.3 billion in debt that was due between 2011 and 2013, which has resulted in a 27% reduction in our total debt, extending its average maturity while retaining significant liquidity.”

Mr. Cooke confirmed that for the full-year 2010, Elan remains on target to record revenue growth, Adjusted EBITDA of more than $150 million and operating income before other charges or gains. Mr. Cooke also noted that the Company expected to end 2010 with approximately $400 million in cash and investments and to be cash flow positive in 2011.

[welke91]

Antwort auf Beitrag Nr.: 40.396.657 von Tebi am 27.10.10 08:58:51

hi Ihr,

die Konso vollzieht sich etwas schwächer im Impuls und dauert dabei etwas länger an als gedacht.

Wird also nicht diese woche seinen Tiefpunkt finden sondern so meine Vermutung erst nächste Woche Freitag.



Sonst alles im Lot und ich denke auch, dass dieser neue Antibody GUT für den Kurs sein wird.

Dies würde auch die langzeit Trends bestätigen!

Elan würde demnach auf 7,41 $ bis Mitte Dezember steigen!

Grüße ohne

[Tebi]

Antwort auf Beitrag Nr.: 40.397.611 von welke91 am 27.10.10 10:54:59

hi Du, Danke!
Am optimalsten wäre es das Management in die KURVE NACH UNTEN ZU SCHICKEN::::NETTEN Gruss!B.

[DonServante]

Alzheimer-"Impfung" gefunden
Rund 24 Millionen Menschen leiden weltweit an Demenzerkrankungen. Für mehr als die Hälfte davon ist die Alzheimer-Krankheit verantwortlich. Forscher finden nun einen Impfstoff, mit dem die Krankheit zwar nicht geheilt, aber gestoppt werden könnte.

mehr: http://www.n-tv.de/wissen/Alzheimer-Impfung-gefunden-article…

Wenn das mal nicht ein Schlag ins Kontor ist!

[Tebi]

Wahrscheinlich führen viele Wege nach Rom......

Informationsdienst Wissenschaft

Deutsch / English
Sie sind hier: Home > Pressemitteilung: Therapie gegen Alzheimer: Göttinger ...
Pressemitteilung
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Therapie gegen Alzheimer: Göttinger Forscher entwickeln neuen Ansatz für passive Immunisierung
Stefan Weller

Presse- und Öffentlichkeitsarbeit

Universitätsmedizin Göttingen - Georg-August-Universität
05.11.2010 10:35


Durchbruch in der Alzheimer Forschung veröffentlicht im Journal of Biological Chemistry (2010) doi:10.1074/jbc.M110.178707
(umg) Die Alzheimersche Erkrankung in ihrem Verlauf zumindest anhalten zu können, das ist Prof. Dr. Thomas Bayer und Dr. Oliver Wirths, Alzheimerforscher in der Abteilung Psychiatrie und Psychotherapie an der Universitätsmedizin Göttingen, bei Mäusen gelungen. Ihre Forschungsergebnisse beruhen auf einer passiven "Impfung" gegen Alzheimer. Als Wirkstoff setzen sie einen neu entwickelten Antikörper ein. Neu an dem Ansatz ist: Der Antikörper der Göttinger Forscher zielt gerade nicht auf die Alzheimer typischen Eiweißablagerungen im Gehirn, die so genannten "Plaques". Zielscheibe ist vielmehr eine besondere Molekülstruktur, die das Eiweiß "Pyroglutamat-Abeta" ausbildet. Dieses Eiweiß haben die Göttinger Forscher als eigentlichen "Übeltäter" ausgemacht. Mit einem speziellen Antikörper gegen dieses Eiweiß lässt sich schon früh dessen zerstörerische Kraft stoppen. Die jüngsten Forschungsergebnisse mit einem Mausmodell für die Alzheimer-Erkrankung versprechen einen erfolgreichen neuen Behandlungsansatz. Die Forschungsergebnisse wurden am 22. Oktober 2010 veröffentlicht in: Wirths et al. (2010) Journal of Biological Chemistry online

Bisherige Behandlungsstrategien zielen in erster Linie auf die so genannten Plaques ab. Diese Alzheimer-typischen Eiweißablagerungen bilden sich außerhalb der Nervenzellen. Die Bedeutung der Plaques für den Krankheitsprozess wird jedoch in Fachkreisen kontrovers diskutiert. Berühmtes Beispiel dafür ist die amerikanische Nonnenstudie geworden. Die mehr als 600 Nonnen wurden regelmäßig neuropsychologisch getestet. Einige von ihnen entwickelten auch Alzheimer. Überraschend war jedoch, dass sich auch viele "Plaques" im Gehirn von Nonnen befanden, deren Wahrnehmung und Lernfähigkeiten völlig normal waren und keine Anzeichen für Alzheimer hatten. "Wir gehen davon aus, dass Plaques eine Art Mülleimer für das giftige Abeta-Eiweiß sind. Man sollte zwar die Entstehung bekämpfen, aber wenn sie schon vorhanden sind, ist es therapeutisch sinnvoller sie in Ruhe zu lassen", sagt Prof. Bayer. "Genau da setzt unser Antikörper an".

Bereits in früheren Studien hatten die Göttinger Alzheimerforscher in verschiedenen Tiermodellen nachgewiesen, dass entgegen bisheriger Annahmen nicht die Plaques den Tod der Nervenzellen auslösen. Sie fanden Beweise dafür, dass die zerstörerische Kaskade bereits viel früher und im Inneren der Nervenzelle in Gang gesetzt wird.

In der nun veröffentlichen Studie haben die Göttinger Wissenschaftler in einem von Prof. Thomas Bayer geführten internationalen Konsortium mit Kollegen von Synaptic Systems GmbH (Göttingen) und Wissenschaftlern aus Amsterdam, Berlin, Bonn, Helsinki und Uppsala eine völlig neuartige Struktur des Pyroglutamat-Abeta-Peptids entdeckt und dagegen spezifische Antikörper entwickelt. "Diese Antikörper sind weltweit die ersten, die eine lösliche, besonders toxische Abeta-Variante erkennen. Anders als die bisherigen Antikörper, die für Immunisierungen benutzt wurden, binden sie vor allem nicht an Plaques", sagt Prof. Bayer.

Die neu entwickelten Antikörper erkennen besonders giftige Verklumpungen von Pyroglutamat-Abeta, so genannte "Oligomere". Diese Oligomere häufen sich im Gehirn von Alzheimer Patienten, dort vor allem in Nervenzellen und an Blutgefäßen an. Dies führt vermutlich zu Schädigungen der Blutgefäße. Die Folge: Die Oligomere können nicht mehr aus dem Gehirn abfließen. "Wir können feststellen, dass die Spiegel der Oligomere im Blut von gesunden Personen hoch sind. Bei Alzheimer-Patienten lassen sich nur niedrige Oligomere-Spiegel im Blut finden, dafür sind sie im Gehirn aber viel höher", sagt. Dr. Oliver Wirths: "Damit eignen sich diese Antikörper als potentielle Biomarker für die Diagnose von Alzheimer im Blut und im Gehirn."

In der aktuellen Studie konnten die Göttinger Forscher erstmals belegen, dass die passive Immunisierung mit einem Oligomer-spezifischen Antikörper, der Plaques nicht erkennt, erfolgreich war. Im Tiermodell war der Antikörper therapeutisch wirksam und stabilisierte das Lernverhalten. Durch die passive Immunisierung werden Antikörper zugeführt, binden die giftigen Oligomere und machen sie unschädlich. "Mit dieser Form der passiven Impfung können wir vermutlich keine Heilung erreichen, aber unsere Forschungsergebnisse zeigen, dass die Antikörper offenbar das Fortschreiten der Alzheimer-Krankheit stoppen", sagt Prof. Bayer.

[Tebi]

Antwort auf Beitrag Nr.: 40.468.056 von Tebi am 06.11.10 12:41:31

Inge,Ridge aus dem IV-Board schreibt dazu : "aab-001 erkennt die bes. toxische lösliche Form Oligomere
lässt aber die plaques nicht in Ruhe ... "

[surga]

Antwort auf Beitrag Nr.: 40.468.066 von Tebi am 06.11.10 12:44:25

ist ja so ruhig hier

[Tebi]

Antwort auf Beitrag Nr.: 40.497.687 von surga am 11.11.10 00:35:53

weil Du soooooooooo weit weg bist.... guck mal dies :http://www.youtube.com/watch?v=7OH82C2PpEA&feature=related lg B.

[Poppholz]

gestern mal "ausnahmsweise" ein guter Tag.

Da sich bestimmt einige Teilnehmer finden lassen werden, die den Kurs in den nächsten Tagen wieder nach unten drücken werden, bin ich nicht so euphorisch.

[Tebi]

Antwort auf Beitrag Nr.: 40.498.119 von Poppholz am 11.11.10 08:12:41

Poppi---unsere Zeit kommt noch...wir brauchen ja noch nicht den goldenen Rollator....

[Poppholz]

Antwort auf Beitrag Nr.: 40.499.801 von Tebi am 11.11.10 11:09:31

momentan macht mir Börse nicht so viel Spasse.

[Tebi]

Antwort auf Beitrag Nr.: 40.500.086 von Poppholz am 11.11.10 11:33:44

guck mal in den thread "Tim Lucas reelles Depot 2010"....lg Birgit

[welke91]

Antwort auf Beitrag Nr.: 40.500.086 von Poppholz am 11.11.10 11:33:44

heute noch eine kleine Sportübung?

8%?

sieht doch ganz nett aus...





schönes Wochenende

[Tebi]

Antwort auf Beitrag Nr.: 40.511.205 von welke91 am 12.11.10 13:33:06

Dir auch!

[welke91]

Antwort auf Beitrag Nr.: 40.511.205 von welke91 am 12.11.10 13:33:06

hi leute,

mein selbst gebastelter Indikator zeigt im kurzfristigen Bereich (1-2 Tage) einen Rückschlag an.

dies kann aber so nicht stimmen denn:

MACD hat Divergenzen erzeugt und deutet damit auf steigende Kurse:



5,7 $ müssen stehen bleiben, sonst gibt es fallende Kurse und gedachtes Szenario ist hinfällig!

Indizes stehen auch noch auf Konso!

Grüße

[posimist]

Antwort auf Beitrag Nr.: 40.530.007 von welke91 am 16.11.10 13:57:44

Ich sehe, einige "Alte" sind noch dabei
Ich hoffe, wir werden noch belohnt.
posimist

[Tebi]

Antwort auf Beitrag Nr.: 40.650.090 von posimist am 05.12.10 23:21:07

klar!

[bernie55]

Elan Names Robert A. Ingram Chairman-Designate

Ingram, Former CEO Of Glaxo Wellcome And Former Vice Chairman Of GlaxoSmithKline, Will Become Non-Executive Chairman Of Elan In January, 2011


DUBLIN--(BUSINESS WIRE)-- Elan Corporation, plc ("Elan") (NYSE:ELN - News) today announced that the Company’s Board of Directors has appointed Robert A. Ingram, former Chief Executive Officer of Glaxo Wellcome plc and former Vice Chairman Pharmaceuticals of GlaxoSmithKline, to the Board effective immediately. Further, he will assume his role as Chairman effective January 26, 2011, the date of the next board meeting, and will at that time succeed Kyran McLaughlin, who in April announced his intention to step down as Non-Executive Chairman following the completion of a search for a successor.

Bob Ingram said: “Elan is a company with tremendous science, talent and potential to have a positive impact on millions of patient lives and their families. I am impressed with the progress the company has made over the past several years in advancing the science, improving its financial performance, and constructing unique and far reaching collaborations which will enable the company to continue to invest in science and innovate within the world of novel therapeutic advances. I look forward to working with the Board and the management team to deliver long term benefits to science, patients and shareholders.”

Kyran McLaughlin said: “Bob Ingram is one of the most distinguished leaders in the global pharmaceutical industry. With top level leadership experience at Glaxo Wellcome and GlaxoSmithKline, Bob has a proven track record of successful leadership and a deep understanding of the industry overall. I am proud to be turning over the chairmanship to such a capable and high integrity leader and know that he will make many contributions as the company continues to develop and advance.”

Kieran McGowan, Elan’s Lead Director, said: “On behalf of the Board, I want to thank Kyran again for his leadership as Non-Executive Chairman over the past five years. During this period, Elan has made many significant and fundamental business strides, emerging as a much stronger Company better positioned to deliver on its vital mission of advancing important science and therapies to the benefit of patients around the world.”

Since 2007, Robert Ingram has been a General Partner of Hatteras Venture Partners, LLC, a venture capital firm that invests in early stage life science companies in the southeast United States. He has also served as an advisor to the Chief Executive Officer of GlaxoSmithKline plc, since January 2010. Mr. Ingram previously served as Vice Chairman Pharmaceuticals of GlaxoSmithKline, acting as a special advisor to the Corporate Executive Team and attending its meetings in that capacity, from January 2003 until December 2009. Prior to that, Mr. Ingram was Chief Operating Officer and President, Pharmaceutical Operations of GlaxoSmithKline from January 2001 to January 2003. Previously, he was Chief Executive Officer of Glaxo Wellcome plc from 1997 to 2000 and Chairman of Glaxo Wellcome Inc., Glaxo Wellcome plc’s United States subsidiary, from 1999 to 2000. He currently serves on the boards of directors of Allergan, Inc., Cree, Inc., Edwards Lifesciences Corporation, Lowe’s Companies, Inc. and Valeant Pharmaceuticals International, where he serves as Lead Director.

Elan was assisted in the search and hiring process for the position by Heidrick & Struggles, a leading provider of senior-level executive search and leadership consulting services.

http://finance.yahoo.com/news/Elan-Names-Robert-A-Ingram-bw-…

[Poppholz]

Antwort auf Beitrag Nr.: 40.650.090 von posimist am 05.12.10 23:21:07

so ist der Plan.

[Poppholz]

Antwort auf Beitrag Nr.: 40.651.332 von Poppholz am 06.12.10 10:27:49

auch schön:

In den USA starten wir mit über 6% im Plus und hier schreibt niemand.

[Poppholz]

Antwort auf Beitrag Nr.: 40.654.206 von Poppholz am 06.12.10 15:56:08

UBS upgrade Elan Corporation Plc (NYSE: ELN [FREE Stock Trend Analysis]) from "neutral" to "buy." ELN's shares closed at $5.17 on Friday. Elan's PEG ratio is 0.05.

[Poppholz]

Antwort auf Beitrag Nr.: 40.654.220 von Poppholz am 06.12.10 15:57:32

ich kann mich noch an Zeiten erinnern, da ist der Kurs jedes Mal abgeschmiert, wenn eine Kaufempfehlung kam.

Allerdings hatten wir da auch ein wesentlich höheres Niveau.

[Tebi]

Antwort auf Beitrag Nr.: 40.654.238 von Poppholz am 06.12.10 15:59:00

ein WESENTLICH höheres Niveau---nämloch 5x so hoch----und DA wollen wir wieder hin!!....wegen des goldenene Rollators.....

[Tebi]

Goodbodys - 'Elan has not disappointed.'
Elan this morning announced that Robert Ingram, former CEO of Glaxo Wellcome and Vice
Chairman Pharmaceuticals of GSK, has been appointed to the Board with immediate effect. He
will assume the position of Non-Executive Chairman at the next board meeting on the 26th of
January when the current Chairman, Kyran McLaughlin, will step down. Since 2007, Mr Ingram
has been a general partner of Hatteras Venture Partners, a US venture capital firm that invests
in early stage life science companies and he is on the board of a number of companies, including
Allergan. Since Mr McLaughlin announced last April that he would be stepping down, the
appointment of a Chairman with wide ranging pharmaceutical experience has been anticipated
by the market. Elan has not disappointed.
...........................................

[Tebi]

Bob Ingram said:
Elan Names Robert A. Ingram Chairman-Designate
Ingram, Former CEO Of Glaxo Wellcome And Former Vice Chairman Of GlaxoSmithKline, Will Become Non-Executive Chairman Of Elan In January, 2011 12/06 02:00 AM



DUBLIN--(BUSINESS WIRE)-- Elan Corporation, plc (ELN:$5.1700,$-0.0100,-0.19%) ("Elan") today announced that the Company’s Board of Directors has appointed Robert A. Ingram, former Chief Executive Officer of Glaxo Wellcome plc and former Vice Chairman Pharmaceuticals of GlaxoSmithKline (GSK:$39.1900,$0.2500,0.64%) , to the Board effective immediately. Further, he will assume his role as Chairman effective January 26, 2011, the date of the next board meeting, and will at that time succeed Kyran McLaughlin, who in April announced his intention to step down as Non-Executive Chairman following the completion of a search for a successor.

Bob Ingram said: “Elan is a company with tremendous science, talent and potential to have a positive impact on millions of patient lives and their families. I am impressed with the progress the company has made over the past several years in advancing the science, improving its financial performance, and constructing unique and far reaching collaborations which will enable the company to continue to invest in science and innovate within the world of novel therapeutic advances. I look forward to working with the Board and the management team to deliver long term benefits to science, patients and shareholders.”

Kyran McLaughlin said: “Bob Ingram is one of the most distinguished leaders in the global pharmaceutical industry. With top level leadership experience at Glaxo Wellcome and GlaxoSmithKline, Bob has a proven track record of successful leadership and a deep understanding of the industry overall. I am proud to be turning over the chairmanship to such a capable and high integrity leader and know that he will make many contributions as the company continues to develop and advance.”

Kieran McGowan, Elan’s Lead Director, said: “On behalf of the Board, I want to thank Kyran again for his leadership as Non-Executive Chairman over the past five years. During this period, Elan has made many significant and fundamental business strides, emerging as a much stronger Company better positioned to deliver on its vital mission of advancing important science and therapies to the benefit of patients around the world.”
Since 2007, Robert Ingram has been a General Partner of Hatteras Venture Partners, LLC, a venture capital firm that invests in early stage life science companies in the southeast United States. He has also served as an advisor to the Chief Executive Officer of GlaxoSmithKline plc, since January 2010. Mr. Ingram previously served as Vice Chairman Pharmaceuticals of GlaxoSmithKline, acting as a special advisor to the Corporate Executive Team and attending its meetings in that capacity, from January 2003 until December 2009. Prior to that, Mr. Ingram was Chief Operating Officer and President, Pharmaceutical Operations of GlaxoSmithKline from January 2001 to January 2003. Previously, he was Chief Executive Officer of Glaxo Wellcome plc from 1997 to 2000 and Chairman of Glaxo Wellcome Inc., Glaxo Wellcome plc’s United States subsidiary, from 1999 to 2000. He currently serves on the boards of directors of Allergan, Inc., Cree, Inc., Edwards Lifesciences Corporation, Lowe’s Companies, Inc. and Valeant Pharmaceuticals International, where he serves as Lead Director.

Elan was assisted in the search and hiring process for the position by Heidrick

[posimist]

Was ist los in Sachen Alzheimer?
Wann können wir hier Neuigkeiten erwarten?

[bernie55]

Worst Biotech CEO of 2010 Is...

By Adam Feuerstein 12/09/10 - 07:01 AM EST

The Worst Biotech CEO of 2010 is Dan Bradbury of Amylin Pharmaceuticals(AMLN_).

""""""""""""""""""""""""""""""""""""

"""""""""""""""""""""""""""""""""""""


"""""""""""""""""""""""""""""""""""""



Elan(ELN_) CEO Kelly Martin's moniker now adorns the trophy as a gesture to appease the scores of angry Elan shareholders who rattled my email in-box this week for failing to name Martin as a two-time worst biotech CEO winner. (Martin won the first award in 2008.)

Memo to Martin: Your shareholders aren't happy! They accuse you of wasting company money and receiving too many gold-plated executive perks. They believe you're doing a lousy job marketing the multiple sclerosis drug Tysabri and excoriate you for dealing away the Alzheimer's drug bapineuzumab to Johnson & Johnson(JNJ_).

Martin has already announced plans to step down from his leadership role at Elan in 2012, but perhaps sooner would be better? YEPP!!!!!




http://www.thestreet.com/_yahoo/story/10941946/1/worst-biote…

[Tebi]

Antwort auf Beitrag Nr.: 40.661.782 von posimist am 07.12.10 12:29:59

2011

Berni:

[bernie55]

Alzheimer's may result from slow clearance of amyloid protein in brain


Thursday 9 December 2010 19.00 GMT

Alzheimer's may result from slow clearance of amyloid protein in brain
Brains that are inefficient at removing amyloid protein may be more susceptible to Alzheimer's disease, research suggests

Failure to clear amyloid-beta protein from the brain quickly enough may lead to Alzheimer's. Photograph: Nacho Doce/Reuters

Alzheimer's disease could be caused by a failure of the brain to clear away a waste product of normal metabolism fast enough, researchers have found. This leads to a buildup of the waste and the growth of plaques that can degrade brain cells and cause damage.

Of the roughly 750,000 people in the UK who have a form of dementia, more than half have Alzheimer's disease. According to the Alzheimer's Society, in 15 years a million people will be living with dementia and this figure will rise to 1.7 million people by 2051.

The disease is caused by a build-up of plaques in the brain, made of a protein called amyloid-beta, which is a product of normal metabolism. One of the ways the brain clears away the amyloid-beta is to dump it into the spinal fluid for later disposal. A drop in levels of amyloid-beta in spinal fluid could, therefore, be an early indicator that someone will go on to develop Alzheimer's disease, perhaps because the waste protein cannot be removed from the brain and is beginning to accumulate.

To test how quickly the brain can get rid of this waste protein, Randall Bateman, an assistant professor of neurology at Washington University School of Medicine in St Louis, monitored the spinal fluid of 12 people with Alzheimer's disease over a 36-hour period and compared it to that of 12 cognitively normal individuals. He found that both sets of people were producing amyloid-beta in their brains at the same average rate, but the protein clearance rate was 30% lower on average in the group with Alzheimer's.

In a paper published today in Science, Bateman calculated that it would take 10 years for this decreased clearance to cause the build-up of amyloid-beta that is normally seen in the brains of Alzheimer's patients.

"This exciting study gives us an insight into the building blocks of Alzheimer's disease. It could be that people's natural 'rubbish trucks' are on strike and are not clearing away a protein called amyloid. We now need further research to find out why the system is not working properly and whether amyloid is toxic in higher concentrations," said Clive Ballard, director of research at the Alzheimer's Society. "The burning question is whether this process starts before the onset of symptoms, as this could be vital to the development of new treatments. As the number of people with dementia reaches a million in just 15 years we urgently need more investment in research."
Randall said the finding could have implications for diagnosis and treatment of the disease, even before symptoms developed. In the experiment, for example, some healthy subjects had lower clearance rates than average for their group, close to or slightly within the range seen in Alzheimer's patients. "Cognitive tests show no signs of dementia in these participants now, but we'll be interested to see if a lower clearance rate is a predictive marker for future diagnosis of Alzheimer's disease," said Bateman.

http://www.investorvillage.com/smbd.asp?mb=160&mn=444454&pt=msg&mid=9860157

[Tebi]

Share

Elan shareholders welcome chairman with pharma experience
12 December 2010 By Samantha McCaughren

Elan’s appointment of a new chairman with a strong medical pedigree should go some way to appeasing the dissident shareholders of the company.

Last week Elan said that Robert Ingram, a former top executive at GlaxoSmithKline, would take over from Kyran McLaughlin, who announced his decision to stand down from the role some time ago.

It was expected that a chairman with wide-ranging pharmaceutical experience would be found, and Elan did not disappoint with its choice.

Many backers of the company want to see the company develop its strategy for its multiple sclerosis (MS) drug Tysabri during a tough time for the international drugs market as countries tighten health budgets.

The issue of pharma expertise at board level has been raised by disgruntled shareholders in the company.

Leading the way on this has been investor Ib Sonderby, who has been very critical of chief executive Kelly Martin, who is from a financial background.

At the last Elan agm there was a protest vote against the re-election of two directors; some 28 per cent of votes were cast against the re-election of McLaughlin and non-executive board member Kieran McGowan.

Goodbody analyst Ian Hunter said he believed most investors would be sated by the appointment of Ingram.

‘‘This is the type of thing investors are looking for: a solid person with an industry background who can move the company forward," said Hunter.

‘‘When Kelly Martin was appointed, he was needed for the financial situation they were in.

They were rebuilding the company.

Now we have Tysabri on the go and the focus is on the pharmaceutical side.

Ingram will provide complementary support and a complementary skills set to Martin."

The main issue facing Ingram and the company will be how best to position Tysabri.

The drug has 10 per cent of the market for MS drugs, but will face competition from new rival drugs taken in a pill format rather than intravenously.

Investors will also want visibility on the pipeline of drugs being developed by Elan, which suffered some setbacks with its Alzheimer’s programme in the last couple of years.

Ingram’s guidance may help the company deliver on these issues.

[welke91]

Antwort auf Beitrag Nr.: 40.680.907 von Tebi am 09.12.10 14:44:13

mmh,...

habe so mind. 6-7 Indikatoren nun kommt der achte hinzu.

Ich habe den japanischen Weg beschritten und hoffe in der östlichen Ferne mehr zu erfahren.

Spirituelle Kräfte mögen mich erhellen!

Denn die anderen doch sehr effektiven Indikatoren sagen z.b. ein Ende des jetzigen Kurslaufes voraus. Bin gespannt wer siegt, denn beim letzten Mal habe ich es nicht so verfolgt aber im Overbougt bereich können diese Indikatoren unvermittelt 20 Tage verweilen.

Ich möchte nur etwa 10 und ein Kursziel von 7,14 $ ist das zu viel verlangt?

[GuHu1]

link aus dem IV:

http://www.fiercepharma.com/story/pml-risk-test-could-boost-…
PML risk test could boost Biogen's Tysabri—if it works

What if Biogen Idec could identify the multiple sclerosis patients who are most likely to develop Tysabri's worst side effect? No more blind worry about progressive multifocal leukoencephalopathy, or PML, the potentially deadly brain infection that has struck 42 Tysabri patients since the drug came back on the market in 2006.

Well, that's just what Biogen is trying to do. Later this year, clinical trials start on a diagnostic test for the JC virus that causes PML. If the test works, it's a "game changer," one MS expert tells Bloomberg. "If Biogen can validate it, that takes out the guessing game," says Patricia O'Looney, VP at the National Multiple Sclerosis Society.

And without that guessing game, more doctors would be likely to prescribe Tysabri, even as a first-line treatment. Some 61 percent of neurologists surveyed by RBC Capital Markets said the drug would be their first choice if they knew in advance about an individual's PML risk, Bloomberg reports. Analysts hesitated to put a dollar value on it, but did say that a diagnostic that could ensure Tysabri's safety in some patients would be a "longer-term positive."

Indeed, given that Tysabri is now officially a blockbuster, with $1.1 billion in sales in 2009, a year when Biogen made regular announcements of new PML diagnoses. But first, the test has to prove itself.

[bernie55]

Dec. 27, 2010, 2:31 a.m. EST

Elan, Transition modify Alzheimer's-drug accord
By Robert Daniel


TEL AVIV (MarketWatch) --

Elan Corp and Transition Therapeutics Inc. agreed to modify a deal under which they are developing ELND005, a proposed treatment for Alzheimer's disease. Under the terms, the companies said in a Monday statement, Transition will turn over its 30% ownership of the drug to Elan and won't fund its development. And Elan won't make a Phase III milestone payment. In return, Transition will receive $9 million at the signing of the accord and will be eligible for an $11 million payment when the next clinical trial starts. Transition will be further eligible for as much as $93 million of payments as the drug reaches regulatory and commercial-sales milestones. And it also will receive royalties on sales. The drug in 2007 received fast-track status from the U.S. Food and Drug Administration, entitling it to expedited regulatory review. It is now in Phase II trials.

http://www.marketwatch.com/story/elan-transition-modify-alzh…

[Tebi]

Antwort auf Beitrag Nr.: 40.730.227 von welke91 am 17.12.10 18:20:05

.....was ist der japanische Weg??????????????????????????????????????? tell me....

Herzliche Grüsse aus Bangkok in diese illustre Runde.....werde in unserem Lieblings- Tempel eine Kerze für den Kurs von Elan 2011 entzünden-----für 20 € dieses Jahr....

Guten Rutsch ins Neue!!! Best regards! Birgit

[bernie55]

Antwort auf Beitrag Nr.: 40.764.195 von Tebi am 27.12.10 13:34:06

Hallo Birgit,
Dir bzw euch auch alles Gute und Liebe und natürlich auch einen guten Rutsch ins Neue Jahr

LG
bernie55 und Co

[Poppholz]

Allen LONGIES ein frohes und erfolgreiches neues Jahr.

2011 kann nur besser werden als 2010.

[Tebi]

Antwort auf Beitrag Nr.: 40.788.297 von Poppholz am 03.01.11 11:07:44

:::ir auch !! Und Bernie D A N K E für die vielen Küsschen!!!

[surga]

Antwort auf Beitrag Nr.: 40.788.297 von Poppholz am 03.01.11 11:07:44

aber klaro, 2011 wird es besser sein
Also, ich wünsche Euch allen LONGIES erfolgreiches, gesundes Jahr 2011

[surga]

Antwort auf Beitrag Nr.: 40.790.604 von Tebi am 03.01.11 16:52:24

Tebi,schicke doch mal einbisschen Sonne nach Deutschland. Hier ist zu kalt

[bernie55]

Antwort auf Beitrag Nr.: 40.805.366 von surga am 05.01.11 17:33:17

......wenn schon nicht die Sonne, so soll dich wenigstens ein bisschen grünes Elan einheizen...

LG bernie55

Elan Corporation, plc ADR
(NYSE: ELN )

Real Time 6.30 Up > 0.37 (6.24%)
1:42PM EST

[surga]

Antwort auf Beitrag Nr.: 40.806.400 von bernie55 am 05.01.11 19:46:54

[Tebi]

Antwort auf Beitrag Nr.: 40.808.186 von surga am 06.01.11 09:11:12

Hi mein Lieber,

WER von uns Beiden ist wohl länger unter Sonneneinstrahlung gewesen und daher in der "Bringschuld".....????!!!Eindeutig DUUUUUUUUUUUUUUUU

Ausserdem sitze ich gerade auf der Terasse unseres Hüttchens,schaue über Pool und Palmen aufs Meer und : ES R E G N E T ....................grh.
Wir haben uns gestern schon Regencaps gekauft.....

Warum ist unser Schäzzchen gestiegen....weiss das wer??

Also macht Euch heissen Tee + warme Gedanken + jammert nicht....

Liebe Grüsse in die Runde!

TEBI

[surga]

Antwort auf Beitrag Nr.: 40.808.220 von Tebi am 06.01.11 09:17:55

wir freuen uns auf steigende Kurse

[bernie55]

Antwort auf Beitrag Nr.: 40.808.220 von Tebi am 06.01.11 09:17:55

Elan upgraded by rbs capital

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

[bernie55]

Antwort auf Beitrag Nr.: 40.813.914 von bernie55 am 06.01.11 18:40:42

We are upgrading ELN to Sector Perform and believe shares are unlikely to
depreciate in 2011 given improving outlook.
Investment Opinion
• We believe shares are likely to appreciate this year. ELN has significantly
underperformed over the last two years (-25%) vs BTK +100% and
SPY+40%+ but 2011 suggests shares are unlikely to depreciate if fundamentals
are not as bad as Street has historically perceived. We think shares could
appreciate in 2011 based on:
1. Core MS business of Tysabri will do generally better than bearish Street
expectations and fears of massive competition from NVS Gilenya oral drug
unlikely to crush Tysabri. We think competition is unlikely to take significantly
more share than Street already assumes. Street modeling "flat" Tysabri in 2011 at
$1.3B vs Q4:10 annualized run-rate $1.3B. Pricing power may be sustained in
MS as evidenced by higher priced Gilenya $48k vs Tysabri $43k and new
Copaxone 15% price increase this week.
2. JCV assay could drive increased interest in Tysabri earlier in treatment
paradigm and grow long-term opportunity by 5x in earlier patients (50% of the
350k US MS patients versus 27k currently on US Tysabri. We are above Street
cons for Tysabri in 2011-2012+. It is true that the assay could decline Tysabri
initially because current JCV+ patients may drop off, but Street may understand
this and longer-term value is greater than near-term penalty.
3. Balance sheet improved. ELN raised $1B from JNJ last year and with EDT, is
closer to net zero cash vs prior risk of bankruptcy. Core operations are starting to
generate positive EBIT(2011E $92M).
4. Higher likelihood of takeout from BIIB. Investors have been impatient with
underperformance over the years. This could yield an increased call for change in
mgmt. Or, with possible better than expected Tysabri, partner BIOGEN (with
new CEO) could be more inclined to buy Tysabri rights back if JCV thesis truly
plays out, while selling remaining bapineuzumab to JNJ or PFE.
5. Our negative stance on bapinuzumab is unchanged but Phase III data
pushed out to H2:12. Stock could move higher in anticipation of perceived
"optionality" value in late 2011 or early 2012. However, we continue to think it
will not meet the primary endpoint.

http://www.investorvillage.com/smbd.asp?mb=160&mn=446958&pt=…

[welke91]

Antwort auf Beitrag Nr.: 40.764.195 von Tebi am 27.12.10 13:34:06

Hi, schreib das hier mitn Handy.
Der japanische weg soll mir Erleuchtung bringen was die charttechnik anbelangt.
Die hiesigen Vertreter sind nicht genügend auf die Menschen eingegangen, die
Hinter jeder Bewegung stehen. Ich hoffe neue Ansätze zu finden und der Harmonie ein Stück weit
Naher zu kommen.
Noch einen schönen Urlaub.

Gruss

[welke91]

Antwort auf Beitrag Nr.: 40.805.355 von surga am 05.01.11 17:31:45

Three white Soldiers im Charter.
Ziemlich bullish. Eine Änderung im anlegersentiment.
Gruss

[Tebi]

Antwort auf Beitrag Nr.: 40.815.211 von welke91 am 06.01.11 21:54:37

....spannend!Schreib mal bei Gelegenheit mehr dazu...lg.B.

[welke91]

Antwort auf Beitrag Nr.: 40.816.051 von Tebi am 07.01.11 01:52:53

hi leute,

die Japaner sind uns nicht nur in der Medizin etwas voraus sondern auch was Börse anbelangt gehen sie andere Wege der Erleuchtung.

Wer macht denn die Kurse?

Es sind die Menschen die hinter jeder Bewegung stehen und dabei kaufen oder verkaufen.

Dies haben einige Meister untersucht und einige Indikatoren entwickelt, mir deren hilfe man den Trend näher untersuchen kann.

Stimmt es wenn eine Aktie stets steigt, dass auch die Menschen daran glauben oder stimmt es nicht.

Wenn es nicht simmen sollte oder das Vertrauen schwindet erklärt sich dies in fein abgestimmten Indikatoren.

Dann heißt es aussteigen bevor es die Masse tut. Die ist bekanntlich träge und auch dies kann man erkennen:

ob es sich um eine Konso innerhalb eines Aufwärtstrends handelt oder die Aktie gänzlich abverkauft wird!

Ich muss sagen, dass die westliche Welt zu sehr mit der Statistik gearbeitet hat.

die Candlesticks kommen ja auch aus Japan und können mit so wenig Aufwand eine ganze Menge erklären.

Einfach grandios.

Die westliche Welt hielt sich zu lange an Techniken auf, die die absoluten Gegebenheiten erklären sollen.

Sprich, wenn ein Trend da ist, ob dieser rein mathematisch zielgerichtet ist oder an Fahrt verliert.

Viele starren wie gebannt auf die 200er Tageslinie es sind einfache Chartlinien die bei uns Unterstützung und Widerstand aufzeigen.

Eigentlich nicht schlecht aber der Japaner ging viel weiter indem er dazwischen noch die Bewegungen deutet.

Wenn die 50er die 200 kreuzt wissen wir alle, dass es erst einmal unruhig wird.

In Japan werden die schon eher wach und können demnach besser handeln.

Natürlich gibt es grandiose Errungenschaften auch bei uns, ganz klar, aber dort im Land der aufgehenden Sonne erklärt sich einiges insbesondere mir viel leichter und verständlicher.

Was ich sagen möchte ist:

versteift euch nicht auf Fundamentales,
nicht nur auf grannlinien oder sonstigen linearen Durchschnitten, RSI usw sondern lasst den Markt in allen Facetten sprechen.

Das Thema ist so lang um es hier gebührend einzutragen. Ich sitze allein an diesem Thema nun schon Jahre.

damit alles Gute an alle

Zu Eln,

es wäre schön, wenn sich Eln nun nicht so hängen lässt. Denn damit wäre eine historische Chance aufgetan hier ordentlich an Fahrt zu gewinnen.
Ich erhöhe wenn dies hält mein KZ auf 8,15!

Zeitlich bin ich noch ne Niete aber ich wette auf übernächste Woche Dienstag!

[surga]

Antwort auf Beitrag Nr.: 40.838.050 von welke91 am 11.01.11 11:31:30

sehr schön beschrieben Welke, danke

[ottl2000]

http://seekingalpha.com/article/246048-xoma-and-elan-a-tale-…

[bernie55]

Jefferries upgrade with target of $12

...it´s only a beginning...


Event
We initiate with a Buy and $12 price target. Tysabri has been holding
up well despite new competition from Gilenya; the availability of the
JC virus assay makes PML risk more predictable. If bapineuzumab
works it'll be a home run, and there's an outside chance of seeing P3
data this year.
Key Points
• Tysabri Still Growing. Despite many who have been calling for its
demise, the drug continues to grow. Gilenya's competitive launch
has had a limited impact so far, but new use of the JC virus assay
in the two STRATIFY clinical trials among 13,000 U.S. patients has
led to a drop in new patient adds from what was 77 in Q2 and 69 in
Q3 down to 38 in Q4. There are obviously patients testing positive
who have ceased treatment (we calculate the rate at only 7%
however), but since the net new adds are still positive, we assume
growth will accelerate. We expect approval in Q4 for: 1) the
requested label change to reflect a zero risk of PML (so far) with
negative JCV status; and 2) a commercial version of the assay (we
believe the 510(k) application was already submitted).
• Bapineuzumab has a better chance than a Hail Mary. Bapi is still
in the middle of the most exhaustive clinical trial program ever
conducted on an Alzheimer's disease drug. We like the fact that the
market is betting against it since we see tremendous upside with
little downside and we posit a 65% chance for approval. All three
companies are mostly silent about timing for Phase 3 data but it will
likely not come until Q3 2012 at the earliest. Although the "carrier"
study was completed in mid-2010, the companies have stated they
are waiting for completion of the biomarker supplemental studies
before releasing anything. In addition, the U.S. noncarrier study
won't have the last patient 18-month endpoint until mid 2012. This
drug has the potential to transform the treatment of one of the most
elusive pharmaceutical targets, but it will require investor patience.
Valuation/Risks
To derive our $12 price target, we have used a sum-of-the-parts
analysis and divided the company into five units. The net debt of
$800 million is almost entirely offset by NOL's worth close to $600
million (difference is -$0.50). We value the EDT business at $2, and
Tysabri (burdened with all corporate overhead) at $5.20. Using a high
35% discount rate, we value bapineuzumab at $5 per share. If we're
wrong about bapineuzumab's approvability, we see little downside
from the current stock price of $6.82. Risks include the potential that
Gilenya gains momentum and Tysabri starts to decline, the FDA fails
to approve the proposed label change for Tysabri, and/or that
bapineuzumab fails to deliver positive results in Phase 3.


http://www.investorvillage.com/smbd.asp?mb=160&mn=449186&pt=…

[bernie55]

Elan Corporation, plc (ELN)

After Hours Trading

16:19 $ 6.56 > 213,400


Wer kauft ?? Wer lädt ab ??



16:02 $ 6.94 > 1,400
16:00 $ 6.93 > 100
16:00 $ 6.93 > 100
16:00 $ 6.94 > 100

http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…" target="_blank" rel="nofollow ugc noopener">
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

[bernie55]

Drug maker Elan cuts 130 jobs, mainly in South San Francisco, as execs take private jet

San Francisco Business Times
Date: Tuesday, January 25, 2011, 9:43pm PST - Last Modified: Tuesday, January 25, 2011, 9:51pm PST
Related:
Health Care

Elan Corp. laid off 130 people — primarily at the drug maker’s South San Francisco research and development center — as executives flew across the country in a private jet, Reuters reported.

The job cuts, roughly half being scientist positions, translate to about 10 percent of the company’s workforce but were not announced publicly. The company (NYSE: ELN) confirmed the cuts in response to questions from Reuters.

The news agency said Elan’s board was told about the job cuts after unidentified company executives flew back to New York from San Francisco on a private jet.

The layoffs and jet-setting are the latest problems for Elan, which over the past couple of years has faced investor concerns about excessive air travel, a corporate structure that has spread senior management in the Bay Area, New York and Dublin, Ireland, and safety issues around the multiple sclerosis drug Tysabri.

What’s more, after so-so data from a mid-stage trial of the potential Alzheimer’s disease drug bapineuzumab, a humanized monoclonal antibody, Elan sold a chunk of its Alzheimer’s portfolio in fall 2009 to Johnson for nearly $900 million.

Bapineuzumab now is controlled by Johnson & Johnson’s Janssen Alzheimer Immunotherapy, which has hired a number of former Elan workers in South San Francisco.

http://www.bizjournals.com/sanfrancisco/news/2011/01/26/jet-…

[bernie55]

DAVY

ANALYSIS: J&J confirmed on its Q4 conference call that Phase III enrolment is now complete for Bapineuzumab in North America. The enrolment period had been prolonged due to several factors, including stringent entry criteria and the inclusion of biomarker sub-studies which may become increasingly important in how and when to use the product in practice.

Approximately 2,300 were scheduled to be enrolled in two separate trials across ApoE4 carriers (n=1,000) and non-carriers (n=1,300) (source: clinicaltrials.gov).

DAVY VIEW: The trial period is 18 months long, implying data and potential filing in H2 2012 or early 2013 with two other ex-US trials scheduled to provide data thereafter. There has been no confirmation on whether interim analyses will be used.

All the newsflow on this product is being controlled by J&J/Pfizer, and the time being taken in Phase III would suggest that they want to secure the best possible chance of drug approval rather than the fastest chance of drug approval.

http://www.investorvillage.com/smbd.asp?mb=160&mn=449399&pt=…

[bernie55]

Kurzkommentar zur aktuellen Situation:

Wie in den letzten Woche zu beobachten war, scheint ELAN negative News ( Probleme beim Management , PML, aktuelle Jetdiskussion etc.) gut wegzustecken.
Früher hatte schon ein" FURZ" ausgereicht, um ELAN in " Grund und Boden " zu stampfen.

Die Öffentlichkeit nimmt die Story von ELAN aktuell durch TY und BAPI wahr .

Wenn man nun die Entwicklung hinsichtlich des PML Diagnoseverfahrens und der daraus bestehenden möglichen
" PMLfreien " Behandlungsmöglichkeit bei MS betrachtet , würden BIIB und ELAN durch Lösen des PMLproblems eine sehr gute Basis für höhere Aktienkurse legen.

Sollte BAPI zudem eine Chance auf Zulassung haben, können wir wieder in Höhen vorstoßen, wo nicht nur wir
" Longies" lachende haben werden.

Anmerkung: Vor einigen Jahren haben uns diese Stories in 25-35 $ Höhen katapultiert.

Grüße
bernie55

[surga]

Antwort auf Beitrag Nr.: 40.926.639 von bernie55 am 26.01.11 11:25:54

na dann kann ja nur hoch gehen
Wo sind denn die anderen alten Garde

[Tebi]

Antwort auf Beitrag Nr.: 40.927.306 von surga am 26.01.11 12:53:57

hier....!!! Lieben Gruss!

Bin gerade eher mit den Rohstoffen beschäftigt-----und froh,dass unser Schätzchen mal wieder steigt....hear you...

[posimist]

Antwort auf Beitrag Nr.: 40.927.306 von surga am 26.01.11 12:53:57

Keine Sorge, surga,
ich kann warten.
Sollte es zu dem oben von Bernie beschriebenen pasitiven Szenario kommen,
könnte ich bei 30 Euronen schwach werden,
und die Hälfte verkaufen.

[welke91]

Antwort auf Beitrag Nr.: 40.926.639 von bernie55 am 26.01.11 11:25:54

lieber berni,

man kann es so sagen oder Man(n) kann es so sagen:

welke91
schrieb am 24.09.10 08:16:54


heute:

jedenfalls viel Glück!

muss noch an der Zeit arbeiten dringend!

grüße

[Poppholz]

Antwort auf Beitrag Nr.: 40.927.306 von surga am 26.01.11 12:53:57

hallo surga,

ich bin natürlich auch noch da und dabei.

Bei ELAN würde ich mich sogar gegen ein ausbuchen durch die Bank wehren, da ich mir ein Depot ohne ELAN nicht vorstellen kann.

[Poppholz]

Antwort auf Beitrag Nr.: 40.934.994 von welke91 am 27.01.11 12:23:02

hallo welke,

ich bin immer wieder beeindruckt, wenn die vorausgesagte Entwicklung mit der Realität übereinstimmt.

Dein Chart aus dem September2010 hat die Realität sehr gut getroffen.

Somit würde ich mich über eine aktelle Einschätzung freuen.

[bernie55]

After Hours mit steigendem Kurs und hohem Volumen !!!!!

Time (ET) After Hours
Price After Hours
Share Volume


16:01 $ 6.92 > 4,800

16:01 $ 6.92 > 208,100

http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades_new.…" target="_blank" rel="nofollow ugc noopener">
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades_new.…

[bernie55]

Biogen Idec Inc - EARNINGS


Global in-market 2010 TYSABRI net sales were $1.2 billion, [b]an increase of 16%[/b] over 2009. The total was comprised of $593 million in U.S. sales and $637 million in sales to rest of world markets.


TYSABRI Patient Growth

Based upon data available to us through the TOUCH® prescribing program and other third-party sources as of the end of December 2010, we estimate that approximately 56,600 patients were on commercial and clinical TYSABRI therapy worldwide, and that cumulatively approximately 78,800 patients have ever been treated with TYSABRI in the post-marketing setting.

http://finance.yahoo.com/news/CORRECTING-and-REPLACING-bw-31…

[Tebi]

Antwort auf Beitrag Nr.: 40.960.842 von bernie55 am 01.02.11 14:21:31

Prima!

[Poppholz]

Antwort auf Beitrag Nr.: 40.960.842 von bernie55 am 01.02.11 14:21:31

gute Nachrichten haben in der Vergagenheit "nicht ganz so viel Spass" gemacht.

[surga]

Antwort auf Beitrag Nr.: 40.958.735 von Poppholz am 01.02.11 09:42:45

na dann können wir doch unser ELANIS Treffen realisieren, was sagt Ihr denn dazu?

[bernie55]

Davy- Biogen remain bullish on Tysabri.

Elan Corp

(USc) (ELN US)

BIIB remains bullish on Tysabri

Jack Gorman


Price: $6.72 Rating: Outperform 30/06/09

FACTS: BIIB beats market estimates with a strong Q4 outturn, helped by Tysabri. Tysabri is a key driver of revenue growth in 2011.
ANALYSIS: Tysabri revenues grew by 12% to $333m in Q4, which was a little ahead of our forecast. Our revised $325m forecast had factored in the patient numbers reported in early January (original Davy forecast: $332m).
Revenue per unit was broadly flat year-on-year (yoy), but this disguises sharp divergences across regions. In the US, revenue/unit increased by c.11% yoy, driven primarily by price increases taken over the last 12 months. Dosage/patient was broadly similar though BIIB talked of a shift by some patients towards alternative dosing rather than drug holidays. Meanwhile, in ROW, revenue per unit declined by approximately 11%. FX had a negative (-7%) impact while price/mix was also lower due to EU pricing pressures and possibly lower launch prices elsewhere.
BIIB did not provide guidance specifically on Tysabri, but the group's guidance for 2011 is for flat to low-single-digit revenue growth. This understates Tysabri’s contribution as it is only 26% of BIIB's reported sales. In addition, there are several other headwinds to BIIB’s group revenue in 2011 such as lower Rituxan royalties and the elimination of hedging gains.
The tone of the conference call was positive in that the focus was on the potential increase in Tysabri’s addressable market that could be brought about by commercialisation of the JC-virus assay.

DAVY VIEW: The Q4 outturn indicates that Tysabri’s growth trend remains resilient. Notwithstanding the challenges posed by new competition and the ongoing management of PML risk, we believe that the product can grow strongly through 2011 and beyond. If the JC-virus assay is robust and can provide another risk stratification tool for patients, then the addressable market for Tysabri could increase and this could provide upside to medium-term forecasts.

http://www.investorvillage.com/smbd.asp?mb=160&mn=450216&pt=…

[bernie55]

Zitat von surga: na dann können wir doch unser ELANIS Treffen realisieren, was sagt Ihr denn dazu?

......da war doch was ???

...13 USD.....15 USD......20 USD.....

[bernie55]

Zitat von welke91: lieber berni,

man kann es so sagen oder Man(n) kann es so sagen:

welke91
schrieb am 24.09.10 08:16:54


heute:

jedenfalls viel Glück!

muss noch an der Zeit arbeiten dringend!

grüße

oder man kann es so sagen

If you have most of your money in Elan - God help you.

LG bernie55

[bernie55]

Elan Announces Webcast of Fourth Quarter and Full Year 2010 Financial Results
businesswire


Press Release Source: Elan Corporation, plc On Thursday February 3, 2011, 4:30 pm EST

DUBLIN--(BUSINESS WIRE)-- Elan Corporation, plc (NYSE:ELN - News) announced today that it will host a conference call on Tuesday February 8, 2011 at 8:30 a.m. Eastern Standard Time (EST), 1:30 p.m. Greenwich Mean Time (GMT) with the investment community to discuss Elan’s fourth quarter and full year 2010 financial results, which will be released before the European and U.S. financial markets open.

Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to investors, members of the news media and the general public.

This event can be accessed by visiting Elan’s website at www.elan.com and clicking on the Investor Relations section, then on the event icon. Following the live webcast, an archived version of the call will be available at the same URL.

http://finance.yahoo.com/news/Elan-Announces-Webcast-of-bw-6…

[bernie55]

Antwort auf Beitrag Nr.: 40.981.733 von bernie55 am 04.02.11 11:00:51

.....als Laie würde ich sagen, dass sich die Zahlen auf den ersten Blick ganz gut lesen...

...zukunftsperspektivisch scheint ELAN den Vorwärtsgang eingelegt zu haben....




Goodbody

Q4 numbers ahead of expectations

Elan released its Q4 numbers for Fy10 which were ahead of our expectations.

It reported revenues of $308.9m compared to our forecasts of $284.2m, giving a loss per share of 2.8 cents which is an improvement on the same period in the previous year of a loss of 9.9 cents per share.

EDT was well ahead of expectations of $78.5m versus our forecast of $57m, this appears to have been mainly driven by the revenues for Ampyra of $21.9m.

Numbers for Tysabri were slightly ahead of forecasts $229.4m versus $224.7m and at the end of Q410, there were 56,600 patients on commercial therapy, which was in line with our forecasts.

With regards to its future cash flows for 2011, Elan expects to generate positive cash flows in 2011, with expected EBITDA of $200m, a 20% increase over FY10.

Gross profit margin is expected to be in the range of 47% to 50%.

http://www.investorvillage.com/smbd.asp?mb=160&mn=450951&pt=…

[bernie55]

Antwort auf Beitrag Nr.: 41.000.974 von bernie55 am 08.02.11 12:06:31

Irish Times

Elan reports operating profit

Revenues at the firm rose by 5 per cent to $1.2 billion, with Tysabri revenues up 18 per cent. Operating expenses fell 9 per cent, before other charges and gains.

Adjusted earnings before interest, tax, depreciation and amortisation rose 73 per cent to $166.5 million. The company cut its total debt by 17 per cent in 2010.

However, losses widened to $324.7 million for the year as the company recorded a settlement reserve charge of $206.3 million over problems with the marketing of its Zonegran epilepsy drug. Elan was accused of marketing the drug for therapies other than those approved by the US food and drug administration.

“2010 was a year of tangible advancement for Elan with demonstrated progress in both the BioNeurology and EDT businesses,” Elan chief executive Kelly Martin said.

“Revenue growth combined with prudent and disciplined cost management enabled us to achieve our goal of operating profitability before other charges and gains. This, combined with a further de-leveraging of the balance sheet provided enhanced operating leverage from an overall performance point of view.”

The company said it would focus on improving its operating performance in 2011, and invest in developing science and therapeutics.

For the coming year, Elan forecast adjusted Ebidta of about $200 million, driven by a pick-up in the growth of revenues and reduced operating expenses.

http://www.investorvillage.com/smbd.asp?mb=160&mn=450962&pt=…

[bernie55]

Antwort auf Beitrag Nr.: 41.000.974 von bernie55 am 08.02.11 12:06:31

Davy



Q4 and FY out-turn ahead of company guidance;

c.20% growth in adjusted EBITDA flagged for 2011

Jack Gorman

FACTS: Elan's Q4 results were ahead of guidance and a little higher than our expectations; strong growth guided for 2011.
ANALYSIS: Elan ended the year positively with Q4 revenue growth of 3% to $308.9m; adjusted EBITDA of $45.9m that compared reasonably well with tough comps; and a modest loss per share of -1c on an adjusted basis.
Compared to guidance, the Q4 and FY out-turn was better than expectations – adjusted EBITDA of $166.5m compared to guidance of approximately $150m. It was also modestly ahead of our own forecast of $165m.
The main features of Q4 were:
Revenue growth of 3% was delivered by Tysabri and Ampyra. In aggregate, these grew by 25% year-on-year (yoy) and offset the elimination of Maxipime and Azactam and the genericisation of Skelaxin.
Operating costs were broadly as expected, +12% yoy and all driven by R&D spending.
Gross cash and equivalents totalled $657m ($453.3m excluding the Zonegran settlement). This compares to guidance of approximately $400m and our own forecast of $436m.
For 2011 guidance, Elan has outlined that revenue growth will accelerate beyond the 2010 rate of 5% (Davy: +12%); adjusted EBITDA of approximately $200m (Davy: $225m); operating costs of $470-500m (Davy: $534m). Elan also expects to be cash flow positive this year (we have a net cash inflow of $56m).
More colour on guidance and R&D updates is likely to be provided on the conference call at 13.30 GMT: [phone] [outside US]; 800 747 9564 [in US].

DAVY VIEW:

These are strong numbers from Elan and highlight Tysabri's operational leverage in the P&L and cash flow model. This leverage will become even more apparent in 2011. We will review our own forecasts in light of guidance, but our first instinct is that we are comfortable to remain somewhat above base guidance.

http://www.investorvillage.com/smbd.asp?mb=160&mn=450946&pt=…

[Tebi]

Hi Ihr Lieben

IMMERHIN!! Es wird schon....Party bei 13€ ist PFLICHT!!

[posimist]

Antwort auf Beitrag Nr.: 41.004.198 von Tebi am 08.02.11 18:07:39

Do bin ich dobei!

[bernie55]

Elan and Boehringer Ingelheim Announce Development and Manufacturing Agreement for Elan’s Antibody-Based Therapeutics Pipeline

Press Release Source: Elan plc On Wednesday February 9, 2011, 3:00 am EST



DUBLIN, Ireland & INGELHEIM, Germany--(BUSINESS WIRE)-- Elan plc (NYSE:ELN - News) and Boehringer Ingelheim today announced that they have entered into a global technical development and manufacturing agreement for antibody-based therapeutics.

Under the terms of the agreement, Boehringer Ingelheim will perform the technical development, clinical manufacturing and all related regulatory filing support services for antibodies discovered by Elan. Elan will lead the discovery science, preclinical activities, clinical development and commercialization of such antibodies.

Dr Johannes Roebers, Senior Vice President and Head of Biologic Strategy, Planning and Operations at Elan, said, “We are excited to collaborate with Boehringer Ingelheim, a highly regarded and world-class leader in biological technical development and manufacturing. The agreement enables Elan to focus resources on discovery and the clinical progression of our science while leveraging Boehringer Ingelheim’s process development and production capabilities.”

Simon Sturge, Corporate Senior Vice President of the Biopharmaceuticals Division at Boehringer Ingelheim, said, “The combination of Elan’s successful track record in the discovery and clinical development of antibody-based therapeutics with our proven expertise in technical development and manufacturing and in particular our BI HEX® platform, will be an optimal fit. This is a first step in our new strategy engaging our technology platforms at a very early stage in product development. We look forward to working with the team at Elan.”

Dr Dale Schenk, Executive Vice President and Chief Scientific Officer at Elan, said, “ This collaboration with Boehringer Ingelheim is highly compelling as it leverages our respective capabilities and provides the opportunity to create significant value for Elan. This business model will enable us to rapidly accelerate the advancement of our next generation antibody programs. These programs are broad in scope and are innovative across technology, targets and possible disease application.”

http://finance.yahoo.com/news/Elan-and-Boehringer-Ingelheim-…

[bernie55]

Wall to Wall Street Coverage: Upgrades and Downgrades

Elan (ELN):
Irish drug maker Elan is up sharply before the bell on a Buy-from-Neutral boost at UBS.

[bernie55]

Antwort auf Beitrag Nr.: 41.084.864 von bernie55 am 22.02.11 15:54:23

Top Biotech Takeout Targets in 2011

By Josh Lipton Feb 18, 2011 1:30 pm

Mergers and acquisitions in biotechnology saw a strong year in 2010 with 91 acquisitions of firms with market capitalizations exceeding $100 million. Morningstar research analysts, in their recently released annual report on the health care M&A landscape, say investors can expect another impressive year of M&A activity in 2011, and highlight the biotech companies that they believe are most likely to be bought.

Biotech, in particular, remains an attractive investment for Big Pharma, which as a group has not fully seized the opportunity to put cash balances to work through acquisitions, but still faces pressure from the rapidly approaching patent cliff, says Damien Conover, Morningstar’s associate director of health care.

Topping the 2011 list:
Biogen Idec (BIIB), which secured the No. 1 ranking given its renewed focus on its core strength in neurology, large late-stage pipeline, and growing foundation of profitability.

“There are certain areas that Big Pharma really wants to move into such as neurology and oncology,” says Conover. “It’s easier to get drugs in these therapeutic classes through the regulatory process because there aren’t many treatment options out there. Those are both areas of focus for Biogen Idec.”

Specifically, Conover thinks Biogen could be a logical target for Roche. The two companies already partner on cancer blockbuster Rituxan, and acquiring Biogen would bring full rights to Rituxan, next-generation cancer products, as well as Bio­gen’s growing neurology portfolio.
http://www.minyanville.com/businessmarkets/articles/big-phar…" target="_blank" rel="nofollow ugc noopener">
http://www.minyanville.com/businessmarkets/articles/big-phar…

[bernie55]

Antwort auf Beitrag Nr.: 41.084.906 von bernie55 am 22.02.11 15:58:37

Übernahme von BIIB durch Roche ????


Wenn dem wirklich so sein sollte, dann bin ich gespannt wie TY und BAP in diesen Deal
miteinbezogen werden ?

[Tebi]

...bin extra mal wieder kurz weggefahren (5 Tage La Palma - mein Liebster wurde 60...)damit der Kurs steigt....netten Gruss in die Runde!Birgit

[bernie55]

Biogen and Elan's Growing Problem

By Brian Orelli

February 22, 2011 | Comments (0)

The number of cases of progressive multifocal leukoencephalopathy, or PML, in patients taking Biogen Idec (Nasdaq: BIIB) and Elan's (NYSE: ELN) Tysabri increased by nearly 12% in less than a month. Annualize that out, and it isn't a pretty picture.

The latest monthly update listed 10 new cases of PML, bringing the total count to 95. The brain infection has killed 20 of the 95 patients that have been stricken while taking the multiple sclerosis drug.

As the number of patients taking Tysabri increases, we're bound to see the PML cases increase, but the update for January was considerably higher than the last two updates; November had four new cases and December had six.

Of course, one month doesn't make a trend, and Biogen points out the overall rate is still fairly low at 1.16 per 1,000 patients.

The question is where does it cross the line from being an acceptable risk to being an unacceptable one. Tysabri is the best multiple sclerosis drug out there, but there's a point at which doctors and patients won't think the benefits outweigh the risk, and they'll head to other treatments such as Teva Pharmaceutical's (Nasdaq: TEVA) Copaxone, Novartis' (NYSE: NVS) Gilenya, and Rebif, which is sold by Merck KGaA and Pfizer (NYSE: PFE).

The Tysabri duo could also lose sales if patients decide to go on drug holidays. The risk of getting PML increases the longer a patient is on Tysabri. Patients may try to delay increasing the risk by taking a break from treatment, cutting into Biogen and Elan's sales.

The companies can't do anything to affect the rate of PML, but they can help patients identify risk factors that increase the likelihood of getting PML. If the companies encourage patients who are least likely to get PML to take Tysabri, the overall rate should decrease.

In that vein, the companies are developing a test for the virus that causes PML. Patients who don't have the dormant virus in their systems are less likely to get PML when Tysabri deadens their immune systems.

Biogen and Elan better hurry, before the marketing message is permanently damaged....

...wie wahr.....es wird wirklich Zeit, Ergebnisse hinsichtlich des "PML Diagnoseverfahrens" zu bekommen.......

http://www.fool.com/investing/high-growth/2011/02/22/biogen-…" target="_blank" rel="nofollow ugc noopener">
http://www.fool.com/investing/high-growth/2011/02/22/biogen-…

[bernie55]

Elan and PPD Announce Global Business Relationship in Drug Development

UBLIN & WILMINGTON, N.C.--(BUSINESS WIRE)-- Elan, plc (NYSE:ELN - News) and PPD, Inc. (Nasdaq:PPDI - News) today announced they have formed a global business collaboration focused on the advancement, progression and execution of Elan’s development portfolio. The primary objective of this relationship is to deploy both companies’ skills and expertise in a flexible, integrated manner to drive the execution of Elan’s clinical programs in a parallel and expedited basis and on a global scale.

Under this business agreement, PPD will act as Elan’s primary service provider for all development functions and activities. Elan will retain ownership of its assets and accountability for decision making with regard to strategy and progression of the individual molecules as well as the overall portfolio.
This business construct will enable Elan to leverage the significant and high quality capabilities of PPD across project and data management, biostatistics, regulatory, clinical and medical monitoring, quality assurance, pharmacovigilance and other areas.
Elan and PPD intend to work closely to build upon this initial relationship and continuously explore opportunities to leverage both companies’ respective competencies and maximize the full opportunity of moving Elan’s science into clinical development and advancing toward patients.

“Establishing this strategic collaboration with PPD will enable Elan to accelerate the progression of our science into the clinical development setting in a rapid and global fashion,” said Eliseo Salinas, Chief Medical Officer, Executive Vice President and Head of Development for Elan. “The ability to fluidly access additional expertise and execution capability on a global scale will complement our internal talent and may enable us to move multiple programs forward in a parallel manner.”

Elan’s Executive Vice President and Head of Alliance Management Doug Love commented, “PPD will act as a strategic collaborator and deliver capabilities, resources and expertise that will enable us to advance our business on a global scale while capturing efficiencies and flexibility from a business and operational point of view.”

David Grange, Chief Executive Officer of PPD, added, “PPD and Elan have established an innovative relationship structure that enables Elan to continue to invest in and advance its world-leading work in biology and its broad application in neuroscience while leveraging PPD’s expertise and execution capabilities across key program areas on a global scale. This relationship brings together the strongest resources of both companies, and we are pleased to have created this unique and strategic business arrangement with Elan.”

http://finance.yahoo.com/news/Elan-and-PPD-Announce-Global-b…

[Tebi]

Antwort auf Beitrag Nr.: 41.085.746 von Tebi am 22.02.11 17:26:15

....nützt auch nix...:O

[bernie55]

DPZ unterzeichnet Lizenzabkommen mit Biogen Idec

22.02.2011: Das Deutsche Primatenzentrum (DPZ) und sein Technologietransfer-Partner Ascenion teilen heute mit, dass eine Lizenzvereinbarung mit Biogen Idec unterzeichnet wurde. Damit erhält das Unternehmen exklusive, weltweite Rechte an Patenten des DPZ, die sich auf einen rekombinanten, virusähnlichen Partikel (virus-like particle, VLP) beziehen. Dieser Partikel besteht aus so genannten VP1-Proteinen und kann zum Nachweis von Antikörpern gegen den JC-Virus (JCV) eingesetzt werden. Der Lizenzvereinbarung zufolge darf Biogen Idec den VLP für einen Test im Zusammenhang mit Multipler Sklerose und optional bestimmten weiteren Erkrankungen nutzen. Im Gegenzug erhält das DPZ Vorab- und Meilensteinzahlungen sowie nutzungsabhängige Lizenzgebühren.

Die Patente des DPZ hinsichtlich des JC-Virus umfassen diagnostische und therapeutische Anwendungen des VP1-Proteins. VP1-Proteine lagern sich von selbst zu virusähnlichen Partikeln zusammen, die in ihrer Morphologie dem JC-Virus entsprechen. Sie ermöglichen deshalb den hochspezifischen Nachweis von Antikörpern gegen den JC-Virus in Serum oder Blut.

„Das DPZ hat sein Patentportfolio zum JC-Virus ganz bewusst über viele Jahre hinweg aufgebaut und erhalten”, sagte Michael Lankeit, Administrativer Direktor des DPZ. “Wir freuen uns sehr über die Partnerschaft mit Biogen Idec auf diesem wichtigen Gebiet.”
http://www.bionity.com/de/news/130925/dpz-unterzeichnet-lize…" target="_blank" rel="nofollow ugc noopener">
http://www.bionity.com/de/news/130925/dpz-unterzeichnet-lize…

[bernie55]

23 February 2011
Elan to Present at the Cowen and Company 31st Annual Health Care Conference

DUBLIN, Feb 23, 2011 (BUSINESS WIRE)

Elan Corporation, plc (NYSE: ELN) announced today that it will present at the Cowen and Company 31st Annual Health Care Conference

on Wednesday March 9, 2011 at 10:15 a.m. Eastern Standard Time and 3:15 p.m. Greenwich Mean Time.


Interested parties may access a live audio webcast of the presentation by visiting the Investor Relations section of the Elan website at http://www.elan.com, then clicking on the event icon. Following the live webcast, an archived version of the presentation will be available at the same URL.
http://newsroom.elan.com/phoenix.zhtml?c=88326&p=irol-newsAr…" target="_blank" rel="nofollow ugc noopener">
http://newsroom.elan.com/phoenix.zhtml?c=88326&p=irol-newsAr…

[bernie55]

Elan and Celgene Enter into Settlement and License Agreement Related to ABRAXANE®

Press Release Source:
Elan Corporation plc On Thursday February 24, 2011, 7:34 pm EST

DUBLIN--(BUSINESS WIRE)-- Elan Corporation plc (NYSE:ELN - News) and Celgene Corporation (Nasdaq:CELG - News), today announced that Elan subsidiary Elan PharmaInternational Limited has entered into a settlement and license agreement with Celgene Corporation resolving the patent infringement litigation involving ABRAXANE®. Elan initiated legal action in 2006 against Abraxis BioScience, Inc. Abraxis was acquired by Celgene (NASDAQ:CELG - News) in October, 2010.

In consideration of the terms of the settlement and license agreement, Celgene will pay Elan a one-time fee of $78 million.

Elan will not receive any additional payments for sales of ABRAXANE®, or any other nab®-Paclitaxel product in the United States or globally.
Celgene will acquire a fully-paid up, exclusive, world-wide license to select Elan U.S. and foreign patents for ABRAXANE®.

...tja, zusätzliche Einnahmen durch den Verkauf von ABRAXANE wären nicht schlecht gewesen.....

... jetzt $78 Millionen als Einmalzahlung - ein paar "peanuts" für die Kasse.
.. besser " wenig " als " nichts "...

...OK....

Aber wie ist dieser Deal überhaupt zu Stande gekommen ?
Hätte ELAN mehr fordern können ?
Welche Umstände haben zu dieser " niedrigen " Summe geführt ?

Fragen, die KM , mal wieder , beantworten muss !!!




http://finance.yahoo.com/news/Elan-and-Celgene-Enter-into-bw…

[bernie55]

Elan Announces First European Commission Approval of Injectable Treatment Using Elan’s NanoCrystal® Technology


Press Release Source: Elan Corporation, plc On Wednesday March 9, 2011, 4:30 pm EST

DUBLIN--(BUSINESS WIRE)-- Elan Drug Technologies (EDT), the drug delivery unit of Elan Corporation, plc (NYSE:ELN - News), today announced that the first injectable product using EDT’s NanoCrystal® technology has been approved by the European Commission. XEPLION®, Janssen-Cilag International NV’s long-acting injectable treatment for patients with schizophrenia which uses EDT’s NanoCrystal® technology, was approved by the European Commission earlier today.

“The European approval of XEPLION® is an important milestone for our NanoCrystal® technology as it marks the first long-acting injectable product approved by the European regulatory authorities using this technology,” said Shane Cooke, Executive Vice President and Chief Financial Officer of Elan and Head of EDT. “The versatility of our NanoCrystal® technology enabled the development of a long-acting injectable antipsychotic which is designed to help patients maintain continual treatment, reduce the likelihood of relapse and thereby potentially improve their overall quality of life.”

On March 9, 2011, Janssen-Cilag International NV, one of the Janssen Pharmaceutical Companies, announced the approval of XEPLION®, a once monthly atypical antipsychotic injection, by the European Commission. XEPLION® is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, XEPLION® may be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed.

EDT’s NanoCrystal® technology enables the formulation of poorly water soluble compounds for all routes of administration. The technology allows for a ready-to-use, one-month duration, intramuscular injection formulation of paliperidone palmitate which can be administered by healthcare professionals. The intramuscular injection is administered using a small bore needle and small volume syringe, thereby negating the need for a power injector. By applying the NanoCrystal® technology to paliperidone palmitate, healthcare professionals will be able to provide patients with consistent medication coverage for one month, potentially allowing them to improve compliance for patients with schizophrenia.

NanoCrystal® technology is a proprietary technology developed by EDT through Elan Pharma International Limited and other Elan affiliates. XEPLION® is the fourth licensed product using Elan’s NanoCrystal® technology that has been approved by the EMA.

About Elan Drug Technologies and NanoCrystal® technology

Elan Drug Technologies (EDT), one of the world’s leading drug delivery businesses, is a business unit of Elan (NYSE:ELN - News). As a fully integrated drug delivery business, Elan Drug Technologies delivers clinically meaningful benefits to patients, by using its extensive experience and proprietary delivery technologies in collaboration with pharmaceutical companies. For over 40 years, Elan Drug Technologies has been, and continues to be, a drug delivery provider of choice for a broad range of pharmaceutical companies, including many of the world’s leading pharmaceutical companies. Elan Drug Technologies offer clients drug delivery expertise with a suite of commercially launched, proprietary, technology-driven solutions, from NanoCrystal® technology for poorly water soluble compounds, to customised oral controlled release drug technologies. To date, over 40 products have been developed using EDT’s technologies and are used by millions of patients each day. For more information go to www.elandrugtechnologies.com

NanoCrystal® is a registered trademark of Elan Pharma International Limited, Ireland, a subsidiary of Elan Corporation plc (NYSE:ELN - News).

About Janssen

Janssen- Cilag International NV, is one of the Janssen Pharmaceutical Companies which, are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g. multiple myeloma and prostate cancer), immunology (e.g. psoriasis), neuroscience (e.g. schizophrenia, dementia and pain), infectious disease (e.g. HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g. diabetes). Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. More information can be found at www.janssen-emea.com

XEPLION® is a registered trademark of Johnson & Johnson family of companies.

Safe Harbour/Forward-Looking Statements

The statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. A further list and deion of the risks, uncertainties and other matters that confront us can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2010, and in our Reports of Foreign Issuer on Form 6-K filed with the U.S. Securities and Exchange Commission. We assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Elan Corporation, plc

http://finance.yahoo.com/news/Elan-Announces-First-European-…

[posimist]

Unsere Aktie dümpelt vor sich hin, dass es eine Pracht ist.
Sieht jemand Licht am Ende des Horizonts?

[Tebi]

Antwort auf Beitrag Nr.: 41.269.424 von posimist am 25.03.11 23:40:37

Ja---ich!

[posimist]

Wo und wann?

[Poppholz]

wenn sich die Wellen wieder erneuern, kann es nur eine Richtung geben.

mal sehen wie lange dies noch dauert.

Geduld haben wir ja schon eine Menge bewiesen, da kommt es auf 10 bis 20 Jahr ja nicht an.

;-)

[Poppholz]

Elan call buyers look for springtime rally
Posted 4/6/2011 1:18 AM by David Russell

Elan has been in the dumps since a massive collapse in 2008, but now the bulls are coming back.

optionMONSTER's Heat Seeker tracking system detected a surge of call buying in the Irish drug maker yesterday as investors positioned for a springtime rally. The May 6s were the most active strike, trading more than 20,000 times against open interest of just 50 contracts. Premiums climbed from $1 to $1.30 throughout the session, but most of the large blocks priced at the lower end of that range.

Almost 6,000 May 7 puts were also sold for $0.40, this time against previous positioning of just 20 contracts. ELN was trading for $6.90 when most of the puts crossed our monitors, so they were in the money, which is noteworthy because it's a highly leveraged way to play for upside.

The shares ended the session with a 5.15 percent gain at $7.15, so those puts are now out of the money. If ELN stays above $7 or climbs further, those puts will dwindle to zero.

The stock has been battling its way higher since the later summer, although for the last three months has been consolidating those gains. Yesterday's session, with options volume 32 times greater than average and share turnover more than twice the normal amount, suggests it may be starting to attract interest once again.



The recent gains also seem to have improved ELN's technical position because its 50-day moving average is now above its 100-day moving average (black and blue lines on chart at right, respectively) and its 100-day moving average is above the 200-day moving average (purple line on chart). That configuration is often necessary before a stock can advance.

Its 200-day moving average has also started to climb, another potentially bullish pattern that suggests the longer-term trend is turning upward.

There are also fundamental reasons why investors may be warming to ELN. While its loss was wider than expected the last time it issued results on Feb. 8, revenue was significantly ahead of consensus.

Also in January, the company announced a 7 percent price increase for its Tysabri multiple sclerosis drug, which accounts for more than 80 percent of its revenue. Last month ELN also announced that European regulators approved the first medicine that will use its NanoCrystal drug-delivery technology.

(A version of this post appeared on InsideOptions yesterday. Chart courtesy of tradeMONSTER.)

http://community.nasdaq.com/News/2011-04/elan-call-buyers-lo…

[Poppholz]

Buyers Accumulating Shares of Elan on 1.1x Above-Average Volume (ELN)
Posted on 04/05/11 at 12:40pm by Chip Brian

Shares of Elan (NYSE: ELN) are trading up 2.1% to $6.94 today on above average volume. Approximately 2.4 million shares have traded hands today vs. average 30-day volume of 2.1 million shares.

Spikes in volume can validate a breakout or signify a potential turning point. As such, SmarTrend will continue to monitor shares of ELN to see if this bullish momentum will continue.

SmarTrend currently has shares of Elan in an Uptrend and issued the Uptrend alert on January 05, 2011 at $6.15. The stock has risen 10.6% since the Uptrend alert was issued.

In the last five trading sessions, the 50-day MA has climbed 0.35% while the 200-day MA has risen 0.51%.

In the past 52 weeks, shares of Elan have traded between a low of $4.25 and a high of $8.24 and are now at $6.94, which is 63% above that low price.

Write to Chip Brian at [e-mail]

http://www.benzinga.com/press-releases/11/04/c979629/buyers-…

[Poppholz]

Bullish Option Activity Alert: ELN
Posted on 4/5/2011 in Unusual Activity by Patrick (Rick) Mortimer
Bullish Option Activity Alert: ELN


Elan Corp, plc (ELN) , a neuroscience-based biotechnology company that operates in Ireland and the US, sees a large Bullish Call buyer appear this morning with 10,000 May 6 strike options trading between $1.00 and $1.10. Current open interest shows just 50 contracts so this is an opening transaction that will need ELN to be trading above $7.10 at May expiry to see any profits. Implied vol has seen a 12% spike with today’s activity and total option activity is now 10 times ELN’s daily average.

The chart below shows the impact large option orders can have on the underlying shares if the options are thinly traded. These options trades were execute between 10:36-10:39. Elan’s shares saw a 3.7% spike minutes before the trades crossed the tape as market makers ran to the stock to hedge their option sales.



http://www.theoptionsinsider.com/unusualactivity/?id=6731

[Tebi]

Hi Ihr,

steigende Kurse---frau ist ganz "entwöhnt" von soetwas.....ich glaube,unsere Treue wird letztendlich belohnt werden...

Nette Grüsse in die Runde!

Birgit

[posimist]

Vielen Dank Poppi für deine Mühe.
..."the bulls are coming back", dieser Satz hat mir besonders gut gefallen.

[bernie55]

BRIEF-RESEARCH ALERT-RBC raises Elan Corp to outperform

April 7 (Reuters) -

* RBC raises Elan Corp Plc to outperform from sector perform
* RBC raises Elan Corp price target to $10 from $8
* RBC upgrades Elan Corp on positive lt tysabri, improving sentiment, turnaround thesis

For a summary of rating and price target changes on S&P 500 companies:
Reuters 3000Xtra users, double-click Reuters Station users, click .
1568 Reuters Plus users search on RCH/US

http://classic.cnbc.com/id/42468743

[Poppholz]

April 7, 2011, 2:51 p.m. EDT
Biogen, Elan's Tysabri Label Updated
By Thomas Gryta

The label of multiple sclerosis drug Tysabri, sold by Biogen Idec Corp., has been changed to include the updated incidence of a rare brain infection.

A Biogen spokeswoman said the company worked with the Food and Drug Administration on the change, which includes a table that details the incidence of progressive multifocal leukoencephalopathy, or PML.

The included data shows the risk of getting the infection is 0.3 patients per 1,000 when using the drug for less than two years. That rate rises when using the drug for two to three years, to 1.5 cases, but notably drops to 0.9 cases for the period of three to four years. The data is current as of January, and Biogen said the label will be updated as needed.

Although the company provides monthly updates on the number of PML cases, the incidence rates for patients within the fixed duration ranges of treatment have remained relatively stable.

As of early March, 102 cases of the infection were confirmed, including 21 deaths. The drug is generally regarded as highly effective, but is mostly used for patients that have stopped responding to other drugs or have aggressive cases of the disease.

An FDA spokeswoman said the agency continues to believe that "the clinical benefits of Tysabri outweigh the potential risks." She said the FDA will be posting a "Drug Safety Communication" on the label changes in the coming days.

The agency was in "ongoing discussions" with Biogen about "a couple of label updates and during those discussions everyone agreed that adding the chart would provide useful information," she said.

Aside from the table, the label includes information on a newly identified PML risk factor of patients taking certain immune-system suppressing medication prior to taking Tysabri, she said.

Biogen is developing a blood test that may better determine the chances of patients contracting PML. The test recently received CE Mark approval for use in Europe and the companies are conducting large studies of its effectiveness.

Biogen and Elan has proposed updating the label of Tysabri to include information about certain antibodies in the blood being a risk factor for acquiring the infection.

Tysabri was withdrawn from the market in 2005 and relaunched in 2006—because of its effectiveness—with a strict access plan that monitors patients.


http://www.marketwatch.com/story/biogen-elans-tysabri-label-…

[GuHu1]

This Just In: More Upgrades and Downgrades

By Anders Bylund | More Articles
April 8, 2011 | Comments (0)

At The Motley Fool, we poke plenty of fun at Wall Street analysts, and their endless cycle of upgrades, downgrades, and "initiating coverage at neutral." While the pinstripe-and-wingtip crowd is entitled to its opinions, down here on Main Street, we've got some pretty sharp stock pickers, too. (And we're not always impressed with how Wall Street does its job.)

Given that, perhaps we shouldn't be giving virtual ink to "news" of analyst upgrades and downgrades. And we wouldn't -- if that were all we were doing. Fortunately, in "This Just In," we don't simply tell you what the analysts said. We also show you whether they know what they're talking about. To help, we've enlisted Motley Fool CAPS, our tool for rating stocks and analysts alike. With CAPS, we track the long-term performance of Wall Street's best and brightest -- and its worst and sorriest, too.

And speaking of the best ...
RBC Capital Markets just upgraded biotech company Elan (NYSE: ELN ) from hold to an outperform, also known as a buy. The one-year target price is $10 per depositary share, which would leave room for a 28% upside from current prices. RBC has warmed up significantly to Elan of late, having moved the stock from a sell to a hold as recently as January.

RBC sees high demand for Elan's Tysabri drug over the next few years. The market for multiple sclerosis, or MS, treatments caters to 2.5 million patients worldwide and has become a focal point for drug developers and investors alike in recent years. sanofi-aventis (NYSE: SNY ) structured its blockbuster $20 billion takeover of Genzyme (Nasdaq: GENZ ) around the expected success of Genzyme's Lemtrada drug for MS. This market is a very, very big deal.

Moreover, RBC thinks that Tysabri is making a takeover target out of Elan as well. Given the wave of consolidation in the biotech market in recent years, that wouldn't be a terribly surprising endgame for the Irish drug developer, nor even a remarkably large buyout these days.

Tale of the tape
So should we listen to RBC's advice here? Well, the firm as a whole is an All-Star in our CAPS system thanks to a knack for picking more big winners than big losers. As for consistency, the picture becomes murkier: RBC boasts a middling 54% accuracy rate overall. In the pharmaceuticals sector, the success rate drops to 50% and the correct-picks ratio in the biotech sector is an underwhelming 47%. That includes the following mixed bag of recent picks:

Company RBC Rating CAPS Rating (out of 5) RBC's Picks Beating S&P by
Impax Laboratories Outperform *** 27%
Spectrum Pharmaceuticals Outperform ***** 5%
AVEO Pharmaceuticals Outperform * (37%)

As it turns out, RBC's impressive CAPS score stems from impressive results in oil and gas, real estate investment trusts, and software stocks. If you zoom in on Elan itself, the stock lost 4% of its value while RBC rated it a sell while the broader market gained about 50%. Elan has gained 15% since moving off RBC's sell list, but most of that was yesterday's jump on this very upgrade -- a self-fulfilling prophecy if there ever was one.

In short, RBC's track record isn't terribly impressive in this sector, though the company is getting Elan sort of right most of the time.

Foolish final thought
As an MS patient myself, I see real value in what Elan is doing. In fact, I think there's a serious upside to Tysabri sales as everyone gets used to the risks of progressive multifocal leukoencephalitis (or PML) infections. Elan is working with Tysabri partner Biogen Idec (Nasdaq: BIIB ) to develop an early warning system for that potentially lethal side effect, and the drug label has been updated to show just how common the infection is -- 102 cases have led to 21 deaths in a population of more than 56,000 patients worldwide. With better prescreening programs and early warning tests, I'd expect that rate to drop over the years.

I'd be on Tysabri myself if PML didn't scare my family so badly. At the moment, nothing comes close to the efficacy and -- excepting PML risks -- pleasant side effect profile of this drug, and it'll be years before Tysabri is made obsolete by further advances. That gives Elan investors and potential buyout partners a long window of high growth as the drug moves closer to the mainstream CRAB drugs (Copaxone, Rebif, Avonex, and Betaseron, for the uninitiated) in popularity.

Given all of this, I'm predisposed to agree with RBC's upgrade here. Elan's history of operating losses keeps many investors on the sidelines, including Foolish biotech guru Brian Orelli. Even Brian agrees that the money-burning troubles seem to be behind Elan.

http://www.fool.com/investing/general/2011/04/08/this-just-i…

[bernie55]

9 Healthcare Sector Rotation Buy Ideas

about: AEZS, BIIB, BMY, ELN, HCA, HMA, MRK, SYK, ZMH

by: Investment Underground April 13, 2011

Elan Corporation PLC ADR (ELN):
This leading neuroscience firm comes with many risks for those looking to invest in it. The company has many positives: shared rights to Tysabri, royalties from firms licensing technologies for 25 marketed drugs, and 12 drug candidates in its pipeline as of February 2011. However, the uncertainty surrounding the company outweighs many positive signs it has shown. Like Biogen, much of Elan’s future prospects ride on the success of Tysabri, which recorded $1.2 billion in revenue in 2010. The drug can cause a rare brain infection in patients, and despite more stringent guidelines for prescriptions, the rate of new cases is still increasing.

We remain optimistic over new trials that could identify patients susceptible to the disease, but Elan has less of a cushion than Biogen if the drug does not perform well. Elan is more reliant on Tysabri revenue, and its high levels of debt give it little room to maneuver. Elan does have a promising product in the pipeline in bapineuzumab, an Alzheimer’s drug candidate with $1 billion potential, but phase II data showed mixed results in patients.

If Elan can improve Tysabri’s safety and bring bapineuzumab to market, the firm could reward investors.

However, concerns about both drugs make them a risk, and Elan doesn’t have much room to maneuver if they fail. This is one risk we aren’t willing to take.

Shares trade at $7.43 at the time of this writing.

http://seekingalpha.com/article/263375-9-healthcare-sector-r…" target="_blank" rel="nofollow ugc noopener">
http://seekingalpha.com/article/263375-9-healthcare-sector-r…

[bernie55]

Biogen Test Finds Tysabri Patients With 1% Brain Disease Risk

By Michelle Fay Cortez - Apr 15, 2011 6:00 AM GMT 0200


Biogen Idec Inc. (BIIB) has identified high-risk patients taking its multiple sclerosis drug Tysabri who have a 1 in 100 chance of developing a potentially deadly brain infection from the medicine.

By analyzing risk factors including the length of time taking Tysabri, previous treatments and results of a blood test for antibodies to the virus that causes the infection, doctors may also spot patients with less than a 1 in 10,000 chance of developing the disease known as progressive multifocal leukoencephalopathy, or PML, a study showed. The drug’s U.S. label says the risk of PML is about 1 in 1,000 after two years of treatment.

The test for the JC virus should boost use of Tysabri over time, with peak sales of as much as $3 billion, said Corey Davis, an analyst at Jefferies & Co. in New York.

“If you test negative right now, you have a zero percent chance of getting PML,” since everyone who has the brain disease was previously infected, Davis said today in a telephone interview. “To better delineate the risk is going to be a very powerful tool for Tysabri.”

Tysabri generated $1.2 billion last year for Biogen and its partner, Dublin-based Elan Corp. Knowing the odds of getting PML may reassure patients taking the medicine and help doctors in their treatment decisions.

“We have to tell patients at this point it’s not an entirely proven test, but it certainly will affect our decision making,” said Jack Ratchford, assistant professor of neurology at Johns Hopkins University in Baltimore. “What is done when someone tests positive depends on the individual. Often it is enough of a concern that the possible risk outweighs the benefit” and they stop Tysabri treatment, he said.
Study Results

Results of the analysis of 102 Tysabri patients who developed the brain disease through March 4, including 21 who died, were presented at the American Academy of Neurology meeting in Honolulu. A closer look at 25 patients found all those who developed PML were previously positive for the virus, said Alfred Sandrock, senior vice president of development for Weston, Massachusetts-based Biogen.

Some patients, particularly those with hard-to-control disease, elect to stay on the drug, Ratchford said in a telephone interview. The risk of disability from MS is higher than the risk of the infection for those patients, he said.

Up to half of patients who test negative for the virus may get Tysabri after failing other medicines, and about 14 percent of people with the virus also may be treated, said Michael Yee, an analyst at RBC Capital Markets in San Francisco, in a note to investors last month. About 57,000 patients worldwide take Tysabri, according to a Jan. 11 presentation by Biogen at the J.P. Morgan Healthcare Conference.
Over Time

Studies have shown that after two years of Tysabri, 37 percent of patients taking the drug were free from active disease, including relapses and worsening disability, compared with 7 percent of those given a placebo.

Multiple sclerosis is neurological disorder that robs people of muscle coordination and balance, sometimes leading to damaged vision and paralysis. More than 400,000 Americans and 2.5 million people worldwide have the condition, which is thought to develop when a person’s immune system goes awry and attacks healthy cells in the central nervous system, according to the National Multiple Sclerosis Society.

The risk of PML emerged after Tysabri was on the market, leading Biogen and Elan to suspend sales in February 2005. The drug returned to the market in June 2006 with a risk management program for patients who didn’t benefit from rival medications after research showed it was twice as effective as other MS therapies.

Positive Test

Fifty percent to 60 percent of patients taking Tysabri test positive for antibodies to the JC virus, according to Biogen research. Doctors may think twice before starting patients who are positive for the virus on Tysabri, Ratchford said.

Even testing negative isn’t completely reassuring because patients can be subsequently exposed to the virus, he said.

“We can’t tell them their risk is zero, but it’s considerably lower” if they test negative, he said. “One feels very reassured continuing them on Tysabri.”

There also is a 1 in 25 rate of false negatives with the test, Sandrock said when presenting the results during a poster session at the Neurology meeting. That means some patients with multiple sclerosis who test negative and take Tysabri may develop PML because the test failed to accurately assess their exposure to the virus, he said.
PML Risk

The risk of PML increases after the first year of treatment with the drug, and many doctors consider switching their patients after two years. A question remains about what medicine to use following Tysabri. Stopping treatment appears to trigger flares of the disease and may be detrimental, ruling out the idea of taking a patient off the medication temporarily to reduce the risk, studies at the meeting showed.

One new choice is Novartis AG (NOVN)’s Gilenya, the first pill to treat multiple sclerosis. It is almost twice as effective as Biogen’s Avonex, said Gordon Francis, head of Novartis’s neuroimmunology clinical science unit. It also reduced the risk of worsening disability by 30 percent in previously treated patients, a study presented at the meeting showed.

The company, based in Basel, Switzerland, is considering a study of patients who want to start Gilenya after coming off Tysabri, Francis said. The goal would be to determine short-term risks and see how long patients must be off Tysabri, which can remain in the body for two months or more, before starting another treatment, he said.
Gilenya Oversight

Sales of Gilenya will increase as doctors become more comfortable with it, Francis said. Patients need to be monitored for a slow heart rate for six hours after their first dose, and then checked for vision changes a few months later.

Ultimately, the long-term safety of the drug will be what matters to doctors, he said. The older injected drugs such as Avonex, Bayer AG (BAYN)’s Betaseron, German drugmaker Merck KGaA (MRK)’s Rebif and Teva Pharmaceutical Industries Ltd. (TEVA)’s Copaxone will be favored “until the dust settles,” in perhaps three to five years, he said in an interview.

“There hasn’t been the stampede of the first Tysabri launch, and that is appropriate,” Francis said. “Neurologists are a conservative group, and they are even more conservative than they were five years ago because of Tysabri,” he said.




http://www.bloomberg.com/news/2011-04-15/biogen-test-finds-t…

[Tebi]

Hi @ all,

ich hoffe Ihr seid neben Elan auch in Gold und Silber investiert...

Ansonsten---unser Schätzchen mausert sich..

Dolmen Stockbrokers on results: aus investor village
Link: http://www.dolmenstockbrokers.ie/reports/20th Apr 2011.pdf

Elan issued a solid Q111 numbers this morning, reporting a 3% increase in adjusted EBITDA to $63.3m from revenue of $313.0m, up 0.8% on Q110 and 5% ahead of market expectations ($299m). Incorporating a previously flagged legal settlement gain of $78m saw the company report a fully diluted EPS of $0.12. Ex the gain, losses per share came in at $0.02, in line with consensus. At the end of the quarter, there were 57,800 patients on Tysabri, with the drug generating worldwide revenue of $349.4m. Elan booked revenue of $245.2m. These numbers are in line with our expectations. Growth in Tysabri revenue was offset by a fall off in revenue from other drugs (down from $35.1m to $1.9m) and EDT, which slipped 14% to $65.9m as new products in the portfolio have not yet gained enough traction to replace lost revenue from older drugs. Numbers aside, Elan notes that it may now have to contribute to the development of Bapineuzumab from 2012 onwards. At the time J&J obtained substantially all of Elan’s assets and rights relating to its Alz-heimer’s Immunotherapy Program (sic) (AIP), it committed to spend $500m on the development of drugs in the pipeline, including Bapi. At the time, this was thought to be sufficient to see the drug through Phase III to the market. However, an increase in trial size, delays in patient recruitment (US Phase III only fully recruited this January) and requirement for sub-studies has not only seen a filing date pushed back two to three years, but also ramped up the costs. With Q111 numbers in line with market expectations, there should be little to excite the market, particularly after the strong run over the past two weeks (up 20%) on progress in further stratifying PML risk in MS patients through the anti-JC virus antibody test. The potential requirement to fund part of the AIP programme from 2012 onwards will be seen as a negative and should weigh on cur-rent momentum.

[posimist]

Wenn das so weiter geht, ist mein Einkaufskurs von knapp über 6 Euro
endlich wieder erreicht.
Und was mache ich dann?

[Tebi]

Antwort auf Beitrag Nr.: 41.401.958 von posimist am 21.04.11 15:48:54

....nix- weiter halten!

Heute gab es einen zeitweise herben Einbruch...deshalb:

Elan Shares Plunged: What You Need to Know

By Tim Beyers | More Articles
April 21, 2011 | Comments (0)



Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.

What: Despite beating Wall Street's estimates for first-quarter results, shares of Elan (NYSE: ELN ) plunged as much as 15% in early trading today. The stock has since recovered to be down about 4%.

So what: Elan earned $0.12 per diluted share on $313 million in Q1. Analysts had been calling for a $0.03 loss on $297.04 million, according to Yahoo! Finance data.

Now what: It didn't matter. Biogen Idec (Nasdaq: BIIB ) , an Elan partner in marketing the MS drug Tysabri, reported promising trial results for a competing MS treatment called BG-12. (Click here to read about Biogen's stock pop.) If approved, the new drug could cut into Elan's Tysabri sales because it's administered orally rather than intravenously. Tysabri patients are also regularly screened for a rare brain disease called PML, which can manifest as a side effect.

Investors' fears of Tysabri, which accounted for 78% of Elan's first-quarter revenue, being replaced may be justified someday. For now, it's important to remember that Elan easily beat estimates while Biogen's BG-12 remains in a phase 3 trial. Mr. Market is likely overreacting.

[welke91]

Antwort auf Beitrag Nr.: 40.730.227 von welke91 am 17.12.10 18:20:05

Hi Leute,

nur kurz. Erst einmal ist es schön, dass hier wieder ein wenig Leben reinkommt.

ich habe am
welke91 schrieb am 27.10.10 10:54:59 mitgeteilt, dass ich Mitte Dezember 2010 ein KZ von 7,41 $ sehen wollte.
Leider kam das erst Mitte Januar 11 und das mit meinen adjustierten KZ von dem Post:
welke91 am 17.12.10 18:20:05 auch noch haargenau.

Birgit, vielleicht kannst du dich noch erinnern, dass ich dir vor langer langer Zeit das KZ von rund 8,4 geschrieben hatte?

Es ist doch verblüffend dass es so eingetreten ist. Das ist aber nur das Trader KZ dort hätte der Trader raus gehen müssen weil danach eher eine Grauzone herrscht.

Die wird jetzt kommen.
Es wird ein bissl runter gehen passt auf den 30.4 auf.

Trotzdem alles Gute

Aber danach, ab geht die Lutzi (wenn es das war was ich vermute)!!!

welke

[Tebi]

Antwort auf Beitrag Nr.: 41.409.065 von welke91 am 25.04.11 18:41:25

Hi Welke,schön Dich zu lesen!

Ich hoffe echt auf die LUZIE----aber wir sind ja eh geduldig,gelle???

Nette osterliche Grüsse! Birgit

[Poppholz]

man, man, man.

Da fahre ich ein paar Tage in den Osterurlaub und dann schmiert der Kurs direkt über 10% ab.

Meine Aktien bleiben im Depot bis die Bank diese wegen Wertlosigkeit ausbucht oder der Kurs bei $30,- steht (dann geht ein Teil raus)

[GuHu1]

http://www.fiercebiotech.com/story/researchers-eager-see-piv…

http://www.dailymail.co.uk/health/article-1379749/Alzheimers…" target="_blank" rel="nofollow ugc noopener">
http://www.dailymail.co.uk/health/article-1379749/Alzheimers…

[bernie55]

Alkermes to Merge with Elan Drug Technologies to Create Alkermes plc

WALTHAM, Mass. & DUBLIN--(BUSINESS WIRE)-- Alkermes, Inc. (NASDAQ:ALKS - News) and Elan Corporation, plc (NYSE:ELN - News) today announced the execution of a definitive agreement under which Alkermes will merge with Elan Drug Technologies (EDT), the profitable, world-class drug formulation and manufacturing business unit of Elan, in a cash and stock transaction currently valued at approximately $960 million. Alkermes and EDT will be combined under a new holding company incorporated in Ireland. This newly created company will be named Alkermes plc.

The transaction is expected to be immediately accretive to cash earnings and accelerates Alkermes’ path to building a sustainably profitable biopharmaceutical company with expertise in developing treatments for central nervous system (CNS) diseases and a broad, diversified portfolio of products and pipeline based on proprietary science and technologies. Alkermes plc will have diverse revenue streams from 25 commercialized products, with future near-term growth expected to be driven by five major products: RISPERDAL® CONSTA®, INVEGA® SUSTENNA®, AMPYRA®, VIVITROL® and BYDUREON™. The combined company is expected to have growing product, royalty and manufacturing revenues in excess of $450 million annually and resources to prudently invest in an innovative pipeline of proprietary drugs.

“The merger will be financially transformative and create a profitable, global biopharmaceutical company with a diversified CNS product portfolio and a strong foundation for growth,” stated Richard Pops, Chief Executive Officer of Alkermes. “Both companies have a proven track record as innovators. This merger will bring the scale and resources for strategic and balanced investment across the whole product continuum, from R&D innovation to clinical development, to world-class manufacturing and commercial expansion. We’re looking forward to working with the EDT team to accelerate growth and to create value for our shareholders and the patients we serve.”

Kelly Martin, Chief Executive Officer of Elan plc commented that “upon closing, this transaction aggressively advances a number of long-standing strategic and financial objectives for Elan. Namely, it enables us to reduce the debt on our balance sheet and further improve our capital structure, increases operating leverage, allows for additional focus and continued disciplined investment in a broad array of opportunities within the neurology space from a scientific, clinical and product point of view and lastly, provides Elan shareholders with the opportunity to realize further value – over time – from the equity position in Alkermes plc.”

“The combination of Alkermes and EDT is a strong strategic fit at the right time when both businesses are strong and positioned for growth. With EDT’s two recently approved drugs, INVEGA SUSTENNA and AMPYRA, driving revenue growth, the EDT business is an ideal complement to Alkermes’ portfolio of approved and development-stage drugs,” stated Shane Cooke, Executive Vice President and Head of EDT. “This combination creates opportunities for our employees and provides a platform for future growth.”

Strategic and Financial Benefits of the Transaction

Alkermes plc will have the following strengths:

* Immediate profitability on a cash earnings basis and diversified, growing revenues from 25 commercial products;
* Robust revenue growth with expected Adjusted EBITDA1 margin expansion;
* Five high-growth commercial products (RISPERDAL CONSTA, INVEGA SUSTENNA, AMPYRA, VIVITROL and BYDUREON), all with long patent lives and significant growth potential in large therapeutic areas. In particular, two of these products, RISPERDAL CONSTA and INVEGA SUSTENNA, both commercialized by Johnson & Johnson, represent two very important long-acting injectable atypical antipsychotic medications for schizophrenia and bipolar I disorder;
* A strong, CNS-focused pipeline of proprietary and partnered product candidates in clinical development, including several late-stage proprietary product candidates;
* Complementary new drug development capabilities that leverage proprietary science and innovative medicinal chemistry capabilities. Proprietary technologies include EDT’s NanoCrystal® technology for poorly water soluble drug compounds; EDT’s proprietary technologies for oral controlled release drugs and Alkermes’ long-acting injectable drug technologies; and
* GMP manufacturing facilities in Wilmington, Ohio, Gainesville, Ga., and Athlone, Ireland, with world-class capabilities for producing complex drug products.

Transaction Terms

In connection with the transaction, which was approved by the boards of Elan and Alkermes, at closing, Elan will receive $500 million in cash and 31.9 million ordinary shares of Alkermes plc common stock. Alkermes and Elan will enter into a shareholder agreement that, among other things, contains a lockup, standstill and voting agreement for Elan's shares of Alkermes plc. Existing shareholders of Alkermes, Inc. will receive one ordinary share of Alkermes plc in exchange for each share of Alkermes, Inc. they own at the time of the merger. Alkermes plc shares will be registered in the U.S. and are expected to trade on the NASDAQ exchange. The transaction is expected to be taxable to existing Alkermes, Inc. shareholders. Alkermes has obtained a commitment from Morgan Stanley & Co. and HSBC to provide up to $450 million of term loans to finance the transaction.

Financial Guidance

On a trailing 12-month basis as of March 31, 2011, the combined company would have had pro forma revenues of approximately $450 million and Adjusted EBITDA of approximately $80 million. On a pro forma basis, revenues are expected to grow in fiscal year 2012 and reach double digit growth rates in fiscal year 2013 and beyond. Pro forma Adjusted EBITDA margins for fiscal year 2012 are expected to be in the 15-20% range, yielding pro forma Adjusted EBITDA of between $70 million and $90 million. Pro forma Adjusted EBITDA margins are expected to expand to 30-35% in fiscal year 2013 and beyond. While synergies are not the main driver of the transaction, approximately $20 million of annual synergies in U.S. operations have been identified and are expected to be fully realized by fiscal year 2013. Alkermes plc will be headquartered in Dublin, Ireland, creating a financially and legally efficient structure.

Leadership

Richard Pops, currently Chairman, President and Chief Executive Officer of Alkermes, will serve as Alkermes plc’s Chairman and Chief Executive Officer, and Shane Cooke, currently Executive Vice President and Head of EDT, will join Alkermes plc as President. Alkermes plc’s board will consist of members of the current board of Alkermes, Inc. Elan has the right to appoint one independent director to the board of Alkermes plc, contingent upon Elan’s maintenance of at least 10% ownership in Alkermes plc.

Approvals

The transaction is subject to approval by Alkermes’ stockholders and the satisfaction of customary closing conditions and regulatory approvals, including antitrust approvals in the U.S. The transaction is expected to close during the third quarter of calendar 2011.

Advisors

Alkermes’ financial advisor is Morgan Stanley & Co. Incorporated, and its legal advisors are Cleary Gottlieb Steen & Hamilton LLP (New York) and Arthur Cox (Dublin). Elan’s financial advisors for this transaction are Citigroup and Ondra Partners, and its legal advisors are Cahill Gordon & Reindel LLP (New York) and A&L Goodbody (Dublin).

Conference Calls

* Alkermes will host a conference call at 8:30 a.m. ET (1:30 p.m. BST) on Monday, May 9, 2011, to discuss this transaction. The conference call may be accessed by dialing 1-888-424-8151 for U.S. callers and 1-847-585-4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Monday, May 9, 2011, through 5:00 p.m. ET (10:00 p.m. BST) on Monday, May 16, 2011, and may be accessed by visiting Alkermes’ website or by dialing 1-888-843-7419 for U.S. callers and 1-630-652-3042 for international callers. The replay access code is 6037988.
* Elan plc will host a conference call at 10:00 a.m. ET (3:00 p.m. BST) on Monday, May 9, 2011 to discuss this transaction. 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.

Because this transaction as to Elan is deemed a Class 2 transaction under the Listing Rules of the Irish Stock Exchange (ISE), Elan has issued a further regulatory announcement [via the RNS] containing certain additional prescribed disclosures relating to EDT and the transaction, detailing the proposed management changes in accordance with the requirements of the Listing Rules of the Irish Stock Exchange, and containing further information in connection with the transaction which is of relevance to Elan bondholders. This regulatory announcement will be filed with the U.S. Securities and Exchange Commission (SEC) on a Form 6-K, and will also be accessible on

www.elan.com.

http://finance.yahoo.com/news/Alkermes-to-Merge-with-Elan-bw…

[bernie55]

Antwort auf Beitrag Nr.: 41.472.031 von bernie55 am 09.05.11 11:07:56

Davy

FACTS: Elan has announced that its drug delivery arm, EDT, is to merge with US firm Alkermes in a $960m deal.

ANALYSIS: The main features of the transaction are as follows:

Elan will receive $500m in cash plus 31.9m shares in Alkermes plc (which will have its headquarters in Dublin). Alkermes Inc., for which the new entity will convert shares on a one-to-one basis, closed on Friday (May 6th) at $14.47 so Elan's stake in the new business is worth just over $460m. This equates to a c.25% shareholding.

The new company will have revenues of $450m and adjusted EBITDA of c $80m (year ending March 2011). Revenue growth is anticipated for fiscal year 2012 and willl accelerate to double-digit rates in fiscal 2013 and beyond.

Adjusted EBITDA margins will be in the 15-20% range in fiscal 2012, rising to 30-35% in the following year as cost savings of $20m are fully realised.

Alkermes Plc will comprise five high-growth products – Risperdal Consta, Invega Sustenna, Ampyra, Vivitrol and Bydureon. Alkermes currently has a portfolio of CNS products and has a pulmonary drug delivery technology platform.

Upon closing (probably Q3), Shane Cooke will join Alkermes plc as President.

Elan will use the net proceeds to retire debt.

DAVY VIEW: Our first thoughts are that this transaction makes sense to us, looks strategically sound and is yielding an attractive financial benefit for Elan.

A separation of EDT from Elan's bioneurology business has long been intended as part of Elan's strategic plan; to this end, the cash and investment stake will provide further flexibility to Elan's ongoing business. In its own right, retiring $500m of debt will save c.$40m in annual interest for Elan. For investors, a transaction provides extra focus on the ongoing business (which will be positively perceived) and will reduce financial risk.

Alkermes (at 13.30) and Elan (at 15.00) will host conference calls today to provide further detail.

[bernie55]

Antwort auf Beitrag Nr.: 41.472.031 von bernie55 am 09.05.11 11:07:56

Elan Sells EDT Unit to Alkermes

BY STEN STOVALL

LONDON—Elan Corp. PLC on Monday sealed a transformational deal to sell its drug technology unit EDT to U.S.-based Alkermes Inc. in a deal valued at $960 million that allows the Irish drug maker to pay down debt and fund pipeline development.

EDT and Alkermes will be combined under a new holding company incorporated in Ireland. The combined group, in which Elan will have a 25% stake, will focus on products dealing with the brain and is expected to have annual revenue of around $450 million from 25 products, including treatments for schizophrenia and pain.

Elan said the spinoff of EDT—a .......

http://online.wsj.com/article/SB1000142405274870386420457631…

[bernie55]

Antwort auf Beitrag Nr.: 41.472.031 von bernie55 am 09.05.11 11:07:56

Alkermes to Merge With Irish Drug Business
By CHRIS V. NICHOLSON


Alkermes, an American biotechnology company, said Monday that it would merge with Elan Drug Technologies in a cash and stock deal worth $960 million.

Elan Drug Technologies is the drug-delivery arm of Elan Holdings, a biotech based in Dublin. The newly combined company, to be known as Alkermes, will also be incorporated in Ireland.

Alkermes, which specializes in treatments for central nervous system disorders, said it expected the deal to be immediately accretive to earnings, creating a firm with $450 million in annual revenue.

Richard Pops, head of the biotech, said the deal would give the company a “strong foundation of growth.”


Together, the companies will have five major commercial products — Risperdal Consta, Invega Sustenna, Ampyra, Vivitrol and Bydureon — which include treatments for schizophrenia, bipolar disorder, multiple sclerosis, diabetes and drug addiction.

Kelly Martin, head of Elan, said the transaction would “reduce the debt on our balance sheet” and let Elan shareholders “realize further value – overtime – from the equity position in Alkermes.”

Under the terms of the deal, Elan will be paid $500 million in cash and 31.9 million shares in the combined company, or a 25 percent stake. Alkermes shareholders will receive one share in the new company for every share they own at the time of the deal; the new shares are set to trade on the Nasdaq.

Morgan Stanley and HSBC provided $450 million in loans to finance the deal.

Alkermes hired Morgan Stanley as its financial adviser and Cleary Gottlieb Steen & Hamilton, as well as Arthur Cox in Dublin, as legal counsel. Elan hired Citigroup and Ondra Partners as its financial advisers, and Cahill Gordon & Reindel and A&L Goodbody as legal counsel.

Founded in 1987, Alkermes is headquartered in Waltham, Massachusetts, northwest of Boston, and operates a plant in Wilmington, Ohio. It went public in 1991.

http://dealbook.nytimes.com/2011/05/09/alkermes-to-merge-wit…" target="_blank" rel="nofollow ugc noopener">
http://dealbook.nytimes.com/2011/05/09/alkermes-to-merge-wit…

[Tebi]

From WSJ
Berenberg Bank, which has a buy on the Irish drug maker, said in a note: "Elan's debt position will be significantly improved by this transaction, with the company potentially close to a zero net debt position by year-end 2011."



By STEN STOVALL

LONDON—Elan Corp. PLC on Monday sealed a transformational deal to sell its drug technology unit EDT to U.S.-based Alkermes Inc. in a deal valued at $960 million that allows the Irish drug maker to pay down debt and fund pipeline development.

The move is Elan's latest attempt to draw a line under a troubled nine-year period that has seen it hammered by accounting problems and as the initial high hopes for blockbuster multiple sclerosis drug Tysabri were dashed by side effects of the medicine.

EDT and Alkermes will be combined under a new holding company incorporated in Ireland. The combined group, in which Elan will have a 25% stake, will focus on products dealing with the brain and is expected to have annual revenue of around $450 million from 25 products, including treatments for schizophrenia and pain.

Elan said the spinoff of EDT—a long-standing aim—will allow it to become a pure neurology-based biotechnology business with adequate funding. The company first tried to sell the EDT business in 2008, but failed after the economic crisis led to a financing drought.

"This allows us to reduce debt and have a lot of cash for investment in the research and development part of the business, which is key for Elan, and it allows us to take financial risk off the table and invest in our science and our assets in the intermediate term, which has been a long-term goal of the company," Elan's Chief Executive Kelly Martin said. Mr. Martin went on to emphasize that "reducing debt was the priority."

Mr. Martin said the restructured company will be able to focus more on its flagship multiple sclerosis treatment Tysabri which it manufactures and sells along with its U.S. joint venture partner Biogen Idec Inc.

Multiple sclerosis is a chronic, inflammatory condition that occurs when the body essentially attacks its own central nervous system and can be disabling in advanced stages.

"Tysabri's growth is very significant and continues to accelerate," Mr. Martin said, adding that the medicine's growth potential outside the U.S. looks especially promising.

The new entity will be called Alkermes PLC. Richard Pops, currently chairman, president and CEO of Alkermes, will serve as Alkermes PLC's chairman and chief executive. Elan's Chief Financial Officer Shane Cooke, who is also currently head of EDT, will join the new holding company as president. Nigel Clerkin becomes Elan's CFO from Monday.

Under the terms of the deal, Elan will get $500 million cash and 31.9 million ordinary shares in Alkermes PLC common stock while existing Alkermes shareholders will receive one ordinary share of the new company in exchange for each in Alkerms Inc. The pact contains a lockup, standstill and voting agreement for Elan's shares in Alkermes PLC.

Alkermes CEO Mr. Pops said the deal is a massive milestone for his company.

"Similar to EDT, which has its origins in complex drug-delivery technology and manufacturing, we've built a company with strong growing revenues now, as does EDT, and by putting the two companies together we'll have the financial strength to fund the development of pipeline products—increasingly for our own account—instead of doing this with pharmaceutical companies as partners. So this is definitely a transformational step for us," the Alkermes CEO said in an interview.

For Elan, "This has been a multi-year process. I would describe this as the final step for Elan in defining itself as a biotech company with a focus on neuroscience," CEO Mr. Martin said.

In 2009, U.S.-based Johnson & Johnson paid $885 million for an 18.4% stake in Elan and acquired rights to advanced research into drugs for Alzheimer's disease, representing most of the value credited to the Elan Alzheimer's pipeline at the time.

Mr. Martin, who steps down as CEO in a year from now, said the sale of its EDT business "will allow us to focus even more on the area of neuro-degenerative diseases with significant strategic and financial flexibility. It's a very shareholder-friendly transaction."

Davy analyst Jack Gorman, who has an outperform rating on Elan, said "this transaction makes sense to us, looks strategically sound and is yielding an attractive financial benefit for Elan ... In its own right, retiring $500 million of debt will save circa $40 million in annual interest for Elan."

Elan's debt has built over a number of years as the company has posted big losses and writedowns. Its long-term debt at the end of March stood at $1.27 billion, down from $5 billion in 2002.

Berenberg Bank, which has a buy on the Irish drug maker, said in a note: "Elan's debt position will be significantly improved by this transaction, with the company potentially close to a zero net debt position by year-end 2011."

The market cheered Monday's news, pushing Elan's stock higher on the London Stock Exchange, and at 1237 GMT it was up 5.4%, or 29 euro cents, at €576 in Dublin. The shares were up 39% so far in 2011, according to FactSet.

[posimist]

Da hat dein geliebter Kelly Martin, Tebi,
letztendlich doch etwas für uns Aktionäre getan.

[Tebi]

Antwort auf Beitrag Nr.: 41.479.222 von posimist am 10.05.11 15:33:44

NA JA--ist wie mit 1000Affen vor 1000 Schreibmachinen---da schreibt dann auch mal einer ein richtiges Wort....

------------------------------------------------------------------------




May 12, 2011 16:52 ET
Paladin and Elan Sign Agreement for New Pain Product

MONTREAL, QUEBEC--(Marketwire - May 12, 2011) - Paladin Labs Inc. (TSX:PLB), a leading Canadian specialty pharmaceutical company, today announced that they have entered into a licensing and distribution agreement under which Paladin has been granted exclusive Canadian rights from an affiliate of Elan Corporation, plc ("Elan") to market and sell, upon regulatory approval, Elan's controlled release hydrocodone product for the treatment of moderate to severe pain.

According to IMS Canada, the Canadian oral extended release opioid market in 2010 exceeded 4 million prescriptions representing sales of more than $385 million. At present, there is no single-entity, controlled-release formulation of hydrocodone in Canada presenting a significant unmet medical need in the treatment of moderate to severe pain. The product, which incorporates Elan's proprietary SODAS® technology, offers a unique, controlled-release profile which utilizes both immediate release and extended release properties designed to enable twice daily dosing. This product is expected to allow for less frequent dosing with a customized controlled-release profile and the ability to titrate to higher hydrocodone doses. In the treatment of chronic pain, the product is anticipated to avoid some of the serious side effects associated with the use of combination opioids that contain acetaminophen, or non-steroidal anti-inflammatory drugs (NSAIDs). The product is currently in two pivotal phase III trials in the US and is expected to be submitted for Health Canada approval in the second half of 2012.

"We are excited to add a further treatment option for Canadian pain sufferers and their physicians," said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc. "This product, if approved, will complement our dynamic and growing promoted pain portfolio, which already includes Tridural®, Metadol®, and Abstral® and will provide us an additional pillar upon which to strengthen our pain franchise."

Under the terms of the Agreement, Elan will receive from Paladin undisclosed upfront and milestone payments for the product. Additionally, Elan will receive manufacturing fees and royalty payments based on sales of the product upon commercialization.

About SODAS®Technology

SODAS (Spheroidal Oral Drug Absorption System) is Elan Drug Technologies' multiparticulate drug delivery system. SODAS Technology continues to be an accepted and approved system by regulatory authorities with approvals for the SODAS based system occurring in the US for Avinza®, Ritalin LA® and Focalin XR®. A number of other compounds are in late stage development utilizing Elan's SODAS® technology. The SODAS® technology is part of a suite of capabilities available through Elan Drug Technologies.

SODAS is a registered trademark of Elan Pharma International Ltd.

AVINZA is a registered trademark of King Pharmaceuticals Research and Development, Inc.

FOCALIN XR and RITALIN LA are registered trademarks of Novartis AG

Tridural, Metadol and Abstral are Canadian registered trademarks of Labopharm Inc., Pharmascience Inc. and Strakan International Ltd., respectively.

[bernie55]

Antwort auf Beitrag Nr.: 41.495.620 von Tebi am 13.05.11 00:31:27

WIE ? HÄH ?

Bekommt ELAN wirklich die " undisclosed upfront and milestone payments for the product." ?

Denn SODAS (Spheroidal Oral Drug Absorption System) is Elan Drug Technologies' multiparticulate drug delivery system.

Also müsste der Deal doch durch den Verkauf von EDT an Alkermes über Alkermes laufen oder habe ich da irgendwas falsch verstanden .

Aber vielleicht greift der Vertrag ja " zeitlich" noch nicht, so dass ELAN nochmal "voll" dafür kassieren könnte.

[Tebi]

Antwort auf Beitrag Nr.: 41.497.884 von bernie55 am 13.05.11 12:08:06

So wird´s sein---ich sage nur : GELD zu U N S !!

[surga]

Antwort auf Beitrag Nr.: 41.498.115 von Tebi am 13.05.11 12:36:08

ja, GELD zu U N S !!

Grüße an die ELAN-Runde

[Tebi]

Antwort auf Beitrag Nr.: 41.509.139 von surga am 16.05.11 16:31:49

bist Du schon wieder auf unserem "Verschuldungskontinent" oder noch in den "aufstrebenden" Gegenden?? ( GUT dass Du nicht am Missisippi weilst...)

[surga]

Antwort auf Beitrag Nr.: 41.509.220 von Tebi am 16.05.11 16:42:26

ich bin seit einer Woche wieder da. Bald muss ich wieder weg nach schwarzer Kontinent und Mekong-Delta.

[surga]

Antwort auf Beitrag Nr.: 41.509.220 von Tebi am 16.05.11 16:42:26

Es läuft auf hohe Niveau

[bernie55]

Davys
PHARMA AND HEALTHCARE


FACTS: According to the latest safety update on Tysabri released last night (May 17th), 13 new PML cases were confirmed last month. This brings the total to 124. There have been 69 PML cases in Europe, 49 in the US and 6 in the rest of the world.

ANALYSIS: Overall incidence of PML in patients exposed to Tysabri has thus risen to 1.44 per 1,000 from, 1.31 per 1,000.Given that Elan/BIIB can now stratify a patient's PML risk across three risk factors (prior immunosuppressant use, duration of
treatment and JC-virus status), the monthly PML update is not as relevant as it does not indicate whether patients had some orall of the risk factors associated with PML development.Examining the data by treatment epoch, the major movement month-on-month was in patients with 25-36 infusions. Here the incidence rate rose from 1.74 per 1,000 to 1.89 per 1,000. In the 28 natalizumab-treated patients who developed PML, and for whom serum samples were available 6.5-187 monthsprior to the onset of PML, all had anti-JCV antibodies detected.

DAVY VIEW: In line with what we have seen through most of 2011, incidence rates are higher compared to previous years.

This most likely reflects the larger proportion of Tysabri patients who are on treatment for two years or more.

The focus for Elan/BIIB remains to clarify the PML risk factors and to make available its JCV assay.
Company summary and analysis

http://www.investorvillage.com/smbd.asp?mb=160&mn=463446&pt=…

[bernie55]

Proteostasis Therapeutics & Elan Form Drug Discovery Initiative

Strategic Relationship Combines Proteostasis’ Proprietary “Proteostasis Network” Platform With Elan’s Biology, Genetics And Neurology Disease Expertise


Press Release Source: Elan Corporation On Wednesday May 25, 2011, 2:02 am EDT

CAMBRIDGE, Mass. & DUBLIN--(BUSINESS WIRE)-- Proteostasis Therapeutics (“Proteostasis”) and Elan Corporation (NYSE:ELN - News) today announced a strategic business relationship to advance Proteostasis’ platform for the discovery and development of disease-modifying, small molecule drugs and diagnostics for the treatment of neurodegenerative disorders such as Parkinson’s, Huntington’s, multiple sclerosis and amyotrophic lateral sclerosis (ALS), and a broad array of dementia-related diseases including Alzheimer’s. This innovative initiative will combine Proteostasis’ unique discovery technology, novel targets and compounds that modulate key Proteostasis Network pathways with Elan’s long-standing strength in proprietary animal models, biology, medicinal chemistry and clinical development.

Under terms of the agreement, Elan invested $20 million into equity capital of Proteostasis and will have an opportunity to provide an additional $30 million in collaboration funding over five years. As part of the agreement, Elan will become an approximate 24% shareholder in Proteostasis, obtained a right of first negotiation to exclusively license compounds emerging from the combined initiative and will have the right to a seat on the Proteostasis board of directors as well as its scientific advisory board. By mutual agreement, this innovative relationship can be extended for a further five years.

Peter Reinhart, Ph.D., President and Chief Scientific Officer of Proteostasis, commented, “We are excited to announce this promising collaboration with Elan, a proven leader in innovative neurodegenerative disease drug development. This alliance recognizes our progress to date and provides an opportunity to further advance Proteostasis’ novel drug discovery platform. Elan’s proprietary disease models and development expertise will enable us to accelerate our programs, each of which has the potential for developing therapeutics to treat multiple neurodegenerative diseases.”

Dale Schenk, Ph.D., Executive Vice President and Chief Scientific Officer, as well as Ted Yednock, Ph.D., Executive Vice President and head of research for Elan, added their comments by stating that, “Through an emphasis on protein folding and turnover, the Proteostasis business relationship is both complementary and additive to our internal research effort which is focused on genetic targets associated with a broad array of neurodegenerative disorders. This initiative enables us to simultaneously expand possible targets and accelerate our progress in bringing science to patients, as we believe that this area is central for further scientific and clinical advancements.”

“Proteostasis’ drug discovery platform is based on an emerging concept in biology, namely that perturbations in the Proteostasis Network pathways fundamentally underlie a wide variety of diseases, including neurodegenerative diseases as well as orphan conditions such as cystic fibrosis and lysosomal storage disorders,” said Christopher K. Mirabelli, Ph.D., Chairman of the Board of Proteostasis. “This alliance provides a creative approach to financing our discovery platform and supporting the development of multiple discovery and development programs in parallel.”

Kelly Martin , Chief Executive Officer of Elan, added that, “This initiative with Proteostasis reinforces our commitment and strategic business objective of being an exceptionally high-caliber, science-driven company and provides a multitude of opportunities for Elan to advance its position as a world leader in the broad field of neuroscience. Importantly, and given the construct of the deal as a capital investment, this transaction is being consummated in a manner that will have a minimal near-term financial impact on our income statement and enable shareholders to realize the benefits of the operating leverage, embedded into our business, that combines expected double-digit revenue growth with a stable and well defined overall cost structure.”

About Proteostasis Therapeutics

Proteostasis Therapeutics is developing “Proteostasis Regulators” (PRs), small molecule drugs that restore proper protein function or remove misfolded and aggregated proteins to treat neurodegenerative, metabolic, genetic and inflammatory disorders. The Proteostasis Network is the cellular machinery responsible for protein folding, trafficking and clearance, and can become imbalanced by the cumulative effects of aging, disease, genetics, and environmental factors. PTI was founded by leading scientists who discovered a pioneering approach for treating disease by restoring protein network homeostasis. www.proteostasis.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 and Irish Stock Exchanges. For additional information about the Company, please visit www.elan.com.


http://finance.yahoo.com/news/Proteostasis-Therapeutics-bw-3…

[bernie55]

Antwort auf Beitrag Nr.: 41.553.717 von bernie55 am 25.05.11 11:53:58

Davy:

FACTS: Elan has announced an investment in Proteostasis Therapeutics.

ANALYSIS: Tapping Proteostasis' discovery initiatives in neurology, Elan has invested $20m in the business to become a 24% shareholder and will invest another $30m in collaboration funding over the next five years. Elan will have a right of first negotiation on any compounds that may emerge from the partnership and will have a presence on Proteostasis' board and its scientific advisory board.

Proteostasis is working to develop small molecule drugs that restore proper protein function or remove misfolded or aggregated proteins. This has particular relevance in neurodegenerative, genetic and inflammatory disorders, including many areas in which Elan already has expertise such as Multiple Sclerosis, Alzheimer's Disease, Parkinson's Disease and ALS.

DAVY VIEW: It has not taken long for Elan to use some (albeit a small part) of the anticipated proceeds from the EDT deal. However, it is more instructive to view the investment as part of Elan's broader strategy to strengthen its own discovery capability and increase the potential flow of new compounds into clinical development. This is an investment with a long-term horizon, similar to internal initiatives such as NeoTope.
We would not be surprised to see more activity on this front.

http://www.investorvillage.com/smbd.asp?mb=160&mn=464323&pt=…

[Tebi]

uih,unser Schätzchen STEIGT.,.....das Grün tut meinen Augen direkt WEH---ich bin es echt nicht mehr gewöhnt....

[bernie55]

Zitat von Tebi: uih,unser Schätzchen STEIGT.,.....das Grün tut meinen Augen direkt WEH--
-ich bin es echt nicht mehr gewöhnt....

Last Trade: 9.06
Trade Time: 4:00PM EDT
Change: Up 0.65 (+7.73%)

Volume: 7,693,654
Avg Vol (3m): 3,347,580

[Poppholz]

Hallo liebe Altinvestoren,

unser Baby steigt immer noch und wir haben ein Jahreshoch nach dem anderen.

da bin ich doch mal gespannt, ob wir wieder (annähernd) in alte Kursbereiche kommen werden.

Ab $30,- geht ein Teil raus, mal schaue wie lange ich warten muss.

[welke91]

Antwort auf Beitrag Nr.: 41.566.054 von Poppholz am 27.05.11 11:19:34

gemach gemach

alles steigt und fällt auch wieder das ist der welten lauf,



sollte die obere Linie nicht durchstoßen 9,28 $ dann wäre es etwas anderes.

aber habe kaum zeit so eine analyse zu machen.

technisch gesehen müssten niedrigere Kurse kommen. war eh schon zu stark das ganze.



zu übertrieben!

Trendwende ohne großes nachrechnen heute oder montag!

bräuchte mehr zeit.

aber wir können es so machen, dass tebi mir mal ihre private email adresse schickt und ich dir dann paar bildchen sende damit ihr immer in extremsituationen bescheid wisst.

werde mich mal ein wenig zurückziehen der ärger im dlg thread hat mich mürbe gemacht!

ob 7,90 $ für eine wochenlange korrektur ausreichen ist zu bezweifeln aber nehmt das mal als anhaltspunkt.

grüße

[Tebi]

Antwort auf Beitrag Nr.: 41.567.267 von welke91 am 27.05.11 13:59:56

Hi sweetie,das mach ich doch gerne---aber NUR wenn Du nicht wieder so Bildchen malst wo der Pfeil (pfui!!)wieder nach UNTEN zeigt....

[Tebi]

Msg 464838 of 464862 at 5/27/2011 9:28:46 AM by

mrbluechip von investorvillage







Wells Fargo Comments on Bapineuzumab
In a research report dated May 26, 2011 on Johnson and Johnson they said:

"Alzheimer drug bapineuzumab Phase 2 re-analysis encouraging.
JNJ expects to complete the US Phase 3 studies next year, and file for approval in 2012/13. We are encouraged by some of the re-analysis of Phase 2 data that showed on ApoE4 non-carriers, there was significant separation from placebo in cognition with the difference increasing over time, which is suggestive of a disease-modifying agent profile. We (and the Street) currently exclude the product from our model but recognize the multi-billion opportunity if successful."

[bernie55]

Antwort auf Beitrag Nr.: 41.568.479 von Tebi am 27.05.11 16:59:52

J&J Will Seek FDA Approval by 2013 for Alzheimer’s Drug
By Alex Nussbaum - May 26, 2011 10:19 PM GMT+0200



Johnson & Johnson (JNJ) will seek U.S. regulatory approval of the experimental Alzheimer’s treatment bapineuzumab in 2012 or 2013, sticking with efforts to treat a disease where other drugmakers have failed.

J&J sees bapineuzumab as the “cornerstone” of its efforts to treat the brain-wasting disease, Husseini Manji, J&J’s global therapeutic area head for neuroscience, said at a company conference today. The drug has reduced the growth of plaques in the brain thought tied to the disease, Manji said at the meeting in New Brunswick, New Jersey, where J&J is based.

At least a dozen potential treatments designed to slow or stop the plaques from forming have failed in mid- to late-stage testing since 2003. Indianapolis-based Eli Lilly & Co. (LLY) said in August it was suspending development of one such drug. Manji said J&J is moving ahead with trials of bapineuzumab, which the company shares with New York-based Pfizer Inc. (PFE)

“We continue to remain optimistic that bapineuzumab will be the first treatment” to change the course of the disease instead of merely slowing symptoms, he told investors and analysts at the meeting. “We hope to bear the fruits of these investments.”

The drug was linked to a side effect similar to swelling of the brain when given at high doses in study results released last year. The effects were temporary and ended when patients were taken off the therapy, Manji said.

2012 Results

The first results from four clinical trials of the treatment are due in mid-2012, he said.

Johnson & Johnson fell 21 cents to $65.51 at 4:01 p.m. in New York Stock Exchange composite trading. Pfizer rose 12 cents to $20.90. Pfizer is the world’s biggest seller of health-care products by annual sales, followed by J&J.

J&J expects an U.S. Food and Drug Administration panel to consider data later this year on Xarelto, an experimental blood thinner to prevent strokes shared with Bayer AG of Leverkusen, Germany, said Martin Fitchet, head of J&J’s cardiovascular research.

The agency will probably rule on the drug’s use in patients with atrial fibrillation, an irregular heartbeat that can lead to stroke, by the end of this year, he said at the conference. Another application, to market Xarelto to prevent blood clots in immobilized patients in the hospital, may be delayed past 2011 because of study data that suggested the medicine may raise the risk of bleeding, Fitchet said.

The agency may rule on a third use for the drug, in orthopedic-surgery patients, in July, said Ernie Knewitz, a J&J spokesman, in an interview. The medicine is also called rivaroxaban.


‘Multibillions’

Bapineuzumab, if successful, “could yield multi-billions of dollars in sales given the high unmet need in Alzheimer’s disease,” said Jami Rubin, a Goldman Sachs Group Inc. analyst in New York, in a May 11 note to clients. “Drug development in Alzheimer’s disease has also proven to be very risky given the high failure rate” of experimental treatments, she said.

J&J gained its share in the drug with its 2009 purchase of an 18 percent stake in Dublin-based Elan Corp. for $1 billion. Alzheimer’s affects 5.4 million people in the U.S., and sales of currently approved drugs reached $7 billion last year, Manji said.

The side effects and mixed results in past trials give reason to be skeptical about the drug’s prospects and likely mean additional trials will be needed, said Michael Weinstein, a JPMorgan Chase & Co. analyst based in New York, in a note to clients today.
‘Noteworthy’ Confidence

“Yet, the company’s internal enthusiasm and confidence is noteworthy,” he said.

J&J remains confident in the drug after a re-analysis of the data and evidence that bapineuzumab reduces proteins in the brain tied to Alzheimer’s, said Paul Stoffels, J&J’s worldwide co-chairman for pharmaceuticals, in a news conference after the meeting.

Bapineuzumab may have “the most potential” of any of J&J’s experimental drugs nearing approval, said Sheri McCoy, vice chairman of the company’s executive committee.

“The science is new and evolving so there’s more risk in that, but at the same time, we have the opportunity” to affect millions of patients, she said.

The company’s pharmaceuticals division expects to seek approvals for 11 new products and expand approved uses for more than 30 existing drugs between 2011 and 2015, J&J said in a statement today.

Prescription drugs accounted for 36 percent of last year’s $61.6 billion in revenue for J&J, which also sells consumer products such as Tylenol and Rolaids and medical devices including heart stents, artificial hips and surgical sutures.

To contact the reporter on this story: Alex Nussbaum in New York [e-mail].

To contact the editor responsible for this story: Reg Gale at [e-mail].

http://www.bloomberg.com/news/2011-05-26/j-j-plans-to-file-f…

[surga]

Antwort auf Beitrag Nr.: 41.568.082 von Tebi am 27.05.11 16:01:21

Solange ELAN im steigenden Trend liegt, fallend und steigend ist doch OK, nicht wahr TEBI

[Tebi]

Antwort auf Beitrag Nr.: 41.568.683 von surga am 27.05.11 17:33:15

och,nööö....nur steigend ist SCHÖNER....

[surga]

Antwort auf Beitrag Nr.: 41.568.690 von Tebi am 27.05.11 17:34:36

bis jetzt steigt ja noch

[welke91]

Antwort auf Beitrag Nr.: 41.568.766 von surga am 27.05.11 17:48:13

hi leute,

ich benötige einen langfristchart von eln.

habe mal einen von 1990 an gefunden der ist aber schlecht aufgelöst.

Vielleicht hat ja jemand mal etwas? bitte per BM.

danke & schönes wochenende.

[welke91]

Antwort auf Beitrag Nr.: 41.569.676 von welke91 am 27.05.11 20:40:27

hi leute, alles was besser ist als das hier:



Mein Angebot,

um Birgit nicht zu nerven, dass sie die Charts reinstellen muss (vorrausgesetzt ich würde das überhaupt wollen) , würde ich sie jedem persönlich schicken in einer PDF oder so etwas.

Da die Zeit für solche Analysen sehr großzügig bemessen werden sollte, bräuchte ich von jedem ein Anlagehorizont.

Ich gehe mal davon aus, dass ich hier eine Theorie entwerfe oder zwei drei wenn diese demjenigen passt wird er sicherlich bis zur Rente die Elanis behalten wollen.

Ergo reicht es ja völlig aus, so ein mal im Monat darüber zu sehen, wie der Trend ist?

Das sollte machbar sein und das würde ich so in eine Mail verpacken.

Oder Gegenvorschläge?

Bei Interesse einfach BM an mich.

welke

[Tebi]

Antwort auf Beitrag Nr.: 41.569.757 von welke91 am 27.05.11 20:59:05

....GERNE! Mein Anlagehorizont so 2-3 Jahre.....einen genaueren Chart habe ich auch nicht---finde aber gaaaaaaaaaaaaaaaaanz klasse,wenn Du so 1x im Monat was malen würdest.....

[surga]

Antwort auf Beitrag Nr.: 41.569.676 von welke91 am 27.05.11 20:40:27

Welke,
die Daten für meine Charts bekomme ich von Yahoo. Von 1990 ist nicht dabei, wenn ich so sehe

[bernie55]

Antwort auf Beitrag Nr.: 41.569.757 von welke91 am 27.05.11 20:59:05

Hi welke91 !

Super.........Klasse Ding......einfach nur nett...


Anlagehorizont auch so 2-3 Jahre...



BM mit meiner E MAIL Adresse geht jetzt raus.

[Poppholz]

Antwort auf Beitrag Nr.: 41.567.267 von welke91 am 27.05.11 13:59:56

ich bin auch eher ein Freund von "intakter Aufwärtstrend" und "sehr bullish".

Das unser Baby aber auch fallen kann habe ich in der Vergangenheit auch schon mitbekommen.