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Post by Emperor AAdmin on Aug 1, 2008 22:01:14 GMT -5
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Post by Emperor AAdmin on Aug 1, 2008 22:49:05 GMT -5
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Post by Emperor AAdmin on Aug 1, 2008 22:53:35 GMT -5
The stock tanked due to the fact that its drug actually has killed some patients. Markets tend to view such news in negative light. ----- Biogen, Elan shares plunge on Tysabri safety scare By Val Brickates Kennedy, MarketWatch Last update: 2:17 p.m. EDT Aug. 1, 2008
BOSTON (MarketWatch) -- Shares of Biogen Idec Inc. and partner Elan Corp. spiraled downward Friday, the day after they announced that two more cases of a potentially deadly brain disorder had been confirmed in users of Tysabri, their multiple-sclerosis drug.
Elan shares already had been pushed down about 40% earlier in the week on mixed results from a Phase II study for a hotly anticipated product it has been developing with Wyeth for Alzheimer's disease. While the antibody-based drug, called bapineuzumab, appeared to be effective in many users, a handful developed brain swelling, raising safety concerns.
Late Thursday, Biogen reported in a regulatory filing that it had received word two more cases of PML, an extremely rare but dangerous condition, had been acknowledged in Tysabri users. Both of the patients are in Europe.
Biogen said both patients were alive and stable. One patient remains hospitalized, while the other is recuperating at home. Both received blood-plasma transfusions to flush the drug from their systems.
One of the patients had taken Tysabri for about 17 months and had never taken other MS drugs. The other was on Tysabri for 14 months, and had taken in the past other immune-modulating MS drugs, namely beta interferons.
Tysabri is co-marketed with Irish drugmaker Elan, which first developed the antibody-based therapy.
Tysabri was pulled off the market for several months in 2005 after three users contracted PML -- two of whom subsequently died. About 3,000 patients had used the drug before the PML cases were identified.
The drug was put back on the market in mid-2006 after it was determined that the PML cases were caused by negative drug interactions, such as use with Biogen's popular MS drug Avonex, an interferon therapy.
The current treatment for PML is to remove any immunosuppressing agents from the patient's system in hope that their immune system will rebound to battle the virus that causes the condition. Up to 70% of all people are believed to carry the virus, which is triggered when patients' immune systems become severely compromised, either through the use of certain drugs or illnesses like HIV.
Because of the drug's past, Tysabri users who have used other immune-modulating drugs are required to wait a certain amount of time before starting Tysabri. Patients also are required to sign waivers acknowledging that they understand the drug carries a small risk of developing PML, and that they must undergo periodic exams for early detection of the illness.
100,000 patients
Originally hailed as a breakthrough in the treatment of MS, Tysabri has been considered key to Biogen and Elan's long-term growth. The companies have said they hoped to have about 100,000 patients on the expensive drug by the end of 2010. About 31,800 are currently using the product.
On a conference call with investors early Friday, Biogen executives said their stated goal of having 100,000 patients factored in the risk that some additional cases of PML would be reported at some point.
Biogen said about 31,800 patients currently use Tysabri, which is also approved to treat Crohn's disease. Of those, about 14,000 have been on the product for a year, while another 6,500 have used it for at least 18 months.
The company added that it was "confident" there were no more confirmed cases on PML in the field at this time.
Approved in late 2004, some Wall Street analysts first forecasted Tysabri could bring in revenue in excess of $4 billion, based on its effectiveness in treating MS. After the first reports of PML, estimates were lowered to $1 billion to $2 billion.
Biogen declined to comment Friday what financial impact the new PML cases will have on sales.
Many analysts said Friday that while news of more PML cases shouldn't come as a shock, it puts the companies back under a cloud.
"Although this disclosure it not shocking, we believe it will prove disruptive to Tysabri's commercial prospects and the drug's U.S. sales in particular," wrote Cowen & Co. analyst Eric Schmidt, who tracks Biogen.
"Given Tysabri has been Biogen's major growth driver, we believe earnings visibility is now lacking. We advise investors to remain on the sidelines until a clearer picture of Tysabri's long-term safety profile emerges," he said.
Schmidt also noted that the news might prompt current Tysabri users to take a break from the drug. "In prior calls, consultants had indicated that even a few cases of PML might drive patients to ask for drug holidays as they approach the point in time (two years) beyond which little safety data on Tysabri exist."
Robert W. Baird analyst Christopher Raymond said he was troubled by the fact that one of the new PML sufferers had never received any immunosuppressive drugs.
"Troublingly, while prior PML cases involved patients on either concomitant beta-interferon or with a history of immunosuppressive therapy, one of the patients was naïve to any prior disease-modifying therapy before Tysabri," he wrote.
"While PML is not unexpected, we think the fact that it occurred relatively early on (inside two years) and the fact that it occurred in at least one treatment-naïve patient adds a new level of risk to this agent," Raymond added.
Deutsche Bank analyst Mark Schoenebaum was more optimistic: "We still expect Tysabri to grow to $2 billion, but near-term growth could slow."
"While we expect renewed safety concern, we believe physicians will be comfortable using the drug if the frequency of PML is in line with the label. While Biogen has guided to around 100,000 patients on Tysabri by year-end 2010, we remain below this estimate," he wrote.
Ian Sanderson, who tracks Elan for Cowen & Co., wrote that he thinks doctors will now be reluctant to use Tysabri on patients who have never had MS therapies or are holding their own on other medications -- two markets that once had been considered natural markets for Tysabri. He said that physicians might also begin stopping Tysabri after one year to minimize PML risks.
"Our mid-case scenario assumes no additional treatment-naïve patients are put on Tysabri; the market reverts to beta-interferon/Copaxone treatment failures and some switch patients only," Sanderson wrote. "That yields 40,000 Tysabri patients worldwide in 2012, down from our current 60,000 patient assumption. Our low-case scenario eliminates the switch patients, yielding 20,000 Tysabri patients worldwide in 2012." End of Story Val Brickates Kennedy is a reporter for MarketWatch in Boston. www.marketwatch.com/
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Post by Emperor AAdmin on Aug 1, 2008 23:11:05 GMT -5
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Anthologic
Amicus
"Lord of all Reality"
Ha!
Posts: 1,237
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Post by Anthologic on Aug 2, 2008 22:57:51 GMT -5
Sensationalism at its best.
There's very little call activity, nobody is expecting this to go up as far as professionals are concerned.
edit* I'll re-evaluate this on monday since people will be making moves then, I think it will actually bounce back to 13ish.
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