trial

[Guest guest]

Hi Folks,

It is my understanding that these trials were a failure. Last summer, 2003 there were postings to this effect. Maybe these astounding numbers have somehow altered the results!! I sure wish I was not such a "Doubting " but I am.

FDA asked to approve multiple sclerosis drug

Biogen, Elan seek clearance a year earlier than anticipated

By Zimm and Ostrow, Bloomberg News Biogen Idec Inc., the third-biggest U.S. biotechnology company, and its Irish partner Elan Corp. filed an application for U.S. Food and Drug Administration approval of their Antegren multiple sclerosis drug. The companies said they are asking for clearance a year earlier than analysts had expected, based on results from the first year of continuing two-year studies. They have asked the FDA to complete its review of Antegren in six months instead of the standard 10. Cambridge, Mass.-based Biogen Idec is counting on Antegren to make up for slowing growth of older medicines, such as its top-selling Avonex MS drug. Dublin-based Elan needs a successful product to help return to profit after selling $1.8 billion in assets to pay down debt.

"If they were to get a six-month priority review, they could get an approval from the FDA for Antegren in the late 2004 timeframe," said Chao, an analyst at RBC Capital Markets in New York, who has an "outperform" rating on Biogen Idec. The drug could have sales of $110 million worldwide in 2005, which Biogen Idec and Elan would split, Chao said. Antegren may eventually generate more than $1 billion in sales, analysts have said. The companies are also testing the medicine in patients with Crohn's disease, an inflammatory bowel disorder. Biogen Idec shares rose 89 cents to $63.54 as of 4 p.m. New York time in Nasdaq Stock Market composite trading. The stock has jumped 73 percent this year. Shares of Elan's American depositary receipts, each representing one common share, rose $1.87, or 8.8 percent, to $23.18 in New York Stock Exchange composite trading. They have more than tripled this year on plans for the Antegren filing. A one-year analysis of results from the 2,100-patient studies suggest that Antegren "has the potential to become an important new therapy for MS," Burt Adelman, executive vice president for development for Biogen Idec, said in the statement. No MS product has yet been approved with less than two years of data. Multiple sclerosis is a chronic disease of the central nervous system affecting about 1 million people worldwide. A person with MS may have vision problems, loss of balance and muscle coordination, paralysis and numbness. Existing drugs for MS include virus-fighting proteins called interferons, including Avonex, Serono SA's Rebif and Schering AG's Betaseron. Teva Pharmaceutical Industries Ltd.'s Copaxone, which contains amino acids found in a tissue that insulates nerve cells, also treats MS. "It is a threat to other players in the market," said Geoffrey Porges, an analyst at Sanford C. Bernstein & Co. in New York, who has an "outperform" rating on Biogen Idec. "It's more convenient for patients, it's easier to use and has a better safety profile." Biogen Idec and Elan plan to file for European approval of Antegren for MS by the end of this quarter. The companies expect to announce statistics from the MS trials in October, Elan Chief Executive Officer has said.

Antegren may also have sales of $300 million or more to treat Crohn's disease, Porges said. The companies said last week they would seek European approval this year of Antegren for people with the disease. Crohn's, which causes severe diarrhea and stomach pain, affects as many as 1 million people worldwide. Biogen trails only Amgen Inc. and Genentech Inc. by sales in the U.S. biotechnology industry.