DEVELOPING STORY
What we've all had our fingers crossed for-- it's happening! Antegren has proved itself so effective in Phase III trials that Biogen and Elan are filling for early FDA approval-- something that is almost unheard of! Stay tuned for further developments, we are keeping a strong set of eyes on this story.
"[Biogen and Elan] said they planned to file in mid-2004 for U.S. approval of Antegren, the multiple sclerosis therapy, based on the one-year results of late-stage clinical testing that is scheduled to run for two years. Although the companies didn't release details of the clinical data, investors saw the application plan as a positive sign because the results are presumed to be strong enough already to merit approval....
"This is the first MS treatment to be allowed to file after one year which ... points to very strong data," said Peter Frawley of Dublin-based Merrion Stockbrokers.
"This is huge news. The talk has always been that Antegren could be much better than anything that's currently out there and that if approved would become the gold standard in this area," said Bloxham Stockbroker analyst Peter Jackson. "
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Full Article Text
Elan said that, based on one-year data from a two-year testing programme, it expected to file an application with the U.S. Food and Drug Administration (News - Websites) (FDA) by mid-year for approval of its experimental drug Antegren as a treatment for the neurological disease multiple sclerosis (MS).
"This is the first MS treatment to be allowed to file after one year which ... points to very strong data," said Peter Frawley of Dublin-based Merrion Stockbrokers.
If approved, Antegren, which Elan is developing with its U.S. partner Biogen Idec (NasdaqNM:BIIB - News), could be on the market in early 2005, ahead of a previous target of 2006, Elan said.
The growing and hotly contested MS drug market is estimated by some analysts to be worth up to $4 billion.
"This is huge news. The talk has always been that Antegren could be much better than anything that's currently out there and that if approved would become the gold standard in this area," said Bloxham Stockbroker analyst Peter Jackson.
He said previous trial data from the drug indicated a lack of side effects, which would be a big selling point along with the fact it needed to be taken just once a month and not up to three times a week as is the case with some existing treatments.
IMPACT ON COMPETITORS
The MS drug market is dominated byGerman-based Schering's (XETRA:SCHG.DE - News) Betaseron, Swiss-based Serono's (SEO.VX) Rebif, Israeli firm Teva's (NasdaqNM:TEVA - News) Copaxone, and Biogen's own Avonex. Shares in Schering, Serono and Teva fell on the news, while Biogen jumped 18 percent in New York.
Former stock market high-flier Elan, which has been struggling to recover from the collapse of its share price in 2002, is pinning its future on Antegren, which is also undergoing trials as a treatment for other complaints including the bowel disorder Crohn's disease and rheumatoid arthritis.
Original article can be found here
