Great news... first we saw Elan and Biogen file with the FDA for early approval in the US, and now they have taken the same step with the European regulators-- this demonstrates continued confidence by the company in Antegren's efficacy as an MS therapy. We obviously view that as a huge positive.
"Irish drug company Elan (Irish:ELN.I - News) said on Tuesday it planned to submit Antegren, an experimental multiple sclerosis drug it is developing with Biogen Idec (NasdaqNM:BIIB - News), for approval by European regulators this summer.
"The decision to file was made after discussion with European regulatory officials, based on one-year data from the ongoing phase III trials in MS," Elan said in a statement. "The companies are committed to completing these two-year trials."
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UPDATE - Elan to seek EU approval soon for MS drug
Tuesday March 23, 3:17 am ET
LONDON, March 23 (Reuters) - Irish drug company Elan (Irish:ELN.I - News) said on Tuesday it planned to submit Antegren, an experimental multiple sclerosis drug it is developing with Biogen Idec (NasdaqNM:BIIB - News), for approval by European regulators this summer.
"The decision to file was made after discussion with European regulatory officials, based on one-year data from the ongoing phase III trials in MS," Elan said in a statement. "The companies are committed to completing these two-year trials."
Elan and Biogen surprised the market last month by revealing they were ready to seek approval for Antegren from the U.S. Food and Drug Administration (News - Websites) (FDA) a year ahead of schedule.
The news sent shares in both companies soaring.
Elan has said that, if approved, Antegren could be on the market in early 2005, ahead of a previous target of 2006.
That would give the companies a step up on their rivals in the growing and hotly contested MS drug market, estimated by some analysts to be worth up to $4 billion.
The MS drug market is dominated by German-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.
Former stock market high-flier Elan is still struggling to recover from a 90 percent slide in its share price in 2002 on concerns about debts and a probe by U.S. regulators into accounting practices.
It is pinning its hopes on Antegren, which is also undergoing trials as a treatment for other complaints including the bowel disorder Crohn's disease and rheumatoid arthritis.
Biogen, based in Cambridge, Massachusetts, has said it believes it can make a compelling argument for a swift review by U.S. regulators of the drug.
Original article can be found here
