We found this very interesting tidbit released today:
In January, Biogen Idec is expected to take an interim look at two ongoing phase III Antegren studies involving multiple sclerosis patients. If Antegren shows compelling early efficacy, the company could seek approval for the drug with the Food and Drug Administration. A 2004 Antegren FDA filing would cut a year off the drug's development timeline.
Click read more below for a few more details.
Article Text
Surprise May Be in Store From Biogen Idec
Monday December 22, 8:38 am ET
By Adam Feuerstein, Senior Writer
Biogen Idec (NasdaqNM:BIIB - News) is not exactly the poster child for a fast-growing, big-cap biotech stock. But that negative perception could reverse itself pretty quickly if the experimental drug Antegren behaves like a champ in an early 2004 test.
In January, Biogen Idec is expected to take an interim look at two ongoing phase III Antegren studies involving multiple sclerosis patients. If Antegren shows compelling early efficacy, the company could seek approval for the drug with the Food and Drug Administration.
A 2004 Antegren FDA filing would cut a year off the drug's development timeline. Obviously, this would be a major positive for Biogen Idec, especially because it's not on the radar screens of most investors. But be warned, this is far from a sure thing.
Reward vs. Risk
Antegren is Biogen Idec's second-generation multiple sclerosis drug, which is being developed under a partnership with Irish drugmaker Elan (ELN:NYSE ADR - commentary - research). The drug is now involved in two phase III trials that involve two-year efficacy endpoints, meaning that final data won't be ready for analysis until mid-2005. But, as I mentioned, a team of Biogen Idec and Elan researchers will be taking an early look at one-year data from the studies early next year. If positive, the companies plan to consult with the FDA on an early filing.
We cannot post the entire article as it comes from a pay site (TheStreet.com). You can find this article (and register with them to view it at:
http://biz.yahoo.com/tsp/031222/10133451_1.html