Biogen and Elan are to apply ahead of schedule for FDA approval of MS treatment Antegren
February 19, 2004
Shares of Biogen [BIIB] and Elan [ELN] jumped after they announced they would apply for FDA approval of Antegren for multiple sclerosis treatment ahead of schedule. Antegren is crucial for maintaining Biogen's market share as it is facing stiff competition from Serono's [SRA] Rebif in the US. The drug is equally vital to Elan, which in recent years has suffered numerous financial setbacks.
Biogen and Elan plan to file in mid-2004 for US approval of Antegren (natalizumab) based on the one-year results of two late stage clinical trials that are scheduled to run for two years. The two trials, known as SENTINEL and AFFIRM, began in late 2002 and will continue until their scheduled completion around the end of 2004.
Although the companies have not released clinical data, the application plan suggests the results are strong enough to merit approval. Biogen spokespeople have hinted that the latest Antegren results had "pretty clearly" shown that the drug has promise as a treatment for multiple sclerosis (MS).
MS is the second most common cause (after trauma) of neurological disability in young and middle-aged adults. Although around 500,000 people suffer from this autoimmune disorder in the US, studies suggest the national cost of healthcare exceeds $10 billion a year.
Biogen's blockbuster Avonex (interferon beta 1a) currently leads the MS market, which was worth over $3 billion in 2003. However, competition is strong, especially from Serono's Rebif (interferon beta 1a), which is rapidly capturing a large portion of Biogen's US market share. As such, Antegren is crucial for maintaining future revenue growth for the US biotech.
Antegren is expected to radically alter the dynamics of the market because it offers a new method of treating the disease. Indeed, rival players (Serono, Schering [SHR], and Teva [TEVA]) saw their shares drop following the announcement.
The drug, which is an immunomodulator, is equally as vital to Elan.
In recent years, the Irish company has struggled with numerous problems,
including concerns about accounting practices, heavy debt load, and the
discontinuation of a promising Alzheimer's vaccine in late stage trials.
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