FDA Wants More Data on Merck KGaA’s MS Pill As Biogen Develops Rival Therapy

3/2/11

One of Biogen Idec’s rivals in the development of oral multiple sclerosis drugs got some bad news from the FDA. The agency has informed Germany-based Merck KGaA that it wants more safety data on the firm’s experimental MS pill cladribine, which has failed to gain approval at this time, the company said today.

This news comes as Weston, MA-based Biogen (NASDAQ:BIIB), one of the largest providers of multiple sclerosis treatments, completes late-stage development of its own oral MS drug, dimethyl fumarate (also called BG-12). The company has said that data from two Phase III clinical trials of the drug for relapsing forms of the autoimmune disease are expected this year.

Merck KGaA (which is independent from Whitehouse Station, NJ-based Merck & Co.) has been developing cladribine for MS through its subsidiary, EMD Serono, which has U.S. headquarters in Rockland, MA.

With the exception of Novartis’s oral MS drug, fingolimod (Gilenya), which garnered FDA approval in September 2010, the only treatment options for patients with multiple sclerosis are injected biological drugs. Oral treatments are seen as more convenient for patients and offer the potential for better prescription compliance because of the simpler administration of the pills versus injections.

Biogen’s oral MS drug might be important to building its franchise of approved MS treatments—which now include interferon beta (Avonex) and natalizumab (Tysabri)—while protecting the business from rivals trying to gain more of the market. Cambridge, MA-based Genzyme (NASDAQ:GENZ), for example, is in late-stage development of an injected MS treatment called alemtuzumab (Lemtrada) that has shown promise in clinical trials.

Biogen’s stock has barely moved this morning, and was listed at $70.01 per share this morning as of 10:01 am Eastern time. The stock is already trading near its 52-week high of $70.73 per share, according to Google Finance.

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