FDA Approves Generic Multiple-Sclerosis Drug by Novartis's Sandoz and Momenta -- Update

By Lisa Beilfuss 

The U.S. Food and Drug Administration approved the first generic version of Teva Pharmaceutical's blockbuster multiple-sclerosis drug Copaxone, although it remains unclear when the copycat version may come to market.

The generic, known as Glatopa, was developed by Novartis AG's Sandoz business and Momenta Pharmaceuticals Inc. Sandoz is evaluating the timing of the launch, Momenta said in a news release.

Shares of Momenta jumped 6.1% Thursday to $17.08.

Copaxone, an injection for multiple sclerosis, is the company's most profitable and top-selling product, according to analysts. Teva--which is known mostly for selling generic drugs--reported $4.2 billion in revenue from Copaxone last year, representing 21% of the company's overall revenue.

Earlier this year, the U.S. Supreme Court backed a 2011 decision that ruled that Teva's patent on Copaxone didn't expire until September 2015.

Denise Bradley, a spokeswoman for Teva, said Thursday that the company has acknowledged for some time that a generic version of Copaxone could enter the market and has planned for it.

Analysts at Sanford C. Bernstein agree, saying "Teva has been quite realistic about the risk to Copaxone."

Still, Teva shares fell 3.8% to $63.49.

Sandoz said MS affects about a half-million individuals in the U.S. and that about half of those diagnosed are currently being treated. Glatopa is indicated for patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with the disease.

Write to Lisa Beilfuss at [e-mail]

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