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 lisa.beilfuss@wsj.com
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