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Teva Receives U.S. FDA Response on Generic Lovenox

By Phil Serafino and Lisa Rapaport - Jan 25, 2011

Teva Pharmaceutical Industries Ltd. received a “minor deficiency” letter from the U.S. Food and Drug Administration seeking answers to questions about the company’s application to sell a generic version of Sanofi- Aventis SA’s Lovenox.

Momenta Pharmaceuticals Inc., which receives royalties from the only approved generic version of the blood thinner Lovenox, filed a patent-infringement suit in December to block a potential rival drug from Petah Tikva, Israel-based Teva.

Momenta and its partner, Novartis AG’s Sandoz, began selling copies of Paris-based Sanofi’s drug after receiving FDA approval July 23. In November, Teva, the world’s biggest generic-drug maker, told investors that its proposed generic copy met the FDA’s standard for chemical sameness and it was making progress toward approval.

“Teva could gain approval for generic Lovenox in the near- term,” Eric Schmidt, an analyst with Cowen & Co. in New York, said today in a note to clients. Teva’s FDA clearance could drive Momenta shares down as low as $8, he said.

Shares of Momenta, based in Cambridge, Massachusetts, fell 21 percent, or $3.30, to $12.50 at 4 p.m. New York time in Nasdaq Stock Market composite trading, for the biggest decline since March 2, 2009.

Prices of generic drugs typically fall as more rivals enter the market and, according to Momenta, an additional generic Lovenox would decrease payments it gets from Sandoz.

To contact the reporters on this story: Lisa Rapaport at [e-mail]; Phil Serafino at [e-mail]