Momenta Pharmaceuticals provides update on generic Lovenox ANDA litigation

Jul 27 2010

Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today provided an update regarding a lawsuit that Sanofi-Aventis U.S. LLC filed in the United States District Court for the District of Columbia against the U.S. Food and Drug Administration (FDA), Margaret A. Hamburg, Commissioner of Food and Drugs, and Kathleen Sebelius, Secretary of Health and Human Services. The lawsuit sought, among other things, a temporary restraining order and preliminary injunction directing the FDA to suspend and withdraw its approval of the Abbreviated New Drug Application filed by the Company's collaboration partner, Sandoz Inc., a division of Novartis (Sandoz), for enoxaparin sodium injection, a generic version of Lovenox®. 

The Court held a status conference on July 26, 2010 and set a schedule for consideration of preliminary injunctive relief, with a hearing to be held on August 17, 2010. At the status conference, the Court did not place any restrictions on the sale of enoxaparin sodium injection by Sandoz. The Company believes that Sanofi-Aventis's claims are without merit and is cooperating with Sandoz to vigorously oppose the lawsuit.