Momenta: Sanofi lawsuit is without merit
Momenta Pharmaceuticals Inc., a Cambridge biotechnology company, said a lawsuit that seeks to block its plans for making a generic drug is without merit.
Last week, Momenta and its drug collaboration partner, the Sandoz division of Novartis, said that the Food and Drug Administration had granted them approval to market a generic version of an anti-clotting drug called by Lovenox, which is marketed by French drug maker Sanofi- Aventis. Momenta's stock shares surged on the news.
In a press release today, Momenta said that Sanofi-Aventis has filed a federal lawsuit against the FDA and the US Department of Health and Human Services.
Among other things, the lawsuit is seeking a preliminary injunction directing the FDA to suspend and withdraw its approval of the measure that would allow Momenta and Sandoza to market the generic version of Lovenox.
In its initial filings, Sanofi-Aventis asked the court to issue an order that would immediately prevent Sandoz from selling the generic version of Lovenox, but at a status conference yesterday, the judge did not award emergency relief and scheduled an Aug. 17 hearing to consider preliminary injunctive relief, Momenta said. Pending the outcome of the hearing, there are no restrictions on the sale of the product, Momenta said.
Momenta added, "The company believes that Sanofi-Aventis's claims are without merit and is cooperating with Sandoz to vigorously oppose the lawsuit."