It's a one-two punch for Sanofi-Aventis: One U.S. judge reinstated an investor lawsuit over the rejected weight-loss pill Zimulti. And another refused to block generic Lovenox long enough to weigh Sanofi's argument against its FDA approval.
U.S. District Judge George Daniels decided to let Sanofi shareholders amend their Zimulti complaint against the company. Daniels had tossed out the lawsuit back in September, but the investors came back with new claims that "adequately [plead] violations of the federal securities laws," Daniels said in his order, according to Bloomberg. The shareholders claim that Sanofi misled investors about the prospect of Zimulti's FDA approval; when the drug got the thumbs down from an advisory panel, Sanofi stock plummeted.
In the Lovenox case, the U.S. District Court for D.C. set an Aug. 17 hearing in Sanofi's lawsuit, which seeks to stave off generic copies of its Lovenox blood thinner, approved by the FDA last week. Sanofi alleges that manufacturing Lovenox--a biologically-derived drug--is a complex and sensitive process that would falter on the slightest deviation. The newly approved generic isn't clinically equivalent, Sanofi claims, so the FDA wrongly granted approval. The company is asking the court for a restraining order and injunction against the FDA approval.
But--for the next three weeks or so--Momenta and Sandoz, the generics arm of Novartis, have free rein with their copycat Lovenox, Momenta said in a release. As Sanofi well knows from previous generic launches that were later revoked--think Apotex's version of Plavix--generics makers can quickly ship enough product to disrupt supplies for months. Even if Sanofi gets its restraining order, the damage could be done, presumably until the FDA nod is nullified.
- see the Momenta release
- read the Bloomberg news