Sound the alarm on Lovenox--generic competition is coming. The Sanofi-Aventis (NYSE: SNY) blood thinner will see its first copycat rival now that Sandoz, the generics arm of Novartis, has won FDA approval for its version, developed in partnership with Momenta. Lovenox is Sanofi's second-best-selling product, with roughly $4 billion in 2009 sales.
The French drugmaker immediately cut its earnings guidance on the news. "Clearly, it's bad news for Sanofi," Ambrian Partners analyst Paul Diggle tells Reuters. "They had conceded this was highly possible, but because of the uncertainty, they hadn't got it in their 2010 guidance." Sanofi is now expecting EPS to be flat at best this year. Worst case, earnings could drop 4 percent year-over-year, the company says. Previously, it had projected earnings growth of 2 percent to 5 percent.
Sanofi wasn't certain a Lovenox generic would get the FDA's nod because the blood thinner is a complex, biologically derived drug that's tough to manufacture. And it's true that the agency went above and beyond its usual generic-approval approach in considering the Sandoz/Momenta version. "Before approving generic enoxaparin sodium injection, we expected, among other things, a series of sophisticated analytical tests and a study in healthy volunteers to assure that the drug would be as safe and effective as the brand name product," Keith Webber, deputy director of the FDA's Office of Pharmaceutical Science, says in a statement.
Now that FDA has acted, Sanofi is questioning the copycat's safety, given that it "has not been subjected to extensive clinical trials." The company says it's weighing a legal challenge to the approval. The FDA action could get a legal challenge from generics maker Amphastar, which has had a copycat Lovenox app pending at the agency for years now. And generics giant Teva is also getting into the mix, telling the FDA it believes it has demonstrated that its version of the drug meets the agency's criteria and its pending ANDA is approvable.
ALSO:Teva Pharmaceutical Industries saw its stock drop on the Lovenox news--not because it has its own application for a generic version pending at FDA, but because Momenta and Sandoz are working on a copycat of Teva's branded multiple sclerosis drug Copaxone. If the FDA was willing to approve a copy of Lovenox--a complex biologically-based drug--then it might do the same for a version of Copaxone, investors reason. Article