Sanofi won't fall from Lovenox patent cliff

You know those movie scenes in which our hero is moving downriver in a boat, only to suddenly happen upon an enormous waterfall? We have to watch while the hero frantically paddles upstream or makes for the nearest bank--or falls over the edge, limbs flailing in the void. Well, that's not what's going to happen to Sanofi-Aventis.

So says CEO Chris Viehbacher (photo [1]), who told Reuters that its anti-clotting med Lovenox may be falling off the patent cliff soon, but Sanofi has already been planning for an alternate route downstream. "It will have a hit on sales but for us [Lovenox] is not a growth platform for the future," Viehbacher said on the sidelines of the World Economic Forum in Davos. "[W]e essentially built into our 2013 guidance the appearance of a non-substitutable generic. If there weren't a generic ... it would be an upside for the business."

Why a non-substitutable generic? Because Lovenox is a complex biological drug, Viehbacher said, and regulators will have to carefully study any copies to make sure they're safe and effective. And because it's a complex drug, it may not be subject to the usual generic substitution at the pharmacy; doctors would have to prescribe copycat forms by name.

The complexity hasn't deterred generics makers from promising to launch their versions, and soon. Novartis has been saying that it's confident of eventual FDA approval of its form of Lovenox, developed with partner Momenta Pharmaceuticals. Other companies looking for FDA approval for their Lovenox copies are Teva Pharmaceutical Industries, and a Watson Pharmaceuticals partnership with Amphastar.

- read the Reuters story [2]
- get more [3] on the Novartis copy, also from Reuters