P&G, Sanofi-Aventis File Osteo Suit Against Roche, GSK

Procter & Gamble Pharmaceuticals and Sanofi-Aventis U.S. LLC, a member of the Sanofi-Aventis Group, co-marketers of Actonel, filed a lawsuit under the Lanham Act against Roche and GlaxoSmithKline in the U.S. Federal District Court of NY. The lawsuit alleges that Roche and GSK engaged in false and misleading advertising regarding their prescription osteoporosis medication, Boniva tablets. The lawsuit seeks an injunction to stop that advertising.

The lawsuit specifically alleges that advertising for Boniva falsely claims that the drug has been proven to reduce the risk of nonspinal fractures, and that the drug has demonstrated efficacy against nonspinal fracture comparable to other bisphosphonates, such as Actonel. Claims appear in advertising directed at both consumers and physicians, according to the suit. The complaint further alleges that the Boniva label and clinical study data do not support these claims.

Both Actonel and Boniva have been proven to reduce the risk of spinal fractures at three years in women with postmenopausal osteoporosis. However, Boniva has not been proven to reduce the risk of nonspinal fracture whereas Actonel has been proven to reduce the risk of nonspinal fractures at three years, according to a P&G/SA statement. Because they are less common individually than spinal fractures, nonvertebral fractures were measured as a group that included the wrist, hip, pelvis, femur, forearm and collarbone.