GSK to Market Roche Weight-Loss Drug, File OTC Application

GlaxoSmithKline (GSK) has finalized a deal to market a prescription version of Roche's leading weight-loss drug Xenical in the U.S., the companies said.

GSK's marketing efforts will focus on Xenical's (orlistat) recent FDA-approved label change indicating weight loss with Xenical reduces the risk of developing Type 2 diabetes in obese patients with impaired glucose tolerance. Approved by the FDA in 1999, Xenical is the No. 1 prescription weight-loss drug worldwide, generating sales of approximately $497 million in 2004, according to Roche's latest financial report.

GSK already owns the rights to nonprescription Xenical, which it acquired last July when Roche divested its OTC drug division. The company said it is planning to file an application with the FDA in mid-2005 for permission to sell an OTC version of Xenical. There are currently no FDA-approved weight-loss drugs available in the U.S. without a doctor's prescription.

"This new agreement enables us to get hands-on experience promoting prescription Xenical while we prepare our application to the FDA for an OTC version," said George Quesnelle, president of GSK Consumer Healthcare North America.