GSK GETS RIGHTS FOR OTC ORLISTAT OUTSIDE U.S.

GlaxoSmithKline (GSK) has acquired exclusive rights to weight-loss drug orlistat for OTC use in markets outside the U.S., excluding Japan, and said it plans to file for approval in Europe by the end of the year.

Earlier this month the FDA approved GSK's application to market OTC orlistat in the U.S. under the brand name alli. GSK had obtained the U.S. rights from Roche in 2004. Roche said it retains all worldwide rights for the prescription version of orlistat and continues to market it as Xenical 120 mg.

Roche said will receive an upfront payment from GSK, but the financial terms were not disclosed. Roche will support GSK with supply during an initial period, the company added.

The agreement gives GSK "the opportunity to globalize our efforts around OTC orlistat," GSK President John Clarke said. The license was given because of the firm's ability "to successfully switch prescription medicines to OTC status," he added. "We now have brands dedicated to addressing two of the world's major health issues: smoking and obesity."