GSK Begins Detailing Xenical Ahead Of OTC Switch Opportunity
This article was originally published in The Pink Sheet Daily
Executive Summary
GlaxoSmithKline's Consumer Healthcare division will detail the weight-loss therapy, focusing on diabetes risk reduction data recently added to labeling. Xenical was last detailed by Roche in November 2003. The Rx-to-OTC application is planned for mid-year.
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GlaxoSmithKline's Consumer Healthcare division has signed an agreement with Roche to promote Xenical (orlistat) to physicians nationwide. The weight-loss therapy has not been actively detailed since November 2003, when Roche discontinued the practice as part of its dramatic scaleback of sales force infrastructure. Roche has been supporting the product with patient and prescriber "information resources" since 2003, including the website 1 www.xenical.com. GSK will promote Xenical with "a focus on the recent FDA-approved label change…indicating that weight loss with Xenical reduces the risk of developing type 2 diabetes," the company said in an April 12 announcement of the deal. FDA approved the label change incorporating diabetes risk-reduction data in October (2 (Also see "Xenical Diabetes Risk Reduction Data Added To Labeling" - Pink Sheet, 29 Oct, 2004.)). The capacity to promote Xenical as a therapy to delay progression of type 2 diabetes should help Roche gain some formulary coverage for the drug. Since positioning products strictly for weight loss has had disappointing returns, obesity-agent sponsors have been counting on health claims to better target their message for prescribers and qualify for managed care coverage. GSK and Roche signed the promotion agreement Feb. 8, two days before GSK announced it would file for an Rx-to-OTC switch of orlistat (3 (Also see "Xenical Rx-To-OTC Switch Filing Slated For This Year" - Pink Sheet, 16 Feb, 2005.)). Roche licensed OTC rights for Xenical to GSK's Consumer Healthcare division in July (4 (Also see "Xenical Rx-To-OTC Switch Plans Underway" - Pink Sheet, 19 Jul, 2004.)). Submission of the switch application is planned for mid-2005. "If approved for OTC sale, orlistat will become available as a weight-loss aid with a different dosing regimen and will be marketed under a separate brand name," GSK said. - Andrew Shelton |