GlaxoSmithKline Corporation has acquired exclusive Over-The-Counter (OTC) marketing rights in the United States for orlistat from the Roche Group. Orlistat is currently approved by the US FDA as a prescription product for obesity management, and marketed by Roche as Xenical, a release from GSK informed.
"We are very pleased that Roche has selected GSK to market OTC orlistat in the US. Orlistat is a unique, clinically-proven medicine that helps committed people lose weight. Orlistat works by preventing some of the fat consumed in food from being absorbed," said Jack Ziegler, president, GlaxoSmithKline Consumer Healthcare.
"GSK's experience in OTC switches, their marketing capability and expertise in Consumer Communications were the factors that helped us identify GSK as our preferred partner," said Franz B Humer, CEO, Roche.
"Consumer Healthcare is a key part of GSK's corporate growth strategy and a perfect fit with our goal for orlistat to provide an ongoing revenue stream," he concluded.
GSK secured in the US a distribution agreement for Nicorette as a prescription smoking cessation brand and switched it to its current OTC status, then in-licensed Nicoderm CQ smoking cessation patch, and successfully launched it as an OTC patch first in the US, and then in Europe and Australia.
In addition, the company in-licensed and successfully launched Abreva as a direct-to-OTC treatment for cold sores. George Quesnelle, president, GSK Consumer Healthcare, North America said, "This opportunity to market OTC orlistat in the United States is very exciting. With compelling consumer communications and a credible medicine, we believe we can create a successful business while at the same time addressing a major health issue in this country."
In 2003, Xenical sales in the US were $122 million. Roche will continue to manufacture and market the prescription product in the US. GlaxoSmithKline will begin marketing OTC orlistat in the US when OTC approval is obtained.