GSK applies for licence to market OTC weight loss product In Europe

GlaxoSmithKline (GSK) today announced its marketing application for non-prescription orlistat 60mg for weight loss has been accepted for review by the European Agency for the Evaluation of Medicinal Products (EMEA).

Orlistat 60 mg was approved for non-prescription sale in the US by the FDA in February 2007 for use by overweight adults in conjunction with a reduced-calorie, low-fat dietand went on sale there in June 2007 under the brand name alli™. Alli is the only FDA-approved weight-loss product available to consumers without a prescription, and it is the first clinically-proven over-the-counter product to be combined with a comprehensive support programme.

John Clarke, President GSK Consumer Healthcare said: “This is a significant milestone and an important opportunity for GSK. Obesity is a rapidly increasing problem and a significant burden for healthcare systems in Europeand elsewhere. Leveraging our considerable expertise in OTC switches, we hope to offer consumers a new, clinically-proven option which can help to tackle this problem.

“So far, alli is performing well in the US and, if our application is successful, we will commit to rolling out a similar responsible marketing campaign with the same level of support for consumers in Europeas we have done in the US. We want to see people achieving gradual, sustained weight loss by using alli in tandem with a healthy eating, low-fat diet and increased exercise. We’ve said all along that this is no magic pill. If people are looking for a quick fix, this is not it but it is a powerful motivator, helping people lose up to 50% more weight than with diet alone*.”


If the regulatory process is successful, GSK would be granted a licence to market non-prescription orlistat 60mg in all 27 EU member countries, although initial launch markets have not been confirmed.



*- Anderson JW, Schwartz SM, Hauptman J et al. Low-dose orlistat effects on body weight of mildly to moderately overweight individuals: a 16 week, double-blind, placebo-controlled trial. Ann Pharmacother 2006; 40: 1717-23

- Study BM14149 and study NM14161. GSK data on file.


About Orlistat

§ Orlistat is the most comprehensively studied weight loss medication to date. Its safety and efficacy are well documented and have been established through data from more than 100 clinical studies involving more than 30,000 patients.

One of these studies – for Xenical®** - was the four-year landmark XENDOS trial conducted by Roche, its inventor and manufacturer. In this study alone, over 3,000 people were followed for four years while taking Orlistat, and it isthe longest completed study conducted to date for a weight-loss medicine. In all, since the launch of the 120 mg dose of orlistat as the prescription drug Xenical™ in 1999, there have been more than 28 million patient treatments with orlistat in more that 145 countries worldwide.


§ GlaxoSmithKline completed an agreement with Roche in February 2007 that enables the company to seek regulatory approval for the first non-prescription weight loss medicine in countries outside of the US excluding Japan.


The overweight and obese population in Europe


§ The prevalence of obesity has risen by between 10-50% in the majority of European countries in the last 10 years (International Obesity Taskforce (http://www.iotf.org )


§ Currently almost 400 million adults in Europe are estimated to be overweight and about 130 million to be obese. (WHO 2006; Fact sheet; The challenge of obesity in the WHO European Region http://www.euro.who.int/document/mediacentre/fs1305e.pdf )


§ The average BMI in Europe is nearly 26.5 and overweight affects 25-75% of the adults in Europe. A BMI of 25 and above is overweight and 30 and above is obese. (WHO 2006; Fact sheet; The challenge of obesity in the WHO European Region http://www.euro.who.int/document/mediacentre/fs1305e.pdf


• Obesity and overweight increase the risk of type 2 diabetes, cardiovascular disease, certain cancers, and gallbladder disease, resulting in a decreased quality of life and an increased risk of premature death (WHO 2003; Fact sheet: Obesity and overweight www.who.int/hpr/NPH/docs/gs_obesity.pdf






**Xenical® is a registered trademark of the Roche Group



About GSK

GlaxoSmithKline - one of the world’s leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, please visit www.gsk.com/media