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GlaxoSmithKline (GSK) To Sell Roche Holding's (RHHBF.PK) Drug Xenical In U.S.


10/19/2005 5:13:15 PM

PITTSBURGH, April 12 /PRNewswire/ -- GlaxoSmithKline Consumer Healthcare (GSK Consumer Healthcare) announced today an agreement with Roche to promote the leading prescription weight loss medication Xenical(R) (orlistat) to physicians nationwide. The company's efforts will focus on the recent FDA- approved label change, based on the landmark four-year XENDOS study, indicating that weight loss with Xenical reduces the risk of developing type 2 diabetes in obese patients with impaired glucose tolerance.

"Extensive research shows that excess weight is a primary risk factor for the development of type 2 diabetes, which we know leads to an increase in morbidity and mortality," said David E. Kelley, MD, Director, Obesity and Nutrition Research Center, Department of Internal Medicine, University of Pittsburgh. "With the 57 percent increase in the prevalence of type 2 diabetes over the last decade, the long-term use of Xenical is an important tool for clinicians caring for overweight and obese patients."

The effect of Xenical plus a low-fat, reduced-calorie diet in reducing the risk of type 2 diabetes was confirmed in the landmark double-blind, placebo- controlled study called XENDOS (Xenical in the Prevention of Diabetes in Obese Subjects). XENDOS is the largest and longest study to date of a weight loss treatment, involving more than 3,300 patients and spanning four years. The study showed that patients who experienced weight loss by taking Xenical and eating a reduced-calorie diet lowered their relative risk of developing type 2 diabetes by 37 percent, compared to placebo and diet. XENDOS is also the first and only study involving a weight loss treatment to demonstrate a reduction in an endpoint of this nature.

"When the prevalence of excess weight increases, so does the prevalence of type 2 diabetes, leading to a significant public health problem," said Alan Schaefer, VP Medical Sales and Marketing, GSK Consumer Healthcare North America. "We are pleased to have the opportunity to promote Xenical for weight management. The weight loss effects of Xenical can help prevent the onset of type 2 diabetes and significantly improve related risk factors, including reduced levels of total cholesterol and LDL cholesterol improved fasting glucose and insulin in patients with type 2 diabetes, and reduced blood pressure."

To date, more than 100 clinical studies support Xenical's ability to safely help people achieve meaningful (five to ten percent) weight loss when coupled with diet and exercise. The medication is approved for weight management in over 145 countries around the world. Xenical is also the only weight loss medication included in an NIH-sponsored study called Look AHEAD (Action for HEAlth in Diabetes), a multicenter, randomized clinical trial investigating the long-term effects of intentional weight loss in patients with type 2 diabetes over a period of 12 years.

In addition to promoting prescription Xenical, GSK Consumer Healthcare is planning to file an application in mid-2005 with the FDA to sell an over-the- counter (OTC) version of orlistat. If approved for OTC sale, orlistat will become available for adults as a weight-loss aid with a different dosing regimen and will be marketed under a separate brand name.

About Xenical

Xenical is the only FDA-approved weight loss medication that works in the gastrointestinal tract to prevent the absorption of up to one-third of the fat eaten in a meal. While following a healthy eating plan, such as the one developed by the American Heart Association, Xenical will help patients lose weight.

Xenical is non-systemic, and works in the gut by inhibiting the absorption of dietary fat. Non-absorbed fat can lead to some changes in bowel habits. These changes are minimal if the dietary recommendations are followed, and generally occur in the first weeks of treatment; however, for some people they may continue for 6 months or longer while on Xenical. Patients considering taking Xenical should tell their doctor if they are pregnant, nursing, taking cyclosporine, have food absorption problems or reduced bile flow. A daily multivitamin is recommended because Xenical can reduce the absorption of fat- soluble vitamins.

About Roche-GSK Collaborations

Roche and GSK were one of the first to adopt co-promotion in the US in the 1980's with Zantac. In June 2004, the parties entered into a licensing agreement for Xenical OTC in the US. In addition to expanding this relationship to include prescription Xenical, the parties are jointly developing and co-promoting Boniva (ibandronate) for the treatment of osteoporosis.

About GlaxoSmithKline Consumer Healthcare

GSK Consumer Healthcare is one of the world's largest over-the-counter consumer healthcare products companies. Its more than 30 well-known brands include the leading smoking cessation products, Nicorette(R) and NicoDerm(R), as well as many medicine cabinet staples, Abreva(R), Aquafresh(R), Sensodyne(R) and Tums(R).

About GlaxoSmithKline

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 visit http://www.gsk.com/

GlaxoSmithKline Consumer Healthcare

CONTACT: Malesia Dunn of GlaxoSmithKline Consumer Healthcare,+1-412-200-3544, or malesia.a.dunn@gsk.com ; or Alfred Wasilewski of Roche,+1-973-562-2212, or alfred.wasilewski@roche.com


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