Xenical label change to incorporate new data on overweight and obese patients with type 2 diabetes granted by European Commission

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Basel, 16 July 2002

Roche announced today that the European Commission has granted a label change for the company’s leading weight loss medication, Xenical (orlistat). The new label includes additional and important information on the benefits of Xenical for overweight and obese patients with type 2 diabetes. The decision was based on the positive opinion adopted by the Committee for Proprietary Medicinal Products (CPMP) and is another important endorsement of a Roche application in the European Union this year.

Nine out of ten people with type 2 diabetes are overweight and weight management is the first-line treatment of type 2 diabetes. Even a modest reduction of initial body weight improves blood sugar control in patients with type 2 diabetes and also reduces the severity of cardiovascular risk factors such as high blood pressure and high cholesterol levels.

Xenical clinical studies show that:

Overweight or obese patients with type 2 diabetes taking Xenical lost up to three times more weight than those on diet alone;
More overweight or obese patients with type 2 diabetes taking Xenical had clinically significant improvements in blood sugar control than those on diet alone;
Xenical significantly improves fasting plasma glucose in overweight or obese patients with type 2 diabetes within two weeks of starting treatment;
Xenical may reduce the need for anti-diabetic medications in overweight patients with type 2 diabetes; and
Additional data has also shown that Xenical can improve certain risk factors for cardiovascular disease, such as blood pressure and cholesterol levels in diabetic patients.

It is estimated that there are at least 150 million people in the world with diabetes and that type 2 diabetes accounts for 90 per cent of all cases. This figure is expected to double over the next 25 years.

“This label change for Xenical marks an important step forward as it will allow physicians to address one of the core issues associated with type 2 diabetes – excess weight.” commented William M. Burns, head of the pharmaceutical division at Roche.

About Xenical
Xenical is the only available weight loss medication that works locally in the gut to prevent dietary fat absorption by around 30 per cent and effectively promotes weight loss. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical is well tolerated and unlike appetite suppressants, it does not act on the brain. Since it was first marketed in 1998, there have been more than 13.6 million patient treatments with Xenical world-wide. Xenical is licensed for weight management in 149 countries around the world.

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