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  Xenical approved for obesity

2 June 1999

The U.S. Food and Drug Administration has granted marketing approval of Xenical (orlistat) from Hoffman-La Roche Inc.(CH-4970, Basel, Switzerland; Tel: ++41/61 6811 11, Fax: ++41/61 691 93 91; Website: www.roche.com) for obesity management, including weight loss and weight management, when used in conjunction with a reduced-calorie diet. When compared to diet alone, weight loss with Xenical also results in measurable improvements in obesity-related conditions, such as high blood pressure, high cholesterol, and diabetes.

Xenical is a lipase inhibitor and blocks the absorption of about one-third of dietary fat, unlike other anti-obesity agents that suppress appetite. Since Xenical works in the gastrointestinal tract, it does not require entry into the blood stream or brain.

Xenical is indicated for obese patients with an initial body mass index of greater than or equal to 30, or greater than or equal to 27 in the presence of other risk factors. Xenical is contraindicated in patients with chronic malabsorption syndrome or cholestasis. Organic causes of obesity, such as hypothyroidism, should be excluded before prescribing Xenical.

"Obesity is escalating at epidemic rates in this country," noted Patrick J. Zenner, president and CEO of Hoffman-La Roche, Inc. (Website: www.rocheusa.com), the U.S. affiliate of Swiss-based Roche Holding Ltd. "Upon the availability of Xenical, Roche will also debut a novel education and counseling initiative to ensure appropriate use of Xenical."



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