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US FDA Joint Advisory Committee Recommends Approval of Weight Loss Drug Orlistat 60 Mg Capsules for Over-the-Counter Use

Posted on: Monday, 23 January 2006, 21:00 CST

BASEL, Switzerland, Jan. 23 /PRNewswire/ -- Roche announced today that the U.S. Food and Drug Administration's (FDA) joint Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committee recommended (11 to 3) that orlistat 60 mg capsules be approved for over-the-counter use in the United States to promote weight loss in overweight adults, when used along with a reduced calorie, low-fat diet. If approved by FDA, OTC orlistat, which GlaxoSmithKline Consumer Healthcare proposes to market under the brand name Alli(TM) (pronounced AL-eye), would be the only FDA-approved weight loss drug available over the counter. Alli would be indicated for use by overweight adults along with a reduced calorie, low-fat diet.

GlaxoSmithKline Consumer Healthcare currently promotes prescription Xenical(R) (orlistat 120mg) in the U.S. following an agreement with Roche. Xenical(R) will remain available by prescription for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet and to reduce the risk for weight regain after prior weight loss in patients with an initial body mass index (BMI) greater than or equal to 30 kg/m(2) or greater than or equal to 27 kg/m(2) in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia). Xenical(R) will continue to be marketed by Roche under the throughout the rest of the world.

The safety and efficacy of Xenical(R), which has been marketed as a prescription drug in the U.S. since 1999, is supported by more than 100 controlled clinical studies conducted in more than 30 countries, including the four-year landmark XENDOS trial, the longest study ever of a weight loss medicine, which demonstrated a reduced risk of progressing to diabetes. Xenical(R) has been used in more than 22 million patient treatments in 145 countries

Orlistat is a weight-loss medication that works locally in the gut by inhibiting the absorption of dietary fat and does not act centrally. Orlistat should be used in conjunction with a reduced calorie diet that contains no more than 30 percent of calories from fat. Following such a diet maximizes weight loss and minimizes unwanted gastrointestinal treatment effects. Help and advice on adopting a healthy eating plan will be provided in the Alli program.

About the Overweight Population

Currently, 65 percent (or approximately 130 million) of U.S. adults are overweight or obese, according to the National Institutes of Health. Research suggests that overweight individuals appear to be on the pathway to obesity.(1)(2) Overweight and obesity are associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.(3) Factors that can contribute to overweight include an abundance of high-calorie foods, low levels of physical activity, behavior, environment, and genetics.(4) Multiple studies have shown that a modest reduction in weight improves health outcomes significantly in overweight or obese patients.(5)

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

(1) Flegal KM, Carroll MD, Ogden CL, Johnson CL. Prevalence and trends in obesity among US adults, 1999-2000. JAMA 2002;288:1723-1727. (2) McTigue KM, Garrett JM, Popkin BM. The natural history of the development of obesity in a cohort of young US adults between 1981- 1998. Ann Intern Med 2002;136:857-864. (3) Centers for Disease Control and Prevention: "Overweight and Obesity." http://www.cdc.gov/nccdphp/dnpa/obesity/. Accessed 12/22/05. (4) Centers for Disease Control and Prevention. "Overweight and Obesity: Contributing Factors." http://www.cdc.gov/nccdphp/dnpa/obesity/contributing_factors.htm. Accessed 12/22/05. (5) Hauptman J, Lucas C, Baldrin MN, Collins H, Segal K. "Orlistat in the long-term treatment of obesity in primary care settings." Archives of Family Medicine 9:160-167.

Roche

CONTACT: Terry Hurley, +1-973-562-2882, or terence_j.hurley@roche.com

Source: PRNewswire

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