"The FDA approval of alli should prove a tremendous benefit given the enormous impact of overweight and obesity in the African American community," said Dr. Valentine Burroughs, MD, MBA, who is the Chief Medical Officer and Chairman of the Department of Medicine at North General Hospital, located in Harlem, NY. "alli is more than a pill, it's a program that emphasizes the importance of following a reduced-fat diet, along with exercise, as part of a total weight loss program. I am eagerly awaiting the availability of alli as a resource for my patients who are ready to change their lives for the better."
Why alli is Different
Unlike other products on store shelves, alli is a proven medicine with a comprehensive support program. To help consumers get off to a successful start, the alli package will include Welcome and Companion Guides, a Guide to Healthy Eating, a Daily Journal, a Calorie and Fat Counter, Quick Fact Cards, and free access to an individualized online action plan at myalli.com
"With alli, we're excited to offer a revolutionary approach to weight loss," says Steven L. Burton, Vice President, Weight Control, GlaxoSmithKline Consumer Healthcare. "alli is more than a pill - it's a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn't happen overnight, we're starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes. That's the way to see results, and with alli, we know they can do it."
Starting today, GSK Consumer Healthcare will gear up production to have the product ready for shipment and in stores by the summer. The company is using this period to build awareness and understanding about the product and its intended user – with the message – alli is not for everyone. It's for the committed consumer who can follow a reduced-calorie, low-fat diet. For this consumer, alli will provide a unique, proven approach to weight loss, offering straight talk, educational tools and an online support program – myalli.com
How to Use alli
alli, the only FDA-approved weight-loss medication soon to be available without a prescription, is indicated for weight loss in overweight adults18 years and older when used along with a reduced-calorie, low-fat diet. The recommended dose of alli is one 60 mg capsule three times a day with meals containing fat.
Taken at meal-time, alli works by blocking about 25 percent of the fat in the food a person eats. Because of the way it works, alli must be used in conjunction with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal. The guides and information supplied in the alli package help the consumer to control the amount of fat in their meals, and to follow an appealing, reduced-calorie, low-fat diet. Consuming a meal with too much fat, while taking alli, can result in bowel changes such as having an urgent need to use the bathroom. These changes, called treatment effects, generally occur in the first weeks of treatment, are not harmful, and can be managed by following the recommended diet with about 15 grams of fat per meal. Users should take a multivitamin once a day, at bedtime, because alli can reduce the absorption of some vitamins.
Safety and Efficacy
alli (60 mg orlistat capsules) is safe and effective when used as directed. As the most extensively studied weight-loss medication on the market, the safety and efficacy of orlistat is very well established. A higher dose of orlistat has been marketed as the prescription drug Xenical® (orlistat 120 mg capsules) in the U.S. since 1999 and is supported by nine years of worldwide use in 145 other countries. Orlistat experience in more than 25 million patient treatments and more than 100 clinical studies with more than 30,000 patients is unprecedented. One of these studies with Xenical is the four-year landmark XENDOS trial conducted by Roche, its inventor and manufacturer. This study is the longest study ever conducted for a weight-loss medicine.
Xenical (orlistat 120 mg capsules) will remain available by prescription for those who should be treated under the care of a physician. Xenical will continue to be manufactured and sold by Roche.
For more information on alli, go to myalli.com
About Overweight and Obesity among African Americans
Currently, approximately 65 percent, or approximately 130 million, of U.S. adults are overweight or obese(1). Studies have shown that African American and Hispanic American women are particularly affected by overweight and obesity(2). Many obesity-related diseases including diabetes, hypertension, cancer and heart disease are found in higher rates among various members of racial-ethnic minorities compared with whites(3). Cultural factors related to dietary choices, physical activity, and acceptance of excess weight among African Americans and other racial-ethnic groups, appear to play a role in interfering with weight loss efforts(4). Multiple studies have shown that a modest reduction in weight improves health outcomes significantly in overweight or obese patients(5,6).
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®, NicoDerm® CQ and Commit® as well as many medicine cabinet staples, including Abreva®, Aquafresh®, Sensodyne,® Tums® and Breathe Right®.
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: www.gsk.com
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, the company cautions investors that any forward-looking statements or projections made by the company, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the Group's operations are described under 'Risk Factors' in the Operating and Financial Review and Prospects in the company's Annual Report 2004.
References
1 U.S. Department of Health and Human Services "Statistics Related to Overweight and Obesity." win.niddk.nih.gov/statistics#preval Accessed 6/17/05
2 American Obesity Association. "Obesity in Minority Populations." www.obesity.org/subs/fastfacts/Obesity_Minority_Pop.shtml Accessed 7/6/06.
3 American Obesity Association. "Obesity in Minority Populations."
www.diabetes.org/diabetes-statistics/prevalence.jsp Accessed 7/06/06
4 American Obesity Association. "Obesity in Minority Populations." www.obesity.org/subs/fastfacts/Obesity_Minority_Pop.shtml Accessed 7/5/06
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.
6 NIH, NHLBI. Clinical guidelines on the identification, evaluation, and treatment of overweight and obesity in adults. HHS, PHS; 1998. p. 29-41.
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