"There was a significant difference between the active agent and a placebo in the STORM study that has important clinical benefits," remarked Arne Astrup, M.D., Ph.D., STORM investigator and professor of human nutrition at the Royal Veterinary and Agricultural University of Denmark.

For many people, maintaining weight loss is a difficult task. According to Kelly Brownell, Ph.D., director of the Yale Center for Eating and Weight Disorders at Yale University in New Haven, Conn., "Maintenance is essential for realizing the health and psychological benefits of initial weight loss. Without the right tools, regain of lost weight can be an all too common experience."

MERIDIA works by affecting chemicals in the brain involved in regulating appetite and helps people overcome one of the biggest barriers to losing weight, because it helps them feel full so they can eat less -- a feeling also known as satiety. Since its launch in February 1998, MERIDIA has been taken by more than one million people in the U.S.

Health Benefits of Modest Weight Loss and Maintenance

Obesity is a chronic disease affecting 38 million people in the United States. People who are obese are at an increased health risk for associated diseases including type 2 diabetes, high blood pressure, heart disease, osteoarthritis and certain cancers. According to scientific studies, a weight loss of five to 10 percent in excess body weight in obese patients, followed by maintenance of that loss, can reduce risk factors and provide health benefits (Goldstein et al). Successful, long-term weight reduction and maintenance requires incorporation of lifestyle changes and behavior modification into a person's daily life.

STORM Investigator Nick Finer, M.D., with the Centre for Obesity Research at Luton and Dunstable Hospital in the United Kingdom said, "Usually we say that an acceptable weight loss is five percent, and that five to 10 percent is highly beneficial in terms of cardiovascular risk factors and co-morbidities, which were all going in the right direction in this study."

Clinical studies with MERIDIA have shown it to be a well tolerated, safe and effective weight management medication with the majority of people losing between five and 10 percent of their body weight. Early findings from the STORM study appear to reconfirm previous studies showing weight loss and maintenance of weight loss.

Professor Astrup added, "These interim STORM results show that this anti-obesity compound is much more effective than we had hoped."

Study Design

The two-phase STORM study assessed the effect of MERIDIA on achieving and maintaining weight loss in obese people for up to two years. The study was conducted in eight European Centers including Aberdeen, Copenhagen, Antwerp, London, Luton, Maastricht and Stockholm. The first phase of the study, presented at the International Congress on Obesity in Paris last summer, involved a six-month run-in period with 605 obese people who participated in an integrated weight management program that included taking 10 milligrams of MERIDIA once a day.

Phase II of the study included those patients who had lost more than five percent of their initial body weight during the first phase. These patients were studied for a further 18-months in a double-blind placebo controlled fashion with 352 people receiving MERIDIA and 115 patients receiving placebo. Both groups participated in the same intensive weight management program.

*From results of the first two-year study.

About MERIDIA

MERIDIA is indicated for the management of obesity, including weight loss and maintenance of weight loss when used in conjunction with a reduced-calorie diet. MERIDIA is recommended for patients with an initial BMI (body mass index - weight in kilograms divided by height in meters squared) 30 kg/m² or 27 kg/m² in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). MERIDIA is taken once a day without regard to meals.

A unique, personalized program called the Point of Change^® weight management program is available free of charge to all MERIDIA patients. The tailored program provides individualized support to help people implement vital lifestyle changes in their eating and activity habits. Program participants also receive a free copy of the LEARN^® Program for Weight Control—Special Medication Edition. Written specifically for people taking MERIDIA, this comprehensive manual provides state-of-the-art, easy-to-use information on five key areas: lifestyle, exercise, attitudes, relationships and nutrition. The program was recently expanded to provide an opportunity for people not taking MERIDIA to experience the unique tailoring mechanism by receiving an initial set of materials which they can use to immediately begin a weight management program.

MERIDIA is well tolerated, and most side effects are mild and temporary, and include dry mouth, headache, insomnia and constipation. MERIDIA substantially increases blood pressure in some people and for this reason regular blood pressure monitoring is required when taking MERIDIA. These blood pressure increases generally occur early in treatment and the prescribing physician may decide to decrease the dose of MERIDIA or discontinue the medication. In clinical trials, the number of patients who discontinued MERIDIA use because of hypertension was less than one-half of one percent and was comparable to placebo. MERIDIA should be given with caution to those patients with a history of hypertension and should not be given to patients with uncontrolled or poorly controlled hypertension. As a centrally acting prescription anti-obesity medication, MERIDIA is classified as a schedule IV drug. Data on the efficacy of MERIDIA beyond one year of use have not yet been evaluated by the U.S. Food and Drug Administration.

Sibutramine hydrochloride monohydrate (marketed under the trade name MERIDIA in the U.S.) is currently approved for use in 17 countries, including Argentina, Brazil, Chile, Colombia, Dominican Republic, El Salvador, Germany, Guatemala, Honduras, Hungary, Mexico, Nicaragua, Panama, Poland, South Africa, Switzerland and the United States.

About Knoll

Knoll Pharmaceutical Company, headquartered in Mount Olive, N.J., is the U.S. pharmaceutical unit of BASF Corporation and part of BASF Pharma, the global pharmaceutical business of BASF, AG. Knoll Pharmaceutical Company is dedicated to the discovery, development, and marketing of prescription therapeutics for obesity and other metabolic disorders, cardiovascular disease, pain management, immunology, endocrinology and central nervous system disorders.

BASF Corporation, headquartered in Mount Olive, N.J., is the NAFTA region member of the BASF Group. With sales of $7.2 billion in 1998, BASF Corporation is among the top five producers of chemicals in the United States, Canada and Mexico. Its diversified product mix includes chemicals, nylon fibers, polymers, automotive coatings, colorants, pharmaceuticals, agricultural products and vitamins. In the NAFTA region, the company and its subsidiaries have more than 15,000 employees, of which more than 13,000 are based in the United States and Canada.

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To receive a copy of MERIDIA prescribing information and patient prescribing information by fax, please call 1-888-796-3677.

For more information about MERIDIA and weight management, visit www.4MERIDIA.com. For medical information,
please contact 800-526-0221.

Knoll Pharmaceutical Company