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| |  MERIDIA Receives FDA Approvable Letter for Treatment of Obesity MT. OLIVE, N.J., Nov. 11, 1996 -- Knoll Pharmaceutical Company has announced that it has received an approvable letter from the US Food and Drug Administration (FDA) to market MERIDIA(TM) (sibutramine hydrochloride monohydrate) capsules for the treatment of obesity. When approved, MERIDIA will be the first in a new class of drugs -- serotonin and norepinephrine reuptake inhibitors, or SNRIs -- approved for the treatment of obesity. MERIDIA is unique in that it increases brain levels of both serotonin and norepinephrine, two chemicals involved in appetite control, by preventing reabsorption back into the cells that release them. As a result, MERIDIA helps reduce the amount of food eaten by enhancing the feeling of fullness and, as demonstrated in animal studies, may increase energy expenditure. In clinical trials, MERIDIA produced clinically and statistically significant weight loss (5 to 10 percent reduction from baseline) at various dosage levels, as compared with placebo. Research shows that a 5 to 10 percent weight loss, provided it is maintained, can reduce the risk of obesity-related illnesses such as diabetes, certain cancers and osteoarthritis. "We are very pleased that the application for MERIDIA has reached this regulatory milestone," said Carter Eckert, President of Knoll Pharmaceutical Company. "Obesity is a chronic disease that is linked to approximately 300,000 deaths each year, so new treatments are clearly needed to address this very serious health threat. The availability of a new safe and effective option for managing weight will have a significant impact on public health." Knoll expects to begin marketing MERIDIA in the United States following final FDA marketing clearance, which is subject to agreement on labeling and Phase IV commitments. MERIDIA will be available in a range of dosage strengths by prescription. Knoll Pharmaceutical Company, headquartered in Mt. Olive, N.J., is the U.S. pharmaceutical unit of BASF Corporation and part of BASF Pharma, the global pharmaceutical business of the BASF Group. BASF Pharma is dedicated to the discovery, development and marketing of prescription therapeutics for cardiovascular disease, pain management, oncology and immunology, and endocrinology and central nervous system disorders. BASF Corporation is a member of the worldwide BASF Group and is among the top 10 producers and marketers of chemicals and related products in the NAFTA region. With global sales of $32 billion in 1995, the BASF Group supplies a broad range of products that includes basic, intermediate, specialty and fine chemicals, plastics, nylon fibers, automotive and industrial coatings, dispersions, dyestuffs and pigments, agricultural products, pharmaceuticals and vitamins.
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