Meridia® (Sibutramine) Available for Obesity Knoll Pharmaceuticals (BASF) 02/12/98

Marketing Press Release: Mount Olive, New Jersey, February 12, 1998 --

Wholesalers, retailers and pharmacies in the USA have been stocking up on Meridia® (sibutramine) since the 10 February 1998. This marks the beginning of marketing activities for BASF Pharma's new prescription drug for the treatment of obesity by BASF's American subsidiary, Knoll Pharmaceutical Company. By the middle of March, most American pharmacies will have Meridia® on stock.

Meridia® was granted marketing approval by the American health authority, FDA (Food and Drug Administration), in the USA last November, and with the DEA (US Drug Enforcement Agency) scheduling process now complete we can go ahead with sales.

Meridia® is a component of an integrated weight management programme developed by BASF Pharma for the treatment of obesity and will be taken under strict medical supervision. The aim of the programme is to enable patients to make lasting changes in their lifestyle habits.

Effective weight reduction

Sibutramine has been tested in clinical trials in over 6,000 subjects. The majority of obese patients can be expected to lose at least 5 % to 10% of their baseline weight, and to maintain this weight loss in the long terms.

Obesity is a common cause of secondary diseases, such as cardiovascular and endocrine diseases. Even a modest weight loss of about 5 to 10 % can make a meaningful contribution to the patient's health and considerably reduce the risk of developing secondary diseases.

Milestone for growth

Dr Thorlef Spickschen, Head of the BASF pharmaceuticals division and CEO at Knoll AG, had the following to say about sibutramine: "In bringing sibutramine to market in the USA we have reached an important milestone in the implementation of our pharmaceuticals strategy. This provides us with the foundation for growth through our own products which will be far above market growth in coming years. Our heavy commitment to R & D and the expansion of our worldwide sales operations has been worth the effort as it has allowed us to put four new products - Mavik® (trandolapril), Tarka® (trandolapril/verapa- mil), Vicoprofen® (hydrocodone/ibuprofen) and now Meridia® - in the biggest pharmaceuticals market in the world, the USA, in just 18 months."

The potential global sales turnover for Meridia® - marketed under the tradename Reductil® outside of North America - is DM700 to DM900 million a year. The new product has already been approved in Mexico and will be sold there under the trademark Raductil® as of March this year. Drug approval procedures are in progress in Germany and other countries, and the first European launches are scheduled for later this year.

Knoll AG and its subsidiaries form the core of the BASF AG pharmaceuticals division based in Ludwigshafen. The operating division, known as BASF Pharma, is dedicated to the discovery, development and marketing of prescription therapeutics for cardiovascular disease, oncology, immunology, endocrinology and central nervous system disorders. In addition to its drug products, BASF Pharma also manufactures pharmaceutical chemicals and intermediates. BASF Pharma has four research centres in as many countries: Ludwigshafen (Germany), Nottingham (England), Worcester (USA) and Katsuyama (Japan) as well as 17 production sites supplying more than 100 countries around the world.