EUROPEAN MEDICINES AGENCY COMPLETES COMPREHENSIVE ASSESSMENT OF ABBOTT'S MERIDIA / REDUCTIL (SIBUTRAMINE)

Bangkok--Jul 5--Siam PR. Consultant EUROPEAN MEDICINES AGENCY COMPLETES COMPREHENSIVE ASSESSMENT OF ABBOTT'S MERIDIA‚/ REDUCTIL‚ (SIBUTRAMINE), ISSUES POSITIVE OPINION REAFFIRMING PRODUCT'S FAVORABLE RISK/BENEFIT PROFILE AS TREATMENT FOR OBESITY - Sibutramine most extensively studied prescription medication available for obesity - ABBOTT PARK, Abbott Laboratories announced today that Europe's Committee for Proprietary Medicinal Products (CPMP) issued a positive opinion reaffirming the favorable risk/benefit profile of sibutramine HCl monohydrate capsules for the treatment of obesity. The positive opinion that resulted from this review is consistent with the conclusions of Abbott, and leading experts in the treatment of obesity: sibutramine, marketed in the United States as Meridia‚ and in many other countries as Reductil‚, is safe and effective. "As a physician who treats obese patients, the conclusion that sibutramine is safe and effective for the treatment of obesity is consistent with my own experience using sibutramine in treating this disease," said Dr. Stephan R?ssner, head of the Obesity Unit, Huddinge University Hospital, Stockholm, Sweden. "Obesity is an international epidemic. It contributes significantly to the onset of other serious medical conditions such as diabetes, cardiovascular diseases, cancer and respiratory conditions. Sibutramine, when used in combination with diet and exercise, is an important tool in my practice that helps treat obesity." Eugene Sun, M.D., Abbott's divisional vice president, Global Pharmaceutical Development, added, "The CPMP's conclusion should reassure physicians and patients who depend on sibutramine to treat obesity that the product is safe when used as directed." The positive opinion of the CPMP was supported by an extensive analysis of data provided by Abbott that included more than 100 clinical studies of sibutramine, dating back to 1989. These studies investigated the use of sibutramine in more than 12,000 obese patients. To date, more than 8.5 million people in more than 70 countries have used sibutramine for the management of obesity. Sibutramine is the most extensively studied prescription medication currently available for the treatment of obesity. The risk/benefit assessment by the CPMP was requested in March 2002 following a referral by the Italian Health Ministry. Besides issuing the positive opinion, the CPMP requested that a letter be sent by Abbott to physicians throughout Europe reinforcing appropriate use of the product in accordance with the approved prescribing information. Patients with questions about sibutramine and the proper treatment of obesity should consult their physician. Obesity is a global health problem associated with an increased incidence of certain chronic diseases and premature death The World Health Organization recognizes obesity as a global epidemic and serious public health issue. Being overweight or obese substantially increases the risk of hypertension, type 2 diabetes mellitus, coronary heart disease, stroke, gallbladder disease, osteoarthritis, sleep apnea and other respiratory problems, and certain types of cancers (endometrial, breast, prostate, and colon). Clinical studies show that weight loss of five to 10 percent significantly reduces the incidence of disease and premature death in obese patients - including, for example, a 58 percent reduction in the rate of type 2 diabetes mellitus and a 20 percent reduction in mortality. In studies, sibutramine in combination with diet and exercise was effective in producing and maintaining statistically significant weight loss in the majority of obese patients compared to diet and exercise alone. More than 250 million people worldwide are obese and the consequences of being overweight or obese are now so common that they are replacing the traditional public health concerns such as malnutrition and infectious diseases as some of the most significant contributors to illness. Product Information Patients cannot take sibutramine if they are taking prescription medicines called monoamine oxidase inhibitors (MAOIs), which are sometimes used to treat depression or Parkinson's disease. Sibutramine also cannot be taken if patients have anorexia nervosa, are taking other weight loss medications that act on the brain or are hypersensitive to any of the ingredients of sibutramine. Sibutramine substantially increases the blood pressure in some patients. Regular monitoring of blood pressure is required when taking sibutramine. Sibutramine 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. In clinical trials, the number of patients who discontinued sibutramine use because of hypertension was less than one-half of one percent and was comparable to placebo. Sibutramine should not be used in patients with a history of coronary artery disease, arrhythmias, congestive heart failure or stroke. As with all medications, sibutramine may not be for everyone. The most common side effects include headache, dry mouth, anorexia, constipation and insomnia. Sibutramine is indicated as adjunctive therapy within a weight management program for patients with nutritional obesity and a body mass index (BMI) of 30 kg/m2 or higher, or for patients with nutritional excess weight and a BMI of 27 kg/m2 or higher if other obesity-related risk factors such as type 2 diabetes or dyslipidaemia are present. Patients being treated with sibutramine should see their doctor as directed for regular follow-up visits, during which the doctor can carefully monitor their overall health, including regular monitoring of blood pressure and pulse rate. Through its acquisition of Knoll Pharmaceuticals and sibutramine, its alliance with Millennium Pharmaceuticals to collaborate on the discovery and development of new drugs and diagnostics for metabolic diseases, and its traditional strengths in developing novel medical nutritional products, Abbott Laboratories has assembled the resources to develop innovative treatments for metabolic disorders, including obesity, hyperlipidemia and diabetes. Abbott Laboratories is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries. In 2001, the company's sales and net earnings were $16.3 billion and $2.9 billion, respectively, with diluted earnings per share of $1.88, excluding one-time charges. Abbott's news releases and other information are available on the company's Web site at www.abbott.com. Media Outside the U.S. Laureen Cassidy (847) 938-7743 Financial Community John Thomas (847) 938-2655 U.S. Media Jennifer Smoter (847) 935-8865 End. -SN-

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