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| |  Glyset Cleared by FDA Provides Important, New Diabetes Treatment Option WEST HAVEN, Conn., Dec. 19, 1996 -- Bayer Corporation, Pharmaceutical Division announced today that the U.S. Food and Drug Administration (FDA) has granted market clearance for Glyset (miglitol) tablets, the second alpha-glucosidase inhibitor developed by Bayer, for the treatment of Type II (non-insulin-dependent) diabetes mellitus (NIDDM). Earlier this year, Bayer introduced Precose (acarbose) tablets, the first alpha-glucosidase inhibitor (AGI) for the treatment of Type II diabetes in the U.S. Acarbose was first launched in Germany in 1990 and has since been successfully marketed in Europe and Latin America under the brand names Glucobay, Glucor, and Prandase. "The clearance of Glyset further establishes this important class of therapy and demonstrates our commitment to the diabetes community," said Robert Coniff, M.D., Bayer Corporation, Pharmaceutical Division. "Collectively, Glyset and Precose provide an important therapeutic option for the 16 million Americans with Type II diabetes." Miglitol Authorized for Marketing in Europe In July, miglitol was authorized for marketing in the Netherlands under the trade name Diastabol. On December 3, the Dutch clearance was mutually recognized by the 14 remaining E.U. (European Union) member states. In addition, Switzerland (a non-E.U. country) cleared Diastabol for marketing in November. The parallel clearance of Glyset in the U.S. and of Diastabol in Europe will open the way for further international registration and for Bayer to seek an international out-license partner for miglitol. Acarbose will continue to be marketed by Bayer worldwide. Diabetes, Serious but Controllable Diabetes is a severe, life-threatening, chronic disease resulting from an impairment of the body's ability to turn glucose (sugar) from food into useable energy. In most people, insulin (a hormone made by the pancreas) regulates the level of sugar in the blood and promotes transport and entry of sugar into the muscle cells and other tissues. People with diabetes either produce too little insulin or are unable to use insulin effectively, resulting in an abnormally high concentration of blood sugar in the body. AGI Mechanism of Action Glyset, like Precose, slows down the digestion and absorption of ingested carbohydrates through the small intestine. This decreases the exaggerated rise in blood glucose levels which occurs after meals in diabetic patients, and as a result, reduces levels of glycosylated hemoglobin, also known as hemoglobin Alc (HbAlc), which is an index of long-term blood glucose concentration. AGIs May Reduce Long-Term Diabetes Complications By modulating carbohydrate digestion and decreasing the elevations in blood glucose levels, alpha-glucosidase inhibitors (Glyset, Precose) may help reduce long-term complications of diabetes such as blindness, kidney failure and nerve damage which can lead to lower limb amputation. As the Diabetes Control and Complications Trial (DCCT) demonstrated in Type I (insulin- dependent diabetes mellitus, or IDDM) patients, lower levels of HbAlc are correlated with a reduced risk of developing these long-term complications. The American Diabetes Association's position on these findings is that there is no reason to believe that these effects of better control of blood glucose levels wouldn't also apply to patients with Type II diabetes. The DCCT is a 10-year study that was conducted by the National Institutes of Health. Ideal Treatment as Adjunct to Diet "Alpha-glucosidase inhibitors can be used as an adjunct to diet to improve glycemic control in patients with Type II who cannot be managed by diet alone," said Jaime Davidson, M.D., F.A.C.P., University of Texas Southwestern Medical School Dallas. "Because AGIs reduce blood glucose elevation caused by food intake, they are indicated as first-line pharmacologic agents for Type II diabetes when diet alone fails to adequately control blood glucose. Because of their unique mechanism of action, AGIs are also effective when used in combination with a sulfonylurea." Side Effects, Contraindications Unlike sulfonylureas, another class of drugs to treat Type II diabetes, Glyset and Precose do not cause hypoglycemia, hyperinsulinemia or weight gain. If side effects occur with Glyset, they usually develop during the first few weeks of therapy and are most commonly mild-to-moderate gastrointestinal effects, such as flatulence, soft stools or diarrhea, or abdominal pain. Many of these effects diminish in frequency and intensity over time. Studies have shown no evidence of serious systemic side effects. Glyset is contraindicated in patients with known hypersensitivity to the drug and in patients with diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration or partial intestinal obstruction. Glyset is also contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine. Important Option for Hispanics and African-Americans Two large studies undertaken by Bayer have shown that Glyset is particularly effective among Hispanic and African-American Type II patients. This is significant because Type II diabetes is more prevalent and is more commonly associated with complications in these subpopulations compared to Caucasian Type II patients. Hispanics have a 300 percent higher chance of developing Type II diabetes than the general population and African-Americans are 60 percent more likely to develop Type II diabetes than Caucasians. Hispanic and African-American Type II patients have been typically under-represented in clinical trials of new diabetes therapies. The demonstration of Glyset's efficacy and safety in these sub-populations confirm its importance as a therapeutic option for these patients. Bayer Committed to Diabetes Research, Care In addition to providing breakthrough diabetes therapy options, Bayer Corporation is committed to providing patient education. In October, Bayer launched Repair Your Number, an HbAlc awareness campaign designed to educate people with Type II diabetes about the importance of knowing their HbAlc number and repairing it to help reduce potential long-term diabetes complications. By calling the toll-free number, 1-888-3-REDUCE, patients can receive information about their diabetes and the critical, but underutilized HbAlc blood test that can potentially reduce diabetes complications. Bayer Corporation is a research-based company with major businesses in health care and life sciences, chemicals and imaging technologies. The company had 1995 sales of $8 billion with a net income of $227.5 million and employs 23,500 people. Capital expenditures for 1995 totaled $570 million, and $526 million was spent for research and development. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion chemical and pharmaceutical company based in Leverkusen, Germany.
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