Type-2-Diabetes: FDA extends exclusivity of Glucophage for use in pediatric patients in the United States

Darmstadt/Germany, and Princeton, N.J./USA (PROTEXT) - MerckKGaA announced today that Bristol-Myers Squibb, its U.S. licenseefor Glucophage (metformin), has been granted an extension on themarketing exclusivity of Glucophage through September 3, 2000 bythe U.S. Food and Drug Administration (FDA). Glucophage, theworld's leading Type-2-Diabetes therapy, is a registeredtrademark of Lipha S.A., the Ethicals business of the Merck Groupin France, and is licensed to Bristol Myers Squibb in the UnitedStates. Global sales of Glucophage increased by +53 percent toEUR 1,393 million in 1999, of which USD 1.312 million have beengenerated in the United States. Bristol-Myers Squibb received a six-month extension on theexclusivity of Glucophage after complying with a written requestfrom the FDA to perform clinical studies to assess the safety,efficacy and pharmacokinetic profile of Glucophage in pediatricpopulations. Based on the results of these clinical studies,Bristol-Myers Squibb has filed a supplemental New DrugApplication (sNDA) to gain FDA clearance of Glucophage for use inpediatric patients (ages 10-16) with Type-2-diabetes. The sNDA isunder review by the FDA. As part of the FDA Modernization Act, the U.S. Congressincluded provisions to encourage more investigation of the unmetmedical needs of pediatric patients. One provision allows theAdministration to request in writing that companies voluntarilyconduct clinical studies to evaluate the use of their products inchildren. Companies that chose to comply with the written requestare granted an additional six-month period of exclusivityfollowing the submission of reports on successfully completedpediatric studies that satisfy each aspect of the FDA's request.In accordance with FDAMA, Bristol-Myers Squibb conducted studiesto determine the safety and efficacy of Glucophage in pediatricpatients with Type-2-diabetes. Type-2-diabetes, a condition previously thought to affectmostly adults over the age of 45, is now being more frequentlydiagnosed in children. Physicians attribute increases in Type-2-diabetes in children to environmental factors such as poor dietand limited exercise. Hereditary influences such as familyhistory and ethnic background are also associated with theincreased incidence of the condition in pediatric patients. Type-2-diabetes is a serious disease that if left untreated anduncontrolled, can lead to complications which may causeblindness, kidney failure and amputations. On February 23, 2000,the American Diabetes Association (ADA) recommended in aconsensus statement that "If treatment goals with nutrition,education, and exercise are not met, pharmacologic therapy isindicated. The first oral agent used should be metformin." Bristol-Myers Squibb, as licensee of Merck KGaA, continues toseek additional therapeutic alternatives that offer newmanagement options for patients with Type-2-diabetes. InSeptember 1999, the company announced that it had submitted a NewDrug Application (NDA) to the FDA for a novel product thatleverages and synergizes the benefits of metformin andglybenclamide, a unique and proprietary formulation of a memberof a class of drugs known as sulfonylureas. Bristol-Myers Squibbhas also submitted an NDA for Glucophage XR Extended ReleaseTablets, a once-daily version of Glucophage. Glucophage, as anadjunct to diet and exercise, helps lower blood sugar bydecreasing hepatic glucose production, decreasing intestinalabsorption of glucose and improving insulin sensitivity. otsOriginaltext: Merck KGaA Im Internet recherchierbar:http://recherche.newsaktuell.de Contact: Dr. Hartmut VennenPhone +49 6151 72 2386 Fax +49 6151 72 7707 E-mail:hartmut.vennen@merck.de Merck KGaA Darmstadt Internet http://www.merck.de

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