ANDRX Reacquires Exclusive Marketing Rights From Geneva for Metformin XT and Altocor.Business Editors, Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Oct. 24, 2001 Successfully Completes Analysis of Metformin metformin /met·for·min/ (met-for´min) an antihyperglycemic agent that potentiates the action of insulin, used in the treatment of type 2 diabetes mellitus. met·for·min n. XT Phase III Trials ANDRX CORPORATION - Andrx Group (Nasdaq: ADRX ADRX Andrx Corporation (stock symbol) ) today announced that it has terminated its 1999 agreement with Geneva Geneva, canton and city, Switzerland Geneva (jənē`və), Fr. Genève, canton (1990 pop. 373,019), 109 sq mi (282 sq km), SW Switzerland, surrounding the southwest tip of the Lake of Geneva. Pharmaceuticals, Inc., a member of the Novartis Corporation ("Geneva"), and reacquired all of Geneva's marketing rights for two brand products under development consisting of U.S. and selected international rights for Metformin(TM) XT, a controlled release formulation of the anti-diabetic drug, metformin, and selected international marketing rights to Altocor(TM), a high-potency, extended-release lovastatin lovastatin /lo·va·stat·in/ (lo´vah-stat?in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used in the treatment of hypercholesterolemia and other forms of dyslipidemia and to lower the risks associated with . In return for relinquishing Geneva's marketing rights to these products, Geneva will no longer fund Andrx's development costs and Andrx will pay Geneva certain milestone payments and a royalty on net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight in the United States for Metformin XT after the product is launched. Andrx's distribution operation will continue to distribute Geneva products in the normal course of business. Andrx also announced today that it has successfully completed an analysis of two Phase III trials for Metformin XT. Metformin XT's formulation employs Andrx's patented technology (SCOT(TM)) to provide extended delivery of metformin, allowing for once daily dosing. The data indicate that Andrx's product has a safety and efficacy profile similar to the currently marketed product that is administered two or three times daily. The Andrx trials evaluated doses up to 2500 mg per day. Andrx expects to submit an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. in the first half of 2002, with detailed study results to be published in a peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. thereafter. Andrx President, Elliot F. Hahn, Ph.D., commented: "Our agreement with Geneva enabled us to complete a program for the development of our first two internally developed brand products. We are excited to reacquire the exclusive marketing rights to Metformin XT, with a unique higher dose and enhanced dosing flexibility. Furthermore, since diabetics are typically prone to elevated cholesterol levels, there are synergies between Metformin XT and Altocor, our cholesterol-lowering product, which our sales force can leverage. Metformin XT will complement our brand sales force product offerings while providing better utilization of the force." According to the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of , there are approximately 16 million patients with Type II diabetes Type II diabetes Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise. Mentioned in: Diabetic Ketoacidosis in the U.S. and this number is growing as the population ages, lifestyles change and obesity becomes more prevalent. Metformin XT will compete in this market, in which sales of the currently marketed multiple daily dose metformin product in the U.S. exceeds $1.5 billion annually. Altocor will compete in the cholesterol-lowering category - a $10 billion U.S. market - which has grown at 20% per year. Andrx filed an NDA with the FDA in the first quarter of 2001 and is projecting a launch of Altocor in the second quarter of 2002. Andrx Corporation is a specialty pharmaceutical company engaged in the formulation and commercialization of oral controlled-release generic and brand pharmaceuticals utilizing its proprietary drug delivery technologies. Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology is intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risks and uncertainties, including those risks and uncertainties detailed in the Andrx Corporation's filings with the Securities and Exchange Commission. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com |
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