Andrx Completes Lovastatin XL Studies.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Nov. 13, 2000 ANDRX CORPORATION--ANDRX GROUP (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) announced today that it has completed the pivotal Phase III trials for 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 XL, its first brand product. The initial analyses of these studies indicates that Lovastatin XL's efficacy is similar to those of other potent HMG-CoA reductase inhibitors, with a majority of patients achieving therapeutic goals on the projected starting dose. Lovastatin XL was generally well tolerated and no unexpected safety concerns were identified. Andrx anticipates that it will file a New Drug Application with the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. for its product in the first quarter of 2001. Based on results from the Phase III studies, Andrx has initiated additional new studies with the aim of extending the usages for Lovastatin XL. Initial results from these studies are expected in the first quarter of 2001. Andrx Chief Executive Officer, Alan P. Cohen cohen or kohen (Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male. , commented, "We are pleased that our first 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 project is progressing as planned with the results of our trials in line with expectations. Andrx believes Lovastatin XL will offer an important treatment option for patients with dyslipidemia at risk for cardiovascular disease." Lovastatin XL utilizes Andrx' SCOT technology and was designed to provide extended delivery of drug, especially to the liver, the site of cholesterol biosynthesis Biosynthesis The synthesis of more complex molecules from simpler ones in cells by a series of reactions mediated by enzymes. The overall economy and survival of the cell is governed by the interplay between the energy gained from the breakdown of compounds . Andrx has both an issued patent and a pending patent application relating to this product. Andrx has other products under development in its NDA program, including 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, which is in Phase III clinical trials in over 50 centers in the U.S. Andrx is engaged in the formulation and commercialization of oral controlled-release pharmaceuticals utilizing its proprietary drug delivery technologies. In its ANDA ANDA abbr. abbreviated new drug application program, Andrx is developing generic versions of selected high sales volume controlled-release brand name pharmaceuticals. In its NDA program, Andrx is developing its own brand name formulations of certain existing drugs that it believes may be improved by the application of Andrx Corporation's drug delivery technologies. Andrx also markets and distributes pharmaceutical products manufactured by third parties. Andrx Corporation's Cybear Group (Nasdaq:CYBA CYBA Charter Yacht Broker Association CYBA Conejo Youth Basketball Association (Conejo Valley, California) CYBA California Yacht Brokers Association CYBA Cybertron Army CYBA Columbia Yacht Brokers Association ) intends to use the Internet to improve the efficiency of administrative and communications tasks of managing patient care - while addressing the healthcare industry's critical need for secure and reliable transmission of information. 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," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. Investors are cautioned that all forward-looking statements involve risk and uncertainties. Andrx is a class of common stock of Andrx Corporation, therefore Andrx Corporation shareholders are subject to the risks and uncertainties described in Andrx Corporation's filings with the Securities and Exchange Commission, including Andrx Corporation's Annual Report on Form 10-K for the year ended December 31, 1999. This release and additional information about Andrx Group and Andrx Corporation also available on the Internet at: http://www.andrx.com. |
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