Andrx Submits Marketing Authorization Application for Altocor in European Union.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--April 11, 2002 ANDRX CORPORATION -- Andrx Group (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that it has submitted an application in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community to market its proprietary cholesterol lowering product, Altocor(TM). Elliot F. Hahn, Ph.D., Andrx's President and Chief Executive Officer, commented: "We believe Altocor will be an important product in the rapidly growing market for statin drugs. The European Union, with a total population greater than the U.S., represents a significant part of the market for statin drugs in which Altocor will compete. We are currently in discussions with possible marketing partners, and we look forward to initial approval in 2003." In clinical trials, Altocor reduced LDL LDL - ["LDL: A Logic-Based Data-Language", S. Tsur et al, Proc VLDB 1986, Kyoto Japan, Aug 1986, pp.33-41]. "bad cholesterol bad cholesterol LDL-cholesterol Cardiovascular disease Cholesterol transported in the circulation by low-density lipoprotein, the elevation of which is directly related to the risk of CAD and cholesterol-related morbidity See LDL-cholesterol. Cf Good cholesterol. " by up to 41% and increased HDL (Hardware Description Language) A language used to describe the functions of an electronic circuit for documentation, simulation or logic synthesis (or all three). Although many proprietary HDLs have been developed, Verilog and VHDL are the major standards. "good cholesterol 'good' cholesterol A popular term for HDL-cholesterol, see there. Cf 'Bad' cholesterol. " by up to 13%. Altocor utilizes Andrx's proprietary SCOT(TM) technology to achieve sustained blood levels of the active drug. Altocor is Andrx's first internally developed brand product. In the U.S., Andrx received an approvable letter from 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 January 2002 and anticipates a launch later this year. 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, there can be no assurance as to when or whether the Andrx application for Altocor will receive marketing approval from the European Union, and note that words such as "may," "will," "to," "expect," "plan," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative or 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 Company'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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