Andrx Announces FDA Approval of Altocor.Business Editors/Health & Medical Writers Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) today announced that 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. (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. ) has granted final marketing approval for Altocor(TM), Andrx's proprietary, extended-release, cholesterol-lowering 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 and its first internally developed brand product. Andrx expects to launch Altocor in the third quarter of 2002, initially utilizing its own 280-person sales force. Andrx President and Chairman of the Board, Elliot F. Hahn, Ph.D., commented: "Developing a brand product is difficult for anyone, much less a company like Andrx, which has primarily focused on controlled-release generic pharmaceuticals during its short, but very successful, operating history. Having obtained 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 approval, we have now proven our ability to successfully develop controlled-release branded pharmaceuticals as well." Richard J. Lane, Andrx Chief Executive Officer, added: "I am pleased to join Andrx at the same time it is launching its first brand product. This is an exciting opportunity to leverage Andrx's controlled-release technology into a successful brand business. Our first task will be to educate physicians, patients and payors alike that Altocor's favorable safety and efficacy profile, combined with cost-effective pricing relative to its competitors, makes it an appealing choice for the treatment of hypercholesterolemia." Altocor is a once-daily HMG-CoA reductase inhibitor product, indicated as an adjunct to diet for the reduction of elevated total-cholesterol, LDL cholesterol, Apolipoprotein B, triglycerides, and to increase HDL cholesterol in patients with primary hyper- cholesterolemia. Altocor is also indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease coronary heart disease: see coronary artery disease. coronary heart disease or ischemic heart disease Progressive reduction of blood supply to the heart muscle due to narrowing or blocking of a coronary artery (see atherosclerosis). as part of a treatment strategy to lower total cholesterol and LDL cholesterol to target levels. Since lovastatin has a relatively short half-life in the body, Altocor utilizes Andrx's patented and proprietary SCOT(TM) technology to achieve sustained blood levels of the active drug, resulting in LDL cholesterol lowering of 24% to 41% for the 10 mg to 60 mg dosing ranges approved. Lovastatin has a long history of safe use in over 24 million patient-years of exposure. The United States market for lipid lowering drugs in which Altocor will compete currently exceeds $12 billion per year and is expected to continue to grow. In clinical studies with Altocor, adverse reactions have generally been mild and transient. Pooled results from clinical studies with Altocor show that the most frequently reported adverse reactions in the Altocor group were infection, headache and accidental injury. Similar incidences of these adverse reactions were seen in the Altocor and placebo groups. The most frequent adverse events thought to be related to Altocor were nausea, abdominal pain, insomnia, dyspepsia dyspepsia: see indigestion. , headache, asthenia asthenia /as·the·nia/ (as-the´ne-ah) lack or loss of strength and energy; weakness. neurocirculatory asthenia , and myalgia. In rare cases, inhibitors of HMG hMG menotropins (human menopausal gonadotropin). HMG abbr. human menopausal gonadotropin CoA reductase reductase /re·duc·tase/ (-tas) a term used in the names of some of the oxidoreductases, usually specifically those catalyzing reactions important solely for reduction of a metabolite. , like Altocor, can cause liver dysfunction and myopathy myopathy /my·op·a·thy/ (mi-op´ah-the) any disease of muscle.myopath´ic centronuclear myopathy myotubular m. . These effects and other safety and efficacy information are summarized in the Altocor Package Insert. The full prescribing information will soon be available on Andrx's website at http://www.andrx.com. 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, no assurance is given as to when Altocor will be launched or whether that launch will be commercially successful, and 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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