Andrx Reports Results of Altocor Studies.Business Editors/Health & Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Sept. 10, 2001 Andrx Corporation -- Andrx Group (Nasdaq:ADRX) today reported the results of its clinical program for Altocor(TM) at the Drugs Affecting Lipid Metabolism (DALM DALM Dysplasia-associated lesion/mass GI disease An acronym referring to ↑ incidence of colorectal CA with ulcerative colitis when the pathologist finds dysplasia and the endoscopist finds a tumor mass; DALM alone may be a sufficient criterion for ) Conference at the New York Hilton & Towers in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. . As described in a poster entitled "A Dose-Response, Safety And Efficacy Study Of An Extended-Release Form Of 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 Adult Patients With Hypercholesterolemia," Altocor was evaluated in 172 patients in doses of 10, 20, 40 and 60 mg in a multi-center, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind, placebo-controlled, parallel-group study. Approximately 6% additional lowering of LDL cholesterol (LDL-C LDL-C low-density-lipoprotein cholesterol ) was achieved with each doubling of the dose. At the highest dose tested, 60 mg showed a 42% LDL-C reduction compared to placebo. Other doses (10, 20 and 40 mg) showed 25%, 31% and 37% reductions, respectively. Each reduction was statistically significant (p<0.0001). Secondary efficacy variables including triglycerides (TG) and total cholesterol (Total C) were reduced by 18 to 33% (TG) and 21 to 32% (Total C) respectively, while HDL-cholesterol increased by 3 to 8%. Altocor showed safety generally comparable to placebo, including a comparable or lower incidence of myalgia (muscle pain). There were no cases of important muscle problems (myositis myositis Inflammation of muscle tissue, often from bacterial, viral, or parasitic infection but sometimes of unknown origin. Most types destroy muscle and surrounding tissue. Bacteria may directly infect muscle (usually after injury) or produce substances toxic to it. or rhabdomyolysis rhabdomyolysis /rhab·do·my·ol·y·sis/ (-mi-ol´i-sis) disintegration of striated muscle fibers with excretion of myoglobin in the urine. rhab·do·my·ol·y·sis n. ) in this study. President of Andrx, Elliot F. Hahn, Ph.D., commented: "We are extremely pleased with the clinical profile of Altocor, which suggests it could address the needs of the majority of patients under current treatment guidelines. In addition lovastatin, the active ingredient in Altocor, has a well documented safety profile with a total exposure of approximately 24 million patient-years worldwide." Results reported in an additional poster entitled "A Multiple-Dose Safety, Pharmacokinetic and Pharmacodynamic Study of Lovastatin Extended-Release Relative to Lovastatin Immediate-Release," compared Altocor (40 mg) to immediate-release lovastatin (40 mg) in 26 adult patients under randomized, single-blind, controlled, two-way crossover conditions. The results showed that Altocor decreased LDL-C by 41%, which was significantly better than immediate-release lovastatin (p<0.05). Pharmacokinetic analysis showed that Altocor produced less variable pharmacokinetic measures and reduced differences between peak and trough blood levels in patients, which suggests that the patented SCOT(TM) system employed in the Altocor formulation helps optimize delivery of the lovastatin molecule to the liver, the target organ 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 filed 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 with 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 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. This release and additional information about Andrx Corporation are also available on the Internet at: http://www.andrx.com 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 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, including those risks and uncertainties detailed in the Company's filings with the Securities and Exchange Commission. |
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