Correcting and Replacing Previous Alzheimer's Clinical Study Announcement, BW0368, FL-ANDRX.Business Editors NOTE: The following news release replaces and corrects the previous Andrx news release which ran earlier Wednesday on Business Wire, BW0368 (FL-ANDRX) FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--April 11, 2000 Andrx Announces Results of Alzheimer's Disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. Clinical Study FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--April 11, 2001 ANDRX CORPORATION -- Andrx Group (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) announced today that it has completed a Phase II clinical study that investigated the effects of Avicor(TM) on metabolism of beta amyloid amyloid /am·y·loid/ (am´i-loid) 1. starchlike; amylaceous. 2. the pathologic, extracellular, waxy, amorphous substance deposited in amyloidosis, being composed of fibrils in bundles or in a meshwork of polypeptide protein (A beta). Strong evidence from both genetic and biological studies supports the hypothesis that A beta is a likely cause of Alzheimer's disease (AD). The initial results of this study, which will be published in the International Journal of Neuropsychopharmacology in June 2001, demonstrate that Avicor(TM) diminishes blood levels of A beta in patients with hyperlipidemia hyperlipidemia /hy·per·lip·id·emia/ (-lip?i-de´me-ah) elevated concentrations of any or all of the lipids in the plasma, including hypertriglyceridemia, hypercholesterolemia, etc. . Andrx has recently submitted a New Drug Application for Avicor(TM) as a treatment for lipid disorders. Avicor(TM) utilizes Andrx' patented SCOT(TM) delivery system, and the use of statins Statins A class of drugs commonly used to lower LDL cholesterol levels. Mentioned in: C-Reactive Protein for the treatment of Alzheimer's disease is covered by a patent Andrx obtained from Children's Hospital Medical Center. Andrx has also applied for additional patents based both on the study and its product. "Prior results obtained by Andrx had demonstrated that the active ingredient in Avicor(TM) could diminish A beta production in the test tube. However, these results imply the drug is active in humans and are therefore much more important," commented Dr. Richard Mohs, Professor of Psychiatry at the Mount Sinai Medical School 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. . "To my knowledge, these results represent the first evidence of a beneficial effect of a statin drug on A beta metabolism in humans derived from a blinded, placebo-controlled study. These results help explain why elevated cholesterol appears to be a risk factor for Alzheimer's disease. More importantly, since accumulation of A beta is widely thought to be the initiator of Alzheimer's disease, the results suggest that Avicor(TM) could inhibit the basic disease process. They are especially encouraging because the drug appears to be well tolerated," commented Lawrence T. Friedhoff, M.D., Ph.D., Executive Vice President Clinical Research and Development at Aura Laboratories, an Andrx subsidiary. 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. , Co-Chairman and Chief Executive Officer of Andrx, commented, "We are especially pleased that the basic research results obtained only a few months ago have already been translated successfully to Phase II results in humans. We believe that the current development program represents a significant step for Andrx and for Alzheimer's disease patients and their families". Forward-looking statements (statements which are not historical facts) in this release are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. 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. Andrx Group 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2000. |
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