Andrx Enters into Agreement with Pfizer and Alza Related to Generic Versions of Glucotrol XL.Business Editors/Health/Medical Writers FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Sept. 5, 2003 Andrx Corporation (Nasdaq:ADRX ADRX Andrx Corporation (stock symbol) ) ("Andrx" or the "Company") announced today that it has entered into agreements with Pfizer Inc. and Alza Corporation to resolve patent infringement patent infringement n. the manufacture and/or use of an invention or improvement for which someone else owns a patent issued by the government, without obtaining permission of the owner of the patent by contract, license or waiver. litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. involving the Company's pending Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) for bioequivalent bi·o·e·quiv·a·lent n. A value indicating the rate at which a substance enters the bloodstream and becomes available to the body. versions of Glucotrol XL(R) (extended release glipizide) 10 mg, 5 mg and 2.5 mg extended release tablets. Pfizer and Alza have agreed to dismiss their lawsuits against Andrx and all parties have executed mutual releases of any and all related claims. The settlement is subject to Court approval. Pursuant to the agreement, Andrx will receive a royalty-bearing sublicense under relevant Alza patents, under which it will be able to manufacture and market products under its ANDA. Additionally, commencing no later than January 1, 2004, Pfizer has also agreed to supply Andrx with all or any strength of Pfizer's product, for sale by Andrx as an authorized generic under Pfizer's New Drug Application. Glucotrol XL had U.S. sales of approximately $320 million in 2002, according to IMS (1) See IP Multimedia Subsystem. (2) (Information Management System) An early IBM hierarchical DBMS for IBM mainframes. IMS was widely implemented throughout the 1970s under MVS and continues to be used under z/OS. data. Andrx's Chief Executive Officer, Richard J. Lane, said: "We are extremely pleased that we were able to reach these agreements with Pfizer and Alza, and that we can now advise our shareholders and consumers alike that Andrx will be marketing a full generic line of extended release glipizide tablets in the coming months." As recently announced, the Andrx ANDA for the 10 mg strength of Glucotrol XL has received tentative 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. approval. Andrx's ANDA for the 5 mg and 2.5 mg strengths of Glucotrol XL was submitted after its ANDA for the 10 mg strength, and has not been tentatively approved by the FDA. The Andrx ANDA product was at one time a part of the Company's ANCIRC joint venture with Watson Pharmaceuticals, Inc. Under the agreement reached with Watson, in the event Andrx commercializes its ANDA product, Watson, under certain circumstances, may be entitled to a percentage of the net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight , as therein defined, that Andrx derives from the sale of that product. The Company has also notified the FTC FTC See Federal Trade Commission (FTC). of the terms of this settlement. About Andrx Corporation Andrx Corporation develops and commercializes: bioequivalent versions of controlled-release brand name pharmaceuticals using its proprietary drug delivery technologies; bioequivalent versions of specialty, niche and immediate-release pharmaceutical products, including oral contraceptives Oral Contraceptives Definition Oral contraceptives are medicines taken by mouth to help prevent pregnancy. They are also known as the Pill, OCs, or birth control pills. ; and brand name or proprietary controlled-release formulations of existing immediate-release or controlled-release drugs where it believes the application of Andrx's drug delivery technologies may improve the efficacy or other characteristics of those products. Andrx's distribution operations purchase primarily generic pharmaceuticals manufactured by third parties and sells them primarily to independent pharmacies, pharmacy chains which do not maintain their own central warehousing facilities, pharmacy buying groups and, to a lesser extent, physicians' offices. 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 herein or which are otherwise made by or on behalf of the Company 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," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative 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 but not limited to, court approval of the settlement, the absence of certainty regarding the receipt of required regulatory approvals or the timing or terms of such approvals, the timing and outcome of litigation and future product launches; government regulation generally; competition; manufacturing capacities and output; commercial obstacles to the successful introduction of brand products generally; product liability claims; rising costs and availability of insurance, including product liability insurance. Andrx Corporation is also subject to other risks detailed herein or detailed from time to time in its filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company's Annual Report on Form 10-K for the year ended December 31, 2002 and Forms 10-Q for the quarters ended March 31, 2003 and June 30, 2003. This release and additional information about Andrx Corporation is also available on the Internet at: http://www.andrx.com. |
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