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IVAX And Alpharma Reach Agreement On Metformin ER.

Business Editors/Health/Medical Writers

MIAMI--(BUSINESS WIRE)--Nov. 26, 2003

IVAX Corporation (AMEX:IVX) (LSE:IVX.L) has reached an agreement with Alpharma Inc. (NYSE:ALO) regarding Metformin ER. Under the agreement, Alpharma has withdrawn its lawsuit in U.S. District Court for the District of Columbia against the United States Food and Drug Administration ("FDA") under which Alpharma challenged the FDA's granting final approval and "first to file" status to IVAX for Metformin ER. In return, IVAX and Alpharma will share profits on an equal basis on all sales during the 180-day exclusivity period. IVAX will launch this product through its wholly-owned subsidiary IVAX Pharmaceuticals, Inc. following reinstatement by FDA of IVAX' final approval for Metformin ER.

Metformin ER is the generic equivalent of Glucophage XR(R) which is marketed by Bristol-Myers Squibb and used for the treatment of type 2 diabetes. U.S. sales for Glucophage XR were over $453 million for the twelve months ending June 2003.

IVAX Corporation, headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the U.S. and internationally.

Copies of this and other news releases may be obtained free of charge from IVAX' website at http://www.ivax.com.

Except for the historical matters contained herein, statements in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements, including the statements regarding IVAX' first to file status and final approval for Metformin ER, involve risks and uncertainties which may affect the company's business and prospects, including the risks that the launch of Metformin ER will be delayed; that Alpharma or other third parties may also seek damages against IVAX for patent infringement; as well as the general risks and uncertainties inherent generally in litigation; that sales of Metformin ER may be impacted during the exclusivity period by licensing arrangements between Bristol-Myers and third party competitors; that exclusivity periods and the launch of Metformin ER may be challenged by other third parties; the impact of the FDA's or other administrative or judicial agency's decisions on exclusivity periods; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Glucophage XR(R) is a registered trademark of Bristol-Myers Squibb Company.
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Publication:Business Wire
Geographic Code:1USA
Date:Nov 26, 2003
Words:430
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