Re Agreement
November 27 2003 - 2:00AM
UK Regulatory
IVAX Corporation, Miami
David Malina, 305-575-6043
IVAX And Alpharma Reach Agreement On Metformin ER
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withdrawn its lawsuit in U.S. District Court for the District of Columbia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.