IVAX Confident ''First to File'' Status and Final Approval on Metformin ER Will Be Upheld
30 October 2003 - 11:33PM
UK Regulatory
IVAX Corporation
David Malina, 305-575-6043
IVAX Corporation (AMEX:IVX)(LSE:IVX.L) said that Alpharma, Inc.
(NYSE:ALO) brought legal action in the District Court in Washington,
D.C. against the United States Food and Drug Administration (FDA),
regarding the FDA's granting "first to file" status and final approval
to IVAX' Metformin ER product. A temporary restraining order was
granted against the FDA, pending a preliminary injunction hearing
scheduled for November 12, 2003. Until the court rules on the
preliminary injunction motion, IVAX will suspend further shipment of
its Metformin ER product. The court has not ruled on the merits of the
case and will consider the issues at the November 12th hearing. IVAX
believes that Alpharma's position is completely without merit and that
the FDA's actions were appropriate and correct. IVAX will participate
in these proceedings and support the FDA position. IVAX is confident
it will retain its "first to file" status and final approval for
Metformin ER.
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 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 Alpharma's challenge of FDA's approval of IVAX' metformin ER may
be successful and may result in revocation or suspension of IVAX'
approval to market metformin ER; 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.