IVAX First To File For Metformin ER Tablet And FDA Grants Final Approval
29 October 2003 - 6:00PM
UK Regulatory
IVAX Corporation
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) received final approval and
confirmation of its first to file status from the FDA today on its
Abbreviated New Drug Application (ANDA) for Metformin HCl Extended
Release. The generic product will be immediately marketed by the
company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc.
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 in June 2003.
Neil Flanzraich, vice chairman and president of IVAX Corporation,
said, "We are pleased to obtain final approval for this important
product. Our first to file status makes this an important commercial
opportunity, a product of IVAX' extensive and growing generic
pipeline. We are confident that sales of Metformin ER will
significantly contribute to IVAX' earnings for the fourth quarter of
2003 and beyond."
IVAX' pipeline now consists of 38 ANDAs pending with the FDA of which
9 are potentially first to file submissions with U.S. brand sales of
over $13 billion. IVAX expects, during the next fifteen months, to
gain approvals on and launch up to 18 additional generic drugs; and
would have following these approvals, up to 75 ANDAs pending at the
FDA by the end of 2004.
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.
The "FDA" refers to the United States Food and Drug Administration.
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' pending ANDAs and filing
schedule for ANDA submissions, 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 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 third parties, including challenges regarding
patent infringement; 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; that
IVAX may not receive approval of its pending ANDAs, or that if
approved, the products will not be successfully commercialized; that
IVAX may not be the first to file on 9, or any, of its pending ANDAs;
that IVAX may not receive approvals for, or launch, 18 generic drugs
in the next 15 months; that the compounds and products in IVAX'
generic pipeline will not be successfully developed, will not receive
regulatory approval or will not be successfully commercialized; that
IVAX may not file any additional ANDAs; 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.