Response to IVAX Comments on Lexapro Litigation
24 September 2003 - 3:07AM
UK Regulatory
IVAX Corporation
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) responded today to reports that Forest
Laboratories and H. Lundbeck have filed suit against IVAX regarding IVAX' filing
of a generic drug application for escitalopram oxalate, the generic equivalent
of Lexapro(TM).
"Commencement of this litigation confirms IVAX' first to file status on this
important drug," commented Neil Flanzraich, vice chairman and president of IVAX.
"IVAX considers itself fortunate that we have 39 ANDA's pending at the FDA,
including 10 first to file Paragraph IV filings which we think are potentially
very significant for IVAX and its shareholders."
Lexapro is marketed by Forest Laboratories to treat depression. U.S. sales of
Lexapro for the first quarter of 2003 were $154.7 million and have increased to
$217.7 million in the second quarter of 2003, according to IMS figures.
IVAX continues its aggressive program to increase the number of products in its
generic portfolio.
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' first
to file status and ability to increase the number of products in its generic
portfolio, involve risks and uncertainties which may affect IVAX' business and
prospects. Such risks and uncertainties include: the difficulty in predicting
the timing and outcome of legal proceedings, including those relating to patent
challenge settlements and patent infringement cases; the difficulty of
predicting the timing of U.S. Food and Drug Administration, or FDA, approvals;
court and FDA decisions on exclusivity periods; that IVAX may not have first to
file status; competitor's ability to extend exclusivity periods past initial
patent terms; that IVAX may not receive approval for escitalopram oxalate or
that its launch will be delayed; or that if approved, the products will not be
successfully commercialized; that IVAX may not file any additional ANDAs;
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 IVAX' Annual Report on Form 10-K
and its other filings with the Securities and Exchange Commission. Lexapro(TM)
is a trademark of Forest Laboratories.