Response to: IVAX Confirms First to File Generic Submission on Lexapro
LONDON--(BUSINESS WIRE)--Aug. 6, 2003--
In response to enquiries and speculation arising out of a report
earlier this week that an unknown generic company had filed a generic
drug application containing a patent challenge to Forest Laboratories'
Lexapro(TM), IVAX Corporation (AMEX:IVX) (LSE:IVX.L) confirms that it
has filed an Abbreviated New Drug Application on escitalopram oxalate
in 5, 10, and 20 mg tablet dosage strengths, containing a Paragraph IV
certification. Escitalopram oxalate is the generic equivalent of
Lexapro, which 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 believes that it is first to file
on escitalopram oxalate.
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
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
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.
Short Name: IVAX Corporation
Category Code: RSP
Sequence Number: 00008059
Time of Receipt (offset from UTC): 20030806T160747+0100