Statement re - IVAX Comments On Richest Generic Pipeline In Company's History And On Dramatic Increase In Generic Drug Submissio
29 September 2003 - 11:45PM
UK Regulatory
IVAX Corporation
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced today that its generic
pipeline is the richest in the company's history and that it intends to
dramatically increase that pipeline in 2004. Over the next fifteen months, IVAX
expects approvals and launches of up to 19 generic drugs which have U.S. brand
sales of over $11 billion. IVAX believes that six of these generics are
potentially first to file submissions for products with U.S. brand sales of
almost $6.3 billion.
IVAX intends to make 10 new Abbreviated New Drug Application (ANDA) submissions
by the end of 2003; and an additional 50 ANDA submissions in 2004, which will
include a number of potential first to file submissions. Even with as many as 19
generic approvals and launches over the next fifteen months, IVAX expects to
have up to 75 ANDAs pending with the FDA by the end of 2004.
IVAX' current generic pipeline includes 39 Abbreviated New Drug Applications
(ANDAs) pending with the FDA, of which 10 are potentially first to file generic
submissions relating to U.S. brand product sales of $14 billion.
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 risk 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 file the anticipated ANDAs or any additional ANDAs within the expected time
periods; that budgetary and other capital constraints could impact the number of
products under development and the number and timing of ANDAs to be filed; that
IVAX may not have been the first to file on 10 pending ANDAs and may not be the
first to file on future ANDAs; 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; the impact of
FDA's or other administrative or judicial agency's decisions on exclusivity
periods; competitors' ability to extend exclusivity periods past initial patent
terms; changing market conditions; the availability and cost of raw materials
and other third party products; the impact of competitive products and pricing
may significantly reduce the sales associated with these products; 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.