Research Update
January 23 2004 - 9:54AM
UK Regulatory
IVAX Corporation
IVAX Obtains Positive Recommendation From
European Regulatory Authority For Injectable Paclitaxel
IVAX Corporation (AMEX:IVX) (LSE:IVX.L) announced that the European Union's
Committee for Proprietary Medicinal Products (CPMP), the scientific committee of
the European Medicines Evaluation Agency (EMEA), has issued a positive opinion
recommending the extension of indication of the existing marketing authorization
for IVAX' proprietary injectable paclitaxel (Paxene(R)) to include treatment of
metastatic breast cancer and metastatic ovarian cancer in the 15 member states
of the European Union. Paclitaxel is the active pharmaceutical ingredient in
Taxol(R), a drug marketed by Bristol-Myers Squibb for the treatment of various
cancers. Annual European sales of Taxol are approximately $450 million.
The European Commission is expected to act favorably on the CPMP recommendation.
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 involve risks and uncertainties which may affect
the company's business and prospects, including the risks that the European
Commission may not act favorably on the CPMP recommendation; that other
requisite regulatory authorizations may be achieved later than anticipated or
not at all; that IVAX has in the past and may in the future experience
difficulties in obtaining raw materials and other components necessary for the
production of paclitaxel, on commercially reasonable terms; and the impact of
competitive products and pricing and successful compliance with extensive,
costly, complex and evolving governmental regulations and restrictions. In
addition to the risk factors set forth above, IVAX' forward looking statements
may also be adversely affected by general market factors, competitive product
development, product availability, federal and state regulations and
legislation, the regulatory process for new products and indications,
manufacturing issues that may arise, trade buying patterns, patent positions and
litigation, among other things. For further details and discussion of these and
other risks and uncertainties, see IVAX' Annual Report on Form 10-K and other
filings with the Securities and Exchange Commission. Taxol(R) is a registered
trademark of the Bristol-Myers Squibb Company.
IVAX Corporation, Miami
David Malina, 305/575-6043