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Share Name | Share Symbol | Market | Type |
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Innosis Ecological Ag | TG:IVX | Tradegate | Ordinary Share |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
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0.00 | 0.00% | 0.00 | - |
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
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