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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 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.
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