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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) received final approval and confirmation of its first to file status from the FDA today on its Abbreviated New Drug Application (ANDA) for Metformin HCl Extended Release. The generic product will be immediately marketed by the company's wholly owned subsidiary, IVAX Pharmaceuticals, Inc. Metformin ER is the generic equivalent of Glucophage XR(R) which is marketed by Bristol-Myers Squibb and used for the treatment of type 2 diabetes. U.S. sales for Glucophage XR were over $453 million for the twelve months ending in June 2003. Neil Flanzraich, vice chairman and president of IVAX Corporation, said, "We are pleased to obtain final approval for this important product. Our first to file status makes this an important commercial opportunity, a product of IVAX' extensive and growing generic pipeline. We are confident that sales of Metformin ER will significantly contribute to IVAX' earnings for the fourth quarter of 2003 and beyond." IVAX' pipeline now consists of 38 ANDAs pending with the FDA of which 9 are potentially first to file submissions with U.S. brand sales of over $13 billion. IVAX expects, during the next fifteen months, to gain approvals on and launch up to 18 additional generic drugs; and would have following these approvals, up to 75 ANDAs pending at the FDA by the end of 2004. 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 risks that the launch of metformin ER will be delayed; that sales of metformin ER may be impacted during the exclusivity period by licensing arrangements between Bristol-Myers and third party competitors; that exclusivity periods and the launch of metformin ER may be challenged by third parties, including challenges regarding patent infringement; the impact of the FDA's or other administrative or judicial agency's decisions on exclusivity periods; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing; 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 be the first to file on 9, or any, of its pending ANDAs; that IVAX may not receive approvals for, or launch, 18 generic drugs in the next 15 months; that the compounds and products in IVAX' generic pipeline will not be successfully developed, will not receive regulatory approval or will not be successfully commercialized; that IVAX may not file any additional ANDAs; 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. Glucophage XR(R) is a registered trademark of Bristol-Myers Squibb Company.
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