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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 | - |
BW20030806002073 20030806T155332Z UTC ( BW)(IVAX-CORPORATION)(IVX) Response to: IVAX Confirms First to File Generic Submission on Lexapro Business Editors UK REGULATORY NEWS LONDON--(BUSINESS WIRE)--Aug. 6, 2003-- In response to enquiries and speculation arising out of a report earlier this week that an unknown generic company had filed a generic drug application containing a patent challenge to Forest Laboratories' Lexapro(TM), IVAX Corporation (AMEX:IVX) (LSE:IVX.L) confirms that it has filed an Abbreviated New Drug Application on escitalopram oxalate in 5, 10, and 20 mg tablet dosage strengths, containing a Paragraph IV certification. Escitalopram oxalate is the generic equivalent of Lexapro, which is marketed by Forest Laboratories to treat depression. U.S. sales of Lexapro for the first quarter of 2003 were $154.7 million and have increased to $217.7 million in the second quarter of 2003, according to IMS figures. IVAX believes that it is first to file on escitalopram oxalate. IVAX continues its aggressive program to increase the number of products in its generic portfolio. 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. 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' first to file status and ability to increase the number of products in its generic portfolio, involve risks and uncertainties which may affect IVAX' business and prospects. Such risks and uncertainties include: 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; court and FDA decisions on exclusivity periods; that IVAX may not have first to file status; competitor's ability to extend exclusivity periods past initial patent terms; that IVAX may not receive approval for escitalopram oxalate or that its launch will be delayed; or that if approved, the products will not be successfully commercialized; that IVAX may not file any additional ANDAs; changing market conditions; the availability and cost of raw materials and other third party products; the impact of competitive products and pricing and other risks and uncertainties based on economic, competitive, governmental, technological and other factors discussed in IVAX' Annual Report on Form 10-K and its other filings with the Securities and Exchange Commission. Lexapro(TM) is a trademark of Forest Laboratories. Short Name: IVAX Corporation Category Code: RSP Sequence Number: 00008059 Time of Receipt (offset from UTC): 20030806T160747+0100 --30--PP/mi* ne/uk CONTACT: IVAX Corporation KEYWORD: FLORIDA UNITED KINGDOM INTERNATIONAL EUROPE INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL PRODUCT SOURCE: IVAX Corporation Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. URL: http://www.businesswire.com
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