Ivax Website News Release:
BW2323 SEP 15,2000 11:09 PACIFIC 14:09 EASTERN
( BW)(FL-IVAX)(IVX) IVAX Receives Final Approval for Generic Taxol
Business Editors/Health & Medical Writers
MIAMI--(BUSINESS WIRE)--Sept. 15, 2000--IVAX Corporation (AMEX:IVX) has received final approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for paclitaxel 6 mg/mL injection (packaged in 30 mg/5 mL, 150 mg/25 mL, and 300 mg/50 mL multiple-dose vials). Indicated for the treatment of breast and ovarian cancer, IVAX' paclitaxel injection is the generic equivalent of Bristol-Myers Squibb Company's Taxol(R), estimated to have U.S. sales of $1.2 billion this year. IVAX' first to file position for this product entitles the company to 180 days of marketing exclusivity for generic paclitaxel. The product will be marketed through IVAX' wholly-owned subsidiary, Zenith Goldline Pharmaceuticals, Inc.
"Final marketing approval of our generic Taxol product represents another important milestone for our company, which has a tradition of overcoming special challenges to bring important pharmaceutical products through the regulatory process to their successful commercialization," said Phillip Frost, M.D., chairman and chief executive officer of IVAX Corporation. "This accomplishment was made possible by the outstanding efforts of IVAX' dedicated and hard working employees."
Neil Flanzraich, vice chairman and president of IVAX commented, "Anyone who has followed IVAX' efforts to bring its generic version of Taxol to market in the United States knows IVAX has had to overcome a succession of disruptive and delaying tactics. We strongly believe the system must be changed to eliminate opportunities for abuse by those seeking to prevent or delay generic competition, and we will say more about that in the future. For the moment, we are pleased that this important victory will benefit the thousands of American women suffering from breast and ovarian cancer."
IVAX Corporation, headquartered in Miami, Florida, is a holding company with subsidiaries engaged in the research, development, manufacturing and marketing of branded and generic pharmaceuticals and veterinary and diagnostic products in the U.S. and international markets.
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 Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect IVAX' business and prospects, including the risks that IVAX' marketing exclusivity may be challenged; that IVAX may not be successful in the current Taxol-related litigation or that other Taxol-related patents may be asserted; that IVAX' launch or commercialization may be delayed or interfered with by legal or regulatory actions or for other reasons, and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. In addition to the risk factors set forth above, investors should consider the economic, competitive, governmental, technological and other factors discussed in the Company's Annual Report on form 10KA and other filings with the Securities and Exchange Commission. Taxol(R) is a registered trademark of the Bristol-Myers Squibb Company.
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CONTACT: IVAX Corporation, Miami
Jordan I. Siegel, Vice President & Treasurer
305/575-6043
URL: www.ivax.com
KEYWORD: FLORIDA
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL PRODUCT |
