Federal Court Refuses to Block IVAX' Generic Taxol Approval.Business Editors MIAMI--(BUSINESS WIRE)--Oct. 4, 2000 IVAX Corporation IVAX Corporation was a United States public corporation focused on manufacturing and distributing generic pharmaceutical products. Ivax was acquired by the Israeli company Teva Pharmaceutical Industries in January 2006. External links
See: American Stock Exchange :IVX) announced today that the U.S. District Court in Washington D.C. rejected the motion of American BioScience, Inc. and intervenor Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were to grant an injunction requiring the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) to rescind and revoke its final marketing approval of IVAX' generic Taxol(R) product. Although the lawsuit remains pending, the Court specifically determined that American BioScience was unlikely to succeed in the lawsuit. The Court's ruling leaves standing the final approval granted by the FDA to IVAX IVAX Industrial Vax (Dec Computer) on September 15th and, as previously announced, IVAX intends to begin marketing its generic Taxol product within the next few weeks. "We are pleased that the federal court in Washington, like the federal courts in California, has rejected further efforts by American BioScience and Bristol-Myers to delay or prevent IVAX' launch of its generic version of Taxol," said Neil Flanzraich, vice chairman and president of IVAX. "This is yet another victory for IVAX, and the thousands of American women suffering from breast and ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast ." Flanzraich also stated, "The repeated efforts of American BioScience and Bristol-Myers to delay or prevent IVAX' generic Taxol product from coming to market are not surprising considering that Bristol-Myers makes $3-4 million each additional day its Taxol monopoly is extended. While American BioScience and Bristol-Myers may continue to file lawsuits to try to block IVAX from bringing this important generic cancer drug to market, we believe any such efforts would be frivolous, and we are confident that IVAX will prevail." 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 Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called 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' generic marketing exclusivity may be challenged; that IVAX may not be successful in current or future Taxol-related litigation; 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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