IVAX Enters Marketing and Distribution Agreement with Mayne Pharmaceuticals for Injectable Paclitaxel in Europe.Business Editors/Health/Medical Writers
MIAMI--(BUSINESS WIRE)--Feb. 25, 2004
IVAX Corporation (AMEX AMEX
See: American Stock Exchange :IVX) (LSE LSE - Language Sensitive Editor :IVX.L) entered into an agreement with Mayne Group Limited for the marketing and distribution of IVAX' injectable paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); product, Paxene(R), in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the
European Community nations of Belgium, Finland, France, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Sweden and the United Kingdom and in Norway. Paclitaxel is the active pharmaceutical ingredient in Taxol(R), a drug marketed by Bristol-Myers Squibb for the treatment of various cancers. Annual European sales of Taxol are over $450 million.
Neil Flanzraich, vice chairman and president of IVAX IVAX Industrial Vax (Dec Computer) , said, "Mayne Pharmaceuticals has a substantial and highly effective marketing and sales presence in oncology products in the countries covered by our agreement. We believe this collaboration is the best and most expedient way to maximize our injectable paclitaxel opportunity in Europe."
As previously announced on January 23, 2004, the European Union's Committee for Proprietary Medicinal Products, the scientific committee of the European Medicines Evaluation Agency, issued a positive opinion recommending the extension of indication of the existing marketing authorization for IVAX' Paxene to include treatment of metastatic Metastatic
The term used to describe a secondary cancer, or one that has spread from one area of the body to another.
Mentioned in: Coagulation Disorders
pertaining to or of the nature of a metastasis. breast cancer and metastatic 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 in the European Union.
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.
Mayne Group Limited is Australia's leading provider of private health care services. They are involved in the research, development, manufacture and marketing of generic injectable and oral pharmaceutical products, as well as consumer health products. Their products cover a range of therapeutic categories including oncology, pain management and cardiac care.
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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties which may affect the company's business and prospects, including the risks that the European Commission may not act favorably on the CPMP CPMP Committee for Proprietary Medicinal Products
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CPMP Corporate Planning and Management Practices recommendation; that other requisite regulatory authorizations may be achieved later than anticipated or not at all; that Mayne's sales force may not be as effective as anticipated and the collaboration with Mayne may not achieve the results expected; that IVAX has in the past and may in the future experience difficulties in obtaining raw materials and other components necessary for the production of paclitaxel, on commercially reasonable terms; and the impact of competitive products and pricing and successful compliance with extensive, costly, complex and evolving governmental regulations and restrictions. In addition to the risk factors set forth above, IVAX' forward looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, trade buying patterns, patent positions and 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. , among other things. For further details and discussion of these and other risks and uncertainties, see IVAX' Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Taxol(R) is a registered trademark of the Bristol-Myers Squibb Company.