Will Market and Sell Product in the U.S.
JERUSALEM--(BUSINESS WIRE)--April 27, 2004--Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA - News) announced today the settlement of all patent litigation pending between its subsidiary Pharmachemie and Bristol-Myers Squibb Company (NYSE:BMY - News) relating to carboplatin injection, the generic version of cancer treatment Paraplatin®.
Under the terms of the settlement, which is subject to government review, Teva has entered into a supply and distribution agreement with Bristol-Myers Squibb for carboplatin injection (50 mg, 150 mg, 450 mg) and carboplatin aqueous solution injection (50 mg/5 ml, 150 mg/15 ml, and 450 mg/45 ml). The agreement will permit Teva to begin distributing the Bristol-Myers Squibb products for the U.S. market on June 24, 2004. A final launch date has not yet been determined but it will be prior to the expiration of the pediatric exclusivity later this year, should it be granted by the U.S. Food and Drug Administration. Financial terms of the agreement were not disclosed.
The settlement provides for Teva to continue to pursue final approval of its own abbreviated new drug applications for carboplatin with the FDA.
Bristol-Myers Squibb's Paraplatin had US sales of $769 million in 2003.
Teva will market and sell the products in the U.S. through its newly acquired subsidiary Sicor Inc.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, including its recent acquisition of Sicor Inc., the availability of product liability coverage in the current insurance market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Teva Pharmaceutical Industries Ltd.,Israel Dan Suesskind, 011-972-2-589-2840 or
Dorit Meltzer, 011-972-3-926-7554 or
Teva North America Bill Fletcher, 215-591-8800 www.tevapharm.com
Source: Teva Pharmaceutical Industries Ltd.