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|July 16, 2003 4:40 p.m.|
|Teva Announces District Court Grants Motion for Summary Judgment of Non-Infringement of All Ribapharm Patents Related to Rebetol®|
|Jerusalem, Israel, July 16, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today the Honorable Mariana R. Pfaelzer, U.S. District Court Judge for the Central District of California has granted Teva's motion for summary judgment of non-infringement on U. S. Patents No. 5,767,097, 6,063,772, and 6,150,337, which Ribapharm, Inc. had listed in the Orange Book for Rebetol®. Ribavirin is used in combination with Interferon Alpha-2B injection for the treatment of chronic Hepatitis C and had sales of $721 million for the 12-month period ended March 2003 according to IMS.|
The Food and Drug Administration has been informed of the judge's order, which should allow the FDA to grant final approval for Teva's ANDA that was made under Paragraph IV of the Hatch-Waxman Act.
Further to our March 26, 2003 announcement, all patent litigation between Teva and Schering-Plough Corporation, regarding Schering-Plough's U.S. patents relating to ribavirin, will be dismissed and the licensing agreement between the two companies will become effective. Under the terms of the agreement, Schering-Plough will grant to Teva USA a non-exclusive license to its U.S. ribavirin patents. Teva USA will pay to Schering-Plough a royalty on its ribavirin sales.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 30 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Close to 90% of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients.
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, 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 ("FDA") 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 ("SEC"). 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.
Company Contacts:Dan Suesskind
Chief Financial Officer
Teva Pharmaceutical Industries Ltd.
President and CEO
Teva North America
Director, Investor Relations
Teva Pharmaceutical Industries Ltd.