Jerusalem, Israel, September 28, 2000 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the FDA awarded final U.S. approval for Nifedipine XL 60mg. This approval was issued to Biovail Corporation. The product is included in the exclusive US marketing agreement between Teva and Biovail relating to Biovail's line of generic sustained release products.
Nifedipine XL is the generic version of Pfizer's drug Procardia XL® for the treatment of hypertension and angina. In 1999, U.S. sales of this product were approximately $230 million.
Biovail was the first applicant to file a Paragraph IV certification for the 60mg strength and thus should be eligible for the 180 day exclusivity period. However, another company is currently on the market with this product through a licensing agreement with Pfizer.
A patent infringement case for this product is currently pending in a US Federal District Court in Puerto Rico. The approval follows the expiration of 30 months Hatch-Waxman stay. Teva will launch the product imminently.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 50 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are outside Israel, mainly in the North America and Europe. The Company develops, manufactures and markets generic and branded 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.