JERUSALEM, Israel--(BUSINESS WIRE)--April 29, 2004--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announced today that the U.S. Food and Drug Administration has granted approval for an ANDA for Fludarabine Phosphate Injection, 25 mg/ml, which was submitted by the Company's subsidiary Sicor Inc. Shipment of this product is expected to begin in the near future.
Sicor's Fludarabine Phosphate Injection, indicated for treatment of B-cell chronic lymphocytic leukemia, is substitutable for Berlex's Fludara® for Injection. Sicor was previously awarded marketing approval for a lyophilized formulation of this product in August 2003 and until now both the Sicor product and the brand product are a lyophilized formulation that requires reconstitution. Sicor's new approval today is for a ready to use liquid for injection and it is expected that this new formulation will gradually replace the lyophilized formulation as it offers significant benefits for institutional users.
Current annual sales of Fludarabine Phosphate Injection, including both the brand and generic products, are approximately $80 million.
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.
Dan Suesskind, 011-972-2-589-2840
Teva North America
Bill Fletcher, 215-591-8800
Teva Pharmaceutical Industries Ltd.
Dorit Meltzer, 011-972-3-926-7554
Source: Teva Pharmaceutical Industries Ltd.