JERUSALEM, Israel (BW HealthWire) - Teva Pharmaceutical Industries, Ltd., (NASDAQ:TEVA) announced today that Copaxone(R)was approved for marketing in the U.K. This is the first approval in a major European market and enables Teva to file for approval all over the E.U. under the mutual recognition procedure.
Teva plans to launch Copaxone(R)in the U.K. market in the beginning of the fourth quarter of this year.
Copaxone (R) (glatiramer acetate for injection) is indicated for reduction in frequency of relapses in relapsing-remitting multiple sclerosis.
Eli Hurvitz, President and Chief Executive Officer commented: "We are excited to have received this approval and even more with the opportunity it represents for the rest of the European market."
Teva is currently preparing the filing under the European Mutual Recognition Procedure to make Copaxone (R) available in the remainder of the European Union. The U.K. has agreed to act as the reference member state. The successful completion of this procedure is expected to enable Teva to launch Copaxone (R) in the E.U. around mid 2001.
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 its sales are outside Israel, mainly in North America and Europe. The Company develops, manufactures and markets generic and branded pharmaceuticals and active pharmaceutical ingredients.
Safe Harbor Statement: This report contains forward-looking statements, which express the 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 the Company'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 the impact of pharmaceutical industry regulation, the difficulty of predicting 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, the impact of competitive products and pricing, the availability and pricing of ingredients used in the manufacture of pharmaceutical products, 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, fluctuations in currency, exchange and interest rates, operating results, the impact of the year 2000 issue and other factors that are discussed in the Company's Annual Report on Form 20-F and the Company's other filings with the U.S. Securities and Exchange Commission.
Contact: Teva North America Bill Fletcher, (215) 256-8400 or Teva Pharmaceutical Industries, Ltd. Dan Suesskind, (011) 972-2-589-2840 or Teva Pharmaceutical Industries, Ltd. Judith Vardi, (011) 972-50-512778 www.tevapharm.com