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|May 11, 1999 10:23 a.m.|
|Teva Pharmaceutical Industries Ltd. receives approval from the swiss intercantonal medicines control office (iks) for sale of copaxoneÒ in switzerland|
| First western european approval for copaxoneÒ |
Jerusalem, Israel, May 11, 1999- Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVIY) announced today at its investor seminar and field trip in Hungary that the Swiss Intercantonal Medicines Control office, the IKS, has granted marketing clearance for CopaxoneÒ for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS). This is CopaxoneÒ's first Western European approval. With the addition of Switzerland, Copaxone is now approved in 14 countries.
The approved Multiple Sclerosis therapeutic indication is for the reduction of frequency of relapses and decreasing the progression of disability. CopaxoneÒ is the only MS-specific immunomodulator available today.
In pursuing an approval in Switzerland, Teva submitted data to the IKS, which was evaluated via the fast track procedure. This includes new evidence proving that treatment with CopaxoneÒ significantly reduces MRI measured disease activity and burden of disease in patients with RRMS.
There are approximately 3,500 people with RRMS in Switzerland, of whom only less than one-third are currently being treated. The product will be marketed by Hoechst Roussel Schweiz, pursuant to the existing agreement signed between Teva and Hoechst Marion Roussel for strategic marketing alliance in Europe.
Teva Pharmaceutical Industries Ltd., is Israel's largest pharmaceutical company, with three-quarters of its sales outside Israel, mainly in the United States. The Company develops, manufactures, and markets generic and branded human pharmaceuticals, active pharmaceutical ingredients, medical disposables and veterinary products.
Safe Harbor Statement: This release 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.