Teva & Lundbeck Announce Successful Completion of Rasagiline Phase III Clinical Program in Parkinson's Disease.

Business Editors

JERUSALEM--(BUSINESS WIRE)--March 26, 2003

U.S. and European Submissions Expected in the Second Half of 2003

Teva Pharmaceutical Industries, Ltd. (Nasdaq: TEVA) and H. Lundbeck A/S(CSE: LUN.CO) are pleased to announce the successful completion of two phase III clinical trials of rasagiline in patients with advanced Parkinson's disease.

In both trials, statistically significant results for the primary endpoint were achieved. Each of the studies, which compared once-daily dosages of rasagiline to placebo as an adjunct treatment to levodopa, demonstrated significant reductions in the duration of the "Off" time (a state in which patients are unable to function normally). The results of these two trials follow the successful results of an earlier phase III trial which demonstrated the efficacy of rasagiline as monotherapy in early-stage Parkinson's disease.

With these successful results, rasagiline is now expected to be submitted for regulatory approval in North America and Europe during the second half of 2003.

Israel Makov, President and CEO of Teva said: "The robust results of these trials have met our expectations with regard to the efficacy of rasagiline. We are extremely pleased with the clinical development of this product which holds promise for patients with both early and advanced stages of Parkinson's disease. These results also encourage us to move forward with investigating rasagiline in other neurological disorders."

It is estimated that over one-third of patients diagnosed with advanced Parkinson's disease experience many hours of "Off" time daily, in which they are unable to function normally. The majority of these patients develop complications which respond poorly to current standard levodopa treatments.

The two double blind placebo controlled phase III clinical trials were PRESTO and LARGO. The PRESTO trial, conducted in North America (treatment duration of 26 weeks), compared the effects of two different dosages of rasagiline, 0.5mg and 1mg once-daily, to placebo in 472 patients. The LARGO trial was conducted in Europe, Israel and Argentina (treatment duration of 18 weeks) with 687 patients and compared the effects of rasagiline, 1mg once daily, to placebo and also included an active comparator arm of patients treated with entacapone - 200mg with each levodopa dose. All patients were optimized on levodopa/decarboxylase inhibitor (DCI) treatment but were still experiencing the response fluctuations typical of advanced stage disease. The tolerability of rasagiline as determined by the percent of patients successfully completing these studies was comparable to placebo. The trials also showed that, in addition to the primary endpoints, highly statistically significant positive effects were obtained for additional endpoints dealing with patient's clinical status and function while both in an "Off" and "On" state.

Rasagiline was developed by Teva based on the original research of Prof. M. Youdim and Prof. J. Finberg from the Haifa Technion School of Medicine in Israel.

The development of rasagiline is part of a long-term strategic alliance for global co-development and European marketing between Teva and Lundbeck. Under the terms of the agreement, Lundbeck will market rasagiline in Europe and in a number of overseas markets, in a joint effort with Teva, while Teva retains exclusive marketing rights in the rest of the world, including North America.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 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 branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

H. Lundbeck A/S is an international pharmaceutical company engaged in the research and development, production, marketing and sale of drugs for the treatment of psychiatric and neurological disorders.

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