View printer-friendly version
« Back
April 07, 2000 3:23 p.m.
Teva & Lundbeck Announce the Successful Completion of a Phase III Trial for a New Treatment for Parkinson's Patients

JERUSALEM, Israel, April 7, 2000 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and H. Lundbeck A/S (CSE: LUN.CO) are pleased to announce the positive results of the phase III clinical trial with rasagiline in Parkinson's disease. The results of this mono-therapy study demonstrate highly significant efficacy in the primary endpoint on progression of parkinsonian symptoms. In addition, rasagiline, a selective irreversible MAO-B inhibitor, was well tolerated in this patient population.

This study, which focused on early stage patients not yet treated with levodopa, was conducted in the US and Canada in 32 centers. It included 400 patients who were treated for a period of 6 months with two doses of rasagiline against placebo.

The results will be presented, later this year, at one of the major scientific conferences.
The product was developed by Teva based on the original research of Prof. M. Youdim and Prof. J. Finberg from the Technion School of Medicine. Dr. Benzion Weiner, Head of Research & Development in Teva, said, "I am particularly excited by the results of this study since this new product has the potential to be an important contribution in the clinical treatment of parkinsonian patients."

Teva and Lundbeck will soon initiate two additional pivotal studies with rasagiline, one in Europe and one in North America, which upon completion will be submitted for regulatory approval in US, Canada,EU and other countries.

Rasagiline and TV-1203, (a prodrug of levodopa which is entering phase III), Teva's innovative products targeted for Parkinson's disease, are part of a long-term strategic alliance for global co-development and European marketing with Denmark's H. Lundbeck A/S. Under the terms of the agreement, Teva and Lundbeck will share the marketing of these products in Europe, and Teva will retain exclusive marketing rights in the rest of the world, including North America.

The worldwide market for Parkinson's disease, currently estimated to exceed $1.5 billion, is forecasted to double in size over the next few years. Eli Hurvitz, President and Chief Executive Officer of Teva, stated, "We are pleased and excited that with rasagiline and TV-1203, Teva is developing significant therapies addressing the needs of the growing population of parkinsonian patients. These results support Teva's accelerated pursuit of the development of both of these therapies".

Eric Sprunk-Jansen, President and Chief Executive Officer of H. Lundbeck A/S, stated, "I am pleased that the first of the three pivotal phase III studies for rasagiline has been successfully completed and I am confident that Teva and Lundbeck will be able to launch the product globally in three years time."

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 diseases. It had consolidated net turnover of DKK 4.1 billion in 1999 and employs approximately 2,800 people.

Teva Pharmaceutical Industries Ltd., is Israel's largest pharmaceutical company, with more than 80% of its sales outside Israel, mainly in the United States 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.