Teva (Nasdaq: TEVA) announced today that it submitted a New Drug Application (NDA) with the US Food and Drug Administration, to market Rasagiline as a treatment for Parkinson's disease.
Teva Neuroscience, Inc. and Eisai Inc. will co-promote Rasagiline in the United States once approved by the FDA, as part of a long-term strategic alliance between Teva Pharmaceutical Industries Ltd. and Eisai Co., Ltd. Rasagiline will become Teva Neuroscience's second branded neurology product.
Teva said it anticipated submitting an application to market Rasagiline as a treatment for Parkinson's disease in the European Union later this year. Upon approval, Rasagiline will be co-marketed in Europe by Teva and H. Lundbeck A/S, as part of a long term strategic alliance between the two companies.
Submission of the NDA is based on data from three Phase III clinical trials in early and advanced Parkinson's disease patients, Teva stated.
Rasagiline, an irreversible monoamine oxidase type B inhibitor, is a joint development of Teva and the Technion - Israel institute of Technology. The drug differs from earlier propargylamine MAO-B inhibitors in its chemical structure, its greater potency, lack of amphetamine metabolites, and once-a-day dosing, said Teva. Over 1600 patients with PD participated in clinical trials worldwide, during the development of Rasagiline.
"This is another milestone for Teva's developing franchise in the central nervous system arena." said Teva president and CEO Israel Makov. "This development is further substantiated through our collaboration with Eisai, which will enable us to expand the scope of Rasagaline's use into other indications. More importantly, we are very pleased to be in a position to offer patients with early and advanced stage Parkinson’s disease what may become a new and an important treatment for this disease."
Published by Globes [online] - www.globes.co.il - on 8 September, 2003