Teva Pharmaceutical Industries Ltd. and Takeda Pharmaceutical Co. Ltd. announced the signing of an agreement in which Teva licensed to Takeda the right to commercialize Teva’s innovative glatiramer acetate (active ingredient) formulation for the treatment of multiple sclerosis, in Japan. Teva and Takeda are currently working on further agreements in connection with the implementation of this license.
Developed by Teva, glatiramer acetate for injection is indicated for the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis, including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. It is considered standard treatment for relapsing-remitting multiple sclerosis, and is now approved in 55 countries worldwide. Teva’s glatiramer acetate is designated as an orphan drug in Japan, and currently is under development as an Unapproved New Drug by Teva Pharmaceutical K.K., a subsidiary of Teva, at the request of the Japanese Ministry of Health, Labor and Welfare.
Under the terms of the agreement, Teva will grant Takeda commercialization rights in Japan, and Takeda will submit a New Drug Application for registration of glatiramer acetate in Japan. The financial details of the agreement are confidential.
Teva and Takeda will work under close cooperation so that both parties can provide a new treatment option to patients with multiple sclerosis in Japan as early as possible, where the current available therapies are still limited.
Glatiramer acetate is currently approved in 55 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel and all European countries, and is marketed under the brand name Copaxone.
Date: December 4, 2013
Filed Under: Drug Discovery