Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) announced today that the the Japanese Ministry of Health, Labour and Welfare has approved once-daily Copaxone (glatiramer acetate injection) 20mg injection for the treatment of multiple sclerosis . The product will be commercialized in Japan by Takeda Pharmaceutical Company Ltd.
In Japan, glatiramer acetate was developed as an Unapproved New Drug by Teva Pharmaceutical K.K., a wholly owned subsidiary of Teva, at the request of Japan’s Health Ministry. In March 2013, Takeda and Teva signed an agreement in which Teva granted Takeda the right to commercialize Copaxone in Japan.
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Teva Global Specialty Medicines president Rob Koremans said, “Strengthening our offering of specialty medicines in Japan is an important goal for Teva. We are proud to work with Takeda in very close cooperation to make this product available to multiple sclerosis patients and the physicians treating them in Japan. The partnership has been a success and we look forward to making additional specialty medicines available to Japanese patients.”
Japanese approval for Copaxone is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical K.K. in patients with relapsing-remitting multiple sclerosis in Japan as well as the pivotal trial data sets used for approvals in other countries.
The COPAXONE brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries, and its sales in the second quarter of 2015 were a record $1.1 billion.