The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Israel-based Teva Pharmaceutical Industries’ once-daily Copaxone (glatiramer acetate injection) 20mg injection for prevention of multiple sclerosis relapse.
In Japan, Copaxone will be commercialised by Takeda Pharmaceutical Company.
At the request of the MHLW, Teva subsidiary Teva Pharmaceutical KK has developed glatiramer acetate as an unapproved new drug in Japan.
Under the March 2013 agreement, Teva granted Takeda the right to commercialise Copaxone in Japan.
The Japanese approval is based on the safety and efficacy results of an open-label, 52-week clinical trial conducted by Teva Pharmaceutical KK in patients with relapsing-remitting multiple sclerosis in Japan, as well as the pivotal trial data sets used for approvals in other countries.
Teva president and CEO Global Specialty Medicines 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."
Copaxone is indicated to treat patients with relapsing forms of multiple sclerosis and the drug’s most common side-effects are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain.
The Copaxone brand is approved in more than 50 countries worldwide, including the US, Russia, Canada, Mexico, Australia, Israel and all EU countries.
In July, Teva agreed to acquire Irish pharmaceutical firm Allergan’s generic drugs unit in a $40.5bn deal.
Upon closing of the transaction, which has been unanimously approved by the boards of directors of both companies, Allergan will receive $33.75bn in cash and Teva shares valued at $6.75bn, which represents a 10% stake in the Israel firm.
In addition, Allergan retains 50% of Teva’s future economics from generic lenalidomide (Revlimid).