After a delay, Takeda Pharmaceutical Co. Ltd., the Japanese partner of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA), has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare for Copaxone for the relapse prevention of multiple sclerosis. The application, Takeda reported, is based on the safety and efficacy results of an open label, 52 week clinical trial conducted by Teva in patients with relapsing-remitting multiple sclerosis in Japan as well as data from overseas clinical trials conducted by Teva.
Teva and Takeda signed a marketing cooperation agreement for Copaxone about a year ago of which the details were not disclosed. Several months later a similar agreement was signed for Azilect, Teva's Parkinson's disease treatment. The initial assumption had been that Copaxone would receive marketing approval in Japan in less than a year but yet the application has only now been filed.
Copaxone is Teva's flagship treatment with sales of $3.1 billion in the first nine months of 2014 although the drug's patent is about to expire in the US and Europe. Japan will be a new market for Copaxone with estimated potential annual sales of $700,000-900,000.
Published by Globes [online], Israel business news - www.globes-online.com - on December 29, 2014
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