Published On: Thu, Nov 13th, 2014

Teva’s MS Drug Copaxone Looking for Approval in Japan

Copaxone

Teva’s Copaxone, a new medication under development for the treatment of multiple sclerosis treatment Copaxone, has gotten closer to getting approval for marketing in Japan from that nation’s regulatory agencies. At least that’s what the company is saying now.

The drug is already approved for use in other parts of the world like the U.S. Teva estimates that the annual market potential for Copaxone in Japan is $700-900 million. Over the first three quarters of this year Copaxone brought in $3.1 billion in worldwide sales. But M.S. is a terminal disease and as the sufferers die off the company has fewer customers for the drug. The drug is believed to be responsible for almost half od Teva’s current revenues.

Just last year, Teva predicted that such approval would come by the end of 2014. In preparation for it the company already entered into a development and marketing agreement with Japan’s Takeda Pharmaceutical Co. Ltd. to pave the way for selling Copaxone in the Japanese market. But 2014 is almost over and no such approval has yet been made.

However, Teva has stated, “Our agreement with Takeda to bring this important medicine to patients in Japan is progressing positively. Together with Takeda, we are working through the remaining aspects of the process in order to meet the requirements of the Japanese authorities. We are hopeful to be in a position to complete the filing in the near future.”

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