Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) multiple sclerosis treatment Copaxone is progressing toward regulatory approval in Japan. At the end of 2013, Teva reported a development and marketing agreement with Japan's Takeda Pharmaceutical Co. Ltd. for the Japanese market.
At the time, Teva said that regulatory approval was expected to be received in less than a year. However, nearly a year has passed and no approval has been received.
The annual market potential for Copaxone in Japan is estimated at $700-900 million. Sales of the rug in the first nine months of 2014 totaled $3.1 billion. But in North America and Europe, such high sales of the treatment (in its smaller dosage) are nearing the end of their cycle due to the expiration of patents, and the Japanese market is expected to provide a welcome boost for Copaxone.
Teva said, "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."
Estimates are that Copaxone is responsible for more than half of Teva's profits.
Published by Globes [online], Israel business news - www.globes-online.com - on November 13, 2014
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