Jan. 23 (Bloomberg) -- Mitsubishi Tanabe Pharma Corp., discoverer of the multiple sclerosis treatment Gilenya, fell the most in 10 months in Tokyo trading after U.S. and European regulators said they are reviewing the safety of the medicine.
Mitsubishi Tanabe dropped as much as 9.2 percent, the most on an intraday basis since March 15, to 1,048 yen and traded at 1,065 yen as of the midday break. Japan’s benchmark Topix Index rose 0.3 percent.
The European Medicines Agency and the U.S. Food and Drug Administration are reviewing the drug after the European regulator said Jan. 20 it found 11 deaths among patients using the treatment sold by Mitsubishi Tanabe’s partner Novartis AG. The review came about 16 months after the drug’s initial U.S. approval.
“Few people probably expected that the drug would be reviewed again at this time,” Hiroshi Tanaka, a health-care analyst at Mizuho Securities Co. in Tokyo, said by telephone today. “Also, there was a sudden jump in the number of deaths from what the market knew about in December.”
Novartis said last month a patient died Nov. 23 after starting treatment with Gilenya, the first oral drug for multiple sclerosis. Ten other deaths have been reported, including six unexplained deaths, three heart attacks and one due to disruption of heart rhythm, the London-based EMA said. It isn’t clear what role if any Gilenya had in the deaths, it said.
Osaka-based Mitsubishi Tanabe forecasts operating profit to increase 47 percent over four years to 100 billion yen by March 2016, led by products including Gilenya. The drug generated $291 million in sales for Novartis in the first nine months of 2011. More than 30,000 patients worldwide have now taken the medicine, according to the EMA.
Julie Masow, a spokeswoman for Novartis, said in a Jan. 20 e-mail the death rate is in line with the broader expected death rates based on the 30,000 multiple sclerosis patients who have been treated with Gilenya to date.
--Editors: Terje Langeland, Dave McCombs
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