Industryweek 6466 Takeda Pharmaceuticals 1

Drugmaker Takeda to Fight $6 Billion US Fine

April 8, 2014
The fine was over over the safety of the company's Actos diabetes medicine. "We believe the evidence did not support a finding that Actos caused (the plaintiff's) bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to Actos."

TOKYO -- Japan's biggest drugs maker Takeda Pharmaceutical (IW 1000/264) said Tuesday it would fight a huge $6 billion damages order imposed by a U.S. jury following a trial over the safety of its Actos diabetes medicine.

The company said it "respectfully disagrees" with the judgment awarded in Louisiana on Monday, which also ordered the firm's co-defendant, drugs firm Eli Lilly (IW 1000/89), to pay $3.0 billion in damages.

The issue at the trial, which began in February, was whether the drug could be blamed for bladder cancer in a plaintiff who was taking the medicine, and whether the firm knew about those risks. Other U.S. cases over the drug are still pending.

"Takeda respectfully disagrees with the verdict and we intend to vigorously challenge this outcome through all available legal means, including possible post-trial motions and an appeal," said Kenneth Greisman, senior vice president and general counsel for Takeda's US unit.

"We believe the evidence did not support a finding that Actos caused (the plaintiff's) bladder cancer. We also believe we demonstrated that Takeda acted responsibly with regard to Actos."

While Takeda rang up about half its $15 billion sales last fiscal year in Japan, North America and Europe are also major markets and the firm has operations around the world.

Eli Lilly had partnered with Takeda to help market the drug in the United States.

Drug Firms and Lawsuits 'Inseparable'

Actos -- a prescription medication launched in 2010 to improve blood sugar control in adults with Type 2 diabetes -- had been a promising drug for Takeda, which was recently forced to cancel development of another diabetes treatment due to safety concerns.

The Food and Drug Administration in 2011 issued a safety alert, warning over the possibility of an increased bladder cancer risk with long-term use. The drug is banned in France and Germany.

Sales of the medicine -- also sold as Pioglitazone -- have plunged. They fell 73% in the nine months to December from the same period a year earlier, according to Takeda's latest financial statements.

However, Credit Suisse analyst Fumiyoshi Sakai described the sell-off in Takeda shares "excessive", adding that it may still get the case overturned on appeal.

"It's not like the company is going under or that it must pay $6.0 billion tomorrow," he said.

"Takeda just needs to handle this as a legal matter, separate from day-to-day operations -- lawsuits and drug companies are inseparable these days."

The U.S. judgement comes about a week after former GlaxoSmithKline executive Christophe Weber was installed as Takeda's chief operating officer, one of the few foreign-born managers to sit in the top ranks of a Japanese firm. He is expected to become president in June.

On Monday, Takeda rival Daiichi Sankyo said it was pulling out of its costly ownership of scandal-hit India drugs maker Ranbaxy, which has been slapped with U.S. import bans linked to its manufacturing practice.

Copyright Agence France-Presse, 2014

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