Takeda terminated the development of TAK-875 after it was linked to liver damage, the company said in a statement to the Tokyo Stock Exchange today. The decision was made after consulting with three independent panels on what the trials showed about the drug’s safety, the Osaka-based company said.
The drugmaker now has one less candidate in development to succeed Actos, once the world’s best-selling diabetes medicine, and buffer a decline in sales from cheaper generics. Takeda has been acquiring rivals and stakes in drugs and hiring senior executives from overseas to expand internationally.
“The company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam do not outweigh the potential risks,” Takeda said, referring to TAK-875 by its generic name. “Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the fasiglifam trials are transitioned to appropriate therapies.”
Takeda slumped 5.2 percent, the most since May 10, to 4,835 yen at the close in Tokyo trading. The stock was the biggest decliner on the Topix Index, which rose 0.8 percent.
Takeda’s diabetes pill was in the third and final phase of patient studies in the U.S., Europe and Japan. The medicine is in a new group of diabetes drugs called GPR40 agonists, which aim to stimulate insulin secretion in the pancreas.
Actos faced generic competition in August 2012. Sales of the drug peaked in the year ended March 2011 at 387.9 billion yen ($3.7 billion) for Takeda and accounted for 27 percent of its revenue at that time.
In January, Takeda won U.S. regulatory approval for a new treatment for diabetes called alogliptin, five years after its initial application. The approval was delayed as the regulators asked for more data on cardiovascular risks.
Takeda projects to report net income of 95 billion yen in the year ending March, the lowest level in 15 years. The company forecasts “mid single-digit” annual revenue growth through 2017 and annual operating-profit growth of 20 percent or more over the same period. It aims to cut annual costs by 100 billion yen by 2017, partly by reducing its workforce.
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