Bloomberg News

Achillion’s Hepatitis C Drug Remains on Hold by U.S. Regulators

September 27, 2013

Achillion Pharmaceuticals Inc. (ACHN:US) said U.S. regulators are keeping the company’s experimental hepatitis C drug sovaprevir on hold because of abnormal liver results. The shares plunged 45 percent in extended trading.

While Achillion responded to all the issues raised by the Food and Drug Administration in June, the agency determined the drug’s development shouldn’t resume, the New Haven, Connecticut-based company said today in a statement. Achillion will focus on other hepatitis C drugs in its portfolio, with results of a planned combination study of two medications by next year, Chief Executive Officer Milind Deshpande said.

“While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all oral combination regimens for the treatment of HCV,” Deshpande said in the statement.

High levels of liver enzymes, which can indicate damage, were observed in healthy patients when sovaprevir was combined with two medicines used to treat HIV infections, the company said in July. The tests were performed to look for possible drug interactions. The combination may have resulted in higher-than-expected blood levels of the therapies, Achillion said in July.

Achillion has three drugs in clinical testing for hepatitis C, a liver disease estimated to affect 170 million people worldwide. It is competing with drugmakers including AbbVie Inc. (ABBV:US) and Gilead Sciences Inc. (GILD:US) to develop new treatments for the disease, a market analysts’ estimate may be $20 billion.

The company declined (ACHN:US) to $4 in extended trading at 5:02 p.m. New York time after closing at $7.24. Achillion’s shares had dropped 9.6 percent this year through today’s close.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net


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Companies Mentioned

  • ACHN
    (Achillion Pharmaceuticals Inc)
    • $11.45 USD
    • 0.00
    • 0.0%
  • ABBV
    (AbbVie Inc)
    • $55.6 USD
    • -0.10
    • -0.18%
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