Shares of Achillion Pharmaceuticals Inc. (ACHN) surged 83 percent on Tuesday after the U.S. Food and Drug Administration lifted the clinical hold on the company's investigational hepatitis C drug sovaprevir.
This is the second time in as many days that Achillion shares have seen a rally. Yesterday, the stock surged to its highest level since late January, as investors, seeing promise for its hepatitis C pipeline, speculated that Achillino could be a takeover target.
It was about a year ago, when the FDA placed a clinical hold on Achillion's sovaprevir after elevated liver enzyme levels were observed in patients, due to higher-than-expected exposures to sovaprevir and another drug, atazanavir.
The FDA move to lift clinical hold indicates Achillion can conduct trials with a maximum of 200 mg once daily of sovaprevir in hepatitis C viral infection (HCV) patients and in single dose trials in healthy volunteers.
However, the FDA has maintained a partial clinical hold for multiple dose studies of sovaprevir that may be conducted in healthy volunteers, requiring prior review and approval of the protocol by the Agency.
Achillion said that the previously evaluated dose of sovaprevir—which was well-tolerated with clinical activity in two completed Phase 2 studies—may be used in additional therapeutic clinical trials.
The development at Achillion comes at a time when hepatitis C drug makers are seen as promising acquisition targets. Merck (MRK) on Monday agreed to acquire Idenix Pharmaceuticals (IDIX), a developer of hepatitis C drugs, for $3.85 billion.
A biopharmaceutical company, New Haven, Connecticut-based Achillion focuses on developing combination therapies for the treatment of chronic hepatitis C (HCV) infection and resistant bacterial infections. The company currently has no products on the market.
Sovaprevir is a Phase 2 NS3/4A protease inhibitor being developed for the potential treatment of chronic HCV infection. To date, about 550 subjects have been exposed to sovaprevir with clinical activity reported in two Phase 2 12-week treatment duration studies.
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the U.S.
Achillion stock closed Tuesday at $7.79, up $3.54 or 83.29%, on a volume of 74 million shares on the Nasdaq. In after hours, the stock dropped $0.11 or 1.41%, to trade at $7.68.
by RTT Staff Writer
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