Idenix Pharmaceuticals Inc. (IDIX) was verbally notified by the
U.S. Food and Drug Administration that its drug programs to treat
the virus that causes hepatitis C are on hold.
The biopharmaceutical company said the delay came after Idenix
notified the U.S. regulator of three instances of elevated liver
function related to a drug-interaction study related to two of its
drug compounds. The three patients liver function tests returned to
nearly normal levels during follow-up, the company said.
Chairman and Chief Executive Jean-Pierre Sommadossi said, "We
have not yet received a formal letter from the FDA, nor has the
agency had an opportunity to review the safety and efficacy data
from recently completed clinical trials."
Idenix will submit data to the FDA from recently completed
trials, including toxicology, proof of concept and drug-interaction
studies to assess the next steps in the development of the
treatments.
The company plans to work closely with independent experts and
an external safety committee to determine the cause of the liver
issues.
Shares closed Friday at $5.99 and were inactive premarket.
Markets were closed Monday for Labor Day. The stock has nearly
tripled this year amid favorable interim results in January and
April related to the drug.
-By Tess Stynes, Dow Jones Newswires; 212-416-2481;
Tess.Stynes@dowjones.com