By Nathalie Tadena and Kristin Jones
Idenix Pharmaceuticals Inc. (IDIX) said it will discontinue its
clinical development program for two of its investigational
treatments for hepatitis C, after the U.S. Food and Drug
Administration said the treatments would remain on clinical
hold.
Shares, which were halted briefly on the news, fell 9.7% to
$4.27 after hours Monday. Through the close, the stock was down 42%
in the past six months.
The treatments--IDX184 and IDX19368--were placed on clinical
hold by the FDA in August. The clinical hold was related to the
regulator's heart-safety concerns about rival Bristol-Myers Squibb
Co.'s (BMY) treatment for the liver disease, BMS-986094, which
belongs to the same class of drugs--known as nucleotide polymerase
inhibitors.
In December, Idenix submitted cardiac safety data for IDX184 to
the FDA, and the company said it "has found no evidence of severe
cardiac findings to date." But the FDA told the company earlier
this month that both treatments would remain on clinical hold.
Chief Executive Ron Renaud said the company intends to "maintain
our strong presence in developing nucleotide polymerase inhibitors"
for hepatitis C. It plans to file an investigational new-drug
application for a separate compound in the first half of 2013 and
to continue its preclinical developments of other nucleotide
drugs.
Hepatitis C is a blood-borne virus that afflicts an estimated 4
million Americans and 170 million people world-wide. The disease
often is contracted during sex or by sharing needles.
Current treatment of the drug requires long courses of painful
injections and often doesn't work. Drug makers have been racing to
find pills that are both more potent and easier to take.
Write to Nathalie Tadena at nathalie.tadena@dowjones.com and
Kristin Jones at kristin.jones@dowjones.com
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