Idenix Pharmaceuticals, Inc.'s ( IDIX ) pipeline woes
continue with the company recently receiving a verbal communication
from the US Food and Drug Administration (FDA) for its lead uridine
nucleotide prodrug candidate, IDX20963.
The FDA has asked the company to provide additional preclinical
safety information on IDX20963, which is being developed for the
treatment of hepatitis C virus (HCV). Idenix was looking to move
IDX20963 into clinical studies this year. However, these plans will
now have to be put on hold as the company needs to provide
satisfactory answers to the FDA before it can commence clinical
studies in the US.
Idenix has been hit by several pipeline-related setbacks over
the past few quarters. Last year in August, the FDA had put IDX184
on partial clinical hold and IDX19368 on clinical hold due to
safety concerns after serious cardiac-related adverse events were
found to be associated with Bristol-Myers Squibb
Company's ( BMY ) BMS-986094. All
three candidates were 2′-methyl guanosine nucleotide prodrugs being
studies for the treatment of HCV.
Idenix subsequently submitted the requested cardiac safety data
for IDX184 to the FDA in Dec 2012. However, the FDA informed
Idenix that the IDX184 and IDX19368 programs would remain on
clinical hold. Hence, the company decided to discontinue the
development of these programs in Feb 2013.
The delay in the initiation of clinical studies for IDX20963 is
a major disappointment for Idenix and we expect shares to be
negatively impacted by the news. Currently, we have low visibility
on when the company will be allowed to move the candidate into
phase I studies.
The HCV market is highly competitive with several companies
working on bringing new treatments to market. Therefore, any delay
in the development process would give competitors an edge.
Currently, companies like Vertex
Pharmaceuticals ( VRTX ) and
Bristol-Myers Squibb among others are working on bringing new HCV
treatments to market.
Idenix currently carries a Zacks Rank #3 (Hold). At present,
Biogen Idec ( BIIB ) looks more
attractive with the company carrying a Zacks Rank #1 (Strong
Buy).BIOGEN IDEC INC (BIIB): Free Stock Analysis
ReportBRISTOL-MYERS (BMY): Free Stock Analysis ReportIDENIX PHARMA (IDIX): Free Stock Analysis
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