Regulatory Actions

Valopicitabine Development Program Placed on Clinical Hold in the United States

Published in Medical Letter on the CDC and FDA, August 5th, 2007

Idenix Pharmaceuticals, Inc. (NASDAQ:IDIX) announced that after discussions with the United States Food and Drug Administration (FDA) the development program of valopicitabine (NM283) for the treatment of hepatitis C has been placed on clinical hold in the United States based on the overall risk/benefit profile observed to date in clinical testing.

"We are disappointed with the FDA's perspective on the program and are working with Novartis to evaluate our options for valopicitabine," said Jean- Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "We remain committed to building a leading antiviral franchise and will continue to focus on ensuring a...

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Source: Medical Letter on the CDC and FDA (2007-08-05)

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