By Nathan Sadeghi-Nejad 09/21/12 - 07:48 AM EDT
NEW YORK (TheStreet) -- Thursday, Idenix Pharmaceuticals (IDIX) presented investors with a detailed update on IDX-184 and the earlier-stage IDX-19368, two hepatitis C drug candidates that were placed on clinical hold by the FDA last month.
Idenix' new investor slide deck, also filed as an SEC Form 8-K, offers lots of detail about the compounds' status and highlights management's admirably open-minded communication style. Unfortunately, I'm not convinced the company's woes will be easily fixed.
IDX-184 has had no safety issues to date. Nonetheless, structural similarities between Idenix's IDX-184 and Bristol-Myers Squibb's (BMY) BMS-094 were sufficient to warrant concern. Clinical development of the latter drug, which Bristol-Myers acquired in the $2.5 billion takeover of Inhibitex, has been discontinued because of severe cardiovascular toxicity.
The FDA's clinical hold -- effectively a "stop work" order triggered by unexpected safety issues -- suggests that regulators are also concerned about the safety of IDX-184. In order to get the clinical hold lifted and continue development, Idenix must now convince the FDA that IDX-184 doesn't put patients' lives at unnecessary risk. (At least one patient in the Bristol-Myers study died.)
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