Idenix moves out of FDA limbo with J&J hep C combo pact

Anxious to shake itself out of a painfully long regulatory limbo that has ensnared its top drug prospect, Idenix Pharmaceuticals this morning announced that it has struck a deal to collaborate with J&J ($JNJ) on another new hep C cocktail. Idenix will match its NS5A inhibitor IDX719 with J&J's once-daily protease inhibitor TMC435 (partnered with Medivir) and TMC647055, a once-daily, non-nucleoside polymerase inhibitor, boosted with low dose ritonavir.

No financial terms were disclosed, but the deal puts Idenix ($IDIX) in charge of a drug-drug interaction study that is intended to swiftly open the door to Phase II. Idenix shares got a 10% bounce on the news.

Idenix execs began to openly discuss its strategy to move on at the J.P. Morgan event in San Francisco earlier this month. At one point its "nuc" IDX184 was considered a leading prospect in the field. Then Bristol-Myers Squibb's ($BMY) somewhat similar BMS-094 program went up in flames after the death and injury of several patients, the FDA put a hold on Idenix work--including IDX19368--and the biotech has been in limbo ever since. Idenix now doesn't expect to hear back from the FDA until March, triggering plans to shake itself out of a frozen pose.

"We are very pleased to be working with Janssen and look forward to initiating a Phase II study in the first quarter of this year," said Idenix CEO Ron Renaud. "This will allow us to achieve a key goal of ours for 2013, which is to advance the development of IDX719 as part of all-oral HCV combinations in two- and three-drug regimens."

The new program leaves Idenix well behind hep C leaders like AbbVie ($ABBV) and Gilead ($GILD). TMC435 is also partnered in a separate hep C program with Vertex's experimental "nuc" VX-135.

- here's the press release

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