As Gilead nears a virtually guaranteed FDA approval for the hepatitis C-fighting sofosbuvir, the biotech is facing intellectual property challenges from a bevy of competitors, most recently Idenix Pharmaceuticals, which claims the blockbuster hopeful infringes on its patents.
The FDA has hit the biotech group with a request for more preclinical data on IDX20963, which is Idenix's lead drug in the closely watched class of uridine nucleotide prodrugs, sometimes called "nucs" for short.
Welcome to this week's roundup of hirings and firings throughout the industry. Please send the good word (or the bad) from your shop to Michael Gibney (email | Twitter) or Emily Mullin (email |...
For the past few weeks Idenix has been methodically moving away from its once-promising hepatitis C drugs, put on clinical hold by a jittery FDA in the wake of a catastrophic trial of a somewhat similar drug at Bristol-Myers Squibb.
Anxious to shake itself out of a painfully long regulatory limbo that has ensnared its top drug prospect, Idenix this morning announced that it has struck a deal to collaborate with J&J on another new hep C cocktail.
Idenix, which had hoped to answer regulators' safety queries about IDX184 and IDX19368 and move on, says the FDA wants more time to study the drugs and the implications of the BMS-094 disaster before it makes a decision on the future of the two drugs.
Idenix already faces a partial clinical hold on its top hepatitis C program. Now the FDA has stepped in to add a clinical hold on its preclinical therapy IDX19368, another nucleotide polymerase inhibitor, or "nuc," in the pipeline.
Idenix Pharmaceuticals went into free fall this morning, tumbling about 40% on the news that its nucleotide polymerase inhibitor IDX184 was put on partial clinical hold as the FDA studies whether a recent cardiac event that may well have spiked a similar treatment at Bristol-Myers Squibb raises similar toxicity issues for Idenix.
Idenix and Novartis have agreed to terminate the pharma giant's option rights outlined in a 9-year-old licensing pact. Under a revised agreement, Novartis--which owns 31% of Idenix--will gain a royalty stream on approved hep C drug that comes out of the biotech.
At the BIO CEO & Investor Conference in New York yesterday, Achillion CEO Michael Kishbauch wrapped up his remarks on the biotech's hepatitis C programs by making it clear that he was angling for