Idenix is focused on developing small molecule drugs for hepatitis and HIV. As of December 2010, Novartis owns 43% of Idenix and has the option to license any of Idenix’s compounds after proof of concept data are generated. The first two products licensed by Novartis were Telbivudine for hepatitis B and NM283 for hepatitis C. While Telbivudine received approval in the US and Europe in 2006-2007, sales have been disappointing as the product’s profile is not competitive. In addition, nucleoside polymerase inhibitor NM283 was dropped in Phase II due to toxicity and modest efficacy. Idenix has since created a portfolio of additional compounds for hepatitis C and will have generated a lead compound from each key class of agents by the end of 2011, putting it in a strong position to participate in the race to develop an all-oral, interferon-sparing regimen.

The lead compound is nucleoside polymerase inhibitor IDX184. Initial data from a Phase IIa trial were promising, but the drug was placed on clinical hold in September 2010 following unexpected toxicity seen in a combination study with its protease inhibitor IDX320. We believe that the FDA will remove the hold on IDX184 early in 2011, after which we expect the start of Phase IIb trials and the addition of a partner.

Back