It is not the big event that some might have been hoping for, but Idenix shareholders may feel some comfort from a non-exclusive agreement with Johnson & Johnson to test Idenix’s NS5a-inhibitor IDX719 with J&J's phase III protease inhibitor simeprevir and non-nucleoside inhibitor TMC647055.
Although no terms were disclosed it should shift some of the focus from the clinical hold on Idenix's lead product, IDX184, and get the serial laggard back in the race to develop an all-oral interferon-free hepatitis C treatment. However, with the setbacks the company has experienced its chances of reaping significant rewards from the large population of patients thought to be waiting for a more tolerable treatment regimen have narrowed.
Shares in Idenix, which have been in the doldrums for several months, rose by 4% to $4.73 on news of the deal, indicating that many investors are still waiting for news from the FDA that IDX184, a protease inhibitor, has been released from its partial clinical hold before returning to the stock.
The project was put on ice after serious cardiovascular events emerged from Bristol-Myers Squibb’s BMS-986094, which shares the same active metabolite as IDX184 (Idenix hep C drug hit by cardiovascular worries, August 16, 2012). Late last year Idenix submitted more safety data to the FDA in an attempt to get back into the clinic, but the agency then said it needed more time to review the data, again knocking the shares.
So, while not being the one leap that could set Idenix free, the deal is nevertheless positive and also shows that Idenix can live up to its promises. Management had said last year that it would pull a non-exclusive deal out the bag in 2013, and now it has delivered something that might go some way to restoring investor confidence.
By not being tied to J&J Idenix also leaves itself free to form collaborations with other companies that like J&J have a protease inhibitor but are looking for a pan-genotypic NS5a to help tackle the harder-to-treat hep C genotypes.
Conversely, it also means that J&J, which has struck several such partnerships, is free to make a decision on a combination product that does not include Idenix’s IDX719. This leaves it firmly in control of the partnership, despite Idenix handling the clinical development.
Room in the market
On the clinical front if everything goes to plan, including an initial combination study, the deal with J&J should put Idenix on track to have data from two subsequent 12-week, phase II studies by the end of the year. The first study of IDX719 with simeprevir and interferon is expected to start this quarter and involve patients with type Ib and IV genotypes. Depending on the results a second trial of the two agents and TMC647055, with or without an interferon, will begin.
However, even without hiccups the timing of these trials will leave the J&J-Idenix combination two years behind the market leaders, GileadSciences and Abbott, and at least a year behind a host of other contenders including Vertex and GlaxoSmithKline (Signs are growing that the hep C ship is sailing, August 1, 2012).
This might not be a cause for despair, as it is likely that the hep C market will eventually start to look a lot like the HIV one, where multiple combination products are used, and success can depend on efficacy and tolerability and not just speed to market.
If this is the case, there could still be room for Idenix, which itself will be looking to use the valuable safety database from the J&J trials as a springboard for its own efforts eventually to create an all-oral drug combination.