03-Nov-08 13:00 Idenix in advanced partnership discussions on IDX-899 with more than one party, CFO says
Story Idenix is "far down the path," and in advanced partnership discussions with more than one party on IDX-899, said CFO Ronald Renaud. A deal should be in place by year-end, he added.
Idenix began informal discussions with all major HIV players about a year ago but, once the company amassed proof of concept data, the discussions became more serious, Renaud noted. "We don't have a specific deal in mind. There is no good benchmark for HIV partnering," he said.
IDX899 is a novel non-nucleoside reverse transcriptase inhibitor (NNRTI) that is currently undergoing Phase I/II clinical trials.
Gilead is the "lead suspect," according to an analyst who cited the fact that Sustiva, an NNRTI that is part of the company's triple combination regimen, will go off patent in 2013. Merck, Bristol-Myers Squibb and perhaps GlaxoSmithKline could also be potential partners for IDX-899, the analyst noted.
While Novartis owns 56% of the company, the company has already publicly stated that it is not involved in the HIV space, which is why the company is shopping IDX-899 around, according to the analyst.
Although there has been criticism on the company's lack of co-formulation studies with IDX-899, the rationale was that Idenix did not want to spend USD 5m-10m conducting formulations trials when it is unknown who would ultimately partner the compound, rendering some studies useless, Renaud said.
Renaud noted that the company's expectation is early demonstration of safety and efficacy. The compound has a high barrier to resistance, and its 100 mg pill is potent enough for once-daily dosing. The company's strategy is to forge a deal early on to make sure the compound is partnered with a critical mass of drugs, he added.
The data thus far is promising for combination, Idenix CEO Dr Jean-Pierre Sommadossi said at a recent investor conference.
"Essentially, there would probably be about 18 months of more studies before Phase III trials," Renaud said. "We will continue with the formulation that we have until Phase III."
When asked whether the company would entertain new bidders, Renaud noted that the release of proof of concept data in September indeed caused new bidders to contact the company. "It's never too late, if it's a good offer," he added.
However, since the company is in advanced discussions, if a bidder came in today, it would have to quickly get up to speed. "We have to close before year end. That's our major goal for the year," he said.
A physician speculated that the recent decline in share price is likely due to the fact that the company's hepatitis C virus (HCV) pipeline is still pre-clinical and investors are waiting for validation in a difficult area.
The company is also developing three different classes of direct antivirals to combat HCV - a protease inhibitor, a non-nucleoside inhibitor and a nucleoside inhibitor, which the company hopes can be combined to form a new treatment paradigm.
IDX-184, the company's lead HCV nucleoside polymerase inhibitor, has already completed Phase I studies and will go into proof of concept studies in the coming weeks. The candidate is active against all genotypes, Sommadossi said. Because of costs and timing, the company will only take one protease inhibitor into the clinic. Idenix has completed seven-day toxicology studies with its two protease inhibitors.
"It is clear that we will make a decision in the next two months on which candidate will forward into IND," said Renaud.
by Kimberly Ha and Sasha Damouni in San Francisco and Elizabeth Krutoholow in New York
Source Pharmawire
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