J&J, BMS join forces in race to develop interferon-free hep C combos

As interest in interferon-free hepatitis C combos reaches a fever pitch, a unit of Johnson & Johnson ($JNJ) and Bristol-Myers Squibb ($BMY) revealed plans to combine oral drugs and test them in patients with the liver-damaging illness. The news follows Gilead Sciences' ($GILD) recent move to buy clinical-stage developer Pharmasset ($VRUS) for $11 billion to gain control of its interferon-free treatment for hep C.

With analysts projecting the interferon-free combos to become the next frontier of treatment, BMS and Tibotec Pharmaceuticals will put their respective compounds, daclatasvir and TMC435, to the test in a Phase II study in patients with genotype 1 hepatitis C. The study, slated to begin in early 2012, will test the pair of experimental drugs alone, in combination with the antiviral drug ribavirin and with interferon. It will enable the companies to compare the sustained viral response of the three regimens at 12 weeks and 24 weeks, according to the companies' release.

Tibotec's TMC435, which it's developing with Swedish biotech Medivir, is already in late-stage development, but in combination with interferon, an injected drug notorious for side effects that often make patients with hepatitis C feel sicker than their disease does. Today, even the latest approved treatment regimens, including Vertex's ($VRTX) hot new hep C drug Incivek and Merck's ($MRK) Victrelis, require interferon injections. Doctors are expected to embrace the interferon-free options if they get approved. Pharmasset's lead in developing such an option with its experimental PSI-7977 drew Gilead to the developer for the blockbuster buyout.

Medivir said in July that it planned to begin a midstage trial to test an interferon-free combo of Pharmasset's PSI-7977 and its TMC435. Bristol-Myers Squibb is also testing its experimental antiviral daclatasvir in combination with PSI-7977. Clearly, competitors in this field see a big opportunity to cooperate and combine their assets to grab a piece of the multibillion-dollar market anticipated for interferon-free cocktails to combat the disease. 

"Bristol-Myers Squibb is dedicated to developing innovative treatment options for patients with serious diseases like HCV," stated Brian Daniels, the company's senior vice president of development. "We are pleased to work with Tibotec to advance the scientific understanding for the potential for an all-oral regimen of direct acting antivirals, which would be an important advancement for patients with HCV. This is a continuation of our leadership in forging partnerships to advance combination antiviral therapy."

- here's the release

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