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Vertex, Bristol-Myers mix pills for Phase II study in hepatitis C

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Vertex Pharmaceuticals ($VRTX) has found another ally as the company plays catch up in the race to advance all-oral therapies against hepatitis C. Vertex and Bristol-Myers Squibb ($BMY) have agreed to combine experimental compounds to test in Phase II trials, the first of which will kick off during the current fiscal quarter.

The first study pairs Vertex's nucleotide analogue VX-134 with the NS5A inhibitor daclatasvir as a once-daily oral regimen, targeting 20 patients with genotype 1 disease who have not received prior treatment. Depending on the results of that test, Vertex plans to begin a second Phase II trial of the two compounds in a much larger, 250-patient trial involving patients with genotypes 1, 2 and 3 hepatitis C in the second half of the year. Beyond standard safety and tolerability, the study will measure cure rates at 4 and 12 weeks.

Vertex licensed VX-134 and other compounds from Alios BioPharma in 2011, and last year the company inked separate deals with Johnson & Johnson's Janssen and GlaxoSmithKline ($GSK) to study its lead 'nuc' drug in different all-oral combos against hep C. In 2011, Vertex had a successful commercial campaign for its new hep C drug Incivek only to see the fortunes for the brand diminish last year, as newer all-oral combinations advanced into late-stage development, offering more rapid cure rates and treatment without interferon.

Gilead Sciences ($GILD) has sped ahead of most of the hep C contenders with its all-oral regimen built around a nuc compound from its $11 billion buyout of Pharmasset last year. The drugmaker could have the first all-oral regimen to hit the U.S. market, giving the company an inside track on a $20 billion-plus market opportunity.

Unlike Gilead, Bristol-Myers faired poorly with the company's big gamble on an experimental nuc from its $2.5 billion purchase of Inhibitex last year. The drug giant ended development of the drug, BMS-986094, after one patient suffered from heart failure in a Phase II study last summer.

But Bristol-Myers has moved other candidates into Phase III development and could be the first company with an all-oral regimen on the market in Japan.

- here's Vertex's release
- and Dow Jones' update

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