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

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.

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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.

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