Bristol-Myers snags a hep C approval to piggyback on Gilead's blockbuster

Bristol-Myers Squibb ($BMY), playing catch-up in hepatitis C, picked up FDA approval for a virus-blocking agent to be used in tandem with Sovaldi, Gilead Sciences' ($GILD) blockbuster success.

The FDA approved Bristol-Myers' daclatasvir, to be sold as Daklinza, to work alongside Gilead's drug on patients with genotype 3 hep C, which accounts for about 10% of cases of the virus in the U.S., according to the agency. Daklinza is an NS5A inhibitor designed to halt hep C's ability to replicate. Added to the nucleotide-blocking Sovaldi, the drug posted 12-week cure rates as high as 96% among genotype 3 patients in Phase III trials, all without the need for taxing add-ons like interferon and ribavirin.

Gilead has an NS5A inhibitor of its own, ledipasvir, and combines it with Sovaldi in the market-leading combo treatment Harvoni. But that cocktail is approved only for genotype 1, giving Bristol-Myers a shot at shouldering its way into a hep C market currently dominated by Gilead and rival AbbVie ($ABBV).

UF's David Nelson

"The treatment landscape for HCV has radically evolved in recent years, and while we have achieved impressive (12-week cure) rates in genotype 1, genotype 3 still represents a clinical challenge," University of Florida professor and Daklinza investigator David Nelson said in a statement. "Not only are genotype 3 patients more complicated to manage, but the aggressive nature of their disease means there is a greater urgency to treat them."

Meanwhile, Bristol-Myers is angling to pick up a piece of the burgeoning market for next-generation hep C treatments after a few setbacks. Last year, citing the "rapidly evolving" nature of the field, the company ditched plans to develop a Harvoni-like combo of its own in the U.S., moving forward in Japan but limiting its stateside development to Daklinza alone.

Gilead and AbbVie currently control most of the market with their combo treatments, and each is working to rack up expanded approvals and develop new cocktails that cure more hep C patients in less time. Merck ($MRK), which spent nearly $4 billion on hep C biotech Idenix Pharmaceuticals last year, is also at work in the space.

- read the FDA statement
- here's Bristol-Myers' announcement

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