Bristol-Myers' hep C combo wins Japanese OK, leading the pack

Bristol-Myers Squibb ($BMY) has become the first drugmaker to win regulatory approval for a combination hepatitis C treatment that doesn't require painful injections, picking up a Japanese nod for its all-oral cocktail.

The country's Ministry of Health, Labor and Welfare has OK'd a combination of the NS5A inhibitor daclatasvir (Daklinza) and the NS3/4A protease inhibitor asunaprevir (Sunvepra), making the combo the world's first interferon- and ribavirin-free treatment regimen to be approved. The drug is indicated for patients with genotype 1 hep C--the most common form of the virus--who either can't handle interferon or have failed with other treatments.

Bristol-Myers' win marks the first approval among the cadre of drugmakers working to commercialize all-oral hep C cures around the globe, a group that includes Gilead Sciences ($GILD), AbbVie ($ABBV) and Merck ($MRK). Gilead and AbbVie have already submitted their cocktails to the FDA and expect U.S. approvals this year.

For Bristol-Myers, the Japanese nod is a major development in the company's global plans in hep C, CEO Lamberto Andreotti said. The daclatasvir-asunaprevir combo picked up the FDA's coveted breakthrough therapy designation earlier this year, and a European Medicines Agency committee voted in favor of the former last month, setting the table for a near-term approval on the continent.

"This milestone underscores the company's commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally," Andreotti said.

Once approved, the new class of treatments is expected to dominate a market now ruled by Gilead's top-selling Sovaldi. But, much as interferon-free combos with near-100% 12-week cure rates are likely to unseat that drug, developers believe the next big thing in hep C will be brevity.

Bristol-Myers is running an early-stage test matching its combo with Sovaldi in hopes of crafting a four-week therapy. Meanwhile, Merck is paying $3.9 billion for Idenix Pharmaceuticals ($IDIX) to get its hands on assets that could fuel a similarly fast cure, and Gilead is testing out an in-house combo with the same potential.

- here's the release