European regulators are recommending approval for Bristol-Myers Squibb's ($BMY) daclatasvir, a hepatitis C-fighting antiviral that plays a key role in the company's planned combo treatment.
A European Medicines Agency committee has handed down a positive opinion on daclatasvir, a pan-genotypic NS5A complex inhibitor designed to work in concert with other agents to treat chronic hep C. Bristol-Myers' agent is the first of its kind to win any European backing, the company said, and the drug is now likely to receive full approval in the coming months.
The drug, which will sell as Daklinza, is the cornerstone of Bristol-Myers' in-development cocktail therapy for hep C, an all-oral combination that includes the investigational asunaprevir and BMS-791325 and won the FDA's breakthrough therapy designation last year.
However, the antiviral's greatest promise may come in combination with Sovaldi, the top-selling hep C treatment from rival Gilead Sciences ($GILD). Bristol plans to initiate a trial next month combining its three-drug therapy with the former sofosbuvir, creating an oral cocktail the company believes could notch near-100% cure rates while cutting treatment time down to as little as four weeks. Gilead's drug is approved as a 12-week regimen.
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| Gilead's Sovaldi, Bristol's best-selling hep C competition--Courtesy of Gilead |
Bristol-Myers is among a cadre of drugmakers undaunted by Gilead's brisk success with Sovaldi, which analysts say could bring in more than $8 billion this year. AbbVie ($ABBV) has developed a four-drug cocktail treatment that eliminates the need for painful interferon, expected to receive U.S. and European approvals this year and hit the market just behind a similar Sovaldi-based combo from Gilead. Bristol-Myers and Merck ($MRK) are working up similar piggyback therapies that have notched sky-high cure rates in clinical trials.
Once approved, those interferon-free treatments are likely to dominate the market, but drugmakers believe the next big thing in hep C will be brevity. Aside from Bristol-Myers' work on a four-week treatment, Merck is paying $3.9 billion for Idenix Pharmaceuticals ($IDIX) to get its hands on assets that could fuel a fast cure, and Gilead is testing out an in-house combo with the same potential.
- read Bristol-Myers' statement
- here's the EMA release (PDF)