AbbVie heads to the FDA with its hep C combo in a race with Gilead, Merck

AbbVie ($ABBV) has submitted an FDA application for its promising all-oral hepatitis C treatment, expecting approval this year as it prepares for a three-way race with perceived leaders Gilead Sciences ($GILD) and Merck ($MRK).

The drug, a combination of three antiviral agents, is part of a new class of highly effective hep C treatments that eschew shots and work without interferon, a painful adjunct to standard therapy that keeps some patients at bay. Across 6 Phase III studies in more than 2,300 patients with the tough-to-treat genotype 1 hep C, AbbVie's therapy charted impressive 12-week cure rates, notching a 99% sustained virologic response mark in some populations. The company's FDA filing falls right in line with its previously disclosed schedule, and AbbVie has said it plans to launch the cocktail therapy later this year.

That should put it right behind Gilead, which in February filed an application for a combo of its own that pairs the blockbuster antiviral Sovaldi with an NS5A inhibitor called ledipasvir.

AbbVie had long been in line for a silver medal in the coming wave of next-gen hep C drugs, but some surprisingly strong Phase II data from latecomer Merck have altered the landscape in the minds of analysts. In results unveiled at this month's International Liver Congress in London, Merck's combination of MK-5172 and MK-8742 posted a 12-week cure rate of 98% in genotype 1 patients, leading ISI's Mark Schoenebaum to speculate that peak estimates for the drug could rise as high as $3.2 billion and Citi's Yaron Werber to pencil the company in for an eventual second-place spot behind Gilead.

That may be a bit hasty for a drug that probably won't hit the market until 2016, but Merck is likely to have AbbVie beat in terms of convenience if and when the treatments contend with one another. Unlike the once-a-day, fixed-dose offerings from its rivals, AbbVie's candidate requires patients to handle multiple pills each day to mete out its three antiviral agents: ABT-267, ABT-333 and ABT-450/ritonavir.

But, with 12-week efficacy looking pretty similar for all three treatments, the deciding factor in the coming fight for hep C market share will likely be price, and, with payers already in open revolt over Sovaldi's $1,000-a-pill price tag, there should be plenty of room for AbbVie and Merck to get creative.

Meanwhile, biotech Enanta ($ENTA), which co-developed ABT-450, is due a $20 million milestone payment in line with the FDA filing, and the company will get $20 million more when AbbVie submits a European application.

- read AbbVie's release
- here's Enanta's statement