Gilead hands its hep C combo to the FDA as AbbVie race heats up

Gilead CSO Norbert Bischofberger

Right on schedule, Gilead Sciences ($GILD) has submitted its combination hepatitis C treatment for FDA approval, inching toward the era of interferon-free treatment and widening its lead on rival AbbVie ($ABBV).

Gilead handed in an NDA for its fixed-dose cocktail of the NS5A inhibitor ledipasvir and the polymerase inhibitor sofosbuvir, approved on its own last year as Sovaldi. In three Phase III studies on patients with the tough-to-treat genotype 1 variant of the virus, Gilead's combo notched cure rates as high as 99.1%, all without the need for painful interferon or ribavirin. The company expects its breakthrough-designated drug to win approval this year.

"Today's filing brings us one step closer to our goal of offering all patients with hepatitis C a simple, safe and highly effective all-oral treatment regimen," R&D chief Norbert Bischofberger said in a statement.

Meanwhile, rival AbbVie is preparing an interferon-eschewing combo of its own, planning to submit to the FDA next quarter and launch its contender by year's end, thus setting up an eventual battle for market dominance. Bringing up the rear is Bristol-Myers Squibb ($BMY), whose daclatasvir got the cold shoulder from Gilead when the biotech chose to advance its in-house combo instead of pairing Sovaldi with that NS5A blocker.

Analysts expect Sovaldi to notch peak sales of around $7 billion, assuming the now-filed combo therapy takes off. AbbVie's contender is expected to top out at just $3 billion a year, but the prospect of an eventual price war could well shift the balance of power between the two, and AbbVie could grab a bigger market share if it can woo payers away from Gilead's much-maligned pricing structures.

But once the two go head to head, Gilead will likely have a leg up in the convenience department: Its combination, developed as LDV/SOF, is a fixed dose in a single pill, while AbbVie's--which includes the antiviral agents ABT-267, ABT-333 and ABT-450/ritonavir--requires multiple treatments per day.

Notably, despite both expecting 2014 launches, neither company deigned to include sales from the two combos in their recent full-year revenue guidances.

- read the announcement

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