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Gilead scrambles toward hep C cure-all with next-gen combo pill

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ISI anaylst Mark Schoenebaum

Gilead ($GILD) won the race to be the first to market with an interferon-free oral therapy that can essentially wipe out all traces of the virus for a large group of patients. Now it's angling to follow up that big score with a single combo pill that can do the job for just about everyone in the megablockbuster market.

The biotech--under intense criticism for pricing Sovaldi at $84,000 in the U.S. for the 12-week treatment--posted an abstract for the upcoming meeting of the European Association for the Study of the Liver that outlined 100% cure rates among small groups of patients across 6 genotypes taking one of two doses of a Sovaldi combination treatment. The big add here is GS-5816, a next-gen NS5A inhibitor that added the essential ingredient for a new regimen that promises to eliminate any need for interferon as well as ribavirin.  

Mark Schoenebaum, a high-profile analyst for ISI and a longtime booster of Gilead's blockbuster hepatitis C efforts, gives the biotech the inside track to one of the Holy Grails in biotech: one pill that can conquer the entire global market.

"This molecule is very important (for) Gilead longer term because the "holy grail" of hep C treatment would be a pan-genotypic one pill once per day regimen," Schoenebaum wrote in a hastily penned note to investors Monday morning. "In other words, no matter what genotype of hep C a patient has, there is a single pill that can cure it. This currently does NOT exist. MRK has made some prior claims that they may have a pan genotypic protease inhibitor based regimen, but we have not seen data yet to prove the "pan-genotypic" assertion (very little new data in MRK's EASL abstracts). We expect to learn more at EASL in a few weeks."

Gilead, he adds, plans to start a Phase III study of the combo in the third quarter of this year, with a filing expected in 2015.

As noted, Merck ($MRK) posted an abstract today noting 100% cure rates for genotype 1 patients with the combination of MK-5172/MK-8742 with ribavirin. The combo matches an NS3/4A protease inhibitor with an NS5A inhibitor.

A group of developers are racing ahead in the clinic with new hep C cures, angling for a slice of a huge market pie. Physicians have been warehousing patients looking for a new therapy to come along that eliminates interferon, an injectable that is associated with harsh side effects common to many patients. Among the leaders in the race to develop combo treatments is AbbVie ($ABBV), which is in a late-stage program with a potential breakthrough. Gilead, determined to keep up the hectic R&D pace needed to stay in the lead, filed an NDA for its first combo using the NS5A inhibitor ledipasvir in February.

Related Articles:
Gilead says payers feel comfortable with the cost of Sovaldi
Gilead backs exuberant analyst projections for new hep C drug
Gilead hands its hep C combo to the FDA as AbbVie race heats up

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