Merck looks poised to challenge Gilead

Share this article:
Merck adds heat to HCV competition
Merck adds heat to HCV competition

Gilead's hepatitis C medication Sovaldi may have more than angry lawmakers to contend with: Phase-II data for Merck's daily one-pill combination of MK-5172 and MK-8742 has analysts marking this drug as a potential rival to the $84,000 medication that has become famous both for its price and ability to purge patients of the HCV virus.

Merck's C-WORTHy was a randomized study among treatment-naïve genotype-1 patients. The study included one group which received the NS3/4A protease inhibitor MK-5172 and NS5a replication complex inhibitor MK-8742, without ribavirin for 24 or 12 weeks, and a second group which received the combination drug and ribivirin for 8 or 12 weeks.

The result: 97% clearance among the 12-week ribavirin-free group (97% of genotype 1a, and 100% of genotype 1b), 94% clearance among the 12-week with ribavirin group, and 83% clearance among the eight-week with ribavirin group.

Bump the treatment regimen up to 24 weeks, and the Merck-only therapy hit a 98% clearance rate.

Gilead's Sovaldi has also been shown to have a high 12-week clearance rate, but unlike Merck's experimental therapy, Gilead's approved all-oral is part of a larger anti-viral regimen, whereas Merck's experimental treatment could offer a one-and-done daily regimen.

Market watchers indicate that Merck's drug will put pressure on Gilead, but ISI Group analyst Mark Schoenebaum wrote in a Wednesday research note that it won't unseat Gilead's Sovaldi because of its limited target population—genotype-1 patients.

Gilead's Sovaldi has the potential to be used across multiple genotypes, and the company is also working on its own one-and-done combination which mixes Sovaldi and ledipasvir for genotype-1 patients.

While Schoenebaum's analysis covers a potential face-off between Gilead and Merck, the hepatitis fight includes additional entrants, such as AbbVie, which is working on a multi-pill all-oral regimen in additional to an all-in-one oral treatment, and Bristol-Myers Squibb, which announced Thursday that Phase-III results of its all-oral hepatitis C treatment had a 90% viral clearance rate among treatment-naïve patients after 12 weeks of therapy.

Share this article:
You must be a registered member of MMM to post a comment.

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...