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Merck stakes a claim to all-oral hepatitis C market

Positive data for interferon-free regimen
Merck and Co - US headquarters

Merck & Co presented phase II data on its own interferon-free regimen for hepatitis C virus infection over the weekend, as it vies to get its own share of a market estimated at $10bn-plus.

The US pharma giant is lagging behind some of its competitors in the race to bring an all-oral hepatitis C regimen to market, but is now planning to advance its combination - once-daily NS3/4A protease inhibitor MK-5172 and NS5A replication complex inhibitor MK-8742 with ribavirin once- or twice-a-day - into late-stage testing.

Interim data from the phase II trial - called C-WORTHY - appear to back Merck's decision, with the combination driving hepatitis C to undetectable levels in the blood after just 12 weeks in patients with the most common (genotype 1) form of the virus.

At the moment, standard regimens based on pegylated interferon, a hepatitis C protease inhibitor - currently either Merck's own Victrelis (boceprevir) or Vertex' Incivek (telaprevir) - and ribavirin are the standard therapy for hepatitis C.

However, the combination requires dosing for up to 48 weeks, while interferon therapy is associated with significant side effects that can deter patients from starting or maintaining treatment.

Incivek and Victrelis are both seeing sales fall off after dramatic growth since their launch in 2011, which has been attributed to patients waiting for the new all-oral regimens to reach the market and - in the case of Incivek - concerns about side effects.

The FDA has also been impressed by the regimen, and granted it a breakthrough designation earlier this month, although that status has also been given to all-oral regimens in development at Gilead Sciences, AbbVie and Bristol-Myers Squibb, which are all further along than Merck's candidates.

Last week for example, an FDA advisory committee voted in favour of approving Gilead's NS5B polymerase inhibitor sofosbuvir alongside ribavirin as the first all-oral treatment for genotypes 2 and 3 hepatitis C, and also as a combination with interferon for genotypes 1 and 4. An all-oral combination containing sofosbuvir for genotype 1 is due to report late-stage data in 2014.

Article by
Phil Taylor

4th November 2013

From: Research



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