Merck gets hep C boost as competition ramps up
pharmafile | April 11, 2014 | News story | Research and Development, Sales and Marketing | Merck, daclatasvir, hep C, sovaldi
Merck has released promising data from a trial which uses two of its investigational compounds to treat patients with hepatitis C virus (HCV).
The ongoing C-WORTHy Phase II study is looking at a once-daily, oral regime combining NS3/4A protease inhibitor MK-5172 and NS5A replication complex inhibitor MK-8742 in patients with chronic HCV Genotype 1 infection (GT1).
Merck said that 98% of treatment-naïve, non-cirrhotic patients taking MK-5172/MK-8742 alone for 12 weeks showed a sustained viral response (SVR), while 94% of those administered with this combination plus ribavirin (RBV) had an SVR.
The interim analysis was presented at The International Liver Congress 2014 in London.
This is a boost for Merck, who will be keen to challenge Gilead’s once-daily, oral hepatitis C treatment Sovaldi (sofosbuvir), which was shown the green light by the European Commission in January, just a month after being approved in the US.
“These Phase II results add to growing evidence for the potential efficacy of MK-5172 and MK-8742 for treatment of chronic HCV infection,” says Eliav Barr, vice president, infectious diseases at Merck Research Laboratories.
“These findings are integral to advancing our research of these investigational candidates into C-EDGE, the Phase III clinical program that will seek to more broadly evaluate the potential of MK-5172/MK-8742 in diverse patient populations,” he added.
Around 170 million people worldwide have HCV, a virus that infects the liver and can lead to cirrhosis and liver cancer, with nine million estimated to be living with the disease in the European Union.
Bristol-Myers Squibb’s daclatasvir, an investigational NS5A replication complex inhibitor, is also in the mix as a treatment in this therapy area.
It is currently being looked at by the European Medicines Agency and would be the EU’s first all-oral and ribavirin-free investigational regimen for use in treatment-naïve genotype 1, 2, 3 patients and protease inhibitor treatment failures, should it be approved.
It is a potentially lucrative area for manufacturers: the market for hepatitis C drugs could rise to more than $100 billion over the next decade, according to Bloomberg Industries.
But Sovaldi is seen as becoming the market leader, with analysts at Wall Street forecasting annual sales of an impressive $9 billion or more.
The drug has seen a major backlash this week, however, after the World Health Organization criticised its $1,000 a day, or $84,000 for a 12-week course of treatment price tag, saying these new drugs must be priced in-line with what the world can afford.
Yesterday John Castellani, president of US pharma lobby group PhRMA, said at their annual meeting in Washington: “Their [Sovaldi’s patient group] lives, in short, will be transformed. The value to these patients, and to their loved ones and society – you can’t put a price tag on it.”
Adam Hill
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