Merck & Co. Inc.’s MRK experimental once-daily combination chronic hepatitis C virus (HCV) treatment, grazoprevir (NS3/4A proteaseinhibitor)/elbasvir (NS5A replication complex inhibitor) received two new Breakthrough Therapy designations from the FDA.
The designations are for the treatment of patients suffering from chronic HCV genotype 4 (GT4) infection and chronic HCV genotype 1 (GT1) infection in patients with end-stage renal disease on hemodialysis.
Breakthrough Therapy designation is granted by the FDA to expedite the development and review of a candidate for use alone or in combination that is believed to have the potential to treat a serious or life-threatening disease or condition and which may show substantial improvement over existing therapies on one or more clinically significant endpoints.
We remind investors that the FDA had granted Breakthrough Therapy designation to the combination for the treatment of patients with chronic HCV GT1 in Oct 2013. However, in Jan 2015, the FDA notified the company its intention of revoking the designation due to the availability of other new drugs for HCV GT1.
Merck remains on track to file a new drug application for grazoprevir/elbasvir in the first half of 2015. In addition to this, the company plans to present phase II and III data on the candidate in multiple HCV patient types (chronic kidney disease, HIV co-infection, cirrhosis and prior treatment failures) at the International Liver Congress later this month.
Though encouraged by the FDA granting Breakthrough Therapy designations to the combination, we note that competition in the HCV market is getting intense given the presence of Gilead’s GILD Sovaldi and Harvoni and AbbVie’s ABBV Viekira Pak regimen.
Merck carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Horizon Pharma plc HZNP carrying a Zacks Rank #1 (Strong Buy).
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