The Russian pharmaceutical company R-Pharm—headed by the Ministry of Industry and Trade of the Russian Federation—entered into a licensing agreement with MSD (Merck) for rights to a novel investigational, hepatitis C once-daily protease inhibitor, narlaprevir.
The agreement provides an opportunity for R-Pharm to conduct late-stage clinical trials in Russia, which is among the goals of the Russian government's Pharma 2020 initiative. R-Pharm will gain rights to develop and commercialize narlaprevir in Russia and the Commonwealth of Independent States (CIS). R-Pharm will pay MSD (acting through a subsidiary), an upfront payment and undisclosed royalties on sales of narlaprevir. Merck has retained the right to co-promote narlaprevir in these regions and retains rights to the drug outside of Russia and the CIS countries.
Narlaprevir is a second generation NS3 serine protease inhibitor developed by MSD. In a phase IIa clinical study, narlaprevir administration resulted in a robust decline in the level of hepatitis C virus detected in the blood and high sustained viral response rates when followed by standard of care in both treatment-experienced and treatment-naïve HCV genotype 1-infected patients.
"MSD is pleased that through this agreement, R-Pharm can pursue the development of this potentially important technology for the treatment of hepatitis C, an area of substantial unmet need in Russia," said Kevin Ali, president of emerging markets, MSD. "This unique technology transfer deal is consistent with the Russian government's desire to create a stronger local innovative pharma industry to drive economic growth in the sector. Developing narlaprevir will enable R-Pharm to gain deep experience in late stage clinical trials—the crucial phase of drug development."