Janssen submits simeprevir regulatory application in Japan to treat HCV
Published on February 22, 2013 at 5:43 AM
Medivir AB (STO:MVIR-B) today announced that its partner Janssen now has submitted a regulatory application to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C patients who are treatment naïve, prior non responders or relapsed following treatment with Peg-IFN with or without RBV. Simeprevir, an investigational NS3/4A protease inhibitor, is administered as a single once-daily pill for 12 weeks.
The regulatory submission in Japan is supported by data from four Japanese phase III clinical studies of once-daily simeprevir administered with Peg-IFN and RBV.
The filing of a regulatory application in Japan triggers a milestone payment of €5m to Medivir.
Approximately 1.5 to 2 million people in Japan are infected with HCV. After infection with HCV occurs, the infection persists in about 70 percent of cases, leading to the onset of chronic hepatitis C. Continued inflammation can cause liver fibrosis to progress into liver cirrhosis and liver cancer. In Japan, approximately 35,000 people die from liver cancer each year and HCV has been found to be the cause in about 80 percent of cases.
"This is a major event for simeprevir on its way to the different global registrations. For us as an R&D driven company it is one of the most exciting milestones that we have experienced", comments Maris Hartmanis, CEO of Medivir.