24-Apr-13 Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that Janssen-Cilag International NV (Janssen) today has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) seeking approval for simeprevir (TMC435).
”The filing of simeprevir in Europe represents the third filing in major regions in the last two months. It shows the commitment and speed with which our partner Janssen acts in the process of bringing new hepatitis C treatments to the market”, said Maris Hartmanis, CEO of Medivir AB.
The regulatory submission for simeprevir is supported by data from three phase III studies in patients with genotype 1 hepatitis C: QUEST-1 and QUEST-2 in treatment-naïve patients, and PROMISE in patients who have relapsed after prior interferon-based treatment. The filing for the treatment of patients with the genotype 4 virus is based on phase II data and an ongoing phase III study.
Simeprevir is a new generation NS3/4A protease inhibitor, administered as a capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 and 4 chronic hepatitis C in adult patients. Genotype 1 is the most prevalent form of hepatitis C virus (HCV) worldwide.
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292
Simeprevir is a new generation NS3/4A protease inhibitor jointly developed by Medivir and Janssen for the treatment of chronic hepatitis C in adult patients with compensated liver disease. Janssen recently submitted a new drug application for simeprevir in Japan and the United States.
For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov.
About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause of chronic liver disease and liver transplants, is a rapidly evolving treatment area with a clear need for innovative treatments. Approximately 150 million people are infected with hepatitis C worldwide, and 350,000 people per year die from the disease.
Medivir is an emerging research-based pharmaceutical company focused on infectious diseases.
Medivir has world class expertise in polymerase and protease drug targets and drug development which has resulted in a strong infectious disease R&D portfolio. The Company’s key pipeline asset is simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
For more information about Medivir AB, please visit the Company’s website: www.medivir.com