· Presentations Include late-breaking final results from the phase II COSMOS study
STOCKHOLM--(BUSINESS WIRE)-- Regulatory News:
Medivir AB (STO:MVIR-B) today announces that new data from the clinical development program for simeprevir in the treatment of genotype 1 or genotype 4 chronic hepatitis C virus (HCV) in adult patients with compensated liver disease will be presented at The International Liver Congress of the European Association for the study of the Liver (EASL). The International Liver Congress 2014 will take place from April 9-13 in London, United Kingdom.
Eight oral and poster presentations spanning over the phase II and phase III development program for simeprevir in treatment combinations with and without ribavirin and interferon are planned. New analyses of data from the phase III QUEST-1, QUEST-2 and PROMISE clinical trials of simeprevir in combination with pegylated interferon and ribavirin, as well as final data from the phase II COSMOS study will be presented during the Congress.
The data to be presented at the International Liver Congress 2014 include:
· Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype 1 prior null-responder/treatment-naïve patients (COSMOS Study): primary endpoint (SVR12) results in patients with METAVIR F3-4 (Cohort 2) - Lead Author: Eric Lawitz; The Texas Liver Institute, University of Texas Health Science Center, San Antonio, USA
· Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment-naïve or treatment-experienced chronic HCV genotype-4 infected patients: SVR12 results of a Phase 3 trial (RESTORE Study) - Lead Author: Christopher Moreno; ULB Hôpital Erasme, Brussels, Belgium
· Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 prior null responders with METAVIR F0-2: COSMOS Study Cohort 1 subgroup analysis - Lead Author: Mark Sulkowski; Johns Hopkins University School of Medicine, Baltimore, USA
· Simeprevir with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in European patients who relapsed after previous interferon-based therapy: the PROMISE trial - Lead Author: Xavier Forns; Liver Unit, Hospital Clinic, Barcelona, Spain
· Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve European patients in the QUEST-1 and QUEST-2 Phase 3 trials - Lead Author: Graham R. Foster; Queen Mary’s, University of London, London, UK
· Simeprevir reduces time with peginterferon/ribavirin-induced symptoms and quality-of-life impairments: 72-week results from three Phase 3 studies - Lead Author: Jane Scott; Janssen
· Virology analyses of simeprevir in Phase 2b and 3 studies - Lead Author: Oliver Lenz; Janssen
· Deep sequencing analyses of minority baseline polymorphisms and persistence of emerging mutations in HCV genotype 1-infected patients treated with simeprevir - Lead Author: Bart Fevery; Janssen
Full session details and data presentation listings for The International Liver Congress 2014 can be found at
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 10.15 CET on 24 March 2014.
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 4 infected patients with compensated liver disease, including cirrhosis.
Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S. and in March 2014 in Russia. The Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.
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 for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.
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