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  • Medivir
    Medivir AB, Box 1086, SE-141 22 Huddinge, Sweden Visit: Lunastigen 5
    +46 8 5468 3100
    http://www.medivir.com
  • Jens Lindberg

    CEO


    +46 8 5468 3100
    http://www.medivir.com
  • Magnus Christensen

    CFO


    +46-73 125-0620
    http://www.medivir.com
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    Two phase III trials evaluating once-daily Simeprevir and Sofosbuvir in hepatitis C infected patients have been initiated

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that two phase III trials are recruiting patients to examine the efficacy and safety of the NS3/4A protease inhibitor simeprevir in combination with the nucleotide inhibitor sofosbuvir for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in treatment-naïve and treatment-experienced patients with and without cirrhosis. “Positive safety and efficacy results have previously been demonstrated in genotype 1 HCV infected patients with the interferon- and ribavirin free combination of simeprevir and sofosbuvir in

    Simeprevir receives positive CHMP opinion for the treatment of adults with chronic hepatitis C in the European Union

    · Positive opinion for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. Stockholm, Sweden — Medivir AB (OMX: MVIR) announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending 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. “The recommendation is one additional step in the global strategy that our partner

    Interim results (SVR4) from a phase II all-oral combination study of Simeprevir and Samatasvir (IDX719) for the treatment of hepatitis C

    Stockholm, Sweden—Medivir AB (OMX: MVIR), announces that Idenix Pharmaceuticals, Inc. today released interim data from the ongoing phase II HELIX-1 clinical trial evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of samatasvir (IDX719), Idenix’s once-daily pan-genotypic NS5A inhibitor, and simeprevir , a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, and ribavirin. The combination regimen of the study was well-tolerated. In the treatment-naïve, non-cirrhotic, genotype 1b or 4 HCV-infected patients receiving 50 mg of

    An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated

    Stockholm, Sweden—Medivir AB (OMX: MVIR), announces the initiation of a phase IIa trial in chronic genotype 1 hepatitis C infected patients to evaluate the efficacy, safety and tolerability of a 12-week combination therapy of simeprevir, TMC647055 and JNJ56914845, a NS5A replication complex inhibitor. Study designApproximately 40 patients will be enrolled in this open-label study to assess the efficacy, safety and tolerability of the co-administration of simeprevir, TMC647055 and two different doses of JNJ56914845 without ribavirin. The trial will evaluate genotype 1a and 1b HCV-

    HELIX-2, a phase II all-oral combination study of Simeprevir, TMC647055 and Samatasvir (IDX719) for the treatment of hepatitis C has been initiated

    Stockholm, Sweden—Medivir AB (OMX: MVIR), announces that IDENIX has initiated a phase II clinical trial (HELIX-2) evaluating an all-oral, direct-acting antiviral (DAA) HCV combination regimen of simeprevir, samatasvir and TMC647055 with a pharmacokinetic enhancer. The HELIX-2 trial is a 12-week, randomized, open-label study evaluating the efficacy, safety and tolerability of simeprevir, TMC647055 and samatasvir. The trial will evaluate genotype 1 HCV-infected patients who are either treatment-naïve or who have relapsed after prior treatment with interferon and ribavirin. Patients will

    Medivir announces data from two phase III studies with Simeprevir in hepatitis C subpopulations – HCV/HIV co-infected and genotype 4 infected patients

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced preliminary data from two phase III studies conducted by Janssen R&D Ireland evaluating simeprevir in genotype 4 chronic hepatitis C in adult patients with compensated liver disease, and in genotype 1 hepatitis C and HIV-1 co-infected adult patients. The data were presented today at the ongoing European AIDS Conference (EACS), October 16-19 in Brussels. “Based on these encouraging data with the high cure rates seen in patients co-infected with HCV genotype 1 and HIV-1 we believe that simeprevir could provide a new treatment

    Medivir makes strategic decision to focus proprietary hepatitis C R&D efforts exclusively on nucleotide-based polymerase inhibitors

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that it will focus its proprietary hepatitis C (HCV) research and development efforts exclusively on nucleotide-based polymerase inhibitors. Medivir had been working on the discovery and development of new HCV nucleotide-based inhibitors and NS5A inhibitors (NS5A replication complex inhibitor) to enable additional potential interferon-free combinations. However, based on an evaluation of the competitive landscape and the expected evolution of therapies for HCV infection, Medivir has decided to focus exclusively on nucleotide-

    New Drug Application has been filed with FDA for Simeprevir (TMC435) for combination treatment of adult patients with genotype 1 chronic hepatitis C

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that a new drug application (NDA) has been filed with the U.S. Food and Drug Administration (FDA) seeking approval for simeprevir. The filing is based on phase III data in treatment-naïve and treatment-experienced patients with compensated liver disease. The filing of a regulatory application in the US triggers a milestone payment of €10m to Medivir. Simeprevir is jointly developed by Medivir and Janssen Pharmaceuticals, Inc. (Janssen), and is an investigational NS3/4A protease inhibitor, administered as a 150 mg capsule once

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