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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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    Medivir announces that Janssen has initiated an open-label phase IIb study of the 3DAA combination of simeprevir, odalasvir and AL-335 (JNJ-4178)

    Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that a phase IIb open-label study of the combination of simeprevir, odalasvir and AL-335, also known as JNJ-4178, has been initiated by Janssen Research & Development, LLC., part of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), in treatment-naive and treatment-experienced subjects with chronic hepatitis C virus infection without cirrhosis. This global, multi-center study includes clinical trial sites in North America, Europe and Asia and forms part of Janssen’s global development program for JNJ-

    OLYSIO® sales during the fourth quarter 2014

    Stockholm, Sweden — Medivir AB (OMX: MVIR) announces that the global fourth quarter net sales of OLYSIO® (simeprevir) amounted to 321 MUSD, of which 256 MUSD were sales in the USA. Medivir’s royalties based on sales for the fourth quarter are calculated from the highest royalty tier and currency conversion from USD to Euro is based on the YTD exchange rate.The royalty amounted to 220 MSEK (23.1 MEUR). OLYSIO® global net sales Sales in MUSDMarket Q4 2014  Q3 2014   Q2 2014   Q1 2014 US 256 671

    Stable sales for OLYSIO during the third quarter 2014

    Stockholm, Sweden — Medivir AB (OMX: MVIR) announces that the global third quarter net sales of OLYSIO® (simeprevir) amounted to 796 MUSD, of which 671 MUSD were sales in the USA. Medivir’s royalties based on sales for the third quarter are calculated from the highest royalty tier and currency conversion from USD to Euro is based on the YTD exchange rate.The royalty amounted to 516,4 MSEK (56,2 MEUR). OLYSIO®                      Sales in MUSDglobal netsalesMarket Q3 2014 Q2 2014 Q1 2014US 671

    Phase II IMPACT study initiated to evaluate Simeprevir in combination with Sofosbuvir and Daclatasvir to treat genotype 1 and 4 hepatitis C patients

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that its partner Janssen recently initiated patient enrolment in a phase II study called IMPACT. This study evaluates the efficacy, safety and pharmacokinetics of the NS3/4A protease inhibitor simeprevir administered once daily in combination with Gilead’s nucleotide inhibitor sofosbuvir and Bristol-Myers Squibb’s (BMS) NS5A replication complex inhibitor daclatasvir. The study includes treatment-naïve and treatment-experienced patients with hepatitis C genotype 1 and 4 infection and decompensated liver disease. In the phase II,

    Final data from the phase II COSMOS study with Simeprevir in combination with Sofosbuvir presented at EASL

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that positive new simeprevir data were presented at The International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL) in London.The data presented included; · Final phase II data from the interferon-free COSMOS study · Phase III efficacy data in patients with genotype 4 hepatitis C · Subgroup analyses of patients from phase III studies QUEST-1, QUEST-2 and PROMISE Final phase II data from the interferon-free COSMOS study Cohort 2Final results from cohort 2 of the phase II

    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

    New Simeprevir data will be presented at The International Liver Congress 2014 of the European Association for the Study of the Liver, (EASL)

    · Presentations Include late-breaking final results from the phase II COSMOS study Stockholm, Sweden — Medivir AB (OMX: MVIR) 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

    Simeprevir has now been approved in Russia

    Stockholm, Sweden — Medivir AB (OMX: MVIR) announced today that that the Russian Ministry of Health has approved Sovriad® (simeprevir) for the treatment of chronic hepatitis C genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adults with compensated liver disease (including cirrhosis) who are treatment naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with or without ribavirin. Russia will be the first country within EMEA to gain access to simeprevir, which represents a significant advance in hepatitis C treatment. “The Russian

    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

    New Phase III Data from Once-Daily Simeprevir Presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL)

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that new phase III data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia. · The phase III ATTAIN study in treatment-experienced adult patients with chronic hepatitis C virus (HCV) and compensated liver disease achieved its primary efficacy endpoint by demonstrating non-inferiority of simeprevir compared to telaprevir when both are given in combination with PegIFN/RBV. Simeprevir demonstrated superior

    SVR12 results from a phase IIa study evaluating Simeprevir and Daclatasvir in Hepatitis C patients of genotype 1 have been presented

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that study results from a phase IIa trial evaluating simeprevir, a once-daily protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB, in combination with daclatasvir, an investigational once-daily NS5A inhibitor developed by Bristol-Myers Squibb (NYSE: BMY), with and without ribavirin, in patients with hepatitis C (HCV) genotype 1 infection, have been presented at the 21th Conference on Retroviruses and Opportunistic Infections (CROI) on March 4th in Boston, USA. The study was conducted by Bristol-Myers Squibb.

    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-

    Simeprevir is now available for Hepatitis C patients in Japan, USA and Canada

    Stockholm, Sweden—Medivir AB (OMX: MVIR) Based on the recent approvals in Japan, Canada and USA, simeprevir is now available in all three markets. Simeprevir is administered once-daily for 12 weeks in combination with pegylated interferon and ribavirin, followed by pegylated interferon and ribavirin alone for an additional 12 or 36 weeks. For more information please contact:Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292 Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for

    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

    Simeprevir has been approved in Canada as a new treatment for hepatitis C

    Simeprevir, is the first treatment for chronic hepatitis C to be approved in Canada for once-daily use in combination with pegylated interferon and ribavirin. This will offer physicians and patients a new and tolerable treatment choiceStockholm, Sweden — Medivir AB (OMX: MVIR) today announced that Health Canada has approved simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment‑naïve or who have failed previous interferon therapy (

    Results from the COSMOS study with Simeprevir and Sofosbuvir in cirrhotic and non-cirrhotic HCV genotype 1 patients presented at AASLD

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced data from the interferon-free COSMOS study demonstrating safety and efficacy of the investigational protease inhibitor simeprevir (TMC435) in combination with the investigational nucleotide inhibitor sofosbuvir (GS-7977), with and without ribavirin, in genotype 1 chronic hepatitis C adult patients with compensated liver disease was presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington, D.C. during the late-breaking oral session on Monday, November 4. “The high sustained

    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

    Janssen has acquired an NS5a replication complex inhibitor that will be evaluated with Simeprevir in future clinical development

    Stockholm, Sweden — Medivir AB (OMX: MVIR) announced that Janssen Pharmaceuticals, Inc. (Janssen) has acquired the investigational compound GSK2336805 (GSK805), an NS5a replication complex inhibitor in phase II development for the treatment of chronic hepatitis C. Janssen has acquired all rights to develop and commercialize GSK2336805 including in combination with other drugs. Janssen acquired the compound from an affiliate of GlaxoSmithKline plc, financial details of the agreement have not been disclosed. Janssen plans to initiate phase II studies to evaluate the use of GSK805 in

    Medivir announces that Simeprevir data will be presented at the upcoming AASLD meeting

    Stockholm, Sweden — Medivir AB (OMX: MVIR) announced that data will be presented on the investigational protease inhibitor simeprevir for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease at the upcoming Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will take place November 1 to 5 in Washington, D.C. The data to be presented at the 2013 AASLD Annual Meeting include: Poster Presentations: HCV Therapeutics: New Agents, Poster Hall, November 3, 8:00 a.m. - 5:30 p.m. (EST): · Simeprevir (TMC435)

    Simeprevir has been approved in Japan for the treatment of genotype 1 chronic hepatitis C infection

    Stockholm, Sweden — Medivir AB (OMX: MVIR) today reports that Janssen Pharmaceutical R&D Ireland (Janssen) has been informed by the Japanese Ministry of Health, Labour and Welfare (MHLW) that simeprevir has been approved for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection. "The approval in Japan is a very important step in providing patients with new treatment options. It is the first approval based on the series of global filings that our partner initiated during 2013. Japan is commercially a very exciting market with a huge unmet medical need among hepatitis C

    Primary efficacy and safety data from four phase III Japanese studies of Simeprevir presented at The Japan Society of Hepatology

    Stockholm, Sweden — Medivir AB (OMX: MVIR) reports that its partner Janssen Pharmaceutical R&D Ireland (Janssen) today announced primary efficacy and safety results from four Japanese phase III clinical studies demonstrating that the use of the investigational NS3/4A protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in patients with genotype 1 hepatitis C, when administered once daily with pegylated interferon and ribavirin. The four studies examined the use of simeprevir in genotype 1 chronic hepatitis C patients who were

    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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