Key Developments: Medivir AB (MVRBF.PK)
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25 Apr 2013
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Latest Key Developments (Source: Significant Developments)
Medivir AB's Partner Announces Primary Efficacy and Safety Findings from Phase III Study of Simeprevir in Treatment
Medivir AB announced that the Company's Partner Janssen R&D Ireland (Janssen) has presented primary efficacy and safety results from the global phase III PROMISE study. Results demonstrated that use of the investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 79% of treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir was administered once daily with pegylated interferon and ribavirin. In the study, 37% of patients receiving pegylated interferon and ribavirin (placebo) alone achieved SVR12. In the simeprevir arm, on-treatment failure rates were 3% and relapse rates were 19%, compared to 27% and 48% in the placebo arm. All patients had previously relapsed following pegylated interferon-based therapy. Full Article
Medivir AB Announces Positive Results from Phase Ia Study with MIV-711 for Treatment of Skeletal Disorders
Medivir AB announced that data from a first in man study on the investigational cathepsin K inhibitor MIV-711 for the treatment of osteoarthritis and osteoporosis was presented on May 21, 2013 at the European Calcified Tissue Society (ECTS) Annual Meeting in Lisbon, Portugal. A double-blind, placebo-controlled, randomized study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of 20 to 600 mg of MIV-711 in healthy male and female subjects (N=27). MIV-711 was given as an oral capsule and at each dosing occasion, seven subjects received MIV-711 and two received placebo. The results show that single doses of MIV-711 were safe and well tolerated in healthy subjects and displayed linear pharmacokinetics over the investigated dose range (20 – 600 mg). Serum levels of the bone resorption biomarker CTX-I were suppressed in a dose dependent manner) with up to 79% reduction at 24 hours after dose. Full Article
FDA Grants Priority Review to Simeprevir by Medivir AB's Partner
Medivir AB announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) by Janssen for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease. The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. FDA review will begin approximately 60 days after receipt of the application and will aim to be complete within six months from when the review period begins. Full Article
Medivir AB's Partner Submits Marketing Authorization Application Seeking Approval for Simeprevir
Medivir AB announced that the Company's partner Janssen-Cilag International NV (Janssen) has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) seeking approval for simeprevir (TMC435). Simeprevir is a 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. Simeprevir is Medivir's key pipeline asset that is being developed in collaboration with Janssen R&D Ireland. Full Article
Medivir AB to Present New Data from Simeprevir Phase III Studies Quest 1 and 2 in Hepatitis C Patients
Medivir AB announced that data on the investigational protease inhibitor simeprevir (TMC435) for the treatment of genotype 1 hepatitis C patients is to be presented at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL) in Amsterdam, The Netherlands. These primary efficacy and safety results from two global phase III studies demonstrate that use of the investigational protease inhibitor simeprevir led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 80% and 81%, respectively, of treatment-naive genotype 1 chronic hepatitis C adult patients with compensated liver disease, when administered once daily with pegylated interferon and ribavirin. In both studies, 50% of patients receiving pegylated interferon and ribavirin alone achieved SVR12. The QUEST-1 and QUEST-2 data will also be discussed in an official EASL press conference on April 24, 2013. In QUEST-1 and QUEST-2, patients were randomized to receive simeprevir or placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 36 weeks. In findings related to a secondary endpoint, 85% (QUEST-1) and 91% (QUEST -2) of patients receiving simeprevir were able to shorten therapy with pegylated interferon and ribavirin to 24 weeks due to meeting response-guided therapy (RGT) criteria. Of those patients meeting RGT criteria to stop treatment at 24 weeks, 91% (QUEST-1) and 86% of patients (QUEST-2) achieved SVR12. Full Article
Medivir AB to Present Data from Simeprevir in Hepatitis C Patients
Medivir AB announced that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for treatment of hepatitis C at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL), which will take place between April 24, 2013 and April 28, 2013 in Amsterdam, the Netherlands. These data presentations will include primary efficacy and safety results from the phase III QUEST-1 study of simeprevir administered once daily in combination with pegylated interferon and ribavirin in treatment-naive genotype 1 chronic hepatitis C patients. Additional data from QUEST-2 study have been accepted but are subject to EASL’s embargo policy until April 23, 2013. The data to be presented at The International Liver Congress 2013 include: simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype-1 infection in treatment-naive patients: results from QUEST-1, a phase III trial; pharmacokinetics of simeprevir (TMC435) in volunteers with moderate or severe hepatic impairment.; improved SVR with simeprevir (TMC435) associated with reduced time with patient-reported fatigue in treatment-naive, HCV-infected patients in the PILLAR phase IIb trial; adding simeprevir (TMC435) to pegylated interferon/ribavirin does not increase patient reported fatigue in treatment-experienced patients with chronic HCV infection: results from the ASPIRE trial; combination therapy of TMC647055 with simeprevir (TMC435) in genotype 1 HCV patients. Full Article
Medivir AB Files New Drug Application with FDA for Simeprevir Developed with Janssen Pharmaceuticals, Inc.
Medivir AB announced that a new drug application (NDA) has been filed with the US (United States) Food and Drug Administration (FDA) seeking approval for simeprevir. The filing is based on phase III data in treatment-naive and treatment-experienced patients with compensated liver disease. The filing of a regulatory application in the US triggers a milestone payment of EUR 10 million 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 (milligrams) capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients. Full Article
Medivir AB Changes Research and Development Organization
Medivir AB announced that the Company will divide its current Research & Development (R&D) organization into two parts, Discovery Research and Development, and strengthen the R&D leadership to prepare for future strategic and operational opportunities. The research organization will be led by Richard Bethell, who will assume the position as Executive Vice President Discovery Research on April 22, 2013. Charlotte Edenius, who has the role of Executive Vice President R&D at Medivir, will become responsible for the development organization. In her new role as Executive Vice President Development, she will drive Medivir’s non-clinical and clinical development following the selection of candidate drugs. Medivir’s Executive Vice President Commercial, Henric Juserius, has decided to leave the Company. His departure will not affect the direction of the commercial operations. Full Article
Medivir AB Announces Results from Phase IIa Study Evaluating Jointly-Developed Simeprevir and Sofosbuvir in Prior Null Responder Hepatitis C Patients
Medivir AB announced the interim results from the COSMOS study (Combination of SiMeprevir and sOfosbuvir in HCV genotype 1 infected patients). The results are from the first cohort of a phase IIa study of the investigational protease inhibitor simeprevir (TMC435) administered once daily with Gilead’s investigational nucleotide inhibitor sofosbuvir (GS-7977) with and without ribavirin (RBV) for 12 and 24 weeks in genotype 1 prior null-responder hepatitis C patients with mild to moderate fibrosis (METAVIR F0-2). In an all-oral regimen of simeprevir and sofosbuvir 96.3% (26/27) and 92.9% (13/14) of patients in the 12-week arm with ribavirin and without ribavirin achieved sustained virologic response eight weeks after the end of treatment (SVR8). The results have also shown that once-daily all-oral simeprevir and sofosbuvir with or without ribavirin was generally well tolerated. Simeprevir is jointly developed by Medivir AB and Janssen R&D Ireland, an affiliate of the Janssen Pharmaceutical Companies. Full Article
Medivir AB Announces First Interim Results from Phase II Study for Oral Regimen of Simeprevir and Sofosbuvir in Prior Null Responder Hepatitis C Patients Jointly Developed with Janssen R&D Ireland
Medivir AB announced the first interim results from the cohort 1 of a Phase IIa study of the investigational protease inhibitor simeprevir (TMC435) administered once daily with Gilead’s investigational nucleotide inhibitor sofosbuvir (GS-7977) with and without ribavirin for 12 and 24 weeks in genotype 1 prior null-responder hepatitis C patients with mild to moderate fibrosis (METAVIR F0-2). Simeprevir is jointly developed by Medivir AB and Janssen R&D Ireland, an affiliate of the Janssen Pharmaceutical Companies. Cohort 1 of the phase IIa open-label COSMOS study randomized 80 genotype 1 patients into one of four arms including 150 mg of once-daily simeprevir plus 400 mg of sofosbuvir for 24 weeks with or without ribavirin or for 12 weeks with or without ribavirin. Virologic response rates with 150 mg simeprevir (SMV) and 400 mg sofosbuvir (SOF) q.d. with or without ribavirin (RBV). Full Article
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