11.04.2016 15:46:00

Medivir: New Data for Simeprevir Will Be Presented at Easl's International Liver Congress 2016

Regulatory News:

Medivir (STO:MVIRB)

Medivir AB (Nasdaq Stockholm: MVIR) today informs that new clinical data for simeprevir, an NS3 / 4A protease inhibitor for the treatment of hepatitis C virus infection, will be presented by our partner Janssen Sciences Ireland UC (Janssen) in conjunction with The International Liver Congress ™ 2016 of the European Association for the Study of the Liver (EASL) in Barcelona, on 13-17 April. A total of nine presentations will be made, including one "late breaker" presentation. The presentations will cover the efficacy, safety and tolerability of simeprevir used as a component of various combination therapies in a number of different adult patient populations, and will be based on data from phase II and phase III studies and from on-going clinical use (so-called "real-world data").

Data presented at the International Liver Congress 2015 include:

Late-Breaking Poster Presentation

Simeprevir plus sofosbuvir for hepatitis C virus genotype 4 infection: a phase 3, open-label study.

· Abstract LBP516

· Lead Author: M. Buti; Hospital Vall d’Hebron and Centro Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Barcelona, Spain

Poster Presentations

Pharmacokinetic interactions between simeprevir and ledipasvir in treatment-naïve hepatitis C virus genotype 1-infected patients without cirrhosis treated with a simeprevir/sofosbuvir/ledipasvir regimen

· Abstract SAT-264

· Lead Author: S. Bourgeois, Department of Internal Medicine, ZNA Ster, Antwerp

Deep sequencing results from the Phase 2 IMPACT study of simeprevir in combination with daclatasvir and sofosbuvir in treatment-naïve and -experienced patients with chronic hepatitis C virus genotype 1 or 4 infection and decompensated liver disease

· Abstract THU-215

· Lead Author: C. Sarrazin, Johann Wolfgang Goethe University Medical Center, Frankfurt am Main, Germany

Consistent simeprevir resistance profile in hepatitis C virus genotype 1-infected patients failing simeprevir interferon-free compared with interferon-containing regimens

· Abstract THU-214

· Lead Author: B. Fevery, Janssen Infectious Diseases BVBA, Beerse, Belgium

Effectiveness of simeprevir-containing regimens among patients with chronic hepatitis C virus in various US practice settings: The SONET study

· Abstract SAT-167

· Lead Author: I. Alam, Austin Hepatitis Center, Austin, TX, USA

Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin for 12 weeks in subjects with recurrent genotype 1 hepatitis C post-orthotopic liver transplant: The GALAXY study

· Abstract FRI-457

· Lead Author: J.G. O'Leary, Baylor University Medical Center, Dallas, TX, USA

Efficacy and tolerability of simeprevir and daclatasvir for 12 or 24 weeks in HCV genotype 1b-infected treatment-naïve patients with advanced fibrosis or compensated cirrhosis

· Abstract SAT-130

· Lead Author: C. Hézode, Department of Hepatology and Gastroenterology, Hôpital Henri Mondor, Université Paris-Est, France

Effectiveness of simeprevir treatment for hepatitis C in real practice: preliminary results from the STIly Italian observational study

· Abstract SAT-162

· Lead Author: G.B. Gaeta, Seconda Universita di Napoli, Napoli, Italy

Safety of simeprevir-based treatment for hepatitis C in real practice: preliminary results from the STIly observational study

· Abstract SAT-212

· Lead Author: M. Colombo, Ospedale Maggiore Policlinico, Milano, Italy

Details of all presentations for The International Liver Congress ™ 2016 are available at the conference website: http://www.ilc-congress.eu

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 15.30 CET on 11 April 2016.

About Medivir

Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

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