Stockholm, Sweden — 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
For more information please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580.
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.
