New simeprevir data will be presented at The International Liver Congress 2015 of the European Association for the Study of the Liver (EASL)


Presentations include late-breaking final results from the phase III OPTIMIST
trials and interim results from the phase II IMPACT trial of simeprevir
Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that new
clinical data for simeprevir, the NS3/4A protease inhibitor for the treatment of
hepatitis C virus (HCV) infection, will be presented by our partner Janssen
Sciences Ireland UC at The International Liver Congress™ 2015 of the European
Association for the Study of the Liver (EASL) taking place in Vienna from April
22-26.

Several key presentations will report on the efficacy and tolerability of
simeprevir in interferon-free combination regimens in phase II, phase III and
real-world clinical settings.

A total of 12 abstracts supporting marketed and investigational therapies for
HCV will be presented, including three abstracts on simeprevir accepted as late
-breaking presentations.

The data to be presented at the International Liver Congress 2015 include:

Late-Breaking Poster Presentations

All posters will be displayed electronically from Thursday 23 April, 07:30 to
Saturday 25 April, 20:00 in Hall B.

A phase III, randomised, open-label study to evaluate the efficacy and safety of
12 and 8 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve and
-experienced patients with chronic HCV genotype 1 infection without cirrhosis:
The OPTIMIST-1 study.

  · Abstract LP14
  · Lead Author: P. Kwo; Division of Gastroenterology and Hepatology, Department
of Medicine, Indiana University, Indianapolis, IN, USA

A phase III, open-label, single-arm study to evaluate the efficacy and safety of
12 weeks of simeprevir (SMV) plus sofosbuvir (SOF) in treatment-naïve or
-experienced patients with chronic HCV genotype 1 infection and cirrhosis: The
OPTIMIST-2 study.

  · Abstract LP04
  · Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health
Science Center, San Antonio, TX, USA

Simeprevir (SMV) plus daclatasvir (DCV) and sofosbuvir (SOF) in treatment-naïve
and -experienced patients with chronic hepatitis C virus genotype 1 or 4
infection and decompensated liver disease: Interim results from the phase II
IMPACT study.

  · Abstract LP07
  · Lead Author: E. Lawitz; Texas Liver Institute, University of Texas Health
Science Center, San Antonio, TX, USA

Oral Presentations

On-treatment virologic response and tolerability of simeprevir, daclatasvir and
ribavirin in patients with recurrent hepatitis C virus genotype 1b infection
after orthotopic liver transplantation (OLT): Interim data from the phase II
SATURN Study.

  · Abstract 0004: Thursday 23 April, 16.45 – 17.00, Hall D
  · Lead Author: X. Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations

All posters will be displayed electronically from Thursday 23 April, 07:30 to
Saturday 25 April, 20:00 in Hall B.

Significant drug-drug interaction between simeprevir and cyclosporine A but not
tacrolimus in patients with recurrent chronic HCV infection after orthotopic
liver transplantation: The SATURN study.

  · Abstract P0834
  · Lead Author: S. Ouwerkerk-Mahadevan; Janssen Research & Development, Beerse,
Belgium

Deep sequencing analyses in HCV genotype 1-infected patients treated with
simeprevir plus sofosbuvir with/without ribavirin in the COSMOS study.

  · Abstract P0780
  · Lead Author: B. Fevery; Janssen Infectious Diseases BVBA, Beerse, Belgium

Effectiveness of simeprevir (SMV)-containing regimens among patients with
chronic hepatitis c virus (HCV) in various U.S. practice settings: Interim
analysis of the SONET study.

  · Abstract P0826
  · Lead Author: I. Alam; Austin Hepatitis Center, Austin, TX, USA.

Study protocol for a partly randomised, open-label phase IIa trial of once-daily
simeprevir combined with sofosbuvir for the treatment of HCV genotype 4-infected
patients with or without cirrhosis (OSIRIS)

  · Abstract P1346
  · Lead Author: M. El Raziky, Departments of Pediatrics, Cairo University,
Cairo, Egypt

Baseline factors associated with increased SVR rates in 123 treatment-naïve
chronic HCV genotype 1 patients treated with a shortened 12-week simeprevir plus
pegylated interferon and ribavirin regimen: A multivariate analysis.

  · Abstract P0792
  · Lead Author: T Asselah, Beaujon Hospital, University of Paris, France.

Clinical characteristics and outcomes of chronic hepatitis C (CHC) patients
treated with newer direct-acting antiviral (DAA)-based regimens from a large
U.S. payer perspective.

  · Abstract P0852
  · Lead Author: N. Tandon; Janssen Scientific Affairs, LLC , Titusville, NJ ,
USA

A descriptive analysis of a real-world population with chronic hepatitis C (CHC)
treated with simeprevir (SMV)-and/or sofosbuvir (SOF)-based regimens: Findings
from a U.S. payer database.

  · Abstract P0827
  · Lead Author: J.B. Forlenza; Janssen Scientific Affairs, LLC , Titusville, NJ
, USA

Real world effectiveness and cost of simeprevir- and/or sofosbuvir-based HCV
treatments: $175,000 per SVR12.

  · Abstract P0881
  · Lead Author: K. Bichoupan; Division of Liver Diseases, Icahn School of
Medicine at the Mount Sinai Medical Center, New York, NY, USA

Full session details and data presentation listings for The International Liver
Congress™ 2015 can be found at http://www.ilc-congress.eu.

For further information, please contact:
Ola Burmark, CFO Medivir AB, mobil: +46 (0)725-480 580. Or visit
http://www.janssenrnd.com for more information.

Medivir is required under the Securities Markets Act to make the information in
this press release public.
The information was submitted for publication at 12.00 CET on 8 April 2015.

About Simeprevir (OLYSIO®)
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen Sciences
Ireland UC and Medivir AB and indicated for the treatment of chronic hepatitis C
infection as a component of a combination antiviral treatment regimen.
Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4
infected patients with compensated liver disease, including cirrhosis. Janssen
is responsible for the global clinical development of simeprevir and has
exclusive, worldwide marketing rights, except in the Nordic countries. Medivir
AB retains marketing rights for simeprevir in these countries under the
marketing authorization held by Janssen-Cilag International NV. In November
2013, simeprevir was approved by the U.S. Food & Drug Administration and, in May
2014, it was granted marketing authorisation by the European
Commission. Subsequent marketing authorisations have followed in several other
countries around the world. Indications vary by market.

About Medivir
Medivir is a research based pharmaceutical company with a research focus on
infectious diseases and oncology. 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 growing portfolio of specialty care
pharmaceuticals on the Nordic market. Medivir is listed on the Nasdaq Stockholm
Mid Cap List.

Pièces jointes

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