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 spanning over the phase II and phase III
development program for simeprevir in treatment combinations with and without
ribavirin and interferon are planned. New analyses of data from the phase III
QUEST-1, QUEST-2 and PROMISE clinical trials of simeprevir in combination with
pegylated interferon and ribavirin, as well as final data from the phase II
COSMOS study will be presented during the Congress.

The data to be presented at the International Liver Congress 2014 include:

Late-Breaking Presentations

  · Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype 1 prior
null-responder/treatment-naïve patients (COSMOS Study): primary endpoint (SVR12)
results in patients with METAVIR F3-4 (Cohort 2)
- Lead Author: Eric Lawitz; The Texas Liver Institute, University of Texas
Health Science Center, San Antonio, USA

  · Once-daily simeprevir (TMC435) with peginterferon/ribavirin in treatment
-naïve or treatment-experienced chronic HCV genotype-4 infected patients: SVR12
results of a Phase 3 trial (RESTORE Study)
- Lead Author: Christopher Moreno; ULB Hôpital Erasme, Brussels, Belgium

Oral Presentations

  · Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without
ribavirin in HCV genotype 1 prior null responders with METAVIR F0-2: COSMOS
Study Cohort 1 subgroup analysis
- Lead Author: Mark Sulkowski; Johns Hopkins University School of Medicine,
Baltimore, USA

  · Simeprevir with peginterferon/ribavirin for treatment of chronic HCV
genotype 1 infection in European patients who relapsed after previous interferon
-based therapy: the PROMISE trial
- Lead Author: Xavier Forns; Liver Unit, Hospital Clinic, Barcelona, Spain

Poster Presentations

  · Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic
HCV genotype 1 infection in treatment-naïve European patients in the QUEST-1 and
QUEST-2 Phase 3 trials
- Lead Author: Graham R. Foster; Queen Mary’s, University of London, London, UK

  · Simeprevir reduces time with peginterferon/ribavirin-induced symptoms and
quality-of-life impairments: 72-week results from three Phase 3 studies
- Lead Author: Jane Scott; Janssen

  · Virology analyses of simeprevir in Phase 2b and 3 studies
- Lead Author: Oliver Lenz; Janssen

  · Deep sequencing analyses of minority baseline polymorphisms and persistence
of emerging mutations in HCV genotype 1-infected patients treated with
simeprevir
- Lead Author: Bart Fevery; Janssen

Full session details and data presentation listings for The International Liver
Congress 2014 can be found at

http://www.ilc-congress.eu.

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 publication at
10.15 CET on 24 March 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D
Ireland and Medivir AB and indicated for the treatment chronic hepatitis C
infection in combination with pegylated interferon and ribavirin in HCV genotype
1 and 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 will retain marketing rights for simeprevir in these countries under the
marketing authorization held by Janssen-Cilag International NV. The treatment
was approved for the treatment of genotype 1 hepatitis C in September 2013 in
Japan and in November 2013 in Canada and the U.S. and in March 2014 in Russia.
The Committee for Medicinal Products for Human Use (CHMP) recently recommended
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. An approval is expected during Q2-2014.

About Medivir
Medivir is an emerging research-based pharmaceutical company focused on
infectious diseases. Medivir has world class expertise in polymerase and
protease drug targets and drug development which has resulted in a strong
infectious disease R&D portfolio. The Company’s key pipeline asset is
simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is
being developed in collaboration with Janssen R&D Ireland. The company is also
working with research and development in other areas, such as bone disorders and
neuropathic pain. Medivir has also a broad product portfolio with prescription
pharmaceuticals in the Nordics.

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