Medivir announces that new Simeprevir data will be presented at the AASLD meeting

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| Source: Medivir AB
Stockholm, Sweden — Medivir AB (OMX: MVIR) announces that new data will be
presented on the investigational protease inhibitor simeprevir (TMC435) in
treatment-naïve genotype 1 chronic hepatitis C patients and in treatment
-experienced patients with compensated liver disease. These data will be
presented at the ongoing Annual Meeting of the American Association for the
Study of Liver Diseases (AASLD) taking place during November 1 to 5 in
Washington, D.C.

In the analyses of the QUEST-1 and QUEST-2 phase III studies in treatment-naïve
patients and the phase III PROMISE study in prior relapse patients, efficacy of
simeprevir was demonstrated in hepatitis C patients, including patients with the
IL28B TT genotype and METAVIR scores of F4 (cirrhosis).

On October 24, the U.S. Antiviral Drugs Advisory Committee of the FDA voted
unanimously (19-0) to recommend approval of the new drug application filed by
Janssen Research & Development, LLC for simeprevir administered once daily with
pegylated interferon and ribavirin for the treatment of genotype 1 chronic
hepatitis C virus (HCV) in adult patients with compensated liver disease.

The data to be presented at the 2013 AASLD Annual Meeting include:

Poster Presentations: HCV Therapeutics: New Agents, Poster Hall, November 3,
8:00 a.m. - 5:30 p.m. (EST):

Simeprevir (TMC435) with peg-interferon α-2a/ribavirin for treatment of chronic
HCV
genotype 1 infection in patients who relapsed after previous interferon-based
therapy:
Efficacy and safety in patient sub-populations in the PROMISE Phase III trial

  · Lead Author: Xavier Forns, Hospital Clinic, Barcelona, Spain

Adding simeprevir to peginterferon/ribavirin for HCV shortens time with patient
-reported
symptoms and impairment in quality of life: Results from the simeprevir Phase
III QUEST
1, QUEST 2, and PROMISE studies

  · Lead Author: Jane A. Scott, Janssen

Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV
genotype 1
infection in treatment-naïve patients: Efficacy in difficult-to-treat patient
sub-populations
in the QUEST-1 and 2 Phase III trials

  · Lead Author: Ira M. Jacobson, Weill Cornell Medical College, New York, USA

Resistance analyses of HCV isolates from patients treated with simeprevir in
Phase 2b/3
studies

  · Lead Author: Oliver Lenz, Janssen

The relative efficacy and safety of simeprevir-based triple therapy compared to
boceprevir and telaprevir in treatment naïve patients chronically infected with
genotype-1 hepatitis C virus: Bayesian network meta-analyses

  · Lead Author: George Wan, Janssen

More information about these presentations can be accessed in a press release
issued by Janssen, http://www.janssenrnd.com


The Phase 2a COSMOS data will be presented during the late-breaking oral session
on Monday, November 4, 2:45-4:30 p.m. (EST) in Hall E:
SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS
-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1
treatment-naïve and prior null responder patients: The COSMOS study.

  · Lead Author: Ira M. Jacobson, Weill Cornell Medical College, New York, USA

Full session details and data presentation listings for the 2013 AASLD Annual
Meeting can be found at: http://www.aasld.org/livermeeting.

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 3
p.m. CET on 2 November 2013.

About Hepatitis C
Hepatitis C, a blood-borne infectious disease of the liver and a leading cause
of chronic liver disease, is the focus of a rapidly evolving treatment
landscape. Approximately 150 million people are infected with hepatitis C
worldwide – including approximately 3.2 million people in the United States –
and 350,000 people per year die from the disease globally. When left untreated,
hepatitis C can cause significant damage to the liver including cirrhosis.
Additionally, hepatitis C may increase the risk of developing complications from
cirrhosis, which may include liver failure.

About Simeprevir
Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly
developed by Janssen R&D Ireland and its affiliated companies and Medivir AB for
the treatment of genotype 1 chronic hepatitis C in adult patients with
compensated liver disease, including all stages of liver fibrosis. Simeprevir
works by blocking the viral protease enzyme that enables the hepatitis C virus
to replicate in host cells.

Janssen is responsible for the global clinical development of simeprevir and has
acquired exclusive, worldwide marketing rights, except for the Nordic countries.
Medivir AB will retain marketing rights for simeprevir in these Nordic countries
under the marketing authorization held by Janssen-Cilag International NV.

Simeprevir was approved on September 27, 2013 in Japan for the treatment of
genotype 1 hepatitis C and a Marketing Authorisation Application was submitted
to the European Medicines Agency (EMA) by Janssen-Cilag International NV seeking
approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic
hepatitis C. Simeprevir is also being studied in several interferon-free
regimens using selected combinations of direct-acting antiviral agents with
different mechanisms of action.
To date, more than 3,700 patients have been treated with simeprevir in clinical
trials.

In October, Janssen Pharmaceuticals, Inc. acquired the investigational compound
GSK2336805, an NS5a replication complex inhibitor in phase II development for
the treatment of chronic HCV, from an affiliate of GlaxoSmithKline plc. Since
being acquired, the compound has been renamed JNJ-56914845. Janssen
Pharmaceuticals plans to initiate phase II studies to evaluate the use of JNJ
-56914845 in interferon-free combinations with simeprevir and TMC647055,
Janssen’s non-nucleoside polymerase inhibitor, for the treatment of chronic HCV
in adult patients with compensated liver disease.

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.

For more information about Medivir AB, please visit the Company’s website:
www.medivir.com