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2016-05-11

Medivir: Medivir announces that Janssen decided to start a phase IIb study of combinations of Simeprevir, Odalasvir and AL-335 for the treatment of hepatitis C

Press Release 11 May 2016

Stockholm, Sweden - Medivir AB (Nasdaq Stockholm: MVIR) today
announces that Janssen Research & Development, LLC., part of the
Janssen Pharmaceutical Companies (Janssen), has decided to initiate a
phase IIb study to investigate the efficacy, safety and
pharmacokinetics of different treatment regimens of AL-335,
odalasvir, and simeprevir in treatment-naïve and
treatment-experienced patients with chronic Hepatitis C Virus (HCV)
genotype 1-6 infection, with and without cirrhosis.

This global phase IIb study is a randomized, open-label, four-arm
study of AL-335, a nucleotide-based HCV NS5B polymerase inhibitor,
odalasvir, an HCV NS5A inhibitor and simeprevir, an HCV NS3/4A
protease inhibitor. Approximately 400 patients will be randomized to
one of four treatment arms and receive once daily treatment for a
duration of six or eight weeks. Patients in two of the four arms will
receive AL-335, odalasvir and simeprevir, a compound jointly
developed by Janssen Sciences Ireland UC and Medivir AB, while
patients in the other two arms will receive only AL-335 and
odalasvir. The primary endpoint of the study is the percentage of
chronic HCV-infected subjects who achieve a sustained virologic
response 12 weeks after the end of treatment (SVR12). The study is
intended to start in June 2016 and the estimated date for completion
is July 2017.

Further information about the study can be found at
www.clinicaltrials.gov. Study identifier: NCT02765490.

For further 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 9.15 CET on 11 May
2016.

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 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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http://news.cision.com/medivir/r/medivir-announces-that-janssen-decided-...
http://mb.cision.com/Main/652/2006673/514133.pdf

Författare WKR

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