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2016-11-28

Medivir: Medivir announces that Janssen has initiated an open-label phase IIb study of the 3DAA combination of simeprevir, odalasvir and AL-335 (JNJ-4178)

Press release, 28 November 2016

Stockholm, Sweden - Medivir AB (Nasdaq Stockholm: MVIR) today
announces that a phase IIb open-label study of the combination of
simeprevir, odalasvir and AL-335, also known as JNJ-4178, has been
initiated by Janssen Research & Development, LLC., part of the
Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), in
treatment-naive and treatment-experienced subjects with chronic
hepatitis C virus infection without cirrhosis. This global,
multi-center study includes clinical trial sites in North America,
Europe and Asia and forms part of Janssen's global development
program for JNJ-4178.

The objectives of the phase IIb study are to investigate the efficacy,
safety and pharmacokinetics of JNJ-4178/ AL-335 (800mg QD), odalasvir
(25mg QD), and simeprevir (75mg QD) in treatment-naive and
treatment-experienced non-cirrhotic subjects with chronic hepatitis C
virus genotype 1, 2, 4, 5, and 6 infection.

Patients in the study will receive the triple combination for either
six or eight weeks, and the primary efficacy endpoint will be the
percentage of patients with a sustained virological response 12 weeks
after the end of treatment (SVR12).

An ongoing phase IIa study is assessing the same triple combination in
patients with or without compensated cirrhosis.

Further information on the trial planning and conduct can be found on
www.clinicaltrials.gov with identifier NCT02765490.

For further information, please contact:
Richard Bethell, CSO Medivir AB, mobile +46 (0)72-704 3211
(http://tel+46%20727%20043211)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 8.30 CET on 28
November 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.

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http://news.cision.com/medivir/r/medivir-announces-that-janssen-has-init...
http://mb.cision.com/Main/652/2131894/595967.pdf

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