Medivir announces that Janssen has started a phase I study to evaluate the effect of simeprevir and odalasvir on AL-335 pharmacokinetics

Regulatory News:

Medivir AB (STO:MVIRB) today announces that Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies (Janssen) has started a phase I clinical trial to evaluate the potential effect of simeprevir and odalasvir (also known as ACH-3102), on the pharmacokinetics of AL-335 in healthy volunteers.

This phase I study is an open-label, two-group study of simeprevir, odalasvir, a hepatitis C virus (HCV) NS5A inhibitor, and of AL-335, a nucleotide-based HCV polymerase inhibitor. The primary objective of the study is to investigate the potential effect of simeprevir and odalasvir on the pharmacokinetics of AL-335 when administered in combination to healthy volunteers.

Approximately 150 million people are chronically infected with HCV globally*. When left untreated, HCV causes progressive liver disease in many of those who are chronically infected, and this can lead ultimately to cirrhosis, hepatocellular carcinoma and a requirement for liver transplantation. However, combinations of antiviral agents, including e.g. a protease inhibitor such as simeprevir, have shown the potential to be curative and convenient regimens for patients infected with HCV.

Further information about the study can be found at www.clinicaltrials.gov

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 3 August 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.

*http://www.who.int/mediacentre/factsheets/fs164/en/

http://mb.cision.com/Main/652/9809665/405001.pdf

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