Medivir announces start of a phase I clinical trial of the nucleotide polymerase inhibitor AL-704 for treatment of hepatitis C

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces the
start of a phase I clinical trial with AL-704, also known as JNJ-54257099, by
Alios Biopharma Inc., part of the Janssen Pharmaceutical Companies. AL-704 is a
nucleotide based NS5B polymerase inhibitor intended for the treatment of chronic
hepatitis C virus (HCV) infection in combination with other direct acting
antiviral agents.
Medivir entered a Research & Development agreement in the field of HCV
polymerase with Janssen Products LP in May 2008. AL-704 is the second candidate
drug under this agreement that enters into clinical development, and thus no
additional milestone payment is due for this specific step of development.
This phase I study is a randomized, double-blind, placebo-controlled, 3-part
study of orally administered AL-704 to evaluate the safety, tolerability, and
pharmacokinetics of single ascending doses (Part 1) and food-effect (Part 2) in
healthy volunteers, and multiple doses (7 days) in subjects with chronic
hepatitis C infection of genotype 1 and 3 (Part 3).
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
the infection is curable with combinations of antiviral agents, and nucleotide
inhibitors of the viral polymerase have been shown to be central to some of the
most effective drug combinations for treating HCV.
Further information about the study can be found at www.clinicaltrials.gov
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 17.00 CET on 29 July 2015.
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/