Simeprevir data from COSMOS study in Hepatitis C patients will be presented as late-breaking presentation at AASLD


Stockholm, Sweden — Medivir AB (OMX: MVIR) announced that data from the phase
IIa COSMOS study (Combination Of SiMeprevir and sOfosbuvir in HCV genotype 1
infected patientS) of the investigational protease inhibitor simeprevir (TMC435)
administered once daily with Gilead’s investigational nucleotide inhibitor
sofosbuvir (GS-7977), with and without ribavirin, in genotype 1 chronic
hepatitis C adult patients with compensated liver disease has been accepted as a
late-breaking oral presentation at the upcoming Annual Meeting of the American
Association for the Study of Liver Diseases (AASLD). AASLD will take place
November 1 to 5 in Washington, D.C.

The 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.

About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by
Janssen R&D Ireland and Medivir AB, for the treatment of genotype 1 and genotype
4 chronic hepatitis C in adult patients with compensated liver disease,
including all stages of liver fibrosis. Simeprevir works by blocking the
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 in the Nordic
countries. Medivir will retain marketing rights for simeprevir in these
countries.

Simeprevir was approved in Japan in September 2013 for the treatment of genotype
1 hepatitis C. In the U.S., the New Drug Application (NDA) filed by Janssen for
simeprevir administered once daily in combination with pegylated interferon and
ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients
was granted Priority Review designation by the Food and Drug Administration
(FDA) in May. A Marketing Authorisation Application was submitted to the
European Medicines Agency (EMA) in April seeking approval of simeprevir for the
treatment of genotype 1 or genotype 4 chronic hepatitis C.

To date, more than 3,700 patients have been treated with simeprevir in clinical
trials. Simeprevir is also being studied in several interferon-free regimens
using selected combinations of direct-acting antiviral agents with different
mechanisms of action.

For additional information about simeprevir clinical trials, please visit
www.clinicaltrials.gov.

About Sofosbuvir
Sofosbuvir (formerly referred to as GS-7977) is a once-daily nucleotide analog
polymerase inhibitor for the treatment of HCV infection being developed by
Gilead Sciences, Inc. Sofosbuvir is being evaluated as part of multiple
therapeutic regimens, including programs with RBV alone and in combination with
peg-IFN and RBV.

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. 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

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