Simeprevir has been approved in the USA as a new treatment for hepatitis C

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that U.S. Food and
Drug Administration (FDA) has approved simeprevir for the treatment of chronic
hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa
and ribavirin in adults with compensated liver disease, including cirrhosis, who
are treatment-naïve or who have failed previous interferon therapy (pegylated or
non-pegylated) with ribavirin.

“The USA approval is a large and important milestone in the global strategy that
our partner Janssen has for simeprevir, to offer a new treatment option to many
different hepatitis C patient groups” said Maris Hartmanis CEO, Medivir.

The approval of simeprevir in the USA is based on several studies of patients
with CHC genotype 1 infection. These studies include treatment-naïve patients
(QUEST-1 and QUEST-2), and patients who have failed prior treatment with
pegylated interferon and ribavirin; in PROMISE (prior relapsers) and ASPIRE
(prior non-responders).

The USA approval triggers a milestone payment of €10m to Medivir.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292.

Medivir is required under the Securities Markets Act to make the information in
this press release public. The information was submitted for publication at
11.30 a.m. CET on 23 November 2013.

About Simeprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by
Janssen R&D Ireland and its affiliated companies and Medivir AB for the
treatment of genotype 1 chronic hepatitis C in adult patients with compensated
liver disease, including all stages of liver fibrosis. Janssen is responsible
for the global clinical development of simeprevir and has acquired exclusive,
worldwide marketing rights, except for the Nordic countries. Medivir AB will
retain marketing rights for simeprevir in these Nordic countries under the
marketing authorization held by Janssen-Cilag International NV.

Simeprevir is approved in Japan, Canada and in the USA for the treatment of
genotype 1 chronic hepatitis C. A Marketing Authorisation Application was
submitted in April to the European Medicines Agency (EMA) by Janssen-Cilag
International NV seeking approval of simeprevir for the treatment of genotype 1
or genotype 4 chronic hepatitis C.

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

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. The company is also
working with research and development in other areas, such as bone disorders and
neuropathic pain. 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

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on
infectious diseases and a leading position in hepatitis C. We are passionate and
uncompromising in our mission to develop and commercialize innovative
pharmaceuticals that improve people’s health and quality of life.