SVR12 results from a phase IIa study evaluating Simeprevir and Daclatasvir in Hepatitis C patients of genotype 1 have been presented

Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced that study results
from a phase IIa trial evaluating simeprevir, a once-daily protease inhibitor
jointly developed by Janssen R&D Ireland and Medivir AB, in combination with
daclatasvir, an investigational once-daily NS5A inhibitor developed by Bristol
-Myers Squibb (NYSE: BMY), with and without ribavirin, in patients with
hepatitis C (HCV) genotype 1 infection, have been presented at the 21th
Conference on Retroviruses and Opportunistic Infections (CROI) on March 4th in
Boston, USA. The study was conducted by Bristol-Myers Squibb.

Data from the study demonstrate that sustained virologic response 12 weeks after
the end of treatment (SVR12) was reached in 75 to 85 percent of treatment-naïve
patients and 65 to 95 percent of prior null responders with HCV genotype 1b
after 12 or 24 weeks of treatment.

“We are pleased to report on the successfully completed exploratory phase IIa
clinical trial of simeprevir and daclatasvir. The results are promising, but
further studies would be required in order to fully assess the potential of the
simeprevir/daclatasvir combination.” says Charlotte Edenius, EVP Development,
Medivir AB.

Study Design
In this phase IIa open-label study, HCV genotype 1b treatment-naive patients
(N=104) and prior null responders (N=43) were randomly assigned (1:1) to receive
daclatasvir 30mg QD + simeprevir 150mg QD with or without ribavirin. Two
treatment durations were evaluated: patients who completed 12 weeks treatment
were re-randomized (1:1) to stop at Week 12 or continue treatment through Week
24.

In an exploratory evaluation of HCV genotype 1a patients, treatment naive (N=12)
and prior null responder patients (N=9) received daclatasvir + simeprevir +
ribavirin for 24 weeks.

Summary – Efficacy
In treatment-naïve HCV genotype 1b patients SVR12 was achieved by 75% (38/51)
and 85% (45/53) when treated with simeprevir and daclatasvir, with or without
ribavirin, respectively. In HCV genotype 1b prior null responders SVR12 was
achieved by 95% (19/20) and 65% (15/23) with or without ribavirin, respectively.
Estimated SVR12 rates in HCV genotype 1b patients (adjusted for pre-Week 12
discontinuations) were similar after 12 or 24 weeks of treatment in naive
patients but higher after 12 than 24 weeks in prior null responders.

In treatment-naïve HCV genotype 1a patients 67% (8/12) achieved SVR12. All HCV
genotype 1a prior null responders were offered pegylated interferon alfa-2a in
addition to ribavirin + daclatasvir + simeprevir as rescue therapy due to
frequent on-treatment breakthroughs and were counted as treatment failures.

Overall, patients were 92% white, 49% male, 21% cirrhotic, and 76% IL28B non-CC
genotype and were well-balanced across treatment groups.

Summary - Safety
The all-oral combination of daclatasvir plus simeprevir, with and without
ribavirin, was generally well tolerated. There were two treatment-related
serious adverse events (neurotoxicity, liver disorder) and one on-treatment
death (unrelated trauma-associated intracranial hematoma). Three patients
experienced treatment-related adverse events leading to discontinuation.
Seventeen patients experienced grade 3/4 total bilirubin elevations without
concurrent transaminase elevations, mostly in patients receiving ribavirin
(14/17), consistent with ribavirin-induced hemolysis and known effects of
simeprevir on bilirubin transporters.

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
18.15 CET on 4 March 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by Medivir and
Janssen R&D Ireland for the treatment of chronic hepatitis C infection in
combination with other antivirals in hepatitis C genotype 1 and 4 infected
patients with compensated liver disease, including cirrhosis.

Simeprevir was approved for the treatment of genotype 1 hepatitis C in September
2013 in Japan and in the USA and Canada in November. A Marketing Authorisation
Application was submitted to the European Medicines Agency (EMA) in April 2013
by Janssen-Cilag International NV seeking approval of simeprevir for the
treatment of genotype 1 and and genotype 4 chronic hepatitis C. To date, more
than 3,700 patients have been treated with simeprevir in clinical trials.

About Daclatasvir
Daclatasvir is an investigational NS5A replication complex inhibitor that has
been studied in more than 5,500 patients to date as a foundational agent for
multiple direct-acting antiviral-based combination therapies and is currently in
phase III development. Daclatasvir has shown antiviral potency and pan-genotypic
activity across hepatitis C genotypes in vitro. Daclatasvir has a drug-drug
interaction profile that supports its continued study in a variety of hepatitis
C combination regimens. Daclatasvir-based regimens are currently under review by
regulatory authorities in Japan and Europe.

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 lives.