•  In Hepatitis C patients with advanced liver fibrosis or
  cirrhosis (METAVIR  F3 or F4) 12 weeks all oral treatment with
  simeprevir and sofosbuvir with or without ribavirin led to SVR4 rates of
  96% and 100%, respectively
• Once-daily simeprevir and sofosbuvir with or without ribavirin was generally safe and well tolerated

28-Aug-13
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced interim
results from the second Cohort in the ongoing COSMOS study evaluating a
once daily combination of simeprevir and sofosbuvir in hard to cure
hepatitis C (HCV) patients.

SVR4 results from the 12 week arms of
Cohort 2, including treatment naïve or previous null responder HCV
patients all with METAVIR score F3-F4 were reported. Treatment for 12
weeks with simeprevir and sofosbuvir, with or without ribavirin, led to
SVR4 rates of 96% and 100%, respectively.

Interim results from
Cohort 1 of the COSMOS study, which include only prior null responder
HCV patients (METAVIR F0-F2) have been reported earlier and demonstrated
SVR8 rates of 96% and 93% after 12 weeks treatment simeprevir and
sofosbuvir with and without ribavirin, respectively.

“The high
SVR rates seen in genotype 1 prior null responders and treatment-naïve
patients with advanced liver disease, in the COSMOS study and the safety
profile of the combination are highly encouraging. We look forward to
the final results of this study in difficult to cure patients.” says
Charlotte Edenius, EVP Development, Medivir AB.

COSMOS – Study Design
COSMOS
is a randomized, open label, phase IIa clinical trial evaluating a
once-daily combination of the HCV protease inhibitor simeprevir and the
nucleotide sofosbuvir with and without ribavirin (RBV) for 12 and 24
weeks. Cohort 1 (n=80) evaluates prior null responder genotype 1
hepatitis C (HCV) patients with METAVIR scores F0-F2 and Cohort 2 (n=87)
evaluates prior null responder and treatment-naïve genotype 1 hepatitis
C patients with METAVIR scores F3-F4. The METAVIR score is used to
quantify the degree of inflammation and fibrosis of the liver. Liver
fibrosis is scored on a four-point scale.

At the time of the
interim analysis, SVR4 results were available for all patients (n=41) in
the 12 week arms of Cohort 2. In this Cohort, 78.2% of patients had
GT1a subtype with 40% of those having a Q80K baseline polymorphism,
79.3% had IL28B CT or TT genotype, 47.1% had Metavir score F4
(cirrhosis) and 54.0% were prior null responders.

In the
previously reported Cohort 1, 77.5% of the patients had GT1a subtype
with 50% of those having a Q80K baseline polymorphism, 93.7%, had IL28B
CT or TT genotype and 58.8% had METAVIR score F2.

COSMOS – Summary Interim Results: Efficacy

Efficacy
results with 150 mg simeprevir (SMV) and 400 mg sofosbuvir (SOF) once
daily for 12 weeks with or without ribavirin (RBV). Intent-to-treat
(ITT) population.

*
Data reported at the 20th Conference on Retroviruses and Opportunistic
Infections (CROI) in March 2013 in Atlanta, USA. SVR: Sustained
Virologic Response 4 or 8 weeks (SVR4 or SVR8) after end of treatment.

There
were no viral breakthroughs in either Cohort. At the time of respective
cut-off there was 1 relapse in Cohort 2, which was detected 4 weeks
after end of treatment. As previously reported there were 2 relapses
detected in Cohort 1 both at the 4 week time point after end of
treatment.

COSMOS – Summary Interim Results: Safety
Once-daily
simeprevir and sofosbuvir with or without ribavirin for 12 weeks was
generally considered safe and well tolerated. Among events defined in
the protocol as being of special interest, increased bilirubin was
observed in 9.3% of the patients in the ribavirin containing arms,
compared with 0%, for the non-ribavirin containing arms. Anemia was
observed in 13.0% of the patients in the ribavirin containing arms,
compared with 0% for the non-ribavirin containing arms.

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

About Simeprevir
Simeprevir
is a new generation NS3/4A protease inhibitor jointly developed by
Medivir and Janssen R&D Ireland, part of the Janssen Pharmaceutical
Companies for the treatment of chronic hepatitis C in adult patients
with compensated liver disease.

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 Hepatitis C
Hepatitis
C, a blood-borne infectious disease of the liver and a leading cause of
chronic liver disease and liver transplants, is a rapidly evolving
treatment area with a clear need for innovative treatments.
Approximately 150 million people are infected with hepatitis C
worldwide, and 350,000 people per year die from the disease.

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 in late phase III clinical development for
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 (http://www.medivir.com/)

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