Medivir announces interim results from Cohort 2 of the COSMOS study evaluating Simeprevir and Sofosbuvir in HCV patients with METAVIR scores F3-F4

  · 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
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.

+----+----------+----------------+----------------------+-----------------+
|    |         Cohort 1*         |                Cohort 2                |
|    |        Prior null         |Prior null responder and treatment naïve|
|    |         responder         | HCV patients (METAVIR scores F3 or F4) |
|    |            HCV            |                                        |
|    |         patients          |                                        |
|    |         (METAVIR          |                                        |
|    |         score F0          |                                        |
|    |           -F2)            |                                        |
+----+----------+----------------+----------------------+-----------------+
|    |SMV / SOF+|SMV / SOF (n=14)|SMV / SOF + RBV (n=27)| SMV / SOF(n=14) |
|    |RBV (n=27)|                |                      |                 |
+----+----------+----------------+----------------------+-----------------+
|SVR4|26/27(96%)|   13/14(93%)   |      26/27(96%)      |   14/14(100%)   |
+----+----------+----------------+----------------------+-----------------+
|SVR8|26/27(96%)|   13/14(93%)   |          -           |        -        |
+----+----------+----------------+----------------------+-----------------+

* 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/)