Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that
updated interim data from a phase IIa study being conducted by Alios BioPharma
Inc., part of the Janssen Pharmaceutical Companies (Janssen), were presented on
September 23rd at the European Association for the Study of the Liver (EASL)
Special Conference in Paris, France.

The updated results, which include expanded safety and efficacy data, were
presented in the ePoster entitled "Short duration treatment with AL-335 and
odalasvir (ODV), with or without simeprevir (SMV), in treatment naïve patients
with hepatitis C virus (HCV) genotype (GT) 1 infection." The data show that 100
percent of patients receiving treatment for as short as six weeks with a triple
combination of once-daily (QD) simeprevir 75mg and AL-335 800mg with 50mg every
other day (QOD) of ODV achieved a sustained viral response 12 weeks after the
completion of treatment (SVR12) as shown in the table below.

+------+----------+---------+-----------+------------------+-------------------+
|Cohort|Simeprevir|Odalasvir|AL-335 dose|Treatment Duration|  Number (%) with  |
|#     |   dose   |  dose   |   (mg)    |     (weeks)      |  SVR12 or SVR24   |
|      |   (mg)   |  (mg)   |           |                  |                   |
+------+----------+---------+-----------+------------------+-------------------+
|1     |  100 QD  |  50 QD  |  400 QD   |        8         |20/20 (100%), SVR24|
+------+----------+---------+-----------+------------------+-------------------+
|2     |    --    | 50 QOD  |  800 QD   |        8         |18/20 (90%), SVR12 |
+------+----------+---------+-----------+------------------+-------------------+
|3     |  75 QD   | 50 QOD  |  800 QD   |        8         |20/20 (100%), SVR12|
+------+----------+---------+-----------+------------------+-------------------+
|4     |  75 QD   | 50 QOD  |  800 QD   |        6         |20/20 (100%), SVR12|
+------+----------+---------+-----------+------------------+-------------------+

QD: every day; QOD: every other day; SVR: sustained virologic response.

This study was designed to determine the safety, pharmacokinetics, and efficacy
of different dosing regimens containing ODV and AL-335, with or without SMV, in
treatment naïve patients with GT1 HCV infection for treatment durations of eight
or six weeks. In all of these cohorts, the dosing regimens were generally well
-tolerated. The majority of adverse events (AEs) were mild and the most commonly
reported events were headache, fatigue, and upper respiratory tract infection.
As previously reported in the abstract, there was one serious adverse event
(SAE) in cohort 1 that resulted in premature discontinuation of all study drugs.
This consisted of a Mobitz Type 1 2nd degree atrioventricular block and was
deemed probably related to ODV and possibly related to AL-335 and simeprevir.
The event was not associated with clinical or echocardiographic abnormalities,
did not require any therapeutic intervention, resolved following treatment
discontinuation, and the patient went on to achieve SVR24. No clinically
significant laboratory, echocardiography, or ECG abnormalities (except the SAE)
were reported.
Selection of the triple combination for further development
Based on the interim data from this study, the triple combination of simeprevir
75mg QD, odalasvir 25mg QD and AL-335 400mg QD has been selected for further
development. The development program for the triple combination will include a
multi-center, randomized, open-label study that will enroll treatment-naive and
treatment-experienced non-cirrhotic patients chronically infected with hepatitis
C virus genotypes 1, 2, 4, 5, and 6. In addition, the ongoing phase IIa study is
assessing the triple combination in patients with or without compensated
cirrhosis, and with HCV genotype 3 infection.
Further information on these studies is available at www.clinicaltrials.gov with
the reference numbers NCT02569710 and NCT02765490
For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
Richard Bethell, CSO Medivir AB, mobile +46 (0)72 704 3211
Medivir is required under the Securities Markets Act to make the information in
this press release public. The information was submitted for publication at
17.50 CET on 23rdSeptember 2016.
About Medivir
Medivir is a research based pharmaceutical company with a research focus on
oncology and infectious diseases. We have a leading competence within protease
inhibitor design and nucleotide/nucleoside science and we are dedicated to
develop innovative pharmaceuticals that meet great unmet medical need. Our
commercial organization provides a portfolio of specialty care pharmaceuticals
on the Nordic market.
Medivir is listed on the Nasdaq Stockholm Mid Cap List.