Interim results from phase IIa trial evaluating triple combination including simeprevir demonstrates high level of efficacy in HCV patients

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that
interim results from a phase IIa study being conducted by Alios BioPharma Inc.,
part of the Janssen Pharmaceutical Companies (Janssen), were published as part
of the abstracts released for the upcoming European Association for the Study of
the Liver (EASL) Special Conference, September 23-24, 2016, in Paris, France.

Interim results from cohorts 1-4, summarized in the table below, showed that the
triple combination regimen, including simeprevir, was highly effective and well
tolerated in non-cirrhotic patients with GT1 HCV. Additional results, including
sustained viral response 12 weeks after completion of therapy (SVR12) for all
cohorts, will be presented in the eposter presentation on Friday, September 23,
2016.

+------+----------+----------+------+---------+------------------------------+
|Cohort|Simeprevir|Odalasvir |AL-335|Treatment|Number (%) with undetectable* |
|#     |dose (mg) |dose (mg) | dose |Duration |HCV RNA at EOT or SVR12 or 24 |
|      |          |          |(mg)  | (weeks) |                              |
+------+----------+----------+------+---------+------------------------------+
|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%), SVR4      |
+------+----------+----------+------+---------+------------------------------+
|4     |  75 QD   |  50 QOD  |800 QD|    6    |      20/20 (100%), EOT       |
+------+----------+----------+------+---------+------------------------------+

*Or below the limit of quantification (N=2; Cohort 4 only)
EOT: end of treatment; QD: every day; QOD: every other day; RNA: ribonucleic
acid; SVR: sustained virologic response.

Of the 20 patients treated in cohort 1, who received the triple combination of
odalasvir (50mg QD), AL-335 (400mg QD) and simeprevir (100mg QD) for eight weeks
(triplet, 8 weeks), 100 percent remained HCV RNA undetectable 24 weeks after
completing therapy (SVR24). Additional patients were subsequently enrolled into
two further cohorts (3 & 4), where they received adjusted doses of the same
triple combination for either eight or six weeks. In cohort 3 all patients were
HCV RNA negative (N=18) or below the limit of quantitation (N=2) and remained
HCV RNA undetectable 4 weeks after completing therapy (SVR4) and in cohort 4 all
patients were HCV RNA negative at end of treatment. Of the 20 patients treated
in cohort 2, who received the dual combination of odalasvir (50mg QOD) and AL
-335 (800mg QD) for eight weeks (8 weeks), 90 percent remained HCV RNA
undetectable twelve weeks after completing therapy (SVR12).

These all-oral combination regimens containing odalasvir and AL-335, with or
without simeprevir, were generally safe and well tolerated. The majority of
adverse events (AEs) were mild, most commonly headache, fatigue, and upper
respiratory tract infection. No clinically significant laboratory abnormalities
were observed.  In cohort 1, there was a single serious adverse event (Mobitz
Type 1 2nd degree atrioventricular block), which was attributed to treatment.
This ECG abnormality was not associated with clinical or echocardiographic
abnormalities, was transient and resolved following treatment discontinuation,
and the patient went on to achieve SVR24.

Further Development of the Triple Combination
Based upon the interim data from the phase IIa study, a phase II program is in
place for the development of the triple combination of simeprevir, odalasvir and
AL-335. This program will include two multi-center, randomized, open-label
studies that will enroll treatment-naive and treatment-experienced non-cirrhotic
patients chronically infected with hepatitis C virus genotypes 1, 2, 4, 5, and
6. These two studies will be complemented by an expansion of the ongoing phase
IIa study, to allow the triple combination to be studied in additional patients
with or without compensated cirrhosis, and with HCV genotype 2 and 3 infection.

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 12.30 CET on 9thof September
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.