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2014-03-17

Medivir: New Phase III Data from Once-Daily Simeprevir Presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL)

Stockholm, Sweden - Medivir AB (OMX: MVIR) today announced that new
phase III data for the once-daily protease inhibitor simeprevir have
been presented at the Conference of the Asian Pacific Association for
the Study of the Liver (APASL) in Brisbane, Australia.

· The phase III ATTAIN study in treatment-experienced adult patients
with chronic hepatitis C virus (HCV) and compensated liver disease
achieved its primary efficacy endpoint by demonstrating
non-inferiority of simeprevir compared to telaprevir when both are
given in combination with PegIFN/RBV. Simeprevir demonstrated
superior safety profile including fewer adverse events (AEs), fewer
serious adverse events (SAEs) and less anemia versus telaprevir.

· Pooled analysis of data from the phase III QUEST-1 and QUEST-2
studies confirmed efficacy in treatment-naïve genotype 1b HCV
patients, with 85 percent (ITT analysis) of treatment-naïve patients
achieving SVR12 when treated with simeprevir in combination with
PegIFN/RBV, compared to 53 percent when treated with placebo in
combination with PegIFN/RBV.

· In the PROMISE phase III trial of prior relapse patients, a
subgroup analysis of genotype 1b patients demonstrated that 86
percent (ITT analysis) of these patients achieved SVR12 when treated
with simeprevir in combination with PegIFN/RBV, compared to 43
percent when treated with placebo in combination with PegIFN/RBV.

"We are very pleased to report on the successfully completed phase III
ATTAIN study demonstrating non-inferiority of simeprevir compared
with telaprevir, and a superior safety profile in this difficult to
treat patient group. Moreover, the further analysis of the genotype
1b HCV patients of the phase III studies QUEST-1, QUEST-2 and PROMISE
demonstrated very high SVR12 rates supporting the strength of
simeprevir as a treatment option for this large patient population"
says Charlotte Edenius, EVP Development, Medivir AB.

ATTAIN
About the ATTAIN study
The multicenter phase III clinical study of treatment-experienced
genotype 1 HCV patients partial- and null-responder patients to at
least one previous course of PegIFN/RBV therapy called the ATTAIN
study is a randomized, double-blind, two-arm study. In the trial, 771
patients were randomized (1:1) to treatment with either 150 mg of
simeprevir once daily plus PegIFN/RBV or 750 mg of telaprevir three
times per day plus PegIFN/RBV for 12 weeks, followed by 36 weeks of
PegIFN/RBV alone.

Results from the ATTAIN study
Results from ATTAIN show that simeprevir achieved its primary endpoint
of non-inferiority to telaprevir in treatment-experienced HCV
patients and demonstrated a superior safety profile. In the study, 54
percent of chronic HCV genotype 1 prior partial- and null-responder
patients treated with simeprevir administered once daily in
combination with pegylated interferon and ribavirin achieved the
primary endpoint of sustained virologic response 12 weeks after end
of treatment (SVR12) compared to 55 percent of patients treated with
telaprevir administered three-times daily plus pegylated interferon
and ribavirin.

Among prior null-responder patients, 44 percent of patients in the
simeprevir arm achieved SVR12 versus 46 percent of patients in the
telaprevir arm. Among prior partial-responder patients, 70 percent of
patients in the simeprevir arm achieved SVR12 versus 69 percent of
patients in the telaprevir arm.

SVR12 rates across patient subgroups were generally similar between
the simeprevir and telaprevir arms, including among patients with the
HCV genotype 1a Q80K mutation. Twenty-seven percent of patients with
the HCV Q80K mutation achieved SVR12 in the simeprevir arm versus 26
percent in the telaprevir arm. The study also found that 60 percent
of patients with the IL28B CC genotype, 55 percent of CT patients and
48 percent of TT patients in the simeprevir arm achieved SVR12,
versus 67, 57 and 50 percent of patients in the telaprevir arm,
respectively.

The most common adverse events during the first 12 weeks of treatment
occurred at a consistently lower frequency in the simeprevir
treatment arm compared to the telaprevir treatment arm, including
pruritus (31 percent versus 43 percent), fatigue (32 percent versus
38 percent), headache (25 percent versus 29 percent), anemia (13
percent versus 37 percent), and nausea (17 percent versus 28
percent). Thirty-four percent and 18 percent of simeprevir-treated
patients experienced on-treatment failure and relapse, respectively,
compared to 32 percent and 17 percent of telaprevir-treated patients,
respectively. Two percent of patients in the simeprevir arm and eight
percent of patients in the telaprevir arm discontinued treatment
early due to an adverse event. Serious adverse events were reported
in two percent of patients in the simeprevir arm and nine percent of
patients in the telaprevir arm.

QUEST-1, QUEST-2 and PROMISE
Pooled analyses of the QUEST-1, QUEST-2 and PROMISE studies of
simeprevir combination therapy in genotype 1b HCV patients

In a pooled analysis of the QUEST-1 and QUEST-2 studies, 89 percent of
treatment-naïve genotype 1b HCV patients treated with simeprevir in
combination with pegylated interferon and ribavirin and met the
criteria for response guided therapy (94 percent) achieved SVR12
compared to 53 percent of patients treated with placebo in
combination with pegylated interferon and ribavirin (ITT-analysis 85
and 53 percent, respectively). In patients typically considered
difficult to treat, 71 percent of patients with the IL28B TT genotype
and 78 percent with METAVIR F3-F4 scores achieved SVR12 in the
simeprevir arm. Two percent of patients in each treatment arm
discontinued treatment with simeprevir or placebo early due to an
adverse event.

An analysis of the PROMISE study found that 89 percent of
prior-relapser genotype 1b HCV patients treated with simeprevir in
combination with pegylated interferon and ribavirin and met the
criteria for response guided therapy (95 percent) achieved SVR12
compared to 43 percent of patients treated with placebo in
combination with pegylated interferon and ribavirin (ITT-analysis 86
and 43 percent, respectively). In patients typically considered
difficult to treat, 68 percent of patients with the IL28B TT genotype
and 84 percent with METAVIR F3-F4 scores achieved SVR12 in the
simeprevir arm. No patients discontinued treatment with either
simeprevir or placebo due to adverse events during the entire
treatment phase in this analysis of PROMISE.

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 08.30 CET on 17 March 2014.

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

Janssen is responsible for the global clinical development of
simeprevir and has exclusive, worldwide marketing rights, except in
the Nordic countries. Medivir AB will retain marketing rights for
simeprevir in these countries under the marketing authorization held
by Janssen-Cilag International NV. The treatment was approved for the
treatment of genotype 1 hepatitis C in September 2013 in Japan and in
November 2013 in Canada and USA. 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 or genotype 4 chronic
hepatitis C. This application is under review by the EMA.

Simeprevir is also being studied in several interferon-free regimens
using selected combinations of direct-acting antiviral agents with
different mechanisms of action. To date, more than 3,700 patients
have been treated with simeprevir in clinical trials.

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

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http://news.cision.com/medivir/r/new-phase-iii-data-from-once-daily-sime...
http://mb.cision.com/Main/652/9552054/220837.pdf

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