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
- 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
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.
About the ATTAIN study
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
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.
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
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.
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
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.
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
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.
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,
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.
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.
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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