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2014-03-24

Medivir: New Simeprevir data will be presented at The International Liver Congress 2014 of the European Association for the Study of the Liver, (EASL)

Press Release 24 March 2014

· Presentations Include late-breaking final results from the phase
II COSMOS study

Stockholm, Sweden - Medivir AB (OMX: MVIR) today announces that new
data from the clinical development program for simeprevir in the
treatment of genotype 1 or genotype 4 chronic hepatitis C virus (HCV)
in adult patients with compensated liver disease will be presented at
The International Liver Congress of the European Association for the
study of the Liver (EASL). The International Liver Congress 2014 will
take place from April 9-13 in London, United Kingdom.

Eight oral and poster presentations spanning over the phase II and
phase III development program for simeprevir in treatment
combinations with and without ribavirin and interferon are planned.
New analyses of data from the phase III QUEST-1, QUEST-2 and PROMISE
clinical trials of simeprevir in combination with pegylated
interferon and ribavirin, as well as final data from the phase II
COSMOS study will be presented during the Congress.

The data to be presented at the International Liver Congress 2014
include:

Late-Breaking Presentations

· Simeprevir plus sofosbuvir with/without ribavirin in HCV genotype
1 prior null-responder/treatment-naïve patients (COSMOS Study):
primary endpoint (SVR12) results in patients with METAVIR F3-4
(Cohort 2)

- Lead Author: Eric Lawitz; The Texas Liver Institute, University of
Texas Health Science Center, San Antonio, USA

· Once-daily simeprevir (TMC435) with peginterferon/ribavirin in
treatment-naïve or treatment-experienced chronic HCV genotype-4
infected patients: SVR12 results of a Phase 3 trial (RESTORE Study)

- Lead Author: Christopher Moreno; ULB Hôpital Erasme, Brussels,
Belgium

Oral Presentations

· Once-daily simeprevir (TMC435) plus sofosbuvir (GS-7977) with or
without ribavirin in HCV genotype 1 prior null responders with
METAVIR F0-2: COSMOS Study Cohort 1 subgroup analysis

- Lead Author: Mark Sulkowski; Johns Hopkins University School of
Medicine, Baltimore, USA

· Simeprevir with peginterferon/ribavirin for treatment of chronic
HCV genotype 1 infection in European patients who relapsed after
previous interferon-based therapy: the PROMISE trial

- Lead Author: Xavier Forns; Liver Unit, Hospital Clinic, Barcelona,
Spain

Poster Presentations

· Simeprevir (TMC435) with peginterferon/ribavirin for treatment of
chronic HCV genotype 1 infection in treatment-naïve European patients
in the QUEST-1 and QUEST-2 Phase 3 trials

- Lead Author: Graham R. Foster; Queen Mary's, University of London,
London, UK

· Simeprevir reduces time with peginterferon/ribavirin-induced
symptoms and quality-of-life impairments: 72-week results from three
Phase 3 studies

- Lead Author: Jane Scott; Janssen

· Virology analyses of simeprevir in Phase 2b and 3 studies
- Lead Author: Oliver Lenz; Janssen

· Deep sequencing analyses of minority baseline polymorphisms and
persistence of emerging mutations in HCV genotype 1-infected patients
treated with simeprevir

- Lead Author: Bart Fevery; Janssen
Full session details and data presentation listings for The
International Liver Congress 2014 can be found at

http://www.ilc-congress.eu.

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 10.15 CET on 24 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 and 4 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 the U.S. and in March 2014 in Russia. The
Committee for Medicinal Products for Human Use (CHMP) recently
recommended Marketing Authorisation in the European Union for the use
of simeprevir in combination with other medicinal products for the
treatment of chronic hepatitis C (CHC) in adult patients. An approval
is expected during Q2-2014.

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.

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http://news.cision.com/medivir/r/new-simeprevir-data-will-be-presented-a...
http://mb.cision.com/Main/652/9556428/223935.pdf

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