|[March 21, 2014]
Medivir: Simeprevir receives positive CHMP opinion for the treatment of adults with chronic hepatitis C in the European Union
STOCKHOLM --(Business Wire)--
Positive opinion for the use of simeprevir in combination with other
medicinal products for the treatment of chronic hepatitis C (CHC) in
Medivir AB (OMX: MVIR) (STO:MVIR-B) announced today that the Committee
for Medicinal Products for Human Use (CHMP) has adopted a positive
opinion, recommending 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.
"The recommendation is one additional step in the global strategy that
our partner Janssen has for simeprevir, to offer a new and efficacious
treatment option to the many hepatitis C patient groups suffering from
this devastating disease" said Maris Hartmanis CEO, Medivir.
Simeprevir is a new generation, NS3/4A protease inhibitor administered
as a once daily 150 mg capsule with pegylated interferon (PegIFN) and
ribavirin (RBV) offering proven efficacy across a range of different HCV
The CHMP opinion was based on positive and consistent results from three
pivotal phase III studies in patients with GT1 HCV; QUEST-1 and QUEST-2
in treatment-na�ve patients and PROMISE in patients (who have relapsed
after previous interferon-based therapy). QUEST-1 and QUEST-2 included
785 treatment-na�ve patients with chronic HCV GT1 infection. PROMISE
included 393 relapsed patients with chronic HCV GT1 infection. All three
studies met their primary end points and demonstrated simeprevir in
cobination with PegIFN/RBV achieves superior cure rates when compared
with PegIFN/RBV alone, in treatment na�ve and relapsed patients.
Hepatitis C in the European Union
Hepatitis C is a major health problem in the European Union, where nine
million people are living with the disease. The current standard of care
is not always tolerable due to significant side effects of interferon
based therapy and improvements in efficacy for difficult to treat
patients, such as prior null responders, represent a high medical need.
Treatment of HCV is complex because of the heterogeneous population of
patients it affects and that treatment efficacy is highly dependent on
the genotype of the virus.
Medivir is required under the Securities Markets Act to make the
information in this press release public. The information was submitted
for publication at 15.45 CET on 21 March 2014.
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. Simeprevir 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.
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
For more information about Medivir AB, please visit the Company's
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