Medivir: Janssen Has Acquired an NS5a Replication Complex Inhibitor That
Will Be Evaluated with Simeprevir in Future Clinical Development
STOCKHOLM, Sweden -- October 8, 2013
Medivir AB (OMX: MVIR) announced that Janssen Pharmaceuticals, Inc. (Janssen)
has acquired the investigational compound GSK2336805 (GSK805), an NS5a
replication complex inhibitor in phase II development for the treatment of
chronic hepatitis C. Janssen has acquired all rights to develop and
commercialize GSK2336805 including in combination with other drugs. Janssen
acquired the compound from an affiliate of GlaxoSmithKline plc, financial
details of the agreement have not been disclosed.
Janssen plans to initiate phase II studies to evaluate the use of GSK805 in
interferon-free combinations with simeprevir (TMC435) and TMC647055, Janssen’s
non-nucleoside polymerase inhibitor, for the treatment of chronic hepatitis C
in adult patients with compensated liver disease.
“The acquisition shows our partner Janssen’s commitment in the area and their
long term effort to evaluate different treatment possibilities for hepatitis
C. This together with other ongoing interferon free trials will guide how
simeprevir may be used in the best way in different patient groups and
markets” says Maris Hartmanis, CEO of Medivir AB.
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed
by Janssen R&D Ireland and Medivir AB, for the treatment of genotype 1 and
genotype 4 chronic hepatitis C in adult patients with compensated liver
disease, including all stages of liver fibrosis. Simeprevir works by blocking
the protease enzyme that enables the hepatitis C virus to replicate in host
Janssen is responsible for the global clinical development of simeprevir and
has acquired exclusive, worldwide marketing rights, except for in the Nordic
countries. Medivir will retain marketing rights for simeprevir in these
Simeprevir was approved in Japan in September 2013 for the treatment of
genotype 1 hepatitis C. In the U.S., the New Drug Application (NDA) filed by
Janssen for simeprevir administered once daily in combination with pegylated
interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C
in adult patients was granted Priority Review designation by the Food and Drug
Administration (FDA) in May. A Marketing Authorisation Application was
submitted to the European Medicines Agency (EMA) in April seeking approval of
simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C.
To date, more than 3,700 patients have been treated with simeprevir in
clinical trials. Simeprevir is also being studied in several interferon-free
regimens using selected combinations of direct-acting antiviral agents with
different mechanisms of action.
For additional information about simeprevir clinical trials, please visit
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. 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:
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EVP Corporate Affairs & IR
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