Medivir AB (OMX: MVIR) announced that data from the phase IIa COSMOS
study (Combination Of SiMeprevir and sOfosbuvir in HCV genotype 1
infected patientS) of the investigational protease inhibitor simeprevir
(TMC435) administered once daily with Gilead's investigational
nucleotide inhibitor sofosbuvir (GS-7977), with and without ribavirin,
in genotype 1 chronic hepatitis C adult patients with compensated liver
disease has been accepted as a late-breaking oral presentation at the
upcoming Annual Meeting of the American Association for the Study of
Liver Diseases (AASLD). AASLD will take place November 1 to 5 in
The COSMOS data will be presented during the late-breaking oral session
on Monday, November 4, 2:45-4:30 p.m. (EST) in Hall E: SVR results of a
once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with
or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1
treatment-naïve and prior null responder patients: The COSMOS study.
· Lead Author: Ira M. Jacobson, Weill Cornell Medical College, New York,
Full session details and data presentation listings for the 2013 AASLD
Annual Meeting can be found at http://www.aasld.org/livermeeting.
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 cells.
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 countries.
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
Sofosbuvir (formerly referred to as GS-7977) is a once-daily nucleotide
analog polymerase inhibitor for the treatment of HCV infection being
developed by Gilead Sciences, Inc. Sofosbuvir is being evaluated as part
of multiple therapeutic regimens, including programs with RBV alone and
in combination with peg-IFN and RBV.
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
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