Medivir Announces New Studies in Phase III Program for TMC435
HUDDINGE, Sweden, March 13, 2012 /PRNewswire/ –
- Study in previous non-responder Hepatitis C genotype-1 infected patients - Study in Hepatitis C genotype-4 infected patients
MedivirAB (OMX: MVIR) a research based specialty pharmaceutical company focused on
infectious diseases announces that its oral, once daily investigational protease inhibitor
TMC435, developed by Janssen Pharmaceuticals for the treatment of Hepatitis C virus (HCV),
has commenced patient dosing and started screening in two new phase III clinical trials,
HPC3001 and HPC3011, respectively.
HPC3001 is a phase III efficacy, safety and tolerability study comparing TMC435 versus
telaprevir, each in combination with Pegylated Interferon alpha-2a (PegINF) and ribavirin
(RBV), in hepatitis C genotype-1 infected patients who were null or partial responders to
prior PegINF/RBV therapy. The study which is a randomized, double-blind, double-dummy,
two-arm study is targeted to enroll 744 patients.
The aim of the study is to demonstrate the efficacy of TMC435 based therapy compared
to the approved telaprevir regimen in this difficult to treat population.
Patients will receive TMC435 150 mg once daily or telaprevir 750 mg administered every
eight hours (q8h) in combination with PegINF/RBV for 12 weeks followed by 36 weeks of
PegIFN/RBV alone. The primary endpoint of the study is sustained virological response at
12 weeks (SVR12).
HPC3011 is an open label, single arm phase III trial to explore the efficacy, safety
and tolerability of TMC435 150 mg once daily, in combination with PegIFN/RBV in 100
treatment naive or treatment experienced, Hepatitis C genotype-4 infected patients.
Current standard of care treatment for chronic HCV genotype-4 infection consists of 48
weeks of PegIFN/RBV with a large proportion of patients do not achieve SVR with this
All subjects will receive 12 weeks triple therapy of TMC435 150 mg once daily and
PegIFN/RBV, followed by PegIFN/RBV alone. The duration of total treatment is response
guided in treatment naive and prior relapser subjects and patients are eligible to stop
all treatment at week 24 if predefined response-guided criteria are met. Subjects with
cirrhosis will receive 48 weeks of therapy, irrespective of on-treatment virologic
response and treatment history. The primary endpoint in the study is SVR12.
TMC435 – Ongoing global phase III program in brief:
- TMC435-C208 or QUEST-1 in 375 treatment-naive genotype-1 patients - TMC435-C216 or QUEST-2 in 375 treatment-naive genotype-1 patients - TMC435-C3007 or PROMISE in 375 genotype-1 patients who have relapsed after prior interferon-based treatment - Phase III program in Japan, includes 417 genotype-1 treatment naive and treatment experienced patients
Charlotte Edenius, Executive VP Research and Development, of Medivir commented,
“We are extremely pleased to expand the phase III program with these two new trials as
we continue development of TMC435 for broad patient populations. The 744 patient HPC3001
study is aimed at further confirming the positive findings of the ASPIRE phase IIb trial
in genotype-1 non-responder patient populations and in the HPC3011 study, the genotype-4
activity of TMC435 is being investigated.”
TMC435 is an investigational HCV protease inhibitor in late phase III clinical
development. It is an efficacious, safe and well-tolerated once-daily (q.d.) drug jointly
developed by Janssen Pharmaceuticals to treat chronic hepatitis C virus infections.
TMC435 is in phase III clinical development in combination with PegIFN/RBV but is also
being evaluated with Direct-acting Antiviral (DAA) agents in interferon-free combinations
both with and without ribavirin (RBV).
For additional information please visit http://www.medivir.com and
http://www.clinicaltrials.gov [file://C:\Documents and Settings\Local
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Files\Local Settings\AppData ]
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of
chronic liver disease and liver transplants. The WHO estimates that nearly 180 million
people worldwide, or approximately 3% of the world’s population, are infected with
hepatitis C virus (HCV). The CDC has reported that almost three million people in the
United States are chronically infected with HCV.
Medivir is an emerging research-based specialty pharmaceutical company focused on the
development of high-value treatments for 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 TMC435,
a novel protease inhibitor in phase III clinical development for hepatitis C that is being
developed in collaboration with Janssen Pharmaceuticals.
In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to
ensure timely commercialisation of TMC435 in the Nordic markets, once approved.
Medivir’s first product, the unique cold sore product Xerese(R)/Xerclear(R), was
launched on the US market in 2011. Xerese(R)/Xerclear(R), which has been approved in both
the US and Europe, is being launched in collaboration with GlaxoSmithKline to be sold OTC
in Europe, Japan and Russia. Rights in North America, Canada and Mexico were sold to Meda
AB in June 2011. Medivir has retained the Rx rights for Xerclear(R) in Sweden and Finland.
For more information about Medivir, please visit the Company’s website:
For more information about Medivir, please contact: Medivir Rein Piir, EVP Corporate Affairs & IR Mobil: +46-708-537-292 M:Communications Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile Medivir@mcomgroup.com +44(0)20-7920-2330