Medivir Announces an Interferon-Free Phase II Combination Trial With TMC435 and daclatasvir to Commence Shortly
STOCKHOLM, Sweden, June 29, 2012 /PRNewswire/ –
- The phase II interferon-free combination study with TMC435 and daclatasvir will evaluate treatment-naive or previous null responder patients with HCV genotype 1a and 1b - The study will include approx. 180 patients and will evaluate a combination of TMC435 and daclatasvir, with or without Ribavirin, in four different cohorts for 12 or 24 weeks of treatment
Medivir AB (OMX:MVIR), the research-based pharmaceutical company focused on the
development of high-value treatments for infectious diseases, announces that a phase II
combination study with the investigational compound TMC435 and Bristol-Myers Squibb’s
investigational compound daclatasvir will start in July. This study is part of the
clinical collaboration agreement between Janssen R&D Ireland and Bristol-Myers Squibb
Company (NYSE:BMY) announced on 2 December 2011 and on 18 April 2012.
TMC435 and daclatasvir (BMS-790052)
TMC435, a once daily potent NS3/4A protease inhibitor (PI) in phase III clinical
development for the treatment of chronic genotype-1 hepatitis C virus (HCV) infection,
will be investigated in an interferon free phase II trial in combination with
Bristol-Myers Squibb’s investigational NS5A replication complex inhibitor, daclatasvir
(BMS-790052), also in phase III development.
The purpose of this study is to assess the efficacy and safety of TMC435 and
daclatasvir in combination with or without Ribavirin in chronic genotype-1 hepatitis C
infected patients who are treatment-naive or null responders to previous Peginterferon
In this open label phase II study the potential to achieve sustained viral response
(SVR), 12 (SVR12) and 24 (SVR24) weeks post treatment in treatment-naive and null
responder patients infected with HCV genotype 1a and 1b will be evaluated. Patients with
advanced liver disease (F3/F4) will be allowed up to approx. 35% of the total treated
Cohort one and two will include patients with genotype 1b where TMC435 and daclatasvir
will be dosed with or without Ribavirin for 12 weeks with a 36 weeks follow-up or for 24
weeks with a 24 weeks follow-up.
Cohort three and four will include patients with genotype 1a where TMC435, daclatasvir
and Ribavirin will be dosed for 12 or 24 weeks with a 24 weeks post treatment follow-up.
For additional information from these recently updated studies, please see
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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 World Health Organization 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 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), is
launched in collaboration with GlaxoSmithKline to be sold OTC under the brand name ZoviDou
in Europe, Japan and Russia.
For more information about Medivir, please visit the Company’s
For more information about Medivir, please contact:
Rein Piir, EVP Corporate Affairs & IR Mobile: +46-708-537-292
Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile firstname.lastname@example.org