Medivir announces initiation of the second cohort of the interferon-free phase II study combining Simeprevir and sofosbuvir for

  Medivir announces initiation of the second cohort of the interferon-free
  phase II study combining Simeprevir and sofosbuvir for hepatitis C treatment

Business Wire

STOCKHOLM -- December 13, 2012

Regulatory News:

Sweden—Medivir AB (STO:MVIRB)(OMX: MVIR), announced today the initiation of
cohort 2 in the interferon-free phase II trial combining simeprevir with
sofosbuvir (GS7977) based on a safety and efficacy planned interim analysis of
cohort 1 including prior null responder HCV genotype 1 infected patients
without advanced hepatic fibrosis. Data from the cohort 1 study will be
presented at a scientific conference during H1-2013.

Study design Simeprevir, a NS3/4A protease inhibitor is being studied with
sofosbuvir, a nucleotide NS5B polymerase inhibitor, in a phase IIa,
randomized, open-label study to investigate the efficacy and safety of 12 or
24 weeks of simeprevir (150 mg QD) and sofosbuvir (400 mg QD) with or without
ribavirin (RBV) in HCV genotype 1 (GT1) patients.

Cohort 1 included a total of 80 HCV GT1 prior null responders to PegIFN/RBV
therapy with METAVIR score F0-F2.

Cohort 2 (90 patients) will include both HCV GT1 treatment naïve and prior
null responders to PegIFN/RBV patients with advanced hepatic fibrosis (METAVIR
score F3 or F4). Patient screening for cohort 2 was recently initiated.

About Simeprevir (TMC435) Simeprevir is a once-daily potent investigational
hepatitis C protease inhibitor in late phase III clinical development being
jointly developed by Medivir AB and Janssen R&D Ireland to treat chronic
hepatitis C virus infections. Simeprevir is being investigated in combination
with PegIFN/RBV in phase III trials and is also being evaluated with
direct-acting antiviral (DAA) agents in three other phase II interferon free
combinations both with and without ribavirin (RBV). Global phase III studies
of simeprevir include QUEST-1 and QUEST-2 in treatment naïve patients, PROMISE
in patients who have relapsed after prior IFN-based treatment and ATTAIN in
treatment experienced patients. In parallel to these trials, phase III studies
for simeprevir are ongoing in both treatment naïve and treatment experienced
HIV-HCV co-infected patients, HCV genotype 4 infected patients and in Japanese
HCV genotype 1 patients.

The phase II interferon-free combinations of simeprevir, include:

· Simeprevir in combination with Gilead Sciences’ sofosbuvir (GS7977) in
hepatitis C genotype 1 treatment-naïve or prior null responder patients.

· Simeprevir in combination with BMS’s, daclatasvir in hepatitis C genotype 1
treatment-naïve or prior null responder patients

· Simeprevir in combination with Janssen’s TMC647055 and low dose ritonavir in
hepatitis C genotype 1 treatment-naïve, prior relapser or null responder
patients

· Simeprevir in combination with Vertex’s VX-135 in hepatitis C genotype 1
treatment-naïve patients.

For additional information about Simeprevir please see www.clinicaltrials.gov

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 170 million people worldwide, approximately
3% of the world's population, are infected with hepatitis C virus (HCV). The
CDC (Centers for Disease Control and Prevention) has reported that more than
three million people in the United States are chronically infected with HCV.

About Medivir

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 (TMC435), a novel protease inhibitor in phase III clinical
development for hepatitis C that is being developed in collaboration with
Janssen R&D Ireland. In June 2011, Medivir acquired the specialty
pharmaceutical company BioPhausia and today Medivir has a broad product
portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir, please visit the Company’s website:
www.medivir.com

Medivir is a collaborative and agile pharmaceutical company with an R&D focus
on infectious diseases and a leading position in hepatitis C. We are
passionate and uncompromising in our mission to develop and commercialize
innovative pharmaceuticals that improve people’s lives.

This information was brought to you by Cision http://www.cisionwire.com

Contact:

Medivir Rein Piir
EVP Corporate Affairs & IR
Direct: +46 8 440 6550
Mobile: +46 708 537292
 
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