Medivir: New Drug Application has been filed with FDA for Simeprevir (TMC435) for combination treatment of adult patients with

  Medivir: New Drug Application has been filed with FDA for Simeprevir
  (TMC435) for combination treatment of adult patients with genotype 1 chronic
  hepatitis C

Business Wire

STOCKHOLM -- March 28, 2013

Regulatory News:

Medivir AB (OMX: MVIR) today announced that a new drug application (NDA) has
been filed with the U.S. Food and Drug Administration (FDA) seeking approval
for simeprevir. The filing is based on phase III data in treatment-naïve and
treatment-experienced patients with compensated liver disease.

The filing of a regulatory application in the US triggers a milestone payment
of €10m to Medivir.

Simeprevir is jointly developed by Medivir and Janssen Pharmaceuticals, Inc.
(Janssen), and is an investigational NS3/4A protease inhibitor, administered
as a 150 mg capsule once daily with pegylated interferon and ribavirin for the
treatment of genotype 1 chronic hepatitis C in adult patients.

“The filing in the U.S. is a very important milestone for simeprevir, the
hepatitis C patients and for Medivir as a company. In addition it triggers a €
10m milestone payment to us, which strengthens our solid financial situation
even more.” comments Maris Hartmanis, CEO of Medivir.

The regulatory submission for simeprevir is supported in part by data from
three pivotal phase III studies: QUEST-1 and QUEST-2 in treatment-naïve
patients and PROMISE in patients who have relapsed after prior
interferon-based treatment. In each study, participants were treated with one
150 mg simeprevir capsule once daily for 12 weeks plus pegylated interferon
and ribavirin for 24 or 48 weeks. Primary efficacy data from the phase III
studies will be presented at different upcoming medical meetings.

About Simeprevir

Simeprevir, an investigational next generation NS3/4A protease inhibitor
jointly developed by Janssen R&D Ireland and Medivir AB, is currently in late
phase III studies as a once-daily capsule (150 mg) taken in combination with
pegylated interferon and ribavirin for the treatment of genotypes 1 and 4 HCV.

Global phase III studies of simeprevir include QUEST-1 and QUEST-2 in
treatment-naïve patients, PROMISE in patients who have relapsed after prior
interferon-based treatment and ATTAIN in null-responder patients.In parallel
to these trials, phase III studies for simeprevir are ongoing in
treatment-naïve and treatment-experienced HIV-HCV co-infected patients, HCV
genotype 4 patients and Japanese HCV genotype 1 patients. Janssen recently
announced the submission of a new drug application for simeprevir in Japan for
the treatment of genotype 1 hepatitis C.

Simeprevir is being studied in phase II interferon-free trials with and
without ribavirin in combination with:

  *Janssen’s non-nucleoside inhibitor TMC647055 and ritonavir in
    treatment-naïve genotype 1a and 1b HCV patients;
  *Gilead Sciences, Inc.’s nucleotide inhibitor sofosbuvir (GS-7977) in
    treatment-naïve and previous null-responder genotype 1 HCV patients; and
  *Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir
    (BMS-790052) in treatment-naive and previous null-responder genotype 1 HCV

In addition, Janssen has a non-exclusive collaboration with Vertex
Pharmaceuticals to evaluate in a phase II study the safety and efficacy of an
all-oral regimen of simeprevir and Vertex’s investigational nucleotide
analogue polymerase inhibitor VX-135 for the treatment of HCV. As a first
step, Janssen Pharmaceutical Inc. will conduct a drug-drug interaction (DDI)
study with simeprevir and VX-135.

We also recently announced plans to initiate a phase II trial of an
investigational interferon-free regimen with simeprevir, TMC647055 and
Idenix’s IDX719, a once-daily, pan-genotypic NS5A inhibitor, with and without

For additional information about simeprevir clinical trials, please visit

About Hepatitis C

Hepatitis C, a blood-borne infectious disease of the liver and a leading cause
of chronic liver disease and liver transplants, is a rapidly evolving
treatment area with a clear need for innovative treatments. Approximately 150
million people are infected with hepatitis C worldwide, and 350,000 people per
year die from the disease.

About Medivir AB

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 in late phase III clinical development
for hepatitis C that is being developed in collaboration with Janssen R&D

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:

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


For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Office: +46 8546831 23
Mobile: +46 708 537292.
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