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Medivir announces a phase II all-oral study of Simeprevir (TMC435) and VX-135 for the treatment of Hepatitis C to be conducted



  Medivir announces a phase II all-oral study of Simeprevir (TMC435) and
  VX-135 for the treatment of Hepatitis C to be conducted by Janssen and
  Vertex

Business Wire

STOCKHOLM -- November 01, 2012

Regulatory News:

Medivir: (STO:MVIR-B)

- Companies to evaluate a two-drug combination of Medivir/Janssen’s
investigational protease inhibitor simeprevir (TMC435) and Vertex’s
investigational nucleotide analogue VX-135

- Phase II proof-of-concept study to begin in early 2013 to evaluate safety,
tolerability and viral cure rates of 12-week treatment regimen

—Medivir AB (OMX: MVIR), announced today plans for a phase II proof-of-concept
study of an all-oral regimen for the treatment of hepatitis C containing of
Medivir/Janssen’s protease inhibitor simeprevir and Vertex’s nucleotide
analogue hepatitis C virus (HCV) polymerase inhibitor VX-135. Janssen will
conduct a drug-drug interaction study with simeprevir and VX-135 to support
the planned initiation of a phase II proof-of-concept study in early 2013,
pending discussions with regulatory authorities.

The phase II study is expected to evaluate safety, tolerability and viral cure
rates using a 12-week combination of simeprevir and VX-135, with and without
ribavirin. Janssen and Vertex will jointly fund development costs associated
with the collaboration. There are no up-front or milestone payments associated
with the agreement.

Simeprevir is a potent, once-daily investigational hepatitis C protease
inhibitor, currently in phase III trials, being jointly developed by Medivir
AB and Janssen R&D Ireland. VX-135 is an investigational uridine nucleotide
analogue pro-drug designed to inhibit the replication of the hepatitis C virus
by acting on the NS5B polymerase.

“This study will broaden our understanding of simeprevir, which we believe has
the necessary characteristics to become a key component of future hepatitis C
treatment regimens, including combination with interferon and ribavirin as
well as interferon-free therapies and is in line with Medivir’s and Janssen’s
strategy to evaluate different interferon-free HCV treatment possibilities”
comments Charlotte Edenius, EVP of Research and Development, Medivir AB.

Clinical development plans Vertex and Janssen expect to initiate a phase II
proof-of-concept study of VX-135 and simeprevir in early 2013, following the
completion of a drug-drug interaction (DDI) study. Costs associated with the
studies will be shared equally between the two companies. The goals of the
study will be to evaluate safety, tolerability and viral cure rates of
multiple 12-week combination regimens (SVR12*) of VX-135 and simeprevir, with
and without ribavirin. The study will include patients who have chronic
non-cirrhotic genotype 1 hepatitis C and have not previously been treated
(treatment-naïve). Additional information on the phase II study will be
provided upon initiation of the study.

* SVR12 = undetectable hepatitis C virus 12 weeks after the end of treatment.

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 both with and without ribavirin with
simeprevir are:

· Simeprevir is evaluated in combination with Gilead Science, sofosbuvir
(GS7977) in null responder hepatitis C genotype 1 infected patients.

· Simeprevir is evaluated in combination wtih BMS, daclatasvir in
treatment-naïve or previous null responder hepatitis C genotype 1 infected
patients.

· Simeprevir is evaluated in combination with TMC647055 (Janssen R&D) and
ritonavir in low doses in treatment-naïve, relapser or null responder
hepatitis C genotype 1 infected patients.

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

About VX-135

VX-135 (ALS-2200) is a uridine nucleotide analogue pro-drug that appears to
have a high barrier to drug resistance based on in vitro studies. It is
designed to inhibit the replication of the hepatitis C virus by acting on the
NS5B polymerase. In vitro studies of the compound showed antiviral activity
across all genotypes, or forms, of the hepatitis C virus, including genotypes
more prevalent outside of the United States.

Earlier this year, Vertex announced the first 7-day viral kinetic data for
VX-135. Based on these data, the company plans to initiate multiple all-oral,
phase II proof-of-concept studies, including a study of VX-135 and ribavirin
and a study of VX-135 and telaprevir, the company's approved protease
inhibitor marketed as INCIVEK for people with chronic genotype 1 hepatitis C.
Vertex is on track to initiate the study of VX-135 in combination with
ribavirin by the end of 2012, followed by the study with telaprevir in early
2013. The studies will evaluate safety, tolerability and viral cure rates of
12-week combination regimens in people with chronic non-cirrhotic genotype 1
hepatitis C who have not previously been treated (treatment-naïve).

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. Medivir’s first product, the unique cold sore
product Xerese®/Xerclear®, is launched in collaboration with GlaxoSmithKline
to be sold OTC under the brand name ZoviDuo in Europe, Japan and Russia.

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: +46 708 537 292
or
M:Communications
Europe:
Mary-Jane Elliott, Amber Bielecka, Hollie Vile
+44(0)20 7920 2330
medivir@mcomgroup.com
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