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Medivir: MIV-802 has been selected as a candidate drug and enters non-clinical development for the treatment of hepatitis C infection

Hepatitis C Blog Posted on December 22, 2014 by HCV AdvocateDecember 1, 2015

HUDDINGE, Sweden–(BUSINESS WIRE)–Regulatory News:

Medivir AB (STO:MVIR-B) announced that MIV-802 has been selected as a
candidate drug (CD) from its hepatitis C virus (HCV) nucleotide
polymerase inhibitor project for the treatment of HCV infection, and is
entering non-clinical development.

Approximately 120 million people are chronically infected with HCV
globally*. HCV causes progressive liver disease in many of those who are
chronically infected, and this can lead ultimately to cirrhosis,
hepatocellular carcinoma and a requirement for liver transplantation.
However the infection is curable with combinations of antiviral agents,
and nucleotide inhibitors of the viral polymerase have been shown to be
central to many of the most effective drug combinations for treating HCV.

MIV-802 is a highly potent and selective nucleotide inhibitor of the
replication of all genotypes of the hepatitis C virus in antiviral
assays. Preclinical data indicate that it can be used effectively in
combination with other classes of antiviral agents used to treat HCV,
including protease inhibitors and NS5A inhibitors. MIV-802 has been
designed to deliver large amounts of the drug selectively to the liver,
where the hepatitis C virus replicates. Medivir expects to communicate
the preclinical antiviral and pharmacokinetic profile of MIV-802 at a
major scientific meeting in 2015.

Read complete press release here….

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Tagged Medivir, MIV-802

Medivir announces interim results from Cohort 2 of the COSMOS study evaluating Simeprevir and Sofosbuvir in HCV patients with METAVIR scores F3-F4

Hepatitis C Blog Posted on August 28, 2013 by HCV AdvocateAugust 28, 2013
  •  In Hepatitis C patients with advanced liver fibrosis or
    cirrhosis (METAVIR  F3 or F4) 12 weeks all oral treatment with
    simeprevir and sofosbuvir with or without ribavirin led to SVR4 rates of
    96% and 100%, respectively
  • Once-daily simeprevir and sofosbuvir with or without ribavirin was generally safe and well tolerated

28-Aug-13
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announced interim
results from the second Cohort in the ongoing COSMOS study evaluating a
once daily combination of simeprevir and sofosbuvir in hard to cure
hepatitis C (HCV) patients.

SVR4 results from the 12 week arms of
Cohort 2, including treatment naïve or previous null responder HCV
patients all with METAVIR score F3-F4 were reported. Treatment for 12
weeks with simeprevir and sofosbuvir, with or without ribavirin, led to
SVR4 rates of 96% and 100%, respectively.

Interim results from
Cohort 1 of the COSMOS study, which include only prior null responder
HCV patients (METAVIR F0-F2) have been reported earlier and demonstrated
SVR8 rates of 96% and 93% after 12 weeks treatment simeprevir and
sofosbuvir with and without ribavirin, respectively.

“The high
SVR rates seen in genotype 1 prior null responders and treatment-naïve
patients with advanced liver disease, in the COSMOS study and the safety
profile of the combination are highly encouraging. We look forward to
the final results of this study in difficult to cure patients.” says
Charlotte Edenius, EVP Development, Medivir AB.

COSMOS – Study Design
COSMOS
is a randomized, open label, phase IIa clinical trial evaluating a
once-daily combination of the HCV protease inhibitor simeprevir and the
nucleotide sofosbuvir with and without ribavirin (RBV) for 12 and 24
weeks. Cohort 1 (n=80) evaluates prior null responder genotype 1
hepatitis C (HCV) patients with METAVIR scores F0-F2 and Cohort 2 (n=87)
evaluates prior null responder and treatment-naïve genotype 1 hepatitis
C patients with METAVIR scores F3-F4. The METAVIR score is used to
quantify the degree of inflammation and fibrosis of the liver. Liver
fibrosis is scored on a four-point scale.

At the time of the
interim analysis, SVR4 results were available for all patients (n=41) in
the 12 week arms of Cohort 2. In this Cohort, 78.2% of patients had
GT1a subtype with 40% of those having a Q80K baseline polymorphism,
79.3% had IL28B CT or TT genotype, 47.1% had Metavir score F4
(cirrhosis) and 54.0% were prior null responders.

In the
previously reported Cohort 1, 77.5% of the patients had GT1a subtype
with 50% of those having a Q80K baseline polymorphism, 93.7%, had IL28B
CT or TT genotype and 58.8% had METAVIR score F2.

COSMOS – Summary Interim Results: Efficacy

Efficacy
results with 150 mg simeprevir (SMV) and 400 mg sofosbuvir (SOF) once
daily for 12 weeks with or without ribavirin (RBV). Intent-to-treat
(ITT) population.

*
Data reported at the 20th Conference on Retroviruses and Opportunistic
Infections (CROI) in March 2013 in Atlanta, USA. SVR: Sustained
Virologic Response 4 or 8 weeks (SVR4 or SVR8) after end of treatment.

There
were no viral breakthroughs in either Cohort. At the time of respective
cut-off there was 1 relapse in Cohort 2, which was detected 4 weeks
after end of treatment. As previously reported there were 2 relapses
detected in Cohort 1 both at the 4 week time point after end of
treatment.

COSMOS – Summary Interim Results: Safety
Once-daily
simeprevir and sofosbuvir with or without ribavirin for 12 weeks was
generally considered safe and well tolerated. Among events defined in
the protocol as being of special interest, increased bilirubin was
observed in 9.3% of the patients in the ribavirin containing arms,
compared with 0%, for the non-ribavirin containing arms. Anemia was
observed in 13.0% of the patients in the ribavirin containing arms,
compared with 0% for the non-ribavirin containing arms.

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR Mobile: +46 708 537 292.

About Simeprevir
Simeprevir
is a new generation NS3/4A protease inhibitor jointly developed by
Medivir and Janssen R&D Ireland, part of the Janssen Pharmaceutical
Companies for the treatment of chronic hepatitis C in adult patients
with compensated liver disease.

For additional information about simeprevir clinical trials, please visit www.clinicaltrials.gov.

About Sofosbuvir
Sofosbuvir
(formerly referred to as GS-7977) is a once-daily nucleotide analog
polymerase inhibitor for the treatment of HCV infection being developed
by Gilead Sciences, Inc. Sofosbuvir is being evaluated as part of
multiple therapeutic regimens, including programs with RBV alone and in
combination with peg-IFN and RBV.

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
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 Ireland. 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: www.medivir.com (http://www.medivir.com/)

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Tagged COSMOS study, Interferon Free Treatment, Medivir, Simeprevir, Sofosbuvir

Medivir makes strategic decision to focus proprietary hepatitis C R&D efforts exclusively on nucleotide-based polymerase inhibitors

Hepatitis C Blog Posted on August 15, 2013 by HCV AdvocateAugust 15, 2013

15-Aug-13 Stockholm, Sweden — Medivir AB (OMX:
MVIR) today announced that it will focus its proprietary hepatitis C
(HCV) research and development efforts exclusively on nucleotide-based
polymerase inhibitors.

Medivir had been working on the discovery
and development of new HCV nucleotide-based inhibitors and NS5A
inhibitors (NS5A replication complex inhibitor) to enable additional
potential interferon-free combinations. However, based on an evaluation
of the competitive landscape and the expected evolution of therapies for
HCV infection, Medivir has decided to focus exclusively on
nucleotide-based polymerase inhibitors and to discontinue its NS5A
inhibitor program.

“We remain very excited about our HCV
nucleotide-based inhibitor program and the opportunity to develop a
compound that could play an important role in interferon-free
treatment”, said Richard Bethell, EVP Discovery Research, Medivir AB.
“Given the attractive attributes of the nucleotide polymerase class and
the scarcity of safe and effective inhibitors, today’s decision to
discontinue our NS5A program will enable us to focus our resources on
our nucleotide-based polymerase program, which is best placed to deliver
an effective new medication for physicians and their patients.”

For more information please contact:
Rein Piir, EVP Corporate Affairs & IR
Mobile: +46 708 537 292

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, a novel protease inhibitor in late phase III
clinical development for hepatitis C that is being developed in
collaboration with Janssen R&D Ireland. 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: www.medivir.com

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Tagged Drugs in Development, Medivir

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