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2014-05-07

Medivir: A supplemental New Drug Application has been submitted to the U.S. FDA for Simeprevir in combination with Sofosbuvir

· The Supplemental New Drug Application for OLYSIO™ (simeprevir) for
once-daily use in combination with sofosbuvir is for 12 Weeks
treatment of adult patients with genotype 1 chronic hepatitis C.

· The filing includes data from treatment naïve patients with
advanced liver fibrosis and prior null responders with all stages of
liver fibrosis.

Stockholm, Sweden - Medivir AB (OMX: MVIR) today announces that
Janssen has submitted a supplemental New Drug Application (sNDA) to
the Food and Drug Association (FDA) for simeprevir, an NS3/4A
protease inhibitor marketed as OLYSIO™ in the United States, in
combination with the nucleotide analogue NS5B polymerase inhibitor
sofosbuvir developed by Gilead Sciences, Inc.

"It is of great importance to continue to improve the treatments for
hepatitis C. The supplemental filing of the data available on the
combination of simeprevir and sofosbuvir is an important step towards
making an efficacious once daily all-oral treatment available for
these patients", says Charlotte Edenius, EVP Development, Medivir.

OLYSIO™ is currently approved in the U.S. for the treatment of chronic
hepatitis C infection as a component of a combination antiviral
treatment regimen. OLYSIO™ efficacy has been established in
combination with peginterferon alfa and ribavirin in HCV genotype
1-infected patients with compensated liver disease, including
cirrhosis.

This regulatory submission is for the treatment of genotype 1 chronic
hepatitis C (HCV) in adult treatment-naïve patients with advanced
fibrosis and null responders with all stages of liver fibrosis.

The regulatory submission for OLYSIO™ and sofosbuvir is supported by
data from the phase II COSMOS study which included treatment-naïve
patients with advanced fibrosis (METAVIR F3 to F4 scores) and prior
null-responder patients with all stages of liver fibrosis (METAVIR F0
to F4 scores).

Our partner, Janssen R&D Ireland Ltd initiated in April 2014 the phase
III OPTIMIST (Optimal Treatment with a simeprevir and sofosbuvir
Therapy) trials examining the safety and efficacy of simeprevir and
sofosbuvir without interferon or ribavirin for the treatment of
chronic genotype 1 HCV infection. In the first trial, known as
OPTIMIST-1, the combination will be administered once daily for 8 or
12 weeks in chronic HCV genotype 1 infected patients without
cirrhosis who are HCV treatment naive or treatment experienced. In
the second trial, known as OPTIMIST-2, the combination will be
administered once daily for 12 weeks in HCV genotype 1 infected
patients with cirrhosis who are HCV treatment naive or treatment
experienced.

For more information please visit www.clinicaltrials.gov.

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

Medivir is required under the Securities Markets Act to make the
information in this press release public. The information was
submitted for publication at 13.50 CET on 7 May 2014.

About Simeprevir
Simeprevir is an NS3/4A protease inhibitor jointly developed by
Janssen R&D Ireland and Medivir AB and indicated for the treatment
chronic hepatitis C infection in combination with pegylated
interferon and ribavirin in HCV genotype 1 and 4 infected patients
with compensated liver disease, including cirrhosis.

Janssen is responsible for the global clinical development of
simeprevir and has exclusive, worldwide marketing rights, except in
the Nordic countries. Medivir AB retains marketing rights for
simeprevir in these countries under the marketing authorization held
by Janssen-Cilag International NV. Simeprevir was approved for the
treatment of chronic hepatitis C infection as part of an antiviral
treatment regimen in combination with pegylated interferon and
ribavirin in genotype 1 infected adults with compensated liver
disease, including cirrhosis in September 2013 in Japan, in November
2013 in Canada and the U.S. and in March 2014 in Russia. A Marketing
Authorisation Application was submitted to the European Medicines
Agency (EMA) in April 2013 by Janssen-Cilag International NV seeking
approval of simeprevir for the treatment of genotype 1 or genotype 4
chronic hepatitis C and the Committee for Medicinal Products for
Human Use (CHMP) has adopted a positive opinion, recommending
Marketing Authorisation in the European Union for the use of
simeprevir in combination with other medicinal products for the
treatment of chronic HCV. This application is under review by the
EMA.

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 for the
treatment of hepatitis C that is being developed in collaboration
with Janssen R&D Ireland. The company is also working with research
and development in other areas, such as bone disorders and
neuropathic pain. Medivir has also a broad product portfolio with
prescription pharmaceuticals in the Nordics.

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http://news.cision.com/medivir/r/a-supplemental-new-drug-application-has...
http://mb.cision.com/Main/652/9580954/241792.pdf

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