|[July 28, 2014]
Medivir: Phase II COSMOS Study Results Published in The Lancet on World Hepatitis Day
STOCKHOLM --(Business Wire)--
Medivir AB (OMX: MVIR) announces that results from the phase II COSMOS
clinical study were published July 28 in The Lancet, demonstrating that
92 percent of genotype 1 chronic hepatitis C virus adult patients
treated with simeprevir in combination with sofosbuvir achieved
sustained virologic response 12 weeks after the end of treatment
(SVR12). The study included patients with compensated cirrhosis and
prior null response to treatment with pegylated interferon and ribavirin.
According to results from the study, the all-oral, interferon-free
treatment regimen with simeprevir and sofosbuvir resulted in consistent
SVR12 rates regardless of degree of fibrosis, and was an effective and
well-tolerated therapeutic regimen in both treatment-naïve and prior
"The Lancet publication of the COSMOS data on World Hepatitis Day gives
further recognition to these revolutionizing treatment results. I hope
that this will contribute to helping more patients around the world to
get cured." says Henrik Krook, EVP Commercial, Medivir AB.
Based on the findings from the COSMOS study, our partner Janssen in
April initiated the phase III studies OPTIMIST-1 and OPTIMIST-2
examining the safety and efficacy of simeprevir and sofosbuvir without
interferon or ribavirin for the treatment of chronic genotype 1
hepatitis C infection.
About Simeprevir (Olysio®)
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen
R&D Ireland and Medivir AB and indicated for the treatment of chronic
hepatitis C infection as a component of a combination antiviral
treatment regimen. Simeprevir efficacy has been established in HCV
genotype 1 and HCV genotype 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.
Simeprevir was approved in September 2013 in Japan, in November 2013 in
Canada and the U.S., in March 2014 in Russia and in July 2014 in Mexico
In May 2014 simeprevir was granted marketing authorization by the
European Commission (EC) for the treatment of adult patients with
genotype 1 or genotype 4 chronic HCV. Following the EMA (News - Alert) approval, it is
anticipated that simeprevir will be available across a number of
European Union countries in conjunction with reimbursement, in the
second half of 2014. Simeprevir (Olysio) is marketed under the trade
name Sovriad® in Japan and Russia, Galexos™ in Canada and Olysio® in the
U.S. and European Union.
Medivir (STO:MVIR-B) is an emerging and profitable research-based
pharmaceutical company with an established marketing and sales
organisation in the Nordics with a broad portfolio of prescription
pharmaceuticals. Medivir receives royalty from Johnson & Johnson global
sales of the hepatitis C pharmaceutical Olysio. In addition, revenues
for sales of Olysio in the Nordic region is generated through the
companies own sales and marketing organisation.
Medivir's research and development portfolio of pharmaceuticals is based
on the company's expertise in polymerase and protease drug targets for
different disease areas. The company's current research and development
is focused on infectious diseases, bone related disorders, neuropathic
pain and oncology.
Medivir is listed on the Nasdaq OMX Mid-Cap list.
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