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2014-07-28

Medivir: Phase II COSMOS study results published in The Lancet on World Hepatitis Day

The phase II COSMOS study evaluated the interferon-free combination of
simeprevir and sofosbuvir in treatment-naïve and prior null-responder
patients with all stages of liver fibrosis, including cirrhosis.

Stockholm, Sweden - 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 null-responder patients.

"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.

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

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 and Australia.

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 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.

About Medivir
Medivir 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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http://news.cision.com/medivir/r/phase-ii-cosmos-study-results-published...
http://mb.cision.com/Main/652/9621057/269992.pdf

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