HUDDINGE, Sweden–(BUSINESS WIRE
Medivir AB (STO:MVIR-B) announces that the company has entered into an
agreement with Swedish county councils regarding the treatment of
hepatitis C with Olysio® (simeprevir).
The Dental and Pharmaceutical Benefits Agency (TLV) has concluded that
treatment with Olysio® (simeprevir) is beneficial from a health
economics viewpoint in the treatment of HCV genotypes 1 and 4 with
METAVIR scores of F3-F4, irrespective of previous treatment.
A risk-sharing agreement between Medivir and the Swedish county councils
has been drawn up in parallel with TLV’s health economic evaluation. The
agreement offers the county councils and Medivir an increased degree of
predictability with regard to treatment costs and the use of Olysio®, in
that the risk-sharing applies both in relation to treatment results and
to the number of patients who will be treated.
“Treatment with Olysio® has already helped to cure a large number of
people from hepatitis C, both in Sweden and globally. I believe that the
agreement will help to ensure equal treatment across all of Sweden’s
county councils and that more hepatitis C patients will get the
opportunity to become cured through treatment with Olysio® , wherever
they live,” says Henrik Krook, EVP Commercial at Medivir.
Joint county council recommendations related to the use of Olysio® will
be designed by the New Pharmaceutical Product Therapies (NLT) group (a
group within the Swedish Association of Local Authorities and Regions
tasked with evaluating new pharmaceutical products and therapies). The
NLT group will have a meeting October the 30th regarding a protocol for
structured introduction of Olysio®.
Medivir is required under the Swedish Securities Market Act to make the
information in this press release public. The information was submitted
for publication at 08.30 CET on 30 October 2014.
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
authorisation 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 authorisation by the
European Commission (EC) for the treatment of adult patients with
genotype 1 or genotype 4 chronic HCV. Following the EMA approval, it has
so far been made available in several EU countries in conjunction with
reimbursement. 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 is an emerging and profitable research‐based pharmaceutical
company with an established marketing and sales organisation in the
Nordic region with a broad portfolio of prescription pharmaceuticals.
Medivir receives royalties from Johnson & Johnson on the global sales of
the hepatitis C pharmaceutical, Olysio®. In addition, revenues for sales
of Olysio in the Nordic region are generated through the company’s own
sales and marketing organisation. Medivir’s research and development
portfolio of pharmaceuticals is based on the company’s expertise within
protease inhibitor design and nucleoside/nucleotide science. The
company’s research and development focus is within infectious diseases
and oncology and the on-going clinical projects in osteoarthritis and
neuropathic pain. Medivir is listed on the Nasdaq Stockholm Mid Cap List.
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