OLYSIO™ available soon in all Nordic countries for the treatment of adults with hepatitis C genotype 1 and 4 infection
ET | Source:Medivir AB
· Treatment of hepatitis C patients with Olysio (simeprevir) has begun in
Sweden, Finland and Denmark
Stockholm, Sweden — Medivir AB (OMX: MVIR) today announces that Olysio will be
available in all of the Nordic countries within the next few weeks. Treatment
with Olysio began in Sweden in late May, followed by Finland and Denmark, where
the first patients recently began their treatment.
“It is immensely gratifying to now be able to offer a new and much sought-after
treatment option for hepatitis C patients in the Nordic region. The growing
awareness of Olysio and other new antivirals has been welcomed by doctors, who
now have access to safer, more effective treatment options. Our Nordic
commercial organisation has been carefully built up and is staffed by people
with a track record of successful specialist care launches. Our aim is to
continue adding new and innovative specialist care pharmaceuticals to our
product portfolio. In the spring of this year, we launched not only Olysio, but
also Adasuve (a psychiatric pharmaceutical for the treatment of agitation). It
is a fantastic feeling to work with such a competent launch team and receive
regular positive feedback from the health care sector on the ways in which these
new treatment options offer great value for the patients,” says Henrik Krook,
EVP Commercial, Medivir.
The marketing authorisation granted by the European Commission in mid-May
represents a significant milestone in the development of new triple therapy
hepatitis C treatment options for genotype 1 and 4 patients. It also includes
Olysio as part of an all oral 12-week interferon-free direct-acting antiviral
(DAA) regimen with or without ribavirin (RBV), in genotype 1 or 4 patients, who
are intolerant to or ineligible for IFN treatment.
The European Commission approval for Olysio with PegIFN + RBV is based on a
clinical trial programme involving three pivotal phase III studies, QUEST-1,
QUEST-2 and PROMISE. The use of Olysio in combination with sofosbuvir was also
approved on the basis of, amongst others, the COSMOS clinical phase II study.
This study enrolled treatment-naïve patients who were prior null responders.
Patients with fibrosis or cirrhosis of the liver were evaluated in all of these
studies with very good efficacy and safety data.
For more information please contact:
Rein Piir, EVP Corporate Affairs & IR, mobile: +46 708 537 292
Olysio 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 Olysio and has
exclusive, worldwide marketing rights, except in the Nordic countries. Medivir
AB retains marketing rights for Olysio in these countries under the marketing
authorization held by Janssen-Cilag International NV. Olysio 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. Following the EMA approval, it is anticipated that Olysio will be
available across a number of European Union countries in conjunction with
reimbursement, in the second half of 2014.
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 Olysio, 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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