Medivir : Simeprevir approved in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection

OLYSIO™ (Simeprevir) gives another triple treatment alternative, and additionally the first ever 12-week sans interferon and ribavirin autonomous treatment regimen, in blend with sofosbuvir, for suitable patients in Europe

Stockholm, Sweden — Medivir AB (OMX: MVIR) today reports that simeprevir has been allowed promoting authorisation by the European Commission (EC) for the treatment of grown-ups with genotype 1 and 4 interminable hepatitis C in mix with other therapeutic items.

"The support of simeprevir in Europe is a further stride in our accomplice's worldwide technique to empower an enhanced treatment for hepatitis C patients. This likewise implies that Medivir will now have the capacity to offer this treatment to patients in the Nordic district, where we have the promoting rights", says Maris Hartmanis, CEO, Medivir.

This advertising authorisation speaks to a critical turning point in the advancement of new triple treatment hepatitis C (HCV) treatment choices for genotype 1 and 4 patients. It likewise incorporates simeprevir as a major aspect of an all oral 12-week sans interferon direct-acting antiviral (DAA) regimen with or without ribavirin (RBV), in genotype 1 or 4 patients, who are narrow minded to or ineligible for IFN treatment.

* Treatment-innocent and earlier backslide patients with cirrhosis who are co - contaminated with HIV ought to get 48 weeks of treatment. Treatment with simeprevir must be started in mix with PegIFN + RBV and managed for 12 weeks and after that took after by an extra 36 weeks of PegIFN + RBV.

The EC approbation for simeprevir with PegIFN + RBV depends on a clinical trial system including three significant stage III studies, with more than 1000 patients. The trials; QUEST-1, QUEST-2 and PROMISE, investigated the utilization of simeprevir in mix with PegIFN/RBV in treatment-innocent patients and patients who have backslid after former interferon-base treatment. Every one of the three studies met their essential endpoints and exhibited that simeprevir in blend with PegIFN/RBV, accomplishes critical cure rates when contrasted and PegIFN/RBV alone.

The EC endorsement for the blend of simeprevir and sofosbuvir likewise contains the stage II study, COSMOS. This was based upon earlier invalid responder and treatment-gullible patients.

For more data please contact: Rein Piir, EVP Corporate Affairs and IR, portable: +46 708 537 292

Medivir is required under the Securities Markets Act to make the data in this press discharge open. The data was submitted for distribution at 13.00 CET on 16 May 2014.

About Simeprevir is a NS3/4A protease inhibitor together created by Janssen R&D Ireland and Medivir AB and showed for the treatment incessant hepatitis C contamination in blend with pegylated interferon and ribavirin in HCV genotype 1 and 4 tainted patients with repaid liver malady, including cirrhosis.

Janssen is in charge of the worldwide clinical improvement of simeprevir and has selective, overall advertising rights, aside from in the Nordic nations. Medivir AB holds advertising rights for simeprevir in these nations under the promoting approval held by Janssen-Cilag International NV. Simeprevir was endorsed for the treatment of ceaseless hepatitis C contamination as a major aspect of an antiviral treatment regimen in mix with pegylated interferon and ribavirin in genotype 1 tainted grown-ups with remunerated liver sickness, incorporating cirrhosis in September 2013 in Japan, in November 2013 in Canada and the U.S. what's more, in March 2014 in Russia. Taking after the EMA approbation, it is foreseen that simeprevir will be accessible over various European Union nations in conjunction with repayment, in the second 50% of 2014.

About Medivir is a rising exploration construct pharmaceutical organization centered with respect to irresistible maladies. Medivir has world class aptitude in polymerase and protease medication targets and medication advancement which has brought about an in number irresistible infection R&D portfolio. The Company's key pipeline resource is simeprevir, a novel protease inhibitor for the treatment of hepatitis C that is being produced as a team with Janssen R&D Ireland. The organization is additionally meeting expectations with innovative work in different ranges, for example, bone issue and neuropathic torment. Medivir has likewise a wide item portfolio with remedy pharmaceuticals in the Nordics.