September 17, 2013

The regulatory process in Japan for Simeprevir


17-Sep-13 Stockholm, Sweden — Medivir AB (OMX: MVIR) On February 22, 2013 Janssen submitted a regulatory application to the Japanese Ministry of Health & Welfare authorities seeking approval for simeprevir, administered with pegylated interferon (Peg-IFN) and ribavirin (RBV) for the treatment of genotype 1 chronic hepatitis C.

As a part of the regulatory process there has been a closed meeting where simeprevir has been discussed by leading clinicians in Japan. The purpose of the meeting was to evaluate simeprevir and give guidance to the regulatory authorities.

The conclusions from this closed meeting are not officially known to us and Medivir will return with information when the regulatory process allows.

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

About Medivir
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 simeprevir, a novel protease inhibitor in late phase III clinical development for hepatitis C that is being developed in collaboration with Janssen R&D Ireland. Medivir has also a broad product portfolio with prescription pharmaceuticals in the Nordics.

For more information about Medivir AB, please visit the Company’s website:


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