Medivir AB - Interim Report, January - March 2017

The presentation will be available on Medivir's website after completion of the conference.

For further information, please contact:

Christine Lind
CEO
+46-(0)-8-5468 3100

Ola Burmark
CFO
+46-(0)-725-480-580

CEO's comments

The transformation of Medivir

Medivir's research activities are now focused on oncology and projects in other areas will consequently be out-licensed. This out-licensing work will initially relate to the rights to develop and commercialise the MIV-802 hepatitis C project in China, Taiwan, Hong Kong, and Macau – an area that was excluded from the licensing agreement concluded with Trek Therapeutics in 2016. We are also working to out-license MIV-323 for the treatment of RSV infections, which we believe has the potential to be best-in class, but in which Medivir is no longer investing itself.

The final stage in Medivir's transformation process to becoming a company focused on research and development were completed during the first quarter of the year. An agreement was concluded with Janssen, out-licensing the commercial rights in the Nordic region to simeprevir and potential future products containing simeprevir. Medivir consequently no longer conducts commercialization activities for pharmaceutical products and is now fully focused on research and development activities.

The voluntary redemption programme in connection with the divestment of BioPhausia was also completed during the quarter, resulting in the transfer of SEK 857.5 million to the shareholders. Medivir's management bought shares and sold redemption rights from the redemption programme resulting in an increase in the management group's combined shareholding in Medivir.

Further progress for projects

All of our projects continued to develop according to plan during the quarter. The MIV-711 osteoarthritis trial had its fourth and final expected Data Monitoring Committee review of safety data. All four of the independent Data Monitoring Committee's reviews have yielded the best possible outcome, namely that the ongoing phase IIa trial should continue without any modifications. We expect, as previously stated, to present the data from MIV-711 in the third quarter of 2017.

Our research and development activities are now primarily focused on oncology, including the two very interesting projects in this area that were acquired in 2016: remetinostat and birinapant. We reported topline data from the phase II study of remetinostat in CTCL (cutaneous T-cell lymphoma) after the end of the reporting period. The data from the study was positive and we expect to request a meeting with the US FDA in order to enable a phase III study start in the latter half of 2017. We are also looking forward to starting phase I/II studies of birinapant in partnership with both Merck and the University of California (UCLA) in various cancers.

Royalties attributable to the approved hepatitis C drug, OLYSIO® (simeprevir) amounted to SEK 13.7 million during the first quarter, due to the decline in global net sales of OLYSIO®. Our partner, Janssen, continues to develop simeprevir in a fixed-dose combination with other direct-acting antivirals for hepatitis C and data from the ongoing phase II program are expected to be presented by our partner at upcoming conferences.

A strong, balanced R&D portfolio

I am delighted by the opportunity to lead the implementation of our new, oncology-focused strategy. Medivir has a strong, balanced R&D portfolio with interesting projects in various phases. For a more in-depth description of our strategy and portfolio, I recommend the presentations on our website, www.medivir.com. I also have every confidence in the expertise we have built up within our organisation and in our ability to create long-term value for our shareholders.

Christine Lind

President and CEO 

This information is information that Medivir AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 08.30 CET on 28 April 2017.

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SOURCE Medivir