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14-Dec-2018

The Transformation Into a Company Focused on Clinical Development of Pharmaceuticals has now been Completed and Medivir Gives a Project Update

The Transformation Into a Company Focused on Clinical Development of Pharmaceuticals has now been Completed and Medivir Gives a Project Update

PR Newswire

STOCKHOLM, Dec. 14, 2018

STOCKHOLM, Dec. 14, 2018 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR) today announces that the transformation to focus the company's internal resources on its clinical development projects has now been completed. Redundancies, mainly within research and administration, are reducing the number of employees from 75 to 17. This will cut the company's cost base by approximately two thirds, thus freeing up significant resources for the development projects.

The new organization will retain the company's broad competence and extensive experience within the fields of drug development and business development. The staff reporting to Medivir's Chief Executive Officer, Dr Uli Hacksell, now comprise Erik Björk, Chief Financial Officer, Dr Linda Basse, Chief Medical Officer, Dr Christina Herder, Executive Vice President Strategic Business Development, Åsa Holmgren, Executive Vice President Strategic Regulatory Affairs and Market Access, Karin Göhlin, Project Coordinator, Torbjörn Larsson, Director of CMC, and Dr Fredrik Öberg, Director of Biology and Pharmacology. As a result of the transformation process, Dr Richard Bethell will be leaving the position as Chief Scientific Officer.

"I would like to thank our employees for their valuable contribution to the company. They have always shown professionalism and loyalty and have worked hard for Medivir, in many cases over several years. We wish those who will be leaving us every success in their future endeavors," said Dr Uli Hacksell, Medivir's Chief Executive Officer.  

Below is a brief presentation and status update of Medivir's clinical projects portfolio:

Remetinostat is Medivir's topical HDAC inhibitor under development for the treatment of cutaneous T-cell lymphoma (CTCL), a rare form of blood cancer. Medivir has recently concluded a valuable and clarifying dialogue with the FDA on the design of a phase III program for CTCL. One successful phase III study is expected to be sufficient to enable FDA approval. Such a study will, however, have to comply with strict requirements. Medivir will now further define a planned phase III design based on the requirements clarified by the FDA. Medivir aims to identify a business partner for the further development of remetinostat. 

Birinapant is Medivir's SMAC mimetic under development for the treatment of patients with solid tumors. The data monitoring group of a phase I study where 19 cancer patients were treated using the combination of birinapant and MSD's anti PD-1 therapy Keytruda® (pembrolizumab) has recently completed an analysis of safety data from the complete study. The positive safety profile observed at an earlier interim analysis is now confirmed by the analysis of the complete phase I study. The dose of birinapant recommended by the data monitoring committee for phase II studies of the combination of birinapant and Keytruda® is 22 mg/m2, which corresponds to the highest of the four planned dosage levels evaluated. Medivir is expecting to commence enrolment of colorectal cancer patients for a phase II study evaluating combination treatment with birinapant and Keytruda® during Q1 2019.

MIV-818 is Medivir's nucleoside-based prodrug under development for the treatment of liver cancer. Three patients have already been included in an ongoing phase I study and the aim is for the results from the phase Ia part of this study to be available for analysis during Q2 2019.

MIV-711 is Medivir's cathepsin K inhibitor for the treatment of osteoarthritis. The company has completed a phase II study of MIV-711, which demonstrated positive results on both bone and cartilage degradation in osteoarthritis patients following six months of treatment. An extension study demonstrated continued positive effects of the treatment. In August this year, the FDA issued new preliminary guidelines which modified the Agency's view on structural endpoints. As this may enhance Medivir's potential to achieve an advantageous licensing or partnership deal for MIV-711, the company intends to consult with the FDA on the new guidelines' consequences for the design of a phase III program.

Regarding its research portfolio, Medivir continues to evaluate strategic options as well as the licensing of early research results.

For further information, please contact:

Uli Hacksell
CEO
Medivir AB
phone: +46-(0)8-5468-3100

Erik Björk
CFO
Medivir AB
mobile: +46-(0)72-228-2831

This 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 14 December, 2018.

About Medivir

Medivir is a pharmaceutical company with a focus on oncology. We have a leading competence within protease inhibitors and nucleotide/nucleosides and we develop innovative pharmaceuticals that meet great unmet medical needs. Medivir is listed on the Nasdaq Stockholm Main Board (ticker: MVIR). www.medivir.com

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Last Updated: 14-Dec-2018