Press release

Medivir’s fusion inhibitor for the treatment of Respiratory Syncytial Virus infection, MIV-323, enters non-clinical development

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announces that MIV-323 has been selected as a candidate drug (CD) from its fusion inhibitor project for the treatment of respiratory syncytial virus (RSV) infection, and has now entered non-clinical development.

Human respiratory syncytial virus is the main viral cause of respiratory tract infection in infants, the elderly and the severely immunocompromised. Almost all children will have been infected with RSV by the time of their second birthday. It has been estimated that RSV resulted in around 33.8 million lower respiratory tract infections in children younger than 5 years in 2005, with 3.4 million requiring hospitalization and between 66,000 and 199,000 child deaths. Today only one drug is approved for therapeutic use – ribavirin – but its use is limited by a complex administration procedure, limited efficacy, high cost and severe side effects. A humanised monoclonal antibody is available for prophylactic use, but it is approved only for prevention of RSV infection in infants that are at very high risk of serious lower respiratory tract disease following infection by RSV. Patients urgently need new, safe and effective drug options for the treatment and prevention of RSV infection.

Medivir AB entered a license agreement with Boehringer Ingelheim International GmbH for exclusive, global rights to a drug program for the treatment and prevention of RSV infection in August 2014. Under the terms of the agreement Medivir received an exclusive, global license to research, develop, manufacture and commercialise RSV drugs resulting from Boehringer Ingelheim’s program.

“RSV is respiratory pathogen that can cause life-threatening infections, especially in children, the elderly and the immunocompromised. It is a major, underserved disease area today, with no effective treatment available” said Richard Bethell, Medivir’s CSO. “MIV-323 has outstanding potency against diverse RSV isolates and a class-leading preclinical pharmacokinetic and in vitro safety profile. Although Medivir will be focusing its R&D efforts in oncology going forward, we believe that MIV-323 is a CD with best-in-class potential and we look forward to enabling its development by a third party.”

For further information, please contact:
Ola Burmark, CFO Medivir AB, mobile: +46 (0) 725 480 580
Richard Bethell, CSO Medivir AB, mobile +46 (0)72 704 3211 

Medivir is required under the Securities Markets Act to make the information in this press release public.
The information was submitted for publication at 14.30 CET on 14 December 2016.

About Medivir
Medivir is a research based pharmaceutical company with a research focus on oncology and infectious diseases. We have a leading competence within protease inhibitor design and nucleotide/nucleoside science and we are dedicated to develop innovative pharmaceuticals that meet great unmet medical need. Our commercial organization provides a portfolio of specialty care pharmaceuticals on the Nordic market.
Medivir is listed on the Nasdaq Stockholm Mid Cap List.