Medivir and county councils conclude agreement on Olysio®-based treatment for hepatitis C

Regulatory News:

Medivir AB (STO:MVIR-B) announces that the company has entered into an agreement with Swedish county councils regarding the treatment of hepatitis C with Olysio® (simeprevir).

The Dental and Pharmaceutical Benefits Agency (TLV) has concluded that treatment with Olysio® (simeprevir) is beneficial from a health economics viewpoint in the treatment of HCV genotypes 1 and 4 with METAVIR scores of F3-F4, irrespective of previous treatment.

A risk-sharing agreement between Medivir and the Swedish county councils has been drawn up in parallel with TLV’s health economic evaluation. The agreement offers the county councils and Medivir an increased degree of predictability with regard to treatment costs and the use of Olysio®, in that the risk-sharing applies both in relation to treatment results and to the number of patients who will be treated.

"Treatment with Olysio® has already helped to cure a large number of people from hepatitis C, both in Sweden and globally. I believe that the agreement will help to ensure equal treatment across all of Sweden’s county councils and that more hepatitis C patients will get the opportunity to become cured through treatment with Olysio® , wherever they live,” says Henrik Krook, EVP Commercial at Medivir.

Joint county council recommendations related to the use of Olysio® will be designed by the New Pharmaceutical Product Therapies (NLT) group (a group within the Swedish Association of Local Authorities and Regions tasked with evaluating new pharmaceutical products and therapies). The NLT group will have a meeting October the 30th regarding a protocol for structured introduction of Olysio®.

Medivir is required under the Swedish Securities Market Act to make the information in this press release public. The information was submitted for publication at 08.30 CET on 30 October 2014.

About Simeprevir (Olysio®)

Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen. Simeprevir efficacy has been established in HCV genotype 1 and HCV genotype 4 infected patients with compensated liver disease, including cirrhosis. Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV. Simeprevir was approved for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis. Simeprevir was approved in September 2013 in Japan, in November 2013 in Canada and the U.S., in March 2014 in Russia and in July 2014 in Mexico and Australia.

In May 2014, simeprevir was granted marketing authorisation by the European Commission (EC) for the treatment of adult patients with genotype 1 or genotype 4 chronic HCV. Following the EMA approval, it has so far been made available in several EU countries in conjunction with reimbursement. Simeprevir (Olysio) is marketed under the trade name Sovriad® in Japan and Russia, Galexos™ in Canada and Olysio® in the U.S. and European Union.

About Medivir

Medivir is an emerging and profitable research-based pharmaceutical company with an established marketing and sales organisation in the Nordic region with a broad portfolio of prescription pharmaceuticals. Medivir receives royalties from Johnson & Johnson on the global sales of the hepatitis C pharmaceutical, Olysio®. In addition, revenues for sales of Olysio in the Nordic region are generated through the company’s own sales and marketing organisation. Medivir’s research and development portfolio of pharmaceuticals is based on the company’s expertise within protease inhibitor design and nucleoside/nucleotide science. The company’s research and development focus is within infectious diseases and oncology and the on-going clinical projects in osteoarthritis and neuropathic pain. Medivir is listed on the Nasdaq Stockholm Mid Cap List.

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