Medivir: Simeprevir has been approved in Canada as a new treatment for hepatitis C

Regulatory News:

Medivir AB (STO:MVIR-B) today announced that Health Canada has approved simeprevir for the treatment of chronic hepatitis C (CHC) genotype 1 infection, in combination with peginterferon alfa and ribavirin in adults with compensated liver disease, including cirrhosis, who are treatment-naïve or who have failed previous interferon therapy (pegylated or non-pegylated) with ribavirin.

Simeprevir received priority review status and is the first treatment for CHC to be approved for once-daily administration with pegylated interferon and ribavirin in Canada.

In Canada, for a drug to receive priority or accelerated review, it must show effective treatment of a serious, life-threatening or severely debilitating disease or condition for which no drug is presently marketed in Canada. Or, it must show a significant increase in efficacy and/or decrease in risk so that the overall benefit/risk profile is improved over existing therapies for a disease that is not adequately managed by a drug already marketed in Canada.

"Canada is the second market where simeprevir has been approved and will be a new agent in the treatment of hepatitis C. The priority review process shows the importance of offering new treatment options also for the hardest to treat patients and we are very happy that both patients and physicians are given new hope” said Maris Hartmanis CEO, Medivir.

The approval of simeprevir in Canada is based on four pivotal studies of patients with CHC genotype 1 infection: in treatment-naïve patients (QUEST-1 and QUEST-2), and in patients who have failed prior treatment with pegylated interferon and ribavirin; in PROMISE (prior relapsers) and ASPIRE (prior non-responders).

Results from a pooled analysis of QUEST-1 and QUEST-2 demonstrated that 80 percent of treatment-naïve patients in the group receiving simeprevir achieved sustained virologic response 12 weeks after the end of treatment (SVR12), compared with 50 percent of patients in the placebo groups. In PROMISE, 80 percent of prior-relapser patients in the simeprevir arm of the study achieved SVR12 compared with 37 percent of patients in the placebo group. Results from ASPIRE demonstrated that use of simeprevir led to sustained virologic response 24 weeks after the end of treatment (SVR24) in 62 percent of prior partial responder patients and 58 percent of prior-null responder patients compared with 6 percent and 15 percent of prior partial and null-responder patients in the placebo groups, respectively.

Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 2.30 p.m. CET on 20 November 2013.

About Hepatitis C in Canada

More than 250,000 Canadians are living with HCV with thousands of new cases diagnosed each year; however, the actual number of Canadians with the disease is likely much higher because 35 per cent of those who have HCV don’t know it. Combined with the indirect costs of HCV, the financial burden of the disease in Canada is estimated at $500 million annually.

About Simeprevir

Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and its affiliated companies and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir works by blocking the viral protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive, worldwide marketing rights, except for the Nordic countries. Medivir AB will retain marketing rights for simeprevir in these Nordic countries under the marketing authorization held by Janssen-Cilag International NV.

Simeprevir was approved on September 27, 2013 in Japan for the treatment of genotype 1 hepatitis C.

On October 24, the U.S. Antiviral Drugs Advisory Committee of the FDA voted unanimously (19-0) to recommend approval of the new drug application filed by Janssen Research & Development, LLC for simeprevir administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C virus (HCV) in adult patients with compensated liver disease.

A Marketing Authorisation Application was submitted in April to the European Medicines Agency (EMA) by Janssen-Cilag International NV seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C.

Simeprevir is also being studied in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.

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 for the treatment of hepatitis C that is being developed in collaboration with Janssen R&D Ireland. The company is also working with research and development in other areas, such as bone disorders and neuropathic pain. 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: www.medivir.com (http://www.medivir.se/v5/en/)

Medivir is a collaborative and agile pharmaceutical company with an R&D focus on infectious diseases and a leading position in hepatitis C. We are passionate and uncompromising in our mission to develop and commercialize innovative pharmaceuticals that improve people’s health and quality of life.

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