HUDDINGE, Sweden--(BUSINESS WIRE)--Regulatory News:
Medivir AB (STO:MVIR-B) announced today that the Russian Ministry of Health has approved Sovriad® (simeprevir) for the treatment of chronic hepatitis C 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 or without ribavirin. Russia will be the first country within EMEA to gain access to simeprevir, which represents a significant advance in hepatitis C treatment.
“The Russian approval is another important event for simeprevir and provides the hepatitis C patients in Russia with a new HCV treatment” said Maris Hartmanis CEO, Medivir.
Statistics provided by the World Health Organization in 2011 showed that Russia has the third-highest prevalence of HCV, with an estimated 3.7 million infected). Though exact data for current rates is not available, in January 2014 alone, there were 4.858 new cases of HCV diagnosed in Russia. This reflects an increase of 3.5 percent in comparison to January 2013).
Medivir is required under the Securities Markets Act to make the information in this press release public. The information was submitted for publication at 08.30 CET on 24 March 2014.
Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB and indicated for the treatment chronic hepatitis C infection in combination with pegylated interferon and ribavirin in HCV genotype 1 and 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 will retain marketing rights for simeprevir in these countries under the marketing authorization held by Janssen-Cilag International NV. The treatment was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan and in November 2013 in Canada and the U.S. The Committee for Medicinal Products for Human Use (CHMP) recently recommended Marketing Authorisation in the European Union for the use of simeprevir in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult patients. An approval is expected during Q2-2014.
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.
1) World Health Organization. Hepatitis C. http://www.who.int/csr/disease/hepatitis/Hepc.pdf
2) Federal Service on Surveillance for Consumer Rights Protection and Human Wellfare
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