Medivir: Medivir’s Nucleotide Polymerase Inhibitor for the Treatment of Liver Cancer, MIV-818, Enters Non-Clinical Development

Regulatory News:

Medivir AB (Nasdaq Stockholm: MVIR) (STO:MVIRB) today announces that MIV-818 has been selected as a candidate drug (CD) from its nucleotide DNA polymerase inhibitor project for the treatment of hepatocellular carcinoma (HCC), and has now entered non-clinical development.

Liver cancers are orphan indications in North American and Western European markets. However they are the second leading cause of cancer-related death worldwide, and one of the fastest growing forms of cancer in the US, based on incidence and mortality. Hepatocellular carcinoma (HCC) is the most common cancer of the liver. Despite improvements in the detection and management of the disease, the 5-year survival rate for patients in the USA who are diagnosed with liver cancer remains below 20%. While curative surgical treatments are available to HCC patients who are diagnosed early in their disease, the prognosis for all inoperable HCC cases remains poor. There is consequently an urgent need for improved treatments, particularly for patients with advanced stages of HCC and other forms of liver cancer.

Effective therapies for patients with inoperable intermediate HCC include the delivery of drugs directly to the cancer tumour through the liver’s blood supply, which is technically challenging and for which many patients are ineligible. In contrast, most anticancer drugs that are widely distributed throughout the body are ineffective. Sorafenib is the only orally administered drug used to treat liver cancer. It is approved for use in patients with advanced HCC but confers only modest survival benefits. Despite these limitations, sorafenib has achieved over $1B in annual worldwide sales across several cancer indications, with the majority of sales from treatment of HCC.

Medivir has developed substantial capabilities to selectively deliver the active metabolites of nucleoside and nucleotide analogues to the liver, based on its long-standing interests in discovering improved treatments for chronic hepatitis B virus and hepatitis C virus infections. MIV-818 is a potent and selective inhibitor of the proliferation of liver cancer cell lines that has been designed to deliver high levels of the active drug selectively to the liver. MIV-818 has the potential to become the first liver-targeted orally administered drug to address HCC and other liver cancers. Medivir expects to communicate the preclinical antitumour and pharmacokinetic profile of MIV-818 at major scientific meetings in 2017.

"MIV-818 is unique in that it is an orally administered chemotherapeutic that will be developed exclusively for liver cancers. Many treatments that were successful in other cancers have failed to provide benefits to liver cancer patients, often because systemic toxicity prevents effective drug concentrations from being reached at the tumour site. We have designed MIV-818 to be liver-directed in order to overcome these limitations, and we look forward to advancing it into clinical trials as rapidly as possible.” said Richard Bethell, Chief Scientific Officer, Medivir AB. "We are delighted to have delivered the first CD from our internal portfolio of early-stage anti-cancer and immuno-oncology projects since it represents an important milestone in our transition to being an exclusively oncology-focused pharmaceutical company.”

This information 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 CFO set out above, at 15.45 CET on 1 November, 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.

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