Medivir’s nucleotide polymerase inhibitor for the treatment of liver cancer, MIV-818, enters non-clinical development

Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) 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.”
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
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.