STOCKHOLM, April 30, 2020 /PRNewswire/
-- Medivir AB (Nasdaq Stockholm: MVIR) today
announced that it has received positive opinion from the Committee
for Orphan Medicinal Products on orphan medicinal product
designation in the EU for MIV-818 for the treatment of patients
with hepatocellular carcinoma (HCC), the most common type of
primary liver cancer.
Orphan Medicinal Product designation provides certain regulatory
and financial incentives for companies to develop and market
therapies that treat a life-threatening or chronically debilitating
condition affecting no more than five in 10 000 persons in the
European Union. This designation can give access to several
incentives, including protocol assistance, the EU centralized
authorization procedure and reduced regulatory fees and a potential
for a 10-year market exclusivity in the EU.
About hepatocellular carcinoma
HCC represents the fifth most common cancer worldwide but is a
rare disease in Europe and the US.
Although therapies exist, treatment benefits for intermediate and
advanced HCC are low and death rates remain high. HCC is a very
diverse disease with multiple cancer cell types and without the
tumor-specific mutations. This has contributed to the lack of
success of molecularly targeted agents in HCC. The limited overall
benefit, taken together with the poor overall prognosis for
patients with intermediate and advanced HCC, results in a large
unmet medical need.
About MIV-818
MIV-818 is a pro-drug designed to selectively treat liver cancer
cells and to minimize side effects. It has the potential to become
the first liver-targeted, orally administered drug for patients
with HCC.
About Medivir
Medivir develops innovative drugs with a focus on cancer where
the unmet medical needs are high. The drug candidates are directed
toward indication areas where available therapies are limited or
missing and there are great opportunities to offer significant
improvements to patients. Collaborations and partnerships are
important parts of Medivir's business model, and the drug
development is conducted either by Medivir or in partnership.
Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's
Small Cap list. www.medivir.com
For further information, please contact:
Dr Uli Hacksell
CEO
Medivir AB
Phone: +46 (0)8-5468-3100
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/medivir/r/medivir-receives-positive-opinion-on-orphan-medicinal-drug-designation-by-the-european-medicines-age,c3101362
The following files are available for download:
|
https://mb.cision.com/Main/652/3101362/1239581.pdf
|
Press release
(PDF)
|
View original
content:http://www.prnewswire.com/news-releases/medivir-receives-positive-opinion-on-orphan-medicinal-drug-designation-by-the-european-medicines-agency-for-miv-818-301049958.html
SOURCE Medivir
