Healthcare Industry News: HSMN NewsFeed

Biopharmaceuticals Oncology Regulatory

 News Release - April 30, 2020

Medivir Receives Positive Opinion on Orphan Medicinal Drug Designation by the European Medicines Agency for MIV-818

STOCKHOLM, April 30, 2020 -- (Healthcare Sales & Marketing Network) -- 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


Source: Medivir

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



FindReps - Find Great Medical Independent Sales Reps without recruiter fees.
FindReps - available on the Apple App Store for iPhone and iPad.