Amarin Corporation(US:AMRN)2021-06-10 16:40Business Updates - European Commission (EC) and Medicines and Healthcare Product Regulatory Agency (MHRA) authorized marketing of Amarin's VAZKEPA in Europe[4] - Regulatory authorities in Mainland China and Hong Kong accepted icosapent ethyl for review, with decisions expected before the end of 2021[4] - Net total revenue for Q1'21 was $142.2 million, including $140.8 million from net product sales in the US[5] - Net product sales in the US in Q1'21 were down 3% from the prior year due to COVID-19, severe winter weather, generic competition, and a calendar anomaly[5] - The company plans to resume the launch and growth of VASCEPA in the US and pursue market access in Europe on a country-by-country basis[7] - Launch in Germany is expected before the end of Q3'21[7] Market Opportunity - Cardiovascular disease (CVD) is a significant global health burden, with an estimated economic burden exceeding $1 trillion by 2030[19] - In the US, CVD results in 1 stroke, heart attack, or death every 13 seconds, with an annual treatment cost of $555 billion[19] - There are approximately 49 million people in the European Union (EU) with CVD[40] - VASCEPA has been prescribed over 10 million times[28] VASCEPA Differentiation - VASCEPA is the only drug proven to reduce persistent CV risk (P-CVR) in the studied population[12] - Analyses suggest lipid, lipoprotein, and inflammatory markers likely have limited contribution to the overall CV benefit demonstrated with icosapent ethyl (IPE)[22] - VASCEPA has the lowest Number Needed to Treat (NNT) among new therapies proven to reduce Major Adverse Cardiovascular Events (MACE) when added to the current standard of care[23] - Generic competition in the US accounted for approximately 9% of icosapent ethyl prescriptions in Q1'21[5]