Amarin Corporation is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve patient health. Our lead commercial product, VASCEPA® (icosapent ethyl), creates a new paradigm in cardiovascular disease management and is positioned to address cardiovascular risk for millions of patients globally.
The efficacy and safety profile of VASCEPA, as demonstrated in the landmark REDUCE-IT® cardiovascular outcomes study, has been heralded as one of the most significant breakthroughs in preventative cardiovascular care since statin therapy was introduced nearly three decades ago. VASCEPA is supported by over 100 scientific publications and presentations and recommended for use in appropriate at-risk patients by leading medical societies from around the world, including the United States and Europe. The REDUCE-IT results stand in stark contrast to earlier generation drugs, the clinical studies of which failed to show reduction of persistent cardiovascular risk in their studied populations.
In 2013, Amarin launched VASCEPA in the United States for an important niche indication addressing very high triglyceride levels in adult patients. In 2019, based on the unprecedented REDUCE-IT study results, Amarin received approval from the U.S. Food and Drug administration (FDA) for a substantially broader indication for cardiovascular risk reduction in studied high risk patients. Prescription use of VASCEPA in the United States for this indication, as launched in early 2020, now represents the vast majority of VASCEPA prescriptions. In aggregate, since launch in 2013, VASCEPA has been prescribed more than 10 million times in the United States. The European Commission (EC) has also approved the marketing authorization application for VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular events in studied high-risk patients. In addition, through commercial partners, we are in the early stages of introducing VASCEPA to help patients in various other countries.
Amarin’s employees are achieving great things through focus, dedication to science and passion. We are differentiated by our people, product and track record of overcoming challenges to create impactful and affordable patient care solutions. Our clinical development program for VASCEPA began more than a decade ago and reflects the work of our dedicated employees, together with contributions from the many healthcare professionals and patients who participated in the company’s clinical studies.
In 2009, when Amarin initiated its first Phase 3 clinical trials for VASCEPA, the company had fewer than twenty employees. Since then, Amarin has grown substantially, reaching approximately 1,000 employees as of 2020, with broadly integrated operations and expertise ranging from science to product commercialization.
Since FDA approval of the cardiovascular risk indication for VASCEPA in 2019, Amarin’s U.S. commercial team has been substantially increased. In Europe, Amarin is building a commercial organization to launch subject to customary market access negotiations in each country. Amarin continues to support its commercial partners in commercializing, or seeking to commercialize, VASCEPA in Canada, China and the Middle East/North Africa while evaluating other global opportunities for helping appropriate patients with cardiovascular disease management.
Amarin has its principal offices in Dublin, Ireland. Its primary U.S. office is located in Bridgewater, NJ. Its primary commercial hub for Europe is in Zug, Switzerland. Amarin is listed on NASDAQ under the symbol "AMRN."
Cardiovascular disease is an enormous and worsening public health burden. It is the most expensive area in healthcare and the number one cause of death. Proven preventative care treatment options for chronic conditions such as cardiovascular disease are infrequent. For all these reasons, there is an urgent need to help patients reduce the risk of painful, expensive and often debilitating or deadly cardiovascular events, like heart attacks and strokes.
Amarin is highly motivated to improve patient care while creating value for shareholders and society. Despite being the only approved drug for its cardiovascular risk indication, Amarin has elected to price VASCEPA at a level that is considerably lower than other new cardiovascular drugs. Amarin is proud that third-party analyses have concluded that VASCEPA is cost effective, resulting in potential cost saving in most studied scenarios, a result rarely achieved in such analyses.1 With its coverage by most major medical insurance providers in the United States and support by leading medical societies from around the world, including the United States and Europe, we believe that VASCEPA is creating a new paradigm in cardiovascular disease management.
Development and launch of a product with the unprecedented clinical results of VASCEPA, in addition to groundbreaking science and dedicated, passionate people, required prioritization. Throughout VASCEPA’s Phase 3 development, including conducting of the REDUCE-IT cardiovascular outcomes study and advancement of regulatory approvals of VASCEPA in the United States and Europe, no opportunity available to Amarin was judged to have the potential to be more successful or more important than VASCEPA. During this VASCEPA development period, Amarin prioritized VASCEPA over advancing other product opportunities because such other development might have diluted the high level of attention and resources needed for VASCEPA development and approval. As the launch of VASCEPA progresses in the United States and in Europe (as VAZKEPA), Amarin intends to increase its attention on other potential development opportunities.
1 Weintraub WS, Bhatt D, Zhang Z, Zhang C, Sarahfaye D, Boden WE, Steg PG, Miller M, Brinton E, King J, Bress A, Jacobson T, Tardiff JC, Ballantyne CM, Kolm P. Cost-effectiveness of icosapent ethyl in US REDUCE-IT patients [abstract]. J Am Coll Cardiol. 2020;75(11 suppl 1):1914. http://www.onlinejacc.org/content/75/11_Supplement_1/1914