Amarin Corp Plcuk (NASDAQ: AMRN)

Amarin Corporation plc, commonly known as Amarin, operates in the pharmaceutical industry, specifically focusing on the development and commercialization of therapeutics to enhance cardiovascular health and reduce cardiovascular risk. The company's primary product, VASCEPA (icosapent ethyl), is a prescription-only omega-3 fatty acid medication used to lower triglycerides and cardiovascular risk.

Amarin's main business activities involve the commercialization of VASCEPA in various markets around the world, including the United States, Europe, and other international territories. The company generates revenue primarily through the sale of VASCEPA to wholesalers, distributors, and pharmacies. Partnerships with third-party companies also contribute to the company's revenue.

In the United States, VASCEPA is sold primarily to a limited number of major wholesalers, as well as selected regional wholesalers and retail and mail-order pharmacies. Amarin has a strong presence in the U.S. market, with approximately 25 million estimated normalized total prescriptions of VASCEPA reported by Symphony Health since its commercial launch in 2013. The company's product received approval from the U.S. Food and Drug Administration (FDA) in 2013 for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. In 2019, the FDA approved an indication and label expansion for VASCEPA, making it the first and only drug approved as an adjunct to maximally tolerated statin therapy to reduce the risk of cardiovascular events in select high-risk patients.

In Europe, Amarin received marketing authorization and regulatory approval for VAZKEPA in the European Union (EU) in 2021, making it the first and only EC-approved therapy to reduce cardiovascular risk in high-risk statin-treated patients with elevated triglyceride levels. The company has launched VAZKEPA in several EU countries, including Sweden, Finland, England, Wales, Spain, and the Netherlands, with additional launches planned in the future.

Amarin has partnered with various companies to commercialize VASCEPA in international markets, including Canada, the Middle East and North Africa (MENA), China, Australia, New Zealand, and Israel. The company has received regulatory approval for VASCEPA in several of these markets, including Canada, China, and several countries in the MENA region.

The REDUCE-IT study, a multinational, prospective, randomized, double-blind, placebo-controlled trial, evaluated the efficacy of VASCEPA in reducing major cardiovascular events in statin-treated patients with elevated triglyceride levels. The study demonstrated a 25% relative risk reduction (RRR) in first occurrence of major adverse cardiovascular events (MACE) in the intent-to-treat patient population with use of VASCEPA 4 grams/day compared to placebo. The study also showed a 26% RRR in the key secondary composite endpoint of cardiovascular death, heart attacks, and stroke.

Amarin's competitive position is strong, with VASCEPA being the only omega-3 fatty acid medication approved by the FDA as an adjunct to maximally tolerated statin therapy to reduce the risk of cardiovascular events in select high-risk patients. The company's proprietary technology and manufacturing process allow it to produce high-quality, highly purified omega-3 fatty acid products that are not available from other manufacturers.

In the United States, cardiovascular diseases are the leading cause of death and disability among men and women. Approximately 130 million adults in the United States live with one or more types of cardiovascular disease, with an estimated one million new or recurrent coronary events and 795,000 new or recurrent strokes occurring each year. In Europe, cardiovascular diseases remain the leading cause of disease burden, with more than 500 million people reportedly living with cardiovascular diseases globally, including approximately 60 million in the European Union. The proportion of patients dying from cardiovascular disease is reportedly higher in Europe than in the United States, and there are more patients on statin therapy in Europe in aggregate compared to the United States.

Amarin faces competition from other pharmaceutical companies, including large, well-established companies, specialty and generic pharmaceutical companies, and specialized cardiovascular treatment companies. The company also faces competition from dietary supplement manufacturers marketing omega-3 products as nutritional supplements, which are classified as food, not as prescription drugs or as over-the-counter drugs.

In addition to VASCEPA, Amarin has a pipeline of other products in development, including a fixed-dose combination product that combines icosapent ethyl with a statin. The company is also exploring opportunities to expand its product portfolio through partnerships and acquisitions.