Early stages of Vascepa development included extensive investigation of high quality, FDA regulated proprietary manufacturing and packaging designed to protect the active ingredient from damage during the process and through dose administration in patients. Further study of Vascepa included a broad range of laboratory and clinical studies, including two successfully completed Phase 3 studies, the MARINE study and the ANCHOR study, the results of which were published in 2011 and 2012, respectively. The aggregate cost of developing Vascepa has exceeded $500 million.

In 2012, the FDA approved Vascepa as an adjunct to diet for the reduction of triglycerides in adult patients with very high triglyceride levels (>500 mg/dL a.k.a. hypertriglyceridemia). In 2013, Amarin commercially launched Vascepa in the U.S. based on this initial indication and since then VASCEPA has been the fastest growing drug in this market segment. Amarin is pursuing commercialization of Vascepa outside the U.S. through strategic relationships with various companies.

With the completion of the landmark REDUCE-IT™ cardiovascular outcomes study, Amarin intends to seek broader labeling for Vascepa. The drug may become the first therapy, as an adjunct to diet, proven to reduce cardiovascular events when used to treat patients who despite controlled LDL-cholesterol on stable statin therapy have persistent elevated triglyceride levels and other cardiovascular risk factors. It is this large, unmet medical need for potentially tens of millions of patients with dyslipidemia which development of Vascepa has been targeting for many years.

Vascepa is a drug, not a food product

Only Vascepa is a pure, proven and prescription drug consisting of icosapent ethyl, a proprietary single-molecule medicine derived from a natural source (fish).

• Many approved prescription drugs used today had their origins in nature, which provides an infinite resource for drug development. As examples, Premarin was derived from horse urine and aspirin was originally extracted from willow bark.
• Vascepa is manufactured to FDA drug standards through a purification process designed to eliminate impurities and protect the active ingredient from damage starting from the distillation of active ingredient and through dose administration.

Common fish oil is available on retail shelves and online without a prescription as a dietary supplement. Common fish oil is not Vascepa.

• Common fish oil is not an FDA-approved drug and not intended nor proven safe and effective to treat patients with medical conditions.
• Under FDA regulations, fish oil and other dietary supplements are classified as food – never a prescription drug – and as such does not have the proven safety and efficacy of a clinically proven pharmaceutical product.

Further, dietary supplements such as common fish oils are not governed by the same stringent FDA manufacturing regulations as drugs and are not required to be FDA-approved before consumer use.3,4

The FDA has designated Vascepa as a new chemical entity (NCE). Common fish oil does not have this distinction.

• The NCE designation signifies that Vascepa alone contains a proprietary, single active molecule not previously characterized for FDA review and not previously approved by the FDA to treat or prevent a medical condition. Vascepa’s active ingredient is derived from nature with unique effect.
• It is Vascepa’s distinct purity, proprietary manufacturing processes, stability, clinical effect, safety profile and FDA review & oversight that makes it different than common fish oil.
• In FDA-reviewed clinical studies, pure Vascepa showed a clinical profile different than prior generation omega-3 drug product mixtures. Notably, Vascepa lowered triglycerides without raising bad cholesterol, LDL-C, in patients with very high triglycerides.