Amarin Corporation, a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced that it has entered into a multi-faceted collaboration with Mochida Pharmaceutical Co., Ltd., an integrated Japanese pharmaceutical company.
The collaboration is focused on the development and commercialization of early-stage drug products and indications based on the omega-3 acid, EPA (eicosapentaenoic acid). Amarin and Mochida are recognized worldwide as the leading, innovation-driven companies committed to the research and development of EPA-based drug products to treat the needs of tens of millions of patients who are at-risk of cardiovascular disease.
Amarin developed and markets Vascepa (icosapent ethyl) capsules in the USA, the first and only FDA-approved, prescription pure EPA drug product. Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Amarin’s clinical development program for Vascepa includes the REDUCE-IT cardiovascular outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT is the first multinational cardiovascular outcomes study evaluating the effect of prescription pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels. Amarin expects to announce top-line results of this landmark study before the end of Q3 2018.
Mochida is an integrated Japanese pharmaceutical company that developed and markets a prescription pure EPA drug product, Epadel, as a treatment for hyperlipidemia and arteriosclerosis obliterans in Japan. Mochida sponsored and successfully completed a cardiovascular outcomes trial with Epadel in Japan, JELIS. JELIS was the world’s first large-scale randomized controlled cardiovascular outcomes trial of a prescription pure EPA drug product and showed beneficial effects of the drug in further reducing cardiovascular events in statin-treated, hypercholesterolemic Japanese patients.