AMRN
Plans to maximize "Blockbuster potential" of Vascepa in Europe
Amarin to Build Dedicated Organization to Retain Substantial Value of One of the Most Anticipated Cardiovascular Drug Products in Decades
Veteran Cardiovascular Commercial Executive Hired to Lead Focused Launch
DUBLIN, Ireland and BRIDGEWATER, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN),today announced the company's plans to undertake its own focused commercial launch of VASCEPA® (icosapent ethyl) in Europe. Amarin's plan is subject to review and approval of its Marketing Authorization Application (MAA) by the European Medicines Agency and the European Commission, respectively. The application is in the late stages of review for the reduction of cardiovascular (CV) risk in high-risk patients based on the REDUCE-IT® cardiovascular outcomes study.
"With more than 80 million people in Europe with cardiovascular disease1, there is a significant and untapped market opportunity for a safe and effective treatment beyond conventional therapies for cardiovascular risk reduction for appropriate patients based on the REDUCE-IT study," said John Thero, president and chief executive officer, Amarin. "In anticipation of approval, we conducted an extensive evaluation of the commercial options for VASCEPA in Europe. Based on that analysis, we determined that a commercialization team within Amarin and dedicated to VASCEPA is the best choice to maximize the blockbuster potential of the drug in Europe. Amarin's plan will allow the company to retain substantially all of the economic benefits of this sizeable market opportunity in key regions within Europe and is expected to result in select partnering transactions in certain smaller countries. Amarin has the passion, commitment and in-depth understanding of the product and its unique cardiovascular benefits necessary for a commercial launch. We look forward to advancing VASCEPA through the regulatory process and maximizing the blockbuster potential of VASCEPA in Europe to help millions of patients in need."
Ten to eleven years of market protection is anticipated from regulatory exclusivity in connection with VASCEPA approval based on REDUCE-IT in Europe. Amarin has filed for additional patent protection, which has the potential to extend exclusivity into 2039.
Over the past year, Amarin has made considerable progress laying the foundation for a successful commercial launch in Europe. While not yet approved for sale in Europe, VASCEPA is already included in the medical treatment guidelines of the European Society of Cardiology (ESC) and the European Atherosclerosis Society. Amarin is also looking forward to supporting a series of robust clinical data presentations highlighting the role of VASCEPA in CV risk reduction at the ESC annual meeting later this month. In addition, Amarin has been conducting market analysis and payor access research in order to size the market opportunity and prepare for the reimbursement negotiations in the various countries.
To enable Amarin to deliver on its vision in Europe, the company announces its recent hiring of Karim Mikhail as senior vice president, commercial head Europe. Mr. Mikhail joins Amarin from THEODON, a global commercial strategy consultancy that he founded in 2018 and where he served as chief executive officer. Prior to that, he was with Merck for 22 years, in a career spanning seven different countries across three continents. His most recent role was global commercial leader for Merck's $4 billion lipid franchise, where he led the global launch of ezetimibe with the IMPROVE-IT study indication. Prior to that Mr. Mikhail was also chief marketing officer for Europe, Middle East and Africa and chief operating officer for emerging markets. While at Merck, Mr. Mikhail led the successful commercial launch of dozens of products, including ezetimibe and various molecules in diabetes, hypertension, immunology, and oncology.
At Amarin, Karim plans on selecting a team of highly talented professionals to fill key positions while leveraging third-party relationships to focus further on product reimbursement and launch plans. Reimbursement, which needs to be sought for VASCEPA on a country-by-country basis, should be supported by the drug' s demonstrated effectiveness and support from leaders in the medical community.
Based on its current plans and expectations, Amarin believes that its current capital resources are sufficient to achieve sustained positive cash flows from VASCEPA, including commercial launch of VASCEPA in Europe. Physician targets to be educated about VASCEPA in Europe tend to be more concentrated than in the United States. In addition, the efficiency of launching a product and educating physicians in Europe should be aided by innovations in digital communication and other forms of education and promotion.
"We are delighted to welcome Karim to the Amarin team," continued Mr. Thero. "He is an accomplished professional with a successful track record in building organizations and commercializing numerous products in Europe and internationally. Karim brings to Amarin extensive European regulatory experience, market access expertise and the commercial innovation needed to successfully launch VASCEPA in Europe. Importantly, Karim shares our vision and excitement for VASCEPA and its potential multi-billion-dollar market opportunity in Europe."
"Assuming market authorization is granted in early 2021, we look forward to the successful launch of VASCEPA as the first and only non-LDL lowering agent approved in Europe with a cardiovascular disease risk reduction indication as an adjunct to statin therapy in dyslipidemic patients," concluded Mr. Thero.
