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Amarin Corporation plc (NASDAQ:AMRN) today announced the launch of True To Your Heart, an educational campaign to help people learn more about cardiovascular disease and how to better protect against persistent cardiovascular risk. On truetoyourheart.com, people can learn about the impact of and risk factors for cardiovascular disease, as well as ways to reduce cardiovascular risk, including lifestyle choices and medical therapies.
Despite the use of current standard-of-care treatments, such as statin medications, and positive lifestyle choices, many patients with cardiovascular disease may still face persistent cardiovascular risk for life-threatening cardiovascular events such as heart attacks or stroke. However, a recent survey of nearly 500 healthcare professionals (HCPs) revealed that a majority (60%) of HCPs believe that less than half of their patients with persistent cardiovascular disease who are treated with statins realize they are still at risk for a cardiovascular event.
While most (93%) of the HCPs surveyed typically recommend prescription medications as part of their management approach for patients with persistent cardiovascular risk, only half believe available treatment options (both prescription and non-prescription) adequately protect patients from future cardiovascular events. The survey also showed that many HCPs are not up to date on the latest scientific evidence in terms of treating beyond cholesterol management, with many recommending or prescribing outdated, unproven, non-FDA approved and potentially risky treatment approaches for their patients, such as fenofibrates and fish oil dietary supplements. Notably, 55% of the HCPs surveyed admitted to prescribing fenofibrates; and 47% recommended fish oil dietary supplements, on top of statin therapy for their patients with persistent cardiovascular risk.
Dietary fish oil supplements are not intended to treat disease and have not been clinically proven to be safe or effective in the treatment or prevention of cardiovascular risk. In fact, all studies evaluating the use of fish oil supplements as an add-on to statin therapy have failed to show any significant clinical benefits beyond the use of statins alone.1 While there may be appropriate uses for dietary supplements, they should not be used for treating disease.2 Separately, the FDA withdrew approval to use fenofibrates in combination with statins in 2016 because, in its analysis, the benefits did not outweigh the risks.3 Fenofibrates are not proven to reduce cardiovascular risk when paired with a statin.
“The survey points to both a need and opportunity for more healthcare provider and patient education,” said Craig Granowitz, M.D., Ph.D., senior vice president and chief medical officer, Amarin. “Patients with cardiovascular disease who take statins are only lowering their risk of a life-threatening cardiovascular event by 25-35%,4 so while they have taken an important first step, they aren’t fully protected against persistent cardiovascular risk. Unfortunately, some patients then turn to, or are being prescribed, unproven therapeutic options. Through True To Your Heart, we aim to increase consumer awareness that they may be missing out on important cardiovascular risk protection, and hope to encourage everyone, from patients to doctors, to educate themselves so people can make the best health decisions to protect their hearts.”
For more information, visit truetoyourheart.com. And watch the new True To Your Heart commercial, which begins airing nationally on January 16, at truetoyourheart.com/commercial.
Survey MethodologyThe survey among physicians was conducted by APCO Insight between December 27, 2019 – January 2, 2020, including n=255 primary care physicians and n=243 cardiologists who treat patients with persistent cardiovascular disease. The sampling margin of error for this survey is ±4.4%.
About Cardiovascular DiseaseCardiovascular disease is a large and growing problem. Approximately 92.1 million American adults are living with some form of cardiovascular disease or the debilitating effects of stroke. It is estimated that 45% of the U.S. population will have cardiovascular disease by 2035. Cardiovascular disease is the number one cause of death for men and women in the United States, leading to 1 in 3 deaths. It is also the nation’s costliest disease, with annual costs in excess of $500 billion each year. These costs are expected to increase to 1.1 trillion by 2035.5,,
About AmarinAmarin Corporation plc. is a rapidly growing, innovative pharmaceutical company focused on developing and commercializing therapeutics to cost-effectively improve cardiovascular health. Amarin’s lead product, VASCEPA® (icosapent ethyl), is available by prescription in the United States, Lebanon and the United Arab Emirates, and is expected to be available in Canada through an anticipated February 2020 commercial launch. Amarin, together with its commercial partners in select geographies, is pursuing additional regulatory approvals for VASCEPA in China, the European Union and the Middle East. For more information about Amarin, visit www.amarincorp.com.
This press release contains forward-looking statements, including expectations regarding commercialization of VASCEPA in Canada and regulatory submissions and approvals in other markets, as well as timing related thereto. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In addition, Amarin's ability, directly or through licensees, to effectively commercialize VASCEPA in various jurisdictions will depend in part on its ability to continue to effectively finance its business, efforts of third parties, ability to gain regulatory approvals, obtain favorable pricing, and create market demand for VASCEPA to achieve market acceptance of VASCEPA, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of VASCEPA and to maintain exclusivity through grant of regulatory exclusivity and through patent protection for VASCEPA in various markets. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with acceptance of clinical trial results and related regulatory approvals; risks related to factors affecting pricing in various jurisdictions; the risk that exclusivity may not be obtained from governing authorities and that patents may not be upheld in patent litigation. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact InformationInvestor Inquiries:Elisabeth SchwartzInvestor RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315 email@example.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992 firstname.lastname@example.org
Media Inquiries:Gwen Fisher Corporate Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735 email@example.com
1 Theingi Aung, et al., Associations of Omega-3 Fatty Acid Supplement Use with Cardiovascular Disease Risks: Meta-analysis of 10 Trials Involving 77,917 Individuals, JAMA Cardiology, published online January 31, 2018.
4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
5 American Heart Association: Heart Disease and Stroke Statistics -- 2019 At-a-Glance.
6 American Heart Association. Heart Disease and Stroke Statistics – 2019 Update: A Report from the American Heart Association. Published January 31, 2019.
7 American Heart Association. 2017. Cardiovascular disease: A costly burden for America projections through 2035.