Presentations to Include Results of Real World Data Analysis of Patient Cardiovascular Experience from Managed Care Databases
BEDMINSTER, N.J., and DUBLIN, Ireland, November 1, 2017 -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today three of the scientific presentations it is supporting for presentation at the American Heart Association (AHA) 2017 Scientific Sessions in Anaheim, California, November 11-15. These presentations, and the underlying data and findings to be presented, were prepared in collaboration with Kaiser Permanente Center for Health Research, leading health organizations, and physicians.
“Amarin continues to seek ways for itself and health care professionals to get a better understanding of patients with cardiovascular disease and how to provide optimal therapy -- not only by what we learn from randomized, controlled trials, but also from data collected from real-life patient experiences,” said Craig B. Granowitz, M.D., Ph.D., chief medical officer of Amarin. “Real-world evidence studies are critically important in the advancement and application of clinical knowledge, which leads directly to improved patient care.”
Data to be presented includes:
· High Triglycerides Increase Cardiovascular Events, Medical Costs, and Resource Utilization in a Real-World Analysis of Statin-Treated Patients with High Cardiovascular Risk and Well-Controlled Low-Density Lipoprotein Cholesterol (Authors: Peter Toth, M.D., Ph.D., et al)
o AHA Abstract #S2045/2045; November 12, 2017; 3:15-4:30 p.m. Pacific Time
· Icosapent Ethyl Reduces Potentially Atherogenic Lipid and Inflammatory Markers in High-Risk Statin-Treated Patients with Stage 3 Chronic Kidney Disease and Persistent High Triglycerides (Authors: Krishnaswami Vijayaraghavan, MD, et al)
o AHA Abstract control #15097, Presentation #766; November 13, 2017, 1:30-1:35 p.m. Pacific Time
· Increased Cardiovascular Risk in Patients with Statin-Controlled LDL Cholesterol and Residual Hypertriglyceridemia (Authors: Gregory Nichols, Ph.D., et al)
o AHA Abstract control #14161, Presentation #784; November 14, 2017, 11:00-11:05 a.m. Pacific Time
Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin's clinical program includes a commitment to an ongoing outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA approved product, is a highly-pure, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.
About VASCEPA® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug’s ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
Important Safety Information for Vascepa
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.
This press release contains statements related to scientific presentations from real-world evidence and other studies. These statements are not promises or guarantees related to the potential for favorable outcomes from the ongoing REDUCE-IT cardiovascular outcomes trial. As disclosed in filings with the U.S. Securities and Exchange Commission, Amarin's ability to effectively develop and commercialize Vascepa will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to create market demand for Vascepa through education, marketing and sales activities, to achieve increased 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 patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that future legal determinations and interactions with regulatory authorities may impact Vascepa marketing and sales rights and efforts; the risk that Vascepa may not show clinically meaningful effects in REDUCE-IT or support regulatory approvals for cardiovascular risk reduction; and the risk that patents may not be upheld in anticipated 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 Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (http:// 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 information:
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
Lee M. Stern
In U.S.: +1 (646) 378-2992
In U.S.: +1 (212) 583-2791