The review and recommendation of the DMC at this interim look were made independently. Neither Amarin nor the FDA has reviewed the interim clinical results and neither participated in the DMC's closed session deliberation."We are pleased that we are nearing completion of the REDUCE-IT study and thank the independent DMC members for their diligence in overseeing this important study," said Steven Ketchum, Ph.D., president of R&D and chief scientific officer of Amarin. "This interim look provided important operational checks in preparation for study completion. We remain confident that the REDUCE-IT study is positioned for success based on our extensive review of the existing and continually increasing body of data from clinical, epidemiologic, genetic, and real-world evidence studies, and we are preparing for the study conclusion." Residual cardiovascular risk in statin-treated patients Cardiovascular disease remains the leading cause of death in the United States, with the estimated costs of treating heart attacks, strokes and other cardiovascular disease manifestations exceeding $550 billion annually. 1 In the United States, about 40 million patients are treated with statins for the primary and secondary prevention of atherosclerotic cardiovascular events, including heart attacks and stroke. 2 Despite the demonstrated clinical benefits of lowering bad cholesterol (LDL-C) with statins, 60% to 75% residual cardiovascular risk remains for statin-treated patients. 3 Vascepa is being studied in REDUCE-IT as an add-on to statin therapy in patients with persistent elevated triglycerides and other risk factors to further reduce cardiovascular risk, not as a replacement for statin therapy. 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
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (=500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
Availability of other information about AmarinInvestors and others should note that we communicate with our investors and the public using our company website ( www.amarincorp.com), our 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 we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. References 1 AHA Heart and Stroke Statistics https://www.heart.org/idc/groups/heart-public/@wcm/@adv/documents/downloadable/ucm_491543.pdf 2 http://www.acsh.org/news/2015/12/04/cdc-study-reveals-that-too-few-americans-are-on-statins 3 Libby P. J Am Coll Cardiol. 2005:46(7):1225-1228.
Amarin contact information:Investor Relations:Elisabeth Schwartz Investor Relations and Corporate CommunicationsAmarin Corporation plcIn U.S.: +1 (908) firstname.lastname@example.orgLee M. SternTrout Group In U.S.: +1 (646) email@example.comMedia Inquiries: Ovidio TorresFinn PartnersIn U.S.: +1 (312) 329 3911 Ovidio.firstname.lastname@example.org