SOURCE: Amarin Corp. Plc

Amarin Corp. Plc

March 31, 2016 07:00 ET

Amarin Reaches Target Enrollment in Cardiovascular Outcomes Study of Vascepa® in Patients With Elevated Triglycerides Despite Statin Therapy

Over 8,000 Patients Now Enrolled in REDUCE-IT Study Evaluating the Effectiveness of Vascepa in Preventing the Occurrence of a First Major Cardiovascular Event; Interim Analysis by DMC Anticipated in Approximately Six Months

BEDMINSTER, NJ and DUBLIN, IRELAND--(Marketwired - March 31, 2016) - Amarin Corporation plc (NASDAQ: AMRN) today announced that target patient enrollment has been reached in its REDUCE-IT cardiovascular outcomes trial of Vascepa (icosapent ethyl). Amarin also announced that the onset of approximately 60% of the target aggregate number of primary cardiovascular events within the REDUCE-IT study has triggered preparation for a pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee (DMC). Amarin currently expects the independent interim analysis to be conducted in approximately six months.

Enrollment Target Achieved

The REDUCE-IT study was designed to enroll approximately 8,000 patients. This enrollment target has been reached and Amarin is winding down patient enrollment on a country by country basis. Since the study commenced in 2011, over 20,000 patient years of study have been accumulated in REDUCE-IT. 

"We are pleased to announce that we have reached the target enrollment in REDUCE-IT, the first multinational cardiovascular outcomes study prospectively designed to investigate whether there is a meaningful reduction in the occurrence of major cardiovascular events when EPA is added to statin therapy in high-risk patients with elevated triglycerides," said Steven Ketchum, Ph.D., president of research and development and chief scientific officer at Amarin. "Vascepa demonstrated a broad spectrum of favorable effects on lipid, lipoprotein, and inflammatory biomarkers compared to placebo in Phase 3 studies focused on patients with high triglyceride levels after statin therapy and on patients with very high triglyceride levels. Through long-term study of patients treated with Vascepa in REDUCE-IT, we aim to provide a robust dataset to determine whether the effects of highly-pure EPA omega-3 prescription drug therapy will lower the risk of cardiovascular events in the high-risk patient population studied."

Interim Analysis Expected in Approximately Six Months

The REDUCE-IT study's event rate continues to track to prior estimates. A pre-specified interim efficacy and safety analysis was designed to be conducted upon achieving approximately 60% of the 1,612 aggregate primary cardiovascular events within the study. REDUCE-IT patients are in the process of completing a study visit over the next several months, after which additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. As is typical for large-scale, multi-national studies, regardless of the strength of the study results this data preparation and transfer process is expected to take several months. The DMC's analysis is anticipated to occur in approximately six months.

Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study until after the study is ready to be stopped either at the interim analysis or at the final analysis. Guidelines for the independent DMC to recommend stopping the study for overwhelming efficacy require that the study achieve statistical significance on the primary endpoint and generate robust findings on certain, pre-specified secondary outcome measures. Given the high thresholds of overwhelming efficacy required prior to a DMC recommending an early stop to a cardiovascular outcomes trial like REDUCE-IT, Amarin continues to expect that the DMC's interim analysis will result in a recommendation to continue the REDUCE-IT study as planned. Such a recommendation is most common for cardiovascular outcome studies.

First Multinational Outcomes Study to Evaluate Cardiovascular Benefit of High-Dose EPA Therapy as an Add-on to Statin Therapy

Heart disease remains the number one cause of death in the United States. REDUCE-IT is the first multinational outcomes study being conducted to evaluate the cardiovascular benefits of treating patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels.

"In many high-risk patients with cardiovascular disease, substantial residual risk for events remains despite optimal LDL-cholesterol reduction with statin therapy," said Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart and Vascular Center, Professor of Medicine, Harvard Medical School, and Principal Investigator for REDUCE-IT. "By design, the REDUCE-IT study has enrolled patients with high cardiovascular risk and elevated triglyceride levels despite statin therapy and will provide important information regarding the potential for high-dose EPA-only omega-3 therapy to confer incremental cardiovascular benefit beyond statin control of LDL-cholesterol."

Amarin believes that the REDUCE-IT study is positioned for success based on extensive review of existing data from clinical, epidemiologic and genetic studies. With the study's event rate tracking on schedule, the onset of the 1,612th primary cardiovascular event is expected to occur in 2017 with the publication of results anticipated in 2018.

About REDUCE-IT

REDUCE-IT is a global Phase 3, randomized, multicenter, double-blind, placebo-controlled study designed to evaluate whether treatment with Vascepa reduces cardiovascular events in patients who have persistently elevated triglyceride levels despite stabilized statin therapy. The primary endpoint of the study is the time to the first occurrence of the composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina. Secondary endpoints include time to event analyses of components of the primary endpoint.

Additional information on the REDUCE-IT trial and Amarin's other clinical studies of Vascepa can be found at www.clinicaltrials.gov.

About VASCEPA ®  (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram 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.

FDA-approved Indications 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.

Important Safety Information for VASCEPA

  • 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.

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.

About Amarin

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 the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-pure, EPA-only, 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.

Forward-looking statements

This press release contains forward-looking statements, including expectations for continued event rates, interim data review, results and related announcements with respect to Amarin's REDUCE-IT cardiovascular outcomes study; expectations related to the interim and final outcome of the REDUCE-IT study and the anticipated successful completion of the REDUCE-IT study; and statements regarding the potential efficacy, safety and therapeutic benefits of Vascepa. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, 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 historical REDUCE-IT event rates may not be predictive of future results and related cost may increase beyond expectations; the risk that regulatory reviews may impact the current design of the REDUCE-IT study or cause a change in strategic direction with respect to continuation of the study; the risk that future legal determinations and interactions with regulatory authorities may impact Vascepa marketing and sales rights and efforts; and the risk that Vascepa may not show clinically meaningful effects in REDUCE-IT or support regulatory approvals for cardiovascular risk reduction; 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 Annual Report on Form 10-K. 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 we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), 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.

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