REDUCE-IT Cardiovascular Outcomes Study Remains on Schedule to Reach Onset of Target Final Primary Major Adverse Cardiovascular Event Near the End of 2017
BEDMINSTER, N.J., and DUBLIN, Ireland, March 16, 2017 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today the onset of approximately 80% of the target aggregate number of primary cardiovascular events within the REDUCE-IT study. This milestone has triggered preparation for a pre-specified interim efficacy and safety analysis by the study’s independent Data Monitoring Committee (DMC). Amarin currently expects the independent interim analysis to be conducted before the end of the third calendar quarter of this year.
Interim Analysis Expected in Q3
The REDUCE-IT study's event rate continues to track consistently with Amarin’s existing public guidance for the timing of the interim analysis and study completion. A pre-specified interim efficacy and safety analysis is designed to be conducted upon achieving approximately 80% of the target 1,612 aggregate primary major adverse cardiovascular events within the study. REDUCE-IT patients are in the process of completing a study visit over the coming 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. This data preparation and transfer process is expected to take several months as is typical for large-scale, multi-national studies, and consistent with the process for the first pre-specified interim analysis of the REDUCE-IT study, regardless of the strength of the study results. The DMC's analysis is anticipated to occur before the end of the third calendar quarter of 2017.
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 to completion of 100% of the target events. The efficacy requirements detailed to the DMC for early study stoppage after the 80% interim assessment are high and include robustness thresholds for underlying data that go beyond the assessment for statistical significance on the analysis of the primary endpoint after the expected completion of the study at 100% of planned events.
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 having their LCL-cholesterol controlled with statin therapy, have elevated triglyceride levels. The study is designed to examine whether the demonstrated clinical effects and postulated pleiotropic cardioprotective benefits of high-dose EPA-only Vascepa therapy, when added to statin therapy, will offer improved cardiovascular outcomes for patients. The results of this important trial, if successful, could lead to improved medical care for tens of millions of patients.
The design of the REDUCE-IT cardiovascular outcomes study was published in March 2017 in Clinical Cardiology. A copy of this publication is available at: http://onlinelibrary.wiley.com/doi/10.1002/clc.22692/full.
Amarin believes that the REDUCE-IT study is designed for success based on extensive review of data from clinical, epidemiologic and genetic studies. Amarin estimates that results of the trial will become available to Amarin and be publicly communicated in mid-2018. This estimated timing reflects our assumptions of the time necessary to collect vital data from all patients in the study, compile the results, and subject the results to scrutiny of the independent review committees and the REDUCE-IT operational team after reaching the onset of the target final aggregate cardiovascular event in this study. The onset of the target final aggregate cardiovascular event in this study is estimated to occur near the end of 2017.
The primary endpoint of this global, double-blind study is the time to the first occurrence of a composite of major adverse cardiovascular events (MACE). Results will be compared between the Vascepa and placebo groups. The study is being conducted under a special protocol assessment (SPA) agreement with the FDA.
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.
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.
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.
This press release contains forward-looking statements, including expectations for continued event rates, interim data review, results and related timing and announcements with respect to Amarin's REDUCE-IT cardiovascular outcomes study; expectations related to the interim and final outcomes of the REDUCE-IT study and the anticipated successful completion of the REDUCE-IT study; and statements regarding the potential 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; 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 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://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.
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