Amarin's Right to Promote Vascepa(R) Off-Label Affirmed Under First Amendment Litigation Settlement Terms
Current Expanded Vascepa Promotion Continues as Planned
BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 03/08/16 --
Amarin Corporation plc (NASDAQ: AMRN) announced today settlement terms have been reached among the parties to resolve the Amarin First Amendment litigation (Amarin Pharma, Inc. et al. v. FDA et al., No. 15-3588 (S.D.N.Y. May 7, 2015)). Under the terms, the U.S. Food and Drug Administration (FDA) and the U.S. government have agreed to be bound by the August 7, 2015, judicial declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa®
(icosapent ethyl) Capsules. Amarin's expanded promotion of Vascepa, initiated following the August 2015 judicial declaration, continues as planned.
"We are pleased to announce this amicable resolution with and among the physician plaintiffs, FDA and the U.S. government and look forward to continuing to promote Vascepa in a truthful, non-misleading and responsible manner," stated John F. Thero, president and chief executive officer of Amarin. "With more truthful and non-misleading information readily available to healthcare professionals about the potential of Vascepa to improve cardiovascular health, this settlement serves the public interest by supporting informed medical decisions for tens of millions of patients with persistent high triglycerides."
The key settlement terms include:
- FDA and the U.S. government have agreed to be bound by the court's earlier conclusions from the August 7, 2015 declaration that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa and that certain statements and disclosures that Amarin proposed to make to healthcare professionals are truthful and non-misleading.
- Amarin bears the responsibility of assuring that its communications to doctors regarding off-label use of Vascepa remain truthful and non-misleading.
- The settlement terms are to be interpreted consistently with the August 7, 2015 opinion and order and are not to be construed to limit Amarin's constitutional rights to free speech concerning Vascepa.
- FDA has agreed to provide Amarin with an optional preclearance provision through 2020 for new off-label claims.
- The parties have agreed to a dispute resolution provision designed to avoid future litigation on matters arising under the settlement order.
- The court would retain jurisdiction over the matter to ensure compliance with and resolve any future dispute arising from the settlement order.
A complete copy of the proposed settlement order submitted by the parties for court approval is here.
Amarin remains committed to continued clinical study of Vascepa
Amarin remains strongly committed to improving patient care, expanding the current state of scientific research related to the potential of Vascepa and completing the ongoing REDUCE-IT cardiovascular outcomes study. This important study is designed to test whether Vascepa, when added to statin therapy, will significantly reduce cardiovascular risk compared to statins alone in high-risk patients with elevated triglyceride levels.
Cardiovascular disease is the leading cause of death for men and women in the United States. With the residual risk of cardiovascular disease in excess of 60% despite statin therapy and recommended changes in diet and exercise, tens of millions of statin-treated patients with persistently high triglycerides remain in need of additional therapeutic options to further reduce that risk and improve their cardiovascular health.
The REDUCE-IT cardiovascular outcomes study is the first prospective double-blinded cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. The REDUCE-IT study is also the first cardiovascular outcomes study to test a high, 4-gram dose of a pure-EPA only omega-3 prescription product. In the REDUCE-IT study, pure-EPA Vascepa is being studied as an adjunct to, and not as a replacement for, statin therapy. If successful, the REDUCE-IT study could help improve patient care for tens of millions of patients in the United States and worldwide with elevated triglyceride levels despite stable statin therapy.
Amarin is blinded to the results of the REDUCE-IT study. The pooled, blinded event rate in the REDUCE-IT study is tracking to expectations for onset of the final target cardiovascular event in 2017 with results anticipated to be published in 2018. An interim review by the independent data monitoring committee of the efficacy and safety results of the trial is expected to occur during 2016 upon reaching 60% of the target aggregate number of cardiovascular events; however, as is typical for cardiovascular outcomes studies, Amarin believes that it is likely that the REDUCE-IT study will continue until completion.
(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.
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.
This press release contains forward-looking statements, including the anticipated continuation of Vascepa off-label promotional efforts in a truthful, non-misleading and responsible manner, the potential of Vascepa to improve public health and patient care, the planned continuation, and completion of the REDUCE-IT study and Amarin's commitment thereto. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. There is no guarantee that this settlement will be approved by the Court as proposed. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: the risk that Amarin's interpretation of the legal opinion, applicable legal standards, and
determinations regarding the truthfulness and non-misleading nature of promotional claims may not be consistent with FDA's and governments' interpretation or adjudicated definitively in Amarin's favor; whether Vascepa and information related thereto will improve public and patient care; the adequacy of Amarin resources to continue the REDUCE-IT study and Amarin and FDA's commitment thereto; the financial resources of Amarin to support the promotion and clinical development of Vascepa and uncertainties associated generally with litigation, research and development, clinical trials and related regulatory reviews. 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.
Amarin contact information:
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
In U.S.: +1 (646) 378-2954
In U.S.: +1 (212) 583-2791
Source: Amarin Corp. Plc
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