Amarin Provides Update on ANCHOR Trial SPA Agreement Rescission Appeal
BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 09/12/14 -- Amarin Corporation plc (NASDAQ: AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the Office of New Drugs (OND) within the U.S. Food and Drug Administration (FDA) has denied Amarin'sappeal of FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement. Amarin had previously expressed that while it believes strongly in its legal, scientific and regulatory appeal arguments that it would be an uphill battle to achieve an SPA agreement reinstatement. Amarin continues to believe that reinstatement of this SPA agreement and approval of an indication based on the ANCHOR clinical trial results is in the best interest of patient care and is evaluating OND's response and potential next steps. Amarin has not yet received a determination from FDA on the pending ANCHOR supplemental new drug application (sNDA).
Vascepa remains FDA approved and marketed for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe ( > 500 mg/dL) hypertriglyceridemia.
About Vascepa ® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly-pure EPA omega-3 prescription product in a 1 gram capsule.
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 and should be used 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).
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM
Vascepa is under various stages of development for potential use in 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.
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. 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 visitwww.vascepa.com. For more information about Amarin visit www.amarincorp.com.
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
In U.S.: +1 (908) 719-1315
In U.S.: +1 (646) 378-2954
Source: Amarin Corp. Plc