BEDMINSTER, N.J. and DUBLIN, Ireland, Oct. 25, 2016 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) announced today the introduction of a smaller 0.5-gram capsule size for Vascepa® (icosapent ethyl) available now in retail pharmacies nationwide. The smaller capsule is in addition to the original and currently available 1-gram size Vascepa capsule.
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/3f18752c-0265-452a-b8e2-1920b8267071
“Amarin is dedicated to listening to patients and healthcare providers in an effort to deliver solutions that help make it easier for patients to take their doctor prescribed medication,” said Aaron Berg, senior vice president of marketing and sales of Amarin. “We are pleased to now offer the first and only half-gram prescription omega-3 alternative for the subset of patients who prefer a smaller capsule.”
The FDA-approved dosing for Vascepa continues to be four grams per day, taken as two grams twice daily, with food. Based on market research with healthcare providers, Amarin believes that the majority of patients taking Vascepa will continue to be prescribed the 1-gram size Vascepa capsule.
About Vascepa® (icosapent ethyl) capsules
Vascepa capsules are a single-molecule prescription product consisting of 1-gram or 0.5-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 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.
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, Amarin’s first FDA-approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription in a 1-gram or 0.5-gram capsule size. 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 statements about the company’s plans for the launch of Vascepa 0.5-gram capsules and expectations on patient use and preference. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. There can be no guarantee that this product launch will be a commercial success. In particular, management’s expectations regarding Vascepa sales could be affected by, among other things, the uncertainties inherent in the launch of variations of existing commercial products; reliance on third parties and unexpected manufacturing, safety or quality issues. A further list and description of these risks and other uncertainties 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 Quarterly Report on Form 10-Q. 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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