Company Profile
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| Vascepa® cardiovascular outcomes study, REDUCE-IT™, topline results are available. See press release. |
Company Profile
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. This focus includes a commitment to providing grants to support research and education in the disease state including the funding of an ongoing outcomes trial.
Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is an ultra-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.
In July 2012, Vascepa received FDA approval in the United States for use as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia and is now available by prescription. The triglyceride lowering effect of Vascepa® is not associated with increases in LDL-C, bad cholesterol. The only reported adverse reaction with an incidence >2% and greater than placebo in Vascepa treated patients was arthralgia (2.3% for Vascepa vs. 1.0% for placebo).
If you are reporting an adverse event or product complaint, please email amarinmi@druginfo.com or call the Amarin Call Center at 1 855 VASCEPA.
» See important safety information about Vascepa
» See full prescribing information for Vascepa
Amarin recently completed the REDUCE-IT trial and reported topline results on September 24, 2018. Click for press release. Additional data will be presented at the 2018 Scientific Sessions of the American Heart Association on November 10, 2018 in Chicago, Illinois.
Amarin is headquartered in Dublin, Ireland. In the U.S., the company's office is in Bedminster, New Jersey. Amarin is listed in the U.S. on NASDAQ (symbol: "AMRN").
Overview
For web links to papers supporting correlation between TG levels and cardiovascular risk, click here.
Corporate Governance
The Board of Directors of Amarin Corporation plc (the "Company") sets high standards for the Company's employees, officers and directors. Implicit in this philosophy is the importance of sound corporate governance. It is the duty of the Board of Directors to serve as a prudent fiduciary for shareholders and to oversee the management of the Company's business. To fulfill its responsibilities and to discharge its duty, the Board of Directors follows the procedures and standards that are set forth in these guidelines. These guidelines are subject to modification from time to time as the Board of Directors deems appropriate in the best interests of the Company or as required by applicable laws and regulations.
Financial Information
Here you will find a summary of Amarin Corporation plc's latest financial information.
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See www.vascepa.com
Amarin is pleased to announce the publication of “Rationale and Design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl – Intervention Trial” in the March issue of Clinical Cardiology.
The article can be accessed here. Also, an Amarin press release has been issued related to this publication.
The following are key points regarding the study design for REDUCE-IT:
REDUCE-IT: Study Design
- REDUCE-IT is a landmark global study involving approximately 8,000 patients
- It is a randomized, multicenter, double-blind, placebo-controlled study designed to determine if treatment with VASCEPA® 4 g/day versus placebo reduces major adverse cardiovascular events (MACE) in statin-treated patients with persistent hypertriglyceridemia and high cardiovascular risk
- 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
- The study is being conducted under a special protocol assessment agreement with the FDA
For more information, please click here
You can register to receive updates announced by Amarin by submitting your email address on the Mailing List section of our website, which option can be found on each page of the website www.amarincorp.com. Alternatively you can send an email to investor.relations@amarincorp.com requesting to be notified of any new updates announced
Please see the attached document for a detailed response. This information is intended for communication with investors and should not be construed as marketing the use of any Amarin products or product candidates. Click Here.
Most of the studies included in this meta-analysis, except for JELIS, concerned low dose, mixed EPA\DHA omega-3 products. Dose levels are important, as high-dose omega-3 fatty acids are likely to have a more pronounced effect on lipid and other measures and, we believe, outcomes, especially on top of contemporary medical therapy. Furthermore, most omega-3 products include around 10% or more of ingredients which are not omega-3 fatty acids, and contain DHA, which can raise LDL-cholesterol levels. We also believe that patient populations studied matter. If seeking to demonstrate cardiovascular event reduction, selecting higher risk patients is believed to increase the likelihood of identifying a more pronounced result.. Therefore, one cannot draw conclusions between the collection of studies included in this paper and the REDUCE-IT study. REDUCE-IT is a potential landmark study, and different than all studies to date on omega-3's.
The authors of the meta-analysis highlighted the importance of drug studies such as REDUCE-IT, distinguishing Amarin's ongoing study from studies of fish oil supplements: "Importantly, ... REDUCE-IT ... will test the effects on major vascular events of much higher doses of omega-3 FAs (...4 g/d)." Further noting the distinction, the author concluded the following: "The results of the ongoing trials are needed to assess if higher doses of omega-3 FAs (3-4 g/d) may have significant effects on risk of major vascular events."
See Amarin's filings with the SEC for additional context on the information provided. This update was posted on February 1, 2018 and speaks only as of that date. Amarin undertakes no obligation to update or revise the information contained in this update, whether as a result of new information, future events or circumstances or otherwise.
Please click here
Please see the attached document for a detailed response. This information is intended for communication with investors and should not be construed as marketing the use of any Amarin products or product candidates. Click Here.
Amarin has a co-promotion agreement with Kowa through the end of 2018 under which Kowa uses a portion of the time of their sales force to help educate physicians in the U.S. on the use of Vascepa, along with promotion of its flagship branded statin product, LIVALO® (pitavastatin). This co-promotion arrangement increases both the number of sales targets reached and the frequency of sales calls on existing sales targets. Kowa is responsible for the cost of its sales representatives and related promotional materials. Amarin compensates Kowa with a co-promotion fee based on a percentage of Vascepa gross margins which fee is classified by Amarin as part of selling, general and administrative expenses.
Please click here.
Amarin's ordinary shares, represented by American Depositary Shares, are listed on the NASDAQ Capital Market under the ticker AMRN.
Until July 16th 2008, Amarin's ordinary shares were also listed on London's AIM (ticker: AMRN) and Dublin's IEX (ticker: H2E).
An American Depositary Share (ADS) is a security that represents an ownership interest in the shares of a foreign company trading on a U.S. securities market. The shares represented by the ADSs are held by a U.S. depositary bank and are evidenced by certificates called American Depositary Receipts (ADRs), although the terms ADS and ADR are often used interchangeably. ADRs enable U.S. investors to buy shares in foreign companies without undertaking cross-border transactions (i.e., in U.S. dollars), and they trade, clear and settle in accordance with U.S. market regulations and conventions.
Non-U.S. companies whose securities trade on a U.S. securities market.
One Amarin ADR equals one Amarin ordinary share.
Holders of ADRs may authorize Citibank, Amarin's Depositary, to act as a proxy in exercising voting rights according to the number of ordinary shares represented by their respective ADRs.
Amarin's fiscal year is the 12-month calendar year ending December 31st.
Please visit our website at www.amarincorp.com where you can read more on our executive team, board of directors, company strategy, corporate governance, therapeutic focus, product pipeline and partnering activities.
Amarin is headquartered in Dublin, Ireland.
Amarin's financial statements, including annual reports, can be found on Amarin's website www.amarincorp.com in the Investor Relations section here. Alternatively, you can find all of Amarin's filings with the U.S. Securities and Exchange Commission under the SEC Filings section of the website here.
The U.S. Transfer Agent for Amarin's ADS holders is:
Citibank Shareholder Services
P.O. Box 43077
Providence, RI 02940-5000
USA
Tel: +1-877-248-4237
The Registrar for Amarin's ordinary shares is:
Citi - Depositary Receipt Services
388 Greenwich Street
14th Floor
New York, NY 10013
AND
Equiniti
PO Box 4630,
Aspect House,
Spencer Road,
Lancing, West Sussex,
BN99 6QQ, England
Telephone: +44 121 415 7047
The Depositary for Amarin's ADRs is:
Citibank Shareholder Services
P.O. Box 43077
Providence, RI 02940-5000
Tel: +1-877-248-4237 Fax: +1-201-324-3284
citibank@shareholders-online.com
Ernst & Young LLP
99 Wood Avenue South
Iselin, NJ 08830
Please contact: Elisabeth Schwartz
Telephone (U.S.): 908-719-1315
e-mail: investor.relations@amarincorp.com