Amarin is working to complete this submission before the end of Q1 2019 (i.e. on or before March 31, 2019).
Amarin’s plan to submit an sNDA before the end of Q1 2019 to seek expanded indications for Vascepa in the United States is not a promise or guarantee and involves risks and uncertainties. Among the factors that could cause actual results to differ from plan include uncertainties associated generally with planned regulatory submissions and related timing. These 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 forward-looking statements, which speak only as of the date made. Amarin undertakes no obligation to update or revise the information contained in this FAQ, whether as a result of new information, future events or circumstances or otherwise.
The primary results of the REDUCE-IT cardiovascular outcomes study, which demonstrated that Vascepa significantly lowers the rate of occurrence of major adverse cardiovascular events in at-risk patients, was published and can be found at: https://investor.amarincorp.com/publications.
Other publications pertaining to Vascepa and the science supporting Vascepa are available at: https://investor.amarincorp.com/publications.
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 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
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A copy of each complaint is available through Public Access to Court Electronic Records (PACER), an electronic public access service that allows users to obtain case and docket information online from federal courts. Interested parties are encouraged to follow the progress of this lawsuit through the PACER system. Amarin is not responsible for misinformation provided by the PACER system.
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 email@example.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.
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.
Amarin Corporation plc is not subject to the UK City Code on Takeovers and Mergers (the “Code”) because the central management and control of Amarin is situated outside the UK. Amarin is therefore not subject to Code requirements, including but not limited to, press release requirements if, under certain circumstances, the company is “the subject of rumour or speculation” or there is an “untoward movement” in the target share price.
Amarin is subject to the UK Companies Act 2016 as a company organized under the law of England and Wales. For more information, please review the public disclosures in our most recent 10-K, page 67-68: https://www.sec.gov/Archives/edgar/data/897448/000119312517065969/d328533d10k.htm.
Despite being a company organized under such law, Amarin has an Irish, and not UK, tax residency for its parent company and for its wholly-owned subsidiary within which Vascepa revenues are recorded.
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
The Registrar for Amarin's ordinary shares is:
Citi - Depositary Receipt Services
388 Greenwich Street
New York, NY 10013
PO Box 4630,
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
Ernst & Young LLP
99 Wood Avenue South
Iselin, NJ 08830
Please contact: Elisabeth Schwartz
Telephone (U.S.): 908-719-1315