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You are about to review presentations, reports, filings and/or other materials regarding Amarin Corporation plc (NASDAQ: AMRN) that contain time-sensitive information. The information contained therein is only current as of the date thereof and may not be a complete listing of all documents filed with the Securities Exchange Commission, made public or provided to Amarin shareholders.

 

Amarin expressly disclaims any obligation to review, update or correct these materials after the date thereof. Amarin may update, amend, supplement or otherwise alter the information contained in any such materials by subsequent presentations, reports, filings, or other means without notice.

 

Certain statements made on this web site or in materials accessed in or through the investor relations section of our web site are "forward-looking statements," which are subject to risks and uncertainties, and Amarin's actual results may differ (possibly materially) from those indicated in such statements. 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 and its most recent Quarterly Report on Form 10-Q.

 

This website is not an offer or a solicitation to buy or sell securities. Please be aware that decisions regarding investments are the responsibility of users. Although this website includes information regarding pharmaceuticals (including products under development), the information is not intended as any advertisement and/or medical advice.

 

This information is intended for communication with investors and should not be construed as marketing the use of any Amarin products or product candidates.

 

Information on this website may be revised without any prior notice.

Investor Relations / Investor FAQs

Investor FAQs

Please click here for a fact sheet on VASCEPA and a glossary of related terms.

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When does Amarin plan to file an sNDA with FDA for indications based on the REDUCE-IT?

Amarin is working to complete this submission before the end of Q1 2019 (i.e. on or before March 31, 2019).

 

Forward-Looking Statement

 

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.

Where can I find the New England Journal of Medicine (NEJM) publication of the primary results of the REDUCE-IT cardiovascular outcomes study?

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.

What is the type of physician communication which occurred at the American Heart Association’s 2018 scientific sessions?
The AHA scientific sessions include scientific presentations, such as the late breaking clinical trial results discussion of REDUCE-IT results as presented on Saturday, November 10, 2018, as well as various other academically focused discussions.  Examples of those other discussions are in the form of independently organized continuing medical education (CME) programs.  While the organizers of such CME programs do not make their entire presentations public, following is a link to the publicly available portion of the CME program organized by Medtelligence and made public via ReachMD: https://reachmd.com/programs/cme/new-options-to-reduce-cardiovascular-events-in-atherosclerotic-cardiovascular-disease-ascvd/10494/.
Why has an outcomes study not been conducted for patients with TG levels ≥500 mg/dL?
Please click here
How does Vascepa work in lowering cardiovascular risk (Updated November 23, 2018)?
Please click here
What is the difference between using TG levels as an identifier of CV risk and correlating lowering TG levels and lowering CV risk?
Please click here.
What is the clinical need and scientific rationale for the REDUCE-IT study?

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

 

What is Amarin’s perspective on the use of mineral oil in its clinical trials and the variability commonly observed in blood-based lipid values in clinical trials of statin-stabilized patients (updated November 23, 2018)?

Please click here.

I heard the Global Principal Investigator for the REDUCE-IT study comment in his late-breaker presentation at AHA that there was no change in hsCRP in the placebo-arm of the study, please explain why that was referenced?

Please click here.

What is Amarin’s perspective on the editorial in NEJM commenting on the primary publication of REDUCE-IT results in NEJM (Bhatt et al. 2018)?
Please click here
What is Amarin’s opinion on the VITAL clinical trial?

Please click here.

What is Amarin’s opinion on the ASCEND clinical trial?

Please click here.

What is Amarin’s perspective regarding the complete response letter that Novartis received regarding its drug canakinumab as a potential treatment for cardiovascular risk reduction?

Please click here

Where can I find the approved label for Vascepa?
Where can I get a copy of the complaints filed by Amarin to protect the Vascepa® (icosapent ethyl) franchise against dietary supplement companies seeking to unlawfully leverage REDUCE-IT™ results?
Please click here and here
 
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.
What is Amarin doing to protect the Vascepa® franchise against dietary supplement manufacturers that mislead the public by referencing REDUCE-IT™ or Vascepa®?
Please click here
How can I keep up to date with latest developments at Amarin?

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

What is Amarin's perspective on the results of Novartis's CANTOS study on canakinumab?

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.

What does Amarin think about the JAMA and Cochrane omega-3 meta-analyses?

Please click here.

What is the nature of your relationship with Kowa Pharmaceuticals America, Inc. (Kowa)?

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.

Where can I get a copy of the August 2015 First Amendment opinion and March 2016 settlement resulting from the May 2015 lawsuit filed by Amarin and a group of independent physicians?
For opinion click here
For settlement click here 
What is a summary of the Amarin litigation commenced in August 2017 and focused on synthetic omega-3 dietary supplements comprised predominantly of EPA?
Where can I get a copy of the Amarin complaint, public interest statement and jurisdiction brief filed in connection with the litigation focused on synthetic omega-3 dietary supplements comprised predominantly of EPA?

To see the complaint please click here 

To see the public interest statement please click here

To see the jurisdiction brief please click here 

Where can I find a copy of the substantive document related to Amarin's appeal to the Federal Circuit of the U.S. International Trade Commission's determination to not institute an investigation in the matter of synthetic omega-3 dietary supplements comp

Please click here.

On what stock exchanges are Amarin's ordinary shares traded?

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).

What is an ADS/ADR?

    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.

What types of companies issue ADRs?

Non-U.S. companies whose securities trade on a U.S. securities market.

What is the ratio of Amarin ADRs to Amarin ordinary shares?

One Amarin ADR equals one Amarin ordinary share.

Are holders of ADRs entitled to vote at Amarin's annual general meeting?

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.

When is Amarin's fiscal year?

Amarin's fiscal year is the 12-month calendar year ending December 31st.
 

Where can I get information on the company?

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.

Where are Amarin's headquarters?

Amarin is headquartered in Dublin, Ireland.

Where can I find Amarin's financial statements?

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.

Who is Amarin's Registrar/Transfer Agent?

The U.S. Transfer Agent for Amarin's ADS holders is:

Citibank Shareholder Services
P.O. Box 43077
Providence, RI 02940-5000
USA
Tel: +1-877-248-4237d

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 7047d

Who is Amarin's Depositary?

The Depositary for Amarin's ADRs is:

Citibank Shareholder Services
P.O. Box 43077
Providence, RI 02940-5000
Tel: +1-877-248-4237d Fax: +1-201-324-3284d

citibank@shareholders-online.com

Who is Amarin's independent registered public accounting firm?

Ernst & Young LLP

99 Wood Avenue South

Iselin, NJ 08830

Who can I contact regarding Amarin investor and shareholder related queries?

Please contact: Elisabeth Schwartz
Telephone (U.S.): 908-719-1315d
e-mail: investor.relations@amarincorp.com
 

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Amarin Pharma Inc.
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Telephone:
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Fax:
+1 908 719 3012

Amarin Corporation