What is the European market access (pricing and reimbursement) process and what key factors does Amarin believe will make it successful in achieving timely and adequate reimbursement in Europe?
What information is available to aid in understanding of the significance of clinical results from the VASCEPA COVID-19 CardioLink-9 Randomized Trial, which was presented as a Late Breaker Presentation at NLA Scientific Sessions 2020 on December 12, 2020?
Has there been scientific evidence pointing to differences between eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)?
Were the drug and patient population studied in the REDUCE-IT® trial the same as that in the STRENGTH trial?
What were the eicosapentaenoic acid (EPA) levels reached in REDUCE-IT® and how did EPA levels impact the cardiovascular risk reduction seen?
Where can I find a copy of the Amarin patent litigation complaint filed against Hikma on November 30, 2020?
Following VASCEPA’s® FDA approval in December 2019 (and launch in January 2020) for its new cardiovascular risk indication, what percentage of prescriptions for VASCEPA in the United States are for patients with triglyceride (TG) levels ≥ 500 mg/dL?
Where can I find information on the results of the EVAPORATE trial presented at the European Society of Cardiology (ESC) Congress 2020- The Digital Experience on Saturday, August 29, 2020?
Why didn’t Amarin pursue a triglyceride lowering indication for VASCEPA® (icosapent ethyl) prior to seeking a cardiovascular risk reduction indication in Europe, as it did in the United States?
What is Amarin’s plan for operations after the decision by the U.S. Court of Appeals for the Federal Circuit in the company’s ongoing patent litigation?
Where can I find information on the ongoing MARINE patent ANDA litigation appeal and what is Amarin’s policy regarding updates as the litigation and related events progress?
What is Amarin doing to ensure patients prescriptions are filled while generics have limited supply of product?
Where can I find information on the hearing audio, legal briefs and decision in connection with the MARINE patent ANDA litigation appeal at the U.S. Court of Appeals for the Federal Circuit?
Is Amarin researching the use of VASCEPA® (icosapent ethyl) in treating individuals with COVID-19?
Will the European Medicines Agency grant regulatory exclusivity to Amarin® for Icosapent Ethyl (VASCEPA®) if the marketing authorization application is approved?
What are Amarin’s plans and timing for VASCEPA® in Europe?
What is Amarin doing differently to promote VASCEPA® in light of the COVID-19 pandemic?
What medical societies have recognized REDUCE-IT® in their guidelines or scientific statements?
Is there a location at which various slides presented at medical conferences regarding REDUCE-IT® clinical trial results can be found?
Yes, the American College of Cardiology has posted REDUCE-IT related slides as presented at various medical conferences. These presentations can be found by visiting https://www.acc.org/ and search for ‘REDUCE-IT’ in the search bar.
What is Amarin’s position on The Institute for Clinical and Economic Review (ICER) final report on the cost effectiveness and value of VASCEPA®?
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 under the Cardiovascular Outcomes Trials heading.
The results of the Total Events Analysis of the REDUCE-IT cardiovascular outcomes study published in the Journal of American College of Cardiology (JACC) is also available in the above section.
Other publications pertaining to Vascepa and the science supporting VASCEPA are available at: https://investor.amarincorp.com/publications.
Why has an outcomes study not been conducted with VASCEPA® of patients with TG levels ≥500 mg/dL to demonstrate that lowering TG levels in this population lowers the risk of pancreatitis?
How does VASCEPA® work in lowering cardiovascular risk?
What is the difference between using TG levels as an identifier of CV risk and correlating lowering TG levels and lowering CV risk?
What is Amarin’s perspective on the potential for competitors to use changes in biomarkers demonstrated in clinical trials of VASCEPA®, such as triglyceride level reduction, as a regulatory substitute for completing their own CVOT?
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?
What is Amarin’s opinion on the ASCEND and VITAL clinical trials in which Lovaza® failed to demonstrate cardiovascular benefit on top of statin therapy?
Will increased demand for VASCEPA® negatively affect the global fish supply?
What does Amarin think about the JAMA and Cochrane omega-3 meta-analyses?
What is Amarin’s view on the reliability of third-party script reporting services?
What is Amarin's perspective on the results of Novartis' CANTOS study on canakinumab (Updated March 19, 2019)
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 is Amarin’s view on the June 19, 2019 CFSAN evaluation of proposed qualified health claims applicable to food and dietary supplement products containing the omega-3 acids?
What is Amarin doing to protect the VASCEPA® franchise against dietary supplement manufacturers that mislead the public by referencing REDUCE-IT® or VASCEPA?
In May 2018, Amarin announced a settlement agreement with Teva as part of its ANDA litigation, noting that Teva could enter the market prior to the August 9, 2029 settlement date “under the customary circumstances”.
What is the status of the ITC lawsuit Amarin filed in August 2017 to prevent the import and sale into the United States of synthetic omega-3 products that are comprised predominantly of EPA and sold for use in, or as, dietary supplements?
Why did Amarin file a registration statement for a shelf offering on Feb 26, 2020?
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 Email Alerts section of our website, which option can be found on each page of the website www.amarincorp.com.
Where can I find the approved label for VASCEPA®?
What is Amarin’s policy on market rumors, speculation and related stock price movements?
Amarin has a general policy to not comment on rumors or speculation, or stock price movement related to such rumors or speculation. A “no comment” comment from Amarin is neither confirmation nor denial of any given rumor or speculation; it simply relays that Amarin has no comment on the matter.
Is Amarin subject to the UK City Code on Takeovers and Mergers?
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 61-62: https://investor.amarincorp.com/static-files/bfd335ec-2d47-4aa7-8a59-b8a15e5cbaaf.
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.
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: +1-877-248-4237
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
Who is Amarin's Depositary?
The Depositary for Amarin's ADRs is:
Citibank Shareholder Services
P.O. Box 43077
Providence, RI 02940-5000
Tel: +1-877-248-4237 Fax: +1-201-324-3284
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?