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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.
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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.
The information contained in this FAQ section of Amarin's website is accurate only as of the date this page was last updated. Amarin disavows any obligation to update the information contained in this FAQ section after such date. This information is intended for communication with investors and should not be construed as marketing the use of any Amarin products or product candidates.
While settlement discussions remain ongoing, the August 7th declaratory judgment that confirmed Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa remains in effect. Amarin began related promotional activities shortly after the order. FDA did not appeal the preliminary ruling prior to the October 6th deadline for appeal. Both parties continue to engage in settlement discussions related to the underlying litigation.
Communications with the Court regarding this lawsuit can be found at www.pacer.gov.
Following the August 7, 2015 preliminary relief granted in favor of Amarin and the physician plaintiffs, on August 10, 2015, the Honorable Judge Paul A. Engelmayer directed the parties to confer and submit a joint letter on next steps in the case by August 28, 2015.
On August 28, 2015, the Court was notified that the parties have conferred and agreed to explore the possibility of settlement. The parties also requested that further proceedings be stayed until October 30, 2015 on which date the parties plan to file a joint letter advising the Court of their views as to next steps in the case.
The August 7, 2015 ruling remains in effect.
Amarin does not plan to comment further on the case until the completion of settlement discussions.
A copy of the decision is also 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. Investors are encouraged to follow the progress of this lawsuit through the PACER system. Amarin is not responsible for misinformation provided by the PACER system.
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On May 7, 2015, Amarin Pharma, Inc., a wholly-owned subsidiary of Amarin Corporation plc, and four independent physicians, in support of improved patient care, filed a lawsuit to permit Amarin to share truthful and non-misleading information with healthcare professionals in the United States that would be considered off-label by the Food and Drug Administration (FDA). The lawsuit captioned, Amarin Pharma, Inc., et al. v. Food & Drug Administration, et al., was filed in the United States District Court for the Southern District of New York. It seeks a judicial declaration that FDA regulations limiting off-label promotion of such truthful and non-misleading information are unconstitutional under the First Amendment (freedom of speech) or Fifth Amendment (restriction against vague laws) as applied in this case to Amarin’s proposed promotion of Vascepa. The physicians in the suit regularly treat patients at risk of cardiovascular disease and, as the complaint contends, have First Amendment rights to receive truthful and non-misleading information from Amarin. The suit is based on the principle that better informed physicians make better treatment decisions for their patients.
The lawsuit seeks a court declaration that Amarin may communicate to healthcare professionals (not the general public) the following information with respect to Vascepa:
- efficacy data from Amarin’s ANCHOR clinical trial of Vascepa in patients with high triglyceride levels despite statin therapy, which met all primary and secondary endpoints and was conducted under a special protocol assessment agreement with FDA (safety data is already reflected in approved Vascepa labeling);
- the qualified health claim that the FDA has permitted for over a decade for omega-3 dietary supplement products: “Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease;” and
- peer-reviewed scientific publications relevant to the potential effect of EPA on the reduction of the risk of coronary heart disease.
The use covered by the ANCHOR study is consistent with multiple national and international medical treatment guidelines and position statements and relevant to millions of patients on statin therapy still at risk of cardiovascular disease. In the complaint, Amarin has proposed disclaimers be used to ensure the truthful information communicated is not misleading, including that the effect of Vascepa on cardiovascular risk has not been determined and that FDA has not approved Vascepa to reduce the risk of coronary heart disease or for the use studied in the ANCHOR trial.
The plaintiffs contend that broader communication of truthful information about Vascepa will improve patient care by making physicians better informed with current scientific data before deciding how to treat patients consistent with multiple national and international medical treatment guidelines. Currently, FDA regulations restricting off-label promotion limit this type of truthful and non-misleading communication, preventing most physicians from making fully-informed treatment decisions.
The lawsuit does not:
- seek to compel the FDA to approve an expanded indication for Vascepa based on the ANCHOR trial results;
- require the court to evaluate whether FDA’s scientific conclusions about Vascepa are right or wrong;
- seek to strike down off-label promotion laws and regulations as facially unconstitutional; or
- challenge the government's ability to prohibit pharmaceutical companies, including Amarin, from disseminating false or misleading information about their products.
About prohibitions on communication of off-label drug information
Once a drug is approved by FDA for a specific use in a specific patient population, physicians may exercise their medical judgment to prescribe the drug for any use in any patient population. It is estimated that approximately 20% of all prescriptions in the United States are used by physicians for such “off-label” indications. FDA has taken the position, however, that federal law prohibits pharmaceutical companies from proactively promoting data to the medical community regarding off-label uses—even when such information is accurate, not misleading and reflective of accepted medical treatment.
FDA has acknowledged the importance of the off-label use of many pharmaceutical products. In fact, federal, state and private health plans routinely pay for many off-label drug uses, including off-label uses of Vascepa. FDA permits limited communications on off-label uses, such as in response to unsolicited requests for information, under FDA’s publication reprint guidances and in connection with scientific exchanges. These restrictions significantly limit the flow of information about available drug therapies.
Amarin and the individual physician plaintiffs are represented in the lawsuit by Floyd Abrams, Joel Kurtzberg and Michael Weiss, partners at Cahill Gordon & Reindel LLP.
The foregoing information is qualified in its entirety by the subject complaint, a copy of which is available in the FAQ section of the Investor Relations section of Amarin's website at http://www.amarincorp.com/investor-splash.html and 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. Investors are encouraged to follow the progress of this lawsuit through the PACER system. Amarin is not responsible for misinformation provided by the PACER system.
About Vascepa® (icosapent ethyl) capsules
Vascepa® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications 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 and should be used 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.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this update should be construed as marketing the use of Vascepa in any indication that has not been approved by the FDA.
This update contains forward-looking statements, including statements about Amarin's objectives in filing the lawsuit, the merits of Amarin’s legal arguments, whether or not the demonstrated clinical effects of Vascepa will result in cardiovascular risk reduction benefit in the REDUCE-IT trial. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. There can be no guarantee that Amarin will be successful in this lawsuit. Even if Amarin is successful, the litigation process could involve appeals and take a significant amount of time to reach conclusion. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: the risk that Amarin's interpretation of the applicable legal standards may not be determinative or adjudicated in Amarin's favor; the risk that a court will not consider the lawsuit on its merits; and uncertainties associated generally with litigation, research and development, clinical trials and related regulatory approvals. 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 upcoming 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 update, whether as a result of new information, future events or circumstances or otherwise.
On March 31, 2014, Amarin executed a co-promotion agreement with Kowa under which Kowa will help educate physicians in the U.S. on the use of Vascepa. The initial term of the agreement extends through the end of 2018. Kowa has a successful track record of launching and commercializing drugs for the treatment of cardiovascular disease in the United States, including its flagship statin product, LIVALO® (pitavastatin). Kowa’s sales team, which consists of approximately 250 sales representatives, is expected to be trained with respect to Vascepa during May 2014 and thereafter begin Vascepa co-promotion with Amarin’s sales representatives based on a plan designed to substantially increase both the number of sales targets reached and the frequency of sales calls on existing sales targets. The arrangement is designed to enable Amarin to more than double its early 2014 sales calls levels. Kowa is responsible for the cost of its sales representatives and related promotional materials. Amarin will compensate Kowa with a co-promotion fee based on a percentage of Vascepa gross margins that increase during the agreement’s term, from the high single digits in 2014 to the low twenty percent levels in 2018, subject to certain adjustments.
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
Ernst & Young LLP
99 Wood Avenue South
Iselin, NJ 08830
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Updated: March 8, 2016 at 4:00 PM Eastern Time