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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 is conducting a cardiovascular outcomes study designed to evaluate the efficacy of Vascepa® in reducing cardiovascular events in a high-risk patient population on statin therapy called the REDUCE-IT trial.

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").

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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.

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Here you will find a summary of Amarin Corporation plc's latest financial information.


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Stock Quote (AMRN)

3.23 -0.15  (-4.438%)
10:56 AM ET on Feb 23, 2017
Previous Close 3.38
Open 3.39
Volume 1,159,526
Exchange NASDAQ
Day High 3.39
Day Low 3.22
52-Week High 3.65
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A copy of the complaint is also expected to be available over the next few business days 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. 

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.

General information

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.

Forward-looking statements

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.

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.

In this publication (http://online.liebertpub.com/doi/pdfplus/10.1089/met.2014.0137) Drs. Bays, Ballantyne, and colleagues, provide an analysis of the effects of VASCEPA® (icosapent ethyl) on high-sensitivity C-reactive protein (hsCRP) and lipid parameters in patients from the MARINE and ANCHOR studies (two phase 3 studies) with metabolic syndrome, with and without stable statin therapy.

A constellation of metabolic and physical attributes including increased waist circumference, high blood pressure, hyperglycemia and elevated triglyceride (TG) levels comprise metabolic syndrome.1-5 The incidence of metabolic syndrome is increasing with the prevalence of excess body weight, obesity, and sedentary lifestyles, and patients with metabolic syndrome are at increased risk for developing cardiovascular disease (CVD) and type 2 diabetes.2,6 Increased hsCRP is a marker for CVD and can reflect a proinflammatory response from excess body fat and/or from proinflammatory and proatherogenic vasculature.7,8

In this post-hoc analysis, Dr. Bays and colleagues assessed changes in inflammatory markers and lipid parameters in the subgroup of patients in the MARINE trial (TG levels ≥ 500 and ≤ 2000 mg/dL with or without statin therapy) and in the ANCHOR trial (TG ≥ 200 and < 500 mg/dL, despite low-density lipoprotein cholesterol [LDL-C] control with stable statin therapy) who had metabolic syndrome at baseline. Through analysis of baseline characteristics, it was determined that 89.1% of patients in MARINE had metabolic syndrome and that 91.9% of patients in ANCHOR had metabolic syndrome at baseline.

In patients with metabolic syndrome in MARINE (n=204) and ANCHOR (n=645), Vascepa 4 g/day significantly lowered hsCRP levels by 40.0% and 23.0%, respectively, compared with placebo. In the subgroup of patients with metabolic syndrome on statin therapy in the MARINE trial, Vascepa 4 g/day significantly reduced hsCRP levels by 78.0% (n=16).

In MARINE and ANCHOR, respectively, Vascepa 4g/day also significantly reduced: TGs (35.0%, 21.7%); non-high-density lipoprotein cholesterol (non-HDL-C; 19.9%, 13.5%); and apolipoprotein B (Apo B; 9.1%, 8.8%), all compared with placebo. In MARINE this was accomplished without raising LDL-C levels compared with placebo, and in ANCHOR a significant reduction in LDL-C of 5.2% was achieved compared with placebo.

This report is of interest to clinicians as the patient population with the metabolic syndrome continues to increase along with the prevalence of excess body weight and obesity. Importantly, in hypertriglyceridemic patients with metabolic syndrome and with or without statin therapy, Vascepa 4 g/day significantly lowered hsCRP levels and improved other lipid parameters without raising LDL-C.

Amarin sponsored the MARINE and ANCHOR studies and provided funding for writing assistance as acknowledged in the publication.

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.

VASCEPA® is a registered trademark of the Amarin group of companies

____

1. Grundy SM, Brewer HB, Jr., Cleeman JI, et al. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004;109:433-438.

2. Alberti KG, Eckel RH, Grundy SM, et al. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009;120:1640-1645.

3. Bays HE, Toth PP, Kris-Etherton PM, et al. Obesity, adiposity, and dyslipidemia: a consensus statement from the National Lipid Association. J Clin Lipidol. 2013;7:304-383.

4. Yang J, Kang J, Guan Y. The mechanisms linking adiposopathy to type 2 diabetes. Front Med. 2013;7:433-444.

5. Bays HE. Adiposopathy, diabetes mellitus, and primary prevention of atherosclerotic coronary artery disease: treating "sick fat" through improving fat function with antidiabetes therapies. Am J Cardiol. 2012;110:4B-12B.

6. Grundy SM. Metabolic syndrome pandemic. Arterioscler Thromb Vasc Biol. 2008;28:629-636.

7. Ridker PM, Kastelein JJ, Genest J, et al. C-reactive protein and cholesterol are equally strong predictors of cardiovascular risk and both are important for quality clinical care. Eur Heart J. 2013;34:1258-1261.

8. Kaptoge S, Di AE, Pennells L, et al. C-reactive protein, fibrinogen, and cardiovascular disease prediction. N Engl J Med. 2012;367:1310-1320.

In this publication [http://dx.doi.org/10.1016/j.jacl.2014.11.009], Dr. Ballantyne and coauthors report that Vascepa® 4g/day, as an add-on to statin therapy, reduced key atherogenic lipoprotein particle concentrations, compared to placebo, in hypertriglyceridemic patients who are at high cardiovascular (CV) risk and at low-density-lipoprotein cholesterol (LDL-C) goal.

The authors point out that lipoprotein particle concentration plays an important role in atherogenicity and that decreases in key atherogenic lipoprotein particle concentrations in these patients may be of clinical benefit.

Vascepa is a high-purity prescription form of eicosapentaenoic acid ethyl ester approved at a dose of 4 g/day as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG≥500 mg/dL).

From Amarin's perspective, the results of this study show that Vascepa had additional favorable effects on atherogenic lipoproteins in hypertriglyceridemic patients who are on statin therapy which we believe to be consistent with the broad positive effect Vascepa has demonstrated on other lipid markers thought to be associated with heart disease and atherosclerosis.

The authors suggest that the observed reductions in LDL particle number with Vascepa treatment compared with placebo are due, at least in part, to reductions in TG production and increases in TG clearance, coupled with efficient LDL particle clearance. They propose that the reductions in LDL particle number with Vascepa could be related to the finding that Vascepa did not raise LDL-C relative to placebo in either the MARINE or ANCHOR phase 3 clinical studies.

In this article, Dr. Ballantyne and his coauthors detail the results from this prespecified exploratory analysis of the effects of Vascepa on lipoprotein particle concentration and size from the ANCHOR study of patients at high cardiovascular risk with TG ≥200 and <500 mg/dL despite statin control of LDL-C.

The authors report that treatment with Vascepa 4 g/day, compared with placebo, achieved statistically significant reductions in the concentration of: total, large, and medium very-low-density lipoprotein (VLDL) particles; total and small LDL particles; and total and large high-density lipoprotein (HDL) particles. Compared with placebo, Vascepa 4 g/day also statistically significantly reduced VLDL and HDL particle size with a modest but significant increase in LDL particle size.

These reductions in total VLDL particle concentration and size with Vascepa are consistent with its TG-lowering effects.

Amarin sponsored the ANCHOR study and provided funding for writing assistance as acknowledged in the publication.

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.

VASCEPA® is a registered trademark of the Amarin group of companies

This article centers on low-dose dietary supplement products that are not designed or intended to treat cardiovascular disease. The FDA permits a dietary health claim for use with food products and applicable to dietary supplements stating that “supportive but not conclusive research shows that consumption of EPA and DHA may reduce the risk of coronary heart disease.”  This claim and other unapproved claims by dietary supplement manufacturers has led to increased use of dietary supplements in place of appropriate medical treatment for serious disease conditions.

Importantly, dietary supplements with EPA and DHA are not recommended by the FDA at doses of more than 2 grams per day and are not recommended by FDA at any dose to treat or mitigate disease. Dietary supplements are not required to meet strict FDA drug standards for safety, efficacy, and manufacturing. Many dietary supplement fish oils are low in omega-3 content, may vary in content from lot to lot, can contain harmful contaminants, are prone to oxidation that mitigates antioxidant effects, and contain DHA, which is associated with increases in bad cholesterol in patients at high risk characterized by high and very high blood levels of triglycerides. 

Amarin remains a leader in the research and development of the omega-3 acid, EPA, through clinical study of its highly pure pharmaceutical grade lead product, Vascepa® (icosapent ethyl) capsules.  Amarin received FDA approval of 4 gram daily use of Vascepa in July 2012 as an adjunct to diet to lower triglycerides in patients with very high (500 mg/dL) triglycerides (VHTG), and is pursuing FDA approval in the treatment of patients with persistent high (200-499 mg/dL) triglycerides despite statin therapy.  The effect of Vascepa on the risk for cardiovascular mortality and morbidity in patients has not been determined.  FDA approved use of Vascepa is consistent with numerous national and international treatment guidelines and position statements.

Amarin is also investing more than $100 million in a first-of-its-kind cardiovascular outcomes study called the REDUCE-IT study.  REDUCE-IT is being conducted to evaluate the efficacy of Vascepa in reducing cardiovascular risk in a high risk, elevated triglyceride-level patient population on statin therapy.  The REDUCE-IT study is expected to be completed in 2017 with results published in 2018.  The REDUCE-IT study follows the only other outcomes study of a highly pure EPA product, the JELIS study. JELIS, an open label study, showed that EPA in conjunction with statins in Japanese patients (N=18,645) reduced cardiovascular events by 19% compared to statins alone. Importantly, this result was obtained in a population in which triglycerides were in the normal range in approximately half of the patients. The JELIS study showed a 53% reduction in cardiovascular events in the EPA with statin group compared to the statin-only group within the subset of patients (N=957) who had both elevated levels of triglycerides (>150 mg/dL) and low levels of HDL-C (<40 mg/dL).  This result in patients with high triglyceride levels and low HDL-C is directionally consistent with subgroup analyses of patients treated with other triglyceride lowering agents in the ACCORD-Lipid and AIM-HIGH studies.

The REDUCE-IT study is the subject of a special protocol assessment with the FDA and was designed by Amarin to take into account many of the perceived weaknesses of some studies of omega-3s that did not show clinical benefit, including the use of low-doses of omega-3s, the study of patient populations at normal triglyceride levels and the use of omega-3 compositions that are not pharmaceutical grade and include the omega-3 acid, DHA.  Amarin clinical trials have demonstrated that Vascepa is effective in studied patients at lowering triglycerides without increasing bad cholesterol.  

The New York Times article raises important considerations.  Most important, careful analysis of the relevant studies and the latest scientific knowledge are essential for patients and physicians to make informed decisions on how best to care for their health and treat serious medical conditions. Amarin is dedicated to improved patient care and is spending more than $100 million to generate additional outcomes study and other data relevant to the potential of appropriate doses of pharmaceutical grade EPA to reduce cardiovascular risk in high risk patients.

Vascepa has been approved for use by the United States Food and Drug Administration (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 information should be construed as marketing the use of Vascepa in any indication that has not been approved by the FDA.

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 in the United States 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.

In this case series report [DOI:10.1007/s40119-014-0032-9], Dr. Hassan and coauthors share the results of a retrospective analysis of records from a private endocrinology practice of patients with prediabetes or diabetes who received Lovaza® (4 g/day) and were subsequently switched to Vascepa® (4 g/day).  Dr. Hassan and colleagues note that their patients were switched to Vascepa, which contains only icosapent ethyl, an ethyl ester of eicosapentaenoic acid (EPA), due to the potential for Lovaza, which contains docosahexaenoic acid (DHA) as well as EPA, to raise low-density lipoprotein cholesterol (LDL-C) and/or cause gastrointestinal upset in some patients.1   Vascepa was well tolerated by all patients who switched from Lovaza to Vascepa, and LDL-C and other lipid parameters improved in most patients.

Patients with diabetes and prediabetes are at increased risk for dyslipidemia and cardiovascular disease (CVD). To reduce this risk, statins and additional therapies may be considered. The authors note that even when LDL-C and glycemic treatment goals are reached, some patients may have residual risk of cardiovascular (CV) events due to elevated triglycerides (TGs).  Prescription omega-3 fatty acids offer an option to reduce TGs and potentially improve other lipid parameters, although, in some patients, products that contain DHA may increase LDL-C levels.

The authors included the records of the 10 patients in this practice that met the criteria for this analysis, but were outside of Vascepa FDA-approved product labeling. Patient records were analyzed for LDL-C, TG, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and non-HDL-C measured before and after the switch to Vascepa. They found that, in most cases, patients experienced decreases in LDL-C, TG, non-HDL-C, and TC and increases in HDL-C following the switch to Vascepa.

Nine of the 10 patients were on concomitant statin therapy throughout the study period.  Reductions in LDL-C, TC, and non-HDL-C were observed in 8 patients, reductions or no changes in TG were observed in 8 patients, and increases or no changes in HDL-C were observed in 8 patients. No gastrointestinal adverse events were observed.  Two patients experienced increases in LDL-C, TG, non-HDL-C, and TC after switching to Vascepa.

The authors’ findings are similar to those of other recent reports of patients switched from EPA + DHA formulations to Vascepa.2,3  The authors note that their analysis was exploratory and may be of interest to the clinical community for potential future prospective studies.

Dr. Hassan acknowledged that the role for omega-3 fatty acids in the prevention of CV events bears further investigation, and points to the ongoing cardiovascular outcomes study REDUCE-IT as highly anticipated. REDUCE-IT is Amarin’s ongoing, large, phase III trial to assess the efficacy of Vascepa 4 g/day in preventing a first major cardiovascular event in patients with persistent hypertriglyceridemia despite statin treatment who also have established CVD or are at high risk for CVD.

Amarin provided support and funding for writing assistance as acknowledged in the publication.

______

Note:

 

  • LOVAZA® is a registered trademark of the GlaxoSmithKline group of companies
  • VASCEPA® is a registered trademark of the Amarin group of companies

 

  1. LOVAZA (omega-3-acid ethyl esters) capsules [package insert]. Research Triangle Park, NC: GlaxoSmithKline; May 2014.
  2. Hilleman DE, Malesker MA. Potential benefits of icosapent ethyl on the lipid profile: case studies. Clin Med Insights Cardiol. 2014;8:13-15.
  3. Castaldo RS. A retrospective case series of the lipid effects of switching from omega-3 fatty acid ethyl esters to icosapent ethyl in hyperlipidemic patients. Postgrad Med. 2014;126:268-273.

 

In this article (doi: 10.1016/j.bbamem.2014.10.016), Dr. R. Preston Mason (Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School) and his colleague Robert F. Jacob report the results of a study that tested the comparative effects of EPA and other triglyceride-lowering agents (fenofibrate, niacin, and gemfibrozil) on lipid oxidation (i.e. oxidative stress) in human low-density lipoprotein (LDL) as well as on polyunsaturated fatty acids-enriched membrane lipid vesicles.The antioxidant effects were also tested for EPA in combination with the active metabolite arising from atorvastatin (i.e. the o-hydroxy (active) metabolite (ATM)). Additionally, this study compared the effects of EPA and the other triglyceride-lowering agents on the formation of cholesterol crystalline domains that can form in membranes under oxidative stress conditions.Oxidative stress and the resultant damage leads to endothelial dysfunction, inflammation, and foam cell formation during atherogenesis.

In this study, EPA was found to inhibit LDL oxidation in a dose-dependent manner and was distinguished from the other triglyceride-lowering agents, which had no significant effect.Similar effects were observed in membrane lipid vesicles, an effect that was significantly enhanced in combination with ATM.Additionally, in this study, only EPA inhibited glucose-induced cholesterol domain formation.

These data demonstrate that EPA inhibits hyperglycemia-induced changes in membrane lipid structural organization through a potent antioxidant mechanism associated with its distinct physicochemical interactions with the membrane bilayer.

Amarin provided financial support for this study.

In this publication (https://postgradmed.org/doi/10.3810/pgm.2014.11.2828), Dr. Howard S. Weintraub, Clinical Professor of Medicine, New York University School of Medicine, Clinical Director, NYU Center for the Prevention of Cardiovascular Disease, offers a comprehensive summary of efficacy, safety, and key considerations of currently approved prescription omega-3 fatty acids (OM3FA) products in patients with elevated triglycerides, with or without concomitant elevations in other atherogenic parameters, who may be at a higher risk for cardiovascular disease.

Excluding generic formulations of Lovaza, there are four prescription OM3FA formulations approved in the United States:  omega-3-acid ethyl esters (Lovaza® and Omtryg™), omega-3-carboxylic acids (Epanova®), each of which contains both EPA and DHA, and icosapent ethyl (Vascepa®), which is an EPA-only formulation.

The discussion includes review of both older clinical study results of Lovaza as well as more recent clinical results for Lovaza as studied as a separate arm of the phase 3 trial of Omtryg.  All prescription OM3FA products effectively lower triglycerides.  Products that contain DHA can raise levels of low-density lipoprotein cholesterol (LDL-C), which is of particular concern in patients with atherosclerosis.  The only approved prescription OM3FA that does not contain DHA is Vascepa.

The review also emphasizes that omega-3 dietary supplements should not be substituted for prescription OM3FA’s as the efficacy of such products have not been clinically demonstrated or FDA approved and the safety and tolerability of supplements are not well known, particularly at prescription OM3FA dose levels.

Amarin provided support and funding for writing assistance as acknowledged in the publication.

_____________

Note:

  • LOVAZA® is a registered trademark of the GlaxoSmithKline group of companies
  • OMTRYG is a trademark of Trygg Pharma, Inc.
  • EPANOVA® is a registered trademark of the AstraZeneca group of companies
  • VASCEPA® is a registered trademark of the Amarin group of companies

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

In September 2014, the National Lipid Association (NLA) launched a nationwide triglyceride campaign during National Cholesterol Education Month. The NLA's announced goal is to encourage patient education and drive discussions about lipid management and the consequences of high cholesterol and triglyceride levels.

According to the NLA, the mission of the campaign is to encourage physicians to inform patients about the importance of proper treatment and prevention as it relates to their entire lipid profile - not just cholesterol, but elevated triglyceride levels, too.

"We want to raise awareness around elevated triglycerides with patients and health care providers alike, as they may unsuspectingly affect patients' health, even if they look and feel healthy," said NLA President Terry A. Jacobson, MD. "Fortunately, health care providers are committed to offering their patients their best care, and we're committed to ensuring they have the tools to do so."

In a recent survey of health care providers, the NLA discovered a need for standard protocols surrounding the measure of patients' total lipid profiles, including triglycerides. To jumpstart these educational and preventive efforts, the NLA urges health care providers to compare patients' triglyceride levels to the following categories:

With this campaign, NLA hopes to provide the necessary resources for clinical practice and education, as well as generate awareness about lipid management.

Amarin is not responsible for the content of NLA's campaign.

Amarin has reviewed with enthusiasm the publication on June 18th in The New England Journal of Medicine of two independent studies by leading research groups funded by the National Institutes of Health and the European Union related to reduced triglyceride (TG) levels and reduced cardiovascular (CV) risk.  One study was led by Dr. Sekar Katherisan of the Cardiovascular Research Center and Center for Human Genetic Research at Massachusetts General Hospital in Boston (DOI: 10.1056/NEJMoa1307095) and the other by Dr. Anne Tybjærg-Hansen from the Department of Clinical Biochemistry and Molecular Genetics at the Copenhagen University Hospital in Denmark( DOI: 10.1056/NEJMoa1308027).  Amarin did not provide funding or support for either study.  As the medical community eagerly searches for ways to further reduce CV risk beyond LDL-C-lowering, Amarin believes these two independent studies provide encouraging new data connecting reduced TG levels to reduced CV risk.  We encourage investors to review the publications and related press reports on the new studies for more information and consider this new information alongside our public disclosures filed with the Securities and Exchange Commission and other public comments we have made on the results of our ANCHOR study and our related pending REDUCE-IT cardiovascular outcomes study.   Of relevance to the new data, we refer investors to our May 2, 2014 press release titled, Amarin Announces Presentation of New MARINE and ANCHOR Post-Hoc Analyses at National Lipid Association Annual Scientific Sessions Showing Vascepa® Significantly Reduced Apolipoprotein C-III Levels.

The Lancet, August 16th review article, Triglycerides and cardiovascular disease, by Drs. Nordestgaard and Varbo, University of Copenhagen (doi:10.1016/S0140-6736(14)61177-6), discusses how the medical community has sought to further reduce cardiovascular risk beyond low-density lipoprotein cholesterol (LDL-C)-lowering and how the therapeutic raising of high-density lipoprotein cholesterol (HDL-C) has not demonstrated a cardiovascular benefit.  The article then offers an overview of the compelling epidemiological, clinical and genetic data connecting the treatment of elevated triglyceride levels to reduced cardiovascular risk. 

The authors summarize that “[t]he magnitude of the effect caused by triglyceride-lowering compares favourably with the reduction of… major vascular events and… all-cause mortality… [with] reduction in LDL cholesterol in statin trials, while acknowledging that the totality of evidence supporting the therapeutic lowering of LDL-C is more extensive than that for the therapeutic lowering of triglycerides.   Investors can review this publication to consider how this information may influence continued healthcare professional interest in triglyceride lowering therapies.  

The authors note that “[n]o large-scale randomized trial has examined the effect of reducing triglycerides on cardiovascular disease risk in people with raised triglycerides”, and cite REDUCE-IT as a study that is providing an “urgently needed” randomized intervention trial in patients with elevated triglycerides despite statin therapy. 

Please note, in referring to the REDUCE-IT study, the review article presents 2016 as the projected date for study completion.  As described in Amarin’s public disclosures, 2016 is the current estimated timing for an interim look at the study results.

Amarin has no connection to The Lancet article. Investors should consider this information together with Amarin public disclosures filed with the Securities and Exchange Commission, public comments on MARINE and ANCHOR studies and updates on the pending REDUCE-IT cardiovascular outcomes study.

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.

The ethyl ester (EE) and free fatty acid (FFA) forms represent two different ways in which omega-3 fatty acids, such as EPA and DHA, are manufactured.  Prescription omega-3 products are currently produced in both forms with the EE form being the most common and the form which has been successfully used for many years.  Regardless of the manufacturing process, EPA, DHA, and other omega fatty acids are absorbed from the small intestine in the free fatty acid form.  The EE form, which is generally a more stable form of omega-3 fatty acids, is also known as a “prodrug”.  Once the prodrug is ingested, the free acid form is separated from the ester carrier naturally by enzymes in the gastrointestinal tract (a common process known as hydrolysis).  The free acid form is thus readily available for absorption in the small intestine.  In the case of the FFA form, pharmaceutical preparations often require a protective coating, which is designed to release the drug only after the dosage form has passed into the small intestine (so-called “enteric” coating).  These coatings are intended to reduce unpleasant gastrointestinal side effects, such as abdominal discomfort; however, this is not always the case, which can lead to concerns such as tolerability and dose compliance. VASCEPA® Capsules, which contain only EPA, are provided in the EE form.

Amarin does not expect such a shutdown to affect the December 20th PDUFA date (or the October 16th advisory committee) for the ANCHOR indication.  Amarin’s view reflects its current understanding of potential events and is based on a perceived low probability of an interruption in appropriations and no or minimal interruption in FDA operations.  Actual events may vary.

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

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 contact Michael Farrell:
Telephone (U.S.): 908-719-1315
e-mail: investor.relations@amarincorp.com
 

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