Vascepa(R) (Icosapent Ethyl) Showed Significant Reductions in Potentially Atherogenic Lipid Parameters in Statin-Treated Patients With Type 2 Diabetes and Persistent High Triglycerides

BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 06/11/16 -- Amarin Corporation plc (NASDAQ: AMRN) today announced additional data on Vascepa (icosapent ethyl) presented at the annual meeting of the American Diabetes Association (ADA) supporting its efficacy in reducing concentrations of potentially atherogenic lipoproteins (lipoproteins that could promote fat deposits in arteries) in patients with Type 2 diabetes and persistent high triglyceride (TG) levels despite statin therapy.

The poster (#1173), titled "Effects of Icosapent Ethyl on Lipoprotein Particle Concentration and Size in Statin-Treated Patients with Persistent High Triglycerides: ANCHOR Patients with Diabetes Mellitus," was presented on June 11, 2016. Lipoproteins such as low density lipoprotein (LDL) and very low density lipoprotein (VLDL) carry cholesterol, fat, and other lipids in the blood and are considered potentially atherogenic at persistently elevated levels. Researchers using nuclear magnetic resonance (NMR) spectroscopy observed that, compared with placebo, Vascepa administered at 4 g/day significantly reduced the median concentrations of VLDL and LDL particles in patients with Type 2 diabetes who, despite statin therapy, have persistent high TG levels (≥200 and < 500 mg/dL).

The analysis was led by Eliot A. Brinton, MD, FAHA, FNLA; Director of Atherometabolic Research at the Utah Foundation for Biomedical Research, and President of the Utah Lipid Center, both in Salt Lake City. Dr. Brinton will be available at an author question and answer session on Sunday, June 12 from noon to 2:00 PM CDT.

"The findings presented today suggest multiple lipoprotein-related benefits of pure EPA Vascepa in patients with Type 2 diabetes, which merit further investigation of the potential cardiovascular benefits from icosapent ethyl therapy in cardiovascular outcomes trials," said Dr. Brinton. "In addition to the significant reductions in potentially atherogenic lipoprotein particle concentrations with Vascepa 4 g/day, apolipoprotein B (Apo B), which is carried on VLDL and LDL, was also significantly reduced by 9.3% compared with placebo. Furthermore, ApoB levels were correlated with levels of potentially atherogenic lipoproteins. While further study of Vascepa is needed and ongoing, ApoB and potentially atherogenic lipoprotein levels have been linked in the broader scientific literature to atherosclerosis and heart disease, so these new analyses support the hypothesis that Vascepa could prove beneficial to this historically difficult-to-treat patient population believed to be at increased cardiovascular risk."

The clinical implications of lowering triglycerides with Vascepa 4 g/day are being investigated in the REDUCE-IT cardiovascular outcomes study of statin-treated subjects with persistent elevated TG levels.

About the Presented Research

Dr. Brinton's analysis was a post-hoc subgroup analysis of patients with Type 2 diabetes enrolled in the ANCHOR trial for whom NMR data were available. ANCHOR investigated Vascepa as a treatment for patients with residual high TG (≥200 and < 500mg/dL) despite statin-induced control of LDL-C. ANCHOR enrolled 702 patients, of which the majority (73%) had Type 2 diabetes. The primary endpoint was percent change in TG levels from baseline to 12 weeks compared with placebo in subjects treated with placebo or Vascepa at 2 or 4 g/day. In April 2011, Amarin reported top-line results from the ANCHOR trial, which met its primary and secondary endpoints.

The data presented at ADA is an analysis of NMR measurements providing the concentration and size of lipoprotein particles (VLDL, LDL and HDL) in ANCHOR subjects with Type 2 diabetes, and comparing the results of subjects taking 4 g/day Vascepa (n=160) to those taking placebo (n=154).

The analysis showed that, compared with placebo, Vascepa significantly reduced the median concentration of: total (−11.3%; P=0.004), large (−48.9%; P < 0.0001), and medium (−12.0%; P=0.02) VLDL particles; total (−7.4%; P=0.009) and small (−13.1%; P < 0.0001) LDL particles; and total (−7.5%; P < 0.0001) and large (−29.7%; P < 0.0001) HDL particles. In addition, potentially atherogenic particle concentration (defined as total VLDL + IDL + LDL) decreased significantly (−7.7%; P=0.003). Both LDL and potentially atherogenic particle concentrations were significantly correlated with plasma Apo B at baseline (R2=0.49; P < 0.0001 and R2=0.53; P < 0.0001, respectively), which increased numerically for both at 12 weeks (R2=0.56 P < 0.0001 and R2=0.64 P < 0.0001, respectively).

The efficacy and safety of Vascepa 4 g/day in patients with Type 2 diabetes were consistent with the overall ANCHOR results.

As with many subgroup analyses, limitations of this analysis include the smaller sample size, the 12-week study duration and the post-hoc nature. Nonetheless, the results are suggestive of complementary beneficial changes in TG levels and lipoprotein parameters with Vascepa compared with placebo.

Amarin's clinical development program for Vascepa includes a trial known as REDUCE-IT, the first multinational cardiovascular outcomes study evaluating the benefit of pure EPA therapy, or any triglyceride lowering therapy, as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels (≥200 and < 500mg/dL). Amarin recently announced that it has achieved its target enrollment of 8,000 patients for the trial and that an interim efficacy analysis by the independent Data Monitoring Committee of the REDUCE-IT trial is expected in September or October 2016.

Additional information on ANCHOR, REDUCE-IT and Amarin's other clinical studies of Vascepa can be found at www.clinicaltrials.gov.

About VASCEPA ® (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101.

FDA-approved Indication 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.
• Use 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.
• Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
• In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
• Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
• Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

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 press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

About Amarin

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. Amarin's clinical program includes a commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-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.

Forward-looking statements

This press release contains forward-looking statements, including statements about the potential efficacy and therapeutic benefits of Vascepa and EPA, including implications about the potential clinical importance of the findings presented. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with retrospective sub-set analyses, research on biomarkers thought to be relevant in the treatment of cardiovascular disease, research and development and clinical trial risk generally, including the risk that study results in small sample sizes in short-term studies may not be predictive of future results in larger, longer-term studies and that studied parameters may not have clinically meaningful effect. 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 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 press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of other information about Amarin

Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin Contact Information: 

Investor Relations: 
Kathryn McNeil
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com

Media Inquiries: 
Ovidio Torres
Finn Partners
In U.S.: +1 (312) 329 3911
ovidio.torres@finnpartners.com

Source: Amarin Corp. Plc

Amarin Announces FDA New Chemical Entity Market Exclusivity Determination for Vascepa(R) (icosapent ethyl) Capsules

BEDMINSTER, NJ and DUBLIN, IRELAND -- Amarin Corporation plc (NASDAQ: AMRN) announced today that the U.S. Food and Drug Administration (FDA) has determined that Vascepa® (icosapent ethyl) capsules are eligible for five-year, new chemical entity (NCE), marketing exclusivity pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. This determination provides Vascepa with the benefits of NCE exclusivity afforded by statute. NCE exclusivity for Vascepa runs from its date of FDA approval on July 26, 2012 and extends until July 26, 2017. The statutory 30-month stay triggered by patent litigation following generic application submissions permitted on July 26, 2016 would expire on January 26, 2020, seven-and-a-half years from FDA approval.

"Amarin's goal is to protect the commercial potential of Vascepa to 2030," stated John F. Thero, president and chief executive officer of Amarin. "NCE regulatory exclusivity complements multiple patents covering Vascepa with expiration dates in 2030." 

About VASCEPA ®  (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101.

FDA-approved Indication 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.
• Use 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.
• Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
• In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
• Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
• Adverse events and product complaints may be reported by calling
  1-855-VASCEPA or the FDA at 1-800-FDA-1088.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

About Amarin

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. Amarin's clinical program includes a commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-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.

Forward-looking statements  

This press release contains forward-looking statements, including statements about whether NCE exclusivity and Amarin patents would adequately protect Vascepa against competition and Amarin's plan to protect the commercial potential of Vascepa. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described herein include the following: events that could interfere with the continued validity or enforceability of a patent; Amarin's ability generally to maintain adequate patent protection and successfully enforce patent claims against third parties; withstanding any challenge to FDA's NCE determination; commercializing Vascepa without violating the intellectual property rights of others; and uncertainties associated generally with research and development, clinical trials and related regulatory approvals and exclusivity grants. 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 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 press release, whether as a result of new information, future events or circumstances or otherwise. 

Availability of other information about Amarin

Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Amarin contact information:

Investor Relations:

Kathryn McNeil
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com

Media Inquiries:

Kristie Kuhl
Finn Partners
In U.S.: +1 (212) 583-2791
Kristie.kuhl@finnpartners.com

Source: Amarin Corp. Plc

Amarin Reaches Target Enrollment in Cardiovascular Outcomes Study of Vascepa(R) in Patients With Elevated Triglycerides Despite Statin Therapy

BEDMINSTER, NJ and DUBLIN, IRELAND -- Amarin Corporation plc (AMRN) (NASDAQ (NBI): AMRN) today announced that target patient enrollment has been reached in its REDUCE-IT cardiovascular outcomes trial of Vascepa (icosapent ethyl). Amarin also announced that the onset of approximately 60% of the target aggregate number of primary cardiovascular events within the REDUCE-IT study has triggered preparation for a pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee (DMC). Amarin currently expects the independent interim analysis to be conducted in approximately six months.

Enrollment Target Achieved

The REDUCE-IT study was designed to enroll approximately 8,000 patients. This enrollment target has been reached and Amarin is winding down patient enrollment on a country by country basis. Since the study commenced in 2011, over 20,000 patient years of study have been accumulated in REDUCE-IT.

"We are pleased to announce that we have reached the target enrollment in REDUCE-IT, the first multinational cardiovascular outcomes study prospectively designed to investigate whether there is a meaningful reduction in the occurrence of major cardiovascular events when EPA is added to statin therapy in high-risk patients with elevated triglycerides," said Steven Ketchum, Ph.D., president of research and development and chief scientific officer at Amarin. "Vascepa demonstrated a broad spectrum of favorable effects on lipid, lipoprotein, and inflammatory biomarkers compared to placebo in Phase 3 studies focused on patients with high triglyceride levels after statin therapy and on patients with very high triglyceride levels. Through long-term study of patients treated with Vascepa in REDUCE-IT, we aim to provide a robust dataset to determine whether the effects of highly-pure EPA omega-3 prescription drug therapy will lower the risk of cardiovascular events in the high-risk patient population studied."

Interim Analysis Expected in Approximately Six Months

The REDUCE-IT study's event rate continues to track to prior estimates. A pre-specified interim efficacy and safety analysis was designed to be conducted upon achieving approximately 60% of the 1,612 aggregate primary cardiovascular events within the study. REDUCE-IT patients are in the process of completing a study visit over the next several months, after which additional time is required by the contract research organizations to finish collecting and preparing data for transfer to and analysis by the DMC. As is typical for large-scale, multi-national studies, regardless of the strength of the study results this data preparation and transfer process is expected to take several months. The DMC's analysis is anticipated to occur in approximately six months.

Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study until after the study is ready to be stopped either at the interim analysis or at the final analysis. Guidelines for the independent DMC to recommend stopping the study for overwhelming efficacy require that the study achieve statistical significance on the primary endpoint and generate robust findings on certain, pre-specified secondary outcome measures. Given the high thresholds of overwhelming efficacy required prior to a DMC recommending an early stop to a cardiovascular outcomes trial like REDUCE-IT, Amarin continues to expect that the DMC's interim analysis will result in a recommendation to continue the REDUCE-IT study as planned. Such a recommendation is most common for cardiovascular outcome studies.

First Multinational Outcomes Study to Evaluate Cardiovascular Benefit of High-Dose EPA Therapy as an Add-on to Statin Therapy

Heart disease remains the number one cause of death in the United States. REDUCE-IT is the first multinational outcomes study being conducted to evaluate the cardiovascular benefits of treating patients with high cardiovascular risk who, despite stable statin therapy, have elevated triglyceride levels.

"In many high-risk patients with cardiovascular disease, substantial residual risk for events remains despite optimal LDL-cholesterol reduction with statin therapy," said Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs, Brigham and Women's Hospital Heart and Vascular Center, Professor of Medicine, Harvard Medical School, and Principal Investigator for REDUCE-IT. "By design, the REDUCE-IT study has enrolled patients with high cardiovascular risk and elevated triglyceride levels despite statin therapy and will provide important information regarding the potential for high-dose EPA-only omega-3 therapy to confer incremental cardiovascular benefit beyond statin control of LDL-cholesterol."

Amarin believes that the REDUCE-IT study is positioned for success based on extensive review of existing data from clinical, epidemiologic and genetic studies. With the study's event rate tracking on schedule, the onset of the 1,612th primary cardiovascular event is expected to occur in 2017 with the publication of results anticipated in 2018.

About REDUCE-IT

REDUCE-IT is a global Phase 3, randomized, multicenter, double-blind, placebo-controlled study designed to evaluate whether treatment with Vascepa reduces cardiovascular events in patients who have persistently elevated triglyceride levels despite stabilized statin therapy. 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.

Additional information on the REDUCE-IT trial and Amarin's other clinical studies of Vascepa can be found at www.clinicaltrials.gov.

About VASCEPA ® (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules are a single-molecule prescription product consisting of 1 gram of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101.

FDA-approved 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.

Use 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.

Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.

In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.

Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.

Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

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 press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

About Amarin

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. Amarin's clinical program includes a commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-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.

First Amendment Decision a Win for Amarin and Physician Plaintiffs

Federal Court Rules Promotion of ANCHOR Clinical Data of Vascepa(R) and Research on the Potential Connection Between Vascepa and Cardiovascular Risk Reduction Is Constitutionally Protected Speech

BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 08/07/15 -- Amarin Corporation plc (NASDAQ: AMRN) today announced a United States District Court has ruled that Amarin may promote to healthcare professionals certain uses of Amarin's lead product, Vascepa®(icosapent ethyl) capsules, that are not covered by current FDA-approved labeling for the drug so long as the promotion is truthful and non-misleading. The Court declaration covers promotion of the FDA-reviewed and agreed effects of Vascepa demonstrated in the ANCHOR clinical trial of patients with persistently high triglycerides after statin therapy and use of peer-reviewed scientific publications that present the current state of scientific research related to the potential of Vascepa to reduce the risk of cardiovascular disease. Based on today's ruling Amarin plans to begin promotional activities consistent with the opinion as soon as possible.

Decision is a victory aimed at improved patient care

The decision opens more direct and effective paths to communicate truthful and non-misleading information about Vascepa clinical trial results and the state of science relevant to the potential of Vascepa to reduce the risk of cardiovascular disease. With accurate information readily available, healthcare professionals will be better able to assess for themselves how best to choose among available treatment options for their patients. With healthcare professionals better informed, this decision is a victory that Amarin believes will lead to improved patient care.

Cardiovascular disease is the leading cause of death for men and women in the United States. Significant risk from cardiovascular disease remains for tens of millions of Americans after statin therapy and recommended changes in diet and exercise. Given the significant need to reduce the risk of cardiovascular disease, numerous independent national and international treatment guidelines and position statements recommend drug therapy as an adjunct to healthy diet, lifestyle change and statin therapy for at-risk patients with persistently high triglyceride levels in their blood to lower those patients' triglycerides and/or non-high-density lipoprotein cholesterol. The use of Vascepa in this patient population, as studied in the ANCHOR trial, is contemplated by guidelines, is medically accepted and commonly prescribed by physicians. This is the practical reality despite the fact that FDA did not approve Vascepa for this use and even though a link between such treatment and reduced cardiovascular risk has not been determined. Use of Vascepa within these guidelines is also listed on independent drug compendia on which reimbursement from Medicare, Medicaid and private payor plans is based. Amarin's REDUCE-IT cardiovascular outcomes study of Vascepa, which is designed to evaluate the efficacy of Vascepa in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy, is over 95% enrolled.

"This lawsuit is based on the principle that better informed physicians will make better treatment decisions for their patients," said John F. Thero, President and Chief Executive Officer. "Many physicians are aware of the efficacy data included in FDA-approved labeling for Vascepa but are not aware of efficacy data from the ANCHOR study of Vascepa. FDA has already included the safety data from both the MARINE and ANCHOR studies in approved Vascepa labeling. Amarin will now be able to communicate efficacy data from ANCHOR and other relevant study results to these physicians and to others in the medical community in the context of appropriate disclaimers."

The truthful and non-misleading information about Vascepa protected by the Court order

The Court determined that Amarin may engage in truthful and non-misleading speech promoting the off-label use of Vascepa, i.e., to treat patients with persistently high triglycerides, and specifically make to healthcare professionals the following truthful and non-misleading statements:

Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. Vascepa should not be taken in place of a healthy diet and lifestyle or statin therapy.

Vascepa is not FDA-approved for the treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels due to current uncertainty regarding the benefit, if any, of drug-induced changes in lipid/lipoprotein parameters beyond statin-lowered low-density lipoprotein cholesterol on cardiovascular risk among statin-treated patients with residually high triglycerides. No prospective study has been conducted to test and support what, if any, benefit exists.

Recent cardiovascular outcomes trials (ACCORD-Lipid, AIM-HIGH, and HPS2-THRIVE), while not designed to test the effect of lowering triglyceride levels in patients with high triglyceride levels after statin therapy, each failed to demonstrate incremental cardiovascular benefit of adding a second lipid-altering drug (fenofibrate or formulations of niacin), despite raising high-density lipoprotein cholesterol and reducing triglyceride levels, among statin-treated patients with well-controlled low-density lipoprotein cholesterol.

The ANCHOR trial demonstrates that Vascepa lowers triglyceride levels in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy.

In the ANCHOR trial, Vascepa 4g/day significantly reduced TG [triglycerides], non- HDL-C [non-high-density lipoprotein cholesterol or non-"good cholesterol,"] Apo B [Apolipoprotein B], VLDL-C [very-low-density lipoprotein cholesterol], TC [total cholesterol] and HDL-C [high-density lipoprotein cholesterol or "good cholesterol"] levels from baseline relative to placebo in patients with high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels not controlled by diet and statin therapy. The reduction in TG [triglycerides] observed with Vascepa was not associated with elevations in LDL-C [low-density lipoprotein cholesterol or "bad cholesterol] relative to placebo.

The Court's ruling also permits communication to healthcare professionals of the following information:

• peer-reviewed scientific publications relevant to the potential effect of EPA on the reduction of the risk of coronary heart disease, such as the JELIS cardiovascular outcomes trial of a pure-EPA product in Japanese patients and other publications on omega-3 acid studies; and
• more complete efficacy data from the ANCHOR trial.

To ensure that this speech is non-misleading, Amarin would also disclose the following:

• FDA has not approved to Vascepa reduce the risk of coronary heart disease;
• The effect of Vascepa on the risk of cardiovascular mortality and morbidity has not been determined;
• A cardiovascular outcomes study of Vascepa designed to evaluate the efficacy of Vascepa in reducing cardiovascular mortality and morbidity in a high-risk patient population on statin therapy is currently underway;
• Vascepa may not be eligible for reimbursement under government healthcare programs, such as Medicare or Medicaid, for treatment of statin-treated patients with mixed dyslipidemia and high (≥ 200 mg/dL and < 500 mg/dL) triglyceride levels or to reduce the risk of coronary heart disease. We encourage you to check that for yourself; and
• Any potential financial or affiliation biases between the firm and those who conducted the ANCHOR study.

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. Federal, state and private health plans routinely pay for many off-label drug uses, including certain 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 guidance and in connection with scientific exchanges. Prior to this judgment, these restrictions significantly limited the flow of information about the specified off-label uses of Vascepa.

About the ruling and potential future proceedings

The ruling today by the Honorable Judge Paul Engelmayer of the United States District Court for the Southern District of New York granted Amarin and the physician plaintiffs relief in the form of a declaratory judgment. The ruling declared as unconstitutional, in this case with the specified disclosures, FDA off-label promotion restrictions.

An appeal of the Court's ruling can be filed within 60 days. The ruling will remain in effect until the Court makes a final decision in the case unless the ruling is appealed and overturned. The underlying litigation may proceed until the Court enters a final order in the case. The lawsuit did not seek and the ruling did not grant approval of the indication contemplated by the ANCHOR study.

About the REDUCE-IT cardiovascular outcomes study

The REDUCE-IT cardiovascular outcomes study is the first prospective double-blinded cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. The REDUCE-IT study is also the first cardiovascular outcomes study to test a high, 4-gram dose of a pure-EPA only omega-3 prescription product. In the REDUCE-IT study, pure-EPA Vascepa is being studied as an adjunct to, and not as a replacement for, statin therapy. If successful, Amarin plans to seek additional indicated uses for Vascepa that extend beyond the populations studied in the successful MARINE and ANCHOR trials of Vascepa. These additional indications would potentially address tens of millions of patients in the United States and worldwide with elevated triglyceride levels despite stable statin therapy.

Amarin is blinded to the results of the REDUCE-IT study. The pooled, blinded event rate in the REDUCE-IT study is tracking to expectations for the study to continue until 2017 with results anticipated to be published in 2018. An interim review by the independent data monitoring committee of the efficacy and safety results of the trial is expected to occur during 2016 upon reaching 60% of the target aggregate number of cardiovascular events.

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.

FDA-approved 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.
• Use 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.
• Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
• In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
• Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
• Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.

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 press release should be construed as promoting the use of Vascepa in any indication that has not been approved by the FDA.

About Amarin

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. Amarin's clinical program includes commitment to the ongoing REDUCE-IT cardiovascular outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly-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.

Amarin Informed by FDA of October 16th Advisory Committee Date in Connection With Supplemental New Drug Application (sNDA) for Vascepa(R)

Amarin Informed by FDA of October 16th Advisory Committee Date in Connection With Supplemental New Drug Application (sNDA) for Vascepa(R) in the Treatment of Patients With High Triglycerides (TG ≥200 mg/dL and < 500 mg/dL) with mixed dyslipidemia

BEDMINSTER, N.J. and DUBLIN, Ireland, - Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that it was informed yesterday by the U.S. Food and Drug Administration (FDA) that the FDA will convene an advisory committee on October 16, 2013 in connection with the FDA's review of the Supplemental New Drug Application (sNDA) seeking approval for the use of Vascepa® (icosapent ethyl) capsules as an adjunct to diet in the treatment of adult patients with high triglycerides (TG ≥200 mg/dL and < 500 mg/dL) with mixed dyslipidemia. The FDA has previously assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013 for completion of its review of the sNDA. The FDA will consider the recommendation of the advisory committee, but the final decision regarding the approval of the sNDA will be made by the FDA.

"ANCHOR clinical trial results demonstrated the important role EPA-only omega-3 can play in helping adult patients with high triglycerides and mixed dyslipidemia," said Christie M. Ballantyne, M.D., Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center, Houston, Texas, and principal investigator of the ANCHOR trial. "In the ANCHOR trial, Vascepa lowered high triglyceride levels and showed robust reductions in a broad range of other lipid parameters on top of optimized statin therapy compared to placebo. Importantly, these beneficial effects were seen with a safety and tolerability profile comparable to placebo."

Vascepa was approved in 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia, based on the results of Amarin's MARINE clinical trial. The safety data from both the MARINE and ANCHOR clinical trials were reviewed by the FDA as part of the approval of Vascepa in the MARINE indication and are reflected in the approved product labeling for Vascepa. As is customary practice at FDA, yesterday's notification from the FDA is the only communication confirming the need for such a meeting. The FDA advisory committee topics and questions to the committee are anticipated to be made public by the FDA on its website in the week preceding the meeting, consistent with FDA procedure.

"For key first-in-class indications, an FDA advisory committee meeting is expected, and this public forum will be an important opportunity to discuss the ANCHOR data, which demonstrated Vascepa's unique potential as an adjunct to diet in the treatment of adult patients with high triglycerides (TG 200-499 mg/dL) and mixed dyslipidemia," said Eliot A. Brinton, MD, FAHA, FNLA, Director of Atherometabolic Research, Utah Foundation for Biomedical Research, and President, American Board of Clinical Lipidology. "Currently, many of these patients are receiving another prescription omega-3 which is not indicated for this disorder. Having instead an omega-3 product which lowers LDL-cholesterol in addition to triglycerides, has tolerability comparable to placebo, and is FDA-approved for use on top of statin therapy would be a welcome addition to the physician's armamentarium for comprehensive lipid management."

"With the support of the Amarin team, including our outside consultants, such as Christie and Eliot, we look forward to the advisory panel and working with the FDA to obtain regulatory approval of Vascepa for ANCHOR this year," said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin.

Currently, Amarin only markets Vascepa for the MARINE indication, for which it was approved in 2012, and which includes approximately 4 million patients in the United States. The proposed ANCHOR indication would expand the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 mg/dL (and mixed dyslipidemia). Amarin estimates that one in five, or nearly 40 million, U.S. adults have triglyceride levels in this range. Amarin began selling Vascepa on January 28, 2013. Amarin believes that many of the same clinicians who have prescribed Vascepa for its currently approved indication will prescribe Vascepa for the much broader indication, based on the ANCHOR study now under formal FDA review, if approved.

Amarin Announces NDA Submission for AMR101 for the Treatment of Patients with Very High Triglycerides

BEDMINSTER, N.J., and DUBLIN, Ireland, Sept. 26, 2011 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of AMR101 for treatment of patients with very high triglycerides. The submission is based on the entire data set from the Company’s AMR101 development program, including safety and efficacy data from the Phase 3 MARINE and ANCHOR studies.  

“This is another significant milestone achieved for Amarin. Data from our two pivotal Phase 3 studies show that, unlike other triglyceride-lowering therapies, AMR101 does not increase LDL-cholesterol and, in certain cases, significantly decreases it,” said Joseph S. Zakrzewski, Chairman and Chief Executive Officer of Amarin. “The submission of this NDA moves AMR101 one step closer to commercial launch. If AMR101 is approved, we believe it can play a significant role in cardiovascular health management.” 

It is estimated that 75 million people in U.S. alone have triglyceride levels greater than 150mg/dL, including 4 million people with very high triglyceride levels (the triglyceride range studied in the MARINE trial) and 36 million people with high triglyceride levels (the triglyceride range studied in the ANCHOR trial).  Elevated triglycerides are clinically stratified into three groups: very high triglycerides (>500 mg/dL), high triglycerides (>200 and <500 mg/dL) and borderline high triglycerides (>150 and <200 mg/dL).  Clinical treatment guidelines include recommendations for triglyceride reductions in each of these groups and each group represents a multi-billion dollar market opportunity.  In the top seven world markets it is estimated that the number of people with elevated triglyceride levels is at least two times that of the U.S. alone. 

The treatment of patients with very high triglycerides was studied in the Company’s MARINE trial.  The treatment of patients with high triglycerides on statin therapy was studied in the Company’s ANCHOR trial.  Amarin plans to separately seek approval for the treatment of high triglycerides in patients on statin therapy (the population studied in the ANCHOR trial) after its REDUCE-IT cardiovascular outcomes trial is substantially underway, which the Company expects will occur before the end of 2012 (final results of the REDUCE-IT outcomes study are not required for approval of the very high triglyceride indication). 

In both the MARINE and ANCHOR trials, AMR101 achieved all primary endpoints and was well tolerated with a safety profile comparable to placebo. Each trial was conducted under a Special Protocol Assessment (SPA) agreement from the FDA.  As recently announced, an SPA agreement was also reached for the REDUCE-IT cardiovascular outcomes study. 

About AMR101

AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA(icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Triglycerides are fats in the blood. Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 demonstrated a safety profile comparable to placebo in two complete Phase 3 clinical trials.

Amarin Announces Agreement From FDA On Special Protocol Assessment For Amr101 Outcomes Study

Study Positions AMR101 to Potentially Address Patient Populations of More Than 70 Million in the U.S. Alone

MYSTIC, Conn. and DUBLIN, Ireland, Aug. 10, 2011 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) agreement for the design of the previously described cardiovascular outcomes study of AMR101 formally titled REDUCE-IT (Reduction of Cardiovascular Events with EPA - Intervention Trial). Amarin previously announced that it achieved the primary endpoints of two Phase 3 studies of AMR101, both of which were conducted under separate SPAs.

In REDUCE-IT, Amarin will evaluate the effectiveness of AMR101 in reducing the first major cardiovascular events in an at-risk patient population. The control arm of the study will be patients on optimized statin therapy. The active arm of the study will be patients on optimized statin therapy plus AMR101. All subjects enrolled in the study will have elevated triglyceride levels and either coronary heart disease or risk factors for coronary heart disease. Amarin will be responsible for the study which will be conducted internationally. The Company will use an experienced clinical research organization (CRO) to help manage the study and is in the late stages of contract negotiations with a leading CRO for that purpose.

Consistent with prior comments, Amarin estimates that the study will require approximately 8,000 patients and take approximately 6 years for completion. The Company anticipates that if, as intended, it commences Outcomes study activities in 2011 that it will be positioned to achieve approximately 50% enrollment before the end of 2012.

Once REDUCE-IT is substantially underway, the Company believes that it will have met all of the requirements to request approval of AMR101 for treating the mixed dyslipidemia patient population studied in the ANCHOR trial. AMR101 is positioned to be the first drug in its class approved for treatment of this indication. Upon completing REDUCE-IT, and assuming a successful result, Amarin anticipates being able to pursue an indication for the prevention of cardiovascular events; this population is estimated to be greater than twice the size of the combined indications studied in the MARINE and ANCHOR trials. The Company also anticipates that, similar to ANCHOR, a significant number of the patients in REDUCE-IT will have diabetes.

"We are delighted to have finalized the protocol for REDUCE-IT and to have the FDA agree to this via a Special Protocol Assessment, our third SPA for AMR101, which is remarkable," stated Joseph Zakrzewski, Amarin's Executive Chairman and CEO. "Based on the strong safety profile of AMR101, our positive Phase 3 results for AMR101 and success in Japan with an outcomes study of highly pure EPA, we believe that REDUCE-IT is positioned for success." Mr. Zakrzewski added, "The design of REDUCE-IT reflects the diligent evaluation of numerous other outcome studies by our clinical team, advisors and other interested parties all of whom are commended and thanked for their contributions to the very direct and efficient design of this study."

Amarin Announces Global Supply Network for AMR101

–Company adds multiple suppliers to increase capacity and flexibility in preparation for commercial launch of AMR101–

MYSTIC, Conn. and DUBLIN, May 31, 2011 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, announced today the expansion of its capability to supply AMR101 through the addition of two active pharmaceutical ingredient (API) suppliers and two encapsulators. 

Equateq Limited (Equateq) and Chemport Inc. (Chemport) have agreed to provide Amarin with API for AMR101.  Catalent Pharma Solutions LLC (Catalent) and Banner Pharmacaps Europe B.V. (Banner) have agreed to terms with Amarin to provide soft-gel encapsulation services for AMR101.   These agreements expand Amarin’s entire supply chain and provide the Company with significantly greater global capacity and diversification in preparation for the commercial launch of AMR101.   

Joseph Zakrzewski, Executive Chairman and CEO, stated, “A primary 2011 goal for Amarin is to expand our global supply chain to support expected product demand, diversify our supply base and ensure cost-efficient supply.  The positive ANCHOR and MARINE clinical trial results heightened the timing and urgency of achieving that goal. We believe that the addition of these suppliers position us, subject to regulatory approval, for an aggressive launch of AMR101.”

API Suppliers

Equateq, based in Scotland, and Chemport, based in South Korea, are companies with substantial expertise in manufacturing polyunsaturated fatty acids for use in both pharmaceutical and nutraceutical products. Prior to entering into agreements with these companies, Amarin conducted an extensive worldwide evaluation of companies with expertise in manufacturing fatty acid-based products. Based on this evaluation, the Company concluded that the majority of the potential supplier lacked the technical skills and product quality infrastructure needed to consistently produce icosapent ethyl for AMR101 that is greater than 96% pure eicosapentaenoic acid (EPA).  Amarin believes that Equateq and Chemport possess the technical competence, quality capabilities and regulatory experience needed to produce icosapent ethyl, the active ingredient in AMR101, to Amarin’s high quality standards.  Amarin also believes that Equateq and Chemport have the capabilities to scale-up and qualify their facilities to meet the requirements of Amarin and regulatory authorities.

It is the Company’s current plan, subject to the submission of a New Drug Application (NDA) and approval, to launch AMR101 based on product produced by its existing API supplier.  Amarin has created a protocol, with feedback from regulatory authorities, for the qualification of additional API suppliers. The Company’s aim is for Equateq and Chemport to complete all necessary qualification steps needed to facilitate the submission of a supplemental NDA promptly upon any approval of the AMR101 NDA Amarin plans to submit in the third quarter of this year.  This brings the total number of API suppliers in Amarin’s current supply chain to three (3). 

Encapsulation

Catalent Pharma Solutions, headquartered in Somerset, New Jersey, and Banner, headquartered in High Point, North Carolina, are both leading global providers of prescription softgel capsulation services.  The Company selected these suppliers based on their technical abilities, quality standards and cost.  The Company has used Banner for encapsulation services for many years, including encapsulation for all of the Company’s AMR101 clinical trials. 

Financial Considerations

Equateq and Chemport, as well as Amarin’s current API supplier, are each executing phased capacity expansion plans aimed at creating sufficient capacity to meet anticipated demand for metric tons of API for AMR101 (each metric ton provides capacity for approximately a million 1-gram capsules of AMR101). These API suppliers are self-funding these expansion plans with limited contributions from Amarin as described below. Notwithstanding this API support plan, in light of the better than expected Phase 3 ANCHOR clinical trial results and significant anticipated sales volume, the Company is considering adding a fourth API supplier.   

In connection with the Equateq agreement, subject to approval of the Equateq API, in return for certain exclusivity provisions, Amarin is obligated to make minimum annual purchases from Equateq ranging from approximately $10 to $20 million.  In addition, Amarin has agreed pay Equateq a one-time commitment payment of $1.0, development fees up to a maximum of $0.5 million as well as up to $5.0 million payments for purchasing initial raw materials to be credited against future API purchases.  

In connection with the Chemport agreement, subject to approval of the Chemport API, in return for certain exclusivity provisions, Amarin is obligated to make minimum annual purchases from Chemport ranging from approximately $7.5 to $15 million.  Concurrent with its agreement with Chemport for commercial supply, Amarin agreed to make a minority share equity investment in Chemport of up to $3.3 million. 

In conjunction with the Equateq and Chemport agreements, Amarin is responsible for the execution and cost of certain regulatory activities as well as certain minimum purchase requirements. 

The Company anticipates that, subject to regulatory approval to market and sell AMR101, actual levels of API purchased will exceed the minimum levels specified above. The Company anticipates encapsulating the API it purchases, however, no lump-sum or minimum dollar amount payments are required in the terms with which the Company has agreed with Catalent and Banner.  

About AMR101

AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA(icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 demonstrated a safety profile comparable to placebo in both trials.

Investor Contact Information:

Stephen D. Schultz
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (860) 572-4979 x292
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com

Additional Detail of Successful MARINE Phase III Trial to be Presented at the National Lipid Association 2011 Annual Scientific Sessions

-Data presented for secondary and exploratory endpoint of pivotal study of AMR101includes statistically significant reductions compared to placebo for important lipid biomarkers-

NEW YORK, May 19, 2011 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today summarized additional MARINE Phase 3 pivotal trial results being presented at the National Lipid Association 2011 Annual Scientific Sessions (NLA) in New York City. In November 2010, the Company announced top-line results from the MARINE trial, which studied AMR101 as a therapy for patients with very high triglyceride levels (>500 mg/dL). The NLA is an association of clinical lipidologists, lipid researchers and allied clinical team members comprising of a total of five regional chapters representing more than 3,500 members from across the United States.

The MARINE study was the largest study ever conducted with omega-3 fatty acids in treating patients with very high triglycerides (>500 mg/dL). AMR101 (icosapent ethyl) was studied in this population, compared to placebo, at doses of 4 grams and 2 grams per day.  As reported in November 2010, the primary endpoint of the MARINE study was achieved with statistically significant reductions in triglycerides compared to placebo of 33% (P<0.0001) for the 4 gram and 20% (P=0.0051) for the 2 gram doses, respectively. AMR101 did not result in an increase in median LDL-C compared to placebo at either dose. The NLA-presented poster will provide additional data on secondary and exploratory efficacy endpoints, patient demographics and safety and tolerability of AMR101.

Regarding the secondary and exploratory efficacy endpoints, the Company believes these are important lipid biomarkers as they represent predictors of cardiovascular risk. Apo B (Apolipoprotein B) is a sensitive index of residual cardiovascular risk and is generally considered to be a better predictor than LDL-C.  Lp-PLA2 (Lipoprotein-phospholipase A2), is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis. AMR101 4 gram per day demonstrated significant reductions compared to the placebo groups in:

•    Apo B by 8.5% (p = 0.0019)

•    Lp-PLA2 by 13.6% (p = 0.0003)

•    Non–HDL-C by 17.7% (p <0.0001) 

•    VLDL-cholesterol by 28.6% (p = 0.0023)

The 2 gram per day dose significantly reduced placebo-corrected median non–HDL-C by 8.1% (p =0.0182). The 2 gram per day dose also significantly reduced placebo-corrected median VLDL-cholesterol by 15.3% (p<0.05) while reductions in Apo B and Lp-PLA2 compared to placebo were not statistically significant. Both doses significantly reduced total cholesterol (TC) with no significant effect on HDL-C. In addition, AMR101 4 g/day demonstrated statistically significant reduction in high sensitivity C-reactive protein (hsCRP) (p = 0.0012); this is an important marker of vascular inflammation.  

In statin-treated patients, AMR101 4 gram per day reduced placebo-corrected median triglyceride levels by 65% (p = 0.0001) and AMR101 2 gram per day reduced placebo-corrected median triglyceride levels by 40.7% (p = 0.0276). Among patients with baseline triglycerides >750 mg/dL, AMR101 4 gram per day reduced placebo-corrected median triglyceride levels by 45.4% (p = 0.0001); AMR101 2 gram per day reduced placebo-corrected median triglycerides in this subgroup by 32.9% (p = 0.0016). 

In general, most patients were overweight (mean body mass index 30.8 kg/m2), white (88.2%), and male (76.4%), with a mean age of 53 years. Among randomized patients, 25% received background statin therapy, 27.5% had diabetes mellitus, and 55% were at high risk for cardiovascular disease. For the randomized population, the median triglyceride level was 679.5 mg/dL, with 39% of these patients having baseline triglycerides >750 mg/dL. The median baseline LDL-C level was 86.0 mg/dL in the intent-to-treat (ITT) population.

The incidence of treatment-emergent adverse events (TEAEs) was generally similar across the three treatment groups. Most TEAEs were mild to moderate in severity, not related to study drug (as assessed by blinded investigators), and the severity of TEAEs were comparable between treatment groups. The most common TEAEs (>3% in any treatment group) were gastrointestinal (diarrhea, nausea, and eructation), with the highest numerical incidences in the placebo group.

This is the first time these MARINE results will be presented at a medical and scientific forum. The MARINE study results will be presented by its principal investigator, Harold Bays, M.D., Medical Director of Louisville Metabolic and Atherosclerosis Research Center. 

“We believe these data demonstrate pure EPA therapy effectively treats elevated triglycerides without raising LDL-C levels, as often occurs with other DHA containing omega-3 therapies,” said Dr. Bays.  “This trial was the largest study of a highly purified omega-3 fatty acid administered to patients with very high triglycerides.  MARINE showed for the first time that pure EPA therapy reduces triglyceride levels, improves a broad array of lipid and non-lipid parameters, and all without a significant increase in LDL-C.  As importantly, AMR101 was well tolerated, with adverse effects similar to placebo.”

According to Joseph Zakrzewski, Executive Chairman and CEO of Amarin, “the MARINE results exceeded our expectations and position Amarin to be best-in-class for treating patients with very high triglycerides and we believe AMR101 will offer patients the option to reduce triglycerides without the side effects seen with current omega-3 and fibrate therapies. At the same time, the significant reductions seen in the new data on other lipid biomarkers would suggest that pure EPA can potentially provide broader cardiovascular benefit.”

The Company added that further presentation of the MARINE trial results is scheduled for oral presentation at the European Society of Cardiology (ESC) Congress 2011 in August and for publication in The American Journal of Cardiology in September. In addition, Amarin also has a poster accepted for presentation at the ESC congress on novel data from the MARINE study; this will describe the effects of AMR101on the fatty acid profile in plasma and red blood cells in patients with very high triglycerides. 

About AMR101

AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA(icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 demonstrated a safety profile comparable to placebo in both trials.

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). The Company reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010 and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>200 and <500mg/dL] with mixed dyslipidemia), as reported on April 18, 2011. Both the MARINE and the ANCHOR trials were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development.

Disclosure Notice

This press release contains forward-looking statements, including statements about the efficacy, safety and benefits of the Company's product candidates, clinical trial results and the timing of data publication. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that SPAs are not a guarantee that FDA will accept an NDA or approve a product candidate upon submission; the risk that historical clinical trial enrolment and randomization rates may not be predictive of future results; uncertainties relating to the timing of data collection and analysis for the ANCHOR and MARINE trials; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and other matters 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.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact Information:

Stephen D. Schultz
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (860) 572-4979 x292
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com

Media Contact Information:

David Schull or Martina Schwarzkopf, Ph.D.
Russo Partners
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile)
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com

Amarin-Sponsored Posters to be Presented Today at the National Lipid Association 2011 Annual Scientific Sessions

–EPA therapy demonstrates a wide range of lipid lowering benefits

without the LDL-C increase as seen with omega-3s containing DHA–

-Amarin’s AMR101 contains >96% EPA -

NEW YORK, May 19, 2011 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, announced that three Amarin-sponsored studies on the benefits of pure EPA (icosapent ethyl) will be presented today at the National Lipid Association 2011 Annual Scientific Sessions (NLA) in New York City. The NLA is an association of clinical lipidologists, lipid researchers and allied clinical team members comprising of a total of five regional chapters representing more than 3,500 members from across the United States.

These papers cover the following topics:

•    MARINE Phase 3 pivotal trial results in patients with very high triglyceride levels (>500 mg/dL) 

•    A critical review of the comparative effects of EPA and DHA on low-density lipoprotein cholesterol (LDL-C), and 

•    The antioxidant effects of omega-3 fatty acids in combination with HMG-CoA reductase inhibitors (atorvastatin)

MARINE Phase 3 Pivotal Trial Results (Abstract 114)

In the MARINE study, the largest study of omega-3 fatty acids in this population, AMR101 (pure EPA) significantly reduced triglycerides at both the 4 and 2 gram per day doses in patients with very high triglycerides (>500 mg/dL). While top-line data for MARINE was reported by the Company in November 2010, the NLA-presented poster provides additional data on efficacy endpoints, patient demographics and safety and tolerability of AMR101.  In a separate release, the Company discloses additional details from this poster. The MARINE study results, as summarized in this poster, will be presented by its principal investigator, Harold Bays, M.D., Medical Director of Louisville Metabolic and Atherosclerosis Research Center. This is the first time these MARINE results will be presented at a medical and scientific forum.

Comparative Effects of EPA and DHA on LDL-C (Abstract 106)

This paper will present an evaluation of results from 22 published studies discussing the effects of EPA and DHA on LDL-C. Across all studies (n=22), LDL-C increased from baseline in 75% of DHA−treated groups (by 0.2%−16.0%) compared with 40% of EPA−treated groups (by 0.3%−6.5%). The results also showed that both DHA and EPA monotherapies could lower triglyceride levels. The poster is authored by Terry Jacobson, M.D., director of the Office of Health Promotion and Disease Prevention and Professor of Medicine, Emory University.

EPA as an Inhibitor of Lipid Oxidation (Abstract 107)

The paper will present data that shows EPA is a potent inhibitor of lipid oxidation at both normal and elevated cholesterol levels and that antioxidant activity was enhanced in combination with statins.  The ability of EPA to prevent oxidation of lipids was significantly greater than DHA (p<0.001).  The oxidative modification of polyunsaturated fatty acids in low-density lipoproteins is causally related to atherogenesis. The poster discussing EPA as an inhibitor of lipid oxidation is authored by Preston Mason, Ph.D., faculty member of the Department of Medicine, Division of Cardiology, at the Harvard Medical School-affiliated Brigham and Women's Hospital.

Commenting on the NLA abstracts, Paresh Soni, MD, PhD, SVP and Head of Development stated, “We are pleased that the MARINE trial results are getting attention in a forum of specialists in the lipidology field and that the papers on comparative effects of EPA/DHA and oxidation inhibition further support the benefits of AMR101, which is >96% EPA.”

About AMR101

AMR101 is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA(icosapent ethyl), that Amarin is developing as a potentially best-in-class prescription medicine for the treatment of patients with very high triglyceride levels (>500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (>200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia). Significant scientific and clinical evidence support the efficacy and safety of ethyl-EPA in reducing triglyceride levels and other important lipid and inflammation biomarkers, including Apo-B, non-HDL-C, Total-Cholesterol, VLDL-C, Lp-PLA2, and hs-CRP without increasing LDL-C. AMR101 demonstrated a safety profile comparable to placebo in both trials.

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (icosapent ethyl). The Company reported positive, statistically significant top-line results for both of its two pivotal Phase 3 clinical trials, the MARINE trial (investigation of AMR101 as a treatment for patients with very high triglycerides [>500 mg/dL]), as reported on November 29, 2010 and the ANCHOR trial (investigation of AMR101 for the treatment of patients on statin therapy with high triglycerides [>200 and <500mg/dL] with mixed dyslipidemia), as reported on April 18, 2011. Both the MARINE and the ANCHOR trials were conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development.

Disclosure Notice

This press release contains forward-looking statements, including statements about the efficacy, safety and benefits of the Company's product candidates and the timing of data publication. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that SPAs are not a guarantee that FDA will accept an NDA or approve a product candidate upon submission; the risk that historical clinical trial enrolment and randomization rates may not be predictive of future results; uncertainties relating to the timing of data collection and analysis for the ANCHOR and MARINE trials; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and other matters 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.  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Investor Contact Information:

Stephen D. Schultz
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (860) 572-4979 x292
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com

Media Contact Information:

David Schull or Martina Schwarzkopf, Ph.D.
Russo Partners
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile)
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com

Amarin’s AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints

Amarin’s AMR101 Phase 3 ANCHOR Trial Meets all Primary and Secondary Endpoints with Statistically Significant Reductions in Triglycerides at Both 4-Gram and 2-Gram Doses and Statistically Significant Decrease in LDL-C

- Triglyceride levels decreased 21.5% and 10.1% from baseline versus placebo at 4 grams and 2 grams doses, respectively

- LDL-C decreased at both doses within the predefined non-inferiority boundary with a statistically significant 6.2% decrease in LDL-C from baseline versus placebo at 4 gram dose

- All results were incremental to background statin therapy

- Safety profile similar to placebo and similar to MARINE trial results

- Results position AMR101 to be first-in-class product for treatment of high triglycerides

MYSTIC, Conn. and DUBLIN, April 18, 2011 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from its ANCHOR trial for the Company’s lead product candidate, AMR101. The Phase 3 trial met its primary and secondary efficacy endpoints for both the 4 gram and 2 gram daily doses.

The purpose of the ANCHOR trial was to demonstrate that AMR101 is effective in reducing triglyceride levels in patients with high triglycerides without increasing LDL-C (“bad cholesterol”) levels in patients on background statin therapy. The ANCHOR trial investigated AMR101 as a treatment for high triglycerides (≥200 and <500mg/dL) in 702 patients with mixed dyslipidemia (two or more lipid disorders) on background statin therapy at LDL-C (low-density lipoprotein cholesterol) goal who were at high risk of cardiovascular disease. The majority of these patients were diabetic (73%). This is the largest trial with omega-3 therapy conducted in this important patient population. All patients were on background statin therapy with simvastatin, atorvastatin or rosuvastatin. Despite the benefits of statin therapy, patients in this population have significant residual risk for cardiovascular events. The trial’s primary endpoint was defined as the percentage change in triglyceride levels from baseline compared to placebo after twelve weeks of treatment. In addition, the study was powered to demonstrate a lack of LDL-C elevating effect with AMR101 compared to placebo. The trial was conducted under a Special Protocol Assessment (SPA) agreement with the FDA.

Triglyceride Reduction Levels Exceeded Company Expectations

The primary endpoint for triglyceride change was achieved at both 4 grams and 2 grams per day with median placebo-adjusted reductions in triglyceride levels of 21.5% and 10.1% for the 4 grams and 2 grams per day dose groups, respectively.  These reductions were both statistically significant (p<0.0001 and p = 0.0005, respectively). The median baseline triglyceride levels were 259 mg/dL, 265 mg/dL and 254 mg/dL for the patient groups treated with placebo, 4 grams and 2 grams of AMR101 per day, respectively.  Even greater reductions in triglycerides were noted with higher potency statin regimens. Results were positive and statistically significant in both the diabetic and non-diabetic patient groups.

LDL-C Reductions Surpass Target of LDL-C Neutrality

The trial’s key secondary endpoint was to demonstrate a lack of elevation of LDL-C in order to avoid offset to the primary target of cholesterol lowering therapy. The trial’s non-inferiority criterion for LDL-C was met at both AMR101 doses.  The upper confidence boundaries for both doses were below the pre-specified +6% LDL-C threshold limit.  In fact, at the 4 gram dose the upper confidence boundary was below zero (-1.7%) and at the 2 gram dose the upper confidence boundary was close to zero (0.05%). Moreover, for the 4 grams per day AMR101 group, LDL-C decreased significantly by 6.2% from baseline versus placebo, demonstrating superiority over placebo (p=0.0067). For the 2 grams per day group, LDL-C decreased by 3.6% from baseline versus placebo (p=0.0867).

Additional Findings and Safety Profile were Positive

In addition, the ANCHOR trial demonstrated statistically significant decreases in all predefined secondary endpoints at both doses studied. These endpoints were non-HDL-C, Apo B (Apolipoprotein B), Lp-PLA2 (lipoprotein phospholipase A2) and VLDL-cholesterol. Non-HDL-C decreased in the 4 grams per day group by 13.6% (p<0.0001) and in the 2 grams per day group by 5.5% (p=0.0054) compared to placebo. These are important lipid biomarkers as they represent predictors of cardiovascular risk. Apo B is a sensitive index of residual cardiovascular risk and is generally considered to be a better predictor than LDL-C.  Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis. The safety profile of AMR101 was similar to placebo and there were no treatment-related serious adverse events in the trial. These results confirm and build upon the positive results for the MARINE Phase 3 trial announced in November 2010. The Company expects to present more details of these results at an upcoming scientific meeting.

Principal Investigator and Company Very Encouraged by Results

“The design and execution of the ANCHOR trial were robust and the trial results were very clearly positive,” said Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, and principal investigator of the ANCHOR trial.  “I am very impressed with the performance of AMR101. In particular, whereas current triglyceride-lowering drugs may raise LDL-C and causes patient treatment concerns, AMR101 demonstrated a decrease in LDL-C beyond the decrease created by statin therapy. Furthermore, it is very encouraging for patient care that AMR101 caused reductions in significant markers of cardiovascular risk such as Apo B and non-HDL-C. The greater triglyceride reduction in patients with higher potency statin regimens is also very encouraging.”

Commenting on the ANCHOR trial results, Joseph S. Zakrzewski, Chief Executive Officer and Executive Chairman of Amarin, stated, “We are delighted by the results of the ANCHOR trial. In November we announced MARINE trial results which position AMR101 to be best-in-class for treating patients with very high triglycerides. The ANCHOR trial results are even more remarkable than the broadly positive MARINE trial results. We believe these results clearly differentiate AMR101 from other triglyceride lowering therapies and position AMR101 to be both first-in-class and best overall therapy for treating the high triglyceride population. We thank the ANCHOR team, including our investigators, for their many contributions to this outstanding study design and execution.”

Large Market Potential

In the U.S. alone, approximately 40 million people have triglyceride levels above 200 mg/dL. The majority of these patients have high triglyceride levels of ≥200 and <500mg/dL as studied in the ANCHOR trial with approximately 4 million of these people having very triglyceride levels >500 mg/dL as studied in the MARINE trial.  Currently, no omega-3 based product is approved for the indication studied in the ANCHOR trial.  In the seven largest pharmaceutical markets (U.S., Japan and five largest European markets), it is estimated that over 100 million people have mixed dyslipidemia.

Investor Contact Information:

Stephen D. Schultz
Investor Relations and Corporate Communications
Amarin Corporation
In U.S.: +1 (860) 572-4979 x292
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922~
lstern@troutgroup.com

Amarin Corporation announces the pricing of an underwritten public offering

MYSTIC, Conn. and DUBLIN, Jan. 6, 2011 /PRNewswire/ -- Amarin Corporation plc (Nasdaq:AMRN - News) (the "Company"), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the pricing of an underwritten public offering of 12,000,000 American Depositary Shares ("ADSs") at a price to the public of $7.60 per ADS. The net proceeds to the Company from this offering are expected to be approximately $87.1 million, after deducting underwriting discounts and commissions and other estimated offering expenses. The offering is expected to close on or about January 11, 2011, subject to customary closing conditions.

Jefferies & Company, Inc. and Leerink Swann LLC are acting as joint book-running managers in the offering, and Canaccord Genuity Inc. is acting as co-lead manager for the offering. Amarin has granted the underwriters a 30-day option to purchase up to an aggregate of 1,800,000 additional ADSs solely to cover over-allotments, if any. Amarin anticipates using the net proceeds from the offering to prepare for the commercialization of AMR101, its filing of a New Drug Application and for working capital and general corporate purposes.

The securities described above are being offered by Amarin pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on November 23, 2010. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website at http://www.sec.gov. Copies of the final prospectus supplement relating to these securities may be obtained from Equity Syndicate Prospectus Department, Jefferies & Company, Inc., 520 Madison Avenue, 12th Floor, New York, NY, 10022, at 877-547-6340, and at Prospectus_Department@Jefferies.com. This news release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Amarin Completes Patient Randomization in Phase 3 ANCHOR Trial

Study Designed to Position AMR101 as First-in-Class Drug for Treating High Triglyceride Levels in Statin-Treated Patients with Mixed Dyslipidemia;
ANCHOR Trial Studies a Separate Indication for AMR101 than Studied in Recently Reported Phase 3 MARINE Trial

MYSTIC, Conn., and DUBLIN, Dec. 15, 2010 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported the completion of patient randomization for its ANCHOR trial, a pivotal Phase 3 trial of AMR101. The Company indicated that it anticipates reporting top-line results from this trial by the end of Q2 2011 (the Company’s previous guidance for the timing of such results was mid-2011).

The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 (ethyl-EPA) in patients with high triglyceride levels from 200 mg/dL to less than 500 mg/dL who are also on statin therapy. Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders) and are at significant risk of cardiovascular disease. No omega-3 based therapy is approved by the FDA for treating this patient population.

The ANCHOR trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The trial recruited and randomized 702 patients. Prior to randomization into the 12-week treatment period, all patients underwent a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization. The Company expects that the 702 patients randomized will be sufficient to demonstrate statistical significance in accordance with the trial protocol. All of the clinical sites in the trial are in the U.S. The primary endpoint in the trial is the percent change in triglyceride level from baseline to week 12. An important secondary endpoint in the ANCHOR trial is to show that the addition of AMR101 to statin therapy does not increase LDL-cholesterol (LDL-C or “bad cholesterol”) compared to placebo in this population.

“We are pleased that the ANCHOR study has been able to complete the patient randomization process before the end of 2010,”said Joseph S. Zakrzewski, Executive Chairman and Chief Executive Officer of Amarin. “Following the very positive results of the recently reported MARINE study in whichAMR101 demonstrated that it reduced triglyceride levels without increasing LDL-C in patients with very high triglycerides (>500 mg/dL), the ANCHOR study evaluates AMR101 in a different and larger patient population. AMR101 is designed to be first-in-class for this indication. In the U.S. alone, there are 36 million patients with triglyceride levels in the range being studied in the ANCHOR trial.”

On November 29, 2010, the Company reported positive top-line data for its pivotal Phase 3 MARINE study. In that study, AMR101 was shown to effectively lower triglyceride levels in patients with very high triglycerides (>500mg/dl) without increasing LDL-C. AMR101 is the first omega-3 based product outside of Japan to demonstrate statistically significant triglyceride reduction without an increase in LDL-C. The Company believes that this is because AMR101, like a similar product in Japan, consists of >96% ethyl-EPA (ethyl icosapentate) and no DHA (Docosahexaenoic acid). DHA has been linked to increases in LDL-C. The MARINE study results also included favorable findings with respect to significant reductions in total cholesterol, non-HDL-C, Apo B, and Lp-PLA2 levels together with a safety profile for AMR101 that appears to be both comparable to placebo and more favorable compared to other triglyceride lowering therapies.. The MARINE study was conducted in a population representative of millions of people with very high triglyceride levels, including more than 3.8 million in the U.S. Amarin believes that AMR101 is positioned to be best-in-class for this indication.

Amarin’s AMR101 Meets Pivotal Phase 3 Study Endpoints

Amarin’s AMR101 Meets Pivotal Phase 3 Study Endpoints with Highly Statistically Significant Reductions in Triglycerides at 4 Gram and 2 Gram Doses in MARINE Trial with No Statistically Significant Increase in LDL-C and Safety Profile Similar to Placebo

• Largest controlled therapeutics trial in patients with very high triglycerides

• Trial conducted in accordance with Special Protocol Assessment with FDA

• NDA submission moved forward to 2011

MYSTIC, Conn., and DUBLIN, Nov. 29, 2010 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101. The MARINE study, investigating AMR101 as a treatment for very high triglycerides (>500 mg/dL), met its primary efficacy endpoints as defined in the clinical trial protocol and demonstrated a positive safety profile. The Company believes that AMR101 has the potential to be the best-in-class product for this indication and that the MARINE study results may support additional patentable claims that could further protect the Company’s rights to this product through 2030.

The study’s primary endpoint, the percent change in triglyceride (TG) levels from baseline to week 12, was met for both the 4 gram and 2 gram dose groups. The MARINE study was required to meet a stringent level of statistical significance of 1% (p < 0.01), as agreed in the Company’s SPA (Special Protocol Assessment) with the FDA. Twenty-five percent of patients were on background statin therapy. The patient group treated with 4 grams of AMR101 showed a significant median TG decrease of 33 % (P < 0.0001) compared to placebo, and the patient group treated with 2 grams of AMR101 showed a significant median TG decrease of 20 % (P = 0.0051) compared to placebo. The median baseline triglyceride levels were 703 mg/dL, 680 mg/dL and 657 mg/dL for the patient groups treated with placebo, 4 grams of AMR101 and 2 grams of AMR101, respectively.

In a pre-specified secondary analysis in the subgroup of patients with baseline TG > 750 mg/dL, representing 39% of all patients, the effect of AMR101 in reducing TG levels was even more pronounced. In this group, the median decrease in TG levels from placebo was 45% for 4 grams and 33% for 2 grams, both statistically significant (P= 0.0001 for 4 grams and P= 0.0016 for 2 grams, respectively). The median baseline TG levels in this subgroup were 1052 mg/dL, 902 mg/dL and 948 mg/dL for placebo, 4 gram and 2 gram groups, respectively. In addition, the subgroup of patients on background statin therapy had much greater median reductions in TG, which were also statistically significant, than those not on statin therapy.

Importantly, AMR101 did not result in an increase in median LDL-C compared to placebo at either dose (-2.3% for the 4 gram group and +5.2% for the 2 gram group [p=NS]). This is the first and only triglyceride-lowering therapy studied in this population with very high triglyceride levels to show a lack of elevation in LDL-C. Furthermore, there was a statistically significant decrease in median non-HDL-C (total cholesterol less “good cholesterol”) compared to placebo with both of the AMR101 treated groups (-18% for the 4 gram group [p < 0.001] and -8% for the 2 gram group [p < 0.05]).

There were also statistically significant reductions in several important lipid markers, including Apo B, Lp-PLA2 (Lipoprotein-phospholipase A2), VLDL-C and Total Cholesterol. These results are particularly encouraging given that no other TG-lowering therapy studies have shown such results. For these achieved endpoints, p-values were <0.01 for most and <0.05 for all. Apo B (Apolipoprotein B) is a sensitive index of residual cardiovascular risk and is generally considered to be a better predictor than LDL-C. Lp-PLA2 is an enzyme found in blood and atherosclerotic plaque; high levels have been implicated in the development and progression of atherosclerosis. Furthermore, AMR101 appeared to be very well tolerated with a safety profile that appears to be both comparable to placebo and more favorable compared to other triglyceride lowering therapies. There were no treatment-related serious adverse events in the MARINE study. The Company will present more details of these results at an upcoming scientific meeting.

Commenting on the results of the study, Harold Bays, M.D., Medical Director, Louisville Metabolic and Atherosclerosis Research Center, and Principal Investigator of the study, said, “The MARINE trial included a study population of patients with very high TG levels (i.e. > 500 mg/dl). In this study, AMR101 reduced TG levels to within the range observed with common approved triglyceride-lowering drugs. Clinicians are aware, and some may have concerns, that common TG-lowering agents may raise LDL-C by 40 – 50% in patients with very high TG levels. In the MARINE trial, AMR101 did not significantly increase LDL-C levels. Another surprise to me was the degree of TG-lowering efficacy in the statin-treated group, which exceeded the TG lowering in the non-statin treated group. It was also reassuring that the safety and tolerability of AMR101 was similar to placebo. Adding these favorable findings to the significant reductions in total cholesterol, non-HDL-C, Apo B, and Lp-PLA2 levels, this suggests that AMR101 may prove to represent an effective, and safe alternative treatment option to improve cardiovascular risk factors in patients with very high triglycerides. In summary, the results of the MARINE trial suggest that AMR101 may prove to represent a “first in class” EPA TG-lowering agent that not only represents a new chemical entity, but a potential novel therapy with favorable lipid efficacy effects that differ from common TG-lowering agents, such as fibrates and previously approved prescription omega-3 drugs. We very much look forward to presenting the full dataset at a scientific meeting.”

Joseph S. Zakrzewski, Executive Chairman and Chief Executive Officer of Amarin, added, “The MARINE study was conducted in a population representative of millions of people with very high triglyceride levels, including more than 3.8 million in the U.S. alone. We believe that these results and the overall profile of AMR101 position the drug candidate to be best in class in this market. Furthermore, the MARINE study results are encouraging, especially the positive outcomes with respect to LDL-C and other lipids, as we await the results of the ongoing ANCHOR study. This separate Phase 3 study is designed to investigate AMR101 in patients with high triglycerides (¬>200 and <500mg/dL) with mixed dyslipidemia treated with statins, a patient population for which no drug in this class is currently approved. While the market for a drug labeled for treatment of triglycerides of >500 mg/dL is already proven to be a billion dollar market, there are ten times the number of patients with triglycerides of >200 and <500 mg/dL.”

Based on the timing and nature of these results, Amarin intends in 2011 to submit a New Drug Application (NDA) seeking approval to market and sell AMR101 in the U.S. Previous Company guidance projected 2012 for the NDA submission. The Company further added that, based on the positive results of the MARINE trial, Amarin has advanced additional patent claims to add to its growing portfolio of U.S. and international intellectual property claims related to AMR101.

Amarin Corporation Appoints Kristine Peterson to Board of Directors

Dublin, Ireland and Mystic, CT, USA, November 18, 2010 – Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced the appointment of Kristine Peterson to its board of directors.  

Ms. Peterson has more than 27 years of pharmaceutical industry experience, including 20 years at Bristol-Myers Squibb, where she was responsible for sales, marketing and general management in a variety of therapeutic areas, including leading the cardiovascular and metabolic disease business unit. She is currently Chief Executive Officer at Valeritas Inc., a medical technology company committed to the development and commercialization of innovative drug delivery solutions, with its lead product for the treatment of diabetes. Prior to joining Valeritas, Ms. Peterson was Chair for the biotech business at Johnson & Johnson, and was Senior Vice President of commercial operations and President at Biovail Corporation.   

“Kristine’s expertise in cardiovascular and metabolic disease, combined with her track record of success in commercializing products, will be invaluable to Amarin as we move our programs and our lead candidate AMR101 forward,” said Joseph S. Zakrzewski, chief executive officer.  

“I am thrilled to join Amarin’s board of directors at this exciting time,” said Ms. Peterson. “I am looking forward to working with the rest of the board and Amarin’s management team as we anticipate the pivotal results from two Phase 3 clinical trials that may position AMR101 as a best-in-class prescription medicine for treating patients with elevated triglycerides.” 

The appointment of Ms. Peterson increases the Company’s board of directors to eight members.  

About AMR101 

AMR101 is primarily comprised of ethyl icosapentate (ethyl-EPA). Significant scientific and clinical evidence supports the efficacy of ethyl-EPA in reducing triglyceride levels. Near the start of 2010, Amarin initiated two Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two distinct patient populations (the ANCHOR and MARINE trials). As separately reported, patient screening has been completed in both trials with top-line results expected for the MARINE trial before the end of 2010 and for the ANCHOR trial in mid-2011.  

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia on statin therapy. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com. 

Investor Contact Information:  

John F. Thero  
President  
In U.S.: +1 (860) 572-4979  
investor.relations@amarincorp.com
 

Lee M. Stern  
The Trout Group  
In U.S.: +1 (646) 378-2922  
lstern@troutgroup.com

Media Contact Information:  

David Schull or Martina Schwarzkopf, Ph.D.  
Russo Partners  
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)  
+1 (347) 591-8785 (mobile)  
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com 

Mark Swallow or David Dible  
Citigate Dewe Rogerson  
In U.K.: +44 (0)207 638 9571  
mark.swallow@citigatedr.co.uk

Amarin Corporation Announces Senior Management Changes

DUBLIN and MYSTIC, Conn., Nov. 10, 2010 - Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that, effective November 10, 2010, Joseph S. Zakrzewski has been appointed Chief Executive Officer. Mr. Zakrzewski has served as the Chairman of the Board of Amarin since January 2010 and will continue to serve in that capacity. 

Mr. Zakrzewski has more than 20 years of industry experience, including significant contributions to Reliant Pharmaceuticals as Chief Operating Officer during the period when Omacor®/Lovaza® was successfully developed, approved, launched, and marketed for reducing very high triglyceride levels, leading to its 2007 acquisition by GlaxoSmithKline. Mr. Zakrzewski, until recently, was Chief Executive Officer of Xcellerex Inc, a private Massachusetts-based biotechnology company. Although Mr. Zakrzewski currently serves on the boards of directors and in other advisory roles for various companies, Amarin is his primary business commitment.

Additionally, John F. Thero has been appointed President of Amarin. Since November 2009, Mr. Thero had been the Company's Chief Financial Officer, a role in which he has been responsible for a significant portion of the Company's operations. Mr. Thero has more than 20 years of senior management experience, including broad responsibilities in finance, business development and commercial operations. Prior to joining Amarin, Mr. Thero was Chief Financial Officer at ViaCell, Inc., where he helped guide the company to its successful sale, and Abiomed, Inc., during its transition from a development-stage company into a commercial entity.

Mr. Colin Stewart, who has been serving as the Company's President and CEO and a director of the Company, resigned effective November 10, 2010 to address personal matters.

In connection with these changes, Mr. Frederick Ahlholm, Vice President Finance, will be the Company's Principal Accounting Officer. Mr. Ahlholm joined Amarin in March 2010 and has approximately 20 years of financial and management experience at public and private companies. He began his professional career at Ernst & Young LLP and is a Certified Public Accountant.

Mr. Zakrzewski commented, "This is a very exciting time at Amarin as we move closer to pivotal results from our MARINE and ANCHOR Phase 3 clinical trials. Our R&D team has done an impressive job in advancing Amarin to this stage and their contributions will continue to be essential as we move forward. I look forward to leading Amarin beyond its current clinical trials, including increased focus on commercial opportunities for AMR101. The promotion of John to President reflects both his strong record of performance and his experience in managing later-stage companies like Amarin."

Mr. Thero commented, "I am honored to assume this broader role in working with the Amarin team to create value with Amarin's technology and resources. With potential best-in-class positioning for AMR101 and key clinical milestones approaching, this is an opportunity for increased visibility for Amarin and a time for continued execution. The Company has made tremendous progress over the past year in executing on its mission. Assuming favorable Phase 3 study results for AMR101, we plan to move aggressively forward to an NDA submission while seeking to exploit every opportunity to maximize the potential commercial value of this promising drug, including potentially through collaboration with one or more larger pharmaceutical companies."

About AMR101

AMR101 is ultra pure ethyl icosapentate (ethyl-EPA). Significant scientific and clinical evidence supports the efficacy of ethyl-EPA in reducing triglyceride levels. Near the start of 2010, Amarin initiated two Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two distinct patient populations (the ANCHOR and MARINE trials). As separately reported, patient screening has been completed in both trials with top line results expected for the MARINE trial before the end of 2010 and for the ANCHOR trial in mid-2011. 

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

Investor Contact Information: 

John F. Thero
President
In U.S.: +1 (860) 572-4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com 

Media Contact Information: 

David Schull or Martina Schwarzkopf, Ph.D. 
Russo Partners
In U.S.: +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile) 
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com

Mark Swallow or David Dible
Citigate Dewe Rogerson
In U.K.: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

Amarin Reports Third Quarter 2010 Financial Results and Positively Updates Phase 3 Guidance

-Phase 3 milestones moved ahead into 2010 for report of top line results of MARINE trial and completion of ANCHOR trial randomization-

DUBLIN, Ireland and MYSTIC, Conn., Nov. 10, 2010 -Amarin Corporation plc (Nasdaq: AMRN), a clinical-stage biopharmaceutical company focused on cardiovascular disease, today reported its financial and operational results for the three-month period ended September 30, 2010. In addition, the Company provided an update regarding its MARINE and ANCHOR trials, the two on-going Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels, including a positive update regarding the timing of key future milestones for these trials. In summary:

• MARINE trial top-line results are now expected before the end of 2010
• ANCHOR trial patient screening is complete and randomization is now expected to be complete by the end of 2010 with top-line results expected in mid-2011
• The above revised guidance is months ahead of previous guidance for both trials
• Financial resources remain sufficient to complete both Phase 3 clinical trials and submit the NDA for AMR101

The MARINE and ANCHOR trials are pivotal Phase 3 studies designed to evaluate the efficacy and safety of AMR101 in two separate populations of patients with elevated triglyceride levels. According to current treatment guidelines established by NCEP ATPIII, patients with these levels of triglyceride elevation should be treated with triglyceride lowering therapy.

Q3 Financial Update

Amarin's cash balance as of September 30, 2010 was approximately $31.4 million. During the three months ended September 30, 2010, net cash outflows were approximately $6.2 million, including approximately $5.5 million paid in connection with the Company's two ongoing Phase 3 clinical trials.

The Company's net cash outflows during the quarter were partially offset by approximately $2.0 million in net proceeds received from the exercise of warrants. These warrant exercises, at exercise prices from $1.00 to $1.50 per share, resulted in the issuance of 1.5 million new shares during the quarter ended September 30, 2010.

As of September 30, 2010, the Company had 101.3 million shares outstanding, 38.7 million warrants outstanding at an average exercise price of $1.77 and 12.3 million stock options outstanding at an average exercise price of $2.47.

The Company expects that its current financial resources are sufficient to finance its planned operations through the filing of the NDA pending positive clinical results. 

Clinical Trial Update

Amarin's two ongoing Phase 3 clinical trials (MARINE and ANCHOR) were initiated near the beginning of 2010 to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations. As reported on August 10, 2010, randomization to dosing has been completed in the MARINE trial. Amarin now expects to report top-line results from the MARINE trial before the end of 2010, ahead of previously stated guidance of such report in early 2011.

In addition, at the date of this release, Amarin has screened all of the patients needed to complete the ANCHOR trial and, accordingly, has ceased screening additional patients. Most of the patients screened have been randomized to dosing cohorts of 2 grams, 4 grams or placebo of AMR101. Additional patients have been screened and are currently progressing through the six-to-eight week run-in period prior to randomization. Amarin now anticipates that it will complete randomization of the 650 patients targeted for the ANCHOR trial before the end of 2010, ahead of previously stated guidance of completing randomization in 2011. The company now expects to report top-line results from the ANCHOR trial in mid-2011.

"With less than two months remaining before we expect to learn the results of the MARINE trial, it is a very exciting time at Amarin," commented Joseph Zakrzewski, Chairman and Chief Executive Officer. "This can be attributed to the tremendous progress made by our Clinical Development and Operations group as well as the outstanding clinical investigators involved in both the ANCHOR and MARINE studies." 

SEC Filing Status

Amarin Corporation plc is currently a foreign private issuer for U.S. Securities and Exchange Commission (SEC) reporting purposes. In accordance with SEC rules applicable to foreign private issuers, Amarin currently reports its financial results in accordance with International Financial Reporting Standards. Effective January 1, 2011, Amarin will no longer be a foreign private issuer and for SEC purposes will report its financial results in accordance with generally accepted accounting principles in the United States (US GAAP). 

About AMR101 Phase 3 Clinical Trials

The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dL. 

Patients in this trial are characterized as having very high triglyceride levels as per NCEP ATPIII guidelines. Patient randomization in this trial has been completed at 229 patients. The single primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period. Results from the extension period are not required for regulatory approval. The Principal Investigator of the MARINE Study is Harold Bays , M.D., Medical Director Louisville Metabolic and Atherosclerosis Research Center, Kentucky.

The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy. Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders). The trial aims to randomize approximately 650 patients into the study. The primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. This study will also evaluate whether AMR101 is devoid of the LDL-C elevating effects commonly seen in patients with mixed dyslipidemia on statin therapy who take concomitant prescription omega-3 therapies. The Principal Investigator of the ANCHOR study is Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, Texas. No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.

In both the MARINE and ANCHOR trials, all patients undergo a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization, prior to randomization into the 12-week double-blind treatment period. Both the MARINE and ANCHOR trials received Special Protocol Assessment (SPA) agreements in 2009 from the U.S. Food and Drug Administration (FDA). Because the trials address separate and important patient populations the results from one trial may not be indicative of the results of the other trial. 

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company's lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

Contacts:

Investor Contact Information: 

John F. Thero
President
In U.S.: +1 (860) 572-4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S.: +1 (646) 378-2922
lstern@troutgroup.com

Media Contact Information: 

David Schull or Martina Schwarzkopf, Ph.D.
Russo Partners
In U.S. +1 (212) 845-4271 or +1 (212) 845-4292 (office)
+1 (347) 591-8785 (mobile) 
david.schull@russopartnersllc.com
martina.schwarzkopf@russopartnersllc.com

Mark Swallow or David Dible
Citigate Dewe Rogerson
In U.K.: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

Amarin Corporation Appoints Colin W. Stewart as President and Chief Executive Officer

Dublin, Ireland and Mystic, Connecticut, USA, August 17, 2010 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that Colin W. Stewart has been appointed President, Chief Executive Officer (CEO) and a member of the Company’s Board of Directors effective August 16, 2010. Mr. Stewart will be responsible for driving forward the Company’s strategy to maximize the value of its lead product, AMR101, a new drug being studied in Phase 3 clinical trials for the treatment of high triglycerides. The Company announced last week that one of its Phase 3 trials, the MARINE trial, completed patient enrollment and randomization earlier than expected with top-line results now expected in early 2011.

Mr. Stewart has more than 30 years of experience in executive management and commercial positions for pharmaceutical companies, including five years as President and CEO of CollaGenex Pharmaceuticals, Inc. where he was responsible for the company’s growth leading to its successful sale in 2008.

In addition, Mr. Stewart served ten years with the ASTA Medica Group, where he managed several business units in the United States and internationally. He began his career in sales and marketing for Winthrop Laboratories, Ltd. in the United Kingdom, and subsequently held a number of positions of increasing responsibility within the Sterling-Winthrop Group.

Dr. Declan Doogan, who has been serving as the Company’s Interim CEO, will continue to support the Company as Chief Medical Officer providing Amarin access to the majority of his time.

Amarin’s Chairman of the Board, Joseph Zakrzewski, commented, “We are very excited by the addition of Colin Stewart to the Amarin team. He brings a wealth of commercial and executive management experience, which complements the already strong technical and financial functions within the Company. Colin is expected to play a key role as we weigh our various alternatives for commercialization of AMR101.” Mr. Zakrzewski went on to state that, “Declan Doogan deserves many thanks for his contributions as Interim CEO and we look forward to his continued contributions.”

Mr. Stewart added, “I am very impressed by the progress Amarin has made since being restructured and recapitalized late last year. This progress is a tremendous credit to the whole team at Amarin with which I really look forward to working. With Phase 3 studies of AMR101 for two indications advancing well and scheduled to report in 2011, we will continue to explore every opportunity to maximize the potential commercial value of this promising drug, including potentially through one or more collaborations with larger pharmaceutical companies.”

About AMR101

AMR101 is ultra pure ethyl icosapentate (ethyl-EPA). Significant scientific and clinical evidence supports the efficacy of ethyl-EPA in reducing triglyceride levels. Near the start of 2010, Amarin initiated two Phase 3 clinical trials to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations (the ANCHOR and MARINE trials). As separately reported, patient enrollment and randomization to dosing (2 grams, 4 grams and placebo) has been completed in the MARINE trial

and is over half completed in the ANCHOR trial. Amarin expects to report preliminary top-line results from both trials in 2011 with results from the MARINE trial expected in the beginning of 2011.

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused on the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia on statin therapy. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

Investor Contact Information:

John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S. +1 (646) 378-2922
lstern@troutgroup.com

International Media Contact Information:

Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

AMARIN REPORTS Q2 2010 RESULTS -MARINE trial results due early 2011; ANCHOR trial >50% randomized - Conference call today

Dublin, Ireland and Mystic, CT, USA, August 10, 2010 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reports a financial update as of June 30, 2010.  In addition, the Company provides a progress update of its MARINE and ANCHOR trials, the two on-going Phase 3 clinical trials of its lead product candidate AMR101 for treating elevated triglyceride levels.

• MARINE trial patient randomization completed with top-line results expected in early 2011
• ANCHOR trial patient randomization now >50% complete with top line results expected in  2011
• Financial resources sufficient to complete both Phase 3 clinical trials and submit an NDA for AMR101

Q1 Financial Update

Amarin’s cash balance as of June 30, 2010 was approximately $37.6 million.  The Company expects that its current financial resources are sufficient to cover planned operations through completion of the ongoing ANCHOR and MARINE Phase 3 clinical trials, the reporting of results from these trials and, assuming clinical trial success, the submission of an NDA.

During the three months ended June 30, 2010, net cash outflows were approximately $6.8 million, including approximately $5.3 million paid in connection with the Company’s two Phase 3 clinical trials.

The Company’s cash outflows during the quarter were partially offset by approximately $1.5 million in net proceeds received from the exercise of warrants. The warrants were exercised by three investors.  The warrant exercises, at exercise prices from $1.00 to $1.50 per share, resulted in the issuance of 1,044,937 new shares during the quarter ended June 30, 2010.

Clinical Trial Update

Around the beginning of 2010, Amarin initiated two Phase 3 clinical trials (MARINE and ANCHOR) to investigate the efficacy of AMR101 in reducing elevated triglyceride levels in two patient populations. As separately reported, patient enrollment and randomization to dosing (2 grams, 4 grams and placebo) has been completed in the MARINE trial.  Amarin expects to report preliminary top-line results from the MARINE trial early in 2011, towards the early part of the range of guidance provided previously.

As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial have been enrolled and randomized to dosing.  Consistent with previous guidance, the Company anticipates completing enrollment and randomization of ANCHOR in 2011and also anticipates reporting top-line results from the ANCHOR trial in 2011.

“We are excited to be within approximately six months of being able to review and report the results of the MARINE study.  The progress that we have made in both pivotal trials is very encouraging. Being positioned to report results in 2011 for these trials is earlier than we initially expected. This acceleration is a tribute to the commitment, experience and enthusiasm of our employees, clinical investigators and CRO,” commented Dr. Declan Doogan, Interim Chief Executive Officer of Amarin Corporation.

Conference Call and Webcast Information

Amarin will host a conference call today, August 10, 2010 at 4:00 pm UTC/GMT + 1 hour (11:00 am Eastern Time).   To participate in the call, please dial (201) 689-8565 from outside the U.S. and (877) 407-0778 within the U.S.   For both dial in numbers please use account number is 286 and conference id 350729. The conference call can also be heard live via the investor relations section of the Company's website at www.amarincorp.com.

A replay of the call will be available via the Company's website.

About AMR101 Phase 3 Clinical Trials

The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dL.  Patients in this trial are characterized as having very high triglyceride levels.  Patient enrolment and randomization in this trial has been completed at 229 patients, which the Company expects will be sufficient to demonstrate statistical significance in accordance with the trial protocol. The primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment.  Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period.  Results from the extension period are not required for regulatory approval.  The Principal Investigator of the MARINE Study is Harold Bays, M.D., Medical Director Louisville Metabolic and Atherosclerosis Research Center, Kentucky.

The ANCHOR trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels between 200 mg/dL and 500 mg/dL who are on statin therapy.  Patients in this trial are characterized as having high triglyceride levels with mixed dyslipidemia (two or more lipid disorders).  The trial aims to recruit approximately 650 patients into the study. The primary endpoint in the trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment.    The Principal Investigator of the ANCHOR study is Christie M. Ballantyne, M.D., Methodist DeBakey Heart and Vascular Center, Houston, Texas.  No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for treating high triglyceride levels in statin-treated patients who have mixed dyslipidemia.

In both the MARINE and ANCHOR trials, all patients undergo a six-to-eight week washout period of lipid altering drugs, as well as diet and lifestyle stabilization, prior to randomization into the 12-week double-blind treatment period.  Both the MARINE and ANCHOR trials received Special Protocol Assessment (SPA) agreements in 2009 from the U.S. Food and Drug Administration (FDA).

The Company expects to file an NDA for AMR101 in 2012.  The Company expects that its current financial resources are sufficient to finance its planned operations through the filing of this NDA for AMR101 seeking approval for the indication being studied in the MARINE trial while also seeking reference in the label to treatment of high triglyceride levels in statin-treated patients who have mixed dyslipidemia as studied in the ANCHOR trial. The Company expects that its current financial resources are sufficient to cover planned operations through the filing of an NDA for this indication.

In order to potentially obtain a broader indication for AMR101 based on the ANCHOR trial results, the Company’s SPA for the ANCHOR trial requires that the Company has a cardiovascular Outcomes study substantially underway at the time of the NDA filing.  If the Company elects to seek this separate indication in its initial NDA filing and commence an Outcomes study, the Company will need to seek additional financing, through a commercial partner or otherwise, to finance the study.  Importantly, the results of an Outcomes study are not required for FDA approval of this broader indication for AMR101. In addition, an outcome study is not required by the SPA covering the indication being studied in the MARINE trial.

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials are conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

Contacts:

Investor Contact Information:

John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S. +1 (646) 378-2922
lstern@troutgroup.com

International Media Contact Information:

Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk

Amarin’s Amr101 Pivotal Phase 3 Marine Clinical Trial Completes Patient Enrollment And Randomization - Trial Guidance Positively Updated

Dublin, Ireland and Mystic, CT, USA, August 10, 2010 – Amarin Corporation plc (NASDAQ: AMRN), a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today announced that its MARINE trial, a Phase 3 clinical trial of AMR101, has completed patient enrollment and randomization into the treatment phase of this trial. The Company indicated that top line results from this trial are expected early in 2011, towards the early part of the range of guidance provided previously.

The MARINE trial is a multi-center, placebo-controlled, randomized, double-blind, 12-week pivotal study to evaluate the efficacy and safety of 2 grams and 4 grams of AMR101 in patients with fasting triglyceride levels greater than or equal to 500 mg/dl.  Patients in this trial are characterized as having very high triglyceride levels according to the National Cholesterol Education Program Adult Treatment Panel III treatment guidelines.  The primary endpoint in the MARINE trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. Consistent with the protocol for this trial, the Company expects that the 229 patients randomized in this study will be sufficient to achieve statistical significance. The MARINE study is the largest controlled therapeutic trial ever conducted in this population.

As of the date of this release, over half of the 650 patients currently targeted for the ANCHOR trial, a separate on-going Phase 3 trial for AMR101, have been enrolled and randomized to dosing. Consistent with previous guidance, the Company anticipates completing patient enrolment and randomization for ANCHOR in 2011 and reporting top-line results from the ANCHOR trial in 2011. This trial is designed to evaluate the safety and efficacy of 2 grams and 4 grams of AMR101 in patients with high triglyceride levels (between 200 mg/dl and 500 mg/dl) who are also on statin therapy for elevated LDL cholesterol levels. No prescription omega-3 based drug, such as AMR101, is currently approved in the U.S. for this indication.

Dr. Declan Doogan, Amarin’s Interim CEO, said: “We are extremely pleased that the MARINE study has been able to complete recruitment faster than we initially expected and we very much look forward to reviewing and reporting the results of this trial early in 2011.” He added, “Elevated triglyceride levels are increasingly being recognized and treated as an independent modifiable risk factor for cardiovascular disease in much the same way as elevated LDL cholesterol levels were more than a decade ago. We believe that AMR101 represents an improved treatment alternative for patients with higher than normal triglyceride levels.”

About Amarin

Amarin Corporation plc is a clinical-stage biopharmaceutical company with expertise in lipid science focused the treatment of cardiovascular disease. The Company’s lead product candidate is AMR101 (ethyl icosapentate), which is presently being investigated in two Phase 3 clinical trials, one for the treatment of patients with very high triglyceride levels and the other for the treatment of patients with high triglycerides with mixed dyslipidemia. Both of these Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA). Amarin also has next-generation lipid candidates under evaluation for preclinical development. For more information please visit www.amarincorp.com.

Contacts:

Investor Contact Information:

John F. Thero
Chief Financial Officer
In US: +1 (860) 572 4979
investor.relations@amarincorp.com

Lee M. Stern
The Trout Group
In U.S. +1 (646) 378-2922
lstern@troutgroup.com

International Media Contact Information:

Mark Swallow or David Dible
Citigate Dewe Rogerson
In UK: +44 (0)207 638 9571
mark.swallow@citigatedr.co.uk