Ireland’s Genable Technologies Completes €5M Series B Financing

DUBLIN, Ireland, 11th November, 2011 - Genable Technologies (Dublin, Ireland), today announced that is has successfully completed a new financing round for €5m led by new investors Fountain Healthcare Partners alongside existing investors Delta Partners.  This funding will support the on-going development of Genable’s suppression/replacement gene therapy technology and specifically progress Genable’s lead product GT038 for Retinitis Pigmentosa (RP) forward into clinical evaluation in man.

Patients with rhodopsin-linked Retinitis Pigmentosa have a mutation in the rhodopsin gene, which causes a patient’s sight to worsen over time, eventually leading to blindness.  There are currently no available therapies for Retinitis Pigmentosa.  GT038 is a pioneering and unique therapy to treat rhodopsin-linked Retinitis Pigmentosa that utilizes AAV vectors to obtain expression of RNA interference molecules, which suppress the expression of the faulty gene, and replaces this with a gene encoding a functioning protein. This simple combination represents a new paradigm in medicine with the potential to cure this debilitating disease and not just treat the symptoms. Genable Technologies Ltd, was granted orphan drug designation for GT038 by the European Medicines Agency in December 2010.

Commenting on the new funding Dr. Ena Prosser, Partner at Fountain Healthcare Partners said, “This renowned Trinity College-based team, along with the dedication and support of Irish families who carry genes which can lead to inheritable blindness, has pioneered research into this disease over several years. We believe that GT038 offers a significant technological breakthrough to address Retinitis Pigmentosa and we look forward to working closely with the Company to accelerate the development of GT038 and other products to the market.”

Genable Chairman Dr. Geoffrey Vernon commented, “We would like to welcome Fountain Healthcare Partners as an investor with extensive industry expertise onto the Board. We would also like to take the opportunity to thank Delta Partners, Fighting Blindness Ireland, Foundation Fighting Blindness-National Neurovision Research Institute (USA) and Enterprise Ireland for the support they have provided Genable to date and their on-going commitment to the Company and its development of novel therapies for serious ophthalmic diseases.”

Professor Jane Farrar of Trinity College Dublin and co-Founder of Genable Technologies Limited concluded, “We are extremely pleased to see GT038 raise the necessary finance to translate basic research performed at TCD into the clinic.  It will help raise awareness of Retinitis Pigmentosa as a serious disease and ultimately help more patients receive therapy for their disease”.

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."

Civitas Therapeutics Secures $5M in Financing - Accelerating Parkinson’s disease program

Chelsea, MA - July 12, 2011 – Civitas Therapeutics, Inc., a privately held biopharmaceutical company focused on developing transformative pulmonary delivery therapies, announced today that it has secured $5 million of financing from Fountain Healthcare Partners. This additional capital will be primarily used to accelerate Civitas’ lead therapeutic program for Parkinson’s disease as well as to begin advancing additional drug development programs.

“We are excited to add Fountain Healthcare Partners as an investor with their extensive drug delivery technology experience and global industry expertise,” said Glenn Batchelder, Chief Executive Officer of Civitas. “The additional capital will allow us to more rapidly advance this important therapy for Parkinson’s patients.”

“We believe Civitas’ validated and highly differentiated pulmonary delivery technology represents a unique platform to develop transformative therapies for a number of unmet medical needs, currently un- addressable with existing platforms. The company’s initial Parkinson’s program is a prime example of this potential.” said Aidan King, Founding and Managing Partner of Fountain Healthcare. “The remarkable progress made by the company in its initial six months of operation is testament to the quality of the Civitas team and augers well for their ability to deliver these products to the market place.”

Aidan King will join Glenn Batchelder, David Hirsch of Longitude Capital, Blair Jackson of Alkermes, and Tim Shannon of Canaan Partners on the Board of Directors for Civitas.

About Civitas Therapeutics

Civitas is a privately held pharmaceutical company focused on developing products with a clinically proven dry powder pulmonary delivery platform. The proprietary dry powder and device combination is unique in its ability to deliver a large, precise dose independent of inspiratory flow rate from a simple, passive device. The technology has successfully delivered more than one million doses to patients and the manufacturing technology has been scaled to accommodate a significant commercial launch. The lead program is for Parkinson’s disease with clinical proof of concept anticipated to be complete in 2012. Additional programs encompass pulmonary disease, allergy, and pain.

Civitas licensed and purchased the technology and assets from Alkermes which includes a large IP estate, a set of development stage pipeline assets, the specialized pulmonary equipment and the commercial scale GMP manufacturing facility. Civitas’ investors are Canaan Partners, Fountain Healthcare Partners, Longitude Capital, and Alkermes.

For additional information contact:

Stephanie Gillis
sgillis@civitastherapeutics.com

Website
http://www.civitastherapeutics.com

Opsona Therapeutics announces initiation of a Phase 1 clinical trial with its lead drug

DUBLIN, Ireland -- Opsona Therapeutics, a biotechnology company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases today announced that it has initiated a phase 1 clinical trial in healthy volunteers with its lead drug candidate OPN-305. This is a first-in-human study with OPN-305.

OPN-305 is a humanised IgG4 monoclonal antibody (MAb) against Toll-Like Receptor 2 (TLR2), a target within the innate immune system, and is under development as a treatment for the prevention of Delayed Graft Function (DGF) following renal transplantation, in addition to other therapeutic indications.

Opsona has identified the prevention of Delayed Graft Function (DGF) following renal transplantation as its likely first target clinical indication for the development of OPN-305. Delayed Graft Function is a serious complication that can increase the risk of organ rejection in the immediate post-operative period of kidney transplants. Opsona believes that OPN-305 has the potential to provide a novel treatment option for a much wider variety of human diseases, including acute kidney injury, cancer, cardiovascular disease and others. Commenting on today's announcement, Mary Reilly VP Pharmaceutical Development and Operations of Opsona Therapeutics said, "We are very excited to enter the clinic with this drug candidate having managed its progression over the past few years through the development cycle."

Also commenting on today's announcement, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman of Opsona Therapeutics said," OPN-305 is a first-in-class antibody against Toll-like- Receptor 2, one of the most promising novel drug targets in the innate immune system. TLR-2 has been linked to an increasing number of major human diseases, including autoimmune diseases, renal ischemia, myocardial infarction, stroke and cancer. This phase 1 study will provide the basis to explore the broad medical and commercial viability and opportunity of OPN- 305 in a variety of indications with unmet medical needs."

The phase 1 study is a single centre, prospective, randomised, double blind, placebo-controlled, sequential, dose escalating phase I study to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of intraveneously infused single doses of OPN-305 in healthy subjects.

Opsona was recently awarded €5.9 million from the European Commission to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) to advance this clinical trial. Following successful completion of the phase 1 trial, the Company plans to conduct a prospective randomized placebo-controlled phase 2 trials in the prevention of DGF to be initiated in 2012.

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

Dr. Leon Hooftman Appointed Chief Medical Officer As Opsona Therapeutics Transitions Into The Clinic

-    Prof. Luke O’Neill extends role to become Chief Scientific Officer

-    Ms. Mary Reilly assumes broader role as VP Pharmaceutical Development and Operations

06 May, 2011 – DUBLIN, Ireland - Opsona Therapeutics, a drug development company focused on novel therapeutic and preventative approaches to autoimmune and inflammatory diseases, today announced that Leon Hooftman, M.D., has joined the company as Chief Medical Officer, with responsibility for leading the company’s clinical development initiatives.  Dr. Hooftman who will be based at Opsona Therapeutics’ headquarters in Dublin will be a member of the company’s Executive Management Team.

Commenting on Dr. Hooftman’s 18 years of experience in the industry, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman said, “During his successful career Dr. Hooftman has provided extensive clinical development leadership in a variety of therapeutic areas including transplantation and oncology, designing and overseeing numerous multi-center clinical trials.  His credibility and experience as a leading clinical scientist will be invaluable as we move OPN-305, our first-in-class monoclonal antibody against Toll-like-Receptor-2 into clinical development this year.”

Leon Hooftman, M.D., joins Opsona Therapeutics following a high-profile career in clinical development where he was most recently Chief Medical Officer at Chroma Therapeutics (UK).  Previously, Leon was Head of Clinical Development at Celltech (U.K.); Director of Clinical Science for Oncology and Immunology and prior to that International Medical Manager in Immunology at Hoffmann La-Roche.  Dr. Hooftman also served as the Senior Clinical Research Physician at Syntex, U.K.

Dr. Hooftman obtained his medical degree at University of Utrecht (Netherlands) and underwent specialist training in transplantation surgery at Addenbrooke’s Hospital in Cambridge, U.K.

To further strengthen the Executive Management team, one of the Company’s founding scientists and Directors, Professor Luke O’Neill, a world-renowned leader in innate immunity and Professor at Trinity College in Dublin will assume the additional role of Chief Scientific Officer at Opsona.  

Opsona’s VP of Pharmaceutical Development, Ms Mary Reilly, will assume a broader role within the company as Vice President of Pharmaceutical Development and Operations.  Together with the Company’s CFO David Hurley, Dr. Hooftman, Prof. O’Neill and Ms. Reilly will constitute the Company’s Executive Management Team, reporting to Dr. Bernd Seizinger.

Opsona Therapeutics Executive Chairman, Dr. Bernd Seizinger, went on to say, “as Opsona looks forward to an exciting new chapter in its corporate evolution, we have aligned a highly experienced team of senior professionals who will help us to further solidify our position as an international leader in the development of a new generation of therapeutics targeting the innate immune system.” 

For further information: Niamh Lyons for Opsona Therapeutics - +353 1 6633602

European Commission Awards Eur 5.9m To Opsona Therapeutics For Clinical Development Of Lead Drug Candidate Opn-305

-    Trans-European Consortium to start clinical development of OPN-305this year

-    Clinical trials to target solid organ transplantation

06 May,  2011-- DUBLIN, Ireland -- Opsona Therapeutics, a drug development company focused on novel therapeutic approaches to treat autoimmune and inflammatory diseases today announced that it has been awarded€5.9 million from the European Commission to lead a European framework 7 (FP7) consortium of research and clinical groups (termed MABSOT*) in the advancement of clinical trials for its lead drug candidate OPN-305 in solid organ transplantation.  A phase 1 trial in healthy volunteers is due to start this summer. 

Commenting on today’s announcement, Bernd R. Seizinger, M.D., Ph.D., Executive Chairman of Opsona Therapeutics said, “We are very excited to have the opportunity to coordinate this important trans-European consortium.  Improvement of graft function, specifically in renal transplantation, continues to be an area of unmet medical need, requiring truly innovative therapeutic approaches such as OPN-305.”

The specific focus of the Consortium will be the development of OPN-305 as a therapeutic agent for the prevention of Delayed Graft Function (DGF), a serious complication of the immediate postoperative period in renal transplantation.  OPN-305 is a monoclonal antibody inhibitor of Toll-like-receptor-2 (TLR-2). Data generated by Opsona, its collaborators and independent scientists has provided solid scientific evidence for a link between TLR-2 and DGF. The consequences of DGF can be prolonged hospitalisation of patients, additional invasive procedures and transplant rejection.   There is currently no specific therapeutic treatment for DGF.  Following successful completion of the Phase 1 trial this year, the consortium plans to conduct a prospective randomized placebo-controlled Phase 2 trial in the prevention of DGF to be initiated in 2012. 

Dr. Seizinger went on to comment on the broader potential of OPN-305, “Since OPN-305 targets TLR-2, a key component of innate immunity, this first-in-class antibody against TLR-2 may have even greater medical and commercial potential for the novel treatment of a broad range of human diseases including cancer and cardiovascular disease.”

The Monoclonal Antibody Solid Organ Transplantation (MABSOT)* consortium which has been partially funded by the European Commission Seventh Framework Program (FP7) consists ofKings College London (UK),  Katholieke Universiteit Leuven (Belgium),  Fundacio Privada Institut D'Investigacio Biomedica De Bellvitge (Spain), Academisch Ziekenhuis Groningen (Netherlands), Institut Klinické a Experimentální Medicin(Czech Republic), University of Newcastle Upon Tyne (UK), Euram Ltd (UK) and Almac Diagnostics Ltd (UK), together with Opsona Therapeutics Ltd. (Ireland).

“We are proud, particularly as a Small/Medium Enterprise, to lead and coordinate this important collaborative effort which brings together many outstanding scientists, transplant surgeons and medical opinion leaders in the field of immunology and transplantation from across Europe” said Mary Reilly, VP Pharmaceutical Development and Operations, and MABSOT coordinator with the European Commission. 

Further information on the objectives of the MABSOT consortium can be found on the projects website, www.mabsot.eu.

For further information: Niamh Lyons for Opsona Therapeutics - +353 1 6633602

Opsona Therapeutics Appoints Chairman Dr. Bernd R. Seizinger As Executive Chairman; Dr. Mark Heffernan Resigns As Ceo But Remains As Non-Executive Director

06 May, 2011 – DUBLIN, Ireland - Opsona Therapeutics, a drug development company focused on novel therapeutic approaches to target autoimmune and inflammatory diseases today announced that its Board of Directors has appointed Chairman Bernd Seizinger M.D., Ph.D., as Executive Chairman, following the resignation of founding CEO Mark Heffernan, Ph.D.  Dr. Heffernan who has stepped down for personal reasons to return to Australia is joining Opsona’s Board of Directors as a Non-Executive Director of the Board. 

A CEO search committee has been formed.  The committee is led by Dr. Seizinger who also has assumed additional oversight responsibilities of the Company’s operations during this period of transition.

Speaking about Dr. Heffernan’s departure, Dr Seizinger said, “As our founding CEO, Mark, in his seven years with the company has established Opsona as one of Europe’s leading early-stage biotech companies. He successfully managed the company through a number of fundraisings, built collaborations and partnerships with some of the best in the business and ultimately led the company to the door of clinical development.  As we move into our next stage of corporate evolution we are happy that Mark will maintain his association with Opsona as a Non-Executive Director.”

"Opsona has gained considerable product and financial momentum and is evolving into a clinical development company capable of translating key scientific discoveries on the innate immune system into novel therapeutics.   Our roadmap for the year includes moving into Phase I clinical trials with our first-in-class antibody OPN-305 targeting Toll-like-receptor 2 (TLR2).  TLR2 has

been associated with a variety of human diseases including complications in solid organ transplantation, cancer, cardiovascular disease, as well asautoimmune-  and inflammatory diseases.  This is a pivotal and exciting time for the Company," continuedDr. Seizinger.

For more information – Niamh Lyons for Opsona Therapeutics - +353 1 6633602

About Opsona Therapeutics

Opsona is a drug development company, focused on novel therapeutic approaches to key targets of the innate immune systemassociated with a wide range of major human diseases, including autoimmune and inflammatory diseases, transplant rejection, cancer, diabetes, Alzheimer’s disease and atherosclerosis. The company was founded in 2004 by three world-renowned immunologists at Trinity College in Dublin.  Opsona has two lead programs that modulate the innate immune system, including biologics and small molecules.  Opsona’s lead product, a fully humanized monoclonal antibody (OPN-305) against Toll-like-receptor-2 (TLR-2) has demonstratedactivityin a number of animal models and will start clinical trials in 2011 Opsona has also signed significant partnering and collaborative deals, with Pharmaceutical companiessuch asPfizer (USA). Headquartered in Dublin, Opsona most recently completed a €21.3m financing round with an international investor consortium including: Inventages Venture Capital, Novartis Venture Fund,  Roche Venture Fund, Seroba-Kernel Life Sciences, Fountain Healthcare Partnersand Enterprise Ireland.  www.opsona.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.

Cappella Medical Systems Announces First Placements of its New Dual Marker Sideguard® System

GALWAY, Ireland--(BUSINESS WIRE)--Cappella Medical Systems has announced the successful initial placements of its new dual-marker Sideguard® coronary sidebranch stent system by Dr. Antonio Colombo and Dr. Azeem Latib at San Raffaele Hospital in Milan, Italy.

“The additional reference marker is a nice addition to the Sideguard system. The angiographic view that produces the least amount of foreshortening between the two reference markers is helpful and ensures proper placement of the Sideguard system.”

The Cappella Sideguard system is a self-expanding trumpet shaped nitinol stent designed to optimize treatment of bifurcation lesions. The novel, low-profile balloon-catheter delivery system includes proprietary split-sheath technology that helps ensure precise placement. Now, with the introduction of the new dual-marker system, clinicians will have an additional reference point to help visualize the position of the Sideguard system under angiography prior to deployment.

Commenting on the new dual marker Sideguard placement, Dr. Azeem Latib stated, “The additional reference marker is a nice addition to the Sideguard system. The angiographic view that produces the least amount of foreshortening between the two reference markers is helpful and ensures proper placement of the Sideguard system.”

The new Sideguard system with dual reference markers is CE mark approved and available for sale outside of the US. For additional information please visit www.cappella-med.com.

About Cappella Medical Systems

Cappella, Inc. develops novel solutions for the treatment of complex coronary artery disease (CAD) - specifically bifurcation disease. Cappella’s Sideguard® coronary sidebranch technology offers interventional cardiologists a straightforward, effective, solution that focuses on treating the sidebranch of diseased coronary arteries first, rather than the main vessel. Clinicians can then use their preferred stent of choice in the main vessel. The Sideguard delivery system features an innovative split-sheath, balloon released, technology that ensures precise placement on the ostial borderline. The Sideguard self-expanding, nitinol, stent promotes continuous wall apposition and positive remodeling and its’ unique trumpet-shaped design conforms to varying characteristics of the sidebranch ostium. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com.

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.

Cappella Medical Systems Wins Top Medical Technology Industry Awards

GALWAY, Ireland--(BUSINESS WIRE)--Cappella Medical Systems has received two prestigious medical device awards for 2010. It was honored with the prestigious Medical Technology Company of the Year 2010 award at the fourth annual Medical Technology Industry Excellence Awards, jointly hosted by Enterprise Ireland, IDA Ireland and the Irish Medical Devices Association (IMDA). The IMDA represents over 140 medical devices companies that reside within Ireland. Cappella Medical also won the overall Emerging Company of the Year 2010 award.

Established in Galway in May 2005 and now employing more than 30 staff, Cappella Medical won both awards for creating an innovative solution for the treatment of complex coronary artery disease. Cappella’s Sideguard® is a next-generation, self-expanding ostial protection stent with unique delivery system which offers cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries. The CEO of Cappella Medical Systems, Dr. Art Rosenthal, stated, “These awards are confirmation of the unique benefits of our technology. The proprietary Sideguard® balloon activated split-sheath design overcomes the historical problem of implanting self expanding stents. The cardiologist only needs to activate the balloon in customary fashion resulting in quick and precise deployment of the Sideguard® stent. The combined innovations of the Sideguard® delivery catheter and stent design redefine the use of self expanding nitinol stents for cardiology.”

Commenting on the awards, Cappella VP of Engineering, Clinical and Regulatory Affairs, Michael Gilmore said: "I am delighted and honored to accept this award on behalf of the Cappella team. The design and testing of a medical stent is a complex process and I commend each member of the team that brought Sideguard from concept to reality. This award is a wonderful recognition of our work as we look to applying the technology we have created in the development of Sideguard to additional stents for the treatment of coronary artery disease."

The IMDA director Sharon Higgins said: "Despite the current economic climate, we are very much witnessing the fruits of Ireland’s strong and dynamic national innovation strategy. As a young innovative company, Cappella is making an outstanding contribution towards establishing Ireland as ‘Innovation Ireland’ and is a perfect example of how we can retain and grow our position as a world leader in the medical technology sector. It is our pleasure to pay tribute to this up-and-coming medical devices company, and we also warmly commend the other very worthy finalists who each play a vital role in ensuring that Ireland continues to compete on the world stage."

About Cappella Medical Systems

Cappella, Inc. is a medical device company, developing novel solutions for the treatment of complex Coronary Artery Disease (CAD) and specifically bifurcation vascular disease. Cappella’s initial product, the Sideguard® Coronary Sidebranch Stent & Delivery System offers interventional cardiologists a straightforward, effective solution that focuses on treating the sidebranch of diseased coronary arteries first, rather than the main vessel. It allows the clinician’s preferred stent of choice to then be placed in the main vessel. The Sideguard® system combines a proprietary split-sheath technology delivery system that ensures precise placement with a unique trumpet-shape self expanding nitinol design that protects the ostium and promotes continuous wall apposition and positive remodeling. In addition, a new second radio-opaque marker has been added to the catheter as a reference point when visualizing under angiography to help facilitate proper positioning on the ostial borderline. Cappella Medical Devices Ltd., Galway, Ireland is the R&D and manufacturing subsidiary of Cappella, Inc. For more information, please visit the Cappella Medical Systems website at www.cappella-med.com

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