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Information on Competitive Products For investor use only; not to be used for other purposes. v9-7-21-14.

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Presentation on theme: "Information on Competitive Products For investor use only; not to be used for other purposes. v9-7-21-14."— Presentation transcript:

1 Information on Competitive Products For investor use only; not to be used for other purposes. v

2 Product (4g/day) Lovaza [brand/generic] 1,2,3 Omtryg 3 Epanova 4 Section 14 Clinical Studies (N = patients randomized to study drug) Harris Pownall (N=42) NCT ,7a (N=103) NCT ,7a (N=104) Kastelein (N=99) Statin or Statin and/or Ezetimibe Use (all arms) Statin ( 21%) Statin and/or Ezetimibe (35%) Lipid Parameter (mg/dL), Studies Stratified by Median Baseline TG Level for 4 g/day Study Drug Arm % Change vs. Placebo Baseline % Change vs. Placebo Baseline % Change vs. Placebo Baseline % Change vs placebo Baseline Studies in which TG baseline median for study drug arm was >500 and <750/mg/dL * *702-21***655 Studies in which TG baseline median for study drug arm was >750 mg/dL LDL-C * ** Non-HDL- C **225 TC VLDL-C * ** HDL-C †29 APO B Not Reported+2118 Most Common Adverse Events (AEs) b Incidence (N = patients randomized to study drug) N=655N=315 AEs >3% and > placebo Dyspepsia (3%) Eructation (4%) Taste Perversion (4%) Diarrhea (15%) Nausea (6%) Abdominal Pain or Discomfort (5%) Eructation (3%) Efficacy and Safety Data Reporting Median Baseline and Median Percent (%) Change from Baseline in Lipid Parameters From Package Inserts of FDA Approved EPA/DHA-based Drugs at 4g/day dose References: 1. LOVAZA (omega-3-acid ethyl esters) capsules [package insert]. Research Triangle Park, NC: GlaxoSmithKline; May Omega-3-acid ethyl esters capsules USP [package insert]. Sellersville PA: Teva Pharmaceuticals USA; October OMTRYG (omega-3-acid ethyl esters A) capsules [package insert]. Arlington, VA: Trygg Pharma, Inc.; April EPANOVA (omega-3-carboxylic acids) capsules [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; May 2014; excluded from the data reported above are 2g/day and 3g/day daily dose data for Epanova. Epanova at 2g/day, as approved, had baseline TG=[ 717 mg/dL] and TG percent change vs. placebo of [-25]; results at 3g/day are were not reported as they were not meaningfully different than the 2 gram dose. 5. Harris WS, et al. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk. 1997;4: Pownall HJ, et al. Correlation of serum triglyceride and its reduction by v-3 fatty acids with lipid transfer activity and the neutral lipid compositions of high-density and low-density lipoproteins. Atherosclerosis. 1999;143: Efficacy study to treat subjects with severe hypertriglyceridemia. ClinicalTrials.gov Web site. Published October 21, Updated November 23, 2011.http://clinicaltrials.gov/ct2/show/NCT Accessed June 27, Kastelein JJP, et al. Omega-3 Free Fatty Acids for the Treatment of Severe Hypertriglyceridemia: The EpanoVa fOr Lowering Very high triglyceridEs (EVOLVE) Trial. J Clin Lipidol. 2014;8: Note: With the exception of the head-to-head trial reported in the Omtryg label, the above results are not based on head-to-head studies. Trademarks used are not affiliated with Amarin. Lovaza ® is a registered trademark of the GlaxoSmithKline group of companies. Omtryg™ is a trademark of Trygg Pharma AS. Epanova ® is a registered trademark of the AstraZeneca group of companies. Full prescribing information for each product can be found through the FDA website at *p < 0.05, **p < 0.01, ***p < 0.001, †p = not significant a This was a head-to-head study of OMTRYG vs. LOVAZA and placebo reported in OMTRYG (omega-3-acid ethyl esters A) capsules [package insert]. Arlington, VA: Trygg Pharma, Inc.; April b Safety results for OMTRYG reference LOVAZA label. For investor use only; not to be used for any other purpose.

3 Additional Information Regarding FDA Approved EPA/DHA-based Drugs 1-4 WARNINGS and PRECAUTIONSLovaza 1,2 Omtryg 3 Epanova 4 ALT and AST monitoring in patients with hepatic impairment Prolonged bleeding time, periodic monitoring for patients taking anti-platelet agents Increase in LDL-C in some patients, monitoring required periodically Hypersensitivity to Fish/Shellfish More frequent recurrence of AF or Flutter (paroxysmal or persistent) Additional Information from Package Inserts ParameterLovaza® 1,2 Omtryg™ 3 Epanova™ 4 Active Ingredient Omega-3-acid ethyl esters Approximately 375mg DHA Approximately 465mg EPA Omega-3-carboxylic acids Approximately 850 mg of polyunsaturated fatty acids, including EPA and DHA Supplied 1-gram, transparent, soft-gelatin capsules filled with light-yellow oil and bearing the designation LOVAZA 1.2 grams, transparent soft-gelatin capsules filled with light-yellow oil and bearing the designation TP gram, red/brown, polyacrylate-coated, soft- gelatin capsule bearing the designation OME1 Indication As an adjunct to diet to reduce TG levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia Limitations of Use The effect on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. The effect on cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined. References: 1. LOVAZA (omega-3-acid ethyl esters) capsules [package insert]. Research Triangle Park, NC: GlaxoSmithKline; May Omega-3-acid ethyl esters capsules USP [package insert]. Sellersville PA: Teva Pharmaceuticals USA; October OMTRYG (omega-3-acid ethyl esters A) capsules [package insert]. Arlington, VA: Trygg Pharma, Inc.; April EPANOVA (omega-3-carboxylic acids) capsules [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; May ClinicalTrials.gov Web site. Published April 2, Updated May 9, Accessed June 18, 2014.http://clinicaltrials.gov/ct2/show/NCT ?term=epanova&rank=5 Trademarks used are not affiliated with Amarin. Lovaza ® is a registered trademark of the GlaxoSmithKline group of companies. Omtryg™ is a trademark of Trygg Pharma AS. Epanova ® is a registered trademark of the AstraZeneca group of companies. Full prescribing information for each product can be found through the FDA website at For investor informational purposes only. Outcomes Trial Information ProductOutcomes Trial Lovaza No plan disclosed Omtryg No plan disclosed Epanova 5 Not yet enrolling

4 Glossary AF: Atrial fibrillation APO B: Apolipoprotein B DHA: Docosahexaenoic acid EPA: Eicosapentaenoic acid FDA: U.S. Food and Drug Administration HDL-C: High-density lipoprotein cholesterol LDL-C: low-density lipoprotein cholesterol (aka “bad cholesterol”) Non–HDL-C: non—high-density lipoprotein cholesterol TC: Total cholesterol TG: Triglyceride VLDL-C: Very-low-density lipoprotein cholesterol


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