Information on Competitive
Products
For investor use only; not to be used for
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v9-7-21-14
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
Lovaza [brand/generic]1,2,3
Product (4g/day)
Harris 19975
Pownall 19996
(N=42)
Section 14 Clinical Studies
(N = patients randomized to study drug)
Statin or Statin and/or Ezetimibe Use
(all arms)
Lipid Parameter (mg/dL), Studies
Stratified by Median Baseline TG Level
for 4 g/day Study Drug Arm
Studies in which TG baseline median for
study drug arm was >500 and
<750/mg/dL
Studies in which TG baseline median for
study drug arm was
>750 mg/dL
LDL-C
Non-HDL- C
TC
VLDL-C
HDL-C
APO B
Omtryg3
Epanova4
NCT01229566 20123,7a
(N=103)
NCT01229566 20123,7a
(N=104)
Kastelein 20148
(N=99)
Statin ( 21%)
Statin (21%)
Statin and/or Ezetimibe (35%)
% Change vs.
Placebo
Baseline
% Change vs.
Placebo
Baseline
% Change vs.
Placebo
Baseline
% Change vs
placebo
Baseline
-
-
-14.0*
655
-12.2*
702
-21***
655
-51.6
816
-
-
-
-
-
-
+49.3
-10.2
-8.0
-40.8
+9.1
89
271
296
175
22
+24.7**
-8.5
-6.9
-28.7**
+3.9
78
237
270
153
28
+15
-10**
-9
-21
+4†
+2
90
225
254
126
29
118
+18.9*
85
-3.5
210
-1.9
244
-23.7*
117
+5.2
30
Not Reported
Most Common Adverse Events (AEs) b
Incidence
(N = patients randomized to study drug)
AEs >3% and > placebo
N=655
Dyspepsia (3%)
Eructation (4%)
Taste Perversion (4%)
N=315
Diarrhea (15%)
Nausea (6%)
Abdominal Pain or Discomfort (5%)
Eructation (3%)
*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 2014.
b Safety results for OMTRYG reference LOVAZA label.
References:
1. LOVAZA (omega-3-acid ethyl esters) capsules [package insert]. Research Triangle Park, NC: GlaxoSmithKline; May 2014.
2. Omega-3-acid ethyl esters capsules USP [package insert]. Sellersville PA: Teva Pharmaceuticals USA; October 2014.
3. OMTRYG (omega-3-acid ethyl esters A) capsules [package insert]. Arlington, VA: Trygg Pharma, Inc.; April 2014.
4. 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;4:385-91.
6. 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;143:285-297.
7. Efficacy study to treat subjects with severe hypertriglyceridemia. ClinicalTrials.gov Web site. http://clinicaltrials.gov/ct2/show/NCT01229566 . Published October 21, 2010. Updated November 23, 2011.
Accessed June 27, 2014.
8. 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;8:94-106
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
http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm.
For investor use only; not to be used for any
other purpose.
Additional Information Regarding FDA Approved EPA/DHA-based Drugs1-4
Additional Information from Package Inserts
Parameter
Lovaza®1,2
Omtryg™3
Omega-3-carboxylic acids
• Approximately 850 mg of
polyunsaturated fatty acids, including
EPA and DHA
Omega-3-acid ethyl esters
• Approximately 375mg DHA
• Approximately 465mg EPA
Active Ingredient
1-gram,
transparent, soft-gelatin capsules filled with light-yellow
oil and bearing the designation LOVAZA
Supplied
Epanova™4
1.2 grams,
transparent soft-gelatin capsules filled
with light-yellow oil and bearing the
designation TP0001
1-gram,
red/brown, polyacrylate-coated, softgelatin capsule bearing the designation
OME1
As an adjunct to diet to reduce TG levels in adult patients with
severe (≥500 mg/dL) hypertriglyceridemia
Indication
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.
WARNINGS and PRECAUTIONS
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)
Lovaza1,2
Omtryg3
Epanova4
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Outcomes Trial Information
Product
Outcomes Trial
Lovaza
No plan disclosed
Omtryg
Epanova
No plan disclosed
5
Not yet enrolling
References:
1. LOVAZA (omega-3-acid ethyl esters) capsules [package insert]. Research Triangle Park, NC: GlaxoSmithKline; May 2014. 2. Omega-3-acid ethyl esters capsules USP [package insert]. Sellersville PA: Teva Pharmaceuticals USA;
October 2013. 3. OMTRYG (omega-3-acid ethyl esters A) capsules [package insert]. Arlington, VA: Trygg Pharma, Inc.; April 2014. 4. EPANOVA (omega-3-carboxylic acids) capsules [package insert]. Wilmington, DE: AstraZeneca
Pharmaceuticals LP; May 2014. 5. ClinicalTrials.gov Web site. http://clinicaltrials.gov/ct2/show/NCT02104817?term=epanova&rank=5. Published April 2, 2014. Updated May 9, 2014. Accessed June 18, 2014.
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 http://www.accessdata.fda.gov/Scripts/cder/drugsatfda/index.cfm.
For investor informational purposes only.
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