Claims for Patent: 8,455,472

Summary for Patent: 8,455,472

Title:	Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Abstract:	In various embodiments, the present invention provides compositions and methods for treating and/or preventing cardiovascular-related diseases in subject in need thereof.
Inventor(s):	Osterloh; Ian (Kent, GB), Wicker; Pierre (Mystic, CT), Braeckman; Rene (Richboro, PA), Soni; Paresh (Mystic, CT), Manku; Mehar (England, GB)
Assignee:	Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:	12/815,569
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,455,472
Patent Claims:	1. A method of lowering triglycerides in a subject on stable statin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl, the method comprising administering to the subject about 4 capsules per day, each capsule comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of all fatty acids present, for a period of at least about 12 weeks. 2. The method of claim 1 wherein the subject has a baseline LDL-C level of about 40 mg/dl to about 115 mg/dl. 3. The method of claim 2 wherein the step of administering said 4 capsules to the subject daily for the period effects a reduction in serum LDL-C. 4. The method of claim 3 wherein the step of administering said 4 capsules to the subject daily for the period effects at least a 5% reduction in fasting triglycerides and a reduction in LDL-C in the subject. 5. The method of claim 3 wherein the step of administering said 4 capsules daily for the period effects at least a 5% reduction in LDL-C in the subject. 6. The method of claim 3 wherein the step of administering said 4 capsules to the subject daily for the period effects at least a 10% reduction in triglycerides in the subject. 7. The method of claim 3 wherein the step of administering said 4 capsules to the subject daily for the period effects at least a 15% reduction in triglycerides in the subject. 8. The method of claim 7 wherein the step of administering said 4 capsules to the subject daily for the period effects a reduction in Apolipoprotein B, total cholesterol, and lipoprotein associated phospholipase A2 in the subject. 9. The method of claim 1 wherein each capsule comprises at least about 95% ethyl eicosapentaenoate by weight of all fatty acids. 10. The method of claim 9 wherein each capsule comprises about 0.22% to about 0.4% ethyl octadecatetraenoate by weight of all fatty acids, about 0.075% to about 0.2% by weight ethyl nonaecapentaenoate by weight of all fatty acids, about 0.25% to about 0.40% ethyl arachidonate by weight of all fatty acids, about 0.3% to about 0.4% ethyl eicosatetraenoate by weight of all fatty acids, and about 0.075% to about 0.25% ethyl heneicosapentaenoate by weight of all fatty acids. 11. The method of claim 1 wherein the capsules have a shell. 12. The method of claim 11 wherein the shell comprises gelatin. 13. The method of claim 1 wherein the statin is selected from the group consisting of atorvastatin, rosuvastatin and simvastatin. 14. The method of claim 1 wherein the subject has a baseline body mass index not greater than 45 kg/m.sup.2. 15. The method of claim 1 comprising administering said 4 capsules to the subject daily for the period of 12 weeks to effect at least a 15% reduction in triglycerides and a reduction in LDL-C levels compared to a placebo controlled subject. 16. The method of claim 15 comprising administering said 4 capsules to the subject daily for the period to effect at least a 5% reduction in LDL-C compared to a placebo controlled subject. 17. The method of claim 16 comprising administering said 4 capsules to the subject daily for the period to effect at least a 5% reduction in apolipoprotein B compared to a placebo controlled subject. 18. The method of claim 13 wherein the statin comprises rosuvastatin. 19. The method of claim 18 comprising administering said 4 capsules to the subject daily for the period to effect at least a 15% reduction in triglycerides and at least a 5% reduction in LDL-C compared to a subject on the stable statin therapy for said period who has not received said 4 capsules each comprising a fill material comprising about 900 mg to about 1 g of ethyl eicosapentaenoate and not more than about 3% docosahexaenoic acid or its esters, by weight of all fatty acids present.