Claims for Patent: 8,669,245

Summary for Patent: 8,669,245

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 (Birmingham, GB)
Assignee:	Amarin Pharmaceuticals Ireland Limited (Dublin, IE)
Application Number:	13/908,843
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,669,245
Patent Claims:	1. A method of lowering triglycerides in a subject having mixed dyslipidemia on stable statin therapy having baseline fasting triglycerides of about 200 mg/dl to about 500 mg/dl, the method comprising orally administering to the subject daily a pharmaceutical composition comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, for a period of at least about 4 weeks. 2. The method of claim 1, wherein the subject has coronary heart disease or a coronary heart disease risk equivalent. 3. The method of claim 2, wherein the subject has an LDL-C level of 40 mg/dl to 100 mg/dl prior to the administering step. 4. The method of claim 1, wherein LDL-C is reduced in the subject upon 4 weeks of said administering. 5. The method of claim 4, wherein the subject exhibits a reduction in one or more of: non-HDL-C, VLDL-C, Lp-PLA2, apolipoprotein B, total cholesterol, HDL-C or VLDL-TG. 6. The method of claim 1, wherein the subject exhibits a reduction in one or more of: non-HDL-C, VLDL-C, Lp-PLA2, apolipoprotein B, total cholesterol, HDL-C or VLDL-TG. 7. The method of claim 1, wherein the composition is present in one or more dosage units. 8. 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 and an LDL-C level of 40 mg/dl to 100 mg/dl, the method comprising orally administering to the subject daily a pharmaceutical composition, present more than one dosage unit, comprising about 4 g of ethyl eicosapentaenoate and not more than about 4% docosahexaenoic acid or its esters, by weight of all fatty acids, for a period of at least about 4 weeks. 9. The method of claim 8, wherein the subject has coronary heart disease or a coronary heart disease risk equivalent. 10. The method of claim 9, wherein the subject has an LDL-C level of 40 mg/dl to 100 mg/dl prior to the administering step. 11. The method of claim 10, wherein the subject has mixed dyslipidemia. 12. The method of claim 11, wherein LDL-C is reduced in the subject upon 4 weeks of said administering. 13. The method of claim 12, wherein the subject exhibits a reduction in one or more of: non-HDL-C, VLDL-C, Lp-PLA2, apolipoprotein B, total cholesterol, HDL-C or VLDL-TG.