Claims for Patent: 8,410,086

Summary for Patent: 8,410,086

Title:	Compositions and methods for lowering triglycerides
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:	13/272,520
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,410,086
Patent Claims:	1. A method of lowering triglycerides and LDL-C in a subject comprising, administering orally to a subject having fasting triglycerides of about 200 mg/dl to less than 500 mg/dl who is on stable statin therapy about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate for a period of at least about 12 weeks to effect a reduction in fasting triglycerides and fasting LDL-C in the subject compared to fasting triglycerides and fasting LDL-C in a second subject on stable statin therapy who has not received the pharmaceutical composition. 2. The method of claim 1, comprising administering the composition to effect a reduction in fasting non-HDL-C compared to fasting non-HDL-C in the second subject. 3. The method of claim 1, comprising administering the composition to effect a reduction in fasting VLDL-C compared to fasting VLDL-C in the second subject. 4. The method of claim 1, comprising administering the composition to effect a reduction in fasting Apolipoprotein B compared to fasting Apolipoprotein B in the second subject. 5. The method of claim 1, comprising administering the composition to effect a reduction in fasting total cholesterol compared to fasting total cholesterol in the second subject. 6. A method of lowering triglycerides and LDL-C in a subject comprising, administering orally to a subject having fasting triglycerides from about 200 mg/dl to less than 500 mg/dl who is on stable statin therapy about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate for a period of at least about 12 weeks to effect a reduction in fasting triglycerides in the subject by least 5% and to effect a reduction in fasting LDL-C in the subject by at least about 5% compared to fasting triglycerides and fasting LDL-C, respectively, in a second subject on stable statin therapy who has not received the pharmaceutical composition. 7. The method of claim 6, comprising administering the composition to effect a reduction in fasting non-HDL-C compared to a fasting non-HDL-C in the second subject. 8. The method of claim 6, comprising administering the composition to effect at least a 5% reduction in fasting LDL-C compared to a fasting LDL-C in the second subject. 9. The method of claim 6, wherein the subject and the second subject have fasting baseline LDL-C from about 40 mg/dl to about 115 mg/dl. 10. A method of lowering triglycerides in a subject on stable statin therapy and having fasting a baseline triglyceride level from about 200 mg/dl to less than 500 mg/dl comprising administering orally to the subject about 4 g per day of a pharmaceutical composition comprising at least about 96%, by weight of all fatty acids present, ethyl eicosapentaenoate for a period of 12 weeks, which when administered to a first patient population on stable statin therapy and having said baseline triglyceride level at 4 g per day for twelve weeks is effective to reduce fasting triglycerides and fasting LDL-C, compared to fasting triglycerides and fasting LDL-C observed in a second patient population on stable statin therapy and having said fasting baseline triglyceride level who has not received the pharmaceutical composition. 11. The method of claim 1 wherein the stable statin therapy comprises about 10 mg to about 100 mg per day of a statin selected from atorvastatin, rosuvastatin and simvastatin. 12. The method of claim 6 wherein the stable statin therapy comprises about 10 mg to about 100 mg per day of a statin selected from atorvastatin, rosuvastatin and simvastatin. 13. The method of claim 10 wherein the stable statin therapy comprises about 10 mg to about 100 mg per day of a statin selected from atorvastatin, rosuvastatin and simvastatin.