Bravo
You've seen how WS treats Amarin on patent days, right? LOL. '889 is the first of the combo claiming indication for combo to tx > 500 trigs. It includes combining with rosuvastatin, atorvastatin or pravastatin.
It's huge and the reason why GSK aquired Reliant, Provaza's hope was to combine Lovaza/Omacor with statin and enter the cholesterol/>200 trig market. In 2007 the FDA denied this Lovaza indication, because Lovaza raised LDL.
Marine, Anchor, REDUCE-IT is just a combo ramp up. AHA wants to increase patient compliance with combo drugs, a combo Vascepa is the most powerful lipid/Trig drug...ever. Add the possibility of hydroxy-atorvastatin NCE and you have a $10 Billion asset.
----899' claims
1. A method of treating a subject having baseline fasting triglycerides of at least 500 mg/dl comprising, administering to the subject an HMG-CoA reductase inhibitor and 4 g per day of a pharmaceutical composition comprising at least 96% by weight ethyl eicosapentaenoate for a period effective to reduce fasting triglycerides in the subject by at least 45% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
2. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 50% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
3. The method of claim 1 wherein said period is a period effective to reduce fasting triglycerides in the subject by at least 55% without substantially increasing LDL-C relative to a control subject taking a concomitant HMG-CoA reductase inhibitor without said pharmaceutical composition.
4. The method of claim 1 wherein said period is about 1 to about 12 weeks.
5. The method of claim 1 wherein said period is 12 weeks.
6. The method of claim 1 wherein the composition is administered to the subject 1 to 4 times per day.
7. The method of claim 6 wherein the composition is present in one or more capsules.
8. The method of claim 1 wherein the subject has a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, a baseline fasting LDL-C of about 40 mg/dl to about 115 mg/dl and a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
9. The method of claim 8 wherein upon administering to the subject about 4 g of said pharmaceutical composition daily for said period, the subject further exhibits (a) a reduction in fasting non-HDL-C levels compared to a fasting non-HDL-C level at a baseline prior to initial administration of the pharmaceutical composition; and (b) a reduction in fasting VLDL-C compared to a fasting VLDL-C level at a baseline prior to initial administration of the pharmaceutical composition.
10. The method of claim 1 wherein the HMG-CoA reductase inhibitor comprises rosuvastatin, atorvastatin or pravastatin.
