Amarin Corp Plc (AMRN)

[jessellivermore]

G...

Quote:
Defendants did not prove by clear and convincing evidence that the POSA would have been motivated to use substantially pure EPA as a treatment for severe hypertriglyceridemia, or that such a person would have reasonably expected to avoid a substantial increase in LDL-C using EPA in those patients. The prior art taught that every drug approved for lowering TGs in the severely hypertriglyceridemic — whether niacin, fibrates, or omega-3-fatty acids — raised LDL-C dramatically in that population, even though they did not have that effect when administered to patients with lower TG levels. The POSA attributed this increase in LDL-C to the way TG-lowering drugs were understood to work in the severely hypertriglyceridemic—enhancing clearance of the superabundance of VLDL particles to LDL. The POSA expected EPA to work the same way.

I thought you never read any of my posts...Guess the science is still alive and not dead after all..

More to the point is the FDA label for the Marine indication.

-INDICATIONS AND USAGE-----------------------------­
VASCEPA is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an
adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe
(≥500 mg/dL) hypertriglyceridemia. (1)
Limitations of Use:
•The effect of VASCEPA on the risk for pancreatitis in patients with severe
hypertriglyceridemia has not been determined. (1)
•The effect of VASCEPA on cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been determined. (1)

The fact this label is still current and has not changed since the FDA approval in 2012..does not support the notion that a POSA would be motivated to treat severe hypertriglyceridemia with EPA. The FDA states very clearly. The effect of Vascepa on the risk for pancreatitis or on CVD mortality or morbidity Has not been determined..This is still the case today.
A final consideration is that DHA actually is a more potent trig lowering drug than EPA (VASCEPA)..Would more likely motivate POSAs to use drugs like Lovaza

":>) JL