Amarin Corp Plc (AMRN)

[FishyFingers]

A large part of me wonders if Vascepa will ever be approved as a triglyceride lowering agent, no matter how good the R-IT results are.

Would Amarin not be better off re-branding the drug as a treatment targeting non-HDL-C?

The FDA clearly have a bee in their bonnet regarding triglycerides, and the National Lipid Association are not fussed about the high triglyceride ANCHOR indication either, stating:

"An elevated triglyceride level is not a target of therapy per se, except when very high (=500 mg/dL). When triglycerides are between 200 and 499 mg/dL, the targets of therapy are non-HDL-C and LDL-C.

Are Amarin barking up the wrong tree here targeting triglycerides? Will the triglyceride issue finally be laid to rest with once the R-IT data is in? I'm not so sure it will.

The NLA further states that:

"Although LDL-C has traditionally been the primary target of therapy, the NLA Expert Panel's consensus view is that non-HDL-C is a better primary target for modification than LDL-C."

When your total cholesterol level is calculated, it is done by adding your LDL level to your HDL level, and then adding 20% of your triglyceride level reading. Your non-HDL-C reading then, is your total cholesterol reading minus your HDL reading ie: your LDL level plus 20% of your triglyceride level.

So what effect did Vascepa have on non-HDL-C and LDL-C in patients in the ANCHOR study when it was taken with a statin?

Compared with placebo, 4g/day of Vascepa significantly (all P,.0001) reduced levels of TG (21.5%), TC (12.0%), non-HDL-C (13.6%), and ApoB (9.3%); LDL-C was also significantly reduced by 6.2% (P 5 .0067).

The scientific data proving that Vascepa enhances the effects of statins is already in, and the R-IT trial will soon prove that this translates to a reduced risk of heart disease.

Both parties want a satisfactory settlement from this 1st Amendment case and Amarin are holding all the aces with the full backing of Wall St., the Washington legal foundation, and all big pharma.

A decent settlement for the FDA would amount to not getting sued multi million $$$'s by Amarin for damages relating to ANCHOR. In return, the FDA could agree to approve Vascepa as a treatment for lowering non-HDL-C, as per the NLA recommendations, rather than as one that lowers triglycerides. BP also win in this scenario as they can still develop their LDL-C targeting PCSK9's, safe in the knowledge that the focus will remain on LDL-C and non-HDL-C rather than shifting to triglycerides once R-IT is complete. The food and beverage corporations raking in billions of $$$'s/year from their triglyceride raising products can also breath a sigh of relief. Everyone's a winner.

http://www.lipidjournal.com/article/S1933-2874(14)00274-8/fulltext