Yellow Bluff thanks for sharing and here's my take for what it's worth:
"Under the SPA for our ESPRIT study, we are able to submit an NDA for an indication for Epanova for the reduction of non-HDL-C and triglycerides in patients with high triglycerides in combination with statin therapy after we obtain approval for Epanova for patients with severe hypertriglyceridemia and are substantially underway with a cardiovascular outcomes study."
Omethera/AZN's designed path:
1) get approval for the Fatty Acid version of Lovaza, that increased DHA levels 250% higher than the A.fib warning drug Lovaza
A) convince GSK your not launching a generic
B) convince TEVA your not launching a generic (they WON dibs in court against Pronova)
C) convince Amarin, Pronova that your not infringing on their FA omega 3 patents...that's right Amarin and Pronova have FA patents
D) 2015 at the earliest, and TEVA will have a generic at this time, could be FA generic since Omthera has NO IP
2) After easly jumping the above hurdles, Design a similar REDUCE-IT study for your combo ( notice it's NOT mono therapy due to complete lack of efficacy in the high trig population with JUST Epanova.
A) Then find a partner, AZN, who is willing to front a $50 million dollar per year outcomes study for a drug that likely will have the same A.fib warnings, and has NO IP protection, and likely violates Amarin's IP protection. It'll wrap up in 2021 assuming approval in 2015 for severe trig., but they'll somehow get 8000 patients interested in a CV outcomes trial after Amarin already finished REDUCEIT. Assuming it takes them the same two years to be "substantially underway" they can apply for the NO IP protected combo in 2017 and approval in 2018 assuming everything went PERFECT with an inferior drug.
So, 2018 AZN will be ready to do battle with Vascepa/AMR102 with their non patented Epanova Combo violating multiple Amarin/Pfizer/Merck/TEVA patents???
AZN has clearly frick'n lost all it's marbles here!!! (For $5 million AZN, I'll find you a loophole to can that Omthera "deal".)
Pfizer is going to own your ass again AZN if you don't wake up!
Williams
