Replies to post #5635 on Amarin Corp Plc (AMRN)

[Studyhard]

Zetia has an extensive list of side effects and Vascepa is basically free from any side effects. Seems like the better choice would obviously be the AMR-102 combo when it becomes available. The timeline of a vascepa/statin combo being approved might be hard to judge given the fickleness of the FDA.

[ggwpq]

Akanz, where you get the info. about it's for sale next week, I can't find any info about the combo pill. Please let me know. TIA.

[Biobillionair]

Akanz
AMR 102 Lipitor/Vascepa would be a 505b2 standard review. Need dosing studies...which appear to be done. (good results, adequate Lipitor and Vascepa levels) Also need Patent, if your read the 505b2 guidelines...I'll post later. Combo patent should get NOA for '899 this month. sNDA June, 74 day reply Aug, 10 month PDUFA...June 2014 at the earliest.
Interesting to note patent '994 is a metabolite of Lipitor and would be considered a completely separate drug. This poses an interesting dilemma for Amarin as it could be considered a NCE. Separately this molecule isn't as potent as Lipitor, but combined with Vascepa it's synergistic effects equal the non NCE Lipitor molecule. Not a bad problem to have when your the owner of both patents.

Good to hear from you;)

Williams