Amarin Corp Plc (AMRN)

[Biobillionair]

Icosapent Ethyl is an FDA approved drug to treat Very High Triglycerides 500 <. It will VERY likely be approved to treat high Triglycerides in December. Fish oil, AKA, Lovaza was denied approval for this high trig market and Combo market because of the increase in LDL. GSK bought fish oil for $1.6 billion dollars from Amarin's CEO back in 2004 planing to launch a combo drug per Pronova:http://www.drugs.com/clinical_trials/study-demonstrating-lovaza-omacor-co-administered-atorvastatin-reduces-non-hdl-cholesterol-6201.html

Now, if you believe this is AZN's only M&A, they should have talked to GSK before spending half a billion dollars on a drug with NO IP protection, raises LDL in Omthera's Marine & Anchor equivalent studies. IMO AZN just opened a can of sardines... Epanova is likely not to get approved until after Lovaza goes generic in 2015, LOL.

Epanova's active moiety is EPA and DHA dissolved in the blood plasma and RBC's, with a "mix of Omega-3's that also might be active" The FDA doesn't grant exclusivity based on API, but on ACTIVE MOIETY. Epanova's API is a mix of triglycerides in a patented protected capsule creating superior bioavailability when compared to Lovaza. Thus, Amarin's API is Icosapent Ethyl an EPA pro-drug. It very well could be defined as a NCE because the ACTIVE MOIETY in Lovaza was ill defined at the point of Amarin's application and the Active Moiety for Lovaza is now defined as a mix of Omega 3's including EPA and DHA. The monograph describes the API and NOT the active moiety. The active moieties for both drugs have just been posted in the September 2012, after Vascepa approval;) Draft Giudance for Lovaza and the completely separate guidance posted for Vascepa in April 2013.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM347002.pdf

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM320011.pdf
"Omega-3-Acid Ethyl Esters is a natural source drug obtained from
the body oil of several fish sources. The Omega-3-Acid Ethyl Esters USP monograph defines the active pharmaceutical ingredient (API) as composed of seven individual omega-3-acid ethyl ester components. The Omega-3-Acid Ethyl Esters Capsules USP monograph
establishes ranges for the two most abundant components (EPAee and DHAee) of the active pharmaceutical ingredient (API) and
ranges for the sum of the two components. The reference product contains lesser quantities of the other five omega-3 acid ethyl esters, although quantitative ranges are not specified in the USP
monographs. The Agency has determined the quantitative ranges of the other five omega-3-acid ethyl ester components based on assay of multiple batches of the RLD using the USP monographanalytical method.

I'm confident a NDA application for Epanova would be outright denied until generics can compete with Lovaza. Yes the bioavailablity seems supior with Epanova compared to Lovaza but the both have the exact ACTIVE Moiety's with separate API's.
At the time of Epanova's entry into the GENERIC Lovaza market Amarin will have Marine, Anchor and combo all with extensive IP.

If AZN would have paid me $5 million dollars I could have saved them close to a half a billion. Please contact me AZN, I do some contract work in my spare time. The API cost for the pure triglyceride form of Epanova and capsules are much higher than the COGs for both Lovaza and Vascepa by the way.

They key, API is not Active Moiety, Active Moiety's are the defining base for market entry and exclusivity.

Williams