Replies to post #398383 on Amarin Corp Plc (AMRN)

[oneragman]

zip, we have talked about that! People here have emailed management about doing that! Dr. Bhatt has mentioned it. My dog has mentioned it. Nothing has been done...except the form 4's... those get done. If I didn't know better, a BP is paying management to fail, because I am amazed that fundamentally, this management has done nothing that I can point to and say yes I am impressed

[CaptBeer]

VASCEPA vs. Generic VASCEPA:

You are calling for an “oxidative stress testing program” on the patented capsule vs. the standard soft gel cap. This has already been done in conjunction with at least one patent (#8298554) “Stable pharmaceutical composition and methods of using same.” We know that EPA begins to oxidize immediately when exposed to heat, light and oxygen even when encapsulated.

This oxidation is measured in a value called the “peroxide value” (mwq/kg). Claim # 1 of this patent says that value should not exceed 5 meq/kg at baseline and not more than 8 meq/kg at 6 months storage, or more than 20 meq/kg for its shelf life.

I haven’t been able to find what the peroxide values are for the standard Type IIa soft gel cap that the generics use, but I’m sure this value is known to Amarin. The question remains at what peroxide value of EPA does the oxidized molecule begin to lose its effectiveness and absorption into the phospholipid bilayer? It’s totally ridiculous that the bioequivalence testing by the FDA for the generics doesn’t require this peroxide value testing.

Three ways in which generic IPE may be less efficacious that branded VASCEPA®:

1. Oxidative degradation of the EPA product in an inferior capsule.
2. The inferior manufacturing process of the EPA molecule (the active ingredient).
3. The content/quantity of the excipients (fillers) see my $AMRN Sunday School Class: “The Fillers Are the Killers.”

https://drive.google.com/file/d/16oI01YBkQCRiIpWEwwmAtDLxYYX-4pPQ/view?usp=sharing

Thus, short of the FDA requiring an outcome study for the generics, which defeats their whole purpose, the only way to compare the two is to run a comparative study of the differences in serum levels of EPA, AA and other biomarkers. This was done in Japan with

EPADEL vs. Generics:

Fatty Acid Treatment with Pure Omega-3 Eicosapentaenoic Acid Ethyl Ester for Patients with Cardiovascular Diseases: Differences between Branded (EPADEL®) and Generic Products (scirp.org)

The Conclusion of this study:

“The results of the present study indicated that the increase of EPA and the reduction of AA occurred as the therapeutic response to PUFA with EPA ethyl ester. The improvement was superior with the branded product (EPADEL®), which is a highly purified EPA ethyl ester, compared to the generic product.”

*Note: The EPADEL product in this study did not have the patented capsule. Thus, a similar study with VASCEPA® vs. generic VASCEPA® should yield even better results.