Amarin Corp Plc (AMRN)

[CaptBeer]

$AMRN SUNDAY SCHOOL CLASS for 11/22/2020
Topic: “The Fillers are the Killers”

The past few weeks I have discussed the bioequivalence issues regarding the Generic VASCEPA capsule that launched last week. Bioequivalence is a complex issue, and here is a primer for those interested:

https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface

There are two “dependent” issues at play here. Although as far as the FDA is concerned there’s only one. The two issues are:

1. Compositional Equivalence
2. Therapeutic Equivalence

The FDA’s AB Rating in The Orange Book is only concerned with Therapeutic Equivalence. The Orange Book is the definitive reference for doctors and pharmacists in determining the appropriate medication, (generic or brand name), for the patient.

Compositional Equivalence is of less import, within certain boundaries, if it delivers the same therapeutic effect as the Reference Listed Drug (RLD), for “The Indicated Use”.

There’s where things become dicey. Hikma’s generic icosapent ethyl is indicated for severe hypertriglyceridemia, (TG’s ≥ 500 mg/dl). Therefore, the composition of generic icosapent ethyl, even if not exactly equivalent to name brand VASCEPA should produce the equivalent therapeutic effect, (maybe)?

However, Hikma is diabolical in their launching of GV. We know from data collected from Symphony and IQVIA, that ≤ 10% of current prescriptions of VASCEPA are for the severe hypertriglyceridemia indication, which may be as low as 2-3%. Any percentages above this range would suggest inducing infringement.

Now here’s the diabolical and dangerous part:
If doctors, pharmacists and insurance companies are writing GV “off-label” for the CVD indication they are not only inducing infringement, but they may be prescribing a drug that doesn’t work for the indication they are writing it for!

Here’s where “Compositional Equivalence” becomes important.
Some drugs listed in the Orange Book with their generic equivalents, Synthroid/Levothyroxine for example, are so sensitive to their exact compositions that their therapeutic equivalences are not equal. These drugs in the Orange Book are given AB1, AB2 Ratings. Hikma in my opinion, is being devious, diabolical, unethical, and presenting clear danger to the uniformed community. They know that their generic VASCEPA does NOT meet therapeutic equivalence for a CVD indication, and furthermore, they don’t care.

We need to get independent lab experts involved in submitting to the FDA compositional properties of the GV capsules so to encourage the FDA to require Hikma to supply their product for further analysis, and to change the AB Rating to AB1, AB2. This will force prescribers and payors to only allow generic VASCEPA for the severe hypertriglyceridemia indication.

Remember: “The Fillers are The Killers”

You can download this and other documents from my CaptBeer's Google Drive:

https://drive.google.com/drive/folders/1-WZpUjclmshpTua8MX0L-f1kfumEi2Nj?usp=sharing