Amarin Corp Plc (AMRN)

[Biobillionair]

Re: Vascepa vs. Bapineuzumab

Bapineuzumab (nicknamed "bapi")[1] is a humanized monoclonal antibody that acts on the nervous system and may have potential therapeutic value for the treatment of Alzheimer's disease and possibly glaucoma.[2] However, in 2012 it failed to produce significant cognitive improvements in patients in two major trials, despite lowering key biomarkers of AD, amyloid brain plaque and hyperphosphorylated tau protein in CSF.[3][4]

Bapineuzumab has been shown to recognise the extreme N-terminal 5 residues of Aß peptide in a helical conformation (4HIX.pdb) stabilized by internal hydrogen bonds involving the first three amino acids.[5]

Bapineuzumab is an antibody to the beta-amyloid (Aß) plaques that are believed to underlie Alzheimer's disease neuropathology. In previous clinical trials for vaccination against human beta amyloid, called AN-1792, patients with Alzheimer's disease using active immunization had positive outcomes with removal of plaques, but 6% of subjects developed aseptic meningitis and the trial was stopped.[6]

https://en.wikipedia.org/wiki/Bapineuzumab

Discussion of approvability:
"Bapi" would likely meet the basis of radiologic evidence standard the FDA put forward yesterday;however, 6% of the subjects developed aseptic meningitis...IE: sounds like it removed the plaque but not inflammation. With the side effect profile it would never be approved. The costs of making the "Bapi" antibody are also prohibitive.

Vascepa has placebo like side effect profile and if it removes plaque (beta-amyloids) it would be approvable under the recent FDA scheme of Alzheimer's drug approval. I am very confident Amarin is likely going this route and have a good chance of getting approval within the next 5 years. Yes, 5 years with accelerated SPA approval is attainable.

If you contact Amarin IR, they will likely admit Amarin is providing the drug for the BRAVE-EPA clinical trial.

BB