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Vascepa: Forget About The Italian Fish Oil Study, Compare It To... VASCEPA!

|Includes:Amarin Corporation PLC (AMRN)

Amarin investors have most likely heard all about the recent Fish Oil study from Italy (The Risk and Prevention Study Collaborative Group), supported by Società Prodotti Antibiotici, Pfizer, and Sigma-Tau.

We've seen the headlines, and the select quotes from Dr. Topol and others, no need to repeat them, they're easily found in a plethora of articles comparing the trial to Amarin's Vascepa.

So first and foremost, we must know that the study implemented 85% EPA/DHA and filler at 1,000mg/day (One Gram/day). 425mg EPA + 425mg DHA + 150mg filler mixture. That more closely resembles Lovaza from GSK, which also has DHA.

Now let's equate the 425mg dose of EPA from the 'Over The Counter' Fish Oil pills to Vascepa. You need 9.5 OTC pills to match the daily dose of Vascepa, and you would be getting 4,000 mg of DHA, which is NOT what a person with cardiovascular disease would want in their plasma as it raises LDL-C (Bad cholesterol).

Okay, now that we have covered the simple point of comparing doses between the Italian Study and Vascepa's approved dose, let's look at something more remarkable.

Vascepa likely would NOT have been approved even at 2,000mg per day. That's right, Vascepa itself failed to show enough significance in reducing several cardiovascular markers at 2,000mg per day. This secondary endpoint was established with the input from the FDA for their SPA. Can you imagine the headlines if the recent bearish articles tried to spin this bit of information? Let's look:

"This endpoint was achieved at doses of 4 grams and 2 grams per day with median placebo-adjusted reductions in triglyceride levels of 21.5% (P<0.0001 value) for 4 grams and 10.1% (P=0.0005) for 2 grams. The median baseline triglyceride levels were 259 mg/dL, 265 mg/dL and 254 mg/dL for the patient groups treated with placebo, 4 grams and 2 grams of AMR101 per day, respectively. The analysis of subgroups by baseline triglyceride tertiles showed that higher baseline triglycerides resulted in greater triglyceride reductions.

Secondary efficacy endpoints included the median placebo-adjusted percent change in non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (apo B), and lipoprotein-associated phospholipase A2 (Lp-PLA2). The 4 gram dose was associated with statistically significant reductions in non-HDL-C (13.6%), LDL-C (6.2%), apo B (9.3%), Lp-PLA2 (19%) and high-sensitivity C-reactive protein (hsCRP )(22%) at week 12 compared to placebo. The 2 gram dose was associated with statistically significant reductions in non-HDL-C (5.5%), apo B (3.8%), Lp-PLA2 (8.0%) and a non-statistically significant reduction in LDL-C (3.6%) and high-sensitivity C-reactive protein (hsCRP) (6.8%) at week 12 compared to placebo."

2 grams vs 4 grams, reduction by Vascepa and Statin vs. Statin alone

non-HDL-C 5.5% vs. 13.6%

apo B 3.8% vs. 9.3%

lp-PLA2 8.0% vs. 19%

LDL-C 3.6% (not sig.) vs. 6.2%

hsCRP 6.8% (non sig.) vs. 22%

As you can clearly see, the efficacy is pretty much doubled when you double the dose from 2,000mg to 4,000mg a day over a period of 12 weeks. Interesting tidbit about ANCHOR, there were several patients who had under 200mg/dL trigs in the trial and if you remove them, the trig reduction is 23% compared to statin and placebo.

With the non-significant reduction in hsCRP and the lower efficacy, chances are Vascepa would have been denied approval at 2,000mg, so is it any surprise that 425mg of EPA failed to show any significant benefit in people whose baseline trigs were between 100-200mg/dL? (P.S. Those are lower trigs compared to those in the ANCHOR trial).

Next time, let's take a closer look at just what these secondary markers indicate as far as cardiovascular risk is concerned. Every Amarin investor should be aware of the importance of each.

Disclosure: I am long AMRN.

Stocks: AMRN