REDUCE-IT
was a global study of 8,179 statin-treated adults with elevated cardiovascular risk. We announced topline results from the
REDUCE-IT
study on September 24, 2018. On November 10, 2018, we announced the more detailed, primary results from the
REDUCE-IT
study at the 2018 Scientific Sessions of
the American Heart Association, or AHA, and the results were contemporaneously published in
The New England Journal of Medicine
. See Recent DevelopmentsThe REDUCE-IT Study.
Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving
significant persistent residual risk despite the achievement of target
LDL-C
levels. Worldwide, cardiovascular disease, or CVD, remains the number one killer of men and women. In the United States, CVD leads
to one in every three deathsone death approximately every 38 secondswith annual treatment cost in excess of $500 billion.
In May 2016, the FDA
determined Vascepa to be eligible for five-year, new chemical entity, or NCE, marketing exclusivity thereby providing Vascepa with the benefits of NCE exclusivity afforded by statute from its July 2012 FDA approval. Vascepa is available in the
United States by prescription only.
As of December 31, 2017, Vascepa was covered by payers representing over 140 million lives in the United States
with tier 2 coverage, without restrictions. The number of Vascepa prescriptions, on both a total and normalized basis continues to grow. Normalized total prescriptions represent the estimated total number of Vascepa prescriptions dispensed to
patients, calculated on a normalized basis (i.e., a one month supply, or total capsules dispensed, multiplied by the number of grams per capsule divided by 120 grams). Based on data reported to us by third parties, as of September 30, 2018, the
total number of Vascepa prescriptions represented approximately 33.5% of the total number of prescriptions for prescription-only
omega-3
fatty acids and approximately 6.6% of the total number of prescriptions
for prescription-only
non-statin
lipid therapy.
Recent Developments
Mandatory Exchange of 2017 Notes
On November 7, 2018, Corsicanto II
Designated Activity Company, or Corsicanto II, a wholly-owned subsidiary of our company, completed a mandatory exchange of its January 2017 3.50% Exchangeable Senior Notes due 2047, or Notes, into our ADSs, in the aggregate principal amount of
$30 million, pursuant to the terms and conditions of the Indenture, dated January 25, 2017, by and among Corsicanto II, us, and Wilmington Trust National Association, as trustee, governing the Notes. This exchange resulted in our issuance
of 7,716,046 shares of ADSs in aggregate. The mandatory exchange of the Notes retired all of the outstanding Notes, and the issuance of the ADSs also satisfied our obligations with respect to any accrued and unpaid interest on the Notes as of the
effective date of the mandatory exchange.
The
REDUCE-IT
Study
On November 10, 2018, we announced primary results from our
REDUCE-IT
study as late-breaking clinical results at the 2018
Scientific Sessions of the American Heart Association and the results were contemporaneously published in
The New England Journal of Medicine
.
REDUCE-IT
met its primary endpoint demonstrating a 25%
relative risk reduction, or RRR, to a high degree of statistical significance (p<0.001), in first occurrence of major adverse CV events, or MACE, in the
intent-to-treat
patient population with use of Vascepa 4 grams/day as compared to placebo. Patients qualified to enroll in
REDUCE-IT
had
LDL-C
between
41-100
mg/dL (median baseline
LDL-C
75 mg/dL) controlled by
statin therapy and various cardiovascular risk factors including persistent elevated triglycerides, or TG, between
135-499
mg/dL (median baseline 216 mg/dL) and either established cardiovascular disease
(secondary prevention cohort) or age 50 or more with diabetes mellitus and at least one other CV risk factor (primary prevention cohort). Approximately 59% of the patients had diabetes at baseline, approximately 71% of the patients had established
cardiovascular disease at time of enrollment and approximately 29% were primary prevention subjects at high risk for cardiovascular disease.
REDUCE-IT
also showed a 26% RRR in its key secondary composite
endpoint of cardiovascular death, heart attacks and stroke (p<0.001). We commenced the REDUCE-IT trial in 2011 and have expended more than $300 million to fund its completion.