Amarin Corp Plc (AMRN)

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Vascepa® (icosapent ethyl) Showed 30% Reduction in Total Cardiovascular Events Including Recurrent Events in REDUCE-IT™
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Vascepa® (icosapent ethyl) Showed 30% Reduction in Total Cardiovascular Events Including Recurrent Events in REDUCE-IT™
Approximately 159 Fewer Major Adverse Cardiovascular Events per 1000 Patients Studied
Data Show Relative Benefits of Vascepa Usage Grow Over Time
Amarin Schedules Webcast Discussion of Presented Data Today, March 18, 2019 at 4:00-5:00 pm CT

PR Newswire

BEDMINSTER, N.J. and DUBLIN, March 18, 2019

BEDMINSTER, N.J. and DUBLIN, March 18, 2019 /PRNewswire/ -- Amarin Corporation
plc (NASDAQ: AMRN), presented new data from its landmark cardiovascular
outcomes study of its prescription therapy, Vascepa® (icosapent ethyl), the
REDUCE-IT™ study, showing that Vascepa provided a statistically significant
30% risk reduction in total (first and subsequent) cardiovascular events
compared to placebo in the statin-treated patient population studied in
REDUCE-IT. These data presented today as a late-breaker presentation at the
American College of Cardiology's (ACC) 68th Annual Scientific Session in New
Orleans, LA, and published simultaneously in the Journal of the American
College of Cardiology, extend the scope of consistent effects of Vascepa
beyond a patient's first cardiovascular event to all subsequent cardiovascular
events, including cardiovascular death.(1)

Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8512651-amarin-reduce-it-vascepa-30-percent-reduction-total-cardiovascular-events/
(https://c212.net/c/link/?t=0&l=en&o=2405195-1&h=4256134329&u=https%3A%2F%2Fwww.multivu.com%2Fplayers%2FEnglish%2F8512651-amarin-reduce-it-vascepa-30-percent-reduction-total-cardiovascular-events%2F&a=https%3A%2F%2Fwww.multivu.com%2Fplayers%2FEnglish%2F8512651-amarin-reduce-it-vascepa-30-percent-reduction-total-cardiovascular-events%2F)

In November 2018, groundbreaking primary results of the REDUCE-IT study were
presented and published showing that Vascepa achieved the primary endpoint of
the study demonstrating a statistically significant 25% placebo-controlled
risk reduction in the first occurrence of major adverse cardiovascular events
(MACE) as well as statistically significant relative risk reductions in each
component of the MACE composite, consisting of cardiovascular death, heart
attack, stroke, coronary revascularization and hospitalization for unstable
angina. For the primary endpoint, a clinically impactful number needed to
treat of 21 was reported.

In the newly reported data, investigators led by the study's principal
investigator, Deepak L. Bhatt, MD, MPH, Professor of Medicine at Harvard
Medical School, Executive Director of Interventional Cardiovascular Programs
in the Heart and Vascular Center at Brigham and Women's Hospital, and the
Principal Investigator and Steering Committee Chair for REDUCE-IT, evaluated
patients' total cardiovascular events during the median study follow up of 4.9
years in REDUCE-IT. These analyses were tertiary or exploratory endpoints in
REDUCE-IT. Total events included both a patient's first occurrence of MACE as
well as all subsequent occurrences of MACE. Recurrent cardiovascular events
are common in people who have already had a heart attack. Various studies have
found a recurrence rate of close to 50% for any cardiovascular event or for
subsequent coronary revascularization in the year after a heart attack, and up
to 75% of patients have a recurrent event within 3 years.(2) Vascepa reduced
total events, first and subsequent events, by 30% compared to placebo,
reflecting that for every 1000 patients treated for 5 years with icosapent
ethyl versus placebo approximately 159 MACE could be prevented with Vascepa,
including prevention of approximately 12 cardiovascular deaths, 42 heart
attacks (myocardial infarctions), 14 strokes, 76 coronary revascularizations
and 16 episodes of hospitalization for unstable angina. There was also a 28%
reduction of total events in the key secondary endpoint of 3-point MACE in the
intent-to-treat population consisting of a composite of cardiovascular death,
nonfatal heart attack and nonfatal stroke.

"This is an impressive degree of risk reduction," said Dr. Bhatt. "From a
patient's perspective — and from my perspective as a physician — we care
about repeat events and the risk of surviving a first stroke or heart attack
only to go on to have a subsequent, and potentially fatal, event. The degree
of benefit that this analysis reveals is quite large, especially considering
that this is an additional layer of benefit on top of what statin and other
therapies have already provided."

REDUCE-IT was a global study of 8,179 patients who, despite stable statin
therapy, had elevated triglyceride levels (at least 135 mg/dL) and either
documented cardiovascular disease or diabetes with other cardiovascular risk
factors. Many patients with well-managed LDL-cholesterol remain at high risk
for cardiovascular events. No therapy is currently approved to treat such
residual cardiovascular risk in the population studied in REDUCE-IT and, prior
to the successful results of Vascepa demonstrated in the study, no other
therapy had demonstrated a 25% risk reduction compared to placebo on top of
statin therapy in a major cardiovascular outcomes trial within the primary
endpoint of any patient population. REDUCE-IT studied Vascepa 4 grams/day as
compared to placebo.

Benefits of Vascepa with respect to total cardiovascular event reduction were
shown to continue over time as displayed below in the cumulative event curves
of study results. The cardiovascular event curve for Vascepa visually
separated from the placebo event curve at approximately year one and continued
to separate throughout the remaining follow-up period. This relatively early
and continued separation of total cardiovascular event rates is consistent
with the primary events data (i.e., first occurrence data) from REDUCE-IT
previously reported. The separation was significant with respect to the
primary endpoint of first events and grows further over time for total
cardiovascular events.

The relative risk reduction demonstrated by Vascepa in REDUCE-IT has
implications for both patient health and the cost of
healthcare. Cardiovascular disease is the number one cause of death in the
United States and most of the world. In the U.S., there is one
cardiovascular death every 38 seconds. Cardiovascular disease is the most
expensive area of healthcare. Treating major adverse cardiovascular events is
expensive both at the time of the event and often for years to follow. This
cost is not only financial; it impacts patients through pain and suffering and
loss of productivity. Preventing such cardiovascular events would be
beneficial for patients, their families and for healthcare at-large. Amarin
believes that reducing approximately 159 MACE per 1000 patients treated will
position Vascepa well in pharmacoeconomic analyses planned to be conducted and
reported in 2019.

 

No new safety related results from REDUCE-IT were reported with this new data.
 Safety data associated with REDUCE-IT was previously published in The New
England Journal of Medicine(3) and is provided below.

Commenting on this new data, John F. Thero, president and CEO of Amarin said
"We believe that the robustly positive cardiovascular outcomes results
demonstrated with Vascepa opens the door to a new era in preventative
cardiovascular care which can potentially benefit millions of at-risk
patients. Just as the REDUCE-IT results demonstrated that the effects of
Vascepa are unprecedented in reducing cardiovascular risk in at-risk patients,
as separately published, the mechanism of action of the unique small molecule,
single active ingredient in Vascepa is multifactorial and differentiated from
any other therapy."

Dr. Steven Ketchum, president of research and development and chief scientific
officer of Amarin stated, "We appreciate the ACC's designation of the new
results from REDUCE-IT as late-breaking clinical data as such designation
reflects ACC's recognition of the importance of the REDUCE-IT study and these
potentially paradigm-changing results. As we witnessed with our two earlier
successful Phase 3 studies of Vascepa, the MARINE and ANCHOR studies, we
believe clinical results from Vascepa studies are robust and consistently
favorable. We look forward to witnessing how these results improve patient
care and to further evaluation and publication of data pertaining to Vascepa
and REDUCE-IT. We remain very thankful to everyone involved in this landmark
study."

Amarin Investor/Analyst Conference Call

Amarin plans to webcast live a physician panel discussion for investors and
analysts later today (Monday, March 18) at 4:00 p.m. Central Time (CT) / 5:00
p.m. Eastern Time (ET). During the panel discussion leading physicians are
anticipated to review data pertaining to Vascepa presented at ACC's 68(th)
Annual Scientific Session, including the scheduled presentation today in the
late-breaker session regarding additional data from the REDUCE-IT
cardiovascular outcomes study. The panel discussion may also cover data from
the above described poster and from other posters presented at ACC.

This physician panel discussion will commence at the time shown above and will
be accessible via webcast through the investor relations section of the
company's website at www.amarincorp.com
(https://c212.net/c/link/?t=0&l=en&o=2405195-1&h=4104678049&u=http%3A%2F%2Fwww.amarincorp.com%2F&a=www.amarincorp.com)
. The panel discussion can also be heard via telephone by dialing
877-407-8033. A replay of the panel discussion will be made available for a
period of two weeks following the webcast. To hear a replay of the call, dial
877-481-4010 (inside the United States) or 919-882-2331 (outside the United
States). A replay of the panel discussion will also be available through the
company's website shortly after the webcast. For both dial-in numbers please
use conference ID 44518.