DUBLIN and BRIDGEWATER, N.J., Dec.
13, 2019 /PRNewswire/ -- Amarin Corporation plc
(NASDAQ: AMRN) today announced that the U.S. Food and Drug
Administration (FDA) has approved a new indication and label
expansion for VASCEPA® (icosapent ethyl) capsules. After
more than a decade of development and testing, VASCEPA is now the
first and only drug approved by the FDA "as an adjunct to maximally
tolerated statin therapy to reduce the risk of myocardial
infarction, stroke, coronary revascularization, and unstable angina
requiring hospitalization in adult patients with elevated
triglyceride (TG) levels (≥150 mg/dL) and established
cardiovascular disease or diabetes mellitus and two or more
additional risk factors for cardiovascular disease." It is
estimated that millions of high-risk patients in the United States could benefit from this
one-of-a-kind prescription therapy.1
Experience the interactive Multichannel News Release here:
https://www.multivu.com/players/English/8653351-amarin-vascepa-fda-approval-cardiovascular-risk/
"We at Amarin are excited and gratified to now have the
opportunity to introduce VASCEPA as a new FDA-approved treatment
option to reduce the persistent cardiovascular risk that many
patients face despite use of statins with other contemporary
standard-of-care therapies," said John F.
Thero, president and chief executive officer of Amarin. "We
aim to help millions of high-risk patients, including
statin-treated patients and statin-intolerant patients. For the
first time, physicians, patients and payers have an FDA-approved
treatment option beyond cholesterol lowering that has been
demonstrated to significantly reduce major adverse cardiovascular
events when used on top of a statin. We look forward to helping
educate physicians and patients on the value of VASCEPA. The
expanded indication and related clinical study labeling is broadly
worded, informative on the many effects of VASCEPA and will empower
physicians with critical information to help them apply their
clinical judgment in addressing cardiovascular disease risk for
patients in need."
Amarin reaffirmed its intention to promptly launch VASCEPA in
the United States for this
important new preventative care indication. As previously
disclosed, Amarin doubled the size of its sales force near the
beginning of 2019 and is on track to double the size of its sales
force again to a total of 800 sales representatives near the
beginning of 2020.
"The FDA approval of icosapent ethyl as an addition to statin
therapy to reduce the risk of cardiovascular events is a major
milestone in cardiovascular prevention," said Deepak L. Bhatt, M.D., M.P.H., executive
director of Interventional Cardiovascular Programs at Brigham and
Women's Hospital, professor of medicine at Harvard Medical School, and lead investigator of
the REDUCE-IT study which served as the basis for the supplemental
New Drug Application to the FDA for VASCEPA. "Nothing this
significant has happened in the world of cardiovascular prevention
since the introduction of statins nearly three decades ago. Many
patients stand to benefit from this historic advance in care."
In the global REDUCE-IT®
cardiovascular outcomes study, approximately 28 percent
of patients in the control arm treated with statins and other
contemporary therapy but not treated with VASCEPA experienced a
major adverse cardiovascular event (MACE), defined as the first
occurrence of either myocardial infarction (heart attack), stroke,
coronary revascularization, unstable angina requiring
hospitalization or cardiovascular death.2 As evidenced
by this MACE occurrence, there is a group of patients who, despite
controlling their cholesterol on statin therapy, continue to have a
high need for additional preventative cardiovascular care. For
those adult patients in this group who have elevated triglycerides
(TG) ≥150 mg/dL and established cardiovascular disease or diabetes
and two or more additional risk factors for cardiovascular disease,
VASCEPA is the first drug approved to help reduce this persistent
cardiovascular risk. In a published exploratory analysis of the
REDUCE-IT study, examining total (first and subsequent)
cardiovascular events over a period of approximately five years,
patients taking VASCEPA on average experienced one fewer MACE per
six patients studied, representing a 30 percent risk reduction in
total MACE compared to placebo.3
The overall rates of adverse events and serious adverse events
in the 5-year REDUCE-IT study were similar between
VASCEPA-treated patients and placebo-treated patients. As
reflected in VASCEPA's expanded label and described below,
VASCEPA has been associated with increased risks of bleeding
and atrial fibrillation/flutter, the latter being more prevalent in
patients with a previous history of atrial fibrillation or flutter.
It is recommended that patients taking VASCEPA and concomitant
anticoagulants and/or anti-platelet agents for bleeding be
monitored. Also noted in the REDUCE-IT study is that patients
for whom bleeding and/or atrial fibrillation/flutter were reported
appeared to obtain a similar reduction in MACE as patients not
reporting such adverse events. Such findings are consistent with
published results of the study, which noted that the increased
rates of such adverse events were low, notably lower than the
reduction in MACE.3
Recurrent event analyses were conducted of the total primary
endpoint events and total key secondary endpoints in REDUCE-IT
using a series of statistical models and published in the
Journal of the American College of Cardiology. These
analyses are not in FDA labeling, were tertiary or exploratory
endpoints; most of the models used were prespecified and one was
post hoc. Each recurrent event statistical model has inherent
strengths and weaknesses, with no single model considered
definitive or outperforming the other models, and this is an
evolving field of science. Nonetheless, results from these analyses
are consistent across the various models; they also are consistent
with the original primary and secondary endpoint results. Together,
the REDUCE-IT recurrent event analyses and the original primary and
key secondary endpoint analyses support the robustness of the
clinical benefit of VASCEPA therapy in reducing cardiovascular
risk.
Need Is Acute for a Cost-Effective, Preventative-Care Therapy
Like VASCEPA
Despite current treatment options, in
the United States, there is one
stroke and one heart attack each occurring on average every 40
seconds, and one cardiovascular death occurring on average every 38
seconds, or, in aggregate one such cardiovascular event every 14
seconds.4,5 Cardiovascular disease costs in the United States are in excess of
$500 billion each year, making it the
nation's most expensive disease.6 The number of
cardiovascular deaths is also increasing, serving as the No. 1
cause of death for men and women in the
United States.7 These facts point to an acute
need for more innovation in the cardiovascular disease therapeutic
area.
Since statin therapy was introduced nearly three decades ago,
healthcare professionals have sought effective preventative care
treatment options to reduce persistent cardiovascular risk beyond
management of cholesterol. Many potential solutions failed to show
favorable effects in cardiovascular outcomes studies. The
development of VASCEPA included learnings from these failures and
now VASCEPA is the first and only drug to succeed in reducing that
risk in the patient group included in the new VASCEPA label.
Recently, a health economics study conducted by an expert group
presented at the American Heart Association 2019 Scientific
Sessions showed that use of VASCEPA offers potential cost savings
for the overall healthcare system (i.e., the cost of VASCEPA is
offset by cost savings from reducing the occurrence of high-cost
major adverse cardiovascular events).7 This rare finding
follows conclusions from a separate independent drug pricing
watchdog group that found VASCEPA cost effective for cardiovascular
risk reduction, a result seldom achieved in this organization's
analyses.8
Based on the unprecedented results of the REDUCE-IT outcomes
study, multiple professional societies have updated guidelines or
issued advisories to incorporate icosapent ethyl, including the
American Diabetes Association,9 the European Society of
Cardiology, The European Atherosclerosis Association,10
and the National Lipid Association.11
Today's announced new indication for VASCEPA is incremental to
its indication for which it was initially FDA approved, as an
adjunct to diet to reduce triglyceride levels in adult patients
with severe (≥500 mg/dL) hypertriglyceridemia. The effect of
VASCEPA on the risk for pancreatitis in patients with severe
hypertriglyceridemia has not been determined.
"In achieving this expanded indication, Amarin appreciates the
FDA's guidance in the design and conduct of multiple clinical
trials of VASCEPA across the past decade and for its diligence in
reviewing the results of these studies," said Steven Ketchum, Ph.D., senior vice president and
president, research & development and chief scientific officer,
Amarin. "Moreover, Amarin is grateful to the thousands of patients
and clinical sites who participated in the extensive study of
VASCEPA, which exceeded 37,000 patient-years of study in the
clinical development program. Amarin also thanks its dedicated
employees and advisors who overcame many challenges to achieve this
important life-saving accomplishment."
Revenue Guidance Updated for 2019 and Provided for
2020
Amarin last updated its revenue guidance for 2019 in its press
release dated July 2, 2019.
Amarin now makes the following update to that guidance and issues
its first guidance for 2020:
With respect to the year ending December
31, 2019, while the year is not yet complete, Amarin
increases its guidance for total net revenue to a range of
$410 to $425
million. Prior guidance for this period given in
July 2019 was total net revenue in a
range of $380 to $420 million. The midpoint of this new full-year
2019 guidance, $417.5 million, would
represent an increase of approximately 82% over full year 2018
results.
With respect to 2020, Amarin projects that total net revenue
will be in a range of $650 to
$700 million, mostly from sales of
VASCEPA in the United States.
Amarin is providing this projected revenue guidance for 2020 and
has based its projection on a number of factors, including, but not
limited to, expectations on market acceptance of the newly expanded
label for VASCEPA and current plans for expanded promotion. VASCEPA
revenues are anticipated to continue to increase in 2020,
accompanied by quarterly industry variability, including recurring
seasonal factors, particularly in the first quarter. Given that it
takes time to educate providers and patients, Amarin expects a
delayed impact from planned promotional programs either because
they are new, such as the impact of new sales representatives, or,
in the case of direct-to-consumer promotion, because separate
regulatory approval is required and not currently expected until
mid-2020. In addition, while multiple studies have concluded
that VASCEPA is cost effective, how managed care organizations will
react to a cost-effective therapy lacks adequate precedent.
Beyond 2020, Amarin believes that VASCEPA total net revenue will
grow to reach multiple billions of dollars. However, the history of
other therapies for chronic conditions suggests that growth builds
over multiple years. At this time, the company is not providing
guidance regarding annual revenue levels beyond 2020.
Conference Call and Webcast Information:
Amarin will
host a conference call Monday, December
16, at 7:30 a.m. ET to discuss
this information. The conference call can be heard live on the
investor relations section of the company's website at
www.amarincorp.com, or via telephone by dialing 877-407-8033 within
the United States, 201-689-8033
from outside the United States, or
by using the call back feature at https://bit.ly/35nxY8k. A replay
of the call will be made available for a period of two weeks
following the conference call. To hear a replay of the call, dial
877-481-4010, PIN: 56897. A replay of the call will also be
available through the company's website shortly after the call.
About VASCEPA® (icosapent ethyl)
Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the FDA comprised
solely of the active ingredient, icosapent ethyl (IPE), a unique
form of eicosapentaenoic acid. VASCEPA was initially launched in
the United States in 2013 based on
the drug's initial FDA approved indication for use as an adjunct
therapy to diet to reduce triglyceride levels in adult patients
with severe (≥500 mg/dL) hypertriglyceridemia. Since launch,
VASCEPA has been prescribed over eight million times and is covered
by most major medical insurance plans. The new, cardiovascular risk
indication for VASCEPA was approved by the FDA in December 2019.
Indications and Limitation of Use
VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
-
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for
cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of
its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of
atrial fibrillation or atrial flutter requiring hospitalization in
a double-blind, placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of
atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or
shellfish are at an increased risk of an allergic reaction to
VASCEPA. Patients with such allergies should discontinue VASCEPA if
any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of
bleeding in a double-blind, placebo-controlled trial. The incidence
of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants
and/or anti-platelet agents for bleeding should be monitored.
Key clinical effects of VASCEPA on major adverse cardiovascular
events are included in the Clinical Studies section of the
prescribing information for VASCEPA, as set forth below:
Effect of VASCEPA on Time to First Occurrence
of Cardiovascular Events in Patients with Elevated Triglyceride
Levels and Other Risk Factors for Cardiovascular Disease in
REDUCE-IT
|
VASCEPA
|
Placebo
|
VASCEPA vs Placebo
|
N =
4089
n
(%)
|
Incidence
Rate (per 100
patient
years)
|
N =
4090 n
(%)
|
Incidence
Rate (per 100
patient
years)
|
Hazard Ratio
(95% CI)
|
Primary composite
endpoint
|
Cardiovascular death,
myocardial infarction, stroke, coronary revascularization,
hospitalization for unstable angina (5-point MACE)
|
705
(17.2)
|
4.3
|
901
(22.0)
|
5.7
|
0.75
(0.68,
0.83)
|
Key secondary
composite endpoint
|
Cardiovascular death,
myocardial infarction, stroke (3-point MACE)
|
459
(11.2)
|
2.7
|
606
(14.8)
|
3.7
|
0.74
(0.65,
0.83)
|
Other secondary
endpoints
|
Fatal or non-fatal
myocardial infarction
|
250
(6.1)
|
1.5
|
355
(8.7)
|
2.1
|
0.69
(0.58,
0.81)
|
Emergent or urgent
coronary revascularization
|
216
(5.3)
|
1.3
|
321
(7.8)
|
1.9
|
0.65
(0.55,
0.78)
|
Cardiovascular death
1
|
174
(4.3)
|
1.0
|
213
(5.2)
|
1.2
|
0.80
(0.66,
0.98)
|
Hospitalization for
unstable angina 2
|
108
(2.6)
|
0.6
|
157
(3.8)
|
0.9
|
0.68
(0.53,
0.87)
|
Fatal or non-fatal
stroke
|
98
(2.4)
|
0.6
|
134
(3.3)
|
0.8
|
0.72
(0.55,
0.93)
|
[1] Includes
adjudicated cardiovascular deaths and deaths of undetermined
causality.
[2] Determined to be
caused by myocardial ischemia by invasive/non-invasive testing and
requiring emergent hospitalization.
|
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT
WWW.VASCEPA.COM.
About Amarin
Amarin Corporation plc. is a rapidly
growing, innovative pharmaceutical company focused on developing
and commercializing therapeutics to cost-effectively improve
cardiovascular health. Amarin's lead product,
VASCEPA® (icosapent ethyl), is available by
prescription in the United States,
Lebanon and the United Arab Emirates. Amarin, together with
its commercial partners in select geographies, is pursuing
additional regulatory approvals for VASCEPA in Canada, China, the European Union and the Middle East. For more information about
Amarin, visit www.amarincorp.com.
Forward-Looking Statements
This press release contains
forward-looking statements, including expectations regarding
commercial expansion and the use of VASCEPA to potentially
help millions of patients, revenue and prescription growth,
including updated revenue guidance for 2019 and guidance for 2020
and beyond; sales force expansion and marketing initiatives
expected in 2019 and beyond; managed care acceptance; the
applicability and reliability of REDUCE-IT results and cost
effectiveness data. These forward-looking statements are not
promises or guarantees and involve substantial risks and
uncertainties. In addition, Amarin's ability to effectively
commercialize VASCEPA will depend in part on its ability to
continue to effectively finance its business, efforts of third
parties, its ability to gain regulatory approvals, create market
demand for VASCEPA through education, marketing and sales
activities, to achieve market acceptance of VASCEPA, to receive
adequate levels of reimbursement from third-party payers, to
develop and maintain a consistent source of commercial supply at a
competitive price, to comply with legal and regulatory requirements
in connection with the sale and promotion of VASCEPA and to
maintain patent protection for VASCEPA. Among the factors that
could cause actual results to differ materially from those
described or projected herein include the following: uncertainties
associated generally with acceptance of clinical trial results and
related regulatory approvals; the risk that sales may not meet
expectations and related cost may increase beyond expectations; the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents sufficient to protect
the VASCEPA franchise. A further list and description of these
risks, uncertainties and other risks associated with an investment
in Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including its most recent quarterly report
on Form 10-Q. Existing and prospective investors are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Amarin undertakes no obligation
to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(investor.amarincorp.com), including but not limited to investor
presentations and investor FAQs, Securities and Exchange Commission
filings, press releases, public conference calls and webcasts. The
information that Amarin posts on these channels and websites could
be deemed to be material information. As a result, Amarin
encourages investors, the media, and others interested in Amarin to
review the information that is posted on these channels, including
the investor relations website, on a regular basis. This list of
channels may be updated from time to time on Amarin's investor
relations website and may include social media channels. The
contents of Amarin's website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Amarin Contact Information
Investor
Inquiries:
Elisabeth
Schwartz
Investor Relations
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Solebury Trout
In U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:
Gwen
Fisher
Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 325-0735
pr@amarincorp.com
References
1 Fan W, Philip S, Toth PP, et al. Prevalence of
United States adults with
triglycerides ≥ 135 mg/dL: NHANES 2007–2014. Cardiol J. 2019;26(5).
DOI: 10.5603/CJ.2019.0000.
2 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk
Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J
Med 2019;380:11-22.
3 Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent
Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol
2019; 73:2791-2802.
4 American Heart Association: Heart Disease and Stroke
Statistics -- 2019 At-a-Glance.
5 American Heart Association. Heart Disease and Stroke
Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31,
2019.
6 American Heart Association. 2017. Cardiovascular disease: A
costly burden for America projections through 2035.
7 Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT.
https://www.abstractsonline.com/pp8/#!/7891/presentation/35097.
8 https://icer-review.org/wp-content/uploads/2019/02/ICER_CVD_Final_Evidence_Report_10.17.19.pdf.
9 American Diabetes Association. [web annotation]. Diabetes
Care 2019;42(Suppl.1):S103–S123.
10 Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS
Guidelines for the management of dyslipidaemias: lipid modification
to reduce cardiovascular risk. Eur Heart
J. 2019; ehz455. doi: 10.1093/eurheartj/ehz455.
11 Orringer CE, Jacobson TA, Maki KC. National Lipid
Association scientific statement on the use of icosapent ethyl in
statin-treated patients with elevated triglycerides and high- or
very-high ASCVD risk. J Clin Lipidol. 2019. doi:
10.1016/j.jacl.2019.10.014.
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SOURCE Amarin Corporation plc