Amarin Corporation plc (NASDAQ:AMRN) is pleased to announce that
Health Canada has approved the use of VASCEPA® (icosapent ethyl) to
reduce the risk of cardiovascular events (cardiovascular death,
non-fatal myocardial infarction, non-fatal stroke, coronary
revascularization or hospitalization for unstable angina) in
statin-treated patients with elevated triglycerides, who are at
high risk of cardiovascular events due to established
cardiovascular disease, or diabetes, and at least one other
cardiovascular risk factor. This is the first and only approval by
Health Canada of any drug for this important indication. The
approval was achieved through Amarin’s commercial licensee for
VASCEPA in Canada, HLS Therapeutics, Inc. (“HLS”). Pursuant to an
agreement announced in 2017, HLS has exclusive commercial rights to
VASCEPA in the Canadian market.
“We congratulate HLS on securing this important
approval of VASCEPA. We are confident that HLS will work to
educate healthcare professionals across Canada on the life-saving
and risk-reducing effects of VASCEPA. HLS is managed by an
experienced and capable team of pharmaceutical industry
professionals and we look forward to witnessing their progress,”
stated John F. Thero, president and chief executive officer of
Amarin.
The approval of VASCEPA by Health Canada
positions this important drug to address a large unmet medical
need. In clinical study of VASCEPA over approximately five years of
patient follow-up, approximately 28 percent of patients 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.1 As evidenced by
this MACE occurrence, there is a group of patients who, despite
controlling their cholesterol on statin therapy, continue to have
persistent high cardiovascular risk. As reflected in the Health
Canada approved label, VASCEPA demonstrated a 25% relative risk
reduction in the first occurrence of MACE in these high-risk
patients. More information regarding clinical studies of VASCEPA
can be found at www.amarincorp.com.
The approval of VASCEPA by Health Canada follows
the recent approval of a similar indication for VASCEPA in the
United States. On December 13, 2019, the United States Food and
Drug Administration (FDA) expanded the indicated use of VASCEPA to
include use “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.”
Under the previously announced terms of the
Amarin-HLS’s agreement, in 2017 HLS paid Amarin $5.0 million to
in-license the exclusive Canadian rights to VASCEPA and in 2018
paid an additional $2.5 million following reporting of successful
clinical outcomes study (REDUCE-IT) results for VASCEPA.
Furthermore, under the terms of this agreement, Amarin will receive
$2.5 million as a result of today's approval by Health Canada and
is eligible to receive more than $50.0 million in additional
milestone payments, most of which are sales-based milestones.
Amarin is responsible for supplying VASCEPA for sale in Canada on a
cost-plus basis. In addition to milestone and supply payments, the
agreement for commercialization in Canada provides for payment to
Amarin of double-digit royalties on VASCEPA net sales in
Canada. HLS currently expects Canadian sales of VASCEPA to
reach between CAD $150 and $250 million per year.
Pricing of VASCEPA in Canada will be jointly
established by the parties. In the United States, two separate
health economic studies presented in recent months conclude that
VASCEPA is cost-effective. Such analyses suggested that the price
of VASCEPA in the United States could be considerably higher and
still remain cost-effective. These findings reflect the affordable
pricing of VASCEPA in the United States and the relatively high
costs of MACE, such as heart attacks and stroke, which VASCEPA
helps avoid.
Vascepa is the subject of numerous Canadian
issued patents and pending patents with expiration dates which
could extend to 2039. The eligible patents will be added to
Health Canada’s Patent Register following receipt of NOC and in
accordance with Health Canada’s process.
Pursuant to this approval, VASCEPA is now
approved in three countries in addition to the United States,
Canada, United Arab Emirates and Lebanon. Amarin, together with its
commercial partners in select geographies, is pursuing additional
regulatory approvals for VASCEPA in China, the European Union, the
Middle East and North Africa, and is evaluating other regions for
potential regulatory filings.
About Cardiovascular
Disease
Cardiovascular disease and an enormous and
growing medical issue worldwide.2,3 In the United States
alone, from cardiovascular disease a person experiences a heart
attack, stroke, death or other MACE every 14 seconds.2,4
Controlling bad cholesterol, also known as
LDL-C, is one way to reduce a patient’s risk for cardiovascular
events, such as heart attack, stroke or death. However, even with
the achievement of target LDL-C levels, millions of patients still
have significant and persistent risk of cardiovascular events,
especially those patients with high triglycerides. Statin therapy
has been shown to control LDL-C, thereby reducing the risk of
cardiovascular events by 25-35% – but that still leaves 65-75% of
risk remaining.5 People with high triglycerides have 35% more
cardiovascular events compared to people with normal (in range)
triglycerides taking statins.6,7,8
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 (United
States)
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 (United States)
- 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 U.S. 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 |
VASCEPAvs Placebo |
N = 4089n (%) |
Incidence Rate(per 100patient years) |
N = 4090n (%) |
Incidence Rate(per 100patient 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 UNITED STATES
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, and is expected to be available in
Canada through an anticipated February 2020 commercial launch.
Amarin, together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in China, the European Union and the Middle East. For more
information about Amarin, visit www.amarincorp.com.
About HLS Therapeutics
Inc.Formed in 2015, HLS is a specialty pharmaceutical
company focused on the acquisition and commercialization of late
stage development, commercial stage promoted and established
branded pharmaceutical products in the North American markets.
HLS’s focus is on products targeting the central nervous system and
cardiovascular therapeutic areas. HLS’s management team is composed
of seasoned pharmaceutical executives with a strong track record of
success in these therapeutic areas and at managing products in each
of these lifecycle stages. For more information visit:
www.hlstherapeutics.com
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding regulatory submissions
and approvals and commercialization of VASCEPA in Canada and other
markets, as well as timing related thereto, potential milestone and
other payments to be paid to Amarin, commercial market expectations
including pricing and sales potential, the applicability and
reliability of REDUCE-IT results, and cost effectiveness data
expectations regarding commercial expansion and the use of VASCEPA.
These forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. In addition, Amarin's
ability, directly or through licensees, 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 exclusivity through grant of regulatory exclusivity and
through patent protection for VASCEPA in various markets. 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 exclusivity may not be obtained by
governing authorities and 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
InformationInvestor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646)
378-2992lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
CommunicationsAmarin Corporation plcIn U.S.: +1 (908)
325-0735pr@amarincorp.com
References________________________
1 Bhatt DL, Steg PG, Miller M, Brinton EA,
Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C,
Tardif JC, Ballantyne CM. Cardiovascular Risk Reduction with
Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med
2019;380:11-22.2 American Heart Association. Heart Disease and
Stroke Statistics – 2019 Update: A Report from the American Heart
Association. Published January 31, 2019.3 American Heart
Association / American Stroke Association. 2017. Cardiovascular
disease: A costly burden for America projections through 2035.4
American Heart Association: Heart Disease and Stroke Statistics --
2019 At-a-Glance.5 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need
for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.6 Budoff M.
Triglycerides and triglyceride-rich lipoproteins in the causal
pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.7
Toth PP, Granowitz C, Hull M, et al. High triglycerides are
associated with increased cardiovascular events, medical costs, and
resource use: A real-world administrative claims analysis of
statin-treated patients with high residual cardiovascular risk. J
Am Heart Assoc. 2018;7(15):e008740.8 Nordestgaard BG.
Triglyceride-rich lipoproteins and atherosclerotic cardiovascular
disease - New insights from epidemiology, genetics, and biology.
Circ Res. 2016;118:547-563.
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