Amarin Corporation plc (NASDAQ:AMRN) today shared positive,
statistically significant top-line results from Protocol Number
EDPC003R01, a Phase 3 clinical trial of VASCEPA® (icosapent ethyl)
conducted in China by Amarin partner, Edding. The study, which
investigated VASCEPA as a treatment for patients with very high
triglycerides (≥500 mg/dL), met its primary efficacy endpoint as
defined in the clinical trial protocol and demonstrated a safety
profile similar to placebo. The findings are being prepared to
support Edding’s dossier for seeking regulatory approval of VASCEPA
in Mainland China.
The EDPC003R01 trial was a multi-center,
randomized, double-blind, placebo-controlled, 12-week pivotal study
in adult patients in China with qualifying fasting triglyceride
(TG) levels greater than or equal to 500 mg/dL and less than or
equal to 2000 mg/dL. The median baseline TG levels in the
study were 812 mg/dL and 837 mg/dL for the patients assigned to
placebo (n=123) and 4 grams per day of VASCEPA (n=122),
respectively. Prior to randomization into the 12-week double-blind
treatment period, all patients underwent a six- to eight-week
washout period of lipid altering drugs, as well as diet and
lifestyle stabilization.
The study’s primary endpoint, the percent change
in TG levels from baseline to week 12, was met for the 4 gram per
day VASCEPA dose group. The patient group assigned to 4 grams per
day of VASCEPA showed a statistically significant median TG
decrease of 19.9% (p<0.001) compared to placebo at the end of
the 12-week treatment period.
Consistent with Amarin’s MARINE study in a
similar patient population, the 4 gram per day dose of VASCEPA in
the EDPC003R01 trial did not result in a significant median
increase from baseline in low-density lipoprotein cholesterol
(LDL-C) compared to placebo at the end of the 12-week treatment
period. The primary results of MARINE were published in the
American Journal of Cardiology1 in June 2011. Results from the
MARINE study were the basis for VASCEPA’s initial approval in the
United States for triglyceride lowering before the successful
results of the REDUCE-IT® cardiovascular outcomes study.
Importantly, the VASCEPA 4 gram per day dose in
EDPC003R01 appeared to be well-tolerated with a safety profile
similar to placebo. There were no treatment-related serious adverse
events in the EDPC003R01 study.
“We are proud to share news of these positive
data from our partner’s pivotal Phase 3 clinical study of VASCEPA
in China. Elevated triglycerides are a known marker of risk for
pancreatitis and for cardiovascular disease. The statistically
significant reduction in TG levels seen with the VASCEPA 4 gram per
day dose in the study highlights its potential to address an unmet
medical need in China, where hypertriglyceridemia is on the rise,”
said Steven Ketchum, Ph.D., senior vice president and president,
research & development and chief scientific officer at Amarin.
“This pivotal study in China mirrored Amarin’s MARINE study in
patients from the United States and other countries, and we are
pleased that the data show consistency across the Chinese and
non-Chinese study populations. With these favorable data, we now
look forward to supporting our partner, Edding, in compiling and
submitting its dossier at the earliest possible opportunity for
regulatory review in China.”
“We are very pleased that the Phase III clinical
study of VASCEPA in Mainland China has achieved positive results.
Cardiovascular (CV) disease is the largest cause of death in China
with significant unmet needs to address. Prevention and treatment
of CV diseases is one of the major initiatives promoted by Health
China 2030. VASCEPA is anticipated to be launched to further
address these pressing needs. We will try our best to promote
VASCEPA to market as soon as possible in order to benefit more
Chinese patients," said Mr. Xin Ni, founder, chairman and CEO of
Edding. "VASCEPA has huge commercial potential in the fast-growing
Chinese market. We will work with Amarin to submit the new drug
application as soon as possible to bring this cross-era innovative
drug to China.”
Amarin intends to support Edding in its pursuit
of an appropriate label for VASCEPA in China reflecting the results
of EDPC003R01 and all other available data supporting the safety
and efficacy of VASCEPA.
About EddingEdding is a
leading integrated pharmaceutical company in China. Edding’s vision
is to become a leading ‘Global for China' pharmaceutical
company focusing on three core therapeutic areas, namely
anti-infectives, cardiovascular disease and respiratory system, by
leveraging Edding’s market-tested full value chain capabilities.
For more information about Edding, visit www.eddingpharm.com.
About
Hypertriglyceridemia in
ChinaThere were approximately 180.4 million
hypertriglyceridemia (HTG) patients in China in 2019, representing
approximately 20.2% of the adult population. Among all HTG patients
in China, there were approximately 9 million adults who had very
high TG levels (≥500 mg/dL). In 2019, there were approximately 36.1
million statin-treated adult patients in China with elevated TG
levels (≥150 mg/dL) and either established CVD or diabetes mellitus
and two or more additional risk factors for CVD, the addressable
patients of the FDA-approved indication for reducing CV events of
VASCEPA in China.
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, Canada, Lebanon and the United Arab Emirates. VASCEPA is
not yet approved and available in any other countries. Amarin, on
its own or together with its commercial partners in select
geographies, is pursuing additional regulatory approvals for
VASCEPA in China, Europe and the Middle East. For more information
about Amarin, visit www.amarincorp.com.
About
VASCEPA®
(icosapent ethyl)
CapsulesVASCEPA (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. VASCEPA 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 UseVASCEPA 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 should be
monitored for bleeding.
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 = 4089n (%) |
Incidence Rate (per 100 patient
years) |
N = 4090n (%) |
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.
Forward-Looking Statements This
press release contains forward-looking statements, including
statements regarding the potential impact of VASCEPA in clinical
use and expectations for regulatory filings and approval
submissions. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. Among
the factors that could cause actual results to differ materially
from those described or projected herein include the following:
uncertainties associated generally with research and development,
clinical trials and regulatory reviews. 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.
Amarin’s forward-looking statements do not reflect the potential
impact of significant transactions the company may enter into, such
as mergers, acquisitions, dispositions, joint ventures or any
material agreements that Amarin may enter into, amend or
terminate.
Availability of Other Information About
AmarinInvestors 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:Investor RelationsAmarin
Corporation plcIn U.S.: +1 (908) 719-1315 IR@amarincorp.com
(investor inquiries)
Solebury Troutlstern@soleburytrout.com
Media Inquiries:Alina
KolomeyerCommunicationsAmarin Corporation plcIn U.S.: +1 (908)
892-2028 PR@amarincorp.com (media inquiries)
________________________1 Bays HE, Ballantyne
CM, Kastelein JJ et al. Eicosapentaenoic Acid Ethyl Ester (AMR101)
Therapy in Patients with Very High Triglyceride Levels (from the
Multi-center, plAcebo-controlled, Randomized, double-blINd, 12-week
study with an open-label Extension [MARINE] Trial). Am J Cardiol.
2011;108:682-690.
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024