Amarin Corporation plc (NASDAQ: AMRN) today provided updates
regarding its plans for the commercial launch of VAZKEPA (icosapent
ethyl) in Europe following the March 30, 2021 announcement of
receipt of market authorization from the European Commission (EC).
VAZKEPA is the first EC-approved product to be marketed and sold
for cardiovascular risk reduction in high-risk, statin-treated
adult patients who have elevated triglycerides (≥150 mg/dL) and
other risk characteristics as studied in REDUCE-IT®.
Following this approval, Amarin commenced
training sales representatives in Germany to advance pre-launch
disease and brand awareness initiatives in preparation for the
planned commercial launch of VAZKEPA in Germany before the end of
Q3 2021. The company expects to have approximately 150 sales
representatives deployed for pre-launch product and disease state
awareness programs by mid-Q2 2021.
“We have hired talented and experienced
pharmaceutical sales and marketing professionals for our European
commercial team and are activating steps to increase product and
market need awareness, while advancing our market access
negotiations,” said Karim Mikhail, senior vice president,
commercial head Europe of Amarin. “We are taking a thoughtful and
proactive approach to leveraging the vast global experience of our
team, while incorporating the learnings from other product launches
made during the COVID-19 era. We are highly motivated to
effectively launch VAZKEPA in Europe as it offers an exciting
opportunity to help patients at risk of cardiovascular events.
VAZKEPA is a safe and effective new product that benefits from more
than a decade of worldwide clinical development and testing that
support its use to significantly reduce cardiovascular events.”
Use of icosapent ethyl is now recommended by 15
medical societies for cardiovascular risk reduction reflecting that
the data supporting the effectiveness of VAZKEPA is robust, the
medical need is high and key opinion leaders in these medical
societies agree this important new drug should be used to improve
patient care. As VAZKEPA was just recently authorized in Europe as
a new drug (new active substance), and there is no other product
approved in Europe for VAZKEPA’s indication, current awareness of
VAZKEPA in Europe among healthcare professionals at-large is
relatively low.
Amarin believes that increasing awareness of
VAZKEPA in Germany and illuminating the patient population that can
benefit from this new drug are important to VAZKEPA’s early launch
success. Prior to VAZKEPA’s recent approval, as is typical for any
new drug, branded market education regarding VAZKEPA was prohibited
in Europe. Consequently, immediately following VAZKEPA’s approval
in the European Union the company has initiated its educational and
promotional plans to underscore the significant residual
cardiovascular risk for the patient population indicated for
VAZKEPA and to introduce to healthcare professionals the value
VAZKEPA has demonstrated in lowering such risk.
Starting in the second quarter 2021, outreach by
Amarin’s field force in Germany will be supplemented by various
forms of market education, including digital outreach and
omnichannel engagement for key stakeholders. Amarin’s planned
educational initiatives are intended to increase awareness among
cardiologists, diabetologists, and general practitioners. In
addition, based on the differentiated safety and efficacy profile
of this unique drug for its approved label and the growing global
data in support of its pharmacoeconomic benefits, our planned
educational efforts will also be aimed at regional payers.
As is typical of drug launches in Europe,
following approval and prior to launch, market access
(reimbursement) needs to be secured on a country-by-country basis
and product awareness of VAZKEPA needs to increase in each
country1. In seeking market access, the company expects to file
dossiers in ten (10) European countries in the coming months,
including the largest countries of Europe. Each of these dossiers
have already undergone months of preparation and include the data
demonstrating the uniqueness of VAZKEPA from a scientific
perspective, various country-specific demographic data sets to
define the eligible patient population based on the label, and
finally proposed pricing. Amarin is seeking pricing that it
believes is well justified based on the demonstrated effectiveness
of VAZKEPA and the high cost to society of heart attacks, strokes
and other cardiovascular events that VAZKEPA can help avoid while
also reducing pain and suffering for at-risk patients and their
families. After the first wave of 10 country submissions in Europe,
Amarin intends to pursue a second wave of European reimbursement
dossiers in its efforts to bring VAZKEPA to all patients who can
benefit from it.
Amarin anticipates direct access to healthcare
professionals and at-risk patients will remain constrained while
COVID-19 persists. Learning from the experience of other drugs
launched during the COVID-19 pandemic, part of the planned
multi-faceted educational programs in Europe will include increased
awareness of the unique effects of VAZKEPA. For example, key
elements of the planned education initiatives are expected to focus
on increasing the scientific awareness of the importance of
measuring and using triglyceride (TG) levels as an identifier of
cardiovascular risk, noting that VAZKEPA’s cardiovascular risk
reduction effects extend beyond TG lowering and are believed to be
multifactorial, including anti-inflammatory and antiplatelet
effects. While many people are speculating that the impact of
COVID-19 will gradually abate around the planned commercial launch
of VAZKEPA in Germany in Q3 2021, digital outreach, and other forms
of educating healthcare professionals will be emphasized to support
the work of the sales professionals being deployed. In order to
advance pre-launch market awareness of VAZKEPA, to allow time for
the impact of COVID-19 to recede and to avoid the challenges of
launching prior to the summer holiday period when access to
healthcare professionals can be more difficult, it is likely that
the launch in Germany will be the latter half of Q3. Launch timing
will be further refined after feedback is received from the
company’s early branded awareness and education initiatives.
Amarin is giving initial priority to launching
VAZKEPA in Germany while making plans for commercialization in
countries throughout Europe. Staffing in other European countries,
and launch timing in these other countries, will depend on progress
in gaining market access on a country-by-country basis.
Previously Amarin had provided guidance that its
European staffing at the end of 2021 would be approximately 200
people. Based on the company’s current plans and expectations,
Amarin now expects to grow its staffing in Europe to approximately
300 people by the end of 2021, with further increases planned as
market access is expanded in various countries. This increase in
expected staffing reflects the breadth of the EC-approved label for
VAZKEPA, positive initial feedback Amarin is receiving from
European scientific leaders, and optimism that the impact of
COVID-19 will recede during the second half of 2021.
About Amarin Amarin is an
innovative pharmaceutical company leading a new paradigm in
cardiovascular disease management. From our scientific research
foundation to our focus on clinical trials, and now our commercial
expansion, we are evolving and growing rapidly. Amarin has offices
in Bridgewater, New Jersey in the United States, Dublin in Ireland,
and Zug in Switzerland as well as commercial partners and suppliers
around the world. We are committed to rethinking cardiovascular
risk through the advancement of scientific understanding of the
impact on society of significant residual risk that exists beyond
traditional therapies, such as statins for cholesterol
management.
About REDUCE-IT®REDUCE-IT was a
global cardiovascular outcomes study designed to evaluate the
effect of VASCEPA in adult patients with LDL-C controlled to
between 41-100 mg/dL (median baseline 75 mg/dL) by statin therapy
and various cardiovascular risk factors including persistent
elevated triglycerides between 135-499 mg/dL (median baseline 216
mg/dL) and either established cardiovascular disease (secondary
prevention cohort) or diabetes mellitus and at least one other
cardiovascular risk factor (primary prevention cohort).
REDUCE-IT, conducted over seven years and
completed in 2018, followed 8,179 patients at over 400 clinical
sites in 11 countries with the largest number of sites located
within the United States. REDUCE-IT was conducted based on a
special protocol assessment agreement with FDA. The design of the
REDUCE-IT study was published in March 2017 in Clinical
Cardiology.2 The primary results of REDUCE-IT were published in The
New England Journal of Medicine in November 2018.3 The total events
results of REDUCE-IT were published in the Journal of the American
College of Cardiology in March 2019.4 These and other publications
can be found in the R&D section on the company’s website at
www.amarincorp.com.
About VASCEPA® (icosapent ethyl)
CapsulesVASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. 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 ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, Lebanon and the United Arab
Emirates. In Europe, marketing authorization was granted to
icosapent ethyl in the European Union for the reduction of risk of
cardiovascular events in patients at high cardiovascular risk,
under the brand name VAZKEPA.
Indications and Limitation of Use (in the 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
- 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 U.S. FDA-APPROVED VASCEPA
PRESCRIBING INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Forward-Looking Statements This
press release contains forward-looking statements, including
statements about the timing of promotional and educational
initiatives, the timing of market access initiatives and the
potential of VAZKEPA (known as VASCEPA in the United States) to
favorably affect cardiovascular risk in appropriate patients, to
make a difference in the lives of the many millions of patients
throughout Europe who are at risk of a cardiovascular event, with
respect to Amarin being well-positioned for a successful European
launch and related to the potential for extended patent protection.
These forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties that may individually
or together impact the matters herein and cause actual results,
events and performance to differ materially from such
forward-looking statements. Among the factors that could cause
actual results to differ materially from those described or
projected herein include the following: events that could impact
future regulatory assessment by the European Commission, such as
delays due to COVID-19 restrictions, later arising data, regulatory
reviews and pricing assessments, and the successful implementation
of commercialization plans or other information, events that could
interfere with the grant or issuance of a patent, continued
validity or enforceability of a patent; uncertainties associated
with litigation generally and patent litigation specifically;
Amarin's ability generally to maintain adequate patent protection
and successfully enforce patent claims against third parties; and
uncertainties associated generally with research and development
and regulatory submissions, reviews, action dates and approvals. 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 annual report on Form 10-K. 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
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 Troutamarinir@troutgroup.com
Media Inquiries:CommunicationsAmarin Corporation
plcIn U.S.: +1 (908) 892-2028 PR@amarincorp.com (media
inquiries)
AMARIN, VASCEPA, VAZKEPA and REDUCE-IT are trademarks of Amarin
Pharmaceuticals Ireland Limited. VAZKEPA is a registered trademark
in Europe and other countries and regions and is pending
registration in the United States.
________________________
1 For more information see the FAQ titled, What are Amarin’s
plans and timing for VAZKEPA initial commercial launch in Europe?,
in the investor relations section of the Amarin corporate website
at https://investor.amarincorp.com/. 2 Bhatt DL, Steg PG, Brinton
E, et al., on behalf of the REDUCE-IT Investigators. Rationale and
Design of REDUCE‐IT: Reduction of Cardiovascular Events with
Icosapent Ethyl–Intervention Trial. Clin Cardiol. 2017;40:138-148.3
Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction
with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med.
2019;380(1):11-22.4 Bhatt DL, Steg PG, Miller M, et al., on behalf
of the REDUCE-IT Investigators. Reduction in first and total
ischemic events with icosapent ethyl across baseline triglyceride
tertiles. J Am Coll Cardiol. 2019;74:1159-1161.
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