Amarin Corporation plc (NASDAQ: AMRN) today announced that NICE has
issued its final guidance recommending VAZKEPA® (icosapent ethyl)
for reimbursement and use across the National Health Service (NHS)
in England and Wales to help reduce the risk of major CV events in
high-risk statin-treated patients with eCVD, at a price of £144.21
per 120 soft capsules (i.e. 30 day supply; the equivalent of
approximately 171 EUR or 172 USD*).
This announcement marks a major milestone for
Amarin globally and in the UK, as following final guidance, all
local NHS formularies in England and Wales will need to make
VAZKEPA available within 90 and 60 days, respectively. Today’s
final guidance also further supports the successful execution of
Amarin’s European growth strategy, and the Company’s efforts to
unlock the multi-billion-dollar revenue opportunities for the
product outside of the U.S.**
Karim Mikhail, president and chief executive
officer of Amarin said, “Receiving this final guidance from NICE is
a significant moment, as it is another important step in our
international expansion. Our teams in Europe are working incredibly
hard to ensure a successful launch of VAZKEPA, so we can help
transform the lives of CV patients across the region and move
closer to realizing our bold vision of reaching the day when heart
disease is no longer a leading cause of death.”
The publication of the final guidance supports
the growing recognition of VAZKEPA’s clinical benefits. It is the
last step in the NICE Health Technology Appraisal (HTA) process,
used to assess the clinical benefits and cost-effectiveness of
medicines and treatments in England to ensure the NHS uses its
resources fairly and cost-effectively. Based on the collaborative
relationship between the Welsh Government and the All-Wales
Medicines Strategy Group (AWMSG), the final NICE guidance will also
be implemented across the NHS in Wales, in line with the devolved
powers of the Welsh Assembly.
Commenting on today’s news, Laurent Abuaf,
senior vice president and president, Amarin Europe said, “We have a
once in a generation opportunity to transform the lives of
cardiovascular patients across Europe, and today’s announcement
regarding NICE’s final guidance will help us realize that mission
in one of our key markets. Following the successful completion of
the HTA assessment in the UK, and the positive reimbursement
guidance, our local teams in every country in Europe will be
inspired by how the UK will be prioritizing access to local health
economies. Our teams in the UK will of course work tirelessly to
make this medicine available across the whole territory in the
coming months.”
Off the back of this success, Amarin continues
to drive forward reimbursement discussions in other major European
markets and remains on track to receive pricing decisions in up to
eight countries with plans to launch VAZKEPA in up to six European
countries this year.
*Based on exchange rate of EUR and USD as of the
date of this release.** U.S. Dollar
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,
Zug in Switzerland, and other countries in Europe 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 VAZKEPA® (icosapent ethyl)
Capsules
VAZKEPA capsules are the first prescription
treatment comprised solely of the active ingredient, icosapent
ethyl, a highly purified form of eicosapentaenoic acid. Since
launch, icosapent ethyl has been prescribed more than 18 million
times globally. In addition to the United States, icosapent ethyl
is approved and sold in Canada, Lebanon and the United Arab
Emirates under the brand name VASCEPA. In March 2021, marketing
authorization was granted to icosapent ethyl in the European Union
under the brand name VAZKEPA to reduce the risk of cardiovascular
events in adult statin-treated patients at high cardiovascular risk
with elevated triglycerides (≥ 150 mg/dL [≥ 1.7 mmol/L]) and
established cardiovascular disease or diabetes and at least one
other cardiovascular risk factor3. In April 2021 marketing
authorization for VAZKEPA (icosapent ethyl) was granted in Great
Britain (applying to England, Scotland and Wales). VAZKEPA
(icosapent ethyl) is currently approved and sold in Europe in
Germany, Sweden, Denmark and the UK.
EU Product Information
VAZKEPA® SOFT CAPSULES This medicine is subject to additional
monitoring. This will allow quick identification of new safety
information. Healthcare professionals are asked to report any
suspected adverse reactions.
Indication: Vazkepa is indicated to reduce the risk of
cardiovascular events in adult statin-treated patients at high
cardiovascular risk with elevated triglycerides (≥150 mg/dL; ≥ 1.7
mmol/L) and either: established cardiovascular disease, or diabetes
and at least one other cardiovascular risk factor.
Further information about the Summary of Product Characteristics
(SmPC) for VAZKEPA® in Europe, can be found here.
Globally, prescribing information varies; please refer to the
individual country product label for complete information.
Forward-Looking StatementsThis press release
contains forward-looking statements which are made pursuant to the
safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, including, but not limited to, beliefs about
the market potential for VAZKEPA; expectations regarding
performance such as prescription growth and market access for
VAZKEPA; plans for Amarin’s go-to-market model in the UK; the
timing and outcome of related reimbursement decisions and
commercial launches in the UK and elsewhere; and expectations for
the timing, effectiveness and outcome of promotional activities.
These forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties, including, with
respect to the UK, Amarin’s ability to effectively commercialize
VAZKEPA and maintain or grow market share will depend in part on
Amarin’s ability to continue to effectively finance its business;
Amarin’s ability to create and increase market demand and achieve
broad market acceptance for VAZKEPA; to develop and maintain a
consistent source of commercial supply at a competitive price; and
to comply with legal and regulatory requirements in connection with
the sale and promotion of VAZKEPA. Among the factors that could
cause actual results to differ materially from those described or
projected include the following: the risk that Amarin has
overestimated the market potential for VAZKEPA; risks associated
with Amarin's expanded enterprise; uncertainties associated
generally with research and development, clinical trials and
related regulatory approvals; and the risk that sales may not meet
expectations and related costs may increase beyond expectations. 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 Amarin’s annual report on Form 10-K for the year ended
December 31, 2021, filed on or about the date hereof. Existing
and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date they are made. Amarin undertakes no obligation to update or
revise the information contained in its forward-looking statements,
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, U.S. 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 U.S. Securities Act of 1933.
Amarin Contact
Information
Media Inquiries:
Mark MarmurCommunications Amarin Corporation plc
PR@amarincorp.com
Investor Inquiries: Lisa
DeFrancesco Investor Relations Amarin Corporation
plc investor.relations@amarincorp.com
________________________________________________________________________________________________
1 National Institute for Health and Care Excellence. Final
Guidance: Icosapent ethyl with statin therapy for reducing the risk
of cardiovascular events in people with raised triglycerides
[ID3831]. NICE; 2022.
https://www.nice.org.uk/guidance/gid-ta10736/documents/final-appraisal-determination-document.
Accessed July 2022.2 VAZKEPA (icosapent ethyl) Summary of Product
Characteristics (April 2022)
https://www.medicines.org.uk/emc/product/12964/smpc#gref. Accessed
July 2022.3 Vazkepa® (icosapent ethyl): Summary of Product
Characteristics. Available from:
https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf
[accessed July 2022]
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