Amarin Corporation plc (NASDAQ:AMRN) and Lotus Pharmaceuticals
(1795:TT; “Lotus”) today announced that the two companies have
entered into a long-term exclusive partnership to distribute and
commercialize VAZKEPA® (icosapent ethyl) across 10 countries,
including nine in Southeast Asia (the Association of Southeast
Asian Nations - ASEAN) and South Korea.
VAZKEPA capsules have been approved and commercialized in a
number of global markets, including the U.S. and European markets,
as the first prescription treatment comprised solely of the active
ingredient, icosapent ethyl, a highly purified form of
eicosapentaenoic acid (EPA).
"We are excited to announce this exclusive partnership with
Lotus, a leading pharmaceutical commercialization partner in Asia,”
said Patrick Holt, President & CEO, Amarin. “Lotus’ strong
commercialization capabilities and footprint across ASEAN markets
and South Korea make them the ideal partner to help us expand
patient access to VAZKEPA -- an innovative treatment option to
reduce cardiovascular risk -- across the region and fuel our
international growth.”
Petar Vazharov, Chief Executive Officer of Lotus, commented, "We
are thrilled to embark on this strategic partnership with Amarin.
This agreement aligns seamlessly with Lotus' strategic objective to
bring novel and transformative treatments to patients and allows us
the opportunity to further leverage our commercial infrastructure
that we have built in key markets across Asia."
The ASEAN region and South Korea includes a total of 14 million
statin-treated patients representing a total hyperlipidemia market
of approximately $2 billion.i The largest markets within the ASEAN
region include Thailand, Malaysia and
Philippines.i Cardiovascular disease (CVD) remains the leading
cause of morbidity, mortality, and health care costs in South
Korea.ii
Under the terms of the agreement, Lotus will have exclusive
rights to distribution and commercial promotion for VAZKEPA in
South Korea and nine countries in ASEAN: Brunei, Cambodia,
Indonesia, Malaysia, Myanmar, the Philippines, Singapore, Thailand,
and Vietnam. As part of the agreement, Amarin will receive an
upfront payment as well as pricing and reimbursement and sales
milestone payments based on net sales of the product. Amarin will
be responsible for supplying finished product to Lotus at a
pre-defined supply price.
About
Amarin
Amarin is an innovative pharmaceutical company leading a new
paradigm in cardiovascular disease management. We are committed to
increasing the scientific understanding of the cardiovascular risk
that persists beyond traditional therapies and advancing the
treatment of that risk for patients worldwide. 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.
About Lotus Pharmaceuticals
Founded in 1966, Lotus (1795: TT) is an international
pharmaceutical company with global presence, focused on
commercializing novel and generic pharmaceuticals, offering
patients better, safer and more accessible medicines. The Company
has a recognized best-in-class R&D and manufacturing platform
in Asia and has established partnerships in nearly every global
market including the U.S., Europe, Japan, China, and Brazil. Lotus
runs over 100 strategically selected pharmaceutical projects in
development and registrations across Asia and the US, with over 250
commercial products. The Company invests in diversified best
portfolio consisting of high-barrier oncology, complex generics as
well as 505(b)2 and NCE via internal R&D investment and
licensing-in partnership, and also strengthens its portfolio
competitiveness by adding biosimilar products with support from
strategic partners. Its industry-leading infrastructure certified
by most of the advanced regulatory authorities around the world,
including US FDA, EU EMA, Japan PMDA, China FDA, and Brazil
ANVISA.
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 over 18 million times.
In addition to the United States, icosapent ethyl is approved and
sold in Canada, Lebanon, 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 factor1. 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 Sweden, Denmark, Finland, Austria and the UK.
Forward-Looking Statements
This press release contains forward-looking statements which are
made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, including beliefs about
Amarin’s partnership in the ASEAN region and South Korea and the
potential impact in those territories; Amarin’s overall efforts to
expand access and reimbursement to VAZKEPA across global markets;
and the overall potential and future success of VASCEPA/VAZKEPA
generally. These forward-looking statements are not promises or
guarantees and involve substantial risks and uncertainties. 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 full year
ended 2022. 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
Amarin
Amarin communicates with its investors and the public using the
company website (www.amarincorp.com) and the investor relations
website (investor.amarincorp.com), including but not limited to
investor presentations and 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: Jordan Zwick Amarin Corporation plc
IR@amarincorp.com Media
Inquiries: Mark Marmur Amarin Corporation
plc PR@amarincorp.com
1 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 Nov 2022]
i Source: IQVIA MAT 1Q 2022ii Implementation of National Health
Policy for the Prevention and Control of Cardiovascular Disease in
South Korea: Regional-Local Cardio-Cerebrovascular Center and
Nationwide Registry. Korean Circulation Journal 2021; 51(5):
383-398. Published online: 12 April 2021DOI:
https://doi.org/10.4070/kcj.2021.0001
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