Amarin Corporation plc (NASDAQ:AMRN) and Neopharm Israel announced
today that the two companies have entered into an exclusive
marketing and commercialization agreement for VAZKEPA® (icosapent
ethyl) in the State of Israel, Gaza, West Bank and the territories
of the Palestinian Authority. VAZKEPA capsules are the first
prescription treatment comprised solely of the active ingredient,
icosapent ethyl, a highly purified form of eicosapentaenoic acid.
"We are excited to announce this agreement with Neopharm, a
leading provider of pharmaceutical commercialization in Israel,”
said Patrick Holt, President & CEO, Amarin. “Neopharm is
well-positioned with its commercial capabilities, as well as its
pedigree and experience in cardiology and related disease
categories, to enable access to this important medicine for
patients in Israel."
“The addition of VAZKEPA to our portfolio and the opportunity to
serve and improve the lives of Israeli statin-treated patients
suffering from cardiovascular events is a privilege,” said Efi
Shnaidman, General Manager of Neopharm Israel. “We look forward to
working together with Amarin in making VAZKEPA available and
accessible to patients.”
The agreement follows Israel’s Ministry of Health (MOH)
Pharmaceuticals Division granting regulatory approval to VAZKEPA
(icosapent ethyl). The MOH issued its approval of 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 either established
cardiovascular disease or diabetes and at least one other
cardiovascular risk factor.
According to data from the Israeli Ministry of
Health, heart diseases are the second leading cause of death in
Israel, in both men and women, aged 45 and older.i Heart disease
accounted for about one-sixth of all male and female deaths in
recent years in Israel.i
“The regulatory approval of VAZKEPA in Israel
marks continued progress in our effort to bring this product to
patients with residual cardiovascular risk around the world,” said
Steven Ketchum, PhD., President, Research & Development and
Chief Scientific Officer, Amarin. “We are proud of this important
milestone in that effort, and that patients in Israel will soon be
able to access this important therapeutic option to address their
residual cardiovascular risk.”
Under the terms of the agreement with Neopharm,
Amarin has appointed Neopharm as its sole and exclusive distributor
of VAZKEPA in the territory to import, register, distribute and
commercialize the product, in order to ensure access to patients.
Amarin grants Neopharm the right to hold under its own name the
Regulatory Approvals and Regulatory filings as the Marketing
Authorization Holder for VAZKEPA in this territory. Amarin will be
responsible for supplying finished product to Neopharm at a
transfer price paid to Amarin.
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 Neopharm
Established in 1941, Neopharm is one of Israel's
leading providers of innovative integrated solutions across the
pharmaceutical, medical and healthcare markets. Neopharm focuses on
the sale and marketing of novel groundbreaking specialty and orphan
medications as well as home healthcare services in Israel via
partnerships with the world's leading multinational bio-pharma
companies. Neopharm is the partner-of-choice and one-stop-shop for
multinational bio-pharma companies seeking to enter or expand their
business in the Israeli pharmaceutical, medical and biotechnology
markets and is proud of its best-in-class platform, reputation and
track-record of success for launching and marketing groundbreaking
novel therapies in Israel.
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 entry into Israel and continued expansion in other key
international markets; Amarin’s partnership discussions for Israel;
the potential pricing and reimbursement for VAZKEPA in Israel
beginning in 2024; and the overall potential and future success of
VASCEPA (marketed as VAZKEPA in Europe) and Amarin 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 InformationInvestor
Inquiries:Jordan Zwick Amarin Corporation plcIR@amarincorp.com
Media Inquiries:Mark Marmur Amarin Corporation
plcPR@amarincorp.com____________________________
1 VAZKEPA® (icosapent ethyl) Summary of Product Characteristics
(Accessed August 2023)
i Israeli Ministry of Health – Health Information Division.
Leading causes of death in Israel 2000 – 2019.
https://www.gov.il/BlobFolder/reports/leading-causes-of-death-in-israel/he/files_publications_units_info_CausesOfDeaths2019_Summary.pdf
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