Amarin Announces Vascepa® (Icosapent Ethyl) Approved to Reduce Cardiovascular Risk in the Kingdom of Saudi Arabia (KSA)
21 Junho 2023 - 10:00AM
Amarin Corporation plc (NASDAQ:AMRN) and its commercialization
partner Biologix FZco, a company based in the United Arab Emirates
and a pioneer in the distribution of pharmaceutical and biological
products in the Middle East and North Africa, today announced that
the Kingdom of Saudi Arabia’s (KSA) Saudi Food and Drug Authority
(SFDA) has approved a new indication and label expansion for
VASCEPA® (icosapent ethyl) capsules. VASCEPA is now the first and
only drug approved by SFDA as an adjunct to statin therapy in adult
patients with elevated triglycerides (TG) levels (≥150 mg/dL) who
are at high-risk of cardiovascular (CV) events due to established
cardiovascular disease or diabetes mellitus and at least one other
risk factor for cardiovascular disease.
There is an urgent need to address
cardiovascular disease (CVD) in KSA.i Over 30 percent of adults (18
years) in KSA are at risk of a CVD event.i
“We are excited that patients in KSA will now
have the opportunity to benefit from the proven cardiovascular risk
reduction with VASCEPA following the approval by the SFDA,” said
Steven Ketchum, PhD., President, Research & Development and
Chief Scientific Officer, Amarin. “Today’s approval also marks an
important step in our strategy to expand the global footprint where
VASCEPA/VAZKEPA is indicated for cardiovascular risk reduction,
built from the results seen in the REDUCE-IT outcomes trial. By
executing against this strategy, we can bring the cardiovascular
risk reduction benefit of VASCEPA/VAKEPA to millions more patients
around the world.”
Both the Saudi National Diabetes Center (SNDC)
and The National Heart Center (NHC) in their published guidelines
for diabetes and dyslipidemia, under the Saudi Health Council
(SHC), mention icosapent ethyl (IPE) for CV risk reduction as an
adjunct to statin therapy in patients with elevated and high TG
levels.ii,iiiThe inclusion of IPE in the Saudi Diabetes Clinical
Practice Guidelines (SDCPG)-2021 was done based on the results of
the REDUCE-IT trial and publications, and prior to product
registration in KSA.
Under a previously announced agreement between
Amarin and Biologix, Biologix is responsible for registering
VASCEPA in the licensed territory, as well as providing all
marketing, sales, and distribution services for the product. Amarin
is responsible for providing regulatory assistance, supply and
maintaining intellectual property in the region.
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 Biologix
Biologix FZ co, a privately owned pharmaceutical
company organized and existing under the laws of the United Arab
Emirates (UAE), was incorporated in the Dubai Airport Free Zone in
September 2002 as a regional distributor and promoter of
pharmaceutical specialties in the Middle East & North Africa
(MENA) countries. Biologix provides end to end services from the
pre-registration phase including named patient supply, medical and
disease awareness activities, to registration, promotion, cold
chain distribution, tender management, market access programs,
pharmacovigilance and product safety, as well as the administration
of risk management plans, on behalf of its partners. Biologix
focuses on the following therapeutics areas: hematology-oncology,
cardiology, immunology and rare diseases.
www.biologixpharma.com
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 regulatory approval in the Kingdom of Saudi
Arabia (KSA); the patient population and market potential for
VASCEPA in KSA; 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 InformationInvestor
Inquiries:Lisa DeFrancescoAmarin Corporation
plcIR@amarincorp.com
Media Inquiries:Mark MarmurAmarin Corporation
plcPR@amarincorp.com
i Saudi Health Council – National Heart Center. Cardiovascular
Disease: A Public Health Priority. March 2022.
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://shc.gov.sa/Arabic/NHC/Activities/Documents/Cardiovascular%20disease%20in%20KSA%20-%20a%20public%20health%20priority.pdf
(Accessed May 2, 2023).ii Saudi Diabetes Clinical Practice
Guidelines (SDCPG). 2021. Available
at:https://www.moh.gov.sa/Ministry/MediaCenter/Publications/Documents/Saudi-Diabetes-Clinical-Practice-Guidelines.pdf.
Accessed: May 2, 2023.iii AlRahimi J, AlSaif S, Alasnag M, et al.
Saudi Guidelines for Dyslipidemia Management. Saudi Health Council;
2022.
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