Amarin Announces VAZKEPA® (icosapent ethyl) Approved by the Therapeutic Goods Administration (TGA) in Australia
November 15 2022 - 7:00AM
Amarin Corporation plc (NASDAQ:AMRN) today announced that
Australia’s Therapeutic Good Administration (TGA) has granted
approval to VAZKEPA (icosapent ethyl). The TGA approved VAZKEPA to
reduce the risk of cardiovascular (CV) events in adult
statin-treated patients with high CV risk with elevated
triglycerides in Australia.
Dyslipidemia is a significant healthcare issue
for patients in Australia. According to estimates from the most
recent large-scale biomedical survey of the Australian population,1
nearly 2 in 3 people aged 18 and older have dyslipidemia, and one
in seven people have high triglycerides in Australia.
“The regulatory approval of VAZKEPA in Australia
marks important progress for patients in that country with unmet
need to address residual cardiovascular risk as well as for
Amarin’s efforts to expand access to VAZKEPA across global
markets,” said Steven Ketchum, PhD., President, Research &
Development and Chief Scientific Officer, Amarin. “We are proud of
this important step in our effort to bring this important product
to as many patients around the world as possible who may benefit
from treatment.”
The approval in Australia marks the fifth
regulatory approval for the VASCEPA/VAZKEPA franchise in key
international markets in 2022. In line with our international
expansion strategy, Amarin is committed to partnering in these
markets to commercialize the product.
Amarin has been granted patents in Australia
providing market exclusivity into the early 2030s and will now
initiate the reimbursement process to support the commercialization
of VAZKEPA in the Australian market.
About
Amarin
Amarin is an innovative pharmaceutical company leading a new
paradigm in cardiovascular disease management. From our foundation
in scientific research 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 increasing the scientific understanding of the
cardiovascular risk that persists beyond traditional therapies and
advancing the treatment of that risk.
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 Australia and the potential impact
in that country; 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 2021.
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: Lisa DeFrancescoAmarin Corporation
plc IR@amarincorp.com
Media Inquiries: Mark Marmur Amarin Corporation
plc PR@amarincorp.com
REFERENCES
1. Australian Government. Australian Institute of Health &
Welfare. Risk factors to health. Accessed on November 13,
2022: https://www.aihw.gov.au/reports/biomedical-risk-factors/risk-factors-to-health/contents/abnormal-blood-lipids-dyslipidaemia
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024