Amarin Corporation plc (NASDAQ:AMRN) today announced that its
commercial partner in China, EddingPharm (EDDING), has received
regulatory approval for VASCEPA® (icosapent ethyl) from China’s
National Medical Products Administration (NMPA). NMPA granted
approval for VASCEPA as an adjunct to diet to reduce triglyceride
levels in adult patients with severe hypertriglyceridemia (≥500
mg/dL).
Following regulatory approval, EDDING is now
focusing on National Reimbursement Drug Listing (NRDL) and
preparing for commercial launch in China, expected by year-end, as
well as on advancing regulatory submission and review for an
additional indication in cardiovascular risk reduction (CVRR).
According to a recent report on cardiovascular
health and disease in China,i cardiovascular disease (CVD)
accounted for 44-47% of all death in urban and rural areas in
China, meaning two out of every five deaths were due to CVD. It is
estimated that 330 million patients suffer from CVD in China,i and
that China has one of the highest CVD death rates in the world.ii
According to the World Heart Federation, cardiovascular events,
such as ischemic heart disease and stroke, are projected to
increase by 50 percent among the population in China between 2010
and 2030 (based on population aging and growth alone).ii
“We congratulate our partner, EDDING, on the
regulatory approval of VASCEPA in Mainland China, as this marks an
important step in the process of offering this novel treatment to
patients across that country,” said Steven Ketchum, Ph.D.,
President, Research & Development and Chief Scientific Officer,
Amarin. “This milestone represents important progress in our vision
and efforts to ensure that the unique benefits of VASCEPA are made
available to patients throughout the world. We look forward to
EDDING’s continued progress in introducing VASCEPA to patients
across Mainland China.”
“We are glad to receive this regulatory approval
of VASCEPA from the NMPA China, and we are looking forward to
securing reimbursement for this important product for patients and
to a future CVRR indication approval,” said Rebecca Xu, Vice
President of Clinical Development, EDDING. “Prevention and
treatment of cardiovascular disease (CVD) is one of the major
initiatives promoted by Healthy China 2030. However, few new CVD
medications other than statins were launched in the market during
the past several decades. In November 2020, EDDING announced the
positive, statistically significant top-line results of the Phase 3
clinical trial conducted in Mainland China in severe
hypertriglyceridemia patients. We will continue working with Amarin
to bring this innovative drug into China to benefit Chinese
patients.”
Under the partnership agreement, EDDING is
responsible for development and commercialization activities in the
China territory and associated expenses. Amarin provides
development assistance and is responsible for supplying finished
bulk product. Following the NMPA approval for this indication,
Amarin is now entitled to receive a regulatory milestone payment of
$5 million. EDDING will also pay Amarin tiered double-digit
percentage royalties on net sales of VASCEPA in the territory.
Amarin will supply product to EDDING under negotiated supply
terms.
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 VASCEPA®/VAZKEPA® (icosapent ethyl)
Capsules
VASCEPA capsules are the first prescription treatment approved
by the U.S. Food and Drug Administration (FDA) comprised solely of
the active ingredient, icosapent ethyl, a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. VASCEPA was initially
launched in the United States in 2013 based on the drug’s initial
FDA approved indication for use as an adjunct therapy to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been
prescribed more than 20 million times. VASCEPA is covered by most
major medical insurance plans. In addition to the United States,
icosapent ethyl is approved and sold in Canada, Lebanon, and the
United Arab Emirates. In Europe, in March 2021 marketing
authorization was granted to icosapent ethyl in the European Union
for the reduction of risk of cardiovascular events in patients at
high cardiovascular risk, under the brand name VAZKEPA. VAZKEPA is
being commercialized in multiple European countries, including
England, Wales, Sweden and Finland.
United States Indications and Limitation of
Use VASCEPA is indicated:
- As an adjunct to maximally tolerated statin therapy to reduce
the risk of myocardial infarction, stroke, coronary
revascularization and unstable angina requiring hospitalization in
adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL)
and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for
cardiovascular disease.
- As an adjunct to diet to reduce TG levels in adult patients
with severe (≥ 500 mg/dL) hypertriglyceridemia.
The effect of VASCEPA on the risk for pancreatitis in patients
with severe hypertriglyceridemia has not been determined.
Important Safety Information
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of
its components.
- VASCEPA was associated with an increased risk (3% vs 2%) of
atrial fibrillation or atrial flutter requiring hospitalization in
a double-blind, placebo-controlled trial. The incidence of atrial
fibrillation was greater in patients with a previous history of
atrial fibrillation or atrial flutter.
- It is not known whether patients with allergies to fish and/or
shellfish are at an increased risk of an allergic reaction to
VASCEPA. Patients with such allergies should discontinue VASCEPA if
any reactions occur.
- VASCEPA was associated with an increased risk (12% vs 10%) of
bleeding in a double-blind, placebo-controlled trial. The incidence
of bleeding was greater in patients receiving concomitant
antithrombotic medications, such as aspirin, clopidogrel or
warfarin.
- Common adverse reactions in the cardiovascular outcomes trial
(incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal
pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs
4%), gout (4% vs 3%), and atrial fibrillation (5% vs
4%).
- Common adverse reactions in the hypertriglyceridemia trials
(incidence >1% more frequent than placebo): arthralgia (2% vs
1%) and oropharyngeal pain (1% vs 0.3%).
- Adverse events may be reported by calling 1-855-VASCEPA or the
FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and concomitant anticoagulants
and/or anti-platelet agents should be monitored for bleeding.
FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING
INFORMATION CAN BE FOUND
AT WWW.VASCEPA.COM.
Europe
For further information about the Summary of Product
Characteristics (SmPC) for VAZKEPA® in Europe, please click
here.
Globally, prescribing information varies; refer to the
individual country product label for complete
information.
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
the regulatory approval of VASCEPA in mainland China and the
potential impact in that territory; 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 InformationInvestor
Inquiries:Lisa DeFrancescoAmarin Corporation
plcIR@amarincorp.com
Media Inquiries:Mark MarmurAmarin Corporation
plcPR@amarincorp.com
_____________________________________
i The Writing Committee of the Report on Cardiovascular Health
and Diseases in China. Report on Cardiovascular Health and Diseases
in China 2021: An Updated Summary[J]. Biomedical and Environmental
Sciences, 2022, 35(7): 573-603. doi: 10.3967/bes2022.079ii World
Heart Federation Fact Sheet: Cardiovascular Disease in China.
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://world-heart-federation.org/wp-content/uploads/2017/05/Cardiovascular_diseases_in_China.pdf
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