Reconstituted Amarin Board Ready for the Challenge of Unlocking True Potential of VASCEPA®/VAZKEPA® (Icosapent Ethyl)
New Amarin Board Believes the Company Will Thrive with Proper Stewardship
New Amarin Directors are Working with Urgency to Address Issues at Amarin
DUBLIN, Ireland and BRIDGEWATER, N.J., March 16, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN) today released the following statement:
Since joining the company two weeks ago, the new Amarin board has rolled up its sleeves and begun the hard work of creating value for shareholders.
We continue to believe that Amarin has tremendous potential. Our drug has the potential to both improve cardiovascular outcomes for patients and create significant savings for payors – a unique proposition for a drug. Unfortunately for society, in our view, not enough patients worldwide are taking VASCEPA.
Although the new board has begun its work with urgency, we appreciate that Rome was not built in a day. The work to be done is substantial. We will proceed diligently and thoughtfully as shareholders deserve our best efforts.
To the hard-working employees at the company, we understand that any change, in this case a new board, can create uncertainty. We want employees to rest assured that we intend to create a great culture of success at Amarin where employees have the tools to succeed and are rewarded for their performance.
We remain confident in our ability to leverage VASCEPA’s clinically important drug profile to unlock tremendous value for shareholders. With shareholders on the board, we believe Amarin’s best days are ahead.
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.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the first-and-only prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), 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 over ten million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA 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.
Indications and Limitation of Use (in the United States)
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.
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of securities laws, including the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties, and include statements regarding the potential of Vascepa (including its potential to improve cardiovascular outcomes for eligible patients and potential to create significant savings for payors), the ability to advance employee engagement, and the ability to create tremendous value, and the potential value opportunity, for shareholders. Various factors that could cause Amarin’s actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include any negative developments relating to VASCEPA, increasing competition from generic drug companies, government and commercial payor actions outside of the United States, and extensive post-approval government regulation of our products and marketing efforts. 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 and in Amarin’s other filings with the Commission, including its quarterly reports on Form 10-Q and current reports on Form 8-K. 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, except as required by law. 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.
Amarin Contact Information
Investor Relations Amarin Corporation plc
email@example.com (investor inquiries)
Corporate Communications, Amarin Corporation plc
PR@amarincorp.com (media inquiries)
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