Amarin Announces VAZKEPA® (Icosapent Ethyl) Approved By Medsafe In New Zealand

Rhea-AI Summary

Amarin Corporation (NASDAQ: AMRN) announced that Medsafe in New Zealand has granted regulatory approval for VAZKEPA (icosapent ethyl) to reduce cardiovascular (CV) event risks in statin-treated adults with high CV risk and elevated triglycerides. This marks the seventh approval for the VASCEPA/VAZKEPA franchise in key international markets since 2022. Cardiovascular disease significantly impacts New Zealand, with about 175,000 adults affected. Amarin is now seeking commercialization partners to support VAZKEPA's introduction in New Zealand.

Positive

• Regulatory approval in New Zealand for VAZKEPA enhances market reach.
• Seventh regulatory approval for VASCEPA/VAZKEPA franchise in international markets since 2022.

Negative

• None.

Marks 7th Regulatory Approval for VASCEPA®/VAZKEPA® Franchise in Key International Markets Since 2022

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in adult statin-treated patients with high CV risk with elevated triglycerides.

Cardiovascular disease is a significant health issue for people living in New Zealand. Currently, an estimated 175,000 adult New Zealanders are living with cardiovascular disease, and one in three deaths in New Zealand are caused by cardiovascular disease.ⁱ

“The regulatory approval of VAZKEPA in New Zealand adds to the ongoing progress by Amarin to bring an important treatment to patients to help address their residual cardiovascular disease risk,” said Steven Ketchum, EVP & President, Research & Development, Amarin. “We are proud of this important step in our effort to extend the reach and access to this important product to patients around the world who may benefit from the treatment and reduce their risk of a cardiovascular event.”

The approval in New Zealand marks the seventh regulatory approval for the VASCEPA/VAZKEPA franchise in key international markets since 2022. Amarin is now actively engaging with potential commercialization partners in New Zealand to support the introduction of VAZKEPA across the New Zealand 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 strategic direction and actions management has taken to stabilize our U.S. business and position Amarin for growth and value creation; the runway for growth as Amarin’s strategic focus shifts toward expanding the business in Europe and other international markets; Amarin’s continued focus on comprehensive cost reduction program and other cash preservation initiatives, Amarin’s commitment to identifying and rigorously evaluating new highly qualified, independent candidates for Amarin’s Board of Directors, including full, comprehensive evaluation of Sarissa Capital Management LP’s proposed nominees; 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 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 DeFrancesco
Amarin Corporation plc   
IR@amarincorp.com
  
Media Inquiries:  
Mark Marmur 
Amarin Corporation plc   
PR@amarincorp.com

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ⁱ New Zealand Heart Foundation: General Heart Statistics in New Zealand. https://www.heartfoundation.org.nz/statistics 

FAQ

What recent approval did Amarin receive for VAZKEPA?

Amarin received regulatory approval from Medsafe in New Zealand for VAZKEPA to reduce cardiovascular event risks.

How many regulatory approvals has Amarin achieved for VASCEPA/VAZKEPA since 2022?

Amarin has achieved seven regulatory approvals for the VASCEPA/VAZKEPA franchise in international markets since 2022.

What is the significance of cardiovascular disease in New Zealand?

Approximately 175,000 adults in New Zealand live with cardiovascular disease, representing a major health issue.

What is Amarin's strategy following the approval in New Zealand?

Amarin is engaging with potential commercialization partners to support the introduction of VAZKEPA in New Zealand.