Amarin Announces VAZKEPA® (icosapent ethyl) Approved by the Therapeutic Goods Administration (TGA) in Australia

Rhea-AI Summary

Amarin Corporation announced that Australia's Therapeutic Goods Administration (TGA) has approved VAZKEPA (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adult statin-treated patients with high CV risk and elevated triglycerides. This marks the fifth regulatory approval for the VAZKEPA franchise in key international markets in 2022. The company will initiate the reimbursement process to support commercialization in Australia, backed by patents providing market exclusivity into the early 2030s.

Positive

• TGA approval for VAZKEPA enhances market expansion opportunities.
• Fifth regulatory approval for VAZKEPA in 2022 indicates robust international growth.
• Patents secured in Australia provide market exclusivity until early 2030s, bolstering competitive position.

Negative

• None.

-- VAZKEPA® Approved in Australia to Reduce the Risk of CV Events in Adult Statin-Treated Patients with High CV Risk with Elevated Triglycerides --

-- Marks Fifth Regulatory Approval for VASCEPA®/VAZKEPA® Franchise in Key International Markets in 2022 --

DUBLIN, Ireland and BRIDGEWATER, N.J., Nov. 15, 2022 (GLOBE NEWSWIRE) -- 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 DeFrancesco
Amarin 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 

 

FAQ

When was VAZKEPA approved in Australia?

VAZKEPA was approved by Australia's Therapeutic Goods Administration on November 15, 2022.

What does VAZKEPA treat?

VAZKEPA is approved to reduce the risk of cardiovascular events in adult statin-treated patients with high cardiovascular risk and elevated triglycerides.

How many regulatory approvals has VAZKEPA received in 2022?

VAZKEPA has received five regulatory approvals in key international markets in 2022.

What is the market exclusivity status of VAZKEPA in Australia?

Amarin has secured patents in Australia providing market exclusivity into the early 2030s.