Melbourne, 1 March 2023
CSL Seqirus (Seqirus Pty Ltd) and Amarin Corporation plc (NASDAQ:AMRN) have today announced the signing of an exclusive license and distribution agreement to commercialise Vazkepa (icosapent ethyl) in Australia and New Zealand.
Under the terms of the agreement Amarin will be responsible for product supply and CSL Seqirus will be responsible for commercialisation.
Vazkepa was approved by the Therapeutic Goods Administration in November 2022 and Medsafe in January 2023 to reduce the risk of cardiovascular (CV) events in adult statin-treated patients at high CV risk with elevated triglycerides and established cardiovascular disease, or diabetes and at least one other CV risk factor.
Danielle Dowell, CSL Seqirus Executive Director of Commercial Operations Asia Pacific, says that the agreement is an important step in helping address unmet need for patients.
“We are very excited to be working with Amarin to bring this treatment to patients with cardiovascular disease. This product is an important addition to Seqirus' growing broad portfolio of in-licensed medicines in Australia and New Zealand,” says Danielle Dowell.
“Alongside our work in infectious diseases and antivenoms, we’re focused on working with international partners to make innovative treatments available in ANZ that can address diseases with a high burden on our community.
“As part of commercialisation, we’re now looking to submit an application for reimbursement to the PBAC.”
High triglycerides and elevated levels of cholesterol or fats in the blood, known as dyslipidemia, are established risk factors for cardiovascular disease. According to the latest data from the Australian Institute of Health and Welfare, nearly 2 in 3 people aged 18 and older have dyslipidemia and one in seven Australians have high triglycerides.1
In New Zealand, an estimated 175,000 adults are living with cardiovascular disease, and one in three deaths are caused by cardiovascular disease.2
Dr Jonathan Anderson, CSL Seqirus Executive Medical Director – International Regions, says that reducing the burden of cardiovascular disease is a key health priority and one intervention can be the adequate management and control of elevated lipids including cholesterol and triglycerides.3
“In Australia, cardiovascular disease affects 1.2 million people, and its impact can be far reaching.3, 4 High triglycerides, alongside raised cholesterol can increase the chances of developing and maintaining fatty plaques in the arteries leading to the recurrence of heart attack and stroke.5 Management of high lipid levels to reduce risk includes healthy eating, increased regular exercise, as well in some cases the use of medicines,” says Dr Anderson.
“We are delighted to be partnering with Amarin to work towards making the product available here to help provide another management option for reduction of recurrence of cardiovascular disease associated with elevated triglycerides.”
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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 CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
In Australia, CSL Seqirus operates the only local manufacturing facility for seasonal and pandemic influenza vaccine, and produces a range of unique medicines in the national interest including antivenoms and the world’s only human vaccine for Q fever. The company also in-licenses a broad range of paediatric and adult vaccines and specialty pharmaceutical products.
CSL (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 30,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.
For more information about CSL, visit www.csl.com.
This press release is issued from CSL Seqirus ANZ is intended to provide information to about our business to industry and business journalists. Please be aware that information relating to the approval status and labels of approved CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL Seqirus products.
This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward- looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
1. Australian Institute of Health and Welfare (2017) Risk factors to health, Abnormal blood lipids. https://www.aihw.gov.au/reports/biomedical-risk-factors/risk-factors-to-health/contents/abnormal-blood-lipids-dyslipidaemia. Accessed February 2023.
2. NZ Ministry of Health (2020) Annual Data Explorer 2020/21: New Zealand Health Survey. https://minhealthnz.shinyapps.io/nz-health-survey-2020-21-annual-data-explorer/. Accessed February 2023
3. Baker Heart and Diabetes Institute (2020) Code Red: overturning Australia’s cholesterol complacency. https://www.baker.edu.au/impact/advocacy/code-red. Accessed February 2023.
4. AIHW Australian Institute of Health and Welfare (2023) Heart, stroke and vascular disease. https://www.aihw.gov.au/getmedia/88095d15-88f7-4b64-a954-846d2f1cdd26/Heart-stroke-and-vascular-disease-Australian-facts.pdf.aspx?inline=true. Accessed February 2023.
5. Heart Foundation (2023) High Blood Cholesterol. https://www.heartfoundation.org.au/bundles/your-heart/high-blood-cholesterol. Accessed February 2023.