- Under the licensing and distribution agreement, CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialisation of neffyTM (adrenaline nasal spray) ARS Pharma will be responsible for manufacturing and product supply.
- Anaphylaxis is the most severe form of an allergic reaction and involves more than one body system. Adrenaline (epinephrine) is a first line treatment of anaphylaxis.
- Emergency department presentations and hospitalisations due to anaphylaxis grew by 51% and 35%, in Australian public hospitals in the 5 years to 2019-20.1
Melbourne, 1 May 2024
CSL Seqirus, a subsidiary of CSL Limited (ASX:CSL), and ARS Pharmaceuticals, Inc. (Nasdaq: SPRY) have today announced the signing of an exclusive license and distribution agreement to commercialise neffyTM (adrenaline nasal spray) in Australia and New Zealand.
Adrenaline (epinephrine) is the first line treatment of anaphylaxis. It is currently available as injectable formulation. neffyTM is a needle-free, intranasal adrenaline nasal spray for use as a rescue medication for people with Type 1 severe allergic reactions including anaphylaxis.
Anaphylaxis is the most severe form of an allergic reaction and involves more than one body system, such as the skin, respiratory, gastrointestinal and/or cardiovascular systems. Symptoms include acute onset of difficult or noisy breathing, swelling of tongue, swelling or tightness in throat, wheeze or persistent cough, difficulty talking or hoarse voice, persistent dizziness or collapse, pale and floppiness in young children.2
Anaphylaxis occurs after exposure to an allergen, such as food, medications and insect bites and stings, and can be life threatening if not immediately treated with adrenaline. 3 Adrenaline rapidly reverses the effects of anaphylaxis by reducing throat swelling, opening the airways, and maintaining heart function and blood pressure.3
Anaphylaxis is reported to occur in 0.2% of children and 3% of adults, but an increase in incidence has been reported over recent decades.4
Under the terms of the agreement, CSL Seqirus will be responsible for applying for regulatory approval, reimbursement and commercialisation. ARS Pharma will be responsible for manufacturing and product supply.
Richard Lowenthal, Co-Founder, President and CEO of ARS Pharma says the company is looking forward to supporting public health in Australia and New Zealand through its partnership with CSL Seqirus.
“We are encouraged that CSL Seqirus recognizes the importance of making a needle-free epinephrine treatment available to severe allergy patients in Australia and New Zealand.”
“CSL Seqirus is not only one of the leading fully integrated commercialization partners for vaccines and pharmaceuticals in Australia and New Zealand, but it has a proven track record of successfully commercializing multiple innovative medicines that it has in-licensed for its allergy portfolio over the years.”
Danielle Dowell, CSL Seqirus’ Executive Director for Asia Pacific Commercial Operations, says the agreement is an important step towards making the product available in Australia and New Zealand.
“We’re thrilled to be partnering with an innovative company in ARS Pharma to work towards making this innovative needle free adrenaline device for anaphylaxis treatment available for people who live with severe allergies,” says Ms Dowell.
“CSL has been helping protect the public health of Australia since 1916. We continue to do that through our research and development as well as scanning the globe for innovative treatments that we can help make available in Australia to improve people’s lives.”
Dr Jonathan Anderson, CSL Seqirus Executive Medical Director for International Regions, says additional ways of delivering adrenaline treatment, could help reduce the burden of anaphylaxis in Australia.
“Anaphylaxis is still a significant problem in Australia. It is estimated that allergies and anaphylaxis have been on the rise in Australia over several decades. As there is no cure this has become a significant public health issue.”4
“Emergency department presentations and hospitalisations due to anaphylaxis grew by 51% and 35%, respectively in Australian public hospitals in the 5 years to 2019-20.1 Unlike the UK or USA, anaphylaxis fatalities have increased in Australia in parallel with hospitalisations, which is a concerning trend.”4
“Healthcare professionals and Australians living with severe allergies have limited options for management of anaphylaxis, so this is a welcome development to have additional alternative options available in Australia for the future.”
REFERENCES
- Australian Commission on Safety and Quality in Health Care, Acute Anaphylaxis Clinical Care Standard. 2021. Available at: https://www.safetyandquality.gov.au/standards/clinical-care-standards/acute-anaphylaxis-clinical-care-standard. Accessed February 2024.
- Australasian Society of Clinical Immunology and Allergy, ASCIA Guidelines Acute management of anaphylaxis. 2023. Available at: https://www.allergy.org.au/hp/papers/acute-management-of-anaphylaxis-guidelines. Accessed February 2024.
- ASCIA, Adrenaline for Treatment of Anaphylaxis. 2023. Available at: https://www.allergy.org.au/patients/allergy-treatments/adrenaline-for-severe-allergies. Accessed February 2024.
- Parliament of the Commonwealth of Australia, Walking the Allergy Tightrope. 2020. Available at: https://parlinfo.aph.gov.au/parlInfo/download/committees/reportrep/024422/toc_pdf/Walkingtheallergytightrope.pdf;fileType=application%2Fpdf. Accessed February 2024.
About ARS Pharmaceuticals, Inc.
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffyTM (also referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis. For more information, visit www.ars-pharma.com.
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. Our commitment to Australia’s health also extends to providing access to paediatric and adult vaccines, and innovative pharmaceuticals for patients living with allergies, cardiovascular disease, severe pain, dry eye disease, iron deficiency, kidney diseases, rare diseases and neurological conditions
About CSL
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.