AstraZeneca will showcase new data across its Vaccines and Immune Therapies Respiratory Syncytial Virus (RSV) portfolio at the 7th Respiratory Syncytial Virus Foundation (ReSViNET) Conference in Lisbon, Portugal from 22-24 February 2023, reinforcing its commitment to help protect infants from RSV. The Company is set to present five abstracts and posters at the event, including new data featuring Beyfortus (nirsevimab) and Synagis (palivizumab). 

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: "I am proud of AstraZeneca's commitment to respiratory syncytial virus (RSV) and our continued focus on innovating antibodies to provide protection to the most vulnerable. We believe that Beyfortus has the potential to transform the medical community's approach to preventing RSV infections in infants, and this is of particular importance given the recent surges of the virus amongst infants this past winter season."

Underscoring the continued need for RSV protection
AstraZeneca is working with the global clinical community to advance the understanding of RSV and is partnering with the ReSViNET Foundation to create the first global RSV surveillance dashboard set to launch in March 2023.  RSV is a highly contagious virus that causes respiratory illness in infants, including lung infections such as bronchiolitis and pneumonia.[1] This seasonal respiratory virus is the most common cause of lower respiratory tract infections and a leading cause of hospitalisation in infants.[1-5 ]

Dr. Louis Bont, Pediatrician Infectologist at the Wilhelmina Children's Hospital in the University Medical Center Utrecht, The Netherlands, and the founder and chairman of ReSViNET, said: "The ReSViNET Foundation's new dashboard will make it easier and more accessible to track worldwide changes in RSV seasonality, helping clinicians to protect babies and prevent the rise in hospitalisations that RSV can cause."

Pursuing a breakthrough for broad RSV prevention
AstraZeneca is presenting the safety and efficacy findings from the full cohort of the Phase III MELODY clinical trial investigating Beyfortus in healthy late preterm and term infants (35 weeks gestational age or greater) entering their first RSV season. These data reinforce Beyfortus' consistent efficacy across endpoints and studies with approximately 70-80% efficacy against medically attended RSV lower respiratory tract infections vs placebo, including hospitalisations.[6-10]

New cost effectiveness data for high-risk infant protection
Synagis continues to build on 25 years of real-world usage with a new cost effectiveness analysis being presented at ReSViNet.  This analysis is the first to incorporate the International Risk Scoring Tool, which helps clinicians identify pre-term infants with the highest risk of hospitalisation.

Key AstraZeneca presentations during ReSViNet Conference 2023

Abstract title Presentation details
Safety and Oral presentation #35; Session III: (Thursday 23 February,
efficacy of 11:40am-1pm) EPIC SANA Lisboa Hotel, Morus Hall
nirsevimab for
prevention of
medically
attended RSV
lower
respiratory
tract infection
in all infants
enrolled in the
Phase III MELODY
trial
Safety and Poster #127; EPIC SANA Lisboa Hotel, Foyer
pharmacokinetics
of nirsevimab
for prevention
of RSV disease
in children with
congenital heart
disease or
chronic lung
disease of
prematurity
Fc mediated Poster #184; EPIC SANA Lisboa Hotel, Foyer
function of
nirsevimab
complements
direct RSV
neutralisation
but is not
required for
optimal
protection in
preclinical
models
Genotypic and Poster #170; EPIC SANA Lisboa Hotel, Foyer
phenotypic
features of RSV
infections in
MEDLEY, a
randomised
double-blind
Phase III study
of nirsevimab in
children at high
risk of severe
disease
New cost Poster #155; EPIC SANA Lisboa Hotel, Foyer
-effectiveness
analysis of
palivizumab for
the prevention
of RSV infection
in otherwise
healthy Canadian
infants born 29
-35 weeks'
gestational age
(wGA)

Notes

RSV
RSV is the most common cause of lower respiratory infections, including bronchiolitis and pneumonia in infants.[1] It is also a leading cause of hospitalisation in all infants.[1-5] Globally, in 2019, there were approximately 33 million cases of acute lower respiratory infections leading to more than three million hospitalisations, and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.[11] RSV-related direct medical costs, globally - including hospital, outpatient and follow-up care - were estimated at €4.82 billion in 2017.[12]

Beyfortus (nirsevimab)
Beyfortus is a single dose long-acting antibody, developed and commercialised in partnership by AstraZeneca and Sanofi using AstraZeneca's YTE technology. It is designed to protect infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Beyfortus has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent LRTI caused by RSV. Monoclonal antibodies do not require the activation of the immune system to help offer timely, rapid and direct protection against disease.[14]

Beyfortus has been granted regulatory and other designations to facilitate expedited development by several major regulatory agencies around the world. These include Breakthrough Therapy Designation by the China Center for Drug Evaluation under the National Medical Products Administration; Breakthrough Therapy Designation (https://www.astrazeneca.com/media-centre/press-releases/2019/us-fda-grants-breakthrough-therapy-designation-for-potential-next-generation-rsv-medicine-medi8897.html) from the US Food and Drug Administration; access granted to the European Medicines Agency (EMA) PRIority Medicines (https://www.astrazeneca.com/media-centre/press-releases/2019/ema-grants-prime-eligibility-for-potential-next-generation-rsv-medicine-medi8897-05022019.html) (PRIME) scheme; and named "a medicine for prioritized development" under the Project for Drug Selection to Promote New Drug Development in Pediatrics by the Japan Agency for Medical Research and Development (AMED). In November 2022, Beyfortus was approved by the European Commission and by the UK Medicines and Healthcare products Regulatory Agency (MHRA).[15-16]

Sanofi Alliance
In March 2017, AstraZeneca and Sanofi announced an agreement (https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.astrazeneca.com%2Fmedia-centre%2Fpress-releases%2F2017%2Fmedimmune-and-sanofi-pasteur-form-alliance-to-develop-and-commercialise-potential-next-generation-respiratory-syncytial-virus-antibody-medi8897-030317.html&data=04%7C01%7Celeanor.read%40edelman.com%7Ca3c20243fe85477f1b3808d90636596f%7Cb824bfb3918e43c2bb1cdcc1ba40a82b%7C0%7C0%7C637547652770793519%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=ZcJELgHfl6iZMI7f3qCFUOW4miRNoLSrIxbCrVRDGzk%3D&reserved=0) to develop and commercialise nirsevimab. Under the terms of the agreement, AstraZeneca leads all development and manufacturing activities, and Sanofi leads commercialisation activities and records revenue. Under the terms of the global agreement, Sanofi made an upfront payment of €120m, has paid a development milestone of €30m and will pay up to a further €465m upon achievement of certain development and sales-related milestones. The two companies share costs and profits. Revenue from the agreement is reported as Collaboration Revenue in the Company's financial statements.

Sobi agreement
Related, in November 2018, AstraZeneca agreed to sell US commercial rights for Synagis (palivizumab) to Swedish Orphan Biovitrum AB (publ) (Sobi) in addition to the right to participate in payments that may be received by AstraZeneca from the US profits or losses for nirsevimab. Under the agreement (https://www.astrazeneca.com/media-centre/press-releases/2018/astrazeneca-to-divest-us-synagis-rights-to-sobi131120180.html),AstraZeneca received upfront consideration, non-contingent payments for nirsevimab during 2019-2021, and following the FDA's acceptance of the Biologics License Application (BLA) filing for nirsevimab, will receive a $175m cash payment. AstraZeneca is also entitled to receive certain other milestone payments for nirsevimab, including a $90m cash payment following the date on which BLA approval in the US occurs. AstraZeneca will continue to manufacture and supply nirsevimab globally and is entitled to an additional royalty from Sobi if profits from nirsevimab in the US exceed a pre-specified level.
Synagis (palivizumab)
Synagis (palivizumab) is an RSV F protein inhibitor monoclonal antibody indicated for the prevention of serious lower respiratory tract disease caused by RSV in paediatric patients with a history of premature birth (less than or equal to 35 weeks gestational age) and who are 6 months of age or younger at the beginning of the RSV season, with bronchopulmonary dysplasia (BPD) that required medical treatment within the previous 6 months and who are 24 months of age or younger at the beginning of the RSV season, or with hemodynamically significant congenital heart disease (CHD) and who are 24 months of age or younger at the beginning of the RSV season.[13]

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com (https://www.astrazeneca.com/) and follow the Company on Twitter @AstraZeneca (https://twitter.com/AstraZeneca).

Contacts
For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

References

1.    R K. Respiratory Syncytial Virus Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds Plotkin's Vaccines 7th ed Philadelphia. 2018;7th ed. Philadelphia:943-9.

2.     Leader S, Kohlhase K. Respiratory syncytial virus-coded pediatric hospitalizations, 1997 to 1999. The Pediatric infectious disease journal. 2002;21(7):629-32.

3.     McLaurin KK, Farr AM, Wade SW, Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization outcomes and costs of full-term and preterm infants. Journal of Perinatology: official journal of the California Perinatal Association. 2016;36(11):990-6.

4.     Rha B, et al. Respiratory Syncytial Virus-Associated Hospitalizations Among Young Children: 2015-2016. Pediatrics. 2020;146:e20193611.

5.     Arriola CS, et al. Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15. J Pediatric Infect Dis Soc. 2020;9:587-595

6.     Hammitt LL, et al. Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants. N Engl J Med. 2022;386 (9): 837-846. DOI: 10.1056/NEJMoa2110275.

7.     Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Late Preterm and Term Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313. Accessed February 2023.

8.     Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897 Ph2b). https://clinicaltrials.gov/ct2/show/results/NCT02878330. Accessed February 2023.

9.     Griffin P, et al. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. NEJM 2020;383: 415-425. DOI: 10.1056/NEJMoa1913556.

10.   Simões E, et al. Pooled efficacy of nirsevimab against RSV lower respiratory tract infection in preterm and term infants. ESPID 2022 Congress; 2022 May 9-13. Hybrid Congress.

11.   Li Y, et al. Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis. Lancet 2022;399:92047-64.

12.   Zhang S, et al. Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis. J Infect Dis. 2020;222(Suppl 7):S680-687.

13.   Synagis SmPC. https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf. Accessed February 2023.

14.   Centers for Disease Control and Prevention. Vaccines & Immunizations. August 18, 2017. https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed February 2023.

15.   European Commission. https://www.ema.europa.eu/en/documents/product-information/beyfortus-epar-product-information_en.pdf. Accessed February 2023.

16.   Medicines & Healthcare products Regulatory Agency. 
https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1119040/Marketing_authorisations_granted_1_-_14_November_2022.pdf. Accessed February 2023.