Astrazeneca Regulatory News (AZN)

ASTRAZENECA PROVIDES UPDATE ON FLUMIST QUADRIVALENT VACCINE IN THE US FOR THE 2016-17 INFLUENZA SEASON

AstraZeneca today confirmed that the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) has provided its interim recommendation on the use of FluMist® Quadrivalent Live Attenuated Influenza Vaccine (FluMist Quadrivalent) in the US for the 2016-2017 influenza season. The updated guidance states the vaccine should not be used in any setting, based on CDC vaccine effectiveness data from the last three influenza seasons in the US, which indicated FluMist Quadrivalent did not demonstrate statistically significant effectiveness in children 2-17 years of age.

The US CDC effectiveness data for 2015-2016 season contrast with studies by AstraZeneca as well as preliminary independent findings by public health authorities in other countries . These findings demonstrate FluMist Quadrivalent was 46-58% effective overall against the circulating influenza strains during the 2015-2016 season. As influenza vaccine effectiveness varies from season to season, it is evaluated in annual observational studies. The CDC states that when there is a good match between the strains in the vaccine and those that circulate during the influenza season, vaccines are typically 50-60% effective. AstraZeneca is working with the CDC to better understand its data to help ensure eligible patients continue to receive the vaccine in future seasons in the US.

The distribution and use of the vaccine in other countries are progressing as planned for the forthcoming influenza season, pending the annual release process from relevant regulatory authorities.

Financial considerations

The US Product Sales of FluMist Quadrivalent in FY 2015 amounted to $206 million. The ACIP's updated recommendation is expected to result in very limited US demand in the second half of 2016 and consequently the Company will take an inventory write-down of approximately $80 million in the second quarter of 2016. The Company maintains its financial guidance for 2016. 

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - oncology; respiratory and autoimmunity; and cardiovascular and metabolic disease. We are also active in infection, neuroscience and inflammatory diseases through collaborations with others. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

About FluMist Quadrivalent Live Attenuated Influenza Vaccine

FluMist Quadrivalent is the only widely available quadrivalent live attenuated influenza vaccine (LAIV), which is administered as a nasal spray and contains four protective strains for the prevention of influenza. FluMist Quadrivalent was originally approved in the US in 2003 and since then more than 116 million doses have been distributed around the world. Global Product Sales of Fluenz/FluMist Quadrivalent in FY 2015 amounted to $290 million.

1 UK: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/530756/Influenza_vaccine_effectiveness _in_primary_care_in_children.pdf

2 Finland: http://www.nvm2016.is/sites/default/files/Nohynek_NorVac_influenzaLessonsNohynek_short.pdf

3 US: http://www.cdc.gov/flu/about/qa/vaccineeffect.htm

CONTACTS

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal

23 June 2016

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