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 FluMistQuadrivalent 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. FluMistQuadrivalent 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 (https://www.gov.uk/government/uploads/system/up l oads/attachment_data/file/530756/Influenza_vaccine_effectiveness_in_primary_care _ in_children.pdf) _in_primary_care_in_children.pdf (https://www.gov.uk/government/uploads/system/u p loads/attachment_data/file/530756/Influenza_vaccine_effectiveness_in_primary_car e _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 Media Enquiries Neil Burrows UK/Global +44 7824 350541 Vanessa Rhodes UK/Global +44 7880 400690 Karen Birmingham UK/Global +44 7818 524012 Jacob Lund Sweden +46 8 553 260 20 Michele Meixell US +1 302 885 2677 Investor Enquiries UK Thomas Kudsk Larsen +44 7818 524185 Nick Stone RIA +44 7717 618834 Henry Wheeler Oncology +44 7788 354619 Craig Marks Finance +44 7881 615764 Christer Gruvris ING +44 7827 836825 US Lindsey Trickett CVMD +1 240 543 7970 Mitchell Chan Oncology +1 240 477 3771 Dial / Toll-Free +1 866 381 7277 Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal 23 June 2016 -ENDS-
ASTRAZENECA PROVIDES UPDATE ON FLUMIST QUADRIVALENT VACCINE IN THE US FOR THE 2016-17 INFLUENZA SEASON
| Source: AstraZeneca PLC