AstraZeneca discontinues development of motavizumab for RSV prophylaxis indication

Tuesday, 21 December 2010 AstraZeneca today announced it has discontinued further development of motavizumab for the prophylaxis of serious respiratory syncytial virus (RSV) disease. The Company has requested withdrawal of the Biological License Application (BLA) pending at the US Food and Drug Administration (FDA). As a result of this decision, AstraZeneca will incur a financial impairment charge of $445 million in the fourth quarter 2010 accounts. As previously disclosed, the Group holds intangible assets of $445 million relating specifically to motavizumab. Consistent with previous disclosures, the impairment will be excluded from Core earnings, and thus has no impact on the Company’s guidance for Core earnings per share for 2010. Motavizumab is an investigational monoclonal antibody that was being considered to help prevent RSV disease. MedImmune filed the original BLA on 30 January 2008, and received its first complete response letter (CRL) in November 2008. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory Committee on 2 June 2010, and the FDA issued a second CRL requesting additional clinical data in August 2010. Subsequently MedImmune has decided to discontinue certain motavizumab development paths and withdraw the prophylaxis BLA from the FDA; however, motavizumab remains in development for other RSV treatment. NOTES TO EDITORS About AstraZeneca AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit www.astrazeneca.com About MedImmune MedImmune, the worldwide biologics unit for AstraZeneca, has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. For more information, visit MedImmune’s website at www.medimmune.com CONTACTS Media Enquiries Neil McCrae +44 20 7604 8236 (24 hours) Sarah Lindgreen +44 20 7604 8033 (24 hours) Abigail Baron +44 20 7604 8034 (24 hours) Investor Enquiries UK Jonathan Hunt +44 20 7604 8122 mob: +44 7775 704032 Karl Hård +44 20 7604 8123 mob: +44 7789 654364 Investor Enquiries US Ed Seage +1 302 886 4065 mob: +1 302 373 1361 Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043 tags Corporate and financial AstraZeneca Websites This website is intended for people seeking information on AstraZeneca's worldwide business. Our country sites can be located in the AZ Network. Veeva ID: Z4-8411 Date of next review: August 2020 Resources All resources Open Innovation Externally sponsored scientific research MedImmune US prescription assistance programmes Global clinical trials information Medicines Report a possible side effect Pearl Therapeutics Quick links Media Investor Relations Partnering Careers Sustainability Modern Slavery Statement Supplier information Social Media Facebook LinkedIn Twitter Glassdoor Instagram utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2018 You are now leaving AstraZeneca.com You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. AstraZeneca provides this link as a service to website visitors. AstraZeneca is not responsible for the privacy policy of any third party websites. We encourage you to read the privacy policy of every website you visit. Click ‘cancel’ to return to AstraZeneca’s site or ‘continue’ to proceed. Cancel Continue ? Important notice for users You are about to access AstraZeneca historic archive material. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Please refer to your approved national product label (SmPC) for current product information. I have read this warning and will not be using any of the contained product information for clinical purposes. I disagree I agree ? ?

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