MedImmune receives complete response letter on motavizumab

Monday, 30 August 2010 AstraZeneca today announced that MedImmune, its biologics unit, has received a second complete response letter (CRL) on motavizumab from the US Food and Drug Administration (FDA). Based on the preliminary assessment of the CRL, it contains the following requirements that the company should address to advance the motavizumab registration: The FDA has requested evidence from an additional clinical trial that supports a satisfactory risk/benefit profile in the population(s) for which the prophylaxis indication is being requested. The company continues to believe in the clinical benefit of motavizumab, and it will conduct a complete review of the CRL, continue ongoing constructive dialogue with the FDA as well as make a decision regarding next steps in due course. Motavizumab is an investigational monoclonal antibody (MAb) being considered to help prevent serious respiratory syncytial virus (RSV) disease. MedImmune filed the original Biologics License Application (BLA) on 30 January 2008, and received a (CRL) in November 2008. It filed the response to the CRL in December 2009. Motavizumab was reviewed by the FDA’s Antiviral Drugs Advisory Committee on 2 June 2010. As previously disclosed, the Group holds intangible assets of $445 million relating specifically to motavizumab, which may be subject to impairment following completion of the Group’s analysis of the CRL. Any impairment would be excluded from Core earnings and, as such, the company’s Core earnings per share guidance for 2010 remains unchanged at $6.35-$6.65. NOTES TO EDITORS About MedImmune MedImmune, the worldwide biologics unit for AstraZeneca PLC, has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. 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 CONTACTS: Media Enquiries: Neil McCrae +44 20 7304 5045 (24 hours) Chris Sampson +44 20 7304 5130 (24 hours) Sarah Lindgreen +44 20 7304 5033 (24 hours) Abigail Baron +44 20 7304 5034 (24 hours) Investor Enquiries UK: Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032 Karl Hård +44 207 304 5322 mob: +44 7789 654364 Clive Morris +44 207 304 5084 mob: +44 7710 031012 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 Science 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 utility links Legal notice and Terms of Use Privacy notice Cookie policy Site map Contact us © AstraZeneca 2019 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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