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
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
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
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