AstraZeneca discontinues development of motavizumab for RSV prophylaxis indication
Tuesday, 21 December 2010
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.
Sarah Lindgreen +44 20 7604 8033 (24 hours)
Abigail Baron +44 20 7604 8034 (24 hours)
Karl Hård +44 20 7604 8123 mob: +44 7789 654364
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043