AstraZeneca will face impairment charges of $445m following the discontinued development of motavizumab for the prevention of RSV
AstraZeneca (AZ) will face impairment charges of $445m following the discontinued development of motavizumab for the prevention of serious respiratory syncytial virus (RSV) disease.
The charge, which relates to a reduction in the value of a company based on poor previous estimates regarding intangible assets, will occur in the financial results of the fourth quarter of 2010.
AZ has also requested withdrawal of the biological licence application (BLA) currently pending with the US Food and Drug Administration (FDA).
The original BLA for motavizumab was filed in January 2008, with the first complete response letter (CRL) sent in November 2008.
The investigational monoclonal antibody was then reviewed by the FDA's Antiviral Drugs Advisory Committee in June 2010, with concerns over some of the drug's side effects and a request for additional clinical data.
AZ then decided to discontinue motavizumab for the prevention of RSV, which causes infection to the lungs and breathing passages, though the drug remains in development for other types of RSV treatment.
This is the second recent setback for AZ, following the FDA's decision to deny approval for Brilinta (ticagrelor), a potential new drug for acute coronary syndrome.
The agency asked for additional analyses of trial data, with concerns that patients were more likely to experience heart problems with Brilinta over other treatments.