Please login to the form below

Not currently logged in
Email:
Password:

AZ hit by $445m charge

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.

21st December 2010

Share



Related Hub content

    Your search did not contain any words. Please try again.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
90TEN Healthcare

At 90TEN, our expertise resides in integrating public relations, medical education and patient engagement techniques to deliver solutions that help...

Latest intelligence

Online Physician Communities
Study highlights value of internet for doctors in Eastern Europe
Electronic direct mail is proving popular as online access increases...
England’s clinical commissioning landscape
Who are the real masters in the new NHS?...
How will the new landscape of Hep C treatments affect patients?
The development of new therapeutic agents is set to transform the treatment of hepatitis C over the coming years....