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

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
CSafe Global

CSafe Global is the only global provider of a full line of cold chain solutions and is the world’s largest...

Latest intelligence

the_other_side_of_rheumation_arthritis_thumb.jpg
THE OTHER SIDE OF … RHEUMATOID ARTHRITIS
“I harassed my GP enough to get it caught early”...
The big dilemma in international digital pharma marketing
How to get consistent international marketing while meeting local affiliates’ needs....
Why pharma content marketing campaigns should be agile
Agile pharma content marketing is simply about responding to customer needs, rather than your own whims....

Infographics