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
Just::Health Communications

Just:: is a different kind of healthcare communications agency. Since 2006, we’ve been collaborating with clients around the world to...

Latest intelligence

Market access improvements in Turkey
...
annual-marketing-summit.jpg
Showcasing our multichannel capabilities in Berlin
Join Anthill for conferences in October to understand how to bring value to HCPs through multichannel communications...
What is MaxDiff?
MaxDiff - (aka maximum difference scaling) can help market researchers pare down a wealth of information into precise and actionable insights. Sarah Mackinnon, Research Manager at Creative Medical Research, looks...

Infographics