AstraZeneca (NYSE:AZN) said Tuesday it will incur some $445 million in charges for halting development of its drug that was being developed for the prevention of a serious respiratory virus that is most dangerous in infants.
The London-based pharmaceutical company has requested withdrawal of the Biological License Application pending at the US Food and Drug Administration. The drug, called motavizumab, was being developed as a prophylaxis of serious respiratory syncytial virus.
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AstraZeneca, which holds intangible assets of $445 million related specifically to the drug, said the impairment charge will be excluded from its core earnings, thus taking no impact on its 2010 guidance.
The application was originally filed by MedImmune in January 2008, and received its first complete response letter about 10 months later. In June, the FDA’s Antiviral Drugs Advisory Committee reviewed motavizumab, and in August, the FDA issued a second complete response letter requesting additional clinical data.
Following the second letter, MedImmune decided to discontinue certain development paths and withdraw the application. The drug, however, does remain in development for other RSV treatment, the company said.