AstraZeneca takes $445m hit to halt motavizumab
AstraZeneca has withdrawn a US licence application for its biologic respiratory treatment motavizumab in a move that will cost the company $445 million.
Motavizumab was developed by AstraZeneca’s biologics arm MedImmune as an update to its Synagis drug and had been submitted for FDA approval as a prophylaxis treatment for serious respiratory syncytial virus (RSV).
MedImmune originally filed the biologic for approval in January 2008, subsequently receiving a first complete response letter (CRL) in November of that year. Motavizumab was then reviewed again by FDA advisors in June this year who decided it showed a poor risk/benefit ratio, and two months later the US regulator requested further clinical data.
AstraZeneca has now decided to discontinue certain motavizumab development paths, in addition to withdrawing its Biological Licence Application, but says motavizumab remains in development for other RSV indications.
The company will incur a ‘financial impairment charge’ of $445 million, which it will book in the fourth quarter this year, but said this will have no impact on its share earnings guidance for 2010.
But the move is still a blow to the firm – analysts at EvaluatePharma forecast motavizumab’s ‘net present value’, or long-term profitability, to be over $5 billion.
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