Faced with deep-seated skepticism over the potential benefits and risks associated with its experimental RSV drug motavizumab, AstraZeneca ($AZN) has opted to scuttle the disease prevention program and write off $445 million in the process. But far worse than the hefty charge, AstraZeneca loses its bid to gain an approval for a successor to its blockbuster Synagis.
Motavizumab's failure has been a long and expensive process. The FDA handed out its first complete response letter in 2008 and followed with a second in the summer containing new demands for more clinical data. During last summer's expert panel session, a number of agency advisers took AstraZeneca to task for failing to demonstrate that motavizumab is superior to Synagis. And there were some concerns as well about evidence of side effects associated with the therapy. AstraZeneca said in a release, though, that other programs involving motavizumab will continue.
AZ paid $15.6 billion for Medimmune, outlining plans to generate one new drug approval per year from its new biologics arm. But the expected approvals haven't arrived, leaving Astrazeneca in a perilous spot as its key products lose market exclusivity.
- check out the AZ release
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