Dalvance Protocol Accord With FDA + Actavis Marketing = Home Run?
This article was originally published in The Pink Sheet Daily
With a Special Protocol Agreement and an experienced sales team lined up, all the firm has to do now is get hospitals excited about an expensive antibiotic in a highly-genericized market.
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Actavis snaps up Durata for less than $1 billion, with significant contingent value tied to success of antibiotic Dalvance; meanwhile Actavis will likely continuing pursuing M&A.
Durata has post-marketing requirements to continue resistance-related studies, but its label includes stewardship language similar to other antibiotics.
Durata has honor of having first drug approved under Qualified Infectious Disease Product designation and gains the benefits of an added five years of market exclusivity.