Durata Sets Sights On Commercialization As Dalbavancin Nears Filing
This article was originally published in The Pink Sheet Daily
After completing an initial public offering in July, announcing plans to relocate its corporate headquarters to Chicago in November and releasing positive Phase III data on its lead drug, the antibiotic dalbavancin, Dec. 11, Durata Therapeutics is laying the groundwork to transition to a commercial drug company.
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Company plans to file an NDA for the antibiotic in September, built partly on clinical work done by the drug’s previous owner, Pfizer. Given hospitals’ emphasis on cost, Durata’s marketing plan will highlight the drug’s two-dose regimen, which could help move treatment to the ambulatory-care setting.
Optimer has signed a string of partnerships to commercialize the antibiotic around the world; the latest is with AstraZeneca, which will market the drug in South America, Central America, Mexico and the Caribbean.
FDA and industry are turning their attention to implementation of the Generating Antibiotic Incentives Now provisions of PDUFA V, which include an additional five years of marketing exclusivity for certain products and new guidance aimed at streamlining the drug development process.