The Medicines Co. Joins Crowded Antibiotic Field With Q4 Orbactiv Launch
This article was originally published in The Pink Sheet Daily
Company is banking on its single-dose treatment course to propel it over competitors in a crowded generic and branded space, but this may involve major changes in treatment practice, analysts say.
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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.
FDA’s new early endpoint for efficacy in ABSSSI had been criticized at the time it was released. But reporting positive results for a second Phase III study of oritavancin, The Medicines Co CEO says the agency’s ABSSSI endpoints are “appropriate” for industry.
In a rare application of its Medicare “new technology add-on payments” policy to drugs, the Centers for Medicare and Medicaid Services announced it will supplement reimbursement to hospitals for the oral antibiotic Deficid and methotrexate toxicity antidote Voraxaze.