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news.Durata Therapeutics has entered into a multi-year manufacturing agreement and has completed the production of clinical supplies of dalbavancin.
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The agreement has been signed between Durata and one of the manufacturers who were involved in dalbavancin manufacturing.
Dalbavancin is an intravenous (IV) lipoglycopeptide used to treat of acute bacterial skin and skin structure infections (abSSSI).
Further details of the agreements were not disclosed.
Durata CEO Paul Edick said they now have produced supplies of drug for clinical testing at two facilities, allowing them to further accelerate their lead program towards potential launch and commercialization.
Durata chief medical officer Michael Dunne said due to its unique features and PK profile, dalbavancin offers the significant convenience of once-a-week dosing and short, 30-minute infusion time.
"Based on these characteristics, the safety data in over 1300 patients, and our expectations for the pivotal program, we believe this product has the potential to set the bar for activity against important Gram-positive bacterial infections, including those due to methicillin-resistant Staphylococcus aureus (MRSA)," Dunne said.