(Adds share price, company comment, background)
By Toni Clarke
WASHINGTON May 23 The U.S. Food and Drug
Administration said on Friday it has approved a new drug to
treat acute bacterial skin infections made by Durata
Approval of the drug, Dalvance, follows a positive
recommendation by the FDA's advisory committee, which also gave
a favorable review to a rival product from Cubist
Pharmaceuticals Inc. The FDA is set to rule on the
Cubist drug shortly.
Both drugs are designed to treat serious acute bacterial
skin and skin structure infections, or ABSSSI. The infections
involve deep tissue or are associated with an underlying disease
such as diabetes. They are aimed at serious Gram-positive
infections, including methicillin-resistant Staphylococcus
aureus, or MRSA.
Durata's drug, known generically as dalbavancin, is given in
two doses, the first on day one and the second on day eight.
"Dalvance's unique dosage regimen offers a new approach to
treatment of these serious skin infections by allowing patients,
health care professionals and hospitals to move beyond the
standard daily or twice-daily IV antibiotic infusions," Paul
Edick, Durata's chief executive, said in a statement.
Edick said the company is "executing on all fronts" to
prepare for the launch of the drug, and said he expects the
company to begin shipping the product in the third quarter.
Dalvance is expected to generate annual sales of about $446
million by 2019 according to Thomson Reuters data. Durata's
shares closed up 5.5 percent at $16.89.
Clinical trials of the drug showed Dalvance was not inferior
to a control arm that included vancomycin, a treatment that is
available generically, or vancomycin followed by Pfizer Inc's
linezolid, which is sold under the brand Zyvox.
(Reporting by Toni Clarke in Washington; Editing by Chizu
Nomiyama; Editing by Chizu Nomiyama)