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 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.
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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)
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