Durata Therapeutics, Inc
) continues to progress with its lead candidate, dalbavancin,
which is being developed for the treatment of patients with
complicated skin and soft tissue infections (cSSTI).
Earlier this month, Durata submitted its Marketing
Authorization Application (MAA) to the European Medicines Agency
(EMA) for dalbavancin seeking approval for the marketing and sale
of dalbavancin for the treatment of patients with cSSTI.
Durata recently announced that its MAA has been accepted for
review by the EMA. Durata expects a decision by the first
half of 2015.
The MAA was submitted based on positive results from three
phase III trials - DISCOVER 1, DISCOVER 2 and VER001-9.
The data from DISCOVER 1 and DISCOVER 2 indicated that
dalbavancin achieved its primary efficacy endpoint of
non-inferiority of clinical response at 48 to 72 hours after
initiation of therapy. Dalbavacin also achieved its secondary
endpoint, which was clinical success at the end of treatment.
We remind investors that the U.S. Food and Drug Administration
(FDA) accepted Durata's New Drug Application (NDA) for Dalvance
(dalbavancin) for priority review in Nov 2013.
Durata is seeking FDA approval of Dalvance for the treatment
of patients with acute bacterial skin and skin structure
infections (ABSSSI) caused by susceptible gram-positive
microorganisms, including MRSA (methicillin resistant
Staphylococcus aureus). A decision by the FDA is expected by May
Durata currently does not have any marketed product in its
portfolio. Hence, the successful development and
commercialization of dalbavancin will be a big boost to the
Durata currently carries a Zacks Rank #3 (Hold). Better-ranked
), all with a Zacks Rank #1 (Strong Buy).
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