Durata Therapeutics Submits Marketing Authorization Application for
CHICAGO, Dec. 3, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc.
(Nasdaq:DRTX) today announced that it has submitted a 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 complicated skin and soft tissue infections (cSSTI) caused by
susceptible Gram-positive microorganisms, including Staphylococcus aureus
(including methicillin-resistant strains) and Streptococcus pyogenes, as well
as certain other streptococcal species. Following the standard EMA review
cycle timing, the Company anticipates a decision in 1H2015.
"The EMA marketing authorization application submission is an important
milestone in the development of dalbavancin. If approved, dalbavancin will be
the first drug for cSSTI with unique once-weekly dosing given in a short,
30-minute IV infusion time, which may help reduce the overall burden of care
without sacrificing patient outcome," said Paul R. Edick, Durata Therapeutics'
Chief Executive Officer. "In the US, there is a focus on optimizing the
location of treatment and clinical outcomes, as well as controlling the cost
of IV antibiotic delivery. We believe a similar shift will take place in
Europe in the next few years.With a long-acting, once weekly IV antibiotic
treatment option, there may be a dramatic potential savings in terms of total
cost of care when compared to daily IV antibiotic delivery."
The submission included results from the two Phase 3 trials, DISCOVER 1 and
DISCOVER 2, as well as a previous Phase 3 study (VER001-9). In the DISCOVER
trials, cSSTI was defined as cellulitis, wound infection, or major cutaneous
abscess with an associated area of surface erythema measuring at least 75 cm^2
accompanied by at least two other local signs of infection and at least one of
the following systemic signs of infection: fever, leukocytosis, or increased
The EMA submission follows the US Food and Drug Administration's (FDA)
acceptance for priority review of the New Drug Application (NDA) for Dalvance™
(dalbavancin hydrochloride) with an action date of May 26, 2014, which was
announced on November 26, 2013.
Dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which
consists of lipophilic side-chains attached to glycopeptides. When compared to
vancomycin, dalbavancin has a longer half-life resulting in a duration of
antibacterial activity of 5-7 days per dose.^iIf approved by EMA,
dalbavancin would be the first drug for cSSTI requiring only two once-weekly
30-minute intravenous doses (1000 mg on Day 1 and 500 mg on Day 8). This may
shorten the length of stay for patients who are hospitalized and, for
appropriate patients, enable therapy in an outpatient setting eliminating the
hospital admission altogether.^ii Ultimately, this may lower the overall cost
of care for these patients.
ABOUT DURATA THERAPEUTICS, INC.
Durata Therapeutics, Inc. is a pharmaceutical company focused on the
development and commercialization of novel therapeutics for patients with
infectious diseases and acute illnesses. Durata has completed two global Phase
3 clinical trials with its lead product candidate, dalbavancin, for the
treatment of patients with complicated skin and soft tissue infections, or
cSSTI (or, in the US, acute bacterial skin and skin structure infections –
Statements contained in this press release contain forward-looking statements
that involve substantial risks and uncertainties. All statements, other than
statements of historical facts, contained in this press release, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words "anticipate," "believe,"
"estimate," "expect," "intend," "may," "plan," "predict," "project," "target,"
"potential," "will," "would," "could," "should," "continue," and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words.
Forward-looking statements in this press release include statements about the
EMA approval of dalbavancin and the potential impact of dalbavancin's dosing
schedule on hospital costs and readmissions. Actual results may differ
materially from those indicated by these forward-looking statements as a
result of various important factors, including those discussed in the "Risk
Factors" section of our most recent quarterly report on Form 10-Q, which is on
file with the SEC and is also available on our website. In addition, any
forward-looking statements represent our views only as of today and should not
be relied upon as representing our views as of any subsequent date. While we
may elect to update these forward-looking statements at some point in the
future, we specifically disclaim any obligation to do so, even if our views
change. Therefore, you should not rely on these forward-looking statements as
representing our views as of any date subsequent to today.
^i Durata DOF.
^ii Durata Therapeutics website. About dalbavancin.
CONTACT: Investor Relations and Public Affairs Contact
Vice President, Investor Relations and Public Affairs
Media Relations Contact
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