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European Medicines Agency Accepts Marketing Authorization Application for Dalbavancin



European Medicines Agency Accepts Marketing Authorization Application for
Dalbavancin

CHICAGO, Dec. 23, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc.
(Nasdaq:DRTX) today announced that the European Medicines Agency (EMA) has
accepted for review a Marketing Authorization Application (MAA) for
dalbavancin. Durata is 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. The
start of the review procedure begins December 26, 2013.  The Company
anticipates a decision in 1H2015.

"We are pleased the EMA has accepted our marketing authorization application
submission for a potential new treatment option for patients with cSSTI.  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.

The submission, which was announced on December 3, 2013, 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 immature neutrophils.

The EMA acceptance 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. 

ABOUT DALBAVANCIN

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.^i  If 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 –
ABSSSI).

FORWARD-LOOKING STATEMENTS

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.
http://www.duratatherapeutics.com/product-pipeline/dalbavancin/overview
(Durata DOF)

CONTACT: Investor Relations and Public Affairs Contact
         Allison Wey
         Durata Therapeutics
         Vice President, Investor Relations and Public Affairs
         (312) 219-7017
         awey@duratatherapeutics.com
        
         Media Relations Contact
         Geoff Curtis
         DJE Science
         (312) 233-1253
         geoff.curtis@djescience.com

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