Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced that the
New Drug Application (NDA) for its investigational drug, Dalvance™
(dalbavancin hydrochloride) for injection, has been accepted for
priority review by the U.S. Food and Drug Administration (FDA) with
an action date of May 26, 2014. 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).
The NDA, submitted on September 26, 2013, was based on the
entire data set from Durata Therapeutics' clinical development
program, including results from two Phase 3 trials DISCOVER 1 and
DISCOVER 2, as well as a previous Phase 3 study (VER001-9). Both
DISCOVER 1 and DISCOVER 2 trials were conducted under a Special
Protocol Assessment (SPA) with the FDA.
"We are very pleased with the FDA's acceptance for filing of our
NDA, as this represents an important achievement in the development
of Dalvance™. We believe that Dalvance™ has the potential to
make a meaningful difference in the lives of patients with ABSSSI,"
said Paul R. Edick, Durata Therapeutics Chief Executive Officer.
"If approved by the FDA, Dalvance™, with its once weekly dosing,
may help facilitate an important shift in treatment from the
hospital to ambulatory settings."
ABOUT ABSSSI
For the six month period of January to June 2010, a projected
9.2 million patients were treated in U.S. hospitals for infections
of any type, and nearly 17 percent of the diagnostic category
presentations were for skin and skin structure infections (SSSIs).
Of these presentations for SSSI, approximately 74 percent were
disease types included in ABSSSI.i This category of infection
increased by 176 percent from 1997 to 2009 in hospitalized
patients.ii The majority of skin and soft tissue infections in
hospitalized patients are caused by Staphylococcus aureus, and
approximately 59 percent of these infections are estimated to be
caused by MRSA in the U.S.iii,iv Failure to successfully treat
ABSSSI may result in hospital readmissions. Under the new health
care reform laws, hospitals may incur financial penalties for
preventable hospital readmissions, including unresolved
infections.
ABOUT DALVANCE™
Dalvance™ (dalbavancin hydrochloride) for injection is a second
generation, semi-synthetic lipoglycopeptide, which consists of
lipophilic side-chains attached to glycopeptides. When compared to
vancomycin, Dalvance™ has a longer half-life resulting in a
duration of antibacterial activity of 5-7 days per
dose.v If approved, Dalvance™ would be the first drug
for ABSSSI requiring 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.vi 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, Dalvance™, for the treatment of patients with acute
bacterial skin and skin structure infections, or 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 FDA approval of Dalvance™ and the potential
impact of Dalvance'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 AMR Hospital Antibiotic Market Guide - Book 2: Diagnosis and
Surgery Reports, January 2010 – June 2010.
ii Giuliano C, Kale-Pradhan P, et al. Early Response of
Ceftaroline Fosamil in the Treatment of Soft-tissue Infections.
Expert Rev Clin Pharmacol. 5(5):509-512 (2012).
iii Moet G, Jones R, et al. Contemporary causes of skin and soft
tissue infections in North America, Latin America and Europe:
Report from the SENTRY Antimicrobial Surveillance Program
(1998-2004). Diagnostic Microbiology and Infectious Disease. 57,
7-13 (2007).
iv Moran GJ, Krishnadasan A, Gorwitz RJ et al.; EMERGEncy ID Net
Study Group. Methicillin-resistant S. aureus infections among
patients in the emergency department. N. Engl. J. Med. 355(7),
666–674 (2006).
v Durata DOF.
vi 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@duratatx.com
Media Relations Contact
Geoff Curtis
DJE Science
(312) 233-1253
geoff.curtis@djescience.com
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