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Durata Therapeutics Announces
FDA's Acceptance for Priority Review of NDA for Dalvance™
(dalbavancin hydrochloride)
CHICAGO, Nov. 26, 2013 (GLOBE NEWSWIRE) -- 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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