Durata Therapeutics Announces Phase 3 Clinical Trial Results for Dalbavancin
in the Treatment of ABSSSI
Study Meets Primary Endpoint
Conference Call and Webcast Today at 9:00 A.M. ET to Discuss Results
CHICAGO -- December 11, 2012
Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced preliminary, top-line
results for its DISCOVER 1 (“Dalbavancin for Infections of the Skin COmpared
to Vancomycin at an Early Response”) Phase 3 study of dalbavancin, which is
under investigation for the treatment of acute bacterial skin and skin
structure infections (ABSSSI) caused by susceptible gram-positive bacteria,
including MRSA (methicillin resistant Staphylococcus aureus).
Preliminary top-line data show that dalbavancin achieved its primary endpoint
of non-inferiority (10% non-inferiority margin) at 48-72 hours after
initiation of therapy, as determined by the cessation of spread of the lesion,
as well as the resolution of fever. Researchers were comparing two intravenous
(IV) doses of dalbavancin given one week apart with twice-daily vancomycin
doses for 14 days. Patients randomized to the vancomycin regimen had an option
to switch to oral linezolid after three days of vancomycin treatment.In
addition, the key secondary endpoints were supportive of the primary endpoint.
The DISCOVER 1 protocol was conducted pursuant to a special protocol agreement
(SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA’s
Draft Guidance for Developing Drugs for Treatment of ABSSSI. The protocol for
the trial was also designed based on scientific advice provided by the
European Medicines Agency (EMA). DISCOVER 1 was a randomized, double-blind,
double-dummy trial conducted in 573 patients at 92 sites in the United States,
Canada, and Europe comparing dalbavancin to a regimen of vancomycin and an
option for oral linezolid for the treatment of ABSSSI.
Top-Line Data from DISCOVER 1 Trial
Primary Endpoint, Early Response (48-72 hours)
Difference in point
Early Response 239/288 233/285
(ITT) 1.2% (-4.9, 7.6)
Secondary Endpoint, End of Treatment, Day 14
Clinical Status (CE)
Clinical Status (ITT)
ITT = Intent to Treat; CE = Clinically Evaluable
In the clinical trial, the treatment-related adverse event rate for
dalbavancin was 12.3% and for vancomycin/linezolid was 18.3%. Adverse events
reported in ≥ 3% of patients receiving dalbavancin in this trial were nausea,
diarrhea, headache, and pruritus. Discontinuations due to treatment emergent
adverse events were 1.8% and 2.1% for dalbavancin and vancomycin/linezolid,
respectively. This adverse event profile is consistent with results from prior
Phase 3 studies of dalbavancin. Further analyses, including the statistical
analyses for the European regulatory submission, remain ongoing.
“We are very pleased with the preliminary results of this trial. There is a
significant need for an innovative treatment option for patients suffering
with ABSSSI. We anticipate results from our DISCOVER 2 study in the coming
months and are proceeding toward submitting to the FDA a New Drug Application
for dalbavancin in the first half of 2013,” said Durata Chief Executive
Officer Paul R. Edick.
“The development of new products, such as dalbavancin, makes this a very
exciting time for patients and healthcare practitioners. Currently available
IV treatment options for ABSSSI have limitations, including frequent dosing,
antimicrobial resistance, and treatment-limiting adverse events. The potential
opportunity to manage more patients more efficiently in ambulatory settings
may well be an important advancement for providers of healthcare,” said David
Andrew Talan, MD, FACEP, FIDSA, Chairman, Department of Emergency Medicine and
Faculty, Division of Infectious Diseases, Olive View-UCLA Medical Center.
“We believe there are approximately 35 million days of IV antibiotic treatment
annually in the United States for patients with ABSSSI that are at risk for
MRSA, with the majority of these treatments occurring in the hospital setting.
Because therapy with dalbavancin would involve an initial dose followed by a
second dose one week later, an alternative to hospital admission may become
possible for many patients. This change in modality may help reduce the
overall cost of treating ABSSSI to the healthcare provider while decreasing
the potential spread of MRSA within the healthcare facility,” said Durata
Chief Medical Officer Michael Dunne, M.D.
Additional information regarding the trial can be found on clinicaltrials.gov.
Conference Call and Webcast Information
The company will host a conference call today, Tuesday, December 11, 2012 at
9:00 a.m. ET To access the call, please dial 866-632-4021 for participants in
the U.S. or Canada and 404-991-3968 for international callers (reference
Conference ID 79502265). A replay of the call may be accessed through December
25, 2012 by dialing 800-585-8367 for callers in the U.S. and Canada and (404)
537-3406 for international callers (reference Conference ID 79502265). The
conference call will also be webcast live at
Dalbavancin is an intravenous antibiotic product candidate under investigation
for once-weekly dosing, which we believe may facilitate the treatment of
patients with ABSSSI in both the in-patient and out-patient settings,
potentially reducing the length of a patient’s hospital stay or avoiding
hospital admission altogether, with an impact on the overall cost of care for
About Durata Therapeutics
Durata Therapeutics is a pharmaceutical company focused on the development and
commercialization of novel therapeutics for patients with infectious diseases
and acute illnesses. Durata has completed its DISCOVER 1 study and enrollment
in its DISCOVER 2 global Phase 3 clinical trials with its lead product
candidate, dalbavancin, for the treatment of patients with acute bacterial
skin and skin structure infections, or ABSSSI.
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
preliminary top-line results of the DISCOVER I trial, the timing of the filing
of a New Drug Application with the U.S. Food and Drug Administration, our
estimates regarding the potential market opportunity for dalbavancin and the
potential advantages of dalbavancin. 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.
Investor Relations and Public Affairs Contact
Allison Wey, 312-219-7017
Vice President, Investor Relations and Public Affairs
Media Relations Contact
White Oak Communications, Inc.
Jed Weiner, 847-392-4186
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