Durata Therapeutics Meets Primary Endpoints for EMA Review in Phase 3 Clinical Trial

Durata Therapeutics Meets Primary Endpoints for EMA Review in Phase 3 Clinical
Trial

CHICAGO, Jan. 4, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc.
(Nasdaq:DRTX) today announced additional 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). As reported on December 11,
2012, preliminary top-line data show that dalbavancin achieved its primary
endpoint of non-inferiority 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. The subpopulation of patients with MRSA at baseline achieved similar
results. The secondary endpoint of clinical success at the end of treatment,
the expected primary endpoint for regulatory review in Europe, was also met.
Statistical analyses of the results from this secondary endpoint are included
below in the updated table of top-line data.

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. 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Administration (FDA) based on the FDA's Draft Guidance for Developing Drugs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 the DISCOVER 1 Trial
                                                          Difference in point
          Endpoint       Dalbavancin     Vancomycin/     estimates
                                          linezolid       (95% Confidence
                                                          interval)
US Primary Early response 240/288 (83.3%) 233/285 (81.8%) 1.5% (-4.6, 7.9)
Endpoint   (48-72 hours)
          Patients with  37/44 (84.1%)   32/39 (82.1%)   
           MRSA

                                                           Difference in point
           Endpoint         Dalbavancin     Vancomycin/   estimates
                                             linezolid     (95% Confidence
                                                           interval)
EMA Primary Clinical Status                  222/243
Endpoint    (End of          214/246 (87.0%) (91.4%)       -4.4% (-9.6, 1.6)*
            Treatment)
           Patients with    30/35 (85.7%)   30/31 (96.8%) 
            MRSA
            Investigator
           Assessment       233/246 (94.7%) 237/243       -2.8% (-6.7, 0.7)
            (End of                          (97.5%)
            Treatment)
*adjusted for pre-specified baseline variables.


Additional information regarding the trial can be found on clinicaltrials.gov.

"These data are consistent with our previous phase 3 study, VER001-9, which
served as the pivotal study in our prior NDA submission and confirm the
activity of dalbavancin in the treatment of patients with serious skin
infections," said Dr. Michael Dunne, Chief Medical Officer.

Paul R. Edick, Durata's Chief Executive Officer, states, "We anticipate
reporting DISCOVER 2 preliminary top-line results this quarter and, along with
DISCOVER 1 and the reanalysis of the VER001-9 study, we believe that we have
the data we need to re-activate our dalbavancin NDA in the US and file our MAA
in the EU with a filing to the FDA in the middle of 2013 and to the EMA at the
end of 2013."

About Dalbavancin

Dalbavancin is an intravenous antibiotic product candidate under investigation
for once-weekly dosing given twice, 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 these patients.

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 two 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.

The Durata Therapeutics, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=16463

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
preliminary top-line results of the DISCOVER I trial, the status of the
DISCOVER 2 trial, and the content and timing of the filing of a New Drug
Application with the U.S. Food and Drug Administration and the content and
timing of the filing of an Marketing Authorization Application in the EU, 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.

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
         Jed Weiner
         White Oak Communications, Inc.
         (847) 392-4186
         jed.weiner@comcast.net

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