Durata Therapeutics Announces Preliminary, Topline Phase 3 Clinical Trial Results for Dalbavancin in the Treatment of ABSSSI

Durata Therapeutics Announces Preliminary, Topline Phase 3 Clinical Trial
Results for Dalbavancin in the Treatment of ABSSSI

             DISCOVER 2 Study Meets Primary & Secondary Endpoints

    Conference Call and Webcast Today at 8:30 A.M. EST to Discuss Results

CHICAGO, Feb. 25, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc.
(Nasdaq:DRTX) today announced preliminary, top-line results for its DISCOVER 2
("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 methicillin resistant
Staphylococcus aureus (MRSA). DISCOVER 2 results follow the recent release of
data from DISCOVER 1, which also met its primary and secondary endpoints.

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 trial assessed as a secondary outcome measure the
non-inferiority of clinical response at the end of treatment in clinically
evaluable patients. Dalbavancin also achieved this secondary endpoint.

The DISCOVER 2 study 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Draft Guidance for Developing Drugs for Treatment of ABSSSI.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 2 was a randomized, double-blind,
double-dummy trial conducted in 739 patients at 139 sites in the United
States, Europe, Asia and South Africa comparing dalbavancin to a regimen of
vancomycin (with an option to switch to oral linezolid) for the treatment of
ABSSSI.

Top-line Data from the DISCOVER 2 Trial
                                                         Difference in
                                                         point
             Endpoint           Dalbavancin Vancomycin/ estimates
                                             linezolid   (95%
                                                         Confidence
                                                         interval)
FDA Primary   Early response     285/371     288/368     -1.5% (-7.4,
Endpoint      48-72 hours        (76.8%)     (78.3%)     4.6)
             >20% reduction in  325/371     316/368     1.7% (-3.2,
              lesion size       (87.6%)     (85.9%)     6.7 )
FDA Secondary
Endpoint      Clinical Status ^1 303/324     280/302     0.8% (-3.3,
(EMA Primary End of Treatment   (93.5%)     (92.7%)     4.9)
Endpoint)
             Investigators'     314/324     290/302     0.9% (-2.2,
              assessment         (96.9%)     (96.0%)     4.1)
                                                     
^1Pre-specified adjustment to the confidence interval by important        
baseline variables

In this clinical trial, the drug-related treatment-emergent adverse event rate
for dalbavancin was 12.2% and for vancomycin/linezolid was 10.1%. The most
commonly reported adverse events for dalbavancin in this trial were nausea,
diarrhea, vomiting, pruritus and headache. Discontinuations due to treatment
emergent adverse events were 2.4% and 1.9% for dalbavancin and
vancomycin/linezolid, respectively. This adverse event profile is consistent
with results from prior Phase 3 studies and DISCOVER 1. Additional analyses of
the data are ongoing.

"The treatment of serious skin infections remains a challenge for the
healthcare provider," said Mark Wilcox, MD., Head of Microbiology for the
Leeds Teaching Hospitals and Professor of Medical Microbiology at the
University of Leeds, UK. "These promising results from DISCOVER 2 provide
evidence of dalbavancin's role as a safe and effective treatment option for
cellulitis, major abscess and wound infections while also being more
convenient for patients and potentially more cost-effective for healthcare
systems."

"We are very excited with the positive top-line results of the DISCOVER 2
trial as they were consistent with all the prior studies done with
dalbavancin," said Durata Chief Executive Officer Paul R. Edick. "With the
completion of both of our Phase 3 studies, we are on track to submit our NDA
with the FDA in mid-year and the MAA with the EMA at year-end 2013."

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

Conference Call and Webcast Information

The company will host a conference call today, Monday, February 25, 2013 at
8:30 AM EST. 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 10797012).A replay of the call may be accessed through March
11, 2013 by dialing 800-585-8367 for callers in the U.S. and Canada and
404-537-3406 for international callers (reference Conference ID 10797012). The
conference call will also be webcast live at
http://event.on24.com/r.htm?e=585599&s=1&k=6492106EF6010A225EBAAFE767CD2860.

The webcast will as well be available on the Investor Relations section of the
Company's website at www.duratatherapeutics.com.

About Dalbavancin

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
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 now 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 2 trial, the timing of the filing
of a New Drug Application with the U.S. Food and Drug Administration and a
Marketing Authorization Application with the EMA, 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, Inc.
         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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