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New Data Demonstrating Potency of Durata Therapeutics' Dalbavancin Against Bacterial Pathogens Presented at ICAAC 2012

Update: Dalvance (dalbavancin) Now FDA Approved - May 23, 2014

SAN FRANCISCO--(BUSINESS WIRE)--September 10, 2012 07:45 AM Eastern Daylight Time--Durata Therapeutics (NASDAQ: DRTX) today announced data from an in vitro study and surveillance results of its lead product candidate, dalbavancin, currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The data, presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), demonstrate the potency of dalbavancin against numerous significant bacterial isolates in the United States and Europe.

Comparative In Vitro Activity of Dalbavancin (DAL) and Other Gram-Positive Agents Against a Recent Collection of European Bacterial Isolates (Simenauer, et al). Session Number 010, Presentation Number: C2-134

Study conclusions: On a MIC90 (Minimum Inhibitory Concentration required to inhibit the growth of 90% of organisms) basis, dalbavancin was more potent than vancomycin, linezolid or daptomycin for every organism group studied. These findings indicate that dalbavancin continues to have potent activity against target pathogens isolated in Europe. (These in vitro data were generated by Dr. Dan Sahm and his team at Eurofins Medinet, Chantilly, Va.)

Update of Dalbavancin (DAL) Activity in the USA: Report from the SENTRY Program (2011). (Jones, et al). Session Number: 010, Presentation Number: C2-138

Study conclusions: Year 2011 SENTRY Program surveillance results for dalbavancin (DAL) document sustained potent activity against Staphylococcus aureus (SA), coagulase-negative staphylococci (CoNS), beta-hemolytic streptococci (βHS), viridans gr. streptococci (VGS) and vancomycin-susceptible (VANC-S) enterococci, that averaged four-to 32-fold greater than vancomycin, daptomycin or linezolid. Further development of dalbavancin appears warranted by these in vitro potency criteria. (These in vitro data were generated from the laboratories of Dr. Ron Jones and his coauthors at the Jones Microbiology Institute Laboratories in North Liberty, Iowa.)

“These results add to the growing body of evidence that dalbavancin is a highly potent agent against the Gram-positive bacteria associated with ABSSSI and many other infections of global concern,” said Durata Chief Medical Officer Michael Dunne, M.D. “We plan to use these data and clinical trial results to support our New Drug Application with the U.S. Food and Drug Administration for dalbavancin for the treatment of ABSSSI, which we continue to anticipate submitting in the first half of 2013.”

Further Study Details

Comparative In Vitro Activity of Dalbavancin (DAL) and Other Gram-Positive Agents Against a Recent Collection of European Bacterial Isolates (Simenauer, et al). Session Number 010, Presentation Number: C2-134

In this comparator study, non-duplicate, non-consecutive S. aureus (SA; n = 452), coagulase-negative staphylococci (CNS; n = 49), and beta-hemolytic streptococci (BHS; n = 90) isolates were collected from nine sites across Europe during 2011. All isolates were tested by broth microdilution according to appropriate CLSI guidelines. This analysis focused on dalbavancin (DAL) activity and the activities of vancomycin (VAN), linezolid (LZD), and daptomycin (DAP).
 

       

MIC90 (µg/mL)

   

Total N

 

DAL

 

VAN

 

LZD

 

DAP

SA

                   

All

 

452

 

0.06

 

1

 

2

 

0.5

MR

 

110

 

0.12

 

1

 

2

 

0.5

MS

 

342

 

0.06

 

0.5

 

2

 

0.5

CNS

                   
   

49

 

0.12

 

2

 

2

 

0.5

MR

 

28

 

0.12

 

2

 

2

 

1

MS

 

21

 

0.12

 

1

 

1

 

0.5

All BHS

 

90

 

0.03

 

0.25

 

1

 

0.25

pyogenes

 

43

 

0.03

 

0.25

 

1

 

0.12

agalactiae

 

45

 

0.03

 

0.5

 

1

 

0.5

Other BHL

 

2

 

0.015

 

0.25

 

1

 

0.06

                     


Dalbavancin’s potency was assessed in the 2011 SENTRY Antimicrobial Surveillance Program among 1,555 isolates sampled from all nine U.S. Census regions to update the 37,258 organism collection reported for 2006-2009. Researchers monitored Gram-positive cocci, including Staphylococcus aureus (SA; 1,036/50.4% MRSA), coagulase-negative staphylococci (CoNS; 115); Enterococcus faecalis (25); E. faecium (31); Streptococcus pyogenes (155); S. agalactiae (153) and viridans gr. streptococci (VGS; 40). All susceptibility (S) testing used CLSI reference broth microdilution methods and interpretations.

Surveillance data showed that dalbavancin (DAL, MIC50/90, 0.06/0.06 µg/ml) was eight and 16-fold more active than daptomycin (DAPT) and vancomycin (VANC), respectively against SA; with MSSA and MRSA having the same MIC90 results. CoNS was slightly more DAL-S (MIC50, ≤0.03µg/ml). The highest staphylococcal DAL MIC was only 0.25 µg/ml (table. β-haemolytic streptococci (βHS) and VGS had DAL MICs ranging from ≤0.03 to 0.25 µg/ml (MIC90, 0.06-0.12 µg/ml) and only enterococci showed elevated DAL MIC results. VanA phenotype-resistant E. faecalis or E. faecium had DAL MIC values at ≥1 µg/ml; VanB strains were DAL-S (MIC, ≤0.25 µg/ml).

All cited DAL quantitative values were totally consistent with earlier surveillance data (2006-2009), without MIC creep.

 

   

Cum.

 

%

 

inhibited

     

at

 

DAL

 

MIC

 

(µg/ml):

Organism (no.)
 

 

≤ 0.03

 

0.06

 

0.12

     

0.25

 

0.5

 

1

 

≥ 2

S. aureus

                               

MRSA (522)

 

37.9

 

96.7

 

100.0

     

-

 

-

 

-*

 

-

MSSA (514)

 

37.5

 

96.7

 

99.6

     

100.0

 

-

 

-*

 

-

CoNS (115)

 

66.1

 

90.4

 

99.1

     

100.0

 

-

 

-

 

-*

βHS (308)

 

71.8

 

88.6

 

95.5

     

100.0

 

-*

 

-

 

-

VGS (40)

 

82.5

 

97.5

 

100.0

     

-

 

-

 

-*

 

-

Enterococci

                               

Van-susceptible (30)

 

50.0

 

93.3

 

100.0

     

-

 

-

 

-*

 

-

VanA (24)

 

-

 

-

 

-

     

4.2

 

4.2

 

12.5

 

100.0

VanB(2)

 

100.0

 

-

 

-

     

-

 

-

 

-

 

-

*=vancomycin MIC90

                               
                                 

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 is currently enrolling and dosing patients in 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.

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 content and timing of the filing of a New Drug Application with the U.S. Food and Drug Administration. 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.


Contacts
Media Relations:
White Oak Communications, Inc.
Jed Weiner, 847-392-4186
jed.weiner@comcast.net
or
Investor Relations:
Durata Therapeutics
Corey Fishman, 973-993-4865
Chief Operating Officer and Chief Financial Officer
cfishman@duratatherapeutics.com
or
The Trout Group LLC
Lee M. Stern, 646-378-2922
lstern@troutgroup.com
www.troutgroup.com


 

Update of Dalbavancin (DAL) Activity in the USA: Report from the SENTRY Program (2011). (Jones, et al).

Posted: September 2012

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