Durata Therapeutics, Inc.Company Presentation

September 2012

Forward Looking Statements

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This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. 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. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking statements contained in this presentation reflect Durata’s current views with respect to future events, and Durata assumes no obligation to update any forward-looking statements except as required by applicable law.

Durata Enterprise Development

Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. We are currently enrolling and dosing patients in two global Phase 3 clinical trials with our lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or abSSSI.

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20 years of experience in the pharmaceutical industry

Former CFO of MedPointe Healthcare and multiple senior level finance and operations positions

The Durata Management Team

Paul EdickCEO

Corey FishmanCOO/CFO

Michael Dunne MDCMO

John ShannonCCO

34 years of experience in the pharmaceutical industry

Former CEO of MedPointe Healthcare, Group VP and President, Asia Pacific/Latin America at Pharmacia and President of Asia Pacific, Latin America and Canada for G.D. Searle

Over 19 years of experience in the pharmaceutical industry

Former VP and Therapeutic Area Head for clinical development in Anti-Infectives at Pfizer

MD at the State University of New York Health Sciences Center and ID fellowship at Yale

Over 25 years of experience in the pharmaceutical and healthcare industry

Former GM of the Global Hemophilia Franchise and US Biopharm Business, VP Marketing for Biopharm NA and VP Marketing for the US Renal Business at Baxter

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Primary Asset Highlights

Dalbavancin is a highly differentiated, late stage, product candidate

A prior phase 3 program documented efficacy, safety and tolerability

Opportunities exist for expansion beyond the primary indication

Clearly defined clinical and regulatory path with FDA and EMA

New phase 3 studies at an advanced stage

Large and growing category

Value added health-economics

Worldwide development and commercial rights

Patent coverage / exclusivity through 2023

Highly experienced management team

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Dalbavancin: Differentiation and Existing data

Dalbavancin is a semisynthetic glycopeptide (lipoglycopeptide) which interferes with peptidoglycan cross-linking in the cell wall by binding to the D-ala-D-ala terminus of stem peptides.

Dalbavancin: Mechanism of Action

*Streit, et al. DMID 2004, p137

Comparative MIC90 (g/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002)*

 S. aureus (1,815)OX-S

S. aureus (1,177)OX-R

 β-hemolytic streptococci

(234)

viridans group streptococci

(30)PCN-R

 

Dalbavancin 0.06 0.06   0.06 0.03  

Teicoplanin 1 2    

Vancomycin 1 2   0.5 0.5  

Oxacillin S R   PCN = 0.06 R  

Linezolid 2 2   1 1  

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Dalbavancin: Unique Pharmacokinetic Profile

Dalbavancin dosed with 1,000 mg IV on Day 1 and 500 mg IV on Day 8

Dorr, JAC 2005;55 Supp S2:ii25; data on file

Dalbavancin’s pharmacokinetic profile enables:

Broad tissue distribution

Continuous cidality

Once weekly dosing

Maintenance of high plasma concentration

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Dalbavancin Existing Data – Efficacy in Multiple Completed Phase 3 Trials

Dalbavancin Was Shown to be as Effective as Three Different Agents in Respective Treatment Populations

VER001-8VER001-8

VER001-9VER001-9

Non-inferiority established

Non-inferiority established

Non-inferiority established

Non-inferiority established

VER001-16VER001-16

Non-inferiority established

Non-inferiority established

* Luis E. Jauregui, et.al Clinical Infectious Diseases 2005; 41:1407–15

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Adverse Events Occurring in >2% of Patients Receiving Dalbavancin: Phase 2/3 Integrated Database [Number (%) of Patients]

Preferred Term of Adverse Event

Total Dalbavancin(N = 1126)

Total Comparator(N = 573)

Patients with at least 1 Adverse Event

585 (52.0) 326 (56.9)

Nausea 69 (6.1) 47 (8.2)

Diarrhea NOS 63 (5.6) 39 (6.8)

Headache 54 (4.8) 33 (5.8)

Constipation 40 (3.6) 29 (3.3)

Vomiting NOS 40 (3.6) 26 (4.5)

Urinary tract infection NOS 34 (3.0) 12 (2.1)

Anemia NOS 31 (2.8) 12 (2.1)

Rash NOS 29 (2.6) 13 (2.3)

Pruritus 25 (2.2) 14 (2.4)

Dalbavancin: Demonstrated Low Level of Side Effects

The duration of adverse events on dalbavancin was no longer than that of comparators

Source: Durata Therapeutics, data on file

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Dalbavancin: Potential Opportunities Beyond the abSSSI Indication

Dalbavancin in abSSSIProgram to complete re-activated NDA will conclude in 4Q 2012 /1Q 2013

• Data in Bacteremia will be available as a sub-analysis and for publication at time of launch

Dalbavancin in Osteomyelitis Program to pursue a near term publication is underway

Dalbavancin in Diabetic Foot Ulcer Program to pursue a near term publication, probably

with Phase 2 data, could result in publications available during year 1 of commercial sale

Dalbavancin in Hospitalized Community Acquired Pneumonia

Phase 1 to be initiated in 2013

Preclinical Phase 1 Phase 2 Phase 3 NDA

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Regulatory and Clinical Activities

Recent Regulatory Interactions: US & EU

An NDA re-activation is possible using the old number

The non-clinical package is complete and no new studies are required

One new clinical trial & re-analysis of VER001-9 needed to complete the filing

Safety database believed to be sufficient for approval

DUR000-201 – Non-Interventional, observational, Phase 2 clinical trial part of filing

Applying for QIDP designation

End of Phase 2 Meeting

June 2010

Operational Meeting

April 25, 2012

PDUFA V

Special Protocol Agreement for DUR001-301 (September 2010)

Special Protocol Agreement for DUR001-302 (June 2011)

EMA Scientific Advice

December 2010

Previously submitted package supports the claim

DISCOVER program with separate EU statistical analysis plan will be adequate

Durata decision to conduct two new Phase 3 studies to strengthen regulatory filingDurata decision to conduct two new Phase 3 studies to strengthen regulatory filing

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NDA Timing

MAA Timing

Regulatory Filing Timing

2011 2012 2013 2014

3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q/2Q

Pre-NDA Meeting(s)

Phase 3 studies

Submission Preparation

Filing

Review/AC/Approval

2011 2012 2013 2014

3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q

Phase 3 studies

Submission Preparation

Scientific Adv./Rapporteurs

Filing

Review/Defense/Approval

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Market Opportunity

Dalbavancin Commercial Thesis

Large U.S. abSSSI (at risk for MRSA) market; 35mm Days Of Therapy (DOT), dominated by generic vancomycin

High and growing prevalence of MRSA leads to empiric selection of therapies

Providers respond favorably to the Dalbavancin product profile

Dalbavancin profile represents opportunity to move patients to ambulatory or out patient care

Dalbavancin profile is very attractive in indications beyond abSSSI

Reimbursement metrics driving care to hospital ambulatory or out-patient clinics

Reduction in total treatment cost is a major driver of adoption

Customer universe is highly targeted

Source: LEK analysis and interviews

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U.S. Market Opportunity

We believe there are ~35 million days of treatment (DOT) annually, in the U.S., for abSSSI patients at risk for MRSA utilizing intravenous antibiotics; this

represents a market potential of approximately $10 billion at branded pricing *

Product DOT (millions)

Vancomycin 7.2

Cefazolin 3.4

Piperacillin 3.4

Clindamycin 2.5

Ampicillin 1.6

Ceftriaxone 1.3

Levofloxacin 1.1

Gentamicin 0.7

Daptomycin 0.6

Tigecycline 0.4

Leading Products

Market is larger when expanded to include MSSA and oral step-down therapies

* If generic units were converted to branded daptomycin pricingSource: Stanford Group June 2007, AMR 2010

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Clinician Response to Dalbavancin Product Profile

1 2 3 4 5 6 7 8 9 10

Hosp ER ID

1%0% 0% 1%

3%

7%

20%

31%

20%18%

“Very Poor” “Excellent”

• Mean response = 8.1

• 69% responded 8 or higher

• <2% responded below 5

• Responses consistent across ER docs, ID docs and hospitalists

ePocrates market research, May 2009, 150 physicians

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1 = Not favorable at all; 10 = Extremely favorable

8.9

8.7

8.7

8.7

8.5

8.3

8.1

6.2

Ensured compliance for 7 days

Potential to reduce in-patient stay

Dose regime (day 1 & 8)

No need for PICC line

No blood monitoring

Bactericidal activity

Safety / tolerability profile

Glycopeptide class

Clinician Response to Dalbavancin Product Profile by Feature

ePocrates market research, May 2009, 150 physicians

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Clinicians Response to Treatment Setting Using Dalbavancin

86% of respondents believe that >10% of SSSI patients, currently admitted to the hospital, could be treated as an outpatient with dalbavancin

1%

2%

11%

25%

22%

24%

15%

0

1-5%

6-10%

11-20%

21-30%

31-50%

>50%

Institutional burden is a factor for assessing benefit

Q: What percent of SSSI patients currently admitted to the hospital could now be treated on an

outpatient basis over the entire course of treatment due to this product’s profile?

Q: Will your hospital/institution factor in the savings from administrative benefits, such as lower burden on

nursing time, in assessing the cost/benefit of this drug?

Yes82%

No18%

ePocrates market research, May 2009, 150 physicians

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Customer Insight

We have continued to collect informal customer feedback from selected stakeholders:

Homecare, Urgent care, PBMs

ER management companies & Hospital systems

Large infectious disease practices

Clinical pharmacy at major institutions

High control payors

Themes

Awareness of dalbavancin

Dalbavancin potential to impact OPAT

Ambulatory administration & resulting economics are a potential advantage

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Financial Penalties are Driving Hospitals to Deliver Care in Ambulatory or Out-patient Settings

Hospital Acquired Conditions (HACs)Hospital Acquired Conditions (HACs)

Hospital Readmissions ****Hospital Readmissions ****

Financial penalties for conditions that patients acquire during a hospital stay

Medicare - Hospitals in the top quartile for HACs will receive a 1% decrease in DRG payments*

Medicaid - Secretary of HHS adopts regulations prohibiting federal payments for HACs***

Secretary of HHS to publicize information on HAC rates

Medicaid prohibition – FY 2011***

Medicare reductions – FY 2014**

Financial penalties for avoidable hospital readmissions

Hospitals will have payments reduced by 1% in 2013 and increasing to 3% by 2015

Hospitals required to submit data to either the Secretary of HHS or to the States to determine patient readmission rates

Secretary of HHS to publicize information on readmission rates

Begins FY 2013

*The Deficit Reduction Act of 2005, Pub. L. No. 109-171, sec. 5001(c), "Quality Adjustment in DRG Payments for Certain Hospital Acquired Infections“**The Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148, sec. 3008, "Payment Adjustment for Conditions Acquired in Hospitals"***The Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148, sec. 2702, "Payment Adjustment for Health Care-Acquired Conditions" ****PPACA The Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148, sec. 3025, "Hospital Readmissions Reduction Program"

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Reduction in Total Treatment Costs are Expectedto Drive Adoption

Decreased length of stay

Potential admission avoidance

Less indwelling catheters

No therapeutic drug monitoring

Less ancillary supply utilization

Shorter nursing time

Lower drug preparation frequency

Less drug wastage

Re

du

ce

d

Imp

rov

ed

Improved patient convenience, compliance, and satisfaction

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Outpatient infusion codes are more common in HOPD with only 1-3 physician (E/M) services billed per course of therapy

Source: Avalere Health LLC analysis of 2010 Medicare Standard Analytic Files (SAFs)

Daptomycin Length of therapy

Frequency of Physician E/M Billing per Therapy Course

Hypothetical Early Intervention Scenario with Dalbavancin and Potential Cost Implications1

1. Jauregui, et al. Clin. Infect. Dis. 2005;41:1407-1415

Scenario 1: Assumes 1st line treatment only, equal efficacy 88.9%2

Comparators and Selected Assumptions:

1) Dalbavancin:

3 days inpatient11 days outpatient

2) Vancomycin:

3 days inpatient11 days outpatient

3) Daptomycin:

3 days inpatient11 days outpatient

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Scenario : Assumes 1st line treatment only, equal efficacy 88.9%1

Comparators and Selected Assumptions:

1) Dalbavancin:

14 days outpatient(no inpatient admission)

2) Vancomycin:

3 days inpatient

+ Linezolid (oral):

11 days outpatient

3) Daptomycin:

3 days inpatient, 11 days outpatient

1. Jauregui, et al. Clin. Infect. Dis. 2005;41:1407-1415

Hypothetical Early Intervention Scenario with Dalbavancin and Potential Cost Implications

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Commercial Plan Requires Modest Investment

In the US, approximately 2,000 hospitals/ambulatory centers account for a large percentage of the market opportunity

Pre-Launch efforts will focus on key stakeholders:

− Mapping formulary submission processes and evidence requirements

− Development and validation of value dossier, formulary submissions

− Infectious disease and pharmacy -- key thought leader development

− Develop key account plans and value proposition with payers and hospital administration

− Develop reimbursement support services and resources

Target audiences:

− 1,600-2,000 Hospitals

− 7,000 IDs

− 6,000 high volume (gram + utilization) IMs and surgeons

Anticipate a commercial organization of ~140, including hospital specialists, key accounts, formulary, marketing and reimbursement support

Similar characteristics typify the EU5 marketplace

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Intellectual Property/Exclusivity

Timeline of Dalbavancin Protection

Dalbavancin patents/exclusivity provide protection until 2023

Dalbavancin’s patent strength emanates from covering a wide range of dosing intervals, dosages, and the amount of dalbavancin in each dose:

Administering initial and subsequent therapeutically effective doses wherein:

− Each dose is separated by 5 -10 days

− Amount of each dose is about 100mg to 5,000mg

− Amount of initial dose is at least about two times the amount of the subsequent dose

2005 2010 2020 2025 20302015

United StatesUnited States

EuropeEurope

Once-Weekly Patent (USP 6,900,175)Potential Patent Term Extension

EP 0 596 929 EP Data Exclusivity

Pediatric ExtensionPotential GAIN

Exclusivity ExtensionUS Data Exclusivity

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Durata Summary

Primary Asset Highlights

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Dalbavancin is a highly differentiated, late stage, product candidate

A prior phase 3 program documented efficacy, safety and tolerability

Potential opportunities exist for expansion beyond the primary indication

Clearly defined clinical and regulatory path with FDA and EMA

New phase 3 studies at an advanced stage

Large and growing category

Value added health-economics

Worldwide development and commercial rights

Patent coverage / exclusivity through 2023

Highly experienced management team

Durata Therapeutics