Durata Therapeutics, Inc.

1
Durata Therapeutics, Inc.
Company Presentation September 2012
2
Forward Looking Statements
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
Duratas current views with respect to future
events, and Durata assumes no obligation to
update any forward-looking statements except as
required by applicable law.
3
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.
4
The Durata Management Team
Paul EdickCEO

• 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

Corey Fishman COO/CFO

• 20 years of experience in the pharmaceutical
  industry
• Former CFO of MedPointe Healthcare and multiple
  senior level finance and operations positions

Michael Dunne MD CMO

• 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

John Shannon CCO

• 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

5
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

6
Dalbavancin Differentiation and Existing data
7
Dalbavancin Mechanism of Action

• 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.

Comparative MIC90 (mg/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002) Comparative MIC90 (mg/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002) Comparative MIC90 (mg/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002) Comparative MIC90 (mg/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002) Comparative MIC90 (mg/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002) Comparative MIC90 (mg/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002) Comparative MIC90 (mg/ml) of selected agents and dalbavancin tested against Worldwide clinical isolates (2002)
  S. aureus (1,815) OX-S S. aureus (1,177) OX-R   ß-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  
Streit, et al. DMID 2004, p137
8
Dalbavancin Unique Pharmacokinetic Profile
Dalbavancin dosed with 1,000 mg IV on Day 1 and
500 mg IV on Day 8

• Dalbavancins pharmacokinetic profile enables
• Broad tissue distribution
• Continuous cidality
• Once weekly dosing
• Maintenance of high plasma concentration

Dorr, JAC 200555 Supp S2ii25 data on file
9
Dalbavancin Was Shown to be as Effective as Three
Different Agents in Respective Treatment
Populations

• Dalbavancin Existing Data Efficacy in Multiple
  Completed Phase 3 Trials

VER001-8
Trial Description Comparator Total Dosed Dalbavancin Dosed
Treatment of uncomplicated skin infection Cefazolin 553 367
Non-inferiority established
VER001-9
Trial Description Comparator Total Dosed Dalbavancin Dosed
Treatment of complicated skin infections Linezolid 854 571
Non-inferiority established
VER001-16
Trial Description Comparator Total Dosed Dalbavancin Dosed
Treatment of skin infections with suspected or confirmed methicillin resistant staphylococcus aureus (MRSA) Vancomycin 156 107
Non-inferiority established
Luis E. Jauregui, et.al Clinical Infectious
Diseases 2005 41140715
10
Dalbavancin Demonstrated Low Level of Side
Effects
Adverse Events Occurring in gt2 of Patients Receiving Dalbavancin Phase 2/3 Integrated Database Number () of Patients Adverse Events Occurring in gt2 of Patients Receiving Dalbavancin Phase 2/3 Integrated Database Number () of Patients Adverse Events Occurring in gt2 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)
The duration of adverse events on dalbavancin was
no longer than that of comparators
Source Durata Therapeutics, data on file
11
Dalbavancin Potential Opportunities Beyond the
abSSSI Indication
Preclinical
Phase 1
Phase 2
Phase 3
NDA

• Dalbavancin in abSSSI
• Program 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

12
Regulatory and Clinical Activities
13
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
Durata decision to conduct two new Phase 3
studies to strengthen regulatory filing

• 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

14
Regulatory Filing Timing

• NDA Timing
• MAA Timing

2011 2011 2012 2012 2012 2012 2013 2013 2013 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 2011 2012 2012 2012 2012 2013 2013 2013 2013 2014 2014 2014 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
15
Market Opportunity
16
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 outpatient 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
17
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
Leading Products
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
Market is larger when expanded to include MSSA
and oral step-down therapies
Source Stanford Group June 2007, AMR 2010
If generic units were converted to branded
daptomycin pricing
18
Clinician Response to Dalbavancin Product Profile

• Mean response 8.1
• 69 responded 8 or higher
• lt2 responded below 5
• Responses consistent across ER docs, ID docs and
  hospitalists

31
20
20
18
7
3
1
1
0
0
1
2
3
4
5
6
7
8
9
10
Very Poor
Excellent
Hosp
ER
ID
ePocrates market research, May 2009, 150
physicians
19
Clinician Response to Dalbavancin Product Profile
by Feature
1 Not favorable at all 10 Extremely
favorable
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
ePocrates market research, May 2009, 150
physicians
20
Clinicians Response to Treatment Setting Using
Dalbavancin

• 86 of respondents believe that gt10 of SSSI
  patients, currently admitted to the hospital,
  could be treated as an outpatient with dalbavancin

• 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 products 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?
ePocrates market research, May 2009, 150
physicians
21
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

22
Financial Penalties are Driving Hospitals to
Deliver Care in Ambulatory or Out-patient Settings
Hospital Acquired Conditions (HACs)
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"
23
Reduction in Total Treatment Costs are
Expectedto Drive Adoption

• Improved patient convenience, compliance, and
  satisfaction

• 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

24
Outpatient infusion codes are more common in HOPD
with only 1-3 physician (E/M) services billed per
course of therapy
Frequency of Physician E/M Billing per Therapy
Course
Daptomycin
Length of therapy
Source Avalere Health LLC analysis of 2010
Medicare Standard Analytic Files (SAFs)
25
Hypothetical Early Intervention Scenario with
Dalbavancin and Potential Cost Implications1
Scenario 1 Assumes 1st line treatment only,
equal efficacy 88.92 Comparators and Selected
Assumptions 1) Dalbavancin 3 days
inpatient 11 days outpatient 2) Vancomycin 3
days inpatient 11 days outpatient 3) Daptomycin
3 days inpatient 11 days outpatient

• Jauregui, et al. Clin. Infect. Dis.
  2005411407-1415

26
Hypothetical Early Intervention Scenario with
Dalbavancin and Potential Cost Implications
Scenario Assumes 1st line treatment only,
equal efficacy 88.91 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

• Jauregui, et al. Clin. Infect. Dis.
  2005411407-1415

27
Commercial Plan Requires Modest Investment

• In the US, approximately 2,000 hospitals/ambulator
  y 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
28
Intellectual Property/Exclusivity
29
Timeline of Dalbavancin Protection

• Dalbavancin patents/exclusivity provide
  protection until 2023

United States
Potential GAIN Exclusivity Extension
US Data Exclusivity
Pediatric Extension
Europe
EP 0 596 929
EP Data Exclusivity

• Dalbavancins 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

30
Durata Summary
31
Primary Asset Highlights

• 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

32
Durata Therapeutics