Durata Therapeutics, Inc.
Company Presentation
September 2012
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 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.
1
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.
Targeted indication
development and
registration
Acquisition of novel
clinical assets in
infectious disease
targeted at acutely ill
patients
Follow on
indication/formulation
development and lifecycle management
Global
commercialization with
select regional
partnerships and
targeted acquisitions of
commercial stage
products
2
The Durata Management Team
34 years of experience in the pharmaceutical industry
Paul Edick
CEO
Corey Fishman
COO/CFO
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
20 years of experience in the pharmaceutical industry
Former CFO of MedPointe Healthcare and multiple senior level finance and
operations positions
Over 19 years of experience in the pharmaceutical industry
Michael Dunne MD
CMO
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
John Shannon
CCO
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
3
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
4
Dalbavancin: Differentiation and Existing data
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)*
S. aureus
(1,815)
OX-S
S. aureus
(1,177)
OX-R
β-hemolytic
streptococci
(234)
viridans group
streptococci
(30)
PCN-R
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
Dalbavancin
*Streit, et al. DMID 2004, p137
6
Dalbavancin: Unique Pharmacokinetic Profile
Dalbavancin dosed with 1,000 mg IV on Day 1 and 500 mg IV on Day 8
Dalbavancin’s
pharmacokinetic profile
enables:
Broad tissue
distribution
Continuous cidality
Once weekly dosing
Maintenance of high
plasma concentration
Dorr, JAC 2005;55 Supp S2:ii25; data on file
7
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
Non-inferiority
established
VER001-9
Non-inferiority
established
VER001-16
Non-inferiority
established
Trial Description
Treatment of uncomplicated skin
infection
Trial Description *
Treatment of complicated skin
infections
Trial Description
Treatment of skin infections with
suspected or confirmed methicillin
resistant staphylococcus aureus
(MRSA)
Comparator
Total
Dosed
Dalbavancin
Dosed
Cefazolin
553
367
Comparator
Total
Dosed
Dalbavancin
Dosed
Linezolid
854
571
Comparator
Total
Dosed
Dalbavancin
Dosed
Vancomycin
156
107
* Luis E. Jauregui, et.al Clinical Infectious Diseases 2005; 41:1407–15
8
Dalbavancin: Demonstrated Low Level of Side Effects
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)
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)
Patients with at least 1 Adverse
Event
The duration of adverse events on dalbavancin was no longer than that of comparators
Source: Durata Therapeutics, data on file
9
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 subanalysis 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
10
Regulatory and Clinical Activities
Recent Regulatory Interactions: US & EU
An NDA re-activation is possible using the old number
End of Phase 2
Meeting
June 2010
Operational
Meeting
April 25, 2012
PDUFA V
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
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
12
Regulatory Filing Timing
NDA Timing
2011
3Q
4Q
2012
1Q
2Q
2013
3Q
4Q
1Q
2Q
2014
3Q
4Q
1Q/2Q
Pre-NDA Meeting(s)
Phase 3 studies
Submission Preparation
Filing
Review/AC/Approval
MAA Timing
2011
3Q
4Q
2012
1Q
2Q
3Q
2013
4Q
1Q
2Q
3Q
2014
4Q
1Q
2Q
3Q
4Q
Phase 3 studies
Submission Preparation
Scientific
Adv./Rapporteurs
Filing
Review/Defense/Approval
13
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 outpatient care
Dalbavancin profile is very attractive in indications beyond abSSSI
Reimbursement metrics driving care to hospital ambulatory or outpatient clinics
Reduction in total treatment cost is a major driver of adoption
Customer universe is highly targeted
Source: LEK analysis and interviews
15
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
Market is larger when expanded to include MSSA and oral
step-down therapies
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
Source: Stanford Group June 2007, AMR 2010
* If generic units were converted to branded daptomycin pricing
16
Clinician Response to Dalbavancin Product Profile
• Mean response = 8.1
31%
• 69% responded 8 or higher
• <2% responded below 5
• Responses consistent across ER docs, ID docs and hospitalists
20%
20%
18%
7%
1%
1
0%
0%
2
3
3%
1%
4
5
6
7
8
9
10
“Excellent”
“Very Poor”
Hosp
ER
ID
ePocrates market research, May 2009, 150 physicians
17
Clinician Response to Dalbavancin Product Profile by Feature
1 = Not favorable at all; 10 = Extremely favorable
Ensured compliance for 7 days
8.9
Potential to reduce in-patient stay
8.7
Dose regime (day 1 & 8)
8.7
No need for PICC line
8.7
No blood monitoring
8.5
Bactericidal activity
8.3
Safety / tolerability profile
Glycopeptide class
8.1
6.2
ePocrates market research, May 2009, 150 physicians
18
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
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?
>50%
No
18%
24%
21-30%
22%
11-20%
25%
6-10%
0
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?
15%
31-50%
1-5%
Institutional burden is a factor for assessing benefit
11%
Yes
82%
2%
1%
ePocrates market research, May 2009, 150 physicians
19
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
20
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
Financial penalties for avoidable hospital
readmissions
Medicare - Hospitals in the top quartile
for HACs will receive a 1% decrease in
DRG payments*
Hospitals will have payments reduced by 1%
in 2013 and increasing to 3% by 2015
Medicaid - Secretary of HHS adopts
regulations prohibiting federal payments
for HACs***
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 HAC rates
Secretary of HHS to publicize information on
readmission rates
Medicaid prohibition – FY 2011***
Begins FY 2013
Medicare reductions – FY 2014**
*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"
21
Reduction in Total Treatment Costs are Expected
to Drive Adoption
Potential admission
avoidance
Reduced
Less indwelling catheters
Improved
Decreased length of stay
Improved patient convenience,
compliance, and satisfaction
No therapeutic drug
monitoring
Less ancillary supply
utilization
Shorter nursing time
Lower drug preparation
frequency
Less drug wastage
22
Frequency of Physician E/M Billing per Therapy Course
Outpatient infusion codes are more common in HOPD with only 1-3
physician (E/M) services billed per course of therapy
Daptomycin
Length of therapy
Physician
Office
HOPD
Source: Avalere Health LLC analysis of 2010 Medicare Standard Analytic Files (SAFs)
10.88 days
8.56 days
Hypothetical Early Intervention Scenario with Dalbavancin
and Potential Cost Implications1
Scenario 1:
Assumes 1st line
treatment only, equal
efficacy 88.9%2
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
1. Jauregui, et al. Clin. Infect. Dis. 2005;41:1407-1415
24
Hypothetical Early Intervention Scenario with Dalbavancin
and Potential Cost Implications
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
25
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
26
Intellectual Property/Exclusivity
Timeline of Dalbavancin Protection
Dalbavancin patents/exclusivity provide protection until 2023
2005
2010
2015
2020
2025
2030
United States
Potential Patent
Term Extension
Once-Weekly Patent (USP 6,900,175)
US Data Exclusivity
Potential GAIN
Exclusivity Extension
Pediatric Extension
Europe
EP 0 596 929
EP Data Exclusivity
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
28
Durata Summary
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
30
Durata Therapeutics