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Transcript of Durata Therapeutics, Inc.
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
25
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
26
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