Durata Therapeutics, Inc. Company Presentation September 2012

Transcription

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 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

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. 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

4 The Durata Management Team Paul Edick CEO Corey Fishman COO/CFO Michael Dunne MD CMO John Shannon CCO 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 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 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 3

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 4

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 (µg/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 Teicoplanin 1 2 Vancomycin Oxacillin S R PCN = 0.06 R Linezolid *Streit, et al. DMID 2004, p137 6

8 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

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 Non-inferiority established Trial Description Treatment of uncomplicated skin infection Comparator Total Dosed Dalbavancin Dosed Cefazolin VER001-9 Trial Description * Comparator Non-inferiority established Treatment of complicated skin infections Total Dosed Dalbavancin Dosed Linezolid VER Non-inferiority established Trial Description Treatment of skin infections with suspected or confirmed methicillin resistant staphylococcus aureus (MRSA) Comparator Total Dosed Dalbavancin Dosed Vancomycin * Luis E. Jauregui, et.al Clinical Infectious Diseases 2005; 41:

10 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 Patients with at least 1 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) The duration of adverse events on dalbavancin was no longer than that of comparators Source: Durata Therapeutics, data on file 9

11 Dalbavancin: Potential Opportunities Beyond the absssi Indication 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 Preclinical Phase 1 Phase 2 Phase 3 NDA 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

12 Regulatory and Clinical Activities

13 Recent Regulatory Interactions: US & EU End of Phase 2 Meeting June 2010 Operational Meeting April 25, 2012 PDUFA V 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 DUR 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 DUR (September 2010) Special Protocol Agreement for DUR (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

14 Regulatory Filing Timing NDA Timing Pre-NDA Meeting(s) Phase 3 studies Submission Preparation Filing Review/AC/Approval MAA Timing Phase 3 studies Submission Preparation Scientific Adv./Rapporteurs Filing Review/Defense/Approval Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q/2Q Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 1Q 2Q 3Q 4Q 13

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 outpatient clinics Reduction in total treatment cost is a major driver of adoption Customer universe is highly targeted Source: LEK analysis and interviews 15

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 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 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

18 Clinician Response to Dalbavancin Product Profile Mean response = % responded 8 or higher 31% <2% responded below 5 Responses consistent across ER docs, ID docs and hospitalists 20% 20% 18% 7% 1% 0% 0% 1% 3% Very Poor Excellent Hosp ER ID epocrates market research, May 2009, 150 physicians 17

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) 8.7 No need for PICC line 8.7 No blood monitoring 8.5 Bactericidal activity 8.3 Safety / tolerability profile 8.1 Glycopeptide class 6.2 epocrates market research, May 2009, 150 physicians 18

20 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? Institutional burden is a factor for assessing benefit 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? >50% 31-50% 15% 24% No 18% 21-30% 22% 11-20% 25% 6-10% 11% Yes 82% 1-5% 2% 0 1% epocrates market research, May 2009, 150 physicians 19

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 20

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 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*** Secretary of HHS to publicize information on HAC rates Medicaid prohibition FY 2011*** Medicare reductions FY 2014** 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 , 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 , sec. 3008, "Payment Adjustment for Conditions Acquired in Hospitals" ***The Patient Protection and Affordable Care Act of 2010, Pub. L. No , sec. 2702, "Payment Adjustment for Health Care-Acquired Conditions" ****PPACA The Patient Protection and Affordable Care Act of 2010, Pub. L. No , sec. 3025, "Hospital Readmissions Reduction Program" 21

23 Reduction in Total Treatment Costs are Expected to Drive Adoption Decreased length of stay Potential admission avoidance Less indwelling catheters Improved Improved patient convenience, compliance, and satisfaction Reduced No therapeutic drug monitoring Less ancillary supply utilization Shorter nursing time Lower drug preparation frequency Less drug wastage 22

24 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 days HOPD 8.56 days Source: Avalere Health LLC analysis of 2010 Medicare Standard Analytic Files (SAFs)

25 Hypothetical Early Intervention Scenario with Dalbavancin and Potential Cost Implications 1 Scenario 1: Assumes 1 st 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:

26 Hypothetical Early Intervention Scenario with Dalbavancin and Potential Cost Implications Scenario : Assumes 1 st 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:

27 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

28 Intellectual Property/Exclusivity

29 Timeline of Dalbavancin Protection Dalbavancin patents/exclusivity provide protection until United States Once-Weekly Patent (USP 6,900,175) Potential Patent Term Extension US Data Exclusivity Potential GAIN Exclusivity Extension Pediatric Extension Europe EP 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

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 30

32 Durata Therapeutics