Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (May 2015)
15 slides from Heron Therapeutics's corporate update, May 28, 2015
Slide 1: MAGIC: Positive Top-Line Results from Phase 3 Study of SUSTOL in HEC
Exhibit 99.2 MAGIC: Positive May 28, Top-Line 2015 A Phase 3Results Study of SUSTOL® in Patients Receiving Highly Emetogenic Chemotherapy
Slide 2: Legal Disclaimer
Legalpresentation This associated desirable Securities differ 2exceptmaterially Disclaimer as assets, required and withExchange the progress from contains by development, law. theCommission. in results “forward-looking research anticipated regulatory and Thedevelopment Company’s approval, in stateme
Slide 3: SUSTOL Background
SUSTOL® –5-HT3 SUSTOL Prior 3chemotherapy Long Lacks Short randomized, antagonist track half-life, cardiac Background is (granisetron designed record (HEC) toxicity soapproved controlled, limited oftosafe deliver (QT injection, and benefit for prolongation) Phase the granisetron effective extended p
Slide 4: SUSTOL Pharmacokinetics: 5-Day Dosing Profile
54*Data SUSTOL Granisetron for (ng/mL) granisetron of mean concentration All 5 48 0Plasmadays, ±subjects SEM Minimum 20 granisetron* Time 24 after from5-Day providing 15 Pharmacokinetics is 10 released (n= therapeutic 72 Dosing 96 patent of 120Profile: 18)long-acting 144 rapidly20120258164 applicati
Slide 5: Rationale for Pursuing HEC Study
Rationale No There 5Reanalysis 5-HT3 is a for significant antagonist of Pursuing prior Phase unmet has HECdemonstrated 3 study medical Studyof SUSTOL need efficacy for better using in delayed prophylaxis the 2011 nausea ASCO against and definition vomiting delayedfor nausea in HEC patients and sugge
Slide 6: Reanalysis of Prior Phase 3 Study Using ASCO 2011 Guidelines
Reanalysis Protocol-Specified 80% ASCO Benefit 100% Rate 90% 70% Response 50.5% 60% 55.8% Complete 30% 40% mg 0% 10% 0.25 Aloxi 6Acute mg 10 64.3% 80% 80.7% 67.4% SUSTOL with Delayed 2011 mg of 0.25 50% 20% 74.5% SUSTOL of mg Reanalysis 67.3% 81.3% Guidelines 10 Prior Aloxi HEC Phase Enhanced SUSTOL
Slide 7: The MAGIC Trial Background
MAGIC The + Ondansetron 7–patients The Palonosetron NK1only three-drug antagonist receiving (Modified Phase wasis3 combination not selected study HEC +Absorption dexamethasone) approved where for the of the Granisetron for ondansetron, comparator comparator delayed CINV Inarm arm the aprepitant afte
Slide 8: MAGIC: U.S. Study Conducted Entirely in U.S. Community Oncology Centers
MAGIC 883 U.S. Study Conducted Sites Entirely in U.S. Community Oncology Centers
Slide 9: MAGIC Study Design
MAGIC The Efficacy Ondansetron Standard-of-Care 942 scheduled HEC* 1:1 + mg Prospectively Complete 9*HEC fosaprepitant dexamethasone PO +patients First fosaprepitant randomized agents BID Study Three-Drug Response tod3-4 mg receive 0.15 as Defined Design 150 defined PO+12 mg/kg SUSTOL 150 placebo mg
Slide 10: MAGIC: Patient Disposition
MAGIC SUSTOL Regimen Randomized Treated Modified Cisplatin Yes No 10 326 124(72.4%) (Safety (27.6%) Patient Regimen ITT Ondansetron (ITT Population Population) Disposition: 324 128 Population) ?50 (71.7%) (28.3%) mg/m2 450 456 Arms (95.5%) 471 (96.8%) 471 Well452 Balanced 459 (96.0%) (97.5%)
Slide 11: MAGIC: Primary Analysis, Delayed Complete Response
MAGIC Delayed 80% Delta Rate 60% Response 30% 40% SUSTOL 0% 10% Complete 11 70% p==8% 56.6% (24 Primary 0.014 Regimen 50% 20% Response 64.7% to 120 Analysis: Standard-of-Care Hours) definedNausea SUSTOL as no emesis and Regimen Vomiting episodes Statistically after andHEC no rescue Superior medicati
Slide 12: SUSTOL Results: Complete Response and Patient Benefit
SUSTOL Results Complete No Global P-values Patients Patient 12 or Infrequent Satisfaction quality for with are Provides Response Control Delayed based zero, of Nausea2 life (CR one on an with Phase 0.014 (QoL) Important the or plus Therapy3 Cochran-Mantel-Haenszel two 0.032 (24 no question: episodes
Slide 13: MAGIC: Safety Summary
MAGIC No –Consistent 13Noclinically Not significant an Safety impediment with significant Summary previous differences to treatment differences trials, in discontinuations, SAEs injection asbetween evidenced site reactions arms by or on the discontinuations safety significant were relatively improve
Slide 14: MAGIC: Summary
MAGIC –Complete Adverse 14Using aTrial Conducted Complete Significantly SUSTOL events iscontrol Response the patients Control entirely Summary first more were group Phase reported (which in patients as atdelayed U.S. expected that 3 CINV includes receives community significantly hadnausea with no st
Slide 15: Conclusion
SUSTOL, Conclusion Detailed NDA 15 resubmission results as parttoofbe on a presented three-drug schedule at for regimen, future mid-2015 medical is the first meeting 5-HT3 antagonist to demonstrate superiority to a standard-of-care, three-drug regimen in delayed nausea and vomiting in patients recei