Heron Therapeutics, Inc. · NASDAQ:HRTX
Heron Therapeutics — Corporate Update (May 2014)
32 slides from Heron Therapeutics's corporate update, May 15, 2014
Slide 1: Company Update May 2014
Company Update May 2014 Exhibit 99.2
Slide 2: Legal Disclaimer
Legal Disclaimer This presentation contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties, including uncertainties associated with timely development, approval, launch and acceptance o
Slide 3: Senior Management
Barry D. Quart, PharmD Chief Executive Officer Ardea Biosciences Agouron Pharmaceuticals Pfizer Robert Rosen President & Chief Commercial Officer Bayer Healthcare Sanofi-Synthèlabo Imclone Stephen Davis Chief Operating Officer Ardea Biosciences Neurogen Mark Gelder, M.D. Senior Vice President & Chie
Slide 4: Highlights
Highlights • Lead product candidate, SUSTOL™ (formerly known as APF530), is a long-acting, injectable product for the prevention of chemotherapy-induced nausea and vomiting (CINV) – Incorporates widely used 5-HT3 antagonist granisetron (Kytril ® ) with a 5-day delivery profile – Reduces both acute-
Slide 5: SUSTOL Clinical Summary
SUSTOL CLINICAL SUMMARY
Slide 6: 5-Day Profile: APF530 Pharmacokinetics
5-Day Profile: APF530 Pharmacokinetics Granisetron is released rapidly following injection of APF530 and continues to be released over a 5-day period, providing long-acting coverage for CINV *Data from patent application 20120258164 for transdermal granisetron Time after Dosing (h)
Slide 7: SUSTOL Pivotal Phase Study
SUSTOL Pivotal Phase 3 Study Overview • Randomized, controlled, multi-center study • 1,341 patients in primary efficacy population • Two doses of APF530 (5 mg and 10 mg granisetron) compared to the approved dose of Aloxi (results from 10 mg dose group presented) • Patients stratified by type of chem
Slide 8: Primary Efficacy Results: Complete Response (MEC)
Primary Efficacy Results: Complete Response Patients Receiving Moderately Emetogenic Chemotherapy Acute Delayed Difference in Complete Response APF530-Aloxi (97.5% CI)
Slide 9: Primary Efficacy Results: Complete Response (HEC)
Primary Efficacy Results: Complete Response Patients Receiving Highly Emetogenic Chemotherapy Difference in Complete Response APF530-Aloxi (98.33% CI) Acute Delayed
Slide 10: Safety Summary
Safety Summary • ¹ Safety results with the 5 mg dose of APF530 studied in separate arm of the phase 3 study are not included • ² >90% of injection site reactions were reported as mild; one pati ent discontinued due to injection site reaction
Slide 11: Improved Difference Between SUSTOL and Aloxi in HEC Patients
Improves Difference Between SUSTOL and Aloxi in HEC Patients Protocol Specified HEC Population ASCO 2011 Guideline HEC Population FDA-Requested ASCO Reanalysis Acute Delayed Acute Delayed
Slide 12: CR Rates by Treatment Chemotherapeutic Regimen
CR Rates by Treatment Chemotherapeutic Regimen APF530 10 mg Aloxi 0.25 mg Moderately Emetogenic Acute Cyclophosphamide/Doxorubicin 70.7% 65.7% All other regimens 84.4% 85.0% Delayed Cyclophosphamide/Doxorubicin 47.4% 46.3% All other regimens 72.9% 70.0% Highly Emetogenic Acute Cisplatin regimens 81.
Slide 13: Response Rates With Chemotherapy Classified as HEC
Response Rates With Chemotherapy Classified as HEC by Both Hesketh and 2011 ASCO* *Cisplatin, carmustine, dacarbazine, dactinomycin, mechlorethamine, streptozotocin SUSTOL is 9-11% Better Than Aloxi in the Most Emetogenic Chemotherapy
Slide 14: Summary of Clinical Results
Summary of Clinical Results • Biochronomer polymer-based drug delivery technology releases granisetron over 5 days to prevent CINV • Large, randomized, Phase 3 study conducted: SUSTOL showed non- inferiority to Aloxi – For both acute- and delayed-onset CINV with both moderately and highly emetogenic
Slide 15: SUSTOL Life-Cycle Management
SUSTOL LIFE-CYCLE MANAGEMENT PLANS TO OBTAIN POST-APPROVAL INDICATION FOR “DELAYED HEC”
Slide 16: On-Going Phase 3 Delayed HEC Study Design
1000 patients scheduled to receive HEC* randomized 1:1 Ondansetron 0.15 mg/kg IV (up to 16 mg IV) d1 + Fosaprepitant 150 mg IV d1 + Placebo SC d1 + DEX SUSTOL SC d1 + Fosaprepitant 150 mg IV d1 + Placebo IV d1 + DEX On-Going Phase 3 “Delayed” HEC Study Design Cycle 1 1) All subjects will receive dex
Slide 17: New SUSTOL Study Has a High Likelihood of Success
67% 65% 45% 75% New SUSTOL Study Has a High Likelihood of Success Based on Previous Results ^^Average Complete Response rate improvement when adding an NK-1 RA to a 5-HT3 RA and Dex is ~15 - 20% in the delayed HEC *Poll-Bigelli; Cancer, 97:12, 3090, **Projection of what would happen with a 20% incre
Slide 18: SUSTOL Potential Next Generation 5-HT3 Receptor Antagonist
5-HT3 RAs 1 st generation 2 nd generation 3 rd generation Products Duration of action Indications SUSTOL Has the Potential to be the Next Generation 5-HT3 Receptor Antagonist ondansetron granisetron palonosetron SUSTOL Short acting ~ 8 hr half-life Longer acting ~40 hr half-life Long acting PK profi
Slide 19: SUSTOL Regulatory Status
SUSTOL REGULATORY STATUS
Slide 20: SUSTOL NDA Status
SUSTOL NDA Status • Submitted NDA in May 2009 under 505(b)(2) filing pathway • Received Complete Response Letter in March 2010 • FDA raised major issues in multiple areas Resubmitted NDA in September 2012 • CMC: correction of PAI issues and revision of one in-vitro release method • Requirement for H
Slide 21: How We Are Addressing the CRL
How We Are Addressing the CRL • Chemistry, Manufacturing, and Controls – Sites with PAI issues have been eliminated from the supply chain, with work transferred to a well-established site with no PAI issues • Transition is complete, with secondary benefit of improvement in the COGS – New in-vitro re
Slide 22: SUSTOL Commercial Opportunity
SUSTOL COMMERCIAL OPPORTUNITY
Slide 23: U.S. CINV Market Dynamics
U.S. CINV Market Dynamics Source: WK 07/2013
Slide 24: HEC Regimens Represent a Significant Market Opportunity for SUSTOL
HEC Regimens Represent a Significant Market Opportunity for SUSTOL IntrinsiQ data from July 2012 – June 2013 HEC regimens account for ~20% (500K) of palonosetron administrations Of all HEC administrations, ~20% are given without concomitant IV 5-HT3 – inconsistent with clinical guidelines
Slide 25: Post-Operative Pain Program
POST-OPERATIVE PAIN PROGRAM
Slide 26: EFRON ~
x y EFRON ~ THERAPEUTICS ‘Advancing Medicine. Improving Heath.
Slide 27: Goals for Pain Program
Goals for Pain Program • Develop products that provide a clear advantage compared to available therapies • Take advantage of the FDA’s current focus on reducing the use of opiates • Main goals of therapy for our post-operative pain program – Significantly reduce: • pain intensity for 3-4 days post-o
Slide 28: Biochronomer Bupivacaine/Meloxicam Superior to Exparel
Biochronomer Bupivacaine/Meloxicam Significantly Superior to Exparel ® at 24-72 Hours 1. Study #1; All studies used the post-operative pain model in pigs from Castle et al, 2013 EPJ 2. Study #2 compared <½ expected human dose of Biochronomer bupivacaine/meloxicam formulation to the human dose of Exp
Slide 29: A New Formulation of Bupivacaine + Meloxicam Added to Pain Program
A New Formulation of Bupivacaine + Meloxicam Has Been Added to Our Pain Program • While both Biochronomer ropivacaine and bupivacaine formulations produce significant pain relief for 72-96 hrs, and function better than Exparel, neither provide complete elimination of pain for the critical first 2-3
Slide 30: Only One Day of Pain Reduction With Continuous Bupivacaine Infusion
Only One Day of Pain Reduction Observed With 60-hour Continuous Infusion of Bupivacaine Post-Herniorrhaphy Mean Worst Pain Scores Daily Use of Hydrocodone 1. Schurr et al. Surgery 2004;136:761-9 • Continuous infusion of bupivacaine failed to show significant benefits after 24 hr ¹ • Biochronomer for
Slide 31: Next Steps for Post-Operative Pain Program
Next Steps for Post-Operative Pain Program • Combination formulation has been selected • Starting Phase 1 enabling toxicology shortly • Initiate Phase 1 with combination product in Fall • Assuming positive results from Phase 1, initiate Phase 2 program before the end of this year • Continue developm
Slide 32: Financial Summary
Summary Statement of Operations (In thousands, except per share data) Three Months Ended March 31, 2014 Condensed Balance Sheet Data (In thousands) March 31, 2014 Financial Summary Revenue $ – Operating expenses 17,322 Other income (expenses) (216) Net loss $ (17,538) Net loss per share ¹ $ (0.74) C