Indivior Pharmaceuticals, Inc. · NASDAQ:INDV
Indivior Pharmaceuticals — Investor Day (December 2015)
98 slides from Indivior Pharmaceuticals's investor day presentation, Dec 9, 2015
Slide 1: Indivior R&D Day
Indivior R&D Day New York City, USA December 9th, 2015 Our vision is that all patients around the world will have unrestricted access to quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 2: Forward-looking statements
Forward-looking statements This presentation contains forward-looking statements. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words
Slide 3: Welcome - Indivior 2016 Financial Outlook
INDIVIOR R&D DAY WELCOME - INDIVIOR 2016 FINANCIAL OUTLOOK Shaun Thaxter, Chief Executive Officer Our vision is that all patients around the world will have unrestricted access to quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 4: Intranasal Naloxone for Opioid Overdose Treatment
Intranasal Naloxone for Opioid Overdose Treatment History (US) Next steps • Fast-Track Designation granted Jul 7th, 2014 US: • Pre-NDA meeting Nov 13th, 2014 • Under evaluation • NDA submission #205678 on May 29th, 2015 Canada: • FDA Meeting on Naloxone Access on Jul 1st, 2015 • Pre-NDS meeting with
Slide 5: Financial Guidance for 2016
Financial Guidance for 2016 2015 Indivior 2016 Indivior 2016 Analyst Range of Guidance Guidance Consensus Consensus Net Revenue $m 990-1010 945-975 894 860-900 Operating Margin % >30% 30% 27%-35% Net Income $m* 215-225 155-180 166 140-180 • No material change in current • Reinvestment of >$35m of th
Slide 6: Why invest an extra $35m plus?
Why invest an extra $35m plus? We can now afford to Builds the potential of our Invests in our core invest more pipeline for better start on business and supported by launch our core skillset Revenue, profit and cash Intention is to deliver the We have already flow above our earlier sales and
Slide 7: Reinvestment - Buprenorphine Monthly Depot
Reinvestment - Buprenorphine Monthly Depot Pre-launch activities Policy & stakeholder education Market Research Medical Education Additional health policy advisers Publications Additional field medical personnel 6 Indivior R&D Day | December 9th 2015
Slide 8: Reinvestment – R&D Pipeline Advancing
Reinvestment – R&D Pipeline Advancing Buprenorphine Monthly Depot Risperidone Monthly Depot Topline results (TLFs) of Phase 3 Final Human Factor Study Report Efficacy & Safety clinical trial (RB-US- Topline results (Interim analysis TLFs 13-0001) for inclusion in the NDA) of Phase 3 Submissi
Slide 9: So what do we hope you will learn today?
So what do we hope you will learn today? Patient experience Indivior’s focus What is addiction from a patient What is Indivior doing to address these perspective? unmet needs and generate new, successful treatment options? What do patients say about the difficulty of treatment for addiction?
Slide 10: Outline of the Day
INDIVIOR R&D DAY OUTLINE OF THE DAY Christian Heidbreder, Ph.D., Chief Scientific Officer Our vision is that all patients around the world will have unrestricted access to quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 11: R&D Day Agenda & Outline
R&D Day Agenda & Outline Time (EST) Topic Presenter 7:30 AM - 8:00 AM Coffee – Get Together 8:00 AM - 8:15 AM Welcome & Indivior 2016 financial outlook Shaun Thaxter, Chief Executive Officer - Outline of the day 8:15 AM - 8:45 AM Dr. Christian Heidbreder, Chief Scientific Officer - R&D strategy & ca
Slide 12: R&D Strategy & Capabilities
INDIVIOR R&D DAY R&D STRATEGY & CAPABILITIES Christian Heidbreder, Ph.D., Chief Scientific Officer Our vision is that all patients around the world will have unrestricted access to quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 13: What are the challenges in addiction neuroscience?
What are the challenges in addiction neuroscience? Executive function Impulse control Decision-making Understanding addiction as the The “ideal” drug candidate would: Prefrontal Motor planning result of long-term molecular • Inhibit the reinforcing properties of LH Thalamocortical modulation Cortex
Slide 14: R&D strategy to address challenges in addiction medicine
R&D strategy to address challenges in addiction medicine Efficacy 5 Maturity Efficacy Overall Addiction 3 5 3 1 Side 1 Cost effects Cost Side effects Efficacy 5 Efficacy 5 3 Delivery 3 Delivery 1 1 Side Side Cost effects Cost effects Unmet Need Delivery Delivery Type A Type B Type C Type D New disea
Slide 15: Building an R&D organization fit for purpose
Building an R&D organization fit for purpose • Regulatory Strategy • Regulatory Operations • Global Program Management • Regulatory Affairs NA; EU; Australasia • Financial planning • Timelines • KPIs Regulatory • Clinical Operations 31% • Clinical Sciences Clinical Efficacy • HEOR & Safety Clinical
Slide 16: Delivering major milestones across functions
Delivering major milestones across functions Clinical Regulatory CMC • 10 programs in development • Suboxone sublingual film: • Pillar 1: Internal non-GMP capability • Unprecedented number − 2/8mg FDA approval Aug ’10; TGA approval (Innovation) of ongoing trials: Feb ’11; Malaysia approval Jul ‘13 −
Slide 17: Recognized for scientific excellence
Recognized for scientific excellence Indivior R&D Day | December 9th 2015 17
Slide 18: Sponsoring scientific excellence
Sponsoring scientific excellence Nature “Outlook Addiction”, a supplement section within the regular edition of the journal Nature: http://www.nature.com/nature/outlook/addiction Indivior’s White Paper: http://www.nature.com/nature/outlook/addiction/pdf/Indivior.pdf Indivior R&D Day | December 9th 2
Slide 19: Building a new Centre of Excellence in Hull, UK
Building a new Centre of Excellence in Hull, UK Source: Boulting Environmental Services (BES), Manchester, UK Indivior R&D Day | December 9th 2015 19
Slide 20: Enabling Indivior's vision & mission
Enabling Indivior’s vision & mission Disease understanding Pharmacoeconomics Translate scientific knowledge into new Prospective HEOR plans in Indivior’s opportunities pivotal phase III trials respond to payers’ focus on actual medical and financial benefits for patients Pharmacogenetics Therapeutic
Slide 21: Opioid Use Disorder
INDIVIOR R&D DAY OPIOID USE DISORDER Paul J. Fudala, Ph.D, R.Ph., Senior Fellow Clinical Sciences Walter Ling, M.D., Professor & Founding Director of UCLA’s Integrated Substance Abuse Programs Tim Baxter, M.D., Chief Medical Officer Our vision is that all patients around the world will have unrestri
Slide 22: Paul J. Fudala, Ph.D, R.Ph.
Paul J. Fudala, Ph.D, R.Ph. Dr. Fudala is a pharmacist and toxicologist by training • Initially worked as a community and hospital pharmacist, • 14 years at UPENN Dept. of Psychiatry and Philadelphia including as a commissioned officer in the USPHS on the VAMC beginning in 1991; for most of those ye
Slide 23: Prof Walter Ling, MD
Prof Walter Ling, MD Prof Ling is board certified both in neurology and in psychiatry • Based in Los Angeles, he is a physician who is active both in research and in clinical practice • Prof Ling is and has been consistently listed in the Best Doctors in America, Best Doctors in the West and Best Do
Slide 24: RBP-6000 – A Once-Monthly Sustained Release Formulation of Buprenorphine
INDIVIOR R&D DAY RBP-6000 – A ONCE-MONTHLY SUSTAINED RELEASE FORMULATION OF BUPRENORPHINE FOR THE TREATMENT OF OPIOID USE DISORDER Dr. Mark K. Greenwald, Ph.D. Dr. Rick Norton, Ph.D. Dr. Susan Learned, M.D., Pharm.D., Ph.D. Dr. Amit Vijapura, M.D. Our vision is that all patients around the world wil
Slide 25: Introduction to the Opioid Blockade Concept & Clinical Significance
INDIVIOR R&D DAY INTRODUCTION TO THE OPIOID BLOCKADE CONCEPT & CLINICAL SIGNIFICANCE Dr. Mark K. Greenwald, Ph.D. Professor, Associate Chair for Research, and Director of the Substance Abuse Research Division Department of Psychiatry and Behavioral Neurosciences & Department of Pharmacy Practice Way
Slide 26: Objectives
Objectives Introduce opioid blockade concept Highlight mu-opioid receptor (µOR) actions of buprenorphine (BUP) as the critical target Clinical significance Review landmark studies that examined two major functional outcomes of varying µOR occupancy and BUP plasma concentrations in opioid-dependent v
Slide 27: BUP activates Mu-Opioid receptors at physiologically relevant concentrations
BUP activates Mu-Opioid receptors at physiologically relevant concentrations BUP is a partial agonist at µORs but across a wide [35S]GTP-gamma-S binding (% of basal) 200 dose range it does not activate kappa or delta Mu opioid receptors (where it is an antagonist). 180 Kappa Delta 160 There is no co
Slide 28: Do medication plasma concentrations and brain receptor occupancy closely correlate?
Do medication plasma concentrations and brain receptor occupancy closely correlate? Medication plasma levels Need to consider: have sometimes been assumed Dosing regimen as a proxy for CNS receptor Acute vs. chronic daily vs. sustained release concentration, but this assumption may not universally h
Slide 29: µOR occupancy measurement during Buprenorphine exposure
µOR occupancy measurement during Buprenorphine exposure Use PET imaging and [11C]-carfentanil to estimate µOR “occupancy” in vivo • This radiotracer (administered at sub-pharmacological doses) is very selective, and has high affinity, for µORs • Method: Infuse the tracer after a known BUP dose MRI (
Slide 30: Practical application of receptor theory to medication development
Practical application of receptor theory to medication development Target for treating opioid use disorder is the mu-opioid receptor With addiction medicines such as BUP, (µOR), regardless of whether the medication is an agonist we are looking to maximize efficacy (buprenorphine, methadone) or antag
Slide 31: Theoretical ordering of µOR requirements for differing behavioral tests
Theoretical ordering of µOR requirements for differing behavioral tests Reinforcing Analgesic Withdrawal Opioid Respiratory effect effect suppression blockade depression Criterion difference Increasing receptor occupancy -> (or decreasing receptor availability) Indivior R&D Day | December 9th 2015 3
Slide 32: Research objective/strategy
Research objective/strategy Use multi-dimensional assessments to characterize relationships between µOR occupancy (PET and [11C]-Carfentanil), plasma BUP concentrations, and clinically relevant outcomes esp. opioid withdrawal suppression and opioid blockade In two related studies, used complementary
Slide 33: Study 1: Methods
Study 1: Methods Each subject maintained on descending series of daily Study 1 protocol timeline BUP (Subutex) tablet doses: 32-mg, 16-mg, 2-mg and Outpatient then placebo (detoxification) across successive weeks. 32 Inpatient HYD challenge Buprenorphine Dose (mg s. l.) 28 PET scan Outpatient weeks
Slide 34: Study 1: Buprenorphine dose-effect on µOR availability
Study 1: Buprenorphine dose-effect on µOR availability Low occupancy 100 BA 10 (PFC) MRI 90 BA 25 (subgen ACC) Percent µOR availability 80 BA 32 (rostral ACC) 70 Caudate Bup 0 (4-hr post-BUP) 60 N.Accumbens 50 Thalamus 40 Amygdala Bup 2 30 20 10 Bup 16 High 0 occupancy 0.5 1 2 4 8 16 32 64 Bup 32 Bu
Slide 35: Study 1: Global-brain µOR availability predicts withdrawal suppression
Study 1: Global-brain µOR availability predicts withdrawal suppression #5316 #7500 30 r2 = 0.98 r2 = .94 Withdrawal Score (range, 0-64) #3134 20 r2 = .99 #4188 10 r2 = .30 #8086 r2 = .94 0 0.0 0.2 0.4 0.6 0.8 Increasing receptor occupancy -> (or decreasing receptor availability) Greenwald MK (2006)
Slide 36: Study 1: Higher-dose BUP produces significant opioid blockade
Study 1: Higher-dose BUP produces significant opioid blockade (OB) 18 16 14 12 10 8 OB B H * pre-BUP post-BUP post-HYD 6 * 4 2 0 Adapted from Greenwald MK, et al. (2003) Effects of buprenorphine maintenance dose on mu-opioid receptor binding potential, plasma concentration, and 32-mg 16-mg 2-mg 0-mg
Slide 37: Study 2: Vary time since Buprenorphine dose
Study 2: Vary time since Buprenorphine dose Aims Method Determine if µOR availability differs Each volunteer (n=10 completed) was at 4, 28, 52 and 76 hours after omitting tested in all 4 conditions, thereby BUP maintenance dose (16 mg Subutex) serving as his/her own control Do post-BUP time-related
Slide 38: Study 2: µOR availability across post-BUP time and brain regions
Study 2: µOR availability across post-BUP time and brain regions Low occupancy 100 90 Percent µOR availability 80 70 (Adjusted) 60 50 40 BA 10 (PFC) N.Accumbens 30 BA 25 (subgen ACC) Thalamus 20 BA 32 (rostral ACC) Amygdala 10 Caudate 0 High 4 16 28 40 52 64 76 occupancy Time since BUP 16-mg SL tabl
Slide 39: Study 2: Relationships of µOR occupancy to plasma, withdrawal and blockade
Study 2: Relationships of µOR occupancy to plasma, withdrawal and blockade Outcome measure 12 Withdrawal symptoms 11 r2 = 0.839 Plasma level 10 (ng/ml); 9 ∆ HYD agonist 8 symptoms Opioid Withdrawal symptoms r2 = 0.853 7 (0-64 scale), 6 or change in Agonist Symptoms 5 (blockade) 4 3 2 1 BUP plasma le
Slide 40: Conclusions
Conclusions µOR occupancy is non-linearly related to BUP plasma concentrations Significant relationship observed for each individual subject µOR occupancy is linearly related to withdrawal suppression and blockade • In these physically dependent individuals, average µOR occupancy of ≈50% is effectiv
Slide 41: Summary and lessons learned for planning RBP-6000 clinical trials
Summary and “lessons learned” for planning RBP-6000 clinical trials BUP tablet maintenance produces dose- and time-dependent increases in µOR occupancy that closely correlate with its plasma concentrations as well as opioid withdrawal suppression and opioid blockade Opioid blockade is a “taller orde
Slide 42: Introduction to ATRIGEL®
INDIVIOR R&D DAY INTRODUCTION TO ATRIGEL® Dr. Rick Norton, Ph.D. Director, Formulation Development, Indivior Inc.
Slide 43: Outline
Outline ATRIGEL® drug delivery platform • Patient’s point of view • Underlying science RBP-6000 for opioid use disorder ATRIGEL is a registered trademark of Tolmar Therapeutics, Inc. Indivior R&D Day | December 9th 2015
Slide 44: ATRIGEL® drug delivery platform: Patient's point of view
ATRIGEL® drug delivery platform: Patient’s point of view Long acting injectable Subcutaneous Biodegradable One injection per injection in - no removal month (typically) abdomen required Compliance/ Confidence Indivior R&D Day | December 9th 2015 44
Slide 45: ATRIGEL® drug delivery platform: Established products
ATRIGEL® drug delivery platform: Established products ELIGARD Subcutaneous Available in doses for 1, 3, 4 and 6 Currently marketed controlled release month dosages in 67 countries of leuprolide acetate Source – May 18, 2015 Tolmar Press Release (Business Wire) Indivior R&D Day | December 9th 2015
Slide 46: Plasma levels: Typical daily dosing - illustration
Plasma levels: Typical daily dosing - illustration NOTE: Simulated data For illustration purposes Plasma concentration 0 6 12 18 24 Hour Indivior R&D Day | December 9th 2015 46
Slide 47: Plasma levels: Month of daily dosing - illustration
Plasma levels: Month of daily dosing - illustration NOTE: Simulated data For illustration purposes Plasma concentration 0 5 10 15 20 25 30 Day Indivior R&D Day | December 9th 2015 47
Slide 48: Plasma levels: Lack of compliance - illustration
Plasma levels: Lack of compliance - illustration NOTE: Simulated data For illustration purposes Plasma concentration 0 5 10 15 20 25 30 Day Indivior R&D Day | December 9th 2015 48
Slide 49: Plasma levels: Compare with ATRIGEL® depot
Plasma levels: Compare with ATRIGEL® depot - idealized illustration NOTE: Simulated data For illustration purposes Plasma concentration 0 5 10 15 20 25 30 Day Indivior R&D Day | December 9th 2015 49
Slide 50: Plasma levels: Compare with ATRIGEL® depot
Plasma levels: Compare with ATRIGEL® depot - idealized illustration NOTE: Simulated data For illustration purposes Cmax near daily Cmax Plasma concentration 0 5 10 15 20 25 30 Day Indivior R&D Day | December 9th 2015 50
Slide 51: Plasma levels: Compare with ATRIGEL® depot
Plasma levels: Compare with ATRIGEL® depot - idealized illustration NOTE: Simulated data For illustration purposes Cmax near daily Cmax Plasma concentration 0 5 10 15 20 25 30 Day Indivior R&D Day | December 9th 2015 51
Slide 52: Plasma levels: Compare with ATRIGEL® depot
Plasma levels: Compare with ATRIGEL® depot - idealized illustration NOTE: Simulated data For illustration purposes No daily Daily Cmax near daily Cmax fluctuations compliance Plasma concentration not an issue 0 5 10 15 20 25 30 Day Indivior R&D Day | December 9th 2015 52
Slide 53: ATRIGEL® drug delivery platform: Underlying science
ATRIGEL® drug delivery platform: Underlying science Indivior R&D Day | December 9th 2015
Slide 54: ATRIGEL® components
ATRIGEL® components Biodegradable Polymer Biocompatible Solvent + Drug Indivior R&D Day | December 9th 2015 54
Slide 55: How does it work?
How does it work? Injected as a liquid Indivior R&D Day | December 9th 2015
Slide 56: How does it work?
How does it work? Injected Solidifies in the as a liquid subcutaneous space Indivior R&D Day | December 9th 2015
Slide 57: How does it work?
How does it work? Injected Solidifies in the Releases drug as a liquid subcutaneous space into the body Indivior R&D Day | December 9th 2015
Slide 58: How does it work?
How does it work? Biodegrades Injected Solidifies in the Releases drug as a liquid subcutaneous space into the body Indivior R&D Day | December 9th 2015
Slide 59: Solidification demonstration
Solidification demonstration Indivior R&D Day | December 9th 2015 59
Slide 60: How does it work? Solidification
How does it work? Solidification Injected liquid Solvent out Water in Drug out Plasma level 0 2 4 6 Day Indivior R&D Day | December 9th 2015 60
Slide 61: How does it work? Solidification
How does it work? Solidification Injected Polymer liquid solidification Solvent at surface out Water in Drug out Plasma level 0 2 4 6 Day Indivior R&D Day | December 9th 2015 61
Slide 62: How does it work? Solidification
How does it work? Solidification Injected Polymer liquid solidification Solvent Solvent at surface out out Water Water in in Drug Drug out out Plasma level 0 2 4 6 Day Indivior R&D Day | December 9th 2015 62
Slide 63: How does it work? Drug release
How does it work? Drug release • Diffusion • Polymer Degradation – lowers barrier to diffusion over time • Balance of diffusion and Plasma level polymer degradation needed to get desired release rate and pharmacokinetics 0 5 10 15 20 25 30 Day Indivior R&D Day | December 9th 2015 63
Slide 64: Why does it work?
Why does it work? Biocompatible solvent N-methyl-pyrrolidone (NMP) In addition to all the safety requirements Used in all ATRIGEL® products to date • Good solvent for the polymer Great polymer solvent • Water miscible Quickly dissipates into the body Indivior R&D Day | December 9th 2015 64
Slide 65: Why does it work?
Why does it work? Biodegradable Poly(lactide-co-glycolide) polymer family of polymers In addition to biodegradable Used in all ATRIGEL® products to date • Biocompatible Used in wide range of drug delivery systems • Water insoluble and medical devices • Customizable structure Solid safety record Brea
Slide 66: Polymer degradation
Polymer degradation Degradation of Poly(lactide-co-glycolide) polymers O • Hydrolysis of ester bonds O • Molecular weight drops due to random chain scission H2O • Low molecular weight fragments O OH are water soluble HO • Eventually lactic and glycolic acid Indivior R&D Day | December 9th 2015 66
Slide 67: Introduction to RBP-6000: patents
Introduction to RBP-6000 U.S. patents International patents • 8,921,387 • U.K. GB2513267 • 8,975,270 • Australia 2011263478 Various patent • New Zealand 604026 applications • South Africa 2012/09233 pending Indivior R&D Day | December 9th 2015
Slide 68: Introduction to RBP-6000
Introduction to RBP-6000 Solution of Syringe Dosage Buprenorphine Ready to Inject strengths in ATRIGEL® Refrigerated; 100 mg ( 0.5 mL injection) delivery system 7 days at room temperature 300 mg (1.5 mL injection) Indivior R&D Day | December 9th 2015
Slide 69: RBP-6000: Clinical Development
INDIVIOR R&D DAY RBP-6000: CLINICAL DEVELOPMENT THE PATHWAY TO WHERE WE ARE TODAY Dr. Susan Learned, M.D., Pharm.D., Ph.D. Senior Vice-President, Global Clinical Development, Indivior Inc.
Slide 70: RBP-6000 - US clinical development program
RBP-6000 - US clinical development program First-in-man Single Ascending Multiple Ascending study Dose study Dose study (20 mg) (50, 100, and 200 mg) (50, 100, 200, and 300 mg) Opioid Double blind, PC Open label extended blockade study phase 3 study safety study Indivior R&D Day | December 9th 2015
Slide 71: OUD treatment paradigm shift
OUD treatment paradigm shift FDA Type C meeting: Target a dose that will fully block opioid agonist effects in Phase 3 trial Hypotheses testing: • Based on PD analysis, an average buprenorphine plasma level of 2-3 ng/mL will produce ~70% µ receptor occupancy (confirm in Phase 2 MAD study) • Obtain t
Slide 72: Q#1: What is the PK profile of RBP-6000 in a MAD study?
Q#1: What is the PK profile of RBP-6000 in a Multiple Ascending Dose (MAD) study? 50 mg 100 mg 200 mg 300 mg SS Cavg = 0.96 ng/mL SS Cavg = 1.66 ng/mL SS Cavg = 2.8 ng/mL SS Cavg = 5.12 ng/mL Indivior R&D Day | December 9th 2015 72
Slide 73: Q#2: PK/RO relationship & predictions of opioid blockade
Q#2: What is the PK/RO relationship & predictions of opioid blockade with RBP-6000 (200 mg & 300 mg)? 8 Agonist Symptom change (HYD), linear r=0.99 100 Δagonist 7 Subj 1 (200mg) mg ∆agonist 6 Subj 2 (300mg) 5 80 2424mg 4 Linear (Agonist Symptom 70 change (HYD), linear r=0.99) 3 Mu-RO(%) 60 HYD 2 HYD
Slide 74: RBP-6000: Opioid blockade study
RBP-6000: Opioid blockade study Title Patient population Dosing level for all subjects A Multiple-Dose study 39 opioid-dependent 0 mg hydromorphone of blockade of subjective males and females; challenges after 300 mg opioid effects, plasma levels, not treatment-seeking RBP-6000 and safety of subcuta
Slide 75: Opioid blockade study design
Opioid blockade study design Qualification period 1st injection 2nd injection Week Screening -1 1 2 3 4 5 6 7 8 9 10 11 12 (Sublingual) RBP-6000 injection days Hydromorphone challenge days (5th, 6th, and 7th day of each week) Indivior R&D Day | December 9th 2015 75
Slide 76: RBP-6000: Opioid blockade study – outcome measures
RBP-6000: Opioid blockade study – outcome measures Subjective Effects (VAS Scores) Reinforcing Effects • Drug Liking (Primary outcome measure) • No earlier than 5 hours after HM challenge • Any Drug Effect • Choose the amount of HM dosed that day or • Good Drug Effect money in progressive ratio sche
Slide 77: Q#3: Can we confirm the PD predictions with the opioid blockade study?
Q#3: Can we confirm the PD predictions with the opioid blockade study? Opioid blockade study: Drug liking – baseline scores Indivior R&D Day | December 9th 2015 77
Slide 78: Q#3: Can we confirm the PD predictions with the opioid blockade study?
Q#3: Can we confirm the PD predictions with the opioid blockade study? Opioid blockade study: Drug liking – RBP-6000 month 1 Opioid blockade study: Drug liking – RBP-6000 month 2 Indivior R&D Day | December 9th 2015 78
Slide 79: Q#3: Can we confirm the PD predictions with the opioid blockade study?
Q#3: Can we confirm the PD predictions with the opioid blockade study? Opioid blockade study: Drug liking – RBP-6000 month 3 Indivior R&D Day | December 9th 2015 79
Slide 80: RBP-6000: PK/PD/RO relationship
RBP-6000: PK/PD/RO relationship The PK profile of RBP-6000 was derived after single and multiple ascending dose studies A PK/RO model was established and validated with data from the MAD study The “opioid blockade” hypothesis was tested clinically The outcome of the “opioid blockade” study was used
Slide 81: RBP-6000: Phase 3 study design
RBP-6000: Phase 3 study design Treatment 6 double-blind injections; and weekly urine visits (Weeks 1 - 21) Follow Up (option to roll into Randomization RBP-6000 300 mg x 2 months/ safety extension) (n= 470) 100mg x 4 months (188 subjects)* Induction Stabilization RBP-6000 300mg x 6 months Week Scree
Slide 82: Update on Phase 3 Pivotal Trial with RBP-6000
INDIVIOR R&D DAY UPDATE ON PHASE 3 PIVOTAL TRIAL WITH RBP-6000 Dr. Amit Vijapura, M.D.
Slide 83: Dr. Amit Vijapura, M.D.
Dr. Amit Vijapura, M.D. Dr. Vijapura is a medical specialist with board certification in Psychiatry & Addiction Medicine based in Jacksonville, Florida in private practice for the last 25 years. He is running a clinical research site with three research coordinators. He has been involved in clinical
Slide 84: Experience treating OUD patients with RBP-6000 in ongoing clinical trials
Experience treating OUD patients with RBP-6000 in ongoing clinical trials 01 Dealing with non-compliance, 04 Patient experience during research diversion in office-based treatment 05 Physician experience during research 02 Experience with depot Buprenorphine studies 06 Verbal testimonial from subjec
Slide 85: R&D Strategic Pipeline Update
INDIVIOR R&D DAY R&D STRATEGIC PIPELINE UPDATE Christian Heidbreder, Ph.D., Chief Scientific Officer Our vision is that all patients around the world will have unrestricted access to quality treatment services for the chronic relapsing conditions and co-morbidities of addiction
Slide 86: R&D strategy to address challenges in addiction medicine
R&D strategy to address challenges in addiction medicine Efficacy Efficacy 5 Maturity 5 3 3 1 Side 1 Cost effects Cost Side effects Efficacy 5 Efficacy 5 3 Delivery 3 Delivery 1 1 Side Side Cost effects Cost effects Unmet Need Delivery Delivery Early Stage Asset Development Existing Product Developm
Slide 87: Existing Product Development (EPD)
Existing Product Development (EPD) Overview & latest update Indivior R&D Day | December 9th 2015
Slide 88: Suboxone® Tablet
Suboxone® Tablet Target Objective Status Changes to the pregnancy • Briefing Book submitted to FDA Jun 19th, 2014; feedback received Sep 12th, 2014 and nursing mothers USA/Global • sNDA successfully submitted to the FDA on May 15th, 2015 sections of the labeling for all buprenorphine products (1) •
Slide 89: Suboxone® Film
Suboxone® Film Target Objective Status • PDUFA date Feb 21st, 2015 Buccal indication • FDA approval on Sep 22nd, 2015 • Published in Clin Pharmacokinet. 2015 Aug;54(8):837-49. Phase IV Commitment Hepatic USA http://dx.doi.org/10.1007/s40262-015-0238-6 • Clinical Study Protocol successfully sent to t
Slide 90: New Product Development (NPD)
New Product Development (NPD) Overview & latest update Indivior R&D Day | December 9th 2015
Slide 91: New Product Development: Opioid use disorder
New Product Development: Opioid use disorder Product Status US: • Phase III Efficacy study (RB-US-13-0001): LPI achieved on Nov 17th, 2015. RBP-6000: • Phase III Safety extension study (RB-US-13-0003): Screening and enrollment ongoing. Buprenorphine once • US Patent No. 8,975,270 was issued Mar 10th
Slide 92: New Product Development: Rescue medications for drug overdose
New Product Development: Rescue medications for drug overdose Product Status Naloxone intranasal spray for treatment of opioid US: Under evaluation overdose Canada: Pre-NDS meeting with Health Canada on Oct 22nd, 2015 France: Temporary Authorization for Use (ATU) dossier filed on Jun 17th, 2015. ATU
Slide 93: New Product Development: Alcohol use disorder
New Product Development: Alcohol use disorder Product Status • Pre-IND meeting with FDA Jan 29th, 2015 • IND submission: Jun 26th, 2015 Arbaclofen Placarbil • RB-US-14-0001: A randomized, double-blind, placebo-controlled, Dose escalation study to determine the Maximum Tolerated Dose (MTD) of Arbaclo
Slide 94: New Product Development: Psychiatric co-morbidities
New Product Development: Psychiatric co-morbidities Product Status RBP-7000: Risperidone once monthly • Phase 3 pivotal efficacy study (RB-US-09-0010): Completed; Preliminary data from pivotal Phase III in Atrigel® Efficacy study were published on May 5th, 2015 • Phase 3 long-term safety study (RB-U
Slide 95: Early Stage Asset Development (ESAD)
Early Stage Asset Development (ESAD) Overview & latest update Indivior R&D Day | December 9th 2015
Slide 96: Selective dopamine D3 receptor antagonists for Stimulant Use Disorder
Selective dopamine D3 receptor antagonists for the treatment of Stimulant Use Disorder D3 receptors are located D3 receptors are located on a pathway known to on a known addiction modulate reward-related pathophysiology mechanisms pathway Would a selective DA D3 receptor antagonist show efficacy in
Slide 97: Positive Allosteric Modulator of GABA-A receptors for Alcohol Use Disorder
Positive Allosteric Modulator of GABA-A receptors for the treatment of Alcohol Use Disorder The GABA-A receptor is a complex pentameric (five subunit) protein which is composed of particular combinations of α (1–6), β (1–3), γ (1–3), δ, ε, and θ subunits. The presence of the δ subunit-containing GAB
Slide 98: Q&A Session
INDIVIOR R&D DAY Q&A SESSION Our vision is that all patients around the world will have unrestricted access to quality treatment services for the chronic relapsing conditions and co-morbidities of addiction