RedHill Biopharma Ltd. · NASDAQ:RDHL
RedHill Biopharma — Investor Day (April 2017)
88 slides from RedHill Biopharma's investor day presentation, Apr 27, 2017
Slide 1: BEKINDA R&D Day
RedHill Biopharma Ltd. (“RDHL”) BEKINDA® R&D Day BEKINDA® 24mg - Acute Gastroenteritis (Phase III) BEKINDA® 12mg - IBS-D (Phase II) Le Parker Meridien Hotel, New York Thursday, April 27th 2017
Slide 2: Disclaimer and Forward Looking Statements
Disclaimer and Forward Looking Statements This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company’s securities or to participate in any investment in the Company. No representation or warranty is ma
Slide 3: Agenda
Agenda 8:00 - Welcome remarks & introduction Dror Ben-Asher, RedHill CEO 8:05 - Introduction to BEKINDA® Gilead Raday, RedHill COO 8:15 - BEKINDA® clinical studies - acute gastroenteritis (Phase III) and IBS-D (Phase II) Terry F. Plasse, MD, RedHill Medical Director 8:30 - IBS-D, the unmet medical n
Slide 4: Welcome Remarks & Introduction
WELCOME REMARKS & INTRODUCTION Dror Ben-Asher CEO, RedHill Biopharma 4
Slide 5: Company Highlights
Company Highlights Emerging Specialty Focused primarily on development and commercialization of late clinical-stage, proprietary, orally- Biopharmaceutical administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases Company and cancer (NASDAQ/TASE: RDHL) • Pote
Slide 6: Pipeline
Pipeline* NDA/ Product** Indication Pre-Clinical Phase I/II Phase III Marketed IBS and acute Donnatal® enterocolitis*** U.S. CO-PROMOTION Chronic diarrhea EnteraGam® and loose stools**** U.S. EXCLUSIVE LICENSE RHB-105 GI & Inflammation H. pylori infection Successful first U.S. Phase III completed; C
Slide 7: Selected Potential Upcoming Milestones
Selected Potential Upcoming Milestones RHB-104: • Second DSMB meeting for the MAP US Phase III study for Crohn’s disease, including safety and interim efficacy analysis, with evaluation of option of early stop for success for overwhelming efficacy - mid-2017 Q2 RHB-105: 2017 • Initiation of a confir
Slide 8: Introduction to BEKINDA
INTRODUCTION TO BEKINDA® Gilead Raday COO, RedHill Biopharma 8
Slide 9: BEKINDA 24 mg & 12 mg
BEKINDA® 24 mg & 12 mg Bi-modal, extended release, oral formulation of the 5-HT3 antagonist ondansetron • Once daily administration - 24h coverage • Patent-protected Two dose strengths: • BEKINDA® 24 mg for acute gastroenteritis/gastritis • BEKINDA® 12 mg for diarrhea-predominant irritable bowel syn
Slide 10: BEKINDA 24 mg & 12 mg Programs
BEKINDA® 24 mg & 12 mg Programs BEKINDA® targets new indications for which ondansetron is not an approved treatment: Phase III study of BEKINDA® 24 mg for acute gastroenteritis & gastritis (GUARD study): • 321 treated patients with LPI/LPO in February 2017 • Top-line results expected in Q2/2017 • De
Slide 11: BEKINDA - Controlled Delivery Technology
BEKINDA® - Controlled Delivery Technology Pharmacokinetic comparison: Controlled Delivery Technology (CDT®): BEKINDA® 24 mg & 12 mg: 60 • licensed from Temple University • Allows flexible design and dosing BEKINDA® 24 mg • Simple formulation & manufacturing 40 BEKINDA® 12 mg C oncentration (ng/mL) R
Slide 12: BEKINDA Clinical Studies
BEKINDA® CLINICAL STUDIES - ACUTE GASTROENTERITIS (PHASE III) IBS-D (PHASE II) Terry F. Plasse, MD Medical Director, RedHill Biopharma 12
Slide 13: BEKINDA Phase III Study - Acute Gastroenteritis
BEKINDA® Phase III Study - Acute Gastroenteritis Rationale for Indication and Study • Ondansetron is the drug of choice for treatment of acute gastroenteritis It is the most commonly prescribed drug in emergency departments (EDs) in the US • However, it has never been approved for that indication
Slide 14: Prior Studies of Ondansetron in Acute Gastroenteritis
Prior Studies of Ondansetron in Acute Gastroenteritis • 9 studies in literature on use of ondansetron for acute gastroenteritis 5 iv, 4 po 7 placebo control, 2 active control Only 2 had any adult patients; none were primarily adults • Incidence of vomiting is significantly lower in patients re
Slide 15: BEKINDA Phase III Study for Acute Gastroenteritis
BEKINDA® Phase III Study for Acute Gastroenteritis • Randomized, parallel group, placebo-controlled study in patients presenting to ED or urgent care center with clinical diagnosis of acute gastroenteritis • Patients received one dose of BEKINDA® in ED Additional dose if patient vomited within 15
Slide 16: Major Inclusion/Exclusion Criteria
Major Inclusion/Exclusion Criteria • Adults and children ≥age 12 with vomiting from presumed gastroenteritis or gastritis ≤36 hours • Vomiting ≥twice in 4 hour prior to consent • Major exclusions: Severe dehydration Immediate need for IV hydration or meds Likely etiologies other than acute gas
Slide 17: Study Status
Study Status • 330 patients enrolled, 321 treated • Randomized 60:40 to active vs. placebo • All patients off study • Data cleaning under way • No adverse safety signal • Expect top line results in Q2/2017 17
Slide 18: BEKINDA Phase II Study - IBS-D Rationale
BEKINDA® Phase II Study - IBS-D Rationale for Indication and Study • 5-HT3 antagonists active in treatment of IBS-D Alosetron (Lotronex) is approved for treatment of women with IBS-D, but with restrictions due to uncommon but severe toxicities Pilot studies of existing formulations of ondansetr
Slide 19: BEKINDA IBS-D Phase II: Study Objectives
BEKINDA® IBS-D Phase II: Study Objectives Primary Objective • Proportion of patients in each treatment group with response in stool consistency compared to baseline Secondary Objectives • Proportion of patients in each treatment group who are pain responders, per FDA guidance definition • Proportion
Slide 20: FDA Guidance: Responder Definition
FDA Guidance: Responder Definition • Stool Consistency As compared to baseline, decrease ≥50% in number of days per week with at least one stool that has a consistency of 6 or 7 and no increase in abdominal pain over the week • Abdominal Pain Intensity Decrease in weekly average of worst abdominal p
Slide 21: Major Inclusion Criteria
Major Inclusion Criteria 1) Male and female patients age ≥18 years (with a minimum of 25% males in the study) 2) Patient meets FDA guidance and Rome III criteria for IBS-D: a) Recurrent abdominal pain or discomfort over ≥6 months, with frequency ≥3 days/month in the last 3 months associated with ≥2
Slide 22: Major Inclusion Criteria (cont'd)
Major Inclusion Criteria (cont’d) 3) Major laboratory parameters within the following limits (no worse than grade 1 abnormalities per NCI-CTCAE v4) 4) C-reactive protein within normal limits for lab 5) Patients of childbearing potential and male partners of females of childbearing potential must uti
Slide 23: Major Exclusion Criteria
Major Exclusion Criteria • Evidence of other cause for bowel disease: Relevant abnormalities seen on colonoscopy History of and/or positive serologic test for celiac disease Known or suspected lactose intolerance • History of abdominal surgery other than appendectomy or cholecystectomy at any
Slide 24: Major Exclusion Criteria (cont'd)
Major Exclusion Criteria (cont’d) • Use of any 5-HT3 antagonist within 4 weeks of study entry • Use of rifaximin within 4 months of study entry • Use of any other agent specific for IBS (such as alosetron or eluxadoline) or for symptomatic treatment of IBS (such as antispasmotics and antidiarrheals
Slide 25: Study Design
Study Design • Screening - up to 6 Weeks Including 2 weeks’ baseline stool and symptom recording • Randomization: 60:40 active:placebo • Treatment - 8 weeks • Follow up - 4 Weeks • Only rescue med allowed is loperamide None during screening ≤2 x 2 mg 3 days/week during treatment phase 25
Slide 26: Patient-Reported Outcomes
Patient-Reported Outcomes • These form the basis of efficacy assessments Stool consistency: Bristol stool scale Worst pain daily: 11-point Likert scale Worst discomfort daily: 11-point Likert scale Interference with ADL: 5-point Likert scale • Diaries of symptoms • Diaries of adverse events
Slide 27: Study Status
Study Status • 127 patients randomized • Enrollment of last patient announced April 2017 • Last patient treatment ending July, 2017 • Top line results in Q3/2017 27
Slide 28: IBS-D - The Unmet Medical Need and Current Treatment Options
IBS-D - THE UNMET MEDICAL NEED AND CURRENT TREATMENT OPTIONS M. Scott Harris, MD, MS, FACP, AGAF Consultant to RedHill Biopharma Professor of Clinical Pharmacology and Physiology at Georgetown University School, Principal, Middleburg Consultants 28
Slide 29: Irritable Bowel Syndrome (IBS) - Overview
Irritable Bowel Syndrome (IBS) - Overview • A highly prevalent GI disorder characterized by abdominal pain and altered bowel habits without an identifiable pathologic abnormality • Disabling and unpredictable, with significant impact on productivity and quality of life • Prospectively diagnosed by t
Slide 30: IBS - Disease Prevalence and Burden of Illness
IBS - Disease Prevalence and Burden of Illness • Across the world, between 5 and 30% of Primary Care people suffer from IBS symptoms. In the US, about 35 million people are affected 12% • Equally prevalent by gender, but in the US, women seek care 2-fold to 3-fold more often Other than men • One of
Slide 31: Annual Medical & Prescription Costs of Patients with IBS-D
Unadjusted Mean Annual Medical & Prescription Costs of Patients with IBS-D Buono J, J Manag Care Spec Pharm 2017 After adjusting for demographics and comorbidities, incremental annual all-cause costs associated with IBS-D were $2,268 ($9,436 for IBS-D patients vs. $7,169 for matched controls; P < 0.
Slide 32: IBS - Clinical Presentation
Irritable Bowel Syndrome - Clinical Presentation • Abdominal pain or discomfort, bloating, and altered bowel habits; symptoms often relieved by bowel movement • Younger women, typically under 45 years, with most frequent onset in the second to third decade of life • Makes its first appearance after
Slide 33: IBS - Pathophysiology and Etiology
IBS - Pathophysiology and Etiology Multiple hypotheses generated, none are conclusive • Neurotransmitter derangements within the enteric nervous system • Altered microbial homeostasis • Abnormal intestinal permeability • Chronic low-grade intestinal inflammation • Mast cell hyper-reactivity • Abnorm
Slide 34: IBS - The Big Brain and the Little Brain
IBS - The “Big Brain” and the “Little Brain” Brain-Gut Connection • The central and enteric nervous systems share common neuronal, transmitter and innervation pathways • PET scanning indicates cortical areas of activity in IBS patients • Emotional events impact IBS symptoms, although no distinct emo
Slide 35: Classification of IBS - 3 Subtypes
Classification of IBS - 3 Subtypes Subtype Features Therapies One of three IBS subtypes, Alosetron characterized by the Eluxadoline predominant stool pattern Diarrhea- Abdominal pain and Rifaximin bloating with predominant IBS diarrhea, urgency, **Anti-diarrheals (IBS-D) often incontinence **Anti-sp
Slide 36: IBS - Medical Basis of Treatment
IBS - Medical Basis of Treatment Targets for IBS Treatment IBS-D • Suppress excessive activity at serotonin (5HT) receptors (alosetron) • Down-regulate gut contraction and secretion (eluxadoline) • Alter gut flora (rifaximin) IBS-C • Simulate secretion and lubricate the stool (linaclotide, lubiprost
Slide 37: Pharmacology of 5HT3 Antagonists in IBS Treatment
Pharmacology of 5HT3 Antagonists in IBS Treatment Targets for IBS Treatment • Selective serotonin reuptake inhibitors (SSRIs) are routine agents in the treatment of depression • Because of these effects, serotonin (5HT) is often thought of as just a CNS neurotransmitter • However, more than 90% of s
Slide 38: The Spectrum of Prescription Drugs in IBS-D
The Spectrum of Prescription Drugs in IBS-D Drug Manufacturer Mechanism Comments Approved in 2000 for women with IBS-D. Withdrawn, then re-introduced under REMS program at a lower dose Licensed by GSK Lotronex® 5HT3 receptor Limited to patients with severe, chronic symptoms who to Prometheus (aloset
Slide 39: Drugs Currently in Development for IBS-D
Drugs Currently in Development for IBS-D Candidate Sponsor Mechanism Comments Bombesin-2 Early Phase 2 trial completed in 2014 with positive ASP7147 Drais receptor data readout (DDW 2015). But no recent antagonist development Neurokinin-2 Development terminated after failed Phase 3 trials Ibudotant
Slide 40: Prior Studies of Ondansetron in IBS-D
Prior Studies of Ondansetron in IBS-D Treatment Author (Year) n Study Design Treatment Arms Results duration Significant reduction in Randomized, Steadman Ondansetron 16 mg watery stools during last 14 double-blind cross- 4 weeks (1992) vs placebo tid week of treatment over (p < 0.05) Randomized, Tr
Slide 41: Trial of Ondansetron in IBS-D: Garsed 2013
Randomized, Double-Blind, Placebo-Controlled Cross-Over Trial of Ondansetron in IBS-D: Garsed 2013 Significant Response Achieved Across Multiple IBS-D Endpoints Endpoint Treatment effect (95% CI) p value Stool consistency -0.9 (-1.1 to -0.6) < 0.001 Days per week with pain -0.3 (-0.7 to 0.1) 0.203 D
Slide 42: Ischemic Colitis and Constipation Associated with Alosetron
Ischemic Colitis and Constipation Associated with the Use of Alosetron • Subsequent to initial approval in 2000, alosetron was temporarily withdrawn due to reports of ischemic colitis and severe constipation • The adjudicated rates of ischemic colitis and severe constipation were 0.96/1000 patient y
Slide 43: IBS-D - Summary
IBS-D - Summary • IBS-D is a chronic condition with a significant impact on quality of life, work productivity, physician visits and health care utilization • A large, unmet need exists for new drugs in the treatment of IBS-D • However, no new treatments are on the immediate horizon • The mechanism
Slide 44: Acute Gastroenteritis - The Unmet Medical Need and Current Treatment Options
ACUTE GASTROENTERITIS - THE UNMET MEDICAL NEED AND CURRENT TREATMENT OPTIONS Robert A. Silverman, MD, MS Lead Investigator BEKINDA® Phase III study Department of Emergency Medicine, Northwell Health System Hofstra Northwell School of Medicine 44
Slide 45: Acute Gastroenteritis: Introduction
Acute Gastroenteritis: Introduction • Gastroenteritis: Acute infection of the gastrointestinal tract • Gastritis: Inflammation of the stomach • Enteritis: Inflammation of the intestines 45
Slide 46: Gastroenteritis: Presentation
Gastroenteritis: Presentation Most common symptoms: Nausea Diarrhea Vomiting Abdominal pain, usually cramping and diffuse Fever, chills, body aches, malaise Rapid Onset: 1-2 days after exposure to the infection Limited Duration of illness: 2-8 days depending on the cause 46
Slide 47: Gastroenteritis: Causes
Gastroenteritis: Causes Most cases are caused by viruses: Norovirus Rotovirus Adenovirus Less common causes: bacterial Relevance: Viruses causing gastroenteritis are highly contagious, but the disease is self limited Treatment is targeted to the symptoms, as there is no antibiotic or antiviral
Slide 48: Where Does Gastroenteritis Occur?
Where Does Gastroenteritis Occur? Anywhere. Anytime. Most commonly in the Winter and Spring Clusters or outbreaks occur where people gather in close quarters or where food is prepared for large numbers of people Virus is spread by: Person to person Person to food/water to person Person to surf
Slide 49: Where Does Gastroenteritis Occur?
Where Does Gastroenteritis Occur? 49
Slide 50: Where Does Gastroenteritis Occur?
Where Does Gastroenteritis Occur? 50
Slide 51: Frequency of Gastroenteritis in the US
Frequency of Gastroenteritis in the US Gastroenteritis is a major cause of illness in the United States • Frequency difficult to determine; numbers of AGE typically underestimated as it is under-reported and there is no specific test for AGE • Approximately 179 million episodes of AGE occur each yea
Slide 52: Worldwide: Norovirus as an Example
Worldwide: Norovirus as an Example Worldwide, about one out of every five cases of acute gastroenteritis is caused by norovirus • Globally, norovirus is estimated to be the most common cause of acute gastroenteritis • Norovirus is responsible for 685 million cases worldwide every year • 200 million
Slide 53: Trends: ED Visits in the US, All Ages, All Causes
Trends: ED Visits in the US, All Ages, All Causes 53
Slide 54: ED Data: US National Hospital Ambulatory Medical Care Survey
ED Data: US National Hospital Ambulatory Medical Care Survey, 2013, CDC, National Center for Health Statistics Year 2013: 130,353,000 ED Visits Most commonly prescribed ED drugs (dosages): Ondansetron: 20,060,000 Ibuprofen: 16,465,000 Tylenol/codeine: 15,895,000 Acetaminophin: 11,405,000 Ketorolac:
Slide 55: Trends: US Emergency Department Ondansetron Usage
Trends: US Emergency Department Ondansetron Usage - 2008-2013 25 # of Ondansetron ED Drug Mentions 20 15 (millions) 10 5 0 2008 2009 2010 2011 2012 2013 Year CDC, National Hospital Ambulatory Medical Care Survey 55
Slide 56: Assessment of Gastroenteritis
Assessment of Gastroenteritis Most of the time, the assessment is quick and simple History: • Age • Duration of symptoms • Amount of diarrhea and vomiting • Tolerance of symptoms • Co-morbidities • Social history Exam: *How does the individual look and sound*? Vital signs: pulse, blood pressure, res
Slide 57: Gastroenteritis: Clinical Signs of Severe Illness
Gastroenteritis: Clinical Signs of Severe Illness • Altered mental status (confusion, lethargy) • Dizziness on standing • Fainting • Severe weakness • Not urinating/urine dark • Blood in vomit/stool • Prolonged symptoms 57
Slide 58: Treatment for Gastroenteritis
Treatment for Gastroenteritis Important principals of therapy: • Acute viral gastroenteritis is usually self-limited • Typically treated with supportive measures • Dehydration is responsible for the morbidity and deaths associated with gastroenteritis • Fluid repletion is the mainstay of treatment o
Slide 59: Treatment for Gastroenteritis
Treatment for Gastroenteritis Principals: • People feel ill when dehydrated, and better when hydrated • Either oral therapy or IV therapy can be used for rehydration (Cholera) • Anti-emetics are typically given to patients with nausea and vomiting to allow for oral rehydration: In the ED setting, ty
Slide 60: Treatment for Gastroenteritis
Treatment for Gastroenteritis Treatments: • Fluid repletion • Anti-emetics • Anti-diarrheal agents • Other (fever, pain control) No specific antiviral agents are available Treatment based on assessment of illness severity • Evaluation: history, vital signs, examination • Lab testing: occasionally us
Slide 61: Ondansetron ED Data
Ondansetron ED Data US National Hospital Ambulatory Medical Care Survey, 2013, CDC, National Center for Health Statistics ED prescription of ondansetron: 73.5% given in the ED 9.4% given only on discharge 16.9% given both in ED and on discharge 61
Slide 62: Relapse After Emergency Department Treatment
Relapse After Emergency Department Treatment One dose of standard ondansetron treatment given to children in the ED: beneficial in children Return to ED within 7 days of initial ED visit (children 6 months-10 years) 42/206 (20%) Almost all patients relapsed within 3 days of ED visit Freedman, et. al
Slide 63: Common ED Discharge Practices
Common ED Discharge Practices • Assess for ability to tolerate oral fluid ingestion • Increase fluid intake (fever, diarrhea) • Ideally, prescribe anti-emetics (often not done) • Recommend gradual increase in solids • Avoidance/prevent spread of virus 63
Slide 64: Spectrum of Illness
Spectrum of Illness Visit to PCP Visit to ED Fast Main Phone call to Visit to Urgent Track ED PCP Care Mild symptoms Severe symptoms • Nausea • Severe dehydration • Severe pain • Diarrhea • Co-morbidities • Bloody stool • Extremes of age Nausea, vomiting, pain, fever, diarrhea 64
Slide 65: How do People Choose Their Sources of Care?
How do People Choose Their Sources of Care? Visit to PCP Visit to ED Fast Main Phone call to Visit to Urgent Track ED PCP Care Mild symptoms Severe symptoms • Nausea • Severe dehydration • Severe pain • Diarrhea • Co-morbidities • Bloody stool • Extremes of age Nausea, vomiting, pain, fever, diarrhe
Slide 66: ED Visits: Forecasted Utilization
ED Visits: Forecasted Utilization Quid Fast Track Main ED Critical Bay 66
Slide 67: LA Anti-Emetics: Forecasted Non-ED Treatment
LA Anti-Emetics: Forecasted Non-ED Treatment Phone or on-line provider consultations Office visit Pharmacy based clinics Urgi-care visits 67
Slide 68: Long Acting Anti-Emetic Therapy: Study Goals
Long Acting Anti-Emetic Therapy for Acute Gastroenteritis: Study Goals • Acute symptoms from moderate to severe gastroenteritis are successfully treated in patients with a pill that lasts 24 hours; including dehydrated patients who present to the Emergency Department with frequent vomiting • Placeme
Slide 69: Long Acting Anti-Emetic Therapy: Study Goals
Long Acting Anti-Emetic Therapy for Acute Gastroenteritis: Study Goals • A rapid-acting long lasting pill encourages immediate and continued compliance, and removes the ‘up and down’ cycle of symptoms associated with shorter acting agents • Benefit in the acutely ill Emergency Department patient dem
Slide 70: Summary
Summary • Gastroenteritis, a self limited illness characterized by vomiting and diarrhea, is very common, and typically found in young and healthy individuals • Hospitalization is infrequently needed • Morbidity results from dehydration, as a result of vomiting and inability to tolerate oral fluids
Slide 71: IBS & Gastroenteritis - Market Analysis and Forecast
IBS & GASTROENTERITIS – MARKET ANALYSIS AND FORECAST Jerry Rosenblatt, PhD RedHill Biopharma Advisory Board Managing Partner, Foster Rosenblatt 71
Slide 72: IBS: Market Overview
Roce, Biooharma IBS: MARKET OVERVIEW
Slide 73: ~4.5M Annual IBS Patient Diagnoses in the US
There Are An Estimated ~4.5M Annual IBS Patient Diagnoses in the US: Roughly 60% of Patients Have IBS-D Symptoms and Diagnosis Epidemiology Recurrent abdominal pain or discomfort ̴35M Americans are for > 3 days/month during the previous affected with IBS1,2,3 • Most IBS suffers are < 45 y.o. 3 month
Slide 74: Current US Branded IBS Market Estimated at $1.8B
The Current US Branded IBS Market is Estimated at $1.8B; 78% is IBS-C (Linzess & Amitiza) “Current” IBS Market • The overall IBS market has been growing significantly since the introduction of Linzess in 2012, followed by the launches of Viberzi and Xifaxan 550 in 2015, reaching $1.8B in 2016 • The
Slide 75: Overall US IBS Market Growing Rapidly Since 2012
The Overall US IBS Market Has Been Growing Rapidly Since 2012 (TRx CAGR - 38%; $ CAGR - 56% ) “Current” IBS Market • The IBS-C market has been growing steadily since the introduction of Linzess in 2012 • TRx market increased from 1.11M (2012) to 3.74M (2016), CAGR of 36% • Sales ($) value increased
Slide 76: IBS-D Treatments Priced Higher Compared to IBS-C
IBS-D Treatments Are Priced Higher Compared to IBS-C, and Often Placed on Non-Preferred Tiers IBS-D Prices IBS-C Prices • Viberzi and Xifaxan are on most formularies, • Amitiza and Linzess are mainly on preferred both generally in non-preferred Tier 3-5 with brand tiers prior authorizations and othe
Slide 77: US Branded IBS Market Forecast to Double by 2026
The US Branded IBS Market is Forecast to Double by 2026 Reaching Roughly $5B; IBS-D Could Represent 40% of Sales “Forecast” IBS Market The IBS market is forecast to grow significantly over the course of the next 10 years • The TRx volume is forecast to increase from 4.2M in 2016 to 6M in 2026 (CAGR
Slide 78: Gastroenteritis: Market Overview
GASTROENTERITIS: MARKET OVERVIEW 78
Slide 79: ~180M Cases of Acute Gastroenteritis in the US
There Are ~180M Cases of Acute Gastroenteritis in the US, ~1.5M Were Treated With a Rx Medication Symptoms and Diagnosis Epidemiology Gastroenteritis is a common infection of • Gastroenteritis is a nonspecific the gut (intestines) that is associated term for various pathologic ̴179M Americans are wi
Slide 80: Cost of Acute Gastroenteritis Over $4.0 Billion
The Cost of Acute Gastroenteritis to the US Healthcare System Alone is Estimated at Over $4.0 Billion The Hidden Costs of Gastroenteritis • Majority of the patients do not seek medical attention, and are treated at home, often missing days of work • When left untreated, acute gastritis often leads t
Slide 81: Current US Rx Gastroenteritis Market ~$1B
The Current US Rx Gastroenteritis Market is ~$1B, Growing at the Same Rate as Population Growth Current Gastroenteritis Market • Xifaxan was introduced in 2004 - the Rx gastroenteritis market has been relatively flat from 2004 to 2016 (Xifaxan is an approved antibiotic for traveler diarrhea, not spe
Slide 82: US Rx Gastroenteritis Market in 2026 Could be ~$1.8B
The US Rx Gastroenteritis Market in 2026 Could be ~$1.8B, Growth Driven by Launch of New Products Forecast Gastroenteritis Market • The gastroenteritis market is forecast to grow at a faster pace than population growth due to the introduction of two new products - BEKINDA® (P3 - RedHill) and Zemcolo
Slide 83: Q&A
Q&A Moderator: Gilead Raday COO, RedHill Biopharma 83
Slide 84: Thank You!
THANK YOU! RedHill Biopharma Ltd. 21 Ha’arba’a St. Tel-Aviv, 6473921 ,Israel Email: info@redhillbio.com Web: www.redhillbio.com Tel: +972-3-541-3131 84
Slide 85: Backup Slides
Reem, Biooharma 85 BACKUP SLIDES
Slide 86: Oral Ondansetron for Acute Gastroenteritis
Oral Ondansetron for Acute Gastroenteritis Source/ No. Inclusion Dose of Age Outcomes Side effects F/U pts criteria ondansetron 6 m – 1 yr: 1.6 mg; Vomiting episodes, Ramsook et al >5 × vomiting in 6 mo– 1–3 yr: 3.2 mg; 4–12 receipt of IVF, hospital 2002 the preceding 24 Incr. diarrhea 24 hr 12 yr y
Slide 87: Prevention of Vomiting with Oral Ondansetron in Acute Gastroenteritis
Prevention of Vomiting with Oral Ondansetron in Acute Gastroenteritis Ondansetron Placebo p-value for Reference/ comparison comment N N % N n % 74 64 87 71 46 65 0.004a Ramsook et al, 2002 64 37 58 56 30 54 0.8 First 24 hr 62 43 70 51 30 59 0.2 Second 24 hr Freedman et al, 107 92 86 107 70 65 <0.001
Slide 88: Secondary Objectives
Secondary Objectives • Frequency of vomiting, use of IV hydration or rescue med through 4 days following first dose of study medication • Proportion of patients with any component of primary endpoint • Severity of nausea • Diarrhea: reported by BSS and stool consistency • Incidence & severity of oth