RedHill Biopharma Ltd. · NASDAQ:RDHL
RedHill Biopharma — Technical Presentation (October 2018)
44 slides from RedHill Biopharma's technical presentation, Oct 30, 2018
Slide 1: Analyst and Investor Webcast on TALICIA for H. pylori Infection
RedHill Biopharma Ltd. (NASDAQ/ TASE: RDHL) Analyst and Investor Webcast on TALICIA® for H. pylori Infection Tuesday, October 30, 2018
Slide 2: Disclaimer and Forward Looking Statements
Disclaimer and Forward Looking Statements No representation or warranty is made to the accuracy or completeness of this presentation. You must make your own investigation and assessment of the matters contained herein. In particular, no representation or warranty is given, and the Company has no res
Slide 3: TALICIA for H. pylori infection
TALICIA® for H. pylori infection Gilead Raday Chief Operating Officer, RedHill Biopharma 3
Slide 4: Agenda
Agenda • TALICIA® for H. pylori infection Gilead Raday, Chief Operating Officer, RedHill • First Phase III study (ERADICATE Hp) and confirmatory Phase III study (ERADICATE Hp2) with TALICIA® for H. pylori infection Ira Kalfus, MD, Medical Director, RedHill • H. pylori - epidemiology & the unmet medi
Slide 5: RedHill Biopharma - Highlights
RedHill Biopharma - Highlights • Emerging U.S. GI specialty company (NASDAQ/TASE: RDHL) • Focused on development and commercialization in the U.S. of late clinical-stage drugs for GI diseases and cancer Robust Development Pipeline with Multiple Near-Term Milestones Three Phase III-stage Multiple Pha
Slide 6: Emerging U.S. Specialty GI Pharma - Robust Pipeline and Commercial Operation
Emerging U.S. Specialty GI Pharma - Robust Pipeline and Commercial Operation: Select Key Programs* Product Indication Pre-Clinical Phase I/II Phase III Marketed 4 COMMERCIAL GI-Related Donnatal®, Mytesi®, EnteraGam® and Esomeprazole Strontium DR Capsules PRODUCTS Products TALICIA® H. pylori infectio
Slide 7: H. pylori Resistance - Growing Global Health Problem
H. pylori Resistance - Growing Global Health Problem H. pylori Infection • H. pylori Infection Progressive gastro-duodenal damage peptic ulcer disease and gastric cancer* • Highly prevalent: Approx. 50% of the world population, 30-40% of the U.S. population** • Top 10% GIs prescribing H .pylori
Slide 8: TALICIA - Next Generation Solution
TALICIA® - Next Generation Solution • TALICIA® (RHB-105) is a novel, patent-protected, all-in-one combination of two antibiotics and a proton pump inhibitor • Little to no resistance of H. pylori to TALICIA® antibiotics • Unique dosing and PK profile of the rifabutin active - barrier to generic subs
Slide 9: TALICIA - Next Generation Solution (Cont.)
TALICIA® - Next Generation Solution (Cont.) • Final patient assessed for primary endpoint in confirmatory Phase III study - Top-line results expected by year-end 2018 • FDA granted QIDP Designation to TALICIA® under the GAIN Act: Fast-Track and eligibility for Priority Review and 8 years of market e
Slide 10: First Phase III study (ERADICATE Hp) and Confirmatory Phase III study (ERADICATE Hp2)
First Phase III study (ERADICATE Hp) and Confirmatory Phase III study (ERADICATE Hp2) with TALICIA® Ira Kalfus, M.D. Medical Director, RedHill Biopharma 10
Slide 11: TALICIA
TALICIA® • All-in-one capsule formulation • 4 capsules tid - 14 days treatment - Amoxicillin 1000 mg tid → 3 gm daily - Rifabutin 50 mg tid → 150 mg daily - Omeprazole 40 mg tid → 120 mg daily • >90% efficacy in amoxicillin/rifabutin/PPI single site standard-of-care failed treatment study* • Minimal
Slide 12: Rationale for Development of TALICIA
Rationale for Development of TALICIA® • Increasing antibiotic resistance is a worldwide problem, with nearly 800,000 deaths per year due to gastric cancer* • 30%-40% treatment failure with current SOC therapy • H. pylori has been shown to be highly sensitive to rifabutin (a derivative of rifamycin)
Slide 13: ERADICATE Hp First Phase III Completed - Study Design
ERADICATE Hp First Phase III Completed - Study Design Double blind placebo controlled study to assess the safety and efficacy of TALICIA® in the treatment of confirmed Helicobacter pylori infection in dyspepsia patients - Negative ¹³C UBT 28-35 days post treatment with TALICIA® - 90% powered to dete
Slide 14: ERADICATE Hp First Phase III Completed - Efficacy Results
ERADICATE Hp First Phase III Completed – Efficacy Results Primary Endpoint vs. historical control • mITT TALICIA® success rate 89.4% (59/66), p-value<0.001 SOC eradication rate (post-hoc) vs. TALICIA® • 63% (17/27 subjects), p-value=0.006 in mITT 14
Slide 15: ERADICATE Hp First Phase III Completed - Safety
ERADICATE Hp First Phase III Completed - Safety • Adverse events comparable TALICIA® vs. placebo • 2 serious adverse events unrelated to study drug – Anemia noted at screening - subject completed study (TALICIA® arm) – Perirectal abscess 18 days after completing study drug (placebo arm) • 2 Early di
Slide 16: ERADICATE Hp First Phase III Completed - Conclusions
ERADICATE Hp First Phase III Completed - Conclusions • A novel “3 in 1” potential new therapy • Safe, well tolerated and more effective than historical or physician selected SOC treatment • Subject compliance and retention essential 16
Slide 17: ERADICATE Hp2 - Confirmatory Phase III Study Ongoing
ERADICATE Hp 2 - Confirmatory Phase III Study Ongoing Double-blind active comparator study to assess the safety and efficacy of TALICIA® in the treatment of confirmed H. pylori infection - Negative ¹³C UBT 43-71 post initiation of therapy - Sample size for this study has been calculated based on a s
Slide 18: ERADICATE Hp2 - Study Endpoints
ERADICATE Hp2 Confirmatory Phase III Ongoing - Study Endpoints Primary Endpoint • Occurrence of H. pylori eradication is confirmed via 13C Urea Breath Test (UBT) testing 43-71 days after initiation of treatment Secondary Endpoint (Efficacy) • Antibiotic Resistance and Susceptibility Subgroup Analyse
Slide 19: ERADICATE Hp2 - Exploratory and Additional Endpoints
ERADICATE Hp2 Confirmatory Phase III Ongoing - Exploratory and Additional Endpoints • CYP2C19 status summarized and analyzed for efficacy using descriptive methods • Eradication rates in failure to eradicate subjects who receive susceptibility directed standard of care will be analyzed descriptively
Slide 20: ERADICATE Hp2 - Active Comparator Rationale
ERADICATE Hp2 Confirmatory Phase III Ongoing - Active Comparator Rationale • High dose amoxicillin and PPI is an FDA approved regimen • Combination drug policy requires demonstration of clinical benefit of rifabutin added to amoxicillin/PPI • Active Comparator - total daily dose of: - Amoxicillin 30
Slide 21: ERADICATE Hp2 - Statistical Powering
ERADICATE Hp2 Confirmatory Phase III Ongoing - Statistical Powering • FDA referenced high-dose amoxicillin/PPI studies demonstrated 61% and 70% efficacy • H. pylori consensus statement powered TALICIA® “most clinicians may not know the prevalence of clarithromycin resistance in their local populatio
Slide 22: ERADICATE Hp2 - Patient Population
ERADICATE Hp2 Confirmatory Phase III Ongoing – Patient Population • ITT as regulatory requirement with all randomized patients included in efficacy analysis • ERADICATE Hp2 study goal of 100% retention as lesson learned from ERADICATE Hp first Phase III study with TALICIA® • Goal met: 453/455 patien
Slide 23: H. pylori infection - Epidemiology & the Unmet Medical Need
H. pylori infection - Epidemiology & the Unmet Medical Need Prof. David Graham, M.D., M.A.C.G. Principal Investigator of the ERADICATE Hp2 Confirmatory Phase III study Renowned Researcher and Physician at the Baylor College of Medicine 23
Slide 24: Helicobacter pylori
Helicobacter pylori • Gram-negative spiral bacteria • Niche: human stomach 24
Slide 25: H. pylori Infection
H. pylori Infection • Transmissible infectious disease • Acquired in childhood • Disease manifestations usually in adults with variable latent periods • High morbidity, modest mortality • Curable 25
Slide 26: Outcomes of H. pylori Infection
Outcomes of H. pylori Infection Gastric Cancer Environmental Atrophic Factors Gastritis Gastric Ulcer Acute Acute-on-Chronic Gastritis Gastritis Lymphoma Antral Predominant Duodenal Ulcer Gastritis Childhood Mid-life Old Age 26
Slide 27: Maastricht IV (2012)
Maastricht IV (2012) * Gut 2012;61:646-664 27
Slide 28: Kyoto Global Consensus Report on H. pylori gastritis (2015)
Kyoto Global Consensus Report on H. pylori gastritis (2015) “H. pylori gastritis should be defined as an infectious disease, even when patients have no symptoms and irrespective of complications such as peptic ulcers and gastric cancer.” * Gut 2015;64:1315 28
Slide 29: Helicobacter pylori
Helicobacter pylori • H. pylori is an infectious disease • It can be cured with antibiotics • Cure of the infection alters the natural history of the associated diseases • Treatment of infectious diseases with antibiotics should be straight forward 29
Slide 30: H. pylori - Treatment
H. pylori - Treatment • All effective infectious disease therapy is susceptibility-based • Susceptibility testing is rarely available for H. pylori • Most regimens are empiric 30
Slide 31: H. pylori Therapy - Rules of Thumb
H. pylori Therapy - Rules of Thumb • Two or more antibiotics • Acid suppression • Duration: 14 days • Confirm cure (UBT or stool antigen test) 31
Slide 32: Antimicrobial Drugs Used for H. pylori
Antimicrobial Drugs Used for H. pylori • Amoxicillin • Bismuth • Clarithromycin (macrolides) • Metronidazole/Tinidazole • Tetracycline • Proton pump inhibitors • Floroquinolones • Rifabutin 32
Slide 33: Problem: H. pylori Resistance
Problem: H. pylori Resistance Clarithromycin Levofloxacin Metronidazole 33 *Aliment Pharmacol Ther 2016;43;514
Slide 34: Triple Therapy Resistance
Triple Therapy Any PPI PPI& any 2 Clarithromycin Amoxicillin Metronidazole 34
Slide 35: Because of resistance the need for new drugs is becoming acute
Because of resistance the need for new drugs is becoming acute 35
Slide 36: Best Approach: 2018
Best Approach: 2018 Susceptibility Testing Available? Best Locally Available Yes No Regimen Susceptibility Based Regimen Empiric Therapy Currently Unavailable Use drugs for which resistance is rare 36
Slide 37: H. pylori infection - Market Analysis & Forecast
H. pylori infection - Market Analysis & Forecast Jerry Rosenblatt, PhD RedHill Biopharma Advisory Board Managing Partner, Foster Rosenblatt 37
Slide 38: Seroprevalence of H. pylori Infection Between 30-80%
The Seroprevalence of H. pylori Infection is Between 30- 80%, Suggesting More Than 4B Patients are Infected Global Prevalence: 4.32B (US: 117M, EU5: 149M, JP: 66M) CAN: 36% RoA: (14M) 54% RoE: 47% (927M) (196M) US: EU5: 36% 46% China: (117M) (149M) 55% (765M) Japan: 52% (66M) MEX: 53% (69M) Africa:
Slide 39: Over 27M People Worldwide Prescribed Eradication Therapies
Over 27M People Worldwide are Prescribed 32M Rxs of Eradication Therapies for PUD and Related GI Disorders Global Treated Patients: 27M3 (US: 2.5M1,2, EU5: 3.2M, JP: 1.4M) 3Treatment rate for CAN RoE RoA 0.3M other countries are 4.3M 2.0M Tx Patients Tx Patients Tx Patients estimated based on 0.36M
Slide 40: Global Market For H. pylori Eradication Estimated At $4.8B
The Global Market For H. pylori Eradication Is Estimated At $4.8B, Of Which $1.4B (~30%) Is From The U.S. Global Market: $4.8B (US: $1.4B, EU5: $0.6B, JP: $0.3B) US Cost Assumptions (assuming 10-14 DoT) RoW Average $4543 $837 US $1,420 Pylera + PPI ~$1,148 Omeclamox-Pac ~$740 India PrevPac ~$1,035 $
Slide 41: Lack of Clinical Differentiation Has Kept Branded Market Share at ~5.5%
A Lack of Real Clinical Differentiation in the US Amongst Promoted Products Has Kept Branded Market Share at ~5.5% US Market: $1.4B (Branded: $0.08B, Generic: $1.3B) 500 US Market Demand2 16% Branded or 14% (Co-Packaged) 400 12% Share of Total Demand (%) 12% TRx (in thousands) 10% $78 9% 300 8% (5.5
Slide 42: TALICIA Has Significantly Differentiated Clinical Benefits
TALICIA® Has Significantly Differentiated Clinical Benefits, and Could Become the Future SoC for H. pylori Infection Eradication TALICIA® clinical & commercial attributes comparison Generic Triple & Branded Triple & TALICIA® (Fixed-Dose Quadruple Therapies Quadruple Therapies Rifabutin Triple Tx) Br
Slide 43: Reem hii.
Reem hii. Biopharma
Slide 44: 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 44
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