Avenue Therapeutics, Inc. · OTC:ATXI
Avenue Therapeutics — Investor Presentation (July 2017)
20 slides from Avenue Therapeutics's investor presentation, Jul 14, 2017
Slide 1: Avenue Therapeutics, Inc. July 2017
Avenue Therapeutics, Inc. Nasdaq: ATXI July 2017
Slide 2: Forward Looking Statements
Forward Looking Statements Statements in this presentation that are not descriptions of historical facts are forward - looking statements within the meaning of the “ safe harbor ” provisions of the Private Securities Litigation Reform Act of 1995. We have attempted to identify forward - looking stat
Slide 3: Why IV Tramadol?
Why IV Tramadol? • The only intravenous Schedule IV opioid in the U.S. if approved • Less addiction potential than widely prescribed narcotics in the hospital • Oral tramadol has established efficacy and safety • Physicians are already familiar with tramadol • Available “step - down” therapy and no
Slide 4: U.S. Post-Op Pain Market
U.S. Post - Op Pain Market • IV analgesics sold ~$1 billion (~300 million injectable units) in 2015 • IV acetaminophen sells >$250MM per year: >25% of total dollar market with approximately 3 to 4% of the unit volume 4 0% 20% 40% 60% 80% 100% Units Sales U.S. IV Analgesics IV Acetaminophen All Other
Slide 5: Limitations of current IV analgesics: room for improvement
Mild to Moderate Hepatic Impairment Mild to Moderately Severe Bleeding risk GI Side Effects Renal Impairment Moderate to Severe Strong Sedation Respiratory Depression Constipation Risk of Dependence Room for Improvement IV Acetaminophen IV NSAIDS IV Narcotics Common Limitations & Contraindications P
Slide 6: Future Post-Op Pain Management Paradigm
Mild to Moderate Hepatic Impairment Mild to Moderately Severe Bleeding risk GI Side Effects Renal Impairment Moderate to Severe Strong Sedation Respiratory Depression Constipation Risk of Dependence Future Post - Op Pain Management Paradigm IV Acetaminophen IV NSAIDS IV Narcotics Pain Levels 6 Moder
Slide 7: What is Tramadol: Not a typical opioid
What is Tramadol Not a typical opioid 7 Inhibitor of Re - uptake of Norepinephrine and Serotonin Weak Opioid Agonist Opioid Binding Non - Opioid Mechanism Opioid Efficacy with Less Addiction Potential (Cymbalta) (Morphine)
Slide 8: Oral Tramadol in the U.S.
Oral Tramadol in the U.S. Schedule IV and widely prescribed • Approved in 1995 and labeled for “moderate to moderately severe” pain • Prescriptions increased from 24.5 million in 2007 to over 40.0 million in 2012 • Accounts for ~20% of all opioid prescriptions 8 0 10 20 30 40 50 2007 2008 2009 2010
Slide 9: Headlines on Opioid Crisis in the U.S.
Headlines on Opioid Crisis in the U.S. • After Record Year for Fatal Overdoses, New York City Targets Opioids – WSJ 3/13/2017 • Every 45 minutes, a child is poisoned by opioids – CNBC 3/20/2017 • FDA nominee says nation’s opioid crisis is as serious as Ebola, Zika threats – The Washington Post 4/5/2
Slide 10: IV Tramadol Opportunity
IV Tramadol Opportunity • IV tramadol may be used in all types of inpatient and outpatient surgeries and as part of a multimodal analgesic plan for major surgery 10 IV Tramadol may be an improved option for Contra - indicated for NSAIDS Elderly at risk for respiratory depression Obese patients with
Slide 11: Results from a Survey of U.S. Anesthesiologists
Results from a Survey of 30 U.S. Anesthesiologists* 11 * Survey conducted through LEERINK and available upon request Patients taking Switch to IV tramadol Add IV tramadol IV morphine 40% 41% IV NSAIDS 26% 37% IV acetaminophen 24% 35% Overall Impression Favorable initial impression of tramadol as a p
Slide 12: IV Tramadol Widely Used Outside the U.S.
IV Tramadol Widely Used Outside the U.S. Accounts for ~10% of IV analgesic use in the post - op setting in E.U. 12 IV Tramadol Use Post-op All other Analgesics Source: IMS Health
Slide 13: Advantages of IV Tramadol
Advantages of IV Tramadol • Oral tramadol has established efficacy and safety and physicians are familiar with it • Less addiction potential than widely prescribed narcotics in the hospital • Easily fitted into multi - modal pain management to avoid conventional opioids • Available “step - down” the
Slide 14: Novel Dosing Regimen
Novel Dosing Regimen • IV tramadol 50 mg is administered at Hours 0, 2, 4, and once every 4 hours thereafter • This dosing regimen was designed to provide a similar Cmax and AUC to that of 100 mg oral tramadol given every 6 hours at steady state 14
Slide 15: Mean Tramadol Plasma Concentration vs. Time Curve
Mean Tramadol Plasma Concentration vs. Time Curve for IV 50 mg, Oral 100 mg 15 Source: Study AVE - 901 - 101
Slide 16: Intellectual Property
Intellectual Property • Strong patent portfolio on Intravenous Administration of Tramadol • U.S. Patents No. 8,895,622, No. 9,561,195 and No. 9,566,253 • U.S. Patent No. 9,693,949 • Further Patent Applications are contemplated 16
Slide 17: Phase III Program
Phase 3 Program 17 Orthopedic Model (Bunionectomy) 405 Patients IV tramadol 50 mg IV tramadol 25 mg Placebo Soft Tissue Model (Abdominoplasty) 360 Patients IV tramadol 50 mg Placebo Morphine SPID 48 SPID 24 Safety Study 250 Patients
Slide 18: Upcoming Milestones
Upcoming Milestones 18 2017 2018 2019 Commence Bunionectomy Study Commence Safety Study Commence Abdominoplasty Study Commercialization 2020 Phase 3 Data from Bunionectomy Study NDA Filing Phase 3 Data from Abdominoplasty Study
Slide 19: Detailed Calendar of Events
Detailed Calendar of Events 19 Initiate Phase III bunionectomy study 3Q2017 Initiate Safety study 4Q2017 Topline data from Phase III bunionectomy study 2Q2018 Initiate Phase III abdominoplasty study 3Q2018 Topline data from Phase III abdominoplasty study 2Q2019 Complete Safety study 2Q2019 Submit ND
Slide 20: Lucy Lu, M.D., President and Chief Executive Officer
Lucy Lu, M.D. President and Chief Executive Officer Avenue Therapeutics, Inc. 2 Gansevoort St., 9 th Floor New York, NY 10014 Tel: 781 - 652 - 4500/Email: ir@avenuetx.com 20 Avenue Therapeutics, Inc.
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