Avenue Therapeutics, Inc. May 2017

Transcription

1 Avenue Therapeutics, Inc. May 2017

2 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 We have attempted to identify forward looking statements by terminology including anticipates, believes, can, continue, could, estimates, expects, intends, may, plans, potential, predicts, should, or will or the negative of these terms or other comparable terminology. Forward looking statements are based on management s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are risks relating to: our growth strategy; results of research and development activities; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to update or revise any statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances after the date of this presentation. 2

3 Avenue and its Value Proposition We focus on pharmaceuticals for the acute/intensive care hospital setting What We Do and Why U.S. hospital market is concentrated and requires a small sales force Our lead asset intravenous (IV) tramadol is ready to enter Phase III development Trend on multimodal treatment for pain favors new products that help patients avoid strong narcotics Tramadol is an opioid without the typical side effects of narcotics We are a subsidiary of Fortress Biotech that is run by an experienced management team and advisors Backing by Fortress BD effort = New pipeline product candidates 3

4 U.S. Post Op Pain Market IV analgesics sells ~$1 billon (~300 million units)/yr IV acetaminophen sells ~$250MM ~25% of total dollar market with approximately 3 to 4% of the volume Room for Improvement Available Classes Pain Levels Common Limitations & Contraindications IV narcotics Moderate to severe Strong sedation Respiratory depression Constipation Risk of dependence IV NSAIDS Mild to moderately severe Post op bleeding risk GI side effects Renal impairment IV acetaminophen Mild to moderate Hepatic impairment 4

5 What is Tramadol Not a typical opioid Two distinct mechanisms of action: (1)weak opioid agonist, and (2)inhibitor of monoamine neurotransmitter reuptake Labeled for moderate to moderately severe pain Analgesic effect similar to other opioid therapies Differentiated safety profile compared to other opioids Oral tramadol widely prescribed in the U.S. Schedule IV and one of the most prescribed pain medications Prescriptions increased from 23.3 million in 2008 to 43.8 million in 2013 ~$1.2 billion annual sales despite being generic IV tramadol widely used outside the U.S. Accounts for ~10% of IV analgesic use in the post op setting in E.U. 5

6 IV Tramadol Indication Regulatory pathway Summary Moderate to moderately severe pain 505b(2) Stage of development Phase III to begin in 2017 Clinical efficacy* Tolerability* Parenteral tramadol has been tested in several randomized, doubleblind, parallel group, comparative studies. It effectively relieved moderate to severe post op pain associated with several types of surgeries (abdominal, orthopedic, and cardiac surgery) in these studies. In general, tramadol was well tolerated in clinical studies. The most common adverse events were nausea, dizziness, drowsiness, tiredness, sweating, vomiting, and dry mouth. Unlike other opioids, it did not cause clinically relevant respiratory depression. *Tramadol: A Review of its Use in Perioperative Pain. Scott LJ, Perry CM. Drugs Jul;60(1):

7 New Restrictions on Opioids New guidelines from CDC to physicians attempts to limit opioid prescribing Many states have passed laws restricting opioid prescriptions The U.S. DEA has reduced the amount of almost every Schedule II opioid medication that may be produced in the U.S. in 2017 by 25 percent or more 7

8 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 It may be an improved option for patients With poor cardiopulmonary function Elderly patients at risk for respiratory depression Obese patients with sleep apnea Contraindicated for NSAIDS Patients who cannot tolerate strong narcotics such as morphine due to side effects such as sedation, constipation, and history of drug dependence, etc. 8

9 Results from a Survey of 30 U.S. Anesthesiologists* Patients taking Switch to IV tramadol Add IV tramadol IV morphine 40% 41% IV NSAIDS 26% 37% IV acetaminophen 24% 35% *Survey conducted through LEERINK and available upon request 9

10 Advantages of IV Tramadol Documented efficacy and safety Physician familiarity with tramadol Less addictive than widely prescribed narcotics in the hospital Available step down therapy Our IV tramadol dosing regimen provides similar Cmax and AUC to that of oral Ultram 100 mg Q6h at steady state. 10

11 Phase 3 Program* Study Goals Design Orthopedic model (Bunionectomy) Soft tissue model (Abdominoplasty) Safety study *Key elements clarified and confirmed at EOP2 Meeting 1. To demonstrate safety and efficacy of IV tramadol (50 mg dose) versus placebo 2. To understand dose response 1. To demonstrate safety and efficacy of IV tramadol (50 mg dose) versus placebo 2. To understand safety and tolerability versus standard of care 1. To achieve total exposure of 500 patients on IV tramadol (50 mg dose) 2. To understand safety in real world situations 405 patients, 3 arm (IV tramadol 50 mg, 25 mg, or placebo), 1:1:1 randomized, and double blind study 360 patients, 3 arm (IV tramadol 50 mg, placebo, or morphine), 3:3:2 randomized, and doubleblind study 250 patients, open label, single arm, all surgical types 11

12 Executive Team and Key Advisor Lindsay Rosenwald, MD, Executive Chairman Chairman and CEO of Fortress Biotech, Inc. Prolific and successful investor in the life sciences industry for over 20 years Co founder and Co Portfolio Manager of Opus Point Partners Lucy Lu, MD, Interim President & Chief Executive Officer EVP and CFO of Fortress Biotech, Inc. Former Senior Analyst at Citi Investment Research 15 years of experience in life sciences David Horin, Interim Chief Financial Officer Managing Partner, Chord Advisors, LLC. Former Chief Financial Officer of Rodman & Renshaw Capital Group, Inc. Former Managing Director of Accounting Policy and Financial Reporting at Jefferies Group, Inc. Scott Reines, MD PhD, Interim Chief Medical Officer Former Vice President/Senior Vice President at Merck Research Laboratories and Johnson & Johnson Pharmaceutical R&D Oversaw development and approval of drugs including INVEGA, NUCYNTA, RISPERDAL CONSTA, TOPAMAX, EMEND, MAXALT, SINEMET, etc. 12

13 Scientific Advisory Board Robert Dworkin, PhD Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Harold Minkowitz, MD Assistant Professor of Anesthesiology at the University of Texas Health Science Center at Houston Neil Singla, MD Founder and Chief Scientific Officer, Lotus Clinical Research Mark Wallace, MD Director, Center for Pain Medicine, UC San Diego 13

14 Upcoming Milestones Commence Phase 3 program in 2017 Phase 3 Data 2018 NDA filing 2019 ~$30 million to complete Phase 3 Program 14

15 Avenue Therapeutics, Inc. Contact: Lucy Lu, M.D. 2 Gansevoort St., 9 th Floor New York, NY Tel: llu@avenuetx.com 15