Fortress Biotech, Inc. · NASDAQ:FBIO
Fortress Biotech — Investor Presentation (October 2015)
14 slides from Fortress Biotech's investor presentation, Oct 20, 2015
Slide 1: Avenue Therapeutics, Inc. Corporate Overview October 2015
Avenue Therapeutics, Inc. Corporate Overview October 2015
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: Business Overview
Business Overview x We seek to in - license or acquire, develop and commercialize pharmaceutical products for the acute/intensive care hospital setting x Our lead asset is intravenous (IV) of Tramadol, in - licensed from Revogenex Ireland Ltd. x We have an experienced management team and advisors x
Slide 4: Executive Team
Executive Team x Lindsay A. Rosenwald, MD, Executive Chairman ▪ Chairman and CEO of Fortress Biotech, Inc. ▪ Prolific and successful investor in the life sciences industry for over 20 years previously as Chairman of Paramount BioCapital ▪ Co - founder and Co - Portfolio Manager of Opus Point Partner
Slide 5: Clinical Advisors
Clinical Advisors x Scott Reines , MD - PhD ▪ Former Vice President/Senior Vice President at Merck Research Laboratories and Johnson & Johnson Pharmaceutical R&D x Robert Dworkin, PhD ▪ Director of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and
Slide 6: IV Tramadol
IV Tramadol x Centrally acting analgesic with dual mechanisms of action ▪ Weak opioid agonist ▪ Inhibitor of monoamine neurotransmitter reuptake x Effective and safe ▪ Analgesic effect similar to other opioid therapies ▪ Differentiated safety profile compared to other opioids: Reduced risk of respir
Slide 7: IV Tramadol Opportunity Overview
IV Tramadol Opportunity Overview Indication Moderate to moderately severe pain Regulatory pathway 505b(2) Stage of development Phase III to begin in 2016 Competitor drug and where it is used IV narcotic analgesics (morphine, etc ) and NSAIDS, etc. • Post - operative care • ER and other hospital depa
Slide 8: Planned Clinical Studies
Planned Clinical Studies PK Study • PK study to confirm Phase 3 dose Phase 3 Studies • Two adequate and well - controlled Phase 3 studies • Orthopedic model • Soft tissue model • IV tramadol will be compared to placebo • Primary endpoint: SPID (Sum of pain intensity differences) 8
Slide 9: Post-Operative Pain Market
Post - Operative Pain Market x ~30 million in - hospital medical procedures per year in the U.S. x IV analgesics sold ~$1 billon in 2014 (~300 million units) ▪ IV acetaminophen sells ~$250MM - ~25% of total market Opportunities • U.S. hospital market is concentrated and requires a small sales force
Slide 10: Competitive Landscape
Competitive Landscape x Acetaminophen & NSAIDS ▪ Lack potency and may not be effective as monotherapy for pain management after major surgery ▪ E nhance quality of analgesia in conjunction with opioids ▪ Side Effects (NSAIDS) : bleeding , GI and renal impairment, etc. x Opioids ▪ Inexpensive and sta
Slide 11: At a Glance
At a Glance Product Efficacy Side Effects Effective Stand - alone Analgesia Strong Sedation Post - op bleeding Frequent Significant GI Side Effects Peptic Ulcer Other Significant Side Effects Risk of Dependence or Tolerance IV Opioids Moderate to Severe Significant Limitation Significant Limitation
Slide 12: IV Tramadol Patent
IV Tramadol Patent • US Patents 8,895,622 (issued Nov., 2014) • Method of administration • Expir. = 2032 • Additional patents planned 12
Slide 13: Upcoming Milestones
Upcoming Milestones x Commence PK study in 1Q2016 x Commence Phase 3 program in 2016 x Phase 3 Data 2017 x ~$20 million to complete Phase 3 Program 13
Slide 14: Avenue Therapeutics, Inc. Contact
Avenue Therapeutics, Inc. Contact: Lucy Lu, M.D. 3 Columbus Circle, 15 th Floor New York, NY 10019 Tel: 781 - 652 - 4511 Email: llu@fortressbiotech.com 14
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