Harrow, Inc. · NASDAQ:HROW
Harrow — Transdel Pharmaceuticals — Investor Presentation (October 2009)
23 slides from Harrow's investor presentation, Oct 26, 2009
Slide 1: Transdel Pharmaceuticals, Inc. October 2009
Transdel Pharmaceuticals, Inc. Symbol: TDLP.OB October 2009
Slide 2: Safe Harbor Statement
2 Safe Harbor Statement The Company cautions you that the statements included in this presentation that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company's interpretation of the results of its Phase 3 clinical trial for Ketotran
Slide 3: Company Overview
3 Company Overview Specialty pharmaceutical company Focused on the development and commercialization of topically delivered medications Products based on proprietary transdermal delivery technology Lead pain program, Ketotransdel(r), has successfully completed a Phase 3 trial demonstrating significa
Slide 4: Transdel Investment Highlights
4 Transdel Investment Highlights Positive Phase 3 results for lead pain drug, Ketotransdel Reported statistically significant efficacy results and excellent safety in Phase 3 trial Minimal blood concentrations of ketoprofen in pharmacokinetic studies Large market opportunity for Ketotransdel U.S. ma
Slide 5: Transdel Transdermal Delivery System (TDS)
Transdel Transdermal Delivery System (TDS)
Slide 6: TDS is a nanoparticulate matrix topical cream
6 6 TDS is a nanoparticulate matrix topical cream Transdel's proprietary cream formulation enables active drug to penetrate the skin and reach targeted underlying tissue Components generally regarded as safe (GRAS) Delivery system uses synergistic mechanisms to enhance penetration Thermodynamic stab
Slide 7: TDS platform provides significant benefits
7 TDS platform provides significant benefits Compatible with broad range of drugs and molecular sizes Maximizes solubilization of drugs (lipophilic, hydrophilic and amphiphilic) Broad patented technology platform with issued IP covering composition of matter, methods of use and methods of manufactur
Slide 8: Ketotransdel
Ketotransdel(r)
Slide 9: Ketotransdel: Product Profile
Ketotransdel: Product Profile 9 Ketotransdel is comprised of a transdermal cream formulation of ketoprofen, and our proprietary patented Transdel drug delivery system Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) that has been found to be among the most efficacious topical NSAIDs Deli
Slide 10: Pain treatments are the third most-prescribed class of drugs in the U.S.
10 Pain treatments are the third most-prescribed class of drugs in the U.S. According to market research firm BCC Research the global market for pain relievers was worth $19.1 billion in 2008, and is expected to grow to $32.8 billion by 2013 Market for NSAIDs and Cox-2 inhibitors exceeds $6 billion
Slide 11: Pain Therapeutic Market Dynamics
11 The withdrawal of Vioxx and Bextra has resulted in a significant decline in COX-2 prescriptions and a significant increase in NSAID prescriptions After an increase in 2005 when the COX-2's were withdrawn, NSAID TRx's have continued to post steady year-over-year growth Since the introduction of Fl
Slide 12: Ketotransdel Phase 3 Trial
Clinical Design: Randomized, double-blind, placebo controlled Study Population: 364 patients Indication: Acute soft tissue injuries (sprains & strains) Dosing Regimen: Ketoprofen vs. Placebo (Vehicle) cream, 1g three times daily over 7 days Primary Endpoint: Change from baseline in pain intensity on
Slide 13: Primary Efficacy Results
Ketotransdel demonstrated statistically significant higher reduction in pain intensity from baseline in the Per Protocol (PP) analysis and a favorable treatment effect in the Intent-To-Treat (ITT) analysis * p< 0.05 PP (n=252) ITT (n=361) PP population included: Pre-specified minimum use of study me
Slide 14: Safety and Pharmacokinetics
Ketotransdel (n= 182) Placebo (n=182) All potentially related Adverse Events (AEs): 15 (4.1%) 7 (3.8%) 8 (4.4%) 14 Ketotransdel demonstrated excellent safety and tolerability Low overall incidence of AEs No related gastrointestinal, cardiac, liver, kidney or other serious AEs Few potentially related
Slide 15: Conclusions - Ketotransdel Phase 3
Ketotransdel achieved statistical significance in its Primary Efficacy Endpoint in the Per Protocol population (p < 0.05) Ketotransdel demonstrated excellent safety and tolerability No treatment related gastrointestinal, cardiac, liver, kidney or other serious adverse events No clinically relevant c
Slide 16: Patients Who May Benefit From a Topical NSAID
16 Healthy patients with localized pain History of gastrointestinal symptoms / gastrointestinal ulceration History of heart, liver, kidney disease or other serious medical conditions Elderly and Children Intake of multiple drugs for other conditions (minimize drug-to-drug interactions) Corticosteroi
Slide 17: Ketotransdel Competitive Advantages
17 Provides alternative to address the significant safety concerns associated with oral COX-2 inhibitors / nonselective oral NSAIDs and acetaminophen Broad technology platform that is patent protected Less invasive delivery Faster - delivers drugs in few minutes with no residue Large and growing mar
Slide 18: Ketotransdel Next Steps
18 Finalize registration strategy Continue partnering discussions Discussions underway with several potential sales and marketing partners Ketotransdel Next Steps
Slide 19: Cosmeceutical Applications of TDS
19 Lead product - anti-cellulite formulation In June 2009, the Company announced that it entered into a license agreement with JH Direct, LLC for the exclusive worldwide rights to Transdel's anti- cellulite cosmeceutical product which utilizes the Company's Transdel technology Anticipated expansion
Slide 20: Transdel Management Team
20 Transdel Management Team Juliet Singh, Ph.D., Chief Executive Officer/President Over 20 years of pharmaceutical management experience: Allergan; Baxter Healthcare; and, Collateral Therapeutics Corporate Officer responsible for Regulatory Affairs & Quality Assurance Managed worldwide regulatory su
Slide 21: Select Financials
21 Select Financials Key Statistics Key Statistics Key Statistics Key Statistics Symbol: TDLP.OB Fiscal Year End: December 31st Current Price (10/23/09): $1.85 Shares Outstanding: 15.6 million Market Cap: $28.9 million Cash (as of 6/30/09) $2.9 million
Slide 22: Transdel Investment Highlights
22 Transdel Investment Highlights Positive Phase 3 results for lead pain drug, Ketotransdel Reported statistically significant efficacy results and excellent safety in Phase 3 trial Minimal blood concentrations of ketoprofen in pharmacokinetic studies Large market opportunity for Ketotransdel U.S. m
Slide 23: Contact Us
23 Contact Us Transdel Pharmaceuticals, Inc. (OTC BB: TDLP.OB) 4225 Executive Square Suite 485 La Jolla, CA 92037 Corporate Headquarters Investor Contact John Lomoro Chief Financial Officer (858) 457-5300 johnl@transdelpharma.com Please visit www.transdelpharma.com for more information.
Transdel Pharmaceuticals — Investor Presentation (October 2009) on 6ix