Harrow, Inc. · NASDAQ:HROW
Harrow — Transdel Pharmaceuticals — Investor Presentation (June 2010)
16 slides from Harrow's investor presentation, Jun 17, 2010
Slide 1: Transdel Pharmaceuticals, Inc. June 2010
Transdel Pharmaceuticals, Inc. June 2010
Slide 2: Safe Harbor Statement
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 Ketotransd
Slide 3: Transdel Investment Highlights
Transdel Investment Highlights Experienced Management Team Novel transdermal delivery platform applicable to a broad range of drugs Ketotransdel(r) could be first in class topical NSAID cream for treatment of pain Technology applicable for additional pharmaceutical and cosmeceutical development prog
Slide 4: Transdel Management Team
Transdel Management Team John Lomoro, Acting Chief Executive Officer and Chief Financial Officer 18 years of financial experience with public and private organizations, including 5 years with Ernst & Young LLP Director, North America Accounting, Carl Zeiss Vision Inc. Certified Public Accountant Ter
Slide 5: Transdermal Delivery System (TDS)
5 Epidermis Dermis Subcut. Tissue Muscle Transdermal Delivery System (TDS) Compatible with wide range of drugs and molecular sizes Allows solubilization of drugs with different physicochemical properties (lipophilic, hydrophilic and amphiphilic) Utilizes combination of penetration enhancers. Alter t
Slide 6: Selected Pipeline
Selected Pipeline Program Target Status Partner(s) Launch Date Ketotransdel Pain Phase III TBD* TDLP310 Cellulite Subject Trials JH Direct & Jan Marini Skin Research Anticipate 2010 TDLP320 Anti-Aging Formulation TBD* TDLP330 Pigmentation Formulation TBD* 6 *TDB - To Be Determined
Slide 7: Lead Pain Drug Ketotransdel
Lead Pain Drug Ketotransdel Transdermal cream formulation of ketoprofen, and our proprietary patented Transdel drug delivery system Ketoprofen a non-steroidal anti-inflammatory drug (NSAID) among the most efficacious topical NSAIDs Contains 100mg of ketoprofen per 1g of cream Phase 1/2 and Phase 3 t
Slide 8: Ketotransdel Phase 3 Trial
Clinical Design: Randomized, double-blind, placebo-controlled Study Population: Patients with acute soft tissue injuries (sprains & strains) Indication: Relief of pain from acute soft tissue injuries Dosing Regimen: Ketotransdel vs. Placebo (Vehicle) cream, 1g three times daily over 7 days Primary E
Slide 9: Ketotransdel Phase 3 trial TDLP-110-001 Conclusions
Ketotransdel treated patients had statistically significant greater reductions in pain intensity than placebo cream treated patients in the modified ITT population; Pain curves over time show consistent separation between treatment groups reaching statistical significance in favor of Ketotransdel; u
Slide 10: Patients Who May Benefit From a Topical NSAID
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-drug interactions) Corticosteroid use
Slide 11: Ketotransdel Market Opportunity
Pain treatments are the third most-prescribed class of drugs in the U.S. Market for NSAIDs and Cox-2 inhibitors approaches $8 billion in the U.S. Oral NSAIDs are associated with serious gastro-intestinal, cardiac, renal and liver side effects Withdrawal of Bextra and Vioxx leaves multi-billion dolla
Slide 12: NSAID Market Dynamics
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 Flect
Slide 13: Competitive Landscape
Competitive Landscape FDA Approved Topical NSAIDs Product Indication Dosage Company Flector Patch 1.3% diclofenac Acute Pain (strains & sprains) 10 x 14 cm patch, 2 times per day King Pharma/ IBSA Voltaren Gel 1% diclofenac Osteoarthritis knee/ hands 2- 4 g qid (16g/d) ENDO/ Novartis Pennsaid 1.5% d
Slide 14: US Sales of Flector Patch and Voltaren Gel
US Sales of Flector Patch and Voltaren Gel 14 (in millions) FY 2008 FY 2009 FY 2010 (E) Flector Patch (1) $ 128 $ 139 $ 180 Voltaren Gel (1) $ 24 $ 79 $ 96 Pennsaid (2) - - N.A. $ 152 $ 218 $ 276 (E) - Avg. of estimates by various sell-side analysts. - - Product launched in 2008. Product launched in
Slide 15: Cosmeceuticals
Cosmeceuticals TDLP310 Lead product - anti-cellulite formulation License agreement with JH Direct, LLC Anticipate launch in second half of 2010 License agreement with Jan Marini Skin Research, Inc. Exclusive rights to U.S. professional dermatology market Expansion of cosmeceuticals pipeline formulat
Slide 16: Contact Us
Contact Us 16 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 and Acting Chief Executive Officer (858) 457-5300 johnl@transdelpharma.com Please visit www.transdelpharma.co
Transdel Pharmaceuticals — Investor Presentation (June 2010) on 6ix