OneMedForum New York 2010 Company Presentation: Transdel Pharmaceuticals, Inc., a specialty pharmaceutical company, develops non-invasive, topically-delivered medications in the United States. Learn More at: http://www.onemedplace.com/database/list/cid/13943
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Transdel Pharmaceuticals Inc., (TDLP.OB)
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6. Selected Pipeline *TDB – To Be Determined Program Target Status Partner(s) Launch Date Ketotransdel Pain (NSAID) Phase III TBD* TDLP310 Cellulite Subject Trials JH Direct & Jan Marini Skin Research Anticipate 2010 TDLP320 Anti-Aging Formulation TBD* TDLP330 Pigmentation Formulation TBD*
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9. 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 Endpoint: Change from baseline in pain intensity on Day 3 Visit (+1, +2 days) with VAS measurement Secondary Endpoints: Safety assessments, various other efficacy variables Pharmacokinetics in subset of patients Clinical Sites: 26 (USA) Randomized: N=364 Ketotransdel Phase 3 Trial
10. Ketotransdel demonstrated statistically significant higher reduction in pain intensity from baseline in both the modified Intent-To-Treat (ITT) and Per Protocol (PP) analysis. PP (n=252) mITT (n=326) Mean reduction from baseline in mm (100 mm Visual Analogue Scale) mm Reduction in Pain Intensity from baseline on Day 3 Ketotransdel Phase 3 Trial TDLP-110-001: Primary Efficacy Endpoint Results * p < 0.05 * p = 0.038 * A nalysis of all ITT patients who met study entry criteria , ANCOVA on change from baseline in pain intensity during daily activities over the past 24 hours on Day 3 Visit (Day 3, +1 or +2 days)
11. Ketotransdel Phase 3 Trial TDLP-110-001: Efficacy Endpoint: Change from baseline in three-times-daily pain intensity The Pain Curves over time show consistent separation between treatment groups reaching statistical significance in favor of Ketotransdel in ITT analyses . * Time period that primary endpoint “Day 3 Visit” covers: Days 3, 4 and 5. * Ketotransdel Placebo
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17. 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% diclofenac Osteoarthritis knee 40 drops of liquid (10 drops to each of 4 sides of knee), 3-4 times per day Covidien/ NUVO
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20. Select Financials Key Statistics Symbol: TDLP.OB Fiscal Year End: December 31 st Current Price (6/17/10): $1.20 Shares Outstanding: 15.7 million Market Cap: $19 million Proforma cash (as of 3/31/10) (1) $2.0 million ( 1) Includes $1M proceeds from convertible senior promissory note issued in April 2010.
21. 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 and Acting Chief Executive Officer (858) 457-5300 [email_address] Please visit www.transdelpharma.com for more information.