Transdel Pharmaceuticals, Inc.
June 2010
The Company cautions you that the statements included in this presentation that are not a description ofhistorical facts are forward-looking statements. These include statements regarding: the Company'sinterpretation of the results of its Phase 3 clinical trial for Ketotransdel®; the Company's ability to obtainregulatory approval to market Ketotransdel; and the Company's ability to complete additional developmentactivities for products utilizing its proprietary transdermal delivery platform. Actual results may differ materiallyfrom those set forth in this presentation due to the risks and uncertainties inherent in the Company's business,including, without limitation: the outcome of the final analyses of the data from the Phase 3 clinical trial mayvary from the Company's initial conclusions; the FDA may not agree with the Company's interpretation of suchresults or may challenge the adequacy of the Company's clinical trial design or the execution of the clinical trial;the FDA may continue to require the Company to complete additional clinical trials for Ketotransdel® before theCompany can submit a 505(b)(2) NDA application; the results of any future clinical trials may not be favorableand the Company may never receive regulatory approval for Ketotransdel®; and the Company's current need toraise additional funding to complete its product development plans. More detailed information about theCompany and the risk factors that may affect the realization of forward-looking statements is set forth in theCompany's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K andits Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on theSEC's web site at You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. All forward-looking statements are qualified in their entiretyby this cautionary statement and the Company undertakes no obligation to revise or update this presentation toreflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions ofSection 21E of the Private Securities Litigation Reform Act of 1995.
‰ Experienced Management Team
‰ Novel transdermal delivery platform applicable to a broad range of drugs
‰ Ketotransdel® could be first in class topical NSAID cream for treatment of pain‰ Technology applicable for additional pharmaceutical and cosmeceutical ‰ Positive Phase 3 results for lead pain drug, Ketotransdel
‰ Statistically significant efficacy results and excellent safety in Phase 3 trial ‰ Large market opportunity for Ketotransdel
‰ U.S. market for NSAIDs and Cox-2 inhibitors is in excess of $8 billion per year‰ Ketotransdel® may have advantages over recently launched topical pain ‰ Partnership/collaboration opportunity
‰ Discussions underway for sales/marketing opportunities for Ketotransdel‰ Cosmeceutical product TDLP301 targeting cellulite out-licensed to strategic 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 ‰ Director, North America Accounting, Carl Zeiss Vision Inc.
‰ Certified Public Accountant ‰ Terry Nida, Chief Business Officer
‰ 30 years of pharmaceutical management experience: BMS, Centocor and Vivus‰ Corporate Officer - General Management, Business Development, Sales and Marketing ‰ Participated/led development and launch of Centoxin, ReoPro, Remicade and Muse ‰ Joachim P. H. Schupp, M.D. , Chief Medical Officer
‰ 25 years of leadership experience in strategic design and execution of international clinical development projects, cross-functional project management and post-marketing surveillance in the pharmaceutical industry ‰ Senior management positions at Ciba-Geigy, Novartis, ProSanos , Adventrx ‰ Participated/led development and launch of Voltaren, Apligraf, Femara and Exjade Transdermal Delivery System (TDS)
Transdel's proprietary cream formulation enables active drug
to penetrate the skin and reach targeted underlying tissue
† 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 the structure of the
outer layers of the skin
(stratum corneum),

† Enhance the migration of
the compounds through the
skin and facilitate
separation of the active
components from the

Launch Date
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 trials demonstrated: Ketotransdel Phase 3 Trial
Randomized, double-blind, placebo-controlled Patients with acute soft tissue injuries (sprains & strains) Relief of pain from acute soft tissue injuries Ketotransdel vs. Placebo (Vehicle) cream, 1g three times Change from baseline in pain intensity on Day 3 Visit Safety assessments, various other efficacy variables Ketotransdel Phase 3 trial TDLP-110-001
‰ 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; using both the original and modified ITT population; ‰ Ketotransdel demonstrated excellent safety and tolerability; ‰ No treatment related gastrointestinal, cardiac, liver or other serious adverse ‰ No clinically relevant changes in blood and urine tests; ‰ Minimal blood concentrations of ketoprofen detected in pharmacokinetic study support the excellent safety profile of Ketotransdel ‰ approximately 1 - 2 % of oral ketoprofen dose Patients Who May Benefit From a Topical
‰ History of gastrointestinal symptoms / gastrointestinal ulceration ‰ History of heart, liver, kidney disease or other serious medical ‰ Intake of multiple drugs for other conditions ‰ Corticosteroid use with oral NSAIDs increases adverse risks ‰ Anti-coagulants with oral NSAIDs increase mortality by ‰ Cannot take drugs orally / have swallowing difficulties 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 dollar market largely replaced by oral NSAIDs U.S. transdermal drug delivery market projected to reach $4.5 billion in 2012* OTC painkillers such as aspirin, acetaminophen (Tylenol) and Advil may result in safety concerns and may lack potency for acute musculoskeletal pain of moderate intensity Physicians and patients seek alternative options for effective and safe pain medications Ketotransdel, if approved by the FDA, could become the first topical NSAID cream product in the U.S. for acute pain management *Source: U.S. Transdermal Drug Delivery Markets, Frost and Sullivan, August 2006.
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 Flector Patch and Voltaren Gel in late 2007 / early 2008, prescriptions for these two topical medications have increased substantially In 2009, Voltaren Gel prescriptions surpassed Flector Patch prescriptions Total Rx COX2s Vs. NSAIDs
Topical NSAID (Diclofenac) TRx
Note: Graphs denote total prescriptions, per IMS data.
Competitive Landscape
FDA Approved Topical NSAIDs
(10 drops to each of 4 sides of knee), 3-4 times per day US Sales of Flector Patch and Voltaren Gel
FY 2010 (E)
Double digit growth estimated in 2010 for Flector and Voltaren Gel
‰ TDLP310 Lead product - anti-cellulite formulation ‰ License agreement with Jan Marini Skin Research, Inc.
Exclusive rights to U.S. professional dermatology market ‰ Expansion of cosmeceuticals pipeline formulations: ‰ TDLP330 - Facial Fine Lines and Wrinkles ‰ In licensing discussions with potential partners Contact Us
Corporate Headquarters
Investor Contact
Chief Financial Officer and Acting Chief Executive Officer Please visit for more information.



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