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 www.sec.gov. 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 Partner(s) 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 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; 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 Indication
(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 www.transdelpharma.com for more information.
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