Transdel Pharmaceuticals Symbol: TDLP
Transdel Pharmaceuticals INC. TDLP
Stock Price (11/12/07): $2.75
Ave Daily Trading: 1,823
52 Week Low-High: $2.50-$3.50
Shares Outstanding: 13,727,004
Fully Diluted: 14,897,462
Public Float: 2,346,834
Market Capitalization: $37,749,261
Transdel Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of non-invasive topically delivered medications. The Company’s lead topical drug, Ketotransdel™, utilizes the Company’s innovative patented proprietary Transdel™ cream formulation to facilitate the passage of ketoprofen, an NSAID (Non Steroidal Anti-Inflammatory Drug), through the skin barrier to reach targeted underlying tissue where the drug exerts its prolonged localized anti-inflammatory and analgesic effect. The Company is also investigating other drug candidates and treatments for transdermal delivery using the patented Transdel™ platform technology for products in pain management and other therapeutic areas.
The Transdel™ Technology: Transdel™ is the proprietary transdermal cream drug delivery platform of the Company. It consists of a cream that enables transdermal penetration of drugs avoiding first pass metabolism by the liver and minimizing systemic exposure. The Transdel™ drug delivery system facilitates the dissolution and delivery of a drug across the skin barrier to reach the targeted underlying tissues. The Company believes that the biocompatibility of Transdel™ with human skin, its skin penetrating qualities and its ability to deliver sufficient quantities of drugs locally makes it an ideal drug delivery system. Lead Drug Ketotransdel™: Ketotransdel™ is a cream that is comprised of a transdermal formulation of ketoprofen, an NSAID, and the Company’s innovative proprietary Transdel™ drug delivery system. Ketotransdel™ penetrates the skin barrier to reach the targeted underlying tissue where it exerts its prolonged localized anti-inflammatory effect. This drug may minimize systemic exposure, therefore, resulting in fewer concerns pertaining to gastrointestinal, renal, cardiovascular and other adverse systemic effects, which are associated with orally administered NSAIDs. This drug may help address certain safety concerns in the market and potentially provide physicians and patients with a much needed alternative for pain. Development Program for Ketotransdel™ Ketotransdel™ was tested in a double blinded, randomized, placebo-controlled trial that tested the efficacy and safety of Ketotransdel™ for the treatment of acute pain and soreness in a delayed-onset muscle soreness model. The levels of systemic absorption of topical Ketotransdel™ were also measured. The trial demonstrated that Ketotransdel™ provided effective local delivery of ketoprofen resulting in statistically significant relief of pain and soreness. Low serum concentrations of drug support an enhanced safety profile. No adverse reactions to Ketotransdel™ were reported. The Company’s goal is to file with the FDA for Phase 3 clinical trials in the first quarter of 2008. Depending on the FDA’s review of this filing, the Company anticipates starting Phase 3 clinical trials as early as the first half of 2008 for the topical treatment of acute pain.
Market Opportunity: The market for NSAIDs and Cox-2 inhibitors exceeds $6 billion in the U.S. Due to the recognition of cardiovascular, gastrointestinal and other risks associated with orally administered NSAIDs and the decline in the use of Cox-2 inhibitors related to safety concerns, the Company believes there is a significant demand for topical pain management products such as Ketotransdel™. Furthermore, the non-steroidal segment of the transdermal drug delivery pain management market was $419 million in 2005 and is projected to increase to over $1.3 billion in 2012. The Company is in discussions with ideal commercial partners for future Ketotransdel™ sales and marketing strategies. In addition, the Company is in discussions with potential Pharma partners for licensing opportunities related to the Transdel™ delivery system. A market research study conducted by an independent consulting firm concluded that Ketotransdel™ will be well accepted by physicians and patients and could be used for a variety of acute and chronic pain conditions. The study reported that the potential drug utilization frequency of Ketotransdel™ by physicians and patients could be high.
Intellectual Property:
The Company has a broad technology platform that is patent protected. Specifically, the patent covers composition of matter, methods of use and methods of manufacture. The patent also covers the transdermal novel formulation with any active pharmaceutical drug.
Competitive Products in Development: There are limited competitors in the U.S. developing patch products and other pain formulations that the Company is aware of at this time. One such competitor would included Alpharma (NYSE: ALO) who has acquired the exclusive U.S. rights to two transdermal NSAID products in the quarter ended September 30, 2007. The first product is a diclofenac patch for acute pain that was approved by the FDA in January 2007. Alpharma paid $100 million in upfront payments plus 1 million warrants that are exercisable at $35. Alpharma stated that they plan to launch this product in early 2008 and expects it to generate $500 million in sales at its peak. Since Ketotransdel™ is a cream based product, we believe it is not associated with the limitations and inconveniencies of patch products. The second is a Transfersome gel based NSAID for the treatment of osteoarthritis, for which Alpharma paid $60 million in an up-front payment. Additionally, another $122-142 million in payments and the issuance of warrants at contractually determined prices will be provided if milestones are achieved as provided in the agreement. The agreement also calls for royalties based on U.S. product sales. Alpharma expects the drug to be in the U.S. market in 2011, which could be well after Ketotransdel™ is expected to be introduced to the U.S. market. These deals provide a basis for future potential deal terms that may be possible for Transdel Pharmaceuticals.
Management Team:
Dr. Juliet Singh, Ph.D., Chief Executive Officer/President
• Corporate Officer, VP Regulatory Affairs and Quality Assurance, Collateral Therapeutics
• Played key role in acquisition of Collateral Therapeutics (approx. 150 million dollar acquisition value)
• Director of Worldwide Regulatory Affairs at Allergan Corporation
• Lead worldwide regulatory approval for BOTOX™
• Assistant Director Regulatory Affairs, Baxter Healthcare Corp.
• Lead worldwide regulatory approval recombinant factor VIII
• Ph.D. in Endocrinology, UC Davis; post-doc at Genentech
John Lomoro, Chief Financial Officer
•15 years of experience with public and private organizations, including 5 years in public accounting with Ernst and Young LLP
• Director, North America Accounting, Carl Zeiss Vision Inc., (privately held international optical lens manufacturer and distributor)
• Manager, Financial Reporting and Planning – dj Orthopedics, publicly traded medical device company
• Certified Public Accountant
Balbir Brar D.V.M., Ph.D., Vice President of Research and Development
• 25 years of experience working with major pharmaceutical companies in drug development
• VP Drug Safety, Research and Development at Allergan Pharmaceutical
• Filed over 50 INDs and obtained worldwide approval of 10 NDAs for major drugs currently on the market. (BOTOX™, Tazarotene , Alphagan, Lumigan , Restasis and Ketarolac)
• Senior Director for Safety Evaluation, GlaxoSmithKline for Azelex and Ofloxacin
• Senior Scientist at Lederle (currently known as Wyeth) for Azmacort and Aristocort
• DVM from Punjab University, Ph.D. in Toxicology/Pathology, Rutgers University Reasons to Invest:
• Platform technology with broad patent position
• Lead program with positive phase 1/2 clinical data available
• Development and registration in place
• Fills multi-billion dollar void for safe topical pain medication.
• Working with well known and most experienced contract organizations.
• Novel drug delivery platform technology pipeline
• Highly qualified and experienced management team in the development and regulatory approval of drugs.
Transdel Pharmaceuticals Information Center
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