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Transdel Pharmaceuticals
Biotech Specialty Pharma
4225 Executive Square Suite 485
La Jolla, CA 92037 USA
phone:858-457-5300
fax:858-457-5308
Symbol TDLP
Exchange OB
Founded 2006
Employees 4
www.transdelpharma.com
Research Sector Biotech Specialty Pharma
Summary Description
Specialty pharmaceutical company developing non-invasive, topically delivered products.
Management
John T. Lomoro, Acting Chief Executive Officer/Chief Financial Officer; Joachim P. H. Schupp, M.D., Chief Medical Officer; Terry Nida, Chief Business Officer
Ownership
Financials


* numbers in thousands
 

Keywords
dermatology, pain management

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Updated: Mar. 09, 2011

Description
Transdel Pharmaceuticals, Inc. is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel� cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel�, the Company's lead late stage pain product, utilizes the Transdel� technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug (�NSAID�), through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel� platform technology to expand and create a portfolio of topical pharmaceutical and cosmetic/cosmeceutical products.
Products / Services
Pharmaceutical - Ketotransdel is comprised of our proprietary Transdel drug delivery system and ketoprofen, a non-steroidal anti-inflammatory drug (NSAID). Ketotransdel, which has completed one Phase 3 trial is being developed for the treatment of acute pain. Ketotransdel penetrates the skin barrier to reach the targeted underlying tissues where it exerts its localized anti-inflammatory and analgesic effect. The topical delivery of the drug may minimize systemic exposure, therefore, resulting in fewer concerns pertaining to gastrointestinal, hepatic, cardiovascular and other adverse systemic effects, which are associated with orally administered NSAIDs. We believe that this product may be considered for patients with site specific localized pain and who also (i) have a history of gastrointestinal, cardiovascular, kidney or liver problems, (ii) are geriatric or pediatric patients and/or (iii) are patients at risk for drug interactions. We selected ketoprofen as the active ingredient for Ketotransdel based on its efficacy and safety track record when administered topically. We believe that the clinical success of Ketotransdel will facilitate the use of the Transdel delivery technology in other products. We have identified co-development opportunities for potential products in pain management and other therapeutic areas utilizing the Transdel platform technology and we are exploring potential partnerships for these identified products. In addition to others, some of these identified co-development areas include hormone based products, antiemetic and dermatological products using our Transdel delivery system. We are also looking to out-license our Transdel drug delivery technology for the development and commercialization of additional innovative drug products. Cosmeceutical - We have expanded our product development programs to include cosmetic/cosmeceutical products. Our lead product is an anti-cellulite formulation, for which we have initial clinical information supporting the beneficial effects of this key cosmetic/cosmeceutical product on skin appearance. Our potential pipeline of cosmetic/cosmeceutical products includes hyperpigmentation and anti-aging formulations. We are pursuing discussions with potential sales and marketing partners for these cosmetic/cosmeceutical products.
Technology / Differentiation
The Company's innovative-patented Transdel cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. The Company intends to leverage its Transdel platform technology to expand and create a portfolio of topical products for a variety of indications. The patent on the Company's Transdel cream formulation technology covers over 500 different drugs in more than 60 therapeutic areas for approved and established drugs. The patent has a broad technology platform that is patent protected and the patent covers novel formulation with any drug that is capable of being administered transdermally. Also, the patent also covers composition of matter, methods of use and methods of manufacture.
Market / Customers
The market for NSAIDs and COX-2 inhibitors in the United States may exceed $8 billion. Since the withdrawal of major COX-2 inhibitors in 2005, oral NSAIDs have captured a share of the multi-billion retail market for COX-2 inhibitors. Oral NSAIDs remain one of the most prescribed classes of drugs in the pain management market. Over 30 million people worldwide use prescription and over-the-counter NSAIDs daily. We believe that there is a significant unmet medical need for topical pain management products that minimize systemic absorption of NSAIDs such as Ketotransdel. With the success of other topical NSAIDs (a patch and gel) launched in 2008, the market for topical NSAIDS in the U.S. has continued to grow. We expect that Ketotransdel, if and when approved by the FDA, could become a best in class and the first topical NSAID cream product available by prescription in the United States for acute pain management.
Competitors / Substitutes / Alternatives
There are three topical NSAID products that have been launched into the market. Two of those were launched in 2008 and in 2010 another product was launched. With the launch of each product, the market for topical NSAIDs continues to grow. Transdel believes that the topical NSAID market will continue to grow in the U.S. and therefore, the potential approval and launch of Ketotransdel will just add to this growing market.
Strategy
We expect that Ketotransdel, if and when approved by the FDA, could become the first topical NSAID cream product available by prescription in the United States for acute pain management. We are seeking a commercial partner for Ketotransdel, and are actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
Funding
Funding Status - To date, Transdel has raised approximately $11 million. In order to conduct the second Phase 3 trial and the other routine supportive tolerability/pharmacokinetic studies, which are required in order to obtain regulatory approval to market Ketotransdel, we will need to secure additional funds. We intend to seek additional financing through a corporate partnership and/or equity or debt financing to fund the clinical requirements for Ketotransdel as well as to continue our cosmetic cosmeceutical program and to explore co-development opportunities.
Status
Ketotransdel - Completed a Phase 3 trial in 2009 and reported that the Ketotransdel study demonstrated statistical significance in its primary endpoint in the modified Intent-To Treat (ITT) Analysis. Ketotransdel also demonstrated an excellent safety and tolerability profile. Based on discussions with the FDA at least two adequate and well-controlled Phase 3 studies are required in order to obtain regulatory approval to market Ketotransdel. We believe that the first Phase 3 trial will qualify as one adequate and well-controlled trial because there is statistical significance on the primary endpoint in an objectively defined modified ITT population, and statistical significance on secondary endpoints. We are in the process of determining the design of the second Phase 3 trial. There is no assurance that the FDA will accept our conclusion of the modified ITT data from the first Phase 3 study as sufficient as part of the requirements for regulatory approval. Cosmeceutical Anti-Cellulite product - We have entered into a license agreement with JH Direct, LLC ("JH Direct") providing JH Direct with the exclusive worldwide rights to our anti-cellulite cosmeceutical product. Under the terms of the agreement, JH Direct will pay us initial royalty advances if the product is marketed and a continuing licensing royalty on the worldwide sales of the anti-cellulite product. We anticipate that JH Direct will launch the anti-cellulite product through a direct response television campaign during the second half of 2010. As part of the JH Direct agreement, Transdel retained the exclusive rights to seek dermatological partners for the anti-cellulite product for an initial period of one year following the launch of the product, thereafter JH Direct will be allowed to expand in this channel. In June 2010, we out-licensed the exclusive U.S. rights for the anti-cellulite product in the dermatological markt product to Jan Marini Skin Research, Inc.