SOURCE: Transdel Pharmaceuticals, Inc.

October 01, 2007 08:30 ET

Transdel Pharmaceuticals, Inc. Completes Merger Transaction, Equity Financing and Begins Trading Under Symbol "TDLP"

LA JOLLA, CA--(Marketwire - October 1, 2007) - Transdel Pharmaceuticals, Inc. (OTCBB: TDLP), a specialty pharmaceutical company focused on the development and commercialization of non-invasive topically targeted medications, today announced the completion of a merger transaction and the commencement of trading under the symbol "TDLP" on the Over the Counter Bulletin Board. In connection with the merger on September 17, 2007, the Company raised $4.0 million through the sale of common stock and warrants. In addition, in June 2007, the Company completed a raise of $1.5 million through the sale of notes, all of which converted into approximately 1.5 million shares of common stock in connection with the merger. After accounting for the merger and financings, the Company currently has approximately 13.4 million shares of common stock outstanding. The proceeds from these financings will be used for the further development of the Company's lead drug, Ketotransdel™, a novel topical cream based non-steroidal anti-inflammatory drug ("NSAID") for pain.

Ketotransdel™ 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.

Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals, stated, "I am pleased to have completed this transaction as it enables us to broaden our investor base and create a liquid market for our stock. It also gives us the opportunity to access the market to financially support the completion of the required Ketotransdel™ clinical trials for FDA approval and to continue the development of our pipeline." Dr. Singh continued, "We are completely focused on leveraging the Company's versatile proprietary Transdel™ drug delivery platform and capital efficient business model to increase shareholder value. With a proven and experienced management team, strong intellectual property and the utilization of the most experienced contract organizations known in the field, we believe that the Company is well positioned to advance the development of its lead drug Ketotransdel™."

Development Program for Ketotransdel™

Ketotransdel™ was tested in a double blind, randomized placebo-controlled clinical trial. The trial tested the efficacy and safety of topical 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 with minimal systemic exposure to the drug. 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 acceptance 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 (Cyclooxygenase-2 selective NSAIDs) exceeds $6 billion with more than 30 million people worldwide using prescription and over-the-counter NSAIDs daily. 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 that there is a significant demand for topical pain management products such as Ketotransdel™. Moreover, the Company hopes that Ketotransdel™, upon FDA approval, would be the first topical NSAID cream product in the United States for pain management. The drug could address a significant unmet medical need relating to gastrointestinal and cardiovascular safety concerns.

A market research study conducted by an independent consulting firm, concluded that the Ketotransdel™ formulation will be well accepted by physicians and patients and could be used for a variety of acute and chronic pain conditions. The study also reported that the potential drug utilization frequency of Ketotransdel™ by physicians and patients could be high.

The Company plans to continue discussions with ideal commercial partners for future Ketotransdel™ sales and marketing strategies. In addition, the Company will be pursuing discussions with potential pharmaceutical partners for licensing opportunities related to the Transdel™ delivery system.

Transdel™ Technology

Transdel™ is the Company's proprietary transdermal cream drug delivery platform. 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.

Intellectual Property

The Company obtained a patent from the United States Patent and Trademark Office on the Transdel™ technology. Specifically, the patent covers composition of matter, methods of use and methods of manufacture. The U.S. issued patent on the Transdel™ proprietary cream formulation covers the combination of the cream formulation with a number of active drugs. Thus, the Company has a broad technology platform that is patent protected.

About Transdel Pharmaceuticals, Inc.

Transdel Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of topically administered drugs. The Company's lead topical drug, Ketotransdel™, utilizes the Company's proprietary Transdel™ cream formulation to facilitate the passage of ketoprofen, an NSAID, through the epidermis and into underlying tissues where the drug exerts its prolonged localized anti-inflammatory effect. The Company is also investigating other drug candidates and treatments for transdermal delivery using the Transdel™ platform technology for products in pain management and human hormone replacement, amongst others.

Key members of the management team of Transdel Pharmaceuticals include Juliet Singh, Ph.D., who serves as President and Chief Executive Officer. Prior to Transdel, Dr. Singh was a corporate officer-vice president of regulatory affairs and quality assurance of Collateral Therapeutics, Inc. Dr. Singh also served as the director of worldwide regulatory affairs for Allergan Corporation, where she oversaw the registration of BOTOX™ in the United States, Canada, Europe Asia, and South America. Prior to joining Allergan, Dr. Singh was the assistant director of regulatory affairs for Baxter Healthcare Corp., where she provided leadership in obtaining worldwide regulatory approval for recombinant VIII.

John T. Lomoro serves as Transdel's Chief Financial Officer. Mr. Lomoro has over 15 years of finance and accounting experience with private and publicly traded organizations. Most recently, Mr. Lomoro was the director of North American accounting for Carl Zeiss Vision Inc. Earlier in his career Mr. Lomoro was the manager of financial reporting and planning for dj Orthopedics, Inc. Also, Mr. Lomoro worked as an audit manager with Ernst & Young LLP and is a Certified Public Accountant.

Balbir Brar, D.V.M., Ph.D., is currently the Vice President of Research and Development. Dr. Brar has over 25 years of experience working with major pharmaceutical companies where he filed over 50 INDs and obtained worldwide approval of 10 NDAs for major drugs currently on the market. Most recently, Dr. Brar was the Vice President of Drug Safety, Research and Development at Allergan Corporation. While at Allergan he made major contributions to the development and worldwide registration of Alphagan, Lumigan, Restasis, Ketarolac, Avage and BOTOX™. Prior to joining Allergan, he participated in the development and worldwide registration of Tazarotene, Aristocort and Azmacort.

Safe Harbor Statement

The Statements which are not historical facts contained in this press release are forward-looking statements that involve certain risks and uncertainties including but not limited to risks associated with the uncertainty of future financial results, additional financing requirements, development of new products, government approval processes, the impact of competitive products or pricing, technological changes, the effect of economic conditions and other uncertainties detailed in the Company's filings with the Securities and Exchange Commission.

Contact Information

  • For further information, please contact:
    Alliance Advisors
    Thomas P. Walsh
    212-398-3486
    Email Contact

    or

    John Lomoro
    CFO
    Transdel Pharmaceuticals, Inc.
    858-457-5300
    Email Contact