Transdel Pharmaceuticals, Inc. Completes Merger Transaction, Equity Financing and Begins Trading Under Symbol "TDLP"
Transdel Pharmaceuticals, Inc. Completes Merger Transaction, Equity Financing and Begins Trading Under Symbol "TDLP"
Oct. 1, 2007 12:30 PM
LA JOLLA, CA -- (MARKET WIRE) -- 10/01/07 -- 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(TM), a novel topical cream based non-steroidal
anti-inflammatory drug ("NSAID") for pain.
Ketotransdel(TM) is comprised of a transdermal formulation of ketoprofen,
an NSAID, and the Company's innovative proprietary Transdel(TM) drug
delivery system. Ketotransdel(TM) 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(TM)
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(TM) 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(TM)."
Development Program for Ketotransdel(TM)
Ketotransdel(TM) was tested in a double blind, randomized
placebo-controlled clinical trial. The trial tested the efficacy and safety
of topical Ketotransdel(TM) for the treatment of acute pain and soreness in
a delayed-onset muscle soreness model. The levels of systemic absorption of
topical Ketotransdel(TM) were also measured. The trial demonstrated that
Ketotransdel(TM) 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(TM)
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(TM). Moreover,
the Company hopes that Ketotransdel(TM), 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(TM) 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(TM) by physicians and patients could
be high.
The Company plans to continue discussions with ideal commercial partners
for future Ketotransdel(TM) sales and marketing strategies. In addition,
the Company will be pursuing discussions with potential pharmaceutical
partners for licensing opportunities related to the Transdel(TM) delivery
system.
Transdel(TM) Technology
Transdel(TM) 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(TM) 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(TM) 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(TM) technology. Specifically, the patent covers
composition of matter, methods of use and methods of manufacture. The U.S.
issued patent on the Transdel(TM) 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(TM), utilizes the
Company's proprietary Transdel(TM) 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(TM) 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(TM) 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(TM). 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.
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
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