UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
____________________________________________________________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
___________________________________________________________________
Date
of
Report (Date of earliest event reported): June 10, 2008
Transdel
Pharmaceuticals, Inc.
(Exact
Name of Registrant as Specified in Charter)
|
Delaware
|
000-52998
|
45-0567010
|
||
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
||
|
4225
Executive Square, Suite 460
La
Jolla, CA
|
92037
|
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code: (858) 457-5300
|
n/a
|
|
(Former
name or former address, if changed since last
report)
|
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
| o |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
| o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 DFR
240.14a-12)
|
| o |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
| o |
Pre-commencement
communications pursuant to Rule 13e-4 (c) under the Exchange Act
(17 CFR
240.13e-4(c)
|
Item
1.01. Entry
into a Material Definitive Agreement
In
accordance with the Master Services Agreement dated as of April 10, 2007,
between us and Cato Research Ltd., a contract research and development
organization (“Cato”), on June 10, 2008, we entered into a clinical trial
services agreement with Cato (“Agreement”) pursuant to which Cato will serve as
our strategic partner and contract research organization in conducting our
Phase
3 clinical program for Ketotransdel™, our novel topical cream based
non-steroidal anti-inflammatory drug for pain. Pursuant to the Agreement, we
will make payments to Cato upon its completion of certain specified milestones.
If all milestones under the Agreement are completed and the estimated
pass-through costs are incurred, our total costs under the Agreement are
estimated at $3.3 million. In addition, any changes to budget parameters
identified in the Agreement may result in additional costs to us. There can
be
no assurance that Cato will complete its performance under the Agreement, and
to
the extent that such performance is completed, the clinical test results for
Ketotransdel™ will be satisfactory.
Item
8.01 Other
Events.
On
June
16, 2008, we issued a press release announcing that we have initiated our Phase
3 clinical program for Ketotransdel™
and
entered
into an agreement with Cato whereby Cato will serve as our strategic partner
and
contract research organization in conducting the Phase 3 clinical
program.
Item
9.01 Financial
Statements and Exhibits.
(d)
Exhibits
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release, dated June 16, 2008.
|
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
|
TRANSDEL
PHARMACEUTICALS, INC.
|
|
|
Dated:
June 16, 2008
|
By:
/s/ John T.
Lomoro
|
|
Name: John T. Lomoro
|
|
|
Title: Chief Financial Officer
|
EXHIBIT
INDEX
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release, dated June 16, 2008.
|
Contact:
John
Lomoro
Chief
Financial Officer
Transdel
Pharmaceuticals, Inc.
858-457-5300
Transdel
Initiates Ketotransdel™
Phase
3 Clinical Program for Pain
Cato
Research Signed as Strategic Partner for the Phase 3 Program
LA
JOLLA,
CA - June 16, 2008 -- Transdel Pharmaceuticals, Inc. (OTCBB: TDLP), a specialty
pharmaceutical company developing non-invasive, topically administered
medications, today announced the initiation of its Phase 3 clinical program
for
Ketotransdel™, its novel topical cream based non-steroidal anti-inflammatory
drug (“NSAID”) for pain. The Company has engaged Cato Research Ltd., a global
contract research organization (“CRO”), as a strategic partner and as the CRO to
conduct the Phase 3 clinical program.
The
Company’s randomized, double-blind, placebo controlled Phase 3 trial will
evaluate the efficacy and safety of Ketotransdel™ for the
topical treatment of acute pain from soft tissue injuries. Clinical
sites are planned throughout the United States and potentially other regions,
including Canada. The Company expects that Ketotransdel™, if approved by the
U.S. Food and Drug Administration, could become the first topical NSAID cream
product in the United States for acute pain management. The drug could address
what the Company believes is a significant unmet medical need for patients
and
physicians seeking a potentially safer alternative to existing pain management
approaches, such as oral NSAIDs.
“Advancing
Ketotransdel™ into Phase 3 clinical studies is a significant milestone for our
Company. Our top priority is to execute our clinical program as planned,”
said
Dr.
Juliet Singh, President and Chief Executive Officer of Transdel
Pharmaceuticals.“For
the
conduct of the clinical trial we carefully evaluated only select top level
CROs
with extensive experience in the relevant pain area. We selected Cato Research
not only due to their relationship as a strategic partner with us, but because
of their cost efficient approach to the clinical program, expertise in the
pain
space and our direct access to their senior executive management.”
“We
are
enthusiastic
about
our new strategic relationship with Transdel Pharmaceuticals to assist in
advancing this much needed pain drug through the Phase 3 clinical program,” said
Dr. Allen Cato, Chief Executive Officer of Cato Research. “We are uniquely
focused on development of pain and topical drugs and we expect to make a
significant contribution in bringing Ketotransdel™ to the
market.”
Industry
estimates indicate that the market for NSAIDs and Cox-2 inhibitors exceeds
$6
billion per year and that more than 30 million people worldwide use NSAIDs
daily. Due to the recognition of known risks associated with orally administered
NSAIDs, including cardiovascular, gastrointestinal and other medical
complications, and the decline in the use of Cox-2 inhibitors because of safety
concerns, the Company believes that there is a significant demand for topical
pain management products such as Ketotransdel™.
About
Transdel Pharmaceuticals, Inc.
Transdel
Pharmaceuticals, Inc. (OTCBB: TDLP) is a specialty pharmaceutical company
developing non-invasive, topically- delivered medications. The Company's
innovative patented proprietary Transdel™ cream formulation technology is
designed to facilitate the effective penetration of drugs through the tough
skin
barrier to reach the target underlying tissues. In the case of Ketotransdel™,
the Transdel™ cream allows the active ingredient ketoprofen to reach the target
soft tissue and exert its well-known anti-inflammatory and analgesic effects.
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. For
more
information, please visit http://www.transdelpharma.com.
About
Cato Research Ltd.
Cato
Research Ltd. is a global, full-service contract research and development
organization providing strategic and tactical support for clients in the
pharmaceutical, biotechnology, medical device, and medical diagnostic industries
for over 20 years. With a staff of more than 300 employees located in the United
States, Europe, Canada, Israel, and South Africa, Cato Research’s services range
from design and management of preclinical and clinical studies to submission
of
regulatory documents required for marketing approval.
Safe
Harbor Statement
Statements
made in this release that are not historical in nature constitute
forward-looking statements within the meaning of the Safe Harbor Provisions
of
the Private Securities Litigation Reform Act of 1995. Forward-looking statements
can be identified by the use of words such as "expects," plans" "will," "may,"
"anticipates," believes," "should," intends," "estimates," and other words
of
similar meaning. These statements are subject to risks and uncertainties that
cannot be predicted or quantified and consequently, actual results may differ
materially from those expressed or implied by such forward-looking statements.
Such risks and uncertainties include, without limitation, risks and
uncertainties 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, and
technological changes. More detailed information about the Company and the
risk
factors that may affect the realization of forward-looking statements is set
forth in the Company's filings with the Securities and Exchange Commission,
including the Company's Annual Report on Form 10-KSB filed with the SEC on
March
26, 2008. Such documents may be read free of charge on the SEC's web site at
www.sec.gov. All forward-looking statements included in this release are made
as
of the date of this press release, and the Company assumes no obligation to
update any such forward-looking statements.