LA JOLLA, Calif., Feb. 1, 2011 /PRNewswire/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced that the Company has been exploring strategic alternatives aimed at enhancing shareholder value with two investment banks, American MedTech Advisors and ESC Advisors, a division of KEMA Partners. The goal of this engagement is to continue further development of TDLP-110 (aka Ketotransdel®), the Company’s lead late stage pain product.
Transdel has completed the first Phase 3 trial for TDLP-110, and has presented the key data in support of efficacy and safety at the 13th World Congress on Pain in Montreal, Canada, in September 2010. The Company believes that TDLP-110 has an opportunity to be the first topical ketoprofen product approved in the U.S. and also to become a ‘best in class’ product in the growing topical NSAID market.
Strategic alternatives the Company may pursue could include, but are not limited to, partnering or other collaboration agreements, a merger, a equity or debt financing, sale of the Company or other strategic transactions. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or that, if completed, any agreements or transactions will be successful or on attractive terms. The Company does not intend to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the board of directors has approved a specific transaction.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, any securities of the Company, prior to the registration or qualification for exemption of any securities under federal and state securities laws.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP) 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 pain product candidate, has completed a Phase 3 clinical trial and utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug 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 products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. For more information, please visit http://www.transdelpharma.com.
Safe Harbor Statement
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company’s interpretation of the results of its Phase 3 clinical trial for Ketotransdel®; the Company’s ability to obtain regulatory approval to market Ketotransdel; the Company’s ability to complete additional development activities for products utilizing its proprietary transdermal delivery platform and the Company’s ability to complete a strategic alternative. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business, including, without limitation: the FDA may not agree with the Company’s interpretation of the results of the Phase 3 clinical trial for Ketotransdel or may challenge the adequacy of the Company’s clinical trial design or the execution of the clinical trial; the FDA may require the Company to complete additional clinical trials for Ketotransdel® before the Company can submit a 505(b)(2) NDA application; the results of any future clinical trials may not be favorable and the Company may never receive regulatory approval for Ketotransdel®; and the Company’s current need to raise additional funding through a financing or strategic alternative to complete its product development and clinical trial plans. 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 its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC’s web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SOURCE Transdel Pharmaceuticals, Inc.
