FRANKLIN, Mass., April 27 Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing its needle-free Symphony(TM) tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude(TM) SkinPrep System for transdermal drug delivery, in collaboration with its strategic partner, Ferndale Pharma Group, Inc., announced today that the first patients were enrolled in a clinical study of its Prelude SkinPrep System. This clinical study is designed to evaluate the ability of the Prelude SkinPrep System to ablate the skin prior to application of OTC 4% lidocaine cream for local dermal anesthesia. Upon completion of this study, Ferndale and Echo anticipate submitting a 510(k) premarket notification to the United States Food and Drug Administration (FDA) with subsequent commercial launch of the product after 510(k) clearance.
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In May 2009, Echo granted Ferndale a license to develop, market and sell Prelude for delivery of Ferndale's topical 4% lidocaine product in North America and the UK. Echo received $750,000 up front and expects to receive $750,000 upon FDA clearance of the product, as well as $12.5 million in milestone payments and guaranteed minimum royalty payments. Echo will also receive an ongoing royalty on net sales of the product.
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"This clinical study is a milestone event for Echo Therapeutics and is the final step before an FDA submission," commented Patrick T. Mooney, M.D., CEO, President and Chairman of the Board of Echo Therapeutics. "We have worked hard to finalize the design of the Prelude SkinPrep System and as a result of our effort, we are now ready to commence the study. Once completed, we anticipate the submission of a 510(k) with the FDA, clearing the way for a near-term commercial launch after FDA clearance. The use of Prelude for local dermal anesthesia represents the best near-term revenue opportunity for Echo. The topical anesthetic market exceeds $200 million annually and we believe that this new product-candidate, with demonstrably faster activity, has the potential to grow it significantly. We are extremely excited to begin enrolling patients and look forward to providing updates in the near-term."
"Ferndale is a market leader in topical analgesics that are frequently administered to provide pain relief prior to a number of dermal procedures," commented Michael Burns, Ph.D., President of Ferndale. "Based on our extensive knowledge of the market, we expect that the faster onset of analgesia provided by Prelude will dramatically expand usage of topical analgesics by physicians and nurses interested in helping patients avoid painful interventions, particularly chronically ill children and adults who must endure repeated needle sticks and IV therapy. We are excited to begin this study with Prelude and look forward to the conclusion of the study in the near-term."
About Echo Therapeutics
Echo is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units. Echo is also developing its needle-free Prelude SkinPrep System as a platform technology for enhanced skin permeation for transdermal drug delivery of a wide range of novel topical reformulations of widely-used, FDA-approved products.
About Ferndale Pharma Group
The Ferndale Pharma Group of companies specializes in the development, manufacture, distribution and marketing of various dermatologic products including prescription topical drugs for the treatment of several acute and chronic dermatoses, medical devices that support and maintain wound closures and an extensive line of proprietary cosmeceutical products.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo's and its partners' ongoing studies, including the efficacy of Echo's Symphony tCGM and Prelude SkinPrep Systems, the failure of future development and preliminary marketing efforts related to Echo's Symphony tCGM and Prelude SkinPrep Systems, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's and its partners' ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin permeation platform technologies, including the Symphony tCGM and Prelude SkinPrep Systems, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony tCGM and Prelude SkinPrep Systems. These and other risks and uncertainties are identified and described in more detail in Echo's filings with the Securities and Exchange Commission, including, without limitation, its annual report on Form 10-K for the year ended December 31, 2009, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information: Patrick T. Mooney, M.D. Jeffrey Stanlis Chairman and Chief Executive Officer Partner, Hayden IR (508)-530-0329 (602) 476-1821
SOURCE Echo Therapeutics, Inc.
