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2009 Business Review
Licensing
Ferndale will pay all product development and regulatory fees and expenses necessary to obtain product approval in North American and the United Kingdom.
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Handok will pay all product development and regulatory expenses related to Symphony's approval in South Korea.
Operational
2010 Milestones
"With a strengthened and simplified balance sheet, much of the initial product development work complete, and two strong strategic partnerships in place, Echo is focused on completing several key milestones during 2010 that will enable the company to begin generating revenue," commented Patrick T. Mooney, M.D., Chairman and Chief Executive Officer of Echo Therapeutics. "Our primary focus is the successful completion of a critical care study with a commercially ready Symphony system, which we believe will be the basis for us to receive FDA approval for Symphony. In addition, we anticipate the completion of a clinical trial by Ferndale using the Prelude SkinPrep system for a reduced time and enhanced delivery of lidocaine. This will result in a near-term filing of a 510k application with the FDA. These events will enable us to begin manufacturing scale-up for product validation and planned product launch in 2010."
In addition, Echo anticipates:
"The last year was one of significant accomplishment and progress against the backdrop of a very tough macroeconomic climate. Through much hard work, we believe that we have set the stage for an exciting and productive 2010," Dr. Mooney continued. "Looking forward, royalties on Prelude disposables and lidocaine sales provide near-term revenue opportunity for Echo. We look forward to working with Ferndale to grow the topical anesthetic market in the US and UK and generating cash flow for Echo in 2010. Additionally, we are positioned to be 'first-to-market' with tCGM in the hospital critical care market and we estimate that the hospital market opportunity for continuous glucose monitoring is greater than $1 billion. In addition, we plan to develop the Symphony product for use in the consumer market, providing additional upside potential and partnership possibilities in this more than $10 billion market opportunity."
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.
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 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 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, 2008, 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.
-- Echo entered into a $15 million license agreement with Ferndale Pharma Group, Inc. which granted to Ferndale the right to develop, market and sell Echo's Prelude SkinPrep System for enhanced delivery of Ferndale's topical lidocaine product, LMX4, in North America and the United Kingdom. In exchange, Echo received: -- An initial licensing fee of $750,000 and an additional $750,000 fee upon FDA approval; -- $12.5 million in milestones and guaranteed minimum royalty payments; and -- Royalties on net sales of disposable Prelude components.
SOURCE Echo Therapeutics, Inc.
