The 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 the study, Ferndale and Echo anticipate to submit a 510(k) premarket notification to the FDA with subsequent commercial launch of the product after 510(k) clearance.
Reportedly, 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 $12.5m in milestone payments and guaranteed minimum royalty payments. Echo will also receive an ongoing royalty on net sales of the product.
Patrick Mooney, CEO, president and chairman of the board of Echo Therapeutics, said: “This clinical study is a milestone event for Echo Therapeutics and is the final step before an FDA submission. 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 $200m 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.”
Michael Burns, president of Ferndale, said: “Based on our extensive knowledge of the market, we expect that the faster onset of analgesia provided by Prelude will 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.”
