Philadelphia-based Echo Therapeutics ($ECTE) took a $16.7 million loss in 2011, a year in which the company had planned to launch its needle-free, transdermal drug delivery platform, the Prelude SkinPrep System.
But that launch didn't happen, thanks to a regulatory delay. Early last year, the FDA told Echo and its partner, Ferndale Pharma Group, that Prelude would need only "minor" changes before approval. Now, however, Prelude must clear the Health and Human Services Department's Combination Products Department, which has led to a protracted process and an unclear launch date, an Echo spokesperson told FierceDrugDelivery. In the meantime, Echo and Ferndale will pursue European approval for the product, according to Echo.
The company was in the red in 2010 too, losing $4.3 million, but had planned to start bringing in revenues by getting Prelude on the market in the third quarter of 2011. Echo's stock price has taken a hit, as well, dropping more than 50% from its June high of $4.50 a share.
Despite the Prelude delay, Echo brass is optimistic the company can generate revenues in the near future with Symphony tCGM, a wireless glucose monitor that uses the Prelude's noninvasive skin permeation to keep tabs on blood sugar levels in diabetics.
"We made very tangible progress during 2011, and we achieved some very important milestones," CEO Patrick Mooney said in a release. "... With a strengthened and simplified balance sheet and an experienced management team, Echo is focused on the continued, accelerated pace of product development finalization and clinical validation necessary for regulatory clearance of the Symphony tCGM System in both Europe and the U.S."
The good news is that things seem to be moving right along with Symphony. Echo announced in January that it's recruiting critical-care patients for another round of clinical trials of the monitoring system after raising $3.6 million for final development. The company did not say when it hopes to get the product on the market, however.
- read Echo's SEC filing
- check out the company's release