Chelsea Therapeutics Reports Fourth Quarter And Full Year 2010 Results

CHARLOTTE, N.C., March 2, 2011 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the fourth quarter and full year 2010 and will host a conference call this afternoon at 4:30 PM ET to discuss these results and provide an update on the Company's development progress.

2010 Highlights

• Met primary endpoint, achieving highly significant improvement OHQ composite scores (p=0.003) in pivotal Phase III Northera Study 301 in neurogenic orthostatic hypotension (NOH)
• Reported data from Northera NOH Study 303 confirming safety, sustained improvements in blood pressure and statistically significant 3.2 unit improvement in OHQ composite scores (p<0.001) following three months of open label treatment
• Reported results from Northera 24-hour blood pressure monitoring Study 305 in which no patients reported consecutive SBP measurements >180 mmHg for more than 3.5 hours at any time during the study
• Reached agreement with FDA to file Northera new drug application (NDA) in symptomatic neurogenic orthostatic hypotension based on efficacy data from Studies 301 & 302
• Reported positive interim analysis of Phase II trial evaluating novel droxidopa/carbidopa combination therapy in fibromyalgia in which data monitoring committee saw meaningful efficacy in multiple treatment arms
• Supported initiation of investigator-sponsored Phase II trials of droxidopa in both adult attention deficit hyperactivity disorder (ADHD) and chronic fatigue syndrome (CFS)
• Initiated Phase II trial designed to compare the efficacy and tolerability of CH-4051, a novel metabolically inert antifolate, against methotrexate (MTX) in rheumatoid arthritis (RA) patients who show an inadequate response to MTX

"Following the robust data generated by our Phase III clinical program and the success of our recent financing, we believe Chelsea is well positioned to seek approval to market Northera in the U.S. for the treatment of symptomatic neurogenic orthostatic hypotension and well funded for a U.S. launch early next year," commented Dr. Simon Pedder, President and CEO of Chelsea. "In the coming months, I look forward to having the opportunity to report data from multiple Phase II trials of droxidopa in new indications, get our first look at the efficacy of CH-4051 in RA patients and file our first new drug application for Northera."