Results From Chelsea Therapeutics' Phase III Trial of Droxidopa in Neurogenic Orthostatic Hypotension to be Presented at 20th Annual International Symposium on the Autonomic Nervous System

Dr. Horacio Kaufmann to Present Findings From Droxidopa Study 302

CHARLOTTE, N.C., Nov. 12, 2009 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that Horacio Kaufmann, M.D. will present results from Droxidopa Study 302 at the American Autonomic Society's 20th Annual International Symposium on the Autonomic Nervous System in St. Thomas, U.S. Virgin Islands. Preliminary results from Study 302, the first of two pivotal Phase III trials in Chelsea's registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), were first reported on September 24, 2009.

Dr. Kaufmann, who is the Felicia B. Axelrod Professor of Dysautonomia Research at New York University School of Medicine and a principal investigator for the study, will present the results of Study 302 at 10:45 AM ET on Thursday, November 12, 2009. Professor Kaufmann will present a talk entitled: "Treatment with Droxidopa -- a phase III multinational, placebo-controlled, parallel group, withdrawal-design study in subjects with neurogenic orthostatic hypotension and non-diabetic autonomic neuropathy." A copy of his presentation will be available on the Chelsea website, www.chelseatherapeutics.com, following the conclusion of his session at the meeting.

NOH is a neurogenic disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, blurred vision and syncope.

An estimated 300,000 patients suffer from chronic symptomatic NOH in the U.S. and the EU. Symptoms of chronic NOH can be incapacitating -- not only putting patients at high risk for falls and associated injuries -- but also severely impacting the quality of life of patients and their loved ones, and generating significant health care costs. The only current FDA-approved treatment for orthostatic hypotension has not been shown to be effective in alleviating the symptoms of the condition and is limited in its use by a pronounced side-effect profile.

About Droxidopa and the Registration Program in NOH

Currently available in Japan and with over a million patient years of safety and efficacy data, Droxidopa demonstrated significant symptomatic and functional improvement in its first Phase III trial in NOH in the U.S. and EU. As an orally active synthetic precursor of norepinephrine, Droxidopa increases the supply of norepinephrine available for delivery to its receptors, effectively targeting the root cause of NOH to improve orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.

The Droxidopa Phase III registration program in NOH includes two double-blind, placebo-controlled studies: Study 301 and Study 302. Study 301was reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA). An SPA provides a binding agreement that the study design, including trial size, clinical endpoints and/or data analyses is acceptable to support regulatory approval. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal Droxidopa program in NOH. Fast Track designation is designed to facilitate the review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need and provides the option to file a New Drug Application (NDA) on a rolling basis. This permits the FDA to review the filing as it is received, expediting the review process.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).