Results From Chelsea Therapeutics' Phase III Trial of Droxidopa in Neurogenic Orthostatic...

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

CHARLOTTE, N.C., Nov. 12, 2009 (GLOBE NEWSWIRE) -- 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).

This press release contains forward-looking statements regarding future events.
These statements are just predictions and are subject to risks and uncertainties
that could cause the actual events or results to differ materially. These risks
and uncertainties include our need to raise operating capital, our history of
losses, risks and costs of drug development, risk of regulatory approvals, our
reliance on our lead drug candidates Droxidopa and CH-1504, reliance on
collaborations and licenses, intellectual property risks, competition, market
acceptance for our products if any are approved for marketing and reliance on
key personnel including specifically Dr. Pedder.

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CONTACT: Chelsea Therapeutics
Investors:
Kathryn McNeil
718-788-2856
mcneil@chelseatherapeutics.com

Hill & Knowlton
Media:
Sean Leous
212-885-0549
sean.leous@hillandknowlton.com