Chelsea Therapeutics Announces FDA Acceptance of NORTHERA(TM) (droxidopa) NDA Resubmission

Chelsea Therapeutics Announces FDA Acceptance of NORTHERA(TM) (droxidopa) NDA
Resubmission

                      *PDUFA Date Set as January 3, 2014

CHARLOTTE, N.C., July 17, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today announced that the U.S. Food and Drug
Administration (FDA) has acknowledged receipt of the New Drug Application
(NDA) resubmission seeking approval to market NORTHERA™ (droxidopa), an orally
active synthetic precursor of norepinephrine, for the treatment of symptomatic
neurogenic orthostatic hypotension (NOH) in patients with primary autonomic
failure (Parkinson's disease, multiple system atrophy and pure autonomic
failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic
neuropathy. The FDA has deemed the resubmission a complete response to its
March 28, 2012 Complete Response Letter and assigned a new Prescription Drug
User Fee Act (PDUFA) goal date of January 3, 2014.

"Northera holds the potential to serve as an important new therapeutic option
for patients living with the debilitating effects of NOH," said Joseph G.
Oliveto, Interim Chief Executive Officer of Chelsea. "FDA acknowledgement of
the completeness of our NDA resubmission is another key milestone in reaching
this goal. We will continue to work closely with the FDA toward an approval
decision for Northera by early next year, and advance our commercial strategy
in anticipation of a U.S. commercial launch soon after this."

Northera was previously granted Orphan Drug Designation and received Fast
Track designation from the FDA.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.

About Symptomatic NOH

NOH is a chronic neurogenic disorder resulting from deficient release of
norepinephrine that predominantly affects patients with primary autonomic
failure, a group of diseases which includes Parkinson's disease (PD), multiple
system atrophy (MSA) and pure autonomic failure (PAF). Symptoms of NOH
include: dizziness, lightheadedness, blurred vision, fatigue, poor
concentration, and fainting episodes when a person assumes a standing
position, often severely limiting a person's ability to perform routine daily
activities that require standing or walking for both short and long periods of
time.

About Northera

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics'
pipeline, is currently in Phase III development for the treatment of
symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary
autonomic failure — an indication that includes a significant number of
patients with Parkinson's disease, multiple system atrophy (MSA) and pure
autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is
directly converted to norepinephrine (NE) via decarboxylation, resulting in
increased levels of NE in the nervous system, both centrally and peripherally.

Droxidopa, developed by and licensed from Dainippon Sumitomo Pharma Co., Ltd.
(DSP), initially received Japanese approval in 1989 for the treatment of
frozen gait and dizziness on standing associated with Parkinson's Disease and
for the treatment of orthostatic hypotension, syncope or dizziness on standing
associated with Shy-Drager syndrome and Familial Amyloidotic Polyneuropathy.
In 2000, Droxidopa received expanded marketing approval to include prevention
of vertigo, dizziness and weakness associated with orthostatic hypotension in
hemodialysis patients.

About Chelsea Therapeutics

Chelsea Therapeutics (Nasdaq:CHTP) is a biopharmaceutical development company
that acquires and develops innovative products for the treatment of a variety
of human diseases, including central nervous system disorders. Chelsea is
currently pursuing FDA approval in the U.S. for Northera™ (droxidopa), a
novel, late-stage, orally-active therapeutic agent for the treatment of
symptomatic neurogenic orthostatic hypotension in patients with primary
autonomic failure. For more information about the Company, visit
www.chelseatherapeutics.com.

This press release contains forward-looking statements regarding future events
including our intention to pursue the development of Northera. These
statements are subject to risks and uncertainties that could cause the actual
events or results to differ materially. These include reliance on key
personnel and our ability to attract and/or retain key personnel; the risk
that FDA will not agree that our clinical trial results demonstrate the safety
and effectiveness of droxidopa; the risk that the FDA will not accept our
proposal regarding any trial or other data to support a new drug application;
the risk that the FDA will not approve the resubmitted NDA; the risk that our
resources will not be sufficient to conduct any study of Northera that will be
acceptable to the FDA; the risk that we cannot complete any additional study
for Northera without the need for additional capital; the risks and costs of
drug development and that such development may take longer or be more
expensive than anticipated; our need to raise additional operating capital in
the future; our reliance on our lead drug candidate droxidopa; risk that we
will not be able to obtain regulatory approvals of droxidopa or our other drug
candidates for additional indications; risk of volatility in our stock price,
related litigation, and analyst coverage of our stock; reliance on
collaborations and licenses; intellectual property risks; our history of
losses; competition; market acceptance for our products if any are approved
for marketing.

CONTACT: Investors:
         Fara Berkowitz / Susan Kim
         Argot Partners
         212-600-1902
         fara@argotpartners.com
         susan@argotpartners.com
        
         Media:
         David Pitts
         Argot Partners
         212-600-1902
         david@argotpartners.com

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