Chelsea Therapeutics Announces Submission of Additional Information for NORTHERA(TM) (Droxidopa) NDA

Chelsea Therapeutics Announces Submission of Additional Information for
NORTHERA(TM) (Droxidopa) NDA

CHARLOTTE, N.C., Aug. 14, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today announced that it has submitted
additional information to the U.S. Food and Drug Administration (FDA) to
resolve certain technical deficiencies in the Company's resubmitted New Drug
Application (NDA) for NORTHERA™ (droxidopa). Pending confirmation by the FDA,
the resubmission is expected to be deemed a complete response to the March 28,
2012 Complete Response Letter (CRL) issued by the Agency. A new six month
review clock, as specified under the Prescription Drug User Fee Act (PDUFA),
will be set from the date of receipt.

As previously announced on July 17, 2013, Chelsea received written
confirmation from the FDA that the Company's NDA resubmission was deemed to be
a complete response to its CRL. The FDA later notified the Company of
deficiencies in the NDA that related primarily to the formatting of certain
submitted electronic datasets and statistical programs describing the methods
used to generate tables and listings. The deficiencies were unrelated to study
conduct, interpretability of study results, or validity of study conclusions.

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 Amyloid 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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