FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' NORTHERA(TM) (Droxidopa) for the Treatment of Symptomatic nOH

FDA Advisory Panel Recommends Approval of Chelsea Therapeutics' NORTHERA(TM)
(Droxidopa) for the Treatment of Symptomatic nOH

CHARLOTTE, N.C., Jan. 14, 2014 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today announced that the Food and Drug
Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee
(CRDAC) voted 16-1 to recommend approval of NORTHERA™ (droxidopa) 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 is not bound by the CRDAC's recommendation but will take it into
consideration when reviewing the New Drug Application (NDA) for Northera. A
Prescription Drug User Fee Act (PDUFA) action date for the Northera NDA has
been scheduled for February 14, 2014.

"Chelsea is committed to improving the lives of patients with nOH, a
debilitating disorder which often severely limits a person's ability to
perform routine daily activities," said Joseph G. Oliveto, Interim Chief
Executive Officer of Chelsea Therapeutics. "We are appreciative of the FDA
bringing our Northera NDA before the Cardiovascular and Renal Drugs Advisory
Committee, and for the Committee's thoughtful discussion of the application."

Northera was previously granted Orphan Drug Designation, which is granted by
the FDA to treatments for rare diseases/disorders.

About Symptomatic nOH

It is estimated that nearly 300,000 patients suffer from chronic symptomatic
nOH in the U.S. and EU combined. Symptomatic nOH is a chronic disorder that is
caused by an underlying neurogenic disorder, such as Parkinson's disease,
multiple system atrophy or pure autonomic failure. Symptoms of nOH include
dizziness, lightheadedness, blurred vision, fatigue, poor concentration, and
fainting episodes when a person assumes a standing position. These symptoms
often severely limit 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
acquired global development and commercialization rights to droxidopa
(L-DOPS), or NORTHERA, from Dainippon Sumitomo Pharma Co., Ltd. in 2006,
excluding Japan, Korea, China and Taiwan. 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 Study 401 or any other
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; the
risk that we will not be able to obtain regulatory approvals of droxidopa or
our other drug candidates for additional indications; the 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: Media:
         David Connolly
         LaVoie Group
         617-543-3915
         dconnolly@lavoiegroup.com
        
         Investors:
         Fara Berkowitz / Susan Kim
         Argot Partners
         212-600-1902
         fara@argotpartners.com
         susan@argotpartners.com

Chelsea Therapeutics Logo
 
Press spacebar to pause and continue. Press esc to stop.