Chelsea Therapeutics Receives FDA Guidance for a Northera(TM) (Droxidopa) NDA Resubmission With Study 306B

Chelsea Therapeutics Receives FDA Guidance for a Northera(TM) (Droxidopa) NDA
Resubmission With Study 306B

             *Company to Resubmit NDA in Late Second Quarter 2013

           *Short-term Clinical Benefit Adequate to Support Approval

             *Company to Host Conference Call Today at 9:00 AM ET

CHARLOTTE, N.C., Feb. 20, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq:CHTP) today announced that it has received written
guidance from the Director of the Office of New Drugs ("the Director") at the
U.S. Food and Drug Administration (FDA) stating that Study 306B has the
potential to serve as the basis for a resubmission of a Northera™ (droxidopa)
New Drug Application (NDA) for the treatment of symptomatic neurogenic
orthostatic hypotension (NOH). The guidance is in response to a formal appeal
by Chelsea to the Director, and follows a meeting with the Director and top
staff from the Office of Drug Evaluation I and Division of Cardiovascular and
Renal Products (DCRP) at the FDA's Center for Drug Evaluation and Research.

The guidance suggests that "data strongly demonstrating a short-term clinical
benefit (e.g., improvement in symptoms or ability to function) of droxidopa in
patients with NOH would be adequate for approval, with a possible requirement
to verify durable clinical benefit post-approval." It further notes that any
decision regarding the outcome of an FDA review, to be performed by the DCRP
will be based on the strength of Study 306B and its ability to provide
substantial evidence of effectiveness to support approval.

Based on this guidance, Chelsea plans to file a resubmission of the Northera
NDA with the DCRP in the late second quarter of 2013. If accepted by the
Division, the Company's application will be subject to a 6-month review

"We appreciate and are encouraged by FDA's willingness to consider data from
Study 306B in evaluating Northera for the treatment of NOH, and look forward
to submitting the totality of our clinical experience to date to the Agency
for review," said Joseph G. Oliveto, Interim Chief Executive Officer of
Chelsea. "We now have a regulatory path forward, including the potential for
an approval of Northera later this year."

Chelsea also intends to initiate a new clinical trial in the fourth quarter of
2013, given guidance regarding the potential need for Chelsea to verify the
durability of effect of Northera in a post-marketing study. This study would
also include short-term clinical endpoints should the Agency require an
additional clinical trial for the approval of Northera.

Chelsea recently reported that Study 306B demonstrated statistically
significant improvements for Northera compared to placebo in
dizziness/lightheadedness at week 1 (p=0.018), the primary endpoint, and
increase in standing systolic blood pressure at week 1 (p=0.032), an important
secondary endpoint. Treatment with Northera also resulted in a reduction in
patient falls and fall-related injuries, also secondary endpoints, although
the results were not significant. The safety data were consistent with
previous studies, and showed that Northera was well tolerated.

Conference Call Today at 9:00 AM ET

Chelsea will host a conference call to discuss the guidance today, February
20, at 9:00 AM Eastern Time. Interested investors may participate in the
conference call by dialing (877) 638-9567 (domestic) or (720) 545-0009
(international) and referencing conference ID number: 12612161. A replay will
be available for one week following the call by dialing (855) 859-2056 for
domestic participants or (404) 537-3406 for international participants and
referencing conference ID number: 12612161 when prompted. Participants may
also access both the live and archived webcast of the conference call on
Chelsea's web site at

About Northera

NORTHERA™ (droxidopa), the lead investigational agent in Chelsea Therapeutics'
pipeline, is currently in Phase III clinical trials for the treatment of
symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary
autonomic failure – a group of diseases that includes 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.

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

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 we will not be able to resubmit the NDA for Northera and that
the FDA will not approve a 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
         David Pitts
         Argot Partners

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