Designation for Droxidopa
Multi-Center Pivotal Phase III Trial Planned for Second Half 2007

- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced
today that the U.S. Food and Drug Administration (FDA) has granted
Orphan Drug designation to its drug candidate Droxidopa for the
treatment of symptomatic neurogenic orthostatic hypotension (NOH) in
patients with Primary Autonomic Failure, a group of diseases that
includes Parkinson's Disease, Pure Autonomic Failure (PAF) and
Multiple Systems Atrophy (MSA).
The Orphan Drug Act provides for economic incentives to encourage
the development of drugs for diseases affecting fewer than 200,000
people in the United States. Orphan Drug designation will entitle
Chelsea to seven years of market exclusivity for Droxidopa in the
treatment of symptomatic NOH. Additional benefits include tax
credits related to clinical trial expenses, a possible exemption
from the FDA-user fee, and assistance in clinical trial protocol
design.

"Because of the U.S. Orphan Drug Act, there are incentives for
companies like Chelsea to bring desperately needed drug therapies
like Droxidopa to underserved patients who suffer from neurogenic
orthostatic hypotension," said Dr. Horacio Kaufmann, the Alex and
Shirley Aidekman Professor of Neurology, Mount Sinai School of
Medicine and Director, Autonomic Disorders Research and Treatment
Program. "Given its clearly delineated mechanism of action,
extensive body of efficacy data and favorable safety reputation in
the Japanese market, Droxidopa will help improve the health and
quality of life for many patients with neurogenic orthostatic
hypotension."

Chelsea plans to initiate a double-blind pivotal Phase III trial
comparing Droxidopa to placebo at multiple sites in the U.S. and
Europe during the second half of 2007. The trial is intended to
assess the safety and efficacy of Droxidopa in patients suffering
from symptomatic NOH associated with Parkinson's Disease, Pure
Autonomic Failure and Multiple Systems Atrophy with the primary
efficacy endpoint being defined as improvement in orthostatic blood
pressure over time.

"Receiving this designation is an important step in both our
clinical development and planned commercialization of Droxidopa,
providing Chelsea with considerable strategic advantages by
providing market exclusivity, reducing clinical development costs
and facilitating future regulatory filings," said Dr. Simon Pedder,
President and Chief Executive Officer of Chelsea. "With 7-years of
exclusivity in place in the U.S. and 10-years in the EU, either
under Orphan designation or as a new chemical entity, we have
secured the necessary exclusivity to move aggressively ahead in our
planned development of Droxidopa. We are pleased to have reached
this critical milestone and look forward to working with the FDA to
finalize our trial design and initiate our pivotal Phase III study
later this year."

As part of its Orphan Drug strategy for Droxidopa, Chelsea also
filed an application for Orphan designation for the treatment of
symptomatic NOH in patients with Primary Autonomic Failure with the
EMEA. Based on the timing of this filing, Chelsea expects to receive
a determination regarding EU Orphan status late in the first quarter
2007.

About Droxidopa and Symptomatic Neurogenic Orthostatic Hypotension

Symptomatic 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. Droxidopa, an orally active
synthetic precursor of norepinephrine, increases the supply of
norepinephrine available for delivery to its receptors to improve
orthostatic blood pressure and alleviate symptoms of orthostatic
hypotension.

Chelsea estimates that nearly 300,000 patients suffer from chronic
symptomatic neurogenic orthostatic hypotension (NOH) in the U.S. and
EU combined. In the U.S. alone, there is a defined population of
approximately 72,000 patients that experience chronic, symptomatic
NOH associated with Primary Autonomic Failure, a group of diseases
that includes Parkinson's Disease, Pure Autonomic Failure and
Multiple Systems Atrophy.

In addition to creating significant health care costs, symptomatic
NOH has a dramatic impact on the quality of life for those patients
suffering from Primary Autonomic Failure. Midodrine, currently the
only FDA approved treatment for orthostatic hypotension, not only
fails to treat the underlying cause of symptomatic NOH but is
limited in its use by a pronounced side-effect profile and black box
warning for supine hypertension. Given the chronic nature of
symptomatic NOH and the proven safety and tolerability of Droxidopa,
Chelsea expects that daily oral treatment with Droxidopa should
provide a significant improvement in the long-term treatment of
symptomatic NOH.

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. Jan. 22, 2007(Chelsea
Therapeutics)