Chelsea Announces Publication of Clinical Autonomic Research Supplement Focusing On Neurogenic Orthostatic Hypotension

Chelsea Announces Publication of Clinical Autonomic Research Supplement Focusing On Neurogenic Orthostatic Hypotension

Publication Highlights Efficacy of Droxidopa in Key European and U.S. Trials and Provides Insight Into Initial Market Opportunity

CHARLOTTE, N.C., April 22, 2008 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that Clinical Autonomic Research, the official peer reviewed journal of the American Autonomic Society, Clinical Autonomic Research Society and European Federation of Autonomic Societies, has published a special supplement detailing the pathophysiology, prevalence and treatment of neurogenic orthostatic hypotension (NOH).

This supplement features five articles by a distinguished group of thought leaders in the field of autonomic research and includes two articles detailing the results of prior clinical trials demonstrating the safety and efficacy of Droxidopa in the treatment of NOH.

"By highlighting the causes, severity and prevalence of neurogenic orthostatic hypotension, the comprehensive data contained in this supplement underscores the potential of droxidopa and significant market opportunity for Chelsea in this indication," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "We estimate that of all the Parkinson's patients with NOH, close to half are symptomatic and eligible for treatment with Droxidopa. In light of all the prevalence data and given the compelling data supporting the activity of Droxidopa in Parkinson's patients on dopamine decarboxylase inhibitors, we believe that with modest penetration into this market Droxidopa could reach steady-state sales of $200-$250 million within 3-5 years of launch in neurogenic orthostatic hypotension alone."

Droxidopa is currently the subject of a multi-national pivotal Phase III program, which includes a Special Protocol Assessment (SPA), to support an application for U.S. marketing approval in NOH. Additionally, Droxidopa is being evaluated in an ongoing Phase II trial in intradialytic hypotension and will be the subject of a planned Phase II trial in fibromyalgia later this year. Chelsea also continues to explore additional potential indications where decreased norepinephrine function may play a significant role and Droxidopa may be a promising therapeutic. The FDA has not yet reviewed the safety and efficacy of Droxidopa.

This supplement, edited by Dr. Horacio Kaufmann, was supported by an unrestricted educational grant from Chelsea. Copies of this supplement are available for download from the American Autonomic Society website: http://www.mc.vanderbilt.edu/gcrc/aas/CAR/NOH%20Supplement/NOH%20Supple ment.html

About Droxidopa and Symptomatic Neurogenic Orthostatic Hypotension (NOH)

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.

In addition to creating significant health care costs, symptomatic NOH has a dramatic impact on the quality of patient life. 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.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by the development of the I-3D portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.

This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.

CONTACT: Chelsea Therapeutics International, Ltd. Nick Riehle, Chief Financial Officer 704-341-1516 x101 Investor/Media Relations Kathryn McNeil 718-788-2856

 

Posted: April 2008

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