Chelsea presents Northera study data at International Congress on Parkinson's Disease and Movement Disorders

Jun 17 2010

• Clinical Review Highlights Neuroprotective Potential of Norepinephrine in Parkinson's Disease
• Northera, an Orally Available Norepinephrine Pro-drug, Significantly Improves Symptoms of Neurogenic Orthostatic Hypotension in Patients With Parkinson's Disease
• Over 25 Years of Research Support Cardiovascular Safety of Northera in Patient Population Characterized by Advanced Age and Significant Co-Morbidities

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that data from its pivotal studies of Northera™ (droxidopa) in symptomatic neurogenic orthostatic hypotension was presented during a poster session and featured in a symposium highlighting the role of norepinephrine (NE) deficiency in Parkinson's disease at the 14^th International Congress on Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.

A poster entitled, "Safety and Efficacy of Northera for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension (NOH) in Patients with Parkinson's Disease," detailed the results of a subgroup analysis of 44 patients with Parkinson's disease (PD) from Chelsea's pivotal efficacy study 302. Results from this subgroup analysis demonstrate that PD patients, all of whom were on concomitant Levodopa/dopa-decarboxylase inhibitors, showed the strongest therapeutic response to Northera, achieving highly significant improvements in the signs and symptoms of neurogenic orthostatic hypotension.

In addition to the poster session, Chelsea is sponsoring a symposium, featuring a panel of academic thought leaders and experts in the field of movement disorders, to review the role of norepinephrine in PD and therapeutic opportunities for Northera. The session will be moderated by Joseph Jankovic, MD, Baylor College of Medicine, Houston, TX, and Horacio Kaufmann, MD, New York University School of Medicine, New York, NY, and will include the following presentations:

PDF copies of the full poster and each symposium presentation will be available on Chelsea's website at www.chelseatherapeutics.com.

"Each year, thousands of clinicians and researchers gather at the Movement Disorder Society's International Congress of Parkinson's Disease and Movement Disorders," stated Dr. Simon Pedder, Chelsea's President and CEO. "We are pleased to have such experienced and distinguished thought leaders joining us in this forum to share new insight into the motor and non-motor dysfunction in Parkinson's disease, the critical role of norepinephrine in the pathophysiology of the disease and the therapeutic potential of our norepinephrine pro-drug, Northera."

Parkinson's disease is the second most common neurodegenerative disorder in America. As a result of decreased levels of norepinephrine associated with PD, up to an estimated 20% of these patients may experience NOH symptoms associated with the disease or as a complication of medication. NOH is a neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, and syncope. Symptoms of chronic NOH can be incapacitating -- not only putting patients at high risk for falls and associated injuries -- but also severely affecting the quality of life of patients and their loved ones, and generating significant health care costs. The only FDA-approved treatment for orthostatic hypotension has a black box warning indicating that the drug has not been shown to be effective in alleviating the symptoms of the condition and is associated with a pronounced side-effect profile including significant supine hypertension.