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FDA Panel Okays Chelsea Therapeutics' Neuro Drug Northera; Shares Up 70%

Shares of Chelsea Therapeutics International Ltd. (CHTP) rallied 70 percent in extended trade on Thursday after a Committee of the U.S. Food and Drug Administration gave a favorable verdict for its lead drug Northera.

The FDA Cardiovascular and Renal Drugs Advisory Committee recommended that Northera can be approved to treat symptomatic neurogenic orthostatic hypotension, or NOH - a rare, chronic and often debilitating drop in blood pressure on standing up, most often associated with Parkinson's disease.

The Panel voted 7-4 in favor of Northera to treat NOH in primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency, as well as non-diabetic autonomic neuropathy.

While the FDA is not bound by the recommendations of the Committee, its guidance will be considered when the Agency reviews the Northera New Drug Application. The FDA will take a final decision on the drug by March 28, 2012.

Recently, a review by FDA staff said Northera, known generically as droxidopa, questioned the risk-benefit profile of Northera, but left the outcome of the review to outside experts.

Neurogenic orthostatic hypotension, or NOH, results from a deficient release of norepinephrine, the neurotransmitter used by autonomic nerves to send signals to the blood vessels and the heart.

Northera is an orally active synthetic precursor of norepinephrine. In 2007, the drug was granted orphan drug status by the FDA for the treatment of symptomatic NOH and was granted orphan medicinal product designation by the European Medicines Agency, or EMA, for the treatment of patients with Pure Autonomic Failure, or PAF, and patients with multiple system atrophy, or MSA.

In Japan, Northera has been approved since 1989 and is marketed by Dainippon Sumitomo Pharma Co., Ltd.,

Though there is no FDA-approved treatment specifically for NOH, Shire Pharmaceuticals' Midodrine, approved in 1996, is currently the only FDA-approved therapy for the treatment of orthostatic hypotension.

Northera, in phase III trials dubbed 301 and 302, has demonstrated improvement in the symptoms of NOH. The drug has been found to be both safe and very well tolerated.

Chelsea also plans to file a supplemental new drug application intended to expand the future labeling of Northera in the U.S. to include the prevention of falls in NOH associated with Parkinson's disease, based on the results from 306A and 306B studies. Data from the 306B study is anticipated by the second quarter of 2012.

Chelsea is also studying Northera, alone and in combination with Carbidopa, for the treatment of fibromyalgia, a condition marked by chronic body pain and stiffness. Last December, Chelsea revealed positive results from a Phase II study for Northera, alone or in combination with carbidopa, for treating fibromyalgia.

CHTP is trading at $2.41, down $0.23 or 8.71%, on a volume of 3.6 million shares on the NYSE. In after hours, the stock gained $1.69 or 70.12%.

by RTT Staff Writer

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