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Chelsea Therapeutics Shares Soar 36% On Accelerated FDA Approval For Northera

Shares of Chelsea Therapeutics International Ltd. (CHTP: Quote) sky rocketed nearly 36 percent in extended trading on Tuesday after the U.S. Food and Drug Administration granted accelerated approval for Northera (droxidopa) as treatment of symptomatic neurogenic orthostatic hypotension or NOH.

"The approval of NORTHERA is an extraordinary achievement, one for which I thank patients and their families, investigators and the medical community, our partner Dainippon Sumitomo, and our employees," President and CEO Joseph Oliveto said in a statement.

"We will now turn our efforts towards delivering NORTHERA to patients with NOH in the United States, an important goal we expect to achieve in the second half of the year," Oliveto added.

Northera, an orally active synthetic precursor of norepinephrine, is the first and only FDA approved therapy that demonstrates symptomatic benefit in patients with symptomatic NOH. It is also the first new treatment option for symptomatic NOH in nearly two decades.

The FDA panel voted 16-1 to recommend approval of Northera in mid-January for treatment of symptomatic NOH.

The Northera approval was granted under the FDA's accelerated approval program, which facilitates the fast track review of products that address serious or potentially life-threatening conditions for which there is an unmet medical need, provided additional confirmatory studies are conducted.

Northera is indicated for the treatment of symptomatic NOH in adult patients with orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" caused by primary autonomic failure (Parkinson's disease, multiple system atrophy and pure autonomic failure), dopamine beta hydroxylase deficiency and non-diabetic autonomic neuropathy.

Symptomatic NOH is an autonomic nervous system disorder caused by failure to produce and or release adequate amounts of norepinephrine upon standing. Norepinephrine deficiency results in an inability for a person to maintain adequate blood pressure and blood flow to the brain when upright, frequently resulting in dizziness, lightheadedness, blurred vision, fatigue, poor concentration and fainting episodes. The disorder affects an estimated 80,000 to 150,000 individuals in the U.S.

The company resubmitted the Northera NDA on July 9 that which included data from an additional study, after it was issued a complete response letter in March to submit additional clinical efficacy data.

The resubmitted NDA was accepted by the FDA and was assigned a a Prescription Drug User Fee Act or PDUFA goal date of February 14, when it was reviewed by the Cardiovascular and Renal Drug Advisory Committee.

Northera was earlier granted Orphan Drug Designation and received Fast Track designation from the FDA.

Droxidopa was initially developed by Dainippon Sumitomo Pharma Co., Ltd. (DSP) and first commercialized in Japan in 1989. Chelsea then acquired global development and commercialization rights to droxidopa or Northera from Dainippon in 2006, excluding Japan, Korea, China and Taiwan.

CHTP closed Tuesday's regular trading session at $4.95, up $0.22 or 4.65% on a volume of 14.56 million shares. The stock soared a further $1.77 or 35.66% in after-hours trading.

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by RTT Staff Writer

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