CHARLOTTE, N.C. (AP) - Chelsea Therapeutics International Ltd. reported a wider fourth-quarter loss Wednesday as it continued development of its hypotension drug candidate Northera.
Chelsea Therapeutics does not have any products on the market, and it did not report any revenue. The company is preparing to file for Food and Drug Administration approval of Northera, and hopes to launch the drug in early 2012.
Northera is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure on standing. The FDA plans to conduct an expedited six-month review of the company's marketing application, and if the drug is approved, it will receive extended market exclusivity.
Chelsea Therapeutics said its research and development costs climbed to $10.2 million from $4 million. It said development of Northera, along with initial manufacturing and validation of the active ingredient in the drug, and a mid-stage trial of a rheumatoid arthritis drug were the causes of the increase in spending.
The active ingredient in Northera is droxidopa. Chelsea Therapeutics is also studying droxidopa as a treatment for fibromyalgia, a chronic disease that causes muscle pain and fatigue.
http://www.canadianbusiness.com/markets/market_news/article.jsp?content=D9LNCBS80
Chelsea Therapeutics does not have any products on the market, and it did not report any revenue. The company is preparing to file for Food and Drug Administration approval of Northera, and hopes to launch the drug in early 2012.
Northera is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure on standing. The FDA plans to conduct an expedited six-month review of the company's marketing application, and if the drug is approved, it will receive extended market exclusivity.
Chelsea Therapeutics said its research and development costs climbed to $10.2 million from $4 million. It said development of Northera, along with initial manufacturing and validation of the active ingredient in the drug, and a mid-stage trial of a rheumatoid arthritis drug were the causes of the increase in spending.
The active ingredient in Northera is droxidopa. Chelsea Therapeutics is also studying droxidopa as a treatment for fibromyalgia, a chronic disease that causes muscle pain and fatigue.
http://www.canadianbusiness.com/markets/market_news/article.jsp?content=D9LNCBS80
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