Chelsea Therapeutics International Ltd. fell as much as 29 percent after failing to get the U.S. regulatory approval needed to bring its first drug to market.
The Food and Drug Administration wants more data on Northera, a medicine intended to treat a cause of dizziness and fainting in people with nervous-system disorders, Chelsea said in a statement yesterday. Chelsea tumbled 29 percent to $2.62 at the close in New York, the biggest single-day decline since Feb. 13.
The FDA requested information from an additional study of Northera, which can curb drops in blood pressure, Chelsea said. The Charlotte, North Carolina-based company said it’s conducting a clinical trial that may provide the additional data about the drug’s “efficacy and durability” sought by the FDA.
The trial “may not be sufficient for approval” because the FDA is likely to ask for more information about a range of symptoms instead of measuring only a decrease in falls, Robyn Karnauskas, an analyst with Deutsche Bank Securities in New York. wrote in a note to clients today.
Another trial may cause a two-year delay and lead to a late 2014 product introduction, assuming approval, Scott Henry, an analyst with Roth Capital Partners LLC in Newport Beach, California, wrote in a note to clients.
Black Box Warning
The agency also suggested that if the medicine were to gain approval, it may carry a so-called black box warning, the FDA’s strictest, related to a type of hypertension that could occur, the company said.
An FDA reviewer last month recommended against Northera’s approval, linking the therapy to a life-threatening neurological disorder and saying it wasn’t proven to work long term. A panel of outside advisers voted Feb. 23 in favor of the drug because few treatments exist for the blood-pressure drop known as neurogenic orthostatic hypotension.
“We believe there continues to be an important unmet medical need in addressing the symptoms associated with neurogenic OH and remain committed to working with the FDA to determine the appropriate next steps,” said Simon Pedder, the company’s president and chief executive officer, said in the statement.
About 180,000 patients in the U.S. suffer from the blood-pressure condition that leads to symptoms such as dizziness, becoming light-headed, blurred vision and fainting, Keith Schmidt, sales and marketing vice president for Chelsea, told analysts on a Nov. 2 conference call.
Available in Japan
Northera is available in Japan as part of a marketing agreement with Dainippon Sumitomo Pharma Co. and generates annual revenue of $50 million, Chelsea said on its website. The FDA is concerned that the drug has been associated with 28 reports of a life-threatening neurological disorder known as neuroleptic malignant syndrome in patients in Japan, agency reviewer Melanie Blank told advisers. The reports don’t contain enough detail to determine whether the condition is related to the drug, she said.
No incidents of the disorder have been reported in the company’s studies, Chelsea said in a Feb. 13 statement.