Orexigen's ($OREX) frustration with regulators persists. After failing to sell the FDA on a new regulatory plan for its obesity drug Contrave, the San Diego-based biotech says today that it's putting its obesity programs in the U.S. on hold. On this news, the developer's stock was down more than 31 percent to $2.18 per share as of 11:02 am ET.
The firm met with the FDA after failing to gain approval of its experimental obesity pill in January because of concerns about potential cardiovascular risks to patients on the drug, an event that triggered layoffs at the company and a stock price meltdown. In its latest meetings with the agency, the firm wanted to know if it could seek approval for the drug in patients with low cardiovascular risk until data from a proposed study showed whether the drug is linked to cardiovascular problems. The agency's Division of Metabolic and Endocrinologic Products' (DMEP) answer was no. The firm plans appeal the response.
"The Orexigen team has been working for the last several months with leading experts in the field of cardiovascular outcome trials to develop and submit a proposal to DMEP that we believe would more than adequately address the question of theoretical CV risk," Michael Narachi, Orexigen's CEO, said in a statement. "We remain very disappointed in the stance of DMEP and the outcome of the recent meeting. We have serious concerns about the broader implications these actions may have on innovation in the obesity space and the availability of much needed treatment options for obese patients in the U.S."
This is another setback with regulators for Orexigen, which was denied approval earlier this year after a panel of experts backed its obesity pill in December. With its U.S. plans for the drug on hold, the firm says that it's going to increase efforts to develop its treatments abroad. This might be another of many marks in the loss column for developers of obesity drugs, which continue to be a tough sell at the FDA.
Editor's Note: This story was updated with information on Orexigen's stock price.
- here's the Orexigen's release
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