FDA staffers gave NicOx's naproxcinod a clean bill of health for safety and efficacy for patients with rheumatoid arthritis, but they raised some serious questions about the relative blood pressure benefits the experimental pain therapy could deliver for patients. And with the French biotech company looking to compete in a crowded field of generics, the documents--undercutting its main claim to blockbuster status--caused a number of analysts and investors to lose heart, sending shares of the developer down 25 percent.
NicOx (NASDAQ: NCOX) will attempt to make a case to the agency panel that naproxcinod is a better version of naproxen, a non-steroidal anti-inflammatory drug that is linked to higher blood pressure and stomach ailments. But regulators, who frequently lay out challenges for developers ahead of a panel meeting, said the drug's effect on cardiovascular risk was uncertain.
Dr. Bob Rappaport, the director of the division of anethesia and analgesia products, summed up the staff position by saying that NicOx's documents don't support its claims of comparative benefits to naproxen.
"We believe the documents raise too many questions for the product to receive a favorable label," said Piper Jaffray analyst Sam Fazeli, sending a note of alarm that helped trigger the rapid loss in share value. The FDA panel will meet tomorrow, and NicOx plans to suspend trading in its stock during the discussion.
NicOx is attempting to gain its first approval in the U.S. and, as a result, trading in the developer's shares has been volatile. The share price had risen by half since February, and the panel's decision is likely to trigger a big, immediate swing--up or down.