NicOx's attempt to get regulators to agree that it has made a safe non-steroidal anti-inflammatory drug ran into a wall of doubt yesterday afternoon as a panel of FDA experts voted 16 to 1 to recommend against an approval. The overwhelming majority agreed with staffers at the FDA who had earlier pointed out that the French biotech had not offered solid evidence to prove that its painkiller naproxcinod did not raise blood pressure.
The committee vote spooked the biotech's investors, who bolted for the exits on the decision, which is not binding but is likely to prove extraordinarily persuasive to regulators as they make the final decision. NicOx shares suffered heavily, plunging up to 55 percent at one point before pulling back to a 39 percent slide.
Naproxcinod was supposed to offer the kind of pain relief that could be seen in Celebrex and Vioxx, without the link to strokes and heart attacks that had turned the field into a legal minefield. The FDA now has to July 24 to make its decision, but there's no question how the smart money will bet on that outcome.
"What was supposed to be the most important day in the company's history ended in what we can only describe as a debacle," commented Societe Generale biotech analyst Rodolphe Besserve. A long-term study to overcome the doubts of the skeptics could take years, he added, and probably wasn't worth the expense. NicOx is also seeking a European approval.
- here's the Bloomberg report