France's NicOx ($NCOX) suffered another big blow to its once-promising development program for naproxcinod, saying it would drop its European application for the anti-inflammatory treatment after an expert panel turned thumb's down on the one-time blockbuster hopeful. Soon after the announcement NicOx's shares, already badly battered by last year's rejection at the hands of the FDA, dropped 34 percent.
The FDA had serious issues with the safety of the non-steroidal anti-inflammatory painkiller. An expert committee voted 16 to 1 last year that the developer never made a successful case that the therapy, intended to succeed where Celebrex failed, did not raise blood pressure. That decision paved the way to a major restructuring the developer, which halved its workforce and abandoned its U.S. HQ.
The EU roadblock leaves NicOx in a precarious position, with one unnamed analyst telling Reuters that "it (naproxcinod) is dead. Now it will be wait-and-see what steps management will take next, how they could approach potential merger partners."
In its release, the biotech said it "is now evaluating its options for the potential further development of naproxcinod in Europe, together with its advisors and with Grupo Ferrer Internacional S.A. which has an option for rights to naproxcinod in certain European countries."
NicOx--which has had significant backing from the French government--does have several partnerships to bank on. Bausch & Lomb is partnered on a glaucoma treatment and Merck is collaborating with it as well. Reuters also notes that NicOx had $154 million in cash at the end of 2010. And then there's NicOx's appeal of the FDA rejection, which is a long shot at best.
- see the NicOx release
- take a look at the Reuters report