Unveiling its financials for 2010, NicOx has revealed that it plans to appeal the US Food and Drug Administration's comprehensive rejection last summer of the painkiller naproxcinod.
The French biotech's prospects took a turn for the worse in July when the FDA issued a complete response letter for naproxcinod, which has been developed for the relief of the signs and symptoms of osteoarthritis. The rejection came as no surprise given that in May, the agency’s Arthritis Drugs and Drug Safety and Risk Management Advisory Committees voted 16 to one (with one abstention) that they did not have sufficient evidence to support the approval of naproxcinod.
The effect of that decision has been dramatic on NicOx which has cut its staff to 63 from 128 at the end of 2009 and closed its US headquarters. Nevertheless, the Sophia Antipolis-based firm still feels naproxcinod has a chance and will appeal the FDA decision in the first quarter of 2011, under the agency's Formal Dispute Resolution process. Analysts believe the chances of the rejection being overturned are mimimal.
NiCox is hoping for better news from the European Medicines Agency. The latter's Committee for Medicinal Products for Human Use will give its opinion by mid-2011, with the exact timing "depending on the interactions needed with the health authorities". The company is sounding out potential marketing partners for naproxcinod in Europe and the rest of the world, noting that it is "actively seeking appropriate M&A opportunities".
As for the financials, revenues reached 7.4 million euros, compared to 1.1 million euros in 2009, thanks to a licence payment received from Bausch & Lomb for the investigational glaucoma drug NCX 116, a nitric oxide-donating prostaglandin analogue. Net loss narrowed to 44 million euros from 60.4 million in 2009, and NicOx ended the year with 107.3 million euros in cash.