Fresh from having its pain product naproxcinod rejected by regulators in the USA, NicOx has posted its financial results for the first six months of 2010 which show that the French biotech is still in a reasonable state, cashwise.
Revenues reached 7.4 million euros, compared to 1.1 million euros, thanks to a licence payment received Bausch & Lomb for the investigational glaucoma drug NCX 116, a nitric oxide-donating prostaglandin analogue. Net loss for the period has deepened by 300,000 euros to 27.5 million euros.
Operating expenses were up 11.3% to 36.4 million euros, which NicOx said correspond principally to personnel costs related to the regulatory processes for naproxcinod both in the USA and Europe. However they also include costs related to “the anticipated cancellation of certain manufacturing and pre-commercial activities” following the US Food and Drug Administration’s decision earlier this month to reject naproxcinod for the relief of the signs and symptoms of osteoarthritis.
Observers are now waiting to see how NicOx recovers from that blow and chief executive Michele Garufi said the firm will continue working with regulators on both sides of the Atlantic. The European Medicines Agency is expected to deliver its verdict on naproxcinod by mid-2011.
The FDA recommended conducting “one or more” long-term controlled studies to assess the cardiovascular and gastrointestinal safety of naproxcinod, and the Sophia Antipolis-based company said it will “actively seek to enter into partnerships” that could help fund such trials. Chief financial officer Eric Castaldi declared that NicOx has a strong cash position (128.4 million euros) “with no long-term debt and …we will continue to ensure careful conservation of our funds”.