NicOx has posted a rise in revenues for the first quarter but all eyes are now on a meeting this week which will decide whether the French biotechnology group’s anti-inflammatory naproxcinod is deemed approvable in the USA.

Figures-wise, revenues reached 7.4 million euros compared to 400,000 euros for the corresponding period of 2009. The leap is due to a licence payment received from Bausch & Lomb for the investigational glaucoma drug NCX 116, a nitric oxide-donating prostaglandin analogue.

Operating expenses were 16.2 million euros in the first quarter of 2010, up 18.2%, due principally to the regulatory submissions for naproxcinod in the USA and in Europe and to “investment expenses” in the supply chain for the drug which has been filed for osteoarthritis. Losses for the period were 7.2 million euros, down 55.5%, and at the end of the quarter, NiCox had cash and equivalents of 138.5 million euros.

The US Food and Drug Administration’s Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee are meeting on May 12 to discuss the New Drug Application for naproxcinod. Expectation is high about the treatment, the first in a new class of drugs known as CINODs (COX-inhibiting nitric oxide-donators) and if the FDA’s panellists recommend it, NiCox will hope to sign up a partner and start the process of turning naproxcinod into a blockbuster.

Naproxcinod is an improved version of naproxen, a non-steroidal anti-inflammatory drug that can increase blood pressure and cause stomach problems. Data has shown that the NiCox drug can reduce these problems but some analysts fear that in terms of pain reduction, the levels are similar to naproxen, which is available generically and is very cheap.

NiCox is confident, however, and chief financial officer Eric Castaldi says “we are increasingly investing in the activities of our commercial affairs team in Warren, New Jersey" ahead of a possible launch.