NicOx swings to a loss in 1st-qtr p R&D costs

French drugmaker NicOx SA swung to a loss of 13.0 million euros ($20.2 million) in the first quarter of 2008 from a profit of 1.8 million euros in the like, year period as operating costs reached 17.5 million euros from 10.1 million euros, mainly due to the ongoing Phase III studies for naproxcinod, its lead investigational drug for the treatment of the signs and symptoms of osteoarthritis.

The company ended the period with cash, cash equivalents and financial instruments of 153.7 million euros versus 201.2 million euros. Revenues totaled 1.4 million euros vs 8.7 million euros. The first quarter of 2007 was inflated by two milestone payments from US drug major Merck & Co and world drug giant Pfizer which were fully recognized during that period (Marketletter March 10).

In the first quarter of the year, NicOx initiated two large ambulatory blood pressure monitoring studies for naproxcinod in hypertensive patients with osteoarthritis. These two large clinical pharmacology trials in the USA will assess the blood pressure profile of naproxcinod in comparison to ibuprofen and naproxen, using the ABPM technique. These two trials are 12 and 16 weeks in duration and together are expected to recruit around 420 osteoarthritis patients with controlled hypertension. Results of both studies are expected in the forth quarter.