SOPHIA ANTIPOLIS, France—NicOx's naproxcinod, the first in a new class of anti-inflammatory agents known as CINODs (Cyclooxygenase- Inhibiting Nitric Oxide Donators), is now being reviewed by the U. S. Food and Drug Administration (FDA) for for treatment of osteoarthritis (OA).

In anticipation that naproxinod will be approved and will be a major competitor in the growing OA market, NicOx has launched a $149 million fundraising effort.

The French government has signed on and is investing 25 million euros in Paris-based NicOx through a new fund set up “to assist key industries during the financial crisis.” The company is also expected to launch a new round of talks with potential U.S. partners for the drug.

Based on the Prescription Drug User Fee Act (PDUFA), the FDA is expected to complete review in late July 2010.

"Thanks to these additional financial resources, NicOx will be able to significantly advance the launch preparations for naproxcinod, including the optimization of the commercial supply chain," Chief Executive Michele Garufi said in a statement. A European marketing application is expected soon.

NicOx submitted the NDA following the successful completion of three pivotal phase 3 studies. The naproxcinod NDA application is supported by data from 34 clinical trials that involved more than 4,000 subjects. During clinical trials the researchers paid particular attention to the drug's effect on blood pressure.

Philippe Serrano, Vice President Regulatory Affairs at NicOx, said, “We believe that when approved