NicOx in manufacturing deal with Capsugel

France's NicOx has signed an exclusive agreement with Capsugel, a leading producer of two-piece capsules, for the commercial manufacturing and global supply of naproxcinod capsules. Naproxcinod is NicOx' lead investigational product and the first compound in the cyclooxygenase-inhibiting nitric oxide-donating class of anti-inflammatory agents. The aim of this deal is to ensure sufficient supplies of naproxcinod capsules to underpin its successful commercial launch. The filing of a New Drug Application for the drug with the US Food and Drug Administration is projected for mid-2009.

The accord with Capsugel follows the signature of an agreement for the commercial manufacture and supply of naproxcinod active pharmaceutical ingredient with Archimica in March 2008. NicOx recently announced the results of the second pivotal Phase III study for naproxcinod in patients with osteoarthritis of the knee. The study met all three of its co-primary efficacy endpoints and supported naproxcinod's non-detrimental effect on blood pressure.