SOPHIA ANTIPOLIS, France, September 23 /PRNewswire-FirstCall/ -- NicOx S.A. (Euronext Paris: COX) today announced it has signed an exclusive agreement with Capsugel, the 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 (CINOD) class of anti-inflammatory agents. The aim of this agreement is to ensure sufficient supplies of naproxcinod capsules to underpin its successful commercial launch. The filing of a New Drug Application (NDA) for naproxcinod with the U.S. Food and Drug Administration (FDA) is projected for mid-2009.
The agreement with Capsugel follows the signature of an agreement for the commercial manufacture and supply of naproxcinod active pharmaceutical ingredient (API) with Archimica in March 2008. NicOx recently announced the results of the second pivotal phase 3 study for naproxcinod in patients with osteoarthritis of the knee (the 302 study, see NicOx press release of September 15th, 2008). This study met all three of its co-primary efficacy endpoints and supported naproxcinod's non-detrimental effect on blood pressure.
Staffan Stromberg, Vice President of Technical Development and Operations at NicOx, said: "We are very happy to have concluded this agreement with Capsugel, which is recognized as the world leader in capsule manufacturing. We believe Capsugel's flexibility and production capacity is well adapted to NicOx' launch preparations for naproxcinod. This agreement is also the result of the excellent collaboration between the two companies, in which Capsugel's technology has been used in the production of naproxcinod clinical trial supplies."
Under the terms of this exclusive agreement, Capsugel will be
responsible for the formulation and encapsulation of naproxcinod API, using
its patented LEMS(TM) technology (Liquid Encapsul
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