SOPHIA ANTIPOLIS, France, March 19 /PRNewswire/ -- NicOx S.A. (Euronext Paris: COX) today announced it has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of naproxcinod drug substance (or active pharmaceutical ingredient, API). Naproxcinod is NicOx' lead investigational product and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents. The aim of this agreement is to secure commercial supplies of an appropriate scale to ensure the successful commercial launch of naproxcinod. The filing of a New Drug Application (NDA) for naproxcinod with the U.S. Food and Drug Administration (FDA) is projected for mid-2009.
Michele Garufi, Chairman and CEO of NicOx, declared: "We are very happy to have signed this agreement with Archimica, which is an essential step as we advance naproxcinod towards the market. With Archimica's extensive manufacturing experience and history of producing APIs for the U.S. and other major markets, NicOx is in a strong position to prepare the regulatory submissions and subsequent market launch of naproxcinod. We now have a large capacity producer, which is capable of supporting the high commercial potential of naproxcinod that has been suggested by our market research."
Under the agreement, Archimica will supply naproxcinod API from
Archimica's FDA inspected site in Springfield, Missouri, making Archimica a
significant component of NicOx' supply chain for naproxcinod. As per the
agreement, NicOx envisages the first deliveries of significant quantities
of commercial material being made from the fourth quarter of 2009 onwards,
following the installation of dedicated equipment required to manufacture
naproxcinod API. NicOx evaluated more than ten potential suppliers for the
manufacture of naproxcinod API, prior to the signature of this agreement
with Archimica, and may conclude agreements with up to two additional
|SOURCE NicOx S.A.|
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