SOPHIA ANTIPOLIS, France, December 2 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced it has signed an agreement with DSM for the commercial manufacture and supply of naproxcinod drug substance (or API, active pharmaceutical ingredient). Naproxcinod is NicOx' lead investigational product and the first compound in the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents, which recently achieved positive results in the third pivotal phase 3 study in osteoarthritis patients.
Under the terms of the agreement, DSM will supply naproxcinod API for commercial purposes from its fine chemicals production site in Linz, Austria. DSM is one of the world's leading independent suppliers to the pharmaceutical industry, with some 40% of today's top-selling medicines in the world containing ingredients developed and produced by DSM. This follows the signature of an agreement with Capsugel in September 2008 for the commercial manufacture of naproxcinod oral capsules, which is widely recognized as the world leader in capsule manufacturing.
Staffan Stromberg, Vice President of Technical Development and Operations at NicOx, commented: "The latest positive results observed in the 111 and 303 studies support our confidence in naproxcinod's blockbuster potential. We are therefore very pleased to have signed these contracts with global leaders in high capacity API and capsule production. We project these agreements should cover the high sales forecasts for the initial years of naproxcinod's commercialization that have been suggested by our market research."
The agreement with DSM aims to secure commercial supplies of an
appropriate scale to support the successful launch of 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.
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