NicOx signs agreement with DSM for the commercial manufacture of naproxcinod drug substance

03-Dec-2008 - Austria

NicOx S.A. 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.

Staffan Strömberg, 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. Following this agreement with DSM and the importance of cost control in the current economic environment, NicOx has ended its present API supply agreement with Archimica. At the point of termination, Archimica had met all contract milestones and was in full compliance with the other terms of the contract.

https://www.bionity.com/en/news/90905/nicox-signs-agreement-with-dsm-for-the-commercial-manufacture-of-naproxcinod-drug-substance.html