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news.NicOx, a biopharmaceutical company, has signed an agreement with DSM, a life science and materials sciences company, for the commercial manufacture and supply of naproxcinod drug substance.
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Under the terms of the agreement, DSM will supply naproxcinod active pharmaceutical ingredient (API) for commercial purposes from its fine chemicals production site in Linz, Austria. This follows the signature of an agreement with Capsugel in September 2008 for the commercial manufacture of naproxcinod oral capsules.
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.
Naproxcinod is NicOx’s lead investigational product and the first compound in the cyclooxygenase-inhibiting nitric oxide-donating class of anti-inflammatory agents, which recently achieved positive results in the third pivotal Phase III study in osteoarthritis patients.
Luca Mantovani, president and business unit director at DSM Pharma Chemicals, said: “We are happy to consolidate our relationship with NicOx through this agreement. Naproxcinod is an exciting compound and being part of its pre-launch and future commercialization plans is an interesting opportunity for DSM.”