France-based drug developer NicOx has signed an agreement with Dutch life and materials sciences firm DSM for the manufacture and supply of naproxcinod, the former's lead investigational product, which recently achieved positive results in a third pivotal Phase III study in osteoarthritis patients.
Under the terms of the accord, DSM will manufature naproxcinod active pharmaceutical ingredient at its production site in Linz, Austria, to support the agent's launch. NicOx plans for the first deliveries being made from the fourth quarter of 2009. NicOx has ended its present API supply agreement with Archimica, due to "the importance of cost control in the current economic environment." The company notes that, at the point of termination, Archimica had met all milestones and was in full compliance with the contract.
"The latest positive results observed in the 111 and 303 studies support our confidence in naproxcinod's blockbuster potential," said Staffan Stromberg, vice president of technical development and operations at NicOx. "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," he added.
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