Firm will manufacture naproxcinod API out off Austria plant.
DSM has agreed to manufacture naproxcinod, the API in NicOx’ lead candidate. Recent positive results from a Phase III trial in osteoarthritis prompted NicOx to secure DSM as a commercial supply partner to support a successful launch. DSM will produce naproxcinod at its fine chemicals site in Linz, Austria.
In September, DSM inked a deal with Capsugel for the commercial manufacture of naproxcinod oral capsules. “The latest positive results observed in the 111 and 303 studies support our confidence in naproxcinod’s blockbuster potential,” states Staffan Strömberg, vp 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.”
NicOx envisages the first deliveries of significant quantities of commercial material being made from the fourth quarter of 2009. 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.
About a week ago, NicOx announced that the third pivotal Phase III study for naproxcinod in osteoarthritis of the hip had met all three coprimary efficacy endpoints. An NDA filing for naproxcinod is anticipated in mid-2009, according to the company.