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news.NicOx, a biopharmaceutical company, has signed an exclusive agreement with Capsugel, a provider of two-piece capsules, for the commercial manufacturing and global supply of naproxcinod capsules.
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Under the terms of this exclusive agreement, Capsugel will be responsible for the formulation and encapsulation of naproxcinod active pharmaceutical ingredient (API), using its patented Lems technology. The manufacturing will be performed at one of Capsugel’s plants in France.
The aim of this agreement is to ensure sufficient supplies of naproxcinod capsules to underpin its successful commercial launch. The filing of a new drug application for naproxcinod with the FDA is projected for mid-2009.
The agreement with Capsugel follows the signature of an agreement for the commercial manufacture and supply of naproxcinod API with Archimica in March 2008.
NicOx is developing naproxcinod in Phase III clinical studies, which are designed to demonstrate that it is safe, well tolerated and effective for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to traditional non- steroidal anti-inflammatory drugs and Cox-2 inhibitors. The results of the third Phase III trial for naproxcinod are expected by the end of 2008.
Staffan Stromberg, vice president of technical development and operations at NicOx, said: “We believe Capsugel’s flexibility and production capacity is well adapted to NicOx’s launch preparations for naproxcinod. This agreement is also the result of the excellent collaboration between the two companies, in which Capsugel’s technology has been used in the production of naproxcinod clinical trial supplies.”