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news.NicOx has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of naproxcinod drug substance.
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The aim of this agreement is to secure commercial supplies of an appropriate scale to ensure the successful commercial launch of naproxcinod. The filing of a new drug application for naproxcinod with the FDA is projected for mid-2009.
Under the agreement, Archimica will supply naproxcinod active pharmaceutical ingredient (API) from Archimica’s FDA inspected site in Springfield, Missouri, making Archimica a significant component of NicOx’s supply chain for 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 the installation of dedicated equipment required to manufacture naproxcinod API.
Michele Garufi, chairman and CEO of NicOx, said: “With Archimica’s extensive manufacturing experience and history of producing APIs for the US and other major markets, NicOx is in a strong position to prepare the regulatory submissions and subsequent market launch of naproxcinod.”