NicOx S.A. has announced it has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of naproxcinod drug substance.
Naproxcinod is NicOx’ lead investigational product and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents. 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 (NDA) for naproxcinod with the U.S. Food and Drug Administration (FDA) is projected for mid-2009.
Michele Garufi, Chairman and CEO of NicOx, declared: “We are very happy to have signed this agreement with Archimica, which is an essential step as we advance naproxcinod towards the market. 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. We now have a large capacity producer, which is capable of supporting the high commercial potential of naproxcinod that has been suggested by our market research.”
Under the agreement, Archimica will supply naproxcinod API from Archimica’s FDA inspected site in Springfield, Missouri, making Archimica a significant component of NicOx’ 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.
NicOx evaluated more than ten potential suppliers for the manufacture of naproxcinod API, prior to the signature of this agreement with Archimica, and may conclude agreements with up to two additional suppliers. This is part of NicOx’ strategy to maximize the commercial potential and economic value of aproxcinod, as NicOx owns the global development and marketing rights to this compound.
Going forward, NicOx will be looking for co-commercialization partnerships for naproxcinod, with NicOx retaining certain commercialization rights in the US and selected EU markets, in order to fully exploit the drug’s commercial and strategic value and to aid the Company’s planned transition to a fully integrated pharmaceutical business.
James Harrison, CEO of Archimica, declared: “We are very pleased to have this opportunity to apply our expertise to the manufacturing of naproxcinod and are excited by the clear potential of this innovative product. We look forward to continuing our work with the NicOx team, and leveraging our manufacturing experience to support their timely and successful launch of naproxcinod.”