NicOx S.A. has signed an agreement with
Archimica for the commercial manufacturing and supply of naproxcinod API. Naproxcinod is NicOx's lead candidate in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents. NicOx expects to file a NDA for naproxcinod with the FDA mid-2009.
Michele Garufi, chairman and chief executive officer of NicOx, said, "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 U.S. 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 that 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, MO, making Archimica a significant component of NicOx's supply chain for the drug. NicOx anticipates the first deliveries of significant quantities of commercial material being made from 4Q09 onwards, following the installation of equipment required for its manufacture. As part of the strategy to maximize the commercial potential of naproxcinod, the company may sign agreements with two additional suppliers. Going forward, NicOx will be looking for co-commercialization partnerships for naproxcinod, while retaining certain commercialization rights in the U.S. and selected EU markets.
James Harrison, chief executive officer of Archimica, said, "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."
Naproxcinod is in Phase III studies designed to demonstrate safety and efficacy for treating the signs and symptoms of osteoarthritis, in addition to having no detrimental effect on blood pressure, in contrast to existing therapies.
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