NicOx signs agreement for commercial manufacture of naproxcinod drug substance

French biopharma company NicOx has signed an agreement with US fine chemical company Archimica for the commercial manufacture and supply of naproxcinod, NicOx's lead investigational product and the first compound in the COX-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-inflammatory agents.

The aim of the agreement is to secure commercial supplies of an appropriate scale to ensure the successful commercial launch of naproxcinod.

NicOx is developing naproxcinod in phase 3 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 existing Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The final pivotal phase 3 trials are ongoing (the 302 and 303 studies) and the filing of a New Drug Application (NDA) with the US FDA is projected for mid-2009.

Under the agreement, Archimica will supply naproxcinod API from Archimica's FDA-inspected site in Springfield, Missouri. 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 10 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 maximise the commercial potential and economic value of naproxcinod, as NicOx owns the global development and marketing rights to this compound.

Going forward, NicOx will be looking for co-commercialisation partnerships for naproxcinod, with NicOx retaining certain commercialisation rights in the US and selected EU markets, to exploit fully the drug's commercial and strategic value and to aid the company's planned transition to a fully integrated pharmaceutical business.

According to Michele Garufi, chairman and ceo of NicOx, the agreement with Archimica is an essential step in advancing 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," he said.

"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."