NicOx signs agreement for the commercial manufacture of naproxcinod drug substance

20-Mar-2008

NicOx S.A. announced it has signed an agreement with the fine chemical company Archimica, for the commercial manufacturing and supply of naproxcinod drug substance (or active pharmaceutical ingredient, API). 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.

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 naproxcinod, 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.

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) for naproxcinod is projected for mid-2009.

https://www.bionity.com/en/news/79894/nicox-signs-agreement-for-the-commercial-manufacture-of-naproxcinod-drug-substance.html