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Michele Garufi, Chairman and CEO of NicOx, declared: "We are very happy tohave signed this agreement with Archimica, which is an essential step as weadvance naproxcinod towards the market. With Archimica's extensivemanufacturing experience and history of producing APIs for the U.S. and othermajor markets, NicOx is in a strong position to prepare the regulatorysubmissions and subsequent market launch of naproxcinod. We now have a largecapacity producer, which is capable of supporting the high commercialpotential of naproxcinod that has been suggested by our market research."
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Under the agreement, Archimica will supply naproxcinod API fromArchimica's FDA inspected site in Springfield, Missouri, making Archimica asignificant component of NicOx' supply chain for naproxcinod. As per theagreement, NicOx envisages the first deliveries of significant quantities ofcommercial material being made from the fourth quarter of 2009 onwards,following the installation of dedicated equipment required to manufacturenaproxcinod API. NicOx evaluated more than ten potential suppliers for themanufacture of naproxcinod API, prior to the signature of this agreement withArchimica, and may conclude agreements with up to two additional suppliers.This is part of NicOx' strategy to maximize the commercial potential andeconomic value of naproxcinod, as NicOx owns the global development andmarketing rights to this compound. Going forward, NicOx will be looking forco-commercialization partnerships for naproxcinod, with NicOx retainingcertain commercialization rights in the U.S. and selected EU markets, in orderto fully exploit the drug's commercial and strategic value and to aid theCompany's planned transition to a fully integrated pharmaceutical business.
James Harrison, CEO of Archimica, declared: "We are very pleased to havethis opportunity to apply our expertise to the manufacturing of naproxcinodand are excited by the clear potential of this innovative product. We lookforward to continuing our work with the NicOx team, and leveraging ourmanufacturing experience to support their timely and successful launch ofnaproxcinod."
NicOx is developing naproxcinod in phase 3 clinical studies, which aredesigned to demonstrate that it is safe, well tolerated and effective fortreating the signs and symptoms of osteoarthritis, in addition to having nodetrimental effect on blood pressure, in contrast to existing Non-SteroidalAnti-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) fornaproxcinod is projected for mid-2009.
About Archimica
Archimica is a privately held pharmaceutical fine chemicals company ownedby TowerBrook Capital Partners and Aisling Capital Partners. Archimicacombines first-class chemical manufacturing assets, technologies and processdevelopment with a history of pharmaceutical commercialization that stretchesback over 40 years. With respect to new manufacturing projects, Archimica'sstrategy is focused on phase 2 and phase 3 clinical trial manufacturingopportunities for New Chemical Entities (NCEs) and this partnership with NicOxon naproxcinod is an important examp
