NDA is expected to be filed in mid-2009, while first major lots of API will be delivered in the fourth quarter of 2009.
NicOx signed an agreement with Archimica for the commercial manufacturing and supply of naproxcinod. The compound is in Phase III studies for osteoarthritis.
The goal is to secure commercial-scale quantities to ensure the successful launch of naproxcinod. NicOx expects to file an NDA in mid-2009. Archimica will supply naproxcinod API from its Springfield, MO, facility. NicOx says that the first deliveries of significant quantities of commercial material should be made from the fourth quarter of 2009 onwards. The firm adds that it may add two additional suppliers.
Naproxcinod is NicOx’ lead investigational product and belongs to the COX-inhibiting nitric oxide-donating class of anti-inflammatory agents. The Phase III trials are designed to demonstrate that it is safe, well tolerated, effective, and has no detrimental effect on blood pressure, in contrast to existing NSAIDs.
While NicOx plans to retain commercialization rights in the U.S. and some EU countries, the company says that it will look for partners in other regions.