NovaBay Pharmaceuticals has entered into a commercial partnership agreement with Pioneer Pharmainto for the commercialisation of NeutroPhase in China. As part of the agreement, NovaBay will receive an upfront payment of approximately US$300,000, with the potential for additional payments totalling approximately US$1 million that may be triggered by certain regulatory milestones relating to commercial launch.
NeutroPhase is an FDA-cleared wound cleanser developed by NovaBay to promote healing and improve clinical outcomes for patients with chronic non-healing wounds, including Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, postsurgical wounds, first and second degree burns, abrasions and minor irritations of the skin. A US launch is expected to take place during the first quarter of 2012.
NovaBay will be responsible for preparation and submission of a marketing application for NeutroPhase, which will be reviewed by China's State FDA. The data for this submission will be based on that included within the US FDA 510(k) application and NovaBay does not expect the SFDA will require further clinical testing for approval. NovaBay will export NeutroPhase finished product to Pioneer for sale in Mainland China following its expected approval. NovaBay has retained rights to commercialise or partner the product in selected markets not covered by the agreement, including Hong Kong, Macau and Taiwan.