NeutroPhase is a U.S. Food and Drug Administration (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, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
"We are pleased to announce our partnership with Pioneer Pharma, whose sales network covers every province of Mainland China, including over 7,500 hospitals and 40,000 pharmacies," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. "We are also proud to be counted among Pioneer's strategic partners, which include several leading global pharmaceutical companies, including Alcon and Takeda."
"We are excited to partner with NovaBay for the sales and marketing of NeutroPhase in China," stated President of Pioneer, Mr. XinZhou "Paul" Li. "We believe NeutroPhase represents a significant advancement in the care of chronic non-healing wounds that translates into a large market opportunity here in China. Our 1,000+ member sales force is looking forward to launching the product."
Under the exclusive agreement, NovaBay will be responsible for preparation and submission of a Marketing Approval Application (MAA) for NeutroPhase, which will be reviewed by China's State Food and Drug Administration (SFDA). The MAA in China will be based on the data in the U.S. FDA 510(k) of NeutroPhase 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 commercialize or partner NeutroPhase in select Chinese markets not covered by the agreement, including Hong Kong, Macau, and Taiwan.
Dr. Najafi continued, "NeutroPhase is our first FDA-cleared commercial product and announcing our first strategic marketing partnership for NeutroPhase represents a significant milestone for the Company. As we continue to seek additional partners for NeutroPhase in global markets, we remain on track for potential commercialization of NeutroPhase in the United States in the first quarter of 2012."