NovaBay expands marketing partnership with Pioneer Pharma for NeutroPhase in select Asian market

Emeryville, California Monday, September 17, 2012, 15:00 Hrs[IST] NovaBay Pharmaceuticals, Inc. has expanded its commercial partnership agreement with Shanghai-based, Naqu Area Pioneer Pharma Co., Ltd., a company that markets high-end pharmaceutical products into China, for the commercialization of NeutroPhase skin and wound cleanser in select Asian markets in addition to China.Under the terms of the agreement, NovaBay will receive an upfront payment of $500,000, with additional payments totaling $200,000 that may be triggered by certain milestones. In addition, Pioneer Pharma (Singapore) Pte Ltd., an affiliate of Naqu Area Pioneer Pharma Co., Ltd., has agreed to make a two-tranche equity investment in unregistered and untradeable NovaBay common stock that could reach $5.5 million. After an initial investment of $1.0 million immediately, plus another $1.5 million contingent on obtaining regulatory approval, for the issuance of units consisting of shares and warrants (a total of two million shares and warrants to purchase two million shares) in 2012, Pioneer has the option to invest up to another two million shares at $1.50 per share over the next twelve months upon exercise of the warrants.Developed by NovaBay, NeutroPhase is the only pure hypochlorous acid (HOCI) skin and wound cleanser cleared by the U.S. Food and Drug Administration (FDA) for the treatment of 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.Recently, NovaBay received an additional 510K clearance from the FDA for the use of NeutroPhase to moisten and debride graft and donor sites and to be administered through a new convenient spray pump."The expanded partnership with a premier marketing organization such as Pioneer Pharma opens up the opportunity for NovaBay to provide NeutroPhase in multiple emerging markets in Southeast Asia," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay. “The healthcare market in this region is growing rapidly with the change in lifestyle resulting in an increasing need for new medicines.We have invited Mr. XinZhou “Paul” Li, President of Pioneer, to be the Asia-Pacific Advisor to NovaBay’s Board of Directors.”“In fact, these areas represent the fastest growing diabetic and venous ulcer markets in the world,” continued Dr. Najafi. “This will allow for NovaBay to expand the marketing of NeutroPhase at an accelerated rate and provide these territories with a specialized wound cleanser that has been developed for the treatment of non-healing wounds.”“Our partnership with NovaBay continues to grow due to large unmet medical need NeutroPhase addresses in the Asian continent,” stated President of Pioneer, Mr. XinZhou “Paul” Li. “With the product profile NeutroPhase possesses, it has the capacity to satisfy the large market opportunity that Southeast Asia represents. Our sales and marketing organization is looking forward to launching NeutroPhase over the coming months.”Under the expanded five year agreement, NovaBay will continue to manufacture NeutroPhase in the United States and export the finished product to Pioneer’s subsidiary in Southeast Asia at a set transfer price. In addition to China, where regulatory approval to commence marketing is expected mid-2013, the agreement provides exclusive distribution of NeutroPhase in Hong Kong, Macau, Taiwan, Singapore, Malaysia, Indonesia, Myanmar, Philippines, Thailand, Vietnam, Brunei, Cambodia and Laos, where commercial launch in smaller selected markets is expected by the end of 2012 and others by 2014.The NovaBay will also assist in the training of Pioneer sales representatives and support Pioneer with Key Opinion Leader (KOL) development in the specific markets.NovaBay is currently seeking appropriate potential partners to distribute NeutroPhase in North America, Europe and South America.For more information, visit www.neutrophase.com.NeutroPhase Skin and Wound Cleanser is an FDA-cleared NovaBay proprietary preparation of normal saline containing stabilized pure hypochlorous acid (HOCl) as a preservative.Under the supervision of healthcare professionals it is intended for use in cleansing wounds as well as moistening and debriding acute and chronic lesions.HOCl is a bactericidal compound produced naturally by white blood cells to combat infection in the body.With its proprietary solution, NovaBay is targeting the six-million-patient US market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers.In laboratory studies, NeutroPhase was proven to disrupt bacterial biofilm and kill a range of pathogens including common wound pathogens (both Gram-positive and Gram-negative) in vitro, while leaving human cells unharmed.Extensive toxicology studies have demonstrated safety during application to skin and wounds.A 54 patient double blind investigator sponsored clinical study was conducted at San Francisco Wound Care Center of Seton Medical Center using a precursor formulation to NeutroPhase to moisten dressings in patients with diabetic ulcers, venous ulcers and bedsores.While these data have not been reviewed by the FDA, this formulation was shown to be as safe as dressings moistened with saline used for the control and the results suggested a superior healing rate.NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of products.