NovaBay(R) Pharmaceuticals, Inc. (NYSE AMEX:NBY), a clinical-stage biotechnology company, today announced it has entered into a commercial partnership agreement with Pioneer Pharma Co., Ltd., a Shanghai-based company that markets pharmaceutical products into China, for the commercialization of NeutroPhase in this territory. Under the terms of the agreement, NovaBay will receive an upfront payment of over $300,000, with the potential for additional payments totaling approximately $1 million that may be triggered by certain regulatory milestones pre commercial launch.
“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.”
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on addressing the unmet therapeutic needs of the global, topical anti-infective market.
NeutroPhase® is a 510(k)-cleared wound cleanser and is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material, including: microorganisms and debris from wounds; cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin; as well as moistening absorbent wound dressings. It is also intended for moistening and debriding acute and chronic dermal lesions, such as: Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, as well as grafted and donor sites.
About Pioneer Pharma Co., Ltd.
Shanghai-based Pioneer Pharma was founded in Hainan, China in 1996 and imports and markets high-end pharmaceutical products into China. Pioneer currently markets 27 different pharmaceutical products across a wide range of therapeutic categories on behalf of its strategic partners. The company has over 34 representative offices across China and covers over 7,500 hospitals and 40,000 drugstores. For more information, please visit www.pioneer-pharma.com.
Cautionary Information Regarding Forward-Looking Statements
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. The statements in this press release including, but not limited to, statements regarding NovaBay’s expectations on the value of NeutroPhase in the healing of chronic non-healing wounds; the potential commercialization of NeutroPhase in the United States in the first quarter of 2012 and potential outcome on NovaBay’s efforts to seek potential partners for NeutroPhase globally, as well as other statements that relate to future events or results are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward- looking statements reflect the views of the management of NovaBay as of the date of this press release and are based on assumptions and subject to significant risks and uncertainties (many of which are outside of NovaBay’s control), including: the risk that NovaBay’s Aganocide compounds and NeutroPhase may not prove to be effective in treating wounds; the risk that NovaBay may experience unexpected results in further studies which may limit, delay or prevent NovaBay from manufacturing NeutroPhase; unexpected adverse side effects or inadequate therapeutic efficacy of NeutroPhase may inhibit it from becoming a treatment for chronic wound and the risk of unexpected delays in the regulatory process which may delay the manufacturing and commercialization of NeutroPhase, as well as other risks relating to NovaBay and its Aganocide compounds detailed in NovaBay’s Quarterly Report on Form 10-Q, under the caption “Risk Factors” in Item 1A of Part II of that report, which was filed with the Securities and Exchange Commission on November 7, 2011. The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
Thomas J. Paulson
Chief Financial Officer
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