EMERYVILLE, CA and CARROS, FRANCE – May 28, 2013 — NovaBay Pharmaceuticals, Inc., (NYSE MKT:NBY), a clinical-stage biotechnology company focused on the topical, anti-infective market, today entered into a collaboration and license agreement with Virbac (NYSE Euronext: VIRP), a global veterinary product company. Virbac exercised its March 2012 Feasibility and Option Agreement, thereby acquiring exclusive worldwide rights to develop NovaBay’s proprietary compound, auriclosene (NVC-422), for global veterinary markets. NovaBay will receive an option exercise fee as well as development and pre-commercial milestone payments as a result of the collaboration. NovaBay also expects to receive royalties on the sale of any commercial products in the companion animal field. Virbac’s option exercise follows its extensive testing of auriclosene for veterinary uses during the 12-month option period.
“This agreement with Virbac is an important part of our strategy of exploring the uses of auriclosene for a variety of indications, including veterinary medicine,” said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay Pharmaceuticals. “We look forward to continuing our collaboration with Virbac as it conducts additional studies using auriclosene.”
Jean-Pascal Marc, Corporate Product Innovation Director of Virbac commented: “We are pleased to be using our decades-strong leadership in veterinary medicine to explore the development of NovaBay’s auriclosene in animal health uses. The agreement with NovaBay is in line with Virbac’s strategy of seeking innovative products which have the potential to create value and adapted to animal health market evolution.“
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
NovaBay Pharmaceuticals is a biotechnology company focused on addressing the large unmet therapeutic needs of the global, topical anti-infective market with its two distinct categories of compounds, Aganocides® and NeutroPhase® Skin and Wound Cleanser. The Company’s four core business units – DermaBay, UroBay, EyeBay and MediBay – are developing treatments that tackle infections in the dermatology, urology, ophthalmology, and wound care areas.
NovaBay’s first-in-class Aganocide compounds, led by auriclosene, are patented, topical antimicrobials with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides are not subject to bacterial or fungal resistance, which has been demonstrated in in vitro and in vivo studies. Having demonstrated clinical efficacy in Phase 2 proof-of-concept clinical studies, auriclosene is well suited to treat and prevent a wide range of local, non-systemic infections. NovaBay’s clinical development activities are focused on the following three disease areas:
Dermatology: Partnered with Galderma, a leading dermatology company, to develop a formulation of auriclosene for the treatment of highly contagious skin infection, impetigo, which occurs most commonly in children. Enrollment into a global Phase 2b clinical study has begun and clinical data results are expected in the second half 2013.
Ophthalmology: NovaBay is developing an eye drop formulation of auriclosene for treating adenoviral conjunctivitis, a highly contagious viral eye infection for which there is no approved treatment. Enrollment into a global Phase 2b clinical study has begun, and clinical data results are expected in the second half of 2013.
Urology: NovaBay’s urinary catheter irrigation solution containing auriclosene is currently in a Phase 2 study, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE). The Company reported positive data from an earlier part of an ongoing Phase 2 study and is evaluating the effect of an alternate more potent formulation of auriclosene. Results are expected mid-year.
Distinct from NovaBay’s Aganocides drug platform, NeutroPhase has been cleared by the U.S. Food and Drug Administration as a 510(k) medical device and is indicated as a skin and wound cleanser. NeutroPhase, which targets the 6 million-patient U.S. market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers, is the only pure hypochlorous acid solution available today. For additional information, visit: www.neutrophase.com.
Virbac (NYSE Euronext: VIRP) is one of the largest veterinary pharmaceutical companies in the world and is the first independent company worldwide dedicated exclusively to animal health. Founded in 1968 and headquartered in Carros, France, Virbac develops, manufactures and distributes a wide range of vaccines and medicines for the prevention and treatment of common pathologies in both companion and food-producing animals. With an operating presence on every continent and in more than 100 countries worldwide, Virbac offers a comprehensive range of products and services intended for veterinarians, farmers and animal owners. For more information about Virbac Animal Health and its products, please visit www.virbac.com.
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the expected timing of enrollment and commencement of clinical trials, expected timing of announcement of results of clinical studies, and expected future financial results. The words “continued,” “expected,” “will be,” “believe”, “expect”, “anticipate”, “would,” “planning” and other words (and all variations of these words that imply future events), identify these statements as forward looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company’s product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company’s intellectual property or trade secrets, the company’s ability to obtain additional financing as necessary and unanticipated research and development and other costs. These risks and others are detailed in NovaBay’s latest Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading “Risk Factors.” 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.
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NovaBay Pharmaceuticals, Inc.
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