NovaBay Pharmaceuticals, Inc. (NYSE AMEX: NBY), a clinical-stage biotechnology company developing first-in-class “non-antibiotic anti-infective” products for the treatment and prevention of topical infections, today announced three new composition of matter patent issuances in Australia, New Zealand and Mexico and four Notices of Allowance in Canada, Japan, South Africa and Mexico on its proprietary Aganocide compounds which includes it lead compound, NVC-422.
NVC-422 is a broad-spectrum anti-bacterial, anti-viral compound with a novel mechanism of action to address the unmet medical needs in several large markets. Different topical formulations of NVC-422 are in mid-to-late-stage clinical development in ophthalmology, dermatology and urology. These newly issued patents will give composition-of-matter exclusivity for NVC-422 until August 2024 in Australia, New Zealand and Mexico. In addition, the Canadian and Japanese patent offices have given Notices of Allowance for the corresponding patent applications in those countries. NVC-422 is already covered in the United States by U.S. Patent Nos. 7,462,361 and 7,893,109 providing protection to 2026 in the US.
Ron Najafi, Chief Executive Officer of NovaBay Pharmaceuticals, states, “These seven new patents add to a portfolio of composition of matter patents already granted in the US. They not only validate the innovative nature of our science but also enable us to develop what we believe will be a powerful tool in the fight against highly drug-resistant infections. NVC-422 is now protected by its patents in the US until 2026 and 2024 elsewhere and can address major segments of the $100 billion global market for anti-infectives.”
In addition to NVC-422, these patents cover additional Aganocide compounds. These compounds have unique physicochemical properties and form the basis for a pipeline of non-antibiotic anti-infective compounds to treat topical infections.
For more information about NovaBay’s novel, anti-infective Aganocide compounds, please visit www.novabaypharma.com
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
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.
NovaBay’s first-in-class Aganocide compounds, led by NVC-422, are patented, synthetic molecules 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 possess a reduced likelihood that bacteria or viruses will be able to develop resistance, which is critical for advanced anti-infectives. Having demonstrated therapeutic proof-of-concept in Phase 2 clinical studies, these compounds are suited to treat and prevent a wide range of local, non-systemic infections. NovaBay is currently concentrated on three large therapeutic markets:
Dermatology – Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo. Current product offerings give rise to resistance. A major global clinical study is planned for 2012.
Ophthalmology – NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis, for which there is currently no FDA-approved treatment. Enrollment into a global Phase 2b clinical study has begun with top-line data expected in the first half of 2013.
Urology – NovaBay’s urinary catheter irrigation solution containing NVC-422 is currently in Phase 2 clinical studies, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The Company reported positive data from Part A of this study and expects to announce top-line results from Part B in the second half of 2012
NovaBay is also developing NeutroPhase, which is an FDA 510(k)-cleared product for advanced wound care. We believe that NeutroPhase is the only patented pure hypochlorous acid solution available and has the potential to be best suited to treat the six-million-patients in the U.S. who suffer from chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers.
For additional information, visit:.www.neutrophase.com
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Forward Looking Statements
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. Statements regarding NovaBay’s expectations including, but not limited to, (i) any potential plans for future clinical development of its Aganocide compounds and of bringing products to market including the expected timing of the initiation of the Phase 2b impetigo clinical trial and expected timing of the results of the Phase 2, Part B UCBE trial and Phase 2 conjunctivitis trial; (ii) the potential efficacy of Aganocide compounds; (iii) the development and potential benefits of, and the market opportunities for, NovaBay’s product candidates (iv) the potential to deliver the same or better efficacy than antibiotics and to address the growing problem of antibiotic resistance as well as other statements that relate to future events or results, are forward-looking. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse 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: inherent risks and uncertainties relating to difficulties or delays in conducting clinical trials; the inherent uncertainty of patent protection for the company’s intellectual property or trade secrets, risks and uncertainties relating to difficulties or delays in discovery, development, testing, production and marketing of the company’s product candidates; unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates; the company’s ability to obtain additional financing as necessary; and the risk of unexpected delays in the regulatory process which may delay the commencement or completion of clinical trials. Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay’s Quarterly Report on Form 10-Q for the period ended March 31, 2012, under the caption “Risk Factors” in Item 1A of Part II of that report, filed with the Securities and Exchange Commission on May 3, 2012. 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.
NovaBay Business Development and Licensing:
Roy J. Wu
Sr. VP Business Development
NovaBay Pharmaceuticals Contacts
Thomas J. Paulson
Chief Financial Officer
Contact Thomas Paulson
Investors and Media:
The Ruth Group
Joshua Drumm, PhD (Investors)
Victoria Aguiar (Media)