Business News

NovaBay Announces Advancements In Dermatology Program

2008-07-17 06:24:00

AgaDerm™ Formulation Shown

To Be Effective In Established Antifungal Model

EMERYVILLE, Calif.–(EMWNews)–NovaBay Pharmaceuticals, Inc. (AMEX: NBY) a clinical stage

biopharmaceutical company, gave more details today on its dermatology

program. Dr. Ron Najafi, Chairman and CEO, said that NovaBay

is now accelerating its efforts in dermatology. We formed our DermaBay

subsidiary in 2007, to build up our expertise and move forward in

dermatology. Our Aganocide® compounds have

appeared all along to be of significant potential interest in

dermatology, but we needed to deliver the compounds in acceptable

dermatological formulations. We now have the necessary capabilities to

proceed with product development in dermatology.

Dr. Eric Memarzadeh, Senior Director, Pharmaceutical Development,

explained that as a result of work done over the last year, NovaBay has

succeeded in developing several pharmaceutical formulations of Aganocide

compounds for use in its programs, including some that are specifically

designed for use in dermatology. One formulation, known as AgaDerm,

had been tested in a challenging animal model of dermatophyte infection.

The AgaDerm formulation delivered an Aganocide compound effectively when

applied on the surface of the skin and enhanced its penetration into

hair follicles. The infectious agent was a dermatophyte, Trichophyton

mentagrophytes,

a parasitic fungus that causes infections of the nails, hair and skin,

including ringworm. The Aganocide compound in the AgaDerm formulation

was shown to be highly effective not only on the skin surface, but also

showed potent ability to kill organisms invading the hair. It was equal

or greater in antifungal efficacy to ciclopirox 8% (Sanofi-Aventis,

Penlac®), a standard and well established

topical antifungal agent that is also sold as a 0.77% gel and as a 1%

shampoo by Medicis (Loprox®).

Colin Scott, M.D., Vice-President of Clinical Research and Development,

explained that NovaBay was now optimizing the concentration to be used

for clinical studies. He said that NovaBay will complete the necessary

IND-enabling toxicology studies before beginning a Phase I study. He

added that other NovaBay Phase I studies in humans had already

demonstrated the safety in humans of the compound in nasal passages and

in the bladder.

Dr. Najafi said that he was very satisfied with the way that the program

was proceeding and that he has appointed Jack OReilly

as General Manager of DermaBay to manage the companys

strategic development in dermatology.

Mr. OReilly, who also continues as SVP

Corporate and Business Development for NovaBay, pointed out that there

were several important potential target indications in dermatology. He

said that with the growth of antibiotic

resistance, many health authorities aim to reduce the use of antibiotics

in skin infections. Patients with these infections still need treatment.

The Aganocide compounds, which are not antibiotics, are expected to

deliver the same or better efficacy without giving rise to resistant

bacteria. We also aim to address acne, nail fungus and topical viral

infections, where antibiotics are not effective. In laboratory testing,

we have shown that our Aganocide compounds kill all bacteria, fungi and

viruses against which they have been tested. DermaBay aims to bring to

market products for all indications where the Aganocide compounds are

appropriate. Because of the interest already shown in the results of our

Aganocide compounds, we are exploring several strategic opportunities to

enhance our efforts and ensure the broadest use of the Aganocides in

dermatology.

About NovaBay Pharmaceuticals, Inc.

NovaBay Pharmaceuticals, Inc. is a clinical stage biopharmaceutical

company focused on developing innovative product candidates targeting

the treatment or prevention of a wide range of infections in hospital

and non-hospital environments. NovaBay has discovered and is developing

a class of non-antibiotic anti-infective compounds, which it has named

Aganocide compounds, which are based upon small molecules that are

generated by white blood cells that defend the body against invading

pathogens. NovaBay believes that Aganocide compounds could form a

platform on which to create a variety of products to address differing

needs in the treatment and prevention of bacterial and viral infections,

including resistant bacteria such as MRSA. NovaBay has entered into a

licensing and research collaboration agreement with an affiliate of

Alcon, Inc. for use of the Aganocide compounds in the eye, ear and

sinus, and in contact lens solutions. The company also has a license

agreement with an affiliate of Kinetic Concepts, Inc. for the use of

NovaBays NeutroPhase product in woundcare

applications.

NovaBay, AgaDerm

Aganocide®, AgaNase,

and NeutroPhase are trademarks of NovaBay

Pharmaceuticals, Inc. All other trademarks and trade names are the

property of their respective owners.

Forward-Looking Statements

This release contains forward-looking statements, which are based upon

managements current expectations,

assumptions, estimates, projections and beliefs. These statements

include, but are not limited to, statements regarding the development

and potential benefits of, and the market opportunities for, NovaBays

product candidates. 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,

risks and uncertainties relating to difficulties or delays in discovery,

development, testing, regulatory approval, production and marketing of

the companys product candidates, unexpected

adverse side effects or inadequate therapeutic efficacy of the product

candidates, the uncertainty of patent protection for the companys

intellectual property or trade secrets, the companys

ability to obtain additional financing as necessary and unanticipated

research and development and other costs. 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 Pharmaceuticals, Inc.
Theresa Granados, 510-899-8870
Manager,

Investor Relations
[email protected]
or
The

Investor Relations Group
Investor Relations:
Adam Holdsworth /

Erica Ruderman / Brett Foley
212-825-3210
or
Media

Relations:
Janet Vasquez / Laura Colontrelle
212-825-3210

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