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March 18, 2008

Knobias Clip Report (03-17-2008)

By admin

Submitted By Knobias ClipReport

NBY: CEO Discusses Clinical Programs and Plans for 2008

NovaBay Pharmaceuticals Inc. (NBY) is a clinical stage biopharmaceutical company focused on developing innovative product candidates for the treatment or prevention of a wide range of infections in hospital and non-hospital environments.

Dr. Ron Najafi, CEO of NovaBay, told Knobias on Monday, “Many of these infections have become increasingly difficult to treat because of the rapid rise in drug resistance. We have discovered and are developing a class of non-antibiotic anti-infective compounds, which we have named Aganocide compounds, that are based upon small molecules that are naturally generated by white blood cells when defending the body against invading pathogens. We believe that our 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. Our Aganocide compounds have demonstrated in-vitro the ability to destroy all bacteria against which they have been tested. Furthermore, their mechanism of action, combined with on-going laboratory tests, leads us to believe that bacteria are unlikely to develop resistance to our Aganocide compounds.”

“Initially, we will be focusing our attention on topical applications such as Eye, Ear, Sinus, Wound, MRSA in the Nasal area and a number of device related infections.”

The Company announced last week that it has completed dosing of the first cohort of volunteers in a multi-cohort Phase I safety study of a bladder and catheter lavage solution of NVC-422, NovaBay’s lead Aganocide compound. This clinical program is aimed at preventing the development of catheter associated urinary tract infections (CAUTI).

Dr. Najafi explained, “An antibiotic called Mupirocin is the drug that we will be competing against with our NVC-22. It has an approval for control of MRSA outbreaks in hospitals. Unfortunately, MRSA is now developing resistance toward Mupirocin. In laboratory testing NVC-422 will not only kill MRSA, it will also kill all its variant forms such as USA-100, USA-300.”

“We expect our partner, Alcon Labs, will be in the clinic for non-specific conjunctivitis (Phase I) in 2008; ear infection trials (Phase I) in 2008; and sinusitis (Phase I) in 2009. We are also working with Alcon to develop a new contact lens solution. Our unpartnered programs include MRSA Nasal Preparation (Phase II stage – will be announcing our top line results in Q2-2008); catheter-associated urinary tract infection (Phase I stage – will be announcing result Q2-2008); and dermatology (preclinical work in support of a trial for Acne).”

Dr. Najafi concluded, “NovaBay has key value drivers in 2008 and beyond. We have four clinical programs and the potential launch of NeutroPhase (wound infection prevention) by our partner KCI in early 2009. We continue to achieve the milestones that we set for the company.”

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