April xxxx, 2010 — Alcon, Inc - NovaBay Pharmaceuticals, Inc.

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Dec 3, 2012 (4 years and 6 months ago)

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Positive Data on New Class of Anti
-
infectives Announced by NovaBay Pharmaceuticals
at ARVO 2010

New Studies Confirm
Stability and Antiviral Activity
of NovaBay’s
Aganocide
®

Compounds

Ft. Lauderdale, Fla.


May 6
, 2010



New preclinical

data
demonstrating the antiviral
activity and stability of
NovaBay Pharmaceuticals’

(AMEX: NBY) Aganocide
®

compounds were
presented during three poster sessions at the
Association for Research in Vision and
Ophthalmo
logy

(ARVO) annual meeting in Ft. Lauderdale, Florida this week.

No
vaBay’s Aganocide compounds are
first
-
in
-
class anti
-
infectives being developed for the
treatment and prevention of antibiotic
-
resistant infections.
These broad
-
spectrum antimicrobials
are i
n Phase 2 clinical development for the treatment of conjunctivitis or “Pink Eye,” impetigo
and catheter
-
associated urinary tract infections (CAUTI).

The lead Aganocide compound, NVC
-
422/AL
-
46383A, is a stable compound based on the
chemical structures of
N
-
chlorotaurine (NCT) and
N,N
-
dichlorotaurine, which are naturally
occurring antimicrobial agents produced by white blood cells to fight invasive pathogens.

Data from the following abstracts were featured:

-

An abstract presented today, titled “Topical
N,N
-
dichloro
-
2,2
-
dimethyltaurine(AL
-
46383A)
Inhibits Adenovirus Replication in the Ocular Ad5/NZW Rabbit Replication Model,” revealed that
AL
-
46383A demonstrated significant anti
-
adenoviral activity in the Ad5/NZW rabbit ocular
model. There was no significant

toxicity, as with the currently available treatment cidofovir. AL
-
46383A is under investigation in a masked placebo
-
controlled clinical trial as a topical therapy
for viral conjunctivitis.

Authors of the study are David Stroman, Ph.D., of Alcon Laboratori
es; and Eric G. Romanowski,
Kathleen A. Yates and Dr. Y. Jerold Gordon of the Charles T. Campbell Lab at the University of
Pittsburgh et al.

-

An abstract presented Monday, May, 3, titled

In vitro

Microbicidal Activity in Tears
of

N,N
-
dichloro
-
2,2
-
dimethyltaurine

(NVC
-
422, AL
-
46383A), a Novel Topical Ophthalmi
c Agent,”
showed that NVC
-
422 demonstrated stability in 10 percent synthetic tears after a two
-
hour
incubation. A concentration of 0.3 percent NVC
-
422 in acetate pH4 in the presenc
e of synthetic
tears killed both Gram
-
positive and Gram
-
negative bacteria. Antiviral activity of NVC
-
422 was

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also retained in 10 percent synthetic tears. A concentration of 0.1 percent NVC
-
422 reduced all
titers to the limit of detection.

Authors of the ab
stract are: Dr. Kathryn Najafi, founder and medical director of the Eye
Institute of Marin and a NovaBay advisor; Dr. Stephen Wilmarth, NovaBay advisor and a
founding member of Medical Vision Technology; and David Stroman, Ph.D, and Masood
Chowhan
,

Ph.D.,
of Alcon Laboratories, et al.

-

An abstract presented Monday, May 3, titled “
In vitro

Evaluation of
N,N
-
dichloro
-
2,2
-
dimethyltaurine(AL
-
46383A) as an Antiviral Agent Against Adenovirus and HSV
-
1,” showed that
AL
-
46383A directly inactivated all ocular isola
tes of adenovirus and HSV
-
1 at all concentrations
tested. All AL
-
46383A concentrations demonstrated at least a 1
-
Log
10

reduction in the mean
titers of all viral isolates.

Authors of the abstract are: Dr. Y. Jerold Gordon, Kathleen Yates, and Eric G.
Romanowski of
the Charles T. Campbell Lab at the University of Pittsburgh; and David Stroman, Ph.D. of Alcon
Laboratories, et al.

“These studies demonstrate the potential for this very important new class of antimicrobial
compounds to treat a broad range o
f infections without causing resistance,” said NovaBay CEO
Ron Najafi, Ph.D
.

“We are excited about our work with partner Alcon, Inc. (NYSE:ACL), the
world’s leading eye care company, to commercialize a promising dual treatment for both viral
and bacterial
conjunctivitis. We also expect to release Phase 2 clinical data later this year on
the development of our Aganocide compounds for impetigo, a common, highly contagious skin
infection among children, and Catheter
-
Associated Urinary Tract Infection.”

Abstrac
ts of the presentations may be accessed at www.arvo.org.

About Aganocide Compounds

The Aganocide compounds are novel, proprietary, synthetic
N
-
chlorinated antimicrobial
molecules specifically developed by NovaBay to mimic the body’s natural defense against

infection. The Aganocide compounds maintain biological activities while

demonstrating

improv
ed

stability

over the
naturally occurring
N
-
chlorinated antimicrobial molecules. These
highly differentiated, first
-
in
-
class, small
-
molecule, patented new chemical

entities may deliver
the same or better efficacy than currently used antibiotics without contributing to the growing
rise of antibiotic
-
resistant bacterial strains. In preclinical testing, the Aganocide compounds
have been shown to be highly effective aga
inst bacteria, including multi
-
drug resistant strains
(such as MRSA), viruses and fungi. They also have been demonstrated to be effective against
bacteria in biofilm, which render most antibiotics ineffective. The Aganocide compounds have a

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broad therapeut
ic index while providing a high degree of potency and tolerability as well as
dosing versatility and flexibility.

About NovaBay Pharmaceuticals, Inc.

NovaBay Pharmaceuticals is a c
linical stage biotechnology
company focused on developing its
proprietary and patented Aganocide compounds, which are novel, synthetic anti
-
infective
product candidates with equivalent activity to the active antimicrobial molecules generated
within white blood cells. NovaBay’s Aganoc
ide compounds are being developed to treat and
prevent a wide range of infections without causing bacterial resistance. NovaBay has internal
development programs aimed at addressing hospital and respiratory infections. The company
has a license and researc
h collaboration agreement with Alcon, Inc. for use of its Aganocide
compounds to treat eye, ear and sinus infections as well as for contact lens care. NovaBay has
also entered into an agreement with Galderma S.A. to develop and commercialize Aganocide
comp
ounds in acne, impetigo and other dermatological indications. For more information on
NovaBay, visit:
www.novabaypharma.com
.

Cautionary

Information Regarding Forward
-
Looking Statements

The statements in this press release of NovaBay’s expectations regarding NovaBay’s Aganocide
compounds’ potential to treat
a
broad range of infections without causing resistance are
forward
-
looking statements. These statements are subject to risks and unce
rtainties that could
cause actual results to differ materially from those projected in these forward
-
looking
statements. These risks and uncertainties include, among others, the risk that results obtained
in preclinical

studies

may not be obtained in human
s, and the risk that the Aganocide
compounds may not deliver the same or better efficacy than currently used antibiotics without
contributing to the growing rise of bacterial resistance. Other risks relating to NovaBay and its
Aganocide compounds, includin
g 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
Annual Report on Form 10
-
K for the period ended December 31, 2009, under the caption "Risk
Factors
" in Item 1A of Part I of that report, filed with the Securities and Exchange Commission
on March 29, 2010. The forward
-
looking statements in this release speak only as of this date,
and NovaBay disclaims any intent or obligation to revise or update public
ly any forward
-
looking
statement except as required by law.



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Contact

Investors:

NovaBay Pharmaceuticals, Inc.

Thomas J. Paulson

Chief Financial Officer

510
-
899
-
8809

tpaulson@novabaypharma.com

Media:

NovaBay

Pharmaceuticals, Inc.

Susan L. Thomas

Director of Corporate Communications

510
-
899
-
8841

sthomas@novabaypharma.com

###