Alcon Commences Phase 2 Clinical Trial of NovaBay's NVC-422 for Viral Conjunctivitis

Sun Jul 5, 2009 6:00pm EDT
 
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Alcon Commences Phase 2 Clinical Trial of NovaBay's NVC-422 for Viral
Conjunctivitis

EMERYVILLE, Calif. and HUENENBERG, Switzerland, July 5 /PRNewswire-FirstCall/
-- Alcon, Inc. (NYSE: ACL) and its partner, NovaBay Pharmaceuticals, Inc.
(NYSE-AMEX: NBY), announced today that Alcon has begun treating patients in a
Phase 2 clinical trial of NovaBay's patented lead Aganocide(R) compound,
NVC-422, for viral conjunctivitis, a type of "pink eye".  Conjunctivitis is a
pervasive and painful condition that affects both adults and children, leading
to more than four million doctor and emergency room visits in the United
States each year.

NovaBay has a licensing and research collaboration agreement with Alcon, the
world's leading eye care company, for use of its Aganocide(R) compounds in the
eye, ear and sinus, and in contact lens solutions.

Developed by NovaBay to mimic the body's defense against infection,
Aganocides(R) are proprietary synthetic analogs of the same molecules used by
white blood cells to destroy harmful microbes in the body, such as viruses and
bacteria.  Because of their natural mechanism of action, NovaBay believes that
Aganocide(R) compounds have a low potential for generating microbial
resistance, offering a potential solution to the problem of rising resistance
of microbes to traditional antibiotics.

The Phase 2 viral conjunctivitis study follows a recently completed Phase 1
trial in which safety and tolerability were successfully demonstrated in 120
healthy volunteers with no reported serious adverse events.

"We are pleased to be entering mid-stage clinical testing for viral
conjunctivitis," said Ron Najafi, Ph.D., chairman and chief executive officer
of NovaBay.  "This is the first step in the ophthalmic clinical development
program for NVC-422, which has the immediate goal of developing the first
effective product to address viral conjunctivitis for which there are limited
treatment options."

The Phase 2 multi-center, randomized, placebo-controlled trial is designed to
determine the safety and efficacy of NVC-422 in people with viral
conjunctivitis.  The study calls for enrolling approximately 250 patients at
more than 30 medical centers, mostly in the United States.

"This study is an important step forward with the clinical program for this
potentially dual-acting therapy to address the multiple causes of
conjunctivitis.  Dual action against viral and bacterial conjunctivitis is
important because when an infection is diagnosed it is difficult,
time-consuming and expensive to determine the underlying cause of the
infection and treat it properly," said Dr. Sabri Markabi, M.D., Alcon's senior
vice president of research and development and chief medical officer.

About Conjunctivitis
Conjunctivitis, which can result from either viral or bacterial infection, is
an inflammation of the thin, clear tissue that covers the white part of the
eye and forms the inside lining of the eyelid.  The viral disease is
principally caused by adenoviruses, but also can be caused by other viruses,
such as enterovirus.  There is no specific treatment for adenoviral
conjunctivitis, which can take up to three weeks or longer to clear on its
own.  Bacterial conjunctivitis is caused by a variety of bacteria and is
largely treated with topically applied antibiotic eye drops.  Regular
innovation to develop newer antibiotics is required because over time
antibiotics may encounter increasing bacterial resistance.  

About Aganocide(R) Compounds
The Aganocide(R) compounds are novel, proprietary, synthetic N-chlorinated
antimicrobial molecules specifically developed by NovaBay to mimic the body's
natural defense against infection.  The Aganocide(R) compounds maintain the
biological activities while improving the stability of naturally occurring
N-chlorinated antimicrobial molecules.  These highly differentiated compounds
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(R) compounds have been shown
to be highly effective against bacteria, viruses and fungi.  They also have
been demonstrated to be effective against bacteria in biofilms, which render
most antibiotics ineffective.  Aganocides have a broad therapeutic index while
providing a high degree of potency, good tolerability as well as dosing
versatility and flexibility.

About Alcon 
Alcon, Inc. is the world's leading eye care company, with sales of
approximately $6.3 billion in 2008.  Alcon, which has been dedicated to the
ophthalmic industry for more than 65 years, researches, develops, manufactures
and markets pharmaceutical products, surgical equipment and devices, contact
lens care solutions and other vision care products that treat diseases,
disorders and other conditions of the eye.  For more information on Alcon,
Inc., visit the Company's web site at www.alcon.com. 

About NovaBay
NovaBay Pharmaceuticals is a mid-stage biopharmaceutical company focused on
developing its proprietary and patented Aganocide(R) compounds, which are
novel, synthetic anti-infective product candidates that are bioequivalent to
the active antimicrobial molecules generated within white blood cells 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 licensing and research
collaboration agreement with Alcon, Inc. for use of its Aganocide(R) compounds
to treat eye, ear and sinus infections as well as in contact lens care
solutions.  NovaBay has also entered into an agreement with Galderma S.A. to
develop and commercialize Aganocides in acne, impetigo and other
dermatological indications.  NovaBay(R) and Aganocide(R) are trademarks of
NovaBay Pharmaceuticals, Inc.  For more information on NovaBay, visit:
www.novabaypharma.com.

Forward-Looking Statements
The statements in this press release regarding NovaBay's and Alcon's
expectations regarding the clinical trial and the potential efficacy of
Aganocide(R) compounds are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995.  The forward- looking
statements reflect the views of the management of NovaBay and Alcon as of the
date of this press release with respect to future events and are based on
assumptions and subject to significant risks and uncertainties (many of which
are outside of NovaBay's or Alcon's control), including the risk that FDA or
other regulatory review may delay or prevent the development of Aganocide(R)
compounds, and those detailed in the NovaBay's and Alcon's filings with the
Securities and Exchange Commission.  Given these uncertainties, you should not
place undue reliance on these forward-looking statements.  Except to the
extent required under the federal securities laws and the rules and
regulations promulgated by the Securities and Exchange Commission, we
undertake no obligation to publicly update or revise any of these
forward-looking statements, whether to reflect new information or future
events or circumstances or otherwise.


SOURCE  NovaBay Pharmaceuticals, Inc.; Alcon, Inc.

Doug MacHatton, Vice President, Investor Relations and Strategic
Communications of Alcon, Inc., 1-800-400-8599; or Thomas Paulson, Chief
Financial Officer of NovaBay, +1-510-899-8800

 

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