Pharmaceuticals, Inc. (NYSE MKT:NBY), a biopharmaceutical company
focusing on non-antibiotic anti-infectives, announced today the
distribution of a letter from Ron Najafi, the Company's Chairman, Chief
Executive Officer, to its stockholders. A downloadable version of this
letter may be obtained by visiting the CEO
Blog on the NovaBay website (www.novabay.com/blog).
The purpose of this letter is to provide a brief update on some
important upcoming milestones.
As we recently reported, enrollment in our BAYnovation
clinical trial for viral conjunctivitis has been completed and we
are in the process of accumulating the data from U.S. and international
sites. We anticipate reporting top-line results mid-August.
This global multi-centered, randomized clinical study was conducted in
the United States, India, Sri Lanka, and Brazil. Fifty-four clinical
investigators participated in the study, including 18 in the US, 19 in
India, 6 in Sri Lanka and 11 in Brazil. BAYnovation was designed to
evaluate the efficacy of NovaBay's Auriclosene Ophthalmic Solution in
the treatment of adenoviral infection, specifically for accelerated
clearing the "red eye". While clearing of "red eye" is the primary
efficacy measure, there are a number of valuable and important secondary
measures that will allow us to evaluate the ability to expand our
ultimate label claims. These include: clearing of virus from the eye;
clearing of blurred vision; reduction in the spread of infection from
one eye to the other; prevention of and/or reduction in the severity of
subepithelial infiltrates (or "SEI's") post infection.
i-Lid™ Cleanser was introduced at the 2014 American Society of
Cataract and Refractive Surgery and highlighted at the American
Optometric Association meeting recently by Dr.
Sindt. We expect i-Lid Cleanser to be a major commercial
opportunity. Over the next several weeks we plan to announce our
commercialization plan. I encourage everyone to stay tuned for our
To advance the international commercial launch of NeutroPhase®,
we have been working closely with our partner in China and Southeast
Asia, Pioneer Pharma, to secure final regulatory clearance from the
China Food and Drug Administration, which we expect to receive in the
next few months. This clearance will trigger the commercial launch of
NeutroPhase in mainland China.
Recently introduced at The Aesthetics Meeting in April 2014, our
CelleRx™ product for the aesthetic surgery and dermatology markets is
expected to be a popular post-procedure product in those markets. More
information on this product will be forthcoming at the end of 2014.
Last year we reported positive, statistically-significant results from
our first UCBE Phase 2 study (UROvation)
of Auriclosene Irrigation Solution to prevent blockage and encrustation
in indwelling long-term urinary catheters. We are now in the final
stages of initiating a second Phase 2 study to demonstrate superior
efficacy of auriclosene compared to its vehicle. We anticipate
announcing the first patient enrollment in this study this quarter.
Enrollment is expected at 25 investigational sites in the United States.
We intend to enroll 135 patients into either active or vehicle treatment
arms. If this study is successful, it is possible that this study could
serve as one of the two pivotal studies typically required for FDA
Lastly, working with our partner Galderma, we are using our formulation
development expertise and knowledge gained from previous clinical
studies to create an optimized topical formulation of auriclosene for
skin infections such as impetigo. So far, in vitro data suggest
that we have developed several improved formulations with significantly
longer durations of action. The best performing new formulation will be
evaluated in a clinical study in healthy volunteers, which we expect to
initiate before the end of the calendar year. If this study is
supportive of further development, we will take the new improved
formulation into a Phase 2 efficacy study for impetigo.
I look forward to providing further updates as we continue to advance
Sincerely,Ron Najafi, Ph.D.Chairman & CEONovaBay
This letter to the stockholders of NovaBay Pharmaceuticals, Inc.
contains forward looking statements that are subject to risks and
uncertainties. These statements include statements regarding our
expectations regarding timing of reporting clinical findings, commercial
prospects, receipt of regulatory clearances, and expected regulatory
developments. Words such as "anticipate," "expect," "will be,"
"will," and other words and variations of these words that imply future
events and opinions, identify these statements as forward looking
statements. Actual results may differ materially from those implied by
the forward looking statements due to a number of risks and
uncertainties, including: the regulatory approval process is
subject to unexpected delays or changes; and demand for NovaBay's
products may be different than NovaBay expects. Other risks relating to
NovaBay and its products, including risks that could cause results to
differ materially from those projected in the forward-looking statements
in this letter, are detailed in NovaBay's latest Form 10-K and Form 10-Q
filings with the Securities and Exchange Commission, especially under
the heading "Risk Factors." The forward-looking statements in this
letter 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.
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