Galderma and NovaBay Enroll First Patients in Phase 2b Clinical Study of NVC-422 for Impetigo
Galderma and NovaBay Enroll First Patients in Phase 2b Clinical Study of
NVC-422 for Impetigo
Global Study to Enroll Patients in Four Countries Worldwide
LAUSANNE, Switzerland and EMERYVILLE, Calif., 2012-09-26 06:02 CEST (GLOBE
NEWSWIRE) -- Galderma S.A., a global leading pharmaceutical company exclusively
focused on dermatology and NovaBay Pharmaceuticals, Inc. (NYSE MKT:NBY), a
biotech company developing novel anti-infective products for the treatment and
prevention of topical infections, including those caused by
antibiotic-resistant bacterial strains, today announced that the first patients
have been enrolled in the Companies' Phase 2b clinical study of a proprietary
topical formulation of NVC-422 (CD07223) for the treatment of impetigo. The
study is expected to enroll over 300 patients at 24 clinical sites in four
countries worldwide and aims to confirm efficacy and evaluate 2 different
"We are pleased with the Phase 2b study launch and our continuous progress with
our partner NovaBay. We are highly committed to developing this exciting and
differentiated product candidate for the treatment of impetigo," said Humberto
C. Antunes, Chief Executive Officer of Galderma. "We share NovaBay's enthusiasm
for NVC-422, and together we expect to advance this program through late-stage
clinical development, and potential approval and commercialization."
"If successful, NVC-422 will be the first "non-antibiotic anti-infective"
moving to replace traditional antibiotics in the treatment of impetigo. I
commend both development teams at NovaBay and Galderma on our very successful
collaboration and their efforts in bringing this product closer to the finish
line," said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay.
In further support of product registration, Galderma has established
preclinical and clinical safety for topical NVC-422, including the successful
completion of safety studies involving more than 300 healthy volunteers, as
well as the feasibility of manufacturing scale-up and long-term shelf-life. As
announced previously, following an End of Phase 2a meeting with the Food and
Drug Administration (FDA) attended by both Companies, valuable guidance from
the FDA has been incorporated into the Phase 2b protocol.
Impetigo is a highly contagious skin infection that mainly affects infants and
children, which is caused by Staphylococcus aureus, including MRSA
(methicillin-resistant Staphylococcus aureus), Streptococcus pyogenes, or both.
A review article published recently in Pediatric Dermatology1 reported that
antibiotic-resistant organisms have become more prevalent in impetigo, and that
the disease should be treated with topical agents that will reduce
antibacterial resistance and minimize the incidence of adverse events. In a
Phase 2 clinical study, NVC-422 was shown to be safe and well tolerated, and
demonstrated a 100% response rate for treating patients with impetigo caused by
MRSA, whether MRSA was the sole organism or in a mixed infection2 and more than
a 93-95% response to all strains and full clinical response. Additionally,
NVC-422 was rapidly bactericidal against 55 clinical isolates of MRSA acquired
from a database of patients in the U.S. and Europe.
1Bangert S, Levy M, and Hebert AA, (2012) Bacterial Resistance and Impetigo
Treatment Trends: A Review; Pediatric Dermatology Vol. 29 No. 3 243–248.
2Iovino SM, Krantz KD, Blanco DM, Fernández JA, Ocampo N, Najafi A, Memarzadeh
B, Celeri C, Debabov D, Khosrovi B, Anderson M., (2011) NVC-422 topical gel for
the treatment of impetigo.; Int J Clin Exp Pathol. Aug 15;4(6):587-95. Abstract
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on
addressing the large unmet therapeutic needs of the global anti-infective
market with its two distinct categories of products.
NovaBay's first-in-class Aganocide compounds, led by NVC-422, are patented,
synthetic molecules with a broad spectrum of activity against bacteria, viruses
and fungi. Mimicking the mechanism of action that human white blood cells use
against infections, Aganocides possess a reduced likelihood that bacteria or
viruses will be able to develop resistance, which is critical for advanced
anti-infectives. Having demonstrated clinical efficacy in Phase 2
proof-of-concept clinical studies, NVC-422 is suited to treat and prevent a
wide range of local, non-systemic infections. NovaBay's clinical development
activities are focused on three disease areas:
-- Dermatology - Partnered with Galderma, a leading dermatology company, to
develop a formulation of NVC-422 for treatment of highly contagious skin
infection, impetigo, caused primarily by S. aureus and Group a b-hemolytic
-- Ophthalmology - NovaBay is developing an eye drop formulation of NVC-422
for treating adenoviral conjunctivitis. Enrollment into a global Phase 2b
clinical study has begun with top-line data expected in the first half of
-- Urology – NovaBay's urinary catheter irrigation solution containing NVC-422
is currently enrolling patients in its Phase 2 proof-of-concept clinical
studies, with the goal of reducing the incidence of urinary catheter
blockage and encrustation (UCBE) and associated urinary tract infections.
The Company reported positive data from Part A of this study and expects to
announce top-line results from Part B later in 2012.
NovaBay is also developing NeutroPhase, which is an FDA 510(k)-cleared product
for advanced wound care. We believe that NeutroPhase is the only patented pure
hypochlorous acid solution available and has the potential to be best suited to
treat the six-million-patients in the U.S. who suffer from chronic non-healing
wounds, such as pressure, venous stasis and diabetic ulcers.
For additional information, visit: www.neutrophase.com.
Stay informed on NovaBay's progress:
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Galderma is a global company founded in 1981 committed to delivering innovative
medical solutions to meet the dermatological needs of people throughout their
lifetime while serving healthcare professionals around the world. The company
has 31 wholly-owned affiliates with a worldwide network of distributors and
more than 4,000 employees. Galderma's extensive product portfolio is available
in 70 countries and treats a range of dermatological conditions including:
acne, rosacea, onychomycosis, psoriasis & steroid-responsive dermatoses,
pigmentary disorders, skin cancer and medical solutions for skin senescence.
With approximately 20% of revenues invested each year to discover and develop
new products and access innovative technologies, the company is one of the
world's leading investors in dermatology R&D. Four state-of-the-art R&D centers
and four manufacturing sites are dedicated to providing a wide range of
innovative medical solutions which meet the highest standards of safety and
Strategic global brands include Epiduo, Oracea, Clobex, Differin,
Rozex/MetroGel, Silkis/Vectical, Tri-Luma, Loceryl, Cetaphil, Metvix, Azzalure,
Dysport*, Restylane and Emervel.
For more information about Galderma, please visit: www.galderma.com
*Dysport is a trademark of Ipsen
Cautionary Information Regarding Forward Looking Statements
This release contains forward-looking statements, which are based upon
management's current expectations, assumptions, estimates, projections and
beliefs. These statements include, but are not limited to, statements
regarding NovaBay's expectation on the potential efficacy of Aganocide
compounds for the treatment of impetigo and other indications; any potential
plans for future clinical development of NVC-422; the expected timing of
enrollment and commencement of clinical trials, expected timing of receipt and
announcement of results of clinical studies, and efficacy of NeutroPhase and
Aganocides 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 as of the date of this press
release and are based on assumptions and subject to significant risks and
uncertainties (many of which are outside of NovaBay's control), including:
Galderma may not continue its development of NVC-422, NVC-422 may not prove to
be effective in treating impetigo; and the FDA or other regulatory agencies may
delay clinical trials, or require additional studies or procedures, which could
delay or prevent the development of Aganocide compounds. These and other risks
relating to the development of Aganocide compounds are detailed in NovaBay's
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 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.
Thomas J. Paulson
Chief Financial Officer
Investors and Media:
The Ruth Group
Joshua Drumm, PhD (Investors)
Victoria Aguiar (Media)
Director, Marketing Services & Corporate Communications
Tel: + 33 (0)1 58 86 45 60