SkinMedica to Co-Promote ACZONE(R) (dapsone) Gel 5% to Pediatricians in the U.S.
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ACZONE(R) Gel 5% is the First New FDA-Approved Chemical Entity for Topical
Acne Treatment in a Decade
CARLSBAD, Calif., May 11 /PRNewswire/ -- SkinMedica, Inc. today announced that
it has entered into a co-promotion agreement with Allergan for ACZONE(R)
(dapsone) Gel 5%, a first-in-class topical treatment for acne vulgaris.
Representing the first new molecule in a decade approved by the FDA for the
topical treatment of acne in patients 12 years of age and older, ACZONE(R) Gel
5% combines dapsone in a Solvent Microparticulate(TM)gel, enabling dapsone to
be applied topically in a well-tolerated formulation to provide patients with
a convenient and effective therapy. Under the agreement, SkinMedica will
exclusively promote ACZONE(R) Gel 5% to pediatricians in the United States
through its existing sales force.
"We are delighted to add ACZONE(R) Gel 5% to our dermatology consultations
with pediatricians, as it provides us with a pivotal opportunity to further
educate pediatricians regarding the latest advancements in acne treatment,"
said Mary Fisher, President and CEO of SkinMedica. "This co-promotion
agreement expands the portfolio of products SkinMedica can now offer
pediatricians, enabling us to further meet the demands of physicians and
patients across the country."
Allergan will continue to distribute the product, and its dermatology sales
force will continue to promote the product. Allergan will book all ACZONE(R)
Gel 5% sales and SkinMedica will receive a share of sales above a
pre-specified baseline. There are no upfront payments by either party.
About Acne
Acne vulgaris, or acne, is a common skin disorder with an estimated 80 percent
of all people between the ages of 11 and 30 years old experiencing outbreaks
at some point. Acne treatment depends on whether a patient has a mild,
moderate, or severe form. Fortunately, acne is also one of the most treatable
skin conditions once a physician and patient find an appropriate product and
dosage.
About ACZONE(R) Gel 5%
ACZONE(R) Gel 5% is an aqueous topical gel formulation containing 5% dapsone.
Marketed by Allergan, it was developed by QLT Inc.'s wholly owned subsidiary,
QLT USA, Inc., for the treatment of acne vulgaris. Combining dapsone in a
Solvent Microparticulate(TM) gel enables dapsone to be applied topically.
ACZONE(R) Gel 5% was originally approved by the U.S. Food and Drug
Administration (FDA) in July 2005 and by Health Canada in June 2006. On March
17, 2008 and June 5, 2008 the FDA and Health Canada, respectively, removed
certain restrictive requirements from the ACZONE(R) Gel 5% label. The most
common adverse events reported with ACZONE(R) Gel 5% in controlled clinical
trials included oiliness/peeling, dryness, and erythema. There were no
significant differences in the adverse event rates between ACZONE(R) Gel 5%
and vehicle-control-treated patients.
Important Safety Information
Warnings and Precautions
Hemotological effects: Oral dapsone treatment has produced dose-related
hemolysis and hemolytic anemia. Individuals with glucose-6-phosphate
dehydrogenese (G6PD) deficiency are more prone to hemolysis with the use of
certain drugs. There was no evidence of clinically relevant hemolysis or
anemia in patients treated with ACZONE(R) Gel 5%, including patients who were
G6PD deficient. Some subjects with G6PD deficiency using ACZONE(R) Gel 5%
developed laboratory changes suggestive of mild hemolysis.
If signs and symptoms suggestive of hemolytic anemic occur, ACZONE(R) Gel 5%
should be discontinued. ACZONE(R) Gel 5% should not be used in patients who
are taking oral dapsone or anti-malarial medications because of the potential
for hemolytic reactions. Combination of ACZONE(R) Gel 5% with
trimethroprim/sulfamethoxazole (TMP/SMX) may increase the likelihood of
hemolysis in patients with G6PD deficiency.
Peripheral neuropathy: Peripheral neuropathy (motor loss and muscle weakness)
has been reported with oral dapsone treatment. No events of peripheral
neuropathy were observed in clinical trials with topical ACZONE(R) Gel 5%
treatment.
Skin: Skin reactions (toxic epidermal necrolysis, erythema multiforme,
morbiliform and scarlatiniform reactions, bullous and exfoliative dermatitis,
erythema nodosum, and urticaria) have been reported with oral dapsone
treatment. These types of skin reactions were not observed in clinical trials
with ACZONE(R) Gel 5% treatment.
ADVERSE REACTIONS
The most common adverse reactions of ACZONE(R) Gel 5% (incidence is greater
than or equal to 10%) are oiliness/peeling, dryness, and erythema at the
application site.
For full prescribing information go to www.allergan.com and www.aczone.com
About SkinMedica
SkinMedica, Inc. is focused on developing, acquiring and commercializing
products that treat dermatologic conditions and improve the appearance of
skin. We market and sell primarily to dermatologists and pediatricians, both
prescription pharmaceutical products and physician-dispensed, non-prescription
skin care products. SkinMedica's pharmaceutical products include Desonate(R)
(desonide) Gel 0.05% for the treatment of mild to moderate atopic dermatitis;
VANIQA(R) (eflornithine hydrochloride) Cream, 13.9%, the only FDA-approved
prescription product for the treatment of unwanted facial hair in women; and
EpiQuin(R) Micro Cream (4% hydroquinone) for the treatment of melasma and
post-inflammatory hyperpigmentation.
NeoBenz(R) Micro Wash Plus Pack, NeoBenz(R) Micro Cream Plus Pack, and
NeoBenz(R) Micro SD all incorporate the patented gradual-release
MICROSPONGE(R) delivery system of benzoyl peroxide, for the treatment of acne
in patients 12 years of age and older.
The company's full line of aesthetic products includes the revolutionary TNS
Essential Serum(TM) and hallmark TNS Recovery Complex(R). The formulations in
our clinical skin care collection enhance skin appearance, reduce signs of
aging and provide other skin care benefits. SkinMedica is based in Carlsbad,
California. For more information, visit: www.skinmedica.com.
Desonate(R), EpiQuin(R) Micro, NeoBenz(R) Micro, SkinMedica(R), TNS Recovery
Complex(R) and VANIQA(R) are registered trademarks of SkinMedica, Inc and
affiliates.
CONTACT INFORMATION:
Ted Ebel
Vice President, Corporate Development
(760) 448-3620
tebel@skinmedica.com
SOURCE SkinMedica, Inc.
Ted Ebel, Vice President, Corporate Development of SkinMedica, Inc.,
+1-760-448-3620, tebel@skinmedica.com
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