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SkinMedica
to Co-promote ACZONE® (dapsone) Gel 5% to Pediatricians
in the U.S.
ACZONE® Gel 5% is the First New FDA-Approved Chemical
Entity for Topical Acne Treatment in a Decade
CARLSBAD, CALIF. – May 11, 2009 – SkinMedica, Inc. today
announced that it has entered into a co-promotion
agreement with Allergan for ACZONE® (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® Gel 5% combines
dapsone in a Solvent Microparticulate™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® Gel 5% to pediatricians in
the United States through its existing sales force.
“We are delighted to add ACZONE® 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® 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® Gel 5%
ACZONE® 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™ gel enables
dapsone to be applied topically. ACZONE® 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® Gel 5% label.
The most common adverse events reported with ACZONE® Gel
5% in controlled clinical trials included
oiliness/peeling, dryness, and erythema. There were no
significant differences in the adverse event rates
between ACZONE® 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® Gel 5%, including patients who were
G6PD deficient. Some subjects with G6PD deficiency using
ACZONE® Gel 5% developed laboratory changes suggestive
of mild hemolysis.
If signs and symptoms suggestive of hemolytic anemic
occur, ACZONE® Gel 5% should be discontinued. ACZONE®
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® 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® 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® Gel 5%
treatment.
ADVERSE REACTIONS
The most common adverse reactions of ACZONE® Gel 5%
(incidence ≥ 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® (desonide) Gel 0.05% for the treatment of mild
to moderate atopic dermatitis; VANIQA® (eflornithine
hydrochloride) Cream, 13.9%, the only FDA-approved
prescription product for the treatment of unwanted
facial hair in women; and EpiQuin® Micro Cream (4%
hydroquinone) for the treatment of melasma and
post-inflammatory hyperpigmentation.
NeoBenz® Micro Wash Plus Pack, NeoBenz® Micro Cream Plus
Pack, and NeoBenz® Micro SD all incorporate the patented
gradual-release MICROSPONGE® 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™ and hallmark TNS
Recovery Complex®. 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®, EpiQuin® Micro, NeoBenz® Micro, SkinMedica®,
TNS Recovery Complex® and VANIQA® are registered
trademarks of SkinMedica, Inc and affiliates.
Contact
Ted Ebel
Vice President, Corporate Development
(760) 448-3620
tebel @skinmedica.com
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