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: Ted Ebel, Vice President, Corporate Development of SkinMedica,
Inc., +1-760-448-3620, tebel@skinmedica.com
Web site: http://www.skinmedica.com/
http://www.aczone.com/
