Aczone Gel
Posted by Reporter on Monday
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 Microparticulategel, 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.