FDA Approves Extina(R) for the Treatment of Seborrheic Dermatitis

New foam delivery method for ketoconazole will provide an additional

treatment option for dermatologists and other physicians

    CORAL GABLES, Fla., July 17 /PRNewswire/ -- Stiefel Laboratories, Inc.
 today announced that the U.S. Food and Drug Administration (FDA) has
 approved its new drug application for Extina(R) (ketoconazole) Foam, 2% for
 the treatment of seborrheic dermatitis. The approval, which the company
 received June 12, clears the way for the product to be sold and marketed in
 the United States.
     Different from other treatments for seborrheic dermatitis, which
 contain ketoconazole 2% in a cream, gel or shampoo vehicle, Extina is
 administered using VersaFoam(R) HF(R) (hydroethanolic formulation)
 technology, a unique, versatile topical drug delivery vehicle that is
 quickly absorbed into the skin. Extina Foam proved to be superior to
 placebo foam in a Phase III clinical trial. Of subjects receiving Extina
 (R) Foam, 56% achieved treatment success based on an Investigator Global
 Assessment compared to 42% of subjects receiving vehicle foam. Stiefel
 Laboratories, the world's largest independent pharmaceutical company
 specializing in dermatology, acquired the proprietary VersaFoam HF
 technology with its December 2006 acquisition of Connetics Corporation.
     "We are very pleased with the robust data obtained in the pivotal Phase
 III clinical trial evaluating the safety and efficacy of Extina," said Jim
 Hartman, Senior Vice President, U.S. Commercial Operations for Stiefel
 Laboratories. "It is exciting that this product, combining the proven
 efficacy of ketoconazole 2% in the patient-preferred foam delivery system
 will soon be available for patients with seborrheic dermatitis. It will
 provide dermatologists and other allied health professionals with an
 additional treatment option for this condition and allow patients to choose
 their preferred drug delivery method.
     "Extina is representative of the robust and innovative product pipeline
 at Stiefel Laboratories," Hartman added.
     Stiefel Laboratories plans to launch the product, which will be
 available only by prescription, later this year.
     Extina(R) (ketoconazole) Foam, 2% is indicated for the topical
 treatment of seborrheic dermatitis in immunocompetent patients 12 years of
 age and older. Extina should be applied to the affected skin areas twice a
 day (morning and evening) for four weeks. Extina is administered via
 VersaFoam HF, which studies show offers consistent skin permeation, drug
 distribution and drug delivery. Additional patient benefits include
 versatility (Extina can be used on hair bearing and non hair-bearing skin),
 it absorbs quickly and it is non-drying with no residue.
     For more information about Extina, please visit http://www.extina.com.
     About seborrheic dermatitis
     Seborrheic dermatitis is a chronic, recurrent skin condition that
 affects three to five percent of the U.S. population. More than one million
 patients sought physician treatment of the disease in 2005. Seborrheic
 dermatitis is characterized by flaking, itching and redness and most often
 affects the scalp (dandruff), but also can affect skin on other parts of
 the body, including the face, chest, and the creases of the legs, arms and
 groin.
     About Stiefel Laboratories, Inc.
     Founded in 1847, Stiefel Laboratories (a privately held company) is the
 world's largest independent pharmaceutical company specializing in
 dermatology. The company manufactures and markets a variety of prescription
 and non-prescription dermatological products. Some of the newest and best-
 known brands include Duac(R) Topical Gel (clindamycin, 1% - benzoyl
 peroxide, 5%); Evoclin(R) (clindamycin phosphate) Foam, 1%; Luxiq(R)
 (betamethasone valerate) Foam, 0.12%; MimyX(R) Cream; Olux(TM) (clobetasol
 propionate) Foam, 0.05%; Olux-E(TM) (clobetasol propionate) Foam, 0.05%;
 Soriatane(R) (acitretin) capsules; Verdeso(TM) (desonide) Foam, 0.05%;
 Brevoxyl(R) Creamy Wash (benzoyl peroxide, 4% or 8%) packaged in the
 convenient new Brevoxyl Acne Wash Kit; Oilatum(R); and Sarna(R). Its
 wholly-owned global network is comprised of more than 30 subsidiaries,
 manufacturing plants in six countries, research and development facilities
 on four continents, and products marketed in more than 100 countries around
 the world.
     Stiefel Laboratories supplements its R&D efforts by seeking strategic
 partnerships and acquisitions around the world. To learn more about Stiefel
 Laboratories, Inc. visit http://www.stiefel.com.
 
 

SOURCE Stiefel Laboratories, Inc.