SkinMedica(R) Announces Commercial Launch Of Desonate(TM) (desonide) Gel 0.05 Percent With Patented Hydrogel Technology For Treatment Of Atopic Dermat

Main Category: Dermatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 13 Feb 2007 - 0:00 PDT


SkinMedica, Inc., a specialty pharmaceutical company focused on developing, acquiring, and commercializing products that treat dermatologic conditions and diseases and improve the appearance of skin, today announced the commercial availability of Desonate(TM) (desonide) Gel 0.05percent for treatment of mild-to-moderate atopic dermatitis. Collaboratively developed by SkinMedica and Dow Pharmaceutical Sciences, Inc., Desonate is a low-potency topical steroid formulated in Dow's proprietary water-based Hydrogel vehicle.

Desonate, which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of atopic dermatitis in patients aged 3 months and older for up to four consecutive weeks, is an appropriate therapy for both pediatric and adult patients. Formulated with desonide, the leading low-potency corticosteroid used in dermatology, Desonate is the first and only treatment for atopic dermatitis formulated with patented Hydrogel Technology. The versatile formulation can be used on hair-bearing and non-hair-bearing skin, and is free of alcohol, fragrance, or surfactants that can be irritating or drying to the skin.

Desonate will be jointly promoted by SkinMedica and Galderma Laboratories, L.P. SkinMedica will promote Desonate to the dermatology market, while Galderma will promote Desonate to pediatricians via its highly specialized pediatric sales force.

"The launch of Desonate provides great opportunities for SkinMedica and our partners," said Rex Bright, President & CEO of SkinMedica. "We believe the availability of an atopic dermatitis treatment utilizing Hydrogel Technology fills an unmet need in dermatology. This new alcohol-free Hydrogel formulation represents a novel addition to the therapeutic armamentarium of low-potency steroids for the treatment of atopic dermatitis. The Hydrogel molecule is specifically formulated to provide effective therapy in a cosmetically acceptable, non-drying delivery system."

"This is an exciting addition to the portfolio of products in our pediatric division," said Albert Draaijer, President of Galderma U.S. "The formulation is ideal for the pediatric patient. It incorporates what we like to call 'Smart Science' in that it has the best of both worlds for the patient -- an excellent cosmetically elegant vehicle, plus the proven safety and efficacy of the desonide molecule. We are very pleased with the potential that comes from this agreement with SkinMedica."

The efficacy and safety of Desonate was demonstrated in controlled clinical trials, which assessed the product's ability to clear atopic dermatitis symptoms in patients with mild-to-moderate disease. At the 65th Annual Meeting of the American Academy of Dermatology (AAD) in Washington, D.C. (February 2-6, 2007), clinical data supporting Desonate benefits were unveiled.

Scientific posters at AAD detailed (1) the safety and efficacy of Desonate in two Phase III clinical trials; (2) the moisturizing qualities of Hydrogel, as measured by reduced trans-epidermal water loss (TEWL); and (3) patient preference for the Hydrogel vehicle versus other gel vehicles. For a copy of these data, please call SkinMedica Customer Service at (877) 944-1412.

About Atopic Dermatitis

Atopic dermatitis affects more than 15 million patients, resulting in rash, redness, swelling, crusting, and scaling of the skin. The disease affects nearly 20% of infants and young children, some of which continue to experience symptoms as adults. The exact cause is unknown; however, genetics and environmental factors are considered key factors. Topical corticosteroids are the "gold standard" of treatment for atopic dermatitis, with more than $1 billion in prescriptions written annually by U.S. physicians for inflammatory dermatoses.

Additional Information About Desonate

For information about Desonate, including its approved labeling, please visit http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

About SkinMedica

SkinMedica is a privately held specialty pharmaceutical company marketing both prescription and cosmeceutical dermatology products. SkinMedica's Desonate(TM) (desonide) Gel 0.05% is indicated for the treatment of mild-to-moderate atopic dermatitis; EpiQuin(R) Micro (4% hydroquinone) cream is indicated for melasma and postinflammatory hyperpigmentation; VANIQA(R) (eflornithine hydrochloride) Cream, 13.9%, is the only FDA-approved prescription product for the treatment of unwanted facial hair in women; and NeoBenz(R) Micro Cream and NeoBenz(R) Micro SD (single dose) are the only benzoyl peroxide prescription products that contain a patented gradual-release formulation of benzoyl peroxide to treat acne. The company's full line of cosmeceutical products, which is sold through physicians, includes TNS Recovery Complex(R) with NouriCel-MD(R) to help improve the health and appearance of aging skin. SkinMedica is based in Carlsbad, California. For more information, visit http://www.skinmedica.com.

About Galderma Laboratories, L.P.

Created in 1981 as a joint venture between Nestle and L'Oreal, Galderma Laboratories is the number-one dermatology company in the world, according to a recent IMS D-Class survey. With a worldwide presence in 65 countries, over 1000 sales representatives, and one of the largest research facilities dedicated to dermatology, Galderma provides innovative therapeutic skin care solutions to meet the needs of dermatology patients and physicians. The company is committed to improving the health of skin with an extensive line of products that treat a range of skin care conditions, including acne, rosacea, fungal nail infections, psoriasis, seborrheic dermatitis, hyperpigmentation disorders, non-melanoma skin cancer, and photodamage. With a new research lab in Sophia Antipolis, France, and the introduction of exciting technology and products on the horizon, Galderma is poised to continue making significant impact in dermatology treatment. For more information, visit http://www.galdermaUSA.com.

Desonate(TM) is a trademark of SkinMedica, Inc.

SkinMedica(R), EpiQuin(R) Micro, NeoBenz(R) Micro, NouriCel-MD(R), TNS Recovery Complex(R), and VANIQA(R) are registered trademarks of SkinMedica, Inc.

SkinMedica, Inc.
http://www.skinmedica.com

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