Healthcare Industry News: Galderma Laboratories
News Release - November 7, 2006
SkinMedica and Galderma to Co-Promote Desonate(TM)New Innovative Formula for Atopic Dermatitis
CARLSBAD, Calif., Nov. 7 (HSMN NewsFeed) -- SkinMedica, Inc., a specialty pharmaceutical company focused on dermatology, today announced an agreement with Galderma Laboratories, L.P. for the co-promotion of Desonate(TM) (desonide) Gel 0.05% for treatment of mild-to-moderate atopic dermatitis. Desonate, developed in collaboration between SkinMedica and Dow Pharmaceutical Sciences, Inc., is a low potency topical steroid formulated in Dow's proprietary water-based Hydrogel(TM) vehicle. The patented formula is free of alcohol, fragrance or surfactants that can be irritating or drying to the skin of atopic dermatitis patients.
"We are delighted to have a partner of Galderma's caliber supporting us in commercializing Desonate Hydrogel," said Rex Bright, President & CEO of SkinMedica. "Galderma's experience with the desonide molecule, their exceptional pediatric sales force and their leadership in commercializing topical products for dermatitis made them a natural choice for SkinMedica."
"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."
On October 23rd, SkinMedica announced the U.S. Food and Drug Administration (FDA) approval of the company's New Drug Application (NDA) for Desonate (desonide) Gel 0.05% for treatment of mild-to-moderate atopic dermatitis. Desonide is the leading low potency corticosteroid in the U.S. dermatology market with a long history of proven safety and efficacy. The safety and efficacy of Desonate was demonstrated in two Phase III clinical trials with a total of 582 mild-to-moderate atopic dermatitis subjects aged 3 months to 18 years. The results demonstrated a statistically significant treatment effect for Desonate compared to placebo in both primary and secondary endpoints.
The patented formula is designed to provide a comfortable, non-irritating, silky smooth feel that will not leave a greasy residue. In two pivotal clinical trials, application site burning and rash were reported by 1% and pruritus (itching) by less than 1% of all treated patients. The product is approved for use in children over three months of age and for adults who suffer from the chronic itching and inflammatory symptoms of atopic dermatitis, commonly known as eczema. The safety and efficacy of Desonate was established for up to 4 weeks of use, and the product is contraindicated in patients with a history of hypersensitivity to any of the components of the preparation.
For more information regarding Desonate, including its approved labeling, please visit http://www.fda.gov/cder/whatsnew.htm.
More than 15 million patients have symptoms of atopic dermatitis, characterized by itchy skin, which can lead to rash, redness, swelling, crusting and scaling. The disease affects up to 20% of infants and young children, who continue to have symptoms as adults with significant impact on their quality of life. The exact cause is unknown, but genetics are considered a key factor. Steroids are the gold standard treatment for atopic dermatitis with more than $1 billion worth of prescriptions written annually by U.S. physicians for inflammatory dermatoses.
SkinMedica is a privately-held specialty pharmaceutical company marketing both prescription and cosmeceutical dermatology products. SkinMedica's EpiQuin® Micro (4% Hydroquinone) treats melasma and postinflammatory hyperpigmentation; VANIQA® (eflornithine hydrochloride) Cream, 13.9%, is the only FDA-approved prescription product for the treatment of unwanted facial hair in women; NeoBenz® Micro, which contains a patented gradual-release formulation of benzoyl peroxide, treats acne; and Desonate(TM) (desonide) Gel 0.05% for the treatment of mild to moderate atopic dermatitis. The company's full line of cosmeceutical products, which is sold through physicians, includes TNS Recovery Complex® with NouriCel-MD® to help improve the health and appearance of aging skin. SkinMedica is based in Carlsbad, California. For more information, visit: www.skinmedica.com.
Desonate(TM), EpiQuin® Micro, NeoBenz® Micro, NouriCel-MD®, SkinMedica®, TNS Recovery Complex® and VANIQA® are trademarks of SkinMedica, Inc.
Hydrogel(TM) is a trademark of Dow Pharmaceutical Sciences, Inc.
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 recent IMS D-Class survey. With a worldwide presence in 65 countries and over 1000 sales representatives and one of the largest research facilities dedicated to dermatology, Galderma provides innovative therapeutic skincare 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 skincare conditions including: acne, rosacea, fungal nail infections, psoriasis, seborrheic dermatitis, hyper-pigmentation disorders, non-melanoma skin cancer and photo damage.
With a new research lab in Sophia Antipolis, France and the introduction of exciting technology and products on the horizon, Galderma is also poised to continue making significant impact in dermatology treatment. For more information, visit www.galdermaUSA.com.
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