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SkinMedica(R) Announces Commercial Launch Of Desonate(TM) (desonide) Gel 0.05 Percent With Patented Hydrogel Technology For Treatment Of Atopic Dermat
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
View drug information on Desonate.
SkinMedica (R) anunþã lansarea comercialã a Desonate (tm) (desonide) gel cu 0.05 la sutã Hydrogel patentat tehnologia de tratare a atopic Dermat - SkinMedica(R) Announces Commercial Launch Of Desonate(TM) (desonide) Gel 0.05 Percent With Patented Hydrogel Technology For Treatment Of Atopic Dermat - articole medicale engleza - startsanatate