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SkinMedica(R) Reports Positive Results From Desonate(TM) Phase III Trials; First Topical Steroid Using Patented HydroGel(TM) Technology.


CARLSBAD, Calif. -- SkinMedica, Inc., announced today the positive outcome of two Phase III clinical trials evaluating Desonate (desonide) HydroGel hy·dro·gel
n.
A colloidal gel in which the particles are dispersed in water.



hydrogel

a gel that contains water.

hydrogel Wound care A polymer absorptive wound dressing. See Dressing.
 0.05%, a low-potency topical steroid formulated in a proprietary alcohol-free, aqueous gel delivery vehicle to treat atopic dermatitis Atopic Dermatitis Definition

Eczema is a general term used to describe a variety of conditions that cause an itchy, inflamed skin rash. Atopic dermatitis, a form of eczema, is a non-contagious disorder characterized by chronically inflamed skin and
. SkinMedica, Inc. is a specialty pharmaceutical company focused on developing, acquiring and commercializing products that improve the appearance of skin and treat dermatologic conditions and diseases.

The Desonate Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  studies were conducted as a multi-center, randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind, placebo-controlled comparison involving pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 subjects with mild to moderate atopic dermatitis. These clinical trials included 582 patients from age 3 months to 18 years, and were designed to demonstrate superiority of Desonate HydroGel over vehicle (placebo) without desonide. Patients received either Desonate HydroGel or placebo twice daily for four weeks.

The results of these two studies demonstrated a consistently robust and highly statistically significant treatment effect for Desonate compared to placebo in both primary and secondary end-points. These included Investigator Global Severity Assessment (IGSA IGSA InterScan Gateway Security Appliance
IGSA Indian Graduate Students Association
IGSA International Gravity Sports Association
IGSA Iranian Graduate Students' Association
IGSA International Graduate Students Association
IGSA Industrial Gas Suppliers Alliance
) along with the alleviation of signs and symptoms of atopic dermatitis, including erythema erythema (ĕr'əthē`mə), more or less diffuse redness of the skin due to concentration of an abnormally large amount of blood within the small vessels of the skin (hyperemia), as in burns. , induration/papulation, and scaling. The proportion of patients achieving treatment success using the IGSA primary end-point was 44% for Desonate HydroGel and 14% for the vehicle group in the first trial. In the second trial, treatment success rates were 28% for Desonate HydroGel and 6% for the vehicle group. The p value for each of these comparisons was p less than 0.001.

The data from these trials also demonstrated that Desonate HydroGel was well-tolerated, with the most frequently observed side effects Side effects

Effects of a proposed project on other parts of the firm.
 being mild in nature and largely limited to application site reactions. There were no serious adverse events reported. Overall, the safety analysis revealed no unexpected findings for a topical agent of this type.

"We are very enthusiastic about the robust results of these Desonate HydroGel pivotal trials," said Ron Trancik, PhD, Vice President of Research and Development for SkinMedica. "We are particularly excited about this new, low-potency steroid formulation with desonide, in a novel patented aqueous vehicle. HydroGel will offer dermatologists and their patients, particularly younger children, a product with enhanced properties which we believe will lead to increased patient compliance and satisfaction."

"The collaboration between SkinMedica and Dow Pharmaceutical Sciences is an excellent example of how two companies can work together in planning and executing an important development project," said Rex Bright, Chief Executive Officer of SkinMedica. "We will be seeking approval to market Desonate HydroGel in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. ."

About Desonate HydroGel

Desonide is a leading topical steroid prescribed by dermatologists within the U.S. low-potency steroid market which generates 7.7 million annual prescriptions. If approved, Desonate HydroGel would provide SkinMedica with its first steroid product in the $1.1 billion topical steroid market. SkinMedica believes that the HydroGel delivery system has important advantages over more conventional drug delivery vehicles. Conventional steroid formulations including gels and foams typically contain alcohol that may be irritating to patients with atopic dermatitis. HydroGel, an aqueous-based and alcohol-free system, has been developed by Dow Pharmaceutical Sciences to compete against the conventional formulations as a functionally and cosmetically acceptable delivery system. Patients in the clinical trial noted that the HydroGel formulation helped to relieve dryness, which is often a problem with atopic dermatitis. The patented HydroGel drug-delivery technology was licensed by SkinMedica from Dow Pharmaceutical Sciences in June 2003 for use with desonide. The development of Desonate HydroGel is a collaborative effort between Dow Pharmaceutical Sciences and SkinMedica. In April 2005, the companies expanded their collaboration in which SkinMedica licensed the rights to apply the HydroGel technology to certain other prescription steroids worldwide.

About SkinMedica

SkinMedica is a privately held specialty pharmaceutical company marketing both prescription and cosmeceutical cos·me·ceu·ti·cal
n.
A cosmetic that has or is purported to have medicinal properties.
 dermatology products. SkinMedica's Epiquin(R) Micro (4% Hydroquinone hydroquinone /hy·dro·quin·one/ (hi?dro-kwi-non´) the reduced form of quinone, used topically as a skin depigmenting agent.

hy·dro·qui·none
n.
) treats melasma and postinflammatory hyperpigmentation Hyperpigmentation Definition

Hyperpigmentation is the increase in the natural color of the skin.
Description

Melanin, a brown pigment manufactured by certain cells in the skin called melanocytes, is responsible for skin color.
, VANIQA(R) (eflornithine hydrochloride e·flor·ni·thine hydrochloride
n.
An antineoplastic and antiprotozoal orphan drug used in the treatment of Pneumocystis carinii pneumonia in AIDS and of sleeping sickness caused by Gambian trypanosomia.
) Cream, 13.9%, is the only FDA-approved prescription product for the treatment of unwanted facial hair Noun 1. facial hair - hair on the face (especially on the face of a man)
hair - a covering for the body (or parts of it) consisting of a dense growth of threadlike structures (as on the human head); helps to prevent heat loss; "he combed his hair"; "each hair
 in women, and NeoBenz(TM)Micro, which contains a patented gradual-release formulation of benzoyl peroxide benzoyl peroxide
n.
A flammable white granular solid used as a bleaching agent for flour, fats, waxes, and oils, and in pharmaceuticals.


benzoyl peroxide,
n 1.
, treats acne. The company's full line of cosmeceutical products, which is sold through physicians, includes TNS TNS

transcutaneous neural stimulation.
 Recovery Complex(R) with NouriCel-MD(R) to help improve the health and appearance of aging skin. SkinMedica is based in Carlsbad, California. For information, visit: www.skinmedica.com.

SkinMedica cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by SkinMedica that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in SkinMedica's business due to a number of factors, including: (i) we and our products face significant competition; (ii) if we do not successfully manage any growth we experience, we may experience increased expenses without corresponding revenue increases; (iii) we are dependent on third parties for supply of all the products we offer; (iv) unexpected adverse side effects or inadequate therapeutic efficacy of our products could delay or prevent product development or commercialization, or could result in recalls or product liability claims; and (v) we may not be able to identify appropriate acquisition, licensing, or co-promotion candidates in the future or to take advantage of the opportunities we identify All forward-looking statements are qualified in their entirety by this cautionary statement and SkinMedica undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

VANIQA(R), EpiQuin(R) Micro, TNS Recovery Complex(R), NouriCel-MD(R), SkinMedica(R), NeoBenz(TM)Micro, and Desonate(TM) are trademarks of SkinMedica, Inc. HydroGel(TM) is a trademark of Dow Pharmaceutical Sciences.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Feb 22, 2006
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