SkinMedica obtains $20.5 million debt facility; FDA approves Desonate for atopic dermatitis

By E. Janene Geiss

Philadelphia, June 21 - SkinMedica, Inc. said Thursday that it has closed a $20.5 million debt facility, consisting of a $13 million term loan and a $7.5 million revolving line of credit with Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services, Inc.

The company also said in a new release that the Food and Drug Administration had previously accepted for filing the company's New Drug Application for Desonate (desonide gel) 0.05% for the treatment of atopic dermatitis.

Desonate is a topical formulation containing the low-potency steroid desonide, which uses a proprietary alcohol-free, aqueous gel delivery vehicle (HydroGel technology) to treat atopic dermatitis, officials said.

The product resulted from a collaboration between SkinMedica and Dow Pharmaceutical Services.

The submission for Desonate was based on results of two pivotal phase 3 clinical trials, which enrolled 582 patients at 46 clinical centers across the United States.

Patients in the clinical trial ranged in age from three months to 18 years.

The trials were designed to demonstrate the superiority of Desonate compared to a placebo without desonide.

Patients received either Desonate or a placebo twice daily for four weeks.

Officials said the results of these two clinical trials demonstrated a highly statistically significant treatment effect for Desonate compared to a placebo.

In addition, a study evaluating the safety and systemic tolerance of Desonate was conducted in pediatric patients with moderate to severe atopic dermatitis.

This study measured the effects of Desonate on the hypothalamic-pituitary-adrenal axis in 40 patients ranging in age from three months to five years, 11 months.

At the four week follow-up visit, cortisol levels in these pediatric patients were within normal limits with no incidence of suppressed adrenal function reported.

SkinMedica said it believes that this supports the safety and systemic tolerance of the Desonate formulation.

SkinMedica is a San Diego specialty pharmaceutical company marketing both prescription and cosmeceutical dermatology products.

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