SkinMedica(R) Announces New Debt Facility and FDA Acceptance of Its New Drug Application for Desonate(TM).SAN DIEGO -- SkinMedica, Inc., a specialty pharmaceutical company focused on developing, acquiring and commercializing products that improve the appearance of skin and treat dermatologic conditions and diseases, today announced that it has closed a $20.5 million debt facility, consisting of a $13.0 million Term Loan and a $7.5 million Revolving Line of Credit Revolving line of credit A bank line of credit on which the customer pays a commitment fee and can take and repay funds at will. Normally a revolving LOC involves a firm commitment from the bank for a period of several years. , with Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services, Inc. "This facility will provide us with the resources necessary to continue to execute our business strategy," stated Rex Bright, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . The Company also announced that the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) had previously accepted for filing the Company's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Desonate(TM) (desonide gel) 0.05% for the treatment of 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 . Desonate is a topical formulation containing the low-potency steroid desonide, which utilizes a proprietary alcohol-free, aqueous gel delivery vehicle (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. (TM) Technology) to treat atopic dermatitis. "The acceptance of this NDA represents a milestone for SkinMedica," said Bright. "If approved by the FDA, this product, which resulted from a collaboration between SkinMedica and Dow Pharmaceutical Sciences, 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 NDA submission for Desonate was based on the results of two pivotal Phase III clinical trials, which enrolled 582 patients at 46 clinical centers across the United States. Patients in the clinical trial ranged from 3 months to 18 years of age. The clinical trials were designed to demonstrate the superiority of Desonate compared to vehicle (placebo) without desonide. Patients received either Desonate or placebo twice daily for four weeks. The results of these two clinical trials demonstrated a highly statistically significant treatment effect for Desonate compared to placebo (p value of less than 0.001). 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 (HPA (1) (High Performance Addressing) Refers to a variety of earlier addressing techniques that improved the quality of a passive matrix (LCD) screen. (2) (High Power A ) axis in 40 patients ranging in age from 3 months to five years, 11 months. At the four week follow-up visit, cortisol cortisol (kôr`tĭsôl') or hydrocortisone, steroid hormone that in humans is the major circulating hormone of the cortex, or outer layer, of the adrenal gland. levels in these pediatric patients were within normal limits with no incidence of suppressed adrenal adrenal /ad·re·nal/ (ah-dre´n'l) 1. paranephric. 2. adrenal gland. 3. pertaining to an adrenal gland. ad·re·nal adj. 1. function reported. SkinMedica believes that this supports the safety and systemic tolerance of the Desonate formulation. Low potency steroids are widely used to treat atopic dermatitis in both adults and children. These products are primarily prescribed by dermatologists, pediatricians and primary care physicians. Prescriptions for low potency topical steroids currently account for approximately 7.7 million prescriptions annually. Approval of Desonate(TM) (desonide) would provide SkinMedica with its first steroid product in the $1.1 billion dollar topical steroid market. SkinMedica believes that the HydroGel(TM) Technology delivery system may have important patent benefits compared to 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 provide patent benefits as a functionally and cosmetically acceptable delivery system. The filing of an NDA with the FDA is an important step in the approval process in the United States. Acceptance for filing by the FDA does not mean that the NDA has been or will be approved, nor does it represent an evaluation of the adequacy of the data submitted. 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 in women, and NeoBenz(R) Micro, which contains a patented gradual-release formulation of benzoyl peroxide, 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 more information, visit: www.skinmedica.com. EpiQuin(R) Micro, NeoBenz(R) Micro, NouriCel-MD(R), SkinMedica(R), TNS Recovery Complex(R) and VANIQA(R) are trademarks of SkinMedica, Inc. About Merrill Lynch Capital Merrill Lynch Capital, a division of Merrill Lynch Business Financial Services Inc., is a leading commercial finance business providing a broad range of structured financing solutions to middle market companies nationwide. Based in Chicago and with regional offices throughout the country, Merrill Lynch Capital is focused on four market segments-corporate finance, equipment finance, healthcare finance and real estate finance. The Healthcare Finance Group of Merrill Lynch Capital provides senior financing solutions for middle market healthcare companies, offering cash flow, asset, life sciences related and real estate based credit facilities and junior secured debt, and equity co-investments. The typical transaction size for senior debt is between $10 million and $250 million. |
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