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FDA Approves Connetics' Verdeso Foam for the Treatment of Mild-to-Moderate Atopic Dermatitis.


PALO ALTO, Calif. -- Connetics Corporation (Nasdaq:CNCT CNCT Connect
CNCT Certified Network Computer Technician
):

- First approved product formulated in Connetics' emulsion foam (VersaFoam(R)-EF) delivery vehicle

- Commercial launch planned for fourth quarter 2006

Connetics Corporation (Nasdaq:CNCT), a specialty pharmaceutical company that develops and commercializes dermatology products, today 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.
) has approved Verdeso(TM) (desonide) Foam, 0.05%, for the treatment of mild-to-moderate 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
. Verdeso, previously referred to as Desilux(TM), is a low-potency topical steroid and is the first approved product formulated in Connetics' proprietary VersaFoam(R)-EF emulsion formulation foam vehicle. Connetics expects to begin marketing Verdeso to physicians in the fourth quarter of 2006 in 50g and 100g trade unit sizes.

"Today's approval allows us to bring a new and valuable option to physicians for treating children and adults with atopic dermatitis," said Lincoln Krochmal, M.D., Executive Vice President of Research and Product Development for Connetics. "We look forward to commercializing the first product in our patented emulsion foam vehicle, formulated with emollient emollient /emol·li·ent/ (e-mol´yent)
1. softening or soothing.

2. an agent that softens or soothes the skin, or soothes an irritated internal surface.


e·mol·lient
adj.
 ingredients, and our first product approved for 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.
 use. The low-potency corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and  desonide in VersaFoam-EF has been shown in our clinical trials to be safe and effective in children as young as three months of age. The ethanol-free vehicle in Verdeso is intended to provide an elegant, moisturizing, non-stinging product that absorbs quickly into the skin and does not feel sticky like an ointment or cream. In our pivotal clinical trial, burning sensation at the application site was reported by 3 percent of all treated patients and 1 percent of pediatric patients between three months and three years of age."

Thomas G. Wiggans, Chairman and Chief Executive Officer of Connetics, said, "We have established leading brands in the topical mid- and super-high potency steroid categories with Luxiq(R) and OLUX(R), respectively. With the addition of low-potency Verdeso, Connetics now offers physicians a complete line of topical steroids with enhanced cosmetic elegance, which we believe leads to increased patient compliance and satisfaction. Verdeso is a strong strategic fit for our dermatology sales force as well as the pediatric sales force we acquired earlier this year. Looking forward, we anticipate the potential approval of a second product using the VersaFoam-EF technology, Primolux(TM), with a January 2007 PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA)  date."

About Verdeso

Approximately 7.7 million prescriptions are written annually in the U.S. by dermatologists for low-potency steroid products, and desonide is the leading topical corticosteroid in this market. The approval of Verdeso provides Connetics with its first low-potency steroid product and expands the Company's topical steroid franchise to include a product offering in each of the three potency segments of the total $1.1 billion topical steroid market.

Connetics believes that its emulsion foam delivery vehicle is an important advancement in topical steroid therapy steroid therapy Therapeutics Treatment with corticosteroids to ↓ swelling, pain, and other Sx of inflammation. See Steroid. . The vehicle, which was granted a patent in May 2004, contains no ethanol and is reported by patients to have a moisturizing feel. The vehicle was developed by Connetics as a cosmetically and functionally elegant formulation to compete against creams and ointment-based treatments, and to address a U.S. market opportunity that currently exceeds $725 million annually.

About VersaFoam Technology

Connetics owns worldwide rights to a number of unique topical delivery systems and has branded its proprietary foam drug delivery vehicle VersaFoam. This versatile topical drug Topical drug
Drug or medication applied to a specific area of the skin and affecting only the area to which it is applied.

Mentioned in: Minoxidil
 delivery vehicle is available in three formulations including VersaFoam-HF(TM) , VersaFoam-EF(TM) and VersaFoam-AF(TM). VersaFoam Hydroethanolic Formulation (HF) is neither hydrating nor drying. It dissolves rapidly at skin temperature (90-95(degree) F) and leaves minimal residue on the skin. VersaFoam-EF is an emulsion formulation that provides many of the benefits of ointments, creams and emollient-cream vehicles, but with the cosmetic elegance of VersaFoam. VersaFoam Aqueous Formulation (AF) is a hydrating version of VersaFoam. Medications formulated with VersaFoam-AF are in development. VersaFoam formulations are designed to address specific patient preferences and skin types, and to have important functional benefits and cosmetic benefits compared with conventional delivery vehicles such as creams, ointments, gels and lotions. Each VersaFoam formulation is easy to apply and spread, disappears into the skin quickly and offers the cosmetic elegance of a fine skincare product. In addition to Verdeso, Connetics' VersaFoam-based products are OLUX for scalp dermatoses and non-scalp psoriasis, Luxiq Foam for scalp dermatoses and Evoclin(R) Foam for acne. These formulations have earned wide acceptance by physicians and patients due to their clinical effectiveness, high quality and cosmetic elegance. For more information on VersaFoam, please visit www.VersaFoam.com.

About Atopic Dermatitis

Atopic dermatitis (AD), commonly referred to as eczema, is a chronic skin disorder categorized by scaly scal·y
adj.
1. Covered or partially covered with scales.

2. Shedding scales or flakes; flaking.



scaly

skin condition characterized by scales; scalelike.
 and itching rashes. People with eczema often have a family history of allergic conditions such as asthma, hay fever hay fever, seasonal allergy causing inflammation of the mucous membranes of the nose and eyes. It is characterized by itching about the eyes and nose, sneezing, a profuse watery nasal discharge, and tearing of the eyes.  or eczema.

AD is most common in infants, and at least half of those cases clear by age three. In adults AD generally is a chronic, or recurring, condition. In AD a hypersensitivity reaction (similar to an allergy) occurs in the skin, causing chronic inflammation chronic inflammation
n.
Inflammation that may have a rapid or slow onset but is characterized primarily by its persistence and lack of clear resolution; it occurs when the tissues are unable to overcome the effects of the injuring agent.
. The inflammation causes the skin to become itchy and scaly. Chronic irritation and scratching can cause the skin to thicken thick·en  
tr. & intr.v. thick·ened, thick·en·ing, thick·ens
1. To make or become thick or thicker: Thicken the sauce with cornstarch. The crowd thickened near the doorway.

2.
 and develop a leathery leath·er·y  
adj.
Having the texture or appearance of leather: a leathery face.



leather·i·ness n.
 texture. Exposure to environmental irritants can worsen symptoms, as can dryness of the skin, exposure to water, temperature changes and stress.

Symptoms of AD can include intense itching, blisters with oozing oozing

exudation of fluid.
 and crusting, skin redness or inflammation around the blisters, and rash.

About Connetics

Connetics Corporation is a specialty pharmaceutical company focused on the development and commercialization of innovative therapeutics for the dermatology market. The Company's commercial products are OLUX (clobetasol propionate clobetasol propionate (klōbā´tsol´ prō´pē ) Foam, 0.05%; Luxiq (betamethasone betamethasone /be·ta·meth·a·sone/ (ba?tah-meth´ah-son) a synthetic glucocorticoid, the most active of the antiinflammatory steroids; used topically as the benzoate, dipropionate, or valerate salts as an antiinflammatory, topically or  valerate) Foam, 0.12%; Soriatane(R) (acitretin) capsules; Evoclin (clindamycin) Foam, 1%; and Verdeso (desonide) Foam, 0.05%. Connetics is developing Primolux (clobetasol propionate) Foam, 0.05%, a super high-potency topical steroid formulation to treat atopic dermatitis and plaque psoriasis; Extina(R) (ketoconazole ketoconazole /ke·to·co·na·zole/ (ke?to-kon´ah-zol) a derivative of imidazole used as an antifungal agent.

ke·to·co·na·zole
n.
) Foam, 2%, to treat seborrheic dermatitis Seborrheic Dermatitis Definition

Seborrheic dermatitis is a common inflammatory disease of the skin characterized by scaly lesions usually on the scalp, hairline, and face.
; and Velac(R) (a combination of 1% clindamycin and 0.025% tretinoin tretinoin /tret·i·noin/ (tret´i-noin?) the all-trans stereoisomer of retinoic acid, used as a topical keratolytic in the treatment of acne vulgaris and disorders of keratinization and administered orally in the treatment of acute ) Gel, to treat acne. Connetics' product formulations are designed to improve the management of dermatological diseases and provide significant product differentiation. For more information about Connetics and its products, please visit www.connetics.com.

Forward-Looking Statements

Except for historical information, this press release includes "forward-looking statements" within the meaning of the Securities Litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 Reform Act. All statements included in this press release that address activities, events or developments that Connetics expects, believes or anticipates will or may occur in the future, including, particularly, statements about the timing and outcome of submissions to the FDA, the timing of commercial launch and market potential of Verdeso Foam relative to currently available treatments in the U.S., the impact of Connetics' products on patient compliance and satisfaction, and the significance of providing a topical steroid therapy in an emulsion foam delivery vehicle, are forward-looking statements. All forward-looking statements are based on assumptions made by Connetics' management based on its experience and perception of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond Connetics' control, and which could cause actual results or events to differ materially from those expressed in such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, risks and other factors that are discussed in documents filed by Connetics with the Securities and Exchange Commission from time to time, including Connetics' Annual Report on Form 10-K/A for the year ended December 31, 2005 and the Form 10-Q for the quarter ended June 30, 2006. Forward-looking statements represent the judgment of the Company's management as of the date of this release, and Connetics disclaims any intent or obligation to update any forward-looking statements.

Press Release Code: CNCT-G
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
Date:Sep 19, 2006
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