Healthcare Industry News: Barrier Therapeutics
News Release - August 2, 2007
Barrier Therapeutics Introduces New Xolegel Duo(TM) Offering at the American Academy of Dermatology (AAD) Summer Academy Meeting 2007
Provides Patients With Complete System for the Treatment of Seborrheic Dermatitis of the Scalp, Face, and BodyPRINCETON, NJ--(Healthcare Sales & Marketing Network)--Aug 2, 2007 -- Barrier Therapeutics, Inc. (NasdaqGM:BTRX ), a pharmaceutical company developing and commercializing products in the field of dermatology, is announcing the market introduction of Xolegel Duo(TM) today at the American Academy of Dermatology (AAD) Summer Academy Meeting 2007. Xolegel Duo is a complete system for the treatment of seborrheic dermatitis of the scalp, face, and body. Seborrheic dermatitis is a common, recurring skin inflammation characterized by a red, scaly, itchy rash primarily on the face, scalp, hairline, eyebrows and torso.
"Based on the response we have already received from dermatologists, we firmly believe that this product allows us an opportunity to serve our customer better as well as adding significantly to the value of the Xolegel brand," said Al Altomari, Chief Operating Officer of Barrier Therapeutics. "With an estimated 90% of patients with seborrheic dermatitis believed to have affected areas on the scalp as well as on the face and body(1), we are pleased to offer the complete and convenient system of Xolegel Duo to help patients effectively manage this irritating and often embarrassing condition."
Available by prescription in the United States beginning later this month, Xolegel Duo, consisting of Xolegel(TM) (ketoconazole, USP) Gel 2% (15g tube) and Xolex(TM) (zinc pyrithione 1%) Shampoo (4 oz. bottle), is designed to help enhance patient compliance in effectively treating seborrheic dermatitis by providing a gel formulation for the face and body plus a medicated shampoo for the scalp in one convenient package. Until now, physicians typically recommended two distinct products for patients suffering from seborrheic dermatitis, one product for the scalp and a different product for the face and body.
"Certain disease conditions lend themselves well to combining an over-the-counter product with a prescription treatment. The combination of Xolegel Gel with Xolex Shampoo provides a logical and convenient single solution for patients with seborrheic dermatitis rashes on the scalp, as well as the face and body," said Dr. Hilary Baldwin, Associate Professor and Vice Chair, Department of Dermatology, SUNY Brooklyn. "I believe dermatologists should have every reason to look forward to the introduction of Xolegel Duo."
About Xolegel Duo(TM)
Xolegel Duo, available by prescription only, consists of Xolegel (ketoconazole, USP) Gel 2% (15g tube) and Xolex (zinc pyrithione 1%) Shampoo (4 oz. bottle). Xolegel Duo is designed to help enhance patient compliance in effectively treating seborrheic dermatitis by providing a prescription gel formulation for the face and body plus a medicated shampoo for the scalp in one convenient package.
Xolegel Gel is a cosmetically elegant, steroid-free treatment for seborrheic dermatitis of the face and body in immunocompetent adults and children 12 years of age and older. Xolegel Gel is a topical formulation of 2% ketoconazole, an antifungal agent, in a translucent, non-greasy gel that provides powerful relief comparable to steroid formulations. Xolegel Gel applies smoothly and dries clear. With its unique gel formulation, Xolegel Gel provides patients with a dosing regimen of a once daily application for only 14 days, thus reducing by approximately 75 percent the number of applications required by some traditional seborrheic dermatitis therapies. Xolegel Gel was approved by the FDA in July 2006 and was launched by Barrier Therapeutics in November 2006. Xolegel Gel is the first and only FDA-approved prescription gel formulation of ketoconazole.
Xolex Shampoo uses the latest silicone conditioning agent (an inert, hypoallergenic, non-comedogenic, and non-acnegenic substance) to increase hair smoothness and to decrease friction, coupled with the zinc pyrithione to treat the seborrheic dermatitis. In a clinical study, patients preferred a similar zinc pyrithione 1% medicated shampoo for its cosmetic attributes and overall performance versus 2% ketoconazole shampoo.(2) The U.S. medicated shampoo market has an estimated 30 million adult users.
About Seborrheic Dermatitis
Seborrheic dermatitis is a common skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and torso. Seborrheic dermatitis affects approximately three to five percent of the U.S. population, or 8.5 million people. An estimated 90% of seborrheic dermatitis patients reportedly have affected areas on the scalp as well as on the face and/or body. There is no known cause, cure or way of preventing seborrheic dermatitis but it can be effectively managed. Traditional prescription therapies for this condition have consisted primarily of shampoos, topical antifungal creams and topical steroids that typically require two or more applications per day over periods of up to four weeks to be effective.
About Barrier Therapeutics
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the development and commercialization of products in the field of dermatology. Barrier Therapeutics currently markets three pharmaceutical products in the United States: Xolegel(TM) (ketoconazole, USP) Gel, 2%, for seborrheic dermatitis; Vusion® (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment, for diaper dermatitis complicated by documented candidiasis; and Solage® (mequinol 2.0%, tretinoin 0.01%) Topical Solution, for solar lentigines. Barrier Therapeutics has other product candidates in various stages of clinical development for the treatment of a range of dermatological conditions, including onychomycosis, psoriasis, acne, skin allergies, and acute fungal infections. The company is headquartered in Princeton, New Jersey and has wholly owned subsidiaries in Geel, Belgium and Ontario, Canada. More information about Barrier Therapeutics can be found on its corporate website at: www.barriertherapeutics.com.
Xolegel, Xolex, Xolegel Duo, Vusion and Solagé are trademarks of Barrier Therapeutics, Inc.
(1) James Del Rosso. Keeping It Clean. Skin & Aging. 2003;8:82-88
(2) Z. Draelos, MD, Journal of Investigative Dermatology Symposia Proceedings, 2005;10: 201-204
Safe Harbor Statement
In addition to historical facts or statements of current condition, this press release contains forward-looking statements within the meaning of the "Safe Harbor" provisions of The Private Securities Litigation Reform Act of 1995. Forward-looking statements provide Barrier's current expectations or forecasts of future events including statements regarding adding to the value of the Xolegel brand. Barrier's performance and financial results could differ materially from those reflected in these forward-looking statements due to the marketplace acceptance of Barrier's products, Barrier's ability to execute its commercial and clinical strategy, the decisions of regulatory authorities, the results of clinical trials and strategic decisions regarding its pipeline, general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries generally. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements, please see the risk factors in the company's Quarterly Report on Form 10-Q for the period ended March 31, 2007 which is on file with the Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Barrier undertakes no obligation to update publicly any forward-looking statement.
Source: Barrier Therapeutics
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