July 28, 2008
Barrier Therapeutics Introduces Dual-Component Xolegel CorePak(TM) for Seborrheic Dermatitis
Barrier Therapeutics, Inc. (NASDAQ: BTRX) announced today the introduction of Xolegel CorePak(TM) for the treatment of seborrheic dermatitis. Now, patients with this chronic skin condition need only one prescription to get quick itch relief and to safely manage the overall condition long term.
The two products in Xolegel CorePak are new Xebcort(TM) Gel, a 1% hydrocortisone gel, and Xolegel(R) (ketoconazole, USP) Gel, 2%. Xebcort Gel provides quick symptom relief and is presented as a 0.8 ounce tube designed for short term use to relieve itch. Xolegel CorePak contains 45 grams of Xolegel Gel provided in three 15 gram tubes. In a long-term safety trial with Xolegel Gel, patients remained symptom free for up to 8 weeks post-treatment.
"By providing the hydrocortisone and ketoconazole gels separately in one prescription, Xolegel CorePak encourages patients to comply with their physician's recommendations to better manage this chronic and common inflammatory skin condition," explained Al Altomari, Chief Executive Officer of Barrier Therapeutics.
More About the Xolegel Family of Products
With the addition of Xolegel CorePak, there is now a family of Xolegel products available to treat the variety of seborrheic dermatitis patient types.
Xolegel Gel is a cosmetically elegant treatment which offers powerful relief for seborrheic dermatitis of the face and body in immunocompetent adults and children 12 years of age and older. Xolegel Gel is a patented topical formulation of 2% ketoconazole in a translucent, non-greasy gel. 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 other topical antifungal seborrheic dermatitis therapies. Xolegel Gel was approved by the FDA in July 2006 and is the first and only FDA-approved prescription gel formulation of ketoconazole.
Xolegel Duo(TM), available by prescription, also consists of 45 grams of Xolegel (ketoconazole, USP) Gel, 2% provided in 15 gram tubes, and one 1.7 ounce bottle of Head & Shoulders(R) (pyrithione zinc 1%) anti-dandruff shampoo. It is designed to provide a more complete treatment option for effectively managing seborrheic dermatitis by providing a prescription gel formulation of ketoconazole for the face and body plus a medicated shampoo for the scalp in one convenient package. All Xolegel products are covered under the company's Patient 1st Program. The program allows most commercial insurance patients to receive their prescription for one $10 copay. For additional information on the entire family of Xolegel products, visit www.xolegel.com
About Seborrheic Dermatitis
Seborrheic dermatitis is a common inflammatory skin condition 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 prescription pharmaceutical products in the United States: Xolegel(R) (ketoconazole, USP) Gel, 2%, for seborrheic dermatitis; Vusion(R) (0.25% miconazole nitrate, 15% zinc oxide, 81.35% white petrolatum) Ointment, for diaper dermatitis complicated by documented candidiasis; and Solage(R) (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 superficial fungal infections. The company is headquartered in Princeton, New Jersey and has a wholly-owned subsidiary in Geel, Belgium. More information about Barrier Therapeutics can be found on its corporate website at: www.barriertherapeutics.com. Xolegel, Vusion, Solage, Xolegel CorePak and Xolegel Duo are all trademarks of Barrier Therapeutics, Inc.
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. 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 quarter ended March 31, 2008 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.
Contact: Lazar Partners Ltd. Erich Sandoval, Public Relations (212) 867-1762 Barrier Therapeutics, Inc. Michael Laferrera VP, Marketing & Commercial Planning (609) 945-1242
SOURCE: Barrier Therapeutics, Inc.