PRINCETON, N.J., May 22, 2008 (PRIME NEWSWIRE) -- Barrier Therapeutics, Inc. (Nasdaq:BTRX), a pharmaceutical company developing and commercializing products in the field of therapeutic dermatology, announced that it will package its seborrheic dermatitis treatment Xolegel(r) (ketoconazole, USP) Gel, 2%, with The Procter & Gamble Company's (NYSE:PG) Head & Shoulders(r) (pyrithione zinc 1%) anti-dandruff shampoo as Xolegel Duo(tm). The kit, which will be available by prescription in June, offers patients a complete treatment regimen for seborrheic dermatitis, a recurring inflammatory skin condition characterized by a red, scaly, itchy rash primarily on the face, scalp, hairline, eyebrows and torso.
"We're pleased to include Head & Shoulders shampoo, one of P&G's most trusted brands, in our Xolegel Duo," said Al Altomari, Chief Executive 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, this complete treatment system can help patients effectively manage this irritating and often embarrassing condition."
Under the terms of the deal, P&G will supply Barrier Therapeutics with 1.7oz bottles of Head & Shoulders shampoo for inclusion in Xolegel Duo(tm) and Barrier Therapeutics will handle all logistics of assembling the kits, as well as wholesaler distribution, pricing, and overall marketing, promotion and sale. Barrier Therapeutics will continue to book sales and receive all proceeds from the sale of Xolegel Duo.
Xolegel Duo 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. Barrier Therapeutics launched Xolegel Duo, a kit containing Xolegel and Xolex(tm) (zinc pyrithione 1%) an anti-dandruff shampoo, at the American Academy of Dermatology last August. Until then, 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.
About Xolegel Duo(tm)
Xolegel Duo, available by prescription only, consists of Xolegel (ketoconazole, USP) Gel, 2% (15g tube) and a 1.7oz bottle of Head & Shoulders shampoo.
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 some traditional 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. For additional information visit www.xolegel.com
About Head & Shoulders(r)
One of Procter & Gamble's most trusted billion dollar brands, Head & Shoulders has helped provide millions of consumers with relief from dandruff symptoms including visible flakes, redness, dryness, itchiness and irritation for over 40 years. The proprietary zinc pyrithione (ZPT) formula in Head & Shoulders effectively maximizes the bio-availability of ZPT enabling it to get to the source of dandruff more effectively. Offering a full line of shampoos and conditioners, Head & Shoulders provides both scalp and hair care. Head & Shoulders products are available at food, drug and mass market retailers. For additional information visit www.headandshoulders.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 and Xolegel Duo are trademarks of Barrier Therapeutics, Inc.
Head & Shoulders is a registered trademark of P&G.
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, including statements regarding the expected timing of the availability of the latest Xolegel Duo kit. 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.