Barrier Therapeutics, Inc., a pharmaceutical company developing and commercializing products in the field of dermatology, announced the issuance of United States Patent Number 7,179,475, entitled "Anhydrous Topical Skin Preparations." This patent provides coverage for the specific formulation of ketoconazole in a waterless gel that Barrier Therapeutics markets in the US under the trade name Xolegel (ketoconazole, USP) 2 per cent gel, for the treatment of seborrheic dermatitis.

Barrier Therapeutics intends to list this patent, which is scheduled to expire on December 4, 2018, in the Orange Book published by the US Food and Drug Administration (FDA).

"The issuance of this patent is an important milestone in our ongoing effort to further strengthen the intellectual property position of our marketed products," said Al Altomari, chief operating officer of Barrier Therapeutics. "We believe this patent reinforces our competitive position with this product, which we believe offers distinct advantages in treating this irritating and often embarrassing condition."

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.

Xolegel (ketoconazole, USP) gel, 2 per cent 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 per cent ketoconazole, an antifungal agent, in a translucent, non-greasy gel that results in minimal skin irritation. 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 per cent the number of applications required by some traditional seborrheic dermatitis therapies.

Seborrheic dermatitis is a common skin inflammation characterized by a red, scaly, itchy rash primarily occurring on the face, scalp, hairline, eyebrows and trunk. Seborrheic dermatitis affects approximately three to five percent of the US population, or 8.5 million people. 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.