Barrier Therapeutics Receives Regulatory Approval to Market Xolegel(TM) in Canada
PRINCETON, NJ, Mar 08, 2007 (MARKET WIRE via COMTEX News Network) — Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company that develops and markets dermatology products, today announced that Health Canada’s Therapeutic Products Directorate granted marketing approval to Xolegel(TM) (ketoconazole, topical gel, 2% w/w) for the treatment of seborrheic dermatitis in immunocompetent adults and children twelve years of age and older. Seborrheic dermatitis is a common, recurring skin inflammation characterized by a red, scaly, itchy rash primarily on the face, scalp, hairline, eyebrows and torso.
“We’re very pleased that Health Canada has approved Xolegel and that we will be able to provide this product with its clinical benefit and convenient dosing regimen to patients with this common and distressing skin disorder,” said Joan Chypyha, General Manager of Barrier Therapeutics Canada. “This represents the first Canadian regulatory approval of a product from Barrier Therapeutics’ development pipeline. We anticipate launching Xolegel in Canada in the second half of this year and look forward to adding the product to our line of currently marketed dermatology products in Canada including VANIQA(R), Denavir(R) and Solage(R).”
Traditional prescription therapies for seborrheic dermatitis have previously consisted primarily of treatment options that require multiple applications per day over periods of up to four weeks to be effective. With its unique gel formulation, Xolegel provides patients with a convenient dosing regimen of a once daily application for two weeks, requiring approximately 75% fewer applications compared to some traditional therapies. Xolegel has been shown to be effective with minimal skin irritation and is steroid-free.
Barrier Therapeutics launched Xolegel Gel in the United States in November 2006 after receiving regulatory approval by the U.S. Food and Drug Administration (FDA) in July 2006. Xolegel is the first and only FDA-approved prescription gel formulation of ketoconazole.
For more information about Xolegel or other products mentioned, call 1-866-440-5507 or visit the company web site at www.barriertherapeutics.com.
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. 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 Canada
Barrier Therapeutics Canada is a wholly owned subsidiary of Barrier Therapeutics, Inc. based in Ontario, Canada. The marketing and sales organization currently markets three pharmaceutical products in Canada: VANIQA(R) (eflornithine hydrochloride) Cream 13.9% for slowing the growth of unwanted facial hair in women; Denavir(R) (penciclovir cream) Cream 1% for the treatment of herpes labialis (cold sores) in adults, and Solage(R) (mequinol 2%, tretinoin 0.01%) Topical Solution for the treatment of solar lentigines, a common condition also known as “age spots” or “liver spots.”
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(TM) (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 acne, psoriasis, onychomycosis and other fungal infections of the skin. 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, Vusion and Solage are 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, including statements regarding the anticipated launch timing for Xolegel in Canada. 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 September 30, 2006 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.
Barrier Therapeutics, Inc.
Anne M. VanLent
EVP & CFO
Barrier Therapeutics Canada
Lazar Partners Ltd.
SOURCE: Barrier Therapeutics, Inc.