SOURCE: Barrier Therapeutics, Inc.

May 03, 2007 11:00 ET

Barrier Therapeutics Receives FDA Approval for Solagé® Topical Solution Labeling Expansion

PRINCETON, NJ -- (MARKET WIRE) -- May 3, 2007 -- Barrier Therapeutics, Inc. (NASDAQ: BTRX), a pharmaceutical company that develops and markets dermatology products, today announced that the U.S. Food and Drug Administration (FDA) approved the company's application to add clinical data to the prescribing information for Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution. The newly added information shows that Solagé treatment for solar lentigines (age spots) is safe and effective in patients with darker skin types.

The new prescribing information includes data from a Phase 4 post-approval study that demonstrated favorable results on the efficacy, safety and tolerability of Solagé for the treatment of solar lentigines in patients with darker skin types. Study findings on the safety and tolerability of Solagé in darker phototypes demonstrated a favorable benefit-to-risk ratio in the treatment of solar lentigines in African American, Asian and Latin/Hispanic patients. Over 80% of treated patients in this study achieved a significant response to therapy for facial and arm lesions. Additionally, the majority of subjects maintained clinical benefit during a 4-week post treatment period. These results are consistent with efficacy findings previously reported for Caucasian individuals.

About Solagé

Barrier Therapeutics currently markets Solagé® (mequinol 2%, tretinoin 0.01%) Topical Solution in the United States where it is indicated for the treatment of solar lentigines and also markets the product in Canada where the indication includes use for related hyperpigmented lesions. Solagé Topical Solution is currently the only combination product approved for the treatment of solar lentigines. More importantly, Solagé Topical Solution has been approved as a safe and effective treatment of solar lentigines as part of a comprehensive skin care and sun avoidance program. Solagé Topical Solution is the only FDA approved combination skin lightening agent that does not contain hydroquinone.

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™ (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 Solagé® (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, Vusion and Solagé 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. 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 Annual Report on Form 10-K for the year ended December 31, 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.

In addition, please note that success in clinical trials does not mean that subsequent trials will confirm earlier findings. No assessment of the efficacy or safety of any product candidate can be considered definitive until all clinical trials needed to support a submission for marketing approval are complete.

Contact Information

  • Contact:
    Barrier Therapeutics, Inc.
    Anne M. VanLent
    EVP & CFO
    (609) 945-1202

    Lazar Partners Ltd.
    Gregory Gin
    Investor Relations
    (212) 867-1762