PRINCETON, N.J., June 22 /PRNewswire-FirstCall/ -- Barrier Therapeutics, Inc. (Nasdaq: BTRX), a biopharmaceutical company developing pharmaceutical products in the field of dermatology, today announced that its drug, Liarozole, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of congenital ichthyosis, a group of debilitating and, in certain cases, life-threatening skin disorders that together affect approximately 40,000 people in the United States. There are currently no prescription drugs approved for congenital ichthyosis in the U.S. In prior Phase II and Phase III clinical trials, oral Liarozole, which represents a new concept in treating this condition, was well tolerated and a majority of patients showed marked improvement in their condition. The drug previously was granted Orphan Drug status by the European Commission. "Liarozole provides a promising and novel approach to treating these diseases," said Geert Cauwenbergh, Chairman and Chief Executive Officer of Barrier. "The potential importance of Liarozole for congenital ichthyosis patients is highlighted by its orphan drug designation in both the United States and Europe, and is an example of Barrier's commitment to develop innovative treatments to address common skin diseases, as well as serious unmet medical needs in specific patient populations." Liarozole belongs to a novel class of molecules known as retinoic acid metabolism blocking agents, or RAMBAs. Retinoic acid is a natural vitamin, known as vitamin A, that is essential for optimal functioning of the skin. In contrast to current synthetic retinoid treatments, which introduce man-made forms of vitamin A into the body, RAMBAs work by slowing the metabolism or degradation of the body's own retinoic acid. This causes the body to maintain higher, potentially therapeutic levels of this natural vitamin in cells of the skin. These increased vitamin levels return to normal soon after stopping treatment with Liarozole. Consequently, RAMBAs, such as Liarozole, may provide the same therapeutic benefits as synthetic retinoid therapy but potentially with less risk of retinoid build-up in tissues and the resulting side effects. Barrier's second generation RAMBA, Rambazole, is in early clinical development for psoriasis and acne. Orphan drug designation may be granted by the FDA to drugs intended to treat a rare disease or condition that affects fewer than 200,000 individuals in the United States. If a product which has an orphan drug designation subsequently receives the first FDA approval for the orphan indication, it is entitled to market exclusivity for a period of up to seven years. Congenital ichthyosis represents a family of rare and debilitating disorders characterized by drying and scaling of the body's largest organ, the skin. These disorders may result in excessive fluid loss, increased risk of infection and chronic lesions that can be painful and disfiguring, which in turn have significant social and psychological impact. In infants, certain types of congenital ichthyosis can be life-threatening. There currently are no approved prescription drugs to treat these conditions in the United States. Congenital ichthyosis is distinct from a more common and less severe form of ichthyosis called ichthyosis vulgaris, which is easier to manage. About Barrier Therapeutics, Inc. Barrier Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of innovative pharmaceutical products to treat diseases of the skin. The Company has eight product candidates in various stages of clinical development. The four most advanced product candidates, which are in or entering Phase III clinical trials, are under development for the treatment of seborrheic dermatitis, Candida-associated diaper dermatitis, fungal infections, including vaginal candidiasis and onychomycosis, and congenital ichthyosis. Barrier has product candidates in earlier stages of clinical development for the treatment of acne, psoriasis, fungal infections, allergies and dermatitis. The Company is headquartered in Princeton, New Jersey and has a wholly-owned subsidiary in Geel, Belgium. Website: http://www.barriertherapeutics.com 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 possible therapeutic benefits of Liarozole. 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 general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries. For a discussion of these and other risks and uncertainties that may effect the forward-looking statements please see the risk factors in Form 10-Q for the quarterly period ended March 31, 2004, 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. Therefore, you should not rely on any such factors or forward-looking statements. Barrier undertakes no obligation to update publicly any forward-looking statement.
SOURCE Barrier Therapeutics, Inc.