Barrier Therapeutics' Liarozole Receives FDA Orphan Drug Status

Designation Covers Congenital Ichthyosis, a Group of Severe Hereditary Skin


Jun 22, 2004, 01:00 ET from Barrier Therapeutics, Inc.

    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:
     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.