Barrier Therapeutics Granted European Orphan Drug Status for Liarozole

Jun 13, 2003, 01:00 ET from Barrier Therapeutics, Inc.

    PRINCETON, N.J., June 13 /PRNewswire/ -- Barrier Therapeutics, Inc., an
 emerging specialty pharmaceutical company in the field of dermatology, today
 announced that it has received orphan drug designation from the Commission of
 the European Community for Liarozole, a drug for the treatment of congenital
     "We are very proud that, within one year of launching Barrier
 Therapeutics, we have received this designation from the European Community,"
 said Geert Cauwenbergh, Ph.D., Chairman and Chief Executive Officer of
 Barrier.  "In tandem with our efforts in Europe, we immediately intend to
 begin pursuing an orphan drug designation for Liarozole in the United States.
 These designations provide us with commercialization advantages while bringing
 a therapy to market for an underserved population."
     Congenital ichthyosis is a cluster of rare but often severely debilitating
 diseases of the skin caused by specific genetic defects.  These diseases are
 often characterized by non-inflammatory dryness and scaling of the skin.  They
 are often associated with other defects, as well as abnormalities of lipid
 metabolism.  The different subtypes of ichthyosis are distinguishable
 genetically, clinically, microscopically and by epidermal cell kinetics.
 Congenital ichthyosis affects less than one in 5,000 people. Current systemic
 treatments are limited in use due to the risk of chronic toxicity and acute
 side effects.  Topical treatments have been found to be both limited in
 efficacy and the cause of skin irritation.
     "The limitations associated with current treatment options for congenital
 ichthyosis are of great concern to us," said Dr. Cauwenbergh.  "We intend to
 work closely with the specialists of the European Community to make Liarozole
 available to patients as swiftly as possible."
     About Liarozole
     Liarozole is the first molecule in a new pharmacological class, the RAMBAs
 (Retinoic Acid Metabolism Blocking Agents), to be recognized as a potential
 treatment for this disease cluster.  The drug works by blocking the
 intracellular metabolism of endogenously produced retinoic acid, which is the
 natural active retinoid of the body.  This results in increases in endogenous
 retinoic acid levels to therapeutic quantities; providing the same benefits as
 synthetic retinoid therapy, but with less of the risk for chronic toxicity or
 long term teratogenic effects that may occur with synthetic retinoids.  In
 1997, Lucker G.P. et al. reported the first time on the beneficial therapeutic
 effect of the RAMBA approach with liarozole in ichthyosis (Br J Dermatol 1997;
     About Barrier Therapeutics, Inc.
     Barrier Therapeutics, Inc. is a specialty pharmaceutical company focused
 on the development of novel dermatological therapeutics.  The privately held
 company was formed to develop and market dermatological products based on
 intellectual property initially in-licensed from affiliates of Johnson &
 Johnson.  Barrier's current clinical pipeline includes three products in, or
 entering, Phase III Clinical Trials to treat fungal infections,
 Candida-associated diaper dermatitis, and seborrheic dermatitis.  The
 earlier-stage clinical products -- for psoriasis, acne, skin inflammation,
 fungal infections, allergies, and wound healing -- are complemented by a broad
 portfolio of preclinical candidates.  The Company is headquartered in
 Princeton, New Jersey and has a wholly-owned subsidiary in Geel, Belgium. Web

SOURCE Barrier Therapeutics, Inc.