Barrier Therapeutics Granted European Orphan Drug Status for Liarozole
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 ichthyosis. "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; 136:71-75). 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 site: www.barriertherapeutics.com
SOURCE Barrier Therapeutics, Inc.
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