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."
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.