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.