Barrier Therapeutics, Inc. (NASDAQ: BTRX), a
pharmaceutical company developing and commercializing products in the field
of dermatology, today announced that the U.S. Food and Drug Administration
(FDA) has accepted for filing the Company's New Drug Application (NDA) for
Sebazole(TM) (ketoconazole USP 2%) topical gel for the treatment of
seborrheic dermatitis. Sebazole is a topical formulation consisting of
2.0% ketoconazole, an antifungal agent, formulated in a waterless gel for
once-daily application. The NDA for Sebazole topical gel was submitted to
the FDA in September 2005.
"Sebazole is our second product candidate currently under active FDA
review, following Vusion(TM), which is a significant milestone for
Barrier," stated Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier
Therapeutics, Inc. "If approved by the FDA, we believe Sebazole will
provide significant patient benefits in the non-steroidal management of
seborrheic dermatitis, with less risk for irritation and a more convenient
treatment regimen as compared to currently available ketoconazole cream
products."
The NDA submission for Sebazole was based on the results of a pivotal
confirmatory Phase 3 clinical trial in addition to the results from two
prior supportive Phase 3 trials. In the confirmatory two arm Phase 3
pivotal study, which enrolled 459 subjects at 24 centers across the United
States, Sebazole achieved statistical significance at the primary endpoint
as compared to the vehicle treated patients (p=0.001). The study was a
double blind, vehicle-controlled study of once-a-day Sebazole treatment
compared to the vehicle (the waterless gel formulation alone). Sebazole
also achieved statistical significance for the same primary efficacy
endpoint in both of the prior Phase 3 clinical trials, which enrolled a
combined total of 474 patients in the Sebazole and vehicle arms at 47
centers in the United States and Europe (U.S. study: p < 0.001 and European
study: p=0.021). The earlier two Phase 3 studies had four treatment arms
(Sebazole, the vehicle alone, the vehicle containing a topical steroid
known as desonide, and the combination of desonide with Sebazole). The
primary efficacy endpoint for all three Phase 3 studies was the proportion
of subjects who were effectively treated at day 28, which is 14 days
following the end of a two-week treatment period.
The filing of an NDA with the FDA is an important step in the approval
process in the United States. Acceptance for filing by the FDA does not
mean that the NDA has been or will be approved, nor does it represent an
evaluation of the adequacy of the data submitted.
About Seborrheic Dermatitis
Seborrheic dermatitis is a skin inflammation characterized by a red, scaly,
itchy rash primarily occurring on the face, scalp, hairline, eyebrows and
trunk. The condition often recurs, thereby requiring re-treatment over
time. Seborrheic dermatitis affects approximately 3% to 5% of the U.S.
population. Barrier Therapeutics estimates that approximately 8.5 to 14.3
million people in the U.S. are affected. Current prescription therapies
consist primarily of topical ketoconazole creams and topical steroids.
These treatments typically require multiple applications per day over
periods of up to four weeks to be effective.
About Barrier Therapeutics, Inc.
Barrier Therapeutics, Inc. is a pharmaceutical company focused on the
discovery, development and commercialization of pharmaceutical products in
the field of dermatology. The Company currently markets Solagé®
(mequinol 2%, tretinoin 0.01%) Topical Solution in the U.S. and Canada for
the treatment of solar lentigines, a common condition also known as "age
spots," and markets VANIQA®, (eflornithine hydrochloride) Cream 13.9% for
slowing the growth of unwanted facial hair in women in Canada. Barrier has
eight product candidates in various stages of clinical development. The
four most advanced product candidates include Vusion(TM) (formerly known as
Zimycan(TM)) for the treatment of diaper dermatitis complicated by
candidiasis, Sebazole(TM), for the treatment of seborrheic dermatitis,
which are under FDA review, and two other product candidates in Phase 3 for
the treatment of onychomycosis and congenital ichthyosis, respectively.
Barrier has product candidates in earlier stages of clinical development
for the treatment of acne, psoriasis and fungal infections. The Company is
headquartered in Princeton, New Jersey and has wholly owned subsidiaries in
Geel, Belgium and Ontario, Canada. Web site:
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 potential patient benefits of
Sebazole. 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 decisions of regulatory authorities,
patient and market acceptance of Sebazole, general financial, economic,
regulatory and political conditions affecting the biotechnology and
pharmaceutical industries generally. For a discussion of these and other
risks and uncertainties that may effect the forward-looking statements,
please see the risk factors in our Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2005 that 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.
Barrier undertakes no obligation to update publicly any forward-looking
statement.
Contact:
Barrier Therapeutics, Inc.
Anne M. VanLent
609-945-1202
Noonan Russo
Jane Petrino
212-845-4274