Richard Davies wrote: The UK has a good crop of technology pioneers in cloud computing - for example ElasticHosts, FlexiScale, Flexiant, OnApp - and also some strong government initiatives such as G-Cloud.
We will have to see whether this kind of technical leadership converts into swift mass-market adoption or not.
PRINCETON, NJ -- (MARKET WIRE) -- 10/12/05 -- Barrier Therapeutics, Inc. (NASDAQ: BTRX), a
pharmaceutical company developing and commercializing products in the field
of dermatology, today announced that it received notification from the U.S.
Food & Drug Administration (FDA or the Agency) that the Company's
submission to address the not approvable letter for Zimycan(TM) (0.25%
miconazole nitrate, 15% zinc oxide, and 81.35% white petrolatum ointment)
has been deemed a complete response by the Agency. This designation by the
Agency indicates that the appropriate information has been provided for
their review. The Company believes that this response provides the FDA with
the information necessary to complete its review of the New Drug
Application (NDA) within approximately six months from the date of the
submission of the response, which occurred in August 2005. The FDA has
also approved the Company's recommendation for the use of Vusion(TM) as the
proposed brand name for the product.
"The conversations that we held with the FDA during the summer were very
constructive," stated Geert Cauwenbergh, Ph.D., Chairman and CEO of Barrier
Therapeutics, Inc. "We are happy to have Vusion back under review by the
Agency, taking us another step closer to bringing this product to the
market."
The not approvable letter dated May 24, 2005 stated that the Agency's
action was based on a single deficiency. In that letter, the FDA said that
there was insufficient information in the NDA to characterize the systemic
exposure to miconazole in infants. Characterization of systemic exposure
to miconazole is a component of the safety evaluation of the product. The
response filed by the Company contains additional information to address
this deficiency.
About Vusion
Vusion for the treatment of diaper dermatitis complicated by candidiasis,
contains miconazole nitrate, which directly treats the infection, while
zinc oxide and white petrolatum provide a barrier to keep excessive
moisture away from the skin. This moisture contributes to the cause of the
Candida infection. Diaper dermatitis, commonly known as diaper rash, is
one of the most common skin conditions in infants and is observed in
approximately one million pediatric outpatient visits each year in the U.S.
It is estimated that more than 40% of all diaper dermatitis treated by a
physician involves Candida. In the U.S., there currently is no
prescription drug approved to treat diaper dermatitis complicated by
candidiasis.
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 recently obtained the Canadian distribution rights for
Vaniqa® (eflornithine hydrochloride) Cream 13.9% for slowing the growth
of unwanted facial hair in women. Barrier has eight product candidates in
various stages of clinical development. The four most advanced product
candidates include one for the treatment of diaper dermatitis complicated
by candidiasis, which is under FDA review, and three products, which are in
or entering Phase 3 clinical trials for the treatment of seborrheic
dermatitis, onychomycosis, and congenital ichthyosis. 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 timing for regulatory review of
the response and the possibility of bringing Vusion to market.
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 the decisions of regulatory authorities,
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 10Q, 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. Barrier undertakes no
obligation to update publicly any forward-looking statement.
Contact:
Barrier Therapeutics, Inc.
Anne M. VanLent
609-945-1202