Skinvisible Formulation Submitted to European Union for Orphan Drug Designation
2012年2月23日 - 11:05PM
Skinvisible, Inc. (OTCQB:SKVI), a developer of topical and
transdermal formulations using its patented Invisicare technology,
today announced it has submitted an Orphan Drug Designation
application to the European Medicines Agency (EMA) for its
proprietary formulation to treat Netherton Syndrome. Furthermore,
Skinvisible has received notice that the application has been
validated by the EMA and has begun the review process by the EMA's
Committee for Orphan Medicinal Products (COMP). In conjunction
with this application, Skinvisible has submitted a patent
application for the formulation.
To qualify for Orphan Drug Designation the drug must be used to
treat a life-threatening or chronically debilitating condition
which affects less than 5 in 10,000 people in the European Union
(EU) and for which there is no satisfactory treatment
approved. Receiving an Orphan Drug Designation provides
various incentives in the EU including a reduction or elimination
of registration and market authorization fees, protocol assistance,
a centralized authorization procedure for the member countries of
the EU and upon approval, ten years of market exclusivity for the
product. Netherton Syndrome fits the criteria specified by the EMA
as it is a life threatening disease for which there are currently
no treatments available and limited options to treat the
symptoms.
Netherton Syndrome, a type of ichthyosis, is a genetic disease
that is characterized by excessively scaly, circular red skin,
brittle hair and increased susceptibility to atopic
dermatitis. Patients with Netherton Syndrome have a mutated
SPINK5 gene which is responsible for inhibiting serine proteinase,
resulting in the chronic breakdown of the intra-cellular bounds of
the skin. These patients also have a severe abnormality of their
skin barrier. Skinvisible has developed a formulation which is a
broad spectrum serine proteinase inhibitor which helps prevent this
constant breakdown of the skin in combination with its proprietary
Invisicare polymer base which provides important skin barrier
protection and adherence.
"Skinvisible's Orphan Drug application in the EU follows our
submission to the U.S. Food and Drug Administration (FDA) last year
for which we continue to submit additional data and undergo further
review," said Mr. Terry Howlett, President and CEO. "With both
applications filed, we are moving forward with our plans to seek an
exclusive pharmaceutical partner to expedite the approval and
commercialization of this formulation worldwide." He added,
"Receiving an orphan drug designation in the Europe Union and the
USA, along with Skinvisible's patent protection, will be an
important milestone in the development of Skinvisible's product
pipeline and will provide important regulatory, financial and
commercial advantages for our potential licensee."
About Invisicare
Invisicare is Skinvisible's patented polymer delivery system
that offers life-cycle management and unique enhancements for
topically delivered products. It is a combination of
hydrophilic and hydrophobic polymers that hold active ingredients
on the skin for extended periods of time resisting both wash off
and perspiration. Invisicare can control the release of
actives, reduce irritation and can eliminate some costly
manufacturing processes. It is non-occlusive and allows
for normal skin respiration while protecting against environmental
irritants. www.invisicare.com
About Skinvisible Pharmaceuticals, Inc.
Skinvisible Pharmaceuticals is an R&D company whose primary
business objective is to license its proprietary formulations made
with Invisicare to pharmaceutical, consumer goods and cosmeceutical
companies around the world. Skinvisible receives a combination
of R&D fees, license fees, and ongoing royalties for the life
of the Invisicare patent. Skinvisible has been granted ten
comprehensive patents and has twenty-nine patents
pending. www.skinvisible.com
The Skinvisible, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7744
Forward-Looking Statements: This press release contains
'forward looking' statements within the meaning of Section 21A of
the Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and are subject to the
safe harbors created thereby. Such statements involve certain risks
and uncertainties associated with an emerging company. Actual
results could differ materially from those projected in the forward
looking statements as a result of risk factors discussed in
Skinvisible, Inc. reports on file with the U.S. Securities and
Exchange Commission (including, but not limited to, a report on
Form 10Q for the quarter ending October 31, 2011).
CONTACT: Doreen McMorran
Skinvisible Pharmaceuticals, Inc.
Phone: 702-433-7154
Email: info@skinvisible.com
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