Skinvisible Formulation Submitted to European Union for Orphan Drug Designation

LAS VEGAS, Feb. 23, 2012 (GLOBE NEWSWIRE) -- Skinvisible, Inc. 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

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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).