Skinvisible Formulation Submitted to European Union for Orphan Drug Designation
Invisicare Formulation for Netherton Syndrome Under Review
LAS VEGAS, Nevada. February 23, 2012 - Skinvisible, Inc. (SKVI: OTCQB), 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."