Skinvisible Announces First Invisicare Delivery Technology Product to Receive U.S. FDA Acceptance of Investigational New Drug
Skinvisible, Inc. (OTCQB:SKVI) has announced that its licensee Quoin Pharmaceuticals (NASDAQ:QNRX) received FDA acceptance for an Investigational New Drug (IND) application for QRX003, a treatment for Netherton Syndrome. This marks the first IND approval using Skinvisible's proprietary Invisicare drug delivery technology. Successful clinical trials could lead to a milestone payment of $5 million and ongoing royalties for Skinvisible. The approval underscores the potential for expanding applications of their technology in treating rare skin disorders.
- FDA acceptance of IND application for QRX003 is a significant milestone for Skinvisible.
- Potential for $5 million milestone payment and ongoing royalties from Quoin's product sales.
- Establishes Skinvisible's technology as a viable delivery method for treating rare skin diseases.
- None.
LAS VEGAS, NV / ACCESSWIRE / June 6, 2022 / Skinvisible, Inc. ("Skinvisible") (OTCQB:SKVI), is pleased to announce that its licensee Quoin Pharmaceuticals, Inc. ("Quoin") (NASDAQ:QNRX), has received U.S. FDA acceptance of its Investigational New Drug (IND) application for its licensed formulation which uses Skinvisible's Invisicare® proprietary drug delivery technology. The topical formulation "QRX003" was developed to treat Nethertons Syndrome, a debilitating hereditary disorder that affects the skin, hair and the immune system. There currently is no cure or approved treatment for Netherton Syndrome.
"This is the first IND approval by the FDA which includes our Invisicare technology as the delivery platform, and it further reinforces our vision of developing topical therapeutics for a number of key indications. It is an important milestone for Skinvisible and could potentially lead to other indications receiving approval," said Terry Howlett, President and CEO, Skinvisible. "With the IND approved, the clinical trial will be underway shortly. We look forward to assisting Quoin in their success and potential FDA approval as well as potentially bringing a treatment to patients suffering from Nethertons Syndrome."
Skinvisible granted Quoin an exclusive, royalty-bearing license to its technology for use in select Orphan Rare Skin Diseases and for the right to use its proprietary formula as well as its technology to develop products that will target a number of rare skin related indications. Quoin is responsible for obtaining all FDA and other regulatory body approvals necessary to market the products in the US and other countries. Upon the successful completion of various clinical and regulatory milestones, Skinvisible is entitled to receive a milestone payment of
About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is an emerging specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. They are committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin's innovative pipeline comprises three products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Epidermolysis Bullosa and others. For more information, go to: www.quoinpharma.com.
About Skinvisible Pharmaceuticals, Inc.
Skinvisible Pharmaceuticals is a research and development company that licenses its proprietary formulations made with Invisicare®, its patented polymer delivery system that offers life-cycle management and unique enhancements for topical and transdermal delivered products. Invisicare holds active ingredients on the skin for extended periods of time, allowing for the controlled release of actives. For more information please visit www.skinvisible.com.
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 including with respect to the possible development of any such products, the acceptance of any such products in the market place, the size of any such markets, the ability of any product candidates to be approved by the U.S. Food and Drug Administration among others. 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 period ending March 31, 2022).
Contact:
Doreen McMorran
info@skinvisible.com
PH: 702-433-7154 x 7
SOURCE: Skinvisible Inc.
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FAQ
What does the FDA acceptance of QRX003 mean for Skinvisible and Quoin Pharmaceuticals?
What is Netherton Syndrome and how does QRX003 address it?
What financial benefits could Skinvisible gain from the IND approval of QRX003?
How does Skinvisible's Invisicare technology work?
What other indications could benefit from Skinvisible's technology following the QRX003 approval?
