LAS VEGAS, NV--(Marketwired - May 28, 2014) - Skinvisible Pharmaceuticals, Inc. (OTCQB: SKVI) a pharmaceutical research and development company with a proprietary delivery technology trade named Invisicare®, today announced that it has been granted a new patent by the United States Patent and Trademark Office entitled, "Cationic Pharmaceutically Active Ingredient Containing Composition, and Methods for Manufacturing and Using" (Patent #8,735,422). The patent provides formulation protection until April 2030 and covers the composition of formulations developed with cationic actives such as imiquimod (used for certain skin cancers: actinic keratosis (precancerous skin lesions), superficial basal cell carcinoma (sBCC) and external genital warts), terbinafine and miconazole (anti-fungals used to treat athletes foot, jock itch, ringworm, and other fungal infections of the skin) in combination with Skinvisible's proprietary polymer delivery system, Invisicare. Additionally, Skinvisible has filed a divisional patent application seeking further claims.
For its formulations that require FDA approval / clinical development, the Company proposes the 505B2 process as a cost-effective / quick to market strategy for its prescription products such as imiquimod. The 505B2 clinical development process is an abbreviated submission to the FDA that allows for companies to distinguish its products and avert substitution by generics based on benefits approved by the FDA. Skinvisible will be seeking licensees interested in the clinical development of both its imiquimod and terbinafine formulations for the US and internationally.
"This is a very important patent for Skinvisible and we are excited to receive the acknowledgment from the US Patent and Trademark Office for this significant innovation," said Mr. Terry Howlett, President and CEO. "Cationic actives are vital ingredients in the treatment of many dermatology conditions in both over-the-counter and prescription drug products." He further stated, "This patent, along with our US and international patents protecting our Invisicare technology, increases the value of our formulations and therefore the Company. We are eager to partner with a global pharmaceutical company who will take our finished formulations like imiquimod and other actives through the 505B2 clinical process."
Skinvisible's research and development is focused on its core technology Invisicare; a patented topical drug delivery system which is the foundation of all of the forty-plus products developed at Skinvisible. Along with the new cationic patent, Skinvisible has been granted patents for stabilizing UVA sunscreens, retinoic acid and for dermal barrier products plus fifteen US and international patents on Invisicare. The Company's clinical development and commercialization strategy involves out-licensing these formulations on an exclusive basis for prescription and over-the-counter indications to global pharmaceutical and consumer goods companies.
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 topically delivered products. Invisicare holds active ingredients on the skin for extended periods of time resisting both wash off and perspiration along with controlling the release of actives and reducing irritation. Skinvisible receives a combination of research and development fees, upfront license fees, and ongoing royalties for the life of the Invisicare patent. Skinvisible's value also lies in its ability to continually generate new IP on topical products formulated with Invisicare. www.skinvisible.com and www.invisicare.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. 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 March 31, 2014).