Skinvisible's Patent Portfolio Expands to Cover Cationic Actives
Compositions with Imiquimod, Terbinafine, Miconazole Have Added Protection
Las Vegas, NV– May 28, 2014 - Skinvisible Pharmaceuticals, Inc. (SKVI: OTCQB) 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.