Terry Howlett Pres. & CEO Skinvisible Pharmaceuticals, http://www.skinvisible.com will appear on the Bill Chippas Business Talk Radio and TV Show Tuesday January 17, 2012.
Skinvisible Pharmaceuticals Symbol SKVI
Skinvisible 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 Pharmaceuticals value lies in its ability to continually generate new IP (Intellectual. Property) on dermatology and medical products formulated with Invisicare®.
Development Agreement with Novartis, AG – A Major Opportunity
In February 2011 Skinvisible entered into a feasibility agreement with Novartis Pharma AG, one of the largest pharmaceutical companies in the world. The purpose of the agreement was for Skinvisible to assess the technical feasibility of incorporating our Invisicare® technology into a new topical formulation with an undisclosed active ingredient (“the drug” or “API”). This formulation, still in development, would leverage the benefits of Invisicare by providing controlled release of the active ingredient. After the initial agreement was completed, a new feasibility agreement was entered into in November 2011 and Skinvisible continues to work in conjunction with Novartis to develop a viable formulation.
Skinvisible’s First Orphan Drug Application
In 2011 Skinvisible entered into a new disease area which it had not addressed with any prior formulations. During our research and development process we discovered that we developed a product that may have a significant impact on those people that suffer from a debilitating disease called Netherton Syndrome. Netherton’s is a sub-type of ichthyosis which can affect any age and has some level of dry, thickened, scaly, cracked or flaky skin, with symptoms ranging from mild to life threatening.
In March 2011, Skinvisible submitted an application to the United States Orphan Drug Division in order to receive an Orphan Drug Product Designation for the Company’s product formulated with Invisicare to treat Netherton Syndrome. An adjunct to the original application was submitted in November 2011. In conjunction with this application, Skinvisible has also filed a patent application with the US Patent Office.
Skinvisible is pursuing this product as the United States Orphan Drug Act provides significant incentives to pharmaceutical companies to develop products for patients suffering from rare diseases. In the United States, a rare disease is defined as a condition which has less than 200,000 people with the disease. Receiving this orphan drug designation would add considerable value to this formulation which could result in a multimillion dollar license fee for Skinvisible.
The United States Orphan Drug Department responded to the application and indicated that (1) they accept Netherton Syndrome as an orphan disease and (2) they reviewed the data submitted and have requested that Skinvisible provide an additional specific set of data. Skinvisible is pleased with the feedback of the application so far and has begun putting into place a study that will meet the requirements specified by the FDA.
Dermatology Review Panel(TM) (“DRP”) During 2011 Skinvisible announced that its DermSafe(R) Hand Sanitizing Lotion received the “Seal of Approval” from the Dermatology Review Panel(TM) (“DRP”). DRP is an independent panel of dermatologists that reviews scientific data for non-prescription products in order to authenticate a product’s claims. DRP dermatologists evaluated Skinvisible’s scientific data and validated the following claims for DermSafe Hand Sanitizer: DermSafe is alcohol-free, it offers protection from harmful bacteria, it resists wash-off and it provides a moisture barrier for the hands. DermSafe, marketed by Alto Pharmaceuticals in Canada, will soon display the DRP Seal on its promotional materials and packaging.
European Patent Office (EPO) In late September 2011 Skinvisible announced the European Patent Office (EPO) issued a Notice of Intent to
Grant European patent application number 02752847.0 pertaining to Skinvisible’s drug delivery system, Invisicare, which is a drug delivery technology used in prescription, over-the-counter and cosmeceutical products. The comprehensive patent protects Invisicare® composition , method of combining polymers to make the Invisicare complex and the skin / medical conditions Invisicare is used for. This patent provides protection with claims that were also patented in the other Invisicare international patents. This patent approval is a significant milestone for Skinvisible as multi-national pharmaceutical and consumer goods companies seeking products for global distribution will now have protected products to license from Skinvisible on four continents, covering over twenty-two countries. Invisicare patent coverage now includes Europe, plus previously announced India, Australia, China, Japan, Hong Kong, Korea, Canada and the USA. Skinvisible continues to proactively build and strengthen its global intellectual property portfolio with twenty-eight patents pending. All patents with Invisicare® are owned by Skinvisible.
Women’s Choice Pharmaceuticals LLC and ProCort(R) In July 2011 Skinvisible announced that its licensee, Women’s 
Choice Pharmaceuticals LLC, a specialty pharmaceutical company based in Gilbert, Arizona, launched ProCort(R), Skinvisible’s first prescription product in the United States. ProCort(R) is a topical treatment for hemorrhoids formulated with Skinvisible’s patented polymer delivery system Invisicare(R). Invisicare enhances the delivery of active ingredients by controlling the release and provides superior binding properties. ProCort(R) is made of a combination of hydrocortisone acetate and pramoxine hydrochloride. ProCort(R), launched this week, is a prescription product focused on the women’s health market.
Mr. Howlett founded Skinvisible, Inc. in 1998. With over 30 years of entrepreneurial, business management and market initialization experience, he drives and directs the Company’s development and technology vision. He is adept at guiding emerging and publicly traded start-up companies through the stages of capital formation, strategic planning and business growth; specializing in venture capital financing. Mr. Howlett’s diversified background includes senior management, marketing, and sales positions with both established and start-up companies.
For More Information read the January 2012 Letter to shareholders.
Watch the Bill Chippas Show Business Talk Radio and TV Program for more about Skinvisible Pharmaceuticals plus forex , equity investments, short term winning trades and news at 10:05 AM ET Tuesday January 17, 2012 on WPSLTV.com, Listen Live from 10:05 AM ET till 11:00 AM ET at http://www.billchippasshow.com
