Skinvisible, Inc. (OTCBB: SKVI)
Skinvisible, Inc. develops innovative polymer delivery vehicles and related compositions that hold active ingredients on the skin for extended periods of time when applied topically. A process has been designed for combining water soluble and insoluble polymers that is specifically formulated to carry water insoluble active ingredients in water-based products without the use of alcohol, silicones, waxes, or other organic solvents. This enables active agents the ability to perform their intended functions for an extended period of time.
The company’s over-the-counter products are represented in the $65 billion global dermatology market and other medical international and multi-national pharmaceutica marketsl, cosmetic, skincare and consumer goods companies seeking new products, product enhancements or life cycle management for their existing products.
Research and Development employing the patented technology of Invisicare® includes enhanced, patent protected dermatology and healthcare products to:
- Treat acne
- Skin cancers
- Eczema
- Fungal infections
- Inflammation
- Warts
- Dermatitis
- Sunscreens
- Anti-aging products
- Alcohol-free hand sanitizing lotions
- Pre-surgical preparations
- Various other medical treatments
Invisicare®
Invisicare® offers the following benefits:
- Displays superior skin adherence for extended time periods
- Non-occlusive yet resists water wash-off, respiration and perspiration
- Increased efficacy of active ingredients
- Allows for lower use levels of actives with increased persistence of effect
- Offers advantage of controlled and/or sustained time-release
- Highly compatible with a variety of actives and bases
- Easy to emulsify
- Formulates well at a cream, lotion, or spray viscosity
- Non-irritating emulsion dries quickly with no greasy after-feel
- Non-occlusive film forms protective barrier against environmental irritants
- Broad polymer selection to meet application requirements
- Offers “Life Cycle” management to core products with potential for new patent
- Simplified manufacturing process
Invisicare’s products bind to the skin for 4 hours and more, while resisting wash-off and rub-off. It also enhances the efficacy of ingredients, reduces irritation and can reduce costs.
Revenue Source
Skinvisible has four sources of revenue:
- Licensing Fees
- Research and Development Fees
- Sales of Polymers
- Royalties from Licensed Polymers
Skinvisible’s Core Strengths
- Patents: Intellectual property Invisicare is protected internationally and new patents in progress
- Pipeline: Products available in ten key categories, with more than 25 formulations many with international patents pending a cost-effective solution for companies seeking products to license
- The People: Specialized scientists, experienced Board of Directors, expert pharmaceutical & medical consultants, all focused on the Company’s success
Polymer Formulations for Multiple Products
On an ongoing basis, Skinvisible develops polymer formulations that can successfully be incorporated into other products.
Products that successfully incorporate Invisicare® to date include:
- Antimicrobial hand sanitizer lotions
- Suncare products
- Skincare moisturizers
- Sunless tanning products
- Multiple dermatology products for various skin disorders
Business Milestones
DermSafe, the Company’s hand sanitizing lotion, was proven effective with a greater than 99.99% inactivation/kill on the H1N1 influenza A virus
- Skinvisible has licensed three of its prescription acne formulations
- Skinvisible has licensed three over-the-counter products: two for $1 million each
Business Plan Licenses Invisicare®
Skinvisible’s business plan licenses Invisicare® to established brand manufacturers of dermatological, medical, cosmetic, and skincare markets and marketers of prescription and over-the-counter products.
With the exception of sales to one vendor, Skinvisible’s policy is to only sell Invisicare® to vendors that have executed a license agreement with the Company.
Over-the-Counter License Products
Panalab Internacional S.A. has entered into a license agreement for their anti-acne product formulated with Adapalene The licensed territories are Argentina, Brazil and Chile.
A license agreement exists with Embil Pharmaceutical Co. Ltd. for products formulated with the active ingredients Clindamycine HCL and Retinoic Acid (licensed territories countries in Eastern Europe and three in South East Asia.
RHEI Pharmaceuticals Ltd. License Agreement
RHEI Pharmaceuticals Ltd. (RHEI) is a global pharmaceutical business development firm, with special focus on bringing core medicines from the U.S., Europe and Japan into the fast-growing South-East Asian marketplace. This is a Hong Kong-based pharmaceutical company and a subsidiary of the Luxembourg-based Leeward Ventures SICAR SCA. They are experts in business development, regulatory approval and clinical development and have a management team that combines a Western approach to pharmaceuticals with a long experience in Europe, North America and South-East Asia. They use their development capabilities and network of preferred commercial partners to help other pharmaceutical companies introduce their products into specific niche markets, such as the European institutional health care market and the Chinese hospital market. RHEI is headquartered in Hong Kong and has operations in Belgium, the U.S. and China.
Skinvisible completed an exclusive license agreement granting RHEI, the exclusive rights to three Skinvisible formulations developed using its patented Invisicare polymer delivery system in mid July 2010.
The agreement specifies exclusivity for the products for the institutional / healthcare market for:
- An adult incontinence cream
- Skin barrier cream
- Super moisturizer
Upfront license fees for the territories of Europe and China and milestone payments based on approvals and launch dates for the United States are included. In addition, Skinvisible will receive royalties on sales of the products. RHEI will be responsible for regulatory filings, manufacturing and commercialization of the products.
RHEI will leverage its affiliate BeoCare Group, a leading medical consumables manufacturer with facilities in the United States, Europe and China, to provide access to the institutional / healthcare markets through its established network of multi-national clients. Additionally, RHEI will also sell to its affiliate, Senior Assist NV, one of the largest assisted living providers in Belgium, with a chain of thirty-three seniors’ homes.
RHEI is they are in a prime position to capture significant market share and revenue from these products. The annual institutional spending on incontinence products in the United States alone reaches $32+ million. RHEI is in an ideal position to penetrate this market with their regulatory and commercialization experience and established client list.
Research and Development
Research and development is conducted in-house. An outside party currently handles all of manufacturing and distribution.
Management evaluates new ideas and seeks to develop new products and improvements to existing products to satisfy industry requirements and changing consumer preferences. The identification of trends in consumer preferences are used to generate new product ideas. Specific to the objective of generating new products, research and development toward developing additional applications with Invisicare continues. Various developmental stages are active for the following potential applications using Invisicare.
Skinvisible, Inc. entered into a research and development agreement with Women’s Choice Pharmaceuticals LLC, a specialty pharmaceutical company based in Gilbert, Arizona. The agreement is to develop a prescription formulation using Skinvisible’s technology Invisicare®, a patented polymer delivery system for topical dermatology and consumer goods products.
Under the terms of the agreement, Skinvisible received a fee for the development of the product. Upon the successful completion, Skinvisible and Women’s Choice will enter into a license agreement which includes a license fee paid in milestones plus on-going royalties based on product sales. Development is expected to be completed in the second quarter in anticipation of a third quarter launch.
Women’s Choice Pharmaceuticals is an innovative specialty pharmaceutical company whose primary focus is to provide quality prescription products to healthcare providers in the United States. The company provides technology based prescription products to the women’s health market place, with their primary product portfolio consisting of three patent protected products with market caps exceeding $500 million. Their nationwide sales force will deploy in May of 2010 and will target more than 30,000 OB/GYNS and selected other medical specialties. Their managed markets division will target PBM’s, HMO, GPO, CMS and other managed care organizations ensuring their products are covered under drug benefit plans. (www.wcpharma.com )
Intellectual Property
Skinvisible’s value lies in its ability to continually generate new intellectual property pertaining to dermatology and medical products formulated with Invisicare®. Patent approvals are sought both in the United States and internationally for all products developed. The Company’s growing proprietary position is continually expanding internationally.
There are six patents approved, including three in the US, and internationally in China, India, Australia, Japan and Korea. There are a number of U.S. patents pending in addition to PCTs internationally, with many more to be filed. Some of these PCT patents cover up to five products. All patents with Invisicare are owned by Skinvisible.
- Six approved patents including the US, India, Australia, China and Japan
- Nine U.S. patents pending
- 34 international PCTs
A total of twenty claims have been granted in the South Korean patent which protects Invisicare in the areas of ‘Topical Composition’, ‘Topical Composition Precursor’, and ‘Methods for Manufacturing and Using’.
Pharmaceutical companies are pursuing new or improved revenue streams along with protecting their own intellectual properties. Invisicare allows companies to sell a patent-protected product that has been revitalized with new benefits, giving them a new story to help combat generic competitors. A prescription dermatology product can generate $100 plus million per year. Some can produce even $200 plus million – and that is why the Company believes the investment into a license with an Invisicare® formulation is a very viable option for these companies. Worldwide patent protection submission for products formulated with Invisicare® is ongoing.
Granted Patents & Trademarks
United States Patents Granted
United States Patent No.: 6,756,059
Granted: June 29, 2004
Topical composition, topical composition precursor, and methods for manufacturing and using.
Granted: June 29, 2004
Topical composition, topical composition precursor, and methods for manufacturing and using.
United States Patent No.: 6,582,683
Granted: June 24, 2003
Dermal barrier composition.
Granted: June 24, 2003
Dermal barrier composition.
International Patents Granted
India Patent
Granted: July 26, 2007
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Granted: July 26, 2007
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Australia Patent
Granted: June 3, 2008
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Granted: June 3, 2008
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Japan Patent
Granted: October 31, 2008
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Granted: October 31, 2008
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
China Patent
Granted: July 1, 2009
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Granted: July 1, 2009
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Korea Patent
Granted: February 9, 2010
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Granted: February 9, 2010
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
Patent Product SKVI Opportunity
Pharmaceutical companies pursue new or improved revenue streams along with protecting their own patented products. New product formulations are expensive and time intensive for companies to undertake. Invisicare® allows companies to sell a patent-protected product that has been revitalized with new benefits, providing a new story to help combat generic competitors. A prescription dermatology product can generate $100+ million per year, many even more – that’s why a pharmaceutical company’s investment into an Invisicare® formulated product is a very viable option.
Invisicare® Role in Combating H1N1, MRSA and CDifficile Internationally
DERMSAFE®
DermSafe® Hand Sanitizer Lotion
Skinvisible’s DermSafe® is an antimicrobial hand sanitizer that has the unique ability to kill bacteria and kill/inactivate viruses on the hands for four hours or longer. DermSafe stays bound to the hands, even after frequent washings. This is considered to be a real plus for doctors and nurses as they move from patient to patient.
The Chlorhexidine Hand Sanitizer Lotion “DermSafe” has been marketed in Canada since 2009.
The Company is working toward United States FDA approval this unique product.
DermSafe is alcohol-free, and consequently eliminates fire, safety and skin drying issues associated with alcohol-based products. DermSafe also contains the patented technology Invisicare which allows the product to stay bound to the skin. The active ingredient, 4% chlorhexidine gluconate, has been safely used in pre-surgical scrubs worldwide for over 50 years.
Safe4Hours and Walgreens
JD Nelson and Associates LLC, its license holder of the newly launched Safe4Hours® First Aid Antiseptic Skin Protectant, is expanding their presence in Walgreens stores (NYSE:WAG) with a special marketing promotion. This includes a third nationwide order that JD Nelson has received since the initial launch three weeks ago. The promotion includes prominent end-cap point of purchase displays which will profile Safe4Hours in 4,100 Walgreens. This heightened visibility along with a television advertising campaign, will educate consumers about the product’s benefits. This first aid antiseptic lotion, formulated with the patented Invisicare® delivery system, binds to the skin, resisting both wash off and perspiration while continuing to kill harmful bacteria for up to four hours.
A TV marketing campaign was included in this promotion, profiling the dual benefits of Safe4Hours® in major US markets.
H1N1 Virus and Safe4 Hours®
A research and development company of patented skincare and medical dermatology products, previously announced that DermSafe, the Company’s hand sanitizing lotion, was proven effective in killing the H1N1 virus. The studies were conducted by Retroscreen Virology of London, England, U.K. demonstrating a greater than 99.99% inactivation/kill on the H1N1 influenza A virus. Most importantly, the killing action last up to four hours.
Safe4 Hours® Effective in Killing H1N1 Virus
Skinvisible has announced that DermSafe®, their proprietary hand sanitizing lotion, was proven effective in killing the H1N1 virus. The studies were conducted by Retroscreen Virology of London, England demonstrating a greater than 99.99% inactivation/kill on the H1N1 influenza A virus.
WHO and H1N1 Outlook 2010
In June of 2010, the H1N1 pandemic has passed its peak, although it is not yet over, said the World Health Organization. The pandemic disease is expected to continue to occur noted’ WHO Director General Margaret. Committee members stressed that it remains critical for countries to continue to maintain vigilance concerning the pandemic. Reflecting the worldwide spread of the new flu virus, the Geneva-based U.N. agency this past June 2009 raised the alert level to Phase 6, the highest on its scale. Even though pandemic activity is declining, the phase level will remain untouched for the time being said the WHO spokesperson in June 2010. According to the WHO definitions, a pandemic is characterized by the geographical spread of a new virus, and does not include considerations on its severity or morbidity rates.
The WHO announced in June of 2010, that the virus was responsible for over 18,000 laboratory-confirmed deaths worldwide, although total figures are expected to be higher.
CDC Prevention Strategy for Flu Protection for 20 Percent of U.S. Residents
The CDC said in July of 2010 that a number of core prevention strategies should be used to protect and prevent the spread of the disease. A fundamental core prevention strategy includes implementing environmental and infection control measures. The CDC said up to 20 percent of U.S. residents acquire an influenza virus each year, and an average of more than 200,000 people are hospitalized each year with complications from the flu. Skinvisible has a fundamental role to play in healthcare protection.
MRSA and Safe4 Hours®
Safe4 Hours® has an important role to play in MRSA and C-difficile rates found in hospitals.C-difficile is bacteria found in the colon and can cause diarrhea and a more serious intestinal condition known as colitis. It is spread by spores in feces that are difficult to kill with most conventional cleaners or alcohol-based sanitizers. A recent report from Pennsylvania Patient Safety Advisory shows that almost 40% of gastrointestinal infections reported from nursing homes are due to C-diff and a study to be published in the April journal Emerging Infectious Diseases show that the infection is increasing in hospital pediatric wards.
MRSA or Methicillin-resistant Staphylococcus aureus are bacteria that are often harmless as they come in contact with intact skin, but can enter through wounds and may become deadly once they reach the bloodstream.Methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile (C-diff), and Central line-associated bloodstream infections (CLABSI) are three common superbugs that are threats to patients in hospital and healthcare settings. Both bacteria have become resistant to common antibiotics and can cause serious health concerns.
The United States Department of Human Services National Healthcare Quality Reportnoted100,000 deaths annually from hospital acquired infections and called this an an URGENT ISSUE – published April 14, 2010. The Report indicates that two million people are infected in hospitals annually. In the United States Hospital Acquired Infections kill three times as many people as AIDs. More people die from Hospital Acquired Infections than from car crashes and homicides together.
Congressional Hearing on Health Antibiotic Resistance and Threat to Public Health Held April 2010
MRSA has become a huge problem nationally and internationally. Congress is looking for answers and there is NO dispute: sanitary hand conditions are the absolute starting point for patient protection. MRSA lives on computer keyboards, hospital bed rails and fabric – including the clothing and healthcare professionals. It can spread like wildfire through a hospital setting. Now the United States government and some private insurance companies have refused to pay hospitals for treating patients that were infected in a hospital.
Chlorhexidine gluconate baths are recommended for ICU and emergency room patients to prevent MRSA. This is the very ingredient found in Dermsafe® and even better it is delivered in a polymer that stays on the skin for up to four hours.
Skinvisible has a vital role to play in the MRSA and C Difficile issues facing all hospitals and senior citizen residential facilities.
- More than 70% of the bacteria that cause hospital-acquired infections are resistant to at least one of the antibiotics most commonly used to treat them.
- People infected with drug-resistant organisms are more likely to have longer hospital stays and require treatment with other drugs that may be less effective, more toxic, or more expensive.
- Between 5 and 10 percent of all hospital patients develop an infection, leading to an increase of about $5 billion in annual U.S. healthcare costs.
Recent healthcare legislation has address MRSA and C Difficile issues in hospitals in the most effective fashion known to capitalism: financial penalties for hospital acquired infection rates and financial incentives for reductions in those rates. The law allocates $75 million annually toward improving the measures used to evaluate quality and safety.
The full focus nationally and internationally on sanitary conditions and in particular sanitary hand conditions creates an important opportunity for Skinvisible. Hospital Administrators are scrambling to implement programs and policies to reduce hospital acquired infections as the new healthcare legislation is implemented.
Healthcare Legislation which Mandates Sterile Policies – Hospitals Scrambling for Solutions
Medicare’s Hospital Compare Web site will publish individual hospital errors rates for about a dozen avoidable conditions — the same list of conditions that Medicare stopped paying for in 2008. The public reporting will only include Medicare patients and this will not begin until 2014.
Medicare payments to hospitals hospitals will be adjusted based on patient outcome.
Better outcomes for heart attacks, pneumonia and preventing infections will benefit from higher payments.
High rates of hospital-acquired infections receive reduced payments.
Incentives
The health reform law has modest initiatives to curb medical errors, including:
Rewards hospitals for improving care: Beginning in 2012, hospitals that meet or exceed performance standards in conditions including stroke care, heart attack outcomes and infections will receive higher Medicare payments.
Each hospital’s track record will be published.
Withholds payment for medical injuries: Medicare already restricts payment to hospital for extra care required to treat Medicare patients harmed by certain medical errors and this law expands this policy to Medicaid, the public health program geared for the poor and disabled.
Requires public reporting of medical injuries
In 2014, the Medicare web site Hospital Compare will post each hospital’s record for certain medical errors and hospital-acquired infections. This limited reporting will cover only Medicare patients with certain conditions for which the hospital was not paid.
Requires insurers to demand better care
By 2012, insurers must have contracts with medical providers that include actions to reduce readmission, improve safety and use best practices.
Emphasizes effective practices
The law creates a Patient-Centered Outcomes Research Institute run by a private foundation that will find the most effective drugs, medical devices and procedures.
Establishes a patient safety center
The Center for Quality Improvement and Patient Safety will research and disseminate information about improving the quality and safety of health care, with an initial focus on preventing infections and reducing readmissions.
Recent Developments
Markets for DermSafe:
In Canada DermSafe has received approval allowing the sale of DermSafe for personal use. In the United States DermSafe requires approval by the Federal Drug Administration (FDA The FDA has opened a Pre-Investigational New Drug (Pre-IND) file for DermSafe.
Globally: Skinvisible and select consultants are working with the appropriate governmental regulatory bodies to obtain marketing approvals and to acquire licensees. DermSafe is available for licensing both commercially in healthcare and food services as well as for personal use (retail) worldwide.
Skinvisible is working with potential licensees for DermSafe in the United States, Canada, China, Hong Kong, Singapore and other parts of Southeast Asia, Japan, the United Kingdom, Europe, Australia, Africa and Mexico. In some countries the product requires little or no regulatory approval.
SKVI Pipeline
Products in the pipeline are considered to be those which have been developed by Skinvisible in response to a variety of topical skin applications and product development opportunities identified both independently and in collaboration with established manufacturers and marketers.
These products have been successfully tested in-house to determine “proof of concept” stability, proven active agent activity and sustained release) and are currently ready to be licensed to established pharmaceutical, OTC, cosmetic or skincare manufacturers for commercialization. Regulatory approvals may be required for some products.
Skinvisible’s Invisicare pipeline includes topical products for the following condition or use:
- Acne
- Topical Analgesics and First Aid
- Anti-Aging
- Anti-Fungal
- Anti-Inflammatory
- Antimicrobial Hand Sanitizing Lotions
- Dermatitis/Moisturizers
- Skin Cancer
- UVA /UVB Sunscreens
- Warts
- Other: Scar Treatment/Long-Lasting Fragrances/ Wound Care/ Pre-Surgical Treatments/ Preventative Treatments
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