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Skinvisible Pharmaceuticals, Inc.
(OTCBB: SKVI)

We have covered Skinvisible many times over the past four years, mostly because we like the Company and the people behind the Company so much. Over the years I have visited with the Company and have had the chance to see how they conduct some of their research first hand.  There is nothing like visiting a company to get to know the character of the company. There are a lot of great people at Skinvisible, and the research they are doing every day will benefit all of us over time.

I am going to give you a quick overview of the Company, and then explain where I see value here.  Let’s start with that overview.

This “Overview” was taken from their site.  It is the best explanation of what they do – in general:

Skinvisible, Inc., through its wholly owned subsidiary, Skinvisible Pharmaceuticals, Inc., is an R&D pharmaceutical company that develops enhanced, patent protected dermatology and healthcare products including products to treat acne, skin cancers, eczema, fungal infections, inflammation, warts and dermatitis along with sunscreens, anti-aging products, alcohol-free hand sanitizing lotions, pre-surgical preparations, and various other medical treatments using its patented technology Invisicare®. Skinvisible’s primary objective is to license these prescription and over-the-counter products into the $65 billion global dermatology market and other medical markets. Potential licensees include international and multi-national pharmaceutical, cosmetic, skincare and consumer goods companies seeking new products, product enhancements or life cycle management for their existing products.

 

The Technology: Invisicare® is a patented technology that enhances how drugs are delivered on, in or through the skin. It can control the release of active ingredients, providing a greater and longer release, while at the same time reducing irritation to the skin. It also binds products to the skin for 4 hours and more, resisting wash-off and rub-off. Skinvisible has developed a portfolio of 40+ topical products using Invisicare (prescription, over-the-counter and cosmeceutical) and also works directly with companies to enhance their products, especially ones coming off patent. Invisicare can be tailored to almost any type of molecule and the needs our customers.

 

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Let’s look at Invisicare:

This “polymer delivery system” is really a method of delivering an active ingredient for topical application on the skin.  Their formula is patented and protected to such an extent it really cannot be duplicated by other pharmaceuticals.

Here is a more thorough explanation from the Invisicare website:

Invisicare is specifically formulated to carry water insoluble active and certain cationic active ingredients in water-based products without the use of alcohol, silicones, waxes, or other organic solvents. Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up to four hours and longer. They are non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting against exposure from a wide variety of environmental irritants.

When topically applied, these formulated products adhere to the skin’s outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic or cosmetic skincare agents to the skin. They allow enhanced delivery performance for a variety of skincare agents resulting in improved efficacy, longer duration of action, reduced irritation and lower dosage of active agent required. The “invisible” polymer compositions wear off as part of the natural exfoliation process of the skin’s outer layer cells. 

patent-protection

Patent Protection:

We will look at some of the products shortly that this polymer is already used in. Let’s look at patent protection.

Protecting this polymer delivery system is critical. Skinvisible and its subsidiary Invisicare have many patents, both domestic and foreign. This patent process is on-going.  Here is a current list of patents that have already been granted:

Patents Granted

United States Patents Granted – Skinvisible

United States Patent No.:   8,318,818
Granted:   November 27, 2012 (1420 day extension)
Topical composition, topical composition precursor, and methods for manufacturing and using.

United States Patent No.:   7,674,471
Granted:   Granted: March 9, 2010 (921 day extension)
Topical composition, topical composition precursor, and methods for manufacturing and using.

United States Patent No.:   6,756,059
Granted:   June 29, 2004
Topical composition, topical composition precursor, and methods for manufacturing and using.


United States Invisicare Product Patents Granted

United States Patent No.:   8,299,122
Granted:   October 30, 2012
Method for stabilizing retinoic acid, retinoic acid containing composition, and method of using a retinoic acid containing composition.

United States Patent No.:   8,128,913
Granted:   March 6, 2012
Sunscreen composition with enhanced UV-A absorber stability and methods.

United States Patent No.:   6,582,683
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.

Australia Patent
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.

China Patent
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.

Hong Kong Patent
Granted:  July 27, 2010
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.

Canada Patent
Granted:  February 22, 2011
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.

European Patent(4)
Granted:  September, 2011
Topical Composition, Topical Composition Precursor, and Methods for Manufacturing and Using.
This list does not include pending patent application.  Patents are granted for 20 years from application date and may be extended by the Patent Office beyond 20 years.

 


importanteWhat’s Important with Skinvisible:

Most Importantly, let’s look at some of the news from the past year for Skinvisible. This is not a company that puts out news releases every week or even every month. Skinvisible puts out news when it is real and important.

Here are what I see as two of the most critical releases of the past two years. Don’t take that to mean that others about patent grants and the effectiveness of their hand sanitizer and killing key “super bugs” as any less important.

February 23, 2012
SKINVISIBLE FORMULATION SUBMITTED TO EUROPEAN UNION FOR ORPHAN DRUG DESIGNATION

March 23, 2011
SKINVISIBLE SUBMITS INVISICARE FORMULATION FOR FDA ORPHAN DRUG DESIGNATION

 

About Netherton Syndrome

As outlined in these press releases, Skinvisible believes they have an excellent opportunity to improve the lives of those with Netherton Syndrome.  What is Netherton Syndrome?

Here is a short description that tells about this disease:

“Netherton Syndrome is a serious skin disorder caused by damage in a gene called SPINK5. This gene controls the formation of a protein called LEKTI, which important for skin barrier function. LEKTI inhibits certain enzymes (serine proteinases) in the outermost layer of the skin (epidermis). The function of the serine proteinases is to break down the intracellular cement that holds together the horny cells in the epidermis, in order for the skin to be able to shed cells (known as cell desquamation). LEKTI deficiency leads to an uninhibited desquamation of horny cells, and as a result the skin becomes red and scaly. The barrier function of the skin is also affected. The permeability of the skin increases, and its capacity to bind water decreases, which causes dryness. The thinness of the barrier also results in over absorption of chemicals, for example topical medical treatments. Historically one in ten infants dies before their first birthday. Currently there are no proven treatments to cure this condition.”

No description can ever fully tell the story of suffering of those afflicted with this devastating disease.  Improving the lives of those who suffer from Netherton Syndrome is one of the goals of Skinvisible, and with their polymer delivery system the Company has an opportunity to do just that.

It’s important to not only read about the condition but to see the condition as well.  We certainly do not want to violate the privacy of patients with the disease by showing pictures of patents on our web site, we do want to share with you a link so you can see images of Netherton Syndrome first hand.  SEE IMAGES HERE

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Orphan Drug Designation – The United States and Europe

In either the United States or Europe, a formulation that uses Skinvisible’s polymer delivery system to provide a meaningful active ingredient that alleviates the suffering of Netherton Syndrome would likely qualify the product as an “orphan drug” by the standards of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

What this would mean for advancing this highly important treatment for sufferers of Netherton Syndrome is that many of the costs typically borne by the drug company are elminated. This is effectively a “fast track” process to bringing such a drug to market.

 

This is from the FDA’s web site:

Designating an Orphan Product: Drugs and Biologics

The Orphan Drug Act (ODA) provides for granting special status to a product to treat a rare disease or condition upon request of a sponsor. The combination of the product to treat the rare disease or condition must meet certain criteria. This status is referred to as orphan designation. Orphan designation qualifies the sponsor of the product for the tax credit and marketing incentives of the ODA. A marketing application for a prescription drug product that has been designated as a drug for a rare disease or condition is not subject to a prescription drug user fee unless the application includes an indication for other than a rare disease or condition. READ IT HERE

Skinvisible is actively seeking to gain this status. Should they receive this status in either the United States or in Europe (or both), this would be a very material event for the Company that would certainly affect the market cap in a positive way.

We will provide more information on how orphan drugs have helped patients that would otherwise not get a drug created for their affliction, and what the benefits have been for shareholders of the companies that create these drugs.

 

Products from Invisicare:

SKINVISIBLE OTC & COSMECEUTICAL PRODUCT LINES
Invisicare® Highlights

  • Patented Invisicare® technology in each product with patent protection to 2021 plus extensions to 2029 with additional patent protection pending
  • Invisicare® adds many benefits to products including skin barrier properties to aid skin healing by retaining moisture, superior adherence, and improved delivery of actives
ACNE

ACNE

1. Acne Treatment Cream
2. Acne Treatment Spray
3. Acne Spot Treatment – Rollerball
4. Acne Scrub
5. Acne Treatment Cloths
6. Acne Moisturizer
7. Acne Scar Treatment

HEALING

FOOT & LEG THERAPY

1. Athlete’s Foot Cream
2. Athlete’s Foot Spray
3. Advanced Moisturizing Foot Protectant
4. Healing & Restoring Foot & Leg Cream
5. Therapeutic Heel & Callus Cream
6. Therapeutic Heel & Callus Scrub
7. Cooling Leg Itch Relief
8. Intense Itch Relief
9. Foot & Leg Muscle Pain Relief

SUNCARE

SUN CARE

1. Sun Screen SPF15
2. Sun Screen SPF30
3. Sun Screen SPF50
4. On-The-Go Sunscreen Rollerball
5. After Sun Moisturizer
6. Sunburn Relief

SUNLESS

SUNLESS TANNING

1. Sunless Tanning Lotion – Light
2. Sunless Tanning Lotion – Medium
3. Sunless Tanning Lotion – Dark
4. Sunless Tan Line Corrector Pen
5. Sunless Tan Gradual Extending Moisturizer
6. Sunless Tanning Mitt
7. Sunless Tanning Bronzer Mitt
8. Pre-Sunless Tanning Barrier Cream
9. Daily Touch Sun Moisturizer
10. After Sun Moisturizer with Aloe

ANTIAGE

ANTI-AGING

1. Anti-Aging Day Cream
2. Anti-Aging Hand Cream
3. Anti-Aging Night Cream
4. Anti-Aging Eye Cream
5. Skin Whitener Lotion
6. Broad Spectrum Sunscreen SPF50
7. Youthful Elbow & Heel Repair
8. Stretch Mark Relief

BOOMERS

BABY BOOMER PRODUCT LINE

1. Anti-Aging Day Cream
2. Anti-Aging Hand Cream
3. Anti-Aging Night Cream
4. Anti-Aging Eye Cream
5. Skin Whitener Lotion
6. Broad Spectrum Sunscreen SPF50
7. Youthful Elbow & Heel Repair
8. Stretch Mark Relief
9. Dry Skin Itch Relief
10. Barrier Hand Protection Cream
11. Sore Muscle Pain Relief

 

MORE INFORMATION ON SKINVISIBLE:

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Skinvisible Pharmaceuticals, Inc. (OTCBB: SKVI)

 

CORPORATE CONTACT:

Doreen McMorran
Skinvisible Pharmaceuticals, Inc.
Phone: 702-433-7154
Email: [email protected]

On The Web:

Skinvisible.com

Invisicare.com

 

 

Disclosures: We hold no shares of Skinvisible stock, and are not contracted to receive shares during the present period of coverage. We do not anticipate receiving shares either from the company or any third party.  Had we had shares, we avoid all potential conflicts of interest, as we never sell shares into the open market during an active market awareness or investor relations program. This means that as we release new information about a particular client company either on our site or otherwise authored by us, you can be confident we are not selling shares at the same time. StockGuru is not a registered investment adviser or a broker/dealer. StockGuru makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person, or that an investment in such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk.  StockGuru is retained by Skinvisible for consulting purposes and investor awareness. We have received a total of six thousand two hundred dollars in payments. Previously for coverage in 2009, we were compensated and once held five hundred thousand shares of 144 restricted stock. We anticipate receiving up to six thousand dollars potentially over the next 180 days. We do not anticipate receiving shares of any kind, restricted or otherwise. StockGuru is STOCKGURU.COM. 1601 Berwick Drive, McKinney, Texas 75070 – (469) 252-3030.