Skinvisible, Inc.’s (SKVI) Potential Merger Set to Deliver an Alternative as Opioid Crisis Deepens

Developing opioid alternative for pain treatment
Well-positioned to capture market share as an opioid substitute
Timely market entry as opioid abuse reduces U.S. life expectancy

Opioids are taking a toll on the nation. Data released by the Centers for Disease Control and Prevention (CDC) show that, for the second year in a row, life expectancy in the United States declined due to deaths from opioid overdoses. A major contributing factor to these alarming statistics has been the increasing appearance of synthetic opioid fentanyl. The drug is immensely powerful and is suspected to be the reason why many overdoses turn out to be fatal. Compounding the crisis is the double-headed problem that fentanyl, although manufactured and marketed legally, is also produced and distributed illegally. This duality offers a pernicious path to illicit use for patients introduced to prescription opioids for pain relief. Luckily, alternatives to pain management are under development. One such option will emanate from the proposed merger between Skinvisible, Inc. (OTCQB: SKVI) and Quoin Pharmaceuticals Limited. The combined entity’s proposed first product candidate, QRX001, is expected to be developed for the treatment of post-surgical pain.

The rising use of destructive opioids is reversing the gains eked out by advances in medical science. Since 1963, U.S. life expectancy has improved, as newer drugs and better procedures are keeping us alive for longer. However, owing to increasing reliance on opioids, that trend was reversed in 2015 and 2016. Drug overdoses have now surpassed heart disease as the leading cause of death for Americans under the age of 55, according to the New York Times (http://cnw.fm/Lw1Pr), and fentanyl appears to be the chief malefactor.

Developed in Belgium in the late 1950s, fentanyl is a mighty medication with an analgesic potency that’s 80 times as high as that of morphine. It was introduced into medical practice as an anesthetic in the 1960s because of its effectiveness and, in different forms, remains in extensive use today. By the mid-1970s, illicit fentanyl had begun to appear alongside heroin and cocaine as the fare of drug traffickers. It is now eclipsing those narcotics as a source of concern because of its murderous track record. While the biological effects of fentanyl are indistinguishable from those of heroin, for example, newly developed illicit analogues may be hundreds of times as potent. As a result, the possibility of overdose for a fentanyl user is significantly increased. Moreover, the crisis may get worse. Fentanyl is now commonly being added to boost the effects of heroin and cocaine, and it may even be passed off as those substances.

These disturbing developments make the need for gentler alternatives to opioids more pressing. Despite the ravage they cause, their use continues to increase. Consequently, the U.S. opioid market, currently estimated at around $12 billion, is expected to continue growing at a CAGR of 4.6 percent until 2024 (http://cnw.fm/DM2Yn).

Replacing just a fraction of that use with an option like QRX001 is likely to lift the dark cloud hanging over the nation by weakening the forces driving the opioid onslaught. QRX001, to be the lead drug candidate of the post-merger entity (Quoin Pharmaceuticals Inc.), is a single-use transdermal non-competitive NMDA receptor antagonist intended for the treatment of post-surgical pain. An N-Methyl-D-Aspartate (NMDA) receptor allows the transfer of electrical signals between the brain and the rest of the nervous system. An NMDA receptor antagonist is a drug that inhibits the ability of that NMDA receptor to accept signals, which is very useful when those signals are experienced as pain.

The highly differentiated nature of QRX001 could position it to capture a significant market share either as monotherapy or as a key component of effective multi-modal therapy. As a result, Quoin intends to apply for fast track status for QRX001.

The completion of the merger between Skinvisible and Quoin is subject to the negotiation of a definitive agreement and other customary closing conditions, including Quoin completing a financing round for clinical development.

For more information, visit the company’s website at www.Skinvisible.com

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Skinvisible, Inc.’s (SKVI) Topical Delivery Tech Provides Effective Protection against Deadly Flu Viruses

Skinvisible’s DermSafe® hand sanitizer provides long-term protection against viruses
Patented technology delivers active ingredients topically
Company generates revenue from four income streams

An outbreak of the deadly influenza A (H3N2) virus has devastated families across the United States this winter. Traditionally, the elderly and the very young are most vulnerable to the flu, but, this time around, it is attacking people of all ages. This outbreak follows on the heels of the potent H7N9 avian influenza virus, which has the potential to spread globally, although largely confined to China at present. Hand hygiene is vital to reduce the risk of contracting these flu strains. Skinvisible, Inc. (OTCQB: SKVI) has developed a unique hand sanitizer, DermSafe®, which offers long-term protection against harmful microbes.

DermSafe® uses patented polymer delivery technology developed by Skinvisible called Invisicare®. This proprietary technology binds active ingredients to the skin to enhance their delivery and resists wash-off and rub-off for up to four hours, even with hand washing. It creates a barrier to prevent attack by viruses and damage from toxins, retaining moisture in the skin while allowing normal respiration and perspiration. Left on the skin to do their job, Invisicare® formulations eventually wear off as part of the skin’s natural exfoliation process.

All of Skinvisible’s products utilizing Invisicare® technology are non-drying, as the formulations do not contain any organic solvents such as alcohol, silicones or waxes. Enhanced delivery means a lower dosage of active ingredients is required while still offering improved efficacy, reduced skin irritation and longer duration of action. To validate its marketing claims, the company uses FDA-registered independent laboratories to verify the efficiency of its products.

Through wholly-owned subsidiary Kintari, Skinvisible has developed a range of anti-aging products, including day cream, night cream, sunscreen and hand and body lotion. All of these products use the patented Invisicare® topical delivery technology. The company has 14 global patents for over 40 skincare products powered by Invisicare®. The Kintari website (www.Kintari.com) is a marketing portal for its products, offering consumers the ability to purchase these patented products online.

Looking ahead, Skinvisible’s development pipeline using Invisicare’s topical delivery technology includes products for acne, dermatitis, skin cancer, warts and first-aid pain relief, as well as formulations with anti-aging, anti-fungal and anti-inflammatory properties. In November 2017, the company issued a letter of intent to merge with Quoin Pharmaceuticals Limited, a developer of post-surgical pain relief products that replace or reduce opioid use. Quoin is also developing a transdermal formulation for anti-depression treatment of military veterans showing suicidal tendencies related to post-traumatic stress disorder (PTSD).

Skinvisible’s business model provides four revenue streams. By licensing its formulations, the company generates research and development fees for new products. It also charges license fees to secure exclusive territorial rights to a product, while generating ongoing royalties based on a licensee’s sales. Direct revenue is generated from the sale of Kintari products and the sale of the company’s Invisicare® polymers to its clients.

For more information, visit the company’s website at www.Skinvisible.com

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Skinvisible, Inc. (SKVI) Aims to Increase Shareholder Value through Proposed Deal with Quoin

Drug delivery platform ideal for M&A-driven growth
$80 billion global dermatology market
$30 billion global over-the-counter skincare market
Half of the 100 million surgeries performed in the U.S. require post-surgical pain medication, according to Transparency Market Research report

If history repeats itself, as we are often told, then Skinvisible, Inc.’s (OTCQB: SKVI) proposed deal with Quoin Pharmaceuticals Limited (“Quoin”) could increase shareholder value after execution. In late 2017, the company announced its plan to merge with Quoin, a marriage made in heaven that combines Skinvisible’s virtues as a drug delivery developer with Quoin’s position as a producer of post-surgical pain products that replace or diminish opioid use (http://cnw.fm/Fi2E7). Over the past two decades, mergers in the pharmaceutical industry have generally resulted in positive returns to shareholders, and today’s market leaders are the ones that have been most active in mergers and acquisitions.

There are many reasons why a merger may make sense. Taking over a rival, for example, means acquiring that rival’s market share and most, if not all, of its revenues. If product lines or business divisions overlap, costs can be cut and synergies exploited. In addition, purchasing a rival or merging with one may mean the acquisition of exciting new products at a much-reduced cost. It may cost the acquirer less to buy the target (and its product line) than to attempt to develop similar products in-house. Also, borrowing costs matter. If interest rates are low and likely to rise, now might be the time to borrow and spend. These are all good rationales for corporate consolidations. However, ‘growth is the main driver for most M&A deals: not just growth in drug distribution scale or earnings growth through cost cutting, but in revenues—and especially share price’, according to McKinsey & Company (http://cnw.fm/6WkAw).

Skinvisible is ideally poised to grow by acquisition, since its core business revolves around a drug delivery methodology that’s applicable to a wide range of topical products. Such ‘platform companies’ have a bright future, since they are enablers rather than competitors to other drug companies. Hedge fund manager Bill Ackman, the founder of Pershing Square Capital Management, opined, ‘“platform companies”—those that grow through bolt-on acquisitions—enrich their shareholders with each new deal…’ (http://cnw.fm/M9tG1). If that is to be believed, there’s little doubt that Skinvisible is treading the right path.

Since 1999, pharmaceutical and cosmeceutical companies have been adopting Skinvisible’s Invisicare® technology, developed through wholly-owned subsidiary Skinvisible Pharmaceuticals, Inc. The technology can be used to revitalize or create new medical or skincare products, allowing a company that licenses Skinvisible’s formulations to sell its own patented product and combat generic competitors.

Products utilizing Invisicare have been effective at bonding active ingredients to the skin for up to four hours and longer. Invisicare is non-occlusive; it allows normal skin respiration and perspiration while moisturizing and protecting against exposure from a wide variety of environmental irritants. When topically applied, products formulated with Invisicare 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. This allows enhanced delivery performance for a variety of topicals resulting in improved efficacy, longer duration of action, reduced irritation and lower dosage of active agents required. The ‘invisible’ polymer compositions that make up Invisicare wear off as part of the natural exfoliation process that removes the skin’s outer layer of cells.

With a $80 billion global dermatology market and a $30 billion global over-the-counter skincare market, the patented polymer delivery system for topical products developed by Skinvisible has a great deal of potential to add shareholder value.

For more information, visit the company’s website at www.Skinvisible.com

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Skinvisible, Inc. (SKVI) Products Can Offer Protection against Highly Contagious Viruses like H3N2

2018 flu season could cost U.S. businesses $15 billion in lost productivity
Winter Olympics hit with norovirus, sickening 128 Olympic workers
Centers for Disease Control and Prevention urging public to wash hands, use hand sanitizer in battle against infection
DermSafe® antimicrobial hand sanitizer is 99.9 percent effective against a list of deadly bacteria and viruses

It’s a simple phrase: “Wash your hands and use a hand sanitizer,” but doing it correctly and with the right product can make the difference when it comes to protection against a nasty bacteria or virus. Using an antiseptic hand sanitizer lotion such as DermSafe®, which incorporates Skinvisible’s (OTCQB: SKVI) proprietary Invisicare® drug delivery technology, is another vital tool offering a barrier against potentially serious illnesses. Skinvisible Pharmaceuticals, Inc., developer of over 40 topical prescription, over-the-counter and cosmeceutical products using its patented Invisicare® polymer delivery systems, donated over 1,000 bottles of DermSafe® to the Canadian Olympic team for the 2016 Summer Games in Rio (http://cnw.fm/kP2Zb), the company has now sent the same supply for the Olympic team in South Korea for the 2018 Winter Games. It’s a timely donation and one that could make a significant difference to the welfare of the team.

In fact, every athlete at the 2018 Winter Olympic Games in Pyeongchang, South Korea, is taking extra precautions to stay healthy, especially after an outbreak of the highly contagious norovirus sickened more than 120 security staff and others, prompting organizers to deploy 900 military personnel to assist at the games (http://cnw.fm/xQ8m0). Even more alarming is the continuing number of deaths resulting from an aggressive influenza strain – H3N2 – affecting children and adults living in the continental United States (http://cnw.fm/z3RTl). The common thread running throughout all of these stories is an admonition from health care professionals urging the public to religiously “wash your hands” and use hand sanitizers. Germs can live on any surface, so washing hands and wearing an antimicrobial hand lotion like DermSafe® is one of the best ways to stop germs from hitching a ride (http://cnw.fm/27iFH).

One application of DermSafe provides a four-hour protective barrier that binds to the skin and actively combats the spread of germs between people and hard surfaces. The active ingredient is four percent chlorhexidine gluconate (CHG), the same active ingredient found in soaps used in hospital operating rooms. DermSafe offers long-term protection and destroys both gram-negative and gram-positive bacteria and viruses (http://cnw.fm/8jRb6). It has been tested and proven effective against a host of infectious germs, including Methicillin-resistant Staphylococcus aureus (MRSA), Escherichia coli (E. coli) and salmonella. Sales of DermSafe have already taken off in China, and the product will be marketed throughout the country.

This year’s flu outbreak could conceivably cost U.S. businesses anywhere from $15 billion to $21 billion in lost productivity, Andrew Challenger, vice president of global employment consulting firm Challenger, Gray & Christmas, Inc., said in a 2017-2018 Flu Season report (http://cnw.fm/u9cAg). The agency raised itd earlier estimates by 64 percent, stating the 2018 flu virus could cause more than 18 million U.S. employees to miss at least four 8-hour shifts.

“Sick workers may think they are doing the right thing by ‘toughing it out’ and coming into work when they feel ill,” Challenger said in a news article (http://cnw.fm/S1CJs). However, “they are only likely to spread their illness, potentially further interrupting optimum business operations.”

Prevention and protection is the key when it comes to avoiding infectious germs. Although this season’s flu strain is particularly vicious, experts continue to remind the public that washing hands often and applying a long-term, antimicrobial hand sanitizer such as Skinvisible’s DermSafe® offers scientifically-proven protection against bacteria and viruses.

For more information, visit the company’s website at www.Skinvisible.com

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Skinvisible, Inc. (SKVI), Quoin Pharmaceuticals Proposed Merger to Address Opioid Pain Management Market

A merger between Skinvisible and Quoin will enable a successful entry on the post-surgical pain management market
Opioids – which typically refer to oxycodone, hydrocodone, and fentanyl – are highly addictive painkillers; nearly three in 10 Americans prescribed opioids for chronic pain will abuse them
Opioids are becoming increasingly deadly to Americans; in 2016, two-thirds of drug-related deaths involved opioids; in fact, since 1999, opioid-related deaths in the United States have increased nearly fourfold
Drug abuse is a burden shared by every state; nearly 63,600 Americans lost their lives to drug overdoses in 2016 – a 21 percent increase over the previous year; from 2000 to 2016, the U.S. Centers for Disease Control and Prevention estimates that more than 600,000 people died from drug overdoses in the United States
Every 25 minutes, a baby in the United States is born suffering from opioid withdrawal

Skinvisible, Inc. (OTCQB: SKVI) previously announced the signing of a Letter of Intent for a proposed merger with Quoin Pharmaceuticals Limited – a partnership that could address significant unmet medical needs on the pain management market. If both parties agree on the terms, the merger should be completed this year, and the resulting entity will operate under the name Quoin Pharmaceuticals Inc. and will continue to trade on the OTCQB market.

Quoin’s strength is within the area of pharmaceutical product development for products that address some of the most serious present-day health problems. Skinvisible is the developer of innovative delivery system technologies that can enhance product delivery and performance.

Quoin’s lead product is QRX001 – a transdermal NMDA receptor antagonist for the effective treatment of pain following surgery. QRX001 delivers up to 72 hours of effective pain relief after surgical interventions. Almost 30 clinical studies have been performed to date on the NMDA receptor antagonist, clearly showing that sub-anesthetic doses reduced 24-hour PCA morphine consumption; reduced post-operative nausea and vomiting; reduced pain intensity; resulted in adverse events that were mild or absent; and generated better results than any other single product or combination. The aim of the product is to also reduce the use of opioids for pain management following an operation.

Upon the product’s launch, QRX001 is expected to provide surgeons with a new and effective alternative to opioids. Opioid abuse has reached an epidemic level in the U.S., with opioid overdoses causing more than 90 deaths per day (http://cnw.fm/7vtpP). This number has grown exponentially in the past decade, according to the Centers for Disease Control and Prevention, with opioid use remaining widespread despite the risks. Today, approximately 12 million Americans report that they use pain killers in a non-medicinal way.

The opioid market in the U.S. is estimated at $6 billion annually. With the opioid epidemic now deemed a National Health Emergency, there is a significant push to find new products that reduce or eliminate their use, particularly in a post-surgical setting, which is where 50 percent of people who become addicted first become exposed to these drugs.

In addition to wrecking lives, opioid abuse poses a massive burden on the economy. Adding up money lost from costs related to health care, addiction treatment, reduced work productivity and crime, the Centers for Disease Control and Prevention estimates that the economic burden of the opioid crisis is more than $78.5 billion per year.

Almost half of the victims were first introduced to opioids after undergoing surgery. According to the National Center for Health Statistics, 100 million surgeries take place in the U.S. every year (http://cnw.fm/k4cxW). At least 50 million of these surgical interventions necessitate the use of post-operative pain management pharmaceuticals.

Currently, the pain management market in the U.S. is fueled by a number of sectors. The most prominent ones include post-operative pain relief, arthritis pain, cancer pain, migraine and neuropathic pain. As larger Western populations age and become susceptible to an array of medical conditions, the need for new pain management developments will grow even further. The partnership between Skinvisible and Quoin perfectly positions the two companies to address these growing unmet needs on the pain management market.

The Skinvisible announcement states that new technologies and product synergies between the two companies could potentially provide significant value to shareholders after the merger. Together, Skinvisible and Quoin could maximize their product development opportunities, as noted by Skinvisible President Terry Howlett. The official news release also included a disclaimer regarding ‘forward looking’ statements.

For more information, visit the company’s website at www.Skinvisible.com

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