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Thursday, 03/01/2018 3:07:40 PM

Thursday, March 01, 2018 3:07:40 PM

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SKVI's 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://nnw.fm/BZPr1), 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://nnw.fm/4zmCF).

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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