New company expected to have an exciting product portfolio addressing major unmet medical needs
LAS VEGAS, NV–(Marketwired – Nov 27, 2017) – Skinvisible, Inc. (“Skinvisible”) (OTCQB: SKVI), announced that it has entered into a non-binding term sheet regarding a proposed merger of Skinvisible, Inc. with and into Quoin Pharmaceuticals Limited (“Quoin”) subject to tax, accounting, legal, regulatory, and other considerations.
Founded by industry veterans, each with over 30 years of direct experience and a proven track record of success in drug delivery and specialty pharma, Quoin Pharmaceuticals is committed to developing products which address major societal issues including the opioid epidemic and the military veteran suicide rate. Quoin's two lead products are targeting crises that result in the death of almost 120 people in the US every day.
The company's proposed first lead product, QRX001, is a single use transdermal non-competitive NMDA receptor antagonist intended for the treatment of post-surgical pain. QRX001 will be designed to provide up to 72 hours of effective analgesia post-surgically while reducing opioid consumption. Opioid abuse has become a national epidemic, with over 90 deaths each day resulting from opioid overdose. It is estimated that half of these victims are first introduced to opioids in the post-surgical setting. QRX 001, when developed, may provide surgeons with a more effective alternative to opioids and to current opioid sparing products such as intravenous NSAIDS and long acting local anesthetics. The current market for opioids in the US is estimated at $6 billion annually. 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. Quoin intends to apply for Fast Track status for QRX001.
Quoin's proposed second product, QRX002, will be a once-daily transdermal NMDA receptor antagonist for the treatment of suicidal ideation in military veterans with PTSD. It is estimated that between 25-30 veterans commit suicide every day in the US. Currently, the only approved treatments are standard anti-depressants which are either ineffective or act very slowly resulting in a clear unmet medical need to address this growing crisis. Quoin believes QRX002 may be a candidate for both Orphan Drug status for QRX002 and Breakthrough Therapy status. Quoin will initiate formal development of both products and is targeting generating Phase 2 clinical data in 2018.
We believe that the value of the technology and product synergies between our two companies could be extremely strong,” said Terry Howlett, President of Skinvisible. “This potential merger with Quoin is the best option for our company and may offer significant value to shareholders as Quoin commences and progresses with its clinical development plans. We look forward to working with Quoin's team of experts to maximize the product development opportunities.”
“We are very pleased to announce this proposed merger with Skinvisible and we are excited by the growth platform the combined companies can present.” said Dr. Michael Myers, Chairman and CEO of Quoin Pharmaceuticals. “Skinvisible has done an impressive job developing their technology and building a very robust patent portfolio. The utilization of their unique drug delivery technology could, we believe, enable us to achieve the performance targets of our proposed lead products whilst providing for strong patent protection. Quoin's management has extensive experience in developing and commercializing differentiated products that address unmet medical needs, including a strong background in post-surgical pain. We are looking forward to working with the team at Skinvisible to achieve our goals.”
The completion of the merger is subject to the negotiation of a definitive agreement and thereafter other customary closing conditions. Post-merger, Quoin shareholders would own 72.5% of the new company and Skinvisible shareholders will own 27.5%, prior to any effect from financing activities. The new company will be named Quoin Pharmaceuticals Inc. and will continue to trade on the OTCQB. It is anticipated, should all parties agree, the merger will take place in early 2018.
About Skinvisible Pharmaceuticals, Inc.
Skinvisible Pharmaceuticals 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, allowing for the controlled release of actives. For more information, visit www.skinvisible.com or www.invisicare.com
About Quoin Pharmaceuticals, Inc.
Quoin Pharmaceuticals is a specialty pharmaceutical company dedicated to developing products that help address major societal issues including the opioid crisis and the military veteran suicide rate. Quoin's two lead products are expected to be different applications of an NMDA receptor antagonist delivered transdermally. QRX001 is a single use transdermal patch designed to provide up to 72 hours of effective post-operative analgesia whilst significantly reducing opioid consumption. QRX002 is a once-daily transdermal for the treatment of military related PTSD with suicidal ideation. Quoin believes QRX002 could be the first product approved to treat this major unmet medical need and could be a candidate for both Orphan Drug and Breakthrough Therapy Status. Quoin expects to commence development activities with respect to each of these products and to generate Phase 2 data in 2018.
Forward-Looking Statements: This press release contains 'forward looking' statements within the meaning of Section 21A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbors created thereby including with respect to the possible development of any such products, the acceptance of any such products in the market place, the size of any such markets, the ability of any product candidates to be approved by the U.S. Food and Drug Administration among others. Such statements involve certain risks and uncertainties associated with an emerging company. Actual results could differ materially from those projected in the forward-looking statements as a result of risk factors discussed in Skinvisible, Inc. reports on file with the U.S. Securities and Exchange Commission (including, but not limited to, a report on Form 10Q for the period ending September 30, 2017). Quoin and Skinvisible have signed a non-binding term sheet only. Neither party is obligated to consummate the merger and either party may terminate discussions at any time. No assurances can be given that the parties will reach agreement, that a Merger Agreement will be signed or, that once it is signed, that the closing conditions will be satisfied and the proposed merger will close.
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