New York, New York–(Newsfile Corp. – November 16, 2021) – PCG Digital — Following a successful merger, one firm is developing and commercializing therapies for rare skin conditions. Quoin Pharmaceuticals (NASDAQ: QNRX) is positioned to deliver the first FDA-approved treatment for Netherton Syndrome, a devastating disorder which affects 1 in every 200,000 people worldwide.
Quoin recently completed a successful merger with Cellect Biotechnology Ltd. and is now trading on the Nasdaq Capital Market (NASDAQ: QNRX).
The company has a strong balance sheet, including $25 million in committed funding from sophisticated healthcare investor, Altium Capital.
Quoin’s lead therapeutic candidate, QRX003, has the opportunity to become the first approved therapeutic for Netherton Syndrome.
QRX003 may qualify for Rare Pediatric Designation, which, if approved, will earn a priority review voucher.
Rare and Orphan Diseases
More than 300 million people worldwide are living with rare or orphan diseases and for some drug developers these diseases can represent an attractive commercial opportunity. Although the commercial market for these therapeutics is small, FDA support for developing treatments and the high rate of success for obtaining regulatory approval can mean a faster pathway to market.
Global orphan drug sales are expected to grow at double the rate forecast for the non-orphan drug market and by 2024, orphan drug sales are expected to reach $242 billion and capture one-fifth of worldwide sales.
The regulatory landscape gives Quoin a path forward for the development of QRX003. Clinical testing is expected to begin in early 2022, and the FDA has agreed to lower criteria for a successful clinical outcome. Quoin believes that QRX003 might also be efficacious for treatment of other rare skin disorders such as Peeling Skin Syndrome, SAM Syndrome and Palmoplantar Keratoderma.
Recent Wins on the Road to Commercialization
Quoin has signed an exclusive agreement with AFT Pharmaceuticals to distribute QRX003 in Australia and New Zealand. AFT Pharmaceuticals has a strong commercial presence and a growing portfolio of rare and orphan disease products, making it an excellent strategic partner in the region.
The company has also entered an exclusive license and distribution partnership with Genpharm Services, a pharmaceutical company, focused on rare diseases and specialty therapeutics for the Middle East and North Africa (MENA) region. Under the agreement, Genpharm obtains exclusive rights to commercialize QRX003 in the region, and Quoin will be entitled to a revenue sharing arrangement on net sales of the product.
This month, Quoin entered an agreement with the Queensland University of Technology (QUT) in Australia for an option to supply a key ingredient for a potential treatment for the Netherton Syndrome. Quoin will fund a pre-clinical program at QUT and, upon completion, Quoin will have the right to an exclusive global license to the protein. Quoin Pharmaceuticals CEO, Dr. Myers, said, “The in-licensing of this protein is complementary to QRX003, and further strengthens our leadership position in the development of potential treatments for this devastating disease.”
The Future is Bright
Quoin completed a successful merger with Cellect Biotechnology in October along with a private placement financing of $21.5 million from Altium Capital, supplementing $5.0 million received from Altium earlier this year. The company believes it is in a strong position to advance its pipeline and focus on securing regulatory approvals in the United States and Europe, slated for 2023, 2024 and 2025.
Dr. Myers commented, “We intend to use the proceeds from this financing to advance our innovative product pipeline as we continue to focus on addressing the unmet medical needs of the underserved rare disease communities that we’re targeting. With the ongoing support of our existing investors, and now with access to the capital markets, our key priority remains to rapidly progress the development of our lead clinical assets.”
About Quoin Pharmaceuticals
Quoin Pharmaceuticals Ltd. is an emerging specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. The company is committed to addressing unmet medical needs for patients, their families, communities and care teams. Quoin’s innovative pipeline comprises three products in development that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Epidermolysis Bullosa and others. For more information, go to: www.quoinpharma.com.
Cautionary Note Regarding Forward Looking Statements
The company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. More detailed information about the risks and uncertainties affecting the company is contained under the heading “Risk Factors” included in the company’s Annual Report on Form 20-F filed with the SEC on March 29, 2021 and in other filings the company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
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