New York, NY - 
(NewMediaWire) - February 08, 2022 - PCG Digital - Emerging specialty pharma company, Quoin Pharmaceuticals (NASDAQ: QNRX), coined the phrase ‘Rare diseases are only rare if you don’t live with one’ to emphasize its own mission: to deliver unique solutions to help treat rare disorders that have no approved treatments or cures.
Biotechs count on an innovative pipeline and external collaborations for growth, scaling and fundraising. As a biotech focused on developing and commercializing therapeutic products for rare diseases, Quoin has shown it has all of the above: the ability to raise money and make judicious use of it to advance the company while delivering value for investors.
With its promising pipeline of clinical-stage products, clear pathway to regulatory approval and smart strategy for getting therapeutics to those who need them most, Quoin seems poised for success. We sat down with Michael Myers, CEO of Quoin Pharmaceuticals, to get his take on what the future holds for Quoin.
Q: Quoin Pharmaceuticals has had an exciting introduction to the market followed by someimpressive company milestone announcements. It’s clear the company is focused on delivering long-term returns to investors. Can you talk about some of Quoin’s investment highlights?
A: Quoin is new to the market but a lot of work has gone on behind the scenes since the company was founded in 2018. Our lead asset, QRX003 for Netherton Syndrome, will enter clinical trials in the first half of this year. This therapeutic potentially qualifies for Rare Pediatric Drug Designation and we have received constructive and positive feedback from the FDA providing us with a clear path forward to approval. Approval of QRX003 could result in Quoin receiving a Priority Review Voucher with a potential, non-dilutive value of approximately $100 million. We have sufficient funding to complete our clinical work through the middle of 2023 with $25 million in committed funds from Altium Capital.
Q: Quoin appears to be very patient-focused. Can you tell us more about that?
A: Rare skin disorders such as Netherton Syndrome are debilitating and have no treatment beyond managing the symptoms, which include pain, redness, scaling, itching and infections. Living with a rare disease can be isolating and stressful for patients and their families, so we are 100% committed to doing everything we can to try to get our products to every single patient who needs them. As we work toward securing regulatory approvals in our core markets of the US and EU, we are also establishing relationships with distribution partners worldwide. To date we have signed exclusive agreements for QRX003 covering the MENA region, Russia and the Commonwealth of Independent States, Australasia and key markets in Latin America. We are in advanced discussions with potential partners in a number of additional territories, with a view to be able to reach all Netherton Syndrome patients globally.
Q: Can you tell us more about your lead candidate, QRX003 for Netherton Syndrome?
A: Put simply, Netherton Syndrome is the result of unregulated hyperactivity of skin proteases called kallikreins. This activity causes excessive skin shedding, leaving a patient’s skin very thin and susceptible to infections, atopic eczema and skin cancer. QRX003 is a broad spectrum serine protease with powerful anti-inflammatory and antioxidant action. It works by down regulating the activity of the kallikreins, reducing shedding and allowing skin architecture to recover. Finally, QRX003 provides a barrier over the skin, limiting penetration by unwanted environmental agents.
Q: Drug development is complex and challenging and many small biotechs struggle to go from clinical trials to getting product to patients. Why is Quoin different?
A: We are leveraging our extensive experience in this area to ensure that we are covering all of our bases along the development pathway. For example, we made sure right from the beginning that our contract manufacturers have the capacity to seamlessly move from clinical scale to commercial scale production with no change in facility or personnel required. In addition, we have engaged top level quality control consultants from day one who are ensuring that everything that is done on our behalf by our contractors is at the highest level of compliance.
Many small biotechs overlook these basic activities and focus solely on generating clinical trial results instead of the bigger picture of getting products to patients. We have a dual strategy. While we are advancing our therapeutics through clinical trials and the regulatory process, we are simultaneously working to create the most favorable market environment for our products once they are approved. Some examples of this are identifying patient populations and establishing strong relationships with the foundations that support these patients and their families. We are developing close ties with leading dermatology experts and treating physicians so that they are aware of the product and its development status.
Q: What is the market opportunity for QRX003?
A: We believe we have a long-term marketing opportunity for QRX003. It will be a ‘whole body, whole life’ topical therapeutic, that is applied to the patient’s entire skin surface once a day, every day, for life. We believe we are very well positioned to capture a very significant proportion of the entire Netherton Syndrome population and, in doing so, deliver excellent long term results for our shareholders.
Q: What is your strategy for commercializing Quoin’s products?
A: Our management team has deep experience in commercializing therapeutics, so we have a very clear strategy for getting our products to market. As mentioned, we are establishing distribution partnerships that will allow us to reach patient groups in most parts of the world, and we expect to announce a number of new partnerships in the first half of this year. There are several important value propositions about these partnerships that I’d like to highlight.
First, by establishing these partnerships early, it enables our partners to develop a deep understanding of the market in their respective territories, establish relationships with foundations, KOLs and also address reimbursement issues so that when the product is approved, they are fully ready to launch and maximize the commercial opportunity for the product. Second, many of the countries where we are establishing these partnerships have vibrant early access programs where the product can be supplied on a named patient basis in advance of formal regulatory approval. Programs such as these could begin to generate sales revenue for Quoin earlier than anticipated whilst the product is being used in a real world environment.
The second part of our strategy is addressing sales and distribution throughout our core markets of the US and Europe. In these regions, we intend to establish our own commercial infrastructure and we anticipate that fewer than 50 people will be more than sufficient to fully support both US and European markets. This highly compact sales infrastructure will enable us to successfully launch and commercialize our products whilst maximizing profitability. In addition, this same sales infrastructure will be positioned to commercialize each new product in our pipeline at no material incremental cost, further boosting our profitability.
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