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QNRX: FDA Clearance To Move QRX003 Clinical Testing Forward; Positive Implications


Benzinga · 04/30/2022 13:41

By M. Marin



FDA Clearance - Moving QRX003 forward for potential treatment of NS

Quoin Pharmaceuticals (NASDAQ:QNRX) announced today that it has been granted FDA clearance to initiate clinical testing for its Investigational New Drug (IND) application for QRX003. Quoin had submitted a pre-IND meeting request to the FDA regarding the proposed development of QRX003 as a potential treatment for NS on November 29, 2019. QRX003 is Quoin's investigational product, initially for Netherton Syndrome (NS), a rare disease that currently has no approved treatment or cure.

With this FDA clearance, the company expects to begin clinical testing in patients with NS in 1H22. The company targets receiving regulatory approval in the U.S. and EU in 2024 and is currently laying the foundation for a subsequent commercial launch.

NS patient population…

Quoin is an emerging specialty pharmaceutical company focused on developing and commercializing therapeutic products for the treatment of rare and orphan diseases that have few or no currently approved therapies. Quoin estimates that there are about 6,000-7,000 patients in the U.S. and EU suffering with Netherton syndrome. Data is not readily available and these estimates are within the range of other published estimates. The National Organization for Rare Disorders (NORD) indicates that the actual number of people suffering from NS might exceed the number of reported cases because it is often undiagnosed.

QRX003 is one of three lead products Quoin has in development and it is the most advanced (for treatment of NS). Quoin's goal is to address the unmet medical need of patients suffering from certain rare and orphan diseases, beginning with dermatological indications. Skin is the body's largest organ and first point of contact for microbes and toxins. Demand for products and therapies to treat dermatological disorders has climbed in recent years.

… And potentially other patient populations

Like other products in Quoin's pipeline, QRX003 and the company's assets are generally being designed to treat multiple indications. Thus, QRX003 is planned to target NS initially; Quoin also intends to expand its use to other patient populations, such as those suffering from peeling skin syndrome and other conditions. In turn, this strategy is expected to broaden QRX003's target patient populations and commercial prospects, create operating and cost efficiencies and scale and enhance the commercial opportunities of QRX003 and other drugs in the product pipeline. According to NORD, at least 154 orphan products were approved initially to treat a single rare disease and ultimately earned approval to treat one or more additional orphan indications.

In addition to pursuing FDA approval, Quoin intends to pursue approvals from other international regulatory agencies for QRX003 and, as noted, targets receiving regulatory approval in the U.S. and EU in 2024.

To commercialize QRX003 in the U.S. and Europe, Quoin intends to develop an internal sales infrastructure and expects that a relatively streamlined salesforce can be extremely productive and attain scale quickly and in an economical way by developing outreach to treating physicians and also working with foundations that focus on these diseases. Moreover, the company believes that it can leverage this distribution infrastructure as it moves other products in its product pipeline toward commercialization, given that the company's initial focus is on dermatological indications, which management believes will enable the salesforce to attain scale in a range of disorders.

For other international markets, the company's strategy is to enter into distribution partnerships, Quoin recently forged revenue sharing deals with AFT Pharmaceuticals Ltd. and Genpharm Services for exclusive rights to commercialize QRX003 in Australia and New Zealand (AFT) and the Middle East and North Africa region (Genpharm). Prior to the current geopolitical situation, the company had also signed an agreement with Orpharm LLC for Orpharm to commercialize QRX003 in Russia and CIS.

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