Recce Pharmaceuticals (ASX: RCE) has secured a licensing agreement with a leading Middle Eastern pharmaceutical company to sell and distribute its proprietary R327 topical gel for the treatment of diabetic foot infections (DFIs) across the Middle East and North Africa (MENA) region.
Under the terms of the 10-year deal, the undisclosed company will have exclusive rights to register, market, and distribute R327G for the treatment of DFIs in the Kingdom of Saudi Arabia (KSA), Egypt, Algeria, Morocco, and Gulf Co-operation Council countries the UAE, Kuwait, Oman, Bahrain, Qatar, and Iraq.
Recce confirmed the Middle Eastern company has a distribution network spanning over 30 international markets, along with a strong portfolio of products across dermatology, endocrinology, infectious diseases, and other therapeutic indications.
The multi-billion-dollar firm also has established market access throughout the region, making it well-positioned to accelerate the adoption and distribution of R327G across key MENA markets.
Upfront Signing Fee
Recce will be responsible for the manufacture and supply of R327G, and will receive an upfront signing fee together with milestone payments totalling up to $5 million.
Each unit of R327G will have a proposed selling price of US$1,500 per treatment and Recce will receive 30% of net sales plus 6% annual royalty on any net sales exceeding USD$50m per year.
Recce expects its clinical development pipeline to provide a data package that will support a regulatory submission in KSA.
In light of this, the company continues to enrol patients into a registrational Phase III clinical trial for DFIs with an approvable interim data readout following enrolment of 155 patients.
A total 310 patients will be randomised to receive R327G or a placebo, with expedited regulatory review aimed at commercial approval by year end.
Anti-Infective Platform
Recce chief executive officer James Graham said the licensing agreement was a significant milestone in the development and commercialisation of the company’s anti-infective platform.
“The proposed establishment of marketing and distribution channels for R327G across the MENA region highlights the growing demand for novel, innovative, and ground-breaking treatments for addressing antimicrobial resistance,” he said.
“This agreement represents a positive step in the commercialisation pathway of our innovative pipeline as a next-generation solution for addressing the infectious disease challenges associated with the global pandemic of diabetes.”
Recce’s R327G gel is expected to address a critical unmet need in one of the world’s highest-burden regions for diabetes, with a diabetes prevalence of 17.6% in the MENA region, where more than 84 million people live with the condition.
An estimated 23.1% of Saudi people aged between 20 and 79 years — 5.3 million individuals — have diabetes, placing it among the top 10 countries with regard to prevalence.
