Recce Pharmaceuticals Inks 10-Year Licensing Deal for R327G, Targeting High-Demand MENA Diabetes Market
Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has moved a step closer to bringing its novel anti-infective gel R327G to the Middle East and North Africa (MENA), inking a non-binding term sheet with a leading publicly listed pharmaceutical company in the region. The proposed 10-year exclusive licensing agreement covers commercial sales and distribution for diabetic foot infections across Saudi Arabia, GCC countries, Egypt, Algeria and Morocco.
The MENA region represents a pressing market for diabetes-related therapies, with over 84 million people living with diabetes and Saudi Arabia recording an adult prevalence rate of 23.1% — among the highest globally. The term sheet signals Recce’s shift from pipeline development to concrete commercial traction in a region where antimicrobial resistance is a growing concern.
“This is a major milestone in the development and commercialisation of Recce’s anti-infective platform,” said Recce CEO James Graham. “The proposed establishment of marketing and distribution channels for R327G across the MENA region highlights the growing demand for novel, innovative and groundbreaking treatments for addressing antimicrobial resistance. This term sheet represents a positive step in the commercialisation pathway of Recce’s innovative pipeline as a next-generation solution for addressing the infectious disease challenges associated with the global pandemic of diabetes.”
Under the proposed terms, Recce would receive an upfront signing fee and potential milestone payments totaling up to US$3.5 million (approximately A$5 million), plus 30% of the net selling price. An additional 6% annual royalty would apply on net sales above US$50 million per year. The proposed selling price stands at US$1,500 per treatment, subject to agreement with the Saudi regulatory authority. Recce will retain responsibility for manufacturing and supply.
Recce’s ongoing Phase 3 diabetic foot infection trial in Indonesia is expected to support a regulatory submission in Saudi Arabia. Based on current planning, no further clinical trials are anticipated for a marketing authorisation application, pending trial outcomes. The company and the proposed licensee are working to finalise a definitive agreement in the next quarter, subject to due diligence, negotiations, final documentation and customary approvals.
The MENA deal is the latest in a series of moves underscoring Recce’s global commercial rollout. The company recently secured a Family 4 patent in Brazil from the National Institute of Industrial Property, covering lead compounds RECCE® 327 (R327) and RECCE® 529 (R529), including manufacturing processes, therapeutic use and multiple delivery methods. That marks Recce’s seventh granted patent in the Family 4 portfolio, adding Brazil to jurisdictions including Australia, Canada, China, Hong Kong, Israel and Japan.
On the research front, the United States Army Institute of Surgical Research (USAISR) has entered a second agreement with Recce to evaluate R327G as a treatment for infected burn wounds using a battlefield-relevant burn wound infection model. Under the agreement, USAISR will test R327G in its validated Walker-Mason rat model, designed to replicate battlefield injuries and the systemic response to burns and subsequent infection. This work adds another development pathway alongside the diabetic foot infection program and the proposed MENA commercial rollout.
The combination of patent expansion, military-backed research and a commercial foothold in a high-need diabetes market positions R327G as a candidate with multiple near-term value drivers, particularly as antimicrobial resistance continues to drive demand for novel non-antibiotic anti-infectives.