Recce finds regional partner for RECCE 327 ahead of key Phase 3 review

Arrotex takes exclusive ANZ rights to R327G

Recce Pharmaceuticals Ltd (ASX:RCE) has secured a commercial partner for RECCE 327 topical gel in Australia and New Zealand, giving Arrotex Pharmaceuticals exclusive rights to register and commercialise the investigational treatment for diabetic foot infections and acute bacterial skin and skin structure infections.

The binding agreement gives Recce a significant share of gross margin from product sales, paid quarterly, while Arrotex assumes the local commercialisation burden. The percentage has not been disclosed, nor have expected sales, launch timing or the potential financial value of the opportunity.

Recce keeps manufacturing and product ownership

Recce will remain the exclusive manufacturer and supplier of R327G, providing the product to Arrotex at cost plus a margin that is credited against Recce’s profit share. It also retains ownership of its intellectual property, rights outside the territory and the right to conduct clinical trials in Australia and New Zealand.

The deal arrives as the company advances its pivotal programme, following a blinded Phase 3 review that Recce said indicated strong efficacy and a positive safety profile, with an independent committee expected to assess unblinded data from 75 patients as soon as mid-November. Earlier, regulators approved an active-controlled Phase 3 arm comparing R327G with physician-selected antibiotics.

Approval remains the central condition

R327G remains in registrational Phase 3 development in Australia and Indonesia and has not been approved for commercial use in Australia, New Zealand or the United States. Any eventual availability therefore depends on successful clinical development and regulatory approval, rather than on the signing of this agreement alone.

Arrotex is required to pursue Australian approval only after R327G receives approval from the US Food and Drug Administration, the European Medicines Agency or another regulator recognised by the Therapeutic Goods Administration as comparable. Arrotex will bear local regulatory, Pharmaceutical Benefits Scheme, Pharmac, sales and marketing costs, while Recce continues to fund global clinical development, manufacturing and regulatory work outside the territory.

That structure limits Recce’s immediate cash benefit: the agreement contains no upfront or milestone payments. Its economic value is instead tied to a product that still has to clear late-stage development and overseas regulatory hurdles, with the size of the eventual profit stream dependent on commercial uptake and the undisclosed margin split.