- 01Arrotex gets exclusive R327G rights in Australia/NZ.
- 02Arrotex funds sales; Recce supplies gel and shares margin.
- 03Launch requires Phase 3 success and approval.
Recce Pharmaceuticals (ASX: RCE) has struck a binding exclusive licensing and commercialisation agreement with Arrotex Pharmaceuticals covering its investigational RECCE 327 gel (R327G) in Australia and New Zealand.
The partnership gives Arrotex responsibility for registering and selling the treatment while Recce retains manufacturing and supply rights and a share of future product margins.
R327G is undergoing registrational Phase 3 clinical development for diabetic foot infections (DFIs), with any commercial launch dependent on successful trials and regulatory approval.
DFIs can affect skin, soft tissue and bone, and may lead to hospitalisation, surgery, or amputation when not effectively treated, with approximately 50,000 Australians estimated to have diabetes-related foot ulcers and another 300,000 considered at risk.
The gel is being developed against serious bacterial infections, including infections involving antibiotic-resistant pathogens, with the gel formulation also studied for wounds, burns, and skin infections.
Sales Revenue Split
Recce will receive a significant, but undisclosed, share of gross margin on Arrotex’s sales, calculated from net sales less Recce’s cost of goods and paid quarterly.
The biotechnology developer will supply the gel at cost plus a margin that is credited against its profit-share entitlement.
Arrotex will meet all commercialisation expenses in the two countries, including regulatory submissions, market access applications, marketing, and sales, while Recce remains responsible for global clinical development, manufacturing, and regulatory submissions beyond the licensed territory.
“This agreement brings together Recce's anti-infective development platform and Arrotex's established regulatory, market access and commercial capabilities in Australia and New Zealand,” managing director James Graham said.
"Arrotex is a leading regional partner with the infrastructure and healthcare relationships needed to prepare R327G for the market, [and] we look forward to working together to address a serious area of unmet medical need."
Broadening Commercial Scope
The licensed indications include DFIs, as well as acute bacterial skin and skin structure infections, broadening the commercial scope beyond the initial diabetic foot focus.
Arrotex’s exclusivity prevents Recce from appointing another regional commercial partner for any presentation of RECCE 327, the underlying synthetic anti-infective.
Other presentations, including intravenous and inhaled formulations, require good-faith negotiations, followed by an Arrotex right of first refusal if terms are not settled within 90 days.
Recce retains its intellectual property, rights outside Australia and New Zealand, rights outside human pharmaceutical use, and the ability to conduct clinical trials locally.
The licence lasts until the later of the expiry of the final applicable patent or 10 years after the first Australian sale, with annual continuation thereafter unless notice is given.
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