LTR Pharma (ASX:LTR) has taken a decisive step toward bringing its rapid-acting intranasal erectile dysfunction treatment ROXUS to the United States by signing a binding term sheet with Shed Holdings, a US direct-to-consumer telehealth platform.
LTR Pharma described ROXUS as a US personalised medicine treatment for erectile dysfunction whose rapid-acting intranasal format differentiates it from traditional oral PDE5 inhibitors and suits the on-demand, digitally enabled ways patients increasingly access care.
The agreement establishes the first commercial route to market for ROXUS in the world’s largest commercial market and sets a performance-based minimum commercial volume target of 150,000 prescription units during the first 12 months from commercial launch, subject to supply and execution of Definitive Agreements.
Under the arrangement, LTR Pharma remains the product owner and supplier, while Shed provides patient acquisition, telehealth, and commercial infrastructure.
Mavrox Shed’s consumer-facing men’s health platform will be the primary channel, and ROXUS will be supplied through the US Section 503A personalised medicine pathway via LTR Pharma’s designated US 503A pharmacy partner.
The term sheet grants Shed two years of exclusivity in the US direct-to-consumer telehealth channel from commercial launch, subject to ongoing performance requirements, including the minimum volume commitment.
The binding elements of the term sheet are the minimum commercial volume commitment and the exclusivity provisions, while broader commercial terms will be negotiated in good faith and documented in Definitive Agreements within 60 days of the effective date. If those Definitive Agreements are not executed within that period, the term sheet terminates except for the surviving binding provisions, and exclusivity ends automatically. Commercial launch remains subject to the execution of Definitive Agreements, onboarding of the designated US pharmacy fulfilment partner, completion of technology transfer activities, and satisfaction of customary launch readiness conditions.
LTR Pharma Executive Chairman Lee Rodne said, "This is a defining step in our US commercialisation strategy. The binding term sheet with Shed establishes our first direct route to market in the world’s largest erectile dysfunction market and provides a scalable patient acquisition and telehealth channel for ROXUS. Importantly, the arrangement combines an established U.S. telehealth platform with a performance-based commercial framework and minimum volume targets, creating a clear pathway toward commercial launch and revenue generation. We believe this framework positions ROXUS to become a leading intranasal treatment option within the rapidly growing U.S. men’s health market."
Shed CEO Morley Baker said, "We believe ROXUS represents a highly differentiated addition to the men’s health category. Its rapid-acting intranasal delivery platform offers patients an alternative to traditional oral therapies and aligns well with consumer needs. As we continue expanding our men’s health offering, we see significant opportunity for ROXUS to address an important unmet need and become a valuable treatment option for patients seeking greater flexibility and spontaneity in their care. We’re thrilled to work with LTR Pharma to bring access to ROXUS to consumers across the United States."