LTR Pharma Secures Definitive US Manufacturing Deal for ROXUS Launch

Finalising US Manufacturing and Fulfilment for ROXUS®

LTR Pharma (ASX:LTP) has converted its binding term sheet with Strive Specialties Inc. into a definitive commercial agreement, securing the manufacturing, compounding, fulfilment and nationwide distribution of its intranasal erectile dysfunction treatment, ROXUS®, across the United States. This deal establishes the operational backbone needed to move beyond planning and into execution for the US commercial launch.

The agreement covers critical elements such as quality systems, active pharmaceutical ingredient (API) sourcing, product change control, and supply-chain management. Strive Pharmacy operates a Section 503A compounding platform licensed in five US states but with capabilities to support nationwide prescription fulfilment. This arrangement provides LTR Pharma with a ready-made infrastructure to manufacture and distribute ROXUS® at scale.

Completing the US Commercialisation Blueprint

This manufacturing and fulfilment deal complements LTR Pharma’s earlier definitive agreement with Shed, a telehealth provider responsible for patient acquisition and prescribing. Together, these partnerships form the two core commercial pillars underpinning LTR Pharma’s US launch strategy: telehealth-driven patient access and a robust manufacturing and supply network.

With the Shed agreement committing to at least 150,000 ROXUS units in the first year, the Strive partnership ensures the company can meet demand through a scalable national platform. The dual-partner model positions LTR Pharma to supply telehealth, clinic, and future commercial channels efficiently, reducing execution risk ahead of the commercial launch.

These developments mark a clear transition from partner selection to operational readiness, as the company now focuses on technology transfer, inventory planning, and manufacturing ramp-up.

Strategic Implications and Next Steps

LTR Pharma’s Executive Chairman Lee Rodne highlighted that finalising the Strive agreement “significantly strengthens our US execution pathway and reduces commercial risk.” The partnership leverages Strive’s established regulatory and fulfilment capabilities, which are essential for navigating the complex US pharmaceutical landscape.

Strive Pharmacy’s President Michael Walker emphasised the company’s enthusiasm for supporting the ROXUS launch through its national compounding and fulfilment infrastructure, reflecting confidence in ROXUS as a differentiated product in the erectile dysfunction market.

Looking ahead, LTR Pharma and Strive will prioritise technology transfer and manufacturing readiness to meet the commercial launch timeline. Shareholders can expect updates as key milestones are reached, with the company poised to capitalise on the growing US market for rapid-acting intranasal ED treatments.