LTR Pharma Executes Binding U.S. Telehealth Commercialisation Framework for ROXUS®

LTR Pharma has executed a binding term sheet with Shed Holdings LLC, a U.S. direct-to-consumer telehealth platform, to support the distribution of ROXUS® in the United States.

The agreement establishes LTR Pharma’s first commercial route-to-market framework for ROXUS in the U.S., representing a significant milestone in the Company’s commercialisation strategy.

Under the proposed partnership, LTR Pharma will remain the product owner, intellectual property holder and supplier of ROXUS, while Shed will support patient access through its established telehealth infrastructure, patient acquisition capabilities and consumer-facing men’s health platform, Mavrox, which will be the primary commercialisation and distribution channel for ROXUS in the United States.

The arrangement includes a performance-based minimum commercial volume target of 150,000 ROXUS prescription units during the first 12 months from Commercial Launch, subject to key conditions.

ROXUS is positioned to become the first commercially available PDE5 nasal spray in the U.S. market. Its rapid-acting intranasal format is designed to address one of the key limitations of traditional erectile dysfunction treatments – the need to plan ahead – supporting a more spontaneous, on-demand treatment experience.

Recent Phase II clinical data reinforced the rapid pharmacokinetic profile of LTR Pharma’s intranasal platform, demonstrating a median Tmax, or time to peak concentration, of 10 minutes compared to approximately 60 minutes for oral vardenafil tablets.

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.”

Click to read the ASX release.