LTR Pharma (ASX: LTP) has signed a definitive telehealth distribution agreement with Shed Holdings for the planned US commercialisation of its rapid-onset intranasal erectile dysfunction (ED) treatment ROXUS under a partnership intended to provide a scalable route to patients.
The agreement converts the parties’ previously announced binding term sheet into a long-form framework covering commercialisation, branding, marketing, and operational activities while providing the foundation for a long-term commercial relationship.
Shed has committed to support delivery of at least 150,000 ROXUS units during the first 12 months following commercial launch through its dedicated men’s health platform Mavrox and its broader direct-to-consumer (DTC) channel.
The arrangement gives LTR access to Shed’s established telehealth and patient acquisition infrastructure as the parties complete the remaining work required for the launch.
US Pathway Takes Shape
Subject to clinical appropriateness, Shed will provide patients with a digital pathway to consultation and treatment through Mavrox and its own platform.
Its responsibilities include patient acquisition, platform operations, clinical infrastructure, and related marketing activities supporting the commercialisation of ROXUS.
The DTC group brings a licensed telehealth platform, clinician network, recurring prescription experience, and digital marketing capability developed across multiple therapeutic areas including subscription-based clinician-prescribed treatments and digital fulfilment.
LTR contributes the product and its intranasal delivery platform, allowing it to pursue US market access without building its own patient acquisition and telehealth infrastructure.
Exclusivity Volume Commitment
Shed’s commitment to support delivery of no fewer than 150,000 units during the first year forms part of the performance framework underpinning its ongoing exclusivity.
ROXUS is designed as a fast-acting intranasal spray for ED, with LTR reporting an onset of action in 10 minutes or less.
“Executing this definitive agreement with Shed is a major milestone in our US commercialisation strategy, and one we’re genuinely excited about,” LTR executive chair Lee Rodne said.
“Combined with ROXUS’s differentiated, rapid-onset profile, we believe this partnership gives US patients a genuinely differentiated treatment option and gives LTR Pharma a credible, scaled pathway into the US market.”
Launch Preparations Continue
LTR and Shed will now concentrate on implementation activities required to support the commercial launch under the definitive commercial framework.
Preparatory work is already underway, with ROXUS featured on the Mavrox platform and a patient waitlist established ahead of launch.
“Mavrox will launch with ROXUS as its hero product, furthering our commitment to supporting its successful commercial launch,” Shed and Mavrox chief executive officer Morley Baker said.
“Our teams are eager to bring ROXUS to patients across the US alongside the LTR Pharma team.”
LTR plans to update investors as the remaining launch conditions are satisfied, with timing still dependent on completion of those requirements.