LTR Pharma has executed a definitive Compounding and Supply Agreement with Strive Specialties Inc., a leading U.S. Section 503A compounding pharmacy, converting the previously announced binding Term Sheet into a definitive commercial agreement governing the planned manufacturing, compounding, fulfilment and nationwide supply of ROXUS® in the United States.
The agreement establishes the operational framework for technology transfer, manufacturing, quality systems, API sourcing, product change control, fulfilment and supply-chain management as both companies prepare for Commercial Launch.
Strive Pharmacy operates an established Section 503A compounding platform across five U.S. states, with licensure supporting nationwide compounding, packaging, fulfilment and shipping of prescription treatments. Through this partnership, LTR Pharma gains access to an established national compounding pharmacy with the infrastructure, regulatory systems and fulfilment capability required to support Commercial Launch and future growth across its U.S. commercial channels.
Together with the recently executed definitive agreement with Shed, LTR Pharma now has in place the two core commercial pillars required for launch: patient acquisition and prescribing through telehealth, and national manufacturing and fulfilment through Strive Pharmacy.
LTR Pharma and Strive Pharmacy will now focus on technology transfer, commercial inventory planning, manufacturing readiness and operational implementation ahead of Commercial Launch.
LTR Pharma Executive Chairman, Lee Rodne, said:
“Executing the definitive agreement with Strive Pharmacy completes another major piece of our U.S. commercialisation strategy. While Shed provides patient acquisition and telehealth capability, Strive Pharmacy provides the national manufacturing, compounding and fulfilment infrastructure required to supply ROXUS across the United States. With both definitive agreements now in place, our focus shifts from partner selection to implementation and Commercial Launch. We believe this significantly strengthens our U.S. execution pathway and reduces commercial risk.”
Strive Pharmacy President/Co-Founder, Michael Walker, said:
“We are delighted to formalise our partnership with LTR Pharma. ROXUS is a highly differentiated product, and we look forward to supporting its U.S. launch through Strive Pharmacy’s national compounding, manufacturing and fulfilment capabilities.”