LTR Pharma secures national US manufacturing and fulfilment partner

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LTR Pharma has taken a major step toward its planned US commercial launch by executing a definitive agreement with Strive Specialties, converting a previously announced binding term sheet into a long-form commercial arrangement that will govern the manufacture, compounding, fulfilment and nationwide supply of ROXUS in the United States.

ROXUS is a fast-acting intranasal spray for the treatment of erectile dysfunction, enabling onset of action in 10 minutes or less. 

The agreement establishes the operational framework for technology transfer, manufacturing, quality systems, active pharmaceutical ingredient procurement, product change control, inventory management and nationwide prescription fulfilment.

The deal builds on a complementary agreement LTR Pharma signed with telehealth provider Shed, giving the company two core commercial pillars: patient acquisition and prescribing through telehealth, and national manufacturing and fulfilment through Strive Pharmacy.

Strive Pharmacy operates a Section 503A compounding platform across five US states with licensure that supports nationwide compounding, packaging, fulfilment and shipping of prescription treatments. Under the agreement, Strive will be responsible for preparation, fulfilment, shipping and related quality and supply chain operations for ROXUS, providing the infrastructure LTR says is needed to support both telehealth and clinic channels and future commercial growth.

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 and Co-Founder, Michael Walker, added, “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.”