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- Exclusive pilot agreement executed with Marius Pharmaceuticals for KYZATREX
- Broadens LTR Pharma’s Australian men’s health portfolio
- Initial stock now in Australia, with initial patient access
- LTR Pharma and Marius will evaluate physician adoption
LTR Pharma (ASX: LTP) has entered into an exclusive pilot commercialisation agreement with US pharmaceutical company Marius Pharmaceuticals to introduce Marius’ KYZATREX oral testosterone capsules in Australia.
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KYZATREX is FDA-approved and commercially available in the US with initial stock now in Australia, with initial patient access to be facilitated through the TGA Special Access Scheme (SAS).
Testosterone deficiency affects energy, mood, muscle mass, bone density and sexual function. It remains underdiagnosed and undertreated in Australia, where most replacement therapy is delivered by injection, gel, patch or implant.
LTR Pharma executive chairman, Lee Rodne, said KYZATREX uses a proprietary formulation designed to facilitate lymphatic absorption, reducing the first-pass hepatic metabolism associated with earlier oral testosterone therapies, and is supported by clinical data demonstrating its ability to restore testosterone levels in men with testosterone deficiency.
“We are pleased to partner with Marius to introduce KYZATREX in Australia. As an FDA-approved oral testosterone therapy, KYZATREX represents a complementary opportunity to broaden our men’s health portfolio by leveraging the clinical networks, telehealth channels and commercial infrastructure we have already established through SPONTAN,” Mr Rodne said.
“At the same time, we remain focused on execution of our core programs, with ROXUS moving toward US commercial launch through SHED and Strive, the final SPONTAN Phase II report expected shortly and planning underway for the pivotal phase III study in 2027.”
Testosterone deficiency and erectile dysfunction can present within the same men’s health consultation and involve overlapping prescribers and patient-access channels.
Mr Rodne said KYZATREX therefore represents a complementary opportunity for LTR Pharma to broaden its Australian men’s health portfolio while leveraging the clinical networks, telehealth channels and distribution infrastructure already established through SPONTAN.
“This strategy is being pursued alongside continued execution of LTR Pharma’s core ED programs, including preparations for the U.S. commercial launch of ROXUS and planning for the pivotal SPONTAN Phase III study.”
LTP was steady at 50.5¢. Mkt cap $91.79M.
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