Neurizon strengthens manufacturing base with Elanco supply deal for ALS asset

 

Neurizon has entered a long-term supply agreement with Elanco Animal Health, securing access to good manufacturing practice (GMP) monepantel for its lead investigational therapy NUZ-001, in a move aimed at strengthening its commercialisation readiness.

The agreement, which has an initial five-year term, ensures Neurizon has a scalable supply of the active pharmaceutical ingredient used in NUZ-001, its oral candidate being developed for amyotrophic lateral sclerosis (ALS) and other neurodegenerative conditions.

The company said the arrangement provides a key step in building out its manufacturing and supply chain infrastructure as NUZ-001 advances through the Phase 2/3 HEALEY ALS platform trial.

Interim executive chairman Sergio Duchini said: “This agreement represents a critical milestone in the continued advancement of the NUZ-001 program and furthers our relationship with Elanco.

Importantly, the agreement strengthens Neurizon’s long-term manufacturing and supply framework, supporting potential future commercialisation and operational scalability following completion of the Phase 2/3 program.

The agreement provides Neurizon with a long-term supply of monepantel for human use, reflecting a disciplined, risk-managed approach to capital management.”

The supply deal also establishes what the company described as an important commercial framework for future clinical and regulatory activities, including the creation of strategic inventory to support development and potential launch planning.

Neurizon said the agreement strengthens its Chemistry, Manufacturing and Controls (CMC) infrastructure by securing GMP-grade supply consistency and supporting reproducibility across clinical and future commercial batches.

The company added that the deal enhances capital efficiency by reducing long-term supply risk and improving operational flexibility as it progresses discussions with potential pharmaceutical partners.

Under the agreement, Neurizon will obtain exclusive supply of monepantel from Elanco, alongside provisions covering forecasting, production scheduling and quality responsibilities. The agreement also includes a separate quality framework governing GMP manufacturing, batch release and change management processes.

Neurizon said commercialisation of NUZ-001 remains dependent on clinical outcomes and regulatory approval, but described the agreement as strengthening the programme’s long-term strategic position within the neurodegenerative disease space.

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