Highlights:
- Neurizon executes long-term supply agreement with Elanco Animal Health (Elanco), with an initial five-year term
- The agreement provides long-term access to GMP monepantel, the active pharmaceutical ingredient in Neurizon’s lead asset, NUZ-001
- Agreement represents an important commercialisation milestone and materially strengthens Neurizon’s long-term manufacturing and supply chain readiness
- Execution further strengthens Neurizon’s position as a clinically advanced, capital efficient neurodegenerative disease company with a defined regulatory and commercialisation pathway
Neurizon® Therapeutics Limited (“Neurizon” or “the Company”), a late-stage clinical biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that it has executed a critical strategic supply agreement with Elanco Animal Health (“Elanco”), securing long-term access to human health monepantel, the active pharmaceutical ingredient in its lead asset, NUZ-001. Importantly, the agreement provides Neurizon with access to scalable Good Manufacturing Practice (GMP) supply.
The agreement represents a major milestone for Neurizon and demonstrates the Company’s focus on capital efficient commercialisation readiness. The agreement furthers the Company’s collaboration with Elanco, as NUZ-001 progresses through late-stage clinical development via the Phase 2/3 HEALEY ALS platform trial and into commercialisation.
The agreement builds on the previously executed global license agreement (refer ASX announcement: 2 July 2025) between the parties and reflects Neurizon’s continued confidence in the clinical development of NUZ-001 as a potential therapy for ALS and broader neurodegenerative disease opportunities.
Interim Executive Chairman, Sergio Duchini, said: “This agreement represents a critical milestone in the continued advancement of the NUZ-001 programme 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 programme.
The agreement provides Neurizon with a long-term supply of monepantel for human use, reflecting a disciplined, risk-managed approach to capital management.
Combined with our existing licence agreement, this supply arrangement further enhances the strategic and commercial foundation underpinning NUZ-001 and strengthens Neurizon’s positioning as a clinically advanced and commercially focused neurodegenerative disease company.”
Commercialisation readiness and operational scalability
The agreement provides Neurizon with long-term access to human health monepantel, establishing an important commercial supply framework to support future clinical, regulatory and commercialisation activities for NUZ-001.
Initial orders are intended to support commercialisation and the creation of a strategic inventory holding.
The supply framework supports Neurizon’s broader commercial readiness strategy by strengthening long-term supply certainty and supporting operational scalability.
Capital discipline and economic efficiency
The agreement also strengthens the economic and commercial profile of the NUZ-001 program by providing access to a long-term, scalable, high-quality supply of monepantel for human use.
Neurizon believes this agreement enhances the long-term commercial attractiveness and strategic flexibility of the NUZ-001 program as the Company progresses discussions with potential pharmaceutical partners and broader commercial stakeholders.
Regulatory and CMC infrastructure
The agreement further strengthens Neurizon’s regulatory and Chemistry, Manufacturing and Controls (CMC) infrastructure by combining GMP manufacturing capability with the strategic foundations established under the previously executed global licence agreement with Elanco.
The agreement provides a supply of monepantel manufactured to human pharmaceutical specifications and supports manufacturing consistency and reproducibility across both clinical and future commercial development activities.
Long term strategic positioning
Execution of the agreement further strengthens Neurizon’s position as a clinically advanced, commercially focused and capital efficient neurodegenerative disease company.
Neurizon continues to advance its global regulatory development strategy and believes execution of this agreement complements ongoing regulatory and commercial readiness activities by strengthening the long-term supply framework supporting NUZ-001. Commercialisation of NUZ-001 remains subject to successful clinical development and regulatory approval.
The agreement strengthens the strategic foundation underpinning the NUZ-001 program and supports Neurizon’s continued build-out of a scalable, neurodegenerative disease development platform.
It also reinforces Neurizon’s strategic differentiation within the ALS and neurodegenerative disease sector and enhances the long-term attractiveness of the NUZ-001 program to potential pharmaceutical partners and strategic investors.
Material terms
The agreement has an initial term of five years and includes provisions relating to forecasting, production scheduling, supply, confidentiality and termination. It also details the first two supplies of monepantel under the supply agreement, with Neurizon having a right to request the deferral of supply pending the obtaining of regulatory approval.
Neurizon will exclusively acquire monepantel from Elanco, with a right to manufacture, or acquire from a third party, functionally equivalent active pharmaceutical ingredient to the monepantel in specifically identified circumstances. The Supply Agreement is supported by a separate Quality Agreement that allocates the parties’ responsibilities for GMP manufacturing, quality control, batch release, change management and related regulatory-quality matters.
Commercialisation of NUZ-001 remains subject to successful clinical development, regulatory approval and future commercial outcomes.
