Neurizon inks global licensing deal with NYSE-listed Elanco

Neurizon has inked a global licensing deal with Elanco Animal Health and affiliates for monepantel, the active pharmaceutical ingredient in ALS drug candidate NUZ-001.

Neurizon has entered a global licensing deal with Elanco for monepantel. Pic via Getty Images

Special Report: Neurizon Therapeutics has inked an exclusive global licensing deal with New York Stock Exchange-listed Elanco Animal Health Incorporated and affiliates for monepantel, the active pharmaceutical ingredient in its lead drug NUZ-001. 

• Neurizon enters global licensing deal with Elanco for monepantel, the key ingredient of its lead drug candidate NUZ-001 
• Deal grants Neurizon exclusive global rights to utilise Elanco’s IP, including access to non-clinical studies, and manufacturing data 
• Provides key terms for future supply agreement for GMP-compliant monepantel and pathway for accelerated commercialisation of NUZ-001

Neurizon Therapeutics (ASX:NUZ) said the license agreement represents a critical inflection point, further strengthening its strategic outlook for development, manufacturing and potential future commercialisation of NUZ-001.

Neurizon’s lead investigational therapy NUZ-001 is in development for the most common form of motor neurone disease (MND) called amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.

The company said the licensing deal also significantly supports its regulatory foundations, providing ongoing access to critical animal safety data and manufacturing data – key pillars required to support future clinical trials, potential regulatory approvals and global market entry.

Key terms of the licensing deal

Under the deal Neurizon is granted exclusive global rights to Elanco’s data package and related intellectual property for monepantel to develop and commercialise NUZ-001 and its related compounds for the treatment, palliation, prevention, or cure of neurodegenerative diseases in humans.

Neurizon said a nominal upfront licensing fee was payable to Elanco upon execution of the agreement. 

Elanco will receive total development milestone payments for the initial and subsequent licensed products, indications, or presentations of US$9.75 million and US$5.2m respectively. 

Elanco will also be eligible for milestone payments of up to US$65m based on sales milestones and receive tiered single-digit royalties on global net sales of licensed products.

The agreement outlines certain key terms, including duration and price, for the conclusion of a supply agreement.

Neurizon said the two companies remained focused on finalising a supply agreement, with a follow-up announcement anticipated in H2 CY25.

The next phase of the collaboration is expected to provide Neurizon with a long-term, scalable source of GMP-compliant monepantel to support ongoing clinical development, regulatory submissions, and future global commercialisation of NUZ-001.

Neurizon recently announced the development a new oral liquid formulation of its NUZ-001 drug for the treatment of ALS in a move expected to improve accessibility and ease administration of the treatment.

‘Watershed moment’ for Neurizon

CEO and managing director Dr Michael Thurn said the licensing agreement with Elanco marked a “watershed moment” in Neurizon’s journey to become a leader in the accelerated development of treatments for neurodegenerative diseases. 

“This strategic milestone provides exclusive access to a comprehensive package of non-clinical studies and manufacturing data, dramatically reducing near-term development costs and accelerating development timelines,” he said. 

“All of this is in exchange for a nominal up-front payment, small back-ended regulatory approval and commercial sale milestones and single-digit royalty payments on future global net sales. 

“Neurizon is now well-positioned to accelerate the path to market and advance new treatment options for people affected by devastating neurodegenerative diseases.”

This article was developed in collaboration with Neurizon Therapeutics, a Stockhead advertiser at the time of publishing. 

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

Originally published as Neurizon inks global licensing deal with NYSE-listed Elanco