Neurizon Therapeutics Limited has executed an exclusive global license agreement with Elanco Animal Health Incorporated for monepantel, the active pharmaceutical ingredient in NUZ-001, the company's lead investigational therapy for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases. The agreement marks a critical inflection point for the clinical-stage biotechnology company, providing a clear pathway for accelerated global commercialization while significantly de-risking future regulatory approval processes.
Strategic Partnership Strengthens Development Foundation
The licensing agreement grants Neurizon exclusive worldwide rights to utilize Elanco's intellectual property, providing access to an extensive package of non-clinical studies and manufacturing data. This comprehensive data package is expected to dramatically reduce near-term development costs and accelerate development timelines for NUZ-001, which targets the treatment, palliation, prevention, or cure of neurodegenerative diseases in humans.
"This license agreement with Elanco marks a watershed moment in Neurizon's journey to become a leader in the accelerated development of treatments for neurodegenerative diseases," said Dr. Michael Thurn, Managing Director and Chief Executive Officer of Neurizon. "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."
The agreement significantly supports Neurizon's regulatory foundations by providing ongoing access to critical animal safety data and manufacturing data, which are key pillars required to support future clinical trials, potential regulatory approvals, and global market entry.
Financial Structure and Milestone Framework
Under the terms of the licensing agreement, Neurizon will pay a nominal upfront licensing fee to Elanco upon execution. The financial structure includes tiered milestone payments with total development milestone payments of $9.75 million for the initial licensed product and $5.2 million for subsequent licensed products, indications, or presentations.
Elanco will also be eligible for milestone payments of up to $65 million based on sales milestones, along with 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 future supply agreement.
Supply Agreement Development
Neurizon and Elanco remain focused on finalizing a supply agreement, with a follow-up announcement anticipated in the second half of 2025. This 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 commercialization of NUZ-001.
"On behalf of the Board, I am pleased to endorse this landmark agreement with Elanco, which represents a strategically significant step forward for Neurizon," commented Sergio Duchini, Non-Executive Chairman. "This agreement not only strengthens our clinical and regulatory position but also reflects our strong commitment to accelerating the development of meaningful therapies for people living with neurodegenerative diseases."
Advancing ALS Treatment Development
The agreement represents the first step in formalizing Neurizon's relationship with Elanco, positioning the company to advance new treatment options for people affected by neurodegenerative diseases. NUZ-001 is being developed for ALS, which is the most common form of motor neurone disease, with Neurizon's strategy focused on accelerating access to effective ALS treatments while exploring the therapy's potential for broader neurodegenerative applications.
Through this strategic partnership, Neurizon aims to leverage international collaborations and rigorous clinical programs to create new treatment horizons for patients and families impacted by complex neural disorders. The licensing agreement provides the regulatory and manufacturing foundation necessary to support the company's clinical development pathway and potential future market entry for NUZ-001.
