Australian biotech firm Neurizon Therapeutics has entered into an exclusive global licence agreement with Elanco Animal Health for Monepantel, the active ingredient in NUZ-001.
NUZ-001 is an investigational therapy, currently developed for the treatment of Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases.
Through the licence agreement, Neurizon aims to enhance its strategic outlook for the development and potential commercialisation of NUZ-001.
Under the terms of the deal, Elanco will receive a nominal upfront payment and milestone payments of up to $9.75m for initial and subsequent licensed products.
The US drugmaker may also receive potential sales-based milestones of up to $65m, along with tiered single-digit royalties on global net sales of licensed products.
Neurizon Therapeutics managing director and CEO Michael Thurn said: “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.
“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.
“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.”
Through the agreement, Neurizon obtains exclusive global rights to Elanco’s data package and intellectual property related to Monepantel.
The access to Monepantel will allow Neurizon to develop and commercialise NUZ-001 for treating neurodegenerative diseases in humans.
The licensing deal also supports the Australian biotech firm’s regulatory foundations, providing access to essential animal safety and manufacturing data.
Neurizon and Elanco are set to sign a supply agreement, with a follow-up announcement expected in the second half of this year.
The agreement is anticipated to secure a long-term, scalable source of GMP-compliant Monepantel for Neurizon.
It will support the ongoing clinical development, regulatory submissions, and future global commercialisation of NUZ-001.
Neurizon Therapeutics non-executive chairman Sergio Duchini said: “On behalf of the Board, I am pleased to endorse this landmark agreement with Elanco, which represents a strategically significant step forward for Neurizon.
“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.
“We are also very happy to be making this important step in formalising our relationship with Elanco and look forward to building on this foundation as we progress towards finalising a supply agreement later this year.”
