Neurizon Enters into Global License with Elanco to Accelerate Commercialisation of NUZ-001
Neurizon Therapeutics has entered into an exclusive global licensing agreement with Elanco Animal Health (NYSE:ELAN) for Monepantel, the key ingredient in NUZ-001, their lead investigational therapy for ALS and other neurodegenerative diseases.
The agreement includes exclusive worldwide rights to Elanco's intellectual property, access to non-clinical studies and manufacturing data, and outlines terms for a future GMP-compliant Monepantel supply agreement. Financial terms include a nominal upfront fee, development milestone payments of $9.75 million for initial products and $5.2 million for subsequent products, sales milestones up to $65 million, and single-digit royalties on global net sales.
A formal supply agreement is expected to be finalized in H2 2025, which will provide Neurizon with a long-term source of GMP-compliant monepantel for clinical development and commercialization.
Neurizon Therapeutics ha stipulato un accordo di licenza esclusiva globale con Elanco Animal Health (NYSE:ELAN) per Monepantel, il principio attivo di NUZ-001, la loro principale terapia sperimentale per la SLA e altre malattie neurodegenerative.
L'accordo prevede diritti esclusivi mondiali sulla propriet脿 intellettuale di Elanco, l'accesso a studi non clinici e dati di produzione, e definisce i termini per un futuro accordo di fornitura di Monepantel conforme alle norme GMP. Le condizioni finanziarie includono un pagamento iniziale simbolico, pagamenti per traguardi di sviluppo di 9,75 milioni di dollari per i primi prodotti e 5,2 milioni di dollari per i prodotti successivi, traguardi di vendita fino a 65 milioni di dollari e royalties a una cifra percentuale sulle vendite nette globali.
Si prevede che un accordo formale di fornitura sar脿 finalizzato nella seconda met脿 del 2025, garantendo a Neurizon una fonte a lungo termine di Monepantel conforme alle GMP per lo sviluppo clinico e la commercializzazione.
Neurizon Therapeutics ha firmado un acuerdo exclusivo de licencia global con Elanco Animal Health (NYSE:ELAN) para Monepantel, el ingrediente clave de NUZ-001, su principal terapia en investigaci贸n para ELA y otras enfermedades neurodegenerativas.
El acuerdo incluye derechos exclusivos mundiales sobre la propiedad intelectual de Elanco, acceso a estudios no cl铆nicos y datos de fabricaci贸n, y establece los t茅rminos para un futuro acuerdo de suministro de Monepantel conforme a GMP. Los t茅rminos financieros incluyen una tarifa inicial nominal, pagos por hitos de desarrollo de 9,75 millones de d贸lares para productos iniciales y 5,2 millones de d贸lares para productos posteriores, hitos de ventas de hasta 65 millones de d贸lares y regal铆as de un solo d铆gito sobre las ventas netas globales.
Se espera que un acuerdo formal de suministro se finalice en el segundo semestre de 2025, lo que proporcionar谩 a Neurizon una fuente a largo plazo de Monepantel conforme a GMP para el desarrollo cl铆nico y la comercializaci贸n.
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Neurizon Therapeutics a conclu un accord de licence mondiale exclusive avec Elanco Animal Health (NYSE:ELAN) concernant le Monepantel, l'ingr茅dient cl茅 de NUZ-001, leur principale th茅rapie exp茅rimentale pour la SLA et d'autres maladies neurod茅g茅n茅ratives.
L'accord inclut des droits exclusifs mondiaux sur la propri茅t茅 intellectuelle d'Elanco, l'acc猫s aux 茅tudes non cliniques et aux donn茅es de fabrication, et d茅finit les modalit茅s d'un futur accord de fourniture de Monepantel conforme aux normes GMP. Les conditions financi猫res comprennent un paiement initial symbolique, des paiements d'茅tape pour le d茅veloppement de 9,75 millions de dollars pour les premiers produits et de 5,2 millions de dollars pour les produits suivants, des jalons de ventes pouvant atteindre 65 millions de dollars, ainsi que des redevances 脿 un chiffre sur les ventes nettes mondiales.
Un accord formel de fourniture devrait 锚tre finalis茅 au second semestre 2025, ce qui offrira 脿 Neurizon une source 脿 long terme de Monepantel conforme aux GMP pour le d茅veloppement clinique et la commercialisation.
Neurizon Therapeutics hat eine exklusive globale Lizenzvereinbarung mit Elanco Animal Health (NYSE:ELAN) f眉r Monepantel abgeschlossen, den Hauptbestandteil von NUZ-001, ihrer f眉hrenden experimentellen Therapie f眉r ALS und andere neurodegenerative Erkrankungen.
Die Vereinbarung umfasst exklusive weltweite Rechte an Elancos geistigem Eigentum, Zugang zu nicht-klinischen Studien und Herstellungsdaten sowie die Festlegung der Bedingungen f眉r eine zuk眉nftige GMP-konforme Monepantel-Liefervereinbarung. Die finanziellen Bedingungen beinhalten eine nominale Vorauszahlung, Entwicklungsmeilensteinzahlungen von 9,75 Millionen US-Dollar f眉r Erstprodukte und 5,2 Millionen US-Dollar f眉r Folgeprodukte, Verkaufsmeilensteine von bis zu 65 Millionen US-Dollar sowie einstellige Lizenzgeb眉hren auf den weltweiten Nettoumsatz.
Eine formelle Liefervereinbarung soll im zweiten Halbjahr 2025 abgeschlossen werden, die Neurizon eine langfristige Quelle f眉r GMP-konformes Monepantel f眉r die klinische Entwicklung und Vermarktung sichern wird.
- Exclusive global rights secured for Monepantel development in neurodegenerative diseases
- Access to extensive non-clinical studies and manufacturing data reduces development costs and timeline
- Favorable financial terms with nominal upfront payment and milestone-based structure
- Agreement significantly de-risks future global regulatory approval process
- Additional milestone payments of up to $80 million may strain future cash flows
- Ongoing royalty obligations will impact future profit margins
- Supply agreement terms not yet finalized, creating uncertainty in manufacturing arrangements
Insights
Neurizon's exclusive global license with Elanco significantly accelerates NUZ-001's development pathway while reducing costs and regulatory risks.
This licensing agreement represents a strategic milestone for Neurizon Therapeutics in its development of NUZ-001, a potential treatment for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases. By securing exclusive global rights to Elanco's intellectual property for Monepantel (the active ingredient in NUZ-001), Neurizon gains immediate access to extensive non-clinical studies and manufacturing data that would otherwise require significant time and capital to generate.
The deal structure is notably favorable for Neurizon, requiring only a nominal upfront payment while deferring the bulk of financial obligations to regulatory and commercial milestones. The agreement includes
The most valuable component of this transaction is how it substantially de-risks Neurizon's regulatory pathway. Access to Elanco's existing safety and manufacturing data eliminates the need to duplicate expensive and time-consuming studies, potentially accelerating NUZ-001's path to market by years while significantly reducing development costs. This could potentially save tens of millions in development expenses.
The announcement also mentions a forthcoming supply agreement expected in H2 2025, which would secure Neurizon's access to GMP-compliant Monepantel鈥攁 critical component for clinical trials, regulatory submissions, and eventual commercialization. This integrated approach to both intellectual property and manufacturing creates a more robust foundation for Neurizon's development program.
For a clinical-stage biotech company, this type of agreement represents classic risk mitigation by leveraging existing data and manufacturing capabilities rather than building everything internally. The modest financial terms suggest Elanco sees value in repurposing their animal health compound for human applications without disrupting their core business.
Highlights:
- Neurizon庐 Therapeutics and Elanco Animal Health听enter into an exclusive global licensing agreement
- Provides worldwide rights听for Neurizon to utilise Elanco's intellectual property, providing exclusive access to an extensive package of non-clinical studies and manufacturing data and outlines听key terms for a future supply agreement for GMP-compliant Monepantel
- Provides a听clear pathway for accelerated global commercialisation听of NUZ-001[1] and significantly听de-risks future global regulatory approval processes
- The license agreement represents the听first step in formalising Neurizon's relationship with Elanco, with the听next step focused on finalising a supply agreement expected H2 CY 2025
This license agreement represents a critical inflection point for Neurizon, further strengthening the Company's strategic outlook for the听development, manufacturing and potential future commercialisation听of NUZ-001. It also significantly supports the Company's听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.
Dr. Michael Thurn, Managing Director and Chief Executive Officer, commented: "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."
Mr. Sergio Duchini, Non-Executive Chairman, commented: "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."
Key Terms of the Licensing Agreement:
- Exclusive Global Rights:听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.
- Upfront Payment:听A nominal upfront licensing fee is payable to Elanco upon execution of the agreement[2].
- Milestone Payments: Total Development milestone payments for the initial and subsequent licensed products, indications, or presentations of
US and$9.75 million US , respectively. Elanco will also be eligible for milestone payments of up to US$5.2 million $65 million - 搁辞测补濒迟颈别蝉:听Elanco will receive听tiered single-digit royalties听on global net sales of licensed products.
- Supply: The agreement outlines certain key terms, including duration and price, for the conclusion of a Supply Agreement.
Supply Agreement
Neurizon and Elanco remain focused on finalising a supply agreement, with a follow-up announcement anticipated in H2 CY 2025.
This next phase of the collaboration is expected to provide Neurizon with long-term, scalable source of GMP-compliant monepantel to support ongoing clinical development, regulatory submissions, and future global commercialisation of NUZ-001.
-贰狈顿厂-听听听
This announcement has been authorized for release by the Board of Neurizon Therapeutics Limited.
About Neurizon Therapeutics Limited
Neurizon Therapeutics Limited (ASX: NUZ) is a clinical-stage biotechnology company dedicated to advancing treatments for neurodegenerative diseases. Neurizon is developing its lead drug candidate, NUZ-001, for the treatment of ALS, which is the most common form of motor neurone disease. 听Neurizon's strategy is to accelerate access to effective ALS treatments for patients while exploring NUZ-001's potential for broader neurodegenerative applications. Through international collaborations and rigorous clinical programs, Neurizon is dedicated to creating new horizons for patients and families impacted by complex neural disorders.
Neurizon庐 is a registered trademark of Neurizon Therapeutics Limited
[1] NUZ-001 is Neurizon Therapeutics formulation of monepantel for use in neurodegeneration applications. [2] The amount is not material to Neurizon's current cash position [3] If triggered, the sales milestone payments will not fall due until six months after the first commercial sale.听 The remaining regulatory and commercial milestone payments will become due 30 days after the relevant milestone is met. |
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