Neurocrine Biosciences Announces Amendment to Strategic Collaboration with Takeda to Develop and Commercialize Osavampator (formerly NBI-1065845/TAK-653)
Neurocrine Biosciences (NBIX) has amended its collaboration agreement with Takeda regarding osavampator, a potential first-in-class AMPA positive allosteric modulator for major depressive disorder (MDD). Under the new terms, Neurocrine gains exclusive worldwide development and commercialization rights for all indications, except in Japan, which Takeda will control.
The restructured agreement establishes that each company will be responsible for development costs in their respective regions and both parties will be eligible for royalty payments. Following a successful End-of-Phase 2 meeting with the FDA, Neurocrine plans to initiate the Phase 3 program for osavampator in the first half of this year.
Neurocrine Biosciences (NBIX) ha modificato il proprio accordo di collaborazione con Takeda riguardo a osavampator, un potenziale modulatore allosterico positivo AMPA di prima classe per il disturbo depressivo maggiore (MDD). Sotto i nuovi termini, Neurocrine ottiene diritti esclusivi di sviluppo e commercializzazione a livello mondiale per tutte le indicazioni, eccetto in Giappone, dove Takeda avrà il controllo.
L'accordo ristrutturato stabilisce che ciascuna azienda sarà responsabile delle spese di sviluppo nelle rispettive regioni e entrambe le parti saranno idonee a ricevere pagamenti in royalty. Dopo un incontro di successo di fine fase 2 con la FDA, Neurocrine prevede di avviare il programma di fase 3 per osavampator nella prima metà di quest'anno.
Neurocrine Biosciences (NBIX) ha modificado su acuerdo de colaboración con Takeda en relación a osavampator, un potencial modulador alostérico positivo AMPA de primera clase para el trastorno depresivo mayor (MDD). Bajo los nuevos términos, Neurocrine obtiene derechos exclusivos de desarrollo y comercialización a nivel mundial para todas las indicaciones, excepto en Japón, que Takeda controlará.
El acuerdo reestructurado establece que cada empresa será responsable de los costos de desarrollo en sus respectivas regiones y ambas partes serán elegibles para pagos de regalías. Tras una exitosa reunión de fin de fase 2 con la FDA, Neurocrine planea iniciar el programa de fase 3 para osavampator en la primera mitad de este año.
Neurocrine Biosciences (NBIX)는 주요 우울 장애(MDD)를 위한 잠재적인 최초의 AMPA 긍정적 알로스테릭 조절제인 osavampator에 대한 Takeda와의 협력 계약을 수정했습니다. 새로운 조건에 따라 Neurocrine은 일본을 제외한 모든 적응증에 대한 세계적인 개발 및 상용화 권리를 독점적으로 확보합니다. 일본에서는 Takeda가 이를 통제할 것입니다.
재편성된 계약에 따라 각 회사는 각자의 지역에서 개발 비용을 책임지며, 양 당사자는 로열티 지급 자격을 갖게 됩니다. FDA와의 성공적인 2상 종료 회의 후, Neurocrine은 올해 상반기 내에 osavampator의 3상 프로그램을 시작할 계획입니다.
Neurocrine Biosciences (NBIX) a modifié son accord de collaboration avec Takeda concernant osavampator, un potentiel modulateur allostérique positif AMPA de première classe pour le trouble dépressif majeur (MDD). Selon les nouveaux termes, Neurocrine obtient des droits exclusifs de développement et de commercialisation dans le monde entier pour toutes les indications, sauf au Japon, qui sera contrôlé par Takeda.
L'accord restructuré établit que chaque entreprise sera responsable des coûts de développement dans ses régions respectives et les deux parties seront éligibles aux paiements de redevances. Suite à une réunion réussie de fin de phase 2 avec la FDA, Neurocrine prévoit de lancer le programme de phase 3 pour osavampator dans la première moitié de cette année.
Neurocrine Biosciences (NBIX) hat seine Zusammenarbeit mit Takeda in Bezug auf osavampator, einen potenziellen ersten AMPA-positiven allosterischen Modulator für die Major Depressive Disorder (MDD), geändert. Nach den neuen Bedingungen erhält Neurocrine weltweit exklusive Entwicklungs- und Vermarktungsrechte für alle Indikationen, mit Ausnahme von Japan, das von Takeda kontrolliert wird.
Die umstrukturierte Vereinbarung legt fest, dass jede Firma für die Entwicklungskosten in ihren jeweiligen Regionen verantwortlich ist und beide Parteien Anspruch auf Lizenzgebühren haben. Nach einem erfolgreichen Treffen am Ende der Phase 2 mit der FDA plant Neurocrine, im ersten Halbjahr dieses Jahres das Phase-3-Programm für osavampator zu starten.
- Gained exclusive worldwide rights (excluding Japan) for osavampator development and commercialization
- Successfully completed End-of-Phase 2 FDA meeting
- Phase 3 program advancement planned for first half of 2025
- Additional development costs responsibility for respective territories
- Loss of Japanese market rights
Insights
The amended agreement between Neurocrine Biosciences and Takeda marks a strategic enhancement in osavampator's development pathway, particularly significant given the drug's potential as a first-in-class AMPA positive allosteric modulator for Major Depressive Disorder (MDD).
The restructuring carries several key strategic advantages: First, it streamlines decision-making by giving Neurocrine greater control over development and commercialization in major markets while maintaining Takeda's presence in Japan, where they have strong market expertise. The royalty-bearing structure aligns both companies' interests while reducing Neurocrine's upfront financial burden.
The timing is particularly strategic, following the successful End-of-Phase 2 FDA meeting. This positions Neurocrine to initiate Phase 3 trials in H1 2025, a critical milestone that could accelerate the path to market. The MDD market represents a substantial opportunity, with current treatments often showing inadequate response rates and significant side effects. Osavampator's novel mechanism of action could potentially address these unmet needs.
From an investment perspective, this deal structure offers several advantages:
- Reduced development cost sharing complexity
- Clearer commercialization strategy in respective territories
- Potential for multiple revenue streams through royalties
- Accelerated development timeline potential
The successful progression through clinical phases and planned Phase 3 initiation suggests strong confidence in osavampator's potential, though investors should monitor upcoming trial designs and enrollment progress as key indicators of development success.
- Neurocrine Obtains Exclusive Worldwide Development and Commercialization Rights Excluding Japan and Converts to Royalty-Bearing License for Osavampator
- Takeda Reacquires Rights to Osavampator in
"This streamlined collaboration structure allows Neurocrine to focus on bringing this important medicine to patients as quickly as possible," said Kyle Gano, Ph.D., Chief Executive Officer at Neurocrine Biosciences. "With the recent successful completion of our End-of-Phase 2 meeting with FDA for osavampator, we look forward to beginning the Phase 3 program in the first half of this year."
"With its long-standing expertise developing therapies for serious psychiatric disorders, Neurocrine is the ideal partner to develop osavampator," said Sarah Sheikh, M.Sc., B.M., B.Ch, MRCP, Head, Neuroscience Therapeutic Area Unit and Head, Global Development at Takeda. "As it continues to progress through clinical development, osavampator has the potential to add a meaningful new treatment option for patients with MDD."
About the Collaboration with Takeda
In 2020, Neurocrine Biosciences and Takeda entered into a strategic collaboration to develop and commercialize compounds in depression and schizophrenia, including an exclusive license to both osavampator and NBI-1070770, which are being studied for the treatment of major depressive disorder, as well as a preclinical GPR139 antagonist development program.
About Osavampator
Osavampator is a potential first-in-class, investigational alpha-amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) positive allosteric modulator (PAM) in development for patients with MDD who have not benefited from treatment with at least one antidepressant in their current episode of depression. In April 2024, Neurocrine announced positive topline data for its Phase 2 SAVITRI™ study in adult subjects with MDD. Neurocrine plans to initiate a Phase 3 program in the first half of this year.
About Major Depressive Disorder
Major depressive disorder (MDD) is a serious disorder characterized by a persistently depressed mood, loss of interest, poor concentration, and decreased energy, among other symptoms. According to the World Health Organization, MDD is one of the leading causes of disability, is a serious condition that presents an increased risk of suicide and self-harm, and is associated with increased all-cause mortality rates. More than 21 million people in the
About Neurocrine Biosciences
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (formerly Twitter) and Facebook. (*in collaboration with AbbVie)
The NEUROCRINE BIOSCIENCES Logo Lockup and YOU DESERVE BRAVE SCIENCE are registered trademarks of Neurocrine Biosciences, Inc. SAVITRI is a trademark of Neurocrine Biosciences, Inc.
Forward-Looking Statements
In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to the benefits to be derived from transactions with Takeda Pharmaceutical Company Limited; statements regarding the clinical results from, and our future development plans with respect to, osavampator, as well as the therapeutic potential and clinical benefits or safety profile of osavampator. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements include: risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; our future financial and operating performance; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with
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SOURCE Neurocrine Biosciences, Inc.
FAQ
What are the key terms of NBIX's amended agreement with Takeda for osavampator?
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