Nxera Pharma Secures $35 Million from Neurocrine for NBI-1117568
Nxera Pharma's Milestone Payment from Neurocrine Biosciences
Tokyo, Japan and Cambridge, UK – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; JPX: 4565) has announced a substantial development in its collaboration with Neurocrine Biosciences. The Company will receive a payment of US$35 million due to the successful completion of the Phase 2 trial for their partnered schizophrenia candidate, NBI-1117568 (NBI-‘568). This milestone was officially disclosed after the trial results were made public.
Positive Phase 2 Data Highlights Progress
The recent trial, known as the NBI-‘568-SCZ2028 dose-finding study, achieved its primary endpoint at a once-daily 20 mg dose. Results indicated that the treatment was generally safe and well-received by participants across all doses involved in the study. This positive outcome reinforces Neurocrine's plans to move ahead with NBI-‘568’s development into Phase 3 trials, expected to begin early in the next year.
Significance of NBI-1117568
NBI-‘568 is a groundbreaking oral treatment characterized as a muscarinic M4 selective agonist, specifically created for addressing symptoms related to schizophrenia. As the leading candidate emanating from a comprehensive portfolio of innovative muscarinic receptor therapies, it holds potential for treating a variety of major neurological and neuropsychiatric disorders. This research has been made possible through a strategic collaboration with Neurocrine that was established in 2021.
Financial Implications and Future Prospects
In total, Nxera is positioned to receive up to US$1.5 billion in development milestone payments leading up to regulatory approvals, in addition to commercial milestones that could raise the total to an impressive US$2.6 billion. This agreement also includes royalties on product sales provided that set benchmarks are met. The Company retains the rights to further develop M1 agonist treatments under this collaboration specifically for the Japanese market.
Expert Commentary on the Phase 2 Results
Matt Barnes, the Executive Vice President and President of Nxera Pharma UK, expressed excitement over the trial results. He emphasized, "The positive outcomes of the Phase 2 trial for NBI-‘568 underscore our potential to deliver a novel oral therapy for individuals coping with schizophrenia. Neurocrine’s evaluation highlights our findings that demonstrate efficacy, safety, and tolerability through a simple once-daily administration of 20 mg. We look forward to the next steps in this promising journey.”
Collaboration with Neurocrine Biosciences
The partnership with Neurocrine was initiated in November 2021 and was focused on developing novel muscarinic receptor agonists aimed at battling schizophrenia as well as other neuropsychiatric conditions. Neurocrine has taken on the sole responsibility for development costs on a global scale, with the exception of those associated with M1 agonists being developed in Japan, a territory where Nxera maintains significant rights.
About Nxera Pharma
Nxera Pharma (previously known as Sosei Heptares) strives to pioneer innovative treatments for patients with unmet medical needs, with an extensive pipeline of over 30 initiatives. In addition to ongoing commercialization of products in Japan, Nxera is working collaboratively with leading pharmaceutical and biotech firms to mature its pipeline, which spans critical areas including neurology, gastrointestinal health, immunology, metabolic disorders, and rare diseases.
Company Overview and Workforce
Nxera employs a dedicated team of over 350 professionals across key locations, including Tokyo, Osaka, London, Cambridge, Basel, and Seoul. Listed on the Tokyo Stock Exchange (ticker: 4565), Nxera remains committed to leveraging cutting-edge technology to drive advancements in drug discovery.
Frequently Asked Questions
What was Nxera Pharma's recent announcement?
Nxera Pharma announced they will receive a US$35 million payment from Neurocrine Biosciences based on positive Phase 2 trial results for NBI-1117568.
What is the significance of NBI-1117568?
NBI-1117568 is an oral muscarinic M4 selective agonist intended for treating schizophrenia and it has shown promising results in Phase 2 trials.
How much total funding can Nxera Pharma potentially receive?
Nxera is eligible to receive up to US$2.6 billion through development milestone payments, as well as product royalties, depending on meeting certain criteria.
Who commented on the trial results?
Matt Barnes, EVP and President of Nxera Pharma UK, shared insights regarding the successful Phase 2 trial and future plans for NBI-1117568.
What is Nxera's focus in pharmaceutical development?
Nxera focuses on developing specialty medications to address unmet medical needs across various therapeutic areas, leveraging a robust pipeline in partnership with other companies.
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