Nxera Pharma Secures Milestone Payment from Neurocrine Biosciences
Tokyo, Japan and Cambridge, UK – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; JPX: 4565) has announced a significant development in its collaboration with Neurocrine Biosciences. The Company will receive a payment of US$35 million following the successful completion of the Phase 2 trial for their partnered schizophrenia treatment, NBI-1117568 (NBI-‘568). This milestone was officially revealed after the trial results were made public.
Positive Phase 2 Trial Results Mark Progress
The recent trial, known as the NBI-‘568-SCZ2028 dose-finding study, successfully achieved its primary endpoint with a daily dosage of 20 mg. The results showed that the treatment was generally safe and well-tolerated by participants across all dosage levels tested. This encouraging outcome supports Neurocrine's plans to advance NBI-‘568 into Phase 3 trials, which are anticipated to begin early next year.
Importance of NBI-1117568
NBI-‘568 represents an innovative oral treatment designed as a muscarinic M4 selective agonist, specifically targeting symptoms associated with schizophrenia. As the leading candidate from a comprehensive portfolio of advanced muscarinic receptor therapies, it has the potential to address a range of significant neurological and neuropsychiatric disorders. This research has been made possible through a strategic partnership with Neurocrine that began in 2021.
Financial Outlook and Future Opportunities
Overall, Nxera is set to receive up to US$1.5 billion in development milestone payments leading up to regulatory approvals, along with commercial milestones that could elevate the total to an impressive US$2.6 billion. This agreement also includes royalties on product sales, contingent upon meeting specific benchmarks. The Company retains the rights to further develop M1 agonist treatments under this collaboration, specifically for the Japanese market.
Insights from the Phase 2 Results
Matt Barnes, the Executive Vice President and President of Nxera Pharma UK, expressed enthusiasm regarding the trial results. He stated, "The positive outcomes of the Phase 2 trial for NBI-‘568 highlight our potential to provide a novel oral therapy for individuals dealing with schizophrenia. Neurocrine’s assessment underscores our findings that demonstrate efficacy, safety, and tolerability through a straightforward once-daily administration of 20 mg. We eagerly anticipate the next steps in this promising journey.”
Partnership with Neurocrine Biosciences
The collaboration with Neurocrine began in November 2021, focusing on the development of novel muscarinic receptor agonists aimed at treating schizophrenia and other neuropsychiatric conditions. Neurocrine has assumed full responsibility for development costs on a global scale, with the exception of those related to M1 agonists being developed in Japan, where Nxera holds substantial rights.
About Nxera Pharma
Nxera Pharma (formerly known as Sosei Heptares) is dedicated to pioneering innovative treatments for patients with unmet medical needs, boasting an extensive pipeline of over 30 initiatives. In addition to the ongoing commercialization of products in Japan, Nxera collaborates with leading pharmaceutical and biotech firms to advance its pipeline, which encompasses critical areas such as neurology, gastrointestinal health, immunology, metabolic disorders, and rare diseases.
Company Overview and Workforce
Nxera employs a committed 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 is focused on utilizing cutting-edge technology to drive advancements in drug discovery.
Frequently Asked Questions
What was Nxera Pharma's recent announcement?
Nxera Pharma announced that they will receive a US$35 million payment from Neurocrine Biosciences based on the positive Phase 2 trial results for NBI-1117568.
What is the significance of NBI-1117568?
NBI-1117568 is an oral muscarinic M4 selective agonist designed to treat schizophrenia, and it has demonstrated 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, provided 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.
