Nxera Pharma to Get US$ 35 mn From Neurocrine For Completing Phase 2 Trial With NBI-1117568
Nxera Pharma to get US$ 35 mn from Neurocrine for successful completion of phase 2 trial with NBI-1117568 in adults with schizophrenia
Overview
Nxera Pharma Co., Ltd.(formerly known as Sosei Group or Sosei Heptares), announces that it will receive a US$ 35 million payment from Neurocrine Biosciences (Neurocrine), triggered by the successful completion of the phase 2 trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia, as announced on 28th August, 2024. Receipt of the US$ 35 million payment will be recognized as one-time revenue in the third quarter of 2024.
Successful Primary Endpoint
The NBI-’568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose and was generally safe and well tolerated at all doses studied, supporting Neurocrine’s intentions to advance NBI- ‘568 into phase 3 clinical trials in early 2025.
About NBI-’568
- NBI-’568 is the first oral, muscarinic M4 selective agonist in development for the treatment of schizophrenia.
- The candidate is the most advanced from a broad portfolio of novel clinical and preclinical subtype selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera and advancing under a 2021 global collaboration with Neurocrine for the treatment of major neurological and neuropsychiatric disorders.
Previous Payments from Neurocrine
- To date, Nxera has received multiple, significant payments from Neurocrine including those based on developmental progress of four candidates in clinical trials.
- Overall, Nxera is eligible to receive up to US$ 1.5 billion in development milestone payments through to approvals, plus commercial milestones, which together total up to US$ 2.6 billion, plus product royalties, provided the criteria under the agreement are satisfied.
- Nxera retains rights to develop M1 agonists advancing under this collaboration in Japan in all indications, subject to certain exceptions.
From the Nxera Pharma UK President
Matt Barnes, EVP, president of Nxera Pharma UK and Head of R&D, commented: “The successful phase 2 trial with NBI-‘568 delivered positive data in adults with schizophrenia at the 20mg dose. As stated by Neurocrine, these data support advancing NBI-‘568 into phase 3 trials that would aim to confirm its potential to become a new oral therapy option for patients with a competitive profile based on efficacy, safety and tolerability from a convenient 20mg once-daily administration.
The Collaboration for Neuropsychiatric Disorders
Nxera Pharma and Neurocrine entered a collaboration and licensing agreement in November 2021 to develop a portfolio of novel muscarinic receptor agonists for the treatment of schizophrenia, dementia and other neuropsychiatric disorders.
Terms of the Agreement
- Under the terms of the agreement, Neurocrine gained development and commercialization rights to a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Nxera.
- Neurocrine is responsible for development costs associated with the programmes globally, except for M1 agonists being developed in Japan.
- Nxera retains rights to develop M1 agonists in Japan for any indication, subject to certain exceptions, with Neurocrine receiving co-development and profit share options.
Nxera’s Eligibility for Funding
Nxera is eligible to receive R&D funding plus development, regulatory and commercial milestones of up to US$ 2.6 billion, with further product royalties, provided the criteria under the agreement are satisfied.
About Nxera Pharma
Nxera Pharma (formerly Sosei Heptares) is a technology powered biopharma company, in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally.
