Nxera Pharma to Receive US$35 Million from Neurocrine Biosciences upon Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568
September 01 2024 - 7:30PM
Tokyo, Japan and Cambridge, UK,
2 September 2024 – Nxera Pharma
Co., Ltd. (“Nxera” or “the Company”; TSE 4565) – 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 28 August 2024. Receipt of the US$35 million payment will be
recognized as one-time revenue in the third quarter of 2024.
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. Please refer to “Nxera Pharma Notes Positive
Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568”
dated 28 August 2024 for the full announcement from Nxera on the
positive data from the trial.
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.
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.
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.”
–END–
About the Agreement with Neurocrine
Biosciences 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.
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 programs 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 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.
The four candidates progressing from the
partnership are:
Compound |
Primary Mechanism |
Phase |
Therapeutic Areas |
Potential Areas for Development |
NBI-1117568 |
M4 agonist |
2 |
PsychosisCognition |
Alzheimer’s DiseaseBipolar DisorderParkinson’s DiseaseLewy Body
DementiaSchizophrenia |
NBI-1117569 |
M4 agonist |
1 |
NBI-1117567 |
M1 agonist |
1 |
NBI-1117570 |
M1/M4 dual agonist |
1 |
About Nxera PharmaNxera 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.
In addition to several products being
commercialized in Japan, we are advancing an extensive pipeline of
over 30 active programs from discovery through to late clinical
stage internally and in partnership with leading pharma and biotech
companies. This pipeline is focused on addressing major unmet needs
in some of the fastest-growing areas of medicine across neurology,
GI and immunology, metabolic disorders and rare diseases, and
leverages the power of our unique and industry leading
GPCR-targeted structure-based drug discovery “NxWaveTM” platform to
provide a sustainable source of best- or first-in-class
candidates.
Nxera employs over 350 talented people at key
locations in Tokyo and Osaka (Japan), London and Cambridge (UK),
Basel (Switzerland) and Seoul (South Korea) and is listed on the
Tokyo Stock Exchange (ticker: 4565).
For more information, please visit
www.nxera.lifeLinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube:
@NxeraPharma
Enquiries:
Nxera – Media and Investor
RelationsKentaro Tahara, VP Investor Relations and
Corporate StrategyShinichiro Nishishita, VP Investor Relations,
Head of Regulatory DisclosuresMaya Bennison, Communications
Manager+81 (0)3 5210 3399 | +44 (0)1223 949390 |IR@Nxera.life
MEDiSTRAVA (for International
Media)Mark Swallow, Frazer Hall, Erica Hollingsworth+44
(0)203 928 6900 | Nxera@medistrava.com
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