-
Neurocrine Obtains Exclusive Worldwide Development and
Commercialization Rights Excluding Japan and Converts to
Royalty-Bearing License for Osavampator
- Takeda
Reacquires Rights to Osavampator in Japan
SAN
DIEGO, Jan. 27, 2025 /PRNewswire/ -- Neurocrine
Biosciences, Inc. (Nasdaq: NBIX) today announced it has amended its
agreement with Takeda to develop and commercialize osavampator
(NBI-1065845/TAK-653). Under the amended agreement, Neurocrine will
obtain exclusive rights for all indications to develop and
commercialize osavampator, a potential first-in-class AMPA positive
allosteric modulator in development for patients with inadequate
response to treatment of major depressive disorder (MDD) in all
territories worldwide except Japan, where Takeda will reacquire exclusive
rights. Under the terms of the updated agreement, each company is
responsible for development costs in their respective region, and
both companies are eligible to receive royalty payments.
"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
U.S. live with MDD and it is estimated that roughly a third of
those do not respond to available antidepressants.
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 U.S.
federal or state legislative or regulatory and/or policy efforts
which may result in, among other things, an adverse impact on our
revenues or potential revenue; risks associated with potential
generic entrants for our products; risks that the benefits of the
agreements with Takeda may never be realized; and
other risks described in the Company's periodic reports filed with
the Securities and Exchange Commission, including without
limitation the Company's quarterly report on Form 10-Q for the
quarter ended September 30, 2024.
Neurocrine Biosciences disclaims any obligation to update the
statements contained in this press release after the date hereof
other than required by law.
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SOURCE Neurocrine Biosciences, Inc.
