Neurocrine Biosciences and Sosei Heptares Announce Collaboration to Develop Novel Muscarinic Recep | NBIX Message Board Posts


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Msg  48011 of 48258  at  11/22/2021 8:07:18 AM  by

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Neurocrine Biosciences and Sosei Heptares Announce Collaboration to Develop Novel Muscarinic Receptor Agonists for Schizophrenia and Other Neuropsychiatric DisordersNeurocrine Biosciences anticipates initiating a Phase 2 study with the selective M4

 
 
Neurocrine Biosciences and Sosei Heptares Announce Collaboration to Develop
Novel Muscarinic Receptor Agonists for Schizophrenia and Other Neuropsychiatric
DisordersNeurocrine Biosciences anticipates initiating a Phase 2 study with the
selective M4 agonist HTL-0016878 in schizophrenia in 2022 and Phase 1 studies
for a dual M1/M4 and selective M1 agonist in 2023Sosei Heptares receives US$100
million upfront, ongoing R&D funding, and up to US$2.6 billion in potential
development, regulatory and commercial milestone payments, plus tiered sales
royalties SAN DIEGO and TOKYO and CAMBRIDGE, England, Nov. 22, 2021

SAN DIEGO and TOKYO and CAMBRIDGE, England, Nov. 22, 2021 /PRNewswire/ --
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) and Sosei Group Corporation ("Sosei
Heptares"; TSE: 4565) announce the signing of a strategic collaboration and
licensing agreement to develop novel muscarinic receptor agonists, which
Neurocrine Biosciences intends to study in the treatment for schizophrenia,
dementia and other neuropsychiatric disorders.

Under the terms of the agreement, Neurocrine Biosciences gains 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 Sosei Heptares in development for the treatment of major
neurological disorders. The most advanced program, HTL-0016878, is a selective
M4 agonist. Neurocrine Biosciences plans to submit an Investigational New Drug
(IND) application and initiate a placebo-controlled Phase 2 study with
HTL-0016878 as a potential treatment for schizophrenia in 2022.

Sosei Heptares retains the rights to develop M1 agonists in Japan in all
indications, with Neurocrine Biosciences receiving co-development and profit
share options.

Muscarinic receptors are central to brain function and validated as drug
targets in psychosis and cognitive disorders. Sosei Heptares has discovered
selective muscarinic M4, M1 and M1/M4 dual agonists that offer the potential to
deliver therapeutic effects while avoiding both the harmful side effects caused
by non-selective agonists and efficacy issues experienced in some older
patients caused by positive allosteric modulators that require cooperativity of
diminishing levels of acetylcholine. Sosei Heptares achieved this through
application of its world leading G protein-coupled receptor (GPCR) stabilized
receptor platform (StaR(r)) and subsequent translational medicine studies.

"Our partnership collaboration with Sosei Heptares to advance their
selective muscarinic agonist portfolio leverages the strengths of both our
organizations with one goal in mind, to bring important medicines to patients
who need better treatment options," said Kevin Gorman, Ph.D., Chief Executive
Officer at Neurocrine Biosciences. "We continue to add potential best-in-class
compounds to our growing pipeline, which further positions Neurocrine
Biosciences as a leading neuroscience-focused biopharmaceutical company."

Shinichi Tamura, President and CEO of Sosei Heptares, added: "We are
delighted to partner with Neurocrine Biosciences to advance our selective
muscarinic receptor agonist portfolio. The deal highlights the significant
potential value within this portfolio and brings to bear the substantial
expertise of the Neurocrine team, which is highly experienced in developing and
commercializing novel products for patients with neurological and psychiatric
diseases globally. It also enables Sosei Heptares to retain rights in Japan,
where we are confident that we can make important progress leveraging our own
expertise to advance novel candidates that aim to address this major unmet
need. Overall, the deal is a great example of our strategy to combine our drug
design and early development capabilities with those of later stage development
and commercialization partners, while also providing significant funding to
expand and advance our own pipeline."

Collaboration Details

Under the terms of the agreement, Neurocrine Biosciences will be responsible
for development costs associated with the programs globally, except for M1
agonists being developed in Japan. The agreement will be subject to the
following terms:

* Upfront License Payment: Sosei Heptares will receive a total of $100
million USD in upfront cash.
* Development and Regulatory Milestones: Sosei Heptares is eligible to
receive up to approximately $1.5 billion USD related to the successful
progression of licensed candidates through to regulatory approval.
* Commercial Milestones: Sosei Heptares is eligible to receive up to $1.1
billion USD upon achieving certain global sales milestones of any products
developed under the partnership.
* Product Royalties: Sosei Heptares is eligible to receive tiered
royalties ranging from high single digit to mid-teen percentage on future net
sales of any products developed under the partnership.
* R&D Collaboration: The R&D collaboration will be conducted jointly by
Neurocrine Biosciences and Sosei Heptares to advance preclinical candidates
through Phase 1 clinical studies. The R&D collaboration will be funded by
Neurocrine Biosciences.
* Sosei Heptares M1 Agonist Rights in Japan: Sosei Heptares retains rights
to develop M1 agonists in Japan for any indication, with Neurocrine Biosciences
receiving co-development and profit share options.

This transaction is subject to customary clearances under the
Hart-Scott-Rodino Antitrust Improvements Act. Assuming this transaction
completes by December 31, 2021, the $100 million USD upfront payment will
represent a material positive revenue impact to Sosei Heptares, and is expected
to be recognized as revenue in the fourth quarter of the financial year ended
December 31, 2021, subject to agreement with the Group's auditors.

BofA Securities is acting as financial advisor to Sosei Heptares. Gowling
WLG and Orrick Herrington & Sutcliffe LLP are serving as legal counsel to Sosei
Heptares.

Conference Call and Webcast Information

On Wednesday November 24, Sosei Heptares will host a conference call and
webinar for Japanese investors at 8:00 a.m. Japan Standard Time. The live call
may be accessed by pre-registration here.

A live audio webcast of the conference call will be available from the
Investors section of Sosei Heptares website at www.soseiheptares.com .

A replay of the webcast will be available on Sosei Heptares' website after
the conclusion of the event and will be archived for approximately one month.

About Muscarinic Receptors

Muscarinic receptors are G protein-coupled receptors (GPCRs) found in
multiple tissues including the brain, cardiovascular system, and
gastrointestinal tract. Selective activation of M4 and M1 receptors in the
brain is a clinically validated approach to treating cognitive and
neuropsychological symptoms of neurological diseases, including schizophrenia,
dementia associated with Alzheimer's disease, Parkinson's disease, and others.
Until now, attempts to develop medicines that selectively target M4 and M1
receptors have been unsuccessful because of side effects caused by the
activation of M2 and M3 receptors. Highly selective M4 or M1 agonists that do
not activate M2 or M3 therefore are highly sought after and expected to have
the potential to address major unmet medical needs with blockbuster potential.

About Programs in the Collaboration Agreement

HTL-0016878

HTL-0016878 ("878") is an oral, investigational M4 selective agonist that
has completed multiple Phase 1 studies and Neurocrine Biosciences is preparing
to initiate Phase 2 studies in schizophrenia in 2022. As a selective M4
orthosteric agonist, '878 offers the potential for an improved safety profile
without the need of combination therapy to minimize side effects and avoids the
need of cooperativity with acetylcholine (ACh) when compared to non-selective
muscarinic agonists and positive allosteric modulators in development. Studies
completed to date have shown '878 to be generally well tolerated.

Preclinical Programs

The collaboration includes rights to multiple preclinical programs which
include selective muscarinic compounds targeting M1, M4 receptors and a dual
M1/M4 receptor candidate. In combination with '878, the programs offer the
ability to leverage M1 and M4 selectivity to address the unmet need for
patients suffering from psychosis and cognitive-related diseases.

After signing a R&D and commercialization partnership in 2016, Allergan
returned all program rights to '878 and the preclinical programs to Sosei
Heptares in Q1 2021.

About Neurocrine Biosciences

Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company
dedicated to discovering, developing and delivering life-changing treatments
for people with serious, challenging and under-addressed neurological,
endocrine and psychiatric disorders. The company's diverse portfolio includes
FDA-approved treatments for tardive dyskinesia, Parkinson's disease,
endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic
areas. For nearly three decades, Neurocrine Biosciences has specialized in
targeting and interrupting disease-causing mechanisms involving the
interconnected pathways of the nervous and endocrine systems. For more
information, visit neurocrine.com, and follow the company on LinkedIn. (*in
collaboration with AbbVie).

About Sosei Heptares

We are an international biopharmaceutical group focused on the discovery and
early development of new medicines originating from our proprietary
GPCR-targeted StaR(r) technology and structure-based drug design platform
capabilities. We are advancing a broad and deep pipeline of novel medicines
across multiple therapeutic areas, including neurology, immunology,
gastroenterology, and inflammatory diseases.

We have established partnerships with some of the world's leading
pharmaceutical companies and multiple emerging technology companies, including
AbbVie, AstraZeneca, Biohaven, Genentech (Roche), GSK, Neurocrine Biosciences,
Pfizer, and Takeda. Sosei Heptares is headquartered in Tokyo, Japan with
corporate and R&D facilities in Cambridge, UK.

"Sosei Heptares" is the corporate brand and trademark of Sosei Group
Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei,
Heptares, the logo and StaR(r) are trademarks of Sosei Group companies.

For more information, please visit https://soseiheptares.com/

LinkedIn: @soseiheptaresco | Twitter: @soseiheptaresco | YouTube:
@soseiheptaresco

Neurocrine Biosciences 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 Sosei Group Corporation; our potential milestone
and royalty payments to Sosei Heptares; the development of our product
candidates and the timing of completion of our clinical, regulatory, and other
development activities;Among the factors that could cause actual results to
differ materially from those indicated in the forward-looking statements
are:the possibility that the transaction with Sosei Heptares is not consummated
on the expected timeline or at all or the possibility that regulatory approvals
of the proposed transaction will impose conditions or are not obtained; risks
and uncertainties associated with the scale and duration of the COVID-19
pandemic and resulting global, national, and local economic and financial
disruptions; risks and uncertainties related to any COVID-19 quarantines,
shelter-in-place and similar government orders that are currently in place or
that may be put in place in the future, including the impact of such orders on
our business operations and the business operations of the third parties on
which we rely; our future financial and operating performance; risks or
uncertainties related to the development of the our product candidates; risks
that the FDA or other regulatory authorities may make adverse decisions
regarding our product candidates; risks that clinical development activities
may not be completed on time or at all; risks that clinical development
activities 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;
risks and uncertainties relating to competitive products and technological
changes that may limit demand for a product candidate; risks that the benefits
of the agreements with Sosei Heptares may never be realized; risks that 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; and other risks described in our periodic
reports filed with the SEC, including without limitation our quarterly report
on Form 10-Q for the quarter ended September 30, 2021. Neurocrine disclaims any
obligation to update the statements contained in this press release after the
date hereof.

Sosei Group Corporation Forward-looking statements

This press release contains forward-looking statements, including statements
about the discovery, development, and commercialization of products. Various
risks may cause Sosei Group Corporation's actual results to differ materially
from those expressed or implied by the forward-looking statements, including:
adverse results in clinical development programs; failure to obtain patent
protection for inventions; commercial limitations imposed by patents owned or
controlled by third parties; dependence upon strategic alliance partners to
develop and commercialize products and services; difficulties or delays in
obtaining regulatory approvals to market products and services resulting from
development efforts; the requirement for substantial funding to conduct
research and development and to expand commercialization activities; and
product initiatives by competitors. As a result of these factors, prospective
investors are cautioned not to rely on any forward-looking statements. We
disclaim any intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.

View original
content:https://www.prnewswire.com/news-releases/neurocrine-biosciences-and-sose
i-heptares-announce-collaboration-to-develop-novel-muscarinic-receptor-agonists-
for-schizophrenia-and-other-neuropsychiatric-disorders-301429718.html


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48018 Re: Neurocrine Biosciences and Sosei Heptares Announce Collaboration to Develop Novel Muscarinic Receptor Agonists for Schizophrenia and Other Neuropsychiatric DisordersNeurocrine Biosciences anticipates initiating a Phase 2 study with the selective phition42 0 11/22/2021 4:22:27 PM




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