DUBLIN and LONDON, April 6,
2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading
global pharmaceutical company, and Heptares Therapeutics, the
wholly-owned subsidiary of Sosei Group Corporation ("Sosei"; TSE
Mothers Index: 4565), today announced that Allergan's wholly-owned
subsidiary, Allergan Pharmaceuticals International Limited and
Heptares have entered into a definitive agreement under which
Allergan will license exclusive global rights to a broad portfolio
of novel subtype-selective muscarinic receptor agonists in
development for the treatment of major neurological disorders,
including Alzheimer's disease.
Under the terms of the agreement, Heptares will receive an
upfront payment of $125 million and
is eligible to receive contingent milestone payments of up to
approximately $665 million associated
with the successful Phase 1, 2 and 3 clinical development and
launch of the first three licensed compounds for multiple
indications and up to approximately $2.5
billion associated with achieving certain annual sales
thresholds during the several years following launch. In addition,
Heptares is eligible to receive up to double-digit tiered royalties
on net sales of all products resulting from the partnership.
Allergan is also committing up to $50
million to a research and development program to be
conducted jointly by Allergan and Heptares aimed at advancing
multiple candidates through Phase 2 clinical studies. Allergan will
be responsible for the development of licensed compounds upon
initiation of Phase 2b studies and for subsequent manufacturing and
commercialization of the products.
The agreement covers first-in-class selective small molecule
agonists targeting muscarinic M1 and M4
receptors in the brain, discovered using Heptares' proprietary
StaR® technology platform. Allergan will receive exclusive rights
to a broad clinical and preclinical portfolio of M1,
M4 and dual M1/M4 agonists,
including HTL9936 and HTL18318, selective M1 agonists
currently in Phase 1 clinical development.
M1 selective compounds are in development for the
potential treatment of symptomatic cognitive deficits in
Alzheimer's patients, with the potential upside of better
tolerability and a more pronounced effect compared with available
treatments. M4 selective compounds may provide a novel
approach to treat the neurobehavioral symptoms (psychoses)
associated with Alzheimer's disease and related neurological
disorders, through a different mechanism of action than available
antipsychotics. Combined, dual M1/M4 agonists
may be able to treat both cognitive impairment and neurobehavioral
symptoms.
"Cognitive impairment and psychosis are progressive and
debilitating symptoms associated with many CNS diseases, including
Alzheimer's disease, with few approved therapies available," said
David Nicholson, Executive Vice
President and President, Global Brands Research and Development at
Allergan. "The Heptares M1 compounds have shown
promising results in early development in their ability to
selectively target the M1 receptor without also
activating the M2 or M3 receptors, which are
associated with undesirable side effects. We look forward to
advancing these compounds into the next stages of development, and
potentially adding new approaches to helping physicians treat
patients suffering from the effects of Alzheimer's disease, an area
of medicine where Allergan remains committed to continued
innovation."
The safety, tolerability and pharmacokinetic profile of HTL9936
were assessed in a recently completed Phase 1 study. The data
provide strong evidence of a therapeutic window for the selective
M1 agonist mechanism in general, and for progression of
HTL9936 and similar molecules as medicines to treat cognitive
disorders. HTL9936 exhibited good brain penetration and
M1 selectivity with no adverse events typically
attributed to the stimulation of M2 and M3
receptors. HTL9936 also exhibited robust and statistically
significant changes in brain electrical activity measured using
multiple electroencephalography (EEG) biomarkers relevant to
cognition. These pro-cognitive effects were seen at low doses and
low blood concentrations that were safe and well tolerated.
Malcolm Weir, Chief Executive
Officer of Heptares and Chief R&D Officer at Sosei, said: "We
are delighted that the quality of our muscarinic agonist
candidates, discovered and developed wholly in-house, and our
translational capabilities have been recognized by Allergan, a
global leader in the development and commercialization of
treatments for CNS diseases. We have a highly committed and
experienced partner in Allergan and look forward to working
together towards the development of multiple new breakthrough
medicines over the coming years."
Shinichi Tamura, Chairman and CEO
of Sosei Group Corporation, added: "This new agreement with
Allergan marks an important milestone in our journey to become a
global biopharmaceutical company. This agreement further endorses
our strategic decision to acquire Heptares in February last year,
placing its GPCR-directed drug discovery and development
capabilities at the heart of our business."
This transaction is subject to customary clearances under the
Hart-Scott-Rodino Antitrust Improvements Act.
About Muscarinic Receptors
Muscarinic receptors are G protein-coupled receptors (GPCRs)
found in multiple tissues. Until now, attempts to develop medicines
that target M1 and M4 receptors have been
unsuccessful because of side effects caused by the activation of
M2 and M3 receptors. Selective M1
or M4 agonists that do not activate M2 or
M3 therefore are highly sought after, and expected to
address blockbuster markets.
About Cognitive Impairment in Alzheimer's Disease and other
CNS Diseases1
Today there is significant unmet medical need and heavy economic
burden across multiple diseases characterized by cognitive
impairment and dementia. In Alzheimer's disease (AD), currently
available drugs provide limited and transient effects on cognition.
Healthcare costs associated with AD and dementia (estimated at over
$640 billion for North America, Western Europe and Asia-Pacific) including nursing home care,
continue to grow dramatically and new therapies with better and
more durable efficacy are urgently needed. It is estimated that
over 45 million people worldwide have dementia (4.8 million in
North America, 7.5 million in
Western Europe, 3.6 million in
Asia-Pacific) and this is expected
to increase to over 130 million in 2050. Alzheimer's disease is the
most common cause of dementia and may contribute to 60–70% of
cases. In addition, an estimated 1.4 million patients in the US
suffer from Lewy body dementia.
1Sources: World Health Organization,
Alzheimer's Disease International, National Institute of Mental
Health, Lewy Body Dementia Association.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing innovative branded
pharmaceuticals, high-quality generic and over-the-counter
medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, healthcare
providers and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
About Heptares Therapeutics
Heptares is a clinical-stage company creating transformative
medicines targeting G protein-coupled receptors (GPCRs), a
superfamily of 375 receptors linked to a wide range of human
diseases. Heptares' proprietary StaR® technology and
structure-based drug design (SBDD) capabilities enable us to
engineer and develop drugs for highly validated, yet historically
undruggable or challenging GPCRs. Using this approach, we are
building an exciting pipeline of new medicines (small molecules and
biologics) with the potential to transform the treatment of
Alzheimer's disease, schizophrenia, cancer immuno-oncology,
migraine, addiction, metabolic disease and other indications. We
have partnerships for our novel candidates and technologies with
leading pharmaceutical and biotechnology companies, including
Allergan, AstraZeneca, MedImmune, MorphoSys, Pfizer and Teva.
Heptares is a wholly owned subsidiary of Sosei Group Corporation.
For more information, please visit www.heptares.com and
www.sosei.com.
HEPTARES is a registered trademark in the EU, Switzerland, US and Japan;
StaR® is a
registered trademark in the EU and Japan.
About Sosei
Sosei is a biopharmaceutical company originating from
Japan but with global presence.
Sosei's primary business model is based on identifying novel and/or
differentiated product assets or technology platforms and, through
supporting these in preclinical and clinical development and
establishing commercial partnerships, advancing new medicines to
patients worldwide. For more information about Sosei, please visit
www.sosei.com/en.
Allergan Forward-Looking Statements
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the difficulty of predicting the timing or
outcome of FDA approvals or actions, if any; the impact of
competitive products and pricing; market acceptance of and
continued demand for Allergan's products; difficulties or delays in
manufacturing; and other risks and uncertainties detailed in
Allergan's periodic public filings with the Securities and Exchange
Commission, including but not limited to Allergan's Annual Report
on Form 10-K for the year ended December 31,
2015 (certain of such periodic public filings having been
filed under the "Actavis plc" name). Except as expressly required
by law, Allergan disclaims any intent or obligation to update these
forward-looking statements.
CONTACTS:
Allergan:
Investors:
Lisa DeFrancesco
(862) 261-7152
Media:
Mark Marmur
(862) 261-7558
Heptares Therapeutics:
Mark Swallow (Citigate)
+44 (0)20 7282 2948
+44 7903 737703
Malcolm Weir, CEO
+44 (0)1707 358 629
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SOURCE Allergan plc; Heptares Therapeutics