DUBLIN and CAMBRIDGE, Mass., Jan.
9, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading
global pharmaceutical company, and Lysosomal Therapeutics (LTI)
today announced that Allergan has purchased an exclusive option
right to acquire LTI. LTI is focused on innovative
small-molecule research and development in the field of
neurodegeneration, yielding new treatment options for patients with
severe neurological diseases.
LTI-291, LTI's lead program, aims to stimulate the activity of
glucocerebrosidase (GCase) in the brain. In several lysosomal
storage diseases, the activity of GCase is reduced due to genetic
mutations in the GBA1 gene. Importantly, approximately 5 to 10
percent of patients with Parkinson's disease (PD) have mutations of
the GBA1 gene,[i] and it is well documented that these patients
have a more rapid progression of Parkinson's disease. Thus, it is
hoped that activation of GCase by LTI-291 will impact the
progression of PD in these patients.
Under the option agreement, Allergan purchased an option right
directly from LTI shareholders to acquire LTI following completion
of a Phase 1b trial for LTI-291. In addition, Allergan will
provide a separate upfront research and development payment.
Allergan and LTI will establish a joint development committee to
oversee the development activities for LTI-291. Additional terms
were not disclosed.
Parkinson's disease is an area of strategic alignment for
Allergan and represents an attractive adjacency to Allergan's other
CNS businesses, with emphasis on neurodegeneration and movement
disorders. Allergan's Open Science model enables the Company to
enter areas of innovation with leading partners, while leveraging
their expertise through creative partnerships.
"Parkinson's disease is an area of medicine where significant
unmet need exists, particularly in the development and potential
breakthrough of disease-modifying treatments for the more than 2
million people suffering with Parkinson's today," said David Nicholson, Chief Research &
Development Officer, Allergan. "The pioneering work of the LTI team
in developing its GCase program harnesses the link between GCase
activity and disease progression in patients with a GBA mutation
who suffer from Parkinson's disease. The intention is to provide
therapeutic benefit for the affected patients by modulating GCase
activity. We look forward to working with the LTI team to further
their work in this area and the potential for positive Phase 1
results."
"LTI is paving a new path in the characterization of Parkinson's
disease, including the understanding of a patient's
glycosphingolipid profile and its relevance to therapeutic
response," said Kees Been, CEO of
Lysosomal Therapeutics. "We are pleased to work with Allergan
to support the acceleration of LTI's leading GCase activators to
reach as many Parkinson's patients as soon as possible. The
Allergan team matched its commitment to our leading science with a
compelling approach to collaboration – we are thrilled to provide
our new partner with development candidates for severe
neurodegenerative diseases. We look forward to reaching the
milestones that will deliver significant value to both companies,
and most of all, to developing much needed therapeutics for
patients with PD."
Dr. Kenneth Marek, President and
Senior Scientist at the Institute for Neurodegenerative Disorders
of the Michael J. Fox Parkinson Progression Marker Initiative,
Clinical Professor of Neurology at Yale
University and a member of LTI's Scientific Advisory Board
added, "The key unmet need for Parkinson's disease patients and
families is to slow disease progression. LTI has taken a novel
personal medicine approach to Parkinson's Disease, targeting
rapidly-progressing patients who carry a mutant GBA1 gene.
The LTI drug candidate, which is designed to reverse the loss of
enzyme activity in patients with the genetic mutation, has a chance
to be the first drug in its class."
Covington & Burling LLP served as Allergan's legal
counsel. Goodwin Procter LLP and Faber Daeufer & Itrato PC served as LTI's
legal counsel.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global
pharmaceutical company and a leader in a new industry model –
Growth Pharma. Allergan is focused on developing,
manufacturing and commercializing branded pharmaceuticals, devices
and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class
products for the central nervous system, eye care, medical
aesthetics and dermatology, gastroenterology, women's health,
urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's
R&D model, which defines Allergan's approach to identifying and
developing game-changing ideas and innovation for better patient
care. This approach has led to Allergan building one of the
broadest development pipelines in the pharmaceutical industry with
70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 global
colleagues' commitment to being Bold for Life. Together, we build
bridges, power ideas, act fast and drive results for our customers
and patients around the world by always doing what it is right.
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 healthier lives
every day.
For more information, visit Allergan's website at
www.Allergan.com.
About Lysosomal Therapeutics Inc.
Lysosomal Therapeutics Inc. (LTI) is dedicated to innovative
small-molecule research and development in the field of
neurodegeneration, yielding new treatment options for patients with
severe neurological diseases. LTI's strategy leverages the
clinically validated link between lysosome-based genetic disorders
and neurodegenerative diseases to establish a unique and effective
platform for novel drug discovery. LTI's lead program targets
Gaucher-related neurodegeneration, Parkinson's disease and other
synucleinopathies. Investors include Atlas Venture, Hatteras
Venture Partners, Lilly Ventures, Partners Innovation Fund, Roche
Venture Fund and Sanofi Genzyme BioVentures.
www.lysosomaltx.com
Allergan Cautionary Statement Regarding 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 and Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016 (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.
i Ann Med. 2013 Dec;45(8):511-21. Glucocerebrosidase
mutations and the pathogenesis of Parkinson disease.
CONTACTS:
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ALLERGAN:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Mark
Marmur
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(862)
261-7558
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Lysosomal
Therapeutics:
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Doug
MacDougall
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MacDougall Biomedical
Communications
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(508)
904-5656
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SOURCE Allergan plc