DUBLIN and ANN ARBOR, Mich., Sept.
6, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a
leading global pharmaceutical company, and RetroSense Therapeutics
LLC, a private, clinical-stage biotechnology company focused
on novel gene therapy approaches to restore vision in patients
suffering from blindness, today announced that Allergan has
acquired substantially all of the assets of RetroSense in an
all-cash transaction. Under the terms of the transaction, Allergan
has paid RetroSense a $60 million
upfront payment, and has agreed to potential regulatory and
commercialization milestone payments related to its lead
development program, RST-001, a novel gene therapy for the
potential treatment of Retinitis Pigmentosa (RP).
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"The acquisition of RetroSense and its RST-001 program builds on
Allergan's deep commitment to eye care, and our focus on investing
in game-changing innovation for retinal conditions, including
Retinitis Pigmentosa, where patients desperately need treatment
options," said Brent Saunders, CEO
and President of Allergan.
Retinitis Pigmentosa (RP) is a group of rare, inherited genetic
disorders characterized by progressive peripheral vision loss and
night vision difficulties followed by eventual central vision loss
and blindness in many cases. Approximately 100,000 people living in
the USi and 14 to 33 per 100,000 people worldwide have
the disorder.ii
RST-001 is first-in-class gene therapy application of
optogenetics, a therapeutic approach that confers light sensitivity
to cells that were not previously, or natively, light sensitive. By
applying optogenetics to retinas in which rod and cone
photoreceptors have degenerated, the technology introduces
additional light sensitivity to the retina. In 2014, RST-001
received an Orphan Drug Designation by the US FDA for the treatment
of Retinitis Pigmentosa.
The RST-001 optogenetic approach employs a photosensitivity
gene, channelrhodopsin-2, to create new photosensors in retinal
ganglion cells to potentially restore vision in retinal
degenerative conditions. In August
2015, RetroSense's Investigational New Drug (IND)
application for RST-001 received clearance from the United States
Food and Drug Administration (FDA). In March
2016, RetroSense initiated a Phase I/IIa clinical trial to
evaluate the safety of RST-001 in patients being dosed, and in
August 2016, the low dose cohort of
patients had been safely dosed.
"The RST-001 program and its optogenetic gene therapy approach
could be a real breakthrough in the treatment of unmet needs across
a host of retinal conditions, including RP," said David Nicholson, Chief Research and Development
Officer, Allergan. "The team at Allergan is excited by the
prospect of advancing an entirely new approach in the treatment of
retinal diseases, and this technology is highly complementary to
our ongoing development programs in this critical treatment
area."
"With its deep commitment to eye care, strong eye care
professional community network, and its commitment to advancing
innovation across retinal conditions, Allergan was the most
compelling partner and the best strategic fit to advance the
development of RST-001 and maximize the potential for this
technology platform," said Sean
Ainsworth, former CEO of RetroSense Therapeutics. "The
addition of RST-001 to Allergan's world-class eye care development
and commercialization organization will position this potentially
revolutionary technology to be used by ophthalmology professionals
to improve the treatment of patients with retinal diseases around
the world."
"Retinitis Pigmentosa patients from around the world are closely
following the RST-001 study," stated David
G. Birch, Ph.D., chief scientist and executive officer of
the Retina Foundation of the Southwest and principal investigator
of the Phase I/IIa clinical trial. "Today, the treatment options
are so limited, physicians are excited about the potential to
restore or improve vision for their patients."
For more information about RetroSense, please visit Allergan's
Investor Relations section of its web site at
http://www.allergan.com/investors/events-presentations.
About Retinitis Pigmentosa
Retinitis pigmentosa (RP) is a group of inherited genetic
disorders characterized by progressive peripheral vision loss and
night vision difficulties followed by eventual central vision loss
and blindness in many cases. RP is typically diagnosed in
adolescents and young adults. The rate of progression and degree of
visual loss varies from person to person.
Approximately 100,000 people living in the USi and 14
to 33 per 100,000 people worldwide have the
disorder.ii Currently, there are no FDA or EMA
approved therapies for the prevention or treatment of RP.
RST-001 has received Orphan Drug Designation by the US FDA
for the treatment of Retinitis Pigmentosa.
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 our 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
65+ 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 longer, healthier
lives.
For more information, visit Allergan's website at
www.Allergan.com.
About RetroSense Therapeutics
RetroSense Therapeutics is a privately-held biotechnology
company developing life-enhancing gene therapies designed to
restore vision in patients suffering from blindness due to
retinitis pigmentosa and advanced dry age-related macular
degeneration. There are currently no FDA-approved drugs to improve
or restore vision in patients with these retinal degenerative
conditions. The Company's approach to using optogenetics in vision
restoration is based on pioneering, proprietary research conducted
at Wayne State University and
Massachusetts General Hospital. RetroSense has worldwide exclusive
rights to the relevant intellectual property from both
institutions. RetroSense is led by a team of seasoned veterans with
deep experience in taking products from the discovery stage through
to the clinic. RetroSense's key investors include BlueWater Angels,
Nerveda, Mesa Verde Ventures, Santen Pharmaceuticals, and RBV
Capital.
Forward-Looking Statement
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
June 30, 2016 (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 Foundation Fighting Blindness. Retinitis
Pigmentosa: http://www.blindness.org/retinitis-pigmentosa
ii NCBI – Gene Reviews:
http://www.ncbi.nlm.nih.gov/books/NBK1417/
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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SOURCE Allergan plc