Agreement Includes Global Rights for Risuteganib, An
Investigational Treatment Expected to Help Reverse Vision Loss Due
to Dry AMD, A Significant Unmet Medical Need
LAVAL, QC and SAN JUAN CAPISTRANO, Calif., Sept. 21, 2020 /PRNewswire/ -- Bausch Health
Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") and Bausch + Lomb,
its leading global eye health business, and Allegro Ophthalmics,
LLC (Allegro), a privately held biopharmaceutical company focused
on the development of novel therapies that regulate integrin
functions for the treatment of ocular diseases, announced today
that Bausch Health (through its affiliate) has entered into an
agreement to acquire an option to purchase all ophthalmology assets
of Allegro (the "Option"), including global rights for risuteganib
(Luminate®)1, Allegro's lead investigational
compound in retina, which is believed to simultaneously act on the
angiogenic, inflammatory and mitochondrial metabolic pathways
implicated in diseases such as intermediate dry Age-related Macular
Degeneration (AMD).
It is estimated that as many as 16 million people in
the United States have
AMD2, and globally, the prevalence of AMD is expected to
reach 196 million people worldwide this year and to increase to 288
million by 2040.3 Approximately 90 percent of
people diagnosed with AMD have dry AMD, for which there are
currently no treatments.4
"As part of the ongoing transformation of Bausch Health, we
continue to seek strategic opportunities to build-up our pipeline
in core businesses, including Bausch + Lomb, our global eye health
business. The addition of the ophthalmic assets of Allegro would
significantly enhance our comprehensive portfolio of products for
AMD," said Joseph C. Papa, chairman
and CEO of Bausch Health. "If approved, risuteganib may be the
first treatment indicated to help reverse vision loss due to dry
AMD and would address a significant unmet medical need affecting
millions of people globally."
"Allegro is excited to partner with Bausch Health, an
established global player in ophthalmology that values the
potential of risuteganib and our integrin-regulating platform as
much as we do," said Vicken
Karageozian, M.D., president and CEO, Allegro. "As we
prepare for our Phase 3 clinical program, we look forward to
working closely with Bausch Health on the united goal of one day
being able to offer a treatment option to the millions of people
who are currently losing their vision to dry AMD."
Risuteganib is an investigational integrin-regulating therapy
that is believed to reduce mitochondrial dysfunction involved in
intermediate dry AMD. By targeting multiple pathways, risuteganib
may help reduce the cellular burden of oxidative stress and restore
retinal homeostasis.5 Two concurrent Phase 3
studies evaluating the use of intravitreal risuteganib to treat
intermediate dry AMD are expected to begin within the next 12
months.
Other ophthalmology assets of Allegro include ALG-1007, a
topical integrin regulator under investigation for the treatment of
dry eye disease. It is currently in Phase 2 development outside
the United States.
The Option payment totaling $50
million would be made in two tranches, with the first
payment of $10 million upon signing.
Allegro intends to raise additional funding, following which,
Bausch Health will make a second payment of $40 million, which is expected to be made in
2021. If Bausch Health then elects to exercise the Option,
additional payments will be payable.
About Allegro Ophthalmics, LLC
Allegro Ophthalmics, LLC is a privately held biopharmaceutical
company focused on the development of novel integrin-regulating
therapies for the treatment of ocular diseases. Pre-clinical
data suggest that risuteganib (Luminate®), Allegro's
lead investigational compound in retina, may simultaneously act on
the angiogenic, inflammatory and mitochondrial metabolic pathways
implicated in diseases, such as intermediate dry AMD. A U.S. Phase
2a study with risuteganib in intermediate dry AMD met its primary
endpoint of vision recovery. Expanding its integrin-regulating
portfolio, Allegro has developed ALG-1007 for topical use in dry
eye disease. ALG-1007 demonstrated promising results in an ex-U.S.
proof-of-concept study in humans, and is currently being evaluated
in a second and larger ex-U.S. Phase 2 study. For more information,
visit www.allegroeye.com.
About Bausch + Lomb
Bausch + Lomb, a leading global
eye health business of Bausch Health Companies Inc., is solely
focused on helping people see. Its core businesses include
over-the-counter products, dietary supplements, eye care products,
ophthalmic pharmaceuticals, contact lenses, lens care products,
ophthalmic surgical devices and instruments. Bausch + Lomb
develops, manufactures and markets one of the most comprehensive
product portfolios in the industry, which is available in
approximately 100 countries. For more information, visit
www.bausch.com.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.com.
Forward-looking Statements
This news release may
contain forward-looking statements, which may generally be
identified by the use of the words
"anticipates," "expects," "intends," "plans," "should," "could," "would," "may,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions. These statements are based upon
the current expectations and beliefs of management and are subject
to certain risks and uncertainties that could cause actual results
to differ materially from those described in the forward-looking
statements. These risks and uncertainties include, but are not
limited to, the risks and uncertainties discussed in Bausch
Health's most recent annual report on Form 10-K and detailed from
time to time in Bausch Health's other filings with the U.S.
Securities and Exchange Commission and the Canadian Securities
Administrators, which factors are incorporated herein by reference.
They also include, but are not limited to, risks and uncertainties
caused by or relating to the evolving COVID-19 pandemic, and the
fear of that pandemic and its potential effects, the severity,
duration and future impact of which are highly uncertain and cannot
be predicted, and which may have a material adverse impact on
Bausch Health, including but not limited to its project development
timelines, and costs (which may increase). Readers are cautioned
not to place undue reliance on any of these forward-looking
statements. These forward-looking statements speak only as of the
date hereof. Bausch Health undertakes no obligation to update any
of these forward-looking statements to reflect events or
circumstances after the date of this news release or to reflect
actual outcomes, unless required by law.
1 Provisional name. Luminate® is a registered
trademark of Allegro Ophthalmics, LLC.
2 IRi. Raw Buyer Count Comparison Shows the Percent of
Households and Individuals with AMD is on the Rise. AMD Buyer Group
Analytics. Demographics. March
2018.
3 Wong et al. "Global prevalence of age-related
macular degeneration and disease burden projection for 2020 and
2040: a systematic review and meta-analysis". The Lancet. Volume 2,
No. 2, e106–e116, February 2014.
4 The Discovery Eye Foundation. Dry AMD. 2014.
5 Kaiser PK. Topline results from a prospective,
double-masked, placebo-controlled phase-2b clinical study
evaluating ALG-1001 (Luminate) in patients with diabetic macular
edema. ARVO, May 2017.
Bausch Health
Investor Contact:
|
Allegro
Ophthalmics Media Contact:
|
Arthur
Shannon
|
Michele
Gray
|
arthur.shannon@bauschhealth.com
|
mgray@allegroeye.com
|
(514)
856-3855
|
(917)
449-9250
|
(877) 281-6642 (toll
free)
|
|
|
|
Bausch Health
Media Contact:
|
|
Lainie
Keller
|
|
lainie.keller@bauschhealth.com
|
|
(908)
927-1198
|
|
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SOURCE Bausch Health Companies Inc.