Acquisition includes Restoret™, a novel
late-phase candidate for diabetic macular edema and neovascular
age-related macular degeneration, as well as a preclinical pipeline
targeting retinal diseases
Restoret anticipated to enter pivotal study
for diabetic macular edema in the second half of 2024
Merck to acquire EyeBio for a $1.3 billion
upfront payment and up to $1.7 billion in future milestone payments
for a potential value of $3 billion
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, and Eyebiotech Limited (EyeBio), a privately held
ophthalmology-focused biotechnology company, today announced that
the companies have entered into a definitive agreement under which
Merck, through a subsidiary, will acquire EyeBio.
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“We continue to execute on our science-led business development
strategy to expand and diversify our pipeline,” said Dr. Dean Y.
Li, president, Merck Research Laboratories. “The EyeBio team, under
the leadership of Dr. David Guyer and Dr. Tony Adamis, has a strong
track record of developing groundbreaking ophthalmology therapies.
By combining our strengths, we aim to advance with rigor and speed
the development of their promising pipeline of candidates targeting
retinal diseases.”
Under the terms of the agreement, Merck, through a subsidiary,
will acquire all outstanding shares of EyeBio for up to $3 billion,
including an upfront payment of $1.3 billion in cash and a further
potential $1.7 billion in developmental, regulatory and commercial
milestone payments. The acquisition has been unanimously approved
by the EyeBio Board of Directors.
EyeBio is developing a pipeline of clinical and preclinical
candidates for the prevention and treatment of vision loss
associated with retinal vascular leakage, a known risk factor for
retinal diseases. The company’s lead candidate, Restoret™ (EYE103),
is an investigational, potentially first-in-class tetravalent,
tri-specific antibody that acts as an agonist of the
Wingless-related integration site (Wnt) signaling pathway. Based on
positive results from the open-label Phase 1b/2a AMARONE study in
patients with diabetic macular edema (DME) and neovascular
age-related macular degeneration (NVAMD), Restoret is anticipated
to advance into a pivotal Phase 2b/3 trial to investigate the
treatment of patients with DME in the second half of 2024.
“The EyeBio team has successfully assembled a pipeline of novel
candidates with the potential to provide new treatment options for
patients with retinal disease,” said Dr. David R. Guyer, chief
executive officer and president, EyeBio. “As a subsidiary of Merck,
EyeBio will be positioned to tap into the resources and
infrastructure needed to support the clinical, regulatory and
commercial development of these candidates and help bring them to
patients worldwide.”
In addition to augmenting Merck’s pipeline, the acquisition
significantly expands the company’s presence in ophthalmology. The
EyeBio team and leadership including founders Dr. David Guyer and
Dr. Tony Adamis will leverage their experience and world-class
expertise as part of Merck to continue their pioneering work to
advance the clinical development of Restoret and other ongoing
development programs.
“Less than three years ago, EyeBio was hatched to translate Dr.
David Guyer’s idea for a potential new therapy for retinal diseases
into a reality,” said Kate Bingham, EyeBio board chair and managing
partner, SV Health Investors. “This agreement reflects the hard
work of the talented EyeBio team, led by Dr. Guyer, who through
this agreement have placed Restoret on a defined development path
to patients.”
Closing of the proposed acquisition is subject to approval under
the Hart-Scott-Rodino Antitrust Improvements Act and other
customary conditions. The transaction is expected to close in the
third quarter of 2024 and be accounted for as an asset acquisition.
Merck expects to record a charge of approximately $1.3 billion, or
approximately $0.50 per share, that will be included in non-GAAP
results in the quarter that the transaction closes.
Advisors
Citi acted as financial advisor to Merck in this transaction and
Gibson, Dunn & Crutcher LLP as its legal advisors. Centerview
Partners LLC acted as financial advisor to EyeBio and Skadden,
Arps, Slate, Meagher & Flom LLP as the company’s legal
advisors.
About the blood retina barrier and retinal vascular
leakage
Several retinal conditions are characterized by both
inflammation and breakdown of the inner blood-retinal barrier
(iBRB) resulting in vascular permeability and leakage into the
neighboring retinal tissue. Vascular leakage is a known risk factor
for retinal diseases including diabetic macular edema (DME) and
neovascular age-related macular degeneration (NVAMD).
About Restoret
Restoret is an investigational, potentially first-in-class
tetravalent, tri-specific Wnt antibody designed to address unmet
medical need in patients with retinal diseases, including diabetic
macular edema (DME) and neovascular age-related macular
degeneration (NVAMD). Restoret is administered as an intravitreal
injection seeking to eliminate leakage in retinal vascular diseases
by agonizing the Wnt pathway with the goal of restoring and
maintaining the blood-retinal barrier. Preclinical evidence
indicates that agonizing the Wnt pathway in the retina may reduce
vascular leakage.
About EyeBio (Eyebiotech Limited) and its Investors
Eyebiotech Limited (EyeBio) is a clinical-stage, privately held
ophthalmology biotechnology company dedicated to developing and
delivering a new generation of therapies to protect, restore and
improve vision in patients with sight-threatening eye diseases.
Founded in August 2021 by David Guyer, M.D., and Tony Adamis, M.D.,
and SV Health Investors, EyeBio has a leadership team with a world
class track record in ophthalmology drug development. With
operations in the United States and the United Kingdom, EyeBio is
building and advancing a pipeline of ocular therapies that combine
scientifically robust targets with innovative translational
approaches. To date, EyeBio has raised $130 million. SV Health
Investors (Kate Bingham, DBE and Mike Ross, Ph.D.) founded and
seeded the company in August 2021 and were joined in February 2022
by co-leads Samsara BioCapital (Srini Akkaraju, M.D., Ph.D.), Jeito
Capital (Andreas Wallnoefer, Ph.D.) in raising a $65 million Series
A financing round, with funds from MRL Ventures Fund (Olga
Danilchanka, Ph.D.), the corporate venture arm of Merck. In
November 2023, the Series A round was expanded to $130 million with
the addition of new investors Bain Capital Life Sciences (Leonard
Feiner (M.D., Ph.D., and Amir Zamani, M.D.), Omega Funds (Bernard
Davitian) and Vertex Ventures HC (Christine Brennan, Ph.D.). For
more information, please see www.eyebiotech.com.
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world - and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, N.J., USA
includes statements that are not statements of historical fact, or
“forward-looking statements,” including with respect to Merck’s
proposed acquisition of Eyebiotech Limited (EyeBio), and readers
are cautioned not to place undue reliance on such statements. Such
forward-looking statements include, but are not limited to, the
ability of Merck and EyeBio to complete the transactions
contemplated by the definitive agreement, including the parties’
ability to satisfy the conditions to the consummation of the
acquisition contemplated thereby, statements about the expected
timetable for completing the transaction, Merck’s and EyeBio’s
beliefs and expectations and statements about the benefits sought
to be achieved in Merck’s proposed acquisition of EyeBio, the
potential effects of the acquisition on both Merck and EyeBio, the
possibility of any termination of the definitive agreement, as well
as the expected benefits and success of EyeBio’s product
candidates. These statements are based upon the current beliefs and
expectations of Merck’s management and are subject to significant
risks and uncertainties. There can be no guarantees that the
conditions to the closing of the proposed transaction will be
satisfied on the expected timetable or at all, or that any product
candidates will receive the necessary regulatory approvals or prove
to be commercially successful. If underlying assumptions prove
inaccurate or risks or uncertainties materialize, actual results
may differ materially from those set forth in the forward-looking
statements.
Risks and uncertainties include, but are not limited to,
uncertainties as to the timing of the acquisition; the possibility
that various conditions to the consummation of the acquisition
contained in the definitive agreement may not be satisfied or
waived; the effects of disruption from the transactions
contemplated by the definitive agreement and the impact of the
announcement and pendency of the transactions on EyeBio’s business;
general industry conditions and competition; general economic
factors, including interest rate and currency exchange rate
fluctuations; the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; Merck’s ability to accurately predict future
market conditions; manufacturing difficulties or delays; financial
instability of international economies and sovereign risk;
dependence on the effectiveness of Merck’s patents and other
protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise, except to the extent required by law.
Additional factors that could cause results to differ materially
from those described in the forward-looking statements can be found
in Merck’s 2023 Annual Report on Form 10-K and Merck’s other
filings with the Securities and Exchange Commission (SEC) available
at the SEC’s Internet site (www.sec.gov).
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Merck Investor Contact: Peter Dannenbaum (732) 594-1579 Merck
Media Contacts: Robert Josephson (203) 914- 2372 Justine Moore
(347) 281-3754
EyeBio Media Contact:
Matt Pera SmithSolve (219) 628-0258
Merck (NYSE:MRK)
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