EyePoint Pharmaceuticals Announces Sale of YUTIQ® to Alimera Sciences, Inc. for $82.5 Million Cash Plus Royalties
18 Maio 2023 - 8:00AM
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed
to developing and commercializing therapeutics to improve the lives
of patients with serious eye disorders, today announced that it has
entered into a definitive agreement for the sale of
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18mg to
Alimera Sciences, Inc. (“Alimera”). YUTIQ is a treatment for
chronic non-infectious uveitis affecting the posterior segment of
the eye. Under the terms of the agreement, Alimera will receive
global rights to YUTIQ outside of China, Hong Kong, Taiwan, Macau
and Southeast Asia, where YUTIQ is exclusively licensed to
Ocumension Therapeutics (“Ocumension”), and EyePoint will continue
to receive royalties from Ocumension for its YUTIQ sales. In
exchange for the rights granted to Alimera under the agreement,
EyePoint received a $75 million up-front cash payment at closing
and will receive an additional $7.5 million in equal quarterly
installments in 2024. In addition, commencing in 2025, EyePoint
will receive a low to mid double-digit royalty on Alimera’s related
U.S. net sales above defined thresholds for the calendar years
2025-2028.
“This transaction completes EyePoint’s transformation into a
pure play drug development company focused on advancing and
expanding a pipeline of sustained delivery treatments for serious
eye diseases, including our lead product candidate EYP-1901,
currently in Phase 2 trials in wet age-related macular degeneration
and non-proliferative diabetic retinopathy,” said Nancy Lurker,
Chief Executive Officer of EyePoint Pharmaceuticals. “This
value-creating transaction has enabled EyePoint to pay off all
outstanding bank debt at closing, reduce our projected SG&A
spending and extend our cash runway into 2025 as we prepare for the
potential Phase 3 pivotal trials for EYP-1901.”
Ms. Lurker continued, “The EyePoint commercial organization has
laid a strong foundation for YUTIQ, including 60% year-over-year
revenue growth in Q1 of this year, and we are incredibly grateful
for their exceptional execution and dedication to bringing this
product to patients. Alimera is ideally positioned to deliver
continued access to YUTIQ as they currently commercialize
ILUVIEN® for the treatment of uveitis in various international
markets and for the treatment of diabetic macular edema (DME) in
the U.S. and internationally.”
YUTIQ’s consistently positive feedback from patients and
healthcare providers is underscored by its well-established and
clinically meaningful efficacy and safety. EyePoint and Alimera are
committed to ensuring that patients receive uninterrupted access to
YUTIQ throughout the transition of YUTIQ sales, marketing and other
responsibilities to Alimera.
About Non-Infectious Uveitis Affecting the Posterior
Segment of the Eye
Non-infectious uveitis affecting the posterior segment of the
eye is a chronic form of uveitis that may cause a variety of
complications, including cataracts and glaucoma. When the
inflammation is not controlled in a timely manner, it can lead to
visual impairment or even permanent vision loss. The complex
clinical presentation of non-infectious uveitis and the high degree
of similarity between subtypes pose a significant challenge for
accurate diagnosis.
About YUTIQ®
YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18
mg is indicated for the treatment of chronic, non-infectious
uveitis affecting the posterior segment of the eye, and was
approved by the FDA on October 12, 2018. A link to the full
product label is available on the YUTIQ website
at: https://yutiq.com/downloads/US-YUT-2100035%20YUTIQ%20Prescribing%20Information-2021.pdf.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a company committed
to developing and commercializing therapeutics to help improve the
lives of patients with serious eye disorders. The Company's
pipeline leverages its proprietary erodible Durasert E™ technology
for sustained intraocular drug delivery including EYP-1901, an
investigational sustained delivery intravitreal anti-VEGF treatment
currently in Phase 2 clinical trials. The proven
Durasert® drug delivery platform has been safely administered
to thousands of patients' eyes across four U.S. FDA approved
products, including YUTIQ® for the treatment of posterior
segment uveitis. EyePoint Pharmaceuticals is headquartered in
Watertown, Massachusetts. For more information visit
www.eyepointpharma.com.
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose
mission is to be invaluable to patients, physicians and partners
concerned with retinal health and maintaining better vision longer.
For more information, please visit www.alimerasciences.com.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION
ACT OF 1995: To the extent any statements made in this press
release deal with information that is not historical, these are
forward-looking statements under the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements regarding our potential to receive additional
payments from Alimera pursuant to the agreement; the sufficiency of
our existing cash resources into 2025; our plans following
consummation of the transaction and any other statements about
future expectations, prospects, estimates and other matters that
are dependent upon future events or developments, including
statements containing the words “will,” “potential,” “could,”
“can,” “believe,” “intends,” “continue,” “plans,” “expects,”
“anticipates,” “estimates,” “may,” other words of similar meaning
or the use of future dates. Forward-looking statements by their
nature address matters that are, to different degrees, uncertain.
Uncertainties and risks may cause EyePoint’s actual results to be
materially different than those expressed in or implied by
EyePoint’s forward-looking statements. For EyePoint, this includes
uncertainties regarding our ability to realize the anticipated
benefits of the transaction; significant transaction costs; whether
the royalty thresholds will be achieved; the potential for Alimera
to breach the agreement; our ability to manufacture YUTIQ in
sufficient quantities pursuant to the commercial supply agreement
with Alimera; the timing and clinical development of our product
candidates, including EYP-1901; the potential for EYP-1901 as a
novel sustained delivery treatment for serious eye diseases,
including wet age-related macular degeneration and
non-proliferative diabetic retinopathy; the effectiveness and
timeliness of clinical trials, and the usefulness of the data; the
timeliness of regulatory approvals; the success of current and
future license agreements; our dependence on contract research
organizations, co-promotion partners, and other outside vendors and
service providers; effects of competition market acceptance of our
products, including our out-licensed products; product liability;
industry consolidation; compliance with environmental laws; risks
and costs of international business operations; volatility of stock
price; possible dilution; the impact of instability in general
business and economic conditions, including changes in inflation,
interest rates and the labor market; protection of our intellectual
property and avoiding intellectual property infringement; retention
of key personnel; manufacturing risks; the sufficiency of the
Company’s cash resources and need for additional financing; and
other factors described in our filings with the Securities and
Exchange Commission. We cannot guarantee that the results and other
expectations expressed, anticipated or implied in any
forward-looking statement will be realized. A variety of factors,
including these risks, could cause our actual results and other
expectations to differ materially from the anticipated results or
other expectations expressed, anticipated, or implied in our
forward-looking statements. Should known or unknown risks
materialize, or should underlying assumptions prove inaccurate,
actual results could differ materially from past results and those
anticipated, estimated, or projected in the forward-looking
statements. You should bear this in mind as you consider any
forward-looking statements. Our forward-looking statements speak
only as of the dates on which they are made. EyePoint undertakes no
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Investors:
Christina TartagliaStern IRDirect:
212-698-8700christina.tartaglia@sternir.com
Media Contact:
Amy PhillipsGreen Room CommunicationsDirect:
412-327-9499aphillips@greenroompr.com
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