Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) announced today an
update on the ongoing review of its marketing authorization
application (MAA) for intravitreal pegcetacoplan for the treatment
of geographic atrophy (GA) secondary to age-related macular
degeneration (AMD) by the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA).
Following the oral explanation meeting on December 13, Apellis
was informed of a negative trend vote on the MAA for pegcetacoplan.
Apellis expects the CHMP to adopt a negative opinion at its next
meeting, which is scheduled to be held January 22-25, 2024. If a
negative opinion is adopted, Apellis plans to appeal the outcome
and seek re-examination of the opinion.
“We are very disappointed in this outcome and saddened for the
millions of GA patients in Europe who have no treatment for this
leading cause of blindness,” said Jeffrey Eisele, Ph.D., chief
development officer, Apellis. “We firmly believe in the strength of
the Phase 3 results, and we will continue working closely with the
CHMP, the retina community, and patient advocacy groups with the
goal of bringing pegcetacoplan to GA patients in Europe.”
The MAA is based on results from the Phase 3 OAKS and DERBY
studies at 24 months, which were published in The Lancet. Treatment
with both every-other-month and monthly pegcetacoplan reduced GA
lesion growth with increasing treatment effects over time and
showed a well-demonstrated safety profile. Additionally,
pegcetacoplan preserved visual function longer in multiple post hoc
Phase 3 analyses that have been presented at medical
congresses.
More than 2.5 million people in Europe are living with GA,1 a
progressive and irreversible form of vision loss that severely
impairs independence and quality of life.
Conference Call and WebcastApellis will host a
conference call and webcast to discuss the CHMP trend vote on
Thursday, December 14 at 8:30 a.m. ET. To access the live call
by phone, please pre-register for the call here. A live audio
webcast of the event may also be accessed through the “Events and
Presentations” page of the “Investors and Media” section of the
company’s website. A replay of the webcast will be available
for 30 days following the event.
About the Phase 3 OAKS and DERBY StudiesOAKS
(n=637) and DERBY (n=621) are Phase 3, multicenter, randomized,
double-masked, sham-controlled studies comparing the efficacy and
safety of intravitreal pegcetacoplan with sham injections across a
broad and heterogenous population of patients with geographic
atrophy (GA) secondary to age-related macular degeneration (AMD).
The studies evaluated the efficacy of monthly and every-other-month
pegcetacoplan in patients with GA assessed by change in the total
area of GA lesions from baseline as measured by fundus
autofluorescence.
About Geographic Atrophy (GA)Geographic atrophy
(GA) is an advanced form of age-related macular degeneration and a
leading cause of blindness worldwide, impacting more than one
million Americans and five million people worldwide.2,3 It is a
progressive and irreversible disease caused by the growth of
lesions, which destroy the retinal cells responsible for vision.
The vision loss caused by GA severely impairs independence and
quality of life by making it difficult to participate in daily
activities. On average, it takes only 2.5 years for GA lesions to
start impacting the fovea, which is responsible for central
vision.4
About Pegcetacoplan for Geographic Atrophy
(GA)Pegcetacoplan is an investigational, targeted C3
therapy designed to regulate excessive activation of the complement
cascade, part of the body’s immune system, which can lead to the
onset and progression of many serious diseases. SYFOVRE®
(pegcetacoplan injection) is approved in the United States for the
treatment of GA secondary to age-related macular degeneration.
About Apellis Apellis Pharmaceuticals,
Inc. is a global biopharmaceutical company that combines courageous
science and compassion to develop life-changing therapies for some
of the most challenging diseases patients face. We ushered in the
first new class of complement medicine in 15 years and now have two
approved medicines targeting C3. These include the first and only
therapy for geographic atrophy, a leading cause of blindness around
the world. We believe we have only begun to unlock the potential of
targeting C3 across serious retinal, rare, and neurological
diseases. For more information, please visit
http://apellis.com or follow us
on Twitter and LinkedIn.
Apellis Forward-Looking
Statement Statements in this press release about
future expectations, plans and prospects, as well as any other
statements regarding matters that are not historical facts, may
constitute “forward-looking statements” within the meaning of The
Private Securities Litigation Reform Act of 1995. These statements
include, but are not limited to, statements regarding the appeal
and re-examination of the MAA if CHMP issues a negative opinion for
intravitreal pegcetacoplan and the safety profile of intravitreal
pegcetacoplan. The words “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Actual results may
differ materially from those indicated by such forward-looking
statements as a result of various important factors, including
whether the benefit/risk profile of SYFOVRE following the reported
events of retinal vasculitis will impact our commercialization
efforts; whether SYFOVRE will receive approval from foreign
regulatory agencies for GA when expected or at all, including the
impact on the likelihood and timing of such approvals; and other
factors discussed in the “Risk Factors” section of Apellis’ Annual
Report on Form 10-K with the Securities and Exchange Commission on
February 21, 2023 and Quarterly Report on Form 10-Q filed on
November 1, 2023 and the risks described in other filings that
Apellis may make with the Securities and Exchange Commission. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Apellis specifically disclaims any
obligation to update any forward-looking statement, whether as a
result of new information, future events or
otherwise.Media Contact: Lissa
Pavluk media@apellis.com 617.977.6764
Investor Contact: Meredith
Kaya meredith.kaya@apellis.com617.599.8178
1Apellis data on file reflecting analysis of Colijin et al.,
2016; Wong et al. 2014; Rudnicka et al., 2014; Korb et al., 2014;
Piermarocchi et al., 2011; Fernandez-Arias et al., 2011; Augood et
al., 2006.2Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender
variations in age-related macular degeneration prevalence in
populations of European ancestry: a meta
analysis. Ophthalmology 2012;119:571–580.3Wong WL, Su X,
Li X, et al. Global prevalence of age-related macular degeneration
and disease burden projection for 2020 and 2040: a systematic
review and meta-analysis. Lancet Glob
Health 2014;2:e106–116.4 Lindblad AS, et al, and AREDS
Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
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