WALTHAM, Mass., Jan. 05, 2023 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that leading retina specialist Caroline Baumal, M.D., has joined Apellis as chief medical officer. Dr. Baumal replaces Federico Grossi, M.D., Ph.D., who plans to remain at Apellis until February 28, 2023 to help with the transition and preparations for the potential launch of pegcetacoplan for geographic atrophy (GA).
“Caroline is a world-renowned retina specialist who has been at the forefront of retina research and patient care for over 25 years, and we are thrilled to welcome her to Apellis,” said Cedric Francois, M.D., Ph.D., chief executive officer and co-founder of Apellis. “Caroline’s expertise and deep understanding of GA will be a tremendous asset as we prepare to launch the first potential treatment for this devastating disease. She will undoubtedly make a positive impact at Apellis as we continue toward delivering life-changing medicines to patients with serious unmet needs.”
“We would also like to thank Fede for his substantial contributions to Apellis since its founding in 2009. Fede played an instrumental role in the development of our first approved product EMPAVELI and in the advancement of our robust pipeline including pegcetacoplan for GA,” continued Dr. Francois. “As a valued member of our executive team, Fede fostered our culture of courageous science and compassion and helped to build our company to where it is today.”
Dr. Baumal serves as a professor of ophthalmology at New England Eye Center, Tufts Medical Center, specializing in diseases and surgery of the retina and vitreous. As a board-certified ophthalmologist, she has authored over 170 publications and has been recognized with numerous prestigious awards, including the Senior Achievement Award from the American Academy of Ophthalmology, the Crystal Apple Award from the American Society of Retina Specialists, and the Lifetime Achievement Award from the Vit-Buckle Society. She also has been involved with research and clinical trials investigating novel therapies for retinal diseases, including the Phase 3 OAKS study investigating pegcetacoplan for GA. Dr. Baumal studied biochemistry at McGill University and received her M.D. from the University of Toronto, where she also completed her ophthalmology residency.
“With a PDUFA date next month for GA, I am excited to join Apellis at this truly transformational moment. The Phase 3 DERBY and OAKS data have shown the potential for pegcetacoplan to become the first treatment for GA, which would be a groundbreaking advancement for patients who have long been waiting for a therapy,” said Dr. Baumal. “I look forward to working together with this exceptional team to advance our pipeline and bring breakthrough medicines to patients.”
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness that impacts more than five million people worldwide, including one million people in the United States.1,2 This progressive disease can severely impair visual function, independence, and quality of life as it takes on average 2.5 years for GA lesions to encroach the fovea, which is responsible for central vision.3 GA is caused by destruction of retinal cells through irreversible lesion growth that is driven by excessive complement activation.4 C3 is the only target that can precisely control the complement cascade due to its central location. There are currently no approved treatments for GA.
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. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy.
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in complement, we ushered in the first new class of complement medicine in 15 years with the approval of the first and only targeted C3 therapy. We are advancing this science to continually develop transformative medicines for people living with rare, retinal, 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 timing of anticipated regulatory submissions and decisions. 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 results of the DERBY and OAKS trials are sufficient to support regulatory submissions; whether a submission for approval of intravitreal pegcetacoplan for GA on the basis of the DERBY and OAKS trials will be accepted by foreign regulatory agencies; whether intravitreal pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA when expected or at all; 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 28, 2022 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.
1 Rudnicka 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.
2 Wong 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.
3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174.
4 Seddon, JM, Rosner, B. Validated prediction models for macular degeneration progression and predictors of visual acuity loss identify high-risk individuals. Am J Ophthalmol 2019;198:223–261.