Abeona Therapeutics Appoints Dr. Victor Paulus Senior Vice President of Regulatory Affairs

NEW YORK and CLEVELAND, June 26, 2019 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Victor Paulus, Ph.D. as Senior Vice President, Regulatory Affairs. The Company also announced the appointment of Jodie Gillon, M.P.H. as Vice President of Patient Advocacy and Clinical Affairs. Both Dr. Paulus and Ms. Gillon are reporting to Chief Executive Officer João Siffert, M.D.

"The addition of these seasoned industry leaders will strengthen our relationships with key stakeholders toward the successful development of our therapies,” said Dr. Siffert. "Victor will lead us through the evolving regulatory landscape in close collaboration with the development, CMC, and quality teams as we close in on near-term milestones and prepare to bring new gene and cell therapies to patients. He has a proven track record of shaping preclinical and clinical regulatory strategies and securing product approvals.”

"Jodie brings a unique blend of knowledge, broad experience and empathy to reference as she leads patient advocacy and clinical affairs for Abeona. Her qualifications are critical as we advance the development of potentially transformative therapies for serious rare diseases in close collaboration with patients and their families, and internal and external medical and scientific stakeholders,” added Dr. Siffert. 

Dr. Paulus has over 30 years of experience in the pharmaceutical industry, including over 20 years specializing in Regulatory Affairs. Prior to joining Abeona, he served as Vice President and Global Head of Regulatory Affairs at the clinical-stage immunotherapy company Hookipa Pharma. Previously, Dr. Paulus was Global Head of Regulatory Affairs for Advanced Accelerator Applications, a Novartis Company, where he secured orphan designations and product approvals for Gallium Ga68 dotatate and Lutetium Lu177 dotatate. Earlier in his career, Dr. Paulus served as Director of Regulatory Affairs for Pediatric Vaccines at GlaxoSmithKline and Senior Director of Regulatory Affairs for Biosimilar drug development at Dr. Reddy’s. He also held roles of increasing responsibility at Organon, Elusys Therapeutics, and the Population Council. Dr. Paulus began his career as a laboratory technician at the Salk Institute manufacturing vaccines for the US Army and then managed a cell culture laboratory at Centocor and viral vaccine production at what is now Sanofi Pasteur. He was also Manager of Regulatory Affairs for MCM (Merck-Connaught-Merieux), developing novel combination pediatric vaccines. Dr. Paulus has BSc degrees in Biology and Biochemistry, an MSc in biology (parasitology) and a Ph.D. in public health.

Ms. Gillon has more than 20 years of industry experience in various roles across Development, Medical and Corporate Affairs. Prior to joining Abeona, she cumulatively spent over a decade with Pfizer as the Global Medical Lead for Patient Engagement within the Rare Diseases Business Unit and the Director of Medical Communications within the Chief Medical Office. In these roles, Ms. Gillon facilitated collaborations with patient groups across many therapeutic areas and served as a core member of several cross-functional teams. Prior to Pfizer, she was the Head of Patient Advocacy and Professional Affairs with Achillion Pharmaceuticals. Ms. Gillon also previously served as the Head of the Chief Medical Office of AstraZeneca, which was preceded by additional roles at Novartis and Oridion. She holds a M.P.H. with a dual degree in Health Economics and Epidemiology from Hebrew University in Jerusalem and a BSFS from Georgetown’s School of Foreign Service.

About Abeona Therapeutics
Abeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. The Company’s clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, as well as ABO-102 and ABO-101, novel AAV9-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively. The Company’s portfolio of AAV9-based gene therapies also features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease, respectively. Its preclinical assets include ABO-401, which uses the novel AIM™ AAV vector platform to address all mutations of cystic fibrosis. Abeona has received numerous regulatory designations from the FDA and EMA for its pipeline candidates and is the only company with Regenerative Medicine Advanced Therapy designation for two candidates (EB-101 and ABO-102). For more information, visit www.abeonatherapeutics.com.

Forward Looking Statement
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties.  These statements include statements about the ability of its management team to lead the Company and deliver on key strategies, the market opportunities for the Company’s products and product candidates, and the Company’s goals and objectives.  We have attempted to identify forward looking statements by such terminology as "may,” "will,” "anticipate,” "believe,” "estimate,” "expect,” "intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to continued interest in our rare disease portfolio, our ability to enroll patients in clinical trials, the impact of competition, the ability to secure licenses for any technology that may be necessary to commercialize our products, the ability to achieve or obtain necessary regulatory approvals, the impact of changes in the financial markets and global economic conditions, risks associated with data analysis and reporting, and other risks as may be detailed from time to time in the Company’s Annual Reports on Form 10-K and quarterly reports on Form 10-Q and other reports filed by the Company with the Securities and Exchange Commission.  The Company undertakes no obligation to revise the forward-looking statements or to update them to reflect events or circumstances occurring after the date of this presentation, whether as a result of new information, future developments or otherwise, except as required by the federal securities laws.

Investor Contact:
Sofia Warner
Senior Director, Investor Relations
Abeona Therapeutics
+1 (646) 813-4707
swarner@abeonatherapeutics.com

Media Contact:
Scott Santiamo
Director, Corporate Communications
Abeona Therapeutics
+1 (718) 344-5843
ssantiamo@abeonatherapeutics.com