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Lipocine (LPCN) Announces George Nomikos as Chief Medical Officer, Spyros Papapetropoulos as Board Chair

November 3, 2022 8:04 AM EDT

Lipocine Inc. (NASDAQ: LPCN), a biopharmaceutical company focused on treating CNS disorders by leveraging its proprietary platform to develop differentiated products, today announced George Nomikos, M.D., Ph.D., has joined Lipocine as Chief Medical Officer and Spyros Papapetropoulos, M.D. Ph.D., has been appointed Lead Director and Chairman of the Board.

Lipocine Inc. recently announced that the U.S. Food and Drug Administration ("FDA") has agreed with the Company's proposal for establishing the efficacy of LPCN 1154 in postpartum depression through a pivotal pharmacokinetic ("PK") bridge study to an approved IV infusion brexanolone via a 505(b)(2) NDA filing. Lipocine recently initiated a pilot PK bridge study (a prelude to a pivotal study required for NDA filing) and expects to report results of the pilot study in the first half of 2023. If approved, LPCN 1154 is expected to be the fastest acting oral option for PPD with potential for out-patient use.

"Consistent with our recently announced new strategy to a focus on developing new treatments for CNS disorders, it is important that Lipocine have a leadership team with the appropriate skillset," said Dr. Mahesh Patel, President and CEO of Lipocine Inc. "I am delighted to welcome Dr. Nomikos as Chief Medical Officer and congratulate Dr. Papapetropoulos on his appointment as Lead Director and Chairman of the Board. George's knowledge in the fields of neurology and psychiatry, both from an academic and industry perspective, will be invaluable as we advance our pipeline of CNS candidates. In addition, Spyros' executive and BoD tenure in CNS-focused companies combined with his expertise in clinical and translational neurosciences means that he is well qualified to guide the company. We look forward to the contributions these talented individuals will bring to Lipocine and are excited to have them as an integral part of our leadership team."

Dr. Spyros Papapetropoulos commented, "This is an exciting time for Lipocine. The Company has a compelling opportunity to leverage its best-in-class oral delivery technology to develop differentiated treatments for high unmet need neuropsychiatric disorders. I look forward to continue being a part of the Company's renewed CNS focus in my role as Chairman."

Dr. George Nomikos stated, "I am very pleased to join Lipocine and to have the opportunity to leverage my expertise in neurology and psychiatry as I join a talented and dedicated team working to bring new treatments to patients."

George Nomikos, M.D., Ph.D. is a biopharmaceutical R&D scientist and psychiatry-trained clinician with extensive academic and industry experience in neuropsychiatric, neurometabolic, neurohormonal, neuromuscular and chronic pain therapeutics. He has a proven track record directing large cross-site and cross-functional teams to key advancement decisions in drug discovery research and clinical development. Until recently he served as SVP, Medical & Clinical Sciences at Scholar Rock, a clinical-stage biopharmaceutical company, where he oversaw clinical development and medical functions of neuromuscular therapeutics. Dr Nomikos previously held senior positions at Biogen, Sage, Takeda, Astellas, Amgen and Eli Lilly. He has directed a broad spectrum of early development and registrational/pivotal Phase 1-4 clinical trials, leading to successful regulatory filings and new product launches worldwide. He received an MD and a Doctorate degree in Pharmacology from the Medical School, University of Athens, Athens, Greece, and a PhD in Psychiatry/Neuroscience from the University of British Columbia, Vancouver, BC, Canada. He is licensed to practice medicine in Greece and Sweden and was an Associate Professor of Pharmacology at Karolinska Institutet, Stockholm, Sweden. Dr Nomikos has published more than 180 peer-reviewed articles and reviews, authored several book chapters and patents, and edited a textbook on Translational Medicine in CNS Drug Development.

Spyros Papapetropoulos M.D. Ph.D. has been a member of Lipocine's board since April 2022. He is an experienced biopharmaceutical executive, recognized neuroscientist, neurodegenerative disease clinician and change agent. He is currently Chief Medical Officer at Vigil Neuro. Previously he served as Chief Development Officer, and SVP, Head of Development at Acadia Pharmaceuticals Inc., CEO at SwanBio Therapeutics, and Head of Research & Development and Chief Medical Officer at Cavion. Before Cavion, he held senior/executive positions at Biogen Inc., Allergan plc, Pfizer Inc., and Teva Pharmaceuticals Inc. Over the last 25 years Spyros has overseen a broad spectrum of CNS-focused academic and biopharmaceutical R&D programs (small molecules, biologics, gene therapy) leading to successful regulatory filings and new product launches worldwide. He trained as a Movement Disorders Neurologist at the National Hospital for Neurology and Neurosurgery in London, UK and was faculty at the University of Miami, School of Medicine prior to joining the biopharmaceutical industry. Spyros has authored more than 170 peer-reviewed publications with ~8K citations, several patents, book chapters, presented and chaired meetings since 1997. He received his MD and PhD from University of Patras, School of Health Sciences, Faculty of Medicine (Greece).



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