The company also announces the planned departure of Sylvia Panigone, Ph.D.
ZURICH, SWITZERLAND / ACCESSWIRE / September 8, 2022 / NLS Pharmaceuticals Ltd. (Nasdaq: NLSP, NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that Dr. George Apostol has been appointed as Chief Medical Officer and Global Head of Research and Development (“R&D”). Serving most recently as Global Head of Research and Development at Endo Pharmaceuticals Inc. (“Endo”), Dr. Apostol brings significant expertise in managing and executing early-, mid-, and late-stage drug development. .
“I am excited to join the NLS leadership team and oversee regulatory, clinical and medical activities as the company moves to the next stage,” said Dr. Apostol. “I look forward to Phase 2a results for Quilience® and the implementation of a late-stage clinical program to bring this potentially best-in-class treatment to patients as quickly as possible. With its novel mechanism of action and once-daily dosing, Quilience® has the potential to become a breakthrough treatment for narcolepsy and related sleep-wake disorders such as idiopathic hypersomnia. »
The Company is also announcing that Sylvia Panigone, Ph.D., MBA will leave her position as Chief Operating Officer on November 30, 2022. Chad Hellmann, the Company’s Chief Financial Officer, will assume responsibility for non-clinical operations at NLS.
“As a global R&D leader, Dr. Apostol brings important skills to NLS as our Phase 2a results for Quilience® in the treatment of narcolepsy draw near, and we plan to engage with regulatory authorities. later this year to discuss the registration program,” said Alex Zwyer, NLS Managing Director. “The company’s primary goals are to establish Quilience® as a pivotal trial and to grow our pipeline of novel compounds for central nervous system disorders. We believe Dr. Apostol will be instrumental in helping us achieve our mission of ‘bringing differentiated therapies to patients with debilitating diseases All of us at NLS welcome Dr. Apostol.
Mr. Zwyer added, “We are grateful for Sylvia’s contributions overseeing our initial clinical efforts to develop Quilience® and managing the execution of the Phase 2a and open-label extension studies. We wish him good luck in his future endeavours.
Dr. Apostol joins NLS from Endo where he was Executive Vice President, Head of Global Research and Development and led the transformation of the R&D organization from a generics-focused group into a dynamic Specialized pharmaceutical R&D. He has over 20 years of experience with global pharmaceutical companies managing drug development programs and designing clinical trials. His development experience spans a broad spectrum of compounds designed to treat central nervous system disorders such as Attention Deficit/Hyperactivity Disorder (“ADHD”), Anxiety, Depression, Migraine, Parkinson’s Disease , multiple sclerosis, dyskinesia, schizophrenia, as well as rare diseases such as fragile X syndrome. Dr. Apostol attended Carol Davila Medical School in Bucharest, Romania, where he earned his medical degree, and the University of Minnesota, where he earned a Master of Science in Clinical Research. After completing his graduate studies, Dr. Apostol completed a postdoctoral drug development program at Eli Lilly & Co. in Indianapolis, Indiana. Subsequently, Dr. Apostol acquired extensive expertise in early, mid and late phase drug development while working in the global R&D organizations of Pfizer and Abbott in the United States, as well as Novartis and Shire in Switzerland.
About NLS Pharmaceuticals Ltd.
NLS Pharmaceuticals Ltd. is a clinical-stage Swiss biopharmaceutical company led by an experienced management team with a proven track record in the development and reuse of product candidates to treat rare and complex central nervous system disorders. The Company’s lead product candidate, Quilience®, is a proprietary extended-release formulation of Mazindol (Mazindol ER) and is being developed for the treatment of narcolepsy and potentially other sleep and wakefulness disorders such as than idiopathic hypersomnia. Mazindol is a triple monoamine reuptake inhibitor and partial orexin-2 receptor agonist that has been used for many years to treat patients with narcolepsy in compassionate use programs. A Phase 2a clinical trial evaluating Quiilience® in adult subjects with narcolepsy is currently underway in the United States. Previously, NLS successfully completed a Phase 2 study in the United States evaluating Nolazol® (Mazindol Controlled-Release) in adult subjects with ADHD. The study met all primary and secondary endpoints and Nolazol® was well tolerated. Quilience® has received orphan drug designation in the United States and Europe for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD.
Safe Harbor Statement
This press release contains express or implied forward-looking statements pursuant to United States federal securities laws. For example, NLS uses forward-looking statements when explaining that Quilience® has the potential to become a breakthrough treatment for narcolepsy and related sleep-wake disorders such as idiopathic hypersomnia, the expected announcement of the results of its results of phase 2a for Quilience®, which it plans to engage with regulatory authorities later this year to discuss the registration program and the development of a pipeline of novel compounds for central nervous system disorders. These forward-looking statements and their implications are based on the current expectations of NLS management only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; NLS may encounter delays or obstacles in initiating and/or completing its clinical trials; NLS products may not be approved by regulatory agencies, NLS technology may not be validated as it advances, and its methods may not be accepted by the scientific community; NLS may not be able to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties can develop with NLS processes; NLS products may turn out to be more expensive than expected; laboratory results may not translate to as good results under real clinical conditions; results of preclinical studies may not correlate with results of human clinical trials; NLS patents may not be enough; NLS products may harm recipients; changes in legislation may have a negative impact on the NLS; NLS’s inability to develop and introduce new technologies, products and applications on a timely basis; loss of market share and pricing pressure resulting from competition, which could cause NLS’s actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to issue revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unforeseen events. More detailed information about the risks and uncertainties affecting NLS can be found under the heading “Risk Factors” in NLS’s Annual Report on Form 20-F for the fiscal year ended December 31, 2021 filed with the Securities and Exchange Commission (” SEC”), which is available on the SEC’s website, www.sec.gov, and in subsequent filings by NLS with the SEC.
Corporate contact details
Alex Zwyer, CEO: +41 44 512 21 50
Cindy Rizzo: +1 908-229-7050
Pascal Nigen: +1 917-385-2160
Alpha Bronze, LLC
THE SOURCE: NLS Pharmaceuticals SA
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