NLS Pharmaceutics Obtains License to Full Regulatory Data Package and Proprietary Know-How for Sanorex® (Mazindol)

STANS, Switzerland – NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that it has entered into a License Agreement (the “Agreement”) with Novartis Pharma AG, whereby the Company has obtained, on an exclusive basis in the United States, all of the available data referred to and included in the original NDA for Sanorex® (mazindol) submitted to the United States Food and Drug Administration in February 1972. The Agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward.

Under the Agreement, NLS has obtained the same rights on a non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. The Agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations.

“We are very pleased to have obtained rights to this important clinical and regulatory package for mazindol, as well as proprietary know-how that may save us time, reduce our clinical budget, and enhance our clinical/regulatory programs to advance Quilience®, our controlled release formulation of mazindol, through development,” said Alex Zwyer, Chief Executive Officer of NLS. “Quilience’s unique mechanism of action, including its partial agonism of the orexin-2 receptor, has potential to provide significant benefits to patients suffering from narcolepsy, which remains a major unmet medical need. Other disorders related to sleep-wake cycle disturbances, such as idiopathic hypersomnia and obstructive sleep apnea, may also benefit from Quilience, and we remain focused on bringing this enhanced formulation of mazindol to the market.”

About NLS Pharmaceutics Ltd.

NLS Pharmaceutics Ltd. is a Swiss-based clinical-stage pharmaceutical company led by an experienced management team with a track record of developing and repurposing product candidates to treat rare and complex central nervous system disorders. The Company’s lead product candidate, Quilience® is a proprietary controlled release formulation of mazindol (mazindol CR), and is being developed for the treatment of narcolepsy. Mazindol is a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. NLS completed a phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD. The study met all primary and secondary endpoints and was well-tolerated. Quilience® has received Orphan Drug Designations both in the U.S. and in Europe for the treatment of narcolepsy.


Corporate Contact
Alex Zwyer, CEO: +41 41 618 80 00

Investor Relations Contact
David Moskowitz: +1 202-280-0888