NLS Pharmaceuticals Ltd. (NASDAQ: NLSP) has entered a license agreement with Novartis Pharma AG as the company has obtained all data within the United states that pertains to the original NDA for Sanorex. The agreement holds all preclinical and clinical studies, fromdata used for manufacturing which includes stability and other chemistry manufacturing and controls data. NLS has obtained the same rights on a non-exclusive basis in all territories outside of the United States.
“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.”