Key patents now granted in major markets including the US, Europe, Japan, Canada and South KoreaPatent claims cover the use of the company’s lead product candidate, Quilence® (mazindol ER) in attention deficit hyperactivity disorder (ADHD), narcolepsy and idiopathic hypersomnia
ZURICH, SWITZERLAND / ACCESS CABLE / July 28, 2022 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP), (Nasdaq: 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 disorders of the central nervous system, announces that the Japanese patent Office (JPO) notified the Company of its decision to grant patent application 2018-546837 for the proprietary formulation of Quilence® (Mazindol ER). Once issued, the patent will cover oral formulations containing immediate-release and sustained-release layers of mazindol and their use in the treatment of attention deficit/hyperactivity disorder (ADHD), excessive daytime sleepiness (EDS), including narcolepsy and idiopathic hypersomnia (IH).
“We are pleased to obtain patent coverage in another important market for our proprietary formulation of Quilence® to treat ADHD, narcolepsy and HI,” said Alex Zwyer, CEO of NLS. “Given our patent heritage and orphan drug designations in both the US and Europe, we believe our ownership position in Quilience® is strong. We look forward to reporting the final results of our Phase 2a narcolepsy trial for Quilience by the end of September 2022 and also providing an open-label extension study update later this year.”
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. is a Swiss clinical-stage biopharmaceutical company led by an experienced management team with a track record of developing and repurposing product candidates to treat rare and complex disorders of the central nervous system. 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-wake disorders such as hypersomnia idiopathic (IH). Mazindol is a triple monoamine reuptake inhibitor and orexin-2 receptor partial agonist that has been used for many years to treat patients diagnosed with narcolepsy in compassionate use programs. A Phase 2a clinical trial evaluating Quilience® in adult subjects with narcolepsy is currently underway in the United States. Previously, NLS successfully completed a Phase 2 study in the US evaluating Nolazol® (controlled release of Mazindol) in adult subjects with ADHD. The study met all primary and secondary endpoints and Nolazol® was well tolerated. Quilence® has received orphan drug designations in both the US and Europe for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD. NLS has announced that it plans to allow patients diagnosed with IH to access Quilience® treatment through an early access program (EAP). ECPs have great potential to benefit all the actors involved, from the patient who receives the drug early, to the pharmaceutical company that provides it. While EAPs can represent a significant business, companies that invest in them can see a significant benefit in terms of launch readiness, relationship building, and market penetration.
safe harbor statement
East Press release contains express or implied forward-looking statements under U.S. federal securities laws. For example, NLS is using forward-looking statements when discussing the anticipated timing of reporting the final results of its Phase 2a narcolepsy trial for Quilence® and the expectation that it will provide an update on its open-label extension study later this year. These forward-looking statements and their implications are based solely on NLS management’s current expectations 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 launching and/or successfully completing its clinical trials; NLS products may not be approved by regulatory agencies, NLS technology may not be validated as it progresses, 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 may arise with the NLS process; NLS products may end up being more expensive than you anticipate; results in the laboratory may not translate to equally good results in real clinical settings; the results of preclinical studies may not correlate with the results of clinical trials in humans; NLS patents may not be enough; NLS products may harm recipients; changes in legislation may negatively affect the NLS; failure to timely develop and introduce new technologies, products and applications; loss of market share and pricing pressure resulting from competition, which could cause actual results or performance of NLS to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, NLS undertakes no obligation to publish any 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 is included under the heading “Risk Factors” in NLS’s annual report on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission. and Securities (SEC), which is available on the SEC’s website, www.sec.gov, and in subsequent filings made by NLS with the SEC.
Alex Zwyer, CEO: +41 44 512 21 50
Investor Relations Contact
Cindy Rizzo: +1 908-229-7050
Pascual Nigen: +1 917-385-2160
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FONT: NLS Pharmaceuticals AG