Full Press Release Details
NLS Pharmaceutics Announces Israeli Patent Grant
Covering Mazindol for Treatment of Attention Deficit Hyperactivity Disorder and Other Sleep Disorders Through 2037
Z rich, Switzerland,
December 20, 2022 - NLS Pharmaceutics 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, today announced that the Israeli Patent Office has granted approval for Patent Application 261418, which covers
Mazindol as a method of treatment for Attention Deficit/Hyperactivity Disorder (ADHD).
This patent is expected to expire no earlier than 2037.
"This patent reinforces our continued effort
to build our global franchise in central nervous system disorders, in particular rare sleep disorders, with Mazindol," said Alex
Zwyer, Chief Executive Officer of NLS Pharmaceutics. "We believe that the multi-modal mechanism of action of Quilience
is highly unique and will have meaningful clinical benefits across a number of therapeutic areas."
Mazindol is not currently available in Israel
and has not been promoted for use in ADHD. Quilience (Mazindol ER), the Company's lead product candidate and proprietary extended-release
formulation of Mazindol (Mazindol ER), is being developed for the treatment of narcolepsy, and potentially other sleep-wake disorders
such as idiopathic hypersomnia (IH). Top-line results from our Phase 2a clinical trial evaluating Quilience (Mazindol ER), in the treatment
of narcolepsy, resulted in positive favorable results, meeting the primary endpoint with high statistical significance.
Israel has the world's highest rate of ADHD
diagnoses per capita, according to a study based on data from the Maccabi Healthcare Services, one of the largest health maintenance organizations
in Israel. According to Market Data Forecast , the global ADHD therapeutics market is valued at more than $29 billion currently and
is projected to grow to nearly $45 billion by 2037.
About NLS Pharmaceutics
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 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-wake disorders such as idiopathic hypersomnia (IH), for which NLS recently obtained Orphan Disease Designation (ODD) from
the U. S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Mazindol is a triple monoamine reuptake inhibitor
and partial Orexin-2 Receptor agonist, which was used for many years to treat patients diagnosed with narcolepsy in compassionate use
programs. A Phase 2 multi-center U.S. clinical trial evaluating Quilience
in adult subjects suffering from narcolepsy met its primary endpoint with high statistical significance and demonstrated a favorable
safety and tolerability profile. NLS also successfully completed a Phase 2 study in the U.S. evaluating Nolazol
(Mazindol Controlled-Release) in adult subjects suffering from ADHD. The study met all primary and secondary endpoints and
Nolazol was well-tolerated. Quilience
has received Orphan Drug Designations both in the U.S. and in 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
expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements
when it discusses the Company's potential funding runway, the expected timing of the issuance of the Israeli patent and the earliest
expiration date of the patent, the anticipated submission of its new drug application for Mazindol
ER in narcolepsy, and the potential benefits in the use of Mazindol for the treatment of ADHD and other disorders. These forward-looking
statements and their implications are based on the current expectations of the management of NLS 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 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 further and its
methods may not be accepted by the scientific community; NLS may be unable to retain or attract key employees whose knowledge is essential
to the development of its products; unforeseen scientific difficulties may develop with NLS' process; NLS' products may wind up being
more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results
of preclinical studies may not correlate with the results of human clinical trials; NLS' patents may not be sufficient; NLS' products
may harm recipients; changes in legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products
and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the 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 publicly release any revisions to these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties
affecting NLS is contained under the heading "Risk Factors" in NLS' annual report on Form 20-F for the 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 made by NLS with the SEC.
For additional information:
Marianne Lambertson (investors & media)
NLS Pharmaceutics Ltd.