Full Press Release Details
NLS Pharmaceutics Announces Decision by
Japanese Patent Office to Grant Patent in Japan for Mazindol Extended-Release
July 28, 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, announces that the Japanese Patent Office (JPO) notified the Company of
its decision to grant patent application 2018-546837 for the proprietary formulation of Quilience (Mazindol ER). Once issued, the
patent will cover oral formulations containing immediate-release and sustained-release layers of mazindol and their use in treating attention
deficit disorder/hyperactivity disorder (ADHD), excessive daytime sleepiness (EDS) including narcolepsy and idiopathic hypersomnia (IH).
are pleased to obtain patent coverage in another major market for our proprietary formulation of Quilience to treat ADHD, narcolepsy
and IH," said Alex Zwyer, Chief Executive Officer of NLS. "Given our patent estate and the Orphan Drug Designations that we
have in both the U.S. and Europe, we believe that our proprietary position on Quilience is strong. We look forward to reporting
the final results from our Phase 2a narcolepsy trial for Quilience in late September
2022 and also providing an update from the open-label extension study later this year."
About NLS Pharmaceutics
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). 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 2a
clinical trial evaluating Quilience in
adult subjects suffering from narcolepsy is currently ongoing in the United States. Previously, NLS 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. NLS has announced that it plans to enable
patients diagnosed with IH to access treatment with Quilience through
an early access program (EAP). EAPs have great potential to benefit all stakeholders involved, from the patient who receives the medicine
early, to the pharmaceutical company who provides it. Although EAPs can represent a significant undertaking, companies who invest in them
can see considerable benefit in terms of launch preparedness, relationship building and market penetration.
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
its expected timing to report the final results from its Phase 2a narcolepsy trial for Quilience
and the expectation that it will provide an update from its open-label extension study later this year. 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; 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.
Alex Zwyer, CEO: +41 44 512 21 50
Investor Relations Contact
Cindy Rizzo: +1 908-229-7050
Pascal Nigen: +1 917-385-2160