STANS, Switzerland,
March 29, 2021 /PRNewswire/
-- 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 been awarded Canadian Patent No. 3016852,
entitled A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE
TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). The
patent provides intellectual property protection for oral
formulations containing immediate-release and sustained-release
layers of mazindol for use in treating attention deficit disorders
(ADD or ADHD), related alertness of vigilance or excessive daytime
sleepiness (EDS), narcolepsy, or idiopathic hypersomnia.
"We are very pleased to have obtained the first patent covering
our novel formulation of controlled-release mazindol as we advance
the development of Quilience® to treat narcolepsy and other
potential sleep-wake disorders," said Alex
Zwyer, Chief Executive Officer of NLS. "Our application
for a similar patent in Europe
received notice of allowance in January, and our U.S. patent
application is pending review. Most patients with narcolepsy remain
unsatisfied with current treatment options, and we believe that
Quilience has potential to fill a major need in the market given
mazindol's long history of safety and evidence of effectiveness in
treating the symptoms of narcolepsy. We remain focused on
initiating our prospective Phase 2 clinical study for Quilience and
bringing this treatment option to patients suffering from
narcolepsy as soon as possible."
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. is
a Swiss-based 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 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.
Safe Harbor Statement
This press release contains express or implied forward-looking
statements pursuant to U.S. Federal securities laws. For example,
NLS is using forward-looking statements when it discusses its
belief that Quilience has potential to fill a major need in the
market given mazindol's long history of safety and evidence of
effectiveness in treating the symptoms of narcolepsy and the
expected timing of the initiation of its Phase 2 clinical study for
Quilience. 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's products may not be approved by regulatory agencies,
NLS's 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's process; NLS's 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's patents may not be
sufficient; NLS's 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'
final prospectus, dated January 28,
2021, filed with the SEC, which is available on the SEC's
website, www.sec.gov.
Corporate Contact
Alex
Zwyer, CEO: +41 41 618 80 00
Investor Relations Contact
David Moskowitz: +1 202-280-0888
www.nlspharma.com
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SOURCE NLS Pharmaceutics Ltd.