STANS, Switzerland,
March 12, 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 entered into a License Agreement (the
"Agreement") with Novartis Pharma AG, whereby the Company has
obtained, on an exclusive basis in the
United States, all of the available data referred to and
included in the original NDA for Sanorex® (mazindol) submitted to
the United States Food and Drug Administration in February 1972. The Agreement encompasses all
preclinical and clinical studies, data used for manufacturing
including stability and other chemistry manufacturing and controls
data, formulation data and know-how for all products containing
mazindol as an active substance, and all post-marketing clinical
studies and periodic safety reports from 1973 forward.
Under the Agreement, NLS has obtained the same rights on an
non-exclusive basis in all territories outside of the U.S, except
for Japan, with the right to
cross-reference the Sanorex NDA with non-U.S. regulatory agencies
in the licensed territories. The Agreement includes the right to
sublicense or assign the license to third parties, subject to such
third parties meeting certain obligations.
"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."
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. is a Swiss-based clinical-stage
pharmaceutical 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 the
benefits of the Agreement, including the potential to save time,
reduce its clinical budget, and enhance its clinical/regulatory
programs to advance Quilience®; Quilience's potential to provide
significant benefits to patients suffering from narcolepsy; the
possibility that other disorders related to sleep-wake cycle
disturbances, such as idiopathic hypersomnia and obstructive sleep
apnea, may also benefit from Quilience; and bringing its enhanced
formulation of mazindol to the market. 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' Registration Statement on Form
F-1 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.