RCS - NLS Pharmaceutics AG - NLS Pharmaceutics Announces Launch of Program

NLS Pharmaceutics AGAnnouncement

23/11/2022 14:30

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RNS Number : 3783H  NLS Pharmaceutics AG  23 November 2022

NLS Pharmaceutics Announces Launch of Paid for Named Patient Program with
Mazindol ER for Idiopathic Hypersomnia, a Serious Sleep Disorder with No
Approved Treatment Options in Europe

ZURICH, SWITZERLAND / ACCESSWIRE / November 23, 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 central nervous system
disorders, announces that it has launched a paid for Named Patient Program
(NPP) for patients suffering from idiopathic hypersomnia (IH). NLS has
partnered with Caligor Coghlan Pharma Services, a globally active
pharmaceutical company specializing in named patient, expanded access, early
access and compassionate use programs. The NPP will provide access to Mazindol
ER for the treatment of IH where this medication would not otherwise be
available for this indication in certain countries. The NPP for IH was
launched in the United Kingdom this week and is expected to expand into other
countries over the coming weeks and months.

"After months of preparation we are excited to launch a NPP for people living
with idiopathic hypersomnia who currently have no approved treatment options.
We are deeply grateful to the regulatory bodies as well as medical experts who
facilitate new therapies for IH, and look forward to working quickly to make
Mazindol ER available to patients under this program as soon as possible",
said Alex Zwyer, Chief Executive Officer of NLS.

IH is a chronic, neurological disorder that is characterized by excessive
sleepiness, an uncontrollable need to sleep or daytime sleepiness that
persists for at least three months even with adequate or prolonged night-time
sleep. IH affects approximately three in 10,000 people in the European Union
(EU). This is equivalent to a total of around 156,000 people. As of today, no
therapies are authorised in the EU for the treatment of IH. Patients with IH
usually receive advice on lifestyle changes to help regulate their sleeping
pattern. NLS' Mazindol ER is an alternative therapeutic option that has been
historically used to treat a number of conditions. It is undergoing clinical
trials in narcolepsy and other sleep disorders. This NPP will allow physicians
to prescribe Mazindol ER off-label for use in treating IH.

On November 2, 2022, the U.S. Food and Drug Administration (FDA) granted
Orphan Drug Designation (ODD) for Mazindol ER for the treatment of IH.
Previously, Mazindol ER was granted ODD for IH in Europe on July 21, 2022.

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 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 IH, for which NLS recently obtained ODD from the
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 ODDs 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 that the NNP for IH is expected
to expand into other countries and that physicians will be allowed to
prescribe Mazindol ER off-label for use in treating IH. 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 U.S. 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 more information on how physicians can access the NPP, please contact
mazindolER@calcog.com and request further information to participate in this
program.

Corporate Contact

Alex Zwyer, CEO: +41 44 512 21 50

Investor Relations Contact

Cindy Rizzo

invest@nls-pharma.com
www.nlspharmaceutics.com (https://pr.report/sIqdD-46)

SOURCE: NLS Pharmaceutics AG

 

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