Indication Includes Children Ages 6 Years
and Older and Weighing at Least 30 kg
MONTREAL, March 28,
2024 /CNW/ -- Paladin Labs Inc., a subsidiary of Endo
International plc (OTC: ENDPQ), today announced Health Canada's
approval of WAKIX® (pitolisant hydrochloride tablets) for the
treatment of excessive daytime sleepiness (EDS) or cataplexy in
pediatric patients aged 6 years and older and weighing at least 30
kg with narcolepsy.
"Health Canada's approval of WAKIX® for appropriate pediatric
patients with narcolepsy marks a significant milestone. We are
proud to offer an option for Canadians struggling with narcolepsy's
debilitating symptoms, EDS and cataplexy, and potentially
empowering caregivers to help manage their condition," said
Livio Di Francesco, Vice President
& General Manager of Paladin Labs Inc. "Paladin Labs is
committed to offering innovative treatment options to help support
the unmet medical needs of Canadian patients."
In 2018, Endo Ventures Limited, a subsidiary of Endo
International plc, entered into an agreement with Bioprojet SCR to
register, commercialize, and distribute pitolisant hydrochloride on
an exclusive basis in Canada.
Paladin Labs Inc., an operating company of Endo, is commercializing
pitolisant hydrochloride in Canada.
About Narcolepsy
Narcolepsy is a rare but serious sleep disorder that
significantly impacts the lives of those affected. It is estimated
that this chronic condition affects up to 25,000 people in
Canada1, most commonly
starting during adolescence though proper diagnosis can often take
several years.234 Presently, pediatric patients face a
void in Health Canada approved treatment options. Compounding this
challenge is the fact that other approved treatments singularly
address either excessive daytime sleepiness (EDS) or cataplexy,
leaving a critical need for comprehensive treatment. EDS is the
inability to stay awake and alert during the day, resulting in
periods of an irrepressible need for sleep or unintended lapses
into drowsiness or sleep, and is present in all people living with
narcolepsy.56 Cataplexy, characterized by sudden loss of
muscle tone that is often triggered by strong emotions such as
excitement, laughter or anger, can be present in up to 60% of
narcolepsy patients.2
About WAKIX®
WAKIX® is the first and only Health Canada approved treatment
for children 6 years of age and older and weighing at least 30 kg
experiencing excessive daytime sleepiness or cataplexy symptoms
associated with narcolepsy. WAKIX® was approved in 2021 for the
treatment of excessive daytime sleepiness or cataplexy in adult
patients with narcolepsy. WAKIX® is a first-in-class highly
selective histamine 3 (H₃) receptor antagonist/inverse agonist that
works through a novel mechanism of action to increase the levels of
histamine and other wakefulness promoting neurotransmitters in the
brain.7 It is a once-daily tablet taken in the morning
upon waking. WAKIX® is the only treatment approved by Health Canada
for cataplexy which is not a controlled drug. WAKIX® is also
marketed in Europe and
the United States and is a
registered trademark of Bioprojet Europe Ltd.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty
pharmaceutical company focused on acquiring or in-licensing
innovative pharmaceutical products for the Canadian market. Paladin
has a marketing and sales organization that has helped it evolve
into one of Canada's leading
specialty pharmaceutical companies. Paladin is an operating company
of Endo International plc. For more information visit: www.endo.com
or www.paladin-labs.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements,
including the statements by Mr. Di
Francesco and other statements relating to regulatory,
marketing and reimbursement approvals, efficacy, adverse reactions,
market and product potential and product availability of WAKIX®,
within the meaning of the Private Securities Litigation Reform Act
of 1995 and the relevant Canadian securities legislation.
Statements including words such as "believes," "expects,"
"anticipates," "intends," "estimates," "plan," "will," "may," "look
forward," "outlook," "guidance," "future" or similar expressions
are forward-looking statements. Because these statements reflect
current views, expectations and beliefs concerning future events,
these forward-looking statements involve risks and uncertainties
and readers should not place undue reliance on them, or any other
forward-looking statements or information in this news release.
Actual results may differ materially and adversely from current
expectations based on a number of factors, including, among other
things, the company's restructuring activities and its ability to
complete its plan of reorganization ; the timing, impact or results
of any pending or future litigation, investigations, proceedings or
claims; the company's liquidity, financial performance, cash
position and operations; supply chain interruptions or
difficulties; changes in competitive or market conditions; changes
in legislation or regulatory developments; product recalls,
withdrawals and other unusual items; health care and cost
containment reforms; and the Company's ability to advance its
strategic priorities. Investors should note that these and many
other factors, as more fully described in the documents filed by
Endo International plc with securities regulators in the United States and Canada including under the caption "Risk
Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings with
the Securities and Exchange Commission and with securities
regulators in Canada on System for
Electronic Document Analysis and Retrieval (SEDAR) and as otherwise
enumerated herein or therein, could affect Endo's future financial
results and could cause Endo's actual results to differ materially
from those expressed in any forward-looking statements. The
forward-looking statements in this press release are qualified by
these risk factors which, individually or in the aggregate, could
cause Endo's actual results to differ materially from expected and
historical results. Endo assumes no obligation to publicly update
any forward-looking statements, whether as a result of new
information, future developments or otherwise, except as may be
required under applicable securities law.
___________________________
1 Ohayon MM. Epidemiology of narcolepsy. In: Bassetti
C, Mignot E, Billard M, editors. Narcolepsy and hypersomnia.
New York: Taylor and Francis;
2007. p. 125–32.
2 Silber MH, Krahn LE, Olson EJ, Pankratz VS. The
epidemiology of narcolepsy in Olmsted
County, Minnesota: a population-based study. Sleep.
2002;25(2):197–202.
3 Thorpy MJ, Krieger AC. Delayed diagnosis of
narcolepsy: characterization and impact. Sleep Med.
2014;15(5):502–7.
4 Thorpy M. Recently Approved and Upcoming Treatments
for Narcolepsy. CNS Drugs (2020) 34:9–27
5 Kornum BR, Knudsen S, Ollila HM, Pizza F, Jennum
PJ, Dauvilliers Y, et al. Narcolepsy. Nat Rev Dis Prim.
2017;3:16100.
6 Szabo ST, Thorpy MJ, Mayer G, Peever JH, Kilduff
TS. Neurobiological and immunogenetic aspects of narcolepsy:
implications for
pharmacotherapy. Sleep Med Rev. 2019;43:23–36.
7 WAKIX® product Monograph. Paladin Labs Inc.
January 25,2024
SOURCE Paladin Labs Inc.