MONTREAL, Aug. 8, 2022
/CNW/ -- Paladin Labs Inc., a subsidiary of Endo International plc
(NASDAQ: ENDP), announced today that Health Canada has accepted its
New Drug Submission (NDS) for cenobamate tablets as an adjunctive
therapy for the management of partial-onset seizures in adults with
epilepsy who are not satisfactorily controlled with conventional
therapy. A decision from Health Canada as to whether cenobamate
tablets can be marketed and sold in Canada under this NDS is expected
mid-2023.
"This is an important step in our journey to address the unmet
needs of adult patients diagnosed with partial-onset seizures,"
said Livio Di Francesco, Vice
President and General Manager of Paladin. "Paladin Labs is
committed to working collaboratively with regulatory, pricing and
reimbursement authorities in order to provide cenobamate to
appropriate patients as quickly as possible."
The regulatory submission includes efficacy information from two
pivotal studies (C013 and C017)1,2, which enrolled a
total of 658 patients. The evaluation of safety was conducted over
the course of the two pivotal studies, and their respective
open-label extensions, and is complemented by a long-term
open-label Phase III safety study (C021)3, also
presented in the regulatory submission. A total of 1,944 patients
with epilepsy have been treated with cenobamate in the clinical
development program.
Endo Ventures Limited, a subsidiary of Endo, and SK
Biopharmaceuticals signed a licensing agreement in December 2021 granting Endo Ventures Limited the
exclusive right to commercialize cenobamate in Canada. Under the terms of this agreement,
Paladin Labs is responsible for all commercial activities
in Canada related to cenobamate.
About Cenobamate
Cenobamate is a novel small molecule
with a dual mechanism of action under investigation for treating
seizures.4,5,6 Cenobamate, at clinically relevant
concentrations, acts both as a positive allosteric modulator of the
γ-aminobutyric acid (GABAA) ion channel and inhibits voltage-gated
sodium currents.2,3 Long-term data of cenobamate has
been studied in the open-label extensions of the double-blind
placebo control trials as well as the open-label safety study in
adults with uncontrolled partial-onset seizures. Additionally,
cenobamate is being assessed in an ongoing randomized,
double-blind, placebo-controlled trial evaluating its safety and
efficacy as adjunctive therapy in patients with primary generalized
tonic-clonic seizures (NCT03678753).7
Cenobamate was discovered by SK Biopharmaceuticals and SK life
science, and is an anti-seizure medication for the adjunctive or
monotherapy treatment of partial-onset seizures in adults (also
known as focal-onset seizures). In November
2019, the U.S. Food and Drug Administration approved
cenobamate tablets, marketed under the trademark XCOPRI®
(cenobamate tablets) CV in the U.S., for such treatment. In
March 2021, the European Commission
granted marketing authorization for cenobamate tablets, marketed
under the trademark ONTOZRY® in Europe, for such treatment.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR
XCOPRI® (cenobamate tablets) CV can be found on
www.xcopri.com.
About Endo and Paladin Labs
Endo (NASDAQ: ENDP) is a
specialty pharmaceutical company committed to helping everyone we
serve live their best life through the delivery of quality,
life-enhancing therapies. Our decades of proven success come from
passionate team members around the globe collaborating to bring the
best treatments forward. Together, we boldly transform insights
into treatments benefiting those who need them, when they need
them. Learn more at www.endo.com or connect with us
on LinkedIn.
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 focused marketing, medical 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.
References
1. https://www.clinicaltrials.gov/ct2/show/NCT01397968
2. https://www.clinicaltrials.gov/ct2/show/NCT01866111
3. https://www.clinicaltrials.gov/ct2/show/NCT02535091
4. Guignet M, Campbell A, White HS, Epilepsia. 2020 Oct 16. doi:
10.1111/epi.16718. Online ahead of print
5. Nakamura M, et al. Eur J Pharmacol 2019;855:175-182.
6. Sharma R, et al. Eur J Pharmacol 2020;879:173117.
7. https://www.clinicaltrials.gov/ct2/show/NCT03678753
Cautionary Note Regarding Forward-Looking
Statements
Certain information in this press release may be
considered "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995 and any applicable
Canadian securities legislation including, but not limited to, the
statements by Mr. Di Francesco and
any statements relating to regulatory approval or the development,
registration, supply, commercialization, distribution or launch of
any product. Statements including words or phrases such as
"believe," "expect," "anticipate," "intend," "estimate," "plan,"
"will," "may," "look forward," "intend," "future," "potential" or
similar expressions are forward-looking statements. All
forward-looking statements in this press release reflect Endo's
current expectations of future events based on existing trends and
information and represent Endo's judgment only as of the date of
this press release. Actual results may differ materially and
adversely from current expectations based on a number of factors
affecting Endo's businesses, including, among other things, the
following: the outcome of our strategic review, contingency
planning and any potential restructuring; the timing, impact or
results of any pending or future litigation, investigations,
proceedings or claims, including opioid, tax and antitrust matters;
actual or contingent liabilities; settlement discussions or
negotiations; the impact of competition including loss of
exclusivity and generic competition; our ability to satisfy
judgments or settlements or to pursue appeals including bonding
requirements; our ability to adjust to changing market conditions;
our inability to maintain compliance with financial covenants and
operating obligations which would expose us to potential events of
default under our outstanding indebtedness; our ability to incur
additional debt or refinance our outstanding indebtedness; and a
significant reduction in our short-term or long-term revenues which
could cause us to be unable to fund our operations and liquidity
needs. The occurrence or possibility of any such result has caused
us to engage, and may result in further engagement, in strategic
reviews that ultimately may result in our pursuing one or more
significant corporate transactions or other remedial measures,
including on a preventative or proactive basis. Those remedial
measures could include a potential corporate reorganization,
restructuring or bankruptcy filing involving all or a portion of
our business, asset sales or other divestitures, cost-saving
initiatives, corporate realignments or strategic partnerships. Some
of these measures could take significant time to implement and
others may require judicial or other third-party approval. Any such
actions may be complex, could entail significant costs and charges
or could otherwise negatively impact shareholder value, and there
can be no assurance that we will be able to accomplish any of these
alternatives on terms acceptable to us, or at all, or that they
will result in their intended benefits. Therefore, the reader is
cautioned not to rely on any forward-looking statements. Endo
expressly disclaims any intent or obligation to update these
forward-looking statements, except as required to do so by law.
Additional information concerning risk factors, including those
referenced above, can be found in press releases issued by Endo, as
well as Endo's public periodic filings with the U.S. Securities and
Exchange Commission and with securities regulators in Canada, including the discussion under the
heading "Risk Factors" in Endo's most recent Annual Report on Form
10-K and any subsequent Quarterly Reports on Form 10-Q or other
filings with the U.S. Securities and Exchange Commission.
SOURCE Paladin Labs Inc.
