Indivior Pharmaceuticals, Inc 6-K, filed Sep 4, 2024
Indivior Pharmaceuticals, Inc. (INDV)
6-K
2024-09-04
For: 2024-09-04
View Original
Added on
April 10, 2026
About this 6-K
Indivior Pharmaceuticals, Inc filed this 6-K on September 4, 2024.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
________________________
Washington, D.C. 20549
_____________________
FORM 6-K
_____________________
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of September 2024
Commission File Number: 001-37835
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Indivior PLC
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10710 Midlothian Turnpike, Suite 125
North Chesterfield, Virginia 23235
(Address of principal executive office)
_______________________________
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F
Form
20-F ☒ Form 40-F ☐
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EXHIBIT INDEX
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Exhibit No.
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Description of Exhibit
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99.1
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SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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Indivior PLC
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Date: September 04, 2024
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/s/
Kathryn Hudson
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Name:
Kathryn Hudson
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Title:
Company Secretary
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Exhibit 99.1
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF
ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) 596/2014 (AS IT FORMS
PART OF DOMESTIC LAW IN THE UK BY VIRTUE OF THE EUROPEAN UNION
(WITHDRAWAL) ACT 2018).
Indivior Provides Update on Aelis Farma's
Clinical Phase
2B Study Results with AEF0117
in Participants with Cannabis Use Disorder
- Primary
and Secondary End Points of the Study were Not
Met
- Indivior
Does Not Currently Expect to Exercise AEF0117
Option
Slough, UK, and Richmond, VA, September 4,
2024 - Indivior
PLC (Nasdaq/LSE:
INDV) is today providing an update
following Aelis
Farma's announcement of
the results from its clinical Phase 2B trial with
AEF01171,
evaluating the efficacy and safety in treatment-seeking
participants with moderate to severe Cannabis Use Disorder (CUD).
The purpose of this trial was twofold: (1) to show that AEF0117
(0.1, 0.3, 1 mg once a day for 12 weeks) lowers cannabis use and
(2) to determine the endpoints and optimal dosage of AEF0117 for
use in future studies. In this phase 2B study, patients were
treatment-seeking participants, 84% of whom had severe
CUD.
The results of the study demonstrated that the primary endpoint,
the proportion of participants who reduced their cannabis use to
≤1 day per week, as well as secondary endpoints measuring the
proportion of participants reaching either complete abstinence or
who used ≤2 day per week, were not met. Although these
results are disappointing, they indicate that significant work
remains to be done to understand subpopulations of patients with
CUD, specifically those with severe CUD.
This clinical Phase 2B study is part of the strategic collaboration
between Aelis Farma and Indivior, which includes an exclusive
option for Indivior to license the global rights to AEF0117. Given
the lack of separation from placebo on primary and secondary
endpoints and before seeing further additional favorable clinical
data, Indivior does not currently expect to exercise its
option.
###
Important Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, express and implied statements regarding whether: we will
be able to ultimately demonstrate the safety and efficacy of
AEF0117, which is a prerequisite to filing any New Drug
Application; we might ever exercise our option for AEF0117 and, if
so, when; and other statements containing the words "believe,"
"anticipate," "plan," "expect," "intend," "estimate," "forecast,"
"strategy," "target," "guidance," "outlook," "potential,"
"project," "priority," "may," "will," "should," "would," "could,"
"can," "outlook," "guidance," the negatives thereof, and variations
thereon and similar expressions. By their nature, forward-looking
statements involve risks and uncertainties as they relate to events
or circumstances that may or may not occur in the
future.
Actual results may differ materially from those because they relate
to future events. Various factors may cause differences between
Indivior's expectations and actual results, including, among
others, the risks described in our most recent annual report on
Form 20-F beginning on page 9 as filed with the U.S. SEC and in
subsequent releases; legal and market restrictions that may limit
how quickly we can repurchaser our shares; the substantial
litigation and ongoing investigations to which we are or may become
a party; our reliance on third parties to manufacture commercial
supplies of most of our products, conduct our clinical trials and
at times to collaborate on products in our pipeline; our ability to
comply with legal and regulatory settlements, healthcare laws and
regulations, requirements imposed by regulatory agencies and
payment and reporting obligations under government pricing
programs; risks related to the manufacture and distribution of our
products, most of which contain controlled substances; market
acceptance of our products as well as our ability to commercialize
our products and compete with other market participants;
competition; the uncertainties related to the development of new
products, including through acquisitions, and the related
regulatory approval process; our dependence on third-party payors
for the reimbursement of our products and the increasing focus on
pricing and competition in our industry; unintended side effects
caused by the clinical study or commercial use of our products; our
ability to successfully execute acquisitions, partnerships, joint
ventures, dispositions or other strategic acquisitions; our ability
to protect our intellectual property rights and the substantial
cost of litigation or other proceedings related to intellectual
property rights; the risks related to product liability claims or
product recalls; the significant amount of laws and regulations
that we are subject to, including due to the international nature
of our business; macroeconomic trends and other global developments
such as armed conflicts and pandemics; the terms of our debt
instruments, changes in our credit ratings and our ability to
service our indebtedness and other obligations as they come due;
changes in applicable tax rate or tax rules, regulations or
interpretations and our ability to realize our deferred tax assets;
and volatility in our share price due to factors unrelated to our
operating performance or that may result from the potential move of
our primary listing to the U.S.
Forward-looking statements speak only as of the date that they are
made and should be regarded solely as our current plans, estimates
and beliefs. Except as required by law, we do not undertake and
specifically decline any obligation to update, republish or revise
forward-looking statements to reflect future events or
circumstances or to reflect the occurrences of unanticipated
events.
This release is being made by Kathryn Hudson, Company Secretary
Indivior PLC.
About Indivior
Indivior is a global pharmaceutical company working to help change
patients' lives by developing medicines to treat substance use
disorders (SUD), overdose and serious mental illnesses. Our vision
is that all patients around the world will have access to
evidence-based treatment for the chronic conditions and
co-occurring disorders of SUD. Indivior is dedicated to
transforming SUD from a global human crisis to a recognized and
treated chronic disease.
Building on its global portfolio of OUD treatments, Indivior has a
pipeline of product candidates designed to both expand on its
heritage in this category and potentially address other chronic
conditions and co-occurring disorders of SUD. Headquartered
in the United States in Richmond, VA, Indivior employs over 1,000
individuals globally and its portfolio of products is available in
over 30 countries worldwide.
Visit www.indivior.com to learn more. Connect with Indivior on
LinkedIn by
visiting www.linkedin.com/company/indivior.
References:
1. National Library of
Medicine (U.S.) (2022, April). Effect of AEF0117 on
treatment-seeking patients with cannabis use disorder (CUD)
(SICA2). Identifier
NCT05322941 https://www.clinicaltrials.gov/study/NCT05322941
Media Contacts:
US Media:
Judi Dane
Sr. Director, Communications
Indivior PLC
Tel: +1 804-564-4303
Investors and Analysts:
Jason Thompson
Vice President, Investor Relations
Indivior PLC
Tel: +1 804-402-7123
Tim Owens
Director, Investor Relations
Indivior PLC
Tel: +1 804-263-3978