RICHMOND, Va., June 2, 2023
/PRNewswire/ -- Indivior PLC (LSE: INDV), a leading addiction
treatment company, announced that its subsidiary, Indivior Inc.
(the "Company"), has reached an agreement to resolve the claims
brought by the Attorneys General of 41 states and the District of Columbia ("the Claimants") in
the In re Suboxone Antitrust
Litigation multi-district litigation ("MDL"). The
Agreement marks the comprehensive resolution of the states' claims
against the Company in the MDL. The Agreement will become final
once entered by the United States
District Court for the Eastern District of Pennsylvania (the "Court").
As part of the Agreement, the Company will pay $102.5 million to the Claimants. The settlement
amount is in line with the original provision of $290 million for the overall MDL. Once the
Agreement is entered by the Court, the settlement amount will be
recorded against the $290 million
provision. Payment is expected to be made in June of 2023, funded
from the Company's existing cash.
"Indivior is focused on helping those who suffer from substance
use disorders," said Mark Crossley,
Chief Executive Officer. "We take our role as a responsible steward
of medications for addiction and rescue extremely seriously.
Resolving these legacy matters at the right value allows us to
further this mission for patients," he added.
As part of the Agreement, the Claimants agree to release all
claims related to the MDL, and the Company agrees to certain
notification provisions and restrictions similar to the 10-year
Stipulated Order entered into with the Federal Trade Commission
("FTC") in November 2020. These
notification provisions and restrictions would run concurrently
with the FTC Stipulated Order, in which the Company is
required to make and provide
specified disclosures and notifications to the
Claimants, including regular written reports on
the Company's compliance with the Agreement,
any filing of a Citizen Petition with the United States
Food and Drug Administration ("FDA"), any
filing of a New Drug Application for a Follow-on Drug Product with
FDA, any approval of new drug
products, and any proposed changes to the
Company's corporate structure. In addition, the
Company is prohibited from certain conduct
that may arise from the approval
of a New Drug Application for a Follow-on Drug Product
as described in the Agreement.
Important Cautionary Note Regarding Forward-Looking
Statements
This news release contains certain statements that are
forward-looking. Forward-looking statements include, among other
things, statements regarding expected court approval of the
settlement, the expected timing of settlement payments, the
ultimate cost to resolve certain legacy litigation matters
including the MDL; 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 expressed or
implied in such statements because they relate to future events.
Various factors may cause differences between Indivior's
expectations and actual results, including, among others, the
material risks described in the most recent Indivior PLC Annual
Report and in subsequent releases; 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, some
of which are controlled substances; market acceptance of our
products as well as our ability to commercialize our products and
compete with other market participants; the uncertainties related
to the development of new products, including through acquisitions,
and the related regulatory approval process; our dependence on a
small number of significant customers; our ability to retain key
personnel or attract new personnel; 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 use of hazardous materials in our manufacturing
facilities; our import, manufacturing and distribution of
controlled substances; 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 the
COVID-19 pandemic; 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.
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.
About Indivior
Indivior is a global pharmaceutical
company working to help change patients' lives by developing
medicines to treat addiction 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 substance use disorder (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, including alcohol use disorder and cannabis use
disorder. Headquartered in the United States in Richmond, VA,
Indivior employs more than 1,000 individuals globally and its
portfolio of products is available in 39 countries worldwide.
Visit www.indivior.com to learn more. Connect with Indivior on
LinkedIn by visiting www.linkedin.com/company/indivior.
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