TIDMINDV
RNS Number : 6881V
Indivior PLC
10 April 2019
Statement of Indivior on Grand Jury Indictment
Company Disputes Allegations and Will Contest Them
Slough, UK, and Richmond, VA, April 10, 2019 - Indivior PLC
(LON: INDV) ("Indivior" or the "Company") announced that on April
9, 2019 a grand jury in the Western District of Virginia issued an
indictment in connection with the federal criminal investigation
initiated by the Department of Justice in December 2013.
The indictment includes twenty-eight felony counts - one count
of conspiracy to commit mail, wire and health care fraud; one count
of health care fraud; four counts of mail fraud; and twenty-two
counts of wire fraud. The allegations are based on actions that
occurred almost exclusively prior to Indivior becoming an
independent company in its demerger from Reckitt Benckiser Group
plc at the end of 2014. The Company believes the allegations are
unsupported by the facts and the law. Key allegations have been
contradicted by the U.S. government's scientific agencies, the Food
and Drug Administration and the Centers for Disease Control.
While the Company cannot predict the timing with certainty,
similar cases can take twelve months or more to be heard. While the
Company believes that it will successfully defend itself against
the government's allegations, an adverse verdict may have a
material adverse effect on the Company and its financial position
and outlook.
Indivior has cooperated extensively with the Justice
Department's investigation for several years. In the interest of
resolving this matter and providing certainty to its shareholders,
the Company made numerous attempts to reach a settlement that went
far beyond what it believes the facts of the case support. The
Company believes it is unfortunate the Justice Department decided
to choose an alternative path, but will fight these allegations on
the facts and the law in court.
In terms of business going forward, the Company will continue to
follow its mission of helping patients struggling with opioid
addiction. It does not anticipate any immediate change in its
relationship with government providers due to today's actions by
the Department of Justice.
A statement from the company responding to the Justice
Department's action is appended below. Further information,
including an open letter from its Chairman, may be found on the
Company's website at www.indivior.com/commitment.
About Indivior
Indivior is a global specialty pharmaceutical company with a
20-year legacy of leadership in patient advocacy and health policy
while providing education on evidence-based treatment models that
have revolutionized modern addiction treatment. The name is the
fusion of the words individual and endeavour, and the tagline
"Focus on you" makes the Company's commitment clear. Indivior is
dedicated to transforming addiction from a global human crisis to a
recognized and treated chronic disease. Building on its global
portfolio of opioid dependence treatments, Indivior has a strong
pipeline of product candidates designed to both expand on its
heritage in this category and address other chronic conditions and
co-occurring disorders of addiction, including alcohol use disorder
and schizophrenia. Headquartered in the United States in Richmond,
VA, Indivior employs more than 900 individuals globally and its
portfolio of products is available in over 40 countries worldwide.
Visit www.indivior.com to learn more.
Forward-Looking Statements
This announcement contains certain statements that are
forward-looking and which should be considered, amongst other
statutory provisions, in light of the safe harbor provisions of the
United States Private Securities Litigation Reform Act of 1995. By
their nature, forward-looking statements involve risk and
uncertainty 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. Forward-looking statements include, among
other things, statements regarding the Indivior Group's financial
guidance for 2018 and its medium- and long-term growth outlook, its
operational goals, its product development pipeline and statements
regarding ongoing litigation.
Various factors may cause differences between Indivior's
expectations and actual results, including: factors affecting sales
of Indivior Group's products; the outcome of research and
development activities; decisions by regulatory authorities
regarding the Indivior Group's drug applications; the speed with
which regulatory authorizations, pricing approvals and product
launches may be achieved; the outcome of post-approval clinical
trials; competitive developments; difficulties or delays in
manufacturing; the impact of existing and future legislation and
regulatory provisions on product exclusivity; trends toward managed
care and healthcare cost containment; legislation or regulatory
action affecting pharmaceutical product pricing, reimbursement or
access; claims and concerns that may arise regarding the safety or
efficacy of the Indivior Group's products and product candidates;
risks related to legal proceedings, including the ongoing
investigative and antitrust litigation matters; the Indivior
Group's ability to protect its patents and other intellectual
property; the outcome of patent infringement litigation relating to
Indivior Group's products, including the ongoing ANDA lawsuits;
changes in governmental laws and regulations; issues related to the
outsourcing of certain operational and staff functions to third
parties; uncertainties related to general economic, political,
business, industry, regulatory and market conditions; and the
impact of acquisitions, divestitures, restructurings, internal
reorganizations, product recalls and withdrawals and other unusual
items.
This announcement does not constitute an offer to sell, or the
solicitation of an offer to subscribe for or otherwise acquire or
dispose of shares in the Company to any person in any jurisdiction
to whom it is unlawful to make such offer or solicitation.
Media Contacts
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
Matthew Miller
+1 202-783-0277
UK
Tulchan Communications
+44 207-353-4200
Investor Contact
Jason Thompson, Indivior
Vice President, Investor Relations
+1 804-379-1033
Jason.Thompson@indivior.com
APPIX: Indivior issued the following further statement in
response to the indictment returned by a federal grand jury in the
Western District of Virginia:
"We are extremely disappointed in this action by the Justice
Department, which is wholly unsupported by either the facts or the
law. Key allegations made by the Justice Department are
contradicted by the government's own scientific agencies, they are
almost exclusively based on years-old events from before Indivior
became an independent company in 2014, and they are wrong. The
department has apparently decided it would rather pursue
self-serving headlines on a matter of national significance than
achieve an appropriate resolution, but we will contest this case
vigorously and we look forward to the full facts coming out in
court.
"Indivior's top priority has always been the treatment of
patients struggling with opioid addiction. The medications Indivior
provides play an essential role in treating opioid use disorder and
addressing the national opioid crisis. Indivior does not make pain
pills in the U.S and is not a contributor to the opioid crisis. As
acknowledged by government experts at the Food and Drug
Administration (FDA) and Centers for Disease Control (CDC), we make
a demonstrably effective treatment for opioid addiction. Indivior
discovered buprenorphine, helped develop it as a leading
evidence-based treatment for opioid dependence, and currently
conducts approximately 75% of all private research into opioid
addiction. No other company has done more to fight the opioid
crisis, and we continue to be fully dedicated to helping patients,
doctors, and communities dealing with opioid addiction.
"Indivior has never deliberately diverted its product. The
government claims that the company aided the careless and
clinically unwarranted prescribing by doctors of SUBOXONE(R)
products to too many people or in too high doses. To the contrary,
we have engaged in an extensive education campaign to teach doctors
about recommended SUBOXONE(R) dosing limits and patient caps and
have developed a process to identify concerning prescribers, going
beyond what the law requires. Moreover, though it was under no
legal obligation to do so, the company proactively reported the
conduct of multiple physicians to the appropriate authorities, but
the company's risk manager was told by the Drug Enforcement Agency
that there was no action the agency would take. We have worked
aggressively to try to reduce the risk of diversion through
extensive education of doctors and patients and by other means,
including through the recent launch of a once-monthly injectable
treatment for opioid use disorder, which must be administered by a
healthcare provider, preventing direct distribution to a
patient.
"Regarding the Justice Department's allegations about
SUBOXONE(R) film, the Centers for Disease Control itself has said
that unit-dose packaging is likely to reduce the risk of pediatric
exposure compared to bulk-bottle packaging. And a CDC study
released in 2016 studying the rates of pediatric exposure before
and after the introduction of Suboxone film found that emergency
room visits due to accidental ingestion of buprenorphine/naloxone
by children under six declined 65 percent after film was introduced
to the market. FDA officials have stated that 'unit-dose packaging
is a measure to reduce pediatric exposures,' and encouraged the
industry to move to unit-dose packaging. The Justice Department's
decision to indict a company for making claims that are in fact
supported by the federal government's own scientific research shows
just how flawed its case is.
"Indivior has cooperated extensively with the Justice
Department's investigation for several years. We have turned over
millions of pages of documents and spent extensive time explaining
the company's operations to the department. In the interest of
resolving this matter and providing certainty to our shareholders,
we have made numerous attempts to reach a settlement that went far
beyond what we believe the facts of this case support. It is
unfortunate the Justice Department decided to choose an alternative
path, but we will fight these allegations on the facts and on the
law in court, and we are confident of our position. In the
meantime, we will not be distracted from our mission of helping
patients struggling with opioid addiction.
"In terms of business going forward, the company does not
anticipate any immediate change in its relationship with government
providers due to today's actions by the Justice Department."
Indivior also released an open letter from Howard Pien, Chairman
of the Board Directors, in which he writes:
"As you may know, the Department of Justice has taken the
unusual step of indicting Indivior for events that date almost
exclusively to before the company was formed in 2014. The Indivior
Board of Directors, through a special committee of the board that I
have chaired, has investigated the department's allegations for
several years, and the board believes they are flat wrong. The
board has full confidence in the management of the company, and we
will fight these charges on the facts and on the law in court."
The full letter is available here.
Specific Rebuttals to DOJ Claims:
On Pediatric Safety:
-- Following the 2010 launch of SUBOXONE(R) film, data began to
emerge from the Poison Control Centers showing far lower rates of
pediatric exposure for film than for tablets. SUBOXONE(R) film is
sold in unit-dose packaging, while SUBOXONE(R) tablets were sold in
traditional bottles.
-- Since that time, based on additional research, government
agencies have repeatedly confirmed the safety benefits of unit-dose
packaging. In August 2016, Dr. Daniel Budnitz, Director of the
Medication Safety Program for the CDC, gave written testimony that
he "consider[s] child-resistant, unit-dose packaging to be an
engineering innovation likely to reduce the risk of pediatric
exposure in comparison to child-resistant, bulk- bottle
packaging."
-- In October 2016, the CDC published the results of its study
of pediatric exposure rates before and after the introduction of
Suboxone film in its unit-dose packaging to the market. The CDC
found that when comparing the 2013-2015 period to the 2008-2010
period, the number of annual visits to the emergency department due
to accidental ingestion of buprenorphine/naloxone by children under
six years old declined 65.3 percent. The CDC concluded that the
reduction in emergency room visits "suggests that
packaging/formulation changes might reduce accidental pediatric
ingestions."
-- A study of poison center data published in the Journal of
Pediatrics in June 2018 demonstrated that the industry shift from
non-unit-dose packaging to unit-dose packaging of
buprenorphine-naloxone products was associated with a 78.8 percent
relative decrease in unintentional pediatric exposures reported to
poison centers.
-- In 2013, FDA noted that "child resistant unit-dose packaging
could provide additional deterrence to accidental pediatric
exposure." FDA's Office of Surveillance and Epidemiology ("OSE")
stated that "Suboxone film in unit-dose packaging poses a lower
overall risk of accidental pediatric exposure than Suboxone tablets
in multi-dose packaging." OSE "suspect[ed] that if there [was] a
return to market dominance of buprenorphine/naloxone tablets
without unit-of-use packaging, pediatric exposures are likely to
rise."
-- Consistent with these concerns, the FDA convened an April
2013 meeting with a group of generic buprenorphine manufacturers
and informed them that "unit-dose packaging is a measure to reduce
pediatric exposures." At that meeting, the FDA further stated that
it viewed "the packaging of buprenorphine-containing products as a
significant safety issue in regards to pediatric exposure," and
recommended that each of the industry group's members voluntarily
move to unit-dose packaging for their buprenorphine-containing
products.
On Misuse and Diversion:
-- Suboxone's FDA-approved Package Insert states that the
maintenance dose is usually in the range of 4 mg to 24 mg of
buprenorphine per day. The recommended target dose is 16 mg taken
once daily. Research has shown that for some patients, doses of
less than 16 mg per day may not stop the opioid craving, and doses
at 24 mg per day may be needed. The Substance Abuse and Mental
Health Services Administration (SAMHSA), an agency within the U.S.
Department for Health and Human Services, advises prescribers that
some patients may require up to 32 mg per day and has recommended
dosing at that level for some patients.
-- Though it is under no legal obligation to do so, Indivior's
sales representatives regularly educate doctors about the patient
limits contained in federal law. The company also instructs doctors
about the appropriate dosing levels for Suboxone. It has instructed
its sales representatives to note "red flags" of potential
diversion when seeing prescribers, and it educates doctors about
recommended Suboxone prescribing limits when it develops
concerns.
-- Indivior's compensation structure for sales representatives
does not encourage excessive dosing. As far back as 2006, Indivior
has excluded doses higher than 16 mg per day from its quarterly
compensation algorithm for sales representatives and their
managers.
-- Indivior took many steps during the relevant period to reach
out to risky prescribers and attempt to curtail problematic
prescribing patterns, and it continually buttresses those efforts
to this day. Put simply, Indivior is not a contributor to the
opioid epidemic. Rather, as acknowledged by government experts at
the FDA and CDC, its medicines are a key part of combatting it.
-ends-
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END
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