Indivior Announces Agreement to Resolve Criminal Charges and Civil Complaints Related to SUBOXONE® Film
Slough, UK and Richmond, VA, July 24, 2020 – Indivior PLC (LON: INDV) (“Indivior” or the
“Company”) announced that it has reached an agreement with the United States Department
of Justice (Justice Department), the Federal Trade Commission (“FTC”), and U.S. state
attorneys general to resolve the Company’s criminal and civil liability in connection with an
indictment brought in April 2019 by a grand jury in the Western District of Virginia, a civil
lawsuit joined by the Justice Department in 2018, and an FTC investigation. Under the terms
of the agreement, Indivior Solutions Inc (“Solutions Inc”), a wholly-owned subsidiary of
Indivior PLC, has pleaded guilty to one count of making a false statement relating to health
care matters in 2012. Indivior will make payments to federal and state authorities totaling
$600 million over a period of seven years, has agreed to a stipulated injunction with the FTC,
and entered into a Corporate Integrity Agreement with the Office of Inspector General of the
Department of Health and Human Services (“HHS”). Under the terms of the agreement, the
Justice Department will move to dismiss all charges returned by a grand jury in April 2019.
Under the terms of a related agreement with the HHS, Solutions Inc will be excluded from
participating in government health programs. This exclusion will not affect Indivior PLC or its
other subsidiaries (together the “Group”). Indivior does not anticipate the exclusion of
Solutions Inc will have any material impact on the Group’s ability to continue to participate in
government health programs.
“We are pleased to achieve this resolution and move forward in a way that provides certainty
for our business in respect of this matter and allows us to continue focusing on our important
work for patients suffering from opioid use disorder and mental health illnesses around the
world,” said Indivior Chief Executive Officer Mark Crossley. “The incident to which the
agreement relates occurred well in the past and does not reflect the values Indivior has
strived to demonstrate and uphold during our long history of partnering with healthcare
providers, policymakers, and communities to fight the opioid crisis.”
Under the terms of the agreement, the Group will distribute a payment of $100 million the
week the plea is finalized and approved by a judge. Subsequently, there will be six annual
installments of $50 million due every January 15 from 2022 to 2027. The final balance will be
due on December 15, 2027. The Group carries a provision of $624 million for Department of
Justice and related matters.
Under the terms of the five-year Corporate Integrity Agreement with the HHS Office of the
Inspector General, the Group will continue its commitment to promoting compliance with
laws and regulations and its ongoing evolution of an effective compliance program,
including written standards, training, reporting, and monitoring procedures.
The agreement is subject to approval by a federal judge.
The Group will release its H1 and Q2 2020 results as scheduled on July 30th at 7:00 BST (2:00 AM US
EDT).
About SUBOXONE® Film
Indication
SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine
indicated for treatment of opioid dependence and should be used as part of a complete
treatment plan to include counseling and psychosocial support.
Treatment should be initiated under the direction of healthcare providers qualified under the
Drug Addiction Treatment Act.
Important Safety Information
Do not take SUBOXONE® Film if you are allergic to buprenorphine or naloxone as serious
negative effects, including anaphylactic shock, have been reported.
SUBOXONE® Film can be abused in a manner similar to other opioids, legal or illicit.
SUBOXONE® Film contains buprenorphine, an opioid that can cause physical dependence with
chronic use. Physical dependence is not the same as addiction. Your healthcare provider can
tell you more about the difference between physical dependence and drug addiction. Do not
stop taking SUBOXONE® Film suddenly without talking to your healthcare provider. You could
become sick with uncomfortable withdrawal symptoms because your body has become used
to this medicine.
SUBOXONE® Film can cause serious life-threatening breathing problems, overdose and death,
particularly when taken by the intravenous (IV) route in combination with benzodiazepines or
other medications that act on the nervous system (ie, sedatives, tranquilizers, or alcohol). It is
extremely dangerous to take nonprescribed benzodiazepines or other medications that act on
the nervous system while taking SUBOXONE® Film.
You should not drink alcohol while taking SUBOXONE® Film, as this can lead to loss of
consciousness or even death.
Death has been reported in those who are not opioid dependent.
Your healthcare provider may monitor liver function before and during treatment.
SUBOXONE® Film is not recommended in patients with severe hepatic impairment and may not
be appropriate for patients with moderate hepatic impairment. However, SUBOXONE® Film
may be used with caution for maintenance treatment in patients with moderate hepatic
impairment who have initiated treatment on a buprenorphine product without naloxone.
Keep SUBOXONE® Film out of the sight and reach of children. Accidental or deliberate ingestion
of SUBOXONE® Film by a child can cause severe breathing problems and death.
Do not take SUBOXONE® Film before the effects of other opioids (eg, heroin, hydrocodone,
methadone, morphine, oxycodone) have subsided as you may experience withdrawal
symptoms.
Injecting the SUBOXONE® Film product may cause serious withdrawal symptoms such as pain,
cramps, vomiting, diarrhea, anxiety, sleep problems, and cravings.
Before taking SUBOXONE® Film, tell your healthcare provider if you are pregnant or plan to
become pregnant. If you are pregnant, tell your healthcare provider as withdrawal signs and
symptoms should be monitored closely and the dose adjusted as necessary. If you are pregnant
or become pregnant while taking SUBOXONE® Film, alert your healthcare provider immediately
and you should report it using the contact information provided below.
Opioid‐dependent women on buprenorphine maintenance therapy may require additional
analgesia during labor.
Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of
prolonged use of opioids during pregnancy, whether that use is medically-authorized or illicit.
Unlike opioid withdrawal syndrome in adults, NOWS may be life-threatening if not recognized
and treated in the neonate. Healthcare professionals should observe newborns for signs of
NOWS and manage accordingly.
Before taking SUBOXONE® Film, talk to your healthcare provider if you are breastfeeding or plan
to breastfeed your baby. The active ingredients of SUBOXONE® Film can pass into your breast
milk. You and your healthcare provider should consider the development and health benefits
of breastfeeding along with your clinical need for SUBOXONE® Film and should also consider
any potential adverse effects on the breastfed child from the drug or from the underlying
maternal condition.
Do not drive, operate heavy machinery, or perform any other dangerous activities until you
know how SUBOXONE® Film affects you. Buprenorphine in SUBOXONE® Film can cause
drowsiness and slow reaction times during dose-adjustment periods.
Common side effects of SUBOXONE® Film include nausea, vomiting, drug withdrawal syndrome,
headache, sweating, numb mouth, constipation, painful tongue, redness of the mouth,
intoxication (feeling lightheaded or drunk), disturbance in attention, irregular heartbeat,
decrease in sleep, blurred vision, back pain, fainting, dizziness, and sleepiness.
This is not a complete list of potential adverse events associated with SUBOXONE® Film. Please
see full Prescribing Information www.suboxoneREMS.com.
for a complete list.
*To report pregnancy or side effects associated with taking SUBOXONE® Film, please call 1-877-
782-6966. You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call-1-800-FDA-1088.
For more information about SUBOXONE® Film, SUBOXONE®
(buprenorphine and naloxone)
Sublingual Tablets (CIII), or SUBUTEX®
(buprenorphine) Sublingual Tablets (CIII), please see the
respective full Prescribing Information and Medication Guide at www.suboxoneREMS.com.
Forward-Looking Statements
This press release 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, forwardlooking 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. Forwardlooking statements include, among other things, statements regarding the Indivior Group’s financial guidance for 2020 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 press release 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.
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 cooccurring disorders of
addiction. 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
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 addiction, including alcohol use disorder.
Headquartered in the United States in Richmond, VA, Indivior employs more than 800 individuals
globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com
to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
Media Contacts
US
IndiviorMediaContacts@indivior.com
+1 804-594-0836
UK
Tulchan Communications
+44 207-353-4200
Investor Contact
Jason Thompson
Indivior Vice President, Investor Relations
+1 804-402-7123
Jason.Thompson@indivior.com