TIDMINDV
RNS Number : 8791K
Indivior PLC
27 September 2016
STATEMENT REGARDING CIVIL COMPLAINT FILED BY STATE ATTORNEYS
GENERAL
Indivior to continue to defend its position
Slough, UK, 27 September 2016 -On 23 September, Indivior PLC
(LON: INDV) ("Indivior" or the "Company") reported that it had been
notified that thirty-five U.S. states and the District of Columbia
filed a civil complaint alleging violations of state and federal
antitrust and consumer protection laws. Yesterday, the states
released a redacted copy of this complaint, which alleges, among
other things, that Indivior, along with other defendants, switched
SUBOXONE(R) treatment from a tablet to a film formulation in order
to prevent or delay the introduction of generic alternatives. The
Company continues to take these allegations seriously, intends to
defend this and other related actions, and will continue to
cooperate with the relevant U.S. government agencies in their
investigations of the Company.
Indivior is assessing this matter, the Federal Trade Commission
and Department of Justice investigations, the private class action
and other litigations to determine the implications to the
provision on the Company's balance sheet for such matters.
As the Company has no further information to disclose regarding
this pending legal matter, no investor call will be scheduled.
IMPORTANT SAFETY INFORMATION
Indication
SUBOXONE(R) (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 physicians
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 doctor can tell you more about the
difference between physical dependence and drug addiction. Do not
stop taking SUBOXONE Film suddenly without talking to your doctor.
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 doctor 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 doctor if you are
pregnant or plan to become pregnant. If you are pregnant or become
pregnant while taking SUBOXONE Film, alert your doctor immediately
and you should report it using the contact information provided
below.*
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 doctor 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 doctor 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 for a complete list.
*To report negative 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(R)
(buprenorphine and naloxone) Sublingual Tablets (CIII), or
SUBUTEX(R) (buprenorphine) Sublingual Tablets (CIII), please see
the respective full Prescribing Information and Medication Guide at
www.suboxoneREMS.com.
About Indivior
Indivior is a global specialty pharmaceutical company with a
20-year legacy of leadership in patient advocacy, health policy and
evidence-based best practice models that have revolutionized modern
addiction treatment. The name is the fusion of the words individual
and endeavor, 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 robust, global opioid dependence
portfolio, Indivior has a strong pipeline of product candidates
designed to both expand on its heritage in this category and
address other chronic diseases of addiction - including alcohol use
disorders and cocaine intoxication. It also is pursuing a novel
product candidate in a related mental health disorder,
schizophrenia. Headquartered in the United States in Richmond, VA,
Indivior employs more than 900 individuals globally and its
portfolio is available in over 40 countries worldwide. Visit
www.Indivior.com to learn more.
Forward-Looking Statements
This press release contains forward-looking statements. We may,
in some cases, use terms such as "predicts," "believes,"
"potential," "proposed," "continue," "estimates," "anticipates,"
"expects," "plans," "intends," "may, " "could," "might," "will,"
"should" or other words that convey uncertainty of future events or
outcomes to identify these forward-looking statements.
Forward-looking statements include statements regarding our
intentions, beliefs, projections, outlook, analyses or current
expectations.
Various factors may cause differences between Indivior's
expectations and actual results, including: factors affecting sales
of Indivior products and any future 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; the Indivior Group's ability to
protect its patents and other intellectual property; the outcome of
patent litigation relating to 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.
Any forward-looking statements that we make in this press
release speak only as of the date of this press release. We assume
no obligation to update our forward-looking statements whether as a
result of new information, future events or otherwise, after the
date of this press release.
Media Inquiries
Email: IndiviorMediaContacts@indivior.com
Phone: +1 804-594-0836
This information is provided by RNS
The company news service from the London Stock Exchange
END
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