TIDMINDV
RNS Number : 5180A
Indivior PLC
12 September 2018
INDIVIOR UNABLE TO PARTICIPATE IN MORGAN STANLEY
HEALTHCARE CONFERENCE DUE TO ADVERSE WEATHER
Slough, UK and Richmond, VA, September 12, 2018 - Indivior PLC
(LON: INDV) today announced that due to adverse weather expected
from Hurricane Florence, the recently declared state of emergency
in Virginia and its likely impact on East Coast travel, the Company
is unable to participate in Morgan Stanley's 16(th) Annual Global
Healthcare Conference.
Shaun Thaxter, CEO, was scheduled to address conference
attendees on Thursday, September 13(th) at 11:10 a.m. Indivior has
published a SUBLOCADE(TM) (buprenorphine extended-release)
Injection Update on its website at www.indivior.com under "Webcasts
/ Audiocasts / Presentations."
Shaun Thaxter, CEO of Indivior, Comment:
"Experience and satisfaction with SUBLOCADE continues to be
positive based on anecdotal reports from both patients and
physicians. While early challenges remain, the metrics we have
today published demonstrate that we are continuing to make steady
progress in reducing the time taken for the prescription journey,
improved payor coverage, as well as demonstrating increased trial
and adoption by healthcare professionals. We believe HCP adoption
will increase progressively as we sustain the progress we are
making to alleviate frustration with the medical benefits approval
process and improve the timing of the prescription journey for the
patient. We continue to expect full year 2018 net revenues to be in
the range of $25 million to $50 million, with sales heavily
weighted to the fourth quarter, and we remain confident in
achieving our annual peak net revenue goal of $1 billion-plus."
Teva Cassipsa(R)
Indivior also announced that Teva has agreed that market entry
of its recently FDA approved buprenorphine and naloxone (16mg/4mg)
sublingual film will be tied to the outcome of the U.S. Court of
Appeals for the Federal Circuit (CAFC) decision on the preliminary
injunction that was granted by the U.S. District Court for the
District of New Jersey against Dr. Reddy's Laboratories (DRL). This
agreement will prevent Teva from selling, offering to sell, or
import its generic buprenorphine/naloxone sublingual film product
until the earlier of a CAFC decision lifting the preliminary
injunction against DRL, and the outcome of filed litigation against
DRL related to U.S. patent Nos. 9,931,305, 9,855,221, and
9,687,454.
The CAFC has granted DRL an expedited appeal on the preliminary
injunction. Arguments are scheduled to be heard on October 4(th) ,
with a decision expected in early November.
Indivior Investor Day
Indivior is confirming that it will hold an Investor Day on
Wednesday, December 5(th) , 2018 in New York City. Presentations
will be given by Chief Executive Officer Shaun Thaxter and members
of the Indivior management team. The event will begin at
approximately 9:00 a.m. Eastern Time. A live video / audio webcast
of the event, as well as the presentation slides, will be available
to the public on the day of the event on the Company's website at
www.indivior.com. Additional event details to follow.
The Indivior team will be available to speak with investors
one-on-one on September 13(th) and 14(th) . Please contact Jason
Thompson, Investor Relations, at 804-379-1033 to arrange a
time.
For Further Information
Investor Enquiries Jason Thompson VP Investor Relations, +1 804 379 1033
Indivior PLC jason.thompson@indivior.com
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.
About SUBLOCADE(TM)
INDICATION
SUBLOCADE is indicated for the treatment of moderate to severe
opioid use disorder in patients who have initiated treatment with a
transmucosal buprenorphine-containing product, followed by dose
adjustment for a minimum of 7 days.
SUBLOCADE should be used as part of a complete treatment plan
that includes counseling and psychosocial support.
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS
ADMINISTRATION; SUBLOCADE RISK EVALUATION AND MITIGATION
STRATEGY
-- Serious harm or death could result if administered intravenously. SUBLOCADE
forms a solid mass upon contact with body fluids and may cause
occlusion,
local tissue damage, and thrombo-embolic events, including life
threatening
pulmonary emboli, if administered intravenously.
-- Because of the risk of serious harm or death that could result from intravenous
self-administration, SUBLOCADE is only available through a
restricted program called
the SUBLOCADE REMS Program. Healthcare settings and pharmacies
that order and
dispense SUBLOCADE must be certified in this program and comply
with the REMS
requirements.
HIGHLIGHTED SAFETY INFORMATION
Prescription use of this product is limited under the Drug
Addiction Treatment Act.
CONTRAINDICATIONS
SUBLOCADE should not be administered to patients who have been
shown to be hypersensitive to buprenorphine or any component of the
ATRIGEL(R) delivery system
WARNINGS AND PRECAUTIONS
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine,
a Schedule III controlled substance that can be abused in a manner
similar to other opioids. Monitor patients for conditions
indicative of diversion or progression of opioid dependence and
addictive behaviors.
Respiratory Depression: Life threatening respiratory depression
and death have occurred in association with buprenorphine. Warn
patients of the potential danger of self-administration of
benzodiazepines or other CNS depressants while under treatment with
SUBLOCADE.
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal
syndrome is an expected and treatable outcome of prolonged use of
opioids during pregnancy.
Adrenal Insufficiency: If diagnosed, treat with physiologic
replacement of corticosteroids, and wean patient off of the
opioid.
Risk of Opioid Withdrawal With Abrupt Discontinuation: If
treatment with SUBLOCADE is discontinued, monitor patients for
several months for withdrawal and treat appropriately.
Risk of Hepatitis, Hepatic Events: Monitor liver function tests
prior to and during treatment.
Risk of Withdrawal in Patients Dependent on Full Agonist
Opioids: Verify that patient is clinically stable on transmucosal
buprenorphine before injecting SUBLOCADE.
Treatment of Emergent Acute Pain: Treat pain with a non-opioid
analgesic whenever possible. If opioid therapy is required, monitor
patients closely because higher doses may be required for analgesic
effect.
ADVERSE REACTIONS
Adverse reactions commonly associated with SUBLOCADE (in >=5%
of subjects) were constipation, headache, nausea, injection site
pruritus, vomiting, increased hepatic enzymes, fatigue, and
injection site pain.
For more information about SUBLOCADE, the full Prescribing
Information including BOXED WARNING, and Medication Guide visit
www.sublocade.com.
###
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END
MSCFMGMLKZDGRZG
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