TIDMINDV
RNS Number : 4482R
Indivior PLC
09 December 2016
Indivior PLC Research & Development Day in New York
Slough, UK, 9(th) December 2016 - Indivior PLC is today
presenting its R&D Day in New York at which it is updating
investors on its pipeline of products under development.
Highlights of the day's presentations include the following:
-- Monthly Depot Buprenorphine (RBP-6000) seeking approval for
treatment of Opioid Use Disorder, estimated approval from the FDA
in the U.S. in Q4 2017 under the assumption of a priority
review.
o Phase III efficacy and safety trial: Top Line Results
published August 17(th) , 2016.
o Phase III long-term safety trial: Database lock achieved
October 31(st) , 2016.
o Fast Track Designation granted May 23(rd) , 2016. Pre-NDA
meeting in December 2016.
o Planned NDA submission (pending outcome of pre-NDA meeting) Q2
2017.
o Presentation of Phase III efficacy & safety plus Phase III
HEOR data planned for College on Problems of Drug Dependence (CPDD)
conference in June 2017.
-- Monthly Depot of Risperidone seeking approval for treatment
of schizophrenia (RBP-7000), estimated approval by the FDA in the
U.S. in 2018.
o Phase III efficacy and safety trial: Top line results released
May 5(th) , 2015.
o Phase III long-term safety extension trial: Database lock
achieved October 21(st) , 2016.
o Pre-NDA meeting held August 2016. FDA agreement with proposed
stability testing timelines & NDA submission strategy.
o Planned NDA submission Q4 2017.
-- Investment Priorities for 2017 will focus on organic growth, and in particular on:
o Pre-Commercialisation for RBP-6000.
o Accelerating growth in treatment of opioid use disorder in the
U.S.
o Pre-Commercialisation for RBP-7000.
o Pre-Commercial infrastructure in China following submission of
the NDA for SUBOXONE(R) (buprenorphine and naloxone) Sublingual
Tablet (CIII) in late 2016.
Following the previously announced <$35m additional
investment in 2016 in pre-commercialisation activities primarily
for RBP-6000, most of which is being incurred in SD&A, we
expect to increase our investment in pre-commercialisation in 2017.
The quantum of additional investment for 2017 will be confirmed in
February, but such cost increases will be offset in part by our
previously announced cost optimisation initiative both in respect
of indirect costs and in contained cost inflation on the base
business.
Commenting on the key messages of the day, Shaun Thaxter, CEO,
said: -
"Indivior PLC is focused on empowering patients and striving to
improve their quality of life by pioneering innovative,
high-quality, accessible and cost effective treatments."
"Our performance in 2016 has run well ahead of our plan. As with
last year, this outperformance against our original planning
assumptions allows us to reinvest in the long-term organic growth
drivers of our business."
"Accordingly we are consciously stepping up our investment in
driving long-term growth opportunities for the business. At a time
when there is intensified focus by the U.S. government and
regulators to address the public health epidemic of opioid abuse,
addiction and overdose, it is an appropriate time to accelerate our
investment and dedicate additional resources towards expanding
treatment access. At the same time, we recognize that many patients
and physicians continue to face unmet treatment needs. We believe
that RBP-6000 buprenorphine monthly depot can potentially transform
the treatment of opioid use disorder, if approved, by possibly
reducing patients' treatment administration days. Additionally,
RBP-6000 was designed to offer physicians the potential for
increased certainty of treatment adherence, and developed with the
desire to help mitigate abuse, misuse and diversion of medication.
Early investment in pre-commercialisation educational initiatives
related to need for diagnosis and treatment of Opioid Use Disorder
will help ensure that appropriate patients have access to this
potentially transformational treatment as soon as possible, once
approved. These investments will help drive long-term value for
shareholders and ensure that we are well prepared for a successful
launch and the best possible start in the market considering an
approval is possible as soon as end 2017, assuming an accelerated
review."
The presentations are being webcast. An archive of the
presentations will be available at the Company's website at
www.indivior.com.
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 harbour 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 will or
may 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 2016 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 SUBOXONE(R) (buprenorphine
and naloxone) Sublingual Tablets (CIII), SUBOXONE(R) Film
(buprenorphine and naloxone) Sublingual Film (CIII), SUBUTEX(R)
(buprenorphine) Sublingual Tablets (CIII) 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 the
SUBOXONE Film patent litigation relating to 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.
For Further Information
Investor Tom Corran IR Director, +44 1753 423965
Enquiries Indivior tom.corran@indivior.com
PLC
----------------- ---------------- ----------------- -------------------------
Stephen
Malthouse Tulchan
Jonathan Communications +44 207 353 4200
Sibun Biosector
Media Enquiries Kathy Vincent 2 +1 310 403 8951
----------------- ---------------- ----------------- -------------------------
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. 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 treatments in opioid dependence and address
other chronic diseases of addiction - including alcohol use
disorder, cocaine intoxication and 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. Its name is a fusion of the words individual
and endeavor and its logo radiates the company's patient-centered
holistic focus on expanding access to high-quality treatment
services for addiction worldwide. For additional product
information, please visit www.indivior.com
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 (i.e., 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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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