TIDMINDV
RNS Number : 8167K
Indivior PLC
18 December 2018
Indivior Provides Legal and Trading Update; Confirms Launch of
PERSERIS(TM) and Key Elements of Contingency Plan
Slough, UK, 18 December 2018 - Indivior PLC (the "Company") with
today's announcement and accompanying supplement published on its
website (http://www.indivior.com) is:
-- Providing an update on legal matters relating to the Court of Appeals for the Federal Circuit
(CAFC) vacating the preliminary injunction (PI) against Dr. Reddy's Laboratories (DRL), including
next steps and estimated timelines;
-- Confirming that the Company expects to meet its overall FY 2018 net revenue and net income
guidance, including exceeding FY 2018 SUBLOCADE(TM) net revenue guidance;
-- Providing an update on SUBLOCADE(TM) KPIs;
-- Confirming the launch of PERSERIS(TM); and,
-- Confirming key elements of its contingency plan, should a generic buprenorphine/naloxone sublingual
film product enter the U.S. market
This announcement and the accompanying supplement substitutes
for the Capital Markets Day that was originally scheduled for
December 5th and will now be postponed until after the Company's FY
2018 financial results on February 14th, 2019. A date will be
confirmed later.
CAFC / DRL Update:
On November 20th, the CAFC vacated the preliminary injunction
(PI) granted by the U.S. District Court of New Jersey, which
enjoined DRL from entering the U.S. market. However, the exact
timing for DRL's potential "at-risk" market re-entry in the U.S. is
unknown, as the PI remains in effect until the issuance of a
mandate by the CAFC. The "mandate" is a formal filing by the CAFC
that returns the case to the District Court for actions consistent
with the CAFC's ruling.
On December 11th, the CAFC denied DRL's motion (filed on
November 20th) to issue the mandate immediately or, alternatively,
stay the PI pending issuance of the mandate. Consequently, the PI
will remain in place and DRL will remain enjoined from resuming the
"at-risk" launch in the U.S. market of its generic
buprenorphine/naloxone sublingual film until after the mandate
issues. Indivior will file a petition for a rehearing by the
original panel of judges as well as a rehearing en banc by December
20th. The CAFC must rule on Indivior's petition for the rehearings
before the mandate can be issued.
Even if the CAFC issues the mandate and the PI is vacated, any
DRL generic product sales in the U.S. would be on an "at-risk"
basis, subject to the outcome of the appeal of the non-infringement
judgments related to U.S. Patent Nos. 8,603,514 and 8,017,150 - as
well as ongoing litigation against DRL in the District of New
Jersey asserting recently-granted Orange Book-listed patents (U.S.
Patent Nos. 9,931,305 and 9,687,454).
Indivior has made it clear that it intends to continue its
vigorous assertion and protection of its intellectual property with
respect to SUBOXONE(R) Film and will seek redress and damages from
any "at-risk" launch following success in any of these cases.
Trading Update & Financial Guidance for FY 2018:
Assuming no generic buprenorphine/naloxone sublingual film entry
in the U.S. before the beginning of FY 2019, Indivior confirms that
it expects to meet its FY 2018 financial guidance of net revenue of
$990 to $1,020 million and net income of $230 to $255 million.
Indivior also confirms that SUBLOCADE(TM) net revenues for FY
2018 will exceed the top end of its previous guidance range of $8
to $10 million by approximately $2 million.
The Company expects to give financial guidance for FY 2019 with
its FY 2018 results on February 14th, 2019, when the Company
anticipates having greater clarity on U.S. market conditions.
SUBLOCADE(TM) KPIs Update:
Prescription Journey KPIs have reached or are progressing toward
their target range:
-- As of 11/30/18 formulary access stood at 83% (versus 82% at 9/30/18).
-- As of 10/31/18 (latest available data) the Prescription Journey timeline of 16 to 23 days
was generally in the Company's target range (versus 16 to 22 days at 9/30/18).
-- As of 10/31/18 (latest available data) the Dispense Conversion Rate improved modestly to 37%
(versus 36% at 9/30/18) and continues towards the Company's target of 50%.
HCP trial and adoption KPIs as of November 30th, 2018:
-- HCPs Initiating a Prescription Journey increased to 2,270 (versus 1,870 at 9/30/18).
-- HCPs Administered SUBLOCADE(TM) increased to 1,195 (versus 824 at 9/30/18).
-- HCPs Administered SUBLOCADE(TM) to 5-plus patients increased to 199 (versus 108 at 9/30/18).
Indivior remains confident in its peak net revenue goal for
SUBLOCADE(TM) of $1 billion-plus.
PERSERIS(TM) Update:
Indivior is confirming today that the Company is moving ahead
with the launch of PERSERIS(TM) in the U.S. with a sales force
consisting of approximately 50 representatives. While PERSERIS(TM)
has been available in the U.S. since November 19th, the commercial
launch is scheduled to take place in February 2019. The
PERSERIS(TM) team is currently engaged in creating payor access,
growing prescriber awareness and interest, as well as establishing
its INSUPPORT(TM) patient hub.
Indivior remains confident in its peak net revenue goal for
PERSERIS(TM) of $200 to $300 million.
Contingency Planning:
Indivior has updated its contingency plan to reflect current
market conditions and future outlook. The key event which may
adversely impact consolidated near-term net revenue and cash flow
is the potential launch of generic buprenorphine/naloxone film in
the U.S. market. Until the timing of potential generic film entry
is certain, the full financial impact cannot be assessed.
The objective of the contingency plan is to provide for the
commercial success of SUBLOCADE(TM) and PERSERIS(TM) while ensuring
a minimum cash balance of $250 million to remain in compliance with
the Company's debt covenants. At the end of November 2018, the
Company had a cash balance of approximately $910 million.
The contingency plan is expected to cover the transition period
of net revenue loss due to potential generic erosion of the
Company's SUBOXONE(R) Film franchise until combined net revenue
growth from SUBLOCADE(TM) and PERSERIS(TM) gathers sufficient
momentum to return the Company to profitable growth.
Indivior's actions to meet the Company's objective of
maintaining a $250 million minimum cash balance include:
-- Launching an Authorized Generic of SUBOXONE(R) Film upon entry by a generic buprenorphine/naloxone
film by an ANDA competitor. The launch is expected to capture some share of the generic segment
and generate a small amount of net revenue in the range of tens of $ millions;
-- Optimizing the profitability of the base U.S. and Rest of World businesses; and,
-- Streamlining actions to materially reduce Indivior's cost base to a level appropriate to the
expected level of net revenue in such changed U.S. market conditions, the detail of which
will depend on the exact timing of any generic entry. These savings would be derived primarily
from SG&A and R&D, and would be incremental to the previously-announced targeted annual savings
of $135 to $155 million versus the Company's planned operating and R&D expense base for FY
2018.
Summary:
"As the leading provider of buprenorphine-based
medication-assisted treatment for opioid dependence, Indivior has a
responsibility to sustain our work on behalf of patients suffering
from this condition" said Shaun Thaxter, CEO of Indivior. "With
SUBLOCADE(TM) we believe we have a potentially transformational
treatment for opioid dependence. The setbacks we have experienced
this year will not impede our relentless search for better
treatment outcomes for patients and better options for healthcare
professionals. However, given the potential for a dramatically
altered market, we are prepared to take the difficult but necessary
steps to ensure the viability of the business and, above all else,
our ability to deliver the potential of SUBLOCADE(TM) through a
period of challenge.
"We also remain excited about the potential of PERSERIS(TM) and
currently are looking forward to commercial launch in February
2019. This differentiated treatment for schizophrenia provides us
another attractive growth avenue in a complex disease space that
often is a co-occurring disorder of substance use disorders. We
look forward to sharing more of our go-to-market plans and
performance updates for both SUBLOCADE(TM) and PERSERIS(TM) at our
Capital Markets Day next year."
Details of the December 18(th) call are as follows:
Timing: 13:00 London Time / 8:00 a.m. New York Time
Webcast link: https://edge.media-server.com/m6/p/n2jx9z2b
Confirmation Code: 3538598
Participants, Local - London, United Kingdom: +44 (0) 330 336 9125
Participants, Local - New York, United
States of America: +1 929 477 0324
For Further Information
Investor Enquiries Jason Thompson VP Investor Relations, +1 804 379 1033
Indivior PLC jason.thompson@indivior.com
Media Enquiries Jonathan Sibun Tulchan Communications +44 207 353 4200
US Media Enquiries
+1 804 594 0836
Indiviormediacontacts@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 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 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.
###
About SUBOXONE(R)
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 healthcare
providers qualified under the Drug Addiction Treatment Act.
Important Safety Information
Do not take SUBOXONE(R) Film if you are allergic to
buprenorphine or naloxone as serious negative effects, including
anaphylactic shock, have been reported.
SUBOXONE(R) Film can be abused in a manner similar to other
opioids, legal or illicit.
SUBOXONE(R) 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(R) 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(R) 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(R) Film.
You should not drink alcohol while taking SUBOXONE(R) 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(R) Film is not recommended in patients with severe
hepatic impairment and may not be appropriate for patients with
moderate hepatic impairment. However, SUBOXONE(R) 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(R) Film out of the sight and reach of children.
Accidental or deliberate ingestion of SUBOXONE(R) Film by a child
can cause severe breathing problems and death.
Do not take SUBOXONE(R) Film before the effects of other opioids
(eg, heroin, hydrocodone, methadone, morphine, oxycodone) have
subsided as you may experience withdrawal symptoms.
Injecting the SUBOXONE(R) Film product may cause serious
withdrawal symptoms such as pain, cramps, vomiting, diarrhea,
anxiety, sleep problems, and cravings.
Before taking SUBOXONE(R) 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(R) 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(R) Film, talk to your healthcare provider
if you are breastfeeding or plan to breastfeed your baby. The
active ingredients of SUBOXONE(R) 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(R) 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(R) Film affects
you. Buprenorphine in SUBOXONE(R) Film can cause drowsiness and
slow reaction times during dose-adjustment periods.
Common side effects of SUBOXONE(R) 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(R) Film. Please see full Prescribing
Information www.suboxoneREMS.com for a complete list.
*To report pregnancy or side effects associated with taking
SUBOXONE(R) Film, please call 1-877-782-6966. You are encouraged to
report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch.
For more information about SUBOXONE(R) 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.
SUBLOCADE(TM) (BUPRENORPHINE EXTED-RELEASE) INJECTION FOR
SUBCUTANEOUS USE (CIII)
INDICATION AND HIGHLIGHTED SAFETY INFORMATION
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.
About PERSERIS(TM)
INDICATION
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
See full prescribing information for complete boxed warning.
* Elderly patients with dementia-related psychosis
treated with antipsychotic drugs are at an increased
risk of death.
* PERSERIS is not approved for use in patients with
dementia-related psychosis.
PERSERIS(TM) (risperidone) is indicated for the treatment of
schizophrenia in adults.
CONTRAINDICATIONS
PERSERIS should not be administered to patients with known
hypersensitivity to risperidone, paliperidone, or other components
of PERSERIS.
WARNINGS AND PRECAUTIONS
Cerebrovascular Adverse Reactions, Including Stroke in Elderly
Patients with Dementia-Related Psychosis: Increased risk of
cerebrovascular adverse reactions (e.g., stroke, transient ischemic
attack), including fatalities. PERSERIS is not approved for use in
patients with dementia-related psychosis.
Neuroleptic Malignant Syndrome (NMS): Manage with immediate
discontinuation and close monitoring.
Tardive Dyskinesia: Discontinue treatment if clinically
appropriate.
Metabolic Changes: Monitor for hyperglycemia, dyslipidemia and
weight gain.
Hyperprolactinemia: Prolactin elevations occur and persist
during chronic administration. Long-standing hyperprolactinemia,
when associated with hypogonadism, may lead to decreased bone
density in females and males.
Orthostatic Hypotension: Monitor heart rate and blood pressure
and warn patients with known cardiovascular disease or
cerebrovascular disease, and risk of dehydration or syncope.
Leukopenia, Neutropenia, and Agranulocytosis: Perform complete
blood counts (CBC) in patients with a history of a clinically
significant low white blood cell count (WBC) or history of
leukopenia or neutropenia. Consider discontinuing PERSERIS if a
clinically significant decline in WBC occurs in absence of other
causative factors.
Potential for Cognitive and Motor Impairment: Use caution when
operating machinery.
Seizures: Use caution in patients with a history of seizures or
with conditions that lower the seizure threshold.
ADVERSE REACTIONS
The most common adverse reactions in clinical trials (>= 5%
and greater than twice placebo) were increased weight,
sedation/somnolence and musculoskeletal pain. The most common
injection site reactions (>= 5%) were injection site pain and
erythema (reddening of the skin).
For more information about PERSERIS, the full Prescribing
Information including BOXED WARNING, and Medication Guide visit
www.perseris.com.
This information is provided by RNS, the news service of the
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contact rns@lseg.com or visit www.rns.com.
END
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