Market Overview

Otsuka Announces First Collaboration Agreement to Bring the ABILIFY MYCITE® System to the US Market

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The ABILIFY MYCITE System, the first drug-device combination product
to be approved by FDA to track drug ingestion, will be integrated into
Magellan Health's mental health provider network

Otsuka America Pharmaceutical, Inc. (Otsuka) announced today that it has
signed a Collaboration Agreement to facilitate access to the
ABILIFY MYCITE® System to select regional provider
networks contracted through Magellan Health. The Collaboration Agreement
creates the opportunity for physicians and adult patients to gather
experience in a real-world setting with the ABILIFY MYCITE System.

The ABILIFY MYCITE System provides an opportunity for a connected care
approach to treatment, and tracks if ABILIFY MYCITE (aripiprazole tablet
with sensor) has been taken. The system is comprised of: the
ABILIFY MYCITE tablet (an aripiprazole tablet embedded with an
Ingestible Event Marker (IEM) sensor); the MYCITE® Patch (a
wearable sensor); the MYCITE® APP (a smartphone application)
and the MYCITE® Dashboard (a web-based portal for healthcare
providers and caregivers). Please see About the ABILIFY MYCITE System
and IMPORTANT SAFETY INFORMATION for ABILIFY MYCITE below.

"We are confident that being able to track drug ingestion in patients
with serious mental illness will provide compelling insights for
patients and their healthcare provider teams. We are eager for patients,
doctors and the healthcare community to experience the ABILIFY MYCITE
System in a real-world setting," said Kabir Nath, president and CEO,
Otsuka North America Pharmaceutical Business, Otsuka America, Inc. "This
Collaboration Agreement is an important milestone in our initial rollout
of the ABILIFY MYCITE System to market. We look forward to collaborating
with additional payer groups to continue learning as we move toward a
data-driven treatment approach."

The initial rollout of the ABILIFY MYCITE System is purposeful and
patients in select regional provider networks contracted through
Magellan Health will receive the opportunity to opt in to this program.
By focusing on fewer individuals using the ABILIFY MYCITE System at
first, Otsuka and Magellan Health will be better able to understand how
it fits within the daily lives of those with serious mental illness and
their caregivers, how doctors will integrate it into their daily
practice and how patients may benefit from more information about their
care. As a result, Otsuka will be able to consider ways to improve the
ABILIFY MYCITE System to enhance the experience and better serve
prospective patients, their caregivers, and physicians in the future.

"Our collaboration with Otsuka is a natural progression for Magellan
Health in providing next-generation precision medicine that can empower
individuals with serious mental illness," said Sam K. Srivastava, chief
executive officer of Magellan Healthcare. "The opportunity for new
insights to drive personalized care for the individual will also allow
us to enhance our digital tools and care management model that we offer
for our members. This collaboration aligns with our purpose of leading
humanity to healthy, vibrant lives through a joint commitment to
improving patient outcomes for complex populations."

Otsuka and Magellan Health look forward to bringing the ABILIFY MYCITE
System to patients. More details will be shared in the coming months as
the ABILIFY MYCITE System is integrated into certain healthcare
environments.

"This strategically aligned collaboration between Otsuka and Magellan
Health has the aim of providing real-world evidence to demonstrate the
value of this drug/device combination product over time," said David B.
Nash, MD, MBA, Dean of the Jefferson College of Population Health at
Thomas Jefferson University and chair of the Digital Medicine National
Steering Board. "This is an exciting time, from a Population Health
perspective, as we gather insights into factors that influence adherence
to treatment and consider the related clinical and economic
implications."

About the ABILIFY MYCITE®
System

In November 2017, ABILIFY MYCITE® (aripiprazole tablets
with sensor) was approved by the Food and Drug Administration (FDA) for
adults in the United States as the first drug-device combination product
intended to track the ingestion of medicine. The ABILIFY MYCITE System
is composed of the following components:

  • An aripiprazole tablet embedded with an Ingestible Event Marker (IEM)
    sensor. This IEM sensor is the size of a grain of sand (1 mm) and is
    made up of ingredients found in food. The IEM sensor activates when in
    contact with stomach fluid and communicates to a wearable sensor,
    called the MYCITE Patch. The IEM sensor is then eliminated from the
    body.
  • The MYCITE Patch detects and records the date and time of the
    ingestion of the tablet, as well as certain physiological data such as
    activity level, and communicates this and the tablet ingestion data to
    the MYCITE APP on a compatible mobile device.
  • The MYCITE APP allows patients to review their objective medication
    ingestion and daily activity level, as well as enter their mood and
    rest if they wish to do so. They can also invite others to view their
    data.
  • Web-based dashboards are provided to healthcare providers, and
    caregivers. These dashboards give the healthcare provider the ability
    to display the individual's drug ingestion patterns over time. With
    patient consent, patient-selected caregivers can also access this
    information, as well as the individual's daily activity level and
    self-reported mood and rest.

The ABILIFY MYCITE System is intended to track if ABILIFY MYCITE has
been taken. It can take 30 minutes to 2 hours to detect ingestion of the
tablet. Sometimes the system might not detect that the medication has
been taken. If the MYCITE APP does not indicate that the ABILIFY MYCITE
tablet was taken, do not repeat the dose. Only functions related
to tracking drug ingestion have been evaluated or approved by FDA.

The impact of the ABILIFY MYCITE System on treatment adherence has not
been demonstrated. Some factors, such as connectivity, transmitter
malfunction, or device availability, may impact the consistency and
reliability of data detection, collection and transmission.

Please visit www.ABILIFYMYCITE.com
for more information.

INDICATIONS and IMPORTANT SAFETY INFORMATION for ABILIFY MYCITE® (aripiprazole tablets
with sensor)

INDICATIONS

ABILIFY MYCITE, a drug-device combination product comprised of
aripiprazole tablets embedded with an Ingestible Event Marker (IEM)
sensor intended to track drug ingestion, is indicated in adults for the:

  • Treatment of schizophrenia
  • Treatment of bipolar I disorder as monotherapy and as adjunct to
    lithium or valproate for:
    • Acute treatment of manic and mixed episodes
    • Maintenance treatment
  • Adjunctive treatment of major depressive disorder

Limitations of Use: ABILIFY MYCITE has not been shown to improve
patient compliance or for use in modifying aripiprazole dosage. It
should not be used in "real-time" or during an emergency, because
detection may be delayed or not occur.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death (1.6 to 1.7 times)
compared to placebo-treated patients. ABILIFY MYCITE is not approved for
the treatment of patients with dementia-related psychosis.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior
in children, adolescents, and young adults. Those on antidepressant
therapy should be monitored closely for worsening, and for emergence of
suicidal thoughts and behaviors. Advise families and caregivers of the
need for close observation and communication with the prescriber. The
safety and effectiveness of ABILIFY MYCITE have not been established in
pediatric patients.

Contraindication: Known hypersensitivity reaction to
aripiprazole. Reactions have ranged from pruritus/urticaria to
anaphylaxis.

Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients
with Dementia-Related Psychosis:
Increased incidence of
cerebrovascular adverse events (e.g., stroke, transient ischemic
attack), including fatalities, have been reported in clinical trials of
elderly patients with dementia-related psychosis treated with
aripiprazole.

Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal
symptom complex reported in association with administration of
antipsychotic drugs, including ABILIFY MYCITE. Clinical signs of NMS are
hyperpyrexia, muscle rigidity, altered mental status, and evidence of
autonomic instability. Additional signs may include elevated creatine
phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Manage NMS with immediate discontinuation of ABILIFY MYCITE, intensive
symptomatic treatment, and monitoring.

Tardive Dyskinesia (TD): Risk of TD, and the potential to become
irreversible, are believed to increase with duration of treatment and in
total cumulative dose of antipsychotic drugs. TD can develop after a
relatively brief treatment period, even at low doses, or after
discontinuation. If antipsychotic treatment is withdrawn, TD may remit,
partially or completely. Prescribing should be consistent with the need
to minimize TD.

Metabolic Changes: Atypical antipsychotic drugs have caused
metabolic changes including:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases
    extreme and associated with ketoacidosis, hyperosmolar coma, or death,
    has been reported in patients treated with atypical antipsychotics
    including aripiprazole. Patients with diabetes mellitus should be
    regularly monitored for worsening of glucose control; those with risk
    factors for diabetes (e.g., obesity, family history of diabetes),
    should undergo baseline and periodic fasting blood glucose testing.
    Any patient treated with atypical antipsychotics should be monitored
    for symptoms of hyperglycemia including polydipsia, polyuria,
    polyphagia, and weakness. Patients who develop symptoms of
    hyperglycemia should also undergo fasting blood glucose testing. In
    some cases, hyperglycemia has resolved when the atypical antipsychotic
    was discontinued; however, some patients required continuation of
    anti-diabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been
    observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical
    antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Intense
urges, particularly for gambling, and the inability to control
these urges have been reported while taking aripiprazole. Other
compulsive urges have been reported less frequently. Prescribers should
ask patients or their caregivers about the development of new or intense
compulsive urges. Consider dose reduction or stopping ABILIFY MYCITE if
such urges develop.

Orthostatic Hypotension: ABILIFY MYCITE may cause orthostatic
hypotension and should be used with caution in patients with known
cardiovascular disease, cerebrovascular disease, or conditions which
would predispose them to hypotension.

Falls: Antipsychotics may cause somnolence, postural hypotension,
motor and sensory instability, which may lead to falls causing fractures
or other injuries. For patients with diseases, conditions, or
medications that could exacerbate these effects, complete fall risk
assessments when initiating treatment and recurrently during therapy.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia,
neutropenia and agranulocytosis have been reported with antipsychotics.
Monitor complete blood count in patients with pre-existing low white
blood cell count (WBC)/absolute neutrophil count or history of
drug-induced leukopenia/neutropenia. Discontinue ABILIFY MYCITE at the
first sign of a clinically significant decline in WBC and in severely
neutropenic patients.

Seizures: ABILIFY MYCITE should be used with caution in patients
with a history of seizures or with conditions that lower the seizure
threshold.

Potential for Cognitive and Motor Impairment: ABILIFY MYCITE may
impair judgment, thinking, or motor skills. Instruct patients to avoid
operating hazardous machinery, including automobiles, until they are
certain ABILIFY MYCITE does not affect them adversely.

Body Temperature Regulation: Use ABILIFY MYCITE with caution in
patients who may experience conditions that increase body temperature
(e.g., strenuous exercise, extreme heat, dehydration, or concomitant use
with anticholinergics).

Dysphagia: Esophageal dysmotility and aspiration have been
associated with ABILIFY MYCITE. Use caution in patients at risk for
aspiration pneumonia.

Dosage Adjustments and Cytochrome P450 Considerations: For
patients with schizophrenia and bipolar I disorder taking ABILIFY MYCITE
who are:

  • Known CYP2D6 poor metabolizers, administer half the recommended dose
  • Known CYP2D6 poor metabolizers taking concomitant strong CYP3A4
    inhibitors (e.g., itraconazole, clarithromycin), administer a quarter
    the recommended dose.
  • Taking strong CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) or
    CYP3A4 inhibitors, administer half the recommended dose.
  • Taking strong CYP2D6 and CYP3A4 inhibitors, administer a quarter the
    recommended dose. When co-administered drug is withdrawn, adjust
    ABILIFY MYCITE dosage to its original level.
  • Taking strong CYP3A4 inducers (e.g., carbamazepine, rifampin), double
    recommended dose over 1 to 2 weeks. When co-administered drug is
    withdrawn, reduce ABILIFY MYCITE dosage to original level over 1 to 2
    weeks.

Commonly Observed Adverse Reactions (incidence ≥5% and at least
twice that for placebo) in adult patients:

  • Schizophrenia: akathisia
  • Bipolar mania (monotherapy): akathisia, sedation, restlessness,
    tremor, and extrapyramidal disorder
  • Bipolar mania (adjunctive therapy with lithium or valproate):
    akathisia, insomnia, and extrapyramidal disorder
  • Major depressive disorder (adjunctive treatment to antidepressant
    therapy): akathisia, restlessness, insomnia, constipation, fatigue,
    and blurred vision

Dystonia: Symptoms of dystonia may occur in susceptible
individuals during the first days of treatment and at low doses.

Skin Irritation for MYCITE Patch: Symptoms of skin
irritation localized at the site of the MYCITE Patch may occur. In
clinical studies, 12.4% of patients (n=61) experienced skin rashes at
the site of patch placement.

Pregnancy: Neonates exposed to antipsychotic drugs, including
ABILIFY MYCITE, during the third trimester of pregnancy are at risk for
extrapyramidal and/or withdrawal symptoms. Consider the benefits and
risks of ABILIFY MYCITE and possible risks to the fetus when prescribing
ABILIFY MYCITE to a pregnant woman. Advise pregnant women of potential
fetal risk. There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to ABILIFY MYCITE during pregnancy.
For more information contact the National Pregnancy Registry for
Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.

Lactation: Aripiprazole is present in human breast milk; however,
there are insufficient data to assess the amount in human milk, effects
on the breastfed infant, or effects on milk production. The development
and health benefits of breastfeeding should be considered along with the
mother's clinical need for ABILIFY MYCITE and any potential adverse
effects on the infant or from the underlying maternal condition.

To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America
Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FULL
PRESCRIBING INFORMATION
, including BOXED WARNING.

About Otsuka Pharmaceutical Co., Ltd.

Otsuka Pharmaceutical is a global healthcare company with the corporate
philosophy: "Otsuka-people creating new products for better health
worldwide." Otsuka researches, develops, manufactures and markets
innovative products, with a focus on pharmaceutical products for the
treatment of diseases and nutraceutical products for the maintenance of
everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental
health and has research programs on several under-addressed diseases
including tuberculosis, a significant global public health issue. These
commitments illustrate how Otsuka is a "big venture" company at heart,
applying a youthful spirit of creativity in everything it does.

Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd.
headquartered in Tokyo, Japan. The Otsuka group of companies employed
45,000 people worldwide and had consolidated sales of approximately USD
11 billion (€ 9.9 billion) in 2016.

All Otsuka stories start by taking the road less travelled. Learn more
about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en.
Learn more about Otsuka in the U.S. at www.otsuka-us.com
and connect with us on Twitter at @OtsukaUS.

About Magellan Health

Magellan
Health, Inc.
, a Fortune
500 company
, is a leader in managing the fastest growing, most
complex areas of health, including special populations, complete
pharmacy benefits and other specialty areas of healthcare. Magellan
Health supports innovative ways of accessing better health through
technology, while remaining focused on the critical personal
relationships that are necessary to achieve a healthy, vibrant life.
Magellan Health's customers include health plans and other managed care
organizations, employers, labor unions, various military and
governmental agencies and third-party administrators. For more
information, visit MagellanHealth.com.

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