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

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
PRINCETON, N.J., – August 30, 2018 – 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. Media Contacts Otsuka In U.S.

Lucy Abreu
Corporate Communications
Otsuka America Pharmaceutical, Inc.
lucy.abreu@otsuka-us.com
+1 609 535 9052
Otsuka Outside U.S.

Jeffrey Gilbert
Leader, Pharmaceutical PR
Otsuka Pharmaceutical, Co., Ltd.
gilbert.jeffrey@otsuka.co.jp
+81 3 6361 7379, +81 80 8728 6039