`Sunovion Pharmaceuticals Inc.Sunovion Pharmaceuticals Inc.
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`84 Waterford Drive, Marlborough, MA 01752-7010 84 Waterford Drive, Marlborough, MA 01752-7010
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`Tel 508-481-6700 Tel 508-481-6700
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`N e w s R e l e a s e N e w s R e l e a s e
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`Contact:
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`Patricia Moriarty
`Senior Director, Corporate Communications
`Sunovion Pharmaceuticals Inc.
`508-787-4279
`patricia.moriarty@sunovion.com
`
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`Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda® (lurasidone HCl) as
`Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression
`
`First Atypical Antipsychotic Indicated for the Treatment of Major Depressive Episodes Associated with
`Bipolar I Disorder (Bipolar Depression) Both as Monotherapy and as Adjunctive Therapy with Either
`Lithium or Valproate
`Marlborough, Mass., June 28, 2013 – Sunovion Pharmaceuticals Inc. today announced that the U.S.
`Food and Drug Administration (FDA) approved two new indications for the use of Latuda® (lurasidone
`HCl) as 1) monotherapy and 2) adjunctive therapy with either lithium or valproate, both to treat adult
`patients with major depressive episodes associated with bipolar I disorder (bipolar depression).1
`
`“These two approvals represent a significant milestone not only for Sunovion and DSP, but for the
`millions of Americans who are living with bipolar disorder and struggling to manage the symptoms of
`bipolar depression,” said Masayo Tada, Representative Director, President and Chief Executive Officer of
`Dainippon Sumitomo Pharma Co., Ltd. “We look forward to building on the strong foundation started in
`the United States to bring LATUDA to other markets around the world. In addition, we are preparing for
`Phase 3 clinical trials for bipolar I disorder (bipolar depression) in Japan, an important market for us,
`where Phase 3 clinical trials for schizophrenia are already underway. This is part of Sunovion and DSP’s
`ongoing commitment to researching, developing and commercializing new treatments for people with
`mental illness.”
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`(cid:3)T
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`wo positive double-blind, randomized, placebo-controlled, six-week clinical trials supported the two new
`indications for LATUDA for the treatment of adult patients with bipolar depression, both as monotherapy
`(PREVAIL 2) and as adjunctive therapy (added to background treatment with lithium or valproate)
`(PREVAIL 1). In both studies, the pre-specified primary endpoint was reduction in depressive symptoms,
`as measured by change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS)
`total score at Week 6. The key secondary endpoint (i.e., adjusted for multiple comparisons) was change
`from baseline in the Clinical Global Impression-Bipolar Version-Severity of Illness (CGI-BP-S) score at
`Week 6. Other secondary endpoints included changes from baseline at Week 6 in responder rates; rates
`of remission; Hamilton Anxiety Rating Scale (HAM-A); Sheehan Disability Scale (SDS); Quick Inventory of
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`www.sunovion.com
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`Page 1 of 7
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`Exhibit 2142
`Slayback v. Sumitomo
`IPR2020-01053
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`1
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`Depressive Symptomatology-Self-Report (QIDS-SR16); and Quality of Life, Enjoyment and Satisfaction
`Questionnaire-Short Form (Q-LES-Q-SF).
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`Both studies showed that treatment with LATUDA resulted in statistically significant reductions in MADRS
`scores at study endpoint compared to placebo, with significant separation from placebo observed as early
`as Week 2 of treatment. Additionally, across both studies, patients receiving LATUDA demonstrated
`statistically significant improvements vs. placebo at Week 6 on secondary endpoints, including CGI-BP-S,
`responder rates, rates of remission, anxiety symptoms, self-assessment of depression, as well as
`measures of functionality and quality and enjoyment of life.
`
`The most common adverse reactions (incidence (cid:149)5%, in either dose group, and at least twice the rate of
`placebo) in patients receiving LATUDA as monotherapy were akathisia, extrapyramidal symptoms,
`somnolence, nausea, vomiting, diarrhea, and anxiety; discontinuation rates due to any adverse reaction
`were 6.0% for LATUDA and 5.4% for placebo. In adjunctive treatment, the most common adverse
`reactions in patients receiving LATUDA (incidence (cid:149)5% and at least twice the rate of placebo) were
`akathisia and somnolence; discontinuation rates due to any adverse reaction were 5.8% for LATUDA and
`4.8% for placebo. Patients treated with LATUDA also experienced low rates of change in weight, body
`mass index (BMI), lipid parameters and measures of glycemic control.
`
`“Patients with bipolar disorder spend the majority of their symptomatic time in the depressed phase of the
`illness. This phase most commonly results in impaired function, a remarkable decrease in quality of life
`and may lead to increased risk for attempted suicide,” said Joseph Calabrese, M.D., Professor of
`Psychiatry and Director of the Mood Disorders Program at University Hospitals Case Medical Center,
`Case Western Reserve University. “Unfortunately, there are very few treatments specifically approved to
`treat the symptoms of bipolar depression, which represents a very large unmet medical need for patients
`and their families.”
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`“The pharmacological profile of LATUDA, together with preclinical and initial clinical findings, suggested
`the potential for efficacy in depressive episodes associated with bipolar disorder. Historically, it has been
`difficult to show efficacy in clinical trials for the treatment of bipolar depression, but we felt strongly it was
`the right path to take given the high unmet need,” said Antony Loebel, M.D., Executive Vice President
`and Chief Medical Officer of Sunovion Pharmaceuticals Inc. “We are pleased that the two new LATUDA
`indications for monotherapy and adjunctive treatment of bipolar depression are supported by robust
`evidence demonstrating efficacy and safety.”
`
`About Bipolar Depression
`Bipolar disorder, a mental illness characterized by debilitating mood swings, affects approximately 10.4
`million American adults.2,3 Bipolar I disorder is characterized by at least one lifetime manic or mixed
`episode; often individuals have also had one or more major depressive episodes.4 When symptomatic,
`most people with bipolar disorder spend more time being depressed, rather than manic.5 Bipolar
`depression refers to the depressive phase of bipolar disorder.4 Symptoms of a major depressive episode
`associated with bipolar depression include: depressed mood, loss of interest or pleasure in activities,
`significant weight loss, insomnia, fatigue, feelings of worthlessness, diminished ability to concentrate and
`recurrent thoughts of death or suicide attempt.4 Bipolar disorder can also double a person’s risk of early
`death from a range of medical conditions, including obesity, diabetes and cardiovascular disease.6,7,8
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`Bipolar disorder is the sixth leading cause of disability worldwide and is among the top 10 leading causes
`of disability in the United States.9,10
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`About LATUDA
`LATUDA is a prescription medicine used to treat:
`(cid:120) Depressive episodes in bipolar I disorder in adults when used alone or with lithium or valproate
`(cid:120) Schizophrenia in adults
`
`
`The efficacy of LATUDA in the treatment of adult patients with major depressive episodes associated with
`bipolar I disorder (bipolar depression) both as 1) monotherapy and 2) adjunctive therapy with either
`lithium or valproate was established in one 6-week controlled monotherapy study and one 6-week
`controlled adjunctive study. The efficacy of LATUDA in the treatment of adult patients with schizophrenia
`was established in five 6-week controlled studies. The effectiveness of LATUDA for longer-term use, that
`is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who
`elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of
`the drug for the individual patient. The efficacy of LATUDA in the treatment of mania associated with
`bipolar disorder has not been established.
`
`The recommended starting dose for LATUDA as monotherapy or as adjunctive therapy with either lithium
`or valproate for the treatment of adult patients with bipolar depression is 20 mg/day taken with food (at
`least 350 calories) with no initial dose titration required. LATUDA has been shown to be effective for the
`treatment of patients with bipolar depression in a dose range of 20 mg/day to 120 mg/day. The maximum
`recommended dose for the treatment of patients with bipolar depression is 120 mg/day. In the
`monotherapy study, patients taking LATUDA 80 mg/day to 120 mg/day did not experience additional
`efficacy on average, compared to patients taking LATUDA 20 mg/day to 60 mg/day.
`
`The recommended starting dose for LATUDA for the treatment of adult patients with schizophrenia is
`40 mg/day taken with food (at least 350 calories) with no initial dose titration required. LATUDA has been
`shown to be effective for the treatment of patients with schizophrenia in a dose range of 40 mg/day to 160
`mg/day. The maximum recommended dose for the treatment of patients with schizophrenia is 160
`mg/day.
`
`For patients with moderate to severe renal or hepatic impairment, the recommended starting dose is
`20 mg/day. The dose in moderate to severe renal and moderate hepatic impairment patients should not
`exceed 80 mg/day and the dose in severe hepatic impairment patients should not exceed 40 mg/day.
`LATUDA should not be administered with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin,
`ritonavir, voriconazole, mibefradil). If LATUDA is being prescribed and a moderate CYP3A4 inhibitor (e.g.,
`diltiazem, atazanavir, erythromycin, fluconazole, verapamil) is added to the therapy, the LATUDA dose
`should be reduced to half of the original dose level. If a moderate CYP3A4 inhibitor is being prescribed
`and LATUDA is added to therapy, the recommended starting dose of LATUDA is 20 mg/day with a
`maximum recommended dose of 80 mg/day. Grapefruit and grapefruit juice should be avoided in
`patients taking LATUDA. LATUDA should not be administered with a strong CYP3A4 inducer (e.g.,
`rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine.) If LATUDA is used concomitantly with a
`moderate CYP3A4 inducer, it may be necessary to increase the LATUDA dose after chronic treatment (7
`days or more) with the CYP3A4 inducer.
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`Please see Important Safety Information, including Boxed Warnings, below and full Prescribing
`Information at www.LATUDA.com.
`
`About Sunovion Support™
`As part of its ongoing commitment to the mental health community, Sunovion SupportTM, the Sunovion
`Pharmaceuticals Inc. patient assistance program, may help eligible patients receive LATUDA at no
`charge to the patient. More information on this program, including eligibility criteria, may be found at
`www.SunovionSupport.com.
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`IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA
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`WARNINGS:
`
`INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
`PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS
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`(cid:120) Elderly patients with dementia-related psychosis (having lost touch with reality
`due to confusion and memory loss) treated with this type of medicine are at an
`increased risk of death, compared to patients receiving placebo (sugar pill).
`LATUDA is not approved for treating these patients.
`(cid:120) Antidepressants have increased the risk of suicidal thoughts and actions in
`some children, teenagers, and young adults. Patients of all ages starting
`treatment should be watched closely for worsening of depression, suicidal
`thoughts or actions, unusual changes in behavior, agitation, and irritability.
`Patients, families, and caregivers should pay close attention to any changes,
`especially sudden changes in mood, behaviors, thoughts, or feelings. This is
`very important when an antidepressant medicine is started or when the dose is
`changed. Report any change in these symptoms immediately to the doctor.
`LATUDA is not approved for patients under the age of 18 years.
`
`
`Neuroleptic malignant syndrome (NMS): NMS is a rare and potentially fatal side effect reported with
`LATUDA and similar medicines. Call your doctor right away if you have high fever; stiff muscles;
`confusion; changes in pulse, heart rate, or blood pressure; sweating; or muscle pain and weakness.
`LATUDA should be stopped if you have NMS.
`
`Tardive dyskinesia (TD): TD is a serious and sometimes permanent side effect reported with LATUDA
`and similar medicines. Tell your doctor about any movements you cannot control in your face, tongue, or
`other body parts, as they may be signs of TD. TD may not go away, even if you stop taking LATUDA. TD
`may also start after you stop taking LATUDA.
`
`Metabolic Changes
`High blood sugar: High blood sugar and diabetes have been reported with LATUDA and medicines like it.
`If you have diabetes or risk factors for diabetes, your blood sugar should be tested at the beginning of
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`and throughout treatment with LATUDA. Complications of diabetes can be serious and even life
`threatening. Tell your healthcare provider if you have blood sugar problems or signs of diabetes, such as
`being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry.
`
`High cholesterol and triglycerides: Increases in triglycerides and in LDL (bad) cholesterol and decreases
`in HDL (good) cholesterol have been reported with LATUDA.
`
`Weight gain: Some patients may gain weight while taking LATUDA. Your doctor should check your weight
`regularly.
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`Additional Important Warnings
`(cid:120) Other risks may include feeling dizzy or lightheaded upon standing, decreases in white blood
`cells (which can be fatal), or trouble swallowing. Tell your doctor if you experience any of these.
`(cid:120) LATUDA and medicines like it may raise the levels of prolactin. Tell your healthcare provider if
`you experience a lack of menstrual periods, leaking or enlarged breasts, or impotence.
`(cid:120) Tell your healthcare provider if you have a seizure disorder, have had seizures in the past, or
`have conditions that increase your risk for seizures.
`(cid:120) Tell your healthcare provider if you experience prolonged, abnormal muscle spasms or
`contractions, which may be a sign of a condition called dystonia.
`(cid:120) LATUDA can affect your judgment, thinking, and motor skills. You should not drive or operate
`hazardous machinery until you know how LATUDA affects you.
`(cid:120) LATUDA may make you more sensitive to heat. You may have trouble cooling off. Be careful
`when exercising or when doing things likely to cause dehydration or make you warm.
`(cid:120) Tell your healthcare provider about all prescription and over-the-counter medicines you are taking
`or plan to take, since there are some risks for drug interactions with LATUDA. Avoid drinking
`alcohol while taking LATUDA.
`(cid:120) Tell your healthcare provider if you are pregnant or if you are planning to get pregnant. Avoid
`breast feeding while taking LATUDA.
`
`
`The most common side effects for LATUDA in clinical studies:
`in adults with Bipolar Depression include: an inner sense of restlessness or need to move
`(cid:120)
`(akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; and sleepiness
`in adults with Schizophrenia include: sleepiness; an inner sense of restlessness or need to move
`(akathisia); difficulty moving, slow movements, muscle stiffness, or tremor; and nausea
`
`(cid:120)
`
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`This is not a complete summary of safety information. Please discuss the full Prescribing Information for
`prescription LATUDA with your doctor.
`
`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.
`
`INDICATIONS
`LATUDA is used to treat:
`(cid:120) Depressive episodes in bipolar I disorder (bipolar depression) in adults when used alone or with
`lithium or valproate
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`(cid:120) Schizophrenia in adults
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`About Sunovion Pharmaceuticals Inc. (Sunovion)
`Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing
`therapeutic products that advance the science of medicine in the Psychiatry, Neurology and Respiratory
`disease areas and improve the lives of patients and their families. Sunovion's drug development program,
`together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical
`products including LATUDA® (lurasidone HCl) tablets, LUNESTA® (eszopiclone) tablets, XOPENEX®
`(levalbuterol HCI) inhalation solution, XOPENEX HFA® (levalbuterol tartrate) inhalation aerosol,
`BROVANA® (arformoterol tartrate) inhalation solution, OMNARIS® (ciclesonide) nasal spray, ZETONNA®
`(ciclesonide) nasal aerosol and ALVESCO® (ciclesonide) inhalation aerosol.
`
`Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma Co., Ltd., is
`headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals Inc. is available
`at www.sunovion.com.
`
`About Dainippon Sumitomo Pharma Co., Ltd. (DSP)
`Dainippon Sumitomo Pharma Co., Ltd. (DSP) is a multi-billion dollar, top-ten listed pharmaceutical
`company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty
`products. DSP aims to produce innovative pharmaceutical products in the Psychiatry & Neurology field,
`which has been designated as one of the two key therapeutic areas. DSP is based on the merger in
`2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today,
`DSP has more than 7,000 employees worldwide. Additional information about DSP is available through
`its corporate website at www.ds-pharma.com.
`
`LATUDA is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd. LUNESTA, XOPENEX,
`XOPENEX HFA and BROVANA are registered trademarks of Sunovion Pharmaceuticals Inc. OMNARIS
`and ALVESCO are registered trademarks of Nycomed GmbH, used with permission.
`
`Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. © 2013
`Sunovion Pharmaceuticals Inc.
`
`
`For a copy of this release, visit Sunovion’s web site at www.sunovion.com
`
`###
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`1 Latuda® (lurasidone HCl) Tablets Prescribing Information, Sunovion Pharmaceuticals Inc., Marlborough,
`MA.
`2 National Institute of Mental Health. Bipolar Disorder. [Internet]. Available from: http://www.nimh.nih.gov.
`Accessed June 11, 2013 (To Access: Bipolar Disorder, Featured Publications about Bipolar Disorder).
`3 Bipolar Disorder. Decision Resources. Table 2-1: Number of Total Prevalent Cases of Bipolar Disorder
`in the Major Pharmaceutical Markets, by Subtype, 2008-2018. Waltham, MA. December 2009.
`4 American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,
`Text Revision. Washington, DC, American Psychiatric Association, 2000.
`5 The Depression and Bipolar Support Alliance. Mood Disorders and Different Kinds of Depression.
`[Internet]. Available from: http://www.dbsalliance.org. Accessed March 29, 2013 (To Access: Education,
`Brochures, Mood Disorders and Different Kinds of Depression).
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`6 Roshanaei-Moghaddam, B, Katon, W. Premature Mortality from General Medical Illnesses among
`Persons with Bipolar Disorder: A Review. Psychiatric Services. 2009; 60(2):147-156.
`7 Fagiolini A et al. Bipolar Disorder and the Metabolic Syndrome: Causal Factors, Psychiatric Outcomes
`and Economic Burden. CNS Drugs. 2008; 22(8):655-669.
`8 McIntyre R. et al. Bipolar Disorder and Diabetes Mellitus: Epidemiology, Etiology, and Treatment
`Implications. Annals of Clinical Psychiatry. 2005; (17) 2:83-93.
`9 National Alliance on Mental Illness. The Impact and Cost of Mental Illness: The Case of Bipolar
`Disorder. [Internet]. Available from: http://www.nami.org. Accessed March 29, 2013 (To Access:
`Communities, Living With, Bipolar Disorder).
`10 National Alliance on Mental Illness. A Primer on Depressive, Bipolar and Anxiety Illnesses: Facts for
`Policymakers. [Internet]. Available from: http://www.nami.org. Accessed March 29, 2013 (To Access:
`Inform Yourself, About Public Policy, Policy Research Institute, Policymakers Toolkit).
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