ADDING MULTIMEDIA Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda® (lurasidone HCl) as Monotherapy and

  ADDING MULTIMEDIA 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

Business Wire

MARLBOROUGH, Mass. -- July 1, 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

U.S. Food and Drug Administration Approves Two New Indications for Latuda(R)
(lurasidone HCl) in Bip ...

U.S. Food and Drug Administration Approves Two New Indications for Latuda(R)
(lurasidone HCl) in Bipolar Depression. Please see full Prescribing
Information, including Boxed Warnings at www.Latuda.com (Photo: Business Wire)

“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.”

Two 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 Depressive Symptomatology-Self-Report (QIDS-SR[16]); and Quality of Life,
Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF).

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 ≥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 ≥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.”

“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 Bipolar disorder is the sixth leading cause
of disability worldwideand is among the top 10 leading causes of disability
in the United States.^9,10

About LATUDA

LATUDA is a prescription medicine used to treat:

  *Depressive episodes in bipolar I disorder in adults when used alone or
    with lithium or valproate
  *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.

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
Support^TM, 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.

IMPORTANT SAFETY INFORMATION AND INDICATIONS FOR LATUDA

                                  WARNINGS:

 INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND
                       SUICIDAL THOUGHTS AND BEHAVIORS

  *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.
  *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 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.

Additional Important Warnings

  *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.
  *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.
  *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.
  *Tell your healthcare provider if you experience prolonged, abnormal muscle
    spasms or contractions, which may be a sign of a condition called
    dystonia.
  *LATUDA can affect your judgment, thinking, and motor skills. You should
    not drive or operate hazardous machinery until you know how LATUDA affects
    you.
  *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.
  *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.
  *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 (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

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:

  *Depressive episodes in bipolar I disorder (bipolar depression) in adults
    when used alone or with lithium or valproate
  *Schizophrenia in adults

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

                                     ###

^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).

^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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Contact:

Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Senior Director, Corporate Communications
patricia.moriarty@sunovion.com
 
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