Sunovion presents data from its psychiatric portfolio at the annual meeting of the American Psychiatric Association in 2019

MARLBOROUGH, Mbad .– (BUSINESS WIRE) –Sunovion
Pharmaceuticals Inc. (Sunovion) ​​announced today that it would introduce
data on the clinical and economic results of his psychiatric portfolio
and pipeline of potential drugs for patients living with
schizophrenia, bipolar depression and binge eating, at 2019
Annual Meeting of the American Psychiatric Association (APA 2019), to be held
will be held May 18-22 in San Francisco, California.

"Sunovion's presentations at APA this year include new medical studies
an overview of the safety and long-term effectiveness of LATUDA in children
and adolescents living with bipolar depression, safety data and
the efficacy of dasotraline in the treatment of binge eating disorder and
to present exciting data on our new experimental drug SEP-363856
in adults with schizophrenia, "said Robert Goldman, Ph.D., director, Global
Clinical research and medical affairs, in Sunovion. "Furthermore
this year's APA presentations, we anticipate significant progress
of Sunovion's psychiatry portfolio this year, and we look forward to
share our progress. "

LATUDA^® (lurasidone HCI) is approved in the United States for
treatment of major depressive episodes badociated with bipolar I
disorder (bipolar depression) as monotherapy in adults and children
patients aged 10 to 17 years, bipolar depression in adults
adjuvant therapy with lithium or valproate and schizophrenia in adults
and adolescents (aged 13 to 17).

SEP-363856 is a new study agent for the treatment of
patients with schizophrenia. The Phase 3 program for SEP-363856 is
should be launched during fiscal year 201 (April 1, 2019 to March 31, 2020).
SEP-363856 offers a new mechanism of action likely to
to be the first agent for the treatment of schizophrenia that is not a
dopamine 2 receptor antagonist (D2).

Sunovion's presentations at APA 2019 include:

Schizophrenia

• Poster No. P7-066: Effectiveness and safety of SEP-363856 in the
  Treatment of schizophrenia: a four-week randomized study
  Placebo-controlled trial of a new compound with a non-D2 mechanism
  Action (Tuesday, May 21, 10 am to 12 pm Pacific Time)

Bipolar Depression

• Post No. P8-087: Efficacy and safety of lurasidone in children
  and adolescents with bipolar depression: Results over a two-year period,
  Open Extension Study (Tuesday, May 21, 2:00 pm to 4:00 pm Pacific Time)

Binge eating disorder

• Poster No. P7-090: Efficacy and safety of dasotralin in adults
  with binge-eating: A fixed dose randomized, double-blind
  Trail (Tuesday, May 21, 10 am to noon Pacific Time)
• Post No. P7-079: Effect of Dasotraline on body weight in
  Patients suffering from binge eating (Tuesday, May 21, 10 am –
  12:00 PM PT)
• Poster No. P7-080: Dasotraline for the treatment of adults with frenzy
  Dietary disorder: effect on obsessions and compulsions related to frenzy
  Measured by YBOCS-BE (Tuesday, May 21 from 10am to 12pm Pacific Time)
• Poster No. P7-089: Characteristics of the patient badociated with a frenzy
  Food Disorder (BED): A Study of the Administrative Claims Database
  (Tuesday May 21, 10:00 am – 12:00 pm Pacific Time)

About LATUDA (lurasidone)

LATUDA is a prescription medicine:

• Treat adults and adolescents (aged 13 to 17) with
  schizophrenia

• Alone for treating adults, children and adolescents (10 to 17 years old)
  with depressive episodes related to bipolar I disorder (bipolar disorder
  depression)

• With the drug lithium or valproate to treat adults with depression
  episodes that occur with bipolar I disorder (bipolar depression)

LATUDA is available in five tablet concentrations: 20 mg, 40 mg, 60 mg, 80 mg
and 120 mg.

The effectiveness of LATUDA for long-term use, that is to say more than
six weeks, has not been established by controlled studies. So,
the doctor who chooses to use LATUDA for an extended period of time should
periodically rebadess the long-term usefulness of the drug for the
individual patient. The effectiveness of LATUDA in the treatment of mania
badociated with bipolar disorder has not been established.

Please review important safety information, including Warnings in box,
below and the complete prescription information on www.LATUDA.com.

IMPORTANT SAFETY INFORMATION FOR LATUDA

INCREASED MORTALITY IN DEPENDENT PATIENTS RELATED TO DEMENTIA
PSYCHOSIS; and suicidal thoughts and behaviors

Increased risk of death in seniors with dementia
psychosis. Drugs like LATUDA may increase the risk of death in the elderly
people who have lost touch with reality (psychosis) due to confusion and
memory loss (dementia). LATUDA is not approved for the treatment of
people with psychosis related to dementia.

Antidepressants May Increase Suicidal Thoughts or Behaviors
in some children, adolescents and young adults during the first months
month of treatment and when the dose is changed. Depression and others
Serious mental illnesses are the leading causes of suicide
thoughts and actions. Patients on antidepressants and their families or
caregivers should watch for the onset of depressive symptoms or worsening them,
especially sudden changes in mood, behavior, thoughts or feelings.
This is very important when an antidepressant is started or
when the dose is changed. Report any changes in these symptoms
immediately to the doctor.

LATUDA can cause serious side effects, including:

• Stroke (cerebrovascular problems) in elderly people with
  dementia-related psychosis that can lead to death
• Neuroleptic Malignant Syndrome (NMS) is a serious illness that
  can lead to death. Call your health care provider or go to
  emergency room of the nearest hospital immediately if you have any or all of
  the following signs and symptoms of NMS: high fever, increased
  sweating, stiff muscles, confusion or changes in your breathing,
  heart rate and blood pressure
• Uncontrolled body movements (tardive dyskinesia). LATUDA can
  cause movements that you can not control in the face, tongue or other
  parts of the body. Tardive dyskinesia may not go away even if you stop
  take LATUDA. Tardive dyskinesia may also begin after stopping treatment.
  LATUDA
• Problems with your metabolism such as:
  • High blood sugar (hyperglycemia) and diabetes: Increase of
    Blood glucose can occur in some people taking LATUDA. Extremely
    Hyperglycemia can lead to coma or death. If you have diabetes
    or risk factors for diabetes (such as being overweight or a family problem)
    history of diabetes), your health care provider should check your
    blood glucose level before starting and during treatment with LATUDA
  • Call your health care provider if you have any of these
    symptoms of hyperglycemia (hyperglycemia) when taking LATUDA:
    very thirsty, need to urinate more than usual, very feeling
    hungry, feeling weak or tired, feeling belly, feeling
    confused, or your breath smells fruity
• Increased levels of fat (cholesterol and triglycerides) in the blood
• Weight gain. You and your health care provider should check
  your weight regularly during treatment with LATUDA
• Increased levels of prolactin in your blood (hyperprolactinemia).
  Your health care provider may do blood tests to check your prolactin.
  during treatment with LATUDA. Tell your health care provider if
  you have one of the following signs and symptoms of hyperprolactinemia:
  • The females: absence of your menstrual cycle or secretion of
    bad milk when you are not badfeeding
  • males: problems with getting or keeping an erection
    (erectile dysfunction) or bad enlargement (gynecomastia)
• Low white blood cells Your health care provider can do
  blood tests during the first months of treatment with LATUDA
• Decreased blood pressure (orthostatic hypotension). You can
  feel dizzy or faint when you get up too quickly from a session or
  supine
• Falls. LATUDA may make you sleepy or dizzy, may cause
  lowering your blood pressure when changing position (orthostatic)
  hypotension), and may slow down your thinking and motor skills, which may
  cause falls that can lead to fractures or other injuries
• convulsions
• Problems controlling your body temperature so that you feel too much
  hot. Do not become too hot or dehydrated during treatment with
  LATUDA. Do not do too much exercise. In warm weather, stay indoors in a
  cool place if possible. Stay out of the sun. Do not wear too much
  clothes or heavy clothing. Drink plenty of water
• Mania or hypomania (manic episodes) in people with a history of
  bipolar disorder. Symptoms may include: considerable increase in energy,
  severe sleep problems, racing thoughts, reckless behavior,
  unusually big ideas, excessive happiness or irritability, or talking
  more or faster than usual
• Difficulty swallowing

Do not driving, using heavy machinery or doing any other dangerous work
activities until you know how LATUDA affects you. LATUDA can do you
sleepy.

To avoid eat grapefruit or drink grapefruit juice while you
take LATUDA as these can affect the amount of LATUDA in the blood.

Do not take LATUDA if you are allergic to any of the ingredients
under LATUDA or take certain medications called CYP3A4 inhibitors or
inducers. Ask your health care provider if you are unsure whether
take one of these medications.

Inform your health care provider of any medications you are taking.,
including prescription and over-the-counter medications, vitamins and
herbal supplements. LATUDA and other drugs can affect each other
causing possible serious side effects. LATUDA can affect how others
medications work and other medications may affect how LATUDA works. Your
health care provider can tell you if it is safe to take LATUDA with your
other medicines. Do not start or stop any other medication while
treatment with LATUDA without talking to your health care provider first.

Before taking LATUDA, inform your health care provider of all
your medical conditions, including if you:

• have or have had heart problems or a stroke

• have or have had low or high blood pressure

• have or have had diabetes or hyperglycemia, or have a family
  history of diabetes or hyperglycemia

• have or have had high levels of total cholesterol or triglycerides

• have or have had high levels of prolactin

• have or have had low white blood cells

• have or have had seizures

• have or have had kidney or liver problems

• are pregnant or planning to become pregnant We do not know if LATUDA
  will hurt your unborn baby. Talk to your health care provider about
  the risks for your unborn baby if you take LATUDA during pregnancy

  • Tell your health care provider if you become pregnant or think
    are pregnant while taking LATUDA

  • If you become pregnant while taking LATUDA, talk to your doctor
    health care provider on registration to the national pregnancy
    Register of atypical antipsychotics. You can register by calling
    1-866-961-2388 or go to http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/

• badfeed or plan to badfeed. We do not know if LATUDA
  pbad into your bad milk. Talk to your health care provider about
  the best way to feed your baby during LATUDA treatment

The most common side effects of LATUDA are:

• Adults with schizophrenia: drowsiness or drowsiness; agitation or
  feel compelled to move (akathisie); difficulty moving,
  slow movements, or muscular stiffness; and nausea

• Adolescents (13-17 years old) with schizophrenia: drowsiness or
  drowsiness; nausea; restlessness or feeling that you need to move
  around (aacathisia); difficulty moving, slow movements, muscle
  stiffness or trembling; nasal discharge / nasal inflammation; and vomiting

• Adults with bipolar depression: agitation or feeling you need
  to move (akathisie); difficulty moving or slow movements; and
  drowsiness or drowsiness

• Children (10-17 years) with bipolar depression: nausea; weight
  Gain; and sleep problems (insomnia)

These are not all the possible side effects of LATUDA. For more
information, ask your health care provider or pharmacist.

You are encouraged to report the negative side effects of the prescription
drugs to the FDA. Visit www.fda.gov/medwatch

or call 1-800-FDA-1088.

About bipolar disorder

Bipolar disorder is a chronic mental health problem that can affect
individuals of all ages and is characterized by a debilitating potential
severe mood swings, including periods of depression and mania.^1.2
It affects approximately 12.6 million adults in the United States.^3.4
About 50 to 66% of adults with bipolar disorder
experience their first symptoms before the age of 18, and it can be difficult
diagnose.^5.6 Bipolar disorder affects about 1.7
percentage of the pediatric population in the United States⁷ But this
number could be even higher as bipolar disorder is often misdiagnosed.^8.9
The symptoms of bipolar disorder can be serious and can lead to thoughts
on death or suicide during depressive episodes.^ten

Bipolar disorder is the fourth leading cause of morbidity among
children and adolescents around the world.¹¹ Bipolar I disorder is
characterized by at least one manic or mixed episode for life;
individuals often have one or more depressive episodes.¹²
Bipolar depression refers to the depressive phase of bipolar disorder.
its symptoms include: depressed mood, loss of interest or pleasure in
significant weight loss, insomnia, fatigue, feeling of
lack of value, reduced ability to concentrate and recurring thoughts
attempted death or suicide.¹ When symptomatic, depressive
the symptoms affect the patients more often than the manic symptoms.¹³
Bipolar disorder has been shown to cause significant impairment of
work, family and social function,^14,15 and is badociated with
increased direct and indirect costs of health care.¹⁶

About SEP-363856

SEP-363856 is an agent with a new non-D2 action mechanism.
Sunovion discovered SEP-363856 in collaboration with PsychoGenics
partly on an independent approach of the mechanism using phenotypic in vivo
SmartCube^® platform and badociated artificial intelligence
algorithms. SEP-363856 has been optimized for antipsychotic activity by
Sunovion chemists based on a quantitative activity structure
relationship badysis, in collaboration with PsychoGenics. SEP-363856 is
jointly owned by Sunovion and PsychoGenics. Sunovion has exclusivity
development and commercialization rights of SEP-363856 worldwide.

SEP-363856 is under study as part of a global development program for
schizophrenia as well as for Parkinson's psychosis, with
additional indications under consideration. Results of clinical trials at
have a predictable pharmacokinetic (PK) profile appropriate to
use once a day.

About schizophrenia

Schizophrenia is a chronic brain, severe and often very disabling.
disorder affecting more than 23 million people worldwide¹⁷
and about one in every 100 adults (about 2.4 million people) in the
United States.¹⁸ It is characterized by positive symptoms,
hallucinations, delusions and disorganized thinking, as well as
negative symptoms, such as lack of emotion, social withdrawal, lack of
spontaneity and cognitive impairment including memory problems,
attention and ability to plan, organize and make decisions.¹⁹

About Dasotraline

Dasotraline, an inhibitor of dopamine and norepinephrine reuptake, is
a new chemical entity that does not cause the direct release of dopamine
and norepinephrine from neuronal vesicles. He has an extended half-life
(47-77 hours) that supports stable plasma concentrations during the
24 hour administration interval with one administration per day.

Dasotraline has been discovered by Sunovion Pharmaceuticals Inc. and is in the process of being
evaluated for use in the treatment of Attention Deficit Hyperactivity Disorder
(ADHD) and Binge Bulimia (BED). It has not been approved by the
US Food and Drug Administration (FDA) for the treatment of ADHD or BED.

About the binge eating disorder

BED is characterized by recurrent episodes of binge eating that occur at
less once a week for three months. An episode of binge eating is
defined as eating an abnormally high amount of food in a discrete
period of time. This is usually accompanied by a feeling of lack of
control. Binge eating must be characterized by marked distress and
at least three of the following: eat faster than normal; while eating
until you feel uncomfortably full; eat large amounts of food when not
to be physically hungry to eat alone because of the embarrbadment and
feel disgusted, guilty or depressed afterwards.²⁰ the
The lifetime prevalence of BED among adult women and men in the United States is 3.6
percent and 2.1 percent, respectively.^20.21

The LIT usually begins at the beginning of adulthood, but can also begin later.²² BED
can lead to a number of psychological and physical problems, such as
social isolation, feeling bad about yourself, having problems with functioning
obesity and badociated medical conditions (eg, gastroesophageal
reflux, joint problems, heart disease, type 2 diabetes and some
breathing disorders related to sleep).²³ He is also badociated
with the increased use of health care, medical morbidity and mortality.²³

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a global biopharmaceutical company focused on innovation
application of science and medicine to help people with serious illnesses
conditions. Sunovion's vision is to pave the way for a healthier world.
The company's spirit of innovation is based on the belief that
scientific excellence badociated with meaningful and relevant advocacy
Education can improve lives. With patients at the center of everything
Sunovion traced new paths to life-transforming treatments
reflecting the ongoing investments in research and development and a
unwavering commitment to helping people with psychiatric, neurological disorders
and respiratory conditions.

Headquartered in Marlborough, Mbad., Sunovion is an indirect,
100% Subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are
Direct Subsidiaries Wholly Owned by Sunovion Pharmaceuticals Inc.
Additional information is available on the company's websites: www.sunovion.com,
www.sunovion.eu
and www.sunovion.ca.
Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is one of the ten largest pharmaceutical companies
Japanese companies operating worldwide in major pharmaceutical markets,
including Japan, the United States, China and the European Union. Sumitomo
Dainippon Pharma's goal is to create innovative pharmaceutical products in
Psychiatry and Neurology, Oncology and Regenerative Care
field of medicine / cell therapy, which has been designated as the focus
therapeutic areas. Sumitomo Dainippon Pharma is based on the merger into
2005 between Dainippon Pharmaceutical Co., Ltd. and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has about
6,200 employees worldwide. Additional information about Sumitomo
Dainippon Pharma is available on its website at https://www.ds-pharma.com.

LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. is a US subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
^© 2019 Sunovion Pharmaceuticals Inc.
All rights reserved.

To obtain a copy of this press release, visit the Sunovion website at www.sunovion.com.

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