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Sunovion Highlights Data from Its Psychiatry Portfolio at the 2019 American Psychiatric Association Annual Meeting

BusinessWire

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion
Pharmaceuticals Inc. (Sunovion) today announced that it will present
clinical and health economic outcomes data from its psychiatry portfolio
and pipeline of potential medicines for patients living with
schizophrenia, bipolar depression and binge eating disorder, at the 2019
American Psychiatric Association (APA 2019) Annual Meeting, which will
be held May 18-22, in San Francisco, Calif.

“Sunovion’s presentations at APA this year include further medical
insights into the long-term safety and efficacy of LATUDA for children
and adolescents living with bipolar depression, data on the safety and
efficacy of dasotraline for the treatment of binge eating disorder and
feature exciting data on our novel investigational medicine SEP-363856
in adults with schizophrenia,” said Robert Goldman, Ph.D., Head, Global
Clinical Research & Medical Affairs, at Sunovion. “In addition to this
year’s APA presentations, we expect to see significant advancements
within Sunovion’s psychiatry portfolio this year, and we look forward to
sharing our progress.”

Latuda® (lurasidone HCI) is approved in the U.S. for the
treatment of major depressive episodes associated with bipolar I
disorder (bipolar depression) as monotherapy in adults and pediatric
patients (10 to 17 years of age), bipolar depression in adults as
adjunctive therapy with lithium or valproate and schizophrenia in adults
and adolescents (13 to 17 years of age).

SEP-363856 is a novel agent being investigated for the treatment of
patients with schizophrenia. The Phase 3 program for SEP-363856 is
expected to be initiated in FY2019 (April 1, 2019 – March 31, 2020).
SEP-363856 offers a novel mechanism of action that has the potential to
be the first agent for the treatment of schizophrenia that is not a
dopamine 2 (D2) receptor antagonist.

Sunovion presentations at APA 2019 include:

Schizophrenia

Bipolar Depression

Binge Eating Disorder

About LATUDA (lurasidone)

LATUDA is a prescription medicine used:

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

The effectiveness of LATUDA for longer-term use, that is, for more than
six 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.

Please see Important Safety Information, including Boxed Warnings,
below and full Prescribing Information at www.LATUDA.com.

IMPORTANT SAFETY INFORMATION FOR LATUDA

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

Increased risk of death in elderly people with dementia-related
psychosis. Medicines like LATUDA can raise the risk of death in 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 dementia-related psychosis.

Antidepressant medicines may increase suicidal thoughts or behaviors
in some children, teenagers, and young adults within the first few
months of treatment and when the dose is changed. Depression and other
serious mental illnesses are the most important causes of suicidal
thoughts and actions. Patients on antidepressants and their families or
caregivers should watch for new or worsening depression symptoms,
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 may cause serious side effects, including:

Do not drive, operate heavy machinery, or do other dangerous
activities until you know how LATUDA affects you. LATUDA may make you
drowsy.

Avoid eating grapefruit or drinking grapefruit juice while you
take LATUDA since these can affect the amount of LATUDA in the blood.

Do not take LATUDA if you are allergic to any of the ingredients
in LATUDA or take certain medications called CYP3A4 inhibitors or
inducers. Ask your health care provider if you are not sure if you are
taking any of these medications.

Tell your health care provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins, and
herbal supplements. LATUDA and other medicines may affect each other,
causing possible serious side effects. LATUDA may affect the way other
medicines work, and other medicines 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 medicines during
treatment with LATUDA without talking to your health care provider first.

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

The most common side effects of LATUDA include:

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 negative side effects of 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 condition that can affect
individuals of all ages and is characterized by potentially debilitating
severe mood swings, including periods of depression and mania.1,2
It affects approximately 12.6 million adults in the U.S.3,4
Approximately 50 to 66 percent of adults with bipolar disorder
experience their first symptoms before age 18, and it can be difficult
to diagnose.5,6 Bipolar disorder affects approximately 1.7
percent of the pediatric population in the U.S.7 But, that
number could be even higher as bipolar disorder is often misdiagnosed.8,9
Symptoms of bipolar disorder can be severe and may result in thoughts
about death or suicide during depressive episodes.10

Bipolar disorder is the fourth leading cause of disease burden among
children and adolescents worldwide.11 Bipolar I disorder is
characterized by at least one lifetime manic or mixed episode;
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
activities, significant weight loss, insomnia, fatigue, feelings of
worthlessness, diminished ability to concentrate and recurrent thoughts
of death or suicide attempt.1 When symptomatic, depressive
symptoms affect patients more commonly than manic symptoms.13
Bipolar disorder has been shown to result in significant impairment in
work, family and social function,14,15 and is associated with
increased direct and indirect health care costs.16

About SEP-363856

SEP-363856 is an agent with a novel, non-D2 mechanism of action.
Sunovion discovered SEP-363856 in collaboration with PsychoGenics based
in part on a mechanism-independent approach using the in vivo phenotypic
SmartCube® platform and associated artificial intelligence
algorithms. SEP-363856 was optimized for antipsychotic activity by
Sunovion medicinal chemists based on quantitative structure-activity
relationship analysis, in collaboration with PsychoGenics. SEP-363856 is
jointly owned by Sunovion and PsychoGenics. Sunovion has exclusive
rights to develop and commercialize SEP-363856 globally.

SEP-363856 is being studied in a global development program for
schizophrenia as well as for Parkinson’s disease psychosis, with
additional indications under consideration. Clinical trial results to
date demonstrate a predictable pharmacokinetic (PK) profile suitable for
once daily use.

About Schizophrenia

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

About Dasotraline

Dasotraline, a dual dopamine and norepinephrine re-uptake inhibitor, is
a new chemical entity that does not cause the direct release of dopamine
and norepinephrine from neuronal vesicles. It has an extended half-life
(47-77 hours) that supports stable plasma concentrations over the
24-hour dosing interval with once a day dosing.

Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is being
evaluated for use in treating attention-deficit hyperactivity disorder
(ADHD) and binge eating disorder (BED). It has not been approved by the
U.S. Food and Drug Administration (FDA) for the treatment of ADHD or BED.

About Binge Eating Disorder (BED)

BED is characterized by recurrent episodes of binge eating that occur at
least once per week for three months. An episode of binge eating is
defined as eating an abnormally large amount of food in a discrete
period of time. This is typically accompanied by a sense of lack of
control. Binge eating must be characterized by marked distress and at
least three of the following: eating more rapidly than normal; eating
until feeling uncomfortably full; eating large amounts of food when not
feeling physically hungry; eating alone because of embarrassment and
feeling disgusted, guilty or depressed afterwards.20 The
lifetime prevalence of BED among adult women and men in the U.S. is 3.6
percent and 2.1 percent, respectively.20,21

BED typically begins in young adulthood but can also start later.22 BED
can lead to a number of psychological and physical problems, such as
social isolation, feeling bad about oneself, problems functioning at
work, obesity and related medical conditions (e.g., gastroesophageal
reflux disease, joint problems, heart disease, type 2 diabetes and some
sleep-related breathing disorders).23 It is also associated
with increased healthcare utilization, medical morbidity and mortality.23

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious medical
conditions. Sunovion’s vision is to lead the way to a healthier world.
The company’s spirit of innovation is driven by the conviction that
scientific excellence paired with meaningful advocacy and relevant
education can improve lives. With patients at the center of everything
it does, Sunovion has charted new paths to life-transforming treatments
that reflect ongoing investments in research and development and an
unwavering commitment to support people with psychiatric, neurological
and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect,
wholly-owned 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
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found 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 among the top-ten listed pharmaceutical
companies in Japan, operating globally in major pharmaceutical markets,
including Japan, the U.S., China and the European Union. Sumitomo
Dainippon Pharma aims to create innovative pharmaceutical products in
the Psychiatry & Neurology area, the Oncology area and Regenerative
medicine/Cell therapy field, which have been designated as the focus
therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in
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 through its corporate website at https://www.ds-pharma.com.

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

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

For a copy of this release, visit Sunovion’s web site at www.sunovion.com

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of Clinical Psychiatry. 2005; 66(1):7-12.
2 American
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3 National Institute of Mental
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Accessed April 2017.
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Accessed April 2017.
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Accessed April 2017.
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17 World Health Organization.
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Accessed September 2018.
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DS, Mandercheid RW, Locke B2, Goodwin, FK. The de Facto US Mental and
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Calculated by extrapolating from the 2008 United States Census Bureau
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19 National Institute of Mental
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Accessed September 2018.
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23 Mayo Clinic. Binge-Eating
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Accessed March 2017.

Contacts

Kirsten Fallon
Senior Manager, Portfolio Communications
Sunovion
Pharmaceuticals Inc.
774-369-7116
kirsten.fallon@sunovion.com

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