Sunovion Pharmaceuticals Inc. Announces Data Published in the CHEST Journal from a One-year, Large Simple Safety Study

  Sunovion Pharmaceuticals Inc. Announces Data Published in the CHEST Journal
  from a One-year, Large Simple Safety Study Evaluating BROVANA® (arformoterol
  tartrate) Inhalation Solution

  *The study objective was met demonstrating that chronic obstructive
    pulmonary disease (COPD) patients treated with BROVANA are not at an
    increased risk of respiratory death or COPD exacerbation-related
    hospitalization compared to placebo.
  *BROVANA was well tolerated and improved lung function versus placebo in
    patients with COPD.

Business Wire

MARLBOROUGH, Mass. -- July 8, 2014

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that data from a
one-year, Large Simple Safety Study (LSSS) were published online in the CHEST
Journal (e-publication ahead of print), the official publication of the
American College of Chest Physicians. The objective of the study was to
demonstrate that the risk of respiratory death or chronic obstructive
pulmonary disease (COPD)  exacerbation-related hospitalization for patients
treated with BROVANA^® (arformoterol tartrate) Inhalation Solution was not
greater than 40 percent more than the risk for patients treated with placebo.
The trial objective was met demonstrating that COPD patients treated with
BROVANA are not at an increased risk of respiratory death or COPD
exacerbation-related hospitalizations compared to placebo. The complete study
is available on the journal’s website:
http://journal.publications.chestnet.org/article.aspx?articleid=1884678.

“Approximately 15 million adults living in the country are currently diagnosed
with COPD and many more who have the disease have not yet been diagnosed. In
addition to burdens on the patient, COPD is associated with approximately $50
billion in costs, including those caused by hospitalizations,”^1,2 said James
Donohue, M.D., lead investigator, and Professor of Medicine and the former
Chief of Pulmonary Diseases and Critical Care Medicine at the University of
North Carolina, School of Medicine. “This study supports BROVANA as a safe and
effective treatment option for COPD patients.”

BROVANA is a twice-daily nebulized long-acting beta[2] agonist (LABA) approved
by the U.S. Food and Drug Administration (FDA) for the long-term maintenance
treatment of bronchoconstriction in patients with COPD, including chronic
bronchitis and emphysema.

The primary assessment of the study was time from randomization to respiratory
death or first COPD exacerbation-related hospitalization, whichever occurred
first. Among 841 subjects, 466 completed one year of treatment. Patients who
discontinued treatment for any reason were followed for up to one year after
randomization to assess for primary events. Fewer patients on BROVANA
experienced a primary event (respiratory death or first COPD
exacerbation-related hospitalization) compared to placebo (9.5% vs. 15.0%,
respectively) as well as fewer COPD exacerbation-related hospitalizations
(9.0% vs. 14.3%, respectively). Additionally, the risk for first respiratory
serious adverse event was 50 percent lower with BROVANA than placebo.

The study, which also measured efficacy, showed that BROVANA was associated
with greater improvements in lung function, demonstrating significant
improvements in placebo adjusted trough forced expiratory volume in one second
(FEV[1]) and trough forced vital capacity (FVC) from baseline.

“The data from the Large Simple Safety Study reinforce the long-term safety
and efficacy of BROVANA as a maintenance treatment for COPD and serve to
demonstrate the impact of a long acting bronchodilator administered via
nebulization,” said Alistair Wheeler, M.D., Vice President, Clinical
Development and Medical Affairs at Sunovion. “As part of our commitment to
respiratory care, these findings underscore our dedication to delivering
impactful treatments for patients.”

“Sunovion has a long history in providing therapies for patients suffering
from respiratory disease,” said Richard Russell, Executive Vice President and
Chief Commercial Officer at Sunovion. “This study represents the completion of
our post-marketing commitment to the FDA. More importantly it adds to the
growing body of evidence concerning the safety profile of BROVANA and
reinforces it as an important and relevant option for appropriate patients
with COPD. We are extremely proud of the results from this study.”

About the BROVANA Large Simple Safety Study

This multicenter, double-blind, randomized, placebo-controlled, parallel
group, non-inferiority study enrolled 841 patients at least 40 years old with
COPD and a baseline of ≤65 percent forced expiratory volume in one second
(FEV1), a ≥15-pack-year smoking history and baseline breathlessness severity
grade ≥2. Patients received BROVANA 15 mcg or placebo twice daily for one
year, and were evaluated for the incidence of respiratory-related deaths
and/or COPD exacerbation-related hospitalizations. The study participants were
followed for up to one year after randomization to treatment; 466 subjects
completed one year of treatment. Patients in both groups were also treated
with their previous COPD medications, with the exception of LABAs
[NCT00909779].

About BROVANA^®(arformoterol tartrate) Inhalation Solution

BROVANA^®(arformoterol tartrate) Inhalation Solution is indicated for the
long-term, twice-daily (morning and evening) maintenance treatment of
bronchoconstriction in patients with chronic obstructive pulmonary disease
(COPD), including chronic bronchitis and emphysema. BROVANA is for use by
nebulization only.

Important Safety Information for BROVANA^®


WARNING: ASTHMA-RELATED DEATH

Long-acting beta[2]-adrenergic agonists (LABA) increase the risk of
asthma-related death. Data from a large placebo-controlled US study that
compared the safety of another long-acting beta[2]-adrenergic agonist
(salmeterol) or placebo added to usual asthma therapy showed an increase in
asthma-related deaths in patients receiving salmeterol. This finding with
salmeterol is considered a class effect of LABA, including arformoterol, the
active ingredient in BROVANA (see WARNINGS). The safety and efficacy of
BROVANA in patients with asthma have not been established. All LABA, including
BROVANA, are contraindicated in patients with asthma without use of a
long-term asthma control medication (see CONTRAINDICATIONS).

BROVANA is not indicated for the treatment of acute episodes of bronchospasm,
ie, rescue therapy, and does not replace fast-acting rescue inhalers. BROVANA
should not be initiated in patients with acutely deteriorating COPD, which may
be a life-threatening condition.

BROVANA should not be used in conjunction with other inhaled, long-acting
beta[2]-agonists. BROVANA should not be used with other medications containing
long-acting beta[2]-agonists. Patients who have been taking inhaled
short-acting beta[2]-agonists on a regular basis should be instructed to
discontinue their regular use and to use them only for symptomatic relief for
acute respiratory symptoms.

All LABA, including BROVANA, are contraindicated in patients with asthma
without use of a long-term asthma control medication.

As with other inhaled beta[2]-agonists, BROVANA can produce paradoxical
bronchospasm that may be life-threatening. If paradoxical bronchospasm occurs,
BROVANA should be discontinued immediately and alternative therapy instituted.

BROVANA, like other beta[2]-agonists, can produce a clinically significant
cardiovascular effect in some patients as measured by increases in pulse rate,
blood pressure, and/or symptoms.

BROVANA should be used with caution in patients with cardiovascular disorders,
especially coronary insufficiency, cardiac arrhythmias, and hypertension; in
patients with convulsive disorders or thyrotoxicosis; and in patients who are
unusually responsive to sympathomimetic amines.

BROVANA, as with other beta[2]-agonists, should be administered with extreme
caution to patients being treated with monoamine oxidase inhibitors, tricyclic
antidepressants, or drugs known to prolong the QTc interval because the action
of adrenergic agonists on the cardiovascular system may be potentiated by
these agents.

Overall efficacy of BROVANA was maintained throughout the 12-week trial
duration. Some tolerance to the bronchodilator effect of BROVANA was observed
after 6 weeks of dosing (at the end of the dosing interval), although the
FEV[1]improvement remained statistically significant. This was not
accompanied by other clinical manifestations of tolerance.

The five most common adverse events reported with frequency ≥ 2% in patients
taking BROVANA, and occurring more frequently than in patients taking placebo,
were pain (8% vs 5%), chest pain (7% vs 6%), back pain (6% vs 2%), diarrhea
(6% vs 4%), and sinusitis (5% vs 4%).

For additional information, please see the full Prescribing Information and
Medication Guide for BROVANA (arformoterol tartrate) Inhalation Solution at
SunovionProfile.com/BROVANA.

You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

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.
Sunovion’s drug development program, together with its corporate development
and licensing efforts, has yielded a portfolio of pharmaceutical products
including Aptiom^®(eslicarbazepine acetate), 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 U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd., is headquartered in Marlborough, Mass. More information
about Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan
with a diverse portfolio of pharmaceutical, animal health and food and
specialty products. Sumitomo Dainippon Pharma aims to produce innovative
pharmaceutical products in the Psychiatry & Neurology area and the Oncology
area, 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 7,000 employees worldwide. Additional
information about Sumitomo Dainippon Pharma is available through its corporate
website at www.ds-pharma.com

LATUDA ^ is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.,
Ltd. LUNESTA, XOPENEX, XOPENEX HFA, and BROVANA are registered trademarks of
Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of
Takeda GmbH, used under license.

APTIOM is under license from BIAL.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.^©

2014 Sunovion Pharmaceuticals Inc.

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

^1 http://www.cdc.gov/copd/
^2 http://www.nhlbi.nih.gov/resources/docs/2009_ChartBook.pdf

Contact:

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