Sunovion Presents Data at CHEST 2013 from a One-year, Large Simple Safety Study of BROVANA® (arformoterol tartrate) Inhalation

  Sunovion Presents Data at CHEST 2013 from a One-year, Large Simple Safety
  Study of BROVANA® (arformoterol tartrate) Inhalation Solution

Results Suggest No Increased Risk of Serious Respiratory Events Regardless of
                  Age, Smoking Status, COPD Disease Severity

Chest Physicians Conference 2013

Business Wire

MARLBOROUGH, Mass. -- October 29, 2013

Sunovion Pharmaceuticals Inc. (Sunovion) today announced results from a
one-year, non-inferiority clinical trial, which showed that patients with
moderate to severe chronic obstructive pulmonary disease (COPD) treated with
BROVANA^® (arformoterol tartrate) Inhalation Solution experienced no increased
risk of serious respiratory events, including respiratory death or COPD
exacerbation-related hospitalizations, irrespective of smoking status, age or
disease severity. Additional analyses showed that BROVANA showed no increased
risk or incidence of COPD exacerbations compared to placebo and improved
health related quality of life (HRQoL) compared to placebo. Patients were
allowed to continue treatment with their previous COPD medications, with the
exception of long-acting beta[2] agonists. Data will be presented at the 2013
American College of Chest Physicians Conference (CHEST 2013) in Chicago.

These data are analyses of a Large Simple Safety Study, which evaluated
BROVANA ^ versus placebo for the risk of serious respiratory events
(respiratory death or COPD-related hospitalizations due to exacerbations) in
patients with moderate to severe COPD. The primary endpoint of the study, time
to serious respiratory events, presented earlier this year found that among
patients who experienced an event, the mean time to first event was longer for
BROVANA (171.7 days) as compared to patients receiving placebo (155 days) [HR:
90% repeated CI = 0.606 (RCI: 0.425, 0.864)].

“These data show no increased risk of respiratory death or COPD-related
exacerbations in patients taking BROVANA versus placebo,” said Alistair
Wheeler, M.D., Vice President, Clinical Development and Medical Affairs at
Sunovion Pharmaceuticals. “These data are further testament to our commitment
to help improve the lives of people suffering from serious respiratory disease
by providing them with effective treatment options.”

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.

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
(FEV[1]), 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 COPD exacerbation-related hospitalizations. The study participants
were followed for up to one year after randomization to treatment; 466
subjects completed 1 year of treatment. Patients in both groups were also
treated with their previous COPD medications, with the exception of
long-acting beta[2] agonists [NCT00909779].

Large Simple Safety Study Poster Presentations by Sunovion at CHEST 2013:

  *A Large Simple Safety Study of Nebulized Arformoterol Tartrate: Risk of
    Respiratory-related Deaths and COPD Exacerbation-related Hospitalizations
    by Smoking Status, Age, and Disease Severity (Poster Session 10702 COPD
    Safety of Treatment Posters – Poster # 2473)

Under the conditions of this non-inferiority study, the analysis of 841
patients found that after one year, 9.5 percent of patients treated with
BROVANA had at least one primary event (respiratory death or first COPD
exacerbation-related hospitalization) versus 15 percent of placebo-treated
patients. Secondary analysis of treatment based on baseline smoking status,
age and FEV[1], indicative of COPD disease severity, showed BROVANA ^ did not
increase the risk of respiratory death or COPD exacerbation-related
hospitalizations compared with placebo across all baseline covariates,
including those patients at greatest risk for a primary event, such as current
smokers (n=432; hazard ratio: 0.809) and those over age 75 (n=114; hazard
ratio: 0.269), determined by hazard ratio. Additional baseline covariates
analyzed include:

  *Former smokers (n=409; hazard ratio: 0.445)

  *Patients younger than 65 years old (n=426; hazard ratio: 0.707)
  *Patients 65 to 75 years old (n=301; hazard ratio: 0.786)
  *COPD disease severity: less than 30 percent predicted FEV[1] (n=233;
    hazard ratio: 0.565)
  *30 percent to less than 50 percent predicted FEV[1] (n=388; hazard ratio:
    0.648) and
  *50 percent or greater predicted FEV[1] (n=219; hazard ratio: 0.618)

  *A Large Simple Safety Study of Nebulized Arformoterol Tartrate: Incidence
    and Risk of Protocol-Defined COPD Exacerbations (Poster Session 10701 COPD
    Treatment Posters – Poster # 2490)

This analysis showed that after one year, BROVANA showed no increased risk or
incidence of protocol-defined COPD exacerbations. Among patients treated with
BROVANA, 16.9 percent had one primary event versus 17.1 percent of patients in
the placebo group; 6.9 percent of patients treated with BROVANA versus 8.1
percent in the placebo group had two events; and 5.2 percent of patients
treated with BROVANA versus 6.2 percent of patients in the placebo group had
three or more events.

  *Improved Health Related Quality of Life Outcomes in Subjects with Moderate
    to Severe COPD Treated with Nebulized Arformoterol Tartrate: Results from
    a 52-Week Trial (Poster Session 10701 COPD Treatment Posters – Poster #
    2496)

This analysis of 754 patients found that treatment with BROVANA improved
health related quality of life (HRQoL) versus placebo, as measured by the St.
George’s Respiratory Questionnaire (SGRQ), a validated 50-item
self-administered instrument at randomization, and at months 3, 6 and 12. The
SGRQ yields a total score and subscale scores for symptoms, activities, and
impacts. SGRQ scores range from 0 – 100, with higher scores indicating worse
health status. Patients treated with BROVANA had greater improvements versus
placebo on total score (LS means -4.24 vs. -2.02; p = 0.006), symptoms domain
(p=0.015), and impacts domain (p = 0.001), but not the activity domain (p =
0.052) across the post-baseline trial visits.

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 more information, please see the full
Prescribing Information and Medication Guide for BROVANA.

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

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 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,
(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)

DSP is a 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 areaand the Oncology area, which have been designated as the focus
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
Takeda GmbH, used under license.

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

Contact:

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