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

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

  Data Presented Today at 2013 ATS International Conference Further Supports
                           Long-term Safety Profile

ATS 2013

Business Wire

MARLBOROUGH, Mass. -- May 20, 2013

Sunovion Pharmaceuticals Inc. (Sunovion) today announced results of a
one-year, non-inferiority clinical trial that evaluated BROVANA^®
(arformoterol tartrate) Inhalation Solution versus placebo for the risk of
serious respiratory events (respiratory death or COPD-related hospitalizations
due to exacerbations) in patients with moderate to severe chronic obstructive
pulmonary disease (COPD). The study results, which were presented in three
posters at the American Thoracic Society (ATS) International Conference in
Philadelphia, showed that of 420 patients treated with BROVANA, 40 experienced
at least one serious respiratory event as compared to 63 patients who
experienced at least one serious respiratory event of the 421 receiving
placebo. Among those patients who experienced an event, the mean time to first
event was longer for BROVANA patients (171.7 days) as compared to patients
receiving placebo (155 days).

“These results demonstrate no increased risk of COPD-related exacerbations
leading to hospitalizations and respiratory death in patients taking BROVANA
versus those taking placebo, further supporting the long-term safety profile
of BROVANA,” said Alistair Wheeler, M.D., Vice President, Clinical Development
and Medical Affairs at Sunovion Pharmaceuticals. “These data, along with our
continued commitment to research and development in COPD, affirm Sunovion’s
pledge to helping COPD patients achieve long-term symptom control by providing
bronchodilator treatment via nebulized delivery.”

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 were given BROVANA 15 mcg or
    placebo twice daily for one year, and evaluated for the incidence of
    respiratory-related deaths and COPD exacerbation-related hospitalizations.
    The study participants were to be followed for up to one year after
    randomization to 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 ATS 2013:

  *A Long Term Safety Study Of Arformoterol Tartrate In The Maintenance
    Therapy Of Patients With Moderate To Severe COPD: Incidence Of
    Respiratory-Related Deaths And COPD Exacerbation-Related Hospitalizations
    (Poster Discussion Session B23 – Poster Board # 810; Abstract A2436)

    Under the conditions of this non-inferiority study, the analysis found
    that after one year, patients treated with BROVANA experienced no
    increased risk of COPD-related hospitalization and respiratory death
    compared to placebo, with a hazard ratio of 0.606 (confidence interval
    0.425 to 0.864), indicating a relative reduction in risk. The data also
    showed that, among the COPD patients in the study who experienced a
    serious respiratory event, patients treated with BROVANA experienced a
    longer period until first COPD exacerbation-related hospitalization or
    respiratory death (171.7 days) compared to patients receiving placebo (155
    days).

  *A Long Term Safety Study Of Arformoterol Tartrate In The Maintenance
    Therapy Of Patients With Moderate To Severe COPD: Incidence Of Adverse
    Events (Thematic Poster Session A43 – Poster Board # F66; Abstract A1482)

    This analysis of the large simple safety study evaluated the incidence of
    treatment emergent adverse events (TEAEs) in patients treated with BROVANA
    or placebo.

    The analysis found that after one year of treatment, the incidence of
    TEAEs, treatment emergent serious adverse events (SAEs), treatment related
    adverse events (TRAEs) and adverse events (AEs) resulting in
    discontinuation of study medication were balanced between treatment
    groups. Patients treated with BROVANA had a lower incidence of respiratory
    SAEs compared to placebo (7.6% versus 12.1%, respectively).

  *A Long Term Safety Study Of Arformoterol Tartrate In The Maintenance
    Therapy Of Patients With Moderate To Severe COPD: Evaluation Of Lung
    Function (Thematic Poster Session A43 – Poster Board # F65; Abstract
    A1481)

    This analysis evaluated lung function following one year of treatment with
    BROVANA or placebo in patients with moderate to severe COPD. In this
    study, patients treated with BROVANA maintained lung function (from
    baseline) compared with placebo. Patients treated with BROVANA were found
    to have a greater improvement in both trough FEV[1] (84 ml versus 33 ml
    for placebo) and forced vital capacity (FVC; 121 ml versus 46 ml for
    placebo) from baseline versus placebo.

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,
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)

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
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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