Sunovion to Present Three Posters on Results of One-year Large Simple Safety Study for BROVANA® (arformoterol tartrate)

  Sunovion to Present Three Posters on Results of One-year Large Simple Safety
  Study for BROVANA® (arformoterol tartrate) Inhalation Solution at 2013 ATS
  International Conference

Additional Data Presented by Sunovion Demonstrate Commitment to Nebulized COPD
                                  Treatments

ATS 2013

Business Wire

MARLBOROUGH, Mass. -- May 16, 2013

Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the company will
present six posters at the 2013 American Thoracic Society (ATS) International
Conference, three of which pertain to a recently completed, one-year,
placebo-controlled, large simple safety study (LSSS) for BROVANA^®
(arformoterol tartrate) Inhalation Solution. BROVANA is a twice-daily
nebulized long-acting beta[2] agonist (LABA) that treats bronchoconstriction
in patients with chronic obstructive pulmonary disease (COPD), including
chronic bronchitis and emphysema. The ATS conference is being held in
Philadelphia on May 17-22, 2013.

“We look forward to sharing the LSSS results with the COPD community, as these
data provide insight into the relative frequency of long-term
exacerbation-related hospitalizations and respiratory death in patients using
BROVANA versus those using placebo,” said Antony Loebel, M.D., Executive Vice
President and Chief Medical Officer of Sunovion Pharmaceuticals Inc.“We are
pleased to contribute data at this meeting that grow the body of clinical
research for BROVANA while further supporting nebulized delivery for moderate
and severe COPD patients.”

Sunovion will also be sponsoring two posters reporting retrospective database
analyses of exacerbation risk and re-hospitalization risk in COPD patients
treated with nebulized LABAs [either BROVANA or PERFOROMIST^® (formoterol
fumarate) Inhalation Solution] or nebulized short-acting beta[2] agonists
(SABAs).

Additionally, Sunovion Respiratory Development Inc., a wholly owned subsidiary
of Sunovion Pharmaceuticals Inc., will present a poster regarding
investigational compound SUN-101, a long-acting muscarinic antagonist (LAMA)
bronchodilator in development for the treatment of COPD that will be delivered
via the eFlow^® nebulizer.

“We believe that COPD patients need more options for the management of their
disease,” said Dr. Loebel. “SUN-101 is indicative of our commitment to COPD
research and to our leadership in developing potential treatments that can be
delivered via a nebulizer.”

Further details about the posters presented by Sunovion at ATS 2013 are
available below.

BROVANA Data Presented at ATS:

  *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 – Sunday, May 19, 2013, 8:15 AM-4:30 PM
  *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
    – Sunday, May 19, 2013, 8:15 AM-4:30 PM
  *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 –
    Monday, May 20, 2013, 8:15-10:45AM

[NCT Number: NCT00909779]

Retrospective Database Analyses Presented at ATS:

  *Risk Of Exacerbations In Chronic Obstructive Pulmonary Disease Patients
    Treated With Nebulized LABA Versus Nebulized SABA Treatments – Thematic
    Poster Session C42 – Poster Board # H28 – Abstract A4226 – Tuesday, May
    21, 2013, 8:15 AM-4:30 PM
  *Re-hospitalization Risk In Patients With Chronic Obstructive Pulmonary
    Disease (COPD) Initiating Nebulized Long-acting Vs. Short-acting
    Beta[2]-Agonists – Thematic Poster Session C51 – Poster Board # J100 –
    Abstract A4394 – Tuesday, May 21, 2013, 8:15 AM-4:30 PM

SUN-101 Investigational Data Presented at ATS:

  *Cardiovascular Safety Of Nebulized Glycopyrrolate (SUN-101) Compared With
    Tiotropium, Ipratropium And Placebo In Patients With COPD – Thematic
    Poster Session A43 – Poster Board # F67 – Abstract A1483 – Sunday, May 19,
    2013, 8:15 AM-4:30 PM

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 SUN-101 and Sunovion Respiratory Development Inc.

SUN-101, an inhalation solution of a long-acting muscarinic antagonist (LAMA)
bronchodilator, glycopyrrolate, delivered by a customized eFlow^® Nebulizer
System, is currently in development by Sunovion Respiratory Development Inc.
for the treatment of patients with moderate to severe Chronic Obstructive
Pulmonary Disease (COPD). SUN-101 has not been approved by the U.S. Food and
Drug Administration (FDA) for the treatment of COPD. Studies evaluating the
efficacy and safety of SUN-101 for the treatment of COPD are on-going. Three
Phase II studies have been conducted to evaluate its efficacy and safety in
patients with moderate to severe COPD. Phase III trials are expected to be
initiated in the second half of 2013.

On September 5, 2012, Sunovion Pharmaceuticals Inc. completed an acquisition,
by merger, of Elevation Pharmaceuticals, Inc., which resulted in Elevation,
now known as Sunovion Respiratory Development Inc., becoming a direct
wholly-owned subsidiary of Sunovion Pharmaceuticals Inc. As a result, the
product formerly referred to as EP-101 is presently referred as SUN-101.

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. EFLOW is a registered trademark of PARI GmbH.

  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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