Sunovion Pharmaceuticals Inc. To Present New Clinical Analysis And Health Outcomes Data Supporting Use Of BROVANA In Patients With Moderate-To-Severe COPD At The 110th American Thoracic Society Annual Meeting

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) announced today that new analyses of clinical and health outcomes data for Brovana^® (arformoterol tartrate) Inhalation Solution will be presented at the 2015 American Thoracic Society Annual Meeting (ATS 2015), taking place from May 15-20 in Denver, Colorado. One of the presentations is a clinical data analysis that was conducted to assess the importance of patients completing study participation in an arformoterol tartrate long-term safety study. Other presentations include data illustrating improved outcomes for patients in the same study as well as an assessment of outcomes in patients with acute exacerbations of COPD.

“COPD device selection and proper usage technique are integral to optimal treatment delivery, and ultimately patient adherence”

“The data to be presented at ATS continue to advance our understanding of the value of BROVANA in managing COPD,” said Alistair Wheeler, Head of Global Clinical Research, Respiratory and Biotherapeutics, Sunovion. “These data further illustrate Sunovion’s commitment to the COPD community in providing safe, effective treatment options and improved outcomes for patients with significant respiratory diseases.”

Health outcomes data analyses accepted for presentation highlight issues concerning use of maintenance medications in hospitalized COPD patients; improvements in health status for patients treated with BROVANA as reported from the clinical COPD questionnaire; and an exploration of patients’ confidence in using COPD treatments and its association with treatment adherence.

“COPD device selection and proper usage technique are integral to optimal treatment delivery, and ultimately patient adherence,” said Krithika Rajagopalan, Vice President, Head of Global Health Economics and Outcomes Research, Sunovion. “Part of this process is appropriate device-related education that instills confidence in patients regarding their usage. We strive to provide health outcomes data that are relevant to the COPD community and explore the relationship between patients’ confidence in using their device as directed and overall treatment adherence.”

Further details about Sunovion’s presentations at ATS 2015 are available below.

BROVANA Clinical Data Presented at ATS:

• A Long-Term Safety Study of Arformoterol Tartrate in the Maintenance Therapy of Patients with Moderate to Severe COPD: Sensitivity Analyses for Potential Impact of Missing Data – Poster Board #P540; Wednesday, May 20, 2015, 9:30AM-3:30PM

BROVANA Health Economics and Outcomes Research (HEOR) Data Presented at ATS:

• Treatment Patterns for Inpatients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease – Poster Board #P620; Monday, May 18, 2015, 9:30AM-4:15PM
• Improvements in Health Status for Individuals With COPD Treated With Nebulized Arformoterol Tartrate: Results from a 52-Week Trial – Poster Board #620; Tuesday, May, 19, 2015, 9:30AM-11:30AM
• Confidence in Correct Inhaler Device Technique and its Association with Overall Treatment Adherence: A Retrospective Database Analysis of Real-World US COPD Patients – Poster Board #217; Wednesday, May 20, 2015, 1:30PM-3:30PM

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 beta2-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 beta2-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, i.e., 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 beta₂-agonists. BROVANA should not be used with other medications containing long-acting beta₂-agonists. Patients who have been taking inhaled short-acting beta₂-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 beta₂-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 beta₂-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 beta₂-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the corrected QT interval (QTc) 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 trough forced expiratory volume in 1 second (FEV₁) 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 to improve the lives of patients and their families.

Sunovion, an indirect, wholly owned 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.

BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.

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

^© 2015 Sunovion Pharmaceuticals Inc.

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