Sunovion Pharmaceuticals Inc. Announces Health Outcomes Data On Exacerbation-Related Hospitalizations That Support The Use Of Brovana (Arformoterol Tartrate) Inhalation Solution In People With Moderate-To-Severe COPD At The 2016 American Thoracic Society

SAN FRANCISCO--(BUSINESS WIRE)--

“Sunovion is committed to understanding and sharing critical health outcomes information that may improve current treatment for people with COPD.”

CORRECTING and REPLACING Sunovion Announces Health Outcomes Data on Exacerbation-Related Hospitalizations that Support the Use of Brovana^® (arformoterol tartrate) Inhalation Solution in People with Moderate-to-Severe COPD at the 2016 ATS Conference

Headline of release should read: Brovana^® (arformoterol tartrate) (instead of arfomoterol tartrate).

The corrected release reads:

SUNOVION ANNOUNCES HEALTH OUTCOMES DATA ON EXACERBATION-RELATED HOSPITALIZATIONS THAT SUPPORT THE USE OF BROVANA^® (ARFORMOTEROL TARTRATE) INHALATION SOLUTION IN PEOPLE WITH MODERATE-TO-SEVERE COPD AT THE 2016 ATS CONFERENCE

Sunovion Pharmaceuticals Inc. (Sunovion) today announced the results of a post-hoc analysis of a long-term safety study evaluating Brovana^® (arformoterol tartrate) Inhalation Solution in people with moderate-to-severe chronic obstructive pulmonary disease (COPD) at the 2016 American Thoracic Society International Conference (ATS 2016), taking place May 13-18, 2016 in San Francisco, Calif. Results from this analysis reinforce the use of BROVANA in COPD, as measured by COPD exacerbation-related hospitalizations compared to those treated with placebo.

BROVANA is a twice-daily nebulized long-acting beta₂-agonist (LABA) approved by the U.S. Food and Drug Administration (FDA) for the long-term maintenance treatment of bronchoconstriction in people with COPD, including chronic bronchitis and emphysema.

“Reducing exacerbations is a key goal for health care providers treating people with COPD,” said Krithika Rajagopalan, Vice President, Head of Global Health Economics and Outcomes Research, Sunovion. “Sunovion is committed to understanding and sharing critical health outcomes information that may improve current treatment for people with COPD.”

Chronic Obstructive Pulmonary Disease (COPD)-Related Hospitalizations by Health Status Response Among Patients Receiving Arformoterol Tartrate or Placebo: Post Hoc Analyses from a 52-Week Randomized, Controlled Study (Poster Board #12420)

Data for this post hoc analysis came from a multicenter, randomized, double-blind, 52-week safety trial evaluating BROVANA versus placebo in patients with moderate-to-severe COPD. Data on COPD exacerbation and associated hospitalization events were collected in the study. Post-hoc analyses of these data demonstrated that patients receiving BROVANA exhibited lower annualized COPD exacerbation-related hospitalization rates compared with patients receiving placebo. The BROVANA group also reported a greater reduction in hospitalization risk relative to placebo, and these results were more pronounced in a subset of patients who were responders on the St. George’s Respiratory Questionnaire (SGRQ) (i.e., patients who achieved a minimum 4-point improvement in SGRQ total score at study end). The SGRQ is an index designed to measure and quantify health-related health status in patients with chronic airflow limitation that has been shown to correlate well with established measures of symptom level, disease activity and disability.¹ For the intent-to-treat population, the adjusted annualized hospitalization rate was significantly reduced with BROVANA compared with placebo (relative risk = 0.60 [95% confidence interval (CI) = 0.41, 0.87; P = 0.007]). For those patients who were SGRQ responders, the adjusted relative risk was the lowest at 0.34 (95% CI = 0.12, 0.99; P = 0.048); SGRQ non-responders had an adjusted relative risk of 0.81 (95% CI = 0.39, 1.67; P = 0.573).

About COPD

Chronic obstructive pulmonary disease, also known as COPD, includes chronic bronchitis and emphysema, and is a progressive respiratory disease that causes worsening obstruction to airflow in the lungs over time.² Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD.³ It is estimated that several million more adults have undiagnosed COPD.⁴ COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the U.S.³ COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities.¹ Symptoms of COPD include constant coughing, wheezing, shortness of breath, excess production of mucus in the lungs, the inability to breathe deeply and the feeling of being unable to breathe.³

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

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 LABAs, 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 global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. The Company has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological, and respiratory conditions. Sunovion’s track record of discovery, development and commercialization of important therapies has included Brovana^® (arformoterol tartrate), Latuda^® (lurasidone HCI), and most recently Aptiom^® (eslicarbazepine acetate).

Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional information can be found on the Company’s web sites: www.sunovion.com, www.sunovion.eu and www.sunovion.ca. Connect with Sunovion on Twitter @Sunovion and LinkedIn.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in Japan. 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.
LATUDA is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
APTIOM is used under license from BIAL.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.
© 2016 Sunovion Pharmaceuticals Inc.

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

¹ FDA. Accessed online 17 April 2016 at: http://www.fda.gov/ohrms/dockets/ac/03/briefing/3976B1_01_L-Glaxo-Appendices.pdf
² National Heart, Lung and Blood Institute. What Is COPD? Available at http://www.nhlbi.nih.gov/health/health-topics/topics/copd/. Accessed: March 2, 2016
³ MMWR: Morbidity and Mortality Weekly Report. Employment and Activity Limitations Among Adults with Chronic Obstructive Pulmonary Disease — United States, 2013. March 27, 2015; 64(11). Available at http://www.cdc.gov/mmwr/
⁴ National Heart, Lung, and Blood Institute. “What is COPD?” Available at: http://www.nhlbi.nih.gov/health/educational/copd/what-is-copd/index.htm. Accessed: March 2, 2016