MARLBOROUGH, Mass.--(BUSINESS WIRE)--May 16, 2018--Sunovion Pharmaceuticals Inc. (Sunovion) will present eight posters featuring data from its robust portfolio of treatments for chronic obstructive pulmonary disease (COPD) at the American Thoracic Society International Conference 2018 (ATS 2018), taking place May 18-23, 2018, in San Diego, California. New data analyses include three posters reporting effects of Seebri ® Neohaler ® (glycopyrrolate) Inhalation Powder and Utibron ® Neohaler ® (indacaterol/glycopyrrolate) Inhalation Powder on lung function and patient-reported outcomes.

“Sunovion is committed to research that advances clinical understanding and treatment options for COPD, which affects millions of Americans,” said Thomas H. Goodin, Ph.D., Senior Director of Clinical Development at Sunovion. “We look forward to presenting this data at ATS, reinforcing our focus on providing a portfolio of innovative treatment options to support individual patient needs.”

SEEBRI NEOHALER is a long-acting muscarinic antagonist (LAMA). UTIBRON NEOHALER is a combination long-acting beta 2 agonist (indacaterol) (LABA) and LAMA (glycopyrrolate). Both therapies are approved in the U.S. for the twice-daily, long-term maintenance treatment of airflow obstruction in people with COPD, including chronic bronchitis and/or emphysema.

Sunovion presentations at ATS 2018 include:

SEEBRI NEOHALER:

Poster #8868: Lung Function and Patient-Reported Outcomes Response to Glycopyrrolate (SEEBRI ® NEOHALER ® ) in Chronic Obstructive Pulmonary Disease (COPD) Patients by Reversibility: Pooled Analysis of the GEM1 and GEM2 Studies (Sunday, May 20, 9:15 a.m. – 4:15 p.m. PDT, Area E, Hall A-B2)

UTIBRON NEOHALER:

Poster #8841: Lung Function and Patient-Reported Outcomes Response to Indacaterol/Glycopyrrolate (UTIBRON ® NEOHALER ® ) in Chronic Obstructive Pulmonary Disease (COPD) Patients by Reversibility: Pooled Analysis of the FLIGHT1 and FLIGHT2 Studies (Sunday, May 20, 9:15 a.m. – 4:15 p.m. PDT, Area E, Hall A-B2) Poster #8861: Lung Function and Patient-Reported Outcomes Response to Indacaterol/Glycopyrrolate (UTIBRON ® NEOHALER ® ) in Chronic Obstructive Pulmonary Disease (COPD) Patients by Smoking Status: Pooled Analysis of the FLIGHT1 and FLIGHT2 Studies (Sunday, May 20, 9:15 a.m. – 4:15 p.m. PDT, Area E, Hall A-B2)

Health Economics and Outcomes Research (HEOR) Studies:

Poster #P1328: Inhaler Use Confidence and Treatment Adherence Among Chronic Obstructive Pulmonary Disease Patients Using NEOHALER ®: Analysis of Physician Perceptions From a US Survey (Monday, May 21, 9:15 a.m. – 4:15 p.m. PDT, Area L, Hall A-B2) Poster #P1329: SEEBRI ® NEOHALER ® (glycopyrrolate) Versus Placebo in Patients With Moderate to Severe COPD: Analysis of Health-Related Quality of Life (HRQoL) From the GEM1 Study (Monday, May 21, 9:15 a.m. – 4:15 p.m. PDT, Area L, Hall A-B2) Poster #P1330: SEEBRI ® NEOHALER ® (glycopyrrolate) Versus Placebo in Patients With Moderate to Severe COPD: Analysis of Health-Related Quality of Life (HRQoL) From the GEM2 Study (Monday, May 21, 9:15 a.m. – 4:15 p.m. PDT, Area L, Hall A-B2) Poster #P1340: Incidence of Chronic Obstructive Pulmonary Disease Symptom-Defined Exacerbations: Exploratory Analysis From a Long-Term Open-Label Active-Controlled Safety Trial of Nebulized Glycopyrrolate/eFlow ® CS (Monday, May 21, 9:15 a.m. – 4:15 p.m. PDT, Area L, Hall A-B2) Poster #P1402: Exacerbations, Health Resource Utilization, and Costs Among Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease (COPD) Treated with Nebulized Arformoterol Following A Respiratory Event (Tuesday, May 22, 9:15 a.m. – 4:15 p.m. PDT, Area L, Hall A-B2)

About Seebri® Neohaler®  (glycopyrrolate) Inhalation Powder Seebri ®  Neohaler ®  (glycopyrrolate) Inhalation Powder, 15.6 mcg twice daily, is a long-acting muscarinic antagonist (LAMA) approved in the U.S. for the long-term maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. SEEBRI NEOHALER is delivered by a dry powder inhaler (DPI), and its active ingredient, glycopyrrolate, has an established safety and efficacy profile. In clinical trials, SEEBRI NEOHALER improved lung function and showed reduced use of rescue medication and improvements in health-related quality of life, as measured by the St. George’s Respiratory Questionnaire (SGRQ) total score, which is a composite of patient-reported symptoms, activities and impact on daily living.

The most common adverse reactions (≥1% and more common than placebo) reported in two 12-week clinical trials with SEEBRI NEOHALER (and placebo) were: upper respiratory tract infection, 3.4% (2.3%); nasopharyngitis, 2.1% (1.9%); urinary tract infection, 1.4% (1.3%); sinusitis, 1.4% (0.7%); and oropharyngeal pain, 1.8% (1.2%).

Please see full Prescribing Information for SEEBRI NEOHALER at  http://seebri.sunovion.com.

Important Safety Information for SEEBRI NEOHALER (glycopyrrolate) Inhalation Powder

INDICATION SEEBRI NEOHALER (glycopyrrolate) is a medicine called an anticholinergic. SEEBRI NEOHALER is used long-term, twice each day (morning and evening), for maintenance treatment of COPD, including chronic bronchitis and/or emphysema.

IMPORTANT SAFETY INFORMATION

SEEBRI NEOHALER does not relieve sudden symptoms of COPD and should not be used more than twice daily. Always have a short-acting beta 2 -agonist with you to treat sudden symptoms.

Do not use SEEBRI NEOHALER unless your health care provider has taught you how to use the inhaler and you understand how to use it correctly. Use SEEBRI NEOHALER exactly as your health care provider tells you to use it.

Do not use SEEBRI NEOHALER more often than it is prescribed for you. Do not stop using SEEBRI NEOHALER or other medicines to control or treat your COPD unless told to do so by your health care provider because your symptoms might get worse. Your health care provider will change your medicines as needed.

Get emergency medical care if your breathing problems worsen quickly, you need to use your rescue medication more often than usual, or your rescue medication does not work as well to relieve your symptoms.

Do not use SEEBRI NEOHALER if you are allergic to glycopyrrolate or any of the ingredients in SEEBRI NEOHALER. Ask your health care provider if you are not sure.

Tell your health care provider about all of your health conditions, including if you:

have kidney problems have eye problems such as glaucoma have prostate or bladder problems, or problems passing urine have any other medical conditions are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed are allergic to SEEBRI NEOHALER or any of its ingredients, any other medicines, or food products. SEEBRI NEOHALER contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy

Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. SEEBRI NEOHALER and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your health care provider if you take anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate).

SEEBRI NEOHALER can cause serious side effects, including:

sudden shortness of breath (that may be life-threatening) immediately after use of SEEBRI NEOHALER serious allergic reactions, including: rash; hives; swelling of the tongue, lips, and face; and difficulty breathing or swallowing. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction new or worsened eye problems, including acute narrow-angle glaucoma (symptoms may include eye pain or discomfort, blurred vision, red eyes, nausea or vomiting, seeing halos or bright colors around lights) new or worsened urinary retention (symptoms may include difficulty urinating, urinating frequently, painful urination, urination in a weak stream or drips)

Common side effects of SEEBRI NEOHALER include upper respiratory tract infection, sore throat, and runny nose.

These are not all of the possible side effects with SEEBRI NEOHALER. Tell your health care provider about any side effect that bothers you or that does not go away.

Do not swallow SEEBRI capsules. SEEBRI capsules are for inhalation only with the NEOHALER device. Never place a capsule in the mouthpiece of the NEOHALER device.

SEEBRI capsules should always be stored in the blister strip and only removed immediately before use.

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.

This information is not comprehensive.

How to get more information:

Talk to your health care provider Visit  www.SEEBRI.us  to obtain the FDA-approved product labeling Call 1-888-394-7377

For additional information, please see full  and  for SEEBRI NEOHALER, or visit  .

About Utibron®Neohaler® (indacaterol/glycopyrrolate) Inhalation Powder Utibron ® Neohaler ® (indacaterol/glycopyrrolate) inhalation powder is a combination bronchodilator indicated for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not indicated to treat acute deteriorations of COPD or to treat asthma. UTIBRON NEOHALER combines two medicines in one twice-daily fixed-dose combination: indacaterol 27.5 mcg, a long-acting beta 2 -adrenergic agonist (LABA), and the long-acting muscarinic antagonist (LAMA) glycopyrrolate 15.6 mcg.

Important Safety Information for UTIBRON NEOHALER (indacaterol/glycopyrrolate) Inhalation Powder

INDICATION UTIBRON ®  NEOHALER ®  (indacaterol and glycopyrrolate) is a combination of a long-acting beta 2 -adrenergic agonist, or LABA, medicine (indacaterol) and an anticholinergic medicine (glycopyrrolate). UTIBRON NEOHALER is used long term, twice each day (morning and evening), to treat the symptoms of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

IMPORTANT SAFETY INFORMATION

UTIBRON NEOHALER   has been approved for COPD only and is NOT indicated for the treatment of asthma. People with asthma who take long-acting beta2  -adrenergic agonist (LABA) medicines, such as indacaterol (one of the medicines in UTIBRON NEOHALER), have an increased risk of death from asthma problems. It is not known if LABA medicines, such as indacaterol, increase the risk of death in people with COPD.

UTIBRON NEOHALER does not relieve sudden symptoms of COPD and should not be used more than twice daily. Always have a short-acting beta 2 -agonist with you to treat sudden symptoms.

Do not use UTIBRON NEOHALER unless your health care provider has taught you how to use the inhaler and you understand how to use it correctly. Use UTIBRON NEOHALER exactly as your health care provider tells you to use it.

Do not use UTIBRON NEOHALER more often than it is prescribed for you. Do not stop using UTIBRON NEOHALER or other medicines to control or treat your COPD unless told to do so by your health care provider because your symptoms might get worse. Your health care provider will change your medicines as needed.

Get emergency medical care if your breathing problems worsen quickly, you need to use your rescue medication more often than usual, or your rescue medication does not work as well to relieve your symptoms.

Do not use UTIBRON NEOHALER if you are allergic to indacaterol, glycopyrrolate, or any of the ingredients in UTIBRON NEOHALER. Ask your health care provider if you are not sure.

Tell your health care provider about all of your health conditions, including if you:

have heart problems have high blood pressure have seizures have thyroid problems have diabetes have liver problems have kidney problems have eye problems such as glaucoma have prostate or bladder problems, or problems passing urine have any other medical conditions are pregnant or plan to become pregnant are breastfeeding or plan to breastfeed are allergic to UTIBRON NEOHALER or any of its ingredients, any other medicines, or food products. UTIBRON NEOHALER contains lactose (milk sugar) and a small amount of milk proteins. It is possible that allergic reactions may happen in people who have a severe milk protein allergy

Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. UTIBRON NEOHALER and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your health care provider if you take:

anticholinergics (including umeclidinium, tiotropium, ipratropium, aclidinium, glycopyrrolate) LABA medicines (including formoterol, salmeterol, vilanterol, indacaterol, olodaterol)

UTIBRON NEOHALER can cause serious side effects, including:

sudden shortness of breath (that may be life-threatening) immediately after use of UTIBRON NEOHALER increased blood pressure fast or irregular heartbeat (palpitations) chest pain serious allergic reactions, including rash; hives; swelling of the tongue, lips, and face; and difficulties breathing or swallowing. Call your health care provider or get emergency medical care if you get any symptoms of a serious allergic reaction new or worsened eye problems, including acute narrow-angle glaucoma (symptoms may include eye pain or discomfort, blurred vision, red eyes, nausea or vomiting, seeing halos or bright colors around lights) new or worsened urinary retention (symptoms may include difficulty urinating, urinating frequently, painful urination, urination in a weak stream or drips) changes in laboratory blood levels, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia), which may cause symptoms of muscle spasm, muscle weakness, or abnormal heart rhythm

Common side effects of UTIBRON NEOHALER include sore throat and runny nose, high blood pressure, and back pain.

These are not all of the possible side effects with UTIBRON NEOHALER. Tell your health care provider about any side effect that bothers you or that does not go away.

Do not swallow UTIBRON capsules. UTIBRON capsules are for inhalation only with the NEOHALER device. Never place a capsule in the mouthpiece of the NEOHALER device.

UTIBRON capsules should always be stored in the blister strip and only removed immediately before use.

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.

This information is not comprehensive.

How to get more information:

Talk to your health care provider Visit  www.UTIBRON.com  to obtain the FDA-approved product labeling Call 1-888-394-7377

For additional information, please see full  , including BOXED WARNING and  , for UTIBRON NEOHALER, or visit  .

About Long-Acting Muscarinic Antagonists (LAMAs) A long-acting muscarinic antagonist (LAMA) is a type of long-acting bronchodilator, along with long-acting beta 2 -agonists (LABAs). According to the GOLD 2018 report, these bronchodilators are currently the first-line standard of care maintenance therapy for symptomatic individuals with chronic obstructive pulmonary disease (COPD), and help the muscles around the airways in lungs stay relaxed to prevent symptoms such as wheezing, coughing, chest tightness and shortness of breath. 3,1 LAMAs are widely used and an important therapeutic approach for people with COPD.

About COPD Chronic obstructive pulmonary disease (COPD) is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or lung abnormalities usually caused by significant exposure to toxic particles or gases. The main risk factor for COPD is tobacco smoking, but other environmental exposures may contribute. 3  Approximately 15.7 million adults in the U.S. report that they have been diagnosed with COPD. 2  It is estimated that several million more adults have undiagnosed COPD. 2 COPD is responsible for over 120,000 deaths per year, making it the third leading cause of death in the U.S. 2 COPD develops slowly and the symptoms often worsen over time, potentially limiting the ability to perform routine activities. 3 Symptoms of COPD include 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. 2 The symptoms of COPD can be most severe during the night and early morning. 3  Morning symptoms can be associated with limitation of activities during the day, impaired health status and increased risk of exacerbation. 4 Night-time symptoms disturb sleep, reduce sleep quality and, in the long term, may be associated with development or worsening of cardiovascular diseases, cognition, depression and increased mortality. 5

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 vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion 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.

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 websites:  www.sunovion.com, www.sunovion.eu  and  www.sunovion.ca. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd. Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in Japan operating globally in major pharmaceutical markets, including Japan, the United States, China and the European Union. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry and 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 6,500 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at  www.ds-pharma.com.

SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd. SEEBRI, UTIBRON and NEOHALER are registered trademarks of Novartis AG, used under license. eFlow is a registered trademark of PARI Pharma GmbH.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd. ©   2018 Sunovion Pharmaceuticals Inc. All rights reserved.

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

References

1 National Heart, Lung and Blood Institute. (2013). “What Are the Signs and Symptoms of COPD?” Retrieved from https://www.nhlbi.nih.gov/health/health-topics/topics/copd/signs. 2 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. 3 Partridge MR, Karlsson N, Small IR. Patient insight into the impact of chronic obstructive pulmonary disease in the morning: an internet survey. Curr Med Res Opin. 2009;25:2043–8. 4 Roche N, Small M, Broomfield S, Higgins V, Pollard R. Real world COPD: association of morning symptoms with clinical and patient reported outcomes. COPD. 2013;10:679–86. 5 Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20:183–94.

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CONTACT: Sunovion Pharmaceuticals Inc.

Kristina Coppola, 508-787-4368

Associate Director, Portfolio Communications

kristina.coppola@sunovion.com

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SOURCE: Sunovion Pharmaceuticals Inc.

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PUB: 05/16/2018 08:23 AM/DISC: 05/16/2018 08:23 AM

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