FDA Approves BI’s Striverdi® Respimat® (olodaterol)

For U.S. Media Only

RIDGEFIELD, Conn., August 1, 2014 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Striverdi® Respimat® (olodaterol) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma. STRIVERDI RESPIMAT is a long-acting beta agonist (LABA) delivered via a propellant-free inhaler that generates a soft, slow-moving mist.

“The approval of STRIVERDI RESPIMAT marks another step forward for our diverse respiratory pipeline that includes other compounds being evaluated using the Respimat® inhaler,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Boehringer Ingelheim has been a leading provider of treatments for people living with COPD for more than a decade, and we are continuing to investigate therapies that may provide additional benefits, including a Phase III program evaluating a fixed-dose combination of olodaterol and tiotropium.”

The approval of STRIVERDI RESPIMAT is supported by data from the Phase III olodaterol clinical trial program—including data from 48-week and 6-week duration trials—that demonstrated improvements in lung function provided by the once-daily dosing of olodaterol 5 µg, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo. The olodaterol Phase III clinical trial program involved more than 4,900 people living with COPD. In an effort to more accurately represent the clinical practice setting, patients involved in the 48-week studies were allowed to continue on their usual care with the exception of LABAs. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthines.

“In clinical practice, many COPD patients are likely to be on more than one therapy to treat airflow obstruction,” said Richard Casaburi, MD, PhD, Professor and Associate Chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center.“The Boehringer Ingelheim studies with olodaterol are important from a clinical perspective because they provide confirmation of bronchodilation even when patients are taking other medications.”

About Striverdi® Respimat® (olodaterol) Inhalation Spray

Indication

Striverdi® Respimat® (olodaterol) Inhalation Spray is a long-acting beta₂-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Important Limitations: STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.

IMPORTANT SAFETY INFORMATION ABOUT STRIVERDI RESPIMAT

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 olodaterol, the active ingredient in STRIVERDI RESPIMAT. The safety and efficacy of STRIVERDI RESPIMAT in patients with asthma have not been established. STRIVERDI RESPIMAT is not indicated for the treatment of asthma.

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication.

STRIVERDI RESPIMAT should not be initiated in patients with acutely deteriorating COPD, which may be a life threatening condition, or used as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta₂ agonist.

STRIVERDI RESPIMAT should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing long-acting beta₂ agonists as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs.

STRIVERDI RESPIMAT may produce paradoxical bronchospasm that may be life threatening. If paradoxical bronchospasm occurs, STRIVERDI RESPIMAT should be discontinued immediately and alternative therapy instituted.

STRIVERDI RESPIMAT can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, systolic or diastolic blood pressure, or symptoms, and should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, and hypertension. If cardiovascular symptoms occur, STRIVERDI RESPIMAT may need to be discontinued.

STRIVERDI RESPIMAT should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, in patients with known or suspected prolongation of the QT interval, and in patients who are unusually responsive to sympathomimetic amines.

Immediate hypersensitivity reactions, including angioedema, may occur. If such a reaction occurs, therapy with STRIVERDI RESPIMAT should be stopped at once and alternative treatment should be considered.

The most commonly reported adverse reactions were nasopharyngitis, upper respiratory tract infection, bronchitis, urinary tract infection, cough, dizziness, rash, diarrhea, back pain, and arthralgia.

STRIVERDI RESPIMAT should be used with extreme caution in patients treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated.

STRIVERDI RESPIMAT should be used with caution in patients treated with additional adrenergic drugs, non-potassium-sparing diuretics, and beta-blockers.

STRIVERDI RESPIMAT is for oral inhalation only.

Please see full Prescribing Information, including boxed WARNING, Medication Guide, and Instructions for 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.

About COPD
Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 26 million Americans may have COPD – even those who haven't smoked in years – and nearly half of them remain undiagnosed. COPD is the third leading cause of death in the United States, killing one person every four minutes. Globally, the incidence of COPD is expected to increase in the coming decades.

Common symptoms of COPD include shortness of breath and coughing with or without excess mucus. COPD develops slowly, is progressive and irreversible, and symptoms often worsen over time, limiting people’s ability to perform routine activities.

Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavors.

In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

For more information please visit http://www.us.boehringer-ingelheim.com

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