New COPD Maintenance Treatment Striverdi^® Respimat^® (olodaterol) Inhalation Spray Now Available in U.S. Pharmacies

RIDGEFIELD, Conn., October 8, 2014 – Boehringer Ingelheim today announced that Striverdi^® Respimat^® (olodaterol) Inhalation Spray 5 µg is now available by prescription in pharmacies across the United States. STRIVERDI RESPIMAT is 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 asthma or acute deteriorations of COPD.

Approved by the U.S. Food and Drug Administration (FDA) in July 2014, STRIVERDI RESPIMAT is a long-acting beta agonist (LABA) delivered via the Respimat^® inhaler, which provides a pre-measured amount of medicine in a slow-moving mist that helps patients inhale the medicine. The RESPIMAT inhaler was developed to actively deliver medication in a way that does not depend on how fast air is breathed in from the inhaler.

“For over a half century, Boehringer Ingelheim has been a leader in discovering and developing new therapies for respiratory diseases. We’re proud to build upon our respiratory heritage by bringing STRIVERDI RESPIMAT to market as a new COPD maintenance treatment option,” said Kathleen M. Dowd, senior vice president, Marketing, Boehringer Ingelheim Pharmaceuticals, Inc. “Approximately 15 million Americans have been told by a healthcare provider that they have COPD, and we believe STRIVERDI RESPIMAT will be a welcome option for providers and patients alike.”

The FDA approval of STRIVERDI RESPIMAT was based on data from eight Phase III clinical trials—including data from 48-week and 6-week duration trials—involving 4,450 people living with COPD. 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.

Boehringer Ingelheim will offer a savings card that will allow most eligible patients to get STRIVERDI RESPIMAT at no cost for a limited time, depending on their insurance provider. The savings card is available at www.STRIVERDI.com and can be activated at any pharmacy. For more information about Boehringer Ingelheim’s patient assistance program, BI Cares, please visit BIPatientAssistance.com.

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 LABAs 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.

Be alert to hypokalemia and hyperglycemia.

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 (≥2% incidence and more than placebo) with STRIVERDI RESPIMAT (and placebo) were nasopharyngitis, 11.3% (7.7%); upper respiratory tract infection, 8.2% (7.5%); bronchitis, 4.7% (3.6%); urinary tract infection, 2.5% (1.0%); cough, 4.2% (4.0%); dizziness, 2.3% (2.1%); rash, 2.2% (1.1%); diarrhea, 2.9% (2.5%); back pain, 3.5% (2.7%); and arthralgia 2.1% (0.8%).

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) is a term including chronic bronchitis and/or emphysema. This disease can make breathing harder because less air is able to flow in and out of the lungs. Chronic lower respiratory diseases, which include COPD, are the third leading cause of death in the United States, and approximately 15 million Americans have been told by a healthcare provider that they have COPD.

The most common symptom of COPD is shortness of breath. Coughing, with or without mucus production, is also a common symptom of COPD. These symptoms can be misunderstood as signs of aging. COPD is usually associated with progressive airway damage and loss that cause breathing to get more difficult.

Leading Respiratory Forward
Through research, Boehringer Ingelheim (BI) has developed drug therapies to help patients with lung diseases. 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 help patients with COPD, asthma, lung cancer, and idiopathic pulmonary fibrosis.

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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