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Stiolto Respimat

Treatment for Chronic Obstructive Pulmonary Disease

Update: Stiolto Respimat (olodaterol and tiotropium) Now FDA Approved

NDA for Tiotropium Plus Olodaterol Accepted for Review by FDA

Boehringer Ingelheim Announces U.S. Filing for the Fixed-Dose Combination Tiotropium Plus Olodaterol

RIDGEFIELD, Conn., August 19, 2014 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat® inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Tiotropium + olodaterol FDC will not be indicated to treat acute deteriorations of COPD or to treat asthma.

Tiotropium + olodaterol FDC is an investigational treatment consisting of the long-acting muscarinic antagonist (LAMA) tiotropium and the long-acting beta agonist (LABA) olodaterol, and is being evaluated for once-daily use via the Respimat® inhaler. The Respimat® inhaler is a propellant-free inhaler that generates a slow-moving mist.

“The FDA’s acceptance of our application for the fixed-dose combination of tiotropium and olodaterol is an important milestone for our company, and it reinforces Boehringer Ingelheim’s steadfast commitment to COPD,” said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

The NDA submission for tiotropium + olodaterol FDC is based on results from three global Phase III trials – the 52-week replicate TONADO® 1&2 studies (NCT01431274/NCT01431287) and the 6-week cross-over VIVACITO® study (NCT01559116). The TONADO® 1&2 studies evaluated the long-term effect of tiotropium + olodaterol FDC on lung function, while VIVACITO® investigated the 24-hour bronchodilator profile of two tiotropium + olodaterol dose combinations. These studies are part of a large Phase III clinical trial program (TOviTO®) for tiotropium + olodaterol FDC, which includes more than 7,000 people living with varying severities of COPD worldwide.

Tiotropium monotherapy, which is marketed as Spiriva® HandiHaler® (tiotropium bromide inhalation powder) in the U.S., is a once-daily LAMA indicated for both the maintenance treatment of bronchospasm (narrowing of the airways) associated with COPD and to reduce COPD exacerbations. Olodaterol monotherapy – marketed as Striverdi® Respimat® (olodaterol) Inhalation Spray – is a once-daily LABA indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

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.

Source: Boehringer Ingelheim Pharmaceuticals, Inc.

Posted: August 2014

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