New Spiriva® Respimat® inhaler completes European approval process for COPD

Boehringer IngelheimBoehringer Ingelheim and Pfizer today announced successful completion of the approval process for authorisation to market Spiriva® Respimat® in the European Union for people with chronic obstructive pulmonary disease (COPD). This positive opinion for the Spiriva® Respimat® is the cornerstone of all national approvals in 25 countries of the European Union. Spiriva® Respimat® is a propellant-free, new generation inhaler that combines innovative technology with the proven efficacy of Spiriva® (tiotropium).

"Spiriva® Respimat® represents a major step forward in COPD and inhalation therapy. Many patients find certain inhaler devices difficult to coordinate and use," said Professor Marc Decramer, Respiratory Division, University Hospitals, Katholieke Universiteit Leuven, Belgium "Spiriva® Respimat® has a unique and sophisticated delivery system, and a user friendly design, making it easy to use and suitable for a broad range of patients with COPD. In addition the long-lasting, soft mist cloud generated by Spiriva® Respimat® ensures optimised delivery of Spiriva® to the lungs, helping patients breathe more easily," he added.

In clinical studies comparing inhaler devices, patients preferred Respimat® Soft Mist™ Inhaler, which may help increase patient compliance with therapy. The novel dose-delivery system of the Spiriva® Respimat® also means that unlike dry powder inhalers, the dose delivered is not dependent on patients' inspiratory flow.

Spiriva® (tiotropium), a first-line maintenance therapy for COPD, positively impacts the clinical course of the disease, helping to change the way patients live with their condition. The efficacy of Spiriva® has been demonstrated by an extensive clinical development programme, which has treated over 25,000 patients.1 It is the most prescribed brand in COPD in the world.

The Spiriva® Respimat® delivery system relies on energy released from a spring, rather than propellants, to produce a long-lasting, slow moving Soft Mist™. The innovative design makes Spiriva® Respimat® easy to use, and the Soft Mist™ results in improved delivery of Spiriva® to the lungs, with reduced deposition in the mouth and throat compared to a pressurised metered dose inhaler (pMDI). One study showed that 72% of all patients use pMDIs incorrectly and almost half (47%) have problems with coordinating use of the device.

600 million people worldwide live with COPD and its prevalence is predicted to rise making it the world's third leading cause of death by 2020.10,11 It is estimated that up to 50% of Americans and 75% of Europeans with COPD are undiagnosed.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion Euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development. For further information, please visit www.boehringer-ingelheim.com.

About Pfizer Inc
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products. For further information, please visit www.pfizer.com.

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