New advance in COPD maintenance treatment, Spiolto® Respimat®, approved in first European countries

Boehringer Ingelheim today announced regulatory authority approvals for Spiolto® Respimat® (tiotropium/olodaterol) in first European countries.

PRESS RELEASE Ingelheim, Germany, 2nd July, 2015 — Boehringer Ingelheim today announced regulatory authority approvals for Spiolto® Respimat® (tiotropium/olodaterol) in first European countries. Spiolto® Respimat® is a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Approvals of the treatment in other European countries are expected to follow in the coming months. Spiolto® Respimat® provides significant improvements in lung function, breathlessness, quality of life and rescue medication use over Spiriva® right from the initial stages when patients need maintenance therapy. These additional benefits could enable patients to remain active and avoid the downward spiral of COPD for as long as possible.

COPD is a chronic, progressive, treatable but incurable lung disease that affects 210 million people worldwide and is predicted to become the 3

rd

leading cause of death by 2030. Patients are typically diagnosed when lung function is already significantly impaired and maintenance therapy is needed. They suffer from symptoms including breathlessness and coughing that often stop them from being active. This can lead to a downward spiral of worsening symptoms and even further inactivity,

contributing to an increased risk of disability and death.

“The additional benefits gained from Spiolto® Respimat® compared to Spiriva® are significant for patients and data show the lung function benefits are even greater when used in the initial stages of COPD. It is a promising new therapeutic advance in COPD,” said Roland Buhl, Professor of Medicine and Head of the Pulmonary Department at Mainz University Hospital. “Optimal management right from the start of maintenance therapy may give patients with this highly debilitating lung disease, the best opportunity to stay active, manage their symptoms and have a better quality of life.”

The national regulatory approvals, following finalisation of the decentralised European regulatory procedure on 20th May, are based on data from the >5,000 patient TONADO® 1&2 clinical trials. The TONADO® trials are part of the >15,000 patient TOviTO® clinical trial programme which shows Spiolto® Respimat® provides clinically relevant improvements over Spiriva®:

  • Significant improvement in lung function*, with greatest benefit seen in patients who are at the first stage of needing maintenance therapy for their COPD — and more than double the improvement in lung function* in patients who had no prior maintenance therapy (148ml vs. 72ml)
  • Reduction in breathlessness and less use of rescue medication among patients (22% and 26% improvement in use of daytime and night-time rescue medication over Spiriva® respectively)
  • More patients experiencing noticeable improvements in their quality of life (57.5% vs 48.7%)
  • Spiolto® Respimat® was well tolerated with a safety profile that was similar to tiotropium or olodaterol alone

“Since its first launch in 2002, Spiriva® has brought medical benefits that have made a real difference to the lives of millions of patients with COPD around the world.

Spiolto® Respimat® is our newest advance in COPD treatment. Its recent approval in the US

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, Canada and Australia, alongside the approval in countries across Europe, is an important step forward in our ongoing commitment to provide effective solutions for patients with COPD,” said Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.

“We anticipate further approvals of Spiolto® Respimat® in other European countries over the coming months.”

Spiolto® Respimat® is built on tiotropium, the active ingredient in Spiriva® - the world’s most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities. It is enhanced by olodaterol, a unique and effective long-acting beta2-agonist with a fast onset of action, specifically designed to complement the efficacy of Spiriva®. Spiolto® is delivered by Respimat®, the only inhaler available that actively delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.