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Boehringer Ingelheim. (7/2/14). "Press Release: COPD – Boehringer Ingelheim Submits Applications in Europe for Tiotropium + Olodaterol Respimat® Fixed-dose Combination in COPD [For media outside UK, U.S. and Canada]". Ingelheim.

Region Region EU (European Union)
Organisation Organisation Boehringer Ingelheim (Group)
Products Product Spiriva®
  Product 2 Respimat® Soft Mist Inhaler (SMI)
Person Person Dugi, Klaus (Boehringer 201106 Corporate SVP Medicine)

For media outside UK, U.S. and Canada

> Applications are supported by data from the >8,000 patient TOviTO™ Phase III clinical trial programme

> First Phase III data show lung function (FEV1) benefits of tiotropium + olodaterol fixed-dose combination† (FDC) go even beyond tiotropium (Spiriva®)1

> Further data from TOviTO™ on patient-related outcomes such as quality of life and exercise capacity are due to report later in 2014

Boehringer Ingelheim today announced submission of Marketing Authorisation Applications in 31 European countries for the once-daily fixed-dose combination of tiotropium + olodaterol in the Respimat® Soft Mist™ Inhaler as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD). These applications are based on data from the large Phase III TOviTO™ clinical trial programme. Further submissions in additional countries will be announced in due course.

Tiotropium + olodaterol fixed-dose combination is an investigational treatment that contains the leading COPD maintenance therapy worldwide, tiotropium (Spiriva®), combined with olodaterol (Striverdi®), the new once-daily and fast-acting LABA‡, delivered by the Respimat® Soft Mist™ Inhaler.

"With more than 90 years' experience in the field of respiratory diseases and our leadership in the treatment of COPD, Boehringer Ingelheim is committed to continuing to bring innovative treatment options to physicians and patients," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "The fixed-dose combination of tiotropium + olodaterol represents another major advance from our robust respiratory portfolio. Once approved, we believe it will make an important contribution to addressing the current unmet needs of the millions of patients whose ability to lead a full life is disrupted by COPD."

Spiriva® (tiotropium) has been proven to consistently reduce the risk of COPD exacerbations, provide long-term improvement in quality of life for patients and has a favourable impact on survival#. Olodaterol was specifically designed by Boehringer Ingelheim as a combination partner to Spiriva® to provide added benefits for patients with COPD.

Olodaterol monotherapy has received approval for the maintenance treatment of COPD in over 30 countries and is marketed under the brand name Striverdi® Respimat® in countries where it is available. The Respimat® Soft Mist™ Inhaler is an innovative inhaler delivering a unique slow-moving Soft Mist™ that allows gentle inhalation - making it easy for patients to take their therapy.

The efficacy and safety of the tiotropium + olodaterol FDC are evaluated in the Phase III TOviTO™ clinical trial programme. Involving more than 8,000 patients, TOviTO™ is one of the largest trial programmes ever conducted in COPD. In addition to evaluating the effects of the tiotropium + olodaterol FDC on lung function, TOviTO™ is also focused on the evaluation of other important clinical outcomes related to the daily life of patients with COPD including quality of life, breathlessness and ability to exercise.

In the 6-week VIVACITO™ study, the first study reported from the TOviTO™ programme, the tiotropium + olodaterol FDC demonstrated clear and consistent improvements in lung function (FEV1*) over 24 hours compared with tiotropium or olodaterol monotherapies, and placebo. It was shown to have a safety profile similar to its single components.

Data from the pivotal 52-week Phase III TONADO™ 1&2 trials formed the major part of the regulatory submission. The trials investigated the effect of the tiotropium + olodaterol FDC on lung function and quality of life in patients with moderate to severe COPD. Results from TONADO™ 1&2 as well as other TOviTO™ programme data are expected to be reported later in 2014.

* FEV1 is the maximum volume of air that can be forcibly expired in 1st second, following maximal inspiration and is an important indicator of lung function. FEV1 is reduced in obstructive respiratory diseases

† Tiotropium + olodaterol fixed-dose combination is an investigational treatment. It has not been approved for clinical use. Its safety and efficacy have not yet been fully established

‡ Long-acting beta2-agonist

# The favourable impact on survival was established in UPLIFT® for Spiriva® Handihaler® over 4 years. TIOSPIR™ showed a similar impact for Spiriva® Respimat® compared to Spiriva® HandiHaler®

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 142 affiliates and a total of more than 47,400 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Taking social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2013, Boehringer Ingelheim achieved net sales of about 14.1 billion euros. R&D expenditure corresponds to 19.5% of its net sales.

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1 Derom E, Westerman J, Groenke L et al. The 24-hour lung function profile of once-daily tiotropium and olodaterol fixed-dose combination compared with placebo and monotherapies in chronic obstructive pulmonary disease. ATS Abstract #A148; Thematic Poster Session: D44

Media contact

Dr. Kristin Jakobs
Boehringer Ingelheim
Media & PR
Binger Str. 173
55216 Ingelheim am Rhein
Phone +49/6132/77 144553
Fax +49/6132/77 6601

Record changed: 2017-04-02


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