Boehringer Ingelheim Submits Marketing Authorisation Applications in Europe for tiotropium + olodaterol Respimat® Fixed-dose Combination in COPD

BRACKNELL, England, July 2, 2014 /PRNewswire/ --

• Applications are supported by data from the TOviTO™ Phase III clinical trial programme involving more than 8,000 patients^[1]
• First Phase III data show lung function benefits of tiotropium + olodaterol fixed-dose combination (FDC) go beyond tiotropium (Spiriva®) alone^[2]
• 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 the submission of Marketing Authorisation Applications (MAAs) in 31 European countries for the once-daily fixed-dose combination of tiotropium + olodaterol Respimat® as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD). The 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 FDC is an investigational treatment that contains the world's most prescribed COPD maintenance therapy, tiotropium (Spiriva®),^[3] combined with olodaterol (Striverdi®), a new once-daily and fast-acting LABA , delivered by the Respimat® Soft Mist™ Inhaler.

"The submission of tiotropium + olodaterol for marketing authorisation is a milestone for Boehringer Ingelheim and builds on nearly 100 years of experience in this therapy area of respiratory medicine," said Dr. Brian Wong, Head of Medical and Scientific Affairs, Boehringer Ingelheim UK. "Once approved, tiotropium + olodaterol will realise our commitment to constant innovation by offering patients an additional treatment option for a disease that affects over a million people in the UK."

Building on our heritage 

Spiriva® (tiotropium) was launched more than 11 years ago and has been shown to be an effective, well tolerated drug for patients with the symptoms of COPD, compared with placebo.^[4];[5]

Olodaterol was specifically designed by Boehringer Ingelheim as a combination partner to tiotropium to provide added benefit 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 TOviTO™ clinical trial programme 

The efficacy and safety of the tiotropium + olodaterol FDC are being evaluated in the Phase III TOviTO^[TM] clinical trial programme. Involving more than 8,000 patients, TOviTO™ is one of the largest trial programmes ever conducted in COPD.^[1] 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^[TM] 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.^[2] It was shown to have a safety profile similar to its single components.^[2]

Further data from the TOviTO™ programme are expected to be reported later in 2014.

Notes to Editors 

About tiotropium 

Tiotropium (Spiriva®) is a long-acting muscarinic antagonist (LAMA) delivered via the HandiHaler® (18 mcg) or the Respimat® Soft Mist™ Inhaler (5 mcg). Tiotropium is licensed for the maintenance treatment of chronic obstructive pulmonary disease (COPD) symptoms and has comprehensive clinical trial data, demonstrating extensive experience since its introduction more than 11 years ago and over 34 million patient years of real life experience to support its efficacy and safety profile.^[6]

About olodaterol  

Olodaterol (Striverdi®) is a long-acting B₂-agonist (LABA) delivered via the Respimat® Soft Mist™ Inhaler (5 mcg). Olodaterol is indicated as a maintenance bronchodilator treatment in patients with COPD.

Boehringer Ingelheim is developing olodaterol in combination with tiotropium with the aim of providing additional bronchodilation in the maintenance treatment of patients with COPD. Combining a LAMA and a LABA has the potential to deliver greater improvements in lung function and other outcomes, compared with individual drugs used alone.^[7];[8]

About Respimat®  

Respimat® is a Soft Mist™ Inhaler (SMI); a delivery device which uses mechanical energy (a spring) to generate a long-lasting, slow-moving mist for inhalation.^[9]

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.

References

    (1)     ClinicalTrials.gov. Search results: Tiotropium+Olodaterol. 2014. Available at: http://www.clinicaltrials.gov/ct2/results?term=olodaterol+tiotropium&Search. Last accessed: June 2014.

    (2)     Derom E, Westman 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. 2014. ATS abstract #A148; Thematic Poster Session: D44.

    (3)     Boehringer Ingelheim. Data on File: SPI14-02. 2013.

    (4)     Kesten S, Celli B, Decramer B. Tiotropium HandiHaler in the treatment of COPD: A safety review. J Chron Obstruct Pulmon Dis 2009; 4:397-409.

    (5)     Bateman E, Singh D, Smith D et al. Efficacy and safety of tiotropium Respimat SMI in COPD in two 1-year randomized studies. Int J Chron Obstruct Pulmon Dis 2010; 5:1-12.

    (6)     Boehringer Ingelheim. Data on File: SPI13-02(b). 2013.

    (7)     Tashkin DP, Pearle J, Iezzoni D et al. Formoterol and tiotropium compared with tiotropium alone for treatment of COPD. COPD 2009; 6:17-25.

    (8)     Cazzola M, Molimard M. The scientific rationale for combining long-acting ß2-agonists and muscarinic antagonists in COPD. Pulm Pharmacol Ther 2010; 23:257-267.

    (9)     Hochrainer D, Hölz H, Kreher C et al. Comparison of aerosol velocity and spray duration of Respimat Soft Mist inhaler and pressurized metered dose inhalers. J Aerosol Med 2005; 18:273-282.