Our Medicines - EU/ROW

Ultibro® Breezhaler®
(EU and RoW – launched 2014)

Indication:  COPD
Partner:  Novartis

A first-in-class inhaled dual bronchodilator (LAMA/LABA) approved in over 90 countries, including the EU and Japan. It is a once-daily fixed-dose combination of indacaterol and glycopyrronium bromide, and in the EU is indicated as a maintenance bronchodilator treatment to relieve the symptoms of adult patients with COPD.

Together with Vectura, we sold an exclusive license to Novartis in April 2005 in respect of glycopyrronium and certain use and formulation intellectual property.

For further details on Ultibro® Breezhaler®, please refer to the eMC

+ Press Releases

22 Mar 2019: Sosei Heptares announces that Ultibro® Breezhaler® and Seebri® Breezhaler® launched in China for the treatment of COPD

- 28 Nov 2017: New data showed Ultibro® Breezhaler® significantly improved COPD patients’ lung function after direct switch from Seretide®
- 24 May 2017: New analyses of FLAME study data reinforce the potential of Ultibro® Breezhaler® for COPD patients historically treated with steroids
- 26 Jan 2017: Achievement of sales milestone for COPD products
- 9 Dec 2016: Ultibro® Breezhaler® improved lung function and COPD symptoms after direct switch from previous treatment
- 22 Nov 2016: Major report recommends broad use of dual bronchodilators to treat COPD
- 5 Sep 2016: New findings confirm Ultibro® Breezhaler® is consistently more effective than Seretide® in reducing COPD flare-ups across different patient groups
- 16 May 2016: Major study published in NEJM confirms Ultibro® Breezhaler® superiority over Seretide® in preventing COPD exacerbations
- 3 Dec 2014: Ultibro® Breezhaler® launched in the UK for the treatment of chronic obstructive pulmonary disease (COPD)
- 8 Sep 2014:Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro® Breezhaler® and Seebri Breezhaler®, and promotion agreement with Pfizer in the UK
- 21 May 2014: Positive results at ATS for once-daily Ultibro® Breezhaler® versus combination therapy (tiotropium plus formoterol)
- 30 Apr 2014: Once-daily Ultibro® Breezhaler® showed superior efficacy versus Seretide® for COPD patients in second head-to-head study, and the anticipated timing of China filing
- 29 Jan 2014: Update on Ultibro® Breezhaler® and Seebri Breezhaler® for COPD
- 20 Nov 2013: Once-daily Ultibro® Inhalation Capsules (QVA149) for COPD launched in Japan
- 23 Sep 2013: First in class once-daily dual bronchodilator Ultibro® Breezhaler® (QVA149) approved for the treatment of COPD in Europe
- 20 Sep 2013: First in class once-daily dual bronchodilator Ultibro® Inhalation Capsules (QVA149) approved for the treatment of COPD in Japan
- 9 Sep 2013: Data at ERS further demonstrates efficacy of once-daily Ultibro® Breezhaler® (QVA149) and Seebri Breezhaler® (glycopyrronium bromide)
- 4 Sep 2013: QVA149 and glycopyrronium abstracts to be presented at ERS 2013
- 26 Aug 2013: First in class once-daily dual bronchodilator QVA149 gains endorsement for approval from Drug Committee of MHLW (Ministry of Health, Labour and Welfare) for the treatment of COPD in Japan
- 27 Jul 2013: First in class once-daily dual bronchodilator Ultibro® Breezhaler® (QVA149) gains positive CHMP opinion for the treatment of COPD
- 22 May 2013: New data reinforces strength of once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations
- 24 Apr 2013: Seebri Breezhaler® GLOW 5 and GLOW 6 Phase III studies meet primary endpoint, and data from QVA149 SPARK Phase III study published in a medical journal
- 7 Nov 2012: QVA149 filed by licensing partner as a once-daily maintenance treatment for COPD in Japan

 


Seebri® Breezhaler®
(EU and RoW – launched 2012)

Indication:  COPD
Partner:  Novartis

An inhaled long-acting muscarinic antagonist (LAMA) approved in over 90 countries and indicated as a once-daily maintenance bronchodilator treatment to relieve symptoms of patients with COPD.

Together with Vectura, we sold an exclusive license to Novartis in April 2005 in respect of glycopyrronium and certain use and formulation intellectual property.

For further details on Seebri® Breezhaler®, please refer to the eMC

+ Press Releases

-22 Mar 2019: Sosei Heptares announces that Ultibro® Breezhaler® and Seebri® Breezhaler® launched in China for the treatment of COPD

- 26 Jan 2017: Achievement of sales milestone for COPD products
- 8 Sep 2014: Positive results from three clinical trials presented at ERS 2014 further confirmed efficacy of Ultibro® Breezhaler® and Seebri® Breezhaler®, and promotion agreement with Pfizer in the UK
- 29 Jan 2014: Update on Ultibro® Breezhaler® and Seebri® Breezhaler® for COPD
- 9 Sep 2013: Data at ERS further demonstrates efficacy of once-daily Ultibro® Breezhaler® (QVA149) and Seebri® Breezhaler® (glycopyrronium bromide)
- 4 Sep 2013: QVA149 and glycopyrronium abstracts to be presented at ERS 2013
- 22 May 2013: New data reinforces strength of once-daily COPD portfolio in improving lung function, shortness of breath and reducing rate of exacerbations
- 24 Apr 2013: Seebri® Breezhaler® GLOW 5 and GLOW 6 Phase III studies meet primary endpoint, and data from QVA149 SPARK Phase III study published in a medical journal
- 22 Nov 2012: Seebri® Inhalation Capsules 50 mcg, a new once-daily treatment for the symptoms of COPD, launched in Japan by licensing partner