Once-daily Seebri® (NVA237) (glycopyrronium bromide; Seebri® Breezhaler® (EU), Seebri® Inhalation Capsules 50mcg (Japan)) is an inhaled long-acting muscarinic antagonist (LAMA) that has already been approved in the EU and Japan as a maintenance bronchodilator treatment for COPD.
In the US, NVA237 was approved in October 2015 as a twice daily inhaled monotherapy for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema under the brand name Seebri™ Neohaler® (glycopyrrolate 15.6 mcg).
Milestones and Royalty Revenue
Under the terms of the agreement with Novartis, Sosei is eligible to receive Seebri® development milestones and fixed-rate royalties on worldwide product sales.
- 22 Dec 2016
Out-licensing of COPD products in the US
- 09 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
- 05 Sep 2016
New findings confirm Ultibro® Breezhaler® is consisterntly more fective 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
- 30 Oct 2015
Sosei confirms FDA approvals of new dual combination bronchodilator Utibron™ Neohaler® and monotherapy Seebri™ Neohaler® for patients with chronic obstructive pulmonary disease
- 30 Oct 2015
Sosei confirms FDA approvals of new dual combination bronchodilator Utibron Neohaler and monotherapy Seebri™ Neohaler™ for patients with chronic obstructive pulmonary disease
- 18 Jun 2015
Planned development of inhaled triple therapy QVM149 for asthma
- 21 May 2015
Two positive US phase III programs in COPD for QVA149 and NVA237
- 06 Mar 2015
U.S. FDA filing acceptance of NDAs for QVA149 and NVA237
- 08 Jan 2015
Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237
- 08 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
- 09 Sep 2013
Data at ERS further demonstrates efficacy of once-daily Ultibro® Breezhaler® (QVA149) and Seebri® Breezhaler® (glycopyrronium bromide)
- 04 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
COPD is a chronic obstruction of the airways caused by emphysema or chronic bronchitis induced primarily by smoking or air pollution.
According to a WHO survey, there were 210 million COPD patients worldwide in 2009, and in 2012, COPD became the third leading cause of death.
In 2013, the COPD market was estimated at around $13 billion. It is expected to increase still further in future, reaching $19 billion by 2019 as a result of better recognition of the disease and improved treatment options.
Seebri® Breezhaler® and Seebri® Inhalation Capsules 50mcg are registered trademarks of Novartis AG.