Our Medicines - U.S.

Utibron™ Neohaler®
(US – launched 2017)

Indication:  COPD
Partner:  Novartis
Sub Licensee:  Sunovion

A first-in-class inhaled dual bronchodilator (LAMA/LABA) approved in over 90 countries, including the EU and Japan. 

In the U.S., it was approved as a twice-daily inhaled, fixed-dose combination of indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg for the long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, under the brand name Utibron™ Neohaler®.

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 Utibron™ Neohaler®, please refer to the product website

+ Press Releases
- 4 Apr 2017: Availability of UTIBRON™ NEOHALER® (indacaterol/glycopyrrolate) Inhalation Powder in the United States
- 22 Dec 2016: Out-licensing of COPD products in the US
- 22 Nov 2016: Major report recommends broad use of dual bronchodilators to treat COPD
- 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
- 25 May 2015: Two positive US phase III programs in COPD for QVA149 and NVA237
- 6 Mar 2015:U.S. FDA filing acceptance of NDAs for QVA149 and NVA237
- 8 Jan 2015: Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237

 


Seebri™ Neohaler®
(US – launched late 2017)

Indication:  COPD
Partner:  Novartis
Sub Licensee:  Sunovion

An inhaled long-acting muscarinic antagonist (LAMA) approved in over 90 countries, including the EU and Japan. 

In the U.S., it was approved 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).

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™ Neohaler®, please refer to the product website

+ Press Releases
- 20 Oct 2017: Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder is Now Available in the United States
- 22 Dec 2016: Out-licensing of COPD products in the US
- 30 Oct 2015: Sosei confirms FDA approvals of new dual combination bronchodilator Ultibron™ Neohaler® and monotherapy Seebri™ Neohaler® for patients with chronic obstructive pulmonary disease
- 21 May 2015: Two positive US phase III programs in COPD for QVA149 and NVA237
- 6 Mar 2015: U.S. FDA filing acceptance of NDAs for QVA149 and NVA237
- 8 Jan 2015: Sosei confirms the submission of regulatory applications to US FDA and robust Phase III results for QVA149 and NVA237