TOKYO--(BUSINESS WIRE)--Sosei Group Corporation (“Sosei”)(TOKYO:4565) confirms that Novartis Pharma K.K. launched once-daily Ultibro® Inhalation Capsules (“Ultibro®”; glycopyrronium / indacaterol), for relief of various symptoms due to airway obstruction in chronic obstructive pulmonary disease (COPD). Ultibro® was developed by Novartis under the name of QVA149.
Dual bronchodilation with Ultibro® is expected to set a new standard of care in COPD by combining the proven efficacy benefits and safety profiles of two established Novartis COPD treatments, the LABA*, Onbrez® Inhalation Capsules (indacaterol), and the LAMA**, Seebri® Inhalation Capsules (glycopyrronium bromide). All Novartis inhaled COPD portfolio products are developed for delivery via a single-dose dry powder inhaler (SDDPI) called the Breezhaler® inhalation device which has low air flow resistance, making it suitable for patients with airflow limitation1. The Breezhaler® device allows patients to hear, feel and see that they have taken the full dose correctly.
Ultibro® was approved in Japan and EU (under the brand name Ultibro® Breezhaler®) in September, and has since been launched in Germany and Netherlands. US submission is anticipated in the second half of 2014.
Ultibro®, Seebri®, Onbrez® and Breezhaler® are registered trademarks of Novartis AG.
* a long-acting beta2-adrenergic agonist,
**
a long-acting muscarinic antagonist
About Seebri®
Once-daily Seebri® Breezhaler® (EU)/ Seebri® Inhalation Capsules (Japan), (“Seebri”; glycopyrronium bromide), is a novel inhaled long-acting muscarinic antagonist (LAMA) indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Seebri® was licensed to Novartis in April 2005 by Sosei and its co-development partner Vectura. Seebri® was first approved in the EU and Japan in September 2012 as a maintenance bronchodilator treatment for COPD, and has been approved in over 50 countries including Canada and Australia. Seebri® has been launched in Germany, the UK, Japan and other major markets.
The US filing is expected in the first half of 2014.
About COPD
COPD is a chronic, progressive lung disease that is commonly caused by tobacco smoking, air pollution or occupational exposure, and results in airflow obstruction and debilitating bouts of breathlessness. Although the latest figures show only 220,000 people have been diagnosed with COPD in Japan2, epidemiological data suggest that the total number of patients could be as high as 5.3 million3.
About Sosei
Sosei is an international biopharmaceutical company anchored in Japan with a global reach. It practises a reduced risk business model by acquiring compounds from, and bringing compounds into, Japan through exploitation of its unique position within global markets.
For further information about Sosei, please visit www.sosei.com.
Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development and commercialisation of products. Various risks may cause Sosei’s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programmes; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialise products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialisation activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
References
1. Patient Study 2008. Ministry of Health, Labor and Welfare
2.
Patient Study 2011. Ministry of Health, Labor and Welfare
3.
Fukuchi, et al. The Nippon COPD Epidemiology (NICE) Study. Respirology
2004.
