Sosei Group Corporation: Once-daily Ultibro® Inhalation Capsules (QVA149)
for COPD Launched in Japan
TOKYO -- November 20, 2013
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 limitation^1. 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
* a long-acting beta-adrenergic agonist,
** a long-acting muscarinic antagonist
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.
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 Japan^2,
epidemiological data suggest that the total number of patients could be as
high as 5.3 million^3.
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.
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
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
Sosei Group Corporation
Kathryn LYDON, PA to CEO & Corporate Communication
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