[October 30, 2015] |
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Sosei Confirms FDA Approvals of New Dual Combination Bronchodilator Utibron™ Neohaler® and Monotherapy Seebri™ Neohaler® for Patients with Chronic Obstructive Pulmonary Disease
Sosei Group Corporation (TOKYO:4565) confirms today that the US Food and
Drug Administration (FDA) has approved the new Novartis dual combination
bronchodilator Utibron™ Neohaler® (indacaterol 27.5
mcg/glycopyrrolate 15.6 mcg) inhalation powder for the long-term
maintenance treatment of airflow obstruction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis
and/or emphysema. The FDA also approved Seebri™ Neohaler®
(glycopyrrolate) inhalation powder 15.6 mcg - which is one component of
Utibron Neohaler - as a stand-alone monotherapy for COPD. Sosei is
eligible to receive milestone payments of 22.5 million dollars for
approval of both products.
COPD is a progressive and life-threatening lung disease that makes it
difficult to breathe1. Nearly 27 million people in the US are
affected by COPD2, which ranks as the third leading cause of
death in the US3,4 and is a major cause of serious long-term
disability5.
Utibron Neohaler and Seebri Neohaler are expected to become available in
the first quarter of 2016.
The FDA's decision to approve Utibron Neohaler is based on results of
the phase III EXPEDITION trial program, which included 2,654 patients
with COPD and consisted of two 12-week efficacy studies (FLIGHT 1 & 2)
and one 52-week safety study (FLIGHT 3)6.
In the efficacy studies, Utibron Neohaler demonstrated superior and
sustained improvements in lung function (FEV1 AUC0-12)6
at week 12, compared to its individual bronchodilator components
(indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg) as well as placebo,
all dosed twice-daily6. Improvements in lung function were
seen compared to placebo at 5 minutes after the first dose and sustained
through the 12 hour dosing interval6.
Utibron Neohaler also showed clinically meaningful improvements in
health-related quality of life and reduced use of rescue medication
compared to placebo6. Health status was assessed using the
St. George's Respiratory Questionnaire (SGRQ)6 total score,
which is a composite of symptoms, activities and impact on daily living.
Long-acting beta2-adrenergic agonists, such as indacaterol,
one of the active ingredients in Utibron Neohaler, increase the risk of
asthma-related death. Utibron Neohaler is not indicated for asthma and
should not be initiated in acutely deteriorating COPD patients or for
the relief of acute symptoms. The most common adverse reactions seen in
the efficacy studies (incidence greater than or equal to 1% and higher
than placebo) were sore throat, runny nose, high blood pressure and back
pain6. Adverse reactions reported in the long-term safety
trial were generally consistent with those observed in the 12-week
studies6.
Utibron and Seebri are delivered via the low resistance Neohaler
inhaler, which makes it suitable for patients with different seerities
of airflow limitation.
About Utibron Neohaler Utibron Neohaler, previously known as
QVA149, is a twice-daily fixed-dose combination of the long-acting beta2-adrenergic
agonist (LABA) indacaterol 27.5 mcg and glycopyrrolate 15.6 mcg, a
long-acting muscarinic antagonist (LAMA) approved in the US for the
long-term maintenance treatment of airflow obstruction in patients with
COPD, including chronic bronchitis and/or emphysema. Glycopyrrolate 15.6
mcg is the active ingredient of Seebri Neohaler. Utibron Neohaler is not
indicated to treat asthma or for the relief of sudden symptoms of COPD.
About Seebri Neohaler Seebri Neohaler, previously known as
NVA237, is a twice-daily long-acting muscarinic antagonist (LAMA)
approved in the US for the long-term maintenance treatment of airflow
obstruction in patients with COPD, including chronic bronchitis and/or
emphysema. Glycopyrrolate (also known as glycopyrronium bromide) was
exclusively licensed to Novartis in April 2005 by Sosei and its
co-development partner Vectura.
UTIBRON and SEEBRI are trademarks of Novartis AG. NEOHALER is a
registered trademark of Novartis AG.
References
-
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global
strategy for the diagnosis, management, and prevention of chronic
obstructive pulmonary disease. Updated 2015. Available at http://www.goldcopd.org/uploads/users/files/GOLD_Report_2015_Feb18.pdf.
Accessed August 11, 2015.
-
National Heart, Lung, and Blood Institute. Morbidity & Mortality: 2012
Chart Book on Cardiovascular, Lung, and Blood Diseases. Bethesda,
Maryland: U.S. Department of Health and Human Services, NIH, NHLBI.
February 2012.
-
Centers for Disease Control and Prevention. Chronic Obstructive
Pulmonary Disease. Page last updated: March 12, 2015. http://www.cdc.gov/copd/index.html.
Accessed August 27, 2015.
-
Hoyert DL, Xu JQ. Deaths: preliminary data for 2011. Natl Vital Stat
Rep. 2012;61(6):1-65. Hyattsville, MD: National Center for Health
Statistics.2012.
-
Sin DD, Stafinski T, NG YC, Bell NR, Jacobs P. The impact of chronic
obstructive pulmonary disease on work loss in the United States. Am
J RespirCrit Care Med. 2002; 165: 704-707.
-
Utibron™ Neohaler® (indacaterol and glycopyrrolate)
inhalation powder. East Hanover, NJ: Novartis Pharmaceuticals
Corporation, October 2015.
About Sosei Sosei Group Corporation is an international
biopharmaceutical company originating from Japan that discovers and
develops innovative biopharmaceuticals for the treatment of Alzheimer's
disease, schizophrenia, cancer, migraine, addiction, metabolic disease,
and other indications. By utilizing its platform technologies - GPCR
structure-based drug design platform technology, peptide platform
technologies and nanotechnology - Sosei have established a product
pipeline with first/best in class potential. Through development
and commercialization partnerships Sosei have already delivered three
medicines to the market (two COPD bronchodilators and an emergency
contraceptive), which generate significant and stable revenue streams
that enable further growth. Sosei partners include Novartis,
AstraZeneca, MedImmune, Cubist, MorphoSys, Takeda and we are actively
looking for new partnerships to enhance the development of our products
and help us deliver them to patients worldwide. For further
information about Sosei, please visit http://www.sosei.com/en.
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151029006934/en/
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