TOKYO--(BUSINESS WIRE)--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 severities 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.
- 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.
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.
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.