Navigation Links
NVA237 Filed in Europe and Positive Phase III Data at European Respiratory Society Congress
Date:9/26/2011

TOKYO, September 27, 2011 /PRNewswire/ --

NVA237 has been filed for marketing authorisation by Novartis with the European Medicines Agency (EMA) under the brand-name Seebri® Breezhaler®, triggering a $5m milestone payment to Sosei

Studies show investigational once-daily NVA237 provides superior 24-hour bronchodilation and increases exercise endurance relative to placebo

Additional data show NVA237 significantly prolonged time to first moderate/ severe COPD exacerbation and reduced associated hospitalizations compared to placebo

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565), today announces that NVA237 (glycopyrronium bromide), a long-acting muscarinic antagonist (LAMA) being investigated as a once-daily treatment for chronic obstructive pulmonary disease (COPD), has been filed by Novartis for marketing authorisation with the European Medicines Agency (EMA), under the brand-name Seebri® Breezhaler®, triggering a $5m milestone payment to Sosei.

In addition, Novartis has presented new NVA237 Phase III data at the European Respiratory Society (ERS) congress.  The GLOW1 and GLOW3 studies in chronic obstructive pulmonary disease (COPD) patients show that NVA237 (glycopyrronium bromide) significantly increased patients' lung function compared to placebo with a fast onset of action at first dose, as well as improving exercise endurance.  NVA237 is a new drug in the long-acting anti-muscarinic (LAMA) class.

The GLOW1 study met its primary endpoint by showing that NVA237 50 mcg once-daily produced a significant improvement in lung function of 108 mL in trough FEV1 (forced expiratory volume of breath in one second) after 12 weeks in patients with moderate-to-severe COPD compared to placebo (p<0.001). Moreover, NVA237 had a rapid onset of action, with a 93 mL improvement in FEV1 compared to placebo at five minutes post-dose following the first dose on the first day of treatment (p<0.001).

NVA237 also significantly prolonged the time to first moderate/severe COPD exacerbation compared to placebo, and reduced the percentage of associated hospitalizations. Significant improvement in breathlessness was seen at 26 weeks compared to placebo, accompanied by a significant improvement in health-related quality of life and reduction in the use of rescue medication.

The GLOW3 study investigated the effects of NVA237 50 mcg once-daily on exercise endurance in moderate-to-severe COPD patients. The study met its primary endpoint by showing a significant 21% improvement in exercise endurance versus placebo at the end of the study (i.e. day 21), with a significant 10% increase from day one (both p<0.001).

Both studies showed that NVA237 was well-tolerated, with a similar incidence of adverse events for patients treated with NVA237 and placebo.

Mr Shinichi Tamura, CEO of Sosei, said:"The filing of this product originating from Sosei and Vectura is an important milestone for us and is further endorsement of our capabilities. The NVA237 Phase III data at ERS illustrate the potential benefits of NVA237 for patients with COPD; a multi-billion dollar market that is still growing.  Novartis has a rich portfolio of once-daily inhaled therapies to help COPD patients and has stated that it expects to file QVA149, the fixed-dose combination of NVA237 and their once-daily LABA, indacaterol, in 2012. The combination of two bronchodilators with complementary modes of action is designed to give COPD patients access to two leading classes of therapy in a single inhaler for the first time."

 

Notes for Editors:

About the NVA237 Licence Agreement with Novartis

NVA237 was licensed to Novartis in April 2005 by Sosei and its co-development partner, Vectura.  Novartis has stated that it intends to launch NVA237 in 2012 as a once-daily monotherapy for COPD and as a fixed-dose combination with indacaterol, its once-daily, long-acting beta-agonist (LABA), known as QVA149, in 2013.  Sosei believes that it could be the first once-daily LAMA/LABA combination to come to market for COPD.  The dual activity of a muscarinic antagonist and a beta-adrenergic agonist promises to be a potent bronchodilator and, with convenient once-daily dosing as a fixed-dose combination, has the potential to improve compliance and address a large and unmet need for COPD sufferers. 

Novartis received European regulatory approval for Onbrez® Breezhaler® in November 2009.  In July 2011, Novartis announced approval of the 75 mcg once-daily dose in the US under the brand name Arcapta™ Neohaler™, and of the 150 mcg once-daily dose in Japan under the brand name Onbrez® Inhalation Capsules.

To date, Sosei has received $30m from Novartis and, under the terms of the licence, could receive up to an additional $157.5m for achievement of regulatory and commercialisation targets for both the monotherapy and the combination product. In addition, royalties on product sales will be received in the event of successful product launches.

About COPD

COPD is a progressive, life-threatening disease associated with tobacco smoking, air pollution or occupational exposure, which causes obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. COPD affects 210 million people worldwide and is projected to be the third leading cause of death by 2020. Although often considered a disease of the elderly, research has shown that a majority of COPD patients are under the age of 65 when they are likely to be at the peak of their earning power and family responsibilities.

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 http://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.



'/>"/>
SOURCE Sosei Group Corporation
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Phase III Study Shows Once-Daily NVA237 is Superior to Placebo and Similar to Tiotropium in Improving Lung Function in COPD
2. Sosei and Vectura Announce Start of Phase III Clinical Study With NVA237
3. NVA237 Phase II Results Presented at the European Respiratory Society Annual Meeting Show Promising Efficacy and Tolerability With Potentially Faster Onset Than Tiotropium
4. 13D Amendment Filed for RepliGen Corporation
5. Mr. Ronald L. Chez Filed Amended 13D for RepliGen Corporation
6. Recalled DePuy ASR Hip Implant Lawsuits Filed By John David Hart
7. Simcere Pharmaceutical Group Filed 2010 Annual Report on Form 20-F
8. Recalled DePuy Hip Implant Lawsuits Filed in Fort Worth, Texas
9. Shrink Nanotechnologies Announces That Critical Cell Align Tissue Engineering Platform Patent as Well as IP on a Novel Immunoassay Substrate Material Has Been Filed With the USPTO
10. Law Offices of John David Hart: DePuy Recalled Hip Device Lawsuit Filed by Houston Woman
11. DePuy Recalled Hip Device Lawsuit Filed in Austin, Texas
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... FRANCISCO, Calif. , June 24, 2016 /PRNewswire/ ... ), a biopharmaceutical company developing novel therapeutics for ... unmet needs, today announced the closing of its ... of common stock, at the public offering price ... in the offering were offered by GBT. GBT ...
(Date:6/24/2016)... Dublin - ... " Global Markets for Spectroscopy Equipment" report ... This report focuses on the global market of ... applications in various applications. The report deals with spectroscopy ... industries: pharmaceutical and biotechnology, food and beverage, and environmental ...
(Date:6/24/2016)... ALEXANDRIA, Va. , June 24, 2016 ... a set of recommendations that would allow ... information (HCEI) with entities that make formulary and coverage ... determine the "value" of new medicines. The ... that does not appear on the drug label, a ...
Breaking Medicine Technology:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Austin residents ... the American College of Mohs Surgery and to Dr. Russell Peckham for medical and ... highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar ... M.D from the David Geffen School of Medicine at UCLA. He trained in Internal ... complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van Mitchell, Secretary ... Work award to iHire in recognition of their exemplary accomplishments in worksite health promotion. ... Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
Breaking Medicine News(10 mins):