Navigation Links
Sosei Group Corporation: QVA149 Filed by Licensing Partner as a Once-Daily Maintenance Treatment for COPD in Japan
Date:11/6/2012

TOKYO, November 7, 2012 /PRNewswire/ --

Sosei Group Corporation ("Sosei"; TSE Mothers Index: 4565) confirms the information released today by Novartis Pharma K.K. that it has submitted an application for the registration of QVA149, an investigational fixed dose combination of two long-acting inhaled bronchodilators (indacaterol maleate and glycopyrronium bromide), as a once-daily treatment for chronic obstructive pulmonary disease (COPD) in Japan.

CEO of Sosei, Shinichi Tamura commented:

"This Japanese application, following on from the recent QVA149 filing in Europe, marks a further important milestone in the approval process for this innovative once-daily combination therapy which has the potential to be a safe and effective, dual-activity bronchodilator for the treatment of COPD patients."

Notes for Editors

About QVA149

QVA149, is an investigational fixed dose combination of two long-acting inhaled bronchodilators - indacaterol maleate and glycopyrronium bromide.

Indacaterol maleate is a long-acting beta2 stimulant that dilates the bronchi by acting on the beta2 receptors in bronchial smooth muscle within 5 minutes of dosing. Glycopyrronium bromide is a long-acting anticholinergic agent that has an antagonistic effect on cholinergic muscarinic receptors related to the contraction of bronchial smooth muscle and thus inhibits bronchoconstriction. Both agents have different mechanisms of action. In clinical studies, both agents demonstrated maintenance bronchodilation over 24 hours administered once daily[1],[2].

Novartis has obtained approval for indacaterol maleate in more than 85 countries around the world (as of October 2012) and it was launched under the brand name Onbrez® Inhalation Capsules 150 g in Japan in September 2011.

Novartis also received approval for glycopyrronium bromide (brand name: Seebri® Inhalation Capsules 50 g) in Japan in September 2012, and this agent was approved in the EU during the same month as Seebri® Breezhaler®. The product has since been launched in Germany and the UK and approvals have also been granted in Canada and Australia.

Glycopyrronium bromide was exclusively licensed to Novartis by Sosei and its co-development partner Vectura in April 2005, for its development and marketing worldwide.

The application for QVA149 was filed to the European Medicines Agency in October 2012 and the US application is planned for 2014.

About COPD

COPD is a chronic, progressive lung disease that is caused by the inhalation of harmful substances such as cigarette smoke over a long period. Its major symptoms include cough, sputum, and dyspnea on exertion. COPD not only greatly decreases the quality of life for patients, but is also a life-threatening disease because its symptoms gradually progress and eventually lead to respiratory failure.

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.

Reference:

  1. Vogelmeier C, et al. Respir Res. 2010; 11: 135-142.
  2. Verkindre C, et al. Respir Med. 2010; 104: 1482-1489


'/>"/>
SOURCE Sosei Group Corporation
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sosei Group Corporation: Data at ERS Shows Efficacy of Once-daily COPD Portfolio Versus Comparators, Further Establishes Dual-bronchodilator QVA149
2. Sosei Group Corporation: QVA149 Filed as a Once-Daily Maintenance Treatment for COPD in Europe
3. Top buyers including Atico, Coles Group Asia, Kmart, Staples, Office Depot and Target Australia pre-registered to attend Global Sources spring China Sourcing Fairs
4. Simcere Pharmaceutical Group to Announce First Quarter 2012 Financial Results on Wednesday, May 9, 2012
5. Watson to Acquire Actavis Group for EUR4.25 Billion
6. CentraState and Freehold Radiology Group train physicians from China
7. Winner Medical Group Inc. to Host Second Quarter 2012 Earning Conference Call on Thursday, May 10, 2012 at 9:00 p.m. EDT
8. Okuma America Chooses The Daniel Group To Provide Customer Service Research
9. H. D. Smith Signs Three Year Prime Vendor Agreement with PharmacyGPO Buying Group
10. PharmacyGPO Buying Group Selects H. D. Smith as Primary National Distributor
11. Simcere Pharmaceutical Group Provides Notice of Annual General Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
(Date:6/23/2016)... 23, 2016 Capricor Therapeutics, ... a biotechnology company focused on the discovery, development ... patient enrollment in its ongoing randomized HOPE-Duchenne clinical ... 50% of its 24-patient target. Capricor expects the ... quarter of 2016, and to report top line ...
(Date:6/23/2016)... , June 23, 2016 Bracket , ... launch its next generation clinical outcomes platform, Bracket eCOA (SM) ... held on June 26 – 30, 2016 in ... first electronic Clinical Outcome Assessment product of its kind to ... #715. Bracket eCOA 6.0 is a flexible platform ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star ... , Millions of individuals in the United States and Canada wear eyeglasses. Once considered ... both correct vision and make a fashion statement. Even celebrities use glasses as a ...
(Date:6/26/2016)... ... June 26, 2016 , ... Pixel Film Studios Released ProSlice Levels, a Media ... give their videos a whole new perspective by using the title layers in ... Studios. , ProSlice Levels contains over 30 Different presets to choose from. ...
(Date:6/26/2016)... , ... June 26, 2016 , ... ... once they have been diagnosed with endometriosis. These women need a treatment plan ... require a comprehensive approach that can help for preservation of fertility and ultimately ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June ... , brings up a new, often overlooked aspect of head lice: the parasite’s ability to ... is not a common occurrence, but a necessary one in the event that lice have ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... As a ... Magna Cum Laude and his M.D from the David Geffen School of Medicine at ... returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars ...
Breaking Medicine News(10 mins):