|By PR Newswire||
|September 19, 2013 02:00 AM EDT||
CAMBRIDGE, England, September 19, 2013 /PRNewswire/ --
Mundipharma Research Limited (Mundipharma) announced today a major milestone in the development programme of flutiform® (fluticasone propionate / formoterol fumarate) for the treatment of Chronic Obstructive Pulmonary Disease (COPD) with the commencement of a key clinical trial. COPD is a life-threatening lung disease that interferes with normal breathing, estimated to affect at least 64 million people worldwide. The first patient in the trial is expected to start treatment with flutiform this month.
The Effect (Efficacy of Fluticasone propionate/FormotErol in COPD Treatment) study has been designed to investigate the superiority of flutiform 250/10 μg (2 puffs bid) and flutiform 125/5 μg (2 puffs bid) compared with formoterol 12 μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations over the 52-week treatment period.
"flutiform has already been approved as a maintenance therapy for asthma in adults and adolescents. We're excited with the progress that we've made to date with this combination and we believe that it also has the potential to be an important new treatment option for patients suffering from COPD," commented Prof.Dr. Karen Reimer, Managing Director, Mundipharma Research Limited.
This is the first large scale COPD study to evaluate two different doses of an ICS (Inhaled Corticosteroid) / LABA (Long-Acting Beta Agonist) combination, where the dose of both components is adjusted. The study will include recently developed COPD assessment tools which may further our understanding of this disease and will also evaluate serum biomarkers relevant to this multisystem disease. The study will provide useful new insights for clinicians into the management and assessment of COPD.
"The Mundipharma network of independent associated companies is committed to expanding our product offering in respiratory diseases including COPD, a chronic and debilitating disease which is predicted to become the third leading cause of death worldwide by 2030," added Georg Toufar, Chief Marketing Officer, Mundipharma International Ltd.
The primary objective of the Effect study is to show superiority in the efficacy of fluticasone propionate / formoterol fumarate 250/10 μg (2 puffs bid) compared with formoterol 12 μg (1 puff bid) based on the annual rate of moderate and severe COPD exacerbations during the 52-week treatment period.
The study is a Phase III multi-centre, randomised, double-blind and double dummy, placebo and active-controlled, parallel-group study comparing fluticasone propionate / formoterol fumarate 250/10 μg (2 puffs bid) and fluticasone propionate / formoterol fumarate 125/5 μg (2 puffs bid) versus formoterol fumarate dihydrate 12 μg (1 puff bid) in subjects with COPD.
Approximately 1,530 patients will be randomised in order to achieve 510 patients in each treatment group stratified for FEV1 % predicted category at baseline (FEV1 < 30% predicted, or 30-50 % predicted) and number of exacerbations in the previous year (≥ 2 or < 2).
Patients from approximately 15-20 countries will participate in the trial, including Bulgaria, Czech Republic, Germany, Hungary, Latvia, Macedonia, Poland, Romania, the Russian Federation, Slovakia, South Africa, South Korea, Spain, Ukraine and the United Kingdom.
flutiform is not currently licensed for the treatment of COPD
Notes to editors:
flutiform is a combination treatment for asthma, bringing together, for the first time, the inhaled corticosteroid (ICS) fluticasone propionate and the long-acting β2-agonist (LABA) formoterol fumarate in a single aerosol.
In Europe, flutiform is indicated for adults and adolescents (aged ≥12 years) with asthma that is either not adequately controlled with an ICS plus an as-needed short-acting β2-agonist, or is already adequately controlled with an ICS plus LABA.
flutiform has been approved for the treatment of asthma in 21 European countries and is commercially available in 12: Germany, the UK, Italy, Belgium, Cyprus, Denmark, Finland, Ireland, the Netherlands, Norway, Slovakia and Sweden. Further launches are anticipated during 2013/14.
Chronic Obstructive Pulmonary Disease (COPD) - also called emphysema and/or chronic obstructive bronchitis - is a preventable lung disease caused by the long-term inhalation of pollutants, most commonly cigarette smoke, that progressively and permanently reduces the ability of adults to breathe well and maintain active lives. COPD is characterised by breathlessness (or dyspnoea), coughing, wheezing and increased sputum (mucus or phlegm) production. These symptoms, in particular shortness of breath, can restrict a patient's ability to perform normal daily activities.
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis. These independent associated companies are known as Napp in the UK and Norpharma in Denmark. For further information please visit: http://www.mundipharma.com.
Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group is eligible for revenues from 14 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit http://www.skyepharma.com.
Mundipharma International Corporation Limited is licensed by Jagotec AG, a Skyepharma Group company, as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas. flutiform is a registered trade mark of Jagotec AG.
- World Health Organisation. http://www.who.int/respiratory/copd/en/ (Accessed Sept 2013)
- Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease. 2013. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html. (Accessed: Sept 2013).
ZINC code: MINT FL-13049
Date of preparation: September 2013
The principles behind DevOps are not new - for decades people have been automating system administration and decreasing the time to deploy apps and perform other management tasks. However, only recently did we see the tools and the will necessary to share the benefits and power of automation with a wider circle of people. In his session at DevOps Summit, Bernard Sanders, Chief Technology Officer at CloudBolt Software, explored the latest tools including Puppet, Chef, Docker, and CMPs needed to...
Feb. 6, 2016 10:00 AM EST Reads: 218
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 6, 2016 09:45 AM EST Reads: 315
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 6, 2016 09:00 AM EST
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 6, 2016 08:00 AM EST Reads: 158
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 6, 2016 07:45 AM EST Reads: 119
Father business cycles and digital consumers are forcing enterprises to respond faster to customer needs and competitive demands. Successful integration of DevOps and Agile development will be key for business success in today’s digital economy. In his session at DevOps Summit, Pradeep Prabhu, Co-Founder & CEO of Cloudmunch, covered the critical practices that enterprises should consider to seamlessly integrate Agile and DevOps processes, barriers to implementing this in the enterprise, and pr...
Feb. 6, 2016 07:30 AM EST Reads: 273
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 6, 2016 07:30 AM EST Reads: 148
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 6, 2016 07:15 AM EST Reads: 121
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 6, 2016 05:00 AM EST Reads: 315
Most people haven’t heard the word, “gamification,” even though they probably, and perhaps unwittingly, participate in it every day. Gamification is “the process of adding games or game-like elements to something (as a task) so as to encourage participation.” Further, gamification is about bringing game mechanics – rules, constructs, processes, and methods – into the real world in an effort to engage people. In his session at @ThingsExpo, Robert Endo, owner and engagement manager of Intrepid D...
Feb. 5, 2016 09:00 PM EST Reads: 757
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
Feb. 5, 2016 04:00 PM EST
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 5, 2016 04:00 PM EST Reads: 116
With microservices, SOA and distributed architectures becoming more popular, it is becoming increasingly harder to keep track of where time is spent in a distributed application when trying to diagnose performance problems. Distributed tracing systems attempt to address this problem by following application requests across service boundaries, persisting metadata along the way that provide context for fine-grained performance monitoring.
Feb. 5, 2016 03:45 PM EST Reads: 772
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 5, 2016 03:00 PM EST
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 5, 2016 02:45 PM EST Reads: 106