|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
So you think you are a DevOps warrior, huh? Put your money (not really, it’s free) where your metrics are and prove it by taking The Ultimate DevOps Geek Quiz Challenge, sponsored by DevOps Summit. Battle through the set of tough questions created by industry thought leaders to earn your bragging rights and win some cool prizes.
Oct. 24, 2016 01:15 AM EDT Reads: 3,914
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
Oct. 24, 2016 01:15 AM EDT Reads: 1,872
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 7-9, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and ...
Oct. 24, 2016 01:00 AM EDT Reads: 3,570
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and ...
Oct. 24, 2016 01:00 AM EDT Reads: 770
“Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. CloudBerry Backup is a leading cross-platform cloud backup and disaster recovery solution integrated with major public cloud services, such as Amazon Web Services, Microsoft Azure and Google Cloud Platform.
Oct. 24, 2016 12:45 AM EDT Reads: 1,340
In the next forty months – just over three years – businesses will undergo extraordinary changes. The exponential growth of digitization and machine learning will see a step function change in how businesses create value, satisfy customers, and outperform their competition. In the next forty months companies will take the actions that will see them get to the next level of the game called Capitalism. Or they won’t – game over. The winners of today and tomorrow think differently, follow different...
Oct. 24, 2016 12:45 AM EDT Reads: 960
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Oct. 24, 2016 12:45 AM EDT Reads: 2,470
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
Oct. 24, 2016 12:45 AM EDT Reads: 749
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Oct. 24, 2016 12:15 AM EDT Reads: 874
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTrend processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
Oct. 24, 2016 12:00 AM EDT Reads: 3,973
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
Oct. 23, 2016 11:45 PM EDT Reads: 11,349
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU’s GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes.
Oct. 23, 2016 11:15 PM EDT Reads: 1,642
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, will draw together recent research and lessons learned from emerging and established ...
Oct. 23, 2016 11:00 PM EDT Reads: 1,270
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
Oct. 23, 2016 10:30 PM EDT Reads: 4,580
November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Penta Security is a leading vendor for data security solutions, including its encryption solution, D’Amo. By using FPE technology, D’Amo allows for the implementation of encryption technology to sensitive data fields without modification to schema in the database environment. With businesses having their data become increasingly more complicated in their mission-critical applications (such as ERP, CRM, HRM), continued ...
Oct. 23, 2016 09:15 PM EDT Reads: 985