|By Marketwired .||
|July 16, 2014 02:25 AM EDT||
LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA -- (Marketwired) -- 07/16/14 -- GlaxoSmithKline plc (LSE: GSK) (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced the start of a global phase III study, known as IMPACT, to evaluate the efficacy and safety of the 'closed' triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). IMPACT is the first pivotal phase III study in a programme to evaluate a once-daily closed triple combination treatment of an inhaled corticosteroid (ICS); a long-acting muscarinic antagonist (LAMA); and a long-acting beta2-adrenergic agonist (LABA) in patients with COPD.
The IMPACT study will enrol approximately 10,000 patients and assess whether the combination of FF (fluticasone furoate, an ICS), UMEC (umeclidinium, a LAMA) and VI (vilanterol, a LABA), all delivered in GSK's Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two approved once daily COPD treatments, Relvar/Breo Ellipta (FF/VI), which is an ICS/LABA combination, and Anoro Ellipta (UMEC/VI), which is a LAMA/LABA combination.
Dave Allen, Head, GSK Respiratory Therapy Area Unit, R&D, said: "When developing our respiratory portfolio we recognised the need to offer a range of molecules that could be co-formulated in different combinations to meet the needs of individual patients. We know from the scientific literature and prescribing data that there are already COPD patients who receive three medicines in different inhalers, for whom a once-daily treatment in a single 'closed' device could be valuable. The IMPACT study will be important in advancing our understanding of how the combination of FF/UMEC/VI could be used in this setting when compared to dual combination therapy options."
Rick E Winningham, Chief Executive Officer of Theravance, said: "The start of the IMPACT study marks a significant milestone in our development programme with GSK and we are excited about the potential opportunity for a triple combination treatment approach. This phase III programme has the potential to demonstrate the safety and efficacy profile of a new and important therapy that could deliver additional benefits and convenience to the growing number of adults living with COPD worldwide."
About the IMPACT study
IMPACT (InforMing the PAthway of COPD Treatment) is a double-blind, three-arm, parallel group study enrolling a total of 10,000 patients across 38 countries. Eligible patients will be randomised to receive either FF/UMEC/VI 100/62.5/25mcg, FF/VI 100/25mcg or UMEC/VI 62.5/25mcg once-daily for a period of 52 weeks.
The co-primary endpoints of the study are: the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with FF/VI; and the annual rate of moderate and severe exacerbations comparing FF/UMEC/VI with UMEC/VI. Key secondary endpoints include baseline changes in lung function (trough FEV1) comparing FF/UMEC/VI and FF/VI; time to first moderate or severe exacerbation in all three arms of the study; and the annual rate of severe exacerbations in all three arms of the study.
Chronic obstructive pulmonary disease is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing.
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD(1). Cigarette smoke, breathing in second-hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD(1). Most people who have COPD are at least 40 years old when symptoms begin.
About Relvar®/Breo® Ellipta® (fluticasone furoate + vilanterol)
Relvar/Breo Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta®. Full US prescribing information, including BOXED WARNING and Medication Guide is available at us.gsk.com or US Prescribing Information for Breo Ellipta.
About Anoro® Ellipta® (umeclidinium + vilanterol)
Anoro Ellipta is a once-daily combination treatment comprising two bronchodilators: umeclidinium, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2 agonist, in a single inhaler, the Ellipta®. Full US prescribing information, including BOXED WARNING and Medication Guide is available at: http://us.gsk.com/products/assets/us_anoro_ellipta.pdf.
RELVAR®, BREO®, ANORO® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.
GSK -- one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
Theravance, Inc., A Royalty Management Company -- is focused on maximizing the potential value of the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®, with the intention of providing capital returns to stockholders. Under the Long-Acting Beta2 Agonist (LABA) Collaboration Agreement with GSK, Theravance is eligible to receive the associated royalty revenues from RELVAR®/BREO® ELLIPTA® (fluticasone furoate/vilanterol, "FF/VI"), ANORO® ELLIPTA® (umeclidinium bromide/vilanterol, "UMEC/VI") and if approved and commercialized, VI monotherapy. Theravance is also entitled to a 15% economic interest in any future payments made by GSK relating to the combination of UMEC/VI/FF and the Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA) program, as monotherapy and in combination with other therapeutically active components, such as an inhaled corticosteroid, and any other product or combination of products that may be discovered and developed in the future under its LABA Collaboration Agreement with GSK (other than RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and VI monotherapy). For more information, please visit Theravance's web site at www.thrxinc.com.
(1 ) The Global Initiative for Chronic Obstructive Lung Disease. Pocket guide to COPD diagnosis, management and prevention.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2013.
Theravance forward-looking statements
This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the strategies, plans and objectives of the company following the separation, the timing, manner, amount and planned growth of anticipated potential capital returns to stockholders (including without limitation statements concerning the intention to initiate a cash dividend in the third quarter of 2014, expectations of future cash dividend growth and the potential for future share repurchases), the status and timing of clinical studies, data analysis and communication of results, the potential benefits and mechanisms of action of product candidates, expectations for product candidates through development and commercialization, the timing of seeking regulatory approval of product candidates, and projections of revenue, expenses and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: delays or difficulties in commencing or completing clinical studies, the potential that results from clinical or non-clinical studies indicate product candidates are unsafe or ineffective, dependence on third parties to conduct its clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, and risks of collaborating with third parties to discover, develop and commercialize products. Other risks affecting Theravance are described under the heading "Risk Factors" contained in Theravance's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 7, 2014 and the risks discussed in Theravance's other periodic filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements. (THRX-G)
UK Media enquiries:
+44 (0) 20 8047 5502
+44 (0) 20 8047 5502
+44 (0) 20 8047 5502
+44 (0) 20 8047 5502
+44 (0) 20 8047 5502
US Media enquiries:
+1 919 483 2510
+1 919 483 2678
Juan Carlos Molina
+1 919 483 0471
+1 919 483 0044
+1 919 483 2527
+44 (0) 20 8047 5543
Kirsty Collins (SRI & CG)
+44 (0) 20 8047 5534
+ 1 215 751 5419
+44 (0) 20 8047 5503
+44 (0) 20 8047 2406
+1 215 751 7002
+44 (0) 20 8047 2248
Theravance, Inc. enquiries:
Michael W. Aguiar
+1 650 238 9640
(S. San Francisco)
The cloud is everywhere and growing, and with it SaaS has become an accepted means for software delivery. SaaS is more than just a technology, it is a thriving business model estimated to be worth around $53 billion dollars by 2015, according to IDC. The question is - how do you build and scale a profitable SaaS business model? In his session at 15th Cloud Expo, Jason Cumberland, Vice President, SaaS Solutions at Dimension Data, discussed the common mistakes businesses make when transitioning t...
May. 24, 2015 06:30 AM EDT Reads: 2,717
Are your Big Data initiatives resulting in Big Impact or Big Mess? In her session at Big Data Expo, Penelope Everall Gordon, Emerging Technology Strategist at 1Plug Corporation, shared her successes in improving Big Decision outcomes by building stories compelling to the target audience – and her failures when she lost sight of the plotline, distracted by the glitter of technology and the lure of buried insights. The cast of characters includes the agency head [city official? elected official?...
May. 24, 2015 06:30 AM EDT Reads: 3,116
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial C...
May. 24, 2015 06:30 AM EDT Reads: 5,388
Big Data is amazing, it's life changing and yes it is changing how we see our world. Big Data, however, can sometimes be too big. Organizations that are not amassing massive amounts of information and feeding into their decision buckets, smaller data that feeds in from customer buying patterns, buying decisions and buying influences can be more useful when used in the right way. In their session at Big Data Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positi...
May. 24, 2015 06:30 AM EDT Reads: 2,302
Storage administrators find themselves walking a line between meeting employees’ demands to use public cloud storage services, and their organizations’ need to store information on-premises for security, performance, cost and compliance reasons. However, as file sharing protocols like CIFS and NFS continue to lose their relevance, simply relying only on a NAS-based environment creates inefficiencies that hurt productivity and the bottom line. IT wants to implement cloud storage it can purchase a...
May. 24, 2015 06:30 AM EDT Reads: 2,651
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developmen...
May. 24, 2015 06:00 AM EDT Reads: 2,071
Security can create serious friction for DevOps processes. We've come up with an approach to alleviate the friction and provide security value to DevOps teams. In her session at DevOps Summit, Shannon Lietz, Senior Manager of DevSecOps at Intuit, will discuss how DevSecOps got started and how it has evolved. Shannon Lietz has over two decades of experience pursuing next generation security solutions. She is currently the DevSecOps Leader for Intuit where she is responsible for setting and driv...
May. 24, 2015 06:00 AM EDT Reads: 3,722
The move to the cloud brings a number of new security challenges, but the application remains your last line of defense. In his session at 15th Cloud Expo, Arthur Hicken, Evangelist at Parasoft, discussed how developers are extremely well-poised to perform tasks critical for securing the application – provided that certain key obstacles are overcome. Arthur Hicken has been involved in automating various practices at Parasoft for almost 20 years. He has worked on projects including database dev...
May. 24, 2015 06:00 AM EDT Reads: 2,610
Software-driven innovation is becoming a primary approach to how businesses create and deliver new value to customers. A survey of 400 business and IT executives by the IBM Institute for Business Value showed businesses that are more effective at software delivery are also more profitable than their peers nearly 70 percent of the time (1). DevOps provides a way for businesses to remain competitive, applying lean and agile principles to software development to speed the delivery of software that ...
May. 24, 2015 05:45 AM EDT Reads: 6,284
“Oh, dev is dev and ops is ops, and never the twain shall meet.” With apoloies to Rudyard Kipling and all of his fans, this describes the early state of the two sides of DevOps. Yet the DevOps approach is demanded by cloud computing, as the speed, flexibility, and scalability in today's so-called “Third Platform” must not be hindered by the traditional limitations of software development and deployment. A recent report by Gartner, for example, says that 25% of Global 2000 companies will b...
May. 24, 2015 05:45 AM EDT Reads: 2,644
JFrog on Thursday announced that it has added Docker support to Bintray, its distribution-as-a-service (DaaS) platform. When combined with JFrog’s Artifactory binary repository management system, organizations can now manage Docker images with an end-to-end solution that supports all technologies. The new version of Bintray allows organizations to create an unlimited number of private Docker repositories, and through the use of fast Akamai content delivery networks (CDNs), it decreases the dow...
May. 24, 2015 05:30 AM EDT Reads: 3,158
More organizations are embracing DevOps to realize compelling business benefits such as more frequent feature releases, increased application stability, and more productive resource utilization. However, security and compliance monitoring tools have not kept up and often represent the single largest remaining hurdle to continuous delivery. In their session at DevOps Summit, Justin Criswell, Senior Sales Engineer at Alert Logic, Ricardo Lupo, a Solution Architect with Chef, will discuss how to ...
May. 24, 2015 05:15 AM EDT Reads: 2,962
Sensor-enabled things are becoming more commonplace, precursors to a larger and more complex framework that most consider the ultimate promise of the IoT: things connecting, interacting, sharing, storing, and over time perhaps learning and predicting based on habits, behaviors, location, preferences, purchases and more. In his session at @ThingsExpo, Tom Wesselman, Director of Communications Ecosystem Architecture at Plantronics, will examine the still nascent IoT as it is coalescing, includin...
May. 24, 2015 05:00 AM EDT Reads: 4,177
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises a...
May. 24, 2015 05:00 AM EDT Reads: 2,110
Thanks to Docker, it becomes very easy to leverage containers to build, ship, and run any Linux application on any kind of infrastructure. Docker is particularly helpful for microservice architectures because their successful implementation relies on a fast, efficient deployment mechanism – which is precisely one of the features of Docker. Microservice architectures are therefore becoming more popular, and are increasingly seen as an interesting option even for smaller projects, instead of bein...
May. 24, 2015 05:00 AM EDT Reads: 4,208