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Cylance® Wins Excellence Award For Best Emerging Technology At 2016 SC Magazine Awards Europe

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IRVINE, California /PRNewswire/ — Cylance®, the company that is revolutionizing cybersecurity through the use of artificial intelligence to proactively prevent advanced persistent threats and malware, is pleased to announce that CylancePROTECT® won the award for Best Emerging Technology in the Industry Leaders category group at the 2015 SC Magazine Awards Europe. The award was presented Tuesday, June 7 at the annual SC Awards Gala held at Old Billingsgate, London.

“Cylance technology’s unique incorporation of machine learning and artificial intelligence to predict new and emerging attacks on the endpoint is saving nights and weekends around the globe,” said Cylance CEO Stuart McClure. “Receiving this recognition from such an esteemed organization further empowers our mission to protect every endpoint under the sun. While conventional solutions consistently miss both advanced and commonplace attacks, Cylance prevents 0-day and mutated malware from executing in mere milliseconds, demonstrating value immediately above and beyond the age-old technologies in the market today.”

Each year, a handpicked panel of information technology (IT) security experts from the private and public sectors review hundreds of entries and narrow the field down to a select group of finalists. These finalists then go through a rigorous, in-depth analysis that includes applicable research, analyst reports, and/or product reviews. CylancePROTECT was determined as this year’s winner in the Best Emerging Technology category after a thorough and comprehensive analysis of each finalist’s strengths.

“It is so important to encourage and praise innovation, recognize those who raise the bar, and reward exemplars who facilitate best practice,” said Tony Morin, Editor in Chief, SC Magazine UK. “Cylance is a great example of this within the industry.”

The SC Magazine Awards Europe is lauded as one of the most prestigious awards for IT security professionals and products. The awards recognize the best solutions, services and professionals that work around the clock to defend against the constantly shifting threat landscape in today’s marketplace. For more information and a detailed list of categories and winners, please visit http://www.scawardseurope.com/.

About SC Magazine
SC Magazine provides IT security professionals with in-depth and unbiased information through timely news, comprehensive analysis, cutting-edge features, contributions from thought leaders and the best, most extensive collection of product reviews in the business. By offering a consolidated view of IT security through independent product tests and well-researched editorial content that provides the contextual backdrop for how these IT security tools will address larger demands put on businesses today, SC Magazine enables IT security pros to make the right security decisions for their companies. Besides the monthly print magazine and vibrant daily website, the brand’s portfolio includes the SC Congress (Chicago, London, New York, Toronto), SC Awards (US and UK), SC Marketscope, SC Magazine Newswire and SC Magazine IT Security Executive Forums.

About Cylance Inc.
Cylance® is the only company to offer a preventive cybersecurity solution that stops advanced threats and malware—before they can execute—at the most vulnerable point: the endpoint. Applying a revolutionary artificial intelligence approach, CylancePROTECT® analyzes the DNA of code prior to its execution to find and prevent threats others can’t, while using a fraction of the system resources associated with antivirus and detect and respond solutions deployed in enterprises today. For more information visit: www.cylance.com

For More Information
Cylance press releases and news
Cylance events and Unbelievable Tour dates

Social Networks
Website: www.cylance.com
Blog: blog.cylance.com
Twitter: www.twitter.com/cylanceinc
LinkedIn:  http://www.linkedin.com/company/cylanceinc
YouTube:  www.youtube.com/cylanceinc

Media Contacts
Cynthia Siemens
Director, PR and Communications
Cylance Inc.
+1(949) 242-9221
media@cylance.com

Hannah Whitrow
Zonic Group PR
hwhitrow@zonicgroup.com
+44 (0) 1672 550126

Jill Gerig
InkHouse PR
+1(916) 215-3286
cylance@inkhouse.com

Source: Cylance Inc.
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Written by asiafreshnews

June 10, 2016 at 4:54 pm

Posted in Uncategorized

Medialets Expands Leadership in North America, Europe and Asia-Pacific

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-Leader in mobile measurement and attribution grows team to meet market demand.

NEW YORK /PRNewswire/ — Medialets, the leader in mobile measurement and attribution, continues its global expansion with the opening of its APAC headquarters in Singapore and new senior hires in North Americaand EMEA.

“Medialets works with the biggest advertisers in the world, and our clients demand global solutions for their mobile challenges,” said Medialets CEO Richy Glassberg. “As we push the industry for more accurate measurement standards and roll out the most advanced cross-platform attribution solutions around the globe, we’ve expanded our team to meet our clients’ needs in their local markets.”

Effective today, Medialets is launching an Asia-Pacific division based in Singapore to be run by Vice PresidentAndrew Dryden. Dryden has been with Medialets for six years, in roles covering business development, publisher relations, sales, and operations. In APAC, Dryden will oversee sales, operations, and account management. Prior to joining Medialets in 2010, Dryden worked in international roles at Publicitas and the United Nations.

In North America, John Ruvolo has joined Medialets as Senior Vice President of Sales. Ruvolo joins Medialets from CurtCo Media (owners of Robb Report), where he served as Chief Revenue Officer. Prior to CurtCo, he led sales at Martini Media, PulsePoint, and ContextWeb.

In London, Kiran Kaur joined Medialets earlier this year as Director of Agency Sales for Europe, the Middle East andAfrica. Most recently at Conversant, Kaur has digital and media insights experience from roles at eBookers, the Digital Property Group, Polestar Communications, Global Radio, and ITV.

“Over the past year, Medialets has signed global partnership agreements with agency holding companies like Dentsu, programmatic partners like Light Reaction, The Trade Desk and AppNexus, and location partners like PlaceIQ,” said Glassberg. “With this expansion, we will continue building our global relationships while partnering with local market experts.”

“I’m thrilled to add such significant sales leadership to our global team,” said James O’Connor, SVP Global Sales, Medialets. “We’re continuing our growth around the world because of the overwhelming demand for mobile measurement and attribution solutions. Our brand, agency, and programmatic partners want in-market support as they roll out Medialets’ solutions across their campaigns.”

About Medialets

Medialets makes mobile count for advertisers.

As the first MRC-accredited ad server for mobile formats in applications and mobile web, Medialets sets the bar for accurate measurement and only counts ads that have fully rendered on mobile devices. Our Servo platform works across any inventory source, integrates with all data and viewability partners, and goes beyond the last click to give insight into view-through attribution. Medialets provides accurate and actionable insight for the world’s largest advertisers and their agencies.

Acquired by WPP in April 2015, Medialets is headquartered in New York City with offices in London, Singapore,Chicago and Los Angeles. To learn more, visit https://www.medialets.com/ and follow us on Twitter @medialets.

Contact:
Daniel Feldstein
Senior Director of Marketing
dan.feldstein@medialets.com
212-479-0126

Source: Medialets
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Written by asiafreshnews

June 10, 2016 at 4:41 pm

Posted in Uncategorized

Mobile Packet Data Core Spend Totals US$ 42 Billion through 2021; NFV Accounts for Half

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SCOTTSDALE, Arizona /PRNewswire/ — ABI Research sees the NFV-based mobile packet data core ramping up this year and taking in more than half of the US$ 42 billion in packet data core spending through the end of 2021. The mobile networks are heading toward an IT and telecom convergence, and the entire packet core for 3G and 4G will increasingly turn to NFV virtualization and running on commercial IT gear.

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“As the initial LTE network build-outs wind down, increasing traffic and subscriptions place growing demands on the packet data core,” says Joe Hoffman, Managing Director and Vice President at ABI Research. “Network spend in this market will show a steady uptake. But as NFV virtualization gains ground, it will eventually drive an overall spend reduction as operators get conversant with network virtualization.”

Given swift growth of the NFV packet data core, operators will face the challenge of managing the transition to virtualized telecom networks in the months ahead. While they will continue to rely on primary infrastructure vendors to provide total system integration, ABI Research expects this to change once operators master this technology shift.

The firm therefore anticipates that infrastructure vendors will increase their professional service offerings to assist with this transformation, as well as managed service offerings to allow operators to focus on the other aspects of their business transformation brought on by virtualization.

“Infrastructure vendors have before them an opportunity to help service providers with the transformation to the virtualized network of tomorrow,” concludes Hoffman. “This will probably be through the form of professional and managed services for the next few years. Operators can start small, with virtualization of packet core, IMS and VoLTE, or the Gi-LAN in select markets, and grow as they learn.”

These findings are from ABI Research’s Mobile Gateways (https://www.abiresearch.com/market-research/product/1018473-mobile-gateways/). This report is part of the company’s Future Networks sector (https://www.abiresearch.com/market-research/practice/next-generation-network-services/), which includes research reports, market data, insights, and competitive assessments.

About ABI Research

ABI Research stands at the forefront of technology market research, providing business leaders with comprehensive research and consulting services to help them implement informed, transformative technology decisions. Founded more than 25 years ago, the company’s global team of senior and long-tenured analysts delivers deep market data forecasts, analyses, and teardown services. ABI Research is an industry pioneer, proactively uncovering ground-breaking business cycles and publishing research 18 to 36 months in advance of other organizations. For more information, visit www.abiresearch.com.

Contact Info: Mackenzie Gavel

Tel: +1.516.624.2542

pr@abiresearch.com

Source: ABI Research

Written by asiafreshnews

June 10, 2016 at 4:39 pm

Posted in Uncategorized

Deutsche Telekom (DT) Leads Digital Transformation, Must Prove Ability to Scale, says Strategy Analytics

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-Critical Move to Digital Service Provider Drives Cost Savings, Earnings Power

BOSTON /PRNewswire/ — DT is a leader in telco Digital Transformation with proof to show why transformation is essential. Like any operator, DT faces challenges as it transitions from pilots to larger scale, according to a new report from Strategy Analytics’ Wireless Operator Strategies service, “DT Stands for Digital Transformation as Deutsche Telekom Leads Telco Transition.”

Logo – http://photos.prnewswire.com/prnh/20130207/NE56457LOGO-b

Click here for the report: http://bit.ly/SAWOSDT

In this report, Strategy Analytics shares insights from a briefing with Claudia Nemat, Member of the Deutsche Telekom AG Board of Management, Europe and Technology, about the best practices that have put them on the path to larger scale and sustainable transformation.

Susan Welsh de Grimaldo, Director Wireless Operator Strategies, author of the report, says, “Telcos face a number of key challenges as they undergo digital transformation, most importantly how to shift culture, not just technology.  Keeping focus on the impact on customer experience aligns transition with business growth opportunity, and showing early cost savings impact adds to the bottom line, driving momentum. Failure to transform could lead to shrinking business, leaving money on the table and even losing ground as competitors take value and share.”

DT’s customer-centric Pan-Net is proving cost savings: Pan-Net is creating 50 new greenfield platforms for a cross-Europe network, residing on a single European infrastructure centralized in three data centers, which will replace 650 legacy platforms. The first real product transition is messaging, which will reduce head count by 70% and Opex by 80% by consolidating 33 different messaging platforms from seven vendors across 13 markets onto one new platform.

Martin Bradley, Wireless Consultant, states, “Other operators stand to learn from studying DT’s digital transformation as it unfolds, building on lessons learned and best practices, and tweaking for their own market realities and company position and focus.”

Phil Kendall, Executive Director Wireless Operator Strategies, adds “At DT the process of cultural transformation is taking time to get to the heart of the corporation, but digital transformation is becoming more mainstream. The challenge now is to build scale and keep transformation alive, moving and innovative; and to maintain engagement of the team as it moves from pilots to broader integration into everyday business.”

See also our blog post on digital transformation:

What you need to know about the digital transformation imperative

About Strategy Analytics
Strategy Analytics, Inc. provides the competitive edge with advisory services, consulting and actionable market intelligence for emerging technology, mobile and wireless, digital consumer and automotive electronics companies. With offices in North America, Europe and Asia, Strategy Analytics delivers insights for enterprise success.www.StrategyAnalytics.com

US Contact:
Susan Welsh de Grimaldo, +1 617 614 0724, swelshdegrimaldo@strategyanalytics.com

European Contact:
Phil Kendall: +44 1908 423 620, pkendall@strategyanalytics.com

Source: Strategy Analytics

Written by asiafreshnews

June 10, 2016 at 4:34 pm

Posted in Uncategorized

IBM invests to accelerate development and commercialisation of disruptive technologies in Asia

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— Close to 5,000 IBM Cognitive Solution Professionals across the region co-creating with clients to drive transformation
— New Watson Centre at Marina Bay to house IBM Garage Singapore and IBM Studios – Singapore

SINGAPORE /PRNewswire/ — In less than five years, disruptive technologies such as cognitive computing and blockchain are expected to drive dramatic shifts in every industry, from healthcare, to financial services, to tourism.  To help clients of all sizes in the Asia Pacific region lead in shaping the future of their industries, IBM (NYSE: IBM) today announced plans to assist in the rapid prototyping and commercialisation of solutions based on cognitive computing and blockchain.

Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7724252-ibm-watson-singapore/

Logo – http://photos.prnewswire.com/prnh/20090416/IBMLOGO

IBM today opened The Watson Centre at Marina Bay, an incubator designed to bring together organisations of all sizes, business partners and IBM experts to co-create business solutions that leverage IBM’s cognitive, blockchain and design capabilities.  IBM’s new Asia Pacific headquarters is based in the same location, in the heart ofSingapore’s financial district.

Watson Centre at Marina Bay will act as a centre of expertise for almost 5,000 IBM cognitive solutions professionals in the Asia Pacific region alone, including researchers, IBM Watson specialists, data scientists, software engineers, agile developers and analytics experts. It will also offer education, hackathons, and customised workshops for a broader ecosystem of innovators including software companies, startups, developers and systems integrators.

The Centre will play host to Asia Pacific clients looking to lead in a variety of markets and industries, using Watson technologies that reason, improve through learning, and discover insights hidden in large amounts of complex data. IBM has been working to meet growing demand for cognitive computing in Asia Pacific through a variety of avenues, including partnerships with Bumrungrad International Hospital in Thailand and SK Holdings C&C in Korea, as well as establishing developer ecosystems in the region.

“We are pleased with IBM’s decision to establish their APAC HQ and the new Watson Centre, together with a number of innovation initiatives, in Singapore to develop impactful digital solutions for their clients,” said Yeoh Keat Chuan, Managing Director, Singapore Economic Development Board. “This is a testament to Singapore’s growing start-up ecosystem, presence of strong industry verticals and the availability of digital talent with deep capabilities.”

Financial Services

DBS Bank, a leading financial services group in Asia, will work with Watson Centre at Marina Bay to develop new use cases based on disruptive technologies, and to assist in its strategy to support FinTech startups in the region.

Mr Piyush Gupta, CEO of DBS said, “At DBS, we seek to leverage digital technology to make banking simple and effortless for our customers. As we shape the future of banking, it is important to work with a thriving innovation ecosystem to tap into disruptive technology and ideas. Our partnership with IBM will help us to continue driving innovation within DBS, as well as assist in the acceleration and development of locally-generated Fintech innovations.”

Healthcare

Parkway Pantai, one of Asia’s largest integrated private healthcare groups, is working with IBM to enhance the quality of patient care and improve patient outcomes in its intensive care units at Mount Elizabeth Novena Hospital,Singapore. In line with Parkway Pantai’s effort to leverage new technologies to improve patient care and outcomes, the use of Watson technologies is helping to provide proactive patient monitoring and early intervention through real-time data analysis and notifications to nurses in anticipation of critical and life-threatening events.

Dr Kelvin Loh, Chief Executive Officer of Singapore Operations Division, Parkway Pantai said, “Systems like cognitive computing can continuously read, monitor and quickly make sense of vast amounts of data. With decision support tools like Watson, our clinicians and nurses can get data in the right context, faster, and personalized to the patient’s needs. This translates to greater efficiency and better outcomes for our patients.”

Tourism

A key element of advancing cognitive technologies around the globe is making Watson APIs and services available to enterprises and developers via the Watson Platform. ZUMATA Technologies, a supplier of consolidated hotel inventory services to online travel companies around the world, is leveraging IBM Watson to enable a more personalized experience for hotel recommendations. ZUMATA’s platform continuously learns from every customer interaction, delivering more personalized experiences and thereby improving booking conversions.

Robert Meza, Director of ZUMATA said, “For many people, planning a trip can be overwhelming and time consuming. There is so much information to digest and choosing where to go, where to stay and comparing price with value can be daunting. During the process of booking travel and accommodation, customers are looking for both inspiration and convenience. We aim to make travel personal again and match consumers with their perfect trip more efficiently.”

IBM Garage Singapore

With the advent of blockchain, and the increasing demand from clients across Asia to explore the possibilities of this transformative technology, IBM will help accelerate the design, development and commercialization ofSingapore blockchain applications through the IBM Garage and the IBM Global Entrepreneur program.

At the IBM Garage, experts collaborate with clients, developers and entrepreneurs to test-drive tools, processes, and procedures to make blockchain real. The garage creates a bridge between the scale of enterprise and culture of startups and supports the development of an Open Standards based blockchain ecosystem and creates new work opportunities in Singapore.

IBM Global Entrepreneur Program helps startups and entrepreneurs who are building new generation of distributed ledger applications on the blockchain harness the power of IBM Cloud, as well as deeply connect and embed them into IBM’s vast global network of enterprise clients, consultants, Innovation Centres and more to rapidly build, scale quickly and accelerate growth.

“Watson and blockchain are two technologies that will rapidly change the way we live and work, and our clients inAsia Pacific are eager to lead the way in envisioning and creating that future,” said Randy Walker, Chairman and CEO, IBM Asia Pacific. “Here they can leverage the latest in customer experience design, use cognitive technology to draw insight from vast quantities of data, and draw on IBM’s huge investments in research and development. In partnership with our clients we are nurturing local talent and building an ecosystem to accelerate the development of cognitive solutions and blockchain platforms.”

IBM Studios – Singapore

The Watson Centre at Marina Bay will also host IBM Studios – Singapore, a new centre that will blend experience design and digital expertise to support customer innovation.  With this Studio, IBM will help Asia Pacific clients analyse business challenges and develop solutions grounded in more individualised digital experiences through a combination of IBM’s research technology, cognitive capabilities and experience design.

Stefan Hirsch, ASEAN Lead for IBM iX said, “Our designers work with clients through the customer experience from strategy, creative and design to scalable digital, commerce, mobile and wearable platforms. We sit side-by-side with our clients to invent and co-create personalised, innovative solutions using IBM’s leadership in cognitive, research and design to take digital experiences to the next level for clients. ”

IBM Watson: Pioneering a New Era of Computing

Watson represents a new era in computing called cognitive computing, where systems understand the world the way humans do: through senses, learning, and experience. Watson continuously learns from previous interactions, gaining in value and knowledge over time. With the help of Watson, organizations are harnessing the power of cognitive computing to transform industries, help professionals do their jobs better, and solve important challenges.

To advance Watson, IBM has three dedicated business units: Watson, established for the development of cloud-delivered cognitive computing technologies that represent the commercialization of “artificial intelligence” or “AI” across a variety of industries; Watson Health, dedicated to improving the ability of doctors, researchers and insurers and other related health organizations to surface new insights from data to deliver personalized healthcare; andWatson IoT, focused on making sense of data embedded in more than 9 billion connected devices operating in the world today, which generate 2.5 quintillion bytes of new data daily.

For more information on IBM Watson, visit: ibm.com/Watson and ibm.com/press/watson. Join the conversation at #ibmwatson.

MEDIA CONTACT

Charlene Lee
External Relations Leader
IBM ASEAN
Mobile: +65 97916481
Email: charlee@sg.ibm.com

Joanna Brewer
External Relations
415 971 2777
jmbrewer@us.ibm.com

Source: IBM

Related stocks: NYSE:IBM

Written by asiafreshnews

June 10, 2016 at 4:29 pm

Posted in Uncategorized

Patient-reported Outcomes across Phase 3 studies of Baricitinib demonstrate Statistically Significant Improvements in Physical Function and Quality of Life Symptoms in Patients with Rheumatoid Arthritis (RA)

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-Pivotal trials show treatment with baricitinib resulted in significant improvements in pain, fatigue and ability to perform daily activities compared to methotrexate — the current standard of care — and adalimumab (Humira®)*

INDIANAPOLIS /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced that in two phase 3 trials patients with rheumatoid arthritis (RA) treated with baricitinib reported significant improvements in quality of life symptoms and other patient-reported outcomes compared to methotrexate or adalimumab (Humira®). Patients with RA also reported improvement in productivity at work. In these studies, significant improvements in patient-reported measures, including pain, physical function, tiredness and morning joint stiffness, were observed as early as one week after initial treatment with baricitinib. These findings were presented today at the Annual European Congress of Rheumatology (EULAR 2016) in London.

Key findings include:

  • In the phase 3 RA-BEGIN trial:
    • At 24 weeks, 81 percent of patients receiving baricitinib monotherapy and 79 percent of patients receiving baricitinib plus methotrexate had clinically meaningful improvement in physical function compared with 70 percent among those receiving methotrexate alone (p<0.05). Clinically meaningful improvement was defined as an improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score of >0.22.
    • At 52 weeks, 68 percent of patients on baricitinib monotherapy and 72 percent of patients on baricitinib in combination with methotrexate saw clinically meaningful improvements in physical function compared to 57 percent of those treated with methotrexate alone (p<0.05).
    • At 24 and 52 weeks, baricitinib (as monotherapy or in combination with methotrexate) was also associated with significant improvement in pain, and clinically meaningful improvement in fatigue and the physical health components of the quality of life assessment compared with methotrexate alone.

 

  • In the phase 3 RA-BEAM trial, where all patients received background methotrexate therapy:
    • At 12 weeks, 75 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 71 percent of patients on adalimumab (p=0.302). Clinically meaningful improvement was defined as an improvement in HAQ-DI score of >0.22.
    • At 24 weeks, 73 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 64 percent of patients on adalimumab (p<0.05).
    • At 52 weeks, 68 percent of patients treated with baricitinib reported clinically meaningful improvement in physical function compared with 58 percent of patients on adalimumab (p<0.01).
    • At 52 weeks, baricitinib was also associated with significant improvement in pain, and clinically meaningful improvement in fatigue and the physical health components of quality of life compared with adalimumab.

 

  • An analysis of the phase 3 trials found that in each study, patients taking baricitinib have less impairment in work productivity and daily activities compared to patients taking the comparator.

“Our extensive phase 3 clinical trial program demonstrates that baricitinib could, if approved, offer a potentially significant improvement in the treatment of rheumatoid arthritis,” said Terence Rooney, M.D., medical director, rheumatoid arthritis, Lilly Bio-Medicines. “In these studies, baricitinib demonstrated superiority on a variety of efficacy measures compared to the leading biologic, adalimumab, as well as the current oral standard of care, methotrexate. Additionally, patients reported their personal experience with baricitinib, further highlighting its positive impact on patients’ daily lives and activities.”

Physical function was measured using the patient-reported HAQ-DI questionnaire that assesses the ability of a patient to perform daily activities like dressing, eating, walking, grip, etc. Quality of life assessment was made by using the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute, or SF-36, which is a patient-reported survey that measures overall health quality based on physical and psychological functioning.

RA-BEGIN demonstrated that in RA patients who had limited or no previous treatment with any disease-modifying antirheumatic drugs (DMARDs), baricitinib used as monotherapy or in combination with methotrexate showed statistically significant improvements in the physical quality of life measures, as measured by the SF-36, when compared to methotrexate alone. Reported improvements in patient quality of life symptoms were accompanied by an increase in physical function, and decreased pain and fatigue. All the improvements with baricitinib were statistically significant at week 24 and week 52, compared to methotrexate alone.

The RA-BEGIN study included patients who had limited or no prior treatment with methotrexate, and were naive to other conventional or biologic DMARDs. Part of a larger phase 3 program of more than 3,000 RA patients at various points in the RA treatment continuum, RA-BEGIN enrolled nearly 600 patients who were randomized to one of the following treatment groups:

  • Once-weekly oral methotrexate monotherapy
  • 4 mg once-daily oral baricitinib monotherapy
  • 4 mg once-daily oral baricitinib in combination with once-weekly oral methotrexate.

“Left untreated or uncontrolled, rheumatoid arthritis can dramatically impact patients’ quality of life,” said Steven Stein, M.D., chief medical officer, Incyte Corporation. “Patients and physicians alike deserve better treatment options beyond today’s standard of care. If approved, baricitinib has the potential to become an oral drug option that may improve the clinical symptoms of the disease, as well as patients’ ability to perform daily activities at home and at work.”

The pivotal phase 3 trial, RA-BEAM, showed that RA patients who had previously responded inadequately to methotrexate and were not treated with any biologic, experienced significant improvement in the physical quality of life measures when taking baricitinib compared to patients treated with adalimumab or placebo. Reported improvements in patient quality of life were accompanied by an increase in physical function, and decreased pain and fatigue. The improvements in physical function, pain and physical quality of life with baricitinib were statistically significant at week 24 and week 52, compared to adalimumab.

RA-BEAM was a 52-week trial of 1,305 patients who had active, moderate-to-severe RA, despite ongoing treatment with methotrexate. Patients were randomized to placebo once-daily (n=488), baricitinib 4 mg once-daily (n=487) or adalimumab 40 mg biweekly (n=330). All patients received background methotrexate. At week 24, patients taking placebo were crossed over to the baricitinib treatment group.

In the baricitinib RA development program, no increases in adverse events leading to study drug discontinuation, malignancies, or serious infections were seen for baricitinib vs. placebo or active comparators during the controlled periods of the program. Herpes zoster was reported more frequently for baricitinib vs. placebo. The incidence rates of malignancy, serious infection and herpes zoster did not increase over time including long-term observations.

About Baricitinib
Baricitinib is a once-daily oral highly selective JAK1 and JAK2 inhibitor currently in late-stage clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK3 in kinase assays.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016, and is being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus.

About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease characterized by inflammation and progressive destruction of joints.[i,ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral conventional disease-modifying antirheumatic drugs (cDMARDs), such as methotrexate — the current standard of care  and injectable, biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.[iv] Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.[v,vi] There remains an important need to provide additional treatments to improve overall patient care.

About Baricitinib Phase 3 Trials
Lilly and Incyte conducted four pivotal phase 3 clinical trials of baricitinib in patients with moderately-to-severely active rheumatoid arthritis to support regulatory submission in most countries. An additional phase 3 study was initiated to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate-naive, inadequate responders to methotrexate, inadequate responders to conventional disease-modifying anti-rheumatic drugs, or inadequate responders to TNF inhibitors. Patients completing any of the five phase 3 studies can enroll in a long-term extension study. For additional information on this clinical trial program, please visit www.clinicaltrials.gov.

About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s web site at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atwww.lilly.com and newsroom.lilly.com/social-channels.

*The brand listed is a trademark of AbbVie and not a trademark of Eli Lilly and Company. The maker of this brand is not affiliated with and does not endorse Eli Lilly and Company or its products.

P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for rheumatoid arthritis and the RA-BEGIN and RE-BEAM trials, and reflects Lilly and Incyte’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study findings to-date, or that baricitinib will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s and Incyte’s most recent Form 10-K and 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

i American College of Rheumatology, Rheumatoid Arthritis,http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp (Accessed: May 16, 2016)
ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis,http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf (Accessed: May 16, 2016)
iii WHO Global Burden of Disease Report, (table 7, page 32) 2004,http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf (Accessed May 16, 2016)
iv Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php (Accessed: May 16, 2016)
v Rheumatoid arthritis, Lancet, https://www.ncbi.nlm.nih.gov/pubmed/27156434 (Accessed: May 19, 2016)
vi Sustained rheumatoid arthritis remission is uncommon in clinical practice, Arthritis Research & Therapy,http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/ (Accessed: May 19, 2016)

Refer to:

Nan Frient; frient_nan@lilly.com; +1-317-471-7040 (Lilly media)

Phil Johnson; johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly investors)

Catalina Loveman; cloveman@incyte.com; +1-302-498-6171 (Incyte media)

Michael Booth, DPhil; mbooth@incyte.com; +1-302-498-5914 (Incyte investors) 

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Source: Eli Lilly and Company

Related stocks: NASDAQ-NMS:INCY NYSE:LLY

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June 10, 2016 at 4:24 pm

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Baricitinib significantly reduces joint damage progression in rheumatoid arthritis in patients who do not respond to conventional DMARDs

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-Patients from pivotal 24-week phase 3 trial RA-BUILD who entered long-term extension study, RA-BEYOND, demonstrate baricitinib continues to inhibit radiographic progression of structural joint damage over one year

INDIANAPOLIS /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced that data from a pivotal long-term extension study, RA-BEYOND, was presented at the Annual European Congress of Rheumatology (EULAR 2016) in London. The findings demonstrate that baricitinib was superior to placebo at inhibiting progressive radiographic joint damage in patients with rheumatoid arthritis (RA).

“Together with the improvement of clinical and quality of life symptoms, which are so important for rheumatoid arthritis patients, a key goal of treatment is to restrict the structural damage rheumatoid arthritis causes to joints, a hallmark of the disease,” said Desiree van der Heijde, M.D., Ph.D., professor of rheumatology, Leiden University Medical Center, Leiden, The Netherlands. “These findings have shown us that, for people with rheumatoid arthritis, baricitinib may, if approved, offer an oral option which could help them restrict joint damage over an extended period of time.”

In RA-BEYOND, patients who completed the pivotal 24-week RA-BUILD study continued to receive baricitinib at the same dose of either 2 mg or 4 mg, received at the end of RA-BUILD. Patients receiving placebo at the end of RA-BUILD were switched to baricitinib 4 mg in RA-BEYOND. Following 24 weeks of treatment, baricitinib was superior to placebo in preventing progressive radiographic structural joint damage. These treatment benefits were maintained through 48 weeks of therapy. The most robust benefits across measures of progressive joint damage were observed for the 4 mg baricitinib dose.

“We are pleased to present these data from the RA-BEYOND study, which reinforce our belief in baricitinib as a next generation potential therapy for rheumatoid arthritis,” said James McGill, M.D., distinguished medical fellow and global brand development leader, Lilly Bio-Medicines. “If approved, baricitinib could offer a valuable oral option that may be appropriate for RA patients who are not currently achieving their treatment goals, even with their conventional DMARDs.”

“Findings from this long-term extension study suggest that, if approved, baricitinib has the potential to bring hope to patients with rheumatoid arthritis who deserve better treatment options,” said Steven Stein, M.D., chief medical officer, Incyte Corporation. “We are encouraged by these data, which show baricitinib has a sustained effect in preventing joint damage for those suffering with this debilitating disease.”

At the time of the present evaluation, the ongoing RA-BEYOND study had enrolled more than 2,600 patients who completed previous baricitinib trials, including RA-BUILD. The RA-BUILD study enrolled 684 patients with RA who previously had an inadequate response to, or were intolerant of, at least one conventional DMARD and had not received a biologic DMARD. Patients completing RA-BUILD and entering RA-BEYOND continued to receive the baricitinib dose received at the end of RA-BUILD. Patients receiving placebo at the end of RA-BUILD were switched to 4 mg baricitinib in RA-BEYOND.

Structural joint damage was evaluated using van der Heijde modified Sharp scores, which quantify bone erosion and joint space narrowing in X-rays of patients’ hands and feet. To account for treatment changes or missing scores, two different statistical methods were used, linear extrapolation (LE) and last observation carried forward (LOCF). Using LE, both baricitinib dose groups showed statistically significantly reduced rates of progression at weeks 24 and 48 compared to placebo. Using LOCF, only the 4 mg dose showed statistically significant reduction in progression of joint damage at weeks 24 and 48.

In RA-BUILD, the incidence of treatment-emergent adverse events and serious adverse events was similar between baricitinib and placebo. Discontinuation or interruption in treatment due to adverse events were also similar between baricitinib and placebo in RA-BUILD.

About Baricitinib
Baricitinib is a once-daily oral highly selective JAK1 and JAK2 inhibitor currently in late-stage clinical studies for inflammatory and autoimmune diseases. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a broad range of inflammatory conditions. Baricitinib demonstrates approximately 100-fold greater potency of inhibition against JAK1 and JAK2 than JAK3 in kinase assays.

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. Baricitinib was submitted for regulatory review seeking marketing approval for the treatment of rheumatoid arthritis in the U.S., European Union and Japan in Q1 2016, and is being studied in phase 2 trials for atopic dermatitis and systemic lupus erythematosus.

About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease characterized by inflammation and progressive destruction of joints.[i,ii] More than 23 million people worldwide suffer from RA.[iii] Approximately three times as many women as men have the disease. Current treatment of RA includes the use of non-steroidal anti-inflammatory drugs, oral conventional disease-modifying antirheumatic drugs (cDMARDs), such as methotrexate – the current standard of care – and injectable, biological disease-modifying antirheumatic drugs (bDMARDs) that target selected mediators implicated in the pathogenesis of RA.[iv] Despite current treatment options, many patients do not reach their therapeutic goals or sustained remission.[v,vi] There remains an important need to provide additional treatments to improve overall patient care.

About Baricitinib Phase 3 Trials
Lilly and Incyte conducted four pivotal phase 3 clinical trials of baricitinib in patients with moderately-to-severely active rheumatoid arthritis to support regulatory submission in most countries. An additional phase 3 study was initiated to support clinical development in China. The clinical trial program includes a wide range of patients including those who are methotrexate-naïve, inadequate responders to methotrexate, inadequate responders to conventional disease-modifying anti-rheumatic drugs, or inadequate responders to TNF inhibitors. Patients completing any of the five phase 3 studies can enroll in a long-term extension study. For additional information on this clinical trial program, please visit www.clinicaltrials.gov.

About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit the Company’s web site at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us atwww.lilly.com and newsroom.lilly.com/social-channels.

P-LLY

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about baricitinib as a potential treatment for rheumatoid arthritis, and the RA-BUILD and RA-BEYOND trials, and reflects Lilly and Incyte’s current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with study findings to-date, or that baricitinib will receive regulatory approvals or prove to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly’s and Incyte’s most recent Form 10-K and 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

i American College of Rheumatology, Rheumatoid Arthritis,http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp (Accessed: May 16, 2016)
ii Hand Clinics, Advances in the Medical Treatment of Rheumatoid Arthritis,http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf (Accessed: May 16, 2016)
iii WHO Global Burden of Disease Report, (table 7, page 32) 2004,http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf (Accessed May 16, 2016)
iv Arthritis Foundation, Medications for Rheumatoid Arthritis, http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php (Accessed: May 16, 2016)
v Rheumatoid arthritis, Lancet, https://www.ncbi.nlm.nih.gov/pubmed/27156434 (Accessed: May 19, 2016)
vi Sustained rheumatoid arthritis remission is uncommon in clinical practice, Arthritis Research & Therapy,http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446437/ (Accessed: May 19, 2016)

Refer to:      Nan Frient; frient_nan@lilly.com; +1-317-471-7040 (Lilly media)
Phil Johnson; johnson_philip_l@lilly.com; +1-317-655-6874 (Lilly investors)
Catalina Loveman; cloveman@incyte.com; +1-302-498-6171 (Incyte media)
Michael Booth, DPhil; mbooth@incyte.com; +1-302-498-5914 (Incyte investors)

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Source: Eli Lilly and Company

Related stocks: NASDAQ-NMS:INCY NYSE:LLY

Written by asiafreshnews

June 10, 2016 at 4:22 pm

Posted in Uncategorized

23rd Africa Oil Week / Africa Upstream 2016, Cape Town, South Africa

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CAPE TOWN, South Africa /PRNewswire/ —

31st October-4th November 2016

Governments and Corporate Players shaping Africas Oil, Gas-LNG Game

Global Pacific & Partners with ITE Group will host the 23rd Annual Africa Oil Week/Africa Upstream 2016 Conference over 31st October-4th November 2016, at the Cape Town International Convention Centre, South Africa.

(Photo: http://photos.prnewswire.com/prnh/20160601/374144 )

(Photo: http://photos.prnewswire.com/prnh/20160601/374145 )

  • Acquire knowledge from an outstanding program with 130 top-line speakers
  • Negotiate deals and farm-in/out opportunities with corporates and state oil firms
  • Meet 40 Governments and participate in emerging acreage/asset transactions
  • Discuss ventures with banks institutions, institutional investors and financiers
  • Network with Africa’s growing service and supply industry operators and firms
  • Meet 160 exhibitors and over one thousand-plus senior executive delegates
  • Hear top corporate/state decision-makers, leading thinkers and policy-makers
  • Combine corporate interest with multiple five-star social occasions with peers

Includes inter alia:

  • 23rd Africa Upstream (Tuesday-Friday)
  • 15th Africa Upstream: Africa Independents Forum (Monday)
  • ExxonMobil Ice Breaker, Aquarium (Monday)
  • 78th PetroAfricanus Dinner in Africa, with Guest Speaker (Tuesday)
  • 4th Africa Local Content Forum
  • CNBC-Africa: Panels and Plenary Debates
  • 21st African Institute of Petroleum Luncheon
  • 20th Annual “Big-Five” Board Awards
  • 7th Global Women Petroleum & Energy Club Luncheon
  • Africa Exploration Zone
  • 4th Young Professionals in Africa
  • Corporate Speakers Corner
  • Law of the Sea: Africa Workshop
  • SEEP: Africa Workshop
  • Global Oil Press Club: Africa Breakfast

Confirmed Sponsors to-date, 2016:

Lead Sponsor Tullow Oil, and key sponsors Total, Africa Oil Corp: plus, Anadarko, ACAS- Law, Aker Solutions, Business Council for Africa, Cairn Energy, Discover Exploration, EIC (Energy Industries Council), Eland Oil & Gas, ExxonMobil, Financial Times, Herbert Smith Freehills LLP, Impact Oil & Gas Ltd, MGGS B.V., Moyes & Co, Petroleum Agency SA, Petroleum Geo-Services (PGS), Petrolin Group, Polarcus DMCC, Preng & Associates, Regalis Petroleum, RPS, SacOil Holdings, Seplat Petroleum Development Company Plc, Shell International Exploration & Production B.V, The Corporate Council on Africa,

UKTI-Kenya, Veolia, Wood Group

Some of the confirmed Exhibitors to-date, include:

Ghana Oil & Gas Service Providers Association; CMS Cameron; EMGS; AziNam; Veolia; Polarcus; ION Geophysical; Maersk Oil; Spectrum; Wood Group; NAMCOR; Ministry of Mines & Energy, Namibia; Tullow Oil; Total

Visit: http://www.africa-oilweek.com

Youre only inside Africas oil and gas game, if youre at Africa Upstream 2016

Global Pacific & Partners and ITE Group plc

Source: Global Pacific & Partners

Written by asiafreshnews

June 10, 2016 at 4:11 pm

Posted in Uncategorized

Polaris Group Reports Phase III Study Results of ADI-PEG 20 plus Best Supportive Care in Advanced Hepatocellular Carcinoma

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CHICAGO  /PRNewswire/ — Polaris Group announced today that the phase III study of second line ADI-PEG 20 plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma (HCC) did not meet its primary endpoint of demonstrating overall survival (OS) benefits.  Median OS was 7.8 months for ADI-PEG 20 vs. 7.4 months for placebo (p = 0.884, HR=1.022 [95% CI: 0.847, 1.233]). However, analysis of study data revealed that patients with arginine depletion for 7 weeks or longer had a median OS of 12.5 months, compared to 6.3 months (P < 0.0001) for patients with arginine depletion lasting less than 7 weeks. It is believed that treating patients with ADI-PEG 20 depletes circulating arginine, thus starving cancer cells of arginine, which is an essential amino acid for these cancers. This results in the starved cancer cells being unable to survive and grow while leaving the body’s normal cells unharmed.  The statistically significant findings from the analysis of the study data appears to support this hypothesis. Additionally, sorafenib naive patients appear to have benefited more than those who failed prior sorafenib treatment, suggesting that ADI-PEG 20 may be more efficacious in the first-line setting.

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The study also showed ADI-PEG 20 was well tolerated, with the most common side effects being fatigue and decrease of appetite. The full study results were presented at a plenary session by the lead investigator, Dr. Ghassan K. Abou-Alfa from the Memorial Sloan Kettering Cancer Center, at the American Society of Clinical Oncology’s 2016 annual meeting in Chicago.

“We are encouraged to see the overall survival benefit demonstrated by ADI-PEG 20 in the patient population with prolonged arginine depletion, which supports the theory that arginine depletion can be a safe way to extend life for these very ill patients,” said John Bomalaski, M.D., Executive Vice President, Medical Affairs at Polaris Pharmaceuticals, Inc. “We have already identified new combination therapy strategies that can significantly prolong arginine depletion and enable ADI-PEG 20 to synergize with current cancer treatments as shown in early stage clinical studies. We are making plans to move these combination therapies into late stage clinical development in the near future.”

About ADI-PEG 20

ADI-PEG 20 is a biologic being developed by Polaris Group to treat cancers carrying a major metabolic defect that renders them unable to internally synthesize arginine. Because arginine is essential for protein synthesis and survival of cells, these cancer cells become dependent upon the external supply of arginine to survive and grow. ADI-PEG 20 is designed to deplete the external supply of arginine, causing arginine-dependent cancer cells to die while leaving the patient’s normal cells unharmed.  Multiple cancers have been reported to have a high degree of arginine-dependency and can potentially be treated with ADI-PEG 20.

About Polaris Group

Polaris Group specializes in the research and development of protein drugs to treat cancer and other debilitating diseases. In addition to the ADI-PEG 20 program, Polaris Group is developing other biotherapeutic agents including a small molecule drug program that utilizes a rational structure-based approach to design novel compounds that inhibit the biological function of cancer-related protein targets.

For additional information please visit www.polarispharma.com

Source: Polaris Group

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June 10, 2016 at 4:02 pm

Posted in Uncategorized

Takeda to Present New Data at the American Diabetes Association’s 76th Scientific Sessions

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-Eight abstract presentations include new analyses from the EXAMINE trial and real-world databases

OSAKA, Japan /PRNewswire/ — Takeda Pharmaceuticals Company Limited [TSE: 4502], (“Takeda”) will present eight abstracts at the American Diabetes Association’s 76th Scientific Sessions, which takes place inNew Orleans, LA, on June 10-14, 2016. These abstracts include new analyses from the EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) trial, which assessed patients with Type 2 diabetes who were at a high cardiovascular risk due to recent acute coronary syndrome (ACS),1 as well as several real-world studies.

“Type 2 diabetes is a progressive disease that can lead to serious cardiovascular comorbidities,” said Robert Jackson, MD, MBA, Vice President, Global Medical Head-CVM, Global Medical Affairs, Takeda. “Data from the Phase 3 EXAMINE trial and analyses on the real-world use of diabetic therapy can help physicians in making the best treatment choice for their patients and further our understanding of this complex disease.”

Real-world data, or data collected from “real-life” patient experiences, can provide additional insight into treatment plans in routine clinical practice. These data can complement or supplement clinical trial findings, which evaluate a medicine’s safety and efficacy in a more controlled setting.

A full list of Takeda-sponsored abstracts to be presented at the American Diabetes Association’s 76th Scientific Sessions, all of which are embargoed until 10:00 a.m. Central Time on Saturday, June 11, 2016, follows:

Alogliptin Abstracts Accepted As:

Oral Presentation:

  • Abstract # 2016-A-3107-Diabetes: Optimal Management of Glycaemia in Older Type 2 Diabetes Patients: Relationship Between Treatment Choice, HbA1c Control and Event Incidence (Gordon J., McEwan P., Evans M., et al.)

Moderated Posters:

  • Abstract # 2016-A-2307-Diabetes: Mortality Findings from the EXAMINE Trial (Kupfer S., Cannon C., Mehta C., et al.)
  • Abstract # 2016-A-2395-Diabetes: Hypoglycemia is Associated with Increased Risk of Cardiovascular Events: Results from the EXAMINE Trial (Bergenstal R., Cannon C., Kupfer S., et al.)

Posters:

  • Abstract # 2016-A-4160-Diabetes: Alogliptin in Triple Therapy with Metformin and Sulfonylureas Provides Significant Reductions in HbA1c and is Well Tolerated: an Analysis from the EXAMINE Trial (Cannon C., Howitt, H. Khunti K. et al.)
  • Abstract # 2016-A-3512-Diabetes: Renal Outcomes Associated with Alogliptin vs. Placebo in Patients with Type 2 Diabetes Mellitus and Recent Acute Coronary Syndrome: Results from the EXAMINE Trial (White W., Charytan D., Wilson C., et al.)
  • Abstract # 2016-A-3109-Diabetes: Validating Prescribing Choice in Older Patients with Type 2 Diabetes: an Economic Assessment of Patient Outcomes Using Routinely Collected Primary Care Data (Gordon J., McEwan P., Evans M., et al.)
  • Abstract # 2016-A-6040-Diabetes: Growth Differentiation Factor (GDF)-15 and Long-term Outcomes in Patients with Diabetes Mellitus in the EXAMINE Trial (Cannon C., Jarolim P., Bakris G., et al.)

Abstract Only:

  • Abstract # 2016-A-2067-Diabetes: Comparison of Alogliptin/Pioglitazone Fixed Dose Combination (APC) with DPP4 Inhibitor Monotherapy in Reducing HbA1c (Szymanki K., Klink A., Visaria J., Dybala C.)

About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, the more recent developments of alogliptin and the fixed-dose combinations (FDC) alogliptin and pioglitazone, and alogliptin and metformin HCl. The company’s diverse diabetes portfolio show Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About the EXAMINE Trial
EXAMINE, a large, randomized, double-blind, placebo-controlled outcomes study, was completed as a result of the U.S. FDA 2008 Guidance, titled “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” for all Type 2 diabetes treatments under development since the issuance of the guidance.1,2 The EXAMINE trial was designed to evaluate CV safety following treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care, in patients with Type 2 diabetes who were at high risk for major adverse cardiovascular events (MACE) due to recent acute coronary syndrome (ACS).1 The trial’s primary objective was to evaluate non-inferiority of CV risk based on a primary composite endpoint of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke.

EXAMINE randomized 5,380 patients in 49 countries with Type 2 diabetes with an ACS within the previous 15-90 days.1 The EXAMINE primary endpoint of non-inferiority compared to placebo in addition to standard of care was met, showing no increase in CV risk in a Type 2 diabetes patient population at high risk for CV events based on the primary composite endpoint of CV death, nonfatal MI and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin (n=305) and placebo (n=316) groups (in 11.3 percent of patients vs. 11.8 percent of patients during a median follow-up period of 18 months; hazard ratio (HR), 0.96; upper boundary of the one-sided repeated CI, 1.16). These data, demonstrate that alogliptin does not increase CV risk in Type 2 diabetes patients at high-risk for MACE due to a recent ACS.

About Alogliptin
Alogliptin is a DPP-4 inhibitor for the treatment of Type 2 diabetes in adults as an adjunct to diet and exercise. DPP-4 inhibitors are designed to slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.

Alogliptin is approved as a monotherapy and also in fixed-dose combination (FDC) with pioglitazone and metformin HCl for the treatment of Type 2 diabetes in adults as adjuncts to diet and exercise. These therapies are not for treatment of Type 1 diabetes or diabetic ketoacidosis.

Takeda launched alogliptin in Japan in 2010. Since that time alogliptin and/or its FDC therapies have been approved in over 30 countries across the globe including Brazil, China, the European Union, Mexico, Russia, South Korea andthe United States. Diabetes prevalence continues to grow worldwide, with more than 415 million people impacted by diabetes.3 As the disease becomes increasingly prevalent, Takeda remains focused on expanding access of alogliptin, especially in emerging markets.

INDICATIONS

Alogliptin

Alogliptin is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Alogliptin/Metformin

Alogliptin/Metformin is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin; in combination with pioglitazone (i.e., triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone; in combination with insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.

Alogliptin/Pioglitazone

Alogliptin/Pioglitazone is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; in combination with metformin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Alogliptin/Pioglitazone can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type 2 diabetes mellitus already being treated with this combination.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS – for Alogliptin, Alogliptin/Metformin and Alogliptin/Pioglitazone

Acute Pancreatitis – Postmarketing events of acute pancreatitis have been reported for alogliptin and have been associated with DPP-4 inhibitors. After initiation of alogliptin, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, Alogliptin/Metformin or Alogliptin/Pioglitazone should be promptly discontinued and appropriate management should be initiated.

Hypersensitivity Reactions – Postmarketing events of serious hypersensitivity reactions in patients with alogliptin such as angiodema and severe cutaneous adverse reactions including Stevens-Johnson syndrome have been reported and have been associated with DPP-4 inhibitors. If a serious hypersensitivity reaction is suspected, Alogliptin/Metformin or Alogliptin/Pioglitazone should be discontinued.

Hepatic Effects – Postmarketing reports of hepatic dysfunction including hepatic failure, sometimes fatal, have been received. Baseline liver test panel is recommended. Patients should be observed closely for possible liver abnormalities. Perform liver tests promptly in patients who report symptoms that may indicate liver injury. If an abnormally is found and an alternative etiology is not established, consider discontinuation of Alogliptin/Metformin or Alogliptin/Pioglitazone.

Hypoglycemia – Insulin and insulin secretagogues are known to cause hypoglycemia. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with alogliptin, Alogliptin/Metformin or Alogliptin/Pioglitazone.

WARNINGS AND PRECAUTIONS – for Alogliptin/Metformin

Lactic Acidosis – Lactic Acidosis is very rare, but serious and potentially fatal metabolic complication that can occur due to metformin accumulation. Reported cases have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing other associated risk factors such as excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia. In particular, elderly patients have a tendency to have decreased renal function; hence treatment of the elderly should be accompanied by careful monitoring of renal function (creatinine clearance). If renal acidosis is suspected, treatment with Alogliptin/Metformin should be discontinued.

Renal Function – Metformin is known to be substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increase with the degree of impairment of renal function. Thus patients with raised serum creatinine levels (or serum creatinine levels >135 mcmol/L in males and > 110 mcmol/L in females or creatinine clearance < 60 mL/min) should not receive alogliptin and metformin. Appropriate assessment of renal function is recommended prior to initiation of treatment and periodically thereafter.

WARNINGS AND PRECAUTIONS – for Alogliptin/Pioglitazone

Hepatic Function – Alogliptin/Pioglitazone must not be used in patients with hepatic impairment.

Fluid Retention and Cardiac Failure – Pioglitazone, like other thiazolidinediones, can cause fluid retention, which may exacerbate or precipitate heart failure. Patients with heart failure should be monitored for its signs and symptoms, and discontinuation of pioglitazone should be considered if any deterioration in cardiac status occurs.

Edema – Dose-related edema may occur. Use with caution in patients with edema.

Bladder Cancer – Data suggest an increased risk of bladder cancer in pioglitazone users. Data also suggest that the risk increased with duration of use. Do not use Alogliptin/Pioglitazone in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Tell patients to promptly report any sign of hematuria or other symptoms such as dysuria urgency as these may be due to bladder cancer.

WARNINGS AND PRECAUTIONS – for Alogliptin             

Cardiac Failure: Experience of alogliptin use in clinical trials in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.

CONTRAINDICATIONS

Alogliptin

Alogliptin is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin-containing products such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.

Alogliptin/Metformin

Alogliptin/Metformin is contraindicated in patients with known hypersensitivity to alogliptin, metformin hydrochloride, or any of its components. Additionally, due to the metformin hydrochloride component, Alogliptin/Metformin is contraindicated in patients with the following conditions: Renal disease or renal dysfunction and Diabetic ketoacidosis, diabetic coma or pre-coma.

Alogliptin/Pioglitazone

Alogliptin/Pioglitazone is contraindicated in patients with known hypersensitivity to alogliptin, pioglitazone or any of its components. Initiation of alogliptin/pioglitazone treatment is contraindicated in patients with cardiac failure (NYHA Class III or IV).

DRUG INTERACTIONS

Use with CYP2C8 strong inhibitors (i.e., gemfibrozil or inducers (i.e., rifampin) may require dose adjustment.

ADVERSE REACTIONS

Alogliptin – Adverse reactions include upper respiratory infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux disease, pruritis, and rash.

Alogliptin/Metformin – Adverse reactions include gastroesophageal reflux disease, headache, upper respiratory tract infection, pruritis, nasopharangitis, hypersensitivity reactions, hepatic failure and acute pancreatitis, lactic acidosis, decreased vitamin B12, diarrhea, nausea, vomiting, flatulence, abdominal pain, anorexia, rash and taste disorder.

Alogliptin/Pioglitazone – Adverse reactions include upper respiratory tract infections, sinusitis, headache, nausea, dyspepsia, abdominal pain, pruritis, myalgia, oedema peripheral, weight increased.

Please consult with your local regulatory agency for approved labeling in your country.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

References

1 White, W.B. et al. (2013) Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes. The New England Journal of Medicine. [online] nejm.org. Last accessed May 4, 2016, available at:
http://www.nejm.org/doi/full/10.1056/NEJMoa1305889.
2 Food and Drug Administration (FDA). Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes 2008. Last accessed May 4, 2016, available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf.
3 International Diabetes Federation (IDF). Diabetes Atlas, Seventh Edition 2015. Last accessed May 4, 2016, available at: http://www.idf.org/diabetesatlas.

Source: Takeda Pharmaceutical Company Limited

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June 10, 2016 at 3:55 pm

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