WorldQuant Completes Inaugural International Quant Championship

11,000 Data Scientists Competed from over 1,000 Universities across 80 Nations

47 Finalists Traveled from 15 Countries for the Finals in Singapore

OLD GREENWICH, Conn. & SINGAPORE-Sunday 30 September 2018 [ AETOS Wire ]

(BUSINESS WIRE) -- WorldQuant, the global quantitative asset management firm, announced the completion of its inaugural International Quant Championship, a competition designed to simulate the best algorithms with over 11,000 participants from more than 1,000 universities across 80 countries. The 47 finalists traveled from 15 countries for the ultimate competition in Singapore, following regional finals where over 500 teams competed in Bangkok, Beijing, Hanoi, Moscow, Mumbai, Seoul, Singapore and Taipei.

“The scale and success of our competition cements our philosophy that talent is distributed globally and there remains an untapped pool of extremely smart data scientists seeking professional opportunities that can be delivered virtually. Our vision remains to further scale WorldQuant’s virtual network to bring opportunity to any individual with the interest and ability to put their expertise to use,” said Igor Tulchinsky, Founder, Chairman and CEO of WorldQuant.

The International Quant Championship builds on the 20 competitions that the WorldQuant Virtual Research Center has hosted over the past five years to uncover talent globally, foster interest in quantitative finance and allow participants to compete with top quantitative minds. Participants come from various disciplines, including computer science, engineering, physics, finance, business administration and mechanics, and are evaluated on a range of skills, including the use of operators and datasets and the understanding, selection and execution of high-quality algorithms.

“Academic theory does not directly teach the discipline of quantitative finance, so it is up to industry to build up the skills required by individuals to become successful quants and creating practical algorithm simulations is an essential part of that process. We are also pleased that over a quarter of our International Quant Championship contestants were women, including the winning team of three Russian women living in France,” said Nitish Maini, General Manager of WorldQuant Virtual Research Center.

WorldQuant Virtual Research Center has more than 70,000 users from 180 countries and over 2,000 universities who are given the opportunity to learn about quantitative finance, build financial models, participate in global competitions and be considered for research consultant positions. WorldQuant has discovered over 1,000 consultants through the Virtual Research Center and users have collectively run over 93 million simulations on the Virtual Research Center’s online platform.

About WorldQuant

WorldQuant is a global quantitative asset management firm that was founded in 2007 by Igor Tulchinsky and has over $7 billion in assets under management. The firm has more than 25 offices in 15 countries and over 700 employees and 1,000 consultants. WorldQuant develops and deploys systematic investment strategies across a variety of asset classes in global markets, utilizing a proprietary research platform and investment process. For more information on WorldQuant’s culture and philosophy, please visit www.WeAreWorldQuant.com.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180928005571/en/

Contacts

Media contacts

Beatriz Garcia / Christina Tilt

worldquant@brunswickgroup.com

+1 212 333 3810

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Statement on U.S. Supreme Court Decision to Hear Rimini Street Appeal for $12.8 Million

U.S. Supreme Court to resolve U.S. Circuit Court dispute over copyright law


LAS VEGAS-Sunday 30 September 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today issued the following statement in regard to the Oracle v. Rimini Street case:

Statement:

“On September 27, 2018, the United States Supreme Court granted Rimini Street, Inc.’s petition for review in Oracle v. Rimini Street appealing the decision of the Ninth Circuit Court of Appeals allowing an award of non-taxable costs as part of the final judgment awarded to Oracle by the U.S. District Court for the District of Nevada. The Company’s appeal argues that the award of $12.8 million of non-taxable costs is in direct conflict with decisions in other U.S. Federal Circuit Courts and decisions of the Supreme Court. Rimini Street is seeking a refund of the $12.8 million from Oracle.

Rimini Street is pleased that the Supreme Court has decided to hear this important case and resolve this key point of law, despite Oracle’s opposition. We look forward to this next step in recovering an additional $12.8 million from Oracle.

No amount of bluster and attempted media spin by Oracle can obfuscate the facts that the jury found Rimini Street’s past infringement was ‘innocent’ and not intentional, that Oracle lost 11 out of 12 claims against the Company, that Oracle lost all claims against Rimini Street’s CEO, and that Oracle has already been ordered by the U.S. Court of Appeals to refund $21.5 million of amounts previously paid by Rimini Street in 2016.

Rimini Street is aggressively pursuing claims and additional appeals against Oracle in Federal Court.”

About Rimini Street, Inc.

Rimini Street, Inc. (Nasdaq: RMNI) is a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products. The Company has redefined enterprise software support services since 2005 with an innovative, award-winning program that enables licensees of IBM, Microsoft, Oracle, Salesforce, SAP and other enterprise software vendors to save up to 90 percent on total maintenance costs. Clients can remain on their current software release without any required upgrades for a minimum of 15 years. Over 1,620 global Fortune 500, midmarket, public sector and other organizations from a broad range of industries currently rely on Rimini Street as their trusted, third-party support provider. To learn more, please visit http://www.riministreet.com, follow @riministreet on Twitter and find Rimini Street on Facebook and LinkedIn. (C-RMNI)

Forward-Looking Statements

Certain statements included in this communication are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may,” “should,” “would,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “seem,” “seek,” “continue,” “future,” “will,” “expect,” “outlook” or other similar words, phrases or expressions. These forward-looking statements include, but are not limited to, statements regarding our expectations as to future events, future opportunities and growth initiatives. These statements are based on various assumptions and on the current expectations of management and are not predictions of actual performance, nor are these statements of historical facts. These statements are subject to a number of risks and uncertainties regarding Rimini Street’s business, and actual results may differ materially. These risks and uncertainties include, but are not limited to, continued inclusion in the Russell 2000 Index in the future, changes in the business environment in which Rimini Street operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Rimini Street operates; adverse litigation developments or in the government inquiry; the final amount and timing of any refunds from Oracle related to our litigation; our ability to raise additional equity or debt financing on favorable terms; the terms and impact of our 13.00% Series A Preferred Stock; changes in taxes, laws and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the success of our recently introduced products and services, including Rimini Street Mobility, Rimini Street Analytics, Rimini Street Advanced Database Security, and services for Salesforce Sales Cloud and Service Cloud products; the loss of one or more members of Rimini Street’s management team; uncertainty as to the long-term value of Rimini Street’s equity securities, including its common stock and its Preferred Stock; and those discussed under the heading “Risk Factors” in Rimini Street’s Quarterly Report on 10-Q filed on August 9, 2018, which disclosures amend and restate the disclosures appearing under the heading “Risk Factors” in Rimini Street’s Annual Report on Form 10-K filed on March 15, 2018, and as updated from time to time by Rimini Street’s future Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings by Rimini Street with the Securities and Exchange Commission. In addition, forward-looking statements provide Rimini Street’s expectations, plans or forecasts of future events and views as of the date of this communication. Rimini Street anticipates that subsequent events and developments will cause Rimini Street’s assessments to change. However, while Rimini Street may elect to update these forward-looking statements at some point in the future, Rimini Street specifically disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Rimini Street’s assessments as of any date subsequent to the date of this communication.

© 2018 Rimini Street, Inc. All rights reserved. “Rimini Street” is a registered trademark of Rimini Street, Inc. in the United States and other countries, and Rimini Street, the Rimini Street logo, and combinations thereof, and other marks marked by TM are trademarks of Rimini Street, Inc. All other trademarks remain the property of their respective owners, and unless otherwise specified, Rimini Street claims no affiliation, endorsement, or association with any such trademark holder or other companies referenced herein.

Contacts

Rimini Street, Inc.
Michelle McGlocklin, +1 925-523-8414
mmcglocklin@riministreet.com


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Africa’s Leading BCM Services Provider Secures Client Data Using ExaGrid

 ContinuitySA Chooses ExaGrid as its Standard Go-to-Market Strategy



WESTBOROUGH, Mass. -Sunday 30 September 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- ExaGrid®, a leading provider of hyper-converged secondary storage for backup, today announced that ContinuitySA, Africa’s leading provider of business continuity management (BCM) and resilience services, has chosen ExaGrid’s disk-based backup systems as its standard offering and go-to-market strategy for clients needing to establish or upgrade their backup environments.

In an age of escalating events that threaten mission-critical business data, ContinuitySA’s fully managed services assist clients in understanding their risk profile and developing an appropriate risk-mitigation strategy to enhance business resilience, including Information and Communications Technology (ICT) resilience, enterprise risk management, work area recovery, and BCM advisory.

“We offer fully-managed solutions to our clients for protection of their environments. Using ExaGrid is pivotal in our offerings of backup-as-a-service and disaster-recovery-as-a-service,” said Bradley Janse van Rensburg, CTO of ContinuitySA. "We evaluated a number of virtualized backup solutions but weren't able to find one that offered the level of price-performance that would meet our clients' requirements until we looked at ExaGrid and were impressed with its performance and data deduplication. The system scales quite efficiently, and there are encrypted versions of its appliances at attractive price points. We converted from other technology to ExaGrid, and we’re happy we did.”

A growing number of ContinuitySA’s clients have switched to ExaGrid, most of whom are running Veeam as their backup application. “Over 90% of the workloads that we protect are virtual, so our main strategy is to use Veeam to back up to ExaGrid,” said Janse van Rensburg. “The ExaGrid-Veeam solution provides long-term retention for our clients through the deduplication capabilities of both products. Reliability and consistency of the solution are critical to us to ensure that we can quickly recover a client’s data if they experience an outage.”

ContinuitySA and its clients are pleased with the many improvements to their backup environment since adding ExaGrid, including:

    ExaGrid-Veeam data deduplication reduced storage consumption across the board.
    One client’s backup window was reduced from two days to one hour, and restoring a server took four hours instead of four days when using its previous backup solution.
    Despite a few ransomware attacks, backups remain uncompromised.

“There have been several ransomware attacks on client data, but our backups have been safe and uncrackable. We are always able to restore our clients’ data and save them from complete data loss or the need to pay ransomware funds. We have had zero data loss while using ExaGrid,” said Janse van Rensburg.

Read the complete ContinuitySA customer success story to learn more about the company’s experience using ExaGrid.

ExaGrid’s published customer success stories and enterprise stories number over 360, more than all other vendors in the space combined. These stories demonstrate how satisfied customers are with ExaGrid’s unique architectural approach, differentiated product, and unrivalled customer support. Customers consistently state that not only is the product best-in-class, but ‘it just works.’

About ContinuitySA
ContinuitySA is Africa’s leading provider of business continuity management and resilience services to public and private organisations. Delivered by highly skilled experts, its fully managed services include ICT resilience, enterprise risk management, work area recovery, and BCM advisory—all designed to enhance business resilience in an age of escalating threat. By helping clients understand their risk profile, and then developing an appropriate risk-mitigation strategy, ContinuitySA provides peace of mind for all stakeholders.

ContinuitySA operates the continent’s biggest network of recovery centres, with more than 20 000m2 of space in Gauteng (Midrand and Randburg), the Western Cape (Tyger Valley), in Kwa-Zulu Natal (Mount Edgecombe) as well in Botswana, Mozambique, Kenya, and Mauritius. ContinuitySA is a Gold Partner of the Business Continuity Institute and was inducted into the prestigious BCI Hall of Fame in 2016.

ContinuitySA. Our business is keeping you in business.

Additional information about ContinuitySA can be found at www.continuitysa.com. Network with ContinuitySA on Google+, LinkedIn, Twitter, and Facebook.

About ExaGrid
ExaGrid provides hyper-converged secondary storage for backup with data deduplication, a unique landing zone, and scale-out architecture. ExaGrid’s landing zone provides for the fastest backups, restores, and instant VM recoveries. Its scale-out architecture includes full appliances in a scale-out system and ensures a fixed-length backup window as data grows, eliminating expensive forklift upgrades. Visit us at www.exagrid.com or connect with us on LinkedIn. See what our customers have to say about their own ExaGrid experiences and why they now spend significantly less time on backup.

ExaGrid is a registered trademark of ExaGrid Systems, Inc. All other trademarks are the property of their respective holders.





View source version on businesswire.com: https://www.businesswire.com/news/home/20180927005020/en/

Contacts

ExaGrid
Christine Murphy, +1-508-898-2872 x248
cmurphy@exagrid.com


Permalink : https://www.aetoswire.com/news/africarsquos-leading-bcm-services-provider-secures-client-data-using-exagrid/en

IDEMIA Has Been Selected to Provide Ontario Lottery and Gaming Corporation (OLG) with Next Generation Lottery Terminals in Canada

COLOMBES, France-Sunday 30 September 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- IDEMIA, the global leader in Augmented Identity, is proud to reinforce its relationship with OLG by providing next generation camera-based Lottery Terminals. Thanks to this new technology developed by IDEMIA, OLG will be able to enhance its relationship with players and improve the customer experience.

With more than 25 years of experience in Point of Sale and Lottery / Betting technologies, IDEMIA has already deployed over 280,000 terminals worldwide. Thanks to its industrial leadership and its capacity to innovate, IDEMIA has been able to design the ELITE-Terminals. This next generation solution enables lottery organizations to benefit from more than just a lottery terminal and will allow OLG to improve the retail experience for both customers and retailers.

The ELITE-Terminal offers speed and ease for processing documents (e.g. play slips, receipts, instant tickets, etc.) for retailers; as well as new opportunities for designing innovative play slips for special events.

For this long-term specific project, IDEMIA will work with OLG over the next 18 to 24 months to rollout 10 700 new terminals and associated ticket checkers in retail locations. IDEMIA is also collaborating with Rogers Communication Canada Inc. as the Telecommunications Network Services Provider, with NCR Canada Corp. as the Lottery Terminal Support and Maintenance Services Provider and with FDJ Gaming Solutions (a subsidiary of la Française des Jeux), IDEMIA’s long-term partner, for the delivery of the Lottery Terminal middleware and associated remote management tools.

« IDEMIA is proud to work once again with Ontario Lottery and Gaming Corporation and provide them with the next generation of camera-based Lottery Terminals. IDEMIA has a worldwide experience and the ability to implement, integrate, and maintain leading edge solutions in the lottery and gaming industry. To date, more than 60,000 units of ELITE-Terminals have been sold worldwide, showing strong success for this ground-breaking technology », said Philippe Larcher, Deputy General Manager for Citizen Identity & Public Security activities at IDEMIA.

« Replacing and updating Lottery terminals will help improve the way OLG connects with customers in a responsible way, » said Greg McKenzie, OLG’s Chief Operating Officer. « It’s part of OLG’s plan to ensure our technology is responsive to changing market expectations. New terminals will allow OLG to add more products and provide a better retail experience for customers, while delivering enhanced features for retailers. »

About IDEMIA

IDEMIA, the global leader in Augmented Identity for an increasingly digital world, has the ambition to empower citizens and consumers alike to interact, pay, connect, travel and vote in ways that are now possible in a connected environment. Securing our identity has become mission critical in the world we live in today. By standing for Augmented Identity, we reinvent the way we think, produce, use and protect this asset, whether for individuals or for objects. We ensure privacy and trust as well as guarantee secure, authenticated and verifiable transactions for international clients from Financial, Telecom, Identity, Public Security, Gaming and IoT sectors.
OT (Oberthur Technologies) and Safran Identity & Security (Morpho) have joined forces to form IDEMIA. With close to $3 billion in revenues and 14,000 employees around the world, IDEMIA serves clients in 180 countries.

For more information, visit www.idemia.com / Follow @IdemiaGroup on Twitter

About OLG

OLG is a crown agency that develops world-class gaming entertainment for the Province of Ontario. Acting in a socially responsible way, OLG conducts and manages land-based gaming facilities; the sale of province-wide lottery games; PlayOLG Internet gaming; and the delivery of bingo and other electronic gaming products at Charitable Gaming Centres. OLG is also helping to build a more sustainable horse racing industry in Ontario. Since 1975, OLG has provided nearly $47 billion to the people and Province of Ontario to support key government priorities like health care; the treatment, prevention and research of problem gambling; and support for amateur athletes. Each year, proceeds from OLG’s operations also support host communities, Ontario First Nations, lottery retailers and local charities across the province.



Contacts

Press:
Havas Paris
Hanna SEBBAH
idemia@havas.com

Permalink : https://www.aetoswire.com/news/idemia-has-been-selected-to-provide-ontario-laottery-and-gaming-corporation-olg-with-next-generation-lottery-terminals-in-canada/en

FLIR Systems Awarded US Federal Aviation Administration Contract with Ceiling Value of $94.3M to Support Mobile Surveillance Capability Program

WILSONVILLE, Ore.-Friday 28 September 2018 [ AETOS Wire ]

(BUSINESS WIRE) -- FLIR Systems, Inc. (NASDAQ: FLIR) announced today that it has been awarded an Indefinite Delivery, Indefinite Quantity (IDIQ) contract from the Federal Aviation Administration Logistics Center (FAALC) in support of the United States (U.S.) Department of Homeland Security’s (DHS) Mobile Surveillance Capability (MSC) program. The IDIQ contract has a ceiling value of $94.3 million with a first order of $12.2 million on contract to provide Line Replaceable Units (LRUs) mounted on MSC vehicles, including FLIR TacFLIR 380, FLIR R20SS radar, FLIR Cameleon management software, power storage and management systems, and other electro-mechanical sub systems to support the MSC vehicles. Through an Interagency Agreement with DHS, the FAALC serves as an independent government entity providing engineering, technical, and logistics services to support US Customs and Border Protection (CBP).

“We are pleased to provide FLIR sensing and command center software technology to support the FAALC’s mission,” said James Cannon, President and CEO at FLIR. “Our technology will provide enhanced capabilities and continued mission readiness for CBP. The contract also delivers on a major franchise program opportunity for the company, and we are committed to support this program and the men and women securing our borders.”

The contract has an initial two-year base period with eight individual option years. It will be managed and executed by the FLIR Government and Defense Business Unit in the company’s Elkridge, Maryland, facility.

About FLIR Systems

Founded in 1978 and headquartered in Wilsonville, Oregon, FLIR Systems is a world-leading maker of sensor systems that enhance perception and heighten awareness, helping to save lives, improve productivity, and protect the environment. Through its nearly 3,500 employees, FLIR’s vision is to be “The World’s Sixth Sense” by leveraging thermal imaging and adjacent technologies to provide innovative, intelligent solutions for security and surveillance, environmental and condition monitoring, outdoor recreation, machine vision, navigation, and advanced threat detection. For more information, please visit www.flir.com and follow @flir.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may contain words such as “anticipates,” “estimates,” “expects,” “intends,” and “believes” and similar words and expressions and include the assumptions that underlie such statements. Such statements are based on current expectations, estimates, and projections based, in part, on potentially inaccurate assumptions made by management. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors. Such forward-looking statements speak only as of the date on which they are made and FLIR does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of this release, or for changes made to this document by wire services or Internet service providers.

Contacts

FLIR Systems, Inc.
Media Contact
Tim McDowd, +1-503-498-3146
tim.mcdowd@flir.com
or
Investor Relations
Jay Gentzkow, +1-503-498-3809
jay.gentzkow@flir.com

Permalink : https://www.aetoswire.com/news/flir-systems-awarded-us-federal-aviation-administration-contract-with-ceiling-value-of-943m-to-support-mobile-surveillance-capability-program/en

GSMA Reveals First Details for MWC19 Barcelona

 GSMA Rebrands Annual Barcelona Convention, Reflecting Evolution of Communications Beyond Mobile; Citi, HTC, Vimeo, Vodafone Among Keynotes



LONDON-Saturday 29 September 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- The GSMA today announced the first details of MWC19 Barcelona (formerly Mobile World Congress), including keynote speakers, prominent participating companies, programmes and events. MWC19 Barcelona will take place 25-28 February 2019, with events being staged at Fira Gran Via, Fira Montjuïc and La Farga L’Hospitalet. The GSMA expects that more than 107,000 professionals from over 200 countries and territories, representing a wide range of industry sectors, will attend MWC19 Barcelona.

Under the event theme of “Intelligent Connectivity”, MWC19 Barcelona will highlight the intersection of “hyper-connectivity”, enabled by 5G and the Internet of Things (IoT), and “intelligence”, delivered by artificial intelligence (AI) and big data. In addition to the core elements of intelligent connectivity, MWC19 will explore the key topics of Content, Digital Trust, Digital Wellness and The Future.

“Underpinned by 5G and AI, intelligent connectivity is a major technological force that will shape how the world communicates well into the future,” said Michael O’Hara, Chief Marketing Officer, GSMA. “Attendees will get to experience the impact of intelligent connectivity firsthand, across the conference and exhibition and the many programmes and events taking place at MWC19 Barcelona.”

Brand Update for Flagship Event Series

The GSMA also announced that it has rebranded its flagship event series, moving from “Mobile World Congress” to “MWC”, a refresh that will be applied across all three global MWC events. The 2019 events will be referred to as MWC19 Barcelona, MWC19 Shanghai and MWC19 Los Angeles.

“This marks the first major brand update for our global event portfolio in over a decade,” commented O’Hara. “We are rapidly moving to a world where mobile will connect everyone and everything, but at the same time, we are expanding our reach beyond mobile. The new brand retains the familiar acronym, while placing less emphasis on ‘mobile’ to reflect the broadening scope of communications today.”

Execs from Citi, HTC, Vimeo, Vodafone to Keynote

The GSMA revealed the first confirmed keynote speakers for MWC19 Barcelona, with executives representing a wide range of industries including mobile, e-commerce, financial services and media and entertainment. Executives scheduled to headline the four-day Barcelona conference programme include:

    James Forese, President, Citi
    Blythe Masters, CEO, Digital Asset Holdings
    Rich Williams, CEO, Groupon
    Mats Granryd, Director General, GSMA
    Cher Wang, Founder and CEO, HTC
    Anjali Sud, CEO, Vimeo
    Nick Read, Chief Executive Officer-Designate, Vodafone Group

For more information on the conference, visit www.mwcbarcelona.com/conference-programmes/.

More Than 2,400 Leading Companies to Participate at MWC19 Barcelona

MWC19 Barcelona will bring together leading players from across the mobile ecosystem, as well as adjacent industry sectors such as automotive and consumer electronics, showcasing the latest technologies, products and services. More than 2,400 companies will participate at MWC19, including major brands such as Accenture, Alibaba Cloud, ARM, AT&T, BMW, Cisco Systems, Deutsche Telekom, Ericsson, Facebook, Google, HTC, Huawei, Intel, Lenovo, LG, Mercedes-Benz, Microsoft, NTT DOCOMO, Nokia Solutions and Networks, Ooredoo, Oracle, Orange, Qualcomm Incorporated, SAP, SEAT, SK Telecom, Telefónica, Verizon, Vodafone, Xiaomi and ZTE. The show floor will also include more than 40 country and regional pavilions.

One of the perennial favourites at MWC, the GSMA Innovation City will put a spotlight on how intelligent connectivity – 5G, IoT, AI and big data – is impacting and improving the lives of citizens, enterprises and governments around the world. Visitors will experience intelligent connectivity across a range of sectors including entertainment, transportation, public services and industry, among others, with demonstrations from partners Google, Huawei, KT Corporation, Sierra Wireless and Turkcell, as well as GSMA industry and advocacy programmes. For more information, visit www.mwcbarcelona.com/exhibition/gsma-innovation-city/.

NEXTech Hall 8.0 is the destination for MWC19 attendees seeking cutting-edge technology trends, including AI, IoT, drones, robotics and virtual reality/augmented reality (AR/VR), among others. NEXTech will feature several specialised technology areas including the Drone Zone, the Graphene Pavilion and the IoT Pavilion, alongside the NEXTech Lab, an open theatre where leading industry players will present their latest innovations.

New for 2019, the GSMA introduced “Digital Planet: The Connected Experience” in Hall 8.1, an evolution of App Planet, which has been a mainstay of MWC since 2010. Digital Planet will include over 200 app, ad tech, e-commerce and marketing communication solution providers and other organisations focused on creating connected experiences and solutions that will positively impact citizens’ daily lives. Digital Turbine, Infobip, MessageBird and Toyota are among the companies that will be showcased in Digital Planet. Generalitat de Catalunya has been confirmed as the Official Sponsor of Digital Planet.

The GSMA also announced several other sponsors for MWC19 Barcelona. Husqvarna Group and SES Networks have joined as Networking Garden Sponsors, alongside returning Networking Garden Sponsors Android and Citi. Accenture also continues its support for the Women4Tech Programme as the Official Sponsor of the Women4Tech Summit. For more information on the exhibition, including exhibitors and sponsors, visit www.mwcbarcelona.com/exhibition/.

4YFN: Discover Future Innovation

4YFN is the innovation platform for MWC19 Barcelona, enabling startups, investors and companies to connect and launch new business ventures together. The three-day event, scheduled for 25-27 February 2019 at Fira Montjuïc, is expected to attract 21,000 attendees, who will have the opportunity to meet the growing global tech startup community, take inspiration from onstage talks and workshops, and develop their skills in the newly designed Discovery Area.

Over 600 companies will be exhibiting at 4YFN, including startup delegations from Colombia, France, Greece, Hungary, Japan, Jordan, South Korea and the United Kingdom, among others. Sponsors for 4YFN include Banco Sabadell, Daimler, Intel, SEAT and VISA, as well as public institutions from countries and territories including Japan, South Korea, Spain and Taiwan. For more information, visit: www.4yfn.com/event/4yfn-barcelona-2019/.

A Decade of Partner Programmes at MWC

Over the last 10 years, nearly 125 companies from across the ecosystem have delivered more than 240 sessions in the MWC Partner Programmes, providing attendees the opportunity to engage with and gain insights from the industry’s leaders. Companies confirmed to host Partner Programmes at MWC19 Barcelona include Alibaba, IBM, McCann Worldgroup, Netcracker, Taiwan Excellence, Visa, and ZTE, while Equinix and Software AG will hold Power Hour sessions. For more information, visit: www.mwcbarcelona.com/conference-programmes/partner-programmes/.

Now in Third Year, Women4Tech Expands Programme of Activities

The Women4Tech Programme is back in Barcelona with an expanded set of activities and events in its third year. Running across all four days of MWC19 Barcelona, Women4Tech is designed to address and reduce the gender gap in the mobile industry. A central element of the programme is the Women4Tech Summit, with keynote presentations and panel discussions exploring topics such as gender equality and career development; mentoring and youth education; women in communication and vertical sectors; and women as entrepreneurs and innovators.

In addition to the Summit, the Women4Tech Programme includes the Women4Tech Speed Coaching and Networking session; specialised MWC Tours; Women4Tech GLOMO awards for “Outstanding Achievement in Mobile Industry Leadership”; a Women4Tech panel on Mobile World Live TV; and Women4Tech activities at 4YFN. For more information, visit: www.mwcbarcelona.com/experiences/gsma-women4tech/.

25,000 Students and Educators to Attend 2019 YoMo

The Youth Mobile (YoMo) Festival returns to Barcelona for its third year and is expected to attract approximately 25,000 attendees, including 22,000 school group attendees – nearly 85 per cent more students than in 2018. A dedicated programme designed to inspire young people to pursue education and careers in science, technology, engineering, art/design, and math (STEAM), YoMo will offer an array of educational exhibits, live theatre shows, interactive workshops and hands-on activities, as well as educator-focused workshops, lectures and more. The 2019 edition of YoMo also includes the Enhanced Teacher Track, which focuses on digital transformation of the classroom.

YoMo will be held Tuesday, 26 February through Friday, 1 March at La Farga L’Hospitalet. Energytruck, the new mobile exhibition of Foundation Naturgy, has been confirmed as a corporate sponsor for the programme. For more information, visit: www.yomobcn.com.

The World’s Largest Carbon Neutral Tradeshow

The 2018 edition of MWC was officially certified as carbon neutral by the British Standards Institution (BSI), reiterating its position as the world’s largest carbon neutral tradeshow. In 2019, the GSMA is focused on further reducing the environmental impact and carbon footprint of the event, offsetting any outstanding emissions as necessary. It will also extend the “Donation Room” programme, through which MWC exhibitors donate used materials to Barcelona citizens at the end of the event. At the conclusion of the 2018 event, the GSMA collected 21.5 tonnes of building materials and 10 tonnes of furniture items and worked with the city councils of Barcelona and Hospitalet to provide them to more than 20 local socially responsible entities. For more information, visit www.mwcbarcelona.com/about/about-the-gsma/environmental-programme/.

Get Involved at MWC19 Barcelona

For more information on MWC19 Barcelona, including how to attend, exhibit or sponsor, visit www.mwcbarcelona.com. Follow developments and updates on MWC19 Barcelona on Twitter @GSMAEvents using #MWC19, on our LinkedIn MWC page https://www.linkedin.com/company/gsma-mobile-world-congress or on Facebook at https://www.facebook.com/mobileworldcongress/. Follow other GSMA news and activity on Twitter @GSMA.

-ENDS-

About the GSMA

The GSMA represents the interests of mobile operators worldwide, uniting more than 750 operators with over 350 companies in the broader mobile ecosystem, including handset and device makers, software companies, equipment providers and internet companies, as well as organisations in adjacent industry sectors. The GSMA also produces the industry-leading MWC events held annually in Barcelona, Los Angeles and Shanghai, as well as the Mobile 360 Series of regional conferences.

For more information, please visit the GSMA corporate website at www.gsma.com. Follow the GSMA on Twitter: @GSMA.

Contacts

For the GSMA
Beau Bass
+44 79 7662 4962
beau.bass@webershandwick.com
or
GSMA Press Office
pressoffice@gsma.com

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The Dawning of a New Era in Data Management in the Fund Industry

KNEIP, the Luxembourg based fund industry specialist has unveiled today its ground breaking digital service platform which will allow more transparency, efficiency and effectiveness on the investor’s thinking.

LUXEMBOURG-Saturday 29 September 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- KNEIP, in the pursuit of transforming the financial services industry has invested in creating a new single layered platform to manage the entire fund lifecycle from end to end. This revolutionary concept leads to digitalisation of investor data, will allow more transparency, reporting to be more efficient than ever before and have greater effectiveness on the investor’s thinking.

Bob Kneip, Founder and Chairman of KNEIP comments “This is the beginning of a new era for clients to have full control and transparency on all of their data. By giving the data back to the client, we can unlock the complexity and remove silos for any market, regulatory document, or piece of data to be disseminated and filed to market stakeholders and back.”

“The new single layered, digitally driven platform from KNEIP is putting asset managers back in control of their data. Not only will this dramatically cut complexity and cost, it will also boost effectiveness”.

The platform works by ingesting all unstructured data, with machine learning and artificial intelligence tools, then processes this data to work in a structured format. The new digital platform has intuitive tools that put asset managers directly in control.

Regulatory, distribution and marketing imperatives require asset managers to process data from dozens of sources, transform this data, and then communicate the results effectively to clients, distributors, supervisors, partners, data providers and more.

KNEIP have been assisting asset managers meet regulatory requirements for 25 years, and their new digital platform will take this to the next level. The key short-term advantage is dramatically reduced costs. “We have one client using the platform who is now spending $65,000 on processes that used to cost them $2 million”, commented Bob Kneip.

Streamlining the process was a key component in the digital transformation. Historically, an asset manager who might want to launch a fund was required to use a fund registration team to compile the data and build reports, then external and internal legal departments would need to scrutinise it before sending it to the regulator. Now fund managers just have to drag their fund (be it based in Luxembourg, Dublin, the UK, the US or wherever) into their target market, and the data and documents are compiled automatically to suit the requirements of each national regulator. Similarly, with PRIIPs, MiFID II and pension fund document templates: users log on, choose the option they require, and the information is ready in five minutes.

As well as these streamlined processes saving time and money, they also offer greater ability to trap errors early. If there are any problems with a regulatory application dossier these will be identified instantly and can be corrected. In the past, time and money was wasted as files were rejected by the regulator merely due to an administrative oversight. With correctly filed dossiers will boost effectiveness too.

KNEIP believes this move will revolutionise the fund industry leading to a new dawn in the way data management is perceived across the globe.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180927005501/en/

Contacts

KNEIP

James Urquhart:

james.urquhart@kneip.com

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AURAK Ranks High in the Scopus Database

Ras Al Khaimah, United Arab Emirates-Saturday 29 September 2018 [ AETOS Wire ]

The American University of Ras Al Khaimah (AURAK) ranked twelfth among 103 UAE institutions with Scopus affiliations, with a total of 403 Scopus documents published by the AURAK faculty and researchers.

Scopus is the largest database of peer-reviewed literature, encompassing scientific journals, books, and conference publications. The extensive global scholarship indexed in Scopus includes research in science, arts and humanities, social sciences, medicine, and technology.  A high ranking in Scopus is understood by many to be one of the top indicators of excellence in research worldwide.

AURAK is a public non-profit, independent, coeducational institution of higher education, which provides an integrated North American-style education. It is accredited by the Ministry of Education in the UAE and offers twenty-two undergraduate and graduate programs across a wide range of disciplines. In September 2017 AURAK stood at the 24th position out of 98 institutions with Scopus affiliations in the UAE, with 249 Scopus publications. Within a period of one year there has been a 62 percent increase in Scopus publications with the 2018 ranking, with AURAK climbing the competitive ladder to the twelfth slot out of 103 institutions, and with the faculty publishing 403 Scopus documents. With its prodigious rate of quality publications, AURAK has risen higher in the rankings even with increased numbers of competitors in the field.

The Provost, Professor Stephen Wilhite, observed that faculty engagement in research is fundamental the university’s achievement of its mission to exemplify the highest standards of teaching and research. “As accomplished researchers, faculty members model for their student’s active engagement in advancing knowledge in their discipline.

AURAK President, Professor Hassan Al Alkim, is elated with the hard work and progress of his faculty, “This type of results supports our claim that our faculty is not only certified, but is comprised of highly qualified professionals that are on the forefront of contemporary research and that our institution is indeed highly competitive among the leading Arabic institutions in the UAE.  Not only did our institution improve its status from last year, but it did so even in a broader, more competitive atmosphere. Our students are receiving a first-rate education from first-rate professors who are highly active in the academic world of research and on the cutting edge of innovative ideas.”




Contacts

Jessica Zani, +97172210900 Ext: 1325

jessica.zani@aurak.ac.ae



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Takeda to Present Positive Data from ALUNBRIG® (brigatinib) ALTA-1L Trial Showing a Reduction in Risk of Disease Progression or Death of More Than 50 Percent Versus Crizotinib in First-Line Advanced ALK+ NSCLC

 – ALTA-1L Met its Primary Endpoint Showing Superiority in Blinded Independent Review Committee-Assessed Progression-Free Survival Compared to Crizotinib –

 – Data Will Be Presented During the Presidential Symposium at the 19th World Conference on Lung Cancer (WCLC) with Simultaneous Publication in The New England Journal of Medicine – CAMBRIDGE, Mass. & OSAKA, Japan-Saturday 29 September 2018 [ AETOS Wire ]

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced results from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial, demonstrating that ALUNBRIG reduced the risk of disease progression or death, known as progression-free survival (PFS), as assessed by a blinded independent review committee (BIRC), by more than fifty percent compared to crizotinib in adults with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. Findings from the first interim analysis of the ALTA-1L trial will be presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC) in Toronto on Tuesday, September 25, 2018. The data were also simultaneously published online in The New England Journal of Medicine. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC.

ALTA-1L is a global, randomized, open-label, comparative, multicenter trial, which enrolled 275 patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor but may have received up to one prior regimen of chemotherapy in the advanced setting. Patients were eligible for study entry on the basis of locally determined ALK testing. Patients received either ALUNBRIG, 180 mg once daily with seven-day lead-in at 90 mg once daily, or crizotinib, 250 mg twice daily. Treatment with ALUNBRIG resulted in superior PFS compared to crizotinib as assessed by a blinded independent review committee (hazard ratio = 0.49 [95 percent confidence interval (CI), 0.33 to 0.74]; log-rank p=0.0007), corresponding to a 51 percent reduction in the risk of disease progression or death. The safety profile associated with ALUNBRIG was generally consistent with the existing U.S. prescribing information.

“The ALK+ NSCLC treatment landscape has experienced tremendous change over the last decade, and the ALTA-1L trial demonstrates that brigatinib has the potential to be a key player in the first-line setting,” said D. Ross Camidge, MD, PhD, Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center and the lead investigator of ALTA-1L. “The ALTA-1L trial offers unique aspects, including the real-world applicability of the data. The study’s design offered enrollment to a broader population by allowing patients to participate even if they had received prior chemotherapy and enrolled patients based on local standard of care ALK testing as opposed to mandating confirmation at a central lab. We look forward to further follow-up, which will provide even better understanding of the role of brigatinib in the evolving landscape.”

“We are thrilled to share these highly anticipated results with the lung cancer community,” said David Kerstein MD, Global Clinical Lead for Brigatinib and Lung Cancer Clinical Portfolio Strategy Lead, Takeda. “The ALTA-1L data demonstrate that ALUNBRIG is superior to crizotinib in the first-line setting, reducing disease progression or death by more than half, with particularly pronounced activity in the brain. We would like to thank all the investigators, and especially the patients and their caregivers who participated in this important clinical research.”

Brigatinib vs Crizotinib in Patients with ALK Inhibitor-Naïve Advanced ALK+ NSCLC: First Report of a Phase 3 Trial (ALTA-1L) (Presidential Symposium on Tuesday, September 25, 8:30 a.m. ET at the Metro Toronto Convention Centre North Building, Plenary Hall)

Key findings, which will be presented by D. Ross Camidge, MD, PhD, Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center and lead investigator of ALTA-1L, include:

    A total of 275 patients were randomized to either brigatinib (n=137) or crizotinib (n=138). The median age was 59 years (brigatinib, 58; crizotinib, 60) and 55% of patients in the trial were female (brigatinib, 50%; crizotinib 59%). Twenty-nine percent had brain metastases at baseline (brigatinib, 29%; crizotinib, 30%), with comparable pre-enrollment CNS radiotherapy rates. Overall, 27% of patients had prior chemotherapy in the locally advanced or metastatic setting (brigatinib, 26%; crizotinib, 27%).

    At the data cutoff for the first interim analysis (February 19, 2018), at a median follow-up period of 11.0 and 9.3 months in the brigatinib arm and crizotinib arm, respectively, 95 patients (69%) in the brigatinib arm and 59 patients (43%) in the crizotinib arm remained on study treatment.

    The trial has met the pre-specified threshold for superiority in the primary endpoint at the first interim analysis. With a total of 99 events, BIRC-assessed PFS with brigatinib was superior to crizotinib (hazard ratio, 0.49 [95% confidence interval (CI), 0.33 to 0.74]; log-rank p=0.0007).

    Additional efficacy outcomes are presented in the table below:

ALTA-1L Efficacy Results

Efficacy Endpoint

Brigatinib

Crizotinib

Intention-to-treat population

n=137

n=138

BIRC-assessed PFS

Median, months (95% CI)

NR (NR to NR)

9.8 (9.0 to 12.9)

12-month estimate (95% CI)

67% (56% to 75%)

43% (32% to 53%)

Hazard ratio (95% CI)

0.49 (0.33 to 0.74)

Log-rank p-value

0.0007

Investigator-assessed PFS

Median, months (95% CI)

NR (NR to NR)

9.2 (7.4 to 12.9)

12-month estimate (95% CI)

69% (59% to 76%)

40% (30% to 50%)

Hazard ratio (95% CI)

0.45 (0.30 to 0.68)

Log-rank p-value

0.0001

BIRC-assessed confirmed ORR (95% CI)

71% (62% to 78%)

60% (51% to 68%)

P-value

0.07

BIRC-assessed overall ORR (objective response at 1 or more assessments) (95% CI)

76% (68% to 83%)

73% (65% to 80%)

Patients with BIRC-assessed brain metastases at baseline

n=43

n=47

Intracranial PFS

Median, months (95% CI)

NR (11.0 to NR)

5.6 (4.1 to 9.2)

12-month estimate (95% CI)

67% (47% to 80%)

21% (6% to 42%)

Hazard ratio (95% CI)

0.27 (0.13 to 0.54)

Log-rank p-value

<0.0001

Patients with BIRC-assessed measurable brain metastases at baseline

n=18

n=21

Confirmed intracranial ORR (95% CI)

78% (52% to 94%)

29% (11% to 52%)

P-value

0.0028

Overall intracranial ORR (objective response at 1 or more assessments) (95% CI)

83% (59% to 96%)

33% (15% to 57%)

NR = Not reached CI = Confidence Interval PFS= Progression-Free Survival                                                                         ORR= Objective Response Rate

• The safety profile associated with ALUNBRIG was generally consistent with the existing U.S. prescribing information.
• Any grade treatment-emergent adverse events that occurred at a higher incidence with brigatinib than with crizotinib by more than five percentage points were increased blood creatine phosphokinase (brigatinib, 39% vs crizotinib, 15%), cough (25% vs 16%), hypertension (23% vs 7%), and increased lipase (19% vs 12%).
• Any grade treatment-emergent adverse events that occurred at a higher incidence with crizotinib than with brigatinib by more than five percentage points were nausea (crizotinib, 56% vs brigatinib, 26%), diarrhea (55% vs 49%), constipation (42% vs 15%), peripheral edema (39% vs 4%), vomiting (39% vs 18%), increased alanine aminotransferase (32% vs 19%), decreased appetite (20% vs 7%), photopsia (20% vs 1%), dysgeusia (19% vs 4%), and visual impairment (16% vs 0).
• Grade 3 to 5 treatment-emergent adverse events occurred in 61% of the patients in the brigatinib arm and 55% of the patients in the crizotinib arm. Most common grade 3 or greater treatment-emergent adverse events for brigatinib were increased blood creatine phosphokinase (16%), increased lipase (13%), hypertension (10%), and increased amylase (5%); and for crizotinib were increased alanine aminotransferase (9%), increased aspartate aminotransferase (6%), and increased lipase (5%).
• Interstitial lung disease/pneumonitis at any time occurred in 4% (5/136) of patients in the brigatinib arm and 2% (3/137) in the crizotinib arm. Interstitial lung disease/pneumonitis with early onset (defined as within 14 days of treatment initiation) was observed in 3% of patients in the brigatinib arm (onset: Days 3 to 8) and was not observed in the crizotinib arm.

About the ALTA-1L Trial

The Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial of ALUNBRIG in adults is a global, ongoing, randomized, open-label, comparative, multicenter trial, which enrolled 275 patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor. Patients received either ALUNBRIG, 180 mg once daily with seven-day lead-in at 90 mg once daily, or crizotinib, 250 mg twice daily. Blinded Independent Review Committee (BIRC)-assessed progression-free survival (PFS) was the primary endpoint. Secondary endpoints included objective response rate (ORR) per RECIST v1.1, intracranial ORR, intracranial PFS, overall survival (OS), safety and tolerability. A total of approximately 198 PFS events are planned at the final analysis of the primary endpoint in order to demonstrate a minimum of six months PFS improvement over crizotinib. The trial is designed with two pre-specified interim analyses for the primary endpoint – one at approximately 50 percent of planned PFS events and one at approximately 75 percent of planned PFS events.

About ALK+ NSCLC

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85 percent of the estimated 1.8 million new cases of lung cancer diagnosed each year worldwide, according to the World Health Organization. Genetic studies indicate that chromosomal rearrangements in anaplastic lymphoma kinase (ALK) are key drivers in a subset of NSCLC patients. Approximately three to five percent of patients with metastatic NSCLC have a rearrangement in the ALK gene.

Takeda is committed to continuing research and development in NSCLC to improve the lives of the approximately 40,000 patients diagnosed with this serious and rare form of lung cancer worldwide each year.

About ALUNBRIG® (brigatinib)

ALUNBRIG is a targeted cancer medicine discovered by ARIAD Pharmaceuticals, Inc., which was acquired by Takeda in February 2017. In April 2017, ALUNBRIG received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for ALK+ metastatic NSCLC patients who have progressed on or are intolerant to crizotinib. This indication is approved under Accelerated Approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. In July 2018, Health Canada approved ALUNBRIG for the treatment of adult patients with ALK+ metastatic NSCLC who have progressed on or who were intolerant to an ALK inhibitor (crizotinib). The FDA and Health Canada approvals of ALUNBRIG were primarily based on results from the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial.

ALUNBRIG received Breakthrough Therapy Designation from the FDA for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib and was granted Orphan Drug Designation by the FDA for the treatment of ALK+ NSCLC, ROS1+ and EGFR+ NSCLC.

The brigatinib clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with ALK+ NSCLC worldwide and the healthcare professionals who treat them. The comprehensive program includes the following clinical trials:

    Phase 1/2 trial, which was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ALUNBRIG

    Pivotal Phase 2 ALTA trial investigating the efficacy and safety of ALUNBRIG at two dosing regimens in patients with ALK+ locally advanced or metastatic NSCLC who had progressed on crizotinib

    Phase 3 ALTA-1L, a global randomized trial assessing the efficacy and safety of ALUNBRIG in comparison to crizotinib in patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor

    Phase 2 single-arm, multicenter trial in Japanese patients with ALK+ NSCLC, focusing on patients who have progressed on alectinib

    Phase 2 global, single-arm trial evaluating ALUNBRIG in patients with advanced ALK+ NSCLC who have progressed on alectinib or ceritinib

    Phase 3 global randomized trial comparing the efficacy and safety of ALUNBRIG versus alectinib in participants with ALK+ NSCLC who have progressed on crizotinib

For additional information on the brigatinib clinical trials, please visit www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION (U.S.)

WARNINGS AND PRECAUTIONS

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG. In Trial ALTA (ALTA), ILD/pneumonitis occurred in 3.7% of patients in the 90 mg group (90 mg once daily) and 9.1% of patients in the 90→180 mg group (180 mg once daily with 7-day lead-in at 90 mg once daily). Adverse reactions consistent with possible ILD/pneumonitis occurred early (within 9 days of initiation of ALUNBRIG; median onset was 2 days) in 6.4% of patients, with Grade 3 to 4 reactions occurring in 2.7%. Monitor for new or worsening respiratory symptoms (e.g., dyspnea, cough, etc.), particularly during the first week of initiating ALUNBRIG. Withhold ALUNBRIG in any patient with new or worsening respiratory symptoms, and promptly evaluate for ILD/pneumonitis or other causes of respiratory symptoms (e.g., pulmonary embolism, tumor progression, and infectious pneumonia). For Grade 1 or 2 ILD/pneumonitis, either resume ALUNBRIG with dose reduction after recovery to baseline or permanently discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3 or 4 ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.

Hypertension: In ALTA, hypertension was reported in 11% of patients in the 90 mg group who received ALUNBRIG and 21% of patients in the 90→180 mg group. Grade 3 hypertension occurred in 5.9% of patients overall. Control blood pressure prior to treatment with ALUNBRIG. Monitor blood pressure after 2 weeks and at least monthly thereafter during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 hypertension despite optimal antihypertensive therapy. Upon resolution or improvement to Grade 1 severity, resume ALUNBRIG at a reduced dose. Consider permanent discontinuation of treatment with ALUNBRIG for Grade 4 hypertension or recurrence of Grade 3 hypertension. Use caution when administering ALUNBRIG in combination with antihypertensive agents that cause bradycardia.

Bradycardia: Bradycardia can occur with ALUNBRIG. In ALTA, heart rates less than 50 beats per minute (bpm) occurred in 5.7% of patients in the 90 mg group and 7.6% of patients in the 90→180 mg group. Grade 2 bradycardia occurred in 1 (0.9%) patient in the 90 mg group. Monitor heart rate and blood pressure during treatment with ALUNBRIG. Monitor patients more frequently if concomitant use of drug known to cause bradycardia cannot be avoided. For symptomatic bradycardia, withhold ALUNBRIG and review concomitant medications for those known to cause bradycardia. If a concomitant medication known to cause bradycardia is identified and discontinued or dose adjusted, resume ALUNBRIG at the same dose following resolution of symptomatic bradycardia; otherwise, reduce the dose of ALUNBRIG following resolution of symptomatic bradycardia. Discontinue ALUNBRIG for life-threatening bradycardia if no contributing concomitant medication is identified.

Visual Disturbance: In ALTA, adverse reactions leading to visual disturbance including blurred vision, diplopia, and reduced visual acuity, were reported in 7.3% of patients treated with ALUNBRIG in the 90 mg group and 10% of patients in the 90→180 mg group. Grade 3 macular edema and cataract occurred in one patient each in the 90→180 mg group. Advise patients to report any visual symptoms. Withhold ALUNBRIG and obtain an ophthalmologic evaluation in patients with new or worsening visual symptoms of Grade 2 or greater severity. Upon recovery of Grade 2 or Grade 3 visual disturbances to Grade 1 severity or baseline, resume ALUNBRIG at a reduced dose. Permanently discontinue treatment with ALUNBRIG for Grade 4 visual disturbances.

Creatine Phosphokinase (CPK) Elevation: In ALTA, creatine phosphokinase (CPK) elevation occurred in 27% of patients receiving ALUNBRIG in the 90 mg group and 48% of patients in the 90 mg→180 mg group. The incidence of Grade 3-4 CPK elevation was 2.8% in the 90 mg group and 12% in the 90→180 mg group. Dose reduction for CPK elevation occurred in 1.8% of patients in the 90 mg group and 4.5% in the 90→180 mg group. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK levels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4 CPK elevation. Upon resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Pancreatic Enzyme Elevation: In ALTA, amylase elevation occurred in 27% of patients in the 90 mg group and 39% of patients in the 90→180 mg group. Lipase elevations occurred in 21% of patients in the 90 mg group and 45% of patients in the 90→180 mg group. Grade 3 or 4 amylase elevation occurred in 3.7% of patients in the 90 mg group and 2.7% of patients in the 90→180 mg group. Grade 3 or 4 lipase elevation occurred in 4.6% of patients in the 90 mg group and 5.5% of patients in the 90→180 mg group. Monitor lipase and amylase during treatment with ALUNBRIG. Withhold ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon resolution or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or at a reduced dose.

Hyperglycemia: In ALTA, 43% of patients who received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3 hyperglycemia, based on laboratory assessment of serum fasting glucose levels, occurred in 3.7% of patients. Two of 20 (10%) patients with diabetes or glucose intolerance at baseline required initiation of insulin while receiving ALUNBRIG. Assess fasting serum glucose prior to initiation of ALUNBRIG and monitor periodically thereafter. Initiate or optimize anti-hyperglycemic medications as needed. If adequate hyperglycemic control cannot be achieved with optimal medical management, withhold ALUNBRIG until adequate hyperglycemic control is achieved and consider reducing the dose of ALUNBRIG or permanently discontinuing ALUNBRIG.

Embryo-Fetal Toxicity: Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to pregnant women. There are no clinical data on the use of ALUNBRIG in pregnant women. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of ALUNBRIG.

ADVERSE REACTIONS

Serious adverse reactions occurred in 38% of patients in the 90 mg group and 40% of patients in the 90→180 mg group. The most common serious adverse reactions were pneumonia (5.5% overall, 3.7% in the 90 mg group, and 7.3% in the 90→180 mg group) and ILD/pneumonitis (4.6% overall, 1.8% in the 90 mg group and 7.3% in the 90→180 mg group). Fatal adverse reactions occurred in 3.7% of patients and consisted of pneumonia (2 patients), sudden death, dyspnea, respiratory failure, pulmonary embolism, bacterial meningitis and urosepsis (1 patient each).

The most common adverse reactions (≥25%) in the 90 mg group were nausea (33%), fatigue (29%), headache (28%), and dyspnea (27%) and in the 90→180 mg group were nausea (40%), diarrhea (38%), fatigue (36%), cough (34%), and headache (27%).

DRUG INTERACTIONS

CYP3A Inhibitors: Avoid concomitant use of ALUNBRIG with strong CYP3A inhibitors. Avoid grapefruit or grapefruit juice as it may also increase plasma concentrations of brigatinib. If concomitant use of a strong CYP3A inhibitor is unavoidable, reduce the dose of ALUNBRIG.

CYP3A Inducers: Avoid concomitant use of ALUNBRIG with strong CYP3A inducers.

CYP3A Substrates: Coadministration of ALUNBRIG with CYP3A substrates, including hormonal contraceptives, can result in decreased concentrations and loss of efficacy of CYP3A substrates.

USE IN SPECIFIC POPULATIONS

Pregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.

Lactation: There are no data regarding the secretion of brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment with ALUNBRIG.

Females and Males of Reproductive Potential:

Contraception: Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ALUNBRIG and for at least 3 months after the final dose.

Infertility: ALUNBRIG may cause reduced fertility in males.

Pediatric Use: The safety and efficacy of ALUNBRIG in pediatric patients have not been established.

Geriatric Use: Clinical studies of ALUNBRIG did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Of the 222 patients in ALTA, 19.4% were 65-74 years and 4.1% were 75 years or older. No clinically relevant differences in safety or efficacy were observed between patients ≥65 and younger patients.

Hepatic or Renal Impairment: No dose adjustment is recommended for patients with mild hepatic impairment or mild or moderate renal impairment. The safety of ALUNBRIG in patients with moderate or severe hepatic impairment or severe renal impairment has not been studied.

Please see the full U.S. Prescribing Information for ALUNBRIG at www.ALUNBRIG.com

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries. For more information, visit https://www.takeda.com/newsroom/.

Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website, www.takedaoncology.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180925005644/en/

Contacts

Takeda Pharmaceutical Company Limited

Japanese Media

Kazumi Kobayashi, +81 3 3 278 2095

kazumi.kobayashi@takeda.com

or

European Media

Kate Burd, +41 79 514 9533

kate.burd@takeda.com

or

Media outside Japan/EU

Amanda Loder, +1-212-259-0491

Amanda.Loder@takeda.com

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