Sunday, March 31, 2019

Boehringer Ingelheim Enhances Oncology R&D with Novel MacroDel Delivery Technology Via Acquisition of ICD Therapeutics

INGELHEIM, Germany & BERLIN -Friday 29 March 2019 [ AETOS Wire ]

New molecular platform to access intracellular targets across a broad range of tumor cell types
Opens up new range of therapeutic opportunities for difficult-to-treat cancers
(BUSINESS WIRE)-- Boehringer Ingelheim today announced that it acquired ICD Therapeutics. The acquisition includes rights to ICD’s innovative MacroDel biologics-delivery platform. Boehringer Ingelheim will employ this platform for the development of novel therapeutics in collaboration with nanoPET Pharma GmbH, a former shareholder of ICD Therapeutics. Further details of the acquisition are not being disclosed.

“Boehringer Ingelheim’s collaboration with nanoPET Pharma has the potential to eliminate the hurdle that many cancer biologics face: getting access to targets inside tumor cells,” said Norbert Kraut, Ph.D., Global Head of Cancer Research, Boehringer Ingelheim. “We will use ICD’s MacroDel technology to develop first-in-class potential drug candidates for intracellular targets across a variety of tumor types, for the benefit of patients who so far have no or only inadequate treatment options.”

Engineered proteins and peptides offer great potential to block protein-protein interactions inside cancer cells, but their large size is generally assumed to prevent intracellular delivery. ICD’s MacroDel technology exploits transporter proteins in the cell membrane to deliver such drug candidates inside tumor cells. This opens up therapeutic targets that would be otherwise inaccessible.

“nanoPET Pharma looks forward to collaborating with Boehringer Ingelheim on the pre-clinical refinement of ICD’s MacroDel to achieve effective intracellular delivery of macromolecules such as peptides and proteins,” said Andreas Briel, Ph.D., Managing Director of nanoPET Pharma GmbH. “We are excited to contribute to Boehringer Ingelheim’s discovery and development of innovative medicines for patients in need.”

More about MacroDel
Tree-like highly branched molecules known as dendrimers form a fundamental component of the MacroDel platform. The size, shape and electrical charge of this structure permit it to grasp large therapeutic biological molecules. After binding with the biologic, the resulting compound selectively interacts with transporter proteins known to be highly expressed on tumor cell wall membranes. These transporters help “carry” the compound through the membrane and into the cell. The medicinal cargo is then in position to disrupt the disease process in a precise manner at a molecular level.

A prior investment from Boehringer Ingelheim’s Venture Fund (BIVF) supported ICD’s development of the MacroDel technology. The BIVF strategically invests in groundbreaking therapeutics-focused biotechnology companies to enable development of their technologies for therapeutic applications that have potential for strategic partnerships with Boehringer Ingelheim or other pharmaceutical partners.

Please click on the link for ‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/press-release/acquisition-novel-oncology-delivery-technology

View source version on businesswire.com: https://www.businesswire.com/news/home/20190329005136/en/

Contacts
Media Contacts:
Boehringer Ingelheim
Dr. Reinhard Malin
Head of Communications Innovation Unit
Boehringer Ingelheim Corporate Center GmbH
Media + PR
P: +49 6132 77-90815
press@boehringer-ingelheim.com

Linda Ruckel
Associate Director, Media and Corporate Reputation
Boehringer Ingelheim U.S.
Media + PR
P: + 203-791-6672
linda.ruckel@boehringer-ingelheim.com

nanoPET Pharma GmbH
Dr. Andreas Briel
nanoPET Pharma GmbH
Robert-Koch-Platz 4
D-10115 Berlin
Tel. +49 (0)30 890 49 740
Email: andreas.briel@nanopet.de


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TECNO Mobile Promotes Talent as Sponsor of the Manchester City Abu Dhabi Cup 2019 and To Send Al Ain Team to a Clinic Program with Manchester City Football Coaches

Abu Dhabi, United Arab Emirates-Sunday 31 March 2019 [ AETOS Wire ]

Global premier mobile phone brand, TECNO Mobile, participated as one of the main sponsors of the Manchester City Abu Dhabi Cup 2019 edition as part of its broader strategy to support and develop youth football in the region.

This is the second time that TECNO Mobile, the official handset and tablet partner for Manchester City, is coming in as the tournament sponsor after a successful partnership in 2018.

According to TECNO Mobile, the Manchester City Abu Dhabi 2019 youth football tournament is a noble event that brings together young football enthusiasts from different backgrounds to enjoy and showcase their prowess in this beautiful game.

Jack Long, Brand Director of TECNO Mobile Middle East said: “We are delighted to be part of this year’s Manchester City Abu Dhabi Cup as the tournament sponsor. Sports development is core to our growth strategy. Our renewed participation is aimed at giving sports fans in the Middle East and across the world an opportunity to connect with each other and share memorable sporting moments through an unparalleled mobile experience.”

The tournament, which took place on March 29 and March 30 at Zayed Sports City, Abu Dhabi, brought together over 130 teams and over one thousand players from different parts of the world.

One lucky team by lucky draw is from Al Ain; as part of TECNO Mobile sponsorship, will be treated to an all-expenses-paid training camp with Manchester City Football Club coaches.

TECNO Mobile has rapidly established itself as an active player in the UAE smartphone space. Its growth in popularity among smartphone users in the region is driven by its introduction of camera-centric phones, which resonate well with the market.

TECNO Mobile’s entry into the UAE market received a boost following the unveiling of its CAMON CM and Phantom 8 brands in 2017 October. In 2017, TECNO’s sales volume of smart device achieved 47 million. Currently, TECNO has established its presence in about 50 countries across the globe.

This year, TECNO Mobile will introduce into the middle east market its newest range of 4G camera-focused smartphone series – SPARK 3 Pro. The SPARK 3 Pro camera comes equipped with Artificial Intelligence technologies and high configuration for brighter photos that result in high quality, bright and smooth pictures.

About TECNO Mobile                                                                   

TECNO Mobile is the premium mobile phone brand of TRANSSION Holdings with a comprehensive mobile device portfolio across feature phones, smartphones and tablets. As a brand, TECNO is dedicated to transforming state-of-art technologies into localized products under the guideline of “Think Globally, Act Locally”. Established in 2006, TECNO has presence in more than 50 countries across the globe. It is now one of the top three mobile phone brands in Africa and a major player worldwide. TECNO is also the Official Tablet and Handset Partner of Manchester City Football Club. For more information, please visit: www.tecno-mobile.com

Contacts
Matrix PR

Melwyn Abraham: Melwyn@matrixdubai.com

Krishika Mahesh: Krishika@matrixdubai.com

+97143430888



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Earth Networks Launches Aviation Early Warning System for the Agency for the Safety of Air Navigation in Africa and Madagascar (ASECNA)

African airspace now protected by comprehensive lightning and weather detection network

GERMANTOWN, Md. -Tuesday 26 March 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Earth Networks today announced it has completed a new aviation early weather warning system for The Agency for the Safety of Air Navigation in Africa and Madagascar (ASECNA). The announcement was made at the 6th annual InterMET Asia conference in Singapore.

Designed for air traffic management and airport operations professionals to issue alerts on severe weather and lightning threats that have the potential to affect air and land operations including ground crews, fueling, and aircraft, the newly operational global aviation early warning system includes:

Real-time lightning detection powered by the Earth Networks Total Lightning Network, featuring over 1,700 sensors in more than 100 countries
On-the-ground weather monitoring via the Earth Networks Weather Network
Sferic Maps, a web-based severe weather monitoring and alerting platform
Severe weather data and visualization tools such as Dangerous Thunderstorm Alerts and PulseRad, a lightning-derived radar alternative
Short-range point forecasts powered by ENcast, enabling highly accurate short-term weather prediction for specific areas
Lightning data integration with SYNERGIE, Meteo France International’s (MFI) web-based, multi-task software that manages METAR weather observations from existing automated weather observing systems (AWOS), making all ASECNA AWOS P/T level ready
Comprehensive training and ongoing operational support
Based in Dakar, Senegal, ASECNA is one of Africa’s largest Air Navigation Service Providers (ANSP) covering 17 member states in Africa: Benin, Burkina Faso, Cameroon, Central Africa Republic, Congo, Ivory Coast, Gabon, Guinea Bissau, Equatorial Guinea, Madagascar, Mali, Mauritania, Niger, Senegal, Chad, Togo, Union of Comoros and France. With 6 Flight Information Regions (FIRs), and a vast coverage area 1.5 times the size of Europe’s, ASECNA is responsible for air traffic management for 16.5 million square kilometers of airspace over the African continent.

“We have areas in Central Africa that are affected by heavy cloud cover and thunderstorms nine months out of the year,” said Moctar Mahfoud, Director of Aeronautical Meteorology at ASECNA. “The need to have real-time information about weather phenomena that can cause severe turbulence and plane diversions is crucial.”

Thomas Sobakam, Manager of Meteorological Services at ASECNA added, “After a six-month period of using lightning-derived storm tracking from Earth Networks, we found our rate of false alarms decreased, and have improved our ability to predict when a storm will pass, helping to eliminate delays due to convective storms, which account for 40% of the incident cases in our area of control.”

Jim Anderson, Senior Vice President, Global Sales at Earth Networks said, “We are thrilled with the operational results and their clear impact on safety and operational efficiency improvements in the African airspace. Working with ASECNA, we have substantially enhanced the ability to detect, track and alert for severe weather across an airspace 50 percent larger than all of Europe. These capacity improvements will have significant economic benefits across much of Africa.”

About Earth Networks

Earth Networks is a leader in early warning systems for aviation, with more than 50 airport and aviation customers around the world. Its comprehensive weather monitoring, visualization, alerting and forecasting decision support tools help the aviation industry reduce delays due to weather, eliminate false alerts and provide safe operating conditions during flight and on the ground.





View source version on businesswire.com: https://www.businesswire.com/news/home/20190324005014/en/

Contacts
Anna Porteus
aporteus@earthnetworks.com
+1-301-250-4156

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Saturday, March 30, 2019

BCW Introduces Consulting Unit to Provide End-to-End Counsel for Companies in the Burgeoning Global Cannabis and Hemp Industry

NEW YORK -Saturday 30 March 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- BCW (Burson Cohn & Wolfe), a leading global communications agency, today introduced a strategic consulting unit that will help companies in the emerging cannabis and hemp space gain market entry, navigate policy and regulation challenges, identify and engage the cannabis consumer and communicate product benefits, all on a global scale. BCW’s end-to-end holistic offering includes experts in research, data and analytics, federal policy and grassroots engagement.

The launch of BCW’s cannabis consulting unit comes as the global legal marijuana market is expected to reach USD $146.4 billion by end of 2025, according to a new report by Grand View Research, Inc. The U.S. legal marijuana market size was estimated at USD $7.06 billion in 2016 and is expected to develop at a compound annual growth rate of 24.9 percent from 2017 to 2025. Estimates from New Frontier Data’s Hemp Business Journal suggest the hemp derived CBD market will triple from a $390 million market in 2018 to a $1.3 billion market by 2022.

“While the cannabis industry is significant, it is really at the nascent stage of market development,” said Donna Imperato, Global CEO, BCW. “Companies entering the space must navigate policy, operations, consumer education, marketing, and finance and capital markets – which is no easy feat. Our cannabis consulting unit has the talent and deep expertise to help clients overcome these challenges, take their products into this emerging market and build them into category leaders.

“The growth potential for the cannabis industry is extraordinary,” added Imperato. “We are excited to partner with our clients as first movers in this incredible new market.”

BCW’s cannabis consulting unit currently advises PAX Labs, a leader in the design, development and sale of premium cannabis vaporization technologies and devices; Pyxus International, Inc., a global value-added agricultural company; and Criticality, LLC, a North Carolina-based industrial hemp company that takes a science-based approach to the extraction, refinement and formulation of high-quality cannabidiol (CBD) products; among other clients

In late 2018, Canada legalized recreational use of cannabis at the federal level. BCW’s colleagues in Canada worked to introduce FIGR, Inc., a vertically integrated legal cannabis company, to that market.

“According to BCW’s 2018 Fall Cannabis Culture Poll, developed in conjunction with PSB and Civilized Life, support in North America for legalized cannabis in some form, is strong, and a majority believes it has a positive impact on the economy,” said Chris Foster, President, North America, BCW. “So, there is a tremendous amount of opportunity as the global cannabis market evolves and grows, but this is punctuated by regulatory uncertainty in some markets and highly regulated environments in others. The U.S. is a prime example with its incongruity between federal and state laws. Our team has the expertise to help clients navigate these challenges – from influencing public policy to building brands and establishing new categories – and achieve success in the cannabis and hemp industry.”

About BCW

BCW is one of the world’s largest full-service global communications agencies. Founded by the merger of Burson-Marsteller and Cohn & Wolfe, BCW delivers digitally and data-driven creative content and integrated communications programs grounded in earned media and scaled across all channels for clients in the B2B, consumer, corporate, crisis management, CSR, healthcare, public affairs and technology sectors. BCW is a part of WPP (NYSE:WPP), a creative transformation company. For more information, visit www.bcw-global.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005709/en/

Contacts
Media: Catherine Sullivan
Phone: 212.601.3205
Email: Catherine.Sullivan@bcw-global.com


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Innovid 2018 Global Video Benchmarks Study Shows Meteoric Rise of Connected TV, Uncovers Key Video Advertising Insights

Annual study analyzes thousands of video campaigns for key trends, including surges in personalization and engagement

NEW YORK -Saturday 30 March 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Innovid, the world’s leading connected tv and video advertising platform, today announced the release of its annual Global Video Benchmarks report. The latest study reveals another year of significant growth in the Internet-enabled television space, also known as Connected TV (CTV), along with an increase in data-driven personalized video campaigns and short-form mobile video. The year-long study analyzes thousands of video campaigns with billions of impressions across 340+ top global companies, providing a critical snapshot of the state of video advertising in 2018, along with insights and analysis designed for the top television marketers. As with past installments, the report also compares the performance of standard pre-roll video to interactive video across devices and channels, offering benchmarks and overall performance for key video KPIs including click-through rates, engagement, completion rate and time-earned.

"The Global Video Benchmarks series is designed to serve as a video advertising performance barometer, leveraging original data collected through our connected TV and video advertising platform," said Zvika Netter, CEO and co-founder of Innovid. "This year the barometer has landed on CTV, with its surge in viewership, particularly across premium broadcast content, and growing advertiser appetites. The trend is clear: CTV is now."

The 2018 Global Video Benchmarks themes and top findings include:

Connected TV (CTV) continues growth trajectory - Innovid observed substantial ongoing growth in CTV campaigns throughout 2018 with CTV impressions making up 28 percent of all Innovid impressions (up from 17 percent in 2017). Of all Innovid campaigns, 68 percent contained at least some CTV execution in 2018.
Broadcasters take the lead in CTV - As more viewers shift to streaming content, linear TV viewing is declining while on-demand CTV viewership is surging, particularly amongst broadcasters - and the marketing dollars are following. An incredible 63 percent of all broadcaster impressions served in 2018 were served in CTV environments. Broadcaster impressions made up 83 percent of all CTV campaigns.
CTV’s ascendancy raises the bar for engagement - With CTV taking its place as a preferred channel, marketers can put engagement front and center. Advanced creative units that command greater engagement lift than standard pre-roll and offer the potential for real earned time and attention are delivering on that demand with interactive units producing dramatic figures, such as 71 additional seconds of time earned on broadcast content and more than six times engagement lift compared to standard pre-roll.
Personalization powers results - In a world of increasing hyper-personalization from social media feeds to the retail floor, advertisers are embracing data-driven dynamic video to keep pace with a personal touch. Use of dynamic video—powered by everything from location and weather to first-party data—jumped 79 percent in 2018 with the average campaign producing 12,000 unique versions, while the largest campaigns produced more than 200,000.
Short-form rises on mobile - As more impressions shift to mobile channels, the report shows a marked spike in the number videos shorter than 10 seconds, which jumped from just five percent in 2017 to 11 percent in 2018. The majority of this growth was focused on social and programmatic channels.
"Streaming has already revolutionized consumer viewing habits, and we see even greater expansion in the years ahead," said Alan Wolk, co-founder and lead analyst, TV[R]EV. "As CTV/OTT becomes more commonplace, so do consumer expectations around the relevancy and personalization of advertising. Marketers would be well-served to seize the opportunities available in this still nascent market to deliver video advertising that is more engaging, more personalized and more measurable."

The 2018 Global Video Benchmarks report is available for download at https://info.innovid.com/global-annual_benchmarks.

About Innovid

Innovid is the world's leading video advertising platform, delivering more video than any company across mobile, desktop, connected TVs, streaming devices and social platforms. Innovid partners with brands, agencies, and publishers to deliver new advertising models that increase engagement and time spent in ways that also provide more value to viewers. Our video platform enables personalization of creative, seamless cross-screen delivery, and holistic measurement to fuel next-generation video experiences and grow revenue. Innovid has offices in New York, Chicago, San Francisco, Los Angeles, London, Tel Aviv, Sydney, and Singapore. Please visit www.innovid.com for more information.





View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005822/en/

Contacts
Media Contact:
Rachel Conforti (FOR MEDIA ONLY)
Email: pr@innovid.com

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GSMA: The Government of Uganda and Stakeholders Commit to Pursue Mobile-Enabled Digital Transformation

GSMA Report Shows That By June 2018 Uganda Had Nearly 10 Million Mobile Internet Connections With Mobile Money Being the Main Driver of Financial Inclusion



KAMPALA, Uganda -Saturday 30 March 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- The Government of Uganda, through the Ministry of Information and Communication Technology (ICT) and National Guidance, in partnership with the GSMA, the Swedish International Development Cooperation Agency (Sida), UK Department for International Development (DFID) and United Nations Development Programme (UNDP), held a high-level round table on mobile-enabled digital transformation in Uganda. The event, graced by the Rt.Hon. First Deputy Prime Minister Moses Ali drew the participation of ministers, leaders from mobile network operators – Airtel Uganda, Africell, MTN Uganda and Uganda Telecom - as well as development partners, who discussed how Uganda could advance the national and global sustainable development agenda through mobile-enabled digital transformation.

During the event a report was launched, which was prepared with the guidance of a multi-institutional technical committee, the above partners, as well as UN Capital Development Fund and Pulse Lab Kampala. The report examines the transformative opportunities presented by mobile-enabled digital services in Uganda. Accompanying this report is a draft action plan to be implemented over the next two years, outlining strategic mobile-enabled activities, which will address a range of challenges across sectors.

Today’s roundtable, which included a high-level panel involving experts from the Ministry of ICT and National Guidance, the GSMA, UNDP and private sector practitioners, reiterated the value of collaboration between the public and private sectors to harness mobile technology to deliver digital and economic inclusion. It was agreed that growing mobile connectivity presents an opportunity to accelerate development by enhancing the efficiency of public service delivery and introducing inclusive, integrated and innovative solutions that improve people’s lives.

While officially opening the event, General Moses Ali, Rt. Hon. First Deputy Prime Minister noted that, “To benefit from the fourth industrial revolution in which the key technology is mobile ICT, we need the right partnerships and a conducive legal and regulatory environment. I am happy to note that the National Broadband Policy is an important step towards creating that environment. National dialogues like this one also show that we are moving in the right direction regarding partnerships.”

In his welcome remarks, Honourable Vincent Bagiire, Permanent Secretary of the Ministry of ICT and National Guidance noted, “Mobile technology is evolving rapidly and shaping the way everyone conducts business. To the Government of Uganda, this presents an opportunity to not only reach everyone and provide consistent services, but also involve them in identifying and solving problems that matter to them and will enhance their lives in the future.”

“Few other technologies have grown as fast as mobile. Offering the most widespread and inclusive means of accessing the internet and digital services, which is vital to the Ugandan economy and its growth in an increasingly connected world,” said Akinwale Goodluck, Head of Sub-Saharan Africa, GSMA. “Mobile is the key to maximising the impact of digital transformation and I am very excited about future potential and to see our member operators building on the good work already started, through the dialogue they have undertaken today. It is crucial that all stakeholders build a collective vision to deliver on the vast opportunities mobile can deliver.”

Ms. Almaz Gebru, the UNDP acting Resident Representative emphasised that, “We are living in very dynamic digital era where technology can be leveraged for transformational change; we should however ensure that we bridge the digital divide so as to leave no one behind.’’ She highlighted the recently launched accelerator lab that UNDP has established in Uganda, which will contribute to action agreed under this partnership. The lab is one of the next generation UNDP initiatives designed to strengthen innovation in development through identifying, building on, and investing in local solutions, to step up efforts to explore more agile, novel and responsive approaches to development challenges.

Report Findings

    Mobile is the primary form of internet connectivity for most people in Uganda with 20 million unique individuals, 44 per cent of the population, owning a mobile.1 Nearly half of these also access mobile internet services;
    By June 2018, there were nearly 10 million mobile internet connections in Uganda, a penetration rate of 24 per cent compared to just 174,000 fixed-line connections, representing a fixed line penetration rate of less than 1 per cent;
    Key platforms such as mobile money and Cellular IoT (Internet of Things) enable the creation, distribution and consumption of a wide range of digital services. For example, mobile money is now the main driver of formal financial inclusion in Uganda, with 22 million registered accounts compared to just 5 million registered accounts in traditional banks; and
    Mobile technology is having a notable impact in Uganda in:
        Productivity and efficiency
        Service delivery
        Good governance and social justice
        Climate change and the environment
        Digital entrepreneurship and emerging technologies.

For more information on the findings from the report and sources for data points please visit: www.gsma.com/Uganda-overview

Notes to Editors

1Recent figures from Uganda Communications Commission show the number of registered sim cards to number 23.2 million. GSMA figures refer to unique subscribers to account for ‘multi-simming’ i.e. individuals who have multiple phone connections through more than one registered sim card.

About the GSMA

The GSMA represents the interests of mobile operators worldwide, uniting more than 750 operators and nearly 400 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005387/en/

Contacts

Media Contacts:
David Ntwampe Maila
+ 27 72 015 4702
dmaila@webershandwick.com

Beau Bass
+44 79 7662 4962
beau.bass@webershandwick.com

GSMA Press Office
pressoffice@gsma.com

Michael Mubangizi
Communications Analyst, UNDP Uganda,
michael.mubangizi@undp.org,
+256 772 147 564

Lamine Bal
Communications Specialist
Regional Bureau of Africa
lamine.bal@undp.org
+1 212 906 5937

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JIUN Releases Free Cloud-Based Medical Image Management System “SonicDICOM PACS Cloud Beta”

FUKUOKA, Japan -Saturday 30 March 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- JIUN Corporation (Location: Fukuoka City, Fukuoka Prefecture) started providing its cloud-based medical image management system “SonicDICOM PACS Cloud Beta” on March 28, 2019. By simply registering an account online, you can start using PACS in a few minutes. You can also store images up to 3 GB for free in the cloud-based PACS service.

URL: https://sonicdicom.com/cloud/

Outline of SonicDICOM PACS Cloud
This service enables you to store medical images in the cloud and, simply by accessing a URL from a PC or tablet, to view them from anywhere in the world.
By making use of this service, it is easy to share medical images with other medical facilities.
In addition, as there is no need to install a server in a medical facility, no costs are incurred for purchasing, updating, or managing server equipment, so the system can be operated with low initial cost.

[Usage situations]
1) Using it as the main PACS, or as a backup for the main PACS
As there is no need to have a server in the hospital, and data can be stored in a physically remote location, you can protect against the risk of data loss due to hardware failure or natural disasters.

2) Viewing images from outside facilities
Images can be viewed at any time regardless of the situation or place, whether at home or on the move.
Also, in cases such as nighttime emergencies, when the doctor-in-charge is not present in the hospital, a doctor outside the hospital can view the images.

3) Sharing medical images
Medical images can be shared with other facilities and radiologists from countries with a higher level of medical care to request radiogram interpretations.

4) Personal usage (doctors, researchers, students, patients)
You can store collected medical images and use them for research and presentations at academic conferences.
Also, as the patient can store his/her own or family members’ medical images, this can be used for disclosure of medical history or second opinions.

JIUN has launched this service as part of the efforts to meet SDGs (Sustainable Development Goals), and through this service we are working to promote medical collaboration going beyond national borders and to rectify medical care disparities around the world. Furthermore, this service has been developed with the support of Japan’s Ministry of Economy, Trade and Industry.

[About usage charges]
3GB of storage capacity is available for free.

[Future plans]
With the addition of paid plans, official service will be provided within a few months.

About JIUN Corporation
Since the company’s founding in 2000, we have been developing mainly medical systems.
We have provided highly unique services and been earning excellent reputation from our users.

[Company Overview]

 
Company name: JIUN Corporation
Established: July 2000
Capitalization: 10 million yen

 
Representative Director: Fumitaka Kanda, President

Address: FRC Bldg. 9F, 1-14-1 Tanotsu, Higashi-ku, Fukuoka City, Fukuoka Prefecture

URL
: https://sonicdicom.com/about-us/ [Company overview]

 
 
: https://sonicdicom.com/cloud/ [SonicDICOM PACS Cloud]

 
 
Screenshots
Configuration diagram: https://sonicdicom.com/img/release/cloud.jpg
Viewer screen: https://sonicdicom.com/img/release/viewer.png

View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005058/en/

Contacts
JIUN Corporation
Daisuke Teshima
TEL: +81-92-626-7002
FAX: +81-92-626-7022
Email: sonic@sonicdicom.com



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XPRIZE Foundation Announces $1 Million ‘Moonshot Award’ for Technical Achievements Outside of an Active XPRIZE Competition

Inaugural Award will be Presented to SpaceIL upon a Successful Lunar Landing

LOS ANGELES -Friday 29 March 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- XPRIZE, the global leader in designing and operating world-changing incentive competitions, announces that it will offer a $1 million Moonshot Award in recognition of an XPRIZE team demonstrating the achievement of a “moonshot” technological feat outside the parameters or timeframe of an XPRIZE competition.

The Award is inspired by SpaceIL, a former Google Lunar XPRIZE team, whose mission to become the first private, non-government entity to land on the surface of the Moon is underway, with an anticipated landing on April 11, 2019. A successful lunar landing will result in SpaceIL receiving the inaugural Moonshot Award from XPRIZE.

“Though the Google Lunar XPRIZE went unclaimed, we are thrilled to have stimulated a diversity of teams from around the world to pursue their ambitious lunar missions, and we are proud to be able to recognize SpaceIL’s accomplishment with this Moonshot Award,” said Anousheh Ansari, chief executive officer of XPRIZE.

SpaceIL was founded in 2011 by Yariv Bash, Kfir Damari and Yonatan Winetraub, in order to compete in the Google Lunar XPRIZE. In 2015, SpaceIL became the first team to announce a launch contract, and they launched for the Moon on a SpaceX Falcon 9 on February 21, 2019.

“SpaceIL’s mission represents the democratization of space exploration. We are optimistic about seeing this first domino fall, setting off a chain reaction of increasingly affordable and repeatable commercial missions to the Moon and beyond,” said Peter H. Diamandis, founder and executive chairman of XPRIZE.

XPRIZE will consider future Moonshot Awards in other domains, recognizing both literal and figurative moonshots.

About XPRIZE

XPRIZE designs and operates global competitions to incentivize the development of technological breakthroughs that accelerate humanity toward a better future. Active competitions include the $20M NRG COSIA Carbon XPRIZE, the $15M Global Learning XPRIZE, the $10M ANA Avatar XPRIZE, the $7M Shell Ocean Discovery XPRIZE, and the $5M IBM Watson AI XPRIZE. For more information, visit www.xprize.org.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005073/en/

Contacts

Media Contact:
Eric Desatnik, eric@xprize.org, 310-741-4880


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Velodyne Achieves Half a Billion Dollars in Lidar Sensors Shipped

Velodyne is the Lidar Industry Leader in Mass Production

SAN JOSE, Calif.-Friday 29 March 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Velodyne has shipped a cumulative total of 30,000 lidar sensors with a total value of half a billion dollars. This achievement underscores Velodyne’s lidar market leadership and ability to deliver a broad portfolio of lidar sensor products at mass production levels.

Velodyne is the highest volume supplier of lidar sensors to the automotive industry with more than 250 customers globally. Lidar sensors are a central component of autonomous vehicles (AVs) and advanced driver assistance systems (ADAS). Velodyne’s sensors are used in a myriad of new technologies and rapidly growing industries, including unmanned aerial vehicles, delivery services, mapping, industrial safety, robotics, security, marine uses, and more.

“We broke through this milestone because the Velodyne team develops the smartest, most powerful lidar solutions. Velodyne created the world’s first in-house automated manufacturing processes to produce automotive-grade lidar products at scale,” said David Hall, CEO and Founder, Velodyne Lidar, Inc.

Velodyne’s product portfolio meets the needs for autonomy and driver assistance, providing the real-time perception data that enables safe and reliable operation. Velodyne produces both directional and surround-view sensors with best-in-class range and resolution. The rich computer perception data provided by these sensors allows immediate object and free space detection for safe navigation.

Velodyne’s manufacturing operations include a 200,000 square foot megafactory in San Jose, Calif., where highly-automated robotic assembly techniques are utilized to build a range of sensors. Invented by Velodyne, these revolutionary manufacturing systems form the foundation of the company’s mass production capabilities. Velodyne is also scaling production by licensing core lidar technology to Tier 1 supplier Veoneer for a long-term, high-volume manufacturing agreement with a global automaker.

About Velodyne Lidar

Velodyne provides the smartest, most powerful lidar solutions for autonomy and driver assistance. Founded in 1983 and headquartered in San Jose, Calif., Velodyne is known worldwide for its portfolio of breakthrough lidar sensor technologies. In 2005, Velodyne’s Founder and CEO, David Hall, invented real-time surround view lidar systems, revolutionizing perception and autonomy for automotive, new mobility, mapping, robotics, and security. Velodyne’s high-performance product line includes a broad range of sensing solutions, including the cost-effective Puck™, the versatile Ultra Puck™, the perfect for L4-L5 autonomy Alpha Puck™, the ultra-wide angle VelaDome™, the ADAS-optimized Velarray™, and the groundbreaking software for driver assistance, Vella™. To learn more about lidar, please visit Velodyne’s Lidar 101 webpage.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190328005087/en/

Contacts

Sean Dowdall
Landis Communications for Velodyne Lidar, Inc.
(415) 286-7121
velodyne@landispr.com



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Friday, March 29, 2019

Celgene Receives CHMP Positive Opinions for Both REVLIMID® (lenalidomide) and IMNOVID® (pomalidomide)-Based Triplet Combination Regimens for Patients with Multiple Myeloma

SUMMIT, N.J. -Friday 29 March 2019 [ AETOS Wire ]

The CHMP adopted two positive opinions recommending European Commission approval of:

    REVLIMID in combination with bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma who are not eligible for transplant
    IMNOVID in combination with bortezomib and dexamethasone (PVd), for adult patients with multiple myeloma, who have received at least one prior treatment regimen including lenalidomide

(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions for two triplet regimens based on Celgene’s proprietary IMiD® medications, REVLIMID (lenalidomide) and IMNOVID (pomalidomide).

The CHMP recommended approval of an expanded indication of REVLIMID as combination therapy with bortezomib and dexamethasone (RVd) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

The committee also recommended approval of IMNOVID in combination with bortezomib and dexamethasone (PVd), for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months.

“The CHMP positive opinions for our IMiD combinations, RVd and PVd represent very good news for patients with multiple myeloma in Europe,” said Nadim Ahmed, President, Hematology/Oncology for Celgene. “We look forward to potential EMA approvals, which would make these new triplet regimens available to patients, as we aim to improve patient outcomes across multiple stages of their disease.”

The CHMP positive opinion for REVLIMID was based on the data from SWOG S0777, a phase 3 trial evaluating the triplet combination of REVLIMID, bortezomib and dexamethasone (RVd) in adult patients with previously untreated multiple myeloma, without an intent for immediate autologous stem cell transplant (ASCT).1 Results from SWOG S0777 showed statistically significant progression-free (PFS) and overall survival improvements in patients treated with RVd compared to those treated with REVLIMID and dexamethasone alone (Rd). The choice of treatment in a first-line therapy setting is important2 as patients progressively become less responsive to therapy and experience shorter periods of remission at later lines of treatment.3

The CHMP positive opinion for PVd was based on the data from OPTIMISMM, the first prospective phase 3 trial to evaluate an IMNOVID-based triplet regimen in patients who were previously treated with REVLIMID, and who were, in the majority (70 percent), REVLIMID refractory.4 This patient population represents a growing unmet medical need for which new treatment options are necessary. Results from OPTIMISMM showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm.

REVLIMID in combination with bortezomib and dexamethasone and IMNOVID in combination with bortezomib and dexamethasone are not approved for any use in any country.

About Celgene’s Immunomodulatory Drugs

IMiD® agents are Celgene’s proprietary small molecule, orally available compounds for the treatment of some blood cancers. IMiD agents are hypothesized to have multiple mechanisms of action. They have been found to increase activation and proliferation of T cells, and proliferation of the IL-2 protein and activity of CD8+ effector T cells. IMiD agents have also been found to affect the stimulation and expression of natural killer (NK) cells, working within the environment of the cell to stimulate the immune system to attack the cancer cells, as well as attack the cancer cells directly. In addition to immunomodulatory properties, IMiD agents are hypothesized to have tumoricidal and antiangiogenic activity. Celgene’s portfolio of IMiD agents have become a foundation of multiple myeloma research, with a growing number of studies exploring these compounds as combination partners across a range of settings of the disease.

About Multiple Myeloma

Multiple myeloma is a life-threatening blood cancer that is characterized by tumor proliferation and suppression of the immune system.5 It is a rare but deadly disease—around 42,000 people are diagnosed with multiple myeloma in Europe, and approximately 26,000 people die from the disease each year.6 The typical multiple myeloma disease course includes periods of symptomatic myeloma followed by periods of remission, and eventually, the disease becomes refractory (nonresponsive).

About SWOG S0777

SWOG S0777 is a randomized, open-label, multicentre, phase 3 study aiming to evaluate the efficacy and safety of RVd compared to Rd in treating patients with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT).

SWOG S0777 recruited 525 patients with symptomatic and measurable ndMM aged 18 years and older. Patients were randomly assigned (1:1) to receive either an initial treatment of lenalidomide with bortezomib and dexamethasone (RVd group) or lenalidomide and dexamethasone alone (Rd group). Randomization was stratified based on International Staging System stage (I, II, or III) and intent to transplant (yes versus no). The RVd regimen was given as eight 21-day cycles. Bortezomib was given at 1.3 mg/m2 intravenously on days 1, 4, 8, and 11, combined with oral lenalidomide 25 mg daily on days 1-14 plus oral dexamethasone 20 mg daily on days 1, 2, 4, 5, 8, 9, 11, and 12. The Rd regimen was given as six 28-day cycles. The standard Rd regimen consisted of 25 mg oral lenalidomide once a day for days 1-21 plus 40 mg oral dexamethasone once a day on days 1, 8, 15, and 22.

Results from SWOG S07771 showed that median progression-free survival (PFS) was significantly improved in patients receiving RVd compared to those receiving REVLIMID and dexamethasone (Rd) alone (42 months versus 30 months; HR 0.76, 95% CI 0.62-0.94; P=0.01). Median overall survival was also significantly improved in patients receiving RVd compared to those receiving Rd (89 months versus 67 months; HR 0.72, 95% CI 0.56–0.94; P=0.013). The rates of overall and complete response were higher in those receiving RVd compared to Rd (overall response: 82% RVd vs 72% Rd; complete response: 16% RVd vs 8% Rd). The safety of RVd was also consistent with the well-established safety profiles of each drug in the triplet therapy.7,8

Upon completion of induction, all patients received ongoing maintenance with 25 mg oral lenalidomide once a day for 21 days plus 40 mg oral dexamethasone once a day for days 1, 8, 15, and 22 of each 28-day cycle.

About OPTIMISMM

OPTIMISMM is the first phase 3 trial designed to compare the safety and efficacy of PVd versus Vd, as an early line of therapy in patients with relapsed and refractory multiple myeloma (with 1-3 prior regimens of therapy) and prior REVLIMID-exposure, including REVLIMID-refractory patients.

The multi-center, international, open-label, randomized phase 3 clinical trial included 559 patients (281 patients in the PVd arm and 278 in the Vd arm). Demographic, baseline, and prior disease characteristics were generally well balanced between the two treatment arms. The median number of prior lines of therapy was two, while more than one third had one prior line of treatment (40% across both treatment arms). All patients had prior treatment with REVLIMID® with the majority being REVLIMID refractory (71 percent in the PVd arm vs 69 percent in the Vd arm) and 70 percent vs 66 percent, respectively, were refractory to their last treatment. Median follow-up was 16 months.

Results from OPTIMISMM4 showed that patients receiving PVd achieved a significantly longer PFS than those in the Vd treatment arm (11.20 months vs. 7.10 months, respectively [P= < .0001, HR 0.61; 95% CI: (0.49-0.77)]), reducing the risk of disease progression or death by 39% in the PVd arm. In an exploratory sub-group analysis of patients with one prior line of therapy, median progression-free survival with PVd was 20.73 months vs 11.63 months with Vd (HR 0.54; p=0·0027). In these patients, the benefit of PVd was independent of whether they were refractory or non-refractory to prior therapy with lenalidomide. The safety of PVd was consistent with the well-established safety profiles of each drug in the triplet therapy.7

Patients were stratified based on age (≤ 75 years old vs > 75 years old), number of prior anti-myeloma regimens (1 vs. > 1), and β2-microglobulin levels (< 3.5 mg/L vs ≥ 3.5 to ≤ 5.5 mg/L vs > 5.5 mg/L). Patients were randomized 1:1 to receive PVd or Vd. In 21-day cycles, patients received

IMNOVID 4 mg/d on days 1-14 (PVd arm only); bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11 of cycles 1-8 and on days 1 and 8 of cycles 9 and beyond; and dexamethasone 20 mg/d (10 mg if aged > 75 years) on the days of and after receiving bortezomib treatment.

About REVLIMID®

REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)

REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT)

REVLIMID® is indicated for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities

REVLIMID® is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS® program.

Information about the REVLIMID REMS® program is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS

    Females of Reproductive Potential: See Boxed WARNINGS
    Males: Lenalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 4 weeks after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Male patients taking REVLIMID must not donate sperm
    Blood Donation: Patients must not donate blood during treatment with REVLIMID and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to REVLIMID

REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID as maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction

Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patient’s underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision

Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment

Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered

Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash, or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN, or DRESS is suspected and should not be resumed following discontinuation for these reactions

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to ≤Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physician’s discretion

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy

Early Mortality in Patients with MCL: In another MCL study, there was an increase in early deaths (within 20 weeks), 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (≥10 x 109/L)

ADVERSE REACTIONS

Multiple Myeloma

    In newly diagnosed: The most frequently reported Grade 3 or 4 reactions included neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataract, lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia. The highest frequency of infections occurred in Arm Rd Continuous (75%) compared to Arm MPT (56%). There were more Grade 3 and 4 and serious adverse reactions of infection in Arm Rd Continuous than either Arm MPT or Rd18
    The most common adverse reactions reported in ≥20% (Arm Rd Continuous): diarrhea (46%), anemia (44%), neutropenia (35%), fatigue (33%), back pain (32%), asthenia (28%), insomnia (28%), rash (26%), decreased appetite (23%), cough (23%), dyspnea (22%), pyrexia (21%), abdominal pain (21%), muscle spasms (20%), and thrombocytopenia (20%)
    Maintenance Therapy Post Auto-HSCT: The most frequently reported Grade 3 or 4 reactions in ≥20% (REVLIMID arm) included neutropenia, thrombocytopenia, and leukopenia. The serious adverse reactions of lung infection and neutropenia (more than 4.5%) occurred in the REVLIMID arm
    The most frequently reported adverse reactions in ≥20% (REVLIMID arm) across both maintenance studies (Study 1, Study 2) were neutropenia (79%, 61%), thrombocytopenia (72%, 24%), leukopenia (23%, 32%), anemia (21%, 9%), upper respiratory tract infection (27%, 11%), bronchitis (5%, 47%), nasopharyngitis (2%, 35%), cough (10%, 27%), gastroenteritis (0%, 23%), diarrhea (55%, 39%), rash (32%, 8%), fatigue (23%, 11%), asthenia (0%, 30%), muscle spasm (0%, 33%), and pyrexia (8%, 21%)
    After at least one prior therapy: The most common adverse reactions reported in ≥20% (REVLIMID/dex vs dex/placebo): fatigue (44% vs 42%), neutropenia (42% vs 6%), constipation (41% vs 21%), diarrhea (39% vs 27%), muscle cramp (33% vs 21%), anemia (31% vs 24%), pyrexia (28% vs 23%), peripheral edema (26% vs 21%), nausea (26% vs 21%), back pain (26% vs 19%), upper respiratory tract infection (25% vs 16%), dyspnea (24% vs 17%), dizziness (23% vs 17%), thrombocytopenia (22% vs 11%), rash (21% vs 9%), tremor (21% vs 7%), and weight decreased (20% vs 15%)

Myelodysplastic Syndromes

    Grade 3 and 4 adverse events reported in ≥ 5% of patients with del 5q MDS were neutropenia (53%), thrombocytopenia (50%), pneumonia (7%), rash (7%), anemia (6%), leukopenia (5%), fatigue (5%), dyspnea (5%), and back pain (5%)
    Adverse events reported in ≥15% of del 5q MDS patients (REVLIMID): thrombocytopenia (61.5%), neutropenia (58.8%), diarrhea (49%), pruritus (42%), rash (36%), fatigue (31%), constipation (24%), nausea (24%), nasopharyngitis (23%), arthralgia (22%), pyrexia (21%), back pain (21%), peripheral edema (20%), cough (20%), dizziness (20%), headache (20%), muscle cramp (18%), dyspnea (17%), pharyngitis (16%), epistaxis (15%), asthenia (15%), upper respiratory tract infection (15%)

Mantle Cell Lymphoma

    Grade 3 and 4 adverse events reported in ≥5% of patients treated with REVLIMID in the MCL trial (N=134) included neutropenia (43%), thrombocytopenia (28%), anemia (11%), pneumonia (9%), leukopenia (7%), fatigue (7%), diarrhea (6%), dyspnea (6%), and febrile neutropenia (6%)
    Adverse events reported in ≥15% of patients treated with REVLIMID in the MCL trial included neutropenia (49%), thrombocytopenia (36%), fatigue (34%), anemia (31%), diarrhea (31%), nausea (30%), cough (28%), pyrexia (23%), rash (22%), dyspnea (18%), pruritus (17%), peripheral edema (16%), constipation (16%), and leukopenia (15%)

DRUG INTERACTIONS

Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin

USE IN SPECIFIC POPULATIONS

    PREGNANCY: See Boxed WARNINGS: If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. There is a REVLIMID pregnancy exposure registry that monitors pregnancy outcomes in females exposed to REVLIMID during pregnancy as well as female partners of male patients who are exposed to REVLIMID. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to REVLIMID to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436
    LACTATION: There is no information regarding the presence of lenalidomide in human milk, the effects of REVLIMID on the breastfed infant, or the effects of REVLIMID on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed infants from REVLIMID, advise female patients not to breastfeed during treatment with REVLIMID
    PEDIATRIC USE: Safety and effectiveness have not been established in pediatric patients
    RENAL IMPAIRMENT: Adjust the starting dose of REVLIMID based on the creatinine clearance value and in patients on dialysis

Please see full Prescribing Information, including Boxed WARNINGS.

About IMNOVID® (pomalidomide)

IMNOVID® in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. It belongs to a group of drugs called immunomodulatory drugs (IMiDs®).

IMNOVID, which is marketed under trade name POMALYST® in the US, was first approved for use in the US in 2013 in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Imnovid in combination with bortezomib and dexamethasone is not approved for use in United States.

It was approved in the EU in 2013, in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

It is also approved in a total of 66 countries worldwide including Australia, Canada, Japan and Switzerland for use in combination with dexamethasone for similar indications to US and EU.

About POMALYST

Indication

POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Important Safety Information
           
           

WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity



    POMALYST is contraindicated in pregnancy. POMALYST is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
    Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment.

POMALYST is only available through a restricted distribution program called POMALYST REMS®.

Venous and Arterial Thromboembolism



    Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.

CONTRAINDICATIONS

    Pregnancy: POMALYST can cause fetal harm and is contraindicated in females who are pregnant. If POMALYST is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus.

WARNINGS AND PRECAUTIONS

    Embryo-Fetal Toxicity & Females of Reproductive Potential: See Boxed WARNINGS
    Males: Pomalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 4 weeks after discontinuing POMALYST, even if they have undergone a successful vasectomy. Males must not donate sperm.
    Blood Donation: Patients must not donate blood during treatment with POMALYST and for 4 weeks following discontinuation of POMALYST therapy because the blood might be given to a pregnant female patient whose fetus must not be exposed to POMALYST.
    POMALYST REMS® Program: See Boxed WARNINGS
    Prescribers and pharmacies must be certified with the POMALYST REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive POMALYST. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements.
    Further information about the POMALYST REMS program is available at www.CelgeneRiskManagement.com or by telephone at 1-888-423-5436.
    Venous and Arterial Thromboembolism: See Boxed WARNINGS. Patients with known risk factors, including prior thrombosis, may be at greater risk, and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors.
    Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
    Hematologic Toxicity: Neutropenia (46%) was the most frequently reported Grade 3/4 adverse reaction in patients taking POMALYST in clinical trials, followed by anemia and thrombocytopenia. Monitor complete blood counts weekly for the first 8 weeks and monthly thereafter. Patients may require dose interruption and/or modification.
    Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Monitor liver function tests monthly. Stop POMALYST upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered.
    Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous reactions including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe cutaneous reactions such as SJS, TEN or DRESS, and do not resume therapy.
    Dizziness and Confusional State: In patients taking POMALYST in clinical trials, 14% experienced dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or 4). Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
    Neuropathy: In patients taking POMALYST in clinical trials, 18% experienced neuropathy (2% Grade 3 in one trial) and 12% peripheral neuropathy.
    Second Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma.
    Tumor Lysis Syndrome (TLS): TLS may occur in patients treated with POMALYST. Patients at risk are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken.

ADVERSE REACTIONS

The most common adverse reactions for POMALYST (≥30%) included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, and pyrexia.

In the phase III trial, nearly all patients treated with POMALYST + low-dose dex experienced at least one adverse reaction (99%). Adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥2% higher than control) included neutropenia (51.3%), fatigue and asthenia (46.7%), upper respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia (26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms (15.3%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15% in the POMALYST + low-dose dex arm and ≥1% higher than control) included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia (15.7%).

DRUG INTERACTIONS

Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2. Consider alternative treatments. If a strong CYP1A2 inhibitor must be used, reduce POMALYST dose by 50%.

USE IN SPECIFIC POPULATIONS

    Pregnancy: See Boxed WARNINGS. If pregnancy does occur during treatment, immediately discontinue the drug and refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for further evaluation and counseling. There is a POMALYST pregnancy exposure registry that monitors pregnancy outcomes in females exposed to POMALYST during pregnancy as well as female partners of male patients who are exposed to POMALYST. This registry is also used to understand the root cause for the pregnancy. Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at 1-888-423-5436.
    Lactation: There is no information regarding the presence of pomalidomide in human milk, the effects of POMALYST on the breastfed child, or the effects of POMALYST on milk production. Pomalidomide was excreted in the milk of lactating rats. Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from POMALYST, advise women not to breastfeed during treatment with POMALYST.
    Pediatric Use: Safety and effectiveness have not been established in pediatric patients.
    Geriatric Use: No dosage adjustment is required for POMALYST based on age. Patients >65 years of age were more likely than patients ≤65 years of age to experience pneumonia.
    Renal Impairment: Reduce POMALYST dose by 25% in patients with severe renal impairment requiring dialysis. Take dose of POMALYST following hemodialysis on hemodialysis days.
    Hepatic Impairment: Reduce POMALYST dose by 25% in patients with mild to moderate hepatic impairment and 50% in patients with severe hepatic impairment.
    Smoking Tobacco: Advise patients that smoking may reduce the efficacy of POMALYST. Cigarette smoking reduces the AUC of pomalidomide by 32% by CYP1A2 induction.

Please see full Prescribing Information, including Boxed WARNINGS.

ABOUT CELGENE

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: management’s time and attention is diverted on transaction related issues; disruption from the transaction makes it more difficult to maintain business, contractual and operational relationships; pending legal proceedings or any future litigation instituted against Bristol-Myers Squibb, Celgene or the combined company could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel

References:

___________________________

1 Durie BG, Hoering A, Abidi MH, et al. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet. 2017 Feb 4;389(10068):519-527.

2 Liwing J, Uttervall K, Lund J, et al. Improved survival in myeloma patients: starting to close in on the gap between elderly patients and a matched normal population. Br J Haematol. 2014 Mar;164(5):684-93.

3 Kumar SK, Therneau TM, Gertz MA, et al. Clinical course of patients with relapsed multiple myeloma. Mayo Clin Proc. 2004 Jul;79(7):867–874.

4 Richardson P, Rocafiguera A, Beksac M, et al. OPTIMISMM: Phase 3 trial of pomalidomide, bortezomib, and low‐dose dexamethasone vs bortezomib and low-dose dexamethasone in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. Presented at: American Society of Clinical Oncology Annual Meeting; June 1, 2018; Chicago, IL.

5 Palumbo A and Anderson K. Multiple myeloma. N Engl J Med. 2011;364:1046-1060.
6 European Cancer Information System. Estimates of cancer incidence and mortality in 2018, for all countries. Available at: https://ecis.jrc.ec.europa.eu/explorer.php. Accessed March 2019.

7 Berenson JR, Jagannath S, Barologie B, et al. Safety of prolonged therapy with bortezomib in relapsed or refractory multiple myeloma. Cancer. 2005:104(10):2141-8.
8 European Medicines Agency. REVLIMID summary of product characteristics, 2009. Updated 23/08/2018.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190329005230/en/

Contacts

Celgene Corporation
Investors:
+1-908-673-9628
ir@celgene.com
or
Media:
+1-908-673-2275
media@celgene.com


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Success of Thales Offer for Gemalto Shares



PARIS LA DÉFENSE -Friday 29 March 2019 [ AETOS Wire ]

    85.58% of Gemalto shares have been tendered to the Offer
    All Offer Conditions are now satisfied or waived, making the Offer unconditional
    Settlement of tendered Shares will take place on 2 April 2019
    Remaining Shares can be tendered during the Post-Closing Acceptance Period which will start on Monday 1 April 2019 and end on Monday 15 April 2019
    Gemalto will be consolidated as of 1 April 2019 in Thales’s financial statements

(BUSINESS WIRE)-- Regulatory News:

Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the Offer), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 14 March 2019 in relation to the Acceptance Closing Time.

Terms not defined in this press release will have the meaning set forth in the Offer Document.

Upon expiration of the Acceptance Period at 17:40 (CET) yesterday, approximately 85.58% of the Gemalto shares have been tendered to the Offer. As a result, all Offer Conditions described in the Offer Document have now been satisfied or waived. Thales and Gemalto are therefore pleased to announce that Thales declares the Offer unconditional (doet gestand).

“The integration of Gemalto marks the start of a bold new chapter in the history of Thales. Together, Thales and Gemalto will have the ability to cover the digital needs of all clients, in civilian and defence businesses, across all Thales market segments, with a unique portfolio of advanced technologies in the fields of digital security and the Internet of Things.”
Patrice Caine, Chairman and Chief Executive Officer of Thales

Acceptance
During the Acceptance Period, that expired at 17:40 (CET) yesterday, 79,889,388 Shares (including Shares represented by American depositary shares) have been tendered to the Offer, representing approximately 85.58% of the aggregate issued and outstanding share capital of Gemalto (on a fully diluted basis), and an aggregate value of approximately EUR 4,074 million (for an Offer Price of EUR 51.00 (cum dividend) per Share).

Settlement
In accordance with the Offer Document published on 27 March 2018, holders of Ordinary Shares who accepted the Offer will be paid an amount in cash of EUR 51.00 (the Offer Price) per Share and holders of ADS who accepted the Offer will be paid an amount in U.S. dollar corresponding to 50% of the Offer Price, or EUR 25.50 (the ADS Offer Price) per ADS, the U.S. dollar equivalent being calculated by Thales using the spot market exchange rate for the U.S. dollar against the euro published on Bloomberg at 12:00 p.m. New York time, on the day immediately prior to the date on which funds are received by American Stock Transfer & Trust Co., LLC (the ADS Tender Agent), to pay the ADS Offer Price to the holders of all Tendered ADS.

Payment of the Offer Price and the ADS Offer Price will occur on 2 April 2019 (the Settlement Date). Thales currently does not hold any Shares. Following the Settlement of the Offer, Thales will hold 79,889,388 Shares, representing 85.58% of the issued and outstanding share capital of Gemalto (on a fully diluted basis).

Post-Closing Acceptance Period
Thales hereby announces that Shareholders who have not tendered their Shares during the Acceptance Period will have the opportunity to tender their Shares under the same terms and conditions applicable to the Offer, in a Post-Closing Acceptance Period (na-aanmeldingstermijn) which will start at 09:00 (CET) on Monday 1 April 2019 and end at 17:40 (CET) on Monday 15 April 2019 (the Post-Closing Acceptance Period).

A notice of guaranteed delivery will not be an effective means of tendering ADS during the Post-Closing Acceptance Period and no notice of guaranteed delivery will be accepted following the Acceptance Closing Time. The Offer Price paid to ADS holders in the Post-Closing Acceptance Period shall be converted to U.S. dollars using the Applicable Exchange Rate. In all cases, fluctuations in the euro to the U.S. dollar exchange rate are at the risk of holders of Tendered ADS.

Thales will publicly announce the results of the Post-Closing Acceptance Period and the total number and total percentage of Shares held by it in accordance with Article 17, paragraph 4 of the Decree ultimately on the 3rd Dutch Business Day following the last day of the Post-Closing Acceptance Period.

Thales shall continue to accept for payment all Shares validly tendered (or defectively tendered, provided that such defect has been waived by Thales) during the Post-Closing Acceptance Period and shall pay for such Shares within 5 Business Day following the last day of the Post-Closing Acceptance Period.

During the Post-Closing Acceptance Period, Shareholders have no right to withdraw Shares from the Offer, regardless whether their Shares have been validly tendered (or defectively tendered, provided that such defect has been waived by Thales) during the Acceptance Period or the Post-Closing Acceptance Period.

Buy-Out
If, following the settlement of the Shares tendered during the Post-Closing Acceptance Period, Thales and its Affiliates hold at least 95% of the issued ordinary share capital (geplaatst gewoon aandelenkapitaal) of Gemalto, Thales intends to commence (i) a compulsory acquisition procedure (uitkoopprocedure) in accordance with article 2:92a or 2:201a of the Dutch Civil Code, and/or (ii) a takeover buy-out procedure in accordance with article 2:359c of the Dutch Civil code in order to buy out the Shareholders who have not tendered their Shares.

Delisting
Thales and Gemalto intend to as soon as possible procure the delisting of the Shares from Euronext Amsterdam and Euronext Paris and terminate the listing agreement between Gemalto and Euronext. Gemalto also intends to terminate the Deposit Agreement effective as per the delisting of the Shares. These actions may adversely affect the liquidity and market value of any listed Shares not tendered. Reference is made to Section 6.13 (Liquidity and Delisting) and Section 6.14 (Termination of the ADS Deposit Agreement) of the Offer Document.

Further implications of the Offer being declared unconditional
Remaining Shareholders who do not wish to tender their Shares during the Post-Closing Acceptance Period should carefully review the sections of the Offer Document that further explain the intentions of Thales, such as (but not limited to) Sections 6.12 (Intentions following the Offer being declared unconditional) up to and including Section 6.15.5 (Other measures), which describe certain implications to which such Shareholders will be subject if the Offer is declared unconditional.

Announcements
Any further announcements in relation to the Offer will be issued by press release. Any joint press release issued by Thales and Gemalto will be made available on the websites of Thales (www.thalesgroup.com) and Gemalto (www.gemalto.com). Subject to any applicable requirements of the applicable rules and without limiting the manner in which Thales may choose to make any public announcement, Thales will have no obligation to make any public announcement other than as described above.

Further information
This announcement contains selected and condensed information regarding the Offer and does not replace the Offer Document and/or the Position Statement. The information in this announcement is not complete and additional information is contained in the Offer Document and the Position Statement.

Digital copies of the Offer Document and its French summary are available on the websites of Thales (www.thalesgroup.com) and Gemalto (www.gemalto.com). Such websites do not constitute a part of, and are not included or referred to in, the Offer Document. Copies of the Offer Document are also available free of charge from the 4 Agents listed below.

The Settlement Agent for Ordinary Shares:

ING BANK N.V.
Address: Bijlmerplein 888, 1102 MG Amsterdam, The Netherlands
Telephone: +31 20 56 36 619
E-mail: iss.pas@ing.nl

The ADS Tender Agent:

AMERICAN STOCK TRANSFER & TRUST COMPANY, LLC
Address: 6201 15th Avenue, Brooklyn, New York, 11219, United States
Telephone: +1 (877) 248 6417
E-mail: dapisa@astfinancial.com

The Information Agent for Ordinary Shares:

IPREO
Address: 10, rue du Colisée, 75008 Paris, France
Telephone: +33 (0)1 79 73 12 12
E-mail: Thales-Gemalto@ipreo.com

The U.S. Information Agent for ADS:

D.F. KING & CO., INC
Address: 48 Wall Street, 22nd Floor, New York, New York, 10005, United States
Telephone: +1 (877) 536 1556
E-mail: GTO@dfking.com

****

This is a joint press release by Thales and Gemalto pursuant to Section 16, paragraph 1 and 2, Section 17, paragraph 1 of the Dutch decree on public takeover bids (Besluit openbare biedingen Wft) in connection with the recommended all-cash offer by Thales for all the issued and outstanding shares in the capital of Gemalto, including all American depositary shares (ADS). This announcement does not constitute an offer, or any solicitation of any offer, to buy or subscribe for any securities in Gemalto. Any offer is only made by means of the Offer Document dated 27 March 2018, which is available on the website of Thales at www.thalesgroup.com/en/investors and on the website of Gemalto at www.gemalto.com/investors.

About Thales
The people we all rely on to make the world go round – they rely on Thales. Our customers come to us with big ambitions: to make life better, to keep us safer.

Combining a unique diversity of expertise, talents and cultures, our architects design and deliver extraordinary high technology solutions. Solutions that make tomorrow possible, today. From the bottom of the oceans to the depth of space and cyberspace, we help our customers think smarter and act faster - mastering ever greater complexity and every decisive moment along the way.

With 66,000 employees in 56 countries, Thales reported sales of €15.9 billion in 2018.

www.thalesgroup.com

About Gemalto
Gemalto is the global leader in digital security, with 2017 annual revenues of €3 billion and customers in over 180 countries. We bring trust to an increasingly connected world.

From secure software to biometrics and encryption, our technologies and services enable businesses and governments to authenticate identities and protect data so they stay safe and enable services in personal devices, connected objects, the cloud and in between.

Gemalto’s solutions are at the heart of modern life, from payment to enterprise security and the internet of things. We authenticate people, transactions and objects, encrypt data and create value for software – enabling our clients to deliver secure digital services for billions of individuals and things.

Our 15,000 employees operate out of 112 offices, 43 personalization and data centers, and 30 research and software development centers located in 48 countries.

www.gemalto.com

Notice to U.S. holders of Gemalto Shares
The Offer is made for the securities of Gemalto, a public limited liability company incorporated under Dutch Law, and is subject to Dutch disclosure and procedural requirements, which are different from those of the United States of America. The Offer is made in the United States of America in compliance with Section 14(e) of the U.S. Securities Exchange Act of 1934, as amended (the "U.S. Exchange Act"), and the applicable rules and regulations promulgated thereunder, including Regulation 14E (subject to any exemptions or relief therefrom, if applicable) and otherwise in accordance with the requirements of Dutch law. Accordingly, the Offer is subject to disclosure and other procedural requirements, including with respect to the Offer timetable, settlement procedures, withdrawal, waiver of conditions and timing of payments that are different from those applicable under U.S. domestic tender offer procedures and laws.

The receipt of cash pursuant to the Offer by a U.S. holder of Gemalto Shares may be a taxable transaction for U.S. federal income tax purposes and under applicable state and local, as well as foreign and other tax laws. Each holder of Gemalto shares is urged to consult his independent professional advisor immediately regarding the tax consequences of accepting the Offer.

To the extent permissible under applicable laws and regulations, including Rule 14e-5 under the U.S. Exchange Act, and in accordance with normal Dutch practice, Thales and its affiliates or its broker and its broker’s affiliates (acting as agents or on behalf of Thales or its affiliates, as applicable) may from time to time after the date of the joint press release by Thales and Gemalto dated 17 December 2017, and other than pursuant to the Offer, directly or indirectly purchase, or arrange to purchase Shares or any securities that are convertible into, exchangeable for or exercisable for such Shares. These purchases may occur either in the open market at prevailing prices or in private transactions at negotiated prices. In no event will any such purchases be made for a price per Share that is greater than the Offer Price. To the extent information about such purchases or arrangements to purchase is made public in The Netherlands, such information will be disclosed by means of a press release or other means reasonably calculated to inform U.S. shareholders of Gemalto of such information. No purchases will be made outside of the Offer in the United States of America by or on behalf of the Thales or its affiliates. In addition, the financial advisors to Thales may also engage in ordinary course trading activities in securities of Gemalto, which may include purchases or arrangements to purchase such securities. To the extent required in The Netherlands, any information about such purchases will be announced by press release in accordance with Section 5 paragraph 4 or Section 13 of the Dutch decree on public takeover bids (Besluit openbare biedingen Wft) and posted on the website of Thales at www.thalesgroup.com.

Restrictions
The distribution of this press release may, in some countries, be restricted by law or regulation. Accordingly, persons who come into possession of this document should inform themselves of and observe these restrictions. To the fullest extent permitted by applicable law, Thales and Gemalto disclaim any responsibility or liability for the violation of any such restrictions by any person. Any failure to comply with these restrictions may constitute a violation of the securities laws of that jurisdiction. Neither Thales, nor Gemalto, nor any of their advisors assumes any responsibility for any violation by any of these restrictions. Any Gemalto shareholder who is in any doubt as to his position should consult an appropriate professional advisor without delay.

Forward Looking Statements
This press release may include "forward-looking statements" and language indicating trends, such as the words "anticipate", "expect", "approximate", "believe", "could", "should", "will", "intend", "may", "potential" and other similar expressions. These forward-looking statements are only based upon currently available information and speak only as of the date of this press release. Such forward-looking statements are based upon management’s current expectations and are subject to a significant business, economic and competitive risks, uncertainties and contingencies, many of which are unknown and many of which Thales and Gemalto are unable to predict or control. Such factors may cause Thales and/or Gemalto's actual results, performance or plans with respect to the transaction between Thales and Gemalto to differ materially from any future results, performance or plans expressed or implied by such forward-looking statements. Neither Thales nor Gemalto, nor any of their advisors accepts any responsibility for any financial information contained in this press release relating to the business or operations or results or financial condition of the other or their respective groups. We expressly disclaim any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190328006004/en/

Contacts

Thales, Media Relations
Cédric Leurquin
+33 (0)1 57 77 90 93
cedric.leurquin@thalesgroup.com

Thales, Analysts/Investors
Bertrand Delcaire
+33 1 57 77 89 02
ir@thalesgroup.com

Gemalto, Media Relations
Isabelle Marand
+33 (0)6 1489 1817
isabelle.marand@gemalto.com

Gemalto, Investor Relations
Jean-Claude Deturche
M.: +33 6 2399 2141
jean-claude.deturche@gemalto.com

Gemalto, Media Relations Agency
Arien Stuijt
T: +31 621531233
arien.stuijt@hkstrategies.com

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