Friday, November 30, 2018

Marriott Announces Starwood Guest Reservation Database Security Incident



BETHESDA, Md.-Friday 30 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- Marriott has taken measures to investigate and address a data security incident involving the Starwood guest reservation database. On November 19, 2018, the investigation determined that there was unauthorized access to the database, which contained guest information relating to reservations at Starwood properties* on or before September 10, 2018.

On September 8, 2018, Marriott received an alert from an internal security tool regarding an attempt to access the Starwood guest reservation database in the United States. Marriott quickly engaged leading security experts to help determine what occurred. Marriott learned during the investigation that there had been unauthorized access to the Starwood network since 2014. The company recently discovered that an unauthorized party had copied and encrypted information, and took steps towards removing it. On November 19, 2018, Marriott was able to decrypt the information and determined that the contents were from the Starwood guest reservation database.

The company has not finished identifying duplicate information in the database, but believes it contains information on up to approximately 500 million guests who made a reservation at a Starwood property. For approximately 327 million of these guests, the information includes some combination of name, mailing address, phone number, email address, passport number, Starwood Preferred Guest (“SPG”) account information, date of birth, gender, arrival and departure information, reservation date, and communication preferences. For some, the information also includes payment card numbers and payment card expiration dates, but the payment card numbers were encrypted using Advanced Encryption Standard encryption (AES-128). There are two components needed to decrypt the payment card numbers, and at this point, Marriott has not been able to rule out the possibility that both were taken. For the remaining guests, the information was limited to name and sometimes other data such as mailing address, email address, or other information.

Marriott reported this incident to law enforcement and continues to support their investigation. The company has already begun notifying regulatory authorities.

“We deeply regret this incident happened,” said Arne Sorenson, Marriott’s President and Chief Executive Officer. “We fell short of what our guests deserve and what we expect of ourselves. We are doing everything we can to support our guests, and using lessons learned to be better moving forward.”

“Today, Marriott is reaffirming our commitment to our guests around the world. We are working hard to ensure our guests have answers to questions about their personal information, with a dedicated website and call center. We will also continue to support the efforts of law enforcement and to work with leading security experts to improve. Finally, we are devoting the resources necessary to phase out Starwood systems and accelerate the ongoing security enhancements to our network,” Mr. Sorenson continued.

Guest Support                                                               

Marriott has taken the following steps to help guests monitor and protect their information:

Dedicated Website and Call Center

    We have established a dedicated website (info.starwoodhotels.com) and call center to answer questions you may have about this incident. The frequently-asked questions on info.starwoodhotels.com may be supplemented from time to time. The call center is open seven days a week and is available in multiple languages. Call volume may be high, and we appreciate your patience.

Email Notification

    Marriott will begin sending emails on a rolling basis starting today, November 30, 2018, to affected guests whose email addresses are in the Starwood guest reservation database.

Free WebWatcher Enrollment

    Marriott is providing guests the opportunity to enroll in WebWatcher free of charge for one year. WebWatcher monitors internet sites where personal information is shared and generates an alert to the consumer if evidence of the consumer’s personal information is found. Due to regulatory and other reasons, WebWatcher or similar products are not available in all countries. Guests from the United States who activate WebWatcher will also be provided fraud consultation services and reimbursement coverage for free. To activate WebWatcher, go to info.starwoodhotels.com and click on your country, if listed, for enrollment.

Marriott is furnishing a Form 8-K with the SEC attaching a copy of this press release and presenting certain other information with respect to the incident.

* Starwood brands include: W Hotels, St. Regis, Sheraton Hotels & Resorts, Westin Hotels & Resorts, Element Hotels, Aloft Hotels, The Luxury Collection, Tribute Portfolio, Le Méridien Hotels & Resorts, Four Points by Sheraton and Design Hotels. Starwood branded timeshare properties are also included.

Marriott International, Inc. (NASDAQ: MAR) is based in Bethesda, Maryland, USA, and encompasses a portfolio of more than 6,700 properties in 30 leading hotel brands spanning 129 countries and territories. Marriott operates and franchises hotels and licenses vacation ownership resorts all around the world. The company also operates award-winning loyalty programs: Marriott Rewards®, which includes The Ritz-Carlton Rewards®, and Starwood Preferred Guest®. For more information, please visit our website at www.marriott.com, and for the latest company news, visit www.marriottnewscenter.com. In addition, connect with us on Facebook and @MarriottIntl on Twitter and Instagram.

Contacts

Connie Kim
+1-301-380-4028
NewsRoom@marriott.com

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The Fukushima I Want to Show the World Photo Contest 2018; Fukushima International Association's Announcement of the Prize-Winning Photos

 Please have a look at these photos that are taken from the perspective of Fukushima’s foreign residents and illustrate the current situation of the prefecture.



FUKUSHIMA, Japan-Friday 30 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- Fukushima International Association recently held a photo contest for foreign residents living in Fukushima. We received many photos and messages from foreign residents who wanted to demonstrate Fukushima’s current situation to their hometowns and to the world. The results of the photo contest have now been decided.

The grand prize was awarded to Cheng Tongjun’s “Hope for good harvest.” The photo portrays Fukushima’s Aizu region’s beautiful rice paddies and her message expresses how the rice harvested from those rice paddies is delicious.

For the photo contest, foreign residents from 21 countries submitted over 180 photos. Various perspectives of Fukushima were portrayed such as beautiful sceneries, festivals, daily life as well as the current situation of the tsunami-disaster areas, etc. These photos are filled with an appreciation towards Fukushima as a “second-home”.

The first round of judging was done by foreign residents who are currently residing in Fukushima. The judges were from China, Paraguay/Argentina, Indonesia, Vietnam, and Canada. For the final round of judging, photojournalist Yasuda Natsuki decided the top prize winners out of the photos that were selected from the first round.

Then, on November 4th, the awards ceremony took place at Fukushima City, where Yasuda Natsuki presented the award certificates and supplementary prizes to the winners.

The excellence prizes were awarded to Australia’s Gavin Keane Carvalho with his photo, “Ouchi-juku- Snow Festival”; South Africa’s Michelle Krüger with her photo, “15:40”; and lastly, Indonesia’s Reza Ahmad Fakhrizal with his photo, “Insya Allah you'll find your Way”. Five other people were awarded Special-Pick prizes as well.

You can take a look at the photos as well as the list of winners from the following web address.
http://www.worldvillage.org/files/news_release/files/2632_file01.pdf

About Fukushima International Association
www.worldvillage.org/english/fia/profile.html

View source version on businesswire.com: https://www.businesswire.com/news/home/20181129005254/en/

Contacts

Fukushima International Association
http://www.worldvillage.org/english/index.html
Hashikawa Atsuko
+81-24-524-1315
info@worldvillage.org


MEPRA Creative Festival and 10th PR Awards Brings Together More than 500 Professionals to Learn, Share Knowledge and Celebrate the Industry’s Best



Dubai, United Arab Emirates, -Thursday 29 November 2018 [ AETOS Wire ]

The Middle East Public Relations Association (MEPRA) concluded its inaugural creative communications festival, REMAP, last night with more than 500 industry professionals in attendance. The festival included a creative proposal competition, masterclasses and a congress, and culminated with the 10th MEPRA Awards Gala on the 28th November 2018. The Awards ceremony saw Brazen take home Small Agency of the Year and Hill+Knowlton Strategies win the coveted tile of Large Agency of the Year.

The Small In-House Team of the Year prize was awarded to Marriott International MEA and Large In-House Team of the Year went to Emirates Global Aluminium. Big winners for the night were Hill+Knowlton Strategies, who took home 13 awards, closely followed by Four Communications Group with 12 awards to their name. This year marked the 10th edition of the MEPRA Awards, which celebrates and recognises the most impactful and creative campaigns in the Middle East. More than 30 agencies and in-house communication teams were shortlisted across 26 categories.

Brazen’s Jennifer Love and Etihad Aviation Group’s Ellie Swingewood were crowned The Dave Robinson Outstanding Young Communicators of the Year, for Agency and In-house respectively, and will each receive a MEPRA Academy scholarship. The prize includes eight complimentary training sessions from the 2019 MEPRA Academy calendar to assist with their continuous professional development.

The 2018 Chairman’s award was awarded to Amina Taher, VP Corporate Affairs, Etihad Aviation Group for outstanding contribution to the industry.

This year saw 231 entries submitted, which were assessed by a panel of more than 50 regional and international industry experts to select the 2018 finalists and winners.  The judging process was also reviewed by AMEC CEO Barry Leggetter, who served as an independent adjudicator.

MEPRA Vice Chair, Deema Kingsmill-Moore said:

“The 2018 MEPRA Awards represent the culmination of a decade devoted to nurturing the regional communications sector. The quality of the work and the calibre of PR practitioners recognized this year demonstrate the impact our organization continues to make in regional communications, faithful always to our founding principal of representing our members and amplifying the power of their work.  In recognition of this milestone, MEPRA extended its annual Awards event with the launch of an accompanying series of communications industry events. The ‘REMAP’ masterclass is designed entirely to make us better at what we do. Household industry names came to impart critical insights to an audience of the best and brightest in Middle East Public Relations.”

For the first time, the MEPRA Awards were preluded by a series of industry events under the brand REMAP. The three-day festival provided practitioners from across the region the chance to learn, share knowledge and celebrate the best through one event in Dubai. The REMAP masterclasses, which were held from 26-27 November, 2018 included a workshop on ‘How to Run a PR Agency’, led by David Brain, the former President and CEO of Edelman, Asia Pacific, Middle East and Africa, and a session on ‘Mastering Government Communications’ with Gemmaine Walsh, the Director of Communications for the UK Government.

The REMAP creative communications congress held on the 28th November in the lead up to the Awards brought in six renowned international speakers to discuss the evolution of modern PR, building connections through content and tapping into the minds of content creators to unleash the undiscovered realm of creative thinking.

Speakers included, Anthony Geffen, an Emmy & BAFTA Award winning creative director; Ryan Holiday, a marketing guru and international best-selling author; and Gerry Hopkinson, CEO and Founder of Unity London, an agency which has been awarded ‘Most Creative Agency in the World’ by Holmes Report and Creative Consultancy of the Year by SABRE. VICE MENA, Snapchat, Google, Hyper Island, Promont and RCG Media also joined the stellar line up of speakers to deliver inspiring debates engaging topics and showcase globally recognised campaigns.

MEPRA Chair, Ray Eglington said:  “This festival of creative communications has been the biggest and most successful event in MEPRA’s history, reflecting the growing maturity of the industry in the region. We’ve been delighted to welcome such an impressive array of international experts and to celebrate the excellence of the award-winning campaigns.”

The 2018 MEPRA Awards and REMAP Festival was supported by corporate and agency partners including, APCO Worldwide, Etihad Aviation Group, Mubadala Investment Company, Four Communications Group, Hanover Middle East, CARMA, Multiply Consultancy, Hill+Knowlton Strategies, Kingston Stanley, YouGov, LexisNexis, Middlesex University Dubai and PRWeek.

To view the full list of 2018 MEPRA Award winners visit www.mepra.org/awards 

About MEPRA:

The Middle East Public Relations Association (MEPRA) is the leading industry body for the public relations and communications industry in the Middle East. MEPRA has more than 1,000 members, which include consultancies, corporates with in-house public relations functions, and individual industry professionals. The organisation was founded in 2001 and is headquartered in the United Arab Emirates. MEPRA drives growth and sets standards of excellence in regional public relations. It is the unique voice for the industry and aims to nurture the development of public relations professionals. For more information visit www.mepra.org

Contacts

Sabrina De Palma

Executive Director, Middle East PR Association (MEPRA)

sabrina@mepra.org
+971 (0) 55 531 8920
www.mepra.org




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FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain

Acceptance of Double Blind Degenerative Disc Disease Data is Strong Signal for Company’s Development Path


HOUSTON-Thursday 29 November 2018 [ AETOS Wire ]

(BUSINESS WIRE) -- SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using its universal donor product, CybroCell™, today announced the FDA has cleared its Investigational New Drug (IND) protocol for human trials in the U.S., considered to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses. The clearance allows SpinalCyte to begin recruiting and screening patients for the study. The trial is to be initiated after the first production run is tested for quality and safety to meet the FDA stated criteria.

“The clearance of the IND for our fibroblast-based therapy, CybroCell™, in the treatment of degenerative disc disease validates our clinical science and is our biggest step toward commercialization,” said SpinalCyte Chief Executive Officer, Pete O’Heeron. “After the extremely positive results from our Phase 1/Phase 2 clinical trial, this clearance by the FDA will allow us to continue testing CybroCell™ and will further our mission of bringing back pain relief to the millions of Americans who suffer from it every year. The applications of CybroCell™ go beyond degenerative disc disease and hold promise in other disease pathways including cancer, diabetes, osteoarthritis, liver failure and heart failure.”

The Phase 1/Phase 2 trial assessed pain and structural improvements in patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and MRI scans. The data showed that 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). More than 90% of patients in the treatment group had an over a 10-point reduction in Oswestry Disability Index (ODI), 100% had improvement in Visual Analogue Scale (VAS) and over 84% had an increase or no change in disc height.

“CybroCell’s pain and MRI data show clear superiority to all other cell therapy treatments for degenerative disc disease,” said SpinalCyte Chief Scientific Officer, Thomas Ichim, Ph.D. “This IND clearance allows us to continue our research and application of CybroCell™. This treatment which targets the source of chronic pain in degenerative disc disease is a medical breakthrough. The persistent structural and functional improvements we have observed in patients demonstrate that CybroCell™ has the potential to help combat the opioid epidemic by eliminating chronic pain.”

About Degenerative Disc Disease

Degenerative disc disease (DDD) is a condition in which a patient’s spinal disc breaks down and can begin to collapse. It is estimated that 85% of people over the age of 50 have evidence of disc degeneration and over 1.3 million procedures a year are performed to treat the disease. The most common treatments for patients with DDD are either discectomy or spinal fusion. Discectomy is the partial or full removal of the degenerated disc to decompress and relieve the nervous system but can cause long term spinal pain. In a spinal fusion procedure, the entire disc is removed and the two adjacent vertebrae are fused together. It often increases strain on the adjacent discs and surrounding tissues leading to further degeneration.

About CybroCell™

CybroCell™ is the first off-the-shelf allogenic human dermal fibroblast (HDF) product for the treatment of degenerative disc disease. SpinalCyte’s Phase 1/Phase 2 clinical trial for injected human dermal fibroblasts in the treatment of DDD demonstrated after 12 months, patients who were injected with CybroCell™ had sustained improvement in pain relief and increased back mobility.

About SpinalCyte

Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal disc regeneration using human dermal fibroblasts. Currently, SpinalCyte holds 35 U.S. and international issued patents and has filed for an additional 41 patents pending. SpinalCyte holds 116 U.S. and International Patents pending and issued across a variety of disease pathways, including disc degeneration, cancer, diabetes, liver failure and heart failure. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.



Contacts

David Schull or Ned Berkowitz
Russo Partners LLC
858-717-2310
646-942-5629
david.schull@russopartnersllc.com
ned.berkowitz@russopartnersllc.com

SpinalCyte, LLC
info@spinalcyte.com



Permalink : https://www.aetoswire.com/news/fda-clears-spinalcyte-ind-application-for-universal-donor-cell-therapy-to-treat-lower-back-pain/en

Thursday, November 29, 2018

GSMA Announces First Details for MWC19 Shanghai

MWC19 Shanghai Expected to Attract More Than 60,000 Attendees from Over 110 Countries and Territories; 550 Leading Companies to Showcase Latest Innovations
HONG KONG-Thursday 29 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- The GSMA today announced the first details of MWC19 Shanghai (formerly Mobile World Congress Shanghai), including participating companies, as well as a range of programmes and activities taking place at the annual mobile industry event. MWC19 Shanghai will be held 26-28 June 2019 at the Shanghai New International Expo Centre (SNIEC). The GSMA expects that more than 60,000 professionals from across the mobile ecosystem and adjacent industry sectors will gather for the 2019 event.

“Under the theme of ‘Intelligent Connectivity’, MWC19 Shanghai will highlight the powerful combination of ‘hyper-connectivity’, enabled by 5G and the Internet of Things (IoT) and ‘intelligence’, delivered by artificial intelligence (AI) and big data,” said Michael O’Hara, Chief Marketing Officer, GSMA. “Across all aspects of the event, MWC19 Shanghai will showcase how intelligent connectivity will positively impact individuals, businesses and the economy across the Asia Pacific region.”

More Than 550 Leading Companies Participating at MWC19 Shanghai

Covering seven halls at the SNIEC, MWC19 Shanghai will feature the leading products, services and technologies that are shaping the future of mobile, from handsets and devices to network infrastructure, software and services and much more. The exhibition will again include the Super Hall, where the industry’s largest players including Ericsson, Huawei, Nokia Shanghai Bell and ZTE and others will showcase cutting-edge solutions in areas such as 5G, AI, IoT and more. Other exhibitors confirmed for MWC Shanghai include China Transport Telecommunications Information, CICT, H3C, Hengtong Optic-Electric, Intracom, Lenovo, PwC, Qualcomm, Samsung, Sunsea and Whale Cloud Technology, among others.

The GSMA Innovation City will again be a highlight of MWC19 Shanghai. In this unique space, attendees will immerse themselves in technology-led experiences that illustrate how intelligently connected products and services are improving the daily lives of citizens and businesses. For more information on the MWC Shanghai exhibition, visit www.mwcshanghai.com/#exhibit.

4YFN: Accelerating Business Opportunities

4 Years From Now (4YFN), the innovation platform for MWC, returns to Asia for a fourth year with a comprehensive international programme to accelerate business opportunities for startups, investors and corporations from across the innovation ecosystem. In 2019, the 4YFN exhibition will double in size, showcasing innovative technologies such as 5G, AI, blockchain, fintech and IoT, among others.

As always, 4YFN will offer inspirational presentations and discussions on the 4YFN Stage and the Future Tech Stage, while the new Discovery Area will feature unique connecting initiatives such as business matchmaking and mentoring sessions, along with custom pitching activities. Additionally, the 2019 Asia Mobile Awards will include the “4YFN Startup Award”, which recognises organisations focused on accelerating business development and the investment in new technologies within the startup community. For more information about 4YFN at MWC19 Shanghai, visit: www.mwcshanghai.com/experiences/4yfn/.

In addition to the onsite presence at MWC events around the world, 4YFN has launched two new online business platforms – the 4YFN Community Club and the 4YFN Investor Club – to connect investors, projects, institutions and companies with the end goal of driving entrepreneurship and innovation. For more information on the 4YFN Community Club, visit www.4yfn.com/community-club/; for further details on the 4YFN Investor Club, go to www.4yfn.com/investors-club/.

Conference to Explore Latest Trends and Topics in Mobile

The three-day MWC19 Shanghai conference programme will include three keynote sessions as well a series of summits that will explore a wide range of topics such as 5G, AI, banking and telecom convergence, blockchain, content and media, data trust and security, future mobility, global devices, smart cities and smart industries, among others. Sessions on the Leaders Stage will again focus on wide-ranging trends that are shaping the mobile future and impacting citizens’ everyday lives, including humanitarian innovation, tourism and travel, women in technology and leaders in business, and more.

The Call for Papers for MWC19 Shanghai is now open and prospective speakers can submit proposals through Thursday, 31 January 2019. For more information on the conference programme, including details on submitting speaker proposals, visit www.mwcshanghai.com/#speak.

Women4Tech Expands in Shanghai

The Women4Tech Programme returns to Shanghai with an expanded set of activities designed to address and reduce the gender gap in the mobile industry. A central element of the programme is the Women4Tech Summit, with keynote presentations and panel discussions examining topics such as gender equality and career development, mentoring and youth education, women in communication and vertical sectors, and women as entrepreneurs and innovators. In addition to the Summit, the Women4Tech Programme includes the Women4Tech Speed Coaching and Networking session; a Women4Tech AMO award for “Outstanding Achievement in Mobile Industry Leadership”; and additional Women4Tech activities at 4YFN.

MWC Shanghai: Largest Carbon Neutral Exhibition and Conference in Asia

MWC Shanghai 2018 was officially certified by the British Standards Institution as carbon neutral under the international PAS 2060 standard, reinforcing its position as the largest carbon neutral exhibition and conference in Asia. The GSMA implemented a range of measures to reduce emissions at the 2018 event, such as carpet recycling, waste management and reducing paper consumption, resulting in a greenhouse gas reduction of more than 97 tonnes of carbon dioxide equivalent. To compensate for the remaining carbon footprint, the GSMA is supporting United Nations-certified projects in China, including a N2O decomposition project in Liaoyang and hydropower station projects in Gansu and Guangxi.

In 2019, the GSMA will continue to focus on reducing environmental impact, as well as encouraging our participants to be environmentally conscious. For more information, visit www.mwcshanghai.com/about-the-gsma/environmental-programme/.

Follow Developments at MWC19 Shanghai

For more information on MWC19 Shanghai, including how to attend, exhibit, partner or sponsor, visit www.mwcshanghai.com. Follow developments and updates on MWC19 Shanghai through our social media channels – follow us on Twitter at @GSMA and use #MWC19, get regular updates through our LinkedIn Showcase Page at www.linkedin.com/showcase/mwcshanghai/, and follow us on Facebook at www.facebook.com/mwcshanghai. In China, you can follow us on Sina Weibo http://weibo.com/mwcshanghai or search “GSMA_MWCS” in WeChat.

About the GSMA

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

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



View source version on businesswire.com: https://www.businesswire.com/news/home/20181129005049/en/

Contacts
Media Contacts:
For the GSMA
April Tsui
+852 2533 9956
atsui@webershandwick.com

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

GSMA Press Office
pressoffice@gsma.com


https://www.aetoswire.com/news/gsma-announces-first-details-for-mwc19-shanghai/en

Brightline Initiative Study Identifies Crisis Mode Learnings that Create Stronger Strategy Implementation Capabilities



NEWTOWN SQUARE, Pa. -Thursday 29 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- In partnership with Quartz Insights, Brightline™ Initiative today announces the release of research report “Learning From Crisis Mode – Implications for Better Strategy Implementation”. The report aimed to discern implications of crisis on better strategy implementation, and participants spanned the globe, with the majority holding C-suite positions (52%) and coming from companies with annual global revenues of $1 billion or more (65%). It provides readers with key practices and recommendations to improve strategy implementation capabilities as well as insights for how to leverage crisis experiences and enact change in non-crisis environments.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181128005908/en/

The report shows that a crisis can have a positive and lasting impact on three key areas of strategy implementation: prioritization of initiatives, speed in decision making and execution of process, and team empowerment.

Key findings include the following:

    Expect a crisis: 68% of respondents agreed with the inevitability of their organizations facing a crisis in the future, and 91% of respondents agreed that when faced with a crisis, they changed the standard operating procedures. In the survey, we refer to this as “Crisis Mode.”
    Identify lasting implementations: 79% of respondents agreed that modifications to team structures that were introduced as a result of the crisis remained in place, 74% agreed that close working partnerships between cross-functional teams continued, and 71% agreed that a clearer understanding of the organization’s priorities renewed its vision and sense of direction.
    Prioritize strategic initiatives: Of the 75% of respondents who reported that experiencing Crisis Mode made them stronger in strategy implementation, 91% reported making changes to their prioritization of strategic initiatives. This re-prioritization implies a willingness to quickly assess what is and isn’t working without fear of abandoning a previously established direction.
    Empower key employees: Organizations that empowered non-leadership-level employees who were closer to the crisis emerged stronger post-crisis than those that didn’t. 75% of these high performing organizations believe crises uncover talented leaders from within the organizational ranks, allowing those leaders to advance. This responsibility distribution allows for faster communication and fewer roadblocks.

Ricardo Vargas, Executive Director, Brightline Initiative, observed that “A crisis can bring out the best in your staff, unearth improvements in processes, and reveal new business opportunities, all of which can -- and should -- influence post-crisis strategy design and implementation.”

“We were delighted to partner with The Brightline Initiative. We share a common obsession on ensuring that breakthrough ideas are realized, and -- together -- engaged hundreds of individuals to produce a report grounded in rigor, and oriented towards empowering organizations to benefit from disruption and transformation.” - Ernesto Henriquez, Director, Insights & Brand Strategy, Quartz

The report is the result of 18 qualitative interviews and 1,258 quantitative interviews with executives from the government, non-profit and the private sector who have experienced a crisis. The full report, Learning From Crisis Mode, can be viewed online at https://www.brightline.org/learning-from-crisis-mode/.

About Brightline Initiative
The Brightline™ Initiative is a coalition led by the Project Management Institute together with leading global organizations dedicated to helping executives bridge the expensive and unproductive gap between strategy design and delivery. Learn more at www.brightline.org.

Brightline Coalition
Project Management Institute – The Boston Consulting Group – Bristol Myers Squibb – Saudi Telecom Company – Lee Hecht Harrison – Agile Alliance – NetEase

Academic and Research Collaboration
MIT Consortium for Engineering Program Excellence – Technical University of Denmark – University of Tokyo Global Teamwork Lab – Blockchain Research Institute

About Quartz Insights
Quartz Insights is a unit of Quartz’s commercial team obsessed with the topics that matter to people in business, dedicated to providing breakthrough insights, intelligence, and competitive advantage to Quartz’s partners. Quartz Insights conducts research and publishes thought leadership to inform and inspire the leaders of the new economy.





View source version on businesswire.com: https://www.businesswire.com/news/home/20181128005908/en/

Contacts

Brightline Initiative
Edivandro Conforto
Head of Strategy Research
edivandro.conforto@brightline.org
or
Quartz
Ernesto Henriquez
Director, Insights & Brand Strategy
ehenriquez@qz.com



Permalink : https://www.aetoswire.com/news/brightline-initiative-study-identifies-crisis-mode-learnings-that-create-stronger-strategy-implementation-capabilities/en

European Commission Approves ALUNBRIG® (brigatinib) for ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib, Advancing Treatment Paradigm in Europe

– ALUNBRIG Demonstrated Unprecedented Median Progression-Free Survival of 16.7 Months and Overall Survival of 34.1 Months in the Post-Crizotinib Setting –

– Approval Will Help Address Current Unmet Need in ALK+ NSCLC Treatment in the EU, Building Upon Approvals in the U.S. and Canada –



CAMBRIDGE, Mass. & OSAKA, Japan-Thursday 29 November 2018 [ AETOS Wire ]

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Commission (EC) granted marketing authorization for ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 20, 2018.

“The introduction of targeted therapies has greatly improved the treatment of ALK+ NSCLC, yet for the approximately 70 percent of patients who progress on crizotinib with brain metastases, additional therapeutic options are needed,” said Enriqueta Felip, M.D., PhD., Head of the Thoracic Oncology Unit, Oncology Department at Vall d’Hebron University Hospital in Barcelona. “Data from the ALTA trial investigating ALUNBRIG showed sustained systemic and intracranial efficacy results and a manageable safety profile, leading to the longest progression-free survival and overall survival reported in this setting. This approval gives physicians in the European Union another choice in addressing ALK+ NSCLC patients previously treated with crizotinib.”

“The European Commission’s decision to approve ALUNBRIG for patients with ALK+ NSCLC is a significant advancement for European patients impacted by this life-threatening disease,” said Jesús Gómez-Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “This is the first time a median progression-free survival of over 16 months as assessed by an independent review committee and median overall survival of 34 months have been reported in the post-crizotinib setting, which highlights the strength of the ALTA trial data. The authorization of ALUNBRIG in the EU speaks to our ongoing commitment to developing innovative solutions to improve the lives of the approximately 40,000 patients diagnosed with this disease worldwide each year.”

“Many people are unaware of ALK+ NSCLC and its nuances, including the fact this type of lung cancer tends to affect people at a younger age, and it is not associated with smoking,” said Stefania Vallone, President, Lung Cancer Europe. “These younger patients are often in the prime of their lives and in the middle of raising their families, focusing on their careers, and contributing to their community. The availability of new treatments to potentially extend time without disease progression is very important and cannot be underestimated.”

The European Commission’s approval is based on data from the global Phase 2 ALTA trial, in which patients were randomized to receive one of two dosing regimens of ALUNBRIG: 90 mg once daily (n=112) or the recommended dosing regimen of 180 mg once daily with seven-day lead-in at 90 mg once daily (n=110). Results showed that of the patients who received the recommended dosing regimen, 56 percent achieved an objective response rate (ORR), and the median duration of response (DOR) was 15.7 months as assessed by independent review committee (IRC). ALUNBRIG demonstrated a median progression-free survival (PFS) of 16.7 months by IRC assessment and overall survival of 34.1 months for patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib.

The most common adverse reactions (≥25%) reported in patients treated with ALUNBRIG at the recommended 180 mg dosing regimen were increased aspartate aminotransferase (AST), hyperglycemia, hyperinsulinemia, anemia, increased creatine phosphokinase (CPK), nausea, increased lipase, decreased lymphocyte count, increased alanine aminotransferase (ALT), diarrhea, increased amylase, fatigue, cough, headache, increased alkaline phosphatase, hypophosphatemia, increased abnormal activated partial thromboplastin time (APTT), rash, vomiting, dyspnea, hypertension, decreased blood cell count, myalgia, and peripheral neuropathy. The most common serious adverse reactions (≥ 2 percent) reported in patients treated with ALUNBRIG at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnea.

This decision by the European Commission means that ALUNBRIG is now approved for marketing of this indication in the 28 member states of the European Union, and applicable in Norway, Liechtenstein and Iceland. For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europe.eu/ema.

About the ALTA Trial
The Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) trial of ALUNBRIG in adults is a global, ongoing, two-arm, open-label, multicenter trial, which enrolled 222 patients with locally advanced or metastatic ALK+ NSCLC who had progressed on crizotinib. Patients received either 90 mg of ALUNBRIG once daily (n=112) or 180 mg once daily with seven-day lead-in at 90 mg once daily regimen (n=110). Investigator-assessed confirmed objective response rate (ORR) per RECIST v1.1 was the primary endpoint. Key additional endpoints included Independent Review Committee (IRC)-assessed ORR, duration of response (DOR), progression-free survival (PFS), intracranial ORR, intracranial DOR, safety and tolerability.

Results of the ALTA trial demonstrated that of the patients who received the 180 mg dosing regimen, 56 percent achieved an ORR as assessed by investigator and 56 percent as assessed by IRC. The median DOR was 13.8 months as assessed by investigator and 15.7 months by IRC assessment. Median PFS was 15.6 months as assessed by investigator and 16.7 months by IRC assessment. Additionally, of the patients with measurable brain metastases at baseline (n=18), 67 percent achieved an intracranial ORR by IRC assessment; median duration of intracranial response was 16.6 months by IRC assessment. Median overall survival was 34.1 months.

Among patients who received the 90 mg dosing regimen, 46 percent achieved an ORR as assessed by investigator and 51 percent as assessed by IRC. The median DOR was 12.0 months as assessed by investigator and 16.4 months by IRC assessment. Median PFS was 9.2 months as assessed by both investigator and IRC assessment. Additionally, of the patients with measurable brain metastases at baseline (n=26), 50 percent achieved an intracranial ORR by IRC assessment; median duration of intracranial response was 9.4 months by IRC assessment. Median overall survival was 29.5 months.

About ALK+ NSCLC

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

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

About ALUNBRIG® (brigatinib)

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

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

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

  • Phase 1/2 trial, which was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of ALUNBRIG
  • Pivotal Phase 2 ALTA trial investigating the efficacy and safety of ALUNBRIG at two dosing regimens in patients with ALK+ locally advanced or metastatic NSCLC who had progressed on crizotinib
  • Phase 3 ALTA-1L, a global randomized trial assessing the efficacy and safety of ALUNBRIG in comparison to crizotinib in patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor
  • Phase 2 single-arm, multicenter trial in Japanese patients with ALK+ NSCLC, focusing on patients who have progressed on alectinib
  • Phase 2 global, single arm trial evaluating ALUNBRIG in patients with advanced ALK+ NSCLC who have progressed on alectinib or ceritinib
  • Phase 3 global randomized trial comparing the efficacy and safety of ALUNBRIG versus alectinib in participants with ALK+ NSCLC who have progressed on crizotinib

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

ALUNBRIG® (brigatinib): EUROPEAN IMPORTANT SAFETY INFORMATION

SPECIAL WARNINGS AND PRECAUTIONS FOR USE


Pulmonary Adverse Reactions: Severe, life-threatening, and fatal pulmonary adverse reactions, including those with features consistent with ILD/pneumonitis, can occur. Most pulmonary adverse reactions were observed within the first 7 days of treatment. Grade 1-2 pulmonary adverse reactions resolved with interruption of treatment or dose modification. Increased age and shorter interval (less than 7 days) between the last dose of crizotinib and the first dose of ALUNBRIG were independently associated with an increased rate of these pulmonary adverse reactions. Consider these factors when initiating treatment with ALUNBRIG. Some patients experienced pneumonitis later in treatment with ALUNBRIG. Patients should be monitored for new or worsening respiratory symptoms (e.g., dyspnoea, cough, etc.), particularly in the first week of treatment. Evidence of pneumonitis in any patient with worsening respiratory symptoms should be promptly investigated. If pneumonitis is suspected, the dose of ALUNBRIG should be withheld, and the patient evaluated for other causes of symptoms (e.g., pulmonary embolism, tumour progression, and infectious pneumonia). The dose should be modified accordingly.

Hypertension has occurred. Blood pressure should be monitored regularly during treatment with ALUNBRIG. Hypertension should be treated according to standard guidelines to control blood pressure. Heart rate should be monitored more frequently in patients if concomitant use of a medication known to cause bradycardia cannot be avoided. For severe hypertension (≥ Grade 3), ALUNBRIG should be withheld until hypertension has recovered to Grade 1 or to baseline. The dose should be modified accordingly.

Bradycardia has occurred. Caution should be exercised when administering ALUNBRIG in combination with other agents known to cause bradycardia. Heart rate and blood pressure should be monitored regularly. Treatment with ALUNBRIG should be withheld if symptomatic bradycardia occurs. Concomitant medications known to cause bradycardia should be evaluated. Upon recovery, dose should be modified accordingly. In case of life-threatening bradycardia, permanently discontinue ALUNBRIG if no contributing concomitant medication is identified or in the case of recurrence. If contributing concomitant medication is identified, modify dose accordingly.

Visual Disturbance has occurred with ALUNBRIG. Patients should be advised to report any visual symptoms. For new or worsening severe visual symptoms, an ophthalmologic evaluation and dose reduction should be considered.

Creatine Phosphokinase (CPK) Elevation has been reported. Advise patients to report any unexplained muscle pain, tenderness, or weakness. Monitor CPK levels regularly during treatment. Based on the severity of the CPK elevation, withhold treatment with ALUNBRIG and modify dose accordingly.

Pancreatic Enzyme Elevation: Elevations of amylase and lipase have occurred. Lipase and amylase should be monitored regularly during treatment with ALUNBRIG. Based on the severity of the laboratory abnormalities, withhold ALUNBRIG and modify dose accordingly.

Hepatotoxicity: Elevations of hepatic enzymes (aspartate aminotransferase, alanine aminotransferase) and bilirubin have occurred. Liver function, including AST, ALT and total bilirubin should be assessed prior to the initiation of ALUNBRIG and then every 2 weeks during the first 3 months of treatment. Thereafter, monitoring should be performed periodically. Based on the severity of the laboratory abnormalities, withhold ALUNBRIG and modify dose accordingly.

Hyperglycemia: Elevations of serum glucose have occurred. Fasting serum glucose should be assessed prior to initiation of ALUNBRIG and monitored periodically thereafter. Antihyperglycaemic treatment should be initiated or optimised as needed. If adequate hyperglycaemic control cannot be achieved with optimal medical management, ALUNBRIG should be withheld until adequate hyperglycaemic control is achieved; upon recovery reducing the dose may be considered or ALUNBRIG may be permanently discontinued.

Drug drug interactions: Concomitant use of ALUNBRIG with strong CYP3A inhibitors should be avoided. If concomitant use of strong CYP3A inhibitors cannot be avoided, reduce dose of ALUNBRIG from 180 mg to 90 mg, or from 90 mg to 60 mg. After discontinuation of a strong CYP3A inhibitor, ALUNBRIG should be resumed at the dose that was tolerated prior to the initiation of the strong CYP3A inhibitor. The concomitant use of ALUNBRIG with strong and moderate CYP3A inducers should be avoided.

Fertility: Women of childbearing potential should be advised to use effective non-hormonal contraception during treatment with ALUNBRIG and for at least 4 months following the final dose. Men with female partners of childbearing potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose of ALUNBRIG

Lactose: ALUNBRIG contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medication.

UNDESIRABLE EFFECTS
The most common adverse reactions (≥ 25%) reported in patients treated with ALUNBRIG at the recommended dosing regimen were increased AST, hyperglycaemia, hyperinsulinaemia, anaemia, increased CPK, nausea, increased lipase, decreased lymphocyte count, increased ALT, diarrhoea, increased amylase, fatigue, cough, headache, increased alkaline phosphatase, hypophosphataemia, increased APTT, rash, vomiting, dyspnoea, hypertension, decreased white blood cell count, myalgia, and peripheral neuropathy.

The most common serious adverse reactions (≥ 2%) reported in patients treated with ALUNBRIG at the recommended dosing regimen other than events related to neoplasm progression were pneumonitis, pneumonia, and dyspnoea.

SPECIAL POPULATIONS

Elderly patients: The limited data on the safety and efficacy of ALUNBRIG in patients aged 65 years and older suggest that a dose adjustment is not required in elderly patients. There are no available data on patients over 85 years of age.

Hepatic impairment: No dose adjustment of ALUNBRIG is required for patients with mild hepatic impairment (Child-Pugh class A) or moderate hepatic impairment (Child-Pugh class B). A reduced starting dose of 60 mg once daily for the first 7 days, then 120 mg once daily is recommended for patients with severe hepatic impairment (Child-Pugh class C).

Renal impairment: No dose adjustment of ALUNBRIG is required for patients with mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥ 30 mL/min). A reduced starting dose of 60 mg once daily for the first 7 days, then 90 mg once daily is recommended for patients with severe renal impairment (eGFR < 30 mL/min). Patients with severe renal impairment should be closely monitored for new or worsening respiratory symptoms that may indicate ILD/pneumonitis (e.g., dyspnoea, cough, etc.) particularly in the first week.

Paediatric population: The safety and efficacy of ALUNBRIG in patients less than 18 years of age have not been established. No data are available.

IMPORTANT SAFETY INFORMATION (U.S.)
WARNINGS AND PRECAUTIONS

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

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

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

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

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

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

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

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

ADVERSE REACTIONS

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

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

DRUG INTERACTIONS

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

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

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

USE IN SPECIFIC POPULATIONS

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

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

Females and Males of Reproductive Potential:

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

Infertility: ALUNBRIG may cause reduced fertility in males.

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

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

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

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

About Takeda Pharmaceutical Company


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

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

Contacts

Takeda Pharmaceutical Company Limited
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 3 3 278 2095

Media outside Japan
Amanda Loder
Amanda.Loder@takeda.com
+1-212-259-0491

Permalink : https://www.aetoswire.com/news/european-commission-approves-alunbrigregnbspbrigatinib-for-alk-non-small-cell-lung-cancer-in-patients-previously-treated-with-crizotinib-advancing-treatment-paradigm-in-europe/en

Wednesday, November 28, 2018

E2open Completes Acquisition of INTTRA, Bringing Together Leading Global Cloud Supply Chain Management and Leading Ocean Shipping Network

The One Place in the Cloud to Run Your Supply Chain is Now the One Place in the Cloud to Manage Your Global Logistics

AUSTIN, Texas -Wednesday 28 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- E2open today announced the completion of the acquisition of INTTRA following regulatory approval. This brings together the world leader in ocean shipping logistics covering a majority of ocean shipping container capacity, with the global supply chain and logistics network of E2open. With this unification, customers of both companies will realize extensive efficiencies and ease of use across global supply chain and logistics management.

The combination of the largest ocean shipping network with the largest beneficial cargo owner (BCO) supply chain network will bring powerful benefits including:

Real-time end-to-end visibility with the ability to monitor and react to changing global needs.
More efficient ocean shipping with the integration of procurement, manufacturing and distribution.
Better logistics capacity utilization with enhanced visibility into manufacturing forecasts and future shipping needs.
E2open will offer “INTTRA by E2open” as a dedicated product offering committed to providing INTTRA customers with the transportation management and port system integrations that currently drive more than 25 percent of all ocean containers shipped globally.

John Fay, Chief Executive Officer of INTTRA, will be leaving the organization after a transition period. Under John's leadership INTTRA has made tremendous progress in the face of tough markets. During his tenure, INTTRA volume has grown by 50 percent and revenues by 30 percent with profitability increased sixfold. Santosh Nanda, currently E2open’s senior vice president of product development, will lead the “INTTRA by E2open” business unit following the transition period.

“Global trade slows for no one and customers demand solutions that streamline information flows across manufacturers, suppliers, shipping services, ocean carriers and participants of all sizes,” said Michael Farlekas, president and chief executive officer of E2open. “INTTRA by E2open will bring even more value and ease of use to customers who need to make supply chain and logistics management their competitive advantage through a unified platform and real time end-to-end visibility – further bridging the gap between planning and execution.”

E2open, the largest cloud-based provider of networked supply chain solutions, offers a complete portfolio of intelligent applications that enables the world’s most complex supply chains to better plan, collaborate, and execute their end-to-end operations – from procurement to manufacturing to distribution and fulfilment.

Avantida – part of the INTTRA acquisition – further extends that efficiency by helping to coordinate land-based activities like container reuse and repositioning. Both offerings will see even further reach and efficiencies as part of E2open’s global supply chain network of more than 200,000 users and 70,000 partner companies.

About E2open

At E2open, we are creating a more connected, intelligent supply chain. One that starts with the ability to sense and respond to real-time demand and supply constraints. One that brings together data from customers, channels, suppliers, contract manufacturers and partners. One that enables companies to use data in real time, with cognitive artificial intelligence and machine learning to drive smarter decisions. One that delivers all this complex information through a single pane of glass that provides a clear view across the supply and demand ecosystem. E2open is changing everything. Demand. Supply. Delivered. www.e2open.com.



View source version on businesswire.com: https://www.businesswire.com/news/home/20181127005275/en/

Contacts
Sales and Customer Information:
Diane Mitchell | VP, Marketing | E2open | Diane.Mitchell@e2open.com | 512-735-5692

Media Contact:
WE Communications for E2open | e2open@we-worldwide.com | 512-527-7000


Permalink : https://www.aetoswire.com/news/e2open-completes-acquisition-of-inttra-bringing-together-leading-global-cloud-supply-chain-management-and-leading-ocean-shipping-network/en


Jam City Expands Global Operations to Toronto, Canada, with the Acquisition of Bingo Pop from Uken Games



LOS ANGELES-Wednesday 28 November 2018 [ AETOS Wire ]

(BUSINESS WIRE) -- Jam City, a leader in mobile entertainment, today announced that it has acquired Bingo Pop, one of the top bingo mobile games worldwide, from Uken Games. The veteran Bingo Pop team has joined Jam City and will continue to manage game operations from Jam City’s new Toronto studio. Terms of the acquisition were not disclosed.


 “We are so proud to be continuing Jam City’s rapid global expansion with the acquisition of one of the most popular bingo titles, and its highly talented team,” said Chris DeWolfe, co-founder and CEO of Jam City. “This acquisition provides Jam City with access to leading creative talent in one of the fastest growing and most exciting tech markets in the world. We look forward to working with the talented Jam City team in Toronto as we supercharge the live operations of Bingo Pop and develop innovative new titles and mobile entertainment experiences.”

Canada is quickly becoming a haven for top game developers, engineers, designers, and artists from around the world given its prestigious universities, universal healthcare, affordable housing and diverse communities. In addition, more than 35,000 students are enrolled in digital gaming related programs across the Toronto, Ontario, region. “Jam City is looking forward to tapping into the large pool of talent across the region and expanding our operations in such a vibrant and trend-setting city,” said DeWolfe.

“We are incredibly proud of what the Bingo Pop team has accomplished in creating a leader in the mobile bingo game category. We’re confident that Jam City will be a great home for Bingo Pop and the talented team behind the game in its next phase of growth,” said Chris Ye, co-founder and CEO of Uken Games. “Following this deal, we are excited to focus on the continued success of our iconic trivia titles and introduce brand new game franchises to players around the world. We are fully committed to continue hiring and investing in Toronto as a global hub for gaming.”

Jam City’s acquisition of Bingo Pop follows the company’s recent announcement of a multi-year partnership with Disney.

About Jam City

Jam City is a leader in mobile entertainment, providing unique and deeply engaging games that appeal to broad global audiences. Jam City was founded in 2009 by MySpace cofounder and CEO Chris DeWolfe and former 20th Century Fox executive Josh Yguado. Jam City is the creative powerhouse behind some of the highest grossing and most enduring social gaming franchises for mobile, including Cookie Jam (Facebook “Game of the Year” winner) and Panda Pop. Jam City is the go-to studio for Hollywood, having developed immersive, narrative rich mobile games around iconic entertainment brands including Harry Potter, Family Guy and Marvel Avengers. Jam City has studios in Los Angeles, San Francisco, San Diego, Bogotá and Buenos Aires. The Jam City team is known for its creative excellence and technological innovation in key areas including storytelling, data science and audience insights.

About Bingo Pop

Launched in 2012, Bingo Pop has consistently been one of the top bingo mobile games worldwide. The game is a free, classic bingo game mixed with large jackpots, fast-paced action, power-ups and other features including memorable characters and unique social features. Bingo Pop is available worldwide on the App Store and Google Play.

About Uken Games

Uken builds games that people everywhere love. Who Wants To Be A Millionaire? And Jeopardy! World Tour are the top two trivia games, engaging millions of global players every month. We consider ourselves data-driven designers, technologists and artists. Through collaboration, we pair the craft of design with feedback and data to deliver a pace and rhythm in each game session that immerses our audience and leaves them wanting more. We take your entertainment seriously. Learn more about Uken by visiting our website, https://www.uken.com.

Editor’s Note:

To download supporting assets for Bingo Pop, including the latest gameplay video, please visit: https://app.box.com/v/JamCity-UkenGamesAcquisition.

View source version on businesswire.com: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=51903713&lang=en 

Contacts

Jam City
Sarah Ross
310-924-1404
sarahr@jamcity.com

ONE PR Studio (for Jam City in the US)
Kjell Vistad
Gilberto Williams-Gamboa
510-893-3271
jamcity@oneprstudio.com

Uproar PR for Uken Games
Brianna Hayes
321-236-0102 x237
bhayes@uproarpr.com

Permalink : https://www.aetoswire.com/news/jam-city-expands-global-operations-to-toronto-canada-with-the-acquisition-of-bingo-pop-from-uken-games/en


BRS Ventures furthers commitment to the UAE; inks pact with United Arab Emirates University (UAEU)

MoU signed between BRS Ventures and United Arab Emirates University to provide graduate placement opportunities

Students graduating from UAEU will be recruited by BRS Ventures entities; Internship and career advice to be made available

Abu Dhabi, United Arab Emirates-Wednesday 28 November 2018 [ AETOS Wire ]

BRS Ventures and United Arab Emirates University (UAEU) yesterday signed a Memorandum of Understanding (MoU) to provide graduate placement opportunities. Deserving students graduating from UAEU will be given preferential placement at various entities held by BRS Ventures. Career advice, participation in careers fairs, practical exposure of working in the corporate world will be made available. Competent students will also get to spend 8 to 16 weeks as internship, at BRS Ventures companies.

The collaboration with a UAE based education entity is a first for BRS Ventures. The MoU is a part of BRS Ventures’ Year of Zayed celebrations.

Speaking on the occasion, Dr. B. R. Shetty, Founder and Chairman of BRS Ventures shared, “UAE is the land of opportunities. Whatever I am today, is because of my inspiration – H. H. Sheikh Zayed and benevolence of the royal family.  I have been able to build my enterprises with the able support of highly competent people of this land. I am delighted that with this partnership, we will be able to empower and enrich the students graduating from UAEU. There could not have been a more opportune moment for us to ink this pact, as 2018 is the ‘Year of Zayed’. This is our commitment to the seat of knowledge in UAE.”

Dr. Ateeq Almansoori, Associate Provost for Students’ Affairs, UAEU, stressed the importance of this collaboration as, “it helps both parties benefit from each other’s capacities through joint programs, and communication in various fields of joint interests.” He added that, “the Division of Students’ Affairs aims to strengthen collaboration with private sector’s institutions to create job and internship opportunities for UAEU students in line with the university’s vision.”

BRS Ventures is a leading business house headquartered in Abu Dhabi, UAE. The company manages multiples businesses across Healthcare, Education, Financial Services, Pharmaceuticals, Hospitality, Environment and other sectors in UAE, India, Africa and other parts of the world.

UAEU is the first and foremost comprehensive national university in the United Arab Emirates. Founded in 1976 by the late Sheikh Zayed Bin Sultan Al Nahyan, UAEU currently has more than 15,000 Emirati and international students. As the UAE’s flagship university, UAEU offers a full range of accredited, high-quality graduate and undergraduate programs through nine colleges.

About BRS Ventures (www.brsventures.com)

BRS Ventures is a holding company belonging to Indian Padma Shri recipient Dr. B. R. Shetty. The company manages a diversified portfolio of businesses through its subsidiary companies and JV partnerships operating in Healthcare, Education, Financial Services, Pharmaceuticals, Hospitality, Environment and other Sectors in UAE, India, Africa and other parts of the world.

Contacts
Shamitha Raj, +971502523960

shamitha.r@brsventures.com


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Andersen Global Expands Presence in Africa with the Addition of Mondon Conseil International

SAN FRANCISCO-Wednesday 28 November 2018 [ AETOS Wire ]

(BUSINESS WIRE) -- Today, Andersen Global announced a collaboration agreement with Mondon Conseil International, a notable Western African tax consulting, legal, accounting and financial advisory services firm based in Ivory Coast.

The agreement further establishes Andersen Global’s footprint in Africa. The global organization now has a presence in nine locations since entering the African tax and legal market less than two years ago.

“I started my career over 30 years ago at Arthur Andersen, so my values of transparency and seamless, best-in-class service are already well-aligned with Andersen Global’s core values. It is only fitting that the growing market leader of tax and legal services in the region collaborate with Andersen Global, a name I respect,” said Pacôme Mondon, Founder and Managing Partner of Mondon Conseil International.

Founded in 2001 with the goal of becoming the premier tax firm in the region, Mondon Conseil International advises local and international clients on fiscal and business law issues including trade, labor, and foreign exchange regulations, and works with CFOs, treasurers and other financial leaders on transitioning to the new accounting requirements introduced by regulators and tax administrations.

“Pacôme and his team at Mondon Conseil are paramount to the growth of our global organization in West Africa. Their current firm is already larger than other practices in the region and Pacôme and his colleagues can provide leadership in supporting the French-speaking sector of Africa,” said Mark Vorsatz, Andersen Global Chairman and Andersen Tax LLC CEO. “On top of expanding legal capabilities in the region with Mondon Conseil, we have the added pleasure of welcoming an Arthur Andersen alumnus back into the family and I expect that Pacôme will be a key player in the expansion in West Africa.”

Andersen Global is an international association of legally separate, independent member firms comprised of tax and legal professionals around the world. Established in 2013 by U.S. member firm Andersen Tax LLC, Andersen Global now has nearly 4,000 professionals worldwide and a presence in over 122 locations through its member firms and collaborating firms.



Contacts

Megan Tsuei
Andersen Tax
415-764-2700



Permalink : https://www.aetoswire.com/news/andersen-global-expands-presence-in-africa-with-the-addition-of-mondon-conseil-international/en

Aqdar World Summit Concludes with Recommendations on Human Empowerment

Abu Dhabi, United Arab Emirates-Wednesday 28 November 2018 [ AETOS Wire ]

The second edition of ‘Aqdar World Summit’, launched in Abu Dhabi on November 26, concluded on Wednesday at the Abu Dhabi National Exhibition Centre -ADNEC. Held under the title “Role of Human Empowerment in Developing Stable Societies”, the summit was organized by the Khalifa Empowerment Program, Aqdar, in cooperation with INDEX Conferences and Exhibitions, a member of INDEX Holding, the United Nations, the National Archives, the Ministry of Education, along with several local and international bodies and entities.

Participants praised the efforts of UAE under the leadership of His Highness Sheikh Khalifa bin Zayed Al Nahyan, President of the UAE, to build on the vision of the late Sheikh Zayed bin Sultan Al Nahyan, founder of the UAE, to promote the culture of human empowerment. They also praised his unrelenting efforts, with the support of HH Sheikh Mohammed bin Rashid Al Maktoum, Vice President and Prime Minister of the UAE and ruler of Dubai, and HH Sheikh Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces, to establish educated, conscious and responsible future generations to develop stable societies.

They also thanked Lt. General HH Sheikh Saif bin Zayed Al Nahyan, Deputy Prime Minister and Minister of Interior for his patronage, support and constant follow-up, which had a prominent role in the success of Aqdar World Summit.

At the conclusion of the three-day event, participants issued the “Aqdar Global Declaration on Human Empowerment in Developing Stable Societies”. Addressed to states, governments, communities and relevant institutions, the declaration called for concerted efforts to inculcate a deeper understanding of sustainable development goals (SDGs), and to adopt these goals as a key pillar to empower minds and eradicate extremism.

The declaration called for leveraging the experience of the late Sheikh Zayed in human empowerment and to develop the right mechanisms to share the Aqdar World Summit initiative globally through a variety of events.

The declaration recommended establishing an international committee to follow up on the implementation of the summit’s outcomes and to develop relevant plans and executive programs.

Contacts
UAE Ministry of Interior’s General Secretariat

Security Media Department                   

Raed Al Ajlouni, +971504702790

Or

Amanda Ayass, +971567225338

press@securitymedia.ae

Follow us on: Twitter | Facebook | YouTube | Instagram | Google +

https://www.aetoswire.com/news/aqdar-world-summit-concludes-with-recommendations-on-human-empowerment/en

ARZAN WEALTH Sells Another Property from “Single Tenant Portfolio” in USA



Dubai, United Arab Emirates, -Wednesday 28 November 2018 [ AETOS Wire ]

Arzan Wealth (DIFC) Limited (‘Arzan Wealth’), a Dubai-based advisory firm regulated by the Dubai Financial Services Authority, is pleased to announce that it has successfully advised its clients on the sale of a third property (“The Property”) from the Single Tenant Portfolio in USA. 

The Single Tenant Portfolio was acquired in June 2017, consisting of 6 single-tenant net-leased buildings with a total of 760,533 sq ft, located in 6 states in the US, and sectorally diversified with healthcare, industrial, and office assets, and with tenants that enjoy strong credit ratings and reputations in their markets.

The sold property is an industrial building located in Aiken, South Carolina. Built in 2014, the 175,000 sf building was constructed to the highest institutional standards. Owens Corning occupies 100% of the space on a lease term set to expire on January 31, 2029.  The facility provides Owens Corning with a Class A distribution center with the required supporting office space.

The Portfolio was acquired as part of Arzan Wealth’s yielding asset platform with an objective of producing an average annual yield of 8.50% to investors, and an IRR of around 10% over a three-year holding period. The sale of the Owens Corning asset is consistent with Arzan Wealth’s original strategy of identifying opportunities to break up the portfolio by selling off some of the assets, while enhancing value in the others. This asset was successfully sold at a price that has created a net IRR of around 12.7%, which is above the target IRR of 10% for the whole portfolio.

Arzan Wealth acted as the Strategic Advisor on the structuring and sale of the properties and will continue in this role during the remaining holding period of the remaining assets.

Muhannad Abulhasan, CEO of Arzan Wealth said:

“We are pleased that once again, we have been able to exceed the return expectations of investors.  This transaction reinforces our primary strategy to preserve and protect the wealth of our clients, while producing an attractive and predictable monthly income. Our track record, with a total of nine asset sales, proves that clients who chose to diversify with us by investing in all deals have benefited from this conservative approach, and will have achieved an average IRR, net of taxes and fees, of ~ 15% per annum, which is inclusive of an average monthly yield equal to 8.8% per annum.”

Notes to Editors

About Arzan Wealth (DIFC) Limited

Arzan Wealth is an investment advisory firm registered at the Dubai International Financial Centre (DIFC), and is regulated by the Dubai Financial Services Authority (DFSA).  Arzan Wealth currently advises various professional clients on real estate, private equity and other investments with a total value of assets advised around US$ 1.4 Billion.  Arzan Wealth focuses on arranging yielding investments in major global markets, as well as bespoke investments that meet the requirements of specific clients.

Past or projected performance is not necessarily a reliable indicator of future results.

Contacts

Ahmad AlSabbrei

Senior Investment Analyst

a.alsabbrei@arzanwealth.com

+965 9988 8624



Permalink : https://www.aetoswire.com/news/arzan-wealth-sells-another-property-from-ldquosingle-tenant-portfoliordquo-in-usa/en

Sharjah Celebrates ‘Child-Friendly City’ UNICEF Title in Massive Carnival

• Sharjah’s children tell the world: ‘It is every child’s right to live in a safe place like us’

• 500-plus school children in attendance

SHARJAH, United Arab Emirates-Tuesday 27 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- The children and youth in the emirate of Sharjah in the United Arab Emirates, sent a message to the world, saying: “It is every child’s right to play, be happy, to learn, to be creative, it is every child’s right to live in a safe place like us. The children of Sharjah call on the entire world that every city becomes a child-friendly city.”

The call came during the First Sharjah Child and Youth Friendly Carnival, coinciding with Universal Children’s Day and celebrating Sharjah’s recent accolade of being named a UNICEF Child-Friendly City.

The carnival saw Sharjah’s streets come alive to the sound of music as street performers and 500-plus families, children, and representatives from government organizations took part in a festive 1-km procession along Al Buhaira Corniche Road, located in the heart of the emirate.

The parade was led by the UAE Military Music Band who treated the crowds to a rousing performance on the bagpipes. Next up was ‘The Flying Dreams’ and its larger-than-life inflatable creations, including a giant bird and cartoon-style houses that soared high in the sky. The Bubbles Truck saw colourful bubble-dressed performers turn the city into a giant bubble-filled party, whereas the ‘Magic Garden’ was – quite literally – wild, with stilt walkers dressed as colorful flowers and plants.

Held under the patronage of His Highness Sheikh Dr Sultan bin Muhammad Al Qasimi, Member of the UAE Supreme Council and Ruler of Sharjah, and organized by the Sharjah Baby Friendly Office.

The Carnival culminated with a spectacular firework extravaganza; the perfect end to a delightful celebration paying tribute to the city’s future bright stars.

About Sharjah Baby Friendly Office (SBFO)
SBFO aims to protect and elevate the status and wellbeing of children of all ages in Sharjah, by creating strategies and plans and implementing them in cooperation with relevant institutions and government authorities. The office is currently tasked with the implementation of the Sharjah Baby-Friendly Emirate Project (targeting 0-2 year-olds), and the Sharjah Child Friendly City Project (targeting 0-18 year-olds).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181126005607/en/

Contacts

National Network Communications (NNC)
Fadia Daouk, +971 52 617 2111

Permalink : https://www.aetoswire.com/news/sharjah-celebrates-lsquochild-friendly-cityrsquo-unicef-title-in-massive-carnival/en

Tuesday, November 27, 2018

U.S. Solicitor General and Others Support Rimini Street Position in Supreme Court Case

 Company seeks $12.8 million refund of costs paid to Oracle

LAS VEGAS -Tuesday 27 November 2018 [ AETOS Wire ]

(BUSINESS WIRE)-- Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, provided the following statement relating to Rimini Street v. Oracle, which is currently pending before the United States Supreme Court:

“The Solicitor General of the United States recently filed an amicus curiae brief in the United States Supreme Court case of Rimini Street v. Oracle. The Solicitor General’s brief endorses Rimini Street’s interpretation of the Copyright Act’s cost-shifting provision, concluding that ‘[Oracle’s] contrary reading … stretches [the statute] beyond what its text can bear.’ The brief further concludes that the U.S District Court award of $12.8 million in non-taxable litigation expenses to Oracle, and the subsequent affirmance by the Ninth Circuit Court of Appeals, were erroneous and should be reversed.

The case is expected to be argued in early 2019. If the Supreme Court reverses the decision, Oracle will be ordered to refund the $12.8 million to Rimini Street. This refund would be in addition to the $21.5 million Oracle was previously ordered to refund to Rimini Street by the Ninth Circuit Court of Appeals, which Oracle paid in March 2018.

Rimini Street has appealed the decision of the Ninth Circuit Court of Appeals affirming an award of non-taxable costs as part of the final judgment awarded to Oracle in 2016. On September 27, 2018, the Supreme Court granted Rimini Street’s petition for review. On appeal, Rimini Street argues that the award of $12.8 million in non-taxable costs is in direct conflict with decisions of other federal circuit courts and the Supreme Court.

In addition to the United States Solicitor General, the prestigious American Intellectual Property Law Association also filed an amicus curiae brief in the case, stating that ‘[t]he interests of the copyright registration system, certainty, and predictability weigh against permitting … [statutory] awards for non-taxable costs. This constraint provides greater uniformity and better aligns with the policies underlying the Copyright Act.’

Rimini Street’s position is also supported in amici curiae briefs filed by Professor Patrick Gillen, a scholar who has written on the history and scope of federal cost-shifting statutes, and a group of law school professors and scholars of corpus linguistics, who research the use and meaning of language. All of these amici curiae argue that the Ninth Circuit Court of Appeals decision was erroneous.

Rimini Street looks forward to the argument before the Supreme Court, and is confident that it will result in a reversal of the Ninth Circuit Court of Appeals judgment on non-taxable costs, achieve national consistency to interpretation of the Copyright Act by courts, and bring the refund of $12.8 million previously paid by Rimini Street to Oracle in 2016.”

About Rimini Street, Inc.

Rimini Street, Inc. (Nasdaq: RMNI) is a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products. The Company has redefined enterprise software support services since 2005 with an innovative, award-winning program that enables licensees of IBM, Microsoft, Oracle, Salesforce, SAP and other enterprise software vendors to save up to 90 percent on total maintenance costs. Clients can remain on their current software release without any required upgrades for a minimum of 15 years. Over 1,700 global Fortune 500, midmarket, public sector and other organizations from a broad range of industries currently rely on Rimini Street as their trusted, third-party support provider. To learn more, please visit http://www.riministreet.com/, follow @riministreet on Twitter and find Rimini Street on Facebook and LinkedIn. (C-RMNI)

Forward-Looking Statements

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

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



View source version on businesswire.com: https://www.businesswire.com/news/home/20181126005154/en/

Contacts

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

Permalink : https://www.aetoswire.com/news/us-solicitor-general-and-others-support-rimini-street-position-in-supreme-court-case/en

Manifesto: Call for a Successful Transition to Renewables in the Transportation Sector

MUNICH & PFORZHEIM, Germany-Friday 23 November 2018 [ AETOS Wire ]

(BUSINESS WIRE) -- Political course corrections, coupled with the alarming reports on climate conservation, have led the organizers behind Power2Drive and other endorsers to initiate a manifesto. The aim is to deepen the close connection between e-mobility and renewable sources of energy and achieve a sustainable future. The smarter E Europe, the largest energy industry platform in Europe, will demonstrate the potential held by this combination of mobility and clean energy, and the pressing need to pay greater attention to sector coupling.

The organizers behind Power2Drive have formed a strong alliance committed to the idea of a successful transition to renewable sources of energy in the transportation sector. Some of the declaration’s first signatories include the German Federal Association for eMobility (BEM), the German Association of Energy Market Innovators (bne), the German Association for Solar Mobility (BSM), the German Solar Association (BSW-Solar), the German Wind Energy Association (BWE), the International Solar Energy Society, German Section (DGS) and the International Battery & Energy Storage Alliance (IBESA).

The signatories are not only demanding a clear signal from politicians, but also a progressive and consistent approach by industry and members of the public. The alliance has formulated seven recommendations to demonstrate why a close connection between e-mobility and renewable sources of energy is absolutely essential, and wants to see the mistakes of the past serve to propel people toward decisive action today. Investments in renewable sources of energy are necessary to cope with worsening climate change, and the basis for a successful energy transition can only be established when politicians define clear parameters. Plus, if the reshaping of the transportation sector is to have a positive effect on the climate, there must be a clear focus on renewable sources of energy.

The whole manifesto can be downloaded here: https://bit.ly/2R18gPB

Power2Drive Europe and the parallel events will take place from May 15–17, 2019 under the umbrella of The smarter E Europe at Messe München.

Further information on Power2Drive Europe 2019 can be found at www.PowerToDrive.de.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181121005307/en/

Contacts
Contact:
Solar Promotion GmbH
Sabine Kloos
Tel.: +49 7231 58598-0
Fax: +49 7231 58598-28
info@PowerToDrive.de

Press contact:
fischerAppelt, relations
Robert Schwarzenböck
Tel.: +49 89 747466-23
Fax: +49 89 747466-66
rs@fischerAppelt.de



Permalink : https://www.aetoswire.com/news/manifesto-call-for-a-successful-transition-to-renewables-in-the-transportation-sector/en