Thursday, September 26, 2024

EADV 2024 Late Breaking News Sessions: New Galderma Data Demonstrating Nemolizumab’s Long-term Efficacy and Safety in Atopic Dermatitis and Durability in Prurigo Nodularis to Be Shared During Three Oral Presentations

 ZUG, Switzerland - Wednesday, 25. September 2024 AETOSWire

New 56-week data from an interim analysis of the phase III ARCADIA long-term extension study will be presented, with nemolizumab demonstrating a continuous improvement in clinically meaningful responses to signs and symptoms of atopic dermatitis for more than one year1
 Novel biomarker data from the phase III ARCADIA study will also be shared during an oral presentation, with nemolizumab demonstrating a significant effect on various biomarkers linked to core features of atopic dermatitis, including itch, skin lesions, and inflammation2
Data from the OLYMPIA DURABILITY phase IIIb study demonstrated the clinical benefits of continued use of nemolizumab beyond 52 weeks in clinically responsive prurigo nodularis patients3

(BUSINESS WIRE)--Galderma today announced that it will present new data from the ARCADIA and OLYMPIA clinical trial programs investigating nemolizumab in atopic dermatitis and prurigo nodularis, respectively, at the 2024 European Academy of Dermatology and Venereology (EADV) congress in Amsterdam during three separate oral presentations. These late-breaking data will be presented on Wednesday, September 25, including long-term efficacy and safety results from an interim analysis of the phase III ARCADIA long-term extension study and novel biomarker analyses of nemolizumab in adolescents and adults with moderate-to-severe atopic dermatitis.1,2 Additionally, encouraging data from the phase IIIb OLYMPIA DURABILITY study documenting durability of response to nemolizumab in adults with prurigo nodularis will also be presented.3

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These new data build on previously published results from the robust phase III ARCADIA and OLYMPIA clinical trial programs, which demonstrated nemolizumab’s favorable safety profile and efficacy on itch, skin lesions and sleep disturbance in atopic dermatitis and prurigo nodularis, respectively.4-6 Nemolizumab specifically inhibits IL-31 cytokine signaling, which is known to drive key symptoms, such as skin inflammation, in both of these chronic skin conditions.7,8

 

“These late-breaking data further highlight the potential of nemolizumab as an effective, long-term therapeutic option for patients with atopic dermatitis and prurigo nodularis seeking relief from itch and skin lesions. We remain steadfast in our efforts to bring this potential treatment to patients who need it the most across the world.”

 

BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D.

GLOBAL HEAD OF R&D

GALDERMA

 

Interim results from the ARCADIA long-term extension study at Week 56 demonstrate that continuous nemolizumab treatment leads to clinically meaningful improvements in skin lesions, itch, sleep, and quality of life that increase over time in atopic dermatitis

The ARCADIA long-term extension study enrolled patients from various phase II and phase III studies, including the pivotal phase III ARCADIA 1 and ARCADIA 2 clinical trials (called lead-in studies), to evaluate the long-term safety and efficacy of nemolizumab administered with background topical corticosteroids, with or without topical calcineurin inhibitors, in adolescents and adults with moderate-to-severe atopic dermatitis, over four years of treatment.1,9

Results from a 56-week interim analysis to be presented at EADV 2024 demonstrate that clinically meaningful improvements in skin lesions continued to increase up to Week 56 for atopic dermatitis patients who were previously exposed to nemolizumab in the lead-in study, compared to when they entered the long-term extension study:1

    47% of evaluable patients who were previously exposed to nemolizumab achieved clear or almost clear skin, as defined by an Investigator’s Global Assessment (IGA) score of 0 or 1, respectively, up from 29%.
    73% of evaluable patients who were previously exposed to nemolizumab achieved a 75% improvement in the Eczema Area and Severity Index (EASI) score from baseline of their lead-in study, up from 38%.

The data also demonstrate that improvements in itch, sleep, and quality of life continued to increase over time up to Week 56, and that nemolizumab’s safety profile is consistent with that previously reported in the ARCADIA clinical trials.1,6

 

“Many atopic dermatitis patients struggle to achieve holistic symptom relief with currently available treatments, and the few that do continue to seek treatments with longevity. These new data will add to the growing body of evidence demonstrating the potential long-term benefit of nemolizumab in atopic dermatitis, with patients seeing improvements in skin lesions, itch, and quality of life outcomes that continue to increase over time, for more than a year.”

 

PROFESSOR DIAMANT THAÇI

LEAD INVESTIGATOR OF THE ARCADIA LONG-TERM EXTENSION STUDY

UNIVERSITY OF LUBECK, GERMANY

 
    

 

Additional late-breaking data from the core phase III ARCADIA clinical trials demonstrate nemolizumab’s effect on biomarkers that are linked to features of atopic dermatitis

Novel biomarker data from the phase III ARCADIA clinical trials will also be presented, substantiating that targeting of IL-31 signaling with nemolizumab helps to address key features of atopic dermatitis.2 The data demonstrate that treatment with nemolizumab results in a significant reduction of various biomarkers involved in itch, skin lesions, and inflammation, which also correlates with improvements in clinical outcomes, and that patients with severe itch show more robust reduction in these biomarkers, indicating that nemolizumab may hold even greater promise in patients who are most impacted by this burdensome symptom.2

OLYMPIA DURABILITY study data demonstrates clinical benefits of continued use of nemolizumab for more than one year in responsive prurigo nodularis patients

OLYMPIA DURABILITY is a 24-week phase IIIb withdrawal study conducted in adults with prurigo nodularis. The study included 34 patients who participated in the OLYMPIA long-term extension study and achieved a clinical response, as defined by an IGA score of 0 (clear) or 1 (almost clear) and an at least four point improvement in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) score from baseline of their lead-in study at Week 52.3,10,11

The study met its primary endpoint; results to be presented demonstrate that clinically responsive patients at Week 52 have significantly lower relapse rates (17%) when continuing nemolizumab therapy than those withdrawn from treatment (75%) after 24 weeks.3 These data support the continued use of nemolizumab beyond 52 weeks for patients who are clinical responders and confirm its long-term efficacy.3 In the study, relapse was defined as an at least four-point increase in the PP-NRS score and/or an at least two-point increase in IGA score from baseline.3

The data also demonstrate that nemolizumab’s safety profile is consistent with that previously reported in the OLYMPIA 1 and OLYMPIA 2 pivotal clinical trials.3-5

 

“People living with prurigo nodularis suffer from chronic, severe itch, which disrupts their quality of life, and visible skin lesions, which can impact their self-confidence. These new long-term data demonstrate that nemolizumab’s efficacy on itch and skin lesions in prurigo nodularis is maintained for over one year, and also show that continuous treatment is necessary to ensure that these burdensome symptoms remain controlled.”

 

PROFESSOR FRANZ LEGAT

LEAD INVESTIGATOR OF THE OLYMPIA LONG-TERM EXTENSION AND DURABILITY STUDIES

DEPARTMENT OF DERMATOLOGY AND VENEREOLOGY

MEDICAL UNIVERSITY OF GRAZ, GRAZ, AUSTRIA

 
    

 

Media can find more information about atopic dermatitis and prurigo nodularis in this media toolkit, and can watch this video to find out more about the burden of itch for people living with these skin conditions.

About nemolizumab

Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan and Taiwan. In Japan, nemolizumab is marketed as Mitchga® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients.12,13

Nemolizumab is approved in the United States (under the name Nemluvio®) for the treatment of adults with prurigo nodularis, with the U.S. Food and Drug Administration’s (FDA’s) decision on atopic dermatitis expected later this year.14 Galderma’s marketing authorization applications for nemolizumab in both prurigo nodularis and atopic dermatitis are under review by multiple regulatory authorities, including the European Medicines Agency and Health Canada, as well as in Australia, Singapore, Switzerland, and the United Kingdom, via the Access Consortium framework.15,16 Further submissions to other regulatory authorities will continue throughout 2024.

About Galderma

Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com.

References:

    Thaçi D, et al. Nemolizumab long-term safety and efficacy up to 56 weeks in ARCADIA open-label extension study in adolescents and adults with moderate-to-severe atopic dermatitis. Late-breaking abstract presented at EADV 2024
    Guttman-Yassky E, et al. Tape-strips transcriptomic analysis from patients with moderate to severe atopic dermatitis treated with nemolizumab. Late-breaking abstract presented at EADV 2024.
    Legat FJ, et al. Durability of response to nemolizumab in patients with moderate-to-severe prurigo nodularis: Results from a randomized placebo-controlled withdrawal Phase 3b study. Late-breaking abstract presented at EADV 2024
    Ständer S, et al. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: Results from a global phase 3 trial (OLYMPIA 1): Late breaking abstract presented at EADV 2023
    Kwatra SG, et al. Placebo-controlled phase III trial of nemolizumab in patients with prurigo nodularis. N Engl J Med. 2023;389:1579-89. doi: 10.1056/NEJMoa2301333
    Silverberg JI, et al. Nemolizumab with concomitant topical therapy in adolescents and adults with moderate-to-severe atopic dermatitis (ARCADIA 1 & 2): results from two replicate, double-blind, randomised controlled phase 3 trials. Lancet. 2024. doi: 10.1016/S0140-6736(24)01203-0
    Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013
    Bewley A, et al. Prurigo Nodularis: A Review of IL-31RA Blockade and Other Potential Treatments. Dermatol Ther (Heidelb). 2022;12(9):2039–2048. doi: 10.1007/s13555- 022-00782-2
    ClinicalTrials.Gov. Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis. Available online. Last accessed September 2024
    ClinicalTrials.Gov. A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN). Available online. Last accessed September 2024
    ClinicalTrials.Gov. A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis. Available online. Last accessed September 2024
    Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online. Last accessed September 2024
    Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online. Last accessed September 2024
    Galderma. Galderma receives U.S. FDA approval for Nemluvio® (nemolizumab) for adult patients living with prurigo nodularis. Available online. Last accessed: September 2024
    Galderma. Galderma receives filing acceptances for nemolizumab in prurigo nodularis and atopic dermatitis in four additional countries. Available online. Last accessed: September 2024
    Galderma. Galderma announces regulatory filing acceptance for nemolizumab in prurigo nodularis and atopic dermatitis in the U.S. and EU. Available online. Last accessed: September 2024

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Contacts

For further information:

Christian Marcoux, M.Sc.
Chief Communications Officer
christian.marcoux@galderma.com
+41 76 315 26 50

Emil Ivanov
Head of Strategy, Investor Relations, and ESG
emil.ivanov@galderma.com
+41 21 642 78 12

Sébastien Cros
Corporate Communications Director
sebastien.cros@galderma.com
+41 79 529 59 85

Jessica Cohen
Investor Relations and Strategy Director
jessica.cohen@galderma.com
+41 21 642 76 43

Fujirebio Submits FDA Regulatory Filing for Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio In-Vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer’s Disease

 MALVERN, Pa. & TOKYO - Wednesday, 25. September 2024


—Expected to Be First Commercially-Available Blood-Based In-Vitro Diagnostic for Patients Being Assessed for Alzheimer’s Disease in the U.S.—


—Availability of Accurate, Assessable, Blood-Based Diagnostic Tests Will Aid in Development and Availability of More Effective Interventions for Alzheimer’s Disease—


 


(BUSINESS WIRE)--Fujirebio today announced that its wholly-owned subsidiary Fujirebio Diagnostics, Inc. has filed its Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test with the U.S. Food and Drug Administration (FDA). The new plasma test is expected to be the first commercially available blood-based IVD test in the U.S. to help in the assessment of Alzheimer’s disease (AD).


The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio, which received Breakthrough Device Designation from the FDA, is an IVD test using measurable pTau 217 and β-Amyloid 1-42 concentrations found in human plasma. The test combines these concentrations into a numerical ratio of pTau 217/β-Amyloid 1-42 to identify patients with amyloid pathology associated with AD. β-Amyloid neuritic plaque pathology in the brain is believed to contribute to the loss of cognitive function that characterizes AD.


AD is a devastating condition that afflicts more than 6 million Americans and is a leading cause of disability and death. Access to reliable diagnostic tools is currently limited. Diagnosis involves a variety of subjective measures and costly or invasive procedures, such as amyloid positron emission tomography (PET) scans and cerebral spinal fluid (CSF) tests. As a result, many patients are not diagnosed until their disease has advanced, limiting the benefits of available treatment options.


The Lumipulse pTau 217/β-Amyloid 1-42 Plasma Ratio test uses Fujirebio’s fully automated Lumipulse G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022.


“The lack of effective and accessible diagnostics for AD contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. “We designed our Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test to help physicians and patients with signs and symptoms of cognitive decline obtain an AD diagnosis much earlier when interventions are more effective. An early and accurate diagnosis will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of AD increases with a rapidly aging population globally. As part of our worldwide commitment to improving the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”


About Fujirebio


Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production, and worldwide commercialization of robust IVD products.


Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio remains the only company with such a comprehensive line-up of manual and fully automated neurodegenerative disease assays and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at www.fujirebio.com/alzheimer.


About Fujirebio Diagnostics, Inc.


Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at www.fujirebio.com.


 


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Contacts

MEDIA:

Chris Dague

Fujirebio Diagnostics, Inc.

Office: 484-395-5556

daguec@fdi.com

Standard Foods Partners With Rimini Street to Fund AI-Powered Predictive Data Analytics Project

 LAS VEGAS - Wednesday, 25. September 2024 AETOSWire 



Rimini Support™ for SAP enables manufacturer to reallocate resources towards supply chain improvements, driving stronger profitability and operational efficiency


 


(BUSINESS WIRE)--Rimini Street, Inc. (Nasdaq: RMNI), a global provider of end-to-end enterprise software support, products and services, the leading third-party support provider for Oracle and SAP software, and an AWS partner, today announced that Standard Foods Corporation has selected Rimini Support™ for SAP, enabling it to achieve significant cost savings, improve quality of support for its mission-critical SAP systems, and reallocate IT resources towards projects that will drive stronger profitability and enable growth for the leading Taiwanese food manufacturer and distributor.


Jerry Lee, director of IT at Standard Foods shared, “Rimini Street immediately halved our annual support costs and helped our SAP systems run better than ever before. Because of the efficiencies gained, my IT team can focus on using data to improve sales estimations and benefit our partners and distributors. It will be a game-changer for Standard Foods, made possible by Rimini Street.”


Better Software Support Allows for More Focus on Data Initiatives


On a search for better software support, Standard Foods received strong recommendations by multiple IT partners and peers to explore Rimini Street.


“What impressed me the most about Rimini Street was that they took the time to get to know our systems in detail, and understand our vision,” said Lee. “What sometimes took weeks to get resolved with SAP, compared to the timeliness of the support that Standard Foods gets from Rimini Street is really something else,” according to Lee. He added, “The combination of fast response and expert solutions has allowed us to increase our investment in AI and machine learning but with less staff needed to keep those systems running at full speed.”


“With Rimini Street, we only need three people to support the five SAP modules we use, and we maintain full functionality,” Lee shared. This frees up Standard Foods’ IT team to work on strategic projects such as shifting from SAP’s BI reports to Power BI and cloud-based machine learning for data analysis. By integrating AI with real-time data, Standard Foods has enhanced decision-making across its supply chain.


“Predicting how much to order is an ongoing challenge for manufacturers, and a misstep in calculations in the supply chain can impact profitability,” Lee noted. “By running various models with real-time data and AI tools, we can both refine order recommendations and improve procurement processes.”


Flexibility and Control of its IT Roadmap Alleviates S/4HANA Upgrade Pressure


As an SAP ECC shop, Standard Foods is one of the many SAP customers who will no longer receive vendor support for its ECC platform past 2027. But they are unbothered by the timeline as they are in full control of their IT roadmap since partnering with Rimini Street.


“At this moment, moving to S/4HANA is not a priority nor do we see it as a strategic move for our business. The ROI is just not there. Perhaps in the future, we may want to consider it, but for now, our efforts and focus will be on innovation, growth and profitability,” said Lee.


“One of the impactful areas for AI in the supply chain is demand forecasting. According to industry analysts, AI-based forecasting techniques that incorporate real-time and multivariate data sources can reduce forecasting errors by up to 50% compared to traditional time-series based methods,” said Tyler Munger, vice president of analytics at Rimini Street. “Many of our manufacturing clients partner with Rimini Street to direct resources towards investing in AI-fueled improvements that help with their top and bottom-line goals.”


With Rimini Street, Lee has peace of mind knowing that his team can access SAP expertise 24/7/365 with under 2-minute average response times as they continue to evolve their IT roadmap. This strategic partnership allows Standard Foods to continue its mission of promoting healthy living by using data to optimize operations.


Learn more about the business goals Standard Foods achieved by partnering with Rimini Street here.


Explore the full Rimini Street portfolio of ultra-responsive, trusted and proven support, managed services, security, integration, observability, professional services and Rimini ONE™ end-to-end outsourcing solutions for SAP and Oracle applications to support competitive advantage, profitability and growth.


About Rimini Street, Inc.


Rimini Street, Inc. (Nasdaq: RMNI), a Russell 2000® Company, is a global provider of end-to-end enterprise software support, products and services, the leading third-party support provider for Oracle and SAP software and an AWS partner. The Company has operations globally and offers a comprehensive family of unified solutions to run, manage, support, customize, configure, connect, protect, monitor, and optimize enterprise application, database, and technology software, and enables clients to achieve better business outcomes, significantly reduce costs and reallocate resources for innovation. To date, over 5,600 Fortune 500, Fortune Global 100, midmarket, public sector, and other organizations from a broad range of industries have relied on Rimini Street as their trusted enterprise software solutions provider. To learn more, please visit riministreet.com, and connect with Rimini Street on X (formerly known as Twitter), Instagram, Facebook and LinkedIn. (IR-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 “anticipate,” “believe,” “continue,” “could,” “currently,” “estimate,” “expect,” “future,” “intend,” “may,” “might,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “seem,” “seek,” “should,” “will,” “would” 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, adverse developments in and costs associated with defending pending litigation or any new litigation, including the disposition of pending motions to appeal and any new claims; additional expenses to be incurred in order to comply with injunctions against certain of our business practices and the impact on future period revenue and costs; changes in the business environment in which Rimini Street operates, including the impact of any recessionary economic trends and changes in foreign exchange rates, as well as general financial, economic, regulatory and political conditions affecting the industry in which we operate and the industries in which our clients operate; the evolution of the enterprise software management and support landscape and our ability to attract and retain clients and further penetrate our client base; significant competition in the software support services industry; customer adoption of our expanded portfolio of products and services and products and services we expect to introduce; our ability to grow our revenue, manage our cost of revenue and accurately forecast revenue; the expected impact of recent and anticipated future reductions in our workforce and associated reorganization costs; estimates of our total addressable market and expectations of client savings relative to use of other providers; variability of timing in our sales cycle; risks relating to retention rates, including our ability to accurately predict retention rates; the loss of one or more members of our management team; our ability to attract and retain additional qualified personnel, including sales personnel, and retain key personnel; our business plan, our ability to grow in the future and our ability to achieve and maintain profitability; our plans to wind down the offering of services for Oracle PeopleSoft products; our need and ability to raise equity or debt financing on favorable terms and our ability to generate cash flows from operations to help fund increased investment in our growth initiatives; risks associated with global operations; our ability to prevent unauthorized access to our information technology systems and other cybersecurity threats, protect the confidential information of our employees and clients and comply with privacy regulations; our ability to maintain an effective system of internal control over financial reporting; our ability to maintain, protect and enhance our brand and intellectual property; changes in laws and regulations, including changes in tax laws or unfavorable outcomes of tax positions we take, or a failure by us to establish adequate tax reserves; the impact of environmental, social and governance (ESG) matters; our credit facility’s ongoing debt service obligations and financial and operational covenants on our business and related interest rate risk, including uncertainty from the transition to SOFR or other interest rate benchmarks; the sufficiency of our cash and cash equivalents to meet our liquidity requirements; the amount and timing of repurchases, if any, under our stock repurchase program and our ability to enhance stockholder value through such program; uncertainty as to the long-term value of Rimini Street’s equity securities; catastrophic events that disrupt our business or that of our clients; and those discussed under the heading “Risk Factors” in Rimini Street’s Quarterly Report on Form 10-Q filed on July 31, 2024, and as updated from time to time by Rimini Street’s future Annual Reports on Form 10-K, 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.


 


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Contacts

Janet Ravin

VP, Global Communications

Rimini Street, Inc.

+1 702 285-3532

pr@riministreet.com

BRICS Urban Future Forum draws more than 13,000 attendees from over 30 countries around the globe

Dubai, United Arab Emirates - Wednesday, 25. September 2024

Cloud City BRICS Urban Future Forum wrapped up in Moscow, where experts gathered on September 18 and 19 to discuss the future of sustainable development in megacities within the member countries. Also at the event, Moscow was honored with the World Innovation Award. Additionally, during the forum, several prestigious rankings were released. Moscow ranked first among the top five BRICS cities for technological and spatial development, placed third in the BRICS-250 rating, and was also featured in the top ten list of the HSE Global Cities Innovation Index, as compiled by the National Research University Higher School of Economics.

The Forum was traditionally chaired by Nobel Peace Prize laureate Rae Kwon Chung. During the event, he often highlighted Moscow's achievements in tackling environmental challenges.

"We should all learn from Moscow and Russia. In my opinion, BRICS Urban Future Forum has been instrumental in sharing these lessons and successful management cases. In my perspective as a climate change expert, exchanging experiences and learning from other cities is incredibly valuable," said Rae Kwon Chung.

The Forum was visited by 24 delegations from 21 countries, with attendees coming to the Russian capital from South Korea, China, India, the UAE, Brazil, Turkey, South Africa, and various other nations.

The Forum featured several keynote speakers, including Maimunah Mohd Sharif, Mayor of Kuala Lumpur and former Executive Director of UN-Habitat; Jeffrey Sachs, the world's most influential economist according to The Economist and the New York Times, who serves as an advisor to the UN Secretary-General; Daron Acemoğlu, an economist and professor at the Massachusetts Institute of Technology; Sheikh Rashid bin Abdulrahman bin Rashid Al Khalifa, Governor of the Capital Province of Bahrain; Thomas Südhof, winner of the Nobel Prize in Physiology or Medicine 2013;

American economist Jeffrey Sachs noted during his speech at the Forum that the BRICS countries will soon host more than half of the world's megacities, and the members of the group are seeing impressive results from their collaborative efforts.

"There is cooperation between the BRICS countries. BRICS is a group that really works together. That's amazing. But I would also like to see that kind of interaction between the United States and Russia, as well as between the United States and China. So that instead of having two opposing camps that further divide the world, we could have cooperation. But there definitely is none," mused Jeffrey Sachs.

During the Forum, experts and participants exchanged their experiences in developing innovations, implementing artificial intelligence and augmented reality technologies in urban solutions, advancing "smart city" technologies, and achieving successes in creating cloud services.

The Forum also addressed the threats posed by high rates of urbanization and rapid technological development. Daron Acemoğlu, an economist and professor at the Massachusetts Institute of Technology, voiced concerns about the integration of artificial intelligence into the daily life of megacities.

"It's been proven that AI-assisted decision-making tools don't make the process more efficient. AI models often lack sufficient information and make mistakes. But even when they do have quality data, such technologies demotivate people and undermine their desire to be creative," Daron Acemoğlu stated.

 Alongside discussions about opportunities and threats, the Forum traditionally honored megacities and their leaders for their contributions to sustainable development and tackling environmental issues during the World Innovation Award ceremony. The award emphasizes the importance and priority of technological advancements in achieving sustainable development.  Nobel Peace Prize laureate Rae Kwon Chung presented the award to Moscow Mayor Sergei Sobyanin. Experts named Moscow the best in the "Sustainable Cities and Communities" category for its efforts in implementing innovative sustainable technologies across land, water, and air. Russia's capital was awarded for three projects, including the Pixel cleaning robot, Moscow's municipal fleet, and the city's environmental monitoring laboratories.

During the Cloud City BRICS Urban Future Forum, the top five cities from the BRICS countries were announced based on the Urban & Innovation Environment Index. This index, put together by a consortium of research organizations from China, India, and Russia, evaluates cities on their capacity to provide residents with convenient access to a wide range of physical and digital services. Moscow secured the top position in the ranking, maintaining its standing from the previous year. Shanghai, St. Petersburg, Beijing, and Guangzhou were also among the leaders.

International experts pointed out Moscow's well-balanced spatial development and the easy access residents have to a variety of city services. They also highlighted the city's adoption of new technologies across different sectors, the ongoing advancements in transport infrastructure, and the availability of public transportation. Additionally, they noted Moscow's significant efforts to protect the environment and ensure that green spaces are conveniently accessible to the public. Moscow improved its rankings across several indicators compared to the previous year, thereby reinforcing its leading position.

The results of the BRICS-250 Index, compiled by the international analytical publication World Economic Journal (Hong Kong, China), were also unveiled in Moscow. The Russian capital secured third place among BRICS business capitals, with Beijing taking the top spot and Abu Dhabi coming in second. The following Russian companies were featured in the ranking of BRICS technology firms based on their potential for new technology development, innovation, sustainability, and strategic focus, particularly in relation to their ESG and CSR strategies: Sber, Yandex, Rostelecom, VTB, Vkontakte, MOEX, Rosneft, and X5 Group, among others.

The results of the HSE Global Cities Innovation Index 2024 were also presented at the Forum. Experts from the Institute for Statistical Studies and Economics of Knowledge of the National Research University Higher School of Economics analyzed the competitive advantages of cities in terms of their appeal to leaders in science, high-tech, and creative industries. Moscow ranked in the top ten of the index, achieving high scores in the categories of "Technological Development," "Creative Industries," and "Urban Environment." Also in the top ten were London, New York, Tokyo, Beijing, San Francisco, Paris, Shanghai, Los Angeles, and Seoul.

In addition, guests and participants of the Forum had the opportunity to explore projects from Russian developers and check out innovative technological solutions. Seventeen Moscow high-tech companies were showcased at the stand of the Moscow City Government. The exhibitors included participants from the Moscow Innovation Cluster and Skolkovo. The showcased innovations included plastic recycling technology, robotic complexes, spacecraft models, and cyber prostheses, along with charging stations and portable power supplies for electric vehicles.

Fifteen roadshows were organized for the forum guests, attracting over 150 attendees. Foreign delegations visited such key facilities of Moscow's technological infrastructure as the Metro Situation Center, the Digital Twin of Moscow, and Skolkovo Technology Park, among others.

The BRICS Green Cities Forum, organized by the Moscow City Government, took place for the first time as part of the forum. The forum's extensive environmental program served as a platform for exchanging experiences and discussing the integration of green innovations into urban life.

The BRICS Green Cities Forum focused on both practical and theoretical aspects of addressing challenges: showcasing and testing innovative approaches, minimizing anthropogenic impact, creating sustainable development strategies, promoting green habits, and raising citizens' awareness of ways to preserve the environment.

The participants of the BRICS Green Cities Forum included: Rae Kwon Chung; Mohammed Al-Ahmari, representative of the National Center for Vegetation Development and Combating Desertification; Naseiba Al-Marzouki, Director of Research and Development Department and Director of Innovation at the Ministry of Energy and Infrastructure of the United Arab Emirates; Mariam Ahmed Al-Raisi, Head of Urban Planning Division at the Ministry of Energy and Infrastructure of the United Arab Emirates. Dr. Batyr Berdyklychev, representative of the World Health Organization (WHO) in the Russian Federation; and Sergey Bobylev Head of Environmental Economics Department, Faculty of Economics, Moscow State University, Professor, Doctor of Economics, Honored Scientist of the Russian Federation, Academician of the Russian Academy of Natural Sciences and the Russian Academy of Ecology.

One of the highlights of the BRICS Green Cities Forum was the international ecothon titled "Green Code of Moscow." This event attracted over 1,700 participants from 27 countries, both online and at the Zaryadye venue.

Official website of the forum: https://cloudcityconf.com/

Permalink
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Contacts

Melwyn Abraham
melwyn@matrixdubai.com

Best's Market Segment Report: Sub-Saharan Africa’s Reinsurers Resilient Amid A Complex And Challenging Risk Environment

 (BUSINESS WIRE)--The underwriting results of sub-Saharan Africa’s reinsurers have continued their trend of year-on-year improvement, benefitting from robust pricing actions on loss-affected lines of business, as well as the global hardening of the reinsurance market, according to a report from AM Best.


The Best’s Market Segment Report, “Sub-Saharan Africa’s Reinsurers Resilient Amid a Complex and Challenging Risk Environment,” forms part of AM Best’s look at the global reinsurance industry around Rendez-Vous de Septembre in Monte Carlo. Additional reports, including AM Best’s annual analysis of the world’s largest reinsurance groups and in-depth looks at the insurance-linked securities, life/annuity, health and regional reinsurance markets, have been published during August and September.


“The creditworthiness of many African debt issuers remains under pressure, which is driving heightened levels of asset risk and is continuing to test the balance sheets of sub-Saharan Africa’s reinsurers,” said Dale Kirby, financial analyst, analytics, AM Best. “On the whole, AM Best-rated reinsurers in the region have demonstrated a level of resilience amid these challenging conditions, particularly those that have successfully mitigated risks through diversification and proactive risk management.”


To access the full copy of this market segment report, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=347094.


For additional global reinsurance reports, please visit Best’s Research.


AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.


Copyright © 2024 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.


 


View source version on businesswire.com: https://www.businesswire.com/news/home/20240924764132/en/



Permalink

https://www.aetoswire.com/en/news/2509202441707


Contacts

Dale Kirby

Financial Analyst, Analytics

+44 20 7397 0276

dale.kirby@ambest.com


Ben Diaz-Clegg

Associate Director, Analytics

+44 20 7397 0293

ben.diaz-clegg@ambest.com


Richard Banks

Director, Industry Research – EMEA

+44 20 7397 0322

richard.banks@ambest.com


Edem Kuenyehia

Director, Market Development & Communications

+44 20 7397 0280

edem.kuenyehia@ambest.com


 

Wednesday, September 25, 2024

Corpay Cross-Border Named the Official FX Supplier of Everton Football Club

  


About Corpay

Corpay, Inc. (NYSE: CPAY) is a global S&P500 corporate payments company that helps businesses and consumers pay expenses in a simple, controlled manner. Corpay’s suite of modern payment solutions help its customers better manage vehicle-related expenses (such as fueling and parking), travel expenses (e.g. hotel bookings) and payables (e.g. paying vendors). This results in our customers saving time and ultimately spending less. Corpay Cross-Border refers to a group of legal entities owned and operated by Corpay, Inc.

Corpay – Payments made easy. To learn more visit www.corpay.com.

About Everton Football Club

One of the 12 Founder Members of the Football League, Everton has spent more seasons in England’s top division than any other club (121) and been crowned league champions on nine occasions.

Founded in 1878 as St Domingo, the Club has also lifted the FA (Football Association) Cup five times and, in 1985, added the European Cup Winners’ Cup to its prestigious haul.

Throughout its 146-year history, Everton has been known as a family-oriented club based on proud traditions, affectionately referred to as ‘The People’s Club’. Those traditions have also encouraged innovation, ensuring Everton has remained one of the great pioneering clubs in the history of the game. The first club to construct a purpose-built football stadium, its home, Goodison Park, is one of the most revered stadiums in England. From summer 2025, the Club will be looking to maintain those traditions in a new 52,888-capacity stadium at Bramley-Moore Dock, ensuring the Club’s roots remain in north Liverpool for generations to come.

As a pioneer, the Club is renowned for many firsts that we take for granted in today’s game. Everton was the first club to see its players wear shirts numbered 1 to 11 in a high profile fixture, the first club to go on an overseas tour, the first English club to install dugouts and undersoil heating, the first club to feature in a televised match, the first club to introduce a regular matchday programme, the first club to present its players with medals for winning the Football League championship and the first club to have a player, Dixie Dean, break the 60 goals barrier in a single league season.

*“Corpay” in this document primarily refers to the Cross-Border Division of Corpay, Inc. https://www.corpay.com/cross-border; a full listing of the companies that are part of Corpay Cross-Border is available here: https://www.corpay.com/compliance.

 



Contacts

Corpay Contact:
Brad Loder
Chief Marketing Officer
Corpay Cross-Border Solutions
+1 (647) 627-6635
brad.loder@corpay.com

Despite Increasing Cybersecurity Attacks, People Still Believe Antiquated Username and Passwords Are Strong Enough

  Results from a new study by Yubico show the need for education and taking a more holistic approach to cybersecurity at both work and home

(BUSINESS WIRE)--In the era of uncertainty with AI and an increase in cybersecurity breaches, Yubico, the leading provider of hardware authentication security keys, today shared the results of its 2024 Global State of Authentication survey, just in time for Cybersecurity Awareness Month kicking off next week.

Conducted by Talker Research, the survey polled 20,000 people from around the world, including Australia, France, Germany, India, Japan, Poland, Singapore, Sweden, the United Kingdom and the United States, to gauge perceptions and understanding of the global impact of cybersecurity both personally and in the corporate realm, explore the risks posed by inadequate security practices, the potential threat of technology like Artificial Intelligence (AI), and the impact this has on both personal and organizational safety.

The results of the survey uncovered concerning patterns and behaviors when it comes to personal and workplace cybersecurity, including the extensive underutilization of multi-factor authentication (MFA) and a generally reactive approach to addressing cyber threats. Key global findings include:

  • Despite being the least secure form of authentication, the most common method of authentication is username and password.
    • 58% use username and password to login to personal accounts
    • 54% use username and password to login to work accounts
  • With the rapid advancements of artificial intelligence, respondents said that online scams and phishing attacks have become more sophisticated (72%) and successful (66%).
  • Respondents show a lack of awareness of best practices for authentication
    • 39% think username and password are the most secure and 37% think mobile SMS based authentication is the most secure, both of which are highly susceptible to phishing attacks.
  • 40% don’t think or aren’t sure if the online apps and services they are using are doing enough from a security standpoint to protect their data, accounts and personal information. Even with this uncertainty, 22% have never done a personal cybersecurity audit (e.g., removing personal data from the internet, installing or updating cybersecurity software on their devices, changing compromised passwords, etc.) to better protect themselves online.
  • Respondents report the most commonly compromised passwords are on the apps and services that hold their most confidential, financial and personal information. These include:
    • ​​Social media account – 44%
    • Payment app – 24%
    • Online retailer account – 21%
    • Messaging app – 17%
    • Banking app – 13%
  • For employees, even with security breaches increasing every year, 40% of respondents have never received cybersecurity training from the organization they work for and only a small fraction (27%) believe the security options that their organization has in place are very secure.
  • When looking at the security aspect of onboarding employees, over 1/3 (34%) of respondents said they did not receive instructions to secure their work accounts with more than just a username and password when they first started at the company they work for.
  • Despite the fact that every employee in an organization is a potential target, 41% said security measures and requirements differ based on role and title at their company, leaving room for bad actors to infiltrate within several levels of an organization.

“The findings highlight the need for a holistic cybersecurity strategy that encompasses both home and work environments,” said Derek Hanson, vice president standards and alliances at Yubico. “This includes adopting stronger authentication methods to become phishing-resistant, fostering a culture of security awareness through consistent employee training, and more. Ultimately, building a unified front against cyber threats requires a concerted effort to bridge the gap between perceived and actual security. By integrating advanced security measures into all aspects of our digital lives, we can better protect ourselves, our data, and our organizations.”

Cybersecurity breaches and phishing schemes aren't solely a worry for IT departments or tech-savvy individuals; they also pose serious risks to the general public, especially in the era of Artificial Intelligence (AI). As cyber attacks and online scams become increasingly sophisticated, it is more important than ever for everyone to stay vigilant in both their personal and professional lives.

“When individuals fail to secure their personal accounts, they also put their workplaces at risk. This is why it’s crucial for enterprises to adopt a holistic approach to cybersecurity that considers the security of both work and personal environments,” Hanson continued.

For the full results of the survey, including recommendations for solutions, you can download an overview of the report here, the associated infographic here and our blog post here. For more information on Yubico, visit www.yubico.com.

About Yubico

Yubico (Nasdaq First North Growth Market Stockholm: YUBICO), the inventor of the YubiKey, offers the gold standard for phishing-resistant multi-factor authentication (MFA), stopping account takeovers in their tracks and making secure login easy and available for everyone. Since the company was founded in 2007, it has been a leader in setting global standards for secure access to computers, mobile devices, servers, browsers, and internet accounts. Yubico is a creator and core contributor to the FIDO2, WebAuthn, and FIDO Universal 2nd Factor (U2F) open authentication standards, and is a pioneer in delivering modern, hardware-based passkey authentication security at scale to customers in over 160 countries.

Yubico’s solutions enable passwordless logins using the most secure form of passkey technology. YubiKeys work out-of-the-box across hundreds of consumer and enterprise applications and services, delivering strong security with a fast and easy experience.

As part of its mission to make the internet more secure for everyone, Yubico donates YubiKeys to organizations helping at-risk individuals through the philanthropic initiative, Secure it Forward. The company is headquartered in Stockholm and Santa Clara, CA. For more information on Yubico, visit us at www.yubico.com.

*This survey polled 2,000 employed adults from each of the following countries: United States, United Kingdom, Australia, India, Japan, Poland, Singapore, France, Germany and Sweden. This random double-opt-in survey was conducted by market research company Talker Research, whose team members are members of the Market Research Society (MRS) and the European Society for Opinion and Marketing Research (ESOMAR).

 



Contacts

 

Yubico Communications Team
press@yubico.com