Monday, July 22, 2019

Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Crohn's Disease

 Vedolizumab subcutaneous is currently under review for approval for ulcerative colitis with the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA)



OSAKA, Japan-Monday 22 July 2019 [ AETOS Wire ]

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced top-line results from the VISIBLE 2 clinical trial evaluating the efficacy and safety of an investigational subcutaneous (SC) formulation of the gut-selective biologic vedolizumab as maintenance therapy in adult patients with moderately to severely active Crohn's disease (CD) who achieved clinical response* at week 6 following two doses of open-label vedolizumab intravenous (IV) therapy at weeks 0 and 2.1 In evaluating the primary endpoint of the trial, a statistically significant proportion of patients receiving vedolizumab SC achieved clinical remission** at week 52 compared to placebo. Patients received vedolizumab SC beginning at week 6 and every 2 weeks up to week 50.1 Adverse events were consistent with the known safety profile of vedolizumab IV, and no new signals were identified.

“Meeting the primary endpoint of the VISIBLE 2 study marks a crucial step in our efforts to help patients with Crohn’s disease as to how they may receive treatment with vedolizumab, whether that is intravenously or subcutaneously. These data, alongside the pivotal VISIBLE 1 results in ulcerative colitis, provide a more comprehensive picture of the new investigational subcutaneous formulation of vedolizumab as maintenance therapy for both ulcerative colitis and Crohn’s disease,” said Asit Parikh, MD PhD, Head of Takeda’s Gastroenterology Therapeutic Area Unit.

These results will be shared with regulatory authorities and further data from the VISIBLE 2 trial will be presented at a future scientific congress. The subcutaneous formulation of vedolizumab forms part of Takeda’s ongoing commitment to meet the individual preferences of patients worldwide.

VISIBLE 2 is a phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vedolizumab SC as maintenance therapy in patients with moderately to severely active CD.1 The study enrolled 644 participants, all of whom had an inadequate response with, loss of response to, or intolerance to corticosteroids, immunomodulators, or tumor necrosis factor-alpha (TNFα)-antagonist therapy prior to being enrolled.1 Patients who achieved clinical response at week 6 (n=410),2 following two doses of open-label vedolizumab 300 mg IV therapy at weeks 0 and 2, were randomized into one of two treatment groups, vedolizumab 108 mg SC or placebo SC.1 Both treatment groups received a subcutaneous injection every two weeks starting at week 6 up to week 50.1

* Clinical response is defined as a ≥70 point decrease in Crohn's Disease Activity Index (CDAI) score from baseline (week 0).2

** Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤150 at week 52.1

About the VISIBLE Clinical Trial Program

The VISIBLE clinical trial program aims to assess the efficacy and safety of an investigational subcutaneous (SC) formulation of vedolizumab as maintenance therapy in adult patients with moderately to severely active ulcerative colitis (UC) or Crohn’s disease (CD).1,3,4

VISIBLE consists of three phase 3 studies involving over 1,000 UC and CD patients which includes two randomized, double-blind, placebo-controlled studies examining the proportion of patients achieving clinical remission at week 52, and an open-label extension study to determine the long-term safety and efficacy of vedolizumab SC.1,3,4

About Ulcerative Colitis and Crohn’s Disease

Ulcerative colitis (UC) and Crohn’s disease (CD) are two of the most common forms of inflammatory bowel disease (IBD).5 Both UC and CD are chronic, relapsing, remitting, inflammatory conditions of the gastrointestinal tract that are often progressive in nature.6,7 UC only involves the large intestine as opposed to CD which can affect any part of the GI tract from mouth to anus.8,9 CD can also affect the entire thickness of the bowel wall, while UC only involves the innermost lining of the large intestine.7,8 UC commonly presents with symptoms of abdominal discomfort, loose bowel movements, including blood or pus.8,10 CD commonly presents with symptoms of abdominal pain, diarrhea, and weight loss.6 The cause of UC or CD is not fully understood; however, recent research suggests hereditary, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to UC or CD.8,11,12

About Entyvio® (vedolizumab)

Vedolizumab is a gut-selective biologic and is approved as an intravenous (IV) formulation.13,14 It is a humanized monoclonal antibody designed to specifically antagonize the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).15 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.16 The alpha4beta7 integrin is expressed on a subset of circulating white blood cells.15 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD).15,17,18 By inhibiting alpha4beta7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.15

Vedolizumab IV is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα)-antagonist.13,14 Vedolizumab IV has been granted marketing authorization in over 60 countries, including the United States and European Union, with more than 330,000 patient years of exposure to date.2

Therapeutic Indications (vedolizumab IV)

Ulcerative colitis

Vedolizumab is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

Crohn’s disease

Vedolizumab is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.

Important Safety Information

Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Special warnings and special precautions for use

Vedolizumab should be administered by a healthcare professional prepared to manage hypersensitivity reactions, including anaphylaxis, if they occur. Appropriate monitoring and medical support measures should be available for immediate use when administering vedolizumab. Observe patients during infusion and until the infusion is complete.

Infusion-related reactions

In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity. If a severe IRR, anaphylactic reaction, or other severe reaction occurs, administration of vedolizumab must be discontinued immediately and appropriate treatment initiated (e.g., epinephrine and antihistamines). If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated (e.g., epinephrine and antihistamines). Once the mild or moderate IRR subsides, continue the infusion. Physicians should consider pre-treatment (e.g., with antihistamine, hydrocortisone and/or paracetamol) prior to the next infusion for patients with a history of mild to moderate IRR to vedolizumab, in order to minimize their risks.

Infections

Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity. Physicians should be aware of the potential increased risk of opportunistic infections or infections for which the gut is a defensive barrier. Vedolizumab treatment is not to be initiated in patients with active, severe infections such as tuberculosis, sepsis, cytomegalovirus, listeriosis, and opportunistic infections until the infections are controlled, and physicians should consider withholding treatment in patients who develop a severe infection while on chronic treatment with vedolizumab. Caution should be exercised when considering the use of vedolizumab in patients with a controlled chronic severe infection or a history of recurring severe infections. Patients should be monitored closely for infections before, during and after treatment. Before starting treatment with vedolizumab, screening for tuberculosis may be considered according to local practice. Some integrin antagonists and some systemic immunosuppressive agents have been associated with progressive multifocal leukoencephalopathy (PML), which is a rare and often fatal opportunistic infection caused by the John Cunningham (JC) virus. By binding to the α4β7 integrin expressed on gut-homing lymphocytes, vedolizumab exerts an immunosuppressive effect specific to the gut. Although no systemic immunosuppressive effect was noted in healthy subjects, the effects on systemic immune system function in patients with inflammatory bowel disease are not known. Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms, and consider neurological referral if they occur. If PML is suspected, treatment with vedolizumab must be withheld; if confirmed, treatment must be permanently discontinued. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body, clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. The progression of deficits usually leads to death or severe disability over weeks or months.

Malignancies

The risk of malignancy is increased in patients with ulcerative colitis and Crohn’s disease. Immunomodulatory medicinal products may increase the risk of malignancy.

Prior and concurrent use of biological products

No vedolizumab clinical trial data are available for patients previously treated with natalizumab. No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available. Therefore, the use of vedolizumab in such patients is not recommended.

Vaccinations

Prior to initiating treatment with vedolizumab all patients should be brought up to date with all recommended immunizations. Patients receiving vedolizumab may receive non-live vaccines (e.g., subunit or inactivated vaccines) and may receive live vaccines only if the benefits outweigh the risks.

Adverse reactions include: nasopharyngitis, headache, arthralgia, upper respiratory tract infection, bronchitis, influenza, sinusitis, cough, oropharyngeal pain, nausea, rash, pruritus, back pain, pain in extremities, pyrexia, fatigue and anaphylaxis.

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

For U.S. audiences, please see the full Prescribing Information including Medication Guide for ENTYVIO®.

For EU audiences, please see the Summary of Product Characteristics (SmPC) for ENTYVIO®.

Takeda’s Commitment to Gastroenterology

Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for over 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Gastroenterology (GI), Rare Diseases and Neuroscience. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com

###

References

1 Efficacy and safety of vedolizumab subcutaneous (SC) as maintenance therapy in Crohn's disease. Available at: https://clinicaltrials.gov/ct2/show/NCT02611817. Last updated: June 17, 2019. Last accessed: July 2019.
2 Takeda Data on File. 2019.
3 Efficacy and safety of vedolizumab subcutaneously (SC) as maintenance therapy in ulcerative colitis. Available at: https://clinicaltrials.gov/ct2/show/NCT02611830. Last updated: August 27, 2018. Last accessed: July 2019.
4 Vedolizumab subcutaneous long-term open-label extension study. Available at: https://clinicaltrials.gov/ct2/show/NCT02620046. Last updated: May 6, 2019. Last accessed: July 2019.
5 Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007;369:1627-1640.
6 Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet. 2012;380:1590-1605.
7 Torres J, Billioud V, Sachar DB, et al. Ulcerative colitis as a progressive disease: the forgotten evidence. Inflamm Bowel Dis. 2012;18:1356-1363.
8 Ordas I, Eckmann L, Talamini M, et al. Ulcerative colitis. Lancet. 2012;380:1606-1619.
9 Feuerstein JD, Cheifetz AS. Crohn’s disease: Epidemiology, diagnosis and management. Mayo Clin Proc. 2017;92:1088-1103.
10 Sands BE. From symptom to diagnosis: clinical distinctions among various forms of intestinal inflammation. Gastroenterology. 2004;126:1518-1532.
11 Henckaerts L, Pierik M, Joossens M, et al. Mutations in pattern recognition receptor genes modulate seroreactivity to microbial antigens in patients with inflammatory bowel disease. Gut. 2007;56:1536-1542.
12 Kaser A, Zeissig S, Blumberg RS. Genes and environment: How will our concepts on the pathophysiology of IBD develop in the future? Dig Dis. 2010;28:395-405.
13 Entyvio Prescribing Information. Available at: https://general.takedapharm.com/ENTYVIOPI. Last updated: May 2019. Last accessed: July 2019.
14 European Medicines Agency. Entyvio EPAR product information. EMEA/H/C/002782 - IB/0030 ANNEX 1 Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/entyvio-epar-product-information_en.pdf. Last updated: April 1, 2019. Last accessed: July 2019.
15 Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330:864-875.
16 Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151:97‑110.
17 Eksteen B, Liaskou E, Adams DH. Lymphocyte homing and its roles in the pathogenesis of IBD. Inflamm Bowel Dis. 2008;14:1298‑1312.
18 Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10:1437-1444.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190721005022/en/

Contacts

Media:
Media outside Japan
Luke Willats
luke.willats@takeda.com
+41-44-555-1145

Japanese Media
Tatsuhiro Kanoo
tatsuhiro.kanoo@takeda.com
+81 (0) 3-3278-2095

Permalink : https://www.aetoswire.com/news/investigational-subcutaneous-formulation-of-vedolizumab-meets-primary-endpoint-in-achieving-clinical-remission-at-week-52-in-patients-with-moderately-to-severely-active-crohn39s-disease/en

Sunday, July 21, 2019

Quanergy and Chery Established Partnership to Propel a New Era of Autonomous Vehicles and Smart Cities

SUNNYVALE, Calif.-Saturday 20 July 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Quanergy Systems, Inc., a leading provider of LiDAR (Light Detection and Ranging) sensors and smart sensing solutions, announced a partnership with Chery Automobile, one of the largest automotive manufacturers in China.

On June 20th, 2019, Chery unveiled the logo of its new brand Chery Lion, and announced its strategic plan of working with selected partners to solve technological challenges across the ecosystem. Quanergy signed on to Chery Lion’s Smart Partner Program as the LiDAR partner, to focus efforts on advancing autonomous driving and smart cities in China.

“As the autonomous vehicle industry matures, it is imperative to build an ecosystem that supports a transportation network with reliable solutions.” said Dr. Yong Huang, Vice President, Intelligent Vehicle Business Group of Chery. “We’ll work closely with Quanergy on Chery’s autonomous driving vehicles and smart city installations.”

Quanergy‘s S3 automotive grade solid state LiDARs are based on optical phased arrays (OPA) produced in CMOS silicon. These sensors, being fully solid state with no moving parts on any scale, offer an unparalleled level of quality and reliability. Further, the CMOS silicon node used in wafer fabrication is mature, allowing to rapidly scale manufacturing at high yield and meet performance requirements at the lowest price on the market.

On the way to the realization of an autonomous age, smart city infrastructure plays a crucial role as road paver. Internet of Things (IoT) capability in smart cities connects vehicles with essential digital information, reducing traffic congestion and making roads safer.

QORTEX DTC™ (Detection, Tracking, Classification), Quanergy’s proprietary solution based on LiDAR hardware and artificial intelligence (AI) software, can play a key role in monitoring and regulating the flow of vehicles and people at intersections, and can communicate data to the connected vehicles. When combined with 5G cellular network technology, QORTEX DTC provides the necessary awareness and analytical insight into the city’s various connected components and ensures safe and efficient traffic flow.

“China is at the forefront of mobility innovation, and Chery is making massive strides in bringing not only intelligent vehicles but also intelligent transportation systems to market,” said Dr. Louay Eldada, CEO and co-founder of Quanergy. “Chery has selected Quanergy as its LiDAR partner, and together we will forge the next chapter of autonomy in China.”

Through the partnership with Chery, Quanergy is continuing its commitment to deliver its smart sensing technologies to its partners globally. To learn more about these efforts and how LiDAR can specifically be used to support connected roadways and smart city applications, please visit www.quanergy.com/transportation.

About Quanergy Systems, Inc.

Quanergy Systems, Inc. was founded in 2012 and builds on decades of experience of its team in the areas of optics, photonics, optoelectronics, artificial intelligence software and control systems. Headquartered in Sunnyvale, California, in the heart of Silicon Valley, Quanergy offers smart sensing solutions. It is a leading provider of LiDAR sensors and perception software for real-time capture and processing of 3D spatial data and object detection, identification, classification and tracking. Its sensors are disruptive in price, performance, reliability, size, weight and power. Its solutions are applicable in numerous sectors including transportation, security, industrial automation, 3D mapping, mining, agriculture, drones, robotics, smart spaces and 3D-aware smart devices for improved safety, efficiency and quality of life. For more information, visit www.quanergy.com.

About Chery and Chery Lion.

Chery Automobile Co. Ltd. was founded in 1997 in China with the vision of providing affordable yet robust and reliable passenger and commercial vehicles. Chery is manufactured in 13 plants around the world and its range of vehicles is distributed to over 84 countries. Chery Intelligent Vehicle Business Group (IVG) was established on November 10th, 2017 with the aim to concentrate superior resources within Chery Group and to accelerate the process of Chery intelligent business operations. IVG consists of 5 business units: Autonomous Driving BU, V2X Technologies BU, Digital Operations BU, Intelligent Manufacturing BU and Mobility BU. Wuhu Lion Automotive Technologies Co., Ltd. positioned as the operational entity of Chery Intelligent Vehicle Business Group (IVG), is a subsidiary company of Chery Automobile Co., Ltd. It was renamed in December 2017 from the former company of Wuhu Automotive Technology Research Institute Co., Ltd. which was established in July 2014. The company plans to set up R&D centers in different locations for the sake of attracting professional talents and to build core technical competence. The company has already established R&D centers in North America, Wuhu, Nanjing & Shanghai. For more information, visit www.cheryinternational.com.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190718005616/en/

Contacts
Sona Kim
Marketing Communications Manager
+1.408.245.9500
media@quanergy.com


Permalink : https://www.aetoswire.com/news/quanergy-and-chery-established-partnership-to-propel-a-new-era-of-autonomous-vehicles-and-smart-cities/en

Sharjah Finance Department strengths ties with Japan finance industry

Sharjah, United Arab Emirates, -Sunday 21 July 2019 [ AETOS Wire ]

A delegation from Sharjah Finance Department (SFD) visited Tokyo, Japan and met with key Japanese finance officials to discuss various possibilities that can help bolster relationships between the two sides.

The meetings were held at the Japan Bank for International Cooperation (JBIC) and was attended by Sharjah’s delegation headed by HE Waleed Al Sayegh, Director General of Sharjah Finance Department, Tom Koczwara and Abdellatif Al Ali from the Debt Management Office.  Mr Kazuhisa Yumikura, Global Head of Infrastructure and Environment Finance Group, led the Japanese delegation.

The Sharjah delegation presented the latest developments in Sharjah’s strong economy and financial position, along with the Emirate’s infrastructure plans.

“We have an excellent relationship with JBIC and are delighted to have the opportunity to meet with them to enhance our relationship even further. The meeting helped us utilise the platform for the discussion of the various financial products that can prove beneficial in strengthening our partnership with them in the long-run,” said Al Sayegh.

“Sharjah and JBIC have enjoyed successful ties over the years and have been always committed to deeply strengthening and furthering their relationship towards building a stronger partnership. We are currently engaged with financing power projects and plants in Sharjah and are open for any further opportunities,” said Yumikura.



Contacts
SAHARA Communications

Omnia Tarek, Account Manager, +971544301515, +97143298996
o.tarek@saharapr.com / www.saharagcc.com



https://www.aetoswire.com/news/sharjah-finance-department-strengths-ties-with-japan-finance-industry/en

Schlumberger Appoints Olivier Le Peuch as CEO

Mark G. Papa to Become Chairman of the Board

PARIS-Saturday 20 July 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Schlumberger Limited (NYSE: SLB) announced today that its Board of Directors has appointed Olivier Le Peuch as its Chief Executive Officer and member of the Schlumberger Board, effective August 1, 2019. Mr. Le Peuch succeeds Paal Kibsgaard, who will retire as Chief Executive Officer effective that same date. Also effective August 1, Mr. Kibsgaard will step down as Chairman of the Board and retire as a member of the Board of Directors. Mr. Kibsgaard will retire after more than 22 years of service to the Company, including eight years as CEO and four years as Chairman. Effective the same date, Mark G. Papa, a current non-independent director, will become non-executive Chairman of the Board. Peter Currie will continue to serve as the Board’s Lead Independent Director.

In his 32 years with the Company, Mr. Le Peuch has held a variety of global management positions, including Executive Vice President, Reservoir & Infrastructure; President of the Cameron product lines; President of Schlumberger Completions; and Vice President of Engineering, Manufacturing and Sustaining. Earlier in his career, Le Peuch was GeoMarket Manager for the North Sea and President of Software Integrated Solutions.

Mr. Kibsgaard commented, “Olivier possesses the Company’s values, an in-depth knowledge of our business, and a proven industry track record—all together, he is ideally suited to lead Schlumberger into the next chapter of our history.” Mr. Le Peuch added, “I am truly honored at being chosen to lead Schlumberger and its world-class workforce at a very exciting time in our Company’s history. I would like to thank Paal for his leadership and contributions to the Company, along with his guidance during the succession process.”

Commenting on the CEO succession, Mr. Currie said, “The Board joins me in thanking Paal for his more than 22 years of service to Schlumberger. Paal navigated the Company through the worst downturn in the history of the industry and set us on the right course to win in a different landscape. The Board owes Paal a debt of gratitude for his excellent leadership in modernizing and transforming the Company to ensure its continued future success. We wish Paal the very best as he enters a new chapter in his life.” Mr. Papa added, “The Board welcomes Olivier as Chief Executive Officer and is highly confident that Schlumberger will continue to grow and prosper under his leadership.”

About Schlumberger
Schlumberger is the world's leading provider of technology for reservoir characterization, drilling, production, and processing to the oil and gas industry. With product sales and services in more than 120 countries and employing approximately 100,000 people who represent over 140 nationalities, Schlumberger supplies the industry's most comprehensive range of products and services, from exploration through production, and integrated pore-to-pipeline solutions that optimize hydrocarbon recovery to deliver reservoir performance.

Schlumberger Limited has executive offices in Paris, Houston, London and The Hague, and reported revenues of $32.82 billion in 2018. For more information, visit www.slb.com.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190719005161/en/

Contacts
Investors
Simon Farrant, Vice President of Investor Relations, Schlumberger Limited
Joy V. Domingo, Director of Investor Relations, Schlumberger Limited
Office +1 (713) 375-3535
investor-relations@slb.com

Media
Joao Felix, Director of Corporate Communication, Schlumberger Limited
Office +1 (713) 375-3535
communication@slb.com


https://www.aetoswire.com/news/schlumberger-appoints-olivier-le-peuch-as-ceo/en

Saturday, July 20, 2019

FDA Approves OTEZLA® (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

OTEZLA reduced the number and pain of oral ulcers in the 12-week placebo-controlled Phase 3 RELIEF™ study

With this third indication in the U.S., OTEZLA is the first and only treatment approved for oral ulcers associated with Behçet’s Disease

SUMMIT, N.J.-Saturday 20 July 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral ulcers associated with Behçet’s Disease. OTEZLA, an oral, selective inhibitor of phosphodiesterase 4 (PDE4), is the first and only approved treatment option for oral ulcers associated with Behçet’s Disease, a rare, chronic, multisystem inflammatory disease that is difficult to treat.

“Oral ulcers are a recurring and debilitating manifestation that affects nearly everyone living with Behçet’s Disease, and have an important negative impact on the quality of life for these patients,” said Yusuf Yazici, M.D., Clinical Associate Professor, Department of Medicine, New York University Langone Health. “In the clinical trial, OTEZLA demonstrated improvements in measures of oral ulcers at week 12. OTEZLA has the potential to be a needed treatment option for U.S. patients and their physicians, who previously had limited options available.”

Behçet’s Disease, also known as Behçet’s Syndrome, affects approximately 5 in 100,000 people in the U.S.1,2 Oral ulcers, the most common manifestation of Behçet’s Disease occurring in more than 98% of patients, can be painful, disabling and negatively affect quality of life.3

“We are excited to provide the first and only FDA-approved treatment for oral ulcers associated with Behçet’s Disease,” said Terrie Curran, President, Celgene Inflammation & Immunology. “This approval is a reflection of Celgene’s commitment to research in areas of high unmet need, including rare diseases such as Behçet’s Disease. We remain dedicated to further studying OTEZLA and its role in inflammatory conditions.”

The FDA approval was based on efficacy and safety results from the randomized, placebo-controlled, double-blind Phase 3 RELIEF™ study evaluating OTEZLA in 207 adult patients with Behçet’s Disease with active oral ulcers who were previously treated with at least one nonbiologic medication and were candidates for systemic therapy. Results showed OTEZLA 30 mg BID resulted in a 42.7 point reduction from baseline in the pain of oral ulcers as measured by the visual analog scale (VAS) at week 12, compared with an 18.7 point reduction with placebo. The proportion of patients achieving an oral ulcer complete response (oral ulcer-free) at week 12 was 52.9% in the OTEZLA arm and 22.3% in the placebo arm. The proportion of patients achieving oral ulcer complete response by week 6 and who remained oral ulcer-free for at least six additional weeks during the 12-week treatment phase was 29.8% in the OTEZLA arm and 4.9% in the placebo arm. The daily average number of oral ulcers during the 12-week treatment phase was 1.5 in the OTEZLA arm and 2.6 in the placebo arm (based on oral ulcer counts measured at baseline and at weeks 1, 2, 4, 6, 8, 10 and 12).

“Behçet’s Disease is a chronic inflammatory disease in which patients present with symptoms such as oral ulcers that can have a significant impact on daily life,” said Mirta Avila Santos, M.D., Executive Director, American Behçet’s Disease Association. “Today’s approval for OTEZLA marks an important milestone for people with Behçet’s Disease who have been eagerly waiting for treatment options for their oral ulcers.”

The most common adverse events observed occurring in ≥10% of patients in the RELIEF trial were diarrhea (41.3% with OTEZLA; 20.4% for placebo), nausea (19.2% with OTEZLA; 10.7% for placebo), headache (14.4% with OTEZLA; 10.7% for placebo) and upper respiratory tract infection (11.5% with OTEZLA; 4.9% for placebo). The safety profile was consistent with the known safety profile of OTEZLA.

OTEZLA is now approved for three indications in the U.S., including the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet’s Disease. Since its initial FDA approval in 2014, OTEZLA has been prescribed to more than 250,000 patients with moderate to severe plaque psoriasis or active psoriatic arthritis in the U.S.4

OTEZLA is available in the U.S. and is dispensed through a comprehensive network of specialty pharmacies. For more information about accessing OTEZLA and patient support services (including reimbursement assistance and 24/7 nurse support), doctors and patients can contact OTEZLA® SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952) or visit www.OTEZLA.com for more information.

Celgene anticipates a regulatory decision for OTEZLA in oral ulcers associated with Behçet’s Disease from the Pharmaceuticals and Medical Devices Agency in Japan in the second half of 2019. The Company also submitted a Type II Variation to the Marketing Authorization Application earlier this year seeking approval in the European Union.

About the RELIEF™ Study

The RELIEF™ study is a Phase 3 randomized, placebo-controlled, double-blind study evaluating OTEZLA 30 mg BID in 207 adult patients with Behçet’s Disease with active oral ulcers who were previously treated with at least one nonbiologic medication and were candidates for systemic therapy. This 64-week study was conducted at 53 sites across 10 countries.

In the study, 207 adult patients were randomized 1:1 to receive either OTEZLA 30 mg BID (n=104) or placebo (n=103) for the 12-week placebo-controlled treatment phase. Upon completion of week 12, all patients received OTEZLA for the 52-week active treatment phase. Efficacy was assessed based on the number and pain of oral ulcers, including the daily average number of oral ulcers during the 12-week placebo-controlled treatment phase.

About Behçet’s Disease

Behçet’s Disease is associated with abnormalities of the immune system and inflammation of the blood vessels. Behçet’s Disease is characterized by recurrent oral and genital ulcers, skin lesions, uveitis, arthritis, vascular, central nervous system and gastrointestinal involvement. Oral ulcers are present in more than 98% of Behçet’s Disease patients.

Behçet’s Disease has been classified in the U.S. as a rare or “orphan” disease by the National Institutes of Health. At this time, there are limited approved therapies to treat Behçet’s Disease in the U.S. Prevalence of Behçet’s Disease is highest in the Middle East, Asia and Japan.

About OTEZLA® (apremilast)

OTEZLA® (apremilast) 30 mg tablets is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients is not well defined.

U.S. PRESCRIBING INFORMATION

INDICATIONS

Otezla® (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

IMPORTANT SAFETY INFORMATION

Contraindications

Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting

Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur

Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide

Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla.

Behçet’s Disease: Treatment with Otezla is associated with an increase in depression. During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo.

Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla

Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo

Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo.

Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo.

Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)

Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)

Behçet’s Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9), vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9).

Use in Specific Populations

Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/.

Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition.

Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information.

Please click here for Full Prescribing Information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

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

Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.

All trademarks are the property of their respective owners.

###

1 Zeidan MJ, Saadoun D, Garrido M , Klatzmann D, Six A, Cacoub P. Behçet’s disease physiopathology: a contemporary review. Autoimmun Highlights. 2016;7(1):4.
2 Leonardo NM, McNeil J. Behçet’s disease: is there geographical variation? A review far from the Silk Road. Int J Rheumatol. 2015;2015:945262.
3 Medscape EMedicine. Dermatological Aspects of Behcet Disease Clinical Presentation. https://emedicine.medscape.com/article/1122381-clinical. Accessed February 2019.
4 Symphony Health Solution PrescriberSource PatientFocus, Includes all prescriptions from April 2014 through April 2019.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190719005369/en/

Contacts

For inquiries, please contact:

Investors:
Nina Goworek
Executive Director, Investor Relations
908-673-9711

Media:
Catherine Cantone
Senior Director, Corporate Communications
908-897-4256


Permalink : https://www.aetoswire.com/news/fda-approves-otezlaregnbspapremilast-for-the-treatment-of-oral-ulcers-associated-with-behccediletrsquos-disease/en

Fluke Corporation Acquires Industrial Reliability Leader PRÜFTECHNIK

EVERETT, Wash.-Saturday 20 July 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Fluke Corp., the global leader in test and measurement instruments, has acquired Ismaning, Germany-based PRÜFTECHNIK, a market leader in precision laser shaft alignment, condition monitoring, and non-destructive testing.

“Fluke’s acquisition of PRÜFTECHNIK reflects the growing importance our customers place on reliability systems to keep their equipment in optimum operating condition,” said Marc Tremblay, president of Fluke Corporation. “This business will help us usher in the next generation of solutions for our industrial customers.”

Fluke Corporation                       

For information on Fluke tools and applications, or to find the location of your nearest distributor, contact Fluke Corporation, P.O. Box 9090, Everett, WA USA 98206, call (800) 44-FLUKE (800-443-5853), fax (425) 446-5116, e-mail fluke-info@fluke.com or visit the Fluke Web site at http://www.fluke.com.

About Fluke

Founded in 1948, Fluke Corporation is the world leader in compact, professional electronic test tools and software for measuring and condition monitoring. Fluke customers are technicians, engineers, electricians, maintenance managers, and metrologists who install, troubleshoot, and maintain industrial, electrical, and electronic equipment and calibration processes.

About PRÜFTECHNIK

PRÜFTECHNIK is a worldwide provider of maintenance technology with a wide product, service, and training program tailored to the needs of maintenance experts in the areas of shaft alignment, vibration analysis, condition monitoring and destruction-free testing. Many manufacturing companies worldwide trust our solutions for reliable and condition-based maintenance of rotating machines.

Fluke is a registered trademark of Fluke Corporation. The names of actual companies and products mentioned herein may be the trademarks of their respective owners. For more information, visit the Fluke website.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190719005046/en/

Contacts
Susan Israel
Sr. Communications Manager
(425) 446-6356
susan.israel@fluke.com

Permalink : https://www.aetoswire.com/news/fluke-corporation-acquires-industrial-reliability-leader-pruumlftechnik/en

Rimini Street Becomes Support Service Provider for Hyundai-Kia Motors’ Global Database Portfolio

Leading global car manufacturer anticipates significant cost reduction and benefit from a specialized support model for mass database instances

LAS VEGAS -Tuesday 16 July 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that it has been selected as the software support services provider to global auto manufacturer Hyundai-Kia Motors.

By providing efficient, timely, and cost-effective database maintenance and support, Rimini Street plans to actively support Hyundai-Kia Motors in their endeavor to implement a business-driven IT roadmap.

Cost Optimization and Desire for Quality Support

To support response to paradigm shifts in the automobile industry and active technology innovation, Hyundai-Kia Motors set out a new IT strategy that strives to maximize value across the IT landscape.

Hyundai-Kia Motors has been exploring options to reduce their reliance on the existing software vendor database support and achieve cost optimization by identifying alternative solutions.

After extensive multi-dimensional feasibility analyses and due diligence, Hyundai-Kia Motors selected and contracted with Rimini Street as their database maintenance and support services provider.

“Rimini Street has been demonstrating its competitiveness by offering robust and responsive database support along with cost saving benefits” said Mr. Lee Beom Tae, Head of Hyundai-Kia’s Cloud Infrastructure Team. “On the basis of the partnership that has begun with Rimini Street, we will work to actively push forward innovation and offer greater value to our customers,” he added.

Proven Track Record of Successful Database and Application Support

Today, Rimini Street provides support to clients operating in more than 100 countries, including hundreds of database clients and many thousands of database instances worldwide, and serves clients with database architectures that range from single global instances to large, complex landscapes that include thousands of mission-critical instances.

“We are pleased to welcome Hyundai-Kia Motors to our fast-growing Rimini Street family of global and Korean clients, and we look forward to working together in the years ahead as their trusted partner for mission-critical software support,” said Seth A. Ravin, CEO and chairman of the board, Rimini Street. “Hyundai has achieved its strategic objectives with a switch to Rimini Street support. They are now saving significant costs, getting more robust and responsive service, avoiding costly updates, and able to re-invest the financial, labor and time savings in technology innovation and other initiatives that create competitive advantage to support growth.”

About Rimini Street, Inc.

Rimini Street, Inc. (Nasdaq: RMNI) is a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner. 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 1,850 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, 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 and our ability to generate cash flows from operations to help fund increased investment in our growth initiatives; the sufficiency of our cash and cash equivalents to meet our liquidity requirements; the terms and impact of our outstanding 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, in addition to products and services we expect to introduce in the near future; 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 Form 10-Q filed on May 9, 2019, 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.

© 2019 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/20190715005161/en/

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


https://www.aetoswire.com/news/rimini-street-becomes-support-service-provider-for-hyundai-kia-motorsrsquo-global-database-portfolio/en

Friday, July 19, 2019

Toshiba Memory to Rebrand as “Kioxia” in October

Unique brand name combines Japanese word for “memory” and Greek word for “value”

TOKYO-Friday 19 July 2019 [ AETOS Wire ]
(BUSINESS WIRE)-- Toshiba Memory Holdings Corporation announced today that it will officially change its name to Kioxia Holdings Corporation on October 1, 2019. The name Kioxia (kee-ox-ee-uh) will be adopted for the names of all Toshiba Memory companies, largely effective on the same date.
Kioxia is a combination of the Japanese word kioku meaning “memory” and the Greek word axia meaning “value.” Merging “memory” with “value,” Kioxia represents the company’s mission to uplift the world with “memory,” which forms the foundation of the company’s vision. Kioxia will cultivate the new era of memory, defined by rapidly increasing demands for large-capacity, high-performance storage and data processing, which positions the company to grow sustainably as a leading flash memory producer for many years to come.
“I am delighted to take the next step in our company’s evolution as we continue to enhance our position at the forefront of the memory industry,” said Stacy J. Smith, executive chairman of Toshiba Memory Holdings Corporation. “Using ‘memory’ as our starting point, Kioxia will collaborate with people to meet the various needs of everyday life, making the world more interesting and providing long-lasting value to society.”
Toshiba Memory Corporation has driven the technological evolution of flash memory from its invention of NAND flash memory in 1987 through its introduction of the latest 3D flash memory, BiCS FLASH™. As society creates increasing amounts of active data through new technologies such as 5G, IoT and cloud computing, more memory and storage is needed than ever before. As an industry pioneer and continued global leader in flash memory and solid-state drives, we are well positioned to enable our digital society to launch into a new era of memory.
Kioxia’s Mission 
Uplifting the world with “memory” — 
By evolving “memory,” we create uplifting experiences and change the world.
Kioxia’s Vision 
With progressive memory technology at the core, we offer products, services and systems that create choice and define the future.

Renamed Toshiba Memory Group Companies
Current name
New name
Toshiba Memory Corporation
Kioxia Corporation
Toshiba Memory Systems Co., Ltd.
Kioxia Systems Co., Ltd.
Toshiba Memory Advanced Package Corporation
Kioxia Advanced Package Corporation
Toshiba Memory Etoile Corporation
Kioxia Etoile Corporation
Toshiba Memory Iwate Corporation
Kioxia Iwate Corporation
Toshiba Memory America, Inc.
Kioxia America, Inc.
Toshiba Memory Europe GmbH
Kioxia Europe GmbH
Toshiba Memory Asia, Limited
Kioxia Asia, Limited
Toshiba Memory Singapore Pte. Ltd.
Kioxia Singapore Pte. Ltd.
Toshiba Memory Taiwan Corporation
Kioxia Taiwan Corporation
Toshiba Memory Semiconductor Taiwan Corporation
Kioxia Semiconductor Taiwan Corporation
Toshiba Memory Korea Corporation
Kioxia Korea Corporation
Toshiba Electronics (China) Co., Ltd.
Kioxia (Shanghai) Co., Ltd.
OCZ Israel Ltd.
Kioxia Israel Ltd.
OCZ Storage Solutions Ltd.
Kioxia Technology UK Ltd.


Note:
  • The Chinese notation of Kioxia is 鎧俠 in traditional Chinese and 铠侠 in simplified Chinese.
  • The name of Toshiba Electronics (China) Co., Ltd. is planned to be changed in the spring of 2020.
About Toshiba Memory
Toshiba Memory Group, a world leader in memory solutions, is dedicated to the development, production and sale of flash memory and solid state drives (SSDs). In April 2017, Toshiba Memory was spun off from Toshiba Corporation, the company that invented NAND flash memory in 1987. Toshiba Memory pioneers cutting-edge memory solutions and services that enrich people's lives and expand society's horizons. The company's innovative 3D flash memory technology, BiCS FLASH™, is shaping the future of storage in high-density applications, including advanced smartphones, PCs, SSDs, automotive and data centers. For more information on Toshiba Memory, please visit https://business.toshiba-memory.com/en-jp/.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190717005856/en/

Contacts
For more information 
Sam Ghirardello (phone: +81-3-5427-7396, SGhirardello@webershandwick.com) 
Satoshi Ito (phone: +81-3-5427-7309, SIto@webershandwick.com) 
Weber Shandwick (Tokyo)
Natalie Telson (ntelson@webershandwick.com) 
Weber Shandwick (New York)
Public Relations & Investors Relations 
tmchq-tmchd-info@ml.toshiba.co.jp 
Toshiba Memory Holdings Corporation
Permalink : https://www.aetoswire.com/news/toshiba-memory-to-rebrand-as-ldquokioxiardquo-in-october/en

GSMA Signs £38 Million Funding Partnership With the Department of International Development

 Funding Will Support the GSMA’s Work on Digital Innovation for the Underserved



LONDON-Thursday 18 July 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- The GSMA today announced that it has signed a thirty-eight million-pound partnership with the UK’s Department for International Development (DFID). The ‘Partnership for Inclusion, Innovation and Scale’ will provide funding for the GSMA’s Mobile for Development work on digital inclusion, digital identity, energy, water, sanitation and the reduction of the mobile gender gap. It will also include two new areas of focus: disability and climate.

“This landmark partnership with DFID reinforces the joint power and potential of the private and public sectors working together and ensures that we will continue our crucial role of stimulating digital innovation to deliver both sustainable business and large-scale socio-economic impact for the underserved,” said Mats Granryd, Director General, GSMA. “This project reinforces our commitment to supporting the UN’s Sustainable Development Goals and using the power of technology to reduce global inequalities.”

Inclusion, Innovation and Scale

The partnership will unearth critical insights on the needs of the underserved and identify and invest in mobile-enabled innovations and business models which can drive inclusion at scale. New technologies and business models, such as mobile money and pay-as-you-go (PAYG) solar energy, have been crucial to delivering socio-economic impact to the underserved. DFID, one of the world’s first donors to embrace digital technologies, has been at the forefront of these innovations. The GSMA’s Mobile for Development programme is experienced in bringing digital innovations to scale, by engaging the private sector, especially mobile operators and digital innovators.

The new partnership builds on the GSMA’s long-standing relationship with DFID. Since 2013, over 20 million lives across 39 countries have been impacted, of which over 70% have been women. The link-up has already impacted all 17 SDGs, in particular SDG 5 which focuses on Gender Equality, SDG 10 which focuses on Reduced Inequalities and SDG 7 which looks at Affordable and Clean Energy.

Mobile for Development

The GSMA’s Mobile for Development programme was established to drive innovation in digital technology to reduce inequalities in the world. In particular, the programme aims to deliver sustainable business and large-scale socio-economic impact for the underserved. The programme sits at the intersection of the mobile ecosystem and the development sector and provides unique research and insights, and in-market expertise that unites the mobile industry, tech innovators, governments and the development community.

For further information on the GSMA’s Mobile for Development team, please go to: https://www.gsma.com/mobilefordevelopment/

About the GSMA

The GSMA represents the interests of mobile operators worldwide, uniting more than 750 operators and nearly 400 companies in the broader mobile ecosystem, including handset and device makers, software companies, equipment providers and internet companies, as well as organisations in adjacent industry sectors. The GSMA also produces the industry-leading MWC events held annually in Barcelona, Los Angeles and Shanghai, as well as the Mobile 360 Series of regional conferences.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20190717005566/en/

Contacts

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

GSMA Press Office
pressoffice@gsma.com



Permalink : https://www.aetoswire.com/news/gsma-signs-pound38-million-funding-partnership-with-the-department-of-international-development/en

AHF to WHO: Ebola Response, Too Little, Too Late!

KAMPALA, Uganda -Thursday 18 July 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- The World Health Organization (WHO) has finally declared a Public Health Emergency of International Concern (PHEIC) in the Democratic Republic of the Congo on July 17 as a long overdue acknowledgement that the current Ebola outbreak remains uncontained and still poses a significant threat to global health security.

A PHEIC declaration carries legal obligations requiring affected states to cooperate with the WHO in coordinating an outbreak response plan and also puts the global public health community on notice signifying a substantial health security risk to the world.

“The PHEIC declaration is a step in the right direction, but it should have been declared months ago,” said AHF President Michael Weinstein. “Now, Dr. Tedros must act quickly to mobilize the resources from donor countries and mount a robust response. All available vaccines must be fast-tracked for approval so that a large-scale inoculation campaign can begin immediately—an emergency declaration is only effective if it’s followed by swift action.”

The declaration comes two days before the expiration of a thirty-day period during which AIDS Healthcare Foundation (AHF) called on Director-General of the World Health Organization Dr. Tedros Adhanom Ghebreyesus to demonstrate resolute leadership on Ebola or resign.

According to a news report by the BBC, the WHO is currently facing a shortfall of $54 million needed to address the outbreak.

AHF operates healthcare programs in two countries currently being affected or being threatened by the outbreak—Uganda and Rwanda. Despite lessons learned from the 2014 Ebola outbreak in West Africa, basic medical equipment and supplies are still in short supply. AHF recently donated $30,000 worth of medical supplies to Uganda to help protect medical staff in Western Uganda near the DRC border.

As of July 12, there have been 2,477 Ebola cases in the Democratic Republic of the Congo (DRC) that have resulted in 1,655 deaths. In addition, the virus spread to neighboring Uganda, where as of June 24, there have been a total of three confirmed cases of Ebola. All three individuals had recently traveled to the DRC, and all succumbed to the disease.

AHF encourages you to experience the sobering truth behind the 2014 Ebola outbreak in this short documentary and see the devastation that occurs when outbreak preparedness is not a top global health priority.

For more information, please contact Ged Kenslea at gedk@aidshealth.org or 323-791-5526

About AIDS Healthcare Foundation (AHF)

AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to over 1.2 million people in 43 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190717005850/en/

Contacts

AHF AFRICA MEDIA CONTACT:
Oluwakemi Gbadamosi, Senior Manager, PR and Communications, AHF Africa
+256.771.870.163
Oluwakemi.gbadamosi@aidshealth.org

US MEDIA CONTACTS:
Ged Kenslea, Senior Director, Communications, AHF
+1-323-308-1833 work
+1-323-791-5526 mobile
gedk@aidshealth.org

Denys Nazarov, Director of Global Policy & Communications, AHF
+1-323-219-1091
dn@aidshealth.org

Permalink : https://www.aetoswire.com/news/ahf-to-who-ebola-response-too-little-too-late/en

Visa Acquires Payworks

Acquisition enhances Visa integrated commerce payment management capabilities for clients worldwide


SAN FRANCISCO & MUNICH-Thursday 18 July 2019 [ AETOS Wire ]

(BUSINESS WIRE) -- Visa (NYSE: V) today announced it has acquired Payworks, a Munich-based provider of next-generation payment gateway software for the Point of Sale (POS). Visa will bring Payworks’ cloud-based solution for in-store payment processing together with its CyberSource digital payment management platform to create a fully integrated payment acceptance solution for merchants and acquirers. The joint offering will provide acquirers and payment service providers with a modern, fully white-labeled omnichannel payment management platform.

The combined capability will enable Visa’s clients to offer a unified payment experience whether their customers are paying in-store, in-app or online. The acquisition builds on a strategic partnership and investment Visa made in Payworks in February 2018.

“For the past two years, we have partnered closely with Payworks to deliver cutting-edge integrated commerce solutions for CyberSource’s clients worldwide,” said Carleigh Jaques, SVP, global head of digital merchant products, Visa. “As these solutions become mainstream, aligning more closely with Payworks and combining our businesses is a natural extension of our relationship. Payworks has built a state-of-the art software technology and an impressive client base. We are thrilled to welcome the strong and talented team to our family.”

Payworks is a payment gateway software provider, streamlining face to face payment connectivity. By combining the CyberSource best in-class eCommerce and mobile payment capabilities with Payworks’ cloud-based architecture, Visa’s merchant and acquirer clients will be able to support face-to-face transactions across a variety of POS terminal types, including digital experiences, through a single integration.

According to recent research, 94% of retailers note that an omnichannel fulfillment strategy is one of their company’s top priorities.1 In addition, 58% of shoppers say they have ordered online and picked up in store2, and 37% of shoppers make additional in-store purchases at pick up time3.

“Integrated commerce is an accelerating opportunity for Payworks and its clients,” said Christian Deger, Chief Executive Officer and Co-Founder at Payworks. “By combining our POS technology with CyberSource’s digital commerce capabilities, we can bring our joint solution to merchants and acquirers across the globe at an accelerated pace. We are excited about joining the Visa family and integrating our capabilities to deliver innovative, differentiated integrated-commerce solutions.”

Working with some of the largest payment providers in the world, Payworks’ technology and services currently enables omnichannel commerce experiences in a variety of settings, such as restaurants, retail and transport.

Visa’s merchant and acquirer clients will be able to use Payworks’ automated solutions to run and configure their point-of-sale offerings and terminals, making it easy for merchants to set-up and start accepting any form of electronic payment, both face-to-face and online, through a single integration to CyberSource.

About Visa Inc.

Visa Inc. (NYSE: V) is the world’s leader in digital payments. Our mission is to connect the world through the most innovative, reliable and secure payment network - enabling individuals, businesses and economies to thrive. Our advanced global processing network, VisaNet, provides secure and reliable payments around the world, and is capable of handling more than 65,000 transaction messages a second. The company’s relentless focus on innovation is a catalyst for the rapid growth of digital commerce on any device, for everyone, everywhere.  As the world moves from analog to digital, Visa is applying our brand, products, people, network and scale to reshape the future of commerce. For more information, visit About Visa, visa.com/blog and @VisaNews.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are identified by words such as “will,” “is expected,” and other similar expressions. Examples of forward-looking statements include, but are not limited to, statements we make regarding the benefits to Visa arising from the completion of the transaction.

By their nature, forward-looking statements: (i) speak only as of the date they are made; (ii) are not statements of historical fact or guarantees of future performance; and (iii) are subject to risks, uncertainties, assumptions or changes in circumstances that are difficult to predict or quantify. Therefore, actual results could differ materially and adversely from Visa’s forward-looking statements due to a variety of factors, including the risk that the transaction may not be consummated; the closing conditions relating to the transaction; and various other factors, including those contained in our Annual Report on Form 10-K for the fiscal year ended September 30, 2018, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, and our other filings with the U.S. Securities and Exchange Commission.

You should not place undue reliance on such statements. Except as required by law, we do not intend to update or revise any forward-looking statements as a result of new information, future developments or otherwise.

1 Put Fulfillment At The Heart Of The Customer Experience, IBM, Jan 2019
2 Omnichannel Report, Internet Retailer, 2019
3 “The Rise of the Click & Collect Superconsumer,” OrderDynamics, July 2018

View source version on businesswire.com: https://www.businesswire.com/news/home/20190717005245/en/

Contacts

Will Stickney
415-805-4892
Press@visa.com

Permalink : https://www.aetoswire.com/news/visa-acquires-payworks/en