ASSAR Selects Beyontec to Implement Platform Ecosystems for Rwanda Insurance Industry

NAIROBI, Kenya-Tuesday 2 June 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Beyontec, a leading global provider of insurance technology solutions, announced today that it had been selected by the Insurance Association of Rwanda (ASSAR) to implement a digital ecosystem of different platform solutions for the insurance industry in Rwanda.

Founded in 1992, ASSAR has been at the forefront of driving rapid transformation across the regional insurance markets in Rwanda. Through this partnership, Beyontec will assist ASSAR to accomplish its vision of synergizing and empowering the insurers and other constituents to seamlessly interact and promote business with each other while delivering consistent customer experiences.

Beyontec and ASSAR collaborated to undertake few transformational platform-centric insurance initiatives, such as the end-to-end transformation of motor certificate, moving away from a paper-based system to a fully automated digital motor policy issuance and administration platform. They will also work together to establish a claims recovery platform to manage intra-company claims recovery, a data repository platform for smooth information exchange related to claims and frauds, a comprehensive garage registration and management platform and a finance analytical platform to manage statutory reporting.

Speaking on the occasion, Gaudens Kanamugire, Chairman of ASSAR (The Rwanda Insurers Association), commented, “The current expectations of insurance customers across the African regions have gone up as influenced by the digital revolution. Today, we need to leverage the abundance of customer data and platform ecosystems to create collaborative business models that will help both insurance players and end customers”. On the partnership, he added, “We believe that Beyontec is the right partner to help us navigate past challenges like data management, increase in the number of insurance-related non-compliance, and legacy IT system modernisation while empowering us to invest in a workforce of the future”.

By delivering platforms that offer accountability, transparency, and efficiency into how the industry is performing, Beyontec is confident of alleviating the pain points of insurers, customers, and other industry players.

Commenting on the partnership, Vivek Sethia, Director and Co-founder of Beyontec Solutions (DMCC), said, “We are proud to be associated with ASSAR whose vision for the industry matched ours. Together we are committed to driving platform-driven insurance transformation in Rwanda. Our industry interactions with regional insurers highlighted the pressing demands for relevant platform ecosystems. We are already working with ASSAR on several key initiatives, and we look forward to bringing our world-class best practices into the African market and offer cutting-edge digital platform solutions”.

With Beyontec’s proven track record of delivering future-proof technologies, products, and platforms to aid the digital transformation of insurance providers worldwide, ASSAR’s is confident that their expertise would go a long way to help insurers in Rwanda transact real-time digital business, improve cash flows, and enhance the customer service.

About Beyontec Solutions

Beyontec Solutions is a global insurance solution provider addressing all aspects of insurance business, including general insurance, Takaful, life insurance, medical insurance, and insurance broking. The Beyontec Suite is a workflow-driven solution designed to provide cost-effective solutions by focusing on customers’ requirements and business challenges. The diverse insurance experience and knowledge have enabled Beyontec to create solutions that incorporate the world’s best insurance practices. Supported by experienced insurance professionals and support centres equipped with secure infrastructure, they provide the best service and support to global insurance companies. Learn more at www.beyontec.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200601005791/en/

Contacts
Beyontec Solutions
Anandh Kumar
Email: media@beyontec.com

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Smiths Medical Announces Ventilator Training Alliance App Partnership

MINNEAPOLIS-Thursday 28 May 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Smiths Medical announced today it has joined several of the world’s other ventilator manufacturers in the Ventilator Training Alliance (VTA) to support frontline medical providers access to a centralized repository of ventilator training. The content can be found in a mobile app managed by Allego.

 “Smiths Medical is proud to be a part of the VTA by providing training for our ventilators through the Allego app,” said Jeffrey Hohn, Vice President, Global Product and Commercial Excellence, Strategy and M&A at Smiths Medical. “Improving healthcare around the world is the foundation of our mission. During this critical time, we understand healthcare professionals need ventilator information quickly and the app enables the right care delivered to their patients, quickly.”

The VTA app connects respiratory therapists, nurses and other medical professionals with ventilator training resources from alliance member companies. Included in the app are instructional how-to videos, manuals and troubleshooting guides critical to treating patients suffering from COVID-19 related respiratory distress.

Ventilators play a critical role in the management of patients who require respiratory assistance due to a severe illness, such as COVID-19. Speed and ease of access to ventilator training could have a direct impact on patients’ health during the COVID-19 crisis.

Content on the VTA app can be accessed on iOS and Android devices — even in environments with little to no Wi-Fi access — or from a web browser. The app provides healthcare professionals multi-language closed captioning and mobile background audio when multitasking.

How to Access the Ventilator Training Alliance Hub

The app is provided at no cost to medical professionals. To download the Ventilator Training Alliance knowledge hub application, visit the Apple App Store or Google Play store, or access the hub from any web browser.

Watch a video overview of the VTA app.

About the Ventilator Training Alliance

The Ventilator Training Alliance provides a library of training and product resources for medical professionals. Created through a partnership between ventilator manufacturers, including Dräger, GE Healthcare, Getinge, Hamilton Medical, Medtronic, Nihon Kohden, Smiths Medical, and Philips, and powered by Allego, the central knowledge hub provides free mobile access to video tutorials, instruction manuals, and other training materials for equipment that is critical to helping clinicians treat patients suffering from COVID-19 related respiratory distress.

If you are a ventilator manufacturer and would like to join the alliance, please send your request to: VTA-Join@allego.com.

About Smiths Medical

A leading supplier of specialized medical devices and equipment for global markets, focusing on the medication delivery, vital care and safety devices market segments. For more information, visit www.smiths-medical.com.

About Smiths Group

A global technology company that has been operating for nearly 170 years, delivering products and services for the medical technology, security & defence, general industrial, energy and space & commercial aerospace markets worldwide. Smiths Group plc employs c. 23,000 colleagues in over 50 countries and is listed on the London Stock Exchange. For more information visit www.smiths.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200526005108/en/

Contacts
Smiths Medical Media Relations at media.relations@smiths-medical.com or Vanessa Krier at 763-383-3299.

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Schlumberger Announces Redemption of 100% of Outstanding 4.200% Senior Notes Due 2021

LONDON -Monday 1 June 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Schlumberger Limited (“Schlumberger”) today announced that Schlumberger Oilfield UK Plc, an indirect wholly-owned subsidiary of Schlumberger (“SLB UK”), will redeem the entire outstanding principal amount of its 4.200% Senior Notes due 2021 (CUSIP Nos. 80685QAA4/G7861RAA4; ISIN Nos. US80685QAA40/USG7861RAA44; and Common Codes 56301097/56301046) (the “Notes”). The redemption date for the Notes is June 29, 2020 (the “Redemption Date”). The Notes are currently listed on the Official List of the Luxembourg Stock Exchange and admitted to trading on the Euro MTF market.

The aggregate principal amount of the Notes outstanding is $600,000,000. The Notes will be redeemed on the Redemption Date at a redemption price for the Notes equal to (a) 100% of the aggregate principal amount being redeemed, plus (b) accrued and unpaid on the Notes from the last interest payment date to, but excluding, the Redemption Date, plus (c) a make-whole premium to be calculated three business days prior to the Redemption Date in accordance with the terms of the Notes and the indenture governing the Notes. On and after the Redemption Date, the Notes will cease to be outstanding and interest will cease to accrue on the Notes.

Notices of redemption are being sent by the trustee for the Notes to all currently registered holders of the Notes.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the federal securities laws — that is, statements about the future, not about past, events. Such statements often contain words such as “expect,” “may,” “believe,” “plan,” “estimate,” “intend,” “anticipate,” “should,” “could,” “will,” “see,” “likely” and other similar words. Forward-looking statements address matters that are, to varying degrees, uncertain, such as statements regarding the terms and timing of the redemption of the Notes. Neither Schlumberger nor SLB UK can give any assurance that such statements will prove correct. These statements are subject to, among other things, the risks and uncertainties detailed in Schlumberger’s most recent Forms 10-K, 10-Q, and 8-K filed with or furnished to the Securities and Exchange Commission. Actual outcomes may vary materially from those reflected in Schlumberger’s forward-looking statements. The forward-looking statements speak only as of the date of this press release, and Schlumberger and SLB UK disclaim any intention or obligation to update publicly or revise such statements, whether as a result of new information, future events or otherwise.

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 103,000 people as of the end of the first quarter of 2020 who represent over 170 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 sustainably.

Schlumberger Limited has executive offices in Paris, Houston, London and The Hague, and reported revenues of $32.92 billion in 2019. For more information, visit www.slb.com.

Contacts
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





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Takeda Receives Positive CHMP Opinion for Pre-Filled Syringe Presentation of TAKHZYRO® (lanadelumab) for Use as a Preventive Treatment for Hereditary Angioedema Attacks

Validation of Type II Variation will allow Takeda to commence launches in Europe later this year

The pre-filled syringe presentation is designed to enhance the treatment administration experience for HAE patients receiving TAKHZYRO

OSAKA, Japan-Monday 1 June 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on a Type II Variation regulatory application and recommended the approval of a pre-filled syringe presentation of TAKHZYRO® (lanadelumab). TAKHZYRO is a subcutaneous injectable prescription medication approved in Europe for routine prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. HAE is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.1,2,3

“Our goal is to continuously innovate in all areas of HAE management,” said Isabel Kalofonos, Global Product Strategy Lead, HAE, Takeda. “This positive opinion marks another important step forward as we aim to enhance the experience of treatment administration for people receiving TAKHZYRO. We look forward to bringing the pre-filled syringe innovation to the HAE community in Europe, starting later this year, and continue to progress plans to expand to other geographies in future months.”

TAKHZYRO received European approval in November 2018 based on results of the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study™, which measured the reduction in the number of mean monthly HAE attacks in patients receiving treatment with TAKHZYRO versus placebo.4 It is currently available as a 300 mg solution for injection, presented in a vial. The pre-filled syringe is a next generation fully assembled presentation that requires fewer preparation steps than the current TAKHZYRO vial injection, while also reducing supplies and waste.

The EMA’s Type II Variation to the terms of the marketing authorisation is for medicines that have some type of change, such as administration method, but it does not involve a change to the medicine’s active substance. The CHMP opinion states that the European Commission (EC) decision will be adopted within 12 months, and under the terms of this Type II Variation, Takeda can proceed to commence launches of the TAKHZYRO pre-filled syringe in Europe later this year.

Further regulatory submissions for the pre-filled syringe presentation are under review or planned in other countries during 2020 and beyond.

About Hereditary Angioedema
Hereditary angioedema (HAE) is a rare genetic disorder that results in recurrent attacks of oedema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat. The swelling can be debilitating and painful.1,2,3 Attacks that obstruct the airways can cause asphyxiation and are potentially life threatening.2,3 HAE affects an estimated 1 in 50,000 people worldwide. It is often under-recognized, under-diagnosed and under-treated.1,5

About TAKHZYRO® (lanadelumab)
TAKHZYRO (lanadelumab) is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity. TAKHZYRO is produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.6

TAKHZYRO is formulated for subcutaneous administration and has a half-life of approximately two weeks in patients with HAE. TAKHZYRO is intended for the self-administration or administration by a caregiver, only after training by a healthcare professional.6

TAKHZYRO Safety Information for Europe
Please consult the TAKHZYRO Summary Product Characteristics (SmPC) before prescribing. https://www.ema.europa.eu/en/documents/product-information/takhzyro-epar-product-information_en.pdf.

TAKHZYRO treatment should be initiated under the supervision of a physician experienced in the management of patients with hereditary angioedema (HAE). TAKHZYRO may be self-administered or administered by a caregiver only after training on SC injection technique by a healthcare professional.6

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

Warnings and Precautions
Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Hypersensitivity reactions have been observed. In case of a severe hypersensitivity reaction, administration of TAKHZYRO must be stopped immediately and appropriate treatment must be initiated.

General: TAKHZYRO is not intended for treatment of acute HAE attacks. In case of a breakthrough HAE attack, individualized treatment should be initiated with an approved rescue medication. There are no available clinical data on the use of lanadelumab in HAE patients with normal C1-INH activity.

Interference with coagulation test: Lanadelumab can increase activated partial thromboplastin time (aPTT) due to an interaction of lanadelumab with the aPTT assay. The reagents used in the aPTT laboratory test initiate intrinsic coagulation through the activation of plasma kallikrein in the contact system. Inhibition of plasma kallikrein by lanadelumab can increase aPTT in this assay. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. There were no differences in international normalised ratio (INR) between treatment groups.

Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially 'sodium-free'.

Interactions
No dedicated drug-drug interaction studies have been conducted. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.

As expected, concomitant use of the rescue medication C1 esterase inhibitor results in an additive effect on lanadelumab-cHMWK response based on the mechanism of action (MOA) of lanadelumab and C1 esterase inhibitor.

Immunogenicity
Treatment with lanadelumab has been associated with development of treatment emergent anti-drug antibodies (ADA) in 11.9% (10/84) of subjects. All antibody titres were low. The ADA response was transient in 20% (2/10) of ADA positive subjects. 2.4% (2/84) of lanadelumab-treated subjects tested positive for neutralizing antibodies.

The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response.

Adverse Reactions
The most commonly observed adverse reaction (52.4%) associated with TAKHZYRO was injection site reactions (ISR) including injection site pain, injection site erythema and injection site bruising. Of these ISRs, 97% were of mild intensity, 90% resolved within 1 day after onset with a median duration of 6 minutes.

Hypersensitivity reaction (mild and moderate pruritus, discomfort and tingling of tongue) was observed (1.2%)

Very common

(frequency ≥1/10):
   

Injection site reactions*

Common

(≥1/100 to <1/10):
   

Hypersensitivity**, dizziness, rash maclo-papular, myalgia, alanine aminotransferase increased, aspartate aminotransferase increased.

*Injection site reactions include: pain, erythema, bruising, discomfort, haematoma, haemorrhage, pruritus, swelling, induration, paraesthesia, reaction, warmth, oedema and rash.
** Hypersensitivity includes: pruritus, discomfort and tingling of tongue.

For full U.S. Prescribing Information, including the approved indication and important safety information, please visit https://www.shirecontent.com/PI/PDFs/TAKHZYRO_USA_ENG.pdf.

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, Rare Diseases, Neuroscience, and Gastroenterology (GI). 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.

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

Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

___________________________
1 Cicardi M, Bork K, Caballero T, et al; on behalf of HAWK (Hereditary Angioedema International Working Group). Evidence based recommendations for the therapeutic management of angioedema owing to hereditary C1 inhibitor deficiency: consensus report of an International Working Group. Allergy. 2012; 67(2):147-157.
2 Zuraw BL. Hereditary angioedema. N Engl J Med. 2008;359(10):1027-1036.
3 Banerji A. The burden of illness in patients with hereditary angioedema. Ann Allergy Asthma Immunol. 2013;111(5):329-336.
4 Banerji A, Riedl MA, Bernstein JA, et al; for the HELP Investigators. Effect of lanadelumab compared with placebo on prevention of hereditary angioedema attacks: a randomized clinical trial. JAMA. 2018;320(20):2108-2121.
5 Longhurst HJ, Bork K. Hereditary angioedema: causes, manifestations, and treatment. Br J Hosp Med. 2006;67(12):654-657.
6 TAKHZYRO® (lanadelumab) Summary of Product Characteristics.

Contacts

Media:
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media outside Japan
Emily Bunting
emily.bunting@takeda.com
+41 79 866 9703


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Panasonic and Olympian Katie Ledecky to Host Online STEAM Education Workshop to Inspire Next Generation of "Change Makers" Children

TOKYO-Wednesday 27 May 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Panasonic Center Tokyo (3-5-1 Ariake, Koto-ku, Tokyo, Japan. Referred to as "PC Tokyo"), the corporate global communications hub for Panasonic, has been conducting various communication activities as a corporate pavilion through exhibitions and offline events.

Due to the unprecedented circumstances around the world today, people's daily lives and values have been significantly impacted. We, at Panasonic, believe a new approach blending online and offline communication activities will be an essential element for corporate pavilions now more than ever.

Based on this perspective, we have decided to host an online event called "The power to create the future", on Sunday, May 31, 2020. An event dedicated to children, who we believe have the ability to become "change makers" and bring a positive impact to society, to create a better world.

The theme of the event is "STEAM education*", a very important element required for future education as the world is rapidly changing. During the event, STEAM professionals will conduct a workshop which will give the participants an opportunity to think and understand more about STEAM in their daily lives. Olympian Katie Ledecky will also join the event to introduce the Dive Into STEM Education, Powered by Panasonic program.

Katie Ledecky's Dive Into STEM Education Powered by Panasonic is an interactive educational program created to inspire students to pursue careers in science, technology, engineering and mathematics.

The students participating in the event will be divided into different groups where they will conduct a series of interviews with our guests to learn more about STEAM, and then will make a presentation about what they have learned. At the end of the event, participants will hear from Katie, who is actively working on educational support activities for younger generations.

PC Tokyo aims to proactively support the education program of younger generations by providing fresh contents such as videos of online events available on the pavilion's website.

Message from Katie Ledecky towards the event

"I am thrilled to join Panasonic Center Tokyo to promote STEM education to a group of Japanese students on May 31st.
All are welcome to join our training workshop. Hope to see you soon."

Video: “Katie Ledecky's Dive Into STEM Education Powered by Panasonic”
https://youtu.be/31DmQXq0sTw

*STEAM education is an educational method which was proposed by adding Art to "STEM education"; a method to learn about Science, Technology, Engineering, and Mathematics comprehensively.
STEAM education was introduced in the United States to contribute to the development of younger generations to inspire them to pursue diverse career fields. This method is also attracting a lot of attention in Japan in recent years.

"The power to create the future" Event outline

Date
Saturday, May 30, 2020 at 6:00pm-7:40pm PDT / 9:00pm-10:40pm EDT
Sunday, May 31, 2020 at 10:00am-11:40am JST

Place
Live stream of the online event: https://youtu.be/aiLyPX7SmTM
Details: https://www.panasonic.com/global/corporate/center-tokyo/en.html#steam_0531
*The live stream is recorded and can be viewed afterwards.

Target
Junior and senior high school students, educators, and those who have interest in STEAM education

Cooperation
Kyodo News (junior press), EverFi (contents for the event)

*The event will be conducted in English. Admission free.

About Panasonic

Panasonic Corporation is a global leader developing innovative technologies and solutions for wide-ranging applications in the consumer electronics, housing, automotive, and B2B sectors. The company, which celebrated its 100th anniversary in 2018, operates 528 subsidiaries and 72 associated companies worldwide and reported consolidated net sales of 7.49 trillion yen for the year ended March 31, 2020. Committed to pursuing new value through collaborative innovation, the company uses its technologies to create a better life and a better world for customers. Learn more about Panasonic: https://www.panasonic.com/global.

Source: https://news.panasonic.com/global/topics/2020/78373.html

Related Links

Panasonic Center Tokyo official website
https://panasonic.com/global/center-tokyo/en/

Event Reports - Panasonic Center TOKYO
https://www.panasonic.com/global/corporate/center-tokyo/en/event_report.html#StayHome_contents

Video: Panasonic Partners With The Michael Phelps Foundation #whatmovesus
https://channel.panasonic.com/contents/28784/

Video: Team Panasonic is forward moving #whatmovesus
https://channel.panasonic.com/contents/28785/

View source version on businesswire.com: https://www.businesswire.com/news/home/20200526005385/en/

Contacts
Panasonic Center Tokyo
pct.pr@ml.jp.panasonic.com

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Takeda Announces Compelling Data from the Phase 2 Trial of Pevonedistat Plus Azacitidine in Patients with Higher-Risk MDS

 – Pevonedistat Combination Demonstrates the Potential to Double Complete Remissions and Improve Outcomes in HR-MDS, With Safety Profile Similar to Azacitidine Alone –

– Pevonedistat Could be First New Treatment Option for this Patient Population in More Than a Decade –

– Oral Presentations at the American Society of Clinical Oncology (ASCO) and the European Hematology Association (EHA) Annual Meetings –

CAMBRIDGE, Mass. & OSAKA, Japan-Sunday 31 May 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced the results of the Phase 2 Pevonedistat-2001 trial will be presented during oral sessions at the virtual 56th American Society of Clinical Oncology (ASCO) Annual Meeting and the virtual 25th European Hematology Association (EHA) Annual Meeting. The study evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including higher-risk myelodysplastic syndromes (HR-MDS). These results show that the combination of pevonedistat and azacitidine is a highly active, promising therapeutic approach and suggest benefit in the HR-MDS subgroup across multiple clinically meaningful endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, with a safety profile similar to azacitidine alone.

The Pevonedistat-2001 trial was designed as a proof-of-concept study in patients with HR-MDS, higher-risk chronic myelomonocytic leukemia (HR-CMML) and low-blast acute myeloid leukemia (LB-AML). Though it did not achieve pre-defined statistical significance for the primary endpoint of OS, treatment with the pevonedistat combination demonstrated a numerically longer OS compared with azacitidine alone and a trend towards benefit in EFS, defined as death or transformation to AML.

“We are very optimistic about pevonedistat based on these Phase 2 results, particularly in the higher-risk MDS subgroup, which showed that the combination of pevonedistat and azacitidine provided benefit to patients at the level of several key endpoints, without introducing additional safety concerns. Not only did the combination demonstrate longer survival, but patients in the higher-risk MDS subgroup also achieved higher response rates and increased transfusion independence,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “We are looking forward to building on this dataset with our Phase 3 PANTHER trial, which completed enrollment last fall, and will support registration for pevonedistat globally.”

There have been no treatment advancements for HR-MDS in more than a decade and current treatment options provide limited benefit. Pevonedistat could be the first new treatment option for these patients.

“It’s exciting to see such encouraging results in the Pevonedistat-2001 trial, particularly in higher-risk MDS, an aggressive type of MDS associated with poor prognosis, diminished quality of life, and higher chance of transformation to AML,” said Lionel Adès, MD, PhD, Hôpital Saint-Louis, and a primary investigator of the Pevonedistat-2001 study. “Adding pevonedistat to the current standard of care in higher-risk MDS doubled complete remission rates, increased the duration of response and improved long-term outcomes with a safety profile similar to azacitidine alone, which may address a significant need for people living with this disease.”

Primary Results from the Phase 2 Pevonedistat-2001 Trial of Pevonedistat Plus Azacitidine in Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS), Higher-Risk Chronic Myelomonocytic Leukemia (HR-CMML) and Low-Blast Acute Myeloid Leukemia (LB-AML).

Key findings, to be presented by Dr. Lionel Adès, include:

    Intent to treat population (n=120):
        Median OS was 21.8 months (mos.) in the pevonedistat combination arm, vs. 19.0 mos. with azacitidine alone (HR 0.802; p = 0.334).
        EFS trended longer in the pevonedistat combination arm vs. azacitidine alone with a median of 21.0 mos. vs. 16.6 mos.
    HR-MDS Subgroup (n=67):
        Median OS in the pevonedistat combination arm alone was 23.9 mos. vs. 19.1 mos. with azacitidine alone.
        Median EFS in the pevonedistat combination arm was 20.2 mos. vs. 14.8 mos. with azacitidine alone.
        Overall response rate (ORR) in the pevonedistat combination arm was 79.3% vs. 56.7% with azacitidine alone.
        CR rate in the pevonedistat combination arm was 51.7% vs. 26.7% with azacitidine alone.
        Median duration of response (DoR) in the pevonedistat combination arm was 34.6 months vs. 13.1 mos. with azacitidine alone.
        Of the patients who were red blood cell (RBC) transfusion dependent at baseline, 69.2% receiving pevonedistat plus azacitidine vs. 50.0% receiving azacitidine alone became transfusion independent.
    LB-AML (n=36) & HR-CMML (n=17) Subgroups:
        Median OS in LB-AML was 23.6 mos. in the pevonedistat combination arm vs. 16.0 mos. with azacitidine alone.
        Median OS and EFS in HR-CMML favored the azacitidine alone arm, which may be due to low sample size and/or greater patient heterogeneity.
    Safety data includes:
        The safety profile of pevonedistat combined with azacitidine was similar to azacitidine alone, and did not lead to increased myelosuppression.
        The most common grade ≥3 AEs across both arms were neutropenia (33% vs. 27%), febrile neutropenia (26% vs. 29%), decreased neutrophil count (21% vs. 10%), anemia (19% vs. 27%), thrombocytopenia (19% vs. 23%), and pneumonia (12% vs. 10%).
        On-study deaths occurred in 9% of patients in the pevonedistat combination arm versus 16% with azacitidine alone.

About the Pevonedistat-2001 Trial

Pevonedistat-2001 (NCT02610777) is a global, randomized, controlled, open-label, multi-center, Phase 2 clinical trial designed to evaluate the safety and efficacy of pevonedistat in combination with azacitidine versus single-agent azacitidine in patients with higher-risk MDS or CMML, or low-blast AML, who were ineligible for stem cell transplant and have not received prior therapies. Approximately 120 participants were enrolled worldwide. The primary endpoint of the trial is OS.

About Pevonedistat

Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor, which blocks modifications of select proteins. Pevonedistat treatment disrupts cell cycle progression and cell survival, leading to cell death in cancers including leukemias. Pevonedistat in combination with azacitidine demonstrated antitumor activity in preclinical studies and was well tolerated, with promising clinical activity, in a Phase 1 study of patients with AML. Pevonedistat is currently being evaluated in Phase 3 studies as a first-line treatment for patients with HR-MDS, HR-CMML, and AML, who are ineligible (unfit) for transplant or intensive induction chemotherapy and is also being explored in a Phase 2 study in unfit AML in a triple combination with azacitidine and venetoclax.

About MDS, CMML and AML

MDS, CMML and AML are rare forms of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. These cancers most commonly affect older patients, with the median age of diagnosis ranging from 60 to 74 years. As a result of this irregular production, a person with MDS, CMML or AML does not have enough normal red blood cells, white blood cells and/or platelets in circulation. Symptoms for MDS, CMML and AML are often vague and related to low blood counts, and may include fatigue, shortness of breath, easy bruising or bleeding, loss of appetite, weakness, pale skin, fever and frequent or severe infections.

There are several classifications of MDS – very low risk to very high risk – determined by blood counts, blast counts, mutations and cytogenetics. Higher-risk disease is defined as intermediate, high or very high risk on the International Prognostic Scoring System – Revised (IPSS-R), and these patients have a poorer prognosis. Approximately 40% of patients with HR-MDS transform to AML, an aggressive form of acute leukemia in adults, with poor outcomes.

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

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, Rare Diseases, Neuroscience, and Gastroenterology (GI). 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.

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

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Contacts

Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

Media outside Japan
Emy Gruppo
emy.gruppo@takeda.com
+1 617-444-2252

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LetsGetChecked Debuts FDA EUA-Authorized At-Home Coronavirus (COVID-19) Sure-track Test

FDA EUA-authorized at-home Coronavirus test is now available in the United States, offering unparalleled safety and scale for consumers



NEW YORK-Sunday 31 May 2020 [ AETOS Wire ]

(BUSINESS WIRE)-- LetsGetChecked, the leading direct-to-consumer at-home health testing and insights company, announces today the authorization of the new Coronavirus (COVID-19) Sure-track Test for at-home consumer use by the U.S. Food and Drug Administration under an EUA. The new test is authorized to serve at-risk individuals with a proprietary at-home PCR nasal swab test that delivers accurate and definitive results within 24 hours.

Offering an end-to-end model, LetsGetChecked’s new Sure-track Test introduces the most complete FDA EUA-authorized Coronavirus at-home testing solution. The at-home Coronavirus (COVID-19) test incorporates a nasal swab and PCR lab analysis, offering convenient and secure results in 24 hours. Unlike serology tests that detect the presence of antibodies, the at-home COVID-19 test determines the presence or absence of SARS-CoV-2 viral RNA.

LetsGetChecked’s Sure-track Test is the only FDA EUA-authorized at-home Coronavirus (COVID-19) test that owns all aspects of the testing service, including the collection kit manufacturing process, logistics, lab analysis and physician approval, offering a robust system that delivers unmatched safety and scale for customers. The at-home Coronavirus test is accompanied by LetsGetChecked’s connected platform offering 24/7 telehealth services supported by licensed healthcare professionals and timely guidance on containment and care for those who test positive.

“With the FDA EUA authorization, we are thrilled to introduce the Sure-track Test to offer convenient, secure, and highly accurate at-home testing for coronavirus to communities in need in the United States. We’ve spent years building the only true end-to-end service on the market, which allows us to deliver unparalleled service to our customers.” said Peter Foley, LetsGetChecked founder and CEO.

The company's at-home Coronavirus (COVID-19) test is designed with safety in mind at every touchpoint. After a customer self-collects a swab sample, the collection swab is placed in a special transport tube containing a solution that deactivates the virus, ensuring everyone from shipping providers to lab technicians are protected from contamination and infection. Other tests on the market use a saline solution, which heightens risk by transporting an active virus. The solution also protects the integrity of the SARS-CoV-2 RNA, which heightens accuracy.

“The coronavirus crisis has impacted everyone and we are delighted to not only introduce a reliable testing solution, but one that is safe for everyone involved in the supply chain. Our entire system was considered as part of the review process and we are delighted to have worked with the FDA to deliver a truly unique at-home Coronavirus testing service to our customers,” said Gwen Murphy, PhD, MPH, and Director of Epidemiology and Clinical Studies at LetsGetChecked. “At-home testing will play a central role in ensuring a safe workplace and we are helping to develop and inform protocols with that in mind.”

With a current capacity of 300,000 units per week, LetsGetChecked’s own CLIA/CAP/BSL II certified high complexity laboratory based in Monrovia, California, is building toward a capacity of millions per week in order to meet the demand of partners and individuals in all 50 states.

Prior to today’s EUA authorization from the FDA for at-home use, LetsGetChecked has worked with global leaders from today’s top companies and frontline healthcare workers to offer coronavirus tests to more than 100,000 people. Most recently, LetsGetChecked partnered with the Professional Golfers Association on the TaylorMade Driving Relief tournament to administer tests both before and during the event, assuring that players, crew, and on-site teams were safe to play for the first televised professional sports event since shutdown. The company also developed a mobile app with tracking capabilities to monitor all parties’ symptoms and temperatures. This signals LetsGetChecked's pivotal role in providing industries across all verticals a resource to test individuals nationwide and begin re-opening the country.

The Sure-track Test will be made available for purchase starting on May 28, 2020, for $129 per kit on www.LetsGetChecked.com for at-risk individuals who meet the criteria defined by the website’s guided risk questionnaire. Tests are received within 24 hours from purchase, with definitive results delivered within 24 hours (of the sample being received by the lab).

About LetsGetChecked:

LetsGetChecked is a leading health insights company that allows consumers direct access to a wide range of testing options and clinical services from home. Founded in 2015, the company empowers people to take an active role in their health to live longer, happier lives. By combining health data and diagnostic results, LetsGetChecked provides rich health insights to enable better healthcare decision making. LetsGetChecked tests cover general health, men's health, women's health, and sexual health, and are available nationwide in the U.S., Canada, and Europe. LetsGetChecked has corporate offices located in New York City and Dublin. For more information, visit www.letsgetchecked.com.

Contacts

LetsGetChecked
Alyssa Kluge
press@letsgetchecked.com

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