Friday, December 29, 2023

Moscow Unveils Enchanting 'Journey to Christmas' Festival Dubbed A Winter Wonderland for Gulf Visitors


 Dubai, United Arab Emirates 

From December 15, 2023, to January 8, 2024, Moscow transforms into a winter fairy tale, welcoming visitors from the Gulf region to partake in a spellbinding celebration of traditions, performances, and historical delights. The 12th edition of the 'Journey to Christmas' festival promises an immersive experience, blending the charm of Moscow's past and present, offering a unique cultural encounter for residents and guests alike.


This year "Journey to Christmas" festival will create the atmosphere of New Year miracle on the streets of Moscow for the 12th time and will cover the whole capital with magic. The 36 festival sites will host numerous events dedicated to the main winter holiday, which will acquaint with the history, life and New Year traditions of Moscow. Guests and residents of the capital will be able to go on an amazing journey through the past and present of the city, from boyar times to the present day.


Guests from Middle East countries will have a unique opportunity to get acquainted with traditional winter folk pastimes. Visitors of the festival will be able to skate on skating rinks and attend unusual ice discos, play curling games and slide down a snow slide. More than 1500 mesmerizing New Year's performances and ice shows by professional actors and skaters will take place at the venues. The festival participants will learn how to wrap presents with their own hands, decorate the house and Christmas tree, and serve the New Year's table at exciting master classes.


New Year's celebrations with Ded Moroz and Snegurochka and other fairy tale characters will be held for the young visitors of the festival, where they will be able to make their most cherished wishes. Adults and children will plunge into the festive atmosphere by taking part in snowmen molding, New Year's masquerade, riding on carousels and feeling the magic by participating in the master class "School of Magicians".


Travelers will have a unique opportunity to participate in the "Moscow Tea Party" and get acquainted with its history. Guests will learn about tea etiquette and the rules of hospitality and will be able to feel the atmosphere of historical Moscow of different eras. An exciting immersive theatrical program will unfold on Teatralnaya Square, which will take guests back in time and allow them to taste traditional hot pastries, Moscow tea blends and buy porcelain dishes, jam and other traditional souvenirs.


"Journey to Christmas" festival will allow residents and guests of the capital to plunge into the unforgettable atmosphere of the holiday, feel the magic at each venue of the event and get unforgettable impressions and emotions. The festival is one of many events within the framework of the Moscow Seasons project, where tourists from different countries will be able to get acquainted with the culture and history of Russia.



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https://www.aetoswire.com/en/news/2812202336734

Contacts

Melwyn Abraham


melwyn@matrixdubai.com

Newmont Announces the Settlement of the Exchange Offers and Consent Solicitations

DENVER - Friday, 29. December 2023


(BUSINESS WIRE)--Newmont Corporation (Newmont or the Company) announced the settlement of the previously announced offers to exchange (the “Exchange Offers”) by Newmont and Newcrest Finance Pty Limited, a wholly owned subsidiary of Newmont (“Newcrest Finance” and, together with Newmont, the “Issuers”) for any and all of the (i) 3.250% Notes due 2030 issued by Newcrest Finance (the “Existing Newcrest 2030 Notes”) for up to an aggregate principal amount of $650.0 million new 3.250% Notes due 2030 issued by the Issuers (the “New Newmont 2030 Notes”) and cash, (ii) 5.75% Notes due 2041 issued by Newcrest Finance (the “Existing Newcrest 2041 Notes”) for up to an aggregate principal amount of $500.0 million new 5.75% Notes due 2041 issued by the Issuers (the “New Newmont 2041 Notes”) and cash and (iii) 4.200% Notes due 2050 issued by Newcrest Finance (the “Existing Newcrest 2050 Notes” and, collectively with the Existing Newcrest 2030 Notes and the Existing Newcrest 2041 Notes, the “Existing Newcrest Notes”) for up to an aggregate principal amount of $500.0 million new 4.200% Notes due 2050 issued by the Issuers (the “New Newmont 2050 Notes” and, collectively with the New Newmont 2030 Notes and the New Newmont 2041 Notes, the “New Newmont Notes”) and cash, and the related solicitation of consents (the “Consent Solicitations”) to adopt certain proposed amendments to each of the indentures governing the Existing Newcrest Notes. The Exchange Offers and the Consent Solicitations expired at 5:00 p.m., Eastern Standard Time, on December 26, 2023.


The Exchange Offers and Consent Solicitations were made in connection with Newmont’s business combination transaction with Newcrest Mining Limited (“Newcrest”), pursuant to which Newmont acquired all of the issued and outstanding ordinary shares of Newcrest. Newmont’s acquisition of Newcrest closed on November 6, 2023.


Pursuant to the Exchange Offers, the Issuers issued (i) $624,639,000 in aggregate principal amount of the New Newmont 2030 Notes, (ii) $459,939,000 in aggregate principal amount of the New Newmont 2041 Notes and (iii) $486,128,000 in aggregate principal amount of the New Newmont 2050 Notes.


The New Newmont Notes have not been registered under the Securities Act or any state or foreign securities laws. Therefore, the New Newmont Notes may not be offered or sold absent registration or an applicable exemption from the registration requirements of the Securities Act and any applicable state securities laws or applicable foreign securities laws.


In connection with the issuance of the New Newmont Notes, Newmont entered into the registration rights agreement, dated as of December 28, 2023, by and among Newmont and each of BMO Capital Markets Corp. and Goldman Sachs & Co. LLC, as dealer managers, pursuant to which Newmont agreed to use its commercially reasonable efforts (i) to file a registration statement with the Securities and Exchange Commission with respect to a registered offer to exchange the New Newmont Notes of each series for exchange notes of the same series, which will have terms identical in all material respects to such New Newmont Notes, except that the exchange notes will not contain transfer restrictions, (ii) to keep such exchange offer registration statement effective until the closing of the Exchange Offers and (iii) subject to certain limitations, to cause the Exchange Offers to be consummated not later than December 28, 2024.


BMO Capital Markets and Goldman Sachs & Co. LLC served as dealer managers on this transaction. BMO Capital Markets can be contacted at 151 West 42nd Street, 32nd Floor, New York, New York 10036, attention: Liability Management, email: LiabilityManagement@bmo.com and Goldman Sachs & Co. LLC can be contacted at 200 West Street, New York, New York 10282-2198, attention: Liability Management Group, facsimile: (646) 769-7607. D.F. King & Co., Inc. served as the exchange agent and information agent on this transaction and can be contacted at 48 Wall Street, 22nd Floor, New York, NY 10005, email: newmont@dfking.com, banks and brokers call collect: (212) 269-5550, all others, call toll free: (800) 713-9960.


This press release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, or the solicitation of tenders or consents with respect to, any security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation, purchase or sale would be unlawful. The Exchange Offers and the Consent Solicitations were made solely pursuant to the Offering Memorandum and Consent Solicitation Statement, dated November 27, 2023, and only to such persons and in such jurisdictions as is permitted under applicable law.


About Newmont


Newmont is the world’s leading gold company and a producer of copper, zinc, lead, and silver. The Company’s world-class portfolio of assets, prospects and talent is anchored in favorable mining jurisdictions in Africa, Australia, Latin America & Caribbean, North America, and Papua New Guinea. Newmont is the only gold producer listed in the S&P 500 Index and is widely recognized for its principled environmental, social, and governance practices. The Company is an industry leader in value creation, supported by robust safety standards, superior execution, and technical expertise. Newmont was founded in 1921 and has been publicly traded since 1925.


Cautionary Statement Regarding Forward-Looking Statements


This news release contains “forward-looking statements,” which are intended to be covered by the safe harbor created by such sections and other applicable laws and “forward-looking information” within the meaning of applicable Australian securities laws. Where a forward-looking statement expresses or implies an expectation or belief as to future events or results, such expectation or belief is expressed in good faith and believed to have a reasonable basis. However, such statements are subject to risks, uncertainties and other factors, which could cause actual results to differ materially from future results expressed, projected or implied by the forward-looking statements. Forward-looking statements often address our expected future business and financial performance and financial condition; and often contain words such as “anticipate,” “intend,” “plan,” “will,” “would,” “estimate,” “expect,” “believe,” “pending” or “potential.” Estimates or expectations of future events or results are based upon certain assumptions, which may prove to be incorrect. Such assumptions, include, but are not limited to: (i) there being no significant change to current geotechnical, metallurgical, hydrological and other physical conditions; (ii) permitting, development, operations and expansion of operations and projects being consistent with current expectations and mine plans; (iii) political developments in any jurisdiction in which Newmont operates being consistent with its current expectations; (iv) certain exchange rate assumptions; (v) certain price assumptions for gold, copper, silver, zinc, lead and oil; (vi) prices for key supplies; (vii) the accuracy of current mineral reserve and mineralized material estimates; (viii) other planning assumptions; and (ix) the timely satisfaction of customary closing conditions to the Exchange Offers and the Consent Solicitations. For a more detailed discussion of such risks, see Newmont’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 23, 2023, as updated by the current report on Form 8-K, filed with the SEC on July 20, 2023, as well as Newmont’s other SEC filings, under the heading “Risk Factors”, and other factors identified in Newmont’s reports filed with the SEC, available on the SEC website or www.newmont.com. Newmont does not undertake any obligation to release publicly revisions to any “forward-looking statement,” including, without limitation, outlook, to reflect events or circumstances after the date of this news release, or to reflect the occurrence of unanticipated events, except as may be required under applicable securities laws. Investors should not assume that any lack of update to a previously issued “forward-looking statement” constitutes a reaffirmation of that statement. Continued reliance on “forward-looking statements” is at investors’ own risk.


 


View source version on businesswire.com: https://www.businesswire.com/news/home/20231228263822/en/



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Contacts

Media Contact

Jennifer Pakradooni

+1.720.236.8170

jennifer.pakradooni@newmont.com


Investor Contact

Daniel Horton

+1.303.837.5468

daniel.horton@newmont.com

Thursday, December 28, 2023

AI Redefined Gains Momentum with New Investment, Expands to Europe, and Appoints Industry Veterans to Key Leadership Roles

 


(BUSINESS WIRE)--AI Redefined, a pioneering force in human-AI collaboration technology, unveils key milestones showcasing exceptional growth and momentum. Following a successful Silicon Valley fundraising round, the Canadian company is set for success in the coming year. This is fueled by a new R&D facility in Paris, the cornerstone of its European operations, and the appointment of industry leaders Dr. Yves Lostanlen as General Manager and Bernard Slede as Senior Vice President of Business Development. The expansion aligns with the growing adoption of its award-winning Cogment™ technology.


Situated at Station F in the heart of the Paris AI technopole, the new studio serves as a strategic move to establish a presence in the European AI landscape. Beyond an office, this location aims to be an innovation and collaboration hub for developing new products and partnerships. The expansion includes a dedicated Paris-based R&D team, supporting AI Redefined's commitment to a pivotal role in the dynamic European AI ecosystem.


Leading AI Redefined in Europe is General Manager Dr. Yves Lostanlen, a seasoned industry veteran known for transformative leadership roles in major organizations such as Engie, Siemens, Element AI, government institutions, and academia. With deep and extensive knowledge in AI technologies, Dr. Lostanlen's strategic insights are evidenced through numerous keynote engagements and over 1200 citations for his articles. As a former board member of IEEE Communication Society and an Expert Advisor to prestigious entities like the European Commission and Council of Europe, his appointment reinforces AI Redefined's commitment to attracting top talent to drive further innovation and growth.


About his new role, Dr. Lostanlen states: “Joining AI Redefined and the Cogment team at this exciting time, when human interaction is recognized as essential to AI advancements, is a tremendous opportunity. With Cogment's proven human-in-the-loop AI products, we offer a unique value proposition for deep-expertise industries historically challenged by AI-Human alignment. I am confident AI Redefined has what it takes to lead in today's rapidly evolving AI landscape.”


In another strategic move, Bernard Slede joins AI Redefined as Senior Vice President of Business Development, bringing a proven track record from Intel, Dolby, and Vonage. Excited about joining AIR’s team, Slede notes, “Key markets such as aviation, defense, renewable energy, manufacturing and healthcare view AIR’s human-AI solutions as the missing piece to leverage their data. They’re eager to safely adopt and deploy AI through our trusted Cogment suite of Human-AI collaboration products.”


As AI Redefined gains momentum and prepares to announce key contracts, 2024 is anticipated as a year of exponential growth. The European expansion, coupled with the appointments of industry leaders and ongoing advancements by Cogment, reaffirms AI Redefined's commitment to shaping the future of human-AI collaboration.


For more information about AI Redefined, visit www.ai-r.com.


About AI Redefined: AI Redefined is a multinational, award-winning, applied artificial intelligence research firm dedicated to better human-AI alignment. Founded in Montreal in 2018, the company focuses on developing Human-AI (RLHF) solutions that push the boundaries of what humans and AI can achieve in various industries, including aeronautics, renewable energy, manufacturing, and autonomous (e.g. human-machine teaming) systems.


 


View source version on businesswire.com: https://www.businesswire.com/news/home/20231227136388/en/



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https://aetoswire.com/en/news/2812202336731

Contacts

For media inquiries:

Craig Vachon, AI Redefined (AIR), craig@ai-r.com

‘Nature Research Journal’ Showcases UAEREP’s Cloud-Seeding Achievements

Abu Dhabi, United Arab Emirates - Wednesday, 27. December 2023

The pioneering research and technology achievements of the UAE Research Program for Rain Enhancement Science (UAEREP) are featured in a peer-reviewed article published by the Nature Research journal npj Climate and Atmospheric Science.

 

Titled “Rethinking water security in a warming climate: rainfall enhancement as an innovative augmentation technique”, the article showcases current progress and future directions for rainfall enhancement applications based on the UAE National Center of Meteorology’s (NCM) operational cloud seeding program and its grant-based international research and development ecosystem under UAEREP.

 

The article draws on input from distinguished contributors including HE Dr. Abdulla Al Mandous, Director General of NCM and President of WMO, Omar Al Yazeedi, Deputy Director General of NCM, and Alya Al Mazrouei, UAEREP Director, Dr. Steve Griffiths, SVP of R&D at Khalifa University, is the paper’s corresponding author and Dr. Youssef Wehbe, UAEREP team member, the paper’s lead author.

 

Al Mandous said: "This article underscores the significance of the research work carried by NCM to support the UAE's efforts to achieve water security and contribute to mitigating the consequences of climate change on arid and semi-arid regions. Through such efforts, we aim to promote innovative solutions and foster international collaboration to address global water scarcity challenges."

 

The article references average seasonal precipitation increases of 5-25% from different international cloud seeding efforts based on the WMO Peer Review Report on Global Precipitation Enhancement Activities. Using this benchmark range, corroborated by local radar-based studies over the UAE, the UAE's cloud-seeding efforts are estimated to yield an additional 168-838 million cubic meters of rainfall annually. Adjusted for evaporation and soil retention, the harvestable volume of water from seeded rainfall ranges from 84-419 million cubic meters. This represents a fraction of the approximately 6.7 billion cubic meters of rainfall that the UAE receives annually.

 

The article also revealed that cloud-seeding missions managed by NCM can cost up to US$8,000 per flight hour. In 2020, a total of 390 flights were conducted, each averaging an hour in duration. Considering the range of harvestable rainfall volumes achievable through seeding, the unit cost of harvestable seeded rainfall can be estimated to be between US$0.01 and US$0.04 per cubic meter, compared to the reported estimated desalinated water production cost of US$0.31 per cubic meter in the UAE, presenting a compelling cost advantage over desalination.

Permalink
https://www.aetoswire.com/en/news/2712202336722

Contacts

Osama Dagamseh

oaldagamseh@apcoworldwide.com

CCM Biosciences Announces Launch of 5Prime Sciences Business Unit

  New business unit is focused on DNA Biotechnology and Molecular Diagnostics, leveraging state-of-the-art platforms for enzyme engineering

Global annual revenue from company’s intellectual property portfolio is $30-50M

(BUSINESS WIRE)--Diversified biotechnology company CCM Biosciences (CCM Bio) announced the launch of its business unit CCM 5Prime Sciences (5Prime) focused on the development and application of proprietary technology in the domain of DNA biotechnology. 5Prime’s technology platform includes multiple patent-protected, globally commercialized compositions and methods for molecular cloning, next-generation DNA sequencing and molecular diagnostics.

5Prime has two focus areas: 1) in vitro diagnostic (IVD) tests: a wide array of companion diagnostics (CDx) tests for targeted cancer, rare disease, and prenatal/preimplantation diagnostics, developed using the droplet digital Polymerase Chain Reaction (ddPCR) and Next-Generation Sequencing (NGS) methodologies, which accompany the personalized medicine therapeutic (Rx) pipeline of CCM Bio; 2) synthetic biologyengineered DNA- and RNA-manipulating enzymes that improve upon the enzymes used in IVD tests, in PCR reagents, and also in enzymatic DNA/RNA synthesis.

Proven technology behind market-leading DNA sequencing products and diagnostic tests; including one of the 5 highest revenue-generating technologies invented in the history of Princeton University

Focus areas 1 and 2 are based on the company’s patented technology originating in the PhD thesis work of Co-Founder and CEO Dr. Raj Chakrabarti at Princeton University. According to the Princeton University Office of Technology Licensing, patents in this portfolio, which are now controlled by 5Prime, are among the top 5 revenue-generating patents in the history of the university, having been commercialized in collaboration with companies such as Celera Diagnostics, Quest Diagnostics, Abbott, New England Biolabs, and Toyobo Life Sciences. Diagnostic tests and products based on the company’s intellectual property include the XSense test from Quest Diagnostics, which is the leading DNA-based carrier screening test for autism (Fragile X syndrome); and the Q5 polymerase kit marketed by New England Biolabs, which is the leading high-fidelity polymerase kit for DNA sequencing.

In the context of molecular diagnostics, NGS is typically applied to diagnose in high-throughput the patterns of DNA mutations in genes. A related method called RNA-Seq, which applies NGS to RNA rather than DNA to measure real-time gene expression levels, has emerged as a foundation for modern personalized medicine. However, a notorious difficulty in both traditional NGS and RNA-Seq is sequence bias, which results in inaccurate estimates of the relative copy numbers of different genes and associated disease-causing mutations, and which has limited the transformative potential of these methods. ddPCR is a sensitive method for diagnosing mutations in specific disease-associated genes that is also limited by problems of sequence bias.

5Prime’s technology enables the efficient polymerization and amplification of nearly any DNA or RNA sequence to overcome sequence bias in nucleic acid amplification and associated diagnostic methods like NGS and ddPCR, the global markets for which were valued at $10B and $6B, respectively, in 2022 and expected to surpass $44B and $14B, respectively, by 2032. Its state-of-the-art synthetic biology platform for polymerase enzyme engineering generates proprietary polymerases with optimal properties for NGS or PCR-based diagnostic tests, by applying machine learning algorithms to the big data generated from ultrahigh-throughput, microfluidic experimental screening of enzyme activity. In addition, the company’s technology platform applies proprietary nonaqueous media and computational systems biology methods in conjunction with such enzymes to dramatically improve nucleic acid polymerization and amplification efficiency.

About CCM Biosciences

CCM Biosciences, Inc. is a biotechnology company dedicated to discovering and developing novel drugs - including small molecules, gene therapies, biologics, and nanomedicines - as well as associated companion diagnostics. CCM Bio’s patented molecular discovery platforms were developed at Chakrabarti Advanced Technology, a privately funded R&D institute founded in 2010 with scientists in the US, France and India and with publications in leading scientific journals including PNASNucleic Acids Research, American Chemical Society journals and Nature Publishing Group journals. CCM Bio is partnered with the global chemical and pharmaceutical services company PMC Group, Inc. for fully integrated discovery, development and manufacturing of drugs and diagnostics.

 



Contacts

Dr. Anisha Ghosh
email: anisha@ccm-bio.com


Wednesday, December 27, 2023

SLB Announces Fourth-Quarter and Full-Year 2023 Results Conference Call

  (BUSINESS WIRE)--SLB (NYSE: SLB) will hold a conference call on January 19, 2024 to discuss the results for the fourth quarter and full year ending December 31, 2023.

The conference call is scheduled to begin at 9:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time.

To access the conference call, listeners should contact the Conference Call Operator at +1 (844) 721-7241 within North America or +1 (409) 207-6955 outside of North America approximately 10 minutes prior to the start of the call and the access code is 8858313.

A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until February 19, 2024, and can be accessed by dialing +1 (866) 207-1041 within North America or +1 (402) 970-0847 outside of North America and giving the access code 8122009.

About SLB

SLB (NYSE: SLB) is a global technology company that drives energy innovation for a balanced planet. With a global footprint in more than 100 countries and employees representing almost twice as many nationalities, we work each day on innovating oil and gas, delivering digital at scale, decarbonizing industries, and developing and scaling new energy systems that accelerate the energy transition. Find out more at slb.com.

 



Contacts

Investors
James R McDonald
SVP of Investor Relations & Industry Affairs
Joy V. Domingo
Director of Investor Relations
Tel: +1 (713) 375-3535
Email: investor-relations@slb.com

Media
Moira Duff
Director of External Communications
Tel: +1 (713) 375-3407
Email: media@slb.com


Tuesday, December 26, 2023

Deepening "Belt and Road" Initiatives: Remarkable Global Expansion for DENZA in 2023

SHENZHEN, China - Tuesday, 26. December 2023


(BUSINESS WIRE)--As a luxury new energy brand co-created by BYD, a leader in new energy vehicles, and Mercedes-Benz, the inventor of the gasoline car, DENZA has globalization in its DNA. Not only are all its products designed for a global audience, but it also aspires to be a leading global new energy luxury car brand. Guided by a global strategy, DENZA actively embraces and implements the "Belt and Road" initiative, building a global brand image, honing its internal strengths, and achieving remarkable success both domestically and internationally.


2023 marks DENZA's inaugural year on the international stage, with significant appearances at top global auto shows, such as the Bangkok International Motor Show in March, visited by former Prime Minister Prayut Chan-o-cha; the Munich International Motor Show in September, where its European debut was widely acclaimed; the Japan Mobility Show in October, where it stood out as the sole Chinese luxury car brand and secured its first international order; the Thailand International Motor Expo in November, where the DENZA N7 continued its international journey following the DENZA D9; and the Hong Kong International Auto Show in December, where the DENZA D9 made its debut and opened for pre-orders. With a steady and orderly international expansion, DENZA has not only won the hearts of global media and customers but has also laid a solid foundation for becoming a leading international high-end brand, poised to be the "business card" of Chinese new energy luxury cars, redefining China's automotive industry and introducing DENZA to a global audience.


Beyond its international success, DENZA has also achieved remarkable results in the domestic market. Its first MPV, the DENZA D9, with its luxurious features in design, comfort, intelligence, control, and safety, and its suitability for both family and business use, became the fastest Chinese new energy luxury model to deliver 100,000 units in just 11 months, setting a new industry record. As of early December 2023, the DENZA D9 has been the top-selling luxury MPV over RMB 300,000 for 11 consecutive months and is expected to be the annual sales champion for MPVs in 2023.


Notably, the DENZA D9 excels in both sales volume and pricing, boasting an average selling price exceeding RMB 420,000, making it the highest-priced model among Chinese automotive brands. Additionally, it holds the top position in resale value within the new energy MPV segment after one year, setting a new standard in the luxury MPV market. Beyond its popularity among mainstream families, the DENZA D9 is the vehicle of choice for many modern elites, including national actress Hai Qing, famous TV host Yang Lan, and prominent entrepreneur Cao Hui, all embracing this new luxury.


As a pioneer combining BYD's leading new energy technology and Mercedes-Benz's luxury manufacturing heritage, each step in DENZA's global journey not only opens infinite possibilities for the brand but also showcases the charm and strength of Chinese new energy luxury car brands. In the future, DENZA will continue to accelerate its global development, enrich its luxury product lineup, and create an unparalleled luxury travel experience for global users, further supporting China's journey towards becoming an automotive powerhouse.


About DENZA


In 2010, DENZA, a luxury new energy car brand, was jointly established in Shenzhen by BYD, a leader in new energy vehicles, and Mercedes-Benz, the inventor of the gasoline car. It was the first brand dedicated to the new energy luxury car market. Over the past thirteen years, DENZA has gone through three phases: initiation, accumulation, and innovation. Meanwhile, the Chinese market has witnessed a wave of technological revolution in new energy vehicles, rapidly changing people’s understanding of cars and significantly transforming the luxury car market with the development of new energy. On May 16, 2022, DENZA underwent a brand renewal, embodying three distinct attributes and three leading advantages from the outset. We possess an independent brand, products, and team, and have three core competitive advantages in our products and services. First is the leading new energy and intelligent technology endowed by the BYD Group; second is the leading luxury product quality resulting from thirteen years of joint development with Mercedes-Benz; third is the soft power that DENZA has built to meet the current and future needs of new energy vehicle users – a leading user ecosystem service system. In the future, we aim to create a new luxury and comprehensive travel experience for our users and build a more valuable smart and safe new luxury car brand.


 


View source version on businesswire.com: https://www.businesswire.com/news/home/20231225949027/en/



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Contacts

Asia-Pacific: Liya Huang, pr@byd.com tel: +86-755-8988-8888-69666

Europe: Penny Peng, PressEU@byd.com tel: +31-102070888

North America: Frank Girardot, frank.girardot@byd.com tel: +1 213 245 6503

Latin America: José Miranda, jose.miranda@byd.com tel: +56 9 96443906

Brazil: Pablo Toledo, pablo.toledo@byd.com tel: +19 3514 2554

Middle East and Africa: Nikki Li, meapr1@byd.com tel: +86-755-8988-8888-62319

Adani Promoters to Invest USD 1,125 million equity in Adani Green

 AHMEDABAD, India - Tuesday, 26. December 2023 AETOSWire Print 


The Board of AGEL approved issuance of INR 9,350 crore of warrants on a preferential basis to the promoter group at a share price of INR 1,480.75/share, calculated basis SEBI ICDR regulations

Funds to be utilized for deleveraging and accelerated growth capex in AGEL to deliver 45 GW capacity by 2030

This transaction follows successful debt raise of ~USD 1.4 billion earlier in December 2023, and takes the total capital raised to USD 3 billion

 


(BUSINESS WIRE) -- Adani Green Energy Ltd (“AGEL”), India’s largest and the world’s leading renewable energy developer, announced that the Board of Directors of AGEL have approved a preferential issuance of warrants to the Promoters of AGEL for a quantum of INR 9,350 crore (equivalent to USD 1,125 million) at a per share price of INR 1,480.75/share calculated basis SEBI ICDR regulations. The issuance is subject to the approval of regulatory and statutory authorities as well as the shareholders of the company at the Extraordinary General Meeting (EGM) scheduled on 18 January 2024. The funds shall be utilized for deleveraging and accelerated capital expenditure.


AGEL is now fully equipped to achieve its stated target of 45 GW by 2030, with 20.6 GW locked in capacity, secured land of over 2,00,000 acres (equivalent to over 40 GW of additional capacity) in resource rich areas of India and additional equity infusion of INR 9,350 crore which fully funds this stated target.


“India is on the cusp of becoming a global leader in renewable energy and Adani Green Energy is in the vanguard of this revolution,” said Mr Gautam Adani, Chairman of the Adani Group. “This investment by the Adani family underscores our commitment not only to making our nation’s clean energy dream a reality but also to an equitable energy transition where we phase down traditional power sources while simultaneously phasing up green, affordable alternatives to fuel our accelerating growth and development plans. With the funds infusion, AGEL remains favorably positioned to achieve its accelerated growth trajectory.”


Earlier, AGEL announced USD 1.36 billion construction facility (by 8 leading international banks) for construction of 2,167 MW solar power projects in Khavda, Gujarat, the largest solar park in India. In addition, AGEL has announced USD 1.425 billion of equity capital (USD 1.125 billion from preferential issuance by promoters and USD 300 million from TotalEnergies JV), which translates to a capital raise of ~USD 3 billion.


This demonstrates the deep interest by long term investors, strategic partners, financial institutions, banks coupled with continued promoter commitment, to enable AGEL’s target of adding 45 GW of renewable capacity in India by 2030.


About Adani Green Energy Ltd (AGEL)


AGEL is India's largest renewable energy solutions partner, playing a vital role in enabling the clean energy transition. The company develops, owns, and operates utility-scale grid-connected solar, wind, and hybrid renewable power plants. With an operating renewable portfolio of 8.4 GW spread across 12 states, AGEL is currently the largest renewable energy developer in India, offsetting over 41 million tonnes of CO2 emissions cumulatively. AGEL is committed to its target of achieving 45 GW of renewable energy capacity by 2030, aligned with India's decarbonization goals. The company focuses on leveraging technology to reduce the Levelized Cost of Energy (LCOE) and facilitate the widespread adoption of affordable clean energy. AGEL's operating portfolio is certified as "water positive for plants of more than 200 MW capacity," "single-use plastic-free," and "zero waste-to-landfill," showcasing its commitment to sustainable growth.


 


View source version on businesswire.com: https://www.businesswire.com/news/home/20231226085247/en/



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Contacts

For media queries, contact Roy Paul: roy.paul@adani.com

Hotpack increases eco-friendly food packaging solutions to 96%, reveals its sustainability report

 The GRI certification positions the company as a leader in responsible corporate citizenship and provides stakeholders with reliable and comprehensive insights into ESG impacts


Hotpack, the UAE-based global leader in sustainable packaging solutions, has unveiled its inaugural Sustainability Report, proudly certified by the Global Reporting Initiative (GRI). This certification serves as a powerful testament to Hotpack's unwavering commitment to transparency, accountability, and sustainable business practices, solidifying its position as a trailblazer in responsible corporate citizenship.


The Global Reporting Initiative, an international independent standards organization, plays a pivotal role in helping businesses, governments, and organizations comprehend and articulate their impacts on critical issues such as climate change, human rights, and corruption. Hotpack's attainment of GRI certification underscores its dedication to providing stakeholders with reliable and comprehensive insights into its environmental, social, and economic impacts.


The report reveals that 96 per cent of Hotpack's product lineup is environmentally friendly, reinforcing its pivotal role in advancing a greener, more sustainable future.


Commenting on the certification, Mr. Abdul Jebbar PB, the Group Managing Director of Hotpack Global, said, "The GRI certification serves as a testament to our dedication to achieving the highest ESG (Environmental, Social and Governance) standards. It positions us as a leader in responsible corporate citizenship and provides stakeholders with reliable and comprehensive insights into our environmental, social, and economic impacts."


"I want to express my gratitude to each team member for their hard work, diligence, and commitment throughout this process. Your efforts have not only elevated our organization's standing but have also contributed to the advancement of sustainable practices within our industry. Let's take pride in this achievement and use it as motivation to continue our pursuit of excellence in all facets of our work,” he added.


Hotpack's Sustainability Report reflects a holistic approach to sustainability, showcasing the company's dedication to creating positive environmental, social, and economic impacts. The GRI certification not only substantiates Hotpack's dedication but also reinforces its pledge to stakeholders, ensuring heightened credibility and transparency in its sustainable practices.


The report highlights Hotpack’s dedication to environmental stewardship through initiatives aimed at reducing environmental impact. This encompasses tangible investments in cutting-edge technology, the establishment and adherence to a robust environmental management system, and a steadfast emphasis on resource conservation. Additionally, it involves initiatives such as the adoption of energy-efficient machinery, the integration of sustainable materials into production processes, and continuous efforts to minimize waste generation across operations.


The company is a pioneer in producing eco-friendly materials and packaging solutions, incorporating biodegradable plastics, recycled content, and plant-based packaging. With a robust HACCP food safety management system in place and recognition with nine awards in Sustainable Manufacturing, Excellence, and Leadership, Hotpack continues to set industry benchmarks in sustainable practices.


Hotpack also introduced the eco store, a dedicated platform for eco-conscious food packaging solutions, which exemplifies Hotpack's commitment to providing customers with responsible choices.


Hotpack's social initiatives include an AED 1.2 million investment in the Takkah project, promoting women in business, and the distribution of 2 million meal packs during Ramadan for community welfare. The Hotpack Happiness project, featuring 20 initiatives engaging 1,500 members, highlights the company's dedication to employee and community well-being.


Hotpack has formed strategic collaborations with organisations like RECAPP Veolia and Spinneys Dubai. These partnerships aim to implement recycling initiatives and introduce innovative and sustainable retail packaging solutions, such as 100 per cent post-consumer recycled shopping bags.


Hotpack has also placed significant focus on efforts to reduce carbon emissions. The company actively monitors and reduces its carbon footprint, aligning with global sustainability initiatives. This includes addressing emissions across scopes, focusing on direct emissions, indirect emissions from purchased utilities, and other indirect emissions throughout its value chain.


Hotpack's Sustainability Report reflects a comprehensive and commendable approach to sustainable business practices. The GRI certification enhances the report's credibility, providing stakeholders with confidence in the company's commitment to responsible and transparent reporting, and inviting them to join the journey towards a more environmentally conscious future.


About Hotpack Global


 


Founded in 1995, Hotpack Global is a recognized leader in both the manufacture and supply of food packaging products. Today, the company has operations in 16 countries which include GCC countries, India, the UK, the USA, Morocco, Ivory Coast, Nigeria, Spain, and Australia. Within a limited span of time, the company has grown to become one of the leading players in the packaging sector because of its reputation for supplying quality products, its reasonable price structure and outstanding service. Hotpack is seen as a one-stop shop that offers a complete range of packaging products for HORECA, Retail and Industrial Packaging sectors. It represents other major manufacturing companies worldwide and products are packed hygienically in modern and attractive designs and marketed under “Hotpack” (Disposable Range) and “Soft n Cool” (Tissue Range) brands.


 


As a food packaging company, Hotpack has been certified with BRCGS, FDA, SEDEX, ESMA, PEFC, FSC, ISO 9001: 2015, ISO 22000: 2018, ISO 14001: 2015, ISO 45001: 2018 which ensures the top quality of its products. Hotpack was adjudged winner of the coveted Dubai Quality Award under the category of Dubai Smart Industry Award 2020 for the manufacturing sector. Hotpack today has 47 standalone Retail centres across the MENA offering 600 plus Specialty range products which are not available in Supermarkets. Also, http://www.hotpackwebstore.com is the region’s largest online store for food packaging products. Over the years, Hotpack has become a trusted brand with its excellent products, services, and continuous brand communication.



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Contacts

For media queries, please contact


Mayukh Sikdar


Watermelon Communications


Dubai, U.A.E.


+971 4 283 3655


Email: mayukh@watermelonme.com

Monday, December 25, 2023

EU Organic Journey Hosts Exclusive B2B Dinner in Dubai, Unveiling European Organic Excellence

 


 The European program "EU Organic Journey" hosted a distinguished B2B dinner on the evening of the 14th of December 2023 at 19:00, set against the elegant backdrop of MYOCUM Dubai Restaurant (2D St, Al Wasl, Dubai, United Arab Emirates).

Bringing together key players from the Horeca sector, importers, distributors, wholesalers, grocery chains, organic shops, and esteemed food bloggers, the event showcased an array of delectable European organic products, including virgin olive oil, olives, and organic dairy products.

Attendees were treated to a unique opportunity to engage with representatives from the contributing organizations, fostering connections while savoring the exquisite European offerings. The ambiance of MYOCUM Dubai Restaurant provided the perfect setting for meaningful discussions on potential business opportunities.

Throughout the evening, participants delved into the heart of the European program "EU Organic Journey," gaining valuable insights into its initiatives, organic production methods, and the superior quality of the promoted products. Representatives from the participating organizations were on hand to provide in-depth information, facilitating discussions on potential collaborations and partnerships within the organic industry.

The B2B dinner not only celebrated the richness of European organic products but also served as a platform for networking and knowledge-sharing. Attendees left the event with a deeper understanding of the "EU Organic Journey," equipped with the information needed to explore new business avenues and enhance their involvement in the organic sector.

The EU Financed campaign EU Organic Journey aims to promote and increase the awareness regarding the European organic products from Greece, Romania, and Bulgaria to consumers in UAE, Saudi Arabia and USA with the participation of the organizations Agrodiatrofiki Sympraxi Perifereias Stereas Elladas (ASPSE) from Greece, Bio Carpathia Cooperative from Romania and National Organic Association (NAO)from Bulgaria.

You are also invited to join our social media pages: Follow us on Facebook https://www.facebook.com/euorganicjourney , Instagram https://www.instagram.com/euorganicjourney , website: https://euorganicjourney.eu/  YouTube channel https://www.youtube.com/@EUORGANICJOURNEY  to experience our event through a new perspective.



Contacts

Fujirebio Expands Its Alzheimer’s Disease Test Menu With the Much Awaited and Fully Automated Lumipulse® G pTau 217 Plasma Assay for Research Use Only (RUO)

  (BUSINESS WIRE) -- H.U. Group Holdings Inc. and its wholly-owned subsidiary Fujirebio today announced the availability of the Lumipulse G pTau 217 Plasma assay for the fully automated LUMIPULSE G immunoassay systems. This CLEIA (chemiluminescent enzyme immunoassay) assay allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human K2EDTA plasma within just 35 minutes.

“The launch of the pTau 217 Plasma assay on our fully automated LUMIPULSE platform is an essential step in the efforts of Fujirebio to bring novel, innovative neurodegenerative biomarkers to laboratories and clinicians around the world,” said Goki Ishikawa, President and CEO of Fujirebio Holdings, Inc. “Expectations are high for this new biomarker, and researchers and clinical research professionals can now study its clinical utility on a platform that has the required throughput and meets the regulatory requirements to support possible future routine use.”

About pTau 217
Current research indicates that plasma pTau, including pTau 217, is a predictor of amyloid status determined either by CSF1 or PET2, and therefore able to differentiate between Alzheimer’s disease (AD) and non-AD neurodegenerative diseases3,4 and to predict progression to AD.5,6 Blood-based biomarkers, such as plasma pTau, could potentially be used as inclusion criteria or to evaluate target engagement and treatment efficacy in clinical trials, and could further advance the development and implementation of disease-modifying treatments in the field of AD and related disorders.7 This assay is designed to measure specifically the phosphorylation on position threonine 217 in human plasma.

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

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

References:

  1. Ashton N, et al. Plasma and CSF biomarkers in a memory clinic: head-to-head comparison of phosphorylated tau immunoassays. Alzheimers Dement, 19(5): 1913-1924, 2023.

  2. Mielke M, et al. Performance of plasma phosphorylated tau 181 and 217 in the community. Nat Med, 28(7): 1398-1405, 2022.

  3. Palmqvist S, et al. Discriminative accuracy of plasma phospho-tau 217 for Alzheimer’s disease vs other neurodegenerative disorders. JAMA, 324(8): 772-781, 2020.

  4. Thijssen E, et al. Plasma phosphorylated tau 217 and phosphorylated tau 181 as biomarkers in Alzheimer’s disease and frontotemporal lobar degeneration: a retrospective diagnostic performance study. Lancet Neurol, 20(9): 739-752, 2021.

  5. Jonaitis EM, et al. Plasma phosphorylated tau 217 in preclinical Alzheimer’s disease. Brain Commun, 5(2): fcad057, 2023.

  6. Mattsson-Carlgren N, et al. Prediction of longitudinal cognitive decline in preclinical Alzheimer disease using plasma biomarkers. JAMA Neurol, 80(4): 360-369, 2023.

  7. Gonzalez-Ortiz F, et al. Plasma phospho-tau in Alzheimer’s disease: towards diagnostic and therapeutic trial applications. Mol Neurodegener, 18(1): 18, 2023.

 



Contacts

For media:
Public Relations Section, Public Relations/Sustainability Department,
H.U. Group Holdings, Inc.
Phone: +81-3-6279-0884
E-mail: pr@hugp.com

For investors and analysts:
IR/SR Dept.
Phone: +81-3-5909-3337
E-mail: ir@hugp.com


dSPACE at CES 2024: New Solutions for Data-Driven Development, Simulation, and Validation of Electric and Self-Driving Cars

 PADERBORN, Germany & WIXOM, Mich. - Tuesday, 19. December 2023



(BUSINESS WIRE) -- At CES 2024, dSPACE will show how electric and self-driving cars can get on the road faster with innovative development, simulation, and validation solutions. As the exclusive on-vehicle computer technology sponsor of the Indy Autonomous Challenge (IAC), dSPACE will demonstrate how dSPACE solutions work in demanding racing environments at the Autonomous Challenge @ CES 2024 night race at the Las Vegas Motor Speedway. Eight solutions will be presented at the dSPACE booth no. 4300 in the LVCC, West Hall. Here are some highlights:

E-mobility: Testing of battery management systems, power electronics, and technologies for intelligent charging

Battery management systems (BMS) are crucial for the smooth operation of lithium-ion batteries, and ensure the efficient use of available capacity, optimum temperatures, avoid overcharging as well as deep discharges, and thereby ensure safe operation and long life of the energy storage systems. dSPACE demonstrates a modular system design for the testing of battery management systems (BMS) that enables the testing of modern BMS. The system's field of application in the areas of development and validation range from battery systems for electric cars and planes to energy storage systems for modern power grids.

Power HIL systems from dSPACE are the first choice where inverters, including control and power electronics, have to be tested at full power. Designed specifically for hardware-in-the-loop (HIL) simulation at power level, they combine the flexibility of established HIL systems with full performance, enabling exceptionally precise testing of power electronics. The tests go well beyond endurance and also include testing the control behavior with different dynamic operating points of e-motors.

The Smart Charging Solution is a complete solution for the development and testing of intelligent charging technologies. The solution takes international standards into account, ensures interoperability analyses and tests, and supports developers of onboard chargers, charging stations, and, in future, inductive charging systems, robot charging, and megawatt charging for the truck and aviation sector with a comprehensive range of test options and dynamic models.

Autonomous driving: High-precision tests in the virtual world

The development of functions for highly automated and autonomous driving places increasingly strict requirements on the quality and safety of functions. Virtual tests are frontloaded to earlier development phases and executed by internationally distributed development teams. To meet these requirements, dSPACE has developed solutions such as SIMPHERA, the web-based, highly scalable cloud solution for simulation and virtual validation, and the AURELION sensor simulation. At CES, dSPACE will demonstrate how logical scenarios generated from measurement data can then be used for scenario-based testing in SIMPHERA. In this way, real recorded scenarios can later be used for virtual validation. In addition, it is shown how AURELION achieves a very high degree of realism in the simulation – by comparing the synthetic sensor simulation with the real recorded measurement data of the same scenario.

In a joint demonstration with AWS, dSPACE presents an intelligent fleet and data management environment that enables targeted data collection campaigns for the development and validation of ADAS/AD algorithms. The solution aims to drastically shorten the lead time for data acquisition from the definition of requirements to the availability of the recorded vehicle and sensor data in the data center, thereby increasing the efficiency of the data-driven development process.

The simulation of software stacks on high-performance computers (HPCs) in the newest E/E architectures for software-defined vehicles (SDVs) presents a particular challenge in software integration testing. In order to efficiently validate such systems, cloud-based software-in-the-loop environments are required that enable the simulation of the software components on HPCs based on real ARM processors together with those of the rest of the E/E architecture. To this end, dSPACE is working with AWS to offer an end-to-end solution based on dSPACE VEOS and AWS Graviton.

IAC: dSPACE technology during night racing and at the exhibition stand

At the Autonomous Challenge @ CES 2024, which will be held on January 11 at the Las Vegas Motor Speedway, nine teams comprised of 17 universities will compete against each other with fully autonomous racecars. CES visitors are invited to experience the action on the Las Vegas Motor Speedway. In addition, dSPACE is presenting its technologies for the IAC at booth 5901 in the exhibition area of the Las Vegas Convention Center (LVCC) West. A proven dSPACE component in the vehicles is the AUTERA AutoBox, the central onboard computer that manages all sensor data and performs the complex trajectory calculations. The IAC schedule for 2024 and other innovations will be presented on Monday, January 8, as part of the IAC press conference.

About dSPACE

dSPACE is a leading provider of simulation and validation solutions worldwide for developing networked, autonomous, and electrically powered vehicles. The company's range of end-to-end solutions are used particularly by automotive manufacturers and their suppliers to test the software and hardware components in their new vehicles long before a new model is allowed on the road. Not only is dSPACE a sought-after partner in vehicle development, engineers also rely on our know-how at dSPACE when it comes to aerospace and industrial automation. Our portfolio ranges from end-to-end solutions for simulation and validation to engineering and consulting services as well as training and support. With more than 2,500 employees worldwide, dSPACE is headquartered in Paderborn, Germany; has three project centers in Germany; and serves customers through its regional companies in the USA, the UK, France, Japan, China, Croatia, Korea, and India.

About the IAC

The Indy Autonomous Challenge (IAC) organizes racing competitions among university affiliated teams representing 17 universities from around the world to program fully autonomous racecars and compete in a series of history-making events at iconic tracks. Based in Indiana, the IAC is working to establish a hub for performance automation in the state and is harnessing the power of innovative competitions to attract the best and the brightest minds from around the globe to further state-of-the-art technology in safety and performance of automated vehicles. The IAC started as a $1 million prize competition with 31 university teams signing up to compete more than three years ago, representing top engineering and technology programs from 15 U.S. states and 11 countries. Follow the IAC @IndyAChallenge on LinkedIn, Twitter, Instagram, Facebook, & YouTube.

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20231219166904/en/

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Contacts

dSPACE GmbH
Bernd Schäfers-Maiwald
Vice President Corporate Communications
Tel: +49 5251 1638-714
E-Mail: bschaefers-maiwald@dspace.de

dSPACE GmbH
Ulrich Nolte
Tel.: +49 5251 1638--1448
E-Mail: unolte@dspace.de
press@dspace.de

Allison Fried
Director of Communications
Tel: +1 702.526.4413
Email: afried@onemorevolley.com

Marc Ferlet
Director of Marketing
Tel: +33 6 79 16 96 26
Email: marc.ferlet@indyautonomouschallenge.com

 

Friday, December 22, 2023

Takeda Announces China NMPA Approval of LIVTENCITY® (maribavir) for the Treatment of Adults With Post-transplant Cytomegalovirus (CMV) Refractory to Prior Therapies

 OSAKA, Japan & CAMBRIDGE, Massachusetts - Friday, 22. December 2023


- LIVTENCITY Is the First and Only Inhibitor of CMV-specific UL97 Protein Kinase Approved in China for the Treatment of Adults With Post-transplant CMV Infection/Disease Refractory* to Conventional Anti-CMV Treatment

- Approval Based on Phase 3 TAK-620-303 SOLSTICE Study Demonstrating Maribavir Was Superior to Conventional Therapies at Week 8, for Primary Endpoint1

- CMV Is One of the Most Common and Serious Post-transplant Infections and Can Lead to Other Serious Infections, Loss of Transplanted Organ and Failure of Graft2,3


(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) today announced that LIVTENCITY® (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. LIVTENCITY is the first and only inhibitor of CMV-specific UL97 protein kinase in China for this indication. LIVTENCITY was granted Breakthrough Therapy Designation by China Center for Drug Evaluation (CDE) in 2021.


“The approval of LIVTENCITY by the NMPA of China recognizes the critical need for post-transplant care and that CMV infection, when not successfully treated, can pose serious challenges to transplant recipients that can lead to complications such as increased organ rejection and hospitalization rates,” said Ramona Sequeira, president, Global Portfolio Division, Takeda. “This approval will help redefine the CMV treatment landscape for transplant patients in China and is a positive step forward toward addressing an unmet need for this community.”


The NMPA approval is based on the results of the Phase 3 SOLSTICE trial, which evaluated the safety and efficacy of maribavir versus conventional antiviral therapies – ganciclovir, valganciclovir, cidofovir or foscarnet – for the treatment of patients with CMV infection/disease refractory* to prior therapies. In the SOLSTICE trial, LIVTENCITY was superior to conventional therapies at Week 8 for the primary endpoint of confirmed CMV viremia clearancea in post-transplant adults with refractory* CMV infection.1


The NMPA approval marks the 12th approval of LIVTENCITY around the world for post-transplant CMV refractory* to prior therapies, including four other major markets beyond China: the United States, Canada, Australia and the European Union.4-7


Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common infections experienced by transplant patients with an estimated incidence rate of 16%-56% in SOT and 30%-80% in HSCT recipients.8,9


About LIVTENCITY


LIVTENCITY (maribavir), an orally bioavailable anti-CMV compound, is the first and only antiviral agent that targets and inhibits the UL97 protein kinase and thus its natural substrates.1 It is approved by the National Medical Products Administration (NMPA) of China for the treatment of adults with post-HSCT or SOT cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.


Product Name


LIVTENCITY 200 mg film coated tablets.


Generic Name


Maribavir


Posology and Administration


LIVTENCITY should be initiated by a physician experienced in the management of patients who have undergone solid organ transplant or hematopoietic stem cell transplant. Posology: The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets) twice daily resulting in a daily dose of 800 mg for 8 weeks. Treatment duration may need to be individualized based on the clinical characteristics of each patient. Pediatric population: The safety and efficacy of LIVTENCITY in patients below 18 years of age have not been established. No data are available. Method of administration: Oral use. LIVTENCITY is intended for oral use only and can be taken with or without food. The film coated tablet can be taken as a whole tablet, a crushed tablet, or a crushed tablet through a nasogastric or orogastric tube.


 


About Takeda’s SOLSTICE Trial


The TAK-620-303 (SOLSTICE) trial (NCT02931539, EudraCT 2015-004725-13) was a global, multicenter, randomized, open-label, active-controlled superiority trial to assess the efficacy and safety of treatment with either maribavir or conventional antiviral therapy in 352 hematopoietic stem cell transplant and solid organ transplant recipients with CMV infection refractory* to one or a combination of the conventional antiviral therapies: ganciclovir, valganciclovir, foscarnet, or cidofovir. Adult patients underwent a 2-week screening period, followed by randomization 2:1 to maribavir (n=235) (400 mg, twice daily) or conventional antiviral therapies (n=117) (as dosed by the investigator) for up to 8 weeks. After completion of the treatment period, subjects entered a 12-week follow-up phase.1


The trial’s primary efficacy endpoint was confirmed CMV viremia clearance a at the end of Week 8. The key secondary endpoint was confirmed CMV viremia clearance and CMV infection symptom control† at the end of Study Week 8 with maintenance of this treatment effect through Study Week 16.1


About CMV


CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40-100% of various adult populations.10 CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including HSCT or SOT.8 Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16-56% in SOT recipients and 30-80% in HSCT recipients.8,9


In transplant recipients, reactivation of CMV can lead to serious consequences including graft loss and, in extreme cases, can be fatal.1,2 Existing therapies to treat post-transplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication.11 Additionally, existing therapies may require or prolong hospitalization due to administration.11,12


About Takeda


Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.


LIVTENCITY Safety Information


Contraindications


Hypersensitivity to the active substance or to any of the excipients and co-administration with ganciclovir or valganciclovir.


Special warnings and precautions for use


Virologic failure can occur during and after treatment with LIVTENCITY. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. CMV DNA levels should be monitored, and resistance mutations should be investigated in patients who do not respond to treatment. Treatment should be discontinued if maribavir resistance mutations are detected.


LIVTENCITY is not expected to be effective in treating CMV CNS infections (e.g. meningo encephalitis).


LIVTENCITY has the potential to increase the concentrations of immunosuppressants that are cytochrome P450 (CYP)3A/P-gp substrates with narrow therapeutic margins (including tacrolimus, cyclosporine, sirolimus and everolimus). The plasma levels of these immunosuppressants must be frequently monitored throughout treatment with LIVTENCITY, especially following initiation and after discontinuation of LIVTENCITY, and doses should be adjusted, as needed.


The concomitant use of LIVTENCITY and certain medicinal products may result in known or potentially significant medicinal product interactions, some of which may lead to:


possible clinically significant adverse reactions from greater exposure of concomitant medicinal products.


reduced therapeutic effect of LIVTENCITY.


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


Pregnancy & Breast-feeding: LIVTENCITY is not recommended during pregnancy and in women of childbearing potential not using contraception. Breast feeding should be discontinued during treatment with LIVTENCITY.


Interactions


If dose adjustments of concomitant medicinal products are made due to treatment with maribavir, doses should be readjusted after treatment with maribavir is completed.


Effect of other medicinal products on maribavir: Co-administration of maribavir with strong cytochrome P450 3A (CYP3A) inducers rifampicin, rifabutin or St. John’s wort is not recommended. If co-administration of maribavir with other strong or moderate CYP3A inducers (e.g., carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be avoided, the maribavir dose should be increased to 1 200 mg twice daily. No dose adjustment is needed when maribavir is co-administrated with CYP3A inhibitors.


Effect of maribavir on other medicinal products: Co-administration of maribavir with valganciclovir and ganciclovir is contraindicated. Concomitant administration of maribavir and medicinal products that are sensitive substrates of CYP1A2 with a narrow therapeutic window (e.g., tizanidine and theophylline) should be avoided due to the risk for lack of efficacy of CYP1A2 substrates.


When the immunosuppressants tacrolimus, cyclosporine, everolimus or sirolimus are co-administered with maribavir, immunosuppressant levels should be frequently monitored throughout treatment with maribavir, especially following initiation and after discontinuation of maribavir and dose adjusted, when needed.


Caution should be exercised when maribavir and sensitive P-gp substrates (e.g., digoxin, dabigatran) are co administered. Serum digoxin concentrations should be monitored, and dose of digoxin may need to be reduced, as needed.


Co-administration of maribavir with sensitive BCRP substrates such as rosuvastatin, is expected to increase their exposure and lead to undesirable effects.


Adverse Reactions


Very common


(≥1/10)


Taste disturbance, Diarrhea, Nausea, Vomiting, Fatigue


Common


(≥1/100 to <1/10)


Headache, Abdominal pain upper, Decreased appetite, Immunosuppressant drug level increased, Weight decreased


The most commonly reported serious adverse reactions were diarrhea (2%) and nausea, weight decreased, fatigue, immunosuppressant drug concentration level increased, and vomiting (all occurring at >1%).


Please consult the LIVTENCITY (maribavir) approved label before prescribing, particularly in relation to dosing and treatment monitoring.


For the European Union, please consult the Summary of Products Characteristics (SmPC).


For China, please consult the LIVTENCITY China Package Leaflet.


For full U.S. Prescribing Information, including the approved indication and important safety information, please visit: https://content.takeda.com/?contenttype=pi&product=liv&language=eng&country=usa&documentnumber=1


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, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; 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/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.


Medical information


This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.


* Including a subgroup with genotypic resistance to conventional therapies.

a Defined as confirmed CMV DNA concentration below the lower limit of quantification († CMV infection symptom control was defined as resolution or improvement of tissue-invasive disease or CMV syndrome for symptomatic patients at baseline, or no new symptoms for patients who were asymptomatic at baseline.


References


Avery R, Alain S, Alexander BD, et al. SOLSTICE Trial Investigators. Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: results from a phase 3 randomized clinical trial. Clin Infect Dis. 2022;75(4):690–701. doi:10.1093/cid/ciab988


Ramanan P, Razonable RR. Cytomegalovirus infections in solid organ transplantation: a review. Infection & Chemotherapy. 2013;45(3):260


Camargo JF, Komanduri KV. Emerging concepts in cytomegalovirus infection following hematopoietic stem cell transplantation. Hematol Oncol Stem Cell Ther. 2017;10(4):233-238. doi:10.1016/j.hemonc.2017.05.001


Takeda. Health Canada approves Takeda’s LIVTENCITYTM (maribavir) the first and only treatment for adults with post-transplant cytomegalovirus (CMV) infection. Published September 20, 2022. Accessed December 12, 2023. https://www.takeda.com/en-ca/newsroom/news-releases/2022/health-canada-approves-takedas-livtencity-maribavir-the-first-and-only-treatment-for-adults-with-post-transplant-cytomegalovirus-cmv-infection/


Takeda. Takeda’s LIVTENCITY (maribavir) approved by U.S. FDA as the first and only treatment for people ages 12 and older with post-transplant cytomegalovirus (CMV), refractory (with or without genotypic resistance) to conventional antiviral therapies. Published November 23, 2021. Accessed December 12, 2023. https://www.businesswire.com/news/home/20211123006185/en/Takeda%E2%80%99s-LIVTENCITYTM-maribavir-Approved-by-U.S.-FDA-as-the-First-and-Only-Treatment-for-People-Ages-12-and-Older-with-Post-Transplant-Cytomegalovirus-CMV-Refractory-With-or-Without-Genotypic-Resistance-to-Conventional-Antiviral-Therapies


Therapeutic Goods Administration (TGA). LIVTENCITY maribavir 200 mg film coated tablet bottle (380132) [Australian product information]. Therapeutic Goods Administration (TGA). Published October 8, 2022. https://www.tga.gov.au/resources/artg/380132


Takeda. European Commission (EC) approves LIVTENCITY (maribavir) for the treatment of adults with post-transplant cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies. Published November 11, 2022. Accessed December 12, 2023. https://www.takeda.com/newsroom/newsreleases/2022/european-commission-ec-approves-livtencitytm-maribavir/


Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics (Sao Paolo). 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09


Styczynski J. Who is the patient at risk of CMV recurrence: a review of the current scientific evidence with a focus on hematopoietic cell transplantation. Infect Dis Ther. 2018;(7):1-16. doi:10.1007/s40121-017-0180-z


de la Hoz RE, Stephanie G, Sherlock C. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25(Suppl 1):S1-S12. doi:10.1016/s1386-6532(02)00091-4


Chemaly RF, Chou S, Einsele H, et al. Definitions of resistant and refractory cytomegalovirus infection and disease in transplant recipients for use in clinical trials. Clin Infect Dis. 2019;68(8):1420-1426. doi:10.1093/cid/ciy696


Martín-Gandul C, Pérez-Romero P, González-Roncero FM, et al. Clinical impact of neutropenia related with the preemptive therapy of CMV infection in solid organ transplant recipients. J Infect. 2014;69(5):500-6. doi:10.1016/j.jinf.2014.07.001


 


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Shirley Zhu

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