Takeda Announces Results From Phase 4 Vedolizumab Study in Patients With Chronic Pouchitis Published in New England Journal of Medicine

 −The Phase 4 EARNEST Study Met Its Primary Efficacy Endpoint of Remission of Chronic or Recurrent Pouchitis at Week 14, with 31% of Participants Receiving Vedolizumab Achieving Remission versus 10% Receiving Placebo.¹

−Superiority over Placebo Was Also Demonstrated at Week 34, with 35% of Vedolizumab Patients Achieving Remission Compared with 18% on Placebo.¹

(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) today confirmed that the New England Journal of Medicine (NEJM) has published positive data from the Phase 4 EARNEST study of vedolizumab for the treatment of chronic pouchitis. The NEJM article is titled “Vedolizumab for the Treatment of Chronic Pouchitis”.

A potentially curative surgical option for ulcerative colitis (UC) is total proctocolectomy, followed by creation of an ileal pouch anal anastomosis (IPAA) to aid in stool retention. Inflammation of the ileal pouch, pouchitis, can cause fecal incontinence, abdominal discomfort, and bleeding.2 Chronic pouchitis, defined by symptom duration greater than four weeks, can develop in up to one-fifth of these patients.3

The published results showed the Phase 4 EARNEST study met its primary efficacy endpoint of clinical and endoscopic remission, as measured by modified pouchitis disease activity index (mPDAI), at Week 14 in 31% of participants (16 out of 51) receiving vedolizumab versus 10% (5 out of 51) receiving placebo (95% CI: 5 to 38 percentage point [p.p.] difference; p=0.01). This improved outcome compared with placebo was also seen at the equivalent secondary endpoint at Week 34 (35% of vedolizumab patients [18 out of 51] achieved mPDAI remission compared with 18% [9 out of 51] on placebo [95% CI: 0 to 35 p.p. difference]).1

“Pouchitis is relatively common following pouch surgery for people with ulcerative colitis,” said Professor Simon Travis, Translational Gastroenterology Unit and Kennedy Institute, University of Oxford. “Demonstrating the efficacy of a biologic treatment for this inflammatory condition is important for a group of patients who have previously had no treatment option once antibiotics are no longer effective.”

Beyond mPDAI remission, patients receiving vedolizumab also demonstrated improved clinical response at both Week 14 and Week 34 over placebo, with a difference at Week 14 of 30 p.p. (95% CI, 8 to 48), and a Week 34 difference of 22 p.p. (95% CI, 2 to 40). Serious adverse events occurred in 6% (3 out of 51) and 8% (4 out of 51) of patients in the vedolizumab and placebo groups, respectively.1 No new safety signals were identified. The publication concluded that vedolizumab was more effective than placebo for inducing remission in chronic pouchitis after IPAA for patients with UC.

“We are committed to advancing treatment and care for patients living with debilitating inflammatory gastrointestinal conditions such as active chronic pouchitis,” said Marcelo Freire, Vice President, Global Medical Affairs, Therapeutic Area Head, Gastroenterology, Takeda. “The publication of the latest results from the EARNEST study in the New England Journal of Medicine is great recognition of the work we are doing to reduce the burden of this condition for patients.”

Vedolizumab is indicated only in the European Union for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and IPAA for UC and have had an inadequate response with or lost response to antibiotic therapy.4

In the United States, vedolizumab is indicated in adults for the treatment of moderately to severely active UC and Crohn’s disease (CD).5

About Pouchitis

Patients with ulcerative colitis (UC) may require removal of their colon and rectum (proctocolectomy), and the surgical creation of an ileal pouch (ileal pouch-anal anastomosis or IPAA) to aid stool retention. Pouchitis, where inflammation and irritation are seen in the lining of the new pouch, is the most common complication of an IPAA, affecting approximately 50% of patients with UC or familial adenomatous polyposis (FAP).3 Acute pouchitis may respond to antibiotic therapy, however there are currently no approved therapies indicated for active chronic pouchitis in the European Union, including the refractory form of pouchitis, which does not respond to antibiotic therapy, and where patients frequently relapse.3 Refractory pouchitis affects 10-15% of patients with pouchitis, and can have a considerable impact on their quality of life, causing fecal urgency, incontinence, straining during defecation, bleeding, abdominal or pelvic discomfort, fever and malaise.2,6,7

The prevalence of all pouchitis has been calculated to be 12 to 18 patients per 100,000 in the United States.8

About the EARNEST clinical trial

EARNEST is a randomized, double-blind, placebo-controlled multicenter study that evaluated the efficacy and safety of vedolizumab IV in the treatment of adult patients with UC who had undergone a proctocolectomy and IPAA, had developed active chronic pouchitis, and had inadequate response with or lost response to antibiotics therapy.9

About Vedolizumab

Vedolizumab is a gut-selective biologic and is approved for intravenous (IV) use in the United States and approved in both IV and subcutaneous (SC) formulations in Europe, Canada, Australia, Switzerland and Japan.4,5,10,11,12,13 It is a humanized monoclonal antibody designed to specifically antagonize the α4β7 integrin, inhibiting the binding of α4β7 integrin to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule 1 (VCAM-1).14 MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract.15 The α4β7 integrin is expressed on a subset of circulating white blood cells.14 These cells have been shown to play a role in mediating the inflammatory process in ulcerative colitis (UC) and Crohn’s disease (CD).14,16,17 By inhibiting α4β7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.14

Vedolizumab is approved for the treatment of adult patients with moderately to severely active UC and CD, who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα)-antagonist.4,5 Vedolizumab has been granted marketing authorization in over 70 countries, including the United States and European Union, with more than 1,000,000 patient years of exposure to date.18

Therapeutic Indications for vedolizumab

Ulcerative Colitis

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

Crohn’s Disease

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

Pouchitis

Vedolizumab IV is indicated in the EU for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) and have had an inadequate response with or lost response to antibiotic therapy.

Important Safety Information for vedolizumab

Contraindications

Hypersensitivity (such as dyspnea, bronchospasm, urticaria, flushing and increased heart rate) to the active substance or to any of the excipients.

Special Warnings and Special Precautions for Use

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

Infusion-related reactions and Hypersensitivity Reactions

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

Injection Site Reactions (subcutaneous vedolizumab)

No clinically relevant differences in the overall safety profile and adverse events were observed in patients who received subcutaneous vedolizumab compared to the safety profile observed in clinical studies with intravenous vedolizumab with the exception of injection site reactions (with subcutaneous administration only). Injection-site reactions were mild or moderate in intensity, and none were reported as serious.

Infections

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

Malignancies

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

Prior and concurrent use of biological products

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

Vaccinations

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

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

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

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

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

About Takeda

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI), with expertise in immune and inflammatory diseases. We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.

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.

References

1. Travis S, Silverberg MS, Danese S, et al. Vedolizumab for the Treatment of Chronic Pouchitis. N Engl J Med. 2023; 388:1191-1200
2. Schieffer KM, Williams ED, Yochum GS, et al. Review article: the pathogenesis of pouchitis. Aliment Pharmacol Ther. 2016;44:817–835.
3. Dalal RL, Shen B, Schwartz DA. Management of Pouchitis and Other Common Complications of the Pouch. Inflamm Bowel Dis. 2018;24:989-996.
4. Entyvio Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/entyvio-epar-product-information_en.pdf. Last updated: October 2022. Last accessed: February 2023.
5. Entyvio Prescribing Information. Available at: https://general.takedapharm.com/ENTYVIOPI. Last updated: June 2022. Last accessed: March 2023.
6. Singh A, Khan F, Lopez R, et al. Vedolizumab for chronic antibiotic-refractory pouchitis. Gastroenterol Rep (Oxf). 2019;7:121-126.
7. Bär F, Kühbacher T, Dietrich NA, et al. Vedolizumab in the treatment of chronic, antibiotic-dependent or refractory pouchitis. Aliment Pharmacol Ther. 2018;47:581-587.
8. Sandborn WJ, Pardi DS. Clinical management of pouchitis. Gastroenterology. 2004;127(6):1809–1814.
9. A Study to Evaluate the Efficacy and Safety of Vedolizumab in the Treatment of Chronic Pouchitis (EARNEST). Available at: https://clinicaltrials.gov/ct2/show/NCT02790138. Last updated: February 2022. Last accessed: March 2023.
10. Product Monograph including Patient Medication Information. Available at: https://assets-dam.takeda.com/raw/upload/v1662721781/legacy-dotcom/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/entyvio/ENTYVIO-PM-EN.pdf Last accessed: March 2023
11. Australian Product Information. Entyvio (vedolizumab). Available at: https://www.guildlink.com.au/gc/ws/tk/pi.cfm?product=tkpentyv11118#:~:text=The%20recommended%20dose%20regimen%20of,a%20dose%20at%20Week%2010. Last accessed: March 2023
12. Fachinformation Entyvio. Swissmedic. October 2020.
13. Takeda Receives Approval to Manufacture and Market Entyvio Subcutaneous Injection in Japan for the Maintenance Treatment of Moderate to Severe Ulcerative Colitis. Available at: https://www.takeda.com/newsroom/newsreleases/2023/approval-to-manufacture-and-market-entyvio Last accessed: March 2023
14. Soler D, Chapman T, Yang LL, et al. The binding specificity and selective antagonism of vedolizumab, an anti-alpha4beta7 integrin therapeutic antibody in development for inflammatory bowel diseases. J Pharmacol Exp Ther. 2009;330:864-875.
15. Briskin M, Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion molecule-1 is preferentially expressed in intestinal tract and associated lymphoid tissue. Am J Pathol. 1997;151:97‑110.
16. Eksteen B, Liaskou E, Adams DH. Lymphocyte homing and its role in the pathogenesis of IBD. Inflamm Bowel Dis. 2008;14:1298‑1312.
17. Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of the monoclonal antibody vedolizumab. J Crohns Colitis. 2016;10:1437-1444.
18. Takeda data on file (VV-SUP-116025): Vedolizumab Patient Exposure from Marketing Experience. July 2022.

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Akkodis Selected by Thales to Deliver Customer Support Engineering Services Worldwide

 ZURICH - Thursday, 30. March 2023 AETOSWire 

The global Smart Industry leader expands partnership with Thales to deliver customer support engineering services to help transform the future of Aerospace and other industries.

 

(BUSINESS WIRE)--Akkodis, part of the Adecco Group, today announced that it has been selected by Thales to deliver customer support engineering services. Thales is a worldwide technology leader that provides solutions, products and services to the aerospace, defense, transportation and security sectors.

In this significant partnership development, Akkodis, a global digital engineering company and Smart Industry leader, has been selected to provide customer support engineering services that span the breadth of Thales’ portfolio, including Integrated Logistics Support (ILS), technical publication and training services.

Akkodis’ engineers will work alongside Thales’ teams from ideation through the design and development phases, and beyond to encompass the in-service support phase. This will help to ensure that products and solutions are optimized to accommodate the in-service qualities of safety, reliability and maintenance, as specified by Thales’ end customers. The engineers will also author technical documents associated with all aspects of these solutions, such as their functionality, safety and maintenance procedures. Additionally, the Akkodis teams will perform training on these systems.

Deepak Talwar, VP Global Procurement for Engineering Services, Thales, said “Akkodis brings end-to-end advanced engineering capabilities, technical expertise and the strong global footprint needed to support Thales around the planet. This will contribute value, enabling us to help our customers carry out their critical missions with the most innovative, flexible and compliant solutions on the market,” he added.

Paolo del Noce, Group Senior Vice President Global Sales, Akkodis, said “We are honored to have been selected by Thales as a worldwide customer support engineering services partner.” He continued, “This award underscores Akkodis’ position as a global Smart Industry leader and tech partner of choice for Aerospace and other industries. We are passionate about co-creating solutions with Thales that drive purposeful innovation, improve quality of life and contribute to sustainable societies.”

Following a competitive procurement process, Akkodis was selected on the strength and breadth of its offering, as well as its global footprint and scale, including centers of excellence in France, India, Romania and Morocco – areas of particular importance to Thales. Akkodis’ proven track record of delivering customer support project execution excellence to the world’s leading aerospace companies, combined with its long-standing and close working relationship as a Thales ‘gold status’ engineering services provider were key strengths that led to the selection of Akkodis.

– End –

About Akkodis

Akkodis is a global digital engineering company and Smart Industry leader. We enable clients to advance in their digital transformation with Consulting, Solutions, Talent, and Academy services. Headquartered in Switzerland and part of the Adecco Group, Akkodis is a trusted tech partner to the world’s industries. We co-create and pioneer solutions that help to solve major challenges, from accelerating the clean energy transition and green mobility, to improving user and patient centricity. Empowered by a culture of inclusion and diversity, our 50,000 tech experts across 30 countries combine best-in-class technologies and cross industry knowledge to drive purposeful innovation for a more sustainable tomorrow. We are passionate about Engineering a Smarter Future Together. akkodis.com | LinkedIn | Instagram | Facebook Twitter

About The Adecco Group

The Adecco Group is the world’s leading talent company. Our purpose is making the future work for everyone. Through our three global business units - Adecco, Akkodis and LHH - across 60 countries, we enable sustainable and lifelong employability for individuals, deliver digital and engineering solutions to power the Smart Industry transformation and empower organisations to optimise their workforces. The Adecco Group leads by example and is committed to an inclusive culture, fostering sustainable employability, and supporting resilient economies and communities. The Adecco Group AG is headquartered in Zurich, Switzerland (ISIN: CH0012138605) and listed on the SIX Swiss Exchange (ADEN). www.adeccogroup.com

 

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Quectel Launches KG100S module for Amazon Sidewalk to Bring Advanced Connectivity Solutions to Customers

 NEW YORK - Saturday, 25. March 2023

50th Anniversary Nod to Prism Spectrum Will Rotate in its Mast

(BUSINESS WIRE)--On Friday, March 24, the Empire State Building (ESB) will celebrate the 50th anniversary of Pink Floyd’s legendary album “The Dark Side of the Moon” with a special anniversary version of the famous original album artwork to spin in its mast.

“‘The Dark Side of the Moon’ is as authentic, global, and iconic an album as the Empire State Building is a building, so it is only logical to celebrate it atop ESB’s world-famous tower,” said Anthony E. Malkin, chairman, president, and CEO at Empire State Realty Trust. “On March 24 she will celebrate this milestone anniversary alongside the multitude of Pink Floyd fans throughout the world.”

Released in 1973, “The Dark Side of the Moon” is one of the best-selling albums of all time with more than 45 million copies sold worldwide. The album is praised for its innovative production techniques and creative use of instruments and has influenced countless artists throughout its 50-year history.

Pink Floyd will release a new deluxe box set that day that includes CD and gatefold vinyl of the 2023 remastered studio album and Blu-ray + DVD audio with the original 5.1 mix and remastered stereo versions. The deluxe set will also include new Blu-ray disk of Atmos mix, CD and LP of “The Dark Side of the Moon – Live at Wembley Empire Pool, London 1974,” a 160-page hardback photo book, a music book, replica 7” singles, and memorabilia.

The display will kick off at sunset and can be seen throughout New York City, as well as online from the Empire State Building Live Cam. More information about Pink Floyd and the 50th Anniversary of “Dark Side of the Moon” can be found online. Hi-res b-roll of the dynamic lighting can be downloaded here. More information about the Empire State Building’s world-famous tower lights can be found online.

About the Empire State Building

The Empire State Building, the “World's Most Famous Building," owned by Empire State Realty Trust, Inc. (ESRT: NYSE), soars 1,454 feet above Midtown Manhattan from base to antenna. The $165 million reimagination of the Empire State Building Observatory Experience creates an all-new experience with a dedicated guest entrance, an interactive museum with nine galleries, and a redesigned 102nd Floor Observatory with floor-to-ceiling windows. The journey to the world-famous 86th Floor Observatory, the only 360-degree, open-air observatory with views of New York and beyond, orients visitors for their entire New York City experience and covers everything from the building's iconic history to its current place in pop culture. The Empire State Building Observatory Experience welcomes millions of visitors each year and was declared the world's most popular travel destination by Uber, the #1 Attraction in the United States in Tripadvisor’s 2022 Travelers’ Choice Best of the Best, and the #1 New York City attraction by Lonely Planet.

Since 2011, the building has been fully powered by renewable wind electricity, and its many floors house a diverse array of office tenants such as LinkedIn and Shutterstock, as well as retail options like STATE Grill and Bar, Tacombi, and Starbucks. For more information and Observatory Experience tickets visit esbnyc.com or follow the building's Facebook, Twitter, Instagram, Weibo, YouTube, or TikTok.

Source: Empire State Realty Trust, Inc.
Category: Observatory

 

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Boehringer Ingelheim reaches more patients than ever in 2022 as innovative medicines drive growth

 Medicines reached a record 30 million people, driven by JARDIANCE® and OFEV®

R&D investments of 5 billion EUR, or 21 percent of net sales

Net sales rise 10.5 percent (currency adjusted), up strongly to 24.1 billion EUR

 

(BUSINESS WIRE)--Boehringer Ingelheim today reported a strong performance in 2022, a year in which 30 million patients benefited from its innovative medicines, while deepening investments in the search for new treatments. Research & development investments reached 5 billion EUR, or 21 percent of net sales. Net sales rose by a currency-adjusted 10.5 percent to 24.1 billion EUR.

“2022 has shown that our long-term commitment to medical research is the right strategy. For some patient conditions that were until recently deemed difficult to treat, we have now found medical entities that can be true breakthroughs,” said Hubertus von Baumbach, Chairman of the Board of Managing Directors. “The acceleration of our broad pipeline demonstrates our commitment to transform the treatment of cardiovascular-renal diseases, inflammation, and respiratory diseases, as well as mental health, oncology and retinal diseases.”

Development of the pipeline progressed very well in 2022. Boehringer Ingelheim received one Breakthrough Designation, three Fast Track Designations, and two Orphan Drug Designations from the FDA. In the next seven years the company expects about 20 regulatory approvals in human pharma. Throughout the current year, Boehringer Ingelheim expects to present additional data from its pipeline.

In 2022 operating income at Group level rose by 1.4 percent to 4.8 billion EUR, while income after taxes amounted to 3.2 billion EUR.

“The strong commercial performance provides a solid base to finance our late-stage pipeline, mid-term growth opportunities, as well as further investments in new technologies. It will enable us to address future unmet patient needs,” said Michael Schmelmer, Member of the Board of Managing Directors with responsibility for Finance & Group Functions.

JARDIANCE® and OFEV® drive sales growth in Human Pharma

The Human Pharma business achieved currency-adjusted net sales growth of 13.6 percent to 18.5 billion EUR, driven by JARDIANCE® and OFEV®.

JARDIANCE®, which is used to treat type 2 diabetes and heart failure with reduced and preserved ejection fraction, was the company’s most significant growth and revenue contributor, with net sales of 5.8 billion EUR and a currency-adjusted growth of 39.1 percent in 2022.

OFEV® was the company’s second-strongest revenue contributor. OFEV® is a medicine for the treatment of patients with idiopathic pulmonary fibrosis as well as certain fibrosing interstitial lung diseases. OFEV® generated net sales of 3.2 billion EUR, representing a currency-adjusted growth of 20.6 percent in 2022.

The biopharmaceuticals contract manufacturing business achieved annual net sales of over 1 billion EUR, reinforcing the company’s position as a leading manufacturer of biopharmaceuticals worldwide.

Animal Health to launch around 20 new products, starting in 2023

Animal Health experienced the effects of the economic slowdown in North America, intense competition and declining net sales of swine vaccines in China. Net Sales were on a comparable level with 2021 at 4.6 billion EUR in 2022. NEXGARD®, a medication for flea and tick protection for dogs, rose by currency-adjusted 8.0 percent to reach more than 1 billion EUR in annual sales, marking an industry-first.

R&D investments in Animal Health amounted to 464 million EUR in 2022, or 10 percent of the business unit’s sales, well exceeding industry average. Animal Health has an ambitious schedule to launch about 20 new products, starting this year, including novel flea and tick products for cats and dogs and a breakthrough oral product for diabetes in cats.

Looking ahead, Boehringer Ingelheim anticipates moderate growth in 2023, on a comparable basis, with a slight increase in its operating income, creating the fundamentals for bringing more innovative medicines to patients and animals.

Click here for the full release: Boehringer Ingelheim reaches more patients than ever, innovation drives growth | Boehringer Ingelheim (boehringer-ingelheim.com)

 

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Harro Ten Wolde

Head of Global Media Relations

Email: harro.ten_wolde@boehringer-ingelheim.com

Phone Number: +49 (6132) 77-181352

 

Stellarator Fusion Company, Type One Energy Group, Raises $29 Million in First Financing, Appointing Christofer Mowry as CEO

 MADISON, Wis. - Wednesday, 29. March 2023 AETOSWire Print 

Type One Energy Group, Inc. capitalized with $29M, names new CEO

(BUSINESS WIRE) -- Type One Energy announced today the close of an over-subscribed $29 million financing round. This effort launches the company’s ambitious, partner-rich and capital-efficient FusionDirect program to commercialize its stellarator fusion technology.

Type One Energy’s technical foundations provide a powerful springboard to achieve its mission. Founded by several of the world’s leading stellarator experts, Type One Energy also brings concentrated experience from renowned fusion science institutions, including the University of Wisconsin-Madison in the U.S., the Max Planck Institute for Plasma Physics in Germany and the Massachusetts Institute of Technology (MIT) for its work on advanced magnet technology. The stellarator is a fusion technology characterized by inherently stable and steady-state operations. Related to tokamaks, stellarators do not, however, require massive circulating electric currents to assist in creating the magnetic fields used to confine their fusion plasma. This makes stellarator technology less physically complex and easier to translate into a practical fusion power plant.

Breakthrough Energy Ventures (BEV), TDK Ventures and Doral Energy Tech Ventures co-led the round with additional cleantech investment from Darco, the Grantham Foundation, MILFAM, Orbia Ventures, Shorewind Capital, TRIREC, VAHOCA and others.

The company’s unique FusionDirect commercialization program takes advantage of recent important breakthroughs to pursue a lowest-risk, shortest-schedule pathway to fusion energy. Improvements in stellarator fusion performance and plasma science work together with technical innovations in high-temperature superconducting (HTS) magnet technology and advanced manufacturing to spark Type One Energy’s launch of FusionDirect.

Type One’s commercialization program is being executed through a set of global partnerships with leading fusion science and technology research institutions, universities and industrial companies. These partnerships reflect the career-long collaborative relationships which the company’s industry-recognized technical leaders bring to Type One Energy. This technical leadership team includes Chief Technology Officer Dr. Thomas Sunn Pedersen, Chief Science Officer Dr. John Canik, Chief Engineer Dr. David Anderson, and Head of Stellarator Plasma Science Dr. Chris Hegna.

“Fusion is the ultimate energy source, and its successful commercialization will be a huge leap towards achieving clean and abundant energy for everyone,” said Carmichael Roberts, Breakthrough Energy Ventures. “Advances in stellarator science, including Type One Energy’s ability to execute a stellarator development project, provide the basis for a very exciting and promising path to practical fusion on the grid in the coming decades.”

With this announcement, the company will onboard former Breakthrough Energy Ventures’ (BEV) Senior Advisor on Fusion, Christofer Mowry, to serve as Chief Executive Officer (CEO). “Type One Energy represents a special opportunity. This team’s knowledge and credibility gives Type One the unique ability to effectively integrate recent global advances in stellarator-relevant technology and to deliver a fusion power plant without another costly, large-scale, science validation machine,” stated Type One Energy Group CEO Christofer Mowry. Previously, Mowry held the CEO position at General Fusion, where he scaled up the company and raised over $200M in private investment and government support from three countries.

“The science basis for stellarators has taken major leaps forward in the past several years. Through a combination of experimental demonstrations and the use of high-performance computing, the stage is set for the development of power plant scale machines,” said Dennis Whyte, Director of MIT’s Plasma Science and Fusion Center. “We look forward to collaborating with Type One Energy to realize the advantages of HTS high-field fusion magnets to their stellarator technology.”

“The world will need a source of high energy density low-carbon power in the coming decades to achieve energy transition and decarbonization. Among several startups that we have evaluated, Type One Energy is on a credible accelerated trajectory to commercialize a steady-state baseload fusion power plant. TDK Ventures is excited to back this highly accomplished leadership team,” said Tina Tosukhowong, Investment Director at TDK Ventures.

About Type One Energy Group

Type One Energy Group is mission-driven to provide sustainable, affordable fusion power to the world. The company was formed in 2019 by a team of globally-recognized fusion scientists with a strong track record of building state-of-art stellarator fusion machines, together with veteran business leaders experienced in successfully scaling companies and commercializing energy technologies. Type One Energy applies proven advanced manufacturing methods, modern computational physics and high-field superconducting magnets to develop its optimized stellarator fusion energy system. Its FusionDirect development program pursues the lowest-risk, shortest-schedule path to a fusion power plant over the coming decade, using a partner-intensive and capital-efficient strategy. For more information, visit https://www.typeoneenergy.com/.

About Breakthrough Energy Ventures (BEV)

Founded by Bill Gates and backed by many of the world’s top business leaders, BEV has raised more than $2 billion in committed capital to support cutting-edge companies that are leading the world to net-zero emissions. BEV is a purpose-built investment firm that is seeking to invest, launch and scale global companies that will eliminate GHG emissions throughout the economy as soon as possible. BEV seeks true breakthroughs and is committed to supporting these entrepreneurs and companies by bringing to bear a unique combination of technical, operational, market and policy expertise.

BEV is a part of Breakthrough Energy, a network of investment vehicles, philanthropic programs, policy advocacy and other activities committed to scaling the technologies we need to reach net-zero emissions by 2050. Visit www.breakthroughenergy.org to learn more.

 

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Contacts

Catalina Carvajal, media@typeoneenergy.com, +1 646 480 0356

Vortexa and Energy Aspects Announce Strategic Partnership

 LONDON - Wednesday, 29. March 2023 AETOSWire Print 

(BUSINESS WIRE)--Energy Aspects (EA) and Vortexa today announced a new strategic partnership that combines industry leading energy commodity data and intelligence with best in class cargo tracking analytics to provide energy markets with even greater understanding of short-term market dynamics.

Under the partnership, EA will use Vortexa’s market leading cargo tracking analytics as an input to its world-class research and analysis on global crude, refined products and LNG markets. The partnership will help bring increased clarity to energy markets during a time of historic complexity, volatility and transition.

“We are pleased to announce that Vortexa is our new preferred third-party provider of global flows data”, said Fredrik Fosse, Chief Executive at Energy Aspects. "Trusted data is key to our best-in-class fundamental analytics, and it's important for us to benchmark and complement our primary data sources with those of the leading third-party providers."

“We are very excited to partner with Energy Aspects. Their stellar reputation and global reach across energy markets, now powered by the breadth and depth of Vortexa analytics will drive increased value to our clients and partners. We are proud of this clear endorsement of Vortexa’s best-in-class data in energy and freight analytics as compared to other legacy providers'' said Fabio Kuhn, Founder & CEO, Vortexa.

Ends

About Energy Aspects

Energy Aspects was founded in 2012 by energy industry experts Dr. Amrita Sen, Fredrik Fosse, and Richard Bronze to meet the need for timely, independent research that provides deep dives in energy market and macro fundamentals, grounded on robust data and timely forecasts, all while maintaining a commitment to timeliness and precision. Over 500 organisations rely on Energy Aspects’ broad product range covering short-term, long-term, and macro trends, and direct access to analysts for specific queries. It is headquartered in London with additional offices in New York, Houston, Singapore, Tokyo, Kolkata, Vienna, and Athens.

About Vortexa

Vortexa provides market-leading real-time data and advanced analytics for energy and freight markets. With the most accurate and complete picture of global flows, freight and inventories, Vortexa covers crude oil, refined products, LPG and LNG, across all vessel classes. We help traders, analysts and freight professionals gain a competitive edge into complex and opaque markets by making better trading decisions with confidence. Vortexa is a multidisciplinary force of over 115 employees combining the best of energy and freight expertise, data science and engineering across major hubs in London, Singapore, Houston, New York City and the UAE.

 

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Energy Aspects:

press@energyaspects.com

Vortexa:

Natasha Adams

T: +49 152 5952 8457

E: natasha.adams@vortexa.com

 

From Ukraine to the Whole of Europe: Cyber Conflict Reaches a Turning Point

 The February 2023 report by Thales's Cyber Threat Intelligence unit reviews one year of cyber-attacks across Europe.

The third quarter of 2022 marked a turning point in cyber-attacks related to the conflict in Ukraine, with a clear transition from a cyber-war focused on Ukraine and Russia to a high-intensity hybrid cyber-war across Europe. The cyber-war is targeting Poland and the Baltic and Nordic countries in particular, with an increasing focus on critical national infrastructure in sectors including aviation, energy, healthcare, banking and public services.

From targeted destruction campaigns to guerrilla cyber-harassment, pro-Russian hacktivists are using DDoS1 attacks to make servers temporarily inaccessible and disrupt services. They are part of Russia's strategy to engage in information warfare as a way to wear down public and private organisations.

(BUSINESS WIRE)-- Thales:

Eastern and Northern Europe on the front lines of the cyber conflict

A new attack geography has taken shape over the last 12 months. At the very beginning of the conflict, the majority of incidents only affected Ukraine (50.4% in the first quarter of 2022 versus 28.6% in the third quarter), but EU countries have seen a sharp increase in conflict-related incidents in the last six months (9.8% versus 46.5% of global attacks).

In the summer of 2022, there were almost as many conflict-related incidents in EU countries as there were in Ukraine (85 versus 86), and in the first quarter of 2023, the overwhelming majority of incidents (80.9%) have been inside the European Union.

Candidates for European integration such as Montenegro and Moldova are being increasingly targeted (0.7% of attacks in the first quarter of 2022 versus 2.7% at the end of 2022) and Poland is under constant harassment, with a record number of 114 incidents related to the conflict over the past year. War hacktivists have specifically targeted the Baltic countries (157 incidents in Estonia, Latvia and Lithuania) and Nordic countries (95 incidents in Sweden, Norway, Denmark and Finland). Germany saw 58 incidents in the past year, but other European countries have been relatively spared, such as France (14 attacks), the UK (18 attacks), Italy (14 attacks) and Spain (4 attacks).

"In the third quarter of 2022, Europe was dragged into a high-intensity hybrid cyber-war at a turning point in the conflict, with a massive wave of DDoS attacks, particularly in the Nordic and Baltic countries and Eastern Europe. Cyber is now a crucial weapon in the arsenal of new instruments of war, alongside disinformation, manipulation of public opinion, economic warfare, sabotage and guerrilla tactics. With the lateralisation of the conflict from Ukraine to the rest of Europe, Western Europe should be wary of possible attacks on critical infrastructure in the short term if the conflict continues to accelerate." Pierre-Yves Jolivet, VP Cyber Solutions, Thales.

From war hacktivists to cyber-harassment

Of all cyber-attacks reported worldwide since the start of the conflict, 61% were perpetrated by pro-Russian hacktivist groups, and in particular by Anonymous Russia, KillNet and Russian Hackers Teams, which have emerged since the start of the conflict to mirror the efforts of Ukrainian IT Army hacktivists early in the war. These new groups are more structured and use the type of resources favoured by organised cybercrime groups, including botnet-as-a-service2 resources such as Passion Botnet, with the aim of cyber-harassing Western countries that support Ukraine. These groups of independent, civilian hacktivists have emerged as a new component in the conflict. They can be assimilated to a cybercriminal group with specific political objectives and interests, acting out of conviction yet not directly sponsored by any government. Members of such groups have a broad array of origins, technical skills and backgrounds.

The third quarter of 2022 marked a transition to a wave of DDoS attacks, in contrast to the first quarter of 2022, which saw a range of different kinds of attacks, divided more or less equally among data leaks and theft, DDoS attacks, espionage, influence campaigns, intrusion, ransomware, phishing, wiper and infostealer attacks3. Cyber attackers have since favoured DDoS attacks (75%) against companies and governments. This systematic harassment often has a low operational impact but sustains a climate of anxiety among security teams and decision-makers. Their objective is not to have a major operational impact but to harass targets and discourage them from supporting Ukraine.

On the other end of the spectrum, wiper attacks can destroy an adversary's systems, and long-term espionage can undermine the integrity of an adversary's security apparatus, but such techniques take much longer to prepare and require more resources. Destructive cyber-military operations, along with espionage, account for only 2% of the total number of incidents and are mainly targeted at Ukrainian public-sector organisations.

Russian authorities regularly use cyber to harass their adversaries without engaging in direct confrontation.

Acts of cyber warfare are still taking place in Ukraine – as we saw with the ATK256 (UAC-0056) attack against several Ukrainian public bodies on the anniversary of the conflict (February 23, 2023 ) – yet they are drowned out in the eyes of Westerners by constant cyber harassment.

Thales's contribution to the protection of critical infrastructure

Thales provides cybersecurity solutions for nine of the top ten Internet giants and helps to protect the information systems of more than 130 government agencies and essential services providers. With more than 3,500 cybersecurity experts, the company provides governments and critical infrastructure operators with integrated incident detection and response solutions, including cyber threat intelligence, sovereign probes, Security Operation Centres and encryption systems to prevent data breaches. Organised around three families of products and services – sovereign products, data protection platforms and cybersecurity services – the Group's portfolio of cyber solutions generated a combined total of more than 1.5 billion euros in sales in 2022.

Download the abstract

Download the report

About Thales

Thales (Euronext Paris: HO) is a global technology leader serving the Aerospace, Defence and Digital Identity & Security markets. Our solutions help to make the world safer, greener and more inclusive.

We invest close to 4 billion euros a year in Research and Development, driving innovation in key areas such as quantum technologies, cloud architectures, 6G and cybersecurity.

With 77,000 employees in 68 countries, the Group generated revenues of 17.6 billion euros in 20221.

_______________________________

1 Excluding Transport business, which is being divested

More information:

Cybersecurity solutions | Thales Group

Cyberthreat Hitmap (thalesgroup.com)

1 A distributed denial-of-service attack (DDoS) aims to make one or more services unavailable either by exploiting a software or hardware vulnerability or by saturating a network's bandwidth to deny access to users.

2 Sale or rental of a proxy network to other malicious actors for use in launching cyber-attacks.

3 Phishing is an attempt to lure a user into divulging information. A wiper is a type of malware used to erase data from an infected system. An infostealer is a type of spyware used to collect information from a system.

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Contacts

PRESS CONTACT:

Thales Media Relations

Marion Bonnet

+33 (0)6 60 38 48 92

marion.bonnet@thalesgroup.com