Monday, August 3, 2020
Takeda Announces FY2020 Q1 Results; Confirms Management Guidance & Raises Reported Operating Profit And Reported Net Profit for the Full Year
OSAKA, Japan-Monday 3 August 2020 [ AETOS Wire ]
(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) (“Takeda”) today announced financial results for the first quarter of fiscal year 2020 (quarter ended June 30, 2020). Based on the first quarter performance, the company confirms management guidance, and raises reported operating profit and reported net profit for the full year. The company also announced recent updates to its R&D pipeline and highlighted its R&D momentum with seven potential New Drug Application filings planned for the next 12 months.
Underlying revenue growth was 0.9% year on year. Takeda’s five key business areas, which represent 83% of revenue, delivered underlying revenue growth of 6%, and its 14 global brands, with reported revenue of JPY 308.0 billion in aggregate, posted 20% underlying revenue growth
Reported revenue was JPY 801.9 billion, with the impact of foreign currency and divestitures resulting in a year-on-year decline of 5.6%
Core operating profit1 was JPY 280.9 billion, with the core operating profit margin at 35.0% driven by cost synergies and OPEX efficiencies
Reported operating profit increased significantly, up 270% to JPY 167.3 billion, driven by lower purchase accounting and integration-related expenses; reported net profit increased to JPY 82.5 billion from JPY 7.0 billion a year earlier2
Reported operating cash flow increased by 21% to JPY 145.9 billion; free cash flow of JPY 146.3 billion represents a 64% increase over the prior year
Robust cash generation enabled further deleveraging to 3.7x net debt/adjusted EBITDA, demonstrating strong progress from 4.7x at the end of March 2019
Takeda increased its forecast for FY2020 reported operating profit to JPY 395 billion from JPY 355 billion, reported net profit to JPY 92 billion from JPY 60 billion, and for reported EPS to JPY 59 from JPY 39, to reflect a net gain from one-time items recognized in the first quarter
Takeda Chief Financial Officer Costa Saroukos commented:
“Takeda delivered solid first quarter results even during a period of great challenges for our employees, for patients, and for the communities we serve around the world. The performance of our global brands and key business areas demonstrates the quality of our product portfolio and resilient demand for medicines targeting severe chronic or life-threatening conditions. Among the Q1 highlights, ENTYVIO delivered exceptional underlying growth of 26%, TAKHZYRO is ramping up very well with underlying growth of 66%, and Immunoglobulin delivered strong underlying growth of 30%.
“Momentum is also building in our R&D pipeline, with seven potential Wave 1 New Drug Application filings targeted over the next 12 months, as well as further expansions of our global brands. In addition, we are making progress in various efforts to develop potential therapies for patients at risk from serious complications of COVID-19.
“Takeda has sustained the financial strength which underpins our success, with underlying revenue growth and strong underlying core operating profit growth, margins and cash flow. We continue to make steady progress toward our deleveraging and divestiture targets, and remain confident in Takeda’s growth momentum for the full year and in opportunities to accelerate growth in the medium term.”
Pipeline Update: Momentum in Our Dynamic R&D Growth Engine
Takeda has built a world-class R&D engine leveraging our internal research capabilities, while also actively engaging with innovative ecosystems around the world to translate science into highly innovative medicines. The main drivers for targeted new product launches are 12 unique New Molecular Entities (NMEs) in Wave 1, which represent several potential best-in-class / first-in-class therapies targeted for launch by FY2024 with aggregate potential peak sales of more than $10 billion.
With seven potential Wave 1 NME filings in the next 12 months, as well as additional expansions of our global brands, the momentum of our R&D growth engine is increasing.
In Oncology, pevonedistat was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat could be the first novel therapy in over a decade for HR-MDS and patients with acute myeloid leukemia for whom standard treatments are not appropriate.
We are excited about the transformative medium-term potential of a number of our major R&D programs, including:
In Oncology, TAK-007 for the treatment of hematologic malignancies on an outpatient basis, with encouraging Phase 1/2 data and cohort expansion ongoing for a pivotal study planned for next year and potential approval in FY2023
In Neuroscience, the first patient has been enrolled in a Phase 2 trial of TAK-994 for the treatment of narcolepsy type 1, with potential approval in FY2024
Progress on the extension of our global brands in Q1 included:
Approval of ALUNBRIG for first-line treatment for ALK+ advanced Non-Small Cell Lung Cancer (NSCLC) in the U.S.
Approvals for ADCETRIS in the EU for first-line systemic Anaplastic Large Cell Lymphoma (sALCL); and ADCETRIS in China for relapsed/refractory CD-30+ lymphomas
Wave 1 NME Filings targeted for the next 12 months include TAK-721, TAK-609, CoVIg-19, TAK-003, mobocertinib, pevonedistat and maribavir:
TAK-721 is on track to be the first FDA-approved agent to treat eosinophilic esophagitis
TAK-609 is in preparatory stages for a U.S. NDA submission for Hunter Syndrome with cognitive impairment
CoVIg-19 is expected to start a registration-enabling study in patients with COVID-19 in the coming weeks
TAK-003 is on track for a regulatory filing for Dengue vaccine in a number of endemic countries in Asia and Latin America
Mobocertinib (TAK-788) has the potential to set a new standard of care for a subset of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR exon 20 insertions
Pevonedistat (TAK-924) has the potential to be the first novel HR-MDS therapy in over a decade; anticipated Phase 3 PANTHER trial in HR-MDS readout in second half of FY2020
Maribavir (TAK-620) has the potential to be the first approved treatment for patients with post-transplant Cytomegalovirus (CMV) infection in over a decade
The CoVIg-19 Plasma Alliance continued development of a potential non-branded investigational hyperimmune globulin (H-Ig) treatment for COVID-19. Manufacturing of the first batch of CoVIg-19 was initiated at Takeda’s Georgia U.S, manufacturing site in May, and is ready to be shipped to study sites.
In addition, Takeda is evaluating repositioning of other internal therapies (icatibant and lanadelumab) and investigational medicines (TAK-981 and TAK-671), while also researching novel approaches.
FINANCIAL AND BUSINESS HIGHLIGHTS
Results for First Quarter FY2020 Ended June 30, 2020 [1],[2],[3]
(billion yen, except
percentages and per
share amounts)
REPORTED
CORE
UNDERLYING
Q1 FY2020
vs. PRIOR YEAR
Q1 FY2020
vs. PRIOR YEAR
Revenue
801.9
-5.6%
801.9
-5.6%
+0.9%
Operating Profit
167.3
+270.4%
280.9
-0.7%
+11.2%
Margin
20.9%
+15.5pp
35.0%
+1.7pp
34.7%
Net Profit
82.5
+1,077.2%
190.6
-3.9%
EPS (JPY)
53 yen
+48 yen
122 yen
-5 yen
+8.7%
Operating Cash Flow
145.9
+20.8%
Free Cash Flow
146.3
+64.0%
1 Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.
2 Core Operating Profit represents net profit adjusted to exclude income tax expenses, the share of profit or loss of investments accounted for using the equity method, finance expenses and income, other operating expenses and income, amortization and impairment losses on acquired intangible assets and other items unrelated to Takeda’s core operations, such as purchase accounting effects and transaction related costs.
3 Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at https://www.takeda.com/investors/reports/quarterly-announcements/
Takeda delivered solid performance for the first quarter of FY2020:
Takeda started the fiscal year with underlying revenue growth of 0.9%, consistent with full year guidance of “low-single-digit growth” and with a goal of accelerating growth in the medium term. Reported revenue was impacted by foreign exchange effects and divestitures, declining 5.6% year on year
We delivered a year-on-year increase in reported operating profit to JPY 167.3 billion and an increase in reported net profit to JPY 82.5 billion compared to JPY 7.0 billion for the same period in the prior year3. This is attributable to the effect of purchase accounting expenses in the previous fiscal year and significantly lower costs related to the Shire acquisition compared to last year, as we have successfully completed most of the integration process
Core operating profit of JPY 280.9 billion declined 0.7% year on year, as OPEX improvement including cost synergies could not fully offset the negative impact of foreign exchange and divestiture effects. The core operating profit margin was 35.0%
Underlying core operating profit margin, which adjusts for the impact of foreign exchange and divestiture effects, grew strongly to 34.7%. We are on track to achieve our target of mid-30% within FY2021-2023
Operational efficiencies and cost savings supported margin performance and we are on track to achieve our targeted annual run rate of $2.3 billion in cost synergies by the end of FY2021
Takeda is deleveraging rapidly, with a net debt/adjusted EBITDA ratio of 3.7x, at the end of Q1, down from 3.8x in March 2020 and compared to 4.7x in March 2019; we are on course to meet our medium-term deleveraging goal of 2x within FY2021-FY2023
At the same time as investing in promising R&D programs and efficient pipeline growth and returning cash to shareholders through dividends, Takeda continues to maintain strong cash flow. Reported cash flow from operations of JPY 145.9 billion represents a 21% increase year on year, while free cash flow of JPY 146.3 billion increased 64% over the same period
Takeda continues to make progress in shedding non-core assets as part of its $10 billion divestiture program. Six deals worth up to $8 billion have been announced since April 2019, including three transactions worth up to $6 billion that have already closed
In addition, we plan to unlock more than $700 million of incremental cash in FY2020 through the sale of real estate and marketable securities
Takeda’s five key business areas (Gastroenterology, Rare Diseases, Plasma-Derived Therapies, Oncology, Neuroscience), with JPY 662.0 billion of reported revenue representing 83% of total Q1 revenues, delivered year-on-year underlying revenue growth of 6%. Our 14 global brands, with reported revenue of JPY 308.0 billion in aggregate, delivered a strong 20% increase in underlying revenue growth compared to last year’s fiscal first quarter performance.
Among the highlights:
Our Gastroenterology franchise delivered exceptional growth as ENTYVIO expands its share of patients and enters new markets around the world. In Rare Diseases, TAKHZYRO sales are ramping up as its efficacy profile positions it as a leading option to expand the hereditary angioedema prophylaxis market; and PDT Immunology delivered strong growth driven by GAMMAGARD liquid demand in the U.S. and subcutaneous IG worldwide
Reported revenue and underlying revenue growth rates for notable Q1 FY2020 contributors include:
ENTYVIO JPY 101.2 billion +26% (Gastroenterology);
TAKHZYRO JPY 23.2 billion +66% (Rare Diseases);
ALUNBRIG JPY 2.0 billion +26% (Oncology)
NINLARO JPY 22.9 billion +31% (Oncology)
Immunoglobulin JPY 85.1 billion + 30% (PDT Immunology)
Our PDT Immunology business area delivered reported revenue of JPY 105.3 billion, representing a 19% improvement in underlying revenue growth year on year
Neuroscience reported revenue was JPY 106.9 billion, an underlying revenue decline of 1% year on year as COVID-19-related stay-at-home restrictions significantly reduced patient visits and subsequent diagnoses for VYVANSE; TRINTELLIX achieved continued market share increases in the U.S. market
FY2020 GUIDANCE
Upgrading Full-Year Reported Forecast; Core And Underlying Guidance Unchanged
(billion yen)
FY2020 PRIOR FORECAST (May 2020)
FY2020 UPDATED FORECAST (July 2020)
Underlying
(Management Guidance)
UNCHANGED SINCE MAY 2020
Revenue
3,250.0
3,250.0
Low-single-digit growth
Reported Operating Profit
355.0
395.0
Core Operating Profit
984.0
984.0
High-single-digit growth
Core Operating Profit Margin
30.3%
30.3%
Low-30s%
Reported Net Profit
60.0
92.0
Reported EPS (Yen)
39
59
Core EPS (Yen)
420
420
Low-teen growth
Annual Dividend per Share (Yen)
180
180
Takeda has strong growth momentum heading into FY2020 and potential for accelerated underlying growth and achieving an underlying core profit margin in the mid-30s over the medium term.
Core and underlying guidance for FY2020 remains unchanged. Takeda upgraded its reported operating profit, reported net profit, and reported EPS forecast for FY2020 due to the net positive effect of one-time items recognized during the first quarter of FY2020: an approx. JPY 60 billion increase due to the European Commission’s decision to release Takeda from the obligation to divest SHP647; and a negative approx. JPY 20 billion impact due to the remeasuring to the estimated fair value of the contingent consideration financial asset related to potential milestone receipts of Xiidra® as a result of Novartis’ withdrawal of the Marketing Authorization Application in Europe.
Key assumptions in FY2020 forecast:
Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, underlying revenue growth of our 14 global brands, and accelerated realization of cost synergies.
FY2020 guidance also reflects the following key assumptions, including (i) that there will not be an additional 505(b)2 competitor for subcutaneous VELCADE launched in the U.S. within FY2020; (ii) no impact of any potential further divestitures beyond what has already been disclosed by Takeda; and (iii) management’s current expectations regarding COVID-19.
To date, Takeda has not experienced a material effect on its financial results as a result of the global spread of the novel coronavirus infectious disease (COVID-19), despite the various effects on its operations as detailed in Takeda’s Quick Report for the quarter ended June 30, 2020, released today. Based on currently available information, Takeda believes that its financial results for FY2020 will not be materially affected by COVID-19 and, accordingly, Takeda's FY2020 forecast reflects this belief. However, the situation surrounding COVID-19 remains highly fluid, and future COVID-19-related developments in FY2020, including new or additional COVID-19 outbreaks and additional or extended lockdowns, shelter-in-place orders or other government action in major markets, could result in further or more serious disruptions to Takeda’s business, such as slowdowns in demand for Takeda’s products, supply chain related issues or significant delays in its clinical trial programs. These events, if they occur, could result in additional impacts on Takeda’s business, results of operations or financial condition, as well as resulting in significant deviations from Takeda’s FY2020 forecast.
For more details on Takeda's Q1 FY2020 results and other financial information, please visit: https://www.takeda.com/investors/reports/quarterly-announcements/
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
Certain Non-IFRS Financial Measures
This press release and materials distributed in connection with this press release include certain IFRS financial measures not presented in accordance with International Financial Reporting Standards (“IFRS”), such as Underlying Revenue, Core Operating Profit, Underlying Core Operating Profit, Core Net Profit, Underlying Core EPS, Net Debt, EBITDA, Adjusted EBITDA and Free Cash Flow. Takeda’s management evaluates results and makes operating and investment decisions using both IFRS and non-IFRS measures included in this press release. These non-IFRS measures exclude certain income, cost and cash flow items which are included in, or are calculated differently from, the most closely comparable measures presented in accordance with IFRS. By including these non-IFRS measures, management intends to provide investors with additional information to further analyze Takeda’s performance, core results and underlying trends. Takeda’s non-IFRS measures are not prepared in accordance with IFRS and such non-IFRS measures should be considered a supplement to, and not a substitute for, measures prepared in accordance with IFRS (which we sometimes refer to as “reported” measures). Investors are encouraged to review the reconciliation of non-IFRS financial measures to their most directly comparable IFRS measures.
Further information on certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at https://www.takeda.com/investors/reports/quarterly-announcements/
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.
Financial information
Takeda’s financial statements are prepared in accordance with International Financial Reporting Standards (“IFRS”). The revenue of Shire plc (“Shire”), which was historically, presented by Shire in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”), has been conformed to IFRS, without material difference.
1 Please refer to definitions starting on page 3 of this press release and in Takeda’s financial statements for more details.
2 During FY2019, Takeda completed the purchase price allocation for the assets acquired and the liabilities assumed as part of the Shire acquisition. Accordingly, PL statements for FY2019 Q1 were retrospectively adjusted.
3 During FY2019, Takeda completed the purchase price allocation for the assets acquired and the liabilities assumed as part of the Shire acquisition. Accordingly, PL statements for FY2019 Q1 were retrospectively adjusted.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200731005155/en/
Contacts
Investor Relations:
Takashi Okubo
takashi.okubo@takeda.com
+81-(0)3-3278-2306
Media Contacts:
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095
Media outside Japan
Holly Campbell
holly.campbell@takeda.com
+1 480-213-8368
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Business Daily Africa
Dole Unveils Integrated Strategy Against Banana Disease
One year since the Fusarium Wilt Tropical Race 4 (TR4) presence was confirmed in Latin America, produce leader broadly exploring all available solutions to ensure bananas endure and remain a food staple across the globe.
CHARLOTTE, N.C.-Monday 3 August 2020 [ AETOS Wire ]
(BUSINESS WIRE)-- Dole Food Company today shared the company’s most recent update on its efforts to combat Fusarium Tropical Race 4 (TR4), a plant disease that poses an existential threat to bananas, a major staple crop for much of the world.
Since the discovery of TR4 in northern Colombia one year ago, Dole swiftly ramped-up its TR4 response plan, implementing site-specific TR4 prevention activities throughout Latin America in coordination with local authorities and international experts to contain and prevent spread.
A three-year containment program was immediately implemented in 2019 to ensure biosecurity protocols in every Dole banana farm, as well as those of Dole’s independent suppliers. Those protocols build upon best practices implemented in the banana producing countries where the disease has been successfully contained and are continually reviewed and strengthened per site—based upon the farm layout and location—to maximize the effectiveness of the risk-based mitigation plan.
Dole also continues to share these best practices with independent growers and to engage with governments, multi-stakeholder initiatives and industry partners to ensure that our actions are coordinated with the wider response, both in Latin America and globally. These efforts require significant investment and as of now there is no evidence that TR4 has spread from the area in Colombia in which it was initially detected.
“Fortunately to date, the spread of this disease in Latin America has been contained to only the La Guajira region of Colombia, but this issue is not isolated to one region or one banana grower; it affects the entire industry and we must all be vigilant,” stated Patricio Gutiérrez, Director of Innovation R&D, Dole Tropical Products. “Containment alone is not sufficient. We must find ways to move beyond defense and find a sustainable solution to this issue in the long-term.”
Dole is exploring a number of potential resolutions.
One such solution the company is investigating is how to implement safe and approved biological control measures to prevent disease.
Additionally, Dole is working closely with research institutions around the world toward developing a disease resistant banana variety through crop improvement and conventional breeding methods. Since 2016, Dole has participated in a consortium working in partnership with the Honduran Research Foundation (FHIA) on the development of banana varieties that are resistant to TR4. Although developing a new kind of banana through traditional breeding is painstaking work, the research team is making good progress and a number of lines are currently being pot or field tested for TR4 resistance.
More recently, Dole began collaborating with companies working on precision biotechnology as a means to develop TR4 resistant bananas and is also part of the Global Alliance against TR4 led by IICA and Bayer in collaboration with other large banana stakeholders. When and if either these efforts or the other work being done by third parties succeed, Dole intends to be part of the discussion on how to make the solution available to banana growers worldwide.
About Dole Food Company
Dole Food Company, Inc., is one of the world’s largest producers and marketers of high-quality fresh fruit and fresh vegetables. Dole is an industry leader in many of the products it sells, as well as in nutrition education. For more information, please visit www.dole.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200731005419/en/
Contacts
US Contact: William Goldfield
818-874-4647
william.goldfield@dole.com
Permalink : https://www.aetoswire.com/news/dole-unveils-integrated-strategy-against-banana-disease/en
CHARLOTTE, N.C.-Monday 3 August 2020 [ AETOS Wire ]
(BUSINESS WIRE)-- Dole Food Company today shared the company’s most recent update on its efforts to combat Fusarium Tropical Race 4 (TR4), a plant disease that poses an existential threat to bananas, a major staple crop for much of the world.
Since the discovery of TR4 in northern Colombia one year ago, Dole swiftly ramped-up its TR4 response plan, implementing site-specific TR4 prevention activities throughout Latin America in coordination with local authorities and international experts to contain and prevent spread.
A three-year containment program was immediately implemented in 2019 to ensure biosecurity protocols in every Dole banana farm, as well as those of Dole’s independent suppliers. Those protocols build upon best practices implemented in the banana producing countries where the disease has been successfully contained and are continually reviewed and strengthened per site—based upon the farm layout and location—to maximize the effectiveness of the risk-based mitigation plan.
Dole also continues to share these best practices with independent growers and to engage with governments, multi-stakeholder initiatives and industry partners to ensure that our actions are coordinated with the wider response, both in Latin America and globally. These efforts require significant investment and as of now there is no evidence that TR4 has spread from the area in Colombia in which it was initially detected.
“Fortunately to date, the spread of this disease in Latin America has been contained to only the La Guajira region of Colombia, but this issue is not isolated to one region or one banana grower; it affects the entire industry and we must all be vigilant,” stated Patricio Gutiérrez, Director of Innovation R&D, Dole Tropical Products. “Containment alone is not sufficient. We must find ways to move beyond defense and find a sustainable solution to this issue in the long-term.”
Dole is exploring a number of potential resolutions.
One such solution the company is investigating is how to implement safe and approved biological control measures to prevent disease.
Additionally, Dole is working closely with research institutions around the world toward developing a disease resistant banana variety through crop improvement and conventional breeding methods. Since 2016, Dole has participated in a consortium working in partnership with the Honduran Research Foundation (FHIA) on the development of banana varieties that are resistant to TR4. Although developing a new kind of banana through traditional breeding is painstaking work, the research team is making good progress and a number of lines are currently being pot or field tested for TR4 resistance.
More recently, Dole began collaborating with companies working on precision biotechnology as a means to develop TR4 resistant bananas and is also part of the Global Alliance against TR4 led by IICA and Bayer in collaboration with other large banana stakeholders. When and if either these efforts or the other work being done by third parties succeed, Dole intends to be part of the discussion on how to make the solution available to banana growers worldwide.
About Dole Food Company
Dole Food Company, Inc., is one of the world’s largest producers and marketers of high-quality fresh fruit and fresh vegetables. Dole is an industry leader in many of the products it sells, as well as in nutrition education. For more information, please visit www.dole.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200731005419/en/
Contacts
US Contact: William Goldfield
818-874-4647
william.goldfield@dole.com
Permalink : https://www.aetoswire.com/news/dole-unveils-integrated-strategy-against-banana-disease/en
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Business Daily Africa
Andersen Global Continues West African Expansion with Addition of Tax and Legal Firm in Benin
SAN FRANCISCO-Friday 31 July 2020 [ AETOS Wire ]
(BUSINESS WIRE) -- Andersen Global announces its entrance into Cotonou, Benin with the addition of collaborating firm Fiduciaire Conseil and Assistance (FCA), a full-service tax and legal firm founded 20 years ago.
The firm, led by Managing Partner Sybel Akuesson, combines a strong, balanced tax and legal practice whose staff of 17 professionals provides assistance in labor law and corporate law as well as offers full tax capabilities to businesses involved in a variety of industries.
“In an increasingly complex world, the African market has begun demanding a new pace and scale of doing business, especially when it comes to the demand of legal services,” Sybel said. “In the spirit of stewardship, we are always looking for ways to grow and improve as a firm, and our collaboration with Andersen Global ensures we can meet all of our clients’ tax and legal needs globally in a seamless manner.”
“Sybel and his team share our organization’s commitment to independence and transparency,” said Andersen Global Chairman and Andersen CEO Mark Vorsatz. “Teaming with like-minded individuals positions us to provide even more comprehensive, best-in-class solutions to our clients and adds breadth and depth to our presence in Africa, particularly West Africa. They currently have pre-existing relationships with several of our collaborating firms in West Africa, which is invaluable and allows us to maintain the competitive edge in the region. We have nearly completed our build out in West Africa and are now the largest firm in the region as well as on the continent.”
Andersen Global is an international association of legally separate, independent member firms comprised of tax and legal professionals around the world. Established in 2013 by U.S. member firm Andersen Tax LLC, Andersen Global now has more than 6,000 professionals worldwide and a presence in over 184 locations through its member firms and collaborating firms.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005219/en/
Contacts
Megan Tsuei
Andersen Global
415-764-2700
Permalink : https://www.aetoswire.com/news/andersen-global-continues-west-african-expansion-with-addition-of-tax-and-legal-firm-in-benin/en
(BUSINESS WIRE) -- Andersen Global announces its entrance into Cotonou, Benin with the addition of collaborating firm Fiduciaire Conseil and Assistance (FCA), a full-service tax and legal firm founded 20 years ago.
The firm, led by Managing Partner Sybel Akuesson, combines a strong, balanced tax and legal practice whose staff of 17 professionals provides assistance in labor law and corporate law as well as offers full tax capabilities to businesses involved in a variety of industries.
“In an increasingly complex world, the African market has begun demanding a new pace and scale of doing business, especially when it comes to the demand of legal services,” Sybel said. “In the spirit of stewardship, we are always looking for ways to grow and improve as a firm, and our collaboration with Andersen Global ensures we can meet all of our clients’ tax and legal needs globally in a seamless manner.”
“Sybel and his team share our organization’s commitment to independence and transparency,” said Andersen Global Chairman and Andersen CEO Mark Vorsatz. “Teaming with like-minded individuals positions us to provide even more comprehensive, best-in-class solutions to our clients and adds breadth and depth to our presence in Africa, particularly West Africa. They currently have pre-existing relationships with several of our collaborating firms in West Africa, which is invaluable and allows us to maintain the competitive edge in the region. We have nearly completed our build out in West Africa and are now the largest firm in the region as well as on the continent.”
Andersen Global is an international association of legally separate, independent member firms comprised of tax and legal professionals around the world. Established in 2013 by U.S. member firm Andersen Tax LLC, Andersen Global now has more than 6,000 professionals worldwide and a presence in over 184 locations through its member firms and collaborating firms.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005219/en/
Contacts
Megan Tsuei
Andersen Global
415-764-2700
Permalink : https://www.aetoswire.com/news/andersen-global-continues-west-african-expansion-with-addition-of-tax-and-legal-firm-in-benin/en
Posted by
Business Daily Africa
Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS)
– Designation Based on Phase 2 Data and Reinforces Significant Treatment Need for HR-MDS –
– Pevonedistat Could be First Novel Treatment Option for HR-MDS in More Than a Decade –
CAMBRIDGE, Mass. & OSAKA, Japan-Thursday 30 July 2020 [ AETOS Wire ]
(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat, a first in class NEDD8-activating enzyme (NAE) inhibitor, could be the first novel treatment for HR-MDS patients in more than a decade, expanding treatment options that have so far been limited to hypomethylating agent (HMA) monotherapy alone. Even with current treatment options, outcomes for people living with HR-MDS remain poor.
The Breakthrough Therapy Designation is based on the final analysis of the Pevonedistat-2001 Phase 2 study, which evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including HR-MDS. The FDA considered a number of endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, as well as the adverse event profile. This designation signals a potential advancement in addressing the needs of people living with HR-MDS, for whom few therapies exist and the benefits are limited.
“Higher-risk MDS is associated with poor prognosis, diminished quality of life and a higher chance of transformation to acute myeloid leukemia, another aggressive cancer. The combination of pevonedistat and azacitidine is a promising therapeutic approach with the potential to be the first novel treatment advancement for higher-risk MDS in more than 10 years,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “We thank the FDA for recognizing pevonedistat, and the urgency to develop innovative therapies that address critical treatment needs for higher-risk MDS, a patient population with few options.”
Breakthrough Therapy Designation from the U.S. FDA is granted to accelerate the development and regulatory review of investigational drugs that are intended to treat serious or life-threatening ailments. Agents with this designation have shown preliminary clinical evidence that indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Takeda presented results of the Pevonedistat-2001 trial during oral sessions at the virtual 56th American Society of Clinical Oncology (ASCO) Annual Meeting and virtual 25th European Hematology Association (EHA) Annual Congress.
About Pevonedistat
Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor. In pre-clinical studies, the inhibition of NAE by pevonedistat blocked the modification of select proteins, which resulted in disruption of cell cycle progression and cell survival, leading to cancer cell death. Pevonedistat in combination with azacitidine demonstrated promising clinical activity in a Phase 2 study of patients with higher-risk myelodysplastic syndromes (HR-MDS), higher-risk chronic myelomonocytic leukemia (HR-CMML) and acute myeloid leukemia (AML) and a Phase 1 study of patients with AML. Pevonedistat is currently being evaluated in Phase 3 studies as a first-line treatment for patients with HR-MDS, HR-CMML and AML, who are ineligible (unfit) for transplant or intensive induction chemotherapy, and in a Phase 2 study in unfit AML in a triple combination with azacitidine and venetoclax. Pevonedistat is an investigational drug for which safety and efficacy have not been established.
About MDS
MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. This cancer most commonly affects older patients, with the median age of diagnosis ranging from 60 to 74 years. As a result of this irregular production, a person with MDS does not have enough normal red blood cells, white blood cells and/or platelets in circulation. Symptoms for MDS are often vague and related to low blood counts, and may include fatigue, shortness of breath, easy bruising or bleeding, loss of appetite, weakness, pale skin, fever and frequent or severe infections.
There are several classifications of MDS – very low-risk to very high-risk – determined by blood counts, blast counts, mutations and cytogenetics. Higher-risk disease is defined as intermediate, high or very high risk on the International Prognostic Scoring System – Revised (IPSS-R), and these patients have a poorer prognosis. Approximately 40% of patients with HR-MDS transform to AML, another aggressive cancer with poor outcomes.
Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com
Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005233/en/
Contacts
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095
Media outside Japan
Sara Noonan
sara.noonan@takeda.com
+1 617-551-3683
Permalink : https://www.aetoswire.com/news/takeda-announces-us-fda-breakthrough-therapy-designation-granted-for-pevonedistat-for-the-treatment-of-patients-with-higher-risk-myelodysplastic-syndromes-hr-mds/en
– Pevonedistat Could be First Novel Treatment Option for HR-MDS in More Than a Decade –
CAMBRIDGE, Mass. & OSAKA, Japan-Thursday 30 July 2020 [ AETOS Wire ]
(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for its investigational drug pevonedistat for the treatment of patients with higher-risk myelodysplastic syndromes (HR-MDS). Pevonedistat, a first in class NEDD8-activating enzyme (NAE) inhibitor, could be the first novel treatment for HR-MDS patients in more than a decade, expanding treatment options that have so far been limited to hypomethylating agent (HMA) monotherapy alone. Even with current treatment options, outcomes for people living with HR-MDS remain poor.
The Breakthrough Therapy Designation is based on the final analysis of the Pevonedistat-2001 Phase 2 study, which evaluated pevonedistat plus azacitidine versus azacitidine alone in patients with rare leukemias, including HR-MDS. The FDA considered a number of endpoints, including overall survival (OS), event-free survival (EFS), complete remission (CR) and transfusion independence, as well as the adverse event profile. This designation signals a potential advancement in addressing the needs of people living with HR-MDS, for whom few therapies exist and the benefits are limited.
“Higher-risk MDS is associated with poor prognosis, diminished quality of life and a higher chance of transformation to acute myeloid leukemia, another aggressive cancer. The combination of pevonedistat and azacitidine is a promising therapeutic approach with the potential to be the first novel treatment advancement for higher-risk MDS in more than 10 years,” said Christopher Arendt, Head, Oncology Therapeutic Area Unit, Takeda. “We thank the FDA for recognizing pevonedistat, and the urgency to develop innovative therapies that address critical treatment needs for higher-risk MDS, a patient population with few options.”
Breakthrough Therapy Designation from the U.S. FDA is granted to accelerate the development and regulatory review of investigational drugs that are intended to treat serious or life-threatening ailments. Agents with this designation have shown preliminary clinical evidence that indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Takeda presented results of the Pevonedistat-2001 trial during oral sessions at the virtual 56th American Society of Clinical Oncology (ASCO) Annual Meeting and virtual 25th European Hematology Association (EHA) Annual Congress.
About Pevonedistat
Pevonedistat is a first in class NEDD8-activating enzyme (NAE) inhibitor. In pre-clinical studies, the inhibition of NAE by pevonedistat blocked the modification of select proteins, which resulted in disruption of cell cycle progression and cell survival, leading to cancer cell death. Pevonedistat in combination with azacitidine demonstrated promising clinical activity in a Phase 2 study of patients with higher-risk myelodysplastic syndromes (HR-MDS), higher-risk chronic myelomonocytic leukemia (HR-CMML) and acute myeloid leukemia (AML) and a Phase 1 study of patients with AML. Pevonedistat is currently being evaluated in Phase 3 studies as a first-line treatment for patients with HR-MDS, HR-CMML and AML, who are ineligible (unfit) for transplant or intensive induction chemotherapy, and in a Phase 2 study in unfit AML in a triple combination with azacitidine and venetoclax. Pevonedistat is an investigational drug for which safety and efficacy have not been established.
About MDS
MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. This cancer most commonly affects older patients, with the median age of diagnosis ranging from 60 to 74 years. As a result of this irregular production, a person with MDS does not have enough normal red blood cells, white blood cells and/or platelets in circulation. Symptoms for MDS are often vague and related to low blood counts, and may include fatigue, shortness of breath, easy bruising or bleeding, loss of appetite, weakness, pale skin, fever and frequent or severe infections.
There are several classifications of MDS – very low-risk to very high-risk – determined by blood counts, blast counts, mutations and cytogenetics. Higher-risk disease is defined as intermediate, high or very high risk on the International Prognostic Scoring System – Revised (IPSS-R), and these patients have a poorer prognosis. Approximately 40% of patients with HR-MDS transform to AML, another aggressive cancer with poor outcomes.
Takeda’s Commitment to Oncology
Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com
Important Notice
For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.
The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.
Forward-Looking Statements
This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005233/en/
Contacts
Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095
Media outside Japan
Sara Noonan
sara.noonan@takeda.com
+1 617-551-3683
Permalink : https://www.aetoswire.com/news/takeda-announces-us-fda-breakthrough-therapy-designation-granted-for-pevonedistat-for-the-treatment-of-patients-with-higher-risk-myelodysplastic-syndromes-hr-mds/en
Posted by
Business Daily Africa
Velodyne Lidar Sensors Power Emesent’s Hovermap to Fly Beyond the Visual Line of Sight
Emesent’s AL2 for Hovermap Leverages Velodyne Lidar to Access the Inaccessible
SAN JOSE, Calif.-Friday 31 July 2020 [ AETOS Wire ]
(BUSINESS WIRE) -- Velodyne Lidar, Inc. today announced that Emesent’s newly introduced Autonomy Level 2 (AL2) technology for Hovermap uses Velodyne lidar sensors to provide real-time perception and high-quality, accurate 3D data. Hovermap is a plug-and-play mapping and autonomy payload for industrial drones that enables autonomous flight in areas beyond visual line of sight (BVLOS) and without GPS connectivity.
The AL2 technology uses Velodyne’s Puck LITE lidar as the primary perception and mapping sensor. This allows autonomous exploration, navigation and lidar mapping in challenging inaccessible environments such as mines, civil construction works, telecommunications infrastructure and disaster response environments. As part of Emesent’s simultaneous localization and mapping (SLAM) based autonomy stack, AL2 powers drones to fly beyond communications range, self-navigate and avoid obstacles including thin wires and branches.
AL2 can be operated from take-off to landing by setting smart waypoints in a live 3D map streamed to a tablet. This allows operators to remain a safe distance from hazardous environments such as brows, stope edges, confined spaces and heights. The rich data from the Puck LITE sensor enables companies to gain better data insights on how to make mines and other environments safe.
“The Velodyne Puck LITE is simply a sensational sensor for creating drone-based mapping and autonomy solutions because of its compact size, light weight and performance – all critical for drone-mounted systems,” said Dr. Stefan Hrabar, Emesent CEO. “The sensor was an essential ingredient in helping us to create game-changing new technology that can obtain vital data in challenging environments in real time without risking the machine or operator safety.”
Emesent is an Automated with Velodyne partner at the forefront of GPS-denied drone autonomy. The company recently placed fourth in the urban circuit of the DARPA Subterranean (“SubT”) Challenge together with the Robotics and Autonomous Systems Group at the Commonwealth Scientific and Industrial Research Organization (CSIRO) and Georgia Institute of Technology.
“Emesent’s innovative use of Velodyne’s lidar sensors is helping to deliver valuable data and insights that were previously impossible to access,” said Jon Barad, Vice President of Business Development, Velodyne Lidar. “In addition to what they provide today to the mining, infrastructure, survey and mapping industries, it is exciting to consider how this innovation will help usher in a new era of autonomous drone operation across a variety of other industries.”
In the United States, the Federal Aviation Administration (FAA) currently has restrictions on drones flying beyond the visual line of sight. Emesent’s technology innovation could potentially usher in a new era of safe, autonomous drone flight – not only in mines but everywhere.
Velodyne Puck LITE sensors deliver a high-resolution image to measure and analyze indoor and outdoor environments. Designed for applications that require a sensor with a low weight and compact size, the Puck LITE delivers outstanding resolution and performance for mobile and UAV/drone applications. It provides a full 360-degree environmental view to deliver real-time 3D data.
About Velodyne Lidar
Velodyne provides smart, powerful lidar solutions for autonomy and driver assistance. Headquartered in San Jose, Calif., Velodyne is known worldwide for its portfolio of breakthrough lidar sensor technologies. Velodyne’s founder, David Hall, invented real-time surround view lidar systems in 2005 as part of Velodyne Acoustics. Mr. Hall’s invention revolutionized perception and autonomy for automotive, new mobility, mapping, robotics, and security. Velodyne’s high-performance product line includes a broad range of sensing solutions, including the cost-effective Puck™, the versatile Ultra Puck™, the autonomy-advancing Alpha Prime™, the ADAS-optimized Velarray™, and the groundbreaking software for driver assistance, Vella™.
About Emesent
Emesent is a world-leader in drone autonomy, lidar mapping and data analytics. Founded in 2018, Emesent has since built a reputation for delivering high-quality data capture in the mining, infrastructure, survey and mapping industries. Their flagship product, Hovermap, is a smart mobile scanning unit that combines advanced collision avoidance and autonomous flight technologies to map hazardous and GPS-denied environments. Hovermap is uniquely versatile, it can be handheld, drone- or vehicle-mounted to map challenging, inaccessible areas. With a wide range of applications, Hovermap is being used by customers around the world.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005182/en/
Contacts
Landis Communications Inc.
Sean Dowdall
(415) 286-7121
velodyne@landispr.com
Permalink : https://www.aetoswire.com/news/velodyne-lidar-sensors-power-emesentrsquos-hovermap-to-fly-beyond-the-visual-line-of-sight/en
SAN JOSE, Calif.-Friday 31 July 2020 [ AETOS Wire ]
(BUSINESS WIRE) -- Velodyne Lidar, Inc. today announced that Emesent’s newly introduced Autonomy Level 2 (AL2) technology for Hovermap uses Velodyne lidar sensors to provide real-time perception and high-quality, accurate 3D data. Hovermap is a plug-and-play mapping and autonomy payload for industrial drones that enables autonomous flight in areas beyond visual line of sight (BVLOS) and without GPS connectivity.
The AL2 technology uses Velodyne’s Puck LITE lidar as the primary perception and mapping sensor. This allows autonomous exploration, navigation and lidar mapping in challenging inaccessible environments such as mines, civil construction works, telecommunications infrastructure and disaster response environments. As part of Emesent’s simultaneous localization and mapping (SLAM) based autonomy stack, AL2 powers drones to fly beyond communications range, self-navigate and avoid obstacles including thin wires and branches.
AL2 can be operated from take-off to landing by setting smart waypoints in a live 3D map streamed to a tablet. This allows operators to remain a safe distance from hazardous environments such as brows, stope edges, confined spaces and heights. The rich data from the Puck LITE sensor enables companies to gain better data insights on how to make mines and other environments safe.
“The Velodyne Puck LITE is simply a sensational sensor for creating drone-based mapping and autonomy solutions because of its compact size, light weight and performance – all critical for drone-mounted systems,” said Dr. Stefan Hrabar, Emesent CEO. “The sensor was an essential ingredient in helping us to create game-changing new technology that can obtain vital data in challenging environments in real time without risking the machine or operator safety.”
Emesent is an Automated with Velodyne partner at the forefront of GPS-denied drone autonomy. The company recently placed fourth in the urban circuit of the DARPA Subterranean (“SubT”) Challenge together with the Robotics and Autonomous Systems Group at the Commonwealth Scientific and Industrial Research Organization (CSIRO) and Georgia Institute of Technology.
“Emesent’s innovative use of Velodyne’s lidar sensors is helping to deliver valuable data and insights that were previously impossible to access,” said Jon Barad, Vice President of Business Development, Velodyne Lidar. “In addition to what they provide today to the mining, infrastructure, survey and mapping industries, it is exciting to consider how this innovation will help usher in a new era of autonomous drone operation across a variety of other industries.”
In the United States, the Federal Aviation Administration (FAA) currently has restrictions on drones flying beyond the visual line of sight. Emesent’s technology innovation could potentially usher in a new era of safe, autonomous drone flight – not only in mines but everywhere.
Velodyne Puck LITE sensors deliver a high-resolution image to measure and analyze indoor and outdoor environments. Designed for applications that require a sensor with a low weight and compact size, the Puck LITE delivers outstanding resolution and performance for mobile and UAV/drone applications. It provides a full 360-degree environmental view to deliver real-time 3D data.
About Velodyne Lidar
Velodyne provides smart, powerful lidar solutions for autonomy and driver assistance. Headquartered in San Jose, Calif., Velodyne is known worldwide for its portfolio of breakthrough lidar sensor technologies. Velodyne’s founder, David Hall, invented real-time surround view lidar systems in 2005 as part of Velodyne Acoustics. Mr. Hall’s invention revolutionized perception and autonomy for automotive, new mobility, mapping, robotics, and security. Velodyne’s high-performance product line includes a broad range of sensing solutions, including the cost-effective Puck™, the versatile Ultra Puck™, the autonomy-advancing Alpha Prime™, the ADAS-optimized Velarray™, and the groundbreaking software for driver assistance, Vella™.
About Emesent
Emesent is a world-leader in drone autonomy, lidar mapping and data analytics. Founded in 2018, Emesent has since built a reputation for delivering high-quality data capture in the mining, infrastructure, survey and mapping industries. Their flagship product, Hovermap, is a smart mobile scanning unit that combines advanced collision avoidance and autonomous flight technologies to map hazardous and GPS-denied environments. Hovermap is uniquely versatile, it can be handheld, drone- or vehicle-mounted to map challenging, inaccessible areas. With a wide range of applications, Hovermap is being used by customers around the world.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005182/en/
Contacts
Landis Communications Inc.
Sean Dowdall
(415) 286-7121
velodyne@landispr.com
Permalink : https://www.aetoswire.com/news/velodyne-lidar-sensors-power-emesentrsquos-hovermap-to-fly-beyond-the-visual-line-of-sight/en
Posted by
Business Daily Africa
Empagliflozin meets primary endpoint in reducing risk of cardiovascular death or hospitalization for heart failure in Phase III trial in adults with and without diabetes
- Empagliflozin significantly reduced the risk of cardiovascular death or hospitalization for heart failure versus placebo in the EMPEROR-Reduced heart failure trial. The study evaluated adults with heart failure with reduced ejection fraction
- Treatment of heart failure is an important unmet need with over half of those diagnosed dying within five years1
INGELHEIM, Germany & INDIANAPOLIS, US-Thursday 30 July 2020 [ AETOS Wire ]
(BUSINESS WIRE)-- Positive top-line results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, were announced today by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY). EMPEROR-Reduced met its primary endpoint, demonstrating superiority with empagliflozin (10 mg) compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care. Overall, the safety profile was similar to the known safety profile of empagliflozin.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200730005445/en/
“Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” said Milton Packer, M.D., Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas, Texas, US. “The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments.”
Heart failure is the leading cause of hospitalization in the US and Europe, and the number of patients across Asia is also increasing.2 The risk of death in people with heart failure rises with each hospital admission.3 Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart.4 Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.5
“One in five people can expect to develop heart failure in their lifetime, so it is very encouraging to see these positive results from the EMPEROR-Reduced trial demonstrating that empagliflozin improves heart failure outcomes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are excited to share the full results and are working tirelessly to explore how empagliflozin can improve the lives of people living with heart failure.”
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the European Society of Cardiology (ESC) congress 2020 on 29 August, and regulatory submissions are planned in 2020. A second trial, EMPEROR-Preserved, is exploring the effect of empagliflozin on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction – an area with no approved treatment options.6,7 EMPEROR‑Preserved results are expected in 2021.
The EMPEROR trials are part of the EMPOWER clinical program, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.
“These results build upon the already established cardiovascular benefits of empagliflozin in adults living with type 2 diabetes and cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “Metabolic conditions that affect the heart and kidneys can lead to serious consequences, including hospitalizations and death. Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating clinical outcomes. We look forward to seeing how empagliflozin can help adults around the world living with these conditions.”
About the EMPEROR Heart Failure Studies6,8
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with chronic heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
Number of patients: 3,730
Completion: 2020
EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
Anticipated number of patients: approx. 5,990
Estimated completion: 2021
*Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood.
HFrEF occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.
HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.
About the EMPOWER program
The Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.9 Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and a real-world evidence study, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 27,000 adults enrolled worldwide in clinical trials, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.10 It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages.11 Heart failure is highly prevalent in people with diabetes;12 however, approximately half of all people with heart failure do not have diabetes.11,13
The empagliflozin heart failure program was initiated based on data from the EMPA-REG OUTCOME® trial, which assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo.14
About Cardio-Renal-Metabolic Conditions
Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.9
The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.15,16
Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.
About Empagliflozin
Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.17,18,19
Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, initiation of empagliflozin also prevents salt being re-absorbed, leading to increased excretion of salt from the body and reducing the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.20
Please click on the following link for ‘Notes to Editors’ and ‘References’ https://www.boehringer-ingelheim.com/press-release/emperor-reduced-heart-failure-toplineresults
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005445/en/
Contacts
Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 172209
Stephan Thalen
Global Business Communications
Lilly Diabetes
Email: stephan.thalen@lilly.com
Phone: +1 (317) 276 8304
Permalink : https://www.aetoswire.com/news/empagliflozin-meets-primary-endpoint-in-reducing-risk-of-cardiovascular-death-or-hospitalization-for-heart-failure-in-phase-iii-trial-in-adults-with-and-without-diabetes/en
- Treatment of heart failure is an important unmet need with over half of those diagnosed dying within five years1
INGELHEIM, Germany & INDIANAPOLIS, US-Thursday 30 July 2020 [ AETOS Wire ]
(BUSINESS WIRE)-- Positive top-line results from the EMPEROR-Reduced Phase III trial in adults with heart failure with reduced ejection fraction, with and without diabetes, were announced today by Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY). EMPEROR-Reduced met its primary endpoint, demonstrating superiority with empagliflozin (10 mg) compared to placebo in reducing the risk for the composite of cardiovascular death or hospitalization due to heart failure, when added to standard of care. Overall, the safety profile was similar to the known safety profile of empagliflozin.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200730005445/en/
“Heart failure is a common, but very serious chronic cardiovascular disorder, and it causes substantial disability while threatening the lives of millions of people worldwide,” said Milton Packer, M.D., Chair of the Executive Committee for the EMPEROR Program and Distinguished Scholar in Cardiovascular Science at Baylor University Medical Center in Dallas, Texas, US. “The results of the EMPEROR-Reduced trial indicate that SGLT2 inhibitors have the potential to become a new standard of care for this disease, which will be a meaningful addition to currently established treatments.”
Heart failure is the leading cause of hospitalization in the US and Europe, and the number of patients across Asia is also increasing.2 The risk of death in people with heart failure rises with each hospital admission.3 Heart failure with reduced ejection fraction occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared to a normally functioning heart.4 Symptoms associated with heart failure, such as breathlessness and fatigue, can impact quality of life.5
“One in five people can expect to develop heart failure in their lifetime, so it is very encouraging to see these positive results from the EMPEROR-Reduced trial demonstrating that empagliflozin improves heart failure outcomes,” said Waheed Jamal, M.D., Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “We are excited to share the full results and are working tirelessly to explore how empagliflozin can improve the lives of people living with heart failure.”
Full results from the EMPEROR-Reduced trial will be presented in a hot line session at the European Society of Cardiology (ESC) congress 2020 on 29 August, and regulatory submissions are planned in 2020. A second trial, EMPEROR-Preserved, is exploring the effect of empagliflozin on cardiovascular death or hospitalization in adults with heart failure with preserved ejection fraction – an area with no approved treatment options.6,7 EMPEROR‑Preserved results are expected in 2021.
The EMPEROR trials are part of the EMPOWER clinical program, one of the broadest and most comprehensive of any SGLT2 inhibitor, exploring the impact of empagliflozin on the lives of people across the spectrum of cardio-renal-metabolic conditions.
“These results build upon the already established cardiovascular benefits of empagliflozin in adults living with type 2 diabetes and cardiovascular disease,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Lilly. “Metabolic conditions that affect the heart and kidneys can lead to serious consequences, including hospitalizations and death. Through our EMPOWER clinical program, we are committed to advancing knowledge about these devastating clinical outcomes. We look forward to seeing how empagliflozin can help adults around the world living with these conditions.”
About the EMPEROR Heart Failure Studies6,8
The EMPEROR (EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure) chronic heart failure studies are two Phase III, randomized, double-blind trials investigating once-daily empagliflozin compared with placebo in adults with chronic heart failure with preserved or reduced ejection fraction*, both with and without diabetes, who are receiving current standard of care:
EMPEROR-Reduced [NCT03057977] investigated the safety and efficacy of empagliflozin in patients with chronic heart failure with reduced ejection fraction (HFrEF).
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure
Number of patients: 3,730
Completion: 2020
EMPEROR-Preserved [NCT03057951] investigates the safety and efficacy of empagliflozin in patients with chronic heart failure with preserved ejection fraction (HFpEF).
Primary endpoint: time to first event of adjudicated cardiovascular death or adjudicated hospitalization for heart failure [Time Frame: up to 38 months]
Anticipated number of patients: approx. 5,990
Estimated completion: 2021
*Ejection fraction is a measurement of the percentage of blood the left ventricle pumps out with each contraction. When the heart relaxes, the ventricle refills with blood.
HFrEF occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart.
HFpEF occurs when the heart muscle contracts normally but the ventricle does not fill with enough blood, so less blood can enter the heart compared with a normally functioning heart.
About the EMPOWER program
The Alliance has developed the EMPOWER program to explore the impact of empagliflozin on major clinical cardiovascular and renal outcomes in a spectrum of cardio-renal-metabolic conditions. Cardio-renal-metabolic conditions are the leading cause of mortality worldwide and account for up to 20 million deaths annually.9 Through the EMPOWER program, Boehringer Ingelheim and Lilly are working to advance knowledge of these interconnected systems and create care which offers integrated, multi-organ benefits. Comprised of nine clinical trials and a real-world evidence study, EMPOWER reinforces the long-term commitment of the Alliance to improve outcomes for people living with cardio-renal-metabolic conditions. With more than 27,000 adults enrolled worldwide in clinical trials, it is one of the broadest and most comprehensive clinical programs for an SGLT2 inhibitor to date.
About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body’s demands for oxygenated blood or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues.10 It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages.11 Heart failure is highly prevalent in people with diabetes;12 however, approximately half of all people with heart failure do not have diabetes.11,13
The empagliflozin heart failure program was initiated based on data from the EMPA-REG OUTCOME® trial, which assessed the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo.14
About Cardio-Renal-Metabolic Conditions
Boehringer Ingelheim and Lilly are driven to transform care for people with cardio-renal-metabolic conditions, a group of interconnected disorders that affect more than one billion people worldwide and are a leading cause of death.9
The cardiovascular, renal and metabolic systems are interconnected, and share many of the same risk factors and pathological pathways along the disease continuum. Dysfunction in one system may accelerate the onset of others, resulting in progression of interconnected diseases such as type 2 diabetes, cardiovascular disease, heart failure, and kidney disease, which in turn leads to an increased risk of cardiovascular death. Conversely, improving the health of one system can lead to positive effects throughout the others.15,16
Through our research and treatments, our goal is to support people’s health, restoring the balance between the interconnected cardio-renal-metabolic systems and reducing their risk of serious complications. As part of our commitment to those whose health is jeopardized by cardio-renal-metabolic conditions, we will continue embracing a multidisciplinary approach towards care and focusing our resources on filling treatment gaps.
About Empagliflozin
Empagliflozin (marketed as Jardiance®) is an oral, once daily, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor and the first type 2 diabetes medicine to include cardiovascular death risk reduction data in its label in several countries.17,18,19
Inhibition of SGLT2 with empagliflozin in people with type 2 diabetes and high blood sugar levels prevents sugar being re-absorbed by the kidneys, leading to the excretion of excess sugar in the urine. In addition, initiation of empagliflozin also prevents salt being re-absorbed, leading to increased excretion of salt from the body and reducing the fluid load of the body’s blood vessel system (i.e. intravascular volume). Empagliflozin induces changes to the sugar, salt and water metabolism in the body that may contribute to the reductions in cardiovascular death observed in the EMPA-REG OUTCOME® trial.20
Please click on the following link for ‘Notes to Editors’ and ‘References’ https://www.boehringer-ingelheim.com/press-release/emperor-reduced-heart-failure-toplineresults
View source version on businesswire.com: https://www.businesswire.com/news/home/20200730005445/en/
Contacts
Stefanie Molkenthin
Product Communication Manager
Boehringer Ingelheim
Email: press@boehringer-ingelheim.com
Phone: +49 (6132) 77 172209
Stephan Thalen
Global Business Communications
Lilly Diabetes
Email: stephan.thalen@lilly.com
Phone: +1 (317) 276 8304
Permalink : https://www.aetoswire.com/news/empagliflozin-meets-primary-endpoint-in-reducing-risk-of-cardiovascular-death-or-hospitalization-for-heart-failure-in-phase-iii-trial-in-adults-with-and-without-diabetes/en
Posted by
Business Daily Africa
Sunday, August 2, 2020
Union of Arab Banks, Union of Arab Chambers and INSME Issue Digital Economy Guidelines with GCEL to Reenergize the Banking Industry and Jump-Start the Global Economy
GENEVA-Friday 31 July 2020 [ AETOS Wire ]
(BUSINESS WIRE) -- International organizations released Ten Digital Economy Guidelines in alignment with the G20 Leaders’ policy directives that aim at securing sustainable economic growth. The Guidelines were adopted by the Union of Arab Banks (UAB), Union of Arab Chambers (UAC), International Network for SMEs (INSME), and the Global Coalition for Efficient Logistics (GCEL) to set the foundation for successfully implementing the Digital Economy.
The Digital Economy has been a key G20 policy directive since 2015. However, until today, no one has defined the Digital Economy, nor how it can be deployed to rebalance and grow the high, mid and low-income economies.
Following 15 years of R&D on digitizing the global economy, an international Coalition is leading a global economic development program that digitally “Jump Starts” national economies and their trade partners through a Digital Economy Platform (DEP). This Coalition involves the public sector representing 75% of the world's citizens. The Coalition will also involve the private sector comprised of the world's leading technology, e-commerce, finance, and insurance firms with USD 1.5 trillion revenues and a 4.7 million workforce.
These organizations will be united to deliver the DEP that maximizes the power of what technology makes possible today to reduce excess trade costs by USD 4.8 trillion, increase goods trade by USD 6.3 trillion, and create more than 400 million jobs by 2030.
Mr. Wissam Fattouh, UAB Secretary-General, commented on the benefits for the financial industry, “The DEP tools will better integrate banks to the B2B marketplace through the use of dynamic, high quality, and validated data. Our members will have greater transparency to reduce risks, ease regulatory compliance burdens and realize a new USD 7.5 trillion financial services market opportunity by 2030.”
This global program transforms the manufacturing, agriculture and services sectors by digitizing the value chains in 6 steps: 1) Create an online digital catalog of goods and services globally, 2) Optimize matching of buyers with sellers, 3) Increase the conversion ratio from seeing a product or service to acquisition, 4) Provide digital financing, 5) Secure digital Insurance, and 6) Deliver digital logistics and operations tools for business transactions.
Dr. Sergio Arzeni, INSME President and former OECD Director of the Centre for Entrepreneurship, exclaimed: “To ensure global adoption, the DE must be free of cost to end users, especially benefiting SMEs, yet sustained by a unique business model.”
The program offsets monopolistic and geopolitical concerns by empowering national e-commerce, finance and insurance firms to expand services and realize a new USD 20.5 trillion digital services market opportunity by 2030.
Dr. Khaled Hanafy, UAC Secretary-General, remarked, “The Digital Economy must encompass a global scoring mechanism that enables all users to perform an objective evaluation of performance risk when making business decisions.”
Captain Samuel Salloum, GCEL Chairman, commented that the Digital Economy must be based on a comprehensive solution, “The real Digital Economy provides seamlessly integrated commerce, finance, insurance, and logistics/operations verticals, which represent the main pillars of the B2B market place, the mother of all industries.”
The Ten Digital Economy Guidelines were developed to serve as the foundation for any future initiative related to the implementation of the Digital Economy. The Guidelines followed completion of the G20 Nations Case Study with 90 ministries, IGOs/NGOs, academia, and private sector experts representing 80% of the global GDP. Nearly 95% of the G20 B2B participants defined the digital tools they need to be more competitive.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200730005647/en/
Contacts
Press
GCEL
Gregory D. Bird
Deputy Secretary-General
g.bird@gcel.net
Permalink : https://www.aetoswire.com/news/union-of-arab-banks-union-of-arab-chambers-and-insme-issue-digital-economy-guidelines-with-gcel-to-reenergize-the-banking-industry-and-jump-start-the-global-economy/en
Posted by
Business Daily Africa
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