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Tremendous achievements have been made through public-private partnership since the launch of the London Declaration to 2020. The pharma industry has contributed to the elimination of NTDs via supply of medicines which resulted in donation of 13 billion high-quality treatments. Forty-three countries have eliminated at least one NTD and 600 million people no longer require interventions against NTDs. Despite such progress, more than 1.7 billion people remain threatened by NTDs.
In the event, CEO Haruo Naito said, "Our initiatives toward NTDs elimination are rooted in the pharmaceutical company's fundamental mission to deliver medicines to those who need them to treat illness and save lives. While R&D for NTDs treatments have become more active after the London Declaration, establishment of agile and flexible regulatory approval system as well as expansion of funding which leverages public-private partnership will be required to accelerate further innovations. Utilization of digital technologies such as remote medicine will help ensure delivery of and access to healthcare service under the vulnerable social infrastructure."
Under the London Declaration, Eisai has been manufacturing and supplying diethylcarbamazine (DEC) tablets, one of the lymphatic filariasis (LF) treatments, free of charge to the WHO for the elimination of LF. To date, 2.05 billion DEC tablets manufactured at Eisai's Vizag Plant in India have been supplied to 29 countries (as of January 2022). Although LF has been eliminated in 17 countries and the number of infected people has declined by 74% since 2000, 860 million people worldwide are still exposed to the risk of infection. Eisai is committed to providing DEC tablets for free to endemic countries that need DEC until LF is eliminated in these countries. In addition to the supply of DEC tablets, Eisai is working on various initiatives such as support for the mass drug administrations (MDA), disease awareness and improvements in sanitation.
Furthermore, Eisai is proactively engaged in development of new treatments for NTDs through partnerships with global research organizations. Utilizing the funding from the Global Health Innovative Technology Fund (GHIT Fund) and others, Eisai is conducting joint development of new treatments such as a new treatment for LF in collaboration with the Liverpool School of Tropical Medicine and the University of Liverpool as well as treatments for mycetoma and leishmaniasis in collaboration with the Drugs for Neglected Diseases initiative (DNDi).
Eisai commits to the Kigali Declaration and strengthens collaborations with global partners to tackle NTDs towards the achievement of NTD road map 2021-2030.
Based on human health care (hhc) philosophy, Eisai seeks to contribute to the health and welfare of people in developing and emerging countries. Once they recover their health, they can resume productive activities, which will in turn contribute to economic development and expansion of the middle-income class. Eisai considers this to be a long-term investment in creating the markets for the future. Eisai is actively engaged in leveraging partnerships with governments, international organizations, academia, and non-profit private sector organizations to accelerate the development of new treatments for infectious diseases including NTDs and facilitate initiatives to improve access to medicine such as support for MDAs and disease awareness activities. Through these initiatives, Eisai seeks to further contribute to patients and their families worldwide and increase the benefits that health care provides.
About Neglected Tropic Diseases (NTDs)
Neglected Tropic Diseases (NTDs) include 20 diseases that the WHO identifies as tropical diseases which human race must overcome. More than 1.7 billion people living in the poorest and most marginalized communities worldwide are exposed to the risk of NTDs infection. The spread of NTDs is mainly caused by poor hygienic conditions associated with poverty. Infections from these diseases may result in serious physical impairment and this often results in normal economic and social activities becoming highly challenging to the individual. In the worst cases, NTDs may also result in death. The prevalence of NTDs is a stumbling block to economic growth for developing and emerging countries and represents a serious issue for these regions.
The following 20 NTDs have been designated by WHO for control or elimination: dengue and chikungunya, rabies, trachoma, buruli ulcer, yaws (endemic treponematoses], leprosy (Hansen's disease], Chagas disease, human African trypanosomiasis (sleeping sickness], leishmaniasis, taeniasis / cysticercosis, dracunculiasis (guinea-worm disease), echinococcosis, food-borne trematodiases, lymphatic filariasis, onchocerciasis (river blindness], schistosomiasis, soil-transmitted helminthiases, mycetoma, scabies and other ectoparasites, and snakebite envenoming.
About London Declaration on Neglected Tropical Diseases
On January 30, 2012, the CEOs of 13 pharmaceutical companies*, the Bill & Melinda Gates Foundation, WHO, the U.S. Agency for International Development (USAID), the U.K. Department for International Development (DFID), the World Bank, and officials from NTD-endemic countries gathered in London to pledge their support for a coordinated effort to combat 10 NTDs**. The London Declaration represents the largest international public-private partnership in the field of global health to date, and unlike past approaches undertaken by an individual organization or for a single disease, the group has committed itself to working collaboratively in an effort to comprehensively tackle issues pertaining to drug supply, distribution, development, and implementation programs as it seeks to more effectively combat NTDs.
Commemorating the London Declaration, January 30 has been designated as the World NTD Day since 2020 and campaigns are held worldwide to light up the iconic landmarks and monuments in orange and purple, the symbol colors of NTDs. Eisai is sponsoring the light up of Tokyo Tower to raise disease awareness and disseminate the importance of eliminating NTDs.
* Abbvie, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, GlaxonSmithKline, Gilead, Johnson & Johnson, Merck (Merck KGaA: Germany), Merck Sharp & Dhome, Novartis, Pfizer, Sanofi
** Guinea worm disease, lymphatic filariasis, blinding trachoma, sleeping sickness (human African trypanosomiasis], leprosy, soil-transmitted helminthes, schistosomiasis, river blindness, Chagas disease, and visceral leishmaniasis
About Kigali Declaration on Neglected Tropical Diseases
As the successor of the London Declaration on NTDs launched in 2012, the Kigali Declaration represents a collective commitment from stakeholders to fight against NTDs. With the endorsements from stakeholders being initiated at the online event entitled "100% COMMITTED to End NTDs", a campaign to commemorate the 10th year anniversary of the London Declaration held on January 27, 2022, the Kigali Declaration will be unveiled at the Commonwealth Heads of Government Meeting (CHOGM) scheduled for June 2022 in Kigali, the capital of the Republic of Rwanda. To achieve the WHO's NTD roadmap 2021-2030, the Kigali Declaration aims to tackle NTDs comprehensively and sustainably by sustaining a multisectoral and multidisciplinary approach through public-private partnership, strengthening country ownership including establishment of local health system and domestic financing, accelerating research and development of treatments and diagnostics for NTDs and ensuring equitable access to these NTDs related products and services.
About Lymphatic Filariasis
Lymphatic filariasis (LF) is an NTD transmitted to humans via carrier mosquitoes. LF causes lymphatic dysfunction and can lead to the swelling of body parts such as legs, and cause severe pain, permanent disability and social stigma associated with disfiguring visible manifestations. As a result, patients suffer mental, social and financial losses. It is estimated that 860 million people worldwide, mainly those in developing countries, are exposed to the risk of LF. Elimination of LF is possible by stopping the spread of the infection through MDAs of three types of LF treatments including DEC tablets.
About Eisai's Commitment to Improving Global Access to Medicines including LF Elimination Program
In line with its hhc philosophy, Eisai is committed to improving global access to medicines over the medium-to-long term through partnership strategies that involve working with governments, international organizations, private entities and non-profit organizations.
In November 2010, Eisai agreed to supply a total of 2.2 billion DEC tablets to the WHO free of charge by 2020, as there was a global shortage of high-quality DEC tablets for use in MDAs. In 2012, Eisai became the only Japanese company to participate in the London Declaration, a coordinated effort to eliminate 10 NTDs and the largest public-private partnership of its kind in the field of global health. At the London Declaration's fifth anniversary event held in April 2017, Eisai announced its plan to supply DEC tablets continuously beyond 2020, until LF is eliminated in all endemic countries where DEC tablets are needed.
Eisai has supplied 2.05 billion tablets to 29 countries through the WHO's elimination program (as of January 2022). Furthermore, in order to support the smooth implementation of the WHO's MDA programs, Eisai is engaging in initiatives to raise public awareness of LF in endemic countries. Staff members of Eisai Group cooperate with the relevant representatives in endemic countries to eliminate LF as early as possible.
In addition to the above-mentioned initiatives, Eisai is moving ahead with new drug development projects targeting malaria and NTDs such as mycetoma and LF, based on partnerships with international non-profit organizations such as the Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV), as well as research organizations such as Liverpool School of Tropical Medicine, University of Kentucky, and the Broad Institute (please refer to the table above).
Furthermore, Eisai co-established the Global Health Innovative Technology Fund (GHIT Fund), Japan's first public-private partnership to advance development of new health technologies for the developing world, is a member of the World Intellectual Property Organization (WIPO) Re:Search Consortium, an international joint enterprise for the development of treatments for NTDs, malaria and tuberculosis led by WIPO, is a signatory to the Tuberculosis Drug Accelerator (TBDA) partnership, and is participating in the Access Accelerated initiative to promote prevention and treatment of non-communicable diseases.
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Eisai Co., Ltd.
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Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. announced today that its CEO Haruo Naito participated in the online event entitled "100% COMMITTED to End NTDs" celebrating the 10th anniversary of the London Declaration, an international public-private partnership to eliminate neglected tropical diseases (NTDs), on January 27, 2022.
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Eisai: Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM
Biogen aims to enroll 18 percent of U.S. participants in ENVISION from Black/African American and Latinx populations. This goal is reflective of Biogen's ongoing commitment to increase diversity in clinical trials.
"Historically, patients from diverse backgrounds have been poorly represented in Alzheimer's disease clinical trials, and we are committed to changing this," said Priya Singhal M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen. "This goal matches the diversity among Americans diagnosed with early Alzheimer's disease, while at the same time, the trial will generate substantial data to verify the effectiveness of ADUHELM."
Biogen will implement multiple strategies to help overcome barriers to diverse patient enrollment in Alzheimer's disease trials, such as, lack of access to medical centers, familiarity with benefit/risk profile of treatment, and financial or logistical burdens.
"It's important to see this ambitious focus on diversity being prioritized in enrollment and integrated as a key part of the ENVISION clinical trial, so that we can have data from patients who more closely represent what we see in the clinic," said Dylan Wint, M.D., Cleveland Clinic Lou Ruvo Center for Brain Health, Nevada.
The companies also announced today that the primary endpoint for the global, placebo-controlled ENVISION trial will be measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB) at 18 months after treatment initiation with ADUHELM. The CDR-SB endpoint is a validated measure of both cognition and function that is widely used in clinical trials of patients with early symptomatic Alzheimer's disease, is consistent with ADUHELM's Phase 3 EMERGE and ENGAGE studies, and capable of generating robust outcomes. The update also includes an increase in the previously announced enrollment, from 1,300 to 1,500 people with early Alzheimer's disease (Mild Cognitive Impairment due to Alzheimer's disease and mild Alzheimer's disease), with confirmation of amyloid beta pathology, to further strengthen the data provided by the study.
Although ENVISION and other ADUHELM clinical trials are already planned or underway, the Centers for Medicare and Medicaid Services (CMS) recently released a draft National Coverage Determination (NCD), which would restrict Medicare coverage of ADUHELM and other amyloid-targeting therapies to patients enrolled in additional clinical trials. Biogen is committed to engaging with CMS to avoid unnecessary duplication of clinical trials and work towards finding a path to offer immediate access to patients to the first FDA approved treatment for Alzheimer's disease since 2003.
In addition to the primary endpoint, CDR-SB, secondary endpoints include Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog 13), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Mild Cognitive Impairment Version (ADCS-ADL-MCI), Integrated Alzheimer's Disease Rating Scale (iADRS), Mini-Mental State Examination (MMSE) and Neuropsychiatric Inventory (NPI-10).
The initiation of patient screening for ENVISION is planned for May 2022. Based on enrollment rates from the previous Phase 3 trials with ADUHELM, the primary completion date is expected to be approximately four years after the study begins. The companies are grateful to the healthcare professionals, medical centers, patients and families who will participate in this trial.
Previously, in July 2021(New Window), the companies set another substantial diversity goal in the observational Phase 4 ICARE AD trial, which aims to enroll a total of approximately 6,000 patients.
About ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use
ADUHELM is indicated for the treatment of Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
ADUHELM is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer's disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or "ARIA". ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient's healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.
As of October 2017, Biogen and Eisai Co., Ltd. are collaborating on the global co-development and co-promotion of aducanumab.
About Biogen
As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has a leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.
In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.
About Eisai Co., Ltd.
Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.
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Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; results from ENVISION; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; clinical development programs, clinical trials and data readouts and presentations; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks associated with current and potential future healthcare reforms; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comBiogen Inc. and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer's disease, including details of the study's goal for diverse enrollment and primary endpoint.
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