The Swiss stock exchange, SIX announced that Swissquote has become one of the structured product issuers on its platform. The Swiss banking and trading platform has listed its first structured prod...

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Every cryptocurrency enthusiast needs to take note of crucial industry events, and the long-awaited launch of Astroswap is a highlight of 2022, as the project has sustained solid social excitement ...

Filipino group Titik Poetry launches a full album on NFT on the Tezos blockchain.

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TOKYO, Jan 28, 2022 - (JCN Newswire) - Eisai 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. CEO Naito represented pharmaceutical companies and highlighted the achievements of NTDs elimination activities by the industry and successes achieved by multi-sectoral partnerships. He also expressed Eisai's continued support for the elimination of NTDs towards the achievement of NTD road map 2021-2030 launched by the World Health Organization (WHO) last year. The 10th anniversary event aimed to recognize a decade of progress since the London Declaration, to confirm the strong commitment of stakeholders to continue the efforts for NTDs, and to strengthen endorsements from stakeholders to the Kigali Declaration on NTDs, the successor of the London Declaration which will be unveiled at the Commonwealth Heads of Government Meeting (CHOGM) scheduled for June 2022 in Kigali, the capital of the Republic of Rwanda.

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.

Media Inquiries:
Public Relations Department,
Eisai Co., Ltd.
+81-(0)3-3817-5120


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.

SINGAPORE, Jan 28, 2022 - (ACN Newswire) - SGX-listed Silverlake Axis Ltd, the ASEAN leader in next-generation digital core banking systems and solutions, today announced an expansion of its partnership with Silkbank, a leading commercial and Islamic bank in Pakistan. Through the latest agreement, Silkbank will upgrade its card management suite to use Silverlake's latest platform, Symmetri OmniCard V6.
OmniCard V6 is an internationally certified card management system that allows banks to run flexible and secure operations including issuing and acquiring of all types of credit, debit and prepaid cards, ATM management, 3D secure e-commerce transaction processing, management of fraud, disputes, and cardholder's loyalty. This latest move also strengthens Silverlake's leadership position within Pakistan's credit card market, where it currently commands an 80 percent market share. It also allows Pakistan's and the region's banks to tap into Silverlake's award winning technologies to grow their card footprints, and in the process better cater to customers.

Gyorgy Ladics, CEO of Silverlake Symmetri, commented: "We are immensely proud of the deep and long-standing partnership we have forged with Silkbank. Pakistan continues to establish itself as a fast-growing market, with huge potential for building its credit card market, and we are very optimistic about its growth. To that end, the trust Silkbank has placed in us is a true honor, and as we continue this exciting journey together, we are confident that this trust will see strong returns."

Nabeel Malik, Executive Director, Strategy Implementation & Ops/Admin/IT/CSQ at Silkbank, commented: "Silkbank always aims to stay ahead of the market by introducing unique products supported by latest technological tools. Silverlake has been a trusted partner to Silkbank for 9 years. As we continue to transform and advance the banking landscape in Pakistan with our innovative product offerings and best-in-class services, the in-depth experience, system understanding, and professionalism of Silverlake team will be a key factor for us to grow with confidence. We hope that we will be continuing this beneficial partnership in years to come."

With over 30 years of experience across industries, Silverlake creates technologies to empower businesses in the digital economy, transforming industries like banking, insurance, retail, and logistics. Silverlake Symmetri OmniCard is a universal card and payment management system, designed to help both acquiring and issuing institutions to run efficient, secure and profitable operations. Banks can reduce time to market for new card products while at the same time offer excellent service to drive loyalty across the customer base. The solution also enables them to cross-sell and up-sell, while reducing fraud and risk, and ensuring regulatory compliance.

"With Silverlake Axis already issuing 80% of cards in the market, Silkbank's partnership to deploy our credit card solutions only solidifies our leadership position in Pakistan. However, it's only one step in our growth plan. We are seeing strong opportunities across the MENA, South and Southeast Asia regions with our Islamic and retail banking partners as well," added Ladics.

About Silverlake Axis

Silverlake Axis Ltd. (SLVX.SI; SILV:SP) is a leading enterprise technology, software and services company focused on financial services and serving 40% of the top 20 largest banks in South East Asia. Founded in 1989, Silverlake has an impeccable track record of successful delivery of innovative and transformative solutions to its enterprise customers and their ecosystems. The Group has more than 380 enterprise customers in over 80 countries across Asia, Europe, Middle East, Africa and the Americas.

Silverlake Axis was listed on the Singapore Exchange (SGX) Catalist in 2003 and moved to the SGX Mainboard in 2011. For more information, please visit https://www.silverlakeaxis.com.

Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comSGX-listed Silverlake Axis Ltd (SGX:5CP), the ASEAN leader in core banking systems and solutions, today announced an expansion of its partnership with Silkbank, a leading commercial and Islamic bank in Pakistan. Through the latest agreement, Silkbank will upgrade its card management suite to use Silverlake's latest platform, Symmetri OmniCard V6.

The Metaverse has become a fever among cryptocurrency insiders and outsiders in recent months, with this in mind the team responsible for Shiba Inu announced their plans to launch Shiberse in 2022. The plan was announced via Twitter. The so-called “first surprise of the year” coming for ShibArmy says that Shiba Inu is heading towards […]

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Japan must cooperate with Europe and the United States in creating a global standard on the technical aspects of issuing a central bank digital currency (CBDC), the chief of Japan’s central bank said on Friday. Several central banks across the world are actively working on their national digital currencies.    Bank of Japan is yet […]

Bitcoin was created to obliterate the type of control that the FATF seeks to enforce.

HONG KONG, Jan 28, 2022 - (ACN Newswire) - EuroEyes International Eye Clinic Limited ("EuroEyes" or the "Company", together with its subsidiaries, the "Group", stock code: 1846), a leading global vision correction service provider, is pleased to announce that EuroEyes UK, a wholly-owned subsidiary of the Company, has entered into a Share Purchase Agreement ("Share Purchase Agreement") to acquire the entire issued shares in London Vision Clinic Partners Limited ("LoVC") with the legal and beneficial owners of LoVC ("Sellers").

According to the share purchase agreement, the total cash consideration and consideration shares for the acquisition shall be GBP13,130,000; the maximum amount of earn out payment shall be GBP17,745,000, and subject to the Consideration Adjustment. The maximum consideration for the Acquisition shall be GBP 30,875,000. In terms of earn out payment, under the first profit target, if the Seller maintains an EBIT growth of 12.5% for four consecutive years, EuroEyes shall procure the allotment and issue to the Seller such number of shares having an aggregate value of up to GBP3,120,000; Under the second profit target, if the Seller achieves an EBIT growth rate of 35% for three consecutive years, and 25% in the fourth year, Euroeyes shall pay GBP 9,750,000 to the Seller.

Upon Completion, the Seller (or the Partners as nominated in accordance with the terms and conditions of the Share Purchase Agreement) will hold approximately 1.20% of the issued share capital of EuroEyes as enlarged by the allotment and issue of the Completion Consideration Shares. The Completion Consideration Shares will be issued at the issue price of HK$8.323 per Completion Consideration Share which represents a discount of approximately 6.9% to the average closing price of HK$8.94 per Share as quoted on the Stock Exchange on the five consecutive trading days ended on the trading day immediately preceding 20 January 2022. The shareholding will serve as an share incentive to motivate and retain London Vision Clinic's partners and key surgeons.

London Vision Clinic Partners Limited is one of the leading brands in the vision correction industry and principally engaged in the provision of premium vision correction services, including PRK, LASIK, SMILE, phakic lens (ICL) surgery and refractive cataract surgery. It has been the market segment and price leader in the UK with its capabilities in conducting detailed and comprehensive testing and diagnosis and has a world reputation for expertise in providing training to specialist surgeons and managing complicated cases.

Moreover, LoVC is a world leader in offering laser vision correction option for reading vision in ageing eyes (presbyopia). Its founder, Professor Dan Zoltan Reinstein, has garnered worldwide reputation for his inventions and major contributions to the refractive surgery field, including the invention of the PRESBYOND Laser Blended Vision treatment as commercialised by Carl Zeiss Meditec for presbyopia which is designed to treat patients from the age of 40 years old, who have developed presbyopia (decreased ability to read up close). PRESBYOND provides an additional method of treating younger patients with presbyopia by a LASIK procedure, which avoids the need to perform surgery inside the eye to replace the natural lens. Presbonyd will a perfect addition to EuroEyes' trifocal lens exchange surgery, which enables EuroEyes to treat a larger group of presbyopia patients over 40 years old without buying new equitments.

In addition, London Vision Clinic has a talent pool of high-quality surgeons and doctors. Upon completion of the Acquisition, EuroEyes will continue to hire the expert group to further strengthen its medical expertise. What's more, Professor Reinstein will serve as a medical director of the international medical advisory board of the Group, which will add tremendous value to EuroEye's expert team.

Professor Reinstein is also a bioengineering pioneer, inventor and developer in the field of layered corneal mapping and imaging and biometry. He had pioneered corneal imaging and biometry with very high-frequency digital ultrasound scanning, invented the Arcscan Insight 100 robotic scanner as well as optical coherence tomography (OCT) devices, enabling superior diagnostic capabilities to improve the safety and accuracy of both laser corneal and ICL surgery. Application of his patented biometric technologies has resulted in major contributions to the clinical and scientific development of both LASIK and SMILE.

Moreover, London Vision Clinic Training, a wholly-owned subsidiary of LoVC, will start business afer acquisition, and will be principally engaged in the provision of online and offline training relating to refractive surgery. Professor Reinstein will be one of the key speakers and trainers at London Vision Clinic Training.

In addition, in terms of the financial position of the target company, London Vision Clinic Partners Limited has shown strong growth potential, with a substantial increase in EBIT from GBP 94,000 in 2020 to GBP 2.19 million in 2021. This growth is mainly due to the proactive optimizations and improvements in its business model and operation management made by LoVC started in early 2021.

Dr. Jorn Slot Jorgensen, Founder, Chairman and CEO of EuroEyes said, "The Group has been actively expanding its current footprint in Europe and the acquisition of LoVC is definitely in line with our growth strategy. We believe that the acquisition will enable the Group to quickly tap into the high-end London market for refractive and presbyopic surgeries, create synergy and support the long-term growth of the Group, thereby enhancing its market leader status. With the additions of LoVC and its PRESBYOND Laser Blended Vision treatment, the Group will be able to reach out to more potential patients who are suffering from presbyopia at an early stage. Following the acquisition of LoVC, we plan to open a new clinic in London within 1-2 year, to further expand our service network and provide more patients with high-quality eye care services."

About EuroEyes International Eye Clinic Limited
EuroEyes was established in 1993 and is one of the leading brands in the vision correction industry that combines German ophthalmology excellence and over 25 years of experience with individualised customer care. EuroEyes is one of the few eye clinic groups with a far-reaching geographical coverage, with operations in Germany, Denmark and the PRC. The Group's vision correction services include (i) refractive laser surgery (which includes ReLEx smile and Femto LASIK); (ii) phakic lens (ICL) surgery; (iii) lens exchange surgery (which includes the monofocal and trifocal lens exchange surgery) and (iv) others (which include PRK/LASEK and ICRS implantation).

Issued by Porda Havas International Finance Communications Group for and on behalf of EuroEyes International Eye Clinic Limited. For further information, please contact:

Porda Havas International Finance Communications Group
Email: [email protected]


Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comEuroEyes International Eye Clinic Limited ("EuroEyes" or the "Company", together with its subsidiaries, the "Group", stock code: 1846), a leading global vision correction service provider, is pleased to announce that EuroEyes UK, a wholly-owned subsidiary of the Company

TOKYO, Jan 28, 2022 - (JCN Newswire) - NEC Corporation (NEC; TSE: 6701) today announced it has signed a definitive agreement to acquire privately held Blue Danube Systems, Inc., a U.S.-based provider of CBRS/4G/5G RAN products and AI/ML-based software solutions that help mobile operators address the challenge of 5G network buildouts and spectrum optimization. The deal is expected to close around March of 2022, pending regulatory approval.

NEC, as a leading Open RAN provider that is recognized for its end-to-end Open 5G solutions and system integration capabilities, continues to invest in the 5G business through organic and inorganic initiatives, aligned with its "Mid-term Management Plan 2025." This acquisition expands NEC's customer support capability and assets in North America, and adds to the breadth of its Open RAN solutions portfolio to support the needs and demands of customers.

Blue Danube will join NEC with an innovative team that builds onto NEC's global 5G R&D capabilities, and the company's patented beamforming technologies will further enhance NEC's leadership in 4G and 5G Radio Units based on O-RAN specifications. Additionally, it will accelerate NEC's expansion of RAN software assets to help customers address issues related to spectrum efficiency, RAN optimization and reducing network OPEX.

"Blue Danube's 5G products complement our Open 5G solutions portfolio, enabling us to meet growing market demands and accommodate diversified use cases," said Shigeru Okuya, Senior Vice President, NEC Corporation. "This acquisition is a great opportunity for us to expand our 5G offerings and will bring substantial value to our customers. NEC has committed to a leadership position in Open RAN network development and this move extends our physical reach and innovation roadmap to deliver on that commitment."

About NEC Corporation

NEC Corporation has established itself as a leader in the integration of IT and network technologies while promoting the brand statement of "Orchestrating a brighter world." NEC enables businesses and communities to adapt to rapid changes taking place in both society and the market as it provides for the social values of safety, security, fairness and efficiency to promote a more sustainable world where everyone has the chance to reach their full potential. For more information, visit NEC at https://www.nec.com.

About Blue Danube Systems

Blue Danube Systems designs next generation wireless solutions for mobile networks and other applications. Our Coherent Massive MIMO solution brings 5G beamforming to today's networks, dramatically increasing network capacity and end user experience. Together with a cloud-based software suite utilizing machine learning techniques, our technology enables up to a 10X capacity increase in cellular networks. Blue Danube Systems is a privately held US-based start-up backed by Sequoia Capital and Silver Lake along with other investors including AT&T. For more information, please visit www.bluedanube.com.


Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comNEC Corporation (TSE: 6701) announced it has signed a definitive agreement to acquire privately held Blue Danube Systems, Inc., a U.S.-based provider of CBRS/4G/5G RAN products and AI/ML-based software solutions that help mobile operators address the challenge of 5G network buildouts and spectrum optimization.

Cambridge, MA, Jan 28, 2022 - (JCN Newswire) - Biogen 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.

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.

MEDIA CONTACTS
Biogen Inc.
Ashleigh Koss
+ 1-908-205-2572
[email protected]

Eisai Inc. (U.S. Media)
Public Relations Department
+1-201-753-1945

Eisai Co., Ltd. (Media Outside the U.S.)
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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.

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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.