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JCN Newswire

Eisai to Divest Rights for Anti-Epileptic Drug Fycompa (perampanel) CIII in United States to Catalyst Pharmaceuticals

December 20, 2022

TOKYO, Dec 20, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that it has entered into an agreement to transfer the United States (U.S.) commercial rights for the anti-epileptic drug (AED) Fycompa (generic name: perampanel) CIII to Catalyst Pharmaceuticals, Inc., as well as to provide Catalyst Pharmaceuticals with an exclusive negotiation period for an asset in Eisai's epilepsy pipeline. Eisai will maintain its rights to Fycompa in countries and regions outside the U.S. and continue to contribute to patients with epilepsy. Closing of the transaction is contingent on completion of review under antitrust laws in the U.S.The agreement will provide the opportunity for Eisai's neuroscience team to focus on its long-term strategic priorities on the research, development, and commercialization of its Alzheimer's disease portfolio. Eisai remains committed to drug discovery and research for anti-epileptogenesis through the modulation of neuroinflammation or lipid metabolism in glia cells, as well as the application of new technologies including spatial RNA-sequence. Research is a crucial aspect of Eisai's aim to gain a deeper understanding of human brain biology and technologies that may also ultimately lead to broader neuroscience discoveries. In the U.S., Fycompa was approved in 2012 and has been prescribed to more than 50,000 patients. Catalyst Pharmaceuticals is a company focused on developing therapies for rare neuromuscular as well as neurological disorders, and is increasing its presence in neurology in the U.S. The agreement is expected to maximize the patient value of Fycompa in the U.S. due to its strong commitment to patients living with epilepsy.Under the terms of the agreement, Eisai will receive a contractual up-front payment of $160 million (USD) upon closing of the transaction. In addition, milestone payments and royalties may be received in the future. Eisai will continue to be responsible for the manufacture and supply of Fycompa to global markets including the U.S. Eisai's U.S. subsidiary Eisai Inc. will provide transition services for a period to ensure patients continue to have access to this important medicine.As a result of this transaction, Eisai anticipates no changes to its consolidated financial forecast for the period ended March 31, 2023.Driven by our hhc concept, Eisai strives to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas: Neurology, Oncology and Global Health. As an hhceco company, Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities by creating solutions through building an ecosystem in collaboration with other industries.About Catalyst Pharmaceuticals, Inc.Catalyst Pharmaceuticals, Inc. (Catalyst Pharmaceuticals) is a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare diseases. With exceptional patient focus, Catalyst Pharmaceuticals is committed to developing a robust pipeline of cutting-edge, best-in-class medicines for rare diseases. Catalyst Pharmaceuticals' New Drug Application for FIRDAPSE (amifampridine) Tablets 10 mg for the treatment of adults with Lambert-Eaton myasthenic syndrome ("LEMS") was approved in 2018 by the U.S. Food & Drug Administration ("FDA") and FIRDAPSE is commercially available in the U.S. as a treatment for adults and children ages six to seventeen with LEMS. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120Eisai Inc. (U.S.)Christopher VancheriChristopher_vancheri@eisai.com551-305-0050 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

Asian and Pacific Countries Adopt Jakarta Declaration 2023-2032

October 24, 2022

JAKARTA, Oct 24, 2022 - (ACN Newswire via SEAPRWire.com) - The 'High-level Intergovernmental Meeting on the Final Review of the Asian and Pacific Decade of Persons with Disabilities' (HLIGM APDPD) closed on Friday (Oct 21) with 53 Asia-Pacific and 9 associated countries adopting the landmark Jakarta Declaration, marking the start of the fourth 'Asian and Pacific Decade of Persons with Disabilities'.53 Asia-Pacific and 9 associated UN ESCAP countries adopted the Jakarta Declaration 2023-2032, October 21, 2022. (ANTARA/Ministry of Social Affairs)Participants in the Meeting on the Final Review of the Asian and Pacific Decade of Persons with Disabilities 2013-2023, Oct 21, 2022. (ANTARA/Ministry of Social Affairs)"Today, on the last day of the high-level intragovernmental meeting in the Asia Pacific, we are adopting the Jakarta Declaration 2023-2032, which will be followed up by all members, accelerated and implemented," said the meeting chair and Indonesian Social Affairs Minister, Tri Rismaharini (Risma). "Through the Jakarta Declaration, we reaffirm our global commitment to a better life for all persons with disabilities," said Risma, emphasizing the commitment of Asia Pacific countries in realizing the Incheon Strategy, initiated ten years ago. "The priority issue is an alignment of the Convention on the Rights of Persons with Disabilities (CRPD) at the level of legislation.""It is time to increase efforts and take affirmative steps to implement universal design in all public areas, to increase the capacity of people handling persons living with disabilities in all sectors, and conduct national breakthrough campaigns to build awareness about disability," she said. "Harmonization of legislation is the toughest challenge for our own government, as it has central, provincial and regency/city government levels."Under-Secretary-General of the United Nations, and Executive Secretary of the Economic and Social Commission for Asia and the Pacific (UN ESCAP), Armida Salsiah Alisjahbana said although the implementation of the CRPD was making progress, people with disabilities in the Asia Pacific region face obstacles in education, work, decision making, and many other aspects.She invites UN ESCAP members to strengthen partnerships with disability organizations, the private sector, United Nations entities and the others to create a comprehensive community approach. Armida hopes that people with disabilities can participate in all policies and programs related to disability actively and significantly, in line with the spirit of 'nothing without us about us'.HLIGM APDPD was held on a hybrid basis from 19 - 21 October 2022 and was attended by delegates from 53 member states, 9 association member, observer countries, UN agencies, and civil society organizations.Written by: PR Wire, Editor: PR Wire (c) ANTARA 2022Source article at: https://en.antaranews.com/news/256377/asia-and-pacific-countries-make-jakarta-declaration-agreementUN ESCAP member countries also underlined the importance of making strategic investments to push disability-inclusive development through a whole-society approach in collaboration with relevant stakeholders, especially organizations of persons with disabilities and private sector entities, in order to accelerate action to promote and protect the rights of persons living with disabilities."I encourage all participants to continue their cooperation with one another and to take all necessary steps to make the recommendations formulated during this meeting in Jakarta. Now and in the next decade, we must come together and work it out," Rismaharini said.The first point of the Jakarta Declaration is to harmonize national legislations with the Convention on the Rights of Persons with Disabilities, after the convention is ratified, by conducting a comprehensive and regular review of national legislations and appropriate regional regulations.The second is to promote the meaningful participation of women and men with disabilities of all ages, including by closely consulting and actively involving children and youth with disabilities through their representative organizations, in planning, implementation, and decision-making on policies, programs, and political processes through reasonable accommodation.The third point involves special attention to the special needs of persons with diverse disabilities and women, children, and elderly with disabilities to increase accessibility of the physical environment, including information and communication technology and systems, public transportation, and essential information and services related to disaster risk and public health emergencies and other public services.The fourth is to promote the power of the private sector, including its resources, innovation, and technology talent, to push disability-inclusive development by adopting disability-inclusive public procurement policies to promote the adoption of universal design and accessibility measures for infrastructure, technology, and information and communication services that are publicly obtained.The fifth is to promote a gender-responsive life cycle approach to develop and implement policies and programs related to disability by paying special attention to children, youth, women, and elderly people living with disabilities.The sixth is to take action, based on information provided by competent national institutions and other recognized sources, to close the disability data gap and strengthen the capacity to track progress in disability-inclusive development at the national and subnational levels by producing comparable and qualified data as chosen by gender, age, and disability across sectors. Written by: Devi Nindy Sari R, Resinta S, Editor: Rahmad Nasution (c) ANTARA 2022Source article: https://en.antaranews.com/news/256205/53-asia-pacific-countries-agree-to-jakarta-declaration-on-disability Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

JCN Newswire

Eisai Inc. Collaborates with C2N to Build Awareness and Real-World Evidence for Blood-based Assays

August 24, 2022

TOKYO, Aug 24, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. announced today that its U.S. subsidiary Eisai Inc. has entered into a memorandum of understanding with C2N Diagnostics ("C2N") that will seek to build awareness about how blood-based assays in the diagnosis for people living with cognitive impairment, including Alzheimer's disease (AD), may help patients receive a timely diagnosis and appropriate treatment. Collaborating with C2N, Eisai Inc. will work to build awareness and develop real-world evidence to support the use of blood-based assays in people living with cognitive impairment in clinical practice outside of clinical trial settings in the U.S. Blood-based assays could result in the development of new standards in clinical care that may enable timely and accurate diagnoses for people living with cognitive impairment. The number of people with dementia is growing substantially; more than 55 million people worldwide are living with dementia, and this number is expected to increase to 78 million by 2030.(1) Accurate diagnosis remains a barrier to early and proper care management; research reviews estimate that between 40 and 60 percent of adults with probable dementia are undiagnosed.(2) Importantly, blood-based assays may be able to help identify which patients may benefit from therapy, and therefore may help streamline care and reduce healthcare spending. Early detection, diagnosis and treatment of dementia protects individuals against risks from delayed or missed diagnosis and allows individuals, their families and their caregivers to plan for the future as the condition progresses.(2) The development and adoption of blood-based assays as simple diagnostic tools, in every day clinical practice is an important step in improving care for people in remote and underserved communities where access to the traditional diagnostic tools of positron emission tomography (PET) and lumbar punctures are not a viable option. In collaboration with various partners, Eisai will engage in practical application of simple and less invasive diagnostic technologies and diagnostics for dementia, including blood tests, and will work to improve the medical environment in which people with dementia can receive appropriate treatment, thereby contributing to relieving anxieties of people living with dementia and their families around the world. About C2N Diagnostics and Its Blood-Based Biomarkers for Cognition HealthC2N Diagnostics ("C2N") is a specialty diagnostics company with a vision to bring Clarity Through Innovation. C2N strives to provide exceptional laboratory services and products in the field of brain health. C2N's biomarker services and products are used for: clinical decision making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. Its PrecivityAD blood test is an innovative new blood test intended for use in patients with cognitive impairment. Accurate quantification of Abeta42/40 ratio and ApoE prototyping in blood using its mass spectrometry platform helps healthcare providers determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer's disease. In addition, the P-tau Multi-Analyte Assay (P-tau MAA), which simultaneously measures four types of tau217 and tau181 phosphorylated and non-phosphorylated forms in blood sample, is now available for research use only (ROU). The assay is expected to aid in screening for clinical studies, better understanding of disease biology, as well as investigational drug research. For more information visit www.C2N.com(1) Alzheimer's Disease International. World Alzheimer Report 2021, Journey through the diagnosis of dementia.(2) The Milken Institute. Building Workforce Capacity to Improve Detection and Diagnosis of Dementia 2021.Media Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

JCN Newswire

U.S. FDA Accepts and Grants Priority Review for Eisai’s Biologics License Application of Lecanemab

July 6, 2022

TOKYO, Jul 6, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Eisai's application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023."Alzheimer's disease is a serious disease that causes significant disability and burden to the people living with Alzheimer's disease and their families. Treatment options for Alzheimer's disease are limited and creation of new treatment options is strongly encouraged. Eisai employees have spent time with people living with Alzheimer's disease to truly understand their feelings and challenges and have been working to create new treatments for many years," said Haruo Naito, Chief Executive Officer at Eisai. "The acceptance of lecanemab's BLA with priority review is an important milestone in serving people living with Alzheimer's disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer's disease. We will continue to actively cooperate with the FDA's review in an effort to bring this new treatment option to people living with Alzheimer's disease and their families as soon as possible.""We believe in a future where people living with Alzheimer's disease will have different treatment options to address this complex disease, and today's BLA acceptance with priority review by FDA is an important step towards this vision," said Michel Vounatsos, Chief Executive Officer at Biogen. "Together with Eisai, we are committed to continuing our work to address the tremendous unmet need for these patients and their families."The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and Eisai completed enrollment in March 2021 with 1,795 patients. The readout of the primary endpoint data of Clarity AD will occur in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Eisai utilized the FDA's Accelerated Approval Pathway in an effort to streamline the submission process for the potential traditional approval of lecanemab in order to expedite patients' access to lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai will submit for traditional approval of lecanemab to the FDA during Eisai's fiscal year 2022, which ends on March 31, 2023.In Japan, in March 2022, Eisai initiated the submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the aim of obtaining early approval for lecanemab. Eisai aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai's fiscal year 2022. Also, in Europe, based on the results of the Clarity AD study, Eisai plans to submit a new drug application in fiscal year 2022.Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.For more information, visit www.eisai.com/news/2022/pdf/enews202254pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)