Japan – Eisai: The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

Jan 12, 2024 | Business

Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI®), which is currently under review by the European Medicines Agency (EMA). The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024.

The SAG is convened at the request of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation by the CHMP, or on other scientific issues relevant to the work of the CHMP.

Eisai expects the European Commission’s decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product and Eisai having final decision-making authority.

About Lecanemab (generic name, brand name: LEQEMBI®)

Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). In the U.S., LEQEMBI was granted traditional approval by the U.S. Food and Drug Administration (FDA) on July 6, 2023. LEQEMBI is an amyloid beta-directed antibody indicated as a disease-modifying treatment for Alzheimer’s disease (AD) in the U.S. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment (MCI) 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. In Japan, Eisai received approval from the Ministry of Health, Labour and Welfare (MHLW) on September 25, 2023, to manufacture and market LEQEMBI as a treatment for slowing progression of MCI and mild dementia due to AD. Furthermore, in China, LEQEMBI was approved by the National Medical Products Administration (NMPA) as a treatment of mild cognitive impairment (MCI) due to AD and mild AD dementia on January 5, 2024.

Eisai has also submitted applications for approval of lecanemab in Canada, Great Britain, Australia, Switzerland, South Korea and Israel in addition to EU. In Israel the application has been designated for priority review, and in Great Britain lecanemab has been designated for the Innovative Licensing and Access Pathway (ILAP), which aims to reduce the time to market for innovative medicines.

Eisai has completed a lecanemab subcutaneous bioavailability study, and subcutaneous dosing is still being evaluated in the Clarity AD (Study 301) open-label extension (OLE). A maintenance dosing regimen has been evaluated as part of Study 201.

Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer’s Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen.

Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the Collaboration between Eisai and Biogen for AD

Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority.

About the Collaboration between Eisai and BioArctic for AD

Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market LEQEMBI for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody LEQEMBI back-up was signed in May 2015.

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

Hong Kong – Scientific Committee on Vaccine Preventable Diseases reviews use of pneumococcal vaccine in Hong Kong

Sep 27, 2023 | International

Scientific Committee on Vaccine Preventable Diseases reviews use of pneumococcal vaccine in Hong Kong

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     The Scientific Committee on Vaccine Preventable Diseases (SCVPD) under the Centre for Health Protection of the Department of Health (DH) convened a meeting yesterday (September 26) to review the use of pneumococcal vaccine in Hong Kong. Updated recommendations were published today (September 27). The meeting reviewed the epidemiology of invasive pneumococcal disease (IPD). Experts noted that IPD was more commonly found among children aged 2 to 4 years and elderly aged 65 years or above in Hong Kong, while serotype 3 was the predominant serotype causing IPD accounting for about half of all cases recorded during 2015 to 2019.

     Having reviewed the scientific data, the SCVPD considered that locally available pneumococcal vaccines, including two newly registered vaccines, namely 15-valent pneumococcal conjugated vaccine (PCV15) and 20-valent pneumococcal conjugated vaccine (PCV20), were safe and effective. In addition, PCV15 induced higher immunogenicity, comparing with PCV13 and PCV20, against Serotype 3 which is believed to be more effective in preventing IPD caused by this serotype. 

     Taking into consideration the local epidemiology and available scientific evidence, the SCVPD recommended to replace PCV13 with PCV15 under both the Hong Kong Childhood Immunisation Programme and the Government Pneumococcal Vaccination Programme. Relevant immunisation schedules for children and high-risk individuals would remain unchanged. When PCV15 is available under relevant government vaccination programmes, children can receive PCV15 with two primary doses given at 2 and 4 months of age followed by a booster dose at 12 months. Unvaccinated elderly aged 65 or above without a high-risk condition should receive a single dose of 23-valent pneumococcal polysaccharide vaccine (23vPPV) whereas those with high-risk conditions should receive one dose of PCV15 followed by one dose of 23vPPV one year later. For individuals not eligible for relevant government vaccination programme, they may choose to receive any locally registered pneumococcal vaccine to protect themselves against IPD following the manufacturer’s recommendations and upon discussion with healthcare professionals. Details of the SCVPD’s updated recommendations on the use of pneumococcal vaccine are available on the CHP’s website at www.chp.gov.hk/en/static/24008.html.

     During the same meeting, the SCVPD also discussed the use of herpes zoster vaccines. Experts considered that locally available herpes zoster vaccines were safe and effective. Individual older adults and adults with immunocompromised conditions may consider receiving herpes zoster vaccine in consultation with their doctors to protect themselves against zoster and its complications. The SCVPD considered that more local data from a cost benefit analysis perspective would be essential for future consideration on the inclusion of herpes zoster vaccine into relevant government vaccination programmes.

Philadelphia Scientific is on the Road to Net Zero

Jul 13, 2023 | Business

 Philadelphia Scientific’s journey to reduce environmental impact at Manufacturing UK Headquarters.

Philadelphia Scientific, a leading global innovator in stored energy technologies, is continuing the road to reduce the carbon footprint of the UK Headquarters in Bolton in Greater Manchester. Duncan Jones, Managing Director states, “All companies need to do their part to reduce their impact. The next stage of our journey is to attempt to power the manufacturing part of our business completely from on-site renewables.” Reducing impact is imperative in combating climate change, and manufacturing companies have a pivotal role to play in reducing their carbon footprint.

Recognizing the importance of this initiative, renowned organizations worldwide have emphasized the need for environmental consciousness and sustainability. According to a report by the World Economic Forum, achieving net zero emissions in manufacturing is crucial to limit global warming to 1.5 degrees Celsius, in alignment with the Paris Agreement. The report also highlights that decarbonizing manufacturing processes can create new economic opportunities and foster long-term competitiveness.

In many ways Philadelphia Scientific has been helping reduce the impact of businesses around the world for many years. “Our products help batteries perform better for longer which will reduce the carbon footprint across many different sectors,” says John Worthington, Head of R&D. “If companies are converting to electric powered forklifts, our technology makes the transition easier.”

Philadelphia’s ethos is “Making Batteries Better.” For companies already using electric trucks, Philadelphia Scientific technology helps batteries run longer each cycle which means fewer batteries are needed, and they will last longer before they need replacing. This combination of benefits helps companies around the world consume less batteries resulting in less waste, and less impact.

“We’ve decided to apply this approach to our own headquarters,” says Jones. “Several years ago, we had the opportunity to acquire a fantastic 135-year-old industrial mill. In the renovation we invested in low-loss windows, advanced insulation, led lighting & smart heat controls. Now we’re going to attempt to provide 100% of our manufacturing electricity from on-site renewables.” The plan is to utilize renewable energy sources, such as solar, to meet energy demands. Philadelphia Scientific is also implementing advanced energy monitoring and management systems to detect unnecessary usage and minimize energy consumption.

“At Philadelphia Scientific, we firmly believe that profitability and sustainability can go hand in hand,” says Andy Napoleon Hill, Sales & Marketing Manager. “While we certainly will be mitigating environmental impact we also believe that this investment will also have a healthy financial return on investment over time.”

As they embark on this transformative journey, they invite their industry peers, stakeholders, and customers to follow them on their sustainable manufacturing journey.

About Philadelphia Scientific:
Philadelphia Scientific is a global leader in industrial battery maintenance solutions. With a comprehensive range of products and services, the company helps businesses across various sectors optimize their battery performance, extend battery life, and reduce operational costs. Philadelphia Scientific is committed to providing innovative solutions that make battery maintenance effortless and efficient.

Philadelphia Scientific UK
Andy Napoleon Hill
+447553932367
https://www.phlsci.com

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Hong Kong – Scientific Committees under CHP update consensus interim recommendations on use of COVID-19 vaccines

Dec 1, 2022 | International

Scientific Committees under CHP update consensus interim recommendations on use of COVID-19 vaccines

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     The Scientific Committee on Vaccine Preventable Diseases and the Scientific Committee on Emerging and Zoonotic Diseases (JSC) under the Centre for Health Protection (CHP) of the Department of Health, joined by the Chief Executive’s expert advisory panel (EAP), convened a meeting today (December 1) to discuss and issue the consensus interim recommendations on the use of COVID-19 vaccines in Hong Kong.



     In view of the arrival of the Comirnaty bivalent vaccine to Hong Kong, recent increasing activities of COVID-19 in the community and residential care homes, as well as the anticipating winter surge, the JSC-EAP has specifically discussed the use of the bivalent vaccine to supplement previous recommendations made on October 13.



     Experts urged to arrange vaccination comprising a total of four doses for eligible residents of residential care homes for elderly persons (RCHEs) and residential care homes for persons with disabilities (RCHDs) as soon as feasible, so as to reduce the risk of death and severe disease. Taking into account overseas practice and Comirnaty bivalent vaccine matched with the circulating Omicron strain in Hong Kong, experts considered RCHE and RCHD residents who have completed four doses (or three doses with previous COVID-19 infection) may choose to receive an additional dose of bivalent vaccine for better personal protection, while residents may also choose ancestral strain vaccine under informed consent. In addition, bivalent vaccine can be used as another choice for the third and the fourth dose .



     Noting some adults have received four doses of vaccines (or three doses with prior infection) with more than half a year passed, experts considered that they may choose to receive an additional dose of vaccine six months after their last dose or recovery for personal protection under informed consent. Similar approach also applies to immunocompromised persons aged 18 or above, with a shortened time interval of three months.



     ​Details of the interim recommendations are available at the CHP’s website at www.chp.gov.hk/en/static/24008.html.

Scientific administrators discuss pathways to address issues and specific technology needs of the states

Sep 10, 2022 | Business


Top scientific administrators across Ministries and departments discussed pathways by which science ministries can address issues and specific technology needs of the states and ways to strengthen the centre-state co-ordination for the socio-economic development of the nation.


Principal Scientific Advisor, Government of India, Prof A K Sood, highlighted the need for adequate investment in research and development from the private sector. “Some states have received substantial foreign direct investment, and some like Karnataka and Uttarakhand have made exemplary efforts in some areas like One Health Mission,” he pointed out while explaining the impact of closer linkages between the centre and states.





Showcasing the effort by DST to strengthen the State Startup Ecosystem, Secretary, DST Dr. S. Chandrasekhar said, “DST has supported startup incubation centres in places like Hyderabad and Vadodara.”


“We are working for catalysing Science Technology Innovation (STI) ecosystem in the States by facilitating human resources, S&T infrastructure & socio-economic development through appropriate partnerships and strengthening of the S&T-based delivery system,” he pointed out.


“Indian researchers at all corners of India should pursue scientific research for the benefit of society with practical application-driven innovations,” Dr. Chandrasekhar added.


Dr. Rajesh Gokhale, Secretary DBT, underlined India’s success in combatting the pandemic and said that if such a feat can be achieved in adverse situations, much more can be done in normal situations.  


“The target of bioeconomy has moved up from $150 Bn for 2025 to $300 Bn for 2030. How India needs to set out a National Bio-economy Strategy for the next 25 years,” said Dr. Rajesh Gokhale, Secretary DBT


Director General; CSIR, Dr. N Kalaiselvi,  advocated for technology-enabled socio-economic development in States and a balanced approach of developing technologies for urban and rural needs.


She highlighted R&D carried out by CSIR under thematic areas like smart agriculture, civil infrastructure, energy and environment, aerospace, mining, metals, minerals and materials, health care & specialty chemicals, understanding the unique characteristics and specific needs of the states and regions and bringing customized solutions for critical issues of states.


 “The Ministry of Earth Sciences is translating earth science technologies like earthquake detection, weather and climate forecasting, and exploration of non-living ocean resources to services,” said Secretary Ministry of Earth Sciences Dr. M Ravichandran.


He spoke about observatories for atmosphere and ocean and data transmission, the establishment of automatic weather stations, X band radars,   monitoring of coastal erosion and pollution, and dissemination of information for different stakeholders like farmers, fishermen that have brought benefits to people across India.


Shri KN Vyas, Secretary, DAE, and Chairman, Atomic Energy, shared success stories in agriculture and water technologies such as the use of isotopes to track and recharge aquifers, use of radiation technologies for preserving packaged food materials, water ATMs, and so on which can be of use to the states.


Shri S. Somnath, Secretary, DoS & Chairman, ISRO, presented ‘2047 Space Roadmap’ with a focus on pushing ahead economic aspects of space technologies.


He encouraged states to establish regional, remote sensing centres based on themes and specialties of the states. He also advocated for encouraging entrepreneurship in value-added space products.


The session created a platform for discussing the key challenges for the Technology Vision for 2047 presented by the Sectoral Group of Secretaries and solutions to propel India as a vibrant knowledge economy in the 21st century.




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