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JCN Newswire

Eleven Experts from Leading Medical Institutions and Eight Experts from Eisai Publish Full Results of Lecanemab Phase 3 Confirmatory Clarity Ad Study for Early Alzheimer’s Disease in the New England Journal of Medicine

November 30, 2022

TOKYO, Nov 30, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that the results from Eisai's large global Phase 3 confirmatory Clarity AD clinical study of 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, were published in the New England Journal of Medicine, one of the world's most prestigious peer-reviewed medical journals. For the details of the paper, please refer to: www.nejm.org/doi/full/10.1056/NEJMoa2212948.The rapid publication of the Clarity AD study results demonstrates Eisai's strong commitment to trust and transparency based on Eisai's human health care mission. Eisai and Biogen remain committed to disclosing data and information on lecanemab. If approved, we will work to bring the drug expeditiously to people living with early AD and their families.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.This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully gain health authority approval.For more information, visit www.eisai.com/news/2022/pdf/enews202284pdf.pdf. Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)

Younger Colorectal Cancer Population Highlights the Importance of Early Screening, Highly Sensitive Test Product Prenetics has Launched the Market

September 2, 2022

HONG KONG, Sep 2, 2022 - (ACN Newswire via SEAPRWire.com) - Colorectal cancer (CRC) has become one of the main cancers threatening the health of human beings. In the United States and China, CRC has ranked among the top three cancers that leads to death.CRC screening has been proven to be one of the most effective tools for preventing colorectal cancer. Research indicated that since screening was first recommended in 1980 in the United States, the incidence rate of CRC has dropped by 40%. Meanwhile, it's also important to follow the updated evidence, ensuring that the screening is suitable for the people who benefit most.The onset of Disease Tends to be YoungerLatest research has indicated that 94% of newly CRC cases occur in adults over 45 years old. Among which, the number of newly onset and death cases occurring in individuals under the age of 50 has increased a lot. CRC diagnosis among younger adults is growing.Therefore, National Comprehensive Cancer Network (NCCN) has updated its guidance in 2021, suggesting that people at average risk shall conduct screening from the age of 45.U.S. Preventive Services Task Force (USPSTF) also pointed out that all asymptomatic adults aged 45 years old or above are exposed to CRC risks. Even without high-risk factors, they're recommended to take CRC screening.Although the incidence rate of CRC is as high as thyroid cancer and breast cancer, chance of treating CRC is better at an early age. It is very important to early find and treat the disease to ensure a higher survival rate. Research by the world-leading diagnosis and genetic health testing company Prenetics (PRE.O) showed that the 5-year survival rate of stage I and II CRC is up to 90% and stage III is 72.8%. It falls to 15.1% for stage IV CRC.Despite the significantly higher survival rate in the early treatment of CRC, unfortunately nearly half of the CRC cases are detected in the advanced stage, leading to extremely difficult treatment. Lacking a convenient and highly effective detection method is the vital cause of this phenomenon.Significant Reform of CRC DetectionCRC screening has always relied on invasive detection methods including colonoscopy. Since such detection may cause pain or discomfort, some patients refuse the screening.With the rising popularity of genetic detection science, CRC screening has welcomed a significant reform. Currently, a non-invasive and at-home screening test product - ColoClear has been introduced by Prenetics and New Horizon Health to the Southeast Asia market, which can detect pre-cancerous lesions and early, middle, and advanced stage CRC in an effective way.Combining advanced stool DNA technology with a fecal immunochemical test (FIT), ColoClear is easier, cheaper, and simpler and has high sensitivity, up to 96%, which is comparable to the traditional colonoscopy.On top of ColoClear, CircleDNA, a home health diagnosis product of Prenetics that give over 500 test reports in 20 categories, which plays an important role in the early detection of cancer and other potential disease risks. Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

ACN Newswire

New Horizon Health Announced 2022 Interim Report: Revenue Up 414% YoY, Gross Margin Climbs to 82%

August 19, 2022

HANGZHOU, Aug 19, 2022 - (ACN Newswire via SEAPRWire.com) - New Horizon Health (6606.HK), China's leading biotechnology company for early cancer screening, announced its half-year results for the year ended June 30, 2022 today.Based on the financial information before the audit as of June 30, 2022, New Horizon Health achieved total revenue of RMB226 million in the first half of 2022, an increase of 414% over the same period in 2021; achieved a gross profit of RMB185 million, an increase of 650% over the same period in 2021; gross profit margin climbed to 82.0% from 56.2% in the first half of 2021. The Company's adjusted net loss for the half-year was RMB106 million and the adjusted net loss rate(1) narrowed significantly from 221% to 47%; the ratio of expenses to sales(1) dropped significantly from 161% to 86%, and the ratio of management expense to sales(1) dropped significantly from 80% to 23%. The Company's total cash, including time deposits, cash, and cash equivalents, amounted to RMB1.65 billion.The Company announced its cervical cancer screening product, CerviClear(TM), which had been launched in a large-scale prospective multi-center registered clinical trial in June 2022. CerviClear(TM) is the world's first HPV cervical cancer screening product that provides painless and non-invasive urine self-sampling at home, covering a comprehensive range of 14 high-risk HPV viruses. The clinical trial for LiverClear(TM) is progressing well and is expected to be launched in the fourth quarter of 2022 or the first quarter of 2023. As of June 30, 2022, the Company's R&D expenses(1) were RMB39.4 million, an increase of 111% over the same period in 2021."The results of the interim report were not easy to get. New Horizon Health's team is faithful to its promise that it is able to do what it says and do what it does. The Company's revenue in the first half of the year has exceeded last year's full-year revenue. The performance growth is mainly attributed to the increase in revenue and gross profit of ColoClear and Pupu Tube, as well as the listing of UU Tube. The underlying logic of the high growth and high gross profit of the three products is that more and more people with high risk are accelerating the change of concept, attaching importance to the risk prevention and control of high incidence cancer in personal and family health management, recognizing the important value of cancer early screening product compliance and willing to pay for it", the Chairman and CEO of New Horizon Health, YeQing ZHU, said, "Cancer early screening products are both serious medical and consumer products, and the huge market opportunity is backed by the high barrier of research and development and compliance as well as the high investment in market education. The necessary condition for the approval of cancer early screening products under New Horizon Health is solid prospective large-scale multi-center registration clinical validation, which is the strong barrier of our diversified business strategy and the foundation of user trust."Normalization of COVID-19 epidemic accelerates the market education process for early screening at home: ColoClear and Pupu Tube continue to see 3-digit revenue growthColoClear achieved revenue of RMB73.6 million in the first half of 2022, representing an increase of 419% over the same period in 2021. The shipment volume in the first half of the year was approximately 294,600 kits, representing an increase of 143% over the same period in 2021. The increase in revenue of ColoClear was mainly due to the increase in volume sold and recognized as revenue and the increase in average recognition unit price.China's first at-home self-testing FIT test product, Pupu Tube, achieved revenue of RMB68.5 million in the first half of 2022, an increase of 132% over the same period in 2021; and achieved shipment of 2,929,700 units, an increase of 54% over the same period in 2021. The increase in revenue recognized by Pupu Tube was mainly due to the increase in sales volume and the increase in the average unit price (including the increase in the unit price of direct-to-consumer pipeline and the increase in the unit price of health check centers).Other than New Horizon Health, no domestic player has yet announced the launch of a large-scale prospective multi-center registration clinical trial for colorectal cancer screening. ColoClear is the only product approved by the National Medical Products Administration of China for screening cancer. Pupu Tube is the only approved product for at-home self-testing of FIT in China. In February 2022, ColoClear's multi-target stool FIT-DNA technology was recommended by the latest version of the Cancer Foundation of China's "China Integrated Cancer Treatment Guidelines", making it the only molecular early screening technology in China to be included in all national guidelines for colorectal cancer prevention and treatment.In the first half of 2022, the policy of early screening of cancer at home was intensively favorable. The "14th Five-Year Medical Equipment Industry Development Plan ", the "14th Five-Year National Health Plan " and the "14th Five-Year Bio-economic Development Plan " all focus on "early screening and health management of key diseases" such as cancer and in vitro diagnosis in home scenes. The normalization of the detection of COVID-19 epidemic has accelerated the public's awareness of home screening and healthy "symptom-free" people.The only consumer self-test for H. pylori testing: $83.5 million in half-year sales revenue for UU TubeAs of June 30, 2022, the sales revenue of UU Tube since its listing on January 18, 2022, was RMB83.5 million.On December 31, 2021, UU Tube was approved for registration as a Class III medical device by the National Medical Products Administration of China and is the only product in China that is suitable for "consumer self-testing" for H. pylori detection, for which we have the exclusive patented design of the "pregnancy test stick" which is an integrated design for sampling and testing.Data show that more than half of the users of UU Tube are women, nearly 50% are aged 31-40, and people aged 24-30 and 40-50 are also the main users. Jiangsu, Guangdong and Zhejiang have ranked the top three provinces in terms of the number of UU Tube users, and household users are more concerned about the detection and prevention of H. pylori.The prevention and control of H. pylori is a major focus of the science of gastric cancer prevention and has been receiving widespread attention from the media and the public. Data show that in the first half of 2022, the epidemic prevention and control led to a significant decline in the measurement of H. pylori breath tests in hospitals and health checkups, while the number of online and offline gastroenterology consultations continued to rise during the same period, effectively boosting consumer demand for home testing of H. pylori and strongly supporting the rapid promotion of H. pylori.Diversification of 2C quality pipes in tandem: ColoClear, Pupu Tube and UU Tube have excellent profitability performanceIn the first half of 2022, all the three marketed products demonstrated excellent profitability, with the gross margins of ColoClear and Pupu Tube continuing to increase significantly compared to the same period in 2021. As of June 30, 2022, the gross margin of ColoClear reached 75.7%, the gross margin of Pupu Tube reached 80.0% and the gross margin of UU Tube reached 90.0%. Compared to the same period in 2021, the gross margins of ColoClear and Pupu Tube were 56.6% and 59.0%, respectively.The Company's sales volume of the core pipeline increased steadily in the first half of 2022, and the new pipeline continued to make efforts to take advantage of the favorable macro and micro home inspection policies in the first half of the year with "Resilient" marketing and firmly implementation. The high gross margin of the three products benefited from the Company's continuous and in-depth diversified business strategy, which optimized the pipeline mix for product sales, increased the revenue of single test for direct-to-consumer pipelines and brought about scale production through operational leverage benefits, which further reduced the operating cost of a single test.In the first half of the year, the Company has been making progress online and offline, both inside and outside the hospital. As of June 30, 2022, the Company has completed access and sales to over 800 hospitals in the first half of the year. During the "618" period, New Horizon Health continued to be the champion in sales of JD in three categories: medical devices, consumer medical and genetic testing. UU Tube won the top selling category of Tmall test paper. The Company's total sales in JD and Tmall exceeded RMB40 million, representing a 400% increase in total sales compared to the same period in 2021, and a 300% increase in sales of ColoClear YoY.Based on the mainland market, start international marketing: ColoClear debuted in Hong Kong and will advance to Southeast Asia in phases2022 is a milestone year for the internationalization of New Horizon Health. On May 23rd, the Company and Prenetics (Nasdaq: PRE) made a joint announcement that the two parties have launched in-depth cooperation to fully integrate the quality resources in market and pipeline development and product and service operation, and jointly promote the market coverage of ColoClear in Hong Kong, Macau and Taiwan, China, and explore the market opportunities in countries or regions in Southeast Asian at the same time. On June 8, ColoClear by Circle was officially launched in Hong Kong with an official price of HK$3,000. During the cooperation period, ColoClear is the colorectal cancer early screening product that Prenetics has exclusively partnered with.At the same time as ColoClear's debut in the Hong Kong market, New Horizon Health announced the establishment of the Company's first international R&D center in the Hong Kong Science and Technology Parks to attract global talent and focus on multi-omics cancer screening technology innovation and product development, including NGS, and to drive overseas commercialization and synchronized global clinical trials.About New Horizon HealthFounded in 2015, New Horizon Health is a pioneer and leader in China's cancer screening market, focusing on early home screening of high-incidence cancers, aiming to promote innovation in cancer screening technology and accelerate the popularity of cancer screening technology in China. On February 18, 2021, New Horizon Health was successfully listed on the SEHK with stock code 6606.HK, which became "the first listed Chinese cancer early screening company".New Horizon Health has three marketed products. ColoClear, Pupu Tube and UU Tube have all been approved by the National Medical Products Administration of China and are officially commercialized. ColoClear is the only cancer screening product approved by the National Medical Products Administration of China for people aged 40-74 who are at high risk of colorectal cancer. UU Tube is the only consumer self-test product for Helicobacter pylori approved by the National Medical Products Administration of China. Pupu Tube is the first FIT at-home self-test device approved in China. In addition, the Company has three pipelines of products in development for liver cancer (LiverClear), cervical cancer (CerviClear ) and nasopharyngeal cancer screening. The Company has global rights to all of its marketed and pipeline products. New Horizon Health works extensively with hundreds of hospitals, health check-ups, insurance companies, pharmacies and online channels. The Company has a class 100,000 clean production workshop that meets ISO13485 and ISO9001 international certification standards. The third parties medical testing laboratories in Beijing, Hangzhou and Guangzhou have been certified by international quality standards and the local health care commission and issued licenses to practice, with an annual testing capacity of 2 million people.(1) Excluding equity incentive-related expenses Copyright 2022 ACN Newswire. All rights reserved. (via SEAPRWire)

JCN Newswire

Eisai Publishes Potential Economic Value of Investigational Lecanemab in Peer-Reviewed Neurology and Therapy Journal

June 22, 2022

TOKYO, Jun 22, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. today announced publication of results from an early phase evaluation that aimed to estimate potential economic value of its investigational anti-amyloid-beta (Abeta) protofibril antibody lecanemab in people living with early Alzheimer's disease (AD) using a validated disease simulation model, AD Archimedes Condition Event (AD ACE) model1,2,3 from the healthcare payer and societal perspectives in the United States, in the peer-reviewed journal Neurology and Therapy. This is the second publication of lecanemab's potential value. It follows the evaluation of the long-term health outcomes using simulation modeling of lecanemab published in Neurology and Therapy in April 2022.4 While the healthcare payer perspective focuses on direct care costs (e.g., outpatient and inpatient services, medications, intervention costs, nursing home and home healthcare services), the societal perspective further considers societal costs (e.g., productivity loss and informal care costs). As reported in the previous publication, it was suggested that compared to standard of care* (SoC), individuals treated with lecanemab in addition to SoC (lecanemab+SoC) may potentially experience slower disease progression to mild, moderate and severe AD from baseline by 2.51, 3.13 and 2.34 years on average, respectively. The preliminary results of this model-based simulation could possibly translate into additional quality-adjusted life years (QALY**) and reduction in the formal and informal care costs***. Additionally, the AD ACE model framework used in this study allowed assessment of the potential value of lecanemab in different scenarios and sensitivity analyses, including the impact of patient subsets, alternative treatment stopping rules**** and potential dosing regimens as well as major sources of uncertainty. Eisai is committed to conducting and sharing these types of clinical and socioeconomic analyses to establish trust as we work to potentially bring lecanemab to people living with early AD who have confirmed presence of amyloid pathology in the brain. To that end, Eisai would like to provide a common foundation for stakeholders' discourse regarding the potential clinical and socioeconomic value of lecanemab from the societal perspective, not to assign a price for lecanemab at this time. This model-based simulation was conducted using the results of a Phase 2b clinical trial (Study 201) evaluating the efficacy and safety of lecanemab for early AD with confirmed amyloid pathology as well as published literature. It also estimated the potential economic value of lecanemab+SoC over a broad range of willingness-to-pay thresholds from $50,000 to $200,000 per QALY gained as recommended by the Institute for Clinical and Economic Review (ICER)*****. Lecanemab+SoC was predicted to result in a gain of 0.61 QALYs and a decrease in total non-treatment costs of $8,707 per person from the healthcare payer perspective (Societal perspective: 0.64 QALYs gain and $11,214 decrease) compared to the SoC for patients with early AD who have confirmed presence of amyloid pathology. The potential annual value-based price (VBP) of lecanemab was estimated at $9,249 to $35,605 (Societal perspective: $10,400 to $38,053) based on this early economic assessment. ICER's value framework5 indicates that value cannot be wholly derived from measures of clinical and cost-effectiveness, so contextual considerations and an examination of other benefits and disadvantages are also added into the framework when assessing long-term value. This may lead to using the societal perspective and higher end of the broad range of willingness-to-pay threshold in estimating the justifiable price of lecanemab, given the large societal burden of AD relative to direct healthcare costs. Many people living with AD received informal care from their family and friends totaling more than 16 billion hours of unpaid care valued at $271.6 billion in the U.S. in 2021.6 These predicted and simulated findings suggest that early treatment with lecanemab may reduce these costs and economic burdens, and provide insights for healthcare decision-makers regarding the potential clinical and socioeconomic value of lecanemab. The Phase 3 lecanemab Clarity AD data will soon be available to inform the model inputs and refine the findings. In the event that lecanemab receives the U.S. Food and Drug Administration's (FDA) approval, Eisai may determine a VBP using this framework along with other considerations, such as affordability, health system sustainability, etc. "Eisai's goal is to create therapies, such as our investigational anti-amyloid beta protofibril antibody lecanemab, that may help impact the anxieties of people living with Alzheimer's disease and their families. For Alzheimer's disease, it is important to evaluate the holistic value of therapies taking into account not only medical costs but also the immense societal costs," said Ivan Cheung, Senior Vice President, President Neurology Business Group and Global Alzheimer's Disease Officer, Eisai Co., Ltd., Chairman and CEO, Eisai Inc. "As part of Eisai's commitment to our human health care mission, trust and transparency, we will continue to publish data and information about lecanemab and look forward to sharing the results of the lecanemab confirmatory Phase 3 Clarity AD clinical trial this fall." Eisai completed lecanemab's rolling submission of a Biologics License Application (BLA) for the treatment of early AD to the FDA under the accelerated approval pathway in May 2022. The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and 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. Dependent upon the results of the Clarity AD clinical trial, Eisai may submit for full approval of lecanemab to the FDA during Eisai's fiscal year 2022, which ends in March2023. In Japan, in March 2022, Eisai initiated submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the goal of obtaining early approval for lecanemab, and 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. This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such an investigational agent will successfully complete clinical development or gain health authority approval. * Standard of Care (SoC) for AD currently consists of lifestyle modifications and pharmacologic treatment of symptoms.** The quality-adjusted life year (QALY) is a measure of the value of health outcomes. Since health is a function of length of life (i.e., quantity) and quality of life (QOL), the QALY was developed as an attempt to combine the value of these attributes into a single index number. One QALY equates to one year in perfect health. QALY scores range from 1 (full health) to 0 (dead). For example, a new intervention may increase length of life by 3 years and improve quality of life by 70% (QALY score of 2.1) compared to an existing intervention that may increase length of life by 3 years and only improve QOL by 50% (QALY score of 1.5), the incremental QALY for this new intervention will be 0.6 QALYs.*** Formal and informal care costs do not include lecanemab drug cost.**** Alternative treatment stopping rules were explored in scenario analyses where treatment with lecanemab was stopped after a fixed duration of 1.5, 3 and 5 years.***** ICER is a non-profit research organization in the U.S. that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices and health system delivery innovations. 1 Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: Development and validation. Alzheimers Dement (NY). 2018;4:76-88. Published 2018 Feb 16. doi:10.1016/j.trci.2018.01.001.2) Tafazzoli and Kansal. Disease simulation in drug development, External validation confirms benefit in decision making. The Evidence Forum. 2018. bit.ly/3NgEeDD(3) Tafazzoli A, Weng J, Sutton K, et al. Validating simulated cognition trajectories based on ADNI against 436 trajectories from the National Alzheimer's Coordinating Center (NACC) dataset. 11th edition of Clinical Trials on 437 Alzheimer's Disease (CTAD); Barcelona, Spain: 2018.(4) Tahami Monfared AA, Tafazzoli A, Ye W, Chavan A, Zhang Q. Long-Term Health Outcomes of Lecanemab in Patients with Early Alzheimer's Disease Using Simulation Modeling. Neurol Ther 11, 863-880 (2022). https://link.springer.com/article/10.1007/s40120-022-00350-y.(5) ICER Value Framework 2020-2023. 2022. bit.ly/39HjYO3(6) Alzheimer's Association. 2022 Alzheimer's Disease Facts and Figures 2022 Available from: bit.ly/3bkCR9VMedia Inquiries:Public Relations Department,Eisai Co., Ltd.+81-(0)3-3817-5120 Eisai Inc. USLibby HolmanLibby_Holman@Eisai.com201-753-1945 Copyright 2022 JCN Newswire. All rights reserved. (via SEAPRWire)