BUSINESS INSIGHTS
Athira Pharma, Inc. | October 18, 2022
Athira Pharma, Inc. a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that following an unblinded interim efficacy and futility analysis, an independent data monitoring committee recommended continuation of the LIFT-AD study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. The committee also determined that, with the additional enrollment of fewer than 150 patients for a total enrollment of less than 300 patients without background therapy the study will be well powered for the primary endpoint given the preliminary effect size observed. The primary endpoint of LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition and function.
Results from the completed exploratory ACT-AD Phase 2 study showed a favorable safety profile and suggested positive effects on measures of cognition function and neurodegeneration in patients taking fosgonimeton without background therapy. Guided by these results, the Company proactively amended LIFT-AD to focus on patients not on background therapy. The unblinded interim analysis was then conducted in approximately 100 patients not on background therapy to corroborate observations from ACT-AD and ensure LIFT-AD is well powered to determine the effect of fosgonimeton on clinically meaningful and commercially relevant endpoints.
“The results from the data monitoring committee’s unblinded analysis give us confidence in a potentially positive outcome for LIFT-AD, as stringent evaluation criteria were applied based on validated and clinically meaningful cognitive and functional outcomes. This analysis supports the potential clinical benefits of fosgonimeton treatment and underscores the rationale for continued development of this promising new therapy.”
Hans Moebius, M.D., Ph.D., Chief Medical Officer of Athira
“We are very excited by the results of this independent review as we believe they mitigate the risk of the fosgonimeton development plan, support the potential clinical benefit of fosgonimeton and inform the sample size needed to achieve success with LIFT-AD,” said Mark Litton, Ph.D., President and Chief Executive Officer of Athira. “We are now targeting to complete enrollment in mid-2023 and report topline data in early 2024. Importantly, we have a strong balance sheet to execute our plans through key data readouts and beyond. Moving forward, we remain keenly focused on advancing this novel investigational therapy with the hope of positively impacting the lives of millions of Alzheimer’s patients.
“Our goal with fosgonimeton is to demonstrate its ability to improve cognition and function and to ultimately provide neuroprotection. The ACT-AD study suggested these benefits, and the results of the LIFT-AD interim analysis corroborate those findings,” added Dr. Litton. “We believe any drug that can demonstrate neuroprotection could become a treatment of choice for mild-to-moderate Alzheimer’s patients.”
About the LIFT-AD Clinical Study
LIFT-AD is a randomized, double-blind, placebo-controlled, parallel-group study of fosgonimeton for patients with mild-to-moderate Alzheimer’s disease. Patients are randomized across two dose groups and one placebo group on a 1:1:1 basis to receive a subcutaneous injection of fosgonimeton or placebo once daily over a treatment course of 26 weeks. The primary endpoint for LIFT-AD is the Global Statistical Test, an unweighted composite score comprising measures of cognition (Alzheimer's Disease Assessment Scale-Cognitive Subscale and function. Additional information on the LIFT-AD study can be found at: NCT04488419.
About Fosgonimeton
Fosgonimeton is a small molecule designed to enhance the activity of hepatocyte growth factor (HGF) and its receptor, MET, to impact neurodegeneration and regenerate brain tissue. The function of the HGF/MET receptor system may be impaired in the brain under conditions of neurodegeneration. In addition to Alzheimer’s disease, fosgonimeton has the potential to address the broader dementia population, including Parkinson’s disease dementia and Dementia with Lewy bodies, as the mode of action focuses on network recovery and synaptic signal transmission in the brain.
The ACT-AD trial was supported by a grant from the National Institute on Aging of the National Institutes of Health under Award Number R01AG06268. The information presented in this press release is solely the responsibility of Athira and does not necessarily represent the official views of the National Institutes of Health.
About Athira Pharma, Inc.
Athira Pharma, Inc., headquartered in the Seattle, Washington area, is a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration. Athira aims to provide rapid cognitive improvement and alter the course of neurological diseases with its novel mechanism of action. Athira is currently advancing its pipeline of therapeutic candidates targeting the HGF/MET neurotrophic system for Alzheimer’s and Parkinson’s disease dementia, Dementia with Lewy bodies and neuropsychiatric indications.
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PHARMACY MARKET
Walgreens Boots Alliance and CareCentrix | September 01, 2022
Walgreens Boots Alliance, Inc. announced it has completed its previously announced majority share acquisition of CareCentrix, Inc.—the leading independent home-centered platform that coordinates care to the home for health plans, patients and providers. The majority investment in CareCentrix accelerates Walgreens Health’s capabilities in delivering quality healthcare across a spectrum of settings including primary care, specialty pharmacy care, post-acute care and home care.
By bringing together Walgreens trusted health services and community presence with CareCentrix’s technology-enabled, care-at-home solutions, the partnership better addresses the needs of people with complex or chronic conditions as they transition out of the hospital. CareCentrix’s advanced data analytics capabilities enable highly personalized care plans to help people transition to the right site of care, prioritizing care in the home when appropriate. This approach supports both care quality and value by reducing hospital readmissions and improving patient satisfaction and outcomes.
“We created Walgreens Health to reimagine local healthcare and wellbeing for all. This partnership advances our ability to address the needs of people across care settings immediately following hospital discharge. Our collaboration with CareCentrix is one of the many ways we are expanding on our pharmacy and patient expertise to surround individuals with care when and how they need it.”
Roz Brewer, CEO, WBA
Healthcare services delivered after discharge, including care delivered in the home, are one of the fastest growing segments in healthcare today. Caring for patients from the hospital to the home represents more than $75 billion in annual healthcare costs for payers, providers and patients.
“The most challenging part of the healthcare journey is the last mile – extending healthcare delivery into people’s homes,” said John Driscoll, CEO, CareCentrix. “Together with Walgreens Health, CareCentrix is able to combine Walgreens trusted community presence with our powerful technology-enabled care to better address patients’ unique health needs in their homes.”
In addition to home-based care, CareCentrix connects patients to appropriate providers and sites of care post-discharge, utilizing a predictive analytics platform, HomeFirst Analytics. This level of customization also includes pairing patients with care transition teams that support patient engagement for 90 days post-discharge to improve quality metrics.
Walgreens Health will continue to advance capabilities that integrate CareCentrix data analytics and home care expertise with WBA’s portfolio of health solutions to identify and close care gaps, as well as coordinate patient care across conditions, settings and provider networks. These capabilities will enable Walgreens to support medication reconciliation for CareCentrix patients transitioning from hospital to home and provide primary care options to patients when needed, including Village Medical physicians and advanced practice providers. CareCentrix will also play a critical role in Walgreens Health integrated offerings to manage population level risk for benefits management and post-acute spend and outcomes.
CareCentrix manages care for 19 million members through approximately 7,400 provider locations, and empowers more people to live, heal and age at home. By partnering with health plans and health systems, CareCentrix has reduced total cost of care for members by 20 percent, including a greater than 11 percent reduction in emergency department usage and a 23 percent reduction in skilled nursing costs.
This investment gives WBA majority ownership of CareCentrix, investing approximately $330 million for 55 percent of the company at an $800 million valuation, net of debt, with the option to acquire the remaining equity interests in the future. In WBA’s fiscal year 2021, CareCentrix delivered pro forma sales of $1.5 billion. Following the completion of the investment, CareCentrix will continue to operate as an independent company under its current executive leadership.
Sidley Austin LLP acted as lead legal advisor for WBA, along with Weil, Gotshal & Manges LLP. Citi acted as financial advisor for CareCentrix, Inc., and Cleary Gottlieb Steen & Hamilton LLP acted as lead legal advisor.
About Walgreens Boots Alliance
Walgreens Boots Alliance is an integrated healthcare, pharmacy and retail leader serving millions of customers and patients every day, with a 170-year heritage of caring for communities.
A trusted, global innovator in retail pharmacy with approximately 13,000 locations across the U.S., Europe and Latin America, WBA plays a critical role in the healthcare ecosystem. The company is reimagining local healthcare and well-being for all as part of its purpose – to create more joyful lives through better health. Through dispensing medicines, improving access to a wide range of health services, providing high quality health and beauty products and offering anytime, anywhere convenience across its digital platforms, WBA is shaping the future of healthcare.
WBA has more than 315,000 team members and a presence in nine countries through its portfolio of consumer brands: Walgreens, Boots, Duane Reade, the No7 Beauty Company, Benavides in Mexico and Ahumada in Chile. Additionally, WBA has a portfolio of healthcare-focused investments located in several countries, including China and the U.S.
About CareCentrix
CareCentrix offers value-based home solutions to payors and health systems to help more of their members access the home care they need, when they need it. Through a single platform, CareCentrix coordinates multiple, complex home care needs for over 19 million members through a national network of approximately 7,400 provider locations, resulting in a simplified patient and physician experience. For over 25 years, CareCentrix’s focus on the whole person has improved continuity of care, reduced unnecessary readmissions and unnecessary emergency department utilization, and has delivered positive financial results for health plans. With proprietary HomeFirst Analytics to stratify risk and optimize care delivery, CareCentrix takes on the complexities of care coordination and management of care in the home to provide our clients with essential insights into care at home. CareCentrix has been named one of Fierce Healthcare’s 2022 “Fierce 15” companies and FORTUNE’s Best Workplaces for Aging Services.
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PHARMA TECH
BIOCORP and Merck KGaA, Darmstadt, Germany | October 11, 2022
BIOCORP a French company specialized in the design, development, and manufacturing of innovative medical devices, and Merck KGaA, Darmstadt, Germany, a leading science, and technology company, have entered into an agreement for the development and supply of a specific version of Mallya device as an accessory for one of Merck KGaA, Darmstadt, Germany's drug delivery devices.
Manufactured in Clermont-Ferrand Mallya is a Bluetooth enabled clip-on device for pen injectors that collects dose and time of each injection and transfers information in real time to a companion software. Mallya is the first in its category to receive the CE-mark and commercial versions for insulin pen injectors are already available and distributed in Europe and other geographies. Major agreements have already been signed by BIOCORP with Sanofi, Novo Nordisk and Merck KGaA, Darmstadt, Germany, to develop specific versions of the technology in the field of Insulin and Human Growth Hormone (HGH).
Healthcare companies BIOCORP and Merck KGaA, Darmstadt, Germany, will develop a new version of Mallya to help patients monitor their injection during their treatment. The device will automatically keep track of doses injected with timestamp and indicate that the product is administered properly, aiming to support patients with self-injections and to provide reassurance to patients.
Financial details of the partnership include payments from Merck KGaA, Darmstadt, Germany, up to 5 million € for the development of the product within the first three years of the collaboration. Additional revenues are estimated to reach up to 8 million € during the first 5 years after launch depending on commercial milestones and adoption of Mallya devices by Merck KGaA, Darmstadt, Germany patients with further upside potential in the subsequent years.
"We are delighted with this new partnership with Merck KGaA, Darmstadt, Germany, extending our collaboration to additional therapeutic areas. We had already announced that there is a great opportunity for our connected device Mallya in various therapeutic areas. As in diabetes, Mallya aims to reduce patients' stress and improve compliance with their treatments to optimize and secure the results “,
Éric Dessertenne, CEO of BIOCORP
ABOUT BIOCORP
Recognized for its expertise in the development and manufacture of medical devices and delivery systems, BIOCORP has today acquired a leading position in the connected medical device market thanks to Mallya. This smart sensor for insulin injection pens allows reliable monitoring of injected doses and thus offers better compliance in the treatment of patients with diabetes. Available for sale from 2020, Mallya spearheads BIOCORP's product portfolio of innovative connected solutions. The company has 74 employees. BIOCORP is listed on Euronext since July 2015.
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