MilliporeSigma | November 16, 2022
MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, a leading science and technology company, announced that its Life Science business sector is investing more than $ 286 million in its biosafety testing capacity at the company's site in Rockville, Maryland, USA. This will significantly increase the company's ability to conduct biosafety testing and analytical development services. Biosafety testing and analytical development are critical and fundamental requirements of the drug development and commercialization process to ensure the safety of medicines. Global demand for these services is growing at a double-digit rate.
"MilliporeSigma is harnessing its broad portfolio of modern technologies and enabling services to help ensure the safety of the world's medicines. These significant investments in Rockville and other sites across our global network will help us meet growing demand for the robust testing studies that biologics manufacturers depend upon to comply with stringent regulatory guidelines. This is a prime example of our focus on sustainable growth in areas with strong underlying upwards dynamics."
Belén Garijo, Chair of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany
"This is the largest investment in contract testing in Merck KGaA, Darmstadt, Germany's history. Our Rockville campus has a long track record of testing for both traditional and novel therapies. We have been driving innovation in biosafety testing for 75 years and this expansion enables our Life Science business sector to lead in shaping the future of testing," said Matthias Heinzel, Member of the Executive Board of Merck KGaA, Darmstadt, Germany and CEO Life Science. "We thank the State of Maryland and Montgomery County, Maryland, for their collaboration in making this new campus a reality for our employees and clients. Together, we are impacting life and health with science."
The BioReliance® contract testing portfolio from MilliporeSigma provides best-in-class biosafety testing and analytical development methods for both traditional and novel therapies. The new state-of-the-art, 250,000-square-foot facility at MilliporeSigma's Rockville site will house biosafety testing, analytical development, viral clearance suites, and cell bank manufacturing services. Currently, about 600 employees work at the site. Over the next four years, the expansion will create more than 500 new jobs.
With more than 30 years of drug development, material science and process technology expertise, Millipore® CTDMO Services offerings span pre-clinical development to commercial manufacturing, including testing, across multiple modalities including mAbs, highly potent active pharmaceutical ingredients, antibody-drug conjugates, viral vector therapies, mRNA, and lipid nanoparticle formulation.
Contract testing and the newly formed Millipore® CTDMO Services are part of the Life Science Services business unit, which together with the Process Solutions business is one of Merck KGaA, Darmstadt, Germany's "Big 3" growth drivers. The company aims to increase its Group sales to approximately € 25 billion by 2025.
Recently, the company's Life Science business sector announced investments in Martillac and Molsheim, France; Shanghai, China; Sheboygan and Verona, Wisconsin, USA; Cork, Ireland; Wuxi, China; Carlsbad, California, USA; Jaffrey, New Hampshire and Danvers, Massachusetts, USA; Buchs, Switzerland; and Darmstadt, Germany. These expansions are part of an ambitious, multi-year program. It aims to increase the capacity and capabilities of Merck KGaA, Darmstadt, Germany's Life Science business sector to support the growing global demand for lifesaving medications and to make significant contributions to public health.
About the Life Science business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has more than 26,000 employees and more than 55 manufacturing and testing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services. Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and electronics.
Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck KGaA, Darmstadt, Germany generated sales of € 19.7 billion in 66 countries.
The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.
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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.
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.
Gerresheimer and Stevanato Group | September 08, 2022
Stevanato Group S.p.A. a global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries, and Gerresheimer AG, a leading global provider of healthcare & beauty and drug delivery systems for pharma, biotech and cosmetics, announce that they have jointly developed a high-end Ready-To-Use (RTU) solution platform with an initial focus on vials, based on Stevanato Group’s market-leading EZ-fill® technology. This collaboration is projected to help customers gain efficiencies, improve the quality standard, increase speed to market, reduce total cost of ownership (TCO) and help mitigate supply chain risk.
Stevanato Group and Gerresheimer AG are addressing rising demand for RTU vials in the market and the partnership serves as a market enabler to fully support customers’ evolving needs and establish a gold standard in the industrial filling process. The collaboration aims to make RTU vials a standard, available to a wide number of pharma companies globally – offering premium quality solutions to patients and reducing complexity for pharma operations. The new solution will be available to other players in the market to standardize fill-finish operations from early phase drug development to commercialization. The new RTU solution platform from Stevanato Group and Gerresheimer AG will share the same secondary packaging, production process and sterilization method, ensuring consistent available capacity and a reliable double sourcing to the pharmaceutical industry. A hallmark of the new RTU platform is a significant reduction in particles, improving the overall quality and performance of the RTU solutions. In addition, customers can count on a high-end solution made by two major players in the drug containment industry with a long history of innovation. The new jointly developed vial platform and trademark will be presented in detail to the market at the CPhI Worldwide in Frankfurt in November 2022.
“Our EZ-fill® vial platform is the market’s most established choice for pre-sterilized containers, and this enhanced version for RTU vials will bring to the market its full potential in terms of quality, flexibility and value for Pharmaceutical Companies and CMOs. Through our collaboration with Gerresheimer AG we are responding to market demand, and we expect to achieve another important milestone in creating a reliable ecosystem to support, accelerate and de-risk the conversion from bulk to EZ-fill® vials already underway in the market.”
Mauro Stocchi, Chief Business Officer at Stevanato Group
“The new developed RTU vial platform stands out in terms of quality, TCO and sustainability and takes the use of RTU solutions like vials and, in the future, cartridges to a new level,” said Dr. Lukas Burkhardt, Member of the Management Board of Gerresheimer AG. "Due to the strong reduction of the particle load, the quality is significantly increased. Our new innovative solution will convince the market to significantly accelerate the conversion from bulk to RTU vials.”
About Stevanato Group
Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.
About Gerresheimer AG
Gerresheimer AG is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the commercial product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 11,000 employees and generated annual revenues in 2021 of around EUR 1.5b. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.