AGC Biologics, Inc.

Pluri, an established global leader in the development and manufacturing of cell-based therapeutics, launches new revenue-generating Contract Development and Manufacturing Organization (CDMO) division.PluriCDMO™ will help innovative companies develop and manufacture life-changing therapies within the rapidly growing $5.2 billion cell and gene therapy sector.PluriCDMO™ includes Pluri’s well-established team as well as a Good Manufacturing Practice (GMP) facility and a state-of-the-art, proprietary bioreactor system enabling 3D cell expansion and supporting the manufacture of stem cells, Induced Pluripotent Stem Cells, Exosomes and Immuno therapeutics.PluriCDMO™ will offer manufacturing support from the preclinical and development stages to late stage clinical and commercial production, including fill and finish and logistics. Andy Lewin, an experienced CDMO executive, will head the new business division. HAIFA, Israel, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (“Pluri” or the “Company”), a leading biotech company that transforms cells into solutions that promote global wellbeing and sustainability, today announced it has launched a new business division offering cell therapy manufacturing services as a Contract Development and Manufacturing Organization (CDMO): PluriCDMO™. PluriCDMO™ will offer its unique knowledge and technology and over 20 years of development and manufacturing experience. Its state-of-the-art 47 thousand square foot Good Manufacturing Practice (GMP) cell therapy production facility is expected to help customers and partners address key challenges in the development and manufacturing of cell-based therapies. Clean Room, Pluri’s Manufacturing Facility PluriCDMO™ will offer services relating to early preclinical development, through late-stage clinical trials and commercialization, with a mission to deliver high-quality, essential therapies to patients. Over the past two decades, Pluri has cultivated a wealth of experience in process and analytical development, process scale-up, validation, logistics, automation, and regulatory approved comparability studies. The Company’s proprietary, patented bioreactor system enables 3D cell expansion, producing high-quality cells in mass quantities through an automated, fully controlled and validated process. Pluri’s unique technology supports the large-scale growth of cells, with unique batch-to-batch consistency in a scalable, cost-effective manner, under GMP conditions, and has been used to support late-stage clinical trials in key jurisdictions, including the United States Food and Drug Administration (FDA); the European Medicines Agency; Israeli’s Ministry of Health; Japan’s Pharmaceuticals and Medical Devices Agency; and the Ministry of Food and Drug Safety of the Republic of Korea. Furthermore, the Company’s PluriMatrix™ technology enables unprecedented industrial scale production of cell-based products. Pluri has appointed industry expert, Andy Lewin, to lead the business of its CDMO division. Mr. Lewin brings 25 years of commercial leadership experience within the CDMO sector in global companies including Ascend Gene and Cell Therapies Ltd., Oxford Biomedica, and AGC Biologics Inc. “Pluri has an established track record of development and manufacturing in this arena and has solved many of the challenges that confront innovative companies in the cell therapy market,” said Andy Lewin. “The Company has developed innovative production technologies, which allow it to offer large scale (and further scalable) production of cell-based products in GMP grade. Pluri’s technology, long-standing collaborations and extensive experience enable the manufacturing of a wide range of products, including Mesenchymal Stem Cells (MSCs), Induced Pluripotent Stem Cells (iPSCs), Extracellular Vesicles (EVs) and gene modified cells, including CAR-T cells. Pluri offers a level of support to its partners that is second to none. I am excited to lead this new division, addressing the prevalent challenges and need in this sector, helping to accelerate the development and commercialization of high-quality cell and gene therapy products.” Pluri’s CEO and President Yaky Yanay said, “Opening the CDMO division is a strategic move that we expect will boost revenues and cash flow utilizing our well-established technology and manufacturing facility. PluriCDMO™’s vision is to provide our clients with the best-in-class facility, but more importantly, the access to valuable knowledge in cell therapy development that has been generated over the last two decades. PluriCDMO™, as a high-end boutique CDMO, can accelerate the development efforts of our partners and provide better control of the risks. We believe that our proposition is strong and unique, working with PluriCDMO™ can be the launching pad that so many companies can benefit from. Our new CDMO division is another reflection of Pluri’s strategy to use our robust 3D cell expansion assets and in-house production facilities to create long-term value for our shareholders.” For further information on PluriCDMO™ please visit http://www.pluri-biotech.com/cdmo/ About Pluri Inc. Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability. The Company’s technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of challenges— from medicine and climate change to food scarcity, animal cruelty and beyond. Pluri’s method is uniquely accurate, scalable, cost-effective and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine, food-tech and biologics and offers CDMO services. The company establishes partnerships that leverage its 3D cell-based technology for various industries that require effective, mass cell production. To learn more, visit us at www.pluri-biotech.com or follow us on LinkedIn and X (formerly known as Twitter). Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the potential benefits and services that may be provided by PluriCDMO™, that it expects that PluriCDMO™ will provide it with revenues and cash flow, and that PluriCDMO™ is another reflection of its strategy to use its robust 3D cell expansion assets and in-house production facilities to create long-term value for its shareholders. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission. Media Contacts Investors: investor.relations@pluri-biotech.comIsrael Media: Shachar Yental at shacharye@gitam.co.il U.S. Media: Nathan Miller at nathan@miller-ink.com / Brianna Ziegler at brianna@miller-ink.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ec1ceff2-66b3-4772-b37a-e8b73bdef9c1

DUBLIN--( BUSINESS WIRE )--The "New Drug Approvals and Their Contract Manufacture - 2023 Edition" report has been added to ResearchAndMarkets.com's offering. In 2022, the FDA approved c100+ new drug applications (NDAs) and biologics license applications (BLAs). This figure represents a decrease over the 2017-21 period. Both small molecule and biologic new molecular entity (NME) approvals declined substantially, causing overall NDA approvals to drop, which meant fewer commercial-scale production contracts for the most innovative products comparative to other recent years. In June 2021, the FDA granted accelerated approval of Biogen's Aduhelm for Alzheimer's disease, despite there being little to no evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug's approval. This event caused controversy and added to pre-existing claims that the FDA approval process may not be as rigorous as it was in the past, the long-standing push for speed in the FDA approval process having meant a reduced level of certainty and evidence related to a drug. As a result of these issues, there may have been an increased reluctance to authorize innovative drugs for use. COVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions. Contract Manufacturing Organization's (CMO's) will need to find ways to remain competitive in these difficult conditions while maintaining quality and compliance. High inflation will also impact supply chains and R&D activities, and challenge their feasibility. New Drug Approvals and Their Contract Manufacture - 2023 Edition; is the 13th edition in the series of long-running analysis of the CMO industry, using the FDA's NDA approvals as the primary indicator of performance. New Drug Approvals and their Contract Manufacture (formerly called 'CMO Scorecard') is critical for benchmarking the performance of the contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year's edition includes a discussion of Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers. Scope This report gives important, expert insight you won't find in any other source. 11 tables and 34 figures throughout the report illustrate major points and trends. This report is required reading for: CMO executives who must have deep understanding of drug approvals and outsourcing to make strategic planning and investment decisions Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management Private equity investors that need a deeper understanding of the market to identify and value potential investment targets Reasons to Buy Overview of NDA drug and vaccine approvals and the levels of outsourcing associated with NDA sub segments Detailed view of CDMO performance by number of drug and vaccine approvals An assessment of pharmaceutical companies' propensity to outsource manufacture, by their market caps, based on the publisher's Contract Service Providers database Outsourcing propensity for New Molecular Entities (NMEs), different dosage forms, and other drug attributes Analysis of NME special product approvals such as those with Accelerated Approval, Orphan, Breakthrough or Fast Track designations and assessment of outsourcing Key Topics Covered: Executive Summary Players Technology Briefing Innovative drug approvals Dose outsourcing of drug approvals Trends Industry Analysis Introduction FDA NDA approvals overview More biologic NME approvals than small molecule equivalents Cell and gene therapies First-in-class First-time approvals Rejected drugs Predicted approvals for 2023 Sponsor trends US vs. EU approval performance FDA EUAs in 2022 for COVID-19 FDA: outsourced dose manufacture Dosage form outsourcing Special product categories Accelerated approvals Orphan drug designation Fast track designation Breakthrough therapy designation Containment Solubility enhancement Outsourcing by company market cap CMO performance Dosage form Outsourced API approvals ANDA approvals What it means FDA approvals decline with a large decrease of NMEs approved COVID-19 vaccine demand waning but there are still lucrative contracts A few large CMOs gain majority of dose contracts High inflation and other business conditions Record high number of ATMP approvals in 2022 Value Chain Companies Appendix Methodology Bibliography Primary research - key opinion leaders Further reading About the Authors Contact the Publisher Companies Mentioned AbbVie Inc ACS Dobfar SpA Aenova Holding GmbH Afton Scientific Corp AGC Biologics Inc Ajinomoto Bio-Pharma Services Akorn Operating Company LLC Alcami Corp Alfasigma SpA Allergopharma GmbH & Co KG Almac Group Ltd Alpex Pharma SA Altasciences Co Inc Alvogen Inc AOP Health ARx LLC ASM Aerosol-Service AG AstraZeneca Plc Astrea SA AtomVie Global Radiopharma Inc Aurobindo Pharma Ltd AustarPharma LLC Avara Pharmaceutical Services Inc Baccinex SA Basic Pharma Bausch & Lomb Pharmaceuticals Inc Baxter Biopharma Solutions Bayer AG Berkshire Sterile Manufacturing LLC BioRamo LLC BioReliance Corp Boehringer Ingelheim Biopharmaceuticals GmbH Boehringer Ingelheim RCV GmbH & Co KG Bora Pharmaceuticals Co Ltd Bristol Myers Squibb Co BSP Pharmaceuticals SpA Bushu Pharmaceuticals Ltd Cambrex Corp Catalent Inc Cenexi SAS Cerovene Inc Chia Tai Tianqing Pharmaceutical Group Co Ltd Contract Pharmaceuticals Ltd Corden Pharma International GmbH CoreRx Inc Corium Inc Curia Global Inc Delpharm SAS Dexcel PT Israel Ltd DPT Laboratories Ltd Eisai Co Ltd EMD Serono Inc Emergent BioSolutions Inc EuroAPI SAS Eurofins Scientific SE And Many More Companies! For more information about this report visit https://www.researchandmarkets.com/r/a0j1ls Source: GlobalData About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.