ACS Dobfar SpA

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.

TORONTO, Dec. 13, 2022 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (“Dialco”), today announced it has formed a new joint venture with Infomed SA (“Infomed”), a Swiss company dedicated to the development and manufacturing of blood purification devices. The new joint venture company, i-Dialco Inc. (“i-Dialco” or the “Joint Venture”)), will be exclusively focused on advancing commercialization of the SAMI and DIMI dialysis devices in the North American markets. Key transaction highlights: Joint venture expected to accelerate North American commercial rollout of SAMI and DIMI devices Infomed to fund all working capital and commercialization costs, as well as planned development, clinical and regulatory activities Spectral and Infomed to own 30% and 70% of the joint venture, respectively Transaction expected to reduce Spectral’s cash burn by over $3 million annually Eliminates over $1 million of future minimum purchase orders as well as license fees to be paid by Spectral under the original license agreement with Infomed Dedicated management team and board of directors to be appointed for i-Dialco Spectral to focus resources and activities on the advancement of PMX and Tigris trial Spectral maintains full access to SAMI for potential use with its PMX column through an exclusive, royalty-free license for hemoperfusion treatment Transaction Details Dialco previously licensed the SAMI and DIMI technology from Infomed for the North American market and subsequently commenced initial commercialization activities. Under the Joint Venture, Spectral will contribute SAMI and DIMI regulatory approvals, as well as transfer its Medical Device Single Audit Program (MDSAP) certification to i-Dialco. Infomed, an established medical device manufacturer and original developer of the SAMI and DIMI devices, will contribute all hardware, software and certain other intellectual property to further develop the SAMI and DIMI platforms. All prior license fees and minimum purchase requirements for Spectral have been replaced by a zero-cost, license to the technology, granted by Infomed to the Joint Venture. In addition, Infomed has agreed to fund all future development of the i-Dialco business, including working capital and commercialization costs, as well as planned development activities. Spectral will own 30% of the Joint Venture and Infomed will own 70% of Joint Venture. i-Dialco will focus on increasing penetration within both the acute and chronic dialysis markets. The United States represents the largest dialysis market in the world. The U.S. dialysis market alone was valued at $26.2 billion in 2021 and is projected to reach $32.5 billion by 2028.1 The resources to be contributed by Infomed, given Dialco’s progress to date, are intended to help accelerate commercialization activities, as well as allow for ongoing improvements and enhancements to be made to the systems in a cost-effective manner. The goal of the Joint Venture is to establish SAMI and DIMI as leading dialysis systems in the market, while capitalizing on Infomed’s technology, expertise and resources. Chris Seto, Chief Executive Officer of Spectral, further noted, “We are very pleased to enter this joint venture with Infomed, which is the ideal partner given their technological and manufacturing expertise, as well as the capital resources they will be contributing to the Joint Venture. We have successfully worked with Infomed for many years and taking this next step with a leading medical device manufacturer illustrates our commitment to accelerating SAMI and DIMI’s growth within large, underserved markets, while maximizing value for our shareholders. Given Infomed’s extensive knowledge and experience in the dialysis space, we believe this new joint venture will allow SAMI and DIMI to reach their full commercial potential.” “While we have worked aggressively to advance Dialco within the market, we believe this initiative will enable us to reduce our operating costs by over $3 million annually, in addition to eliminating over $1 million of minimum purchase orders that would have been required over the next twelve months, per our original licensing agreement with Infomed. Moreover, we will no longer carry the substantial costs of funding the DIMI usability trial or incur future development and commercialization costs for the devices. Through the Joint Venture, we will also eliminate prior license fees to Infomed, which have been replaced by a no-cost perpetual license, thereby increasing product margins within the joint venture. By securing a material ownership stake in i-Dialco, we believe we are maximizing value for Spectral and our shareholders, which we hope to monetize in the future Dialco. This Joint Venture will also enable us to increase our focus on PMX for the treatment of patients with septic shock, including advancement of our Tigris trial, which we believe will be highly beneficial to Spectral and its shareholders. Assuming we are granted FDA approval of PMX, we would also have full access to the SAMI System for hemoperfusion through the Joint Venture. Overall, we believe the Joint Venture is a significant achievement for the Company and will drive shareholder value,” concluded Mr. Seto. Olivier Favre, Chief Executive Officer of Infomed SA, commented, “We are excited to embark on this joint venture, as we believe the DIMI and SAMI systems hold tremendous market potential, which should benefit both Spectral and Infomed. Spectral has already significantly advanced the commercialization of these devices, and we believe that with a dedicated management team to be appointed, as well as additional resources, we can help accelerate the commercial rollout. Additionally, we look forward to implementing further technology enhancements to support commercialization, while advancing the usability trial for regulatory approval of DIMI within the sizable North American home hemodialysis and peritoneal dialysis markets.” The SAMI System The SAMI System offers flexible dialysis modalities in hospital or clinical settings, including continuous renal replacement therapy, prolonged intermittent renal replacement therapy, sustained low efficiency dialysis, slow continuous ultrafiltration, hemoperfusion and therapeutic plasma exchange. The SAMI System is an open platform design, specifically intended to assist health care providers to deliver therapy safely and efficiently. SAMI’s built in intelligence reduces complexity, while increasing efficiency and reducing consumable cost, as well as delivering customized therapy. The SAMI system has received 510(k) regulatory clearance in the United States as well as Health Canada approval. The DIMI System The DIMI System is designed for the treatment of treat patients with acute and/or chronic renal failure, with or without fluid overload using hemodialysis, hemodiafiltration, hemofiltration and/or ultrafiltration in hospital or clinical settings. The portability, flexibility and simplicity of the DIMI system facilitates dialysis in a wide variety of settings including hospitals, clinics, and skilled nursing facilities. The DIMI System has received 510(k) regulatory clearance in the United States as well as Health Canada Approval. Dialco is actively seeking FDA approval for home hemodialysis and peritoneal dialysis use. 1Source: About Spectral Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin™ (“PMX”). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis. PMX is approved for therapeutic use in Japan and Europe, and has been used safely and effectively on more than 340,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for PMX, and in November 2010, signed an exclusive distribution agreement for this product in Canada. In July 2022, the U.S. FDA granted Breakthrough Device Designation for PMX for the treatment of endotoxemic septic shock. Approximately 330,000 patients are diagnosed with septic shock in North America each year. Spectral is listed on the Toronto Stock Exchange under the symbol EDT. For more information please visit Forward-looking statement Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral's senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected. The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this statement. For further information, please contact: Ali Mahdavi David Waldman/Natalya Rudman Capital Markets & Investor Relations US Investor Relations Spinnaker Capital Markets Inc. Crescendo Communications, LLC 416-962-3300 212-671-1020 am@spinnakercmi.com edt@crescendo-ir.com Blair McInnis CFO Spectral Medical Inc. 416-626-3233 bmcinnis@spectraldx.com

FDA, Faster Than Ever? At the recent BIO annual convention in Washington, D.C., Biotechnology Industry Organization president Jim Greenwood offered up a legislative blueprint to revamp the mission of FDA's (we previewed it briefly last month). Among the proposals were to make FDA an independent agency of government--rather than arm of the Department of Health and Human Services -- and to make promotion of innovation part of its mission. BIO is even seeking to change the agency's system of basing approval decision on two well-controlled clinical trials. The proposal would instead have approval hinge on the "weight of evidence." All bold stuff, if unlikely to find much traction in Congress anytime soon. But BIO's bold reform initiative is at least in part an expression of industry frustration with the current state of FDA, which they say is approving too few drugs, too slowly, with too many strings attached. Then, lo and behold, comes testimony from Drug Division director Janet Woodcock that FDA is on track to approve more drugs in 2011 than it has in 20 years! In the first half of the year, she said, the agency has already approved 20 new molecular entities--versus 21 for all of 2010. "We’re seeing a lot of innovation, much more than in recent memory," she told the House Energy and Commerce's health subcommittee. A subsequent article in the Wall Street Journal predicts a period of productivity through 2019 exceeding anything in the history of the industry. How could this be? Is BIO speaking out too soon against bureaucratic stagnation at FDA? Or is this year just a fluke, with the large number of approvals coming in part from chance and in part from drugs previously delayed? It seems likely that it's a little bit of both. FDA is governed by politics, and like other political entities it gets far too much blame for things that go wrong. (Presidents, at least, get to balance all the angry finger-pointing with largely undeserved credit for what goes right, but I'm not sure FDA enjoys that benefit.) Approvals correlate more highly with innovation and R&D efficiency than they do with FDA's perceived risk-tolerance, and right now we may be finally starting to see the fruits of more rational approaches to drug discovery born in the late 1990s and early 2000s. It takes that long, after all, for drugs to make it from the lab bench to the market. That, at least, suggests that we may really see a prolonged period of above-average approvals for innovative new products. Here's hoping! -Karl Thiel Read the BioPharm Executive online newsletter July 2011. Sign-up for the free monthly subscription to the BioPharm Executive. More By Karl Thiel