Diabetes, Gestational

DUBLIN--( BUSINESS WIRE )--The "Global Markets for Emerging Insulin Drug and Delivery Technologies: Focus on Syringes and Vials" report has been added to ResearchAndMarkets.com's offering. The Global Emerging Insulin Drug and Delivery Technologies Market was valued at $55.8 Billion in 2023 and is and is expected to reach $88.9 Billion in 2028, rising at a CAGR of 9.8%. This report discusses the implications of the growing diabetes epidemic on the global and regional markets for emerging insulin drug and delivery technologies. It discusses companies in the relevant pharmaceutical and medical industries and provides profiles of the leading players as well as an update on M&A activity. The report's patent analysis focuses on developments in Japan, Europe, and the U.S. Five-year global sales forecasts are provided for the major categories of insulin drug and delivery technologies and devices categories. The Report Includes 57 data tables and 83 additional tables An overview and industry analysis of the global markets for emerging insulin drug and delivery technologies, with an emphasis on plastic insulin syringes and vials Analyses of the global market trends, with historical market revenue data (sales figures) for 2020 to 2022, estimates for 2023, and projections of compound annual growth rates (CAGRs) through 2028 Estimate of the actual market size and revenue growth forecast, and a corresponding market share analysis by product type, application, and region A look at the emerging technologies that have potential in the diabetes market, with improved glucose control, along with improved delivery methods Examination of the current state of the insulin drug and delivery industry structure, focusing on technological updates and issues surrounding insulin pens and insulin syringes, ongoing research activities, and regulatory and pricing scenarios Discussion of market dynamics, clinical trial applications, regulations, and penetration of technologies in the pharmaceutical and biotechnology markets Discussion of the ESG developments and how they impact corporate performance, ratings and matrices, and consumer attitude, as well as the ESG practices of leading pharma and biotech companies Review of the key patent grants/publications for insulin as a drug, along with its delivery methods Analysis of the competitive landscape based on recent developments and segmental revenues of leading companies Profiles of the leading market players The analysis revealed that the fastest-growing market segment is smart pens, which is expected to grow at a predicted CAGR of 12.6% during the forecast period. The insulin syringes and vials segment is expected to have the slowest growth rate, a CAGR of 8.7%. The increase in prevalence of diabetes mellitus, including type 2 diabetes worldwide, the most prevalent form, has reached epidemic levels. Concurrently, instances of type 1 diabetes mellitus are on the rise, albeit to a lesser extent. These escalating trends raise significant alarm, impacting not only those affected but also governments and healthcare providers, as the economic ramifications of diabetes are substantial. They involve the direct burden of managing the disease and its common and often catastrophic complications, including cardiovascular disease, peripheral neuropathy and blindness. Ensuring timely diagnosis of diabetes and delivering efficient treatment are priorities for governments and healthcare organizations. As the prevalence of diabetes continues to rise and diagnostic methods advance, the existing market for insulin drug and delivery technologies is expected to expand significantly. Consequently, diabetes holds substantial commercial importance for both the manufacturers of treatment drugs and the producers of monitoring devices. For companies in this sector to strengthen their market position, they require precise and current evaluations of the present magnitude of the diabetes epidemic, as well as its probable trajectory over the upcoming five years, and the potential impact of insulin drug and delivery devices and technical developments now in the pipeline. The market for insulin drug and delivery technologies will continue to grow significantly in many areas, notably regulatory compliance. Key Attributes: Report Attribute Details No. of Pages 158 Forecast Period 2023 - 2028 Estimated Market Value (USD) in 2023 $55.8 Billion Forecasted Market Value (USD) by 2028 $88.9 Billion Compound Annual Growth Rate 9.8% Regions Covered Global Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market Overview Types of Diabetes Type 1 Diabetes Type 2 Diabetes Gestational Diabetes Mellitus or Hyperglycemia in Pregnancy Impaired Glucose Tolerance and Impaired Fasting Glucose Epidemiology of Diabetes Gender Distribution Regional Disparities Market Dynamics Snapshot Factors Affecting the Market Market Drivers Market Restraints Chapter 4 Global Market for Emerging Insulin Drug and Delivery Technologies, by Type Technological Advances in Insulin Syringes Insulin Delivery Pen Devices Disposable Insulin Pens Reusable Insulin Pens Technological Advances in Insulin Drug and Delivery Pen Devices External Insulin Pumps Technological Advances in Insulin Pump Systems Implantable Insulin Pumps Closed-Loop Artificial Pancreas Bionic Pancreas Smart Pens Chapter 5 Global Market for Emerging Insulin Drug Delivery Devices, by Application Chapter 6 Global Market for Insulin Drug Delivery Devices, by Region Chapter 7 Regulatory Landscape Chapter 8 Sustainability in the Insulin Drug and Delivery Market: An ESG Perspective Chapter 9 Emerging Technologies Patient Outcomes Beyond Glucose Control Chapter 10 Patent Analysis Chapter 11 M&A and Venture Funding Outlook Chapter 12 Competitive Landscape Chapter 13 Company Profiles AstraZeneca B. Braun BD Cardinal Health Debiotech Diabeloop Emperra E-Health Technologies Embecta Corp. F. Hoffmann-La Roche Insulet Corp. Johnson & Johnson Services Lifescan Ip Holdings Lilly Medtronic Novo Nordisk Nugen Medical Devices Owen Mumford Sanofi Sooil Developments Tandem Diabetes Care Terumo Corp. Ypsomed For more information about this report visit https://www.researchandmarkets.com/r/8ravs1 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.

Potential vadadustat U.S. approval on PDUFA date of March 27, 2024 Strengthened balance sheet with $55.0 million term loan financing and $26.0 million in proceeds from ATM Reported 2023 Auryxia (ferric citrate) net product revenue of $170.3 million CAMBRIDGE, Mass., March 14, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full year ended December 31, 2023 and recent business highlights. Akebia is preparing for a potential launch of vadadustat, which is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of March 27, 2024. "We are eagerly awaiting the PDUFA date for vadadustat, now within weeks, and we believe the progress we have made over the past 12 months has positioned our team to successfully launch vadadustat in the U.S., if approved," said John P. Butler, Chief Executive Officer of Akebia. "A U.S. approval for vadadustat will be transformational for Akebia and a significant step toward our goal of bettering the lives of people impacted by kidney disease. Our team remains dedicated to delivering an innovative oral therapeutic treatment for anemia due to chronic kidney disease for patients on dialysis." Fourth Quarter 2023 and Recent Business Highlights: Appointed Nicholas Grund as Chief Commercial Officer, who brings years of expertise in customer-facing roles to Akebia. Mr. Grund's operational, commercial and strategic leadership experience across renal and specialty markets will be critical as Akebia prepares for the vadadustat launch in the U.S., if approved. Introduced new pipeline programs in acute care settings, potentially for acute kidney injury or acute respiratory distress syndrome (AKB-9090) and retinopathy of prematurity in neonates (AKB-10108). Closed a new debt facility with BlackRock that provides access to up to $55.0 million in borrowing capacity and used the proceeds from the first tranche of $37.0 million to pay down principal outstanding under the then loan agreement with Pharmakon Advisors, LP. The BlackRock debt facility, which closed on January 29, 2024, also extends the interest-only period in the event of vadadustat approval in the U.S. on or prior to June 30, 2024 without requiring any principal repayment until December 31, 2026. Concluded its offering of common stock under its "at-the-market" (ATM) sales agreement. Akebia raised approximately $26.0 million in gross proceeds. Akebia reported fourth quarter 2023 Auryxia® (ferric citrate) net product revenues of $53.2 million and full year 2023 revenues of $170.3 million, within Akebia's 2023 Auryxia net product revenue guidance of $170.0 - $175.0 million. "We are approaching a potential U.S. launch of vadadustat from an extremely strong financial position. We expect Auryxia net product revenue growth in 2024, with a quarterly revenue cadence that is similar to 2023, we executed a term loan with BlackRock and implemented other financial strategies that together we believe will support our business operations for at least two years if vadadustat is approved. As we move forward, we will continue to carefully manage expenses, while investing appropriately for a successful potential launch of vadadustat," Mr. Butler added. Financial Results Revenues: Total revenues were $56.2 million for the fourth quarter of 2023 compared to $55.8 million for the fourth quarter of 2022, and $194.6 million for the full-year 2023 compared to $292.5 million for the full-year 2022. Net product revenues were $53.2 million for the fourth quarter of 2023 compared to $50.3 million for the fourth quarter of 2022, and $170.3 million for the full-year 2023 compared to $176.9 million for the full-year 2022. License, collaboration and other revenues were $3.0 million for the fourth quarter of 2023 compared to $5.5 million for the fourth quarter of 2022, and $24.3 million for the full-year 2023 compared to $115.5 million for the full-year 2022. COGS: Cost of goods sold was $18.7 million for the fourth quarter of 2023 compared to a benefit of $3.4 million for the fourth quarter of 2022, and $74.1 million for the full-year 2023 compared to $85.6 million for the full-year 2022. Akebia continues to record a non-cash intangible amortization charge of $9.0 million per quarter through the fourth quarter of 2024. R&D Expenses: Research and development expenses were $9.9 million for the fourth quarter of 2023 compared to $32.1 million for the fourth quarter of 2022, and $63.1 million for the full-year 2023 compared to $130.0 million for the full-year 2022. SG&A Expenses: Selling, general and administrative expenses were $25.4 million for the fourth quarter of 2023 compared to $29.9 million for the fourth quarter of 2022, and $100.2 million for the full-year 2023 compared to $138.6 million for the full-year 2022. Net Income / Loss: Net income was $0.6 million for the fourth quarter of 2023 compared to a net loss of $6.1 million for the fourth quarter of 2022, and $51.9 million for the full-year 2023 compared to $94.2 million for the full-year 2022. Cash Position: Cash and cash equivalents as of December 31, 2023, were approximately $42.9 million. Akebia believes its existing cash resources and the cash it expects to generate from product, royalty, supply and license revenues as well as the borrowings and potential future borrowings that are available under the BlackRock debt facility and the working capital liability are sufficient to fund our current operating plan for at least twenty-four months if vadadustat is approved. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at , which does not form a part of this release. About Vadadustat Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is not approved by the U.S. Food and Drug Administration. Vadadustat is approved in Europe and Australia for the treatment of symptomatic anemia due to CKD in adult patients on chronic maintenance dialysis and in Taiwan for the treatment of anemia due to CKD in adult patients on dialysis. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients. IMPORTANT SAFETY INFORMATION FOR VAFSEO (vadadustat) For safety information, view the European Summary of Product Characteristics (SPC/SmPC) for Vafseo® (vadadustat) at , and and will be available via the Australian Therapeutic Goods Administration website. IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate) CONTRAINDICATION AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis. WARNINGS AND PRECAUTIONS Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy. Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children. ADVERSE REACTIONS Most common adverse reactions with AURYXIA were: Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%). Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), abdominal pain (5%) and hyperkalemia (5%). SPECIFIC POPULATIONS Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman. To report suspected adverse reactions, contact Akebia Therapeutics at 1-844-445-3799. Please see full Prescribing Information Forward-Looking Statements Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia's financial results for the fourth quarter and full year ended December 31, 2023; the anticipated scheduled PDUFA date for vadadustat and the potential approval of vadadustat; Akebia's ability to enable a successful commercial launch of vadadustat, if approved; statements that a U.S. approval for vadadustat will be transformational for Akebia; Akebia's expectations and beliefs regarding the impact that the BlackRock debt facility will have on Akebia; Akebia's expectations for Auryxia revenue growth in 2024 and assumptions related thereto; Akebia's plans with respect to vadadustat as a treatment of anemia due to chronic kidney disease in patients on dialysis in the U.S.; Akebia's expectations with respect to Akebia's pipeline in acute care settings for acute kidney injury or acute respiratory distress syndrome (AKB-9090) and retinopathy of prematurity in neonates (AKB-10108) and market potential; and Akebia's goals, objectives and expectations with respect to its operating plan, expenses, cash resources and sources of funding for its cash runway, including its belief that its existing cash resources and the cash it expects to generate from product, royalty, supply and license revenues as well as the borrowings and potential future borrowings that are available under the BlackRock debt facility and the working capital liability are sufficient to fund our current operating plan for at least twenty-four months if vadadustat is approved. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings, including the anticipated FDA decision on the NDA for vadadustat and the potential effects of a negative decision on Akebia's cash runway; the potential therapeutic benefits, safety profile, and effectiveness of vadadustat; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on regulators and Akebia's business, operations, and the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates. Akebia Therapeutics Contact Mercedes Carrasco [email protected] SOURCE Akebia Therapeutics, Inc.

MELBOURNE, Australia, March 12, 2024 /PRNewswire/ -- Datos Health, a global leader in remote care automation, announced today the company's Open Care platform, was chosen by Northern Health, a major Australian healthcare provider. Northern Health has partnered with Datos Health to develop innovative digital care models to enable a healthier community by improving the health outcomes that matter most to patients. This includes being able to deliver the right care, at the right time, in the right place, by utilising remote patient monitoring. Continue Reading Datos Health's Open Care platform replaces rigid RPM solutions with a comprehensive platform for hybrid care delivery. The company's streamlined solution empowers healthcare organisations like Northern Health to customise remote care protocols to fit their unique approach to healthcare. Clinicians can easily adjust workflows as needed, with changes instantly translated into patient CareApps that deliver automated assisted self-care. Northern Health partners with Datos Health to develop digital care models that help improve patient outcomes. Post this Northern Health will integrate the Open Care platform into its virtual cardiac rehabilitation, back pain, lung cancer, severe asthma and gestational diabetes programs with plans to expand Datos into other programs to support their community's healthcare needs into the future. Datos Health will leverage IKAO Health, its Australian-based partner for their experience implementing localised solutions to meet the unique issues facing healthcare providers and to deliver on-the-ground support and service to Northern Health. Northern Health is committed to delivering safe, person-centred and value-based care by redesigning models of care to improve patient outcomes, automating clinical workflows to reduce administrative burden for clinicians and enhancing greater access to care for patients. The Datos platform offers exceptional flexibility and a seamless user experience for both patients and clinicians. Moreover, its ability to provide real-time data visualisations, ensures that clinicians can tailor and personalise care plans. Northern Health is dedicated to advancing health equity within its diverse community, empowering patients to better self-manage their health, monitor and track their progress over time, and access trusted educational resources. "Northern Health is creating a future where virtual care models enable a healthier community," said Dr. Katharine See, Chief Health Outcomes Officer and Director of Respiratory Medicine at Northern Health. "We're a pioneer in implementing digital health solutions that cater to the changing needs of our community. With Datos Health, we're enabling our healthcare professionals to offer exceptional virtual care options, that are not dependent on patients being in hospital. We look forward to working with Datos Health to roll out even more innovative digital health programs that support our community," she continued. "We're honoured to have been chosen by such a respected healthcare organisation and we look forward to working with Northern Health to design new and innovative care models," said Uri Bettesh, Founder and CEO of Datos Health. "Together with our local partner, IKAO Health, we've developed an excellent grasp of the intricacies of the Australian healthcare system. Our partnership with Northern Health is an excellent next step on our road to increasing access to care for Australia's highly diverse patient population, and our continuing expansion in the Asia-Pacific region," he concluded. About Northern Health Northern Health is a major provider of comprehensive health services in Melbourne's rapidly growing outer north, catering to a vibrant community of diverse backgrounds. Across five main campuses, Northern Health delivers acute, maternity, sub-acute, mental health, specialist, community and home-based services. Handling over 110,000 emergency cases annually and supporting 114,000 admissions, their commitment extends to ensuring accessible care for all, irrespective of language or culture. With over 8,500 dedicated professionals, they are committed to providing exceptional healthcare tailored to each individual, promoting well-being across Melbourne's dynamic northern landscape. For more information, please visit . About Datos Health Datos Health's open platform merges monitoring, care, and engagement, to seamlessly deliver hybrid care across any acuity level or use case. Clinicians can quickly implement and customize any program, choose the devices that fit their workflow, and integrate with any EMR. Workflows can easily be adjusted in our Design Studio by creating remote care programs from scratch or by leveraging existing protocols from leading healthcare organizations. These workflows are instantly translated into patient CareApps that collect biometrics and PROMs, provide self-care guidance and curated content, send escalation alerts to the care team, and facilitate virtual visits. Workflow automation is now easier than ever for both patients and clinicians. For more information, please visit . Datos Health Contact: Farah Parsa Vice President, Marketing [email protected] SOURCE Datos Health