Single center, open and single arm clinical study on the safety and efficacy of r2-mtx-epoch regimen in the treatment of CD5 positive diffuse large B cell lymphoma

Start Date01 Feb 2021

Sponsor / Collaborator

Affiliated Hospital of Xuzhou Medical University

CTRI/2020/10/028220

/ RecruitingPhase 2IIT

A phase II randomized study to evaluate the efficacy of short-course RR CVEP regimen against short course EPOCH-RR in adolescent and adult seropositive Diffuse large B cell lymphoma.

Start Date05 Oct 2020

Sponsor / Collaborator-

NCT03214627

/ TerminatedNot Applicable

ANEMEX UK Trial: Artificial Intelligence for Optimal Anemia Management in End-stage Renal Disease: The Anemia Control Model (ACM) Trial

Fresenius Medical Care has developed a computer software programme called the Anaemia Control Management (ACM) software to assist in the anaemia management of patients with chronic kidney disease (CKD) undergoing hemodialysis. This trial is designed to assess the effectiveness of this ACM software on anaemia management in routine clinical practice. However, all ultimate decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the discretion of the Investigator. The trial consists of a retrospective (historical) control period and a prospective (going forward) period. During the prospective period, the ACM will be used to assist the Investigators' decision making and will help the Investigators to administer a personalised intravenous (IV) iron and red blood cell stimulating agent (ESA) therapy, whereas treatment according to standard of care will be documented retrospectively for the same patients during the retrospective period of the trial. Thus, patients can serve as their own control.

Start Date10 Dec 2018

Sponsor / Collaborator

Vifor Fresenius Medical Care Renal Pharma Ltd.

[+2]

100 Clinical Results associated with Epoetin beta

100 Translational Medicine associated with Epoetin beta

100 Patents (Medical) associated with Epoetin beta

834

Literatures (Medical) associated with Epoetin beta

01 Dec 2025·MOLECULAR BIOLOGY REPORTS

Therapeutic effects of erythropoietin-alginate/chitosan hydrogel on impaired male rat fertility after spinal cord injury

Article

Author: Rasekh, Morteza ; Akbari, Ghasem ; Sadeghinezhad, Javad ; Gilanpour, Hassan ; Mortazavi, Pejman

BACKGROUND:

Infertility is a significant issue in spinal cord injury (SCI) patients. Men with SCI often experience erectile and ejaculatory dysfunctions, and low sperm quality leading to impaired fertility. In this study, we investigated the effectiveness of Erythropoietin (EPO)alginate/chitosan (CH-AL) hydrogel on SCI-induced male rat infertility.

METHODS:

Twenty-four male Wistar rats were divided into three groups: Sham, SCI-induced group without any further intervention (Negative control, NC), and a treatment group receiving 10,000 IU/kg EPO-CH/AL hydrogel (EPO group), immediately following SCI induction. Sperm parameters, oxidative stress markers, apoptosis, and histopathological changes in animal testes were analyzed.

RESULTS:

Sperm viability and motility significantly decreased in the NC group compared to the sham group (p < 0.01). Treatment with 10,000 IU/kg EPO-CH/AL hydrogel significantly improved sperm viability and motility compared to the NC group (p < 0.05). Malondialdehyde (MDA) and Superoxide dismutase (SOD) levels were elevated and reduced, respectively, in the NC group compared to the sham group. Treatment with EPO-CH/AL hydrogel group, significantly decreased MDA level and increased SOD levels compared to the NC group (p < 0.05). Apoptosis analysis revealed upregulation of Bcl-2 and downregulation of Bax genes in EPO-CH/AL hydrogel compared to the NC group (p < 0.05). Histological analysis showed that the EPO-CH/AL hydrogel improved depletion of germ cell population and Luminal spaces compared to NC group but did not fully restore normal histology.

CONCLUSION:

EPO-CH/AL hydrogel effectively improves sperm viability and motility, reduces oxidative stress, and mitigates apoptosis, demonstrating its potential as a therapeutic strategy for SCI-induced infertility.

01 Apr 2025·AMERICAN JOURNAL OF KIDNEY DISEASES

Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD

Article

Author: Bernardo, Marializa ; Luo, Wenli ; Burke, Steven K. ; Toka, Hakan R. ; Tumlin, James ; Burke, Steven K ; Yang, Zhihui ; Toka, Hakan R ; Zhang, Zhiqun ; Manllo-Karim, Roberto ; Ullah, Irfan

RATIONALE & OBJECTIVE:

Hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) may offer an alternative to erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in the setting of chronic kidney disease (CKD). The objective of this study was to investigate the efficacy and safety of conversion from the long-acting ESA methoxy polyethylene glycol-epoetin-ß (MPG-EPO) to the oral HIF-PHI vadadustat 3 times weekly versus maintenance therapy with MPG-EPO.

STUDY DESIGN:

Phase 3b, open-label, noninferiority trial.

SETTING & PARTICIPANTS:

Multicenter study in the United States in 456 adult participants with anemia and dialysis-dependent CKD.

INTERVENTION:

Participants were randomized 1:1:1 to vadadustat at a starting dose of 600mg thrice weekly, vadadustat at a starting dose of 900mg thrice weekly, or MPG-EPO for up to 52 treatment weeks and 4 safety follow-up weeks after the end of treatment or early termination.

OUTCOMES:

Primary and secondary efficacy end points were the mean change in hemoglobin concentration from baseline during primary (weeks 20-26) and secondary (weeks 46-52) evaluation periods, respectively. Noninferiority was specified as a lower bound of the 95% CI above -0.75g/dL for the difference in mean change in hemoglobin concentration from baseline. Other efficacy end points were the proportion of participants with hemoglobin levels within the target range and the proportions of participants requiring ESA or red blood cell transfusion rescue for anemia during the evaluation periods. Primary safety end points were any treatment-emergent and serious adverse events (AEs).

RESULTS:

After combining the vadadustat groups (600mg and 900mg thrice weekly; n=304), vadadustat was noninferior to MPG-EPO (n=152) for primary (least-squares mean treatment difference, -0.33; 95% CI, -0.53 to-0.13) and secondary (-0.33; -0.56 to-0.09) efficacy end points. Mean hemoglobin concentrations were stable for all groups except for an initial slight decrease in the vadadustat 600mg group, which stabilized by week 12. ESA rescue for anemia was more frequent in the MPG-EPO group (primary evaluation period, 27.7%; secondary evaluation period, 16.2%) than in the combined vadadustat (14.2%; 7.3%) groups. Transfusion rates were low and occurred at similar rates across treatment groups (2.7% and 4.0% in the combined vadadustat and MPG-EPO groups, respectively). The incidences of any treatment-emergent and serious treatment-emergent AEs were similar across treatment groups.

LIMITATIONS:

Potential errors in attribution of AEs as drug-related.

CONCLUSIONS:

Three-times-weekly vadadustat was noninferior to MPG-EPO in its effect on hemoglobin levels without detectable differences in AEs.

FUNDING:

Funding from a private entity (Akebia Therapeutics, Inc).

TRIAL REGISTRATION:

Registered at ClinicalTrials.gov with study identifier NCT04707768.

PLAIN-LANGUAGE SUMMARY:

Vadadustat, taken 3 times a week, was noninferior to methoxy polyethylene glycol-epoetin-ß (MPG-EPO) in treating anemia. Vadadustat is an oral drug used to treat anemia in people with chronic kidney disease. This study enrolled participants undergoing dialysis for kidney failure and compared the efficacy and safety of continuing to receive MPG-EPO, a long-acting injectable anemia treatment, or switching to vadadustat, taken by mouth 3 times per week for 1 year. Vadadustat was noninferior to MPG-EPO in maintaining hemoglobin levels. Hemoglobin levels remained stable across all groups, except for a slight decrease in the lower-dose vadadustat group, which stabilized with dose titration by week 12. The occurrence of new or serious side effects was similar across treatment groups.

01 Apr 2025·Lancet Haematology

Epidemiology, clinical features, and outcomes of peripheral T-cell lymphoma in Latin America: an international, retrospective, cohort study

Article

Author: Beltran, Brady ; Valcarcel, Bryan ; Roa, Macarena ; Warley, Fernando ; Chiattone, Carlos ; Malpica, Luis ; Tavarez, Jamila Vaz ; Pereira, Juliana ; Mahuad, Carolina V ; Federico, Massimo ; Pereyra, Patricio H ; Villela, Luis ; Miranda, Eliana C M ; Fischer, Thais ; Gazitua, Raimundo ; Quiroz, Alfredo R ; Idrobo, Henry ; Castro, Denisse ; Korin, Laura ; Duffles, Guilherme ; Fiad, Lorena ; Torres, Maria A ; Baptista, Renata L R ; Roche, Claudia ; Oliver, Carolina ; Vasquez, Jule F ; Enriquez, Daniel J ; Pavlovsky, Astrid ; Valvert, Fabiola ; Brasil, Sergio A B

BACKGROUND:

Peripheral T-cell lymphomas represent a rare and heterogeneous group of mature T-cell neoplasms characterised by aggressive behavior. Previous studies evaluating peripheral T-cell lymphoma epidemiology across Latin America have been restricted in their representation of most countries in the region. In this study, we aimed to describe peripheral T-cell lymphoma epidemiology across Latin America.

METHODS:

We did an international, retrospective, cohort study of patients (aged ≥18 years) with newly diagnosed peripheral T-cell lymphoma across 11 countries in Latin America (Argentina, Brazil, Chile, Colombia, Cuba, Guatemala, Mexico, Paraguay, Peru, Uruguay, and Venezuela). We used the hospital-based registries of the Grupo de Estudio Latinoamericano de Linfoproliferativos (retrospective registry; Jan 1, 2000, to June 30, 2023), the Brazilian T-cell Project (retrospective from Jan 1, 2015, to June 30, 2017 and prospective from July 1, 2017, to June 30, 2023), and the International T-cell Lymphoma Project (prospective registry). The main outcomes were prevalence of peripheral T-cell lymphoma subtypes, overall survival, estimated using the Kaplan-Meier method, and objective response rate. Survival probabilities were estimated using the Kaplan-Meier method and compared with the log-rank test. Overall response rate was calculated by summing complete and partial responses, with 95% CIs estimated using the Clopper-Pearson method.

FINDINGS:

1979 patients diagnosed with peripheral T-cell lymphoma by pathology, between 2000 and 2023, met our inclusion criteria for the distribution analysis and 1349 were included in the treatment patterns and outcome analysis. Median age at diagnosis was 54 years (IQR 41-67), 733 (41%) of 1794 patients were female, and 1061 (59%) patients were male. The most common subtype was peripheral T-cell lymphoma, not otherwise specified (688 [35%] of 1979 patients); the second and third most frequent subtypes were adult T-cell leukaemia or lymphoma (333 [17%] of 1979 patients) and extranodal natural killer T-cell lymphoma (291 [15%] of 1979 patients). The next most common subtypes were ALK-negative anaplastic large T-cell lymphoma (186 [9%] of 1979 patients), mature T-cell lymphoma, not otherwise specified (163 [8%] of 1979), angioimmunoblastic T-cell lymphoma (123 [6%] of 1979 patients), and ALK-positive anaplastic large T-cell lymphoma (73 [4%] of 1979 patients). The observed proportion of people with adult T-cell leukaemia or lymphoma was higher in Peru (158 [39%] of 414 patients; p<0·0001) and Colombia (17 [29%] of 58 patients; p=0·011), whereas the percentage for extranodal natural killer T-cell lymphoma was higher in Central America and the Caribbean (105 [41%] of 255 patients; p<0·0001) and Mexico (22 [31%] of 70 patients; p<0·0001). With a median follow-up of 36 months (IQR 12-60) in the analytical cohort, we observed 674 deaths, and 3-year overall survival was 40% (95% CI 38-44). ALK-positive anaplastic large T-cell lymphoma had the highest survival outcomes, with 11 deaths and a 3-year overall survival of 77% (95% CI 66-90), followed by ALK-negative anaplastic large T-cell lymphoma (52 deaths and 3-year overall survival of 55%, 95% CI 46-65) and extranodal natural killer T-cell lymphoma (108 deaths and 3-year overall survival of 48%, 95% CI 42-56). The use of CHOEP (cyclophosphamide, doxorubicin, etoposide, vincristine, and prednisone) or EPOCH (etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) was associated with superior 3-year overall survival compared with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) among patients with ALK-negative anaplastic large T-cell lymphoma (20 deaths; 67%, 95% CI 56-81 vs 16 deaths; 41%, 26-65; p=0·018) and adult T-cell leukaemia or lymphoma (45 deaths; 20%, 11-38 vs 100 deaths; 18%, 12-27; p=0·0087), but not for all other subtypes.

INTERPRETATION:

Our study underscores the unique epidemiological profile of peripheral T-cell lymphoma in Latin America, with a high prevalence of adult T-cell leukaemia or lymphoma and extranodal natural killer T-cell lymphoma. These findings present a crucial opportunity to prioritise clinical trials on these rare subtypes of peripheral T-cell lymphoma by integrating Latin American countries into global research. However, our findings require further validation in robust epidemiological studies.

FUNDING:

American Society of Hematology Harold Amos Medical Faculty Development Program Award and the Robert A Winn Diversity in Clinical Trials Program Award.

TRANSLATIONS:

For the Portuguese and Spanish translations of the abstract see Supplementary Materials section.

News (Medical) associated with Epoetin beta

23 Jan 2023

·www.prnewswire.com

$12.8 Billion Worldwide Erythropoietin Drugs Industry to 2027 - Featuring Amgen, Biocon, Dr. Reddy's Laboratories and Intas Pharmaceuticals Among Others

DUBLIN, Jan. 21, 2023 /PRNewswire/ -- Research and Markets The "Erythropoietin Drugs Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering. The global erythropoietin drugs market size reached US$ 9.8 Billion in 2021. Looking forward, the publisher expects the market to reach US$ 13.8 Billion by 2027, exhibiting a CAGR of 5.87% during 2021-2027. Keeping in mind the uncertainties of COVID-19, we are continuously tracking and evaluating the direct as well as the indirect influence of the pandemic on different end use sectors. These insights are included in the report as a major market contributor. Erythropoietin (EPO) is a hormone produced by kidneys to stimulate the production of red blood cells (RBCs). Its deficiency can lead to low hemoglobin levels and various medical conditions. As a result, there is a rise in the demand for EPO drugs, also known as EPO stimulating agents (ESAs), which are produced synthetically using recombinant deoxyribonucleic acid (DNA) technology. They are usually administered via the intramuscular route and released into the bloodstream to stimulate RBC production. At present, they are available in various types with different dosage schedules and modes of delivery. EPO drugs are generally given to patients undergoing chemotherapy, chronic renal failure, and antiviral drug therapy or at high risk for perioperative blood loss from surgical procedures. Individuals who have anemia due to cancer, prematurity, and chronic kidney disease (CKD) are usually at the risk of low hemoglobin levels. This represents one of the key factors positively influencing the sales of EPO drugs worldwide. In addition, they are used to treat zidovudine among patients with human immunodeficiency virus (HIV) infection. Moreover, the rising need for surgical interventions on account of the growing aging population across the globe is catalyzing the use of EOP drugs to minimize allogeneic blood transfusions after surgical procedures. Furthermore, the escalating demand for minimally invasive (MI) procedures is bolstering the growth of the market. Apart from this, the increasing use of EPO drugs as a novel therapeutic agent in research settings is projected to expand their applications in treating various diseases. These diseases generally include spinal cord injury (SCI), depression, diabetes, acute kidney injury (AKI), recombinant therapy for patients with heart failure, and a neuroprotective agent in ischemic stroke. Competitive Landscape: The competitive landscape of the industry has also been examined along with the profiles of the key players being Amgen Inc., Biocon Limited, Dr. Reddy's Laboratories Ltd., F. Hoffmann-La Roche AG, Intas Pharmaceuticals Ltd., Johnson & Johnson, LG Chem Ltd., Pfizer Inc., Sun Pharmaceutical Industries Limited and Teva Pharmaceutical Industries Ltd. Key Questions Answered in This Report: How has the global erythropoietin drugs market performed so far and how will it perform in the coming years? What has been the impact of COVID-19 on the global erythropoietin drugs market? What are the key regional markets? What is the breakup of the market based on the drug class? What is the breakup of the market based on the product type? What is the breakup of the market based on the application? What is the breakup of the market based on the end user? What are the various stages in the value chain of the industry? What are the key driving factors and challenges in the industry? What is the structure of the global erythropoietin drugs market and who are the key players? What is the degree of competition in the industry? Key Topics Covered: 1 Preface 2 Scope and Methodology 3 Executive Summary 4 Introduction 4.1 Overview 4.2 Key Industry Trends 5 Global Erythropoietin Drugs Market 5.1 Market Overview 5.2 Market Performance 5.3 Impact of COVID-19 5.4 Market Forecast 6 Market Breakup by Drug Class 6.1 Biologics 6.1.1 Market Trends 6.1.2 Market Forecast 6.2 Biosimilars 6.2.1 Market Trends 6.2.2 Market Forecast 7 Market Breakup by Product Type 7.1 Epoetin-alfa 7.1.1 Market Trends 7.1.2 Market Forecast 7.2 Epoetin-beta 7.2.1 Market Trends 7.2.2 Market Forecast 7.3 Darbepoetin-alfa 7.3.1 Market Trends 7.3.2 Market Forecast 7.4 Others 7.4.1 Market Trends 7.4.2 Market Forecast 8 Market Breakup by Application 8.1 Hematology 8.1.1 Market Trends 8.1.2 Market Forecast 8.2 Kidney Disorder 8.2.1 Market Trends 8.2.2 Market Forecast 8.3 Cancer 8.3.1 Market Trends 8.3.2 Market Forecast 8.4 Others 8.4.1 Market Trends 8.4.2 Market Forecast 9 Market Breakup by End User 9.1 Hospitals 9.1.1 Market Trends 9.1.2 Market Forecast 9.2 Homecare 9.2.1 Market Trends 9.2.2 Market Forecast 9.3 Specialty Clinics 9.3.1 Market Trends 9.3.2 Market Forecast 9.4 Others 9.4.1 Market Trends 9.4.2 Market Forecast 10 Market Breakup by Region 11 SWOT Analysis 12 Value Chain Analysis 13 Porters Five Forces Analysis 14 Price Analysis 15 Competitive Landscape 15.1 Market Structure 15.2 Key Players 15.3 Profiles of Key Players 15.3.1 Amgen Inc. 15.3.1.1 Company Overview 15.3.1.2 Product Portfolio 15.3.1.3 Financials 15.3.1.4 SWOT Analysis 15.3.2 Biocon Limited 15.3.2.1 Company Overview 15.3.2.2 Product Portfolio 15.3.2.3 Financials 15.3.2.4 SWOT Analysis 15.3.3 Dr. Reddy's Laboratories Ltd. 15.3.3.1 Company Overview 15.3.3.2 Product Portfolio 15.3.3.3 Financials 15.3.3.4 SWOT Analysis 15.3.4 F. Hoffmann-La Roche AG 15.3.4.1 Company Overview 15.3.4.2 Product Portfolio 15.3.4.3 Financials 15.3.5 Intas Pharmaceuticals Ltd. 15.3.5.1 Company Overview 15.3.5.2 Product Portfolio 15.3.6 Johnson & Johnson 15.3.6.1 Company Overview 15.3.6.2 Product Portfolio 15.3.6.3 Financials 15.3.6.4 SWOT Analysis 15.3.7 LG Chem Ltd. 15.3.7.1 Company Overview 15.3.7.2 Product Portfolio 15.3.7.3 Financials 15.3.7.4 SWOT Analysis 15.3.8 Pfizer Inc. 15.3.8.1 Company Overview 15.3.8.2 Product Portfolio 15.3.8.3 Financials 15.3.8.4 SWOT Analysis 15.3.9 Sun Pharmaceutical Industries Limited 15.3.9.1 Company Overview 15.3.9.2 Product Portfolio 15.3.9.3 Financials 15.3.9.4 SWOT Analysis 15.3.10 Teva Pharmaceutical Industries Ltd. 15.3.10.1 Company Overview 15.3.10.2 Product Portfolio 15.3.10.3 Financials 15.3.10.4 SWOT Analysis For more information about this report visit Media Contact: Laura Wood | +353-1-481-1716 | [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo - SOURCE Research and Markets

14 Oct 2022

·www.biospace.com

Dosis Demonstrates 40% Reduction in Epoetin Beta Utilization with Maintained Hemoglobin Levels

SAN FRANCISCO--(BUSINESS WIRE)-- Dosis, a market leader in artificial intelligence-powered precision dosing, announced today the publication of two abstracts to be showcased at the American Society of Nephrology’s (ASN) Kidney Week 2022, taking place November 3-6 in Orlando, FL. The abstracts detail the results of statistical analyses performed on clinical data drawn from Strategic Anemia Advisor (SAA), Dosis’s flagship anemia management product. This press release features multimedia. View the full release here: Figure 1: The abstract titled “Artificial Intelligence (AI) Tool Decreases Epoetin Beta (Mircera) Drug Exposure and Maintains Hemoglobin at Desired Levels'' presents a 40% reduction in mean monthly epoetin beta dose using SAA, from 140 micrograms per patient per month to 84 micrograms per patient per month, with maintained hemoglobin levels. (Graphic: Business Wire) One abstract, titled “Artificial Intelligence (AI) Tool Decreases Epoetin Beta (Mircera) Drug Exposure and Maintains Hemoglobin at Desired Levels,” analyzes clinical data from 2,116 patients receiving epoetin beta in 19 dialysis clinics. Mean monthly dose of epoetin beta fell 40% using SAA, from 140 micrograms per patient per month to 84 micrograms per patient per month. Patient hemoglobin averaged 10.7 grams per deciliter (g/dL) in both the control period and in Months 5-12 during SAA use. Results are shown in Figure 1. The full abstract can be accessed here. The other abstract, titled “Discontinuation of Artificial Intelligence (AI) Tool for Anemia Management Results in Higher Drug Exposure, Lower Hemoglobin,” presents clinical data across a 3-year period from 855 patients receiving epoetin beta in 5 dialysis clinics located in the same geographic area. The analysis demonstrates a 50-66% reduction in mean monthly epoetin beta dosage in clinics that used SAA for dosing recommendations, compared to those that did not use SAA or discontinued SAA use during the analyzed period. SAA use was left to the discretion of each clinic’s medical director. Two clinics used SAA over the full duration of the analyzed period, one clinic did not use SAA at all during the analyzed period, and the remaining two clinics discontinued use of SAA during the analyzed period. The two clinics that used SAA for the entire analyzed period had higher hemoglobin levels and 50-66% lower monthly doses of epoetin beta per patient than the clinic that did not use SAA at all. The two clinics that discontinued SAA use during the analyzed period saw hemoglobin levels fall by 0.6 g/dL and monthly epoetin beta dose per patient rise by 50-57%. Results are shown in Figure 2. The full abstract can be accessed here. “Kidney Week 2022 provides us with a unique opportunity to share the irreplaceable value our products deliver to the nephrology community,” said Shivrat Chhabra, Chief Executive Officer and co-founder of Dosis. “Rising costs in the current macroeconomic environment and the shift to value-based care are driving the need for precision medicine tools that maximize patient outcomes while reducing the cost of care. We offer kidney care providers the tools they need to get a step ahead of the competition in this shifting marketplace.” SAA calculates and delivers a personalized dosing recommendation for each patient based on the patient’s past Erythropoiesis Stimulating Agent (ESA) doses, hemoglobin levels, and target hemoglobin range, helping manage their hemoglobin levels while reducing unnecessary ESA exposure and drug cost. SAA’s personalized dosing recommendations represent a generational leap in dosing efficiency when compared to conventional one-size-fits-all dosing approaches. “We are proud to present these results and believe they will drive continued adoption of AI-driven personalized dosing tools by the dialysis industry,” said Chhabra, with Dosis’s momentum continuing to accelerate after its announcement earlier this year of a nationwide implementation of SAA with a major U.S. dialysis provider. About Dosis Inc. Dosis Inc. is a San Francisco-based precision medicine software company on a mission to transform chronic disease management by leveraging advancements in artificial intelligence and control algorithms. With a deep academic foundation, Dosis uses science, data, patient safety, and clinical evidence to create precision dosing tools for health care providers. For more information about the technology behind SAA, visit dosisinc.com/platform, and for more information about Dosis, visit dosisinc.com.

04 May 2006

·www.pharmatimes.com

Astellas in mega deal for oral EPO rivals

Japanese drugmaker Astellas has licensed exclusive rights to a series of anaemia drugs from FibroGen, in a deal that could eventually bring in up to $2 billion to the US firm in the coming years. Astellas had previously licensed Japanese rights to the drugs, known as hypoxia-inducible factor prolyl hydroxylase inhibitors, but in the latest agreement has extended its rights to include Europe, the Commonwealth of Independent States, the Middle East and South Africa. The deal includes FG-2216 and FG-4592, which are currently in human clinical trials, with FibroGen retaining rights to compounds in the rest of the world. Under the terms of the agreement, Astellas will pay a licensing fee of $300 million upon signing, milestones totaling $465 million and share in the costs of a transatlantic development programme and patent support. If all forecast sales targets are achieved, FibroGen could receive in excess of $2 billion during the 10 to 15 years after 2010. In addition, Astellas will purchase $50 million worth of shares in the US biotechnology firm. The oral compounds inhibit the enzyme that degrades erythropoietin, and could be a more patient-friendly therapy option for anaemia, which is currently treated with injectable recombinant forms of EPO such as Amgen’s Epogen (epoetin alfa) and Aranesp (darbepoetin alfa), as well as Roche’s NeoRecormon (epoetin beta). Together these drugs account for a multibillion dollar market worldwide. For example, in Europe, sales of EPO products for anaemia of chronic kidney disease and chemotherapy-induced anaemia total approximately $3 billion a year. Astellas noted that oral treatments to stimulate red blood cell production could address larger, multi-million patient market opportunities currently not penetrated by EPO products, including chronic kidney disease in patients not yet on dialysis and anaemias caused by cancer, congestive heart failure, advancing age and chronic disease. Sales potential Astellas said it plans to start marketing the agents in 2011-2012, and predicts that the drugs have an annual sales potential in Europe of around 50 billion yen (roughly $450 million), which could double at peak. A launch in Japan should occur a little later, and Astellas said the market potential there is in the region of 30-50 billion yen.

100 Deals associated with Epoetin beta

External Link

KEGG	Wiki	ATC	Drug Bank
D03232	Epoetin beta	B03XA01	DB00016

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anemia in chronic kidney disease	Australia	Roche Products Pty Ltd.	09 Jan 2006
Anemia, Neonatal	Australia	Roche Products Pty Ltd.	09 Jan 2006
Anemia	European Union	Roche Registration GmbH	16 Jul 1997
Anemia	Iceland	Roche Registration GmbH	16 Jul 1997
Anemia	Liechtenstein	Roche Registration GmbH	16 Jul 1997
Anemia	Norway	Roche Registration GmbH	16 Jul 1997
chronic renal failure anemia	European Union	Roche Registration GmbH	16 Jul 1997
chronic renal failure anemia	Iceland	Roche Registration GmbH	16 Jul 1997
chronic renal failure anemia	Liechtenstein	Roche Registration GmbH	16 Jul 1997
chronic renal failure anemia	Norway	Roche Registration GmbH	16 Jul 1997
Anemia of renal disease	Japan	Chugai Pharmaceutical Co., Ltd.	23 Jan 1990

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Renal Insufficiency	Phase 3	France	Roche Pharma AG	01 Oct 2007
Diabetes Mellitus	Phase 3	France	Hoffmann-La Roche, Inc.	01 Oct 2005
Kidney Failure, Chronic	Phase 3	France	Hoffmann-La Roche, Inc.	01 Oct 2005
Diabetic Nephropathies	Phase 3	Austria	Hoffmann-La Roche, Inc.	01 Sep 2002
Diabetic Nephropathies	Phase 3	Brazil	Hoffmann-La Roche, Inc.	01 Sep 2002
Diabetic Nephropathies	Phase 3	Czechia	Hoffmann-La Roche, Inc.	01 Sep 2002
Diabetic Nephropathies	Phase 3	Denmark	Hoffmann-La Roche, Inc.	01 Sep 2002
Diabetic Nephropathies	Phase 3	Finland	Hoffmann-La Roche, Inc.	01 Sep 2002
Diabetic Nephropathies	Phase 3	Germany	Hoffmann-La Roche, Inc.	01 Sep 2002
Diabetic Nephropathies	Phase 3	Greece	Hoffmann-La Roche, Inc.	01 Sep 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2022	Not Applicable	Myelodysplastic Syndromes First line	338	ESA	xzfkusssel(maniyrepjk) = hcsgnohtbn dfotgaiyvs (slygnpzliq ) View more	-	10 Jun 2022
ASCO2022	Not Applicable	Myelodysplastic Syndromes First line	338	ESA use	tsxiktpzww(ajurlsppfo) = gmjkvzrwnu iddlgoxrda (usiihayqjx )	Positive	02 Jun 2022
				No ESA use	vayavrqajx(qpqqlianpa) = txfalyexcq vmwzewbkdy (mwbgkbarmp )
ASN2021	Not Applicable	-	260	IV PEG-epoetin beta	qelwxlptqw(lpfuoqokoj) = sehtxehjxk wfgbuiposk (vejxvojuuk ) View more	Positive	27 Oct 2021
				sc epoetin beta	qelwxlptqw(lpfuoqokoj) = vqjboyoknq wfgbuiposk (vejxvojuuk ) View more
NCT02707757 (PRIME, CTgov)	Phase 4	Anemia	197	Iron sucrose (Iron Sucrose)	pcmupbthbj = apjfnqoxaw msghmtnryj (sucfzygwow, dsmukgvfam - bmliaekqoy) View more	-	09 Mar 2021
				Erythopoietin stimulating agent (Neorecormon)	pcmupbthbj = nxeddvpizy msghmtnryj (sucfzygwow, coiovldcjl - zumduswgwh) View more
NCT02145026 (CTgov)	Phase 4	Myelodysplastic Syndromes	100	Epoetin beta	euiyivcqel = uzmbozoowj rkqfekrljn (kbwyimscho, mhoknkmigs - upjphsopxy) View more	-	24 Apr 2020
SP484 (ERA2019)	Not Applicable	Hemodialysis complication erythropoietin (EPO)	4	Epoetin β	uihvrdevha(xoyiwjtpjs) = fsqibxnaqs kfqcklwvaz (azzmpehsky ) View more	Negative	13 Jun 2019
				Darbepoetin α	uihvrdevha(xoyiwjtpjs) = khjekawcit kfqcklwvaz (azzmpehsky ) View more
NCT02761642 (CTgov)	Phase 2	Anemia	200	Epoetin Beta	pkjddjybmb = vpjzwcpgxh slcxniager (jndiakjlur, qrdzyizpof - bmitzvqreh) View more	-	24 Aug 2018
SP609 (ERA2017)	Not Applicable	-	603	Epоetin alpha	qmydivczfc(mognwxdylb) = pkuszjjcjp hfpoxhhwie (qpvkdmohot ) View more	Negative	26 May 2017
				Epоetin beta	qmydivczfc(mognwxdylb) = qxlxcnewsu hfpoxhhwie (qpvkdmohot ) View more
DOPPS (ASN2016)	Not Applicable	-	4,230	C.E.R.A.	zbmcdqlpzg(mccurhtkku) = yhkkqcktfk dhihvfzifm (sjvggbbuuk ) View more	-	15 Nov 2016
				Darbepoetin alfa (DA)	zbmcdqlpzg(mccurhtkku) = tdwefwzlck dhihvfzifm (sjvggbbuuk ) View more
NCT00321919 (CTgov)	Phase 3	chronic renal failure anemia	605	epoetin beta [NeoRecormon] (Early Epoetin Beta Therapy)	dxpngkrtxn(oagxcbtmgn) = qdtaorexrc sgwssysmto (usekpiawbx, vuyzeutvll - whwvtxncsk) View more	-	25 May 2016
				epoetin beta [NeoRecormon] (Late Epoetin Beta Therapy)	dxpngkrtxn(oagxcbtmgn) = nlnoyefyws sgwssysmto (usekpiawbx, xgpwzbghqk - ysopmqskgv) View more

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