A Randomized, 2 Part, 4-treatment, 2-way Cross-over Study in Healthy Volunteers to Compare the Pharmacokinetic and Pharmacodynamic Profiles of 1ug/kg of DA-3880 and EU Sourced ARANESP® (Amgen) After Single Intravenous or Subcutaneous Administration

The main purpose of the study is to determine whether the test product and the reference product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a single intravenous dose and as a single subcutaneous dose of each of the formulations. The study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.

Start Date18 Aug 2014

Sponsor / Collaborator

Dong-A ST Co., Ltd.

100 Clinical Results associated with Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.)

100 Translational Medicine associated with Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.)

100 Patents (Medical) associated with Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.)

126

Literatures (Medical) associated with Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.)

01 Mar 2024·Therapies

Drug-induced hyperglycemia and diabetes

Review

Author: Heurtebize, Marie-Anne ; Faillie, Jean-Luc

BACKGROUNDDrug-induced hyperglycemia and diabetes have negative and potentially serious health consequences but can often be unnoticed.METHODSWe reviewed the literature searching Medline database for articles addressing drug-induced hyperglycemia and diabetes up to January 31, 2023. We also selected drugs that could induce hyperglycemia or diabetes according official data from drug information databases Thériaque and Micromedex. For each selected drug or pharmacotherapeutic class, the mechanisms of action potentially involved were investigated. For drugs considered to be at risk of hyperglycemia or diabetes, disproportionality analyses were performed using data from the international pharmacovigilance database VigiBase. In order to detect new pharmacovigilance signals, additional disproportionality analyses were carried out for drug classes with more than 100 cases reported in VigiBase, but not found in the literature or official documents.RESULTSThe main drug classes found to cause hyperglycemia are glucocorticoids, HMG-coA reductase inhibitors, thiazide diuretics, beta-blockers, antipsychotics, fluoroquinolones, antiretrovirals, antineoplastic agents and immunosuppressants. The main mechanisms involved are alterations in insulin secretion and sensitivity, direct cytotoxic effects on pancreatic cells and increases in glucose production. Pharmacovigilance signal were found for a majority of drugs or pharmacological classes identified as being at risk of diabetes or hyperglycemia. We identified new pharmacovigilance signals with drugs not known to be at risk according to the literature or official data: phosphodiesterase type 5 inhibitors, endothelin receptor antagonists, sodium oxybate, biphosphonates including alendronic acid, digoxin, sartans, linosipril, diltiazem, verapamil, and darbepoetin alpha. Further studies will be needed to confirm these signals.CONCLUSIONSThe risks of induced hyperglycemia vary from one drug to another, and the underlying mechanisms are multiple and potentially complex. Clinicians need to be vigilant when using at-risk drugs in order to detect and manage these adverse drug reactions. However, it is to emphasize that the benefits of appropriately prescribed treatments most often outweigh their metabolic risks.

01 Jul 2023·Kidney Medicine

Safety Endpoints With Vadadustat Versus Darbepoetin Alfa in Patients With Non–Dialysis-Dependent CKD: A Post Hoc Regional Analysis of the PRO2TECT Randomized Clinical Trial of ESA-Treated Patients

Article

Author: Jardine, Alan G ; Winkelmayer, Wolfgang C ; McCullough, Peter A ; Burke, Steven K ; Eckardt, Kai-Uwe ; Luo, Wenli ; Lewis, Eldrin F ; Minga, Todd ; Parfrey, Patrick S ; Chertow, Glenn M ; Matsushita, Kunihiro

Rationale & ObjectiveIn the PRO₂TECT trials, vadadustat was found to be noninferior to darbepoetin alfa in hematologic efficacy but not for major adverse cardiovascular events (MACE; all-cause death or nonfatal myocardial infarction or stroke) in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). We investigated the regional differences in MACE in the PRO₂TECT trials.Study DesignPhase 3, global, open-label, randomized, active-controlled clinical trial.Setting & ParticipantsA total of 1,725 erythropoiesis-stimulating agent (ESA)-treated patients with anemia and NDD-CKD.Intervention1:1 randomization to receive vadadustat or darbepoetin alfa.OutcomesThe primary safety end point was the time to first MACE.ResultsAt baseline, patients in Europe (n=444) were primarily treated with darbepoetin alfa, showed higher proportions on low ESA doses (<90 U/kg/wk epoetin alfa equivalents) with a hemoglobin concentration of ≥10 g/dL compared with patients in the US (n=665) and non-US/non-Europe (n=614) regions. The MACE rates per 100 person-years in the 3 vadadustat groups across regions were 14.5 in the US, 11.6 in Europe, and 10.0 in the non-US/non-Europe groups, whereas event rates in the darbepoetin alfa group were considerably lower in Europe than in the US and non-US/non-Europe groups (6.7 vs 13.3 and 10.5, respectively). The overall hazard ratio for MACE for vadadustat vs darbepoetin alpha was 1.16; 95% CI, 0.93-1.45, but varied by geographical region, with a greater hazard ratio seen in Europe (US, 1.07; 95% CI, 0.78-1.46; Europe, 2.05; 95% CI, 1.24-3.39; non-US/non-Europe, 0.91; 95% CI, 0.60-1.37); interaction between study treatment and geographical region, P = 0.07). In Europe, ESA rescue was associated with a higher risk of MACE in both groups.LimitationsSeveral analyses are exploratory.ConclusionsIn this trial, there was a low risk of MACE in the darbepoetin alfa group in Europe. Patients in Europe were generally on low doses of ESA, with hemoglobin already within target range. The low risk of MACE may have been related to a limited need to switch and titrate darbepoetin alfa compared with the non-US/non-Europe group.FundingAkebia Therapeutics, Inc.Trial RegistrationClinicalTrials.gov identifier: NCT02680574.

25 Feb 2023·Sheng li xue bao : [Acta physiologica Sinica]

Erythropoietin promotes myocardial infarction repair in mice by improving the function of Sca-1⁺ stem cells.

Article

Author: Ma, Xiu-Xia ; Shen, Jing ; Zuo, Lin ; Shi, Shan-Hui ; Li, Duan-Duan ; Gao, Er-He ; Cao, Ji-Min ; Lyu, Ding-Chao ; Zhang, Wei-Fang

Myocardial infarction (MI) is one of the leading causes of death in the world. With the improvement of clinical therapy, the mortality of acute MI has been significantly reduced. However, as for the long-term impact of MI on cardiac remodeling and cardiac function, there is no effective prevention and treatment measures. Erythropoietin (EPO), a glycoprotein cytokine essential to hematopoiesis, has anti-apoptotic and pro-angiogenetic effects. Studies have shown that EPO plays a protective role in cardiomyocytes in cardiovascular diseases, such as cardiac ischemia injury and heart failure. EPO has been demonstrated to protect ischemic myocardium and improve MI repair by promoting the activation of cardiac progenitor cells (CPCs). This study aimed to investigate whether EPO can promote MI repair by enhancing the activity of stem cell antigen 1 positive stem cells (Sca-1⁺ SCs). Darbepoetin alpha (a long-acting EPO analog, EPO_anlg) was injected into the border zone of MI in adult mice. Infarct size, cardiac remodeling and performance, cardiomyocyte apoptosis and microvessel density were measured. Lin^- Sca-1⁺ SCs were isolated from neonatal and adult mouse hearts by magnetic sorting technology, and were used to identify the colony forming ability and the effect of EPO, respectively. The results showed that, compared to MI alone, EPO_anlg reduced the infarct percentage, cardiomyocyte apoptosis ratio and left ventricular (LV) chamber dilatation, improved cardiac performance, and increased the numbers of coronary microvessels in vivo. In vitro, EPO increased the proliferation, migration and clone formation of Lin^- Sca-1⁺ SCs likely via the EPO receptor and downstream STAT-5/p38 MAPK signaling pathways. These results suggest that EPO participates in the repair process of MI by activating Sca-1⁺ SCs.

News (Medical) associated with Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.)

09 Nov 2022

·www.biospace.com

Dong-A ST Signs License-out Deal with Polifarma of Türkiye for NESP® Biosimilar DA-3880

- Dong-A building a foundation for expanding its biosimilar business through license-out and supply agreements to Türkiye, Brazil and Mexico - Creating a synergy effect with STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings SEOUL, South Korea--(BUSINESS WIRE)-- Dong-A ST (Min Young Kim, President and CEO) (KRX: 170900) announced that they signed an exclusive license-out and supply agreement on November 4, 2022, with Polifarma (Mehmet Asri, CEO) for NESP® biosimilar DA-3880. According to the agreement, Dong-A ST will license out the exclusive rights for the development and commercialization of DA-3880 in Türkiye, Brazil, and Mexico to Polifarma. Dong-A ST will receive upfront and developmental/commercial milestone payments and will exclusively supply the finished product through STgen Bio, an affiliated Bio CDMO of Dong-A Socio Holdings. Meanwhile, Polifarma will be responsible for the development and commercialization in Türkiye, Brazil, and Mexico. The details of the upfront, milestone payments, and supply profit structure remain undisclosed as per the consensus between both parties. “DA-3880” is an ARANESP®/NESP® biosimilar for the treatment of anemic patients with chronic renal failure or those undergoing chemotherapy. Dong-A ST signed a license-out agreement with Sanwa Kagaku Kenkyusho in 2014 for the development and commercialization of DA-3880 in Japan. After regulatory approval from PMDA (Pharmaceuticals and Medical Devices Agency, Japan) in 2019, DA-3880 has been successfully commercialized in the Japanese market, making it one of the bestsellers among darbepoetin alfa biosimilar products. Polifarma is a Türkiye pharmaceutical company with 100% domestic capital and 36 years of experience. It has established actual export records of 586 drugs to over 70 countries, including the US, Europe, Brazil, and Mexico. As the most well-known, and most preferred, hospital products brand in Türkiye, Polifarma’s goal is to maintain its lead in the Türkiye market and become one of the biggest global leaders by sustaining its quality and technological superiority. Jae Hong Park (President and CSO of Dong-A ST) said, “This agreement provides an opportunity for Dong-A ST to introduce DA-3880 beyond the Japanese market and into the global biosimilar market including Türkiye and South & Central America. Dong-A ST will commit to expanding its global market presence by showcasing our biosimilar R&D and overseas business capabilities.”

CollaborateBiosimilarLicense out/in

12 Jul 2021

·www.biospace.com

MENAGEN-MiddleEast announces commercializing agreement with CKD for Biosimilar Darbepotein Alfa

July 12, 2021 10:43 UTC DUBAI, United Arab Emirates--(BUSINESS WIRE)-- Menagen Pharmaceutical Industries (“Menagen”) and Chong Kun Dang Pharmaceutical Corp (“CKD”) Korea announced today that they have entered into a strategic partnership in the GCC market for the technology transfer and commercialization for the first biosimilar Darbepoetin alpha, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. The CKD biosimilar is currently approved in South Korea. This press release features multimedia. View the full release here: MENAGEN-Middle East announces commercializing agreement with CKD for Biosimilar Darbepotein Alfa (Photo: AETOSWire) "Through this collaboration with CKD we are establishing our biosimilar footprint in Middle east and Africa markets and reaching more people living with severe chronic diseases. We aim to provide broad accesses to patients with unmet medical needs by leveraging Mengen’s local expertise and capabilities," Rula Fahoom Menagen's VP of Business Development, commented. About Menagen: Menagen is a state of the art bio-manufacturing facility located in Muscat, Oman covering an area of 32000 ft². Menagen will be focused on various niche therapeutic products, including; but not limited to biosimilar, oncology, hematology, Nephrology, orphan and other various medicines. About Chong Kun Dang Pharmaceutical Corp. Founded in 1941, CKD is a fully integrated pharmaceutical company employing over 2,200 people. It is one of the leading local pharma companies in Korea and through in-licensing and in-house R&D, it has significantly contributed to improving health and quality of life of people mainly in Korea for more than 80 years. Domestically, it has a strong presence in cardiovascular, immunosuppressant and biosimilar areas. As a leading pharmaceutical company, CKD continues to strengthen its major therapeutic area by its R&D capability and licensing-in innovative drugs from business partners worldwide. *Source: AETOSWire View source version on businesswire.com: Contacts Rula Fahoom rula@Menagene.com Source: Menagen Pharmaceutical Industries Smart Multimedia Gallery Photo MENAGEN-Middle East announces commercializing agreement with CKD for Biosimilar Darbepotein Alfa (Photo: AETOSWire) Logo View this news release and multimedia online at:

CollaborateInnovative DrugBiosimilar

100 Deals associated with Darbepoetin alfa biosimilar(Dong-A Pharmaceutical Co., Ltd.)

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KEGG	Wiki	ATC	Drug Bank
-	-	B03XA02	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Anemia	JP	Sanwa Kagaku Kenkyusho Co., Ltd.	20 Sep 2019

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Indication	Highest Phase	Country/Location	Organization	Date
Anemia	Phase 3	NL	Dong-A ST Co., Ltd.	18 Aug 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASN2012	Not Applicable	TAFI \| CRP \| MPV	-	Darbepoetin-alpha	(bvfyyzelga) = zmcrmgjrwh apeqzinxdr (xrrixdgule, 1.87)	Positive	30 Oct 2012
				Epoetin alfa	(bvfyyzelga) = efynmlckca apeqzinxdr (xrrixdgule, 2.06)
ASN2010	Not Applicable	-	-	CERA	(ckjgoqqvpq) = cpuhgeezks pvrxcjxuyc (yhiveooxuz ) View more	-	16 Nov 2010
				Darbepoetin-alpha	(ckjgoqqvpq) = wkxfysttpe pvrxcjxuyc (yhiveooxuz ) View more
ASN2010	Not Applicable	-	281	Darbepoetin alpha 1 µg	(rxwfssfaud) = difsvaqqks gchuvrtkss (xpdjjgeedi, 2.7)	Positive	16 Nov 2010
				Epoetin beta 3000 IU	(rxwfssfaud) = mgkmvpdcdl gchuvrtkss (xpdjjgeedi, 3.1)

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