JP2017513831A - 出血の予防および処置のための半減期延長型（ｈａｌｆ−ｌｉｆｅ ｅｘｔｅｎｄｅｄ）第ｆｖｉｉａ因子タンパク質、ならびに、その投与レジメン - Google Patents

出血の予防および処置のための半減期延長型（ｈａｌｆ−ｌｉｆｅ ｅｘｔｅｎｄｅｄ）第ｆｖｉｉａ因子タンパク質、ならびに、その投与レジメン Download PDF

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JP2017513831A
JP2017513831A JP2016561735A JP2016561735A JP2017513831A JP 2017513831 A JP2017513831 A JP 2017513831A JP 2016561735 A JP2016561735 A JP 2016561735A JP 2016561735 A JP2016561735 A JP 2016561735A JP 2017513831 A JP2017513831 A JP 2017513831A
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fviia
life
protein
dose
extended
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JP2017513831A5 (cg-RX-API-DMAC10.html
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デブラ・ベンセン−ケネディ
アレックス・フェルドマン
ザビーネ・ツォルナー
エーファ・ヘルツォーク
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シーエスエル、リミテッド
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38—Albumins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482—Serine endopeptidases (3.4.21)
    • A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643—Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21021—Coagulation factor VIIa (3.4.21.21)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Toxicology (AREA)
  • Wood Science & Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2016561735A 2014-04-11 2015-03-30 出血の予防および処置のための半減期延長型（ｈａｌｆ−ｌｉｆｅ ｅｘｔｅｎｄｅｄ）第ｆｖｉｉａ因子タンパク質、ならびに、その投与レジメン Pending JP2017513831A (ja)

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201461978218P 2014-04-11 2014-04-11
US61/978,218 2014-04-11
EP14167612.2 2014-05-09
EP14167612 2014-05-09
EP14168389.6 2014-05-15
EP14168389 2014-05-15
PCT/AU2015/050137 WO2015154139A1 (en) 2014-04-11 2015-03-30 Half-life extended factor fviia protein for prevention and treatment of bleeding and dosing regimens therefor

Publications (2)

Publication Number Publication Date
JP2017513831A true JP2017513831A (ja) 2017-06-01
JP2017513831A5 JP2017513831A5 (cg-RX-API-DMAC10.html) 2018-05-17

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JP2016561735A Pending JP2017513831A (ja) 2014-04-11 2015-03-30 出血の予防および処置のための半減期延長型（ｈａｌｆ−ｌｉｆｅ ｅｘｔｅｎｄｅｄ）第ｆｖｉｉａ因子タンパク質、ならびに、その投与レジメン

Country Status (12)

Country Link
US (1) US20170042981A1 (cg-RX-API-DMAC10.html)
EP (1) EP3129408A4 (cg-RX-API-DMAC10.html)
JP (1) JP2017513831A (cg-RX-API-DMAC10.html)
KR (1) KR20160143820A (cg-RX-API-DMAC10.html)
CN (1) CN106164097A (cg-RX-API-DMAC10.html)
AU (1) AU2015245941A1 (cg-RX-API-DMAC10.html)
BR (1) BR112016023158A2 (cg-RX-API-DMAC10.html)
CA (1) CA2944174A1 (cg-RX-API-DMAC10.html)
MX (1) MX2016013281A (cg-RX-API-DMAC10.html)
RU (1) RU2016144159A (cg-RX-API-DMAC10.html)
SG (1) SG11201608006QA (cg-RX-API-DMAC10.html)
WO (1) WO2015154139A1 (cg-RX-API-DMAC10.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2963665T3 (es) * 2017-06-29 2024-04-01 CSL Behring Lengnau AG Régimen de dosificación de 21 días para proteínas de fusión que comprenden factor ix y albúmina humana para el tratamiento profiláctico de la hemofilia y procedimientos para ello

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2008074032A1 (en) * 2006-12-15 2008-06-19 Baxter International Inc. Factor viia- (poly) sialic acid conjugate having prolonged in vivo half-life
WO2012002745A2 (en) * 2010-06-30 2012-01-05 Hanmi Holdings Co., Ltd Factor viia complex using an immunoglobulin fragment
US20130243747A1 (en) * 2006-02-03 2013-09-19 Prolor Biotech Inc. Long-acting coagulation factors and methods of producing same

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1816201A1 (en) * 2006-02-06 2007-08-08 CSL Behring GmbH Modified coagulation factor VIIa with extended half-life
EP2467166A2 (en) * 2009-08-20 2012-06-27 CSL Behring GmbH Albumin fused coagulation factors for non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130243747A1 (en) * 2006-02-03 2013-09-19 Prolor Biotech Inc. Long-acting coagulation factors and methods of producing same
WO2008074032A1 (en) * 2006-12-15 2008-06-19 Baxter International Inc. Factor viia- (poly) sialic acid conjugate having prolonged in vivo half-life
WO2012002745A2 (en) * 2010-06-30 2012-01-05 Hanmi Holdings Co., Ltd Factor viia complex using an immunoglobulin fragment

Non-Patent Citations (9)

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Title
DICKNEITE G ET AL.: "P-TU-246", JOURNAL OF THROMBOSIS AND HAEMOSTASIS, vol. 9 (Suppl.2), JPN6019005797, 2011, pages 385 - 386, ISSN: 0003981099 *
F. PEYVANDI ET AL., JOURNAL OF THROMBOSIS AND HAEMOSTASIS, vol. 11 (Supl. 1), JPN6019005795, 2013, pages 84 - 98, ISSN: 0003981097 *
G. GOLOR ET AL., JOURNAL OF THROMBOSIS AND HAEMOSTASIS, vol. 11, JPN6019005784, 2013, pages 1977 - 1985, ISSN: 0003981091 *
HUBERT J. METZNER ET AL., THROMBOSIS AND HAEMOSTASIS, vol. 110, 5, JPN6019005792, 2013, pages 931 - 939, ISSN: 0003981096 *
J. MOSS ET AL., JOURNAL OF THROMBOSIS AND HAEMOSTASIS, vol. 9, JPN6019005794, 2011, pages 1368 - 1374, ISSN: 0003981098 *
R. LJUNG ET AL., JOURNAL OF THROMBOSIS AND HAEMOSTASIS, vol. 11, JPN6019005788, 2013, pages 1260 - 1268, ISSN: 0003981093 *
S. ZOLLNER ET AL., JOURNAL OF THROMBOSIS AND HAEMOSTASIS, vol. 12, JPN6019005785, 2014, pages 220 - 228, ISSN: 0003981092 *
STEFAN SCHULTE, THROMBOSIS RESEARCH, vol. 122, Suppl. 4, JPN6019005791, 2008, pages 14 - 19, ISSN: 0003981095 *
THOMAS WEIMER ET AL., THROMB HAEMOST, vol. 99, JPN6019005789, 2008, pages 659 - 667, ISSN: 0003981094 *

Also Published As

Publication number Publication date
WO2015154139A1 (en) 2015-10-15
KR20160143820A (ko) 2016-12-14
MX2016013281A (es) 2017-01-18
US20170042981A1 (en) 2017-02-16
SG11201608006QA (en) 2016-10-28
BR112016023158A2 (pt) 2017-10-17
RU2016144159A (ru) 2018-05-11
CA2944174A1 (en) 2015-10-15
EP3129408A1 (en) 2017-02-15
AU2015245941A1 (en) 2016-11-17
CN106164097A (zh) 2016-11-23
RU2016144159A3 (cg-RX-API-DMAC10.html) 2018-11-26
EP3129408A4 (en) 2018-04-25

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