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

Info

Publication number
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
Authority
JP
Japan
Prior art keywords
fviia
life
protein
dose
extended
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
JP2016561735A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017513831A5 (OSRAM
Inventor
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
Original Assignee
シーエスエル、リミテッド
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by シーエスエル、リミテッド filed Critical シーエスエル、リミテッド
Publication of JP2017513831A publication Critical patent/JP2017513831A/ja
Publication of JP2017513831A5 publication Critical patent/JP2017513831A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • 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

Landscapes

  • 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 (OSRAM) 2018-05-17

Family

ID=54287020

Family Applications (1)

Application Number Title Priority Date Filing Date
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 (OSRAM)
EP (1) EP3129408A4 (OSRAM)
JP (1) JP2017513831A (OSRAM)
KR (1) KR20160143820A (OSRAM)
CN (1) CN106164097A (OSRAM)
AU (1) AU2015245941A1 (OSRAM)
BR (1) BR112016023158A2 (OSRAM)
CA (1) CA2944174A1 (OSRAM)
MX (1) MX2016013281A (OSRAM)
RU (1) RU2016144159A (OSRAM)
SG (1) SG11201608006QA (OSRAM)
WO (1) WO2015154139A1 (OSRAM)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3645034B1 (en) * 2017-06-29 2023-08-30 CSL Behring Lengnau AG 21-day dosing regimen for fusion proteins comprising factor ix and human albumin for prophylactic treatment of hemophilia and methods thereof

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
CA2770609A1 (en) * 2009-08-20 2011-02-24 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)

* Cited by examiner, † Cited by third party
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
AU2015245941A1 (en) 2016-11-17
US20170042981A1 (en) 2017-02-16
CN106164097A (zh) 2016-11-23
KR20160143820A (ko) 2016-12-14
EP3129408A1 (en) 2017-02-15
BR112016023158A2 (pt) 2017-10-17
RU2016144159A3 (OSRAM) 2018-11-26
MX2016013281A (es) 2017-01-18
EP3129408A4 (en) 2018-04-25
CA2944174A1 (en) 2015-10-15
SG11201608006QA (en) 2016-10-28
WO2015154139A1 (en) 2015-10-15
RU2016144159A (ru) 2018-05-11

Similar Documents

Publication Publication Date Title
KR101567762B1 (ko) Ｆｖⅲ 농축물을 포함하는 프로트롬빈 복합체 농축물의 상승적 치료 용도
JP7741145B2 (ja) 第ｉｘ因子ポリペプチド製剤
JP2017114889A (ja) 再構成後の精製第ｖｉｉｉ因子の安定性を改善するための方法
KR20160070163A (ko) 출혈 또는 응고성 저하와 관련된 상태의 치료 또는 예방용 요법
US20090017007A1 (en) Liquid factor vii composition
KR20160093735A (ko) 혈우병의 예방학적 치료를 위한 인자 ｉｘ를 포함하는 융합 단백질 및 이의 방법
JP2017513831A (ja) 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
WO2023245335A1 (en) Activators of coagulation factor x and formulations thereof for treating bleeding disorders
JP6971301B2 (ja) ヒトにおける長時間作用性第ｉｘ因子の皮下投与
KR102597725B1 (ko) 혈우병의 예방적 치료를 위해 인자 ix 및 사람 알부민을 포함하는 융합 단백질에 대한 21-일 투여 용법 및 이의 방법
WO2010149172A2 (en) SYSTEMIC PRO-HEMOSTATIC EFFECT OF CLOTTING FACTORS IN COMBINATION WITH SYMPATHICOMIMETICS WITH AGONISTIC EFFECTS ON α-ADRENERGIC AND/OR β-ADRENERGIC RECEPTORS OF THE SYMPATHETIC NERVOUS SYSTEM, RELATED TO IMPROVED CLOT STRENGTH.
HK40027732A (en) 21-day dosing regimen for fusion proteins comprising factor ix and human albumin for prophylactic treatment of hemophilia and methods thereof
HK40027732B (en) 21-day dosing regimen for fusion proteins comprising factor ix and human albumin for prophylactic treatment of hemophilia and methods thereof

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180328

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180328

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190226

A02 Decision of refusal

Free format text: JAPANESE INTERMEDIATE CODE: A02

Effective date: 20191008