DK2985033T3 - Faktor vii-sammensætning - Google Patents

Faktor vii-sammensætning Download PDF

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Publication number
DK2985033T3
DK2985033T3 DK15175122.9T DK15175122T DK2985033T3 DK 2985033 T3 DK2985033 T3 DK 2985033T3 DK 15175122 T DK15175122 T DK 15175122T DK 2985033 T3 DK2985033 T3 DK 2985033T3
Authority
DK
Denmark
Prior art keywords
factor vii
vii composition
composition
factor
vii
Prior art date
Application number
DK15175122.9T
Other languages
English (en)
Other versions
DK2985033T6 (da
Inventor
Annie Bardat
Cornelius Pompe
Original Assignee
Lab Francais Du Fractionnement
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 Lab Francais Du Fractionnement filed Critical Lab Francais Du Fractionnement
Application granted granted Critical
Publication of DK2985033T3 publication Critical patent/DK2985033T3/da
Publication of DK2985033T6 publication Critical patent/DK2985033T6/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/48Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/64Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
    • C12N9/6421Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
    • C12N9/6424Serine endopeptidases (3.4.21)
    • C12N9/6437Coagulation factor VIIa (3.4.21.21)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21021Coagulation factor VIIa (3.4.21.21)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
DK15175122.9T 2009-06-26 2010-06-18 Faktor VII-sammensætning DK2985033T6 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR0954390A FR2947181B1 (fr) 2009-06-26 2009-06-26 Composition de facteur vii
EP10734272.7A EP2445516B1 (fr) 2009-06-26 2010-06-18 Composition de facteur vii

Publications (2)

Publication Number Publication Date
DK2985033T3 true DK2985033T3 (da) 2019-06-17
DK2985033T6 DK2985033T6 (da) 2022-11-07

Family

ID=41620211

Family Applications (2)

Application Number Title Priority Date Filing Date
DK10734272.7T DK2445516T3 (da) 2009-06-26 2010-06-18 Faktor vii sammensætning
DK15175122.9T DK2985033T6 (da) 2009-06-26 2010-06-18 Faktor VII-sammensætning

Family Applications Before (1)

Application Number Title Priority Date Filing Date
DK10734272.7T DK2445516T3 (da) 2009-06-26 2010-06-18 Faktor vii sammensætning

Country Status (17)

Country Link
US (3) US9029316B2 (da)
EP (2) EP2985033B3 (da)
JP (3) JP5706888B2 (da)
KR (1) KR101468115B1 (da)
CN (2) CN102458455B (da)
AR (1) AR077234A1 (da)
AU (1) AU2010264369B2 (da)
BR (1) BRPI1010707A2 (da)
CA (1) CA2764779C (da)
DK (2) DK2445516T3 (da)
ES (2) ES2550269T3 (da)
FR (2) FR2947181B1 (da)
IL (1) IL216872A (da)
NL (1) NL301213I2 (da)
PL (2) PL2445516T3 (da)
TR (1) TR201906145T4 (da)
WO (1) WO2010149907A1 (da)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1711513B1 (en) 2003-12-01 2014-07-02 Novo Nordisk Health Care AG Nanofiltration of factor vii solutions to remove virus
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii
US12203113B2 (en) 2009-07-09 2025-01-21 Opko Biologics Ltd. Long-acting coagulation factors and methods of producing same
KR20140093603A (ko) 2010-12-30 2014-07-28 라보라토이레 프란카이즈 듀 프락티온네먼트 에트 데스 바이오테크놀로지스 병원체 불활성화제로서의 글리콜
EP2687595B1 (en) 2012-07-19 2018-05-30 Laboratoire Français du Fractionnement et des Biotechnologies Method for purifying transgenic factor VII
FR3006591B1 (fr) 2013-06-11 2016-05-06 Lab Francais Du Fractionnement Composition de facteur vii presentant un point isoelectrique substantiellement homogene
EP3307237A1 (en) 2015-06-12 2018-04-18 Laboratoire Français du Fractionnement et des Biotechnologies Injectable composition of factor vii and fillers
FR3038517B1 (fr) 2015-07-06 2020-02-28 Laboratoire Francais Du Fractionnement Et Des Biotechnologies Utilisation de fragments fc modifies en immunotherapie
MY206271A (en) 2016-07-11 2024-12-06 Opko Biologics Ltd Long-acting coagulation factor vii and methods of producing same
FR3082427B1 (fr) 2018-06-14 2020-09-25 Lab Francais Du Fractionnement Combinaison de facteur vii et d'un anticorps bispecifique anti-facteurs ix et x
WO2021030787A1 (en) 2019-08-15 2021-02-18 Catalyst Biosciences, Inc. Modified factor vii polypeptides for subcutaneous administration and on-demand treatment
CN117860874B (zh) * 2024-03-12 2024-07-02 正大天晴药业集团南京顺欣制药有限公司 重组人凝血因子VIIa的药物组合物

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GR860984B (en) 1985-04-17 1986-08-18 Zymogenetics Inc Expression of factor vii and ix activities in mammalian cells
DE122007000007I1 (de) 1986-04-09 2007-05-16 Genzyme Corp Genetisch transformierte Tiere, die ein gewünschtes Protein in Milch absondern
JP3543144B2 (ja) * 1995-03-11 2004-07-14 国際試薬株式会社 臨床検査用製剤
DE19538687A1 (de) * 1995-10-17 1997-04-24 Boehringer Mannheim Gmbh Stabile pharmazeutische Darreichungsformen enthaltend Parathormon
AU6558400A (en) 1999-08-17 2001-03-13 Novo Nordisk A/S Stabilisation of freeze-dried cake
DE60143292D1 (de) * 2000-05-03 2010-12-02 Novo Nordisk Healthcare Ag Varianten des menschlichen Koagulationsfaktors VII
JP2005526004A (ja) * 2001-11-09 2005-09-02 ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト 第vii因子ポリペプチドおよびトラネキサム酸を含む薬学的組成物
PT1517698E (pt) 2002-06-21 2014-11-19 Novo Nordisk Healthcare Ag Composições sólidas estabilizadas de polipéptidos do fator viia
NZ573412A (en) * 2003-06-19 2010-09-30 Maxygen Holdings Ltd Factor VII or VIIa Gla domain variants
FR2857267B1 (fr) * 2003-07-09 2006-03-10 Lab Francais Du Fractionnement Formulation stabilisante et solubilisante pour les proteines cryoprecipitables.
ES2574581T3 (es) * 2003-08-14 2016-06-20 Novo Nordisk Health Care Ag Composición farmacéutica líquida acuosa de polipéptidos de tipo Factor VII
WO2006089954A2 (en) * 2005-02-24 2006-08-31 Novo Nordisk Health Care Ag Compounds for stabilizing factor vii polypeptide formulations
WO2006114448A2 (en) * 2005-04-28 2006-11-02 Novo Nordisk Health Care Ag A closed container comprising an activated factor vii polypeptide, processes for the preparation of the same, and a kit and a method for use of the kit
WO2007022784A2 (en) * 2005-08-26 2007-03-01 Maxygen Holdings Ltd. Liquid factor vii composition
FR2894831B1 (fr) 2005-12-16 2008-02-15 Lab Francais Du Fractionnement Colle biologique exempte de thrombine et son utilisation comme medicament.
WO2008078189A2 (en) * 2006-12-20 2008-07-03 Bayer Healthcare Llc Factor vii and viia compositions
FR2910786B1 (fr) 2006-12-29 2017-08-11 Laboratoire Francais Du Fractionnement Et Des Biotechnologies (Lfb) "procede d'extraction d'une proteine presente dans du lait"
ES2595059T3 (es) * 2007-03-20 2016-12-27 Csl Behring Gmbh Métodos para la producción a escala industrial de preparados terapéuticos del Factor H del complemento a partir de plasma humano
US9186323B2 (en) * 2007-05-02 2015-11-17 Novo Nordisk Healthcare Ag High concentration factor VII polypeptide formulations comprising an aromatic preservative and an antioxidant
FR2947181B1 (fr) * 2009-06-26 2012-05-04 Lfb Biotechnologies Composition de facteur vii

Also Published As

Publication number Publication date
CN105106943A (zh) 2015-12-02
AR077234A1 (es) 2011-08-10
US9968662B2 (en) 2018-05-15
AU2010264369A1 (en) 2012-01-19
NL301213I2 (nl) 2023-12-14
CN102458455B (zh) 2015-04-08
US20160271233A1 (en) 2016-09-22
DK2985033T6 (da) 2022-11-07
AU2010264369B2 (en) 2013-06-27
FR2947181B1 (fr) 2012-05-04
BRPI1010707A2 (pt) 2016-03-15
ES2725449T3 (es) 2019-09-24
EP2985033B1 (fr) 2019-03-20
FR23C1001I1 (fr) 2023-03-10
KR101468115B1 (ko) 2014-12-03
FR23C1001I2 (fr) 2025-03-28
US9358275B2 (en) 2016-06-07
JP5706888B2 (ja) 2015-04-22
PL2445516T3 (pl) 2015-12-31
WO2010149907A1 (fr) 2010-12-29
ES2725449T7 (es) 2022-12-20
CN102458455A (zh) 2012-05-16
CA2764779A1 (fr) 2010-12-29
IL216872A (en) 2017-07-31
JP2015134795A (ja) 2015-07-27
CA2764779C (fr) 2015-09-29
US20150216951A1 (en) 2015-08-06
JP2012530770A (ja) 2012-12-06
EP2985033B3 (fr) 2022-10-26
DK2445516T3 (da) 2015-10-19
EP2445516A1 (fr) 2012-05-02
IL216872A0 (en) 2012-02-29
EP2985033A1 (fr) 2016-02-17
US20120087908A1 (en) 2012-04-12
JP2017081978A (ja) 2017-05-18
US9029316B2 (en) 2015-05-12
PL2985033T3 (pl) 2019-08-30
EP2445516B1 (fr) 2015-08-12
NL301213I1 (da) 2023-01-18
ES2550269T3 (es) 2015-11-05
FR2947181A1 (fr) 2010-12-31
TR201906145T4 (tr) 2019-05-21
KR20120047918A (ko) 2012-05-14

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