DK0772452T3 - Farmaceutisk formulering til subkutan, intramuskulær eller intradermal administration af faktor VIII - Google Patents

Farmaceutisk formulering til subkutan, intramuskulær eller intradermal administration af faktor VIII

Info

Publication number
DK0772452T3
DK0772452T3 DK95914669T DK95914669T DK0772452T3 DK 0772452 T3 DK0772452 T3 DK 0772452T3 DK 95914669 T DK95914669 T DK 95914669T DK 95914669 T DK95914669 T DK 95914669T DK 0772452 T3 DK0772452 T3 DK 0772452T3
Authority
DK
Denmark
Prior art keywords
factor viii
factor
subcutaneous
pct
intramuscular
Prior art date
Application number
DK95914669T
Other languages
English (en)
Inventor
Jack Spira
Lars Widlund
Brita Sjoestroem
Marianne Mikaelsson
Thomas Oesterberg
Original Assignee
Biovitrum Ab
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26662019&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK0772452(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from SE9401105A external-priority patent/SE9401105D0/
Priority claimed from SE9500036A external-priority patent/SE9500036D0/xx
Application filed by Biovitrum Ab filed Critical Biovitrum Ab
Application granted granted Critical
Publication of DK0772452T3 publication Critical patent/DK0772452T3/da

Links

Classifications

    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
DK95914669T 1994-03-31 1995-03-31 Farmaceutisk formulering til subkutan, intramuskulær eller intradermal administration af faktor VIII DK0772452T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9401105A SE9401105D0 (sv) 1993-07-05 1994-03-31 Formulation
SE9500036A SE9500036D0 (sv) 1995-01-05 1995-01-05 Formulation
PCT/SE1995/000348 WO1995026750A1 (en) 1994-03-31 1995-03-31 Pharmaceutical formulation for subcutaneous, intramuscular or intradermal administration of factor viii or factor ix

Publications (1)

Publication Number Publication Date
DK0772452T3 true DK0772452T3 (da) 2003-01-06

Family

ID=26662019

Family Applications (1)

Application Number Title Priority Date Filing Date
DK95914669T DK0772452T3 (da) 1994-03-31 1995-03-31 Farmaceutisk formulering til subkutan, intramuskulær eller intradermal administration af faktor VIII

Country Status (19)

Country Link
US (1) US5925739A (da)
EP (1) EP0772452B1 (da)
JP (1) JP3939750B2 (da)
AT (1) ATE222770T1 (da)
AU (1) AU690666B2 (da)
BR (1) BRPI9507227B8 (da)
CA (1) CA2186126C (da)
DE (1) DE69527966T2 (da)
DK (1) DK0772452T3 (da)
ES (1) ES2182899T3 (da)
FI (1) FI118171B (da)
HU (1) HU223314B1 (da)
IL (2) IL113010A0 (da)
NO (1) NO321139B1 (da)
NZ (1) NZ283499A (da)
PL (1) PL180282B1 (da)
PT (1) PT772452E (da)
TW (1) TW400234B (da)
WO (1) WO1995026750A1 (da)

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SE9502285D0 (sv) * 1995-06-22 1995-06-22 Pharmacia Ab Improvements related to injections
US5770700A (en) * 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
EP0954326B2 (en) * 1996-04-19 2009-07-22 Grifols Inc. A process for viral inactivation of lyophilized blood proteins
US7560107B2 (en) 1996-06-26 2009-07-14 Emory University Modified factor VIII
US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
US20050032690A1 (en) * 1997-09-10 2005-02-10 Rojkjaer Lisa Payne Factor VII polypeptides for preventing formation of inhibitors in subjects with haemophilia
US7786070B2 (en) 1997-09-10 2010-08-31 Novo Nordisk Healthcare A/G Subcutaneous administration of coagulation factor VII
US6310183B1 (en) * 1997-09-10 2001-10-30 Novo Nordisk A/S Coagulation factor VIIa composition
WO2001082943A2 (en) 2000-05-03 2001-11-08 Novo Nordisk A/S Subcutaneous administration of coagulation factor vii
DK2193809T3 (da) 1999-02-22 2015-05-26 Univ Connecticut Albumin-frie faktor-VIII-formuleringer
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US8465468B1 (en) 2000-06-29 2013-06-18 Becton, Dickinson And Company Intradermal delivery of substances
JP4663837B2 (ja) * 1999-12-24 2011-04-06 一般財団法人化学及血清療法研究所 第▲ｖｉｉｉ▼因子を主成分とする血小板減少に伴う出血疾患の予防・治療用医薬組成物
US20020123093A1 (en) 2000-04-06 2002-09-05 Zannis Vassilis I. Compounds and methods for lowering cholesterol levels without inducing hypertrigylceridemia
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
HUP0402315A3 (en) * 2001-12-21 2009-03-30 Novo Nordisk Healthcare Ag Liquid composition of factor vii polypeptides
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
CN1671410B (zh) 2002-06-21 2010-05-12 诺和诺德医疗保健公司 因子ⅶ多肽的稳定化固体组合物
WO2004082708A2 (en) * 2003-03-18 2004-09-30 Novo Nordisk Health Care Ag Liquid, aqueous, pharmaceutical compositions of factor vii polypeptides
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
EP1615945B1 (en) 2003-04-09 2011-09-28 BioGeneriX AG Glycopegylation methods and proteins/peptides produced by the methods
CA2465004A1 (en) * 2003-05-19 2004-11-19 National Institute For Biological Standards And Control Composition
AU2004241698A1 (en) * 2003-05-23 2004-12-02 Novo Nordisk Health Care Ag Protein stabilization in solution
ES2382157T3 (es) * 2003-06-25 2012-06-05 Novo Nordisk Health Care Ag Composición líquida de polipépttidos del factor VII
ES2335994T3 (es) * 2003-07-01 2010-04-07 Novo Nordisk Health Care Ag Composicion farmaceutica liquida, acuosa de polipeptidos factor vii.
US9005625B2 (en) 2003-07-25 2015-04-14 Novo Nordisk A/S Antibody toxin conjugates
CA2534028A1 (en) * 2003-08-14 2005-02-24 Novo Nordisk Health Care Ag Liquid, aqueous pharmaceutical composition of factor vii polypeptides
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US20080305992A1 (en) 2003-11-24 2008-12-11 Neose Technologies, Inc. Glycopegylated erythropoietin
EP3378470A1 (en) * 2003-12-19 2018-09-26 Novo Nordisk Health Care AG Stabilised compositions of factor vii polypeptides
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SI1750733T1 (sl) 2004-05-03 2014-03-31 Emory University POSTOPEK DAJANJA PRAĹ IÄŚJEGA fVIII BREZ DOMENE B
US20080300173A1 (en) 2004-07-13 2008-12-04 Defrees Shawn Branched Peg Remodeling and Glycosylation of Glucagon-Like Peptides-1 [Glp-1]
US20080176790A1 (en) 2004-10-29 2008-07-24 Defrees Shawn Remodeling and Glycopegylation of Fibroblast Growth Factor (Fgf)
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US9029331B2 (en) 2005-01-10 2015-05-12 Novo Nordisk A/S Glycopegylated granulocyte colony stimulating factor
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US20070154992A1 (en) 2005-04-08 2007-07-05 Neose Technologies, Inc. Compositions and methods for the preparation of protease resistant human growth hormone glycosylation mutants
US20070105755A1 (en) * 2005-10-26 2007-05-10 Neose Technologies, Inc. One pot desialylation and glycopegylation of therapeutic peptides
US20090048440A1 (en) 2005-11-03 2009-02-19 Neose Technologies, Inc. Nucleotide Sugar Purification Using Membranes
US20080242607A1 (en) 2006-07-21 2008-10-02 Neose Technologies, Inc. Glycosylation of peptides via o-linked glycosylation sequences
US20100075375A1 (en) 2006-10-03 2010-03-25 Novo Nordisk A/S Methods for the purification of polypeptide conjugates
JP5558106B2 (ja) * 2007-01-03 2014-07-23 ノボ ノルディスク ヘルス ケア アーゲー 凝固第ｖｉｉ因子関連ポリペプチドの皮下投与
KR20100016160A (ko) 2007-04-03 2010-02-12 바이오제너릭스 에이지 글리코페길화 ｇ―ｃｓｆ를 이용하는 치료 방법
US8187799B2 (en) * 2007-04-26 2012-05-29 Bayer Healthcare Llc Stabilization of liquid solutions of recombinant protein for frozen storage
MX2009013259A (es) 2007-06-12 2010-01-25 Novo Nordisk As Proceso mejorado para la produccion de azucares de nucleotidos.
EP2486936A1 (en) 2007-06-13 2012-08-15 CSL Behring GmbH A composition comprising VWF and FVIII preparations for use in treating of bleeding disorders
US20130189239A1 (en) 2008-02-27 2013-07-25 Novo Nordisk A/S Conjugated Factor VIII Molecules
CA2740793A1 (en) * 2008-11-03 2010-06-03 Haiyan Jiang Method for the treatment of hemophilia
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US20120148557A1 (en) * 2009-08-20 2012-06-14 Ulrich Kronthaler Albumin fused coagulation factors for non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders
GB201007356D0 (en) 2010-04-30 2010-06-16 Leverton Licence Holdings Ltd Conjugated factor VIIa
ES2721478T3 (es) 2010-11-05 2019-07-31 Baxalta Inc Nueva variante del factor VIII antihemofílico que tiene actividad específica aumentada
AU2012318279B2 (en) 2011-10-18 2015-06-04 Csl Behring Gmbh Use of sulfated glycosaminoglycans for improving the bioavailability of Factor VIII
JP6029674B2 (ja) 2011-10-18 2016-11-24 ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー 第ｖｉｉｉ因子のバイオアベイラビリティを改善するための、硫酸化グリコサミノグリカン及びヒアルロニダーゼの組み合わせ使用
SG11201406492YA (en) * 2012-04-16 2014-11-27 Cantab Biopharmaceuticals Patents Ltd Optimised subcutaneous therapeutic agents
WO2013083858A1 (en) 2012-04-24 2013-06-13 Novo Nordisk A/S Compounds suitable for treatment of haemophilia
AU2013203062C1 (en) 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
TWI629993B (zh) * 2013-03-15 2018-07-21 美商生物化學醫療公司 因子ｖｉｉｉ多肽調配物
DK2796145T3 (da) 2013-04-22 2018-01-29 Csl Ltd Et kovalent kompleks af von Willebrand-faktor og faktor VIII linket af en disulfidbro
EP3152230B1 (en) 2014-06-06 2019-08-07 Octapharma AG Preparation comprising factor viii and von willebrand factor peptides
GB201417589D0 (en) * 2014-10-06 2014-11-19 Cantab Biopharmaceuticals Patents Ltd Pharmaceutical Formulations
EP3481416B1 (en) 2016-07-08 2020-09-09 CSL Behring Lengnau AG Subcutaneous administration of long-acting factor ix in humans
TW201828974A (zh) 2016-11-11 2018-08-16 瑞士商Ｃｓｌ貝林重組技能公司 用於血管外施予以治療或預防凝血疾病之截短型類血友病因子（ｖｏｎ Ｗｉｌｌｅｂｒａｎｄ ｆａｃｔｏｒ）多肽類
CN114929261A (zh) 2020-02-17 2022-08-19 生物测试股份公司 凝血因子viii的皮下施用

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DE4001451A1 (de) * 1990-01-19 1991-08-01 Octapharma Ag Stabile injizierbare loesungen von faktor viii und faktor ix
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SE504074C2 (sv) * 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering

Also Published As

Publication number Publication date
PL316618A1 (en) 1997-01-20
JP3939750B2 (ja) 2007-07-04
MX9604455A (es) 1997-07-31
EP0772452B1 (en) 2002-08-28
CA2186126A1 (en) 1995-10-12
FI963871A (fi) 1996-09-27
PT772452E (pt) 2003-01-31
FI118171B (fi) 2007-08-15
TW400234B (en) 2000-08-01
HU223314B1 (hu) 2004-05-28
HU9602693D0 (en) 1996-11-28
NO321139B1 (no) 2006-03-27
DE69527966D1 (de) 2002-10-02
NO964081D0 (no) 1996-09-27
WO1995026750A1 (en) 1995-10-12
ES2182899T3 (es) 2003-03-16
AU690666B2 (en) 1998-04-30
EP0772452A1 (en) 1997-05-14
AU2156095A (en) 1995-10-23
FI963871A0 (fi) 1996-09-27
NZ283499A (en) 1997-08-22
BR9507227A (pt) 1997-09-09
CA2186126C (en) 2007-11-20
ATE222770T1 (de) 2002-09-15
HUT74918A (en) 1997-03-28
BRPI9507227B8 (pt) 2015-12-08
IL113010A (en) 1999-10-28
PL180282B1 (pl) 2001-01-31
DE69527966T2 (de) 2003-05-28
JPH10501522A (ja) 1998-02-10
NO964081L (no) 1996-11-29
IL113010A0 (en) 1995-10-31
US5925739A (en) 1999-07-20

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