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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
Danish (da)
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

    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • 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
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/44Oils, 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (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 (fr) 1994-03-31 1995-03-31 Formulation pharmaceutique servant a effectuer l'administration sous-cutanee, intramusculaire ou intradermique du facteur viii ou du facteur 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 (fr)
EP (1) EP0772452B1 (fr)
JP (1) JP3939750B2 (fr)
AT (1) ATE222770T1 (fr)
AU (1) AU690666B2 (fr)
BR (1) BRPI9507227B8 (fr)
CA (1) CA2186126C (fr)
DE (1) DE69527966T2 (fr)
DK (1) DK0772452T3 (fr)
ES (1) ES2182899T3 (fr)
FI (1) FI118171B (fr)
HU (1) HU223314B1 (fr)
IL (2) IL113010A0 (fr)
NO (1) NO321139B1 (fr)
NZ (1) NZ283499A (fr)
PL (1) PL180282B1 (fr)
PT (1) PT772452E (fr)
TW (1) TW400234B (fr)
WO (1) WO1995026750A1 (fr)

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SE9403915D0 (sv) * 1994-11-14 1994-11-14 Annelie Almstedt Process A
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
ATE298582T1 (de) * 1996-04-19 2005-07-15 Alpha Therapeutic Corp Verfahren zur inaktivierung von viren und lyophilisierung von blutproteinen
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
US6310183B1 (en) * 1997-09-10 2001-10-30 Novo Nordisk A/S Coagulation factor VIIa composition
US7786070B2 (en) 1997-09-10 2010-08-31 Novo Nordisk Healthcare A/G Subcutaneous administration of coagulation factor VII
DK1820516T3 (da) 1999-02-22 2013-10-28 Univ Connecticut Nye albuminfrie faktor VIII-præparater
US20020156453A1 (en) * 1999-10-14 2002-10-24 Pettis Ronald J. Method and device for reducing therapeutic dosage
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
EP1280548B1 (fr) 2000-05-03 2013-12-11 Novo Nordisk Health Care AG Administration sous-cutanee de facteur coagulant VII
RU2185158C2 (ru) * 2000-06-14 2002-07-20 Нижегородский государственный научно-исследовательский институт травматологии и ортопедии Способ анестезиологического пособия при операциях на тазобедренном суставе
RU2163140C1 (ru) * 2000-07-05 2001-02-20 Гематологический научный центр РАМН Концентрат фактора ix системы свертывания крови и способ его получения
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
AU2002351756A1 (en) 2001-12-21 2003-07-15 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
AU2003240438A1 (en) 2002-06-21 2004-01-06 Novo Nordisk A/S Stabilised solid compositions of factor vii polypeptides
MXPA05009914A (es) * 2003-03-18 2006-01-09 Novo Nordisk Healthcare Ag Composiciones farmaceuticas acuosas, liquidas de polipeptidos del factor vii.
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
US20070026485A1 (en) 2003-04-09 2007-02-01 Neose Technologies, Inc. Glycopegylation methods and proteins/peptides produced by the methods
US7977460B2 (en) * 2003-05-19 2011-07-12 National Institute For Biological Standards And Control Compositions comprising coagulation factors IXA and VIII for the treatment of haemophilia A or B
BRPI0409936A (pt) * 2003-05-23 2006-04-25 Novo Nordisk Healthcare Ag uso de um material, recipiente pelo menos parcialmente cheio, e, kit médico
ATE547114T1 (de) * 2003-06-25 2012-03-15 Novo Nordisk Healthcare Ag Flüssige zusammensetzungen von factor vii polypeptiden
JP5306597B2 (ja) * 2003-07-01 2013-10-02 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因子ポリペプチドの液体水性薬学的組成物
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US20080305992A1 (en) 2003-11-24 2008-12-11 Neose Technologies, Inc. Glycopegylated erythropoietin
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WO2005107776A1 (fr) 2004-05-03 2005-11-17 Emory University Methode d'administration de facteur viii sans domaine b porcin
US20080300173A1 (en) 2004-07-13 2008-12-04 Defrees Shawn Branched Peg Remodeling and Glycosylation of Glucagon-Like Peptides-1 [Glp-1]
EP2586456B1 (fr) 2004-10-29 2016-01-20 ratiopharm GmbH Remodelage et glycopégylation de facteur de croissance de fibroblaste (FGF)
ES2633916T3 (es) 2004-11-12 2017-09-26 Bayer Healthcare Llc Modificación de FVIII dirigida al sitio
JP4951527B2 (ja) 2005-01-10 2012-06-13 バイオジェネリックス アーゲー 糖peg化顆粒球コロニー刺激因子
EP1871801A2 (fr) * 2005-04-01 2008-01-02 Novo Nordisk Health Care AG Analogues du fviii de coagulation sanguine
US9187546B2 (en) 2005-04-08 2015-11-17 Novo Nordisk A/S 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
WO2007056191A2 (fr) 2005-11-03 2007-05-18 Neose Technologies, Inc. Purification de sucre de nucleotide en utilisant des membranes
US20080248959A1 (en) 2006-07-21 2008-10-09 Neose Technologies, Inc. Glycosylation of peptides via o-linked glycosylation sequences
JP2010505874A (ja) 2006-10-03 2010-02-25 ノヴォ ノルディスク アー/エス ポリペプチドコンジュゲートの精製方法
US20100143326A1 (en) * 2007-01-03 2010-06-10 Novo Nordisk Healthcare A/G SUBCUTANEOUS ADMINISTRATION OF COAGULATION FACTOR VIIa-RELATED POLYPEPTIDES
AU2008237411B2 (en) 2007-04-03 2013-10-03 Ratiopharm Gmbh Methods of treatment using glycopegylated G-CSF
CN103990116A (zh) 2007-04-26 2014-08-20 拜尔健康护理有限责任公司 稳定用于冷冻储藏的重组蛋白液体溶液的方法
WO2008154639A2 (fr) 2007-06-12 2008-12-18 Neose Technologies, Inc. Procédé amélioré pour la production de sucres de nucléotide
EP2486936A1 (fr) 2007-06-13 2012-08-15 CSL Behring GmbH Une composition comprenant la préparation du VWF et de FVIII pour utilisation dans le traitement des troubles de la coagulation
WO2009108806A1 (fr) * 2008-02-27 2009-09-03 Novo Nordisk A/S Molécules de facteur viii conjuguées
CA2740793A1 (fr) * 2008-11-03 2010-06-03 Haiyan Jiang Procede de traitement de l'hemophilie
BRPI0921429B1 (pt) 2008-11-07 2022-07-12 Takeda Pharmaceutical Company Limited Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável
JP6250282B2 (ja) * 2009-08-20 2017-12-20 ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー 出血性障害の治療および予防的治療における非静脈内投与のためのアルブミン融合凝固因子
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CN103889445A (zh) * 2011-10-18 2014-06-25 德国杰特贝林生物制品有限公司 硫酸化糖胺聚糖用于改善因子viii的生物利用度的用途
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CN104411716B (zh) 2012-04-24 2018-09-07 诺和诺德股份有限公司 适用于治疗血友病的化合物
PL3666283T3 (pl) * 2013-03-15 2022-10-03 Bioverativ Therapeutics Inc. Formulacje polipeptydu czynnika viii
AU2013203062C1 (en) 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
ES2657291T3 (es) 2013-04-22 2018-03-02 Csl Ltd. Un complejo covalente de factor de von Willebrand y factor VIII asociado por un puente disulfuro
US10251940B2 (en) 2014-06-06 2019-04-09 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
WO2018007601A1 (fr) 2016-07-08 2018-01-11 Csl Behring Recombinant Facility Ag Administration sous-cutanée de facteur ix à action prolongée chez des humains
AU2017358865A1 (en) 2016-11-11 2019-05-09 CSL Behring Lengnau AG Truncated von willebrand factor polypeptides for extravascular administration in the treatment or prophylaxis of a blood coagulation disorder
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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
CA2186126C (fr) 2007-11-20
AU690666B2 (en) 1998-04-30
DE69527966D1 (de) 2002-10-02
NZ283499A (en) 1997-08-22
ES2182899T3 (es) 2003-03-16
DE69527966T2 (de) 2003-05-28
ATE222770T1 (de) 2002-09-15
HUT74918A (en) 1997-03-28
PL180282B1 (pl) 2001-01-31
NO964081L (no) 1996-11-29
FI118171B (fi) 2007-08-15
TW400234B (en) 2000-08-01
IL113010A (en) 1999-10-28
BRPI9507227B8 (pt) 2015-12-08
HU223314B1 (hu) 2004-05-28
FI963871L (fi) 1996-09-27
US5925739A (en) 1999-07-20
JPH10501522A (ja) 1998-02-10
JP3939750B2 (ja) 2007-07-04
IL113010A0 (en) 1995-10-31
WO1995026750A1 (fr) 1995-10-12
MX9604455A (es) 1997-07-31
BR9507227A (pt) 1997-09-09
HU9602693D0 (en) 1996-11-28
NO964081D0 (no) 1996-09-27
EP0772452A1 (fr) 1997-05-14
CA2186126A1 (fr) 1995-10-12
PT772452E (pt) 2003-01-31
PL316618A1 (en) 1997-01-20
AU2156095A (en) 1995-10-23
EP0772452B1 (fr) 2002-08-28
FI963871A0 (fi) 1996-09-27
NO321139B1 (no) 2006-03-27

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