PT772452E - Formulacao farmaceutica para administracao subcutanea intramuscular ou intradermica de factor viii - Google Patents

Formulacao farmaceutica para administracao subcutanea intramuscular ou intradermica de factor viii

Info

Publication number
PT772452E
PT772452E PT95914669T PT95914669T PT772452E PT 772452 E PT772452 E PT 772452E PT 95914669 T PT95914669 T PT 95914669T PT 95914669 T PT95914669 T PT 95914669T PT 772452 E PT772452 E PT 772452E
Authority
PT
Portugal
Prior art keywords
factor viii
factor
pct
subcutaneous
intramuscular
Prior art date
Application number
PT95914669T
Other languages
English (en)
Inventor
Thomas Osterberg
Jack Spira
Lars Widlund
Brita Sjostrom
Marianne Mikaelsson
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=PT772452(E) "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
Publication of PT772452E publication Critical patent/PT772452E/pt

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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (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)
PT95914669T 1994-03-31 1995-03-31 Formulacao farmaceutica para administracao subcutanea intramuscular ou intradermica de factor viii PT772452E (pt)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
PT772452E true PT772452E (pt) 2003-01-31

Family

ID=26662019

Family Applications (1)

Application Number Title Priority Date Filing Date
PT95914669T PT772452E (pt) 1994-03-31 1995-03-31 Formulacao farmaceutica para administracao subcutanea intramuscular ou intradermica de factor viii

Country Status (19)

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

Families Citing this family (69)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4430205A1 (de) * 1994-08-26 1996-02-29 Behringwerke Ag Zusammensetzungen, die als Gegenmittel für Blut-Antikoagulanzien geeignet sind und deren Verwendung
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
DE69733664T3 (de) * 1996-04-19 2011-04-14 Grifols Inc. (n.d. Ges.d.Staates Delaware), Los Angeles 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
US6310183B1 (en) * 1997-09-10 2001-10-30 Novo Nordisk A/S Coagulation factor VIIa composition
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
EP1820516B1 (en) 1999-02-22 2013-07-24 University of Connecticut Novel albumin-free factor VIII formulations
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
JP5090605B2 (ja) 2000-05-03 2012-12-05 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 凝固因子ｖｉｉの皮下投与
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
JP2005530683A (ja) 2001-12-21 2005-10-13 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組成物
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
CN101912601B (zh) 2002-06-21 2012-08-29 诺和诺德医疗保健公司 因子vii多肽的稳定化固体组合物
CA2518327A1 (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
CA2522345A1 (en) 2003-04-09 2004-11-18 Neose Technologies, Inc. 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
KR20060015574A (ko) * 2003-05-23 2006-02-17 노보 노르디스크 헬스 케어 악티엔게젤샤프트 용액 중 단백질 안정화
ES2382157T3 (es) * 2003-06-25 2012-06-05 Novo Nordisk Health Care Ag Composición líquida de polipépttidos del factor VII
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
WO2005012484A2 (en) 2003-07-25 2005-02-10 Neose Technologies, Inc. Antibody-toxin conjugates
EP1656158B1 (en) 2003-08-14 2016-03-09 Novo Nordisk Health Care AG Liquid, aqueous pharmaceutical composition of factor vii polypeptides
ES2229931B1 (es) * 2003-10-03 2006-01-16 Grifols, S.A. Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos.
US20080305992A1 (en) 2003-11-24 2008-12-11 Neose Technologies, Inc. Glycopegylated erythropoietin
EP2311437A1 (en) * 2003-12-19 2011-04-20 Novo Nordisk Health Care AG Stabilised compositions of factor VII polypeptides
FR2868704B1 (fr) * 2004-04-07 2007-09-14 Ethypharm Sa Utilisation de lipides pour ameliorer la biodisponibilite de principes actifs proteiques en formulations injectables sous cutanees ou intra-musculaires
PL1750733T3 (pl) 2004-05-03 2014-05-30 Univ Emory Sposób podawania świńskiego czynnika krzepnięcia VIII pozbawionego domeny B
WO2006010143A2 (en) 2004-07-13 2006-01-26 Neose Technologies, Inc. Branched peg remodeling and glycosylation of glucagon-like peptide-1 [glp-1]
EP1814573B1 (en) 2004-10-29 2016-03-09 ratiopharm GmbH Remodeling and glycopegylation of fibroblast growth factor (fgf)
DK2371856T3 (en) 2004-11-12 2022-08-08 Bayer Healthcare Llc Site-directed modifikation af FVIII
CA2593682C (en) 2005-01-10 2016-03-22 Neose Technologies, Inc. Glycopegylated granulocyte colony stimulating factor
US20080227691A1 (en) * 2005-04-01 2008-09-18 Novo Nordisk Health Care Ag Blood Coagulation FVIII Analogues
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
US20090048440A1 (en) 2005-11-03 2009-02-19 Neose Technologies, Inc. Nucleotide Sugar Purification Using Membranes
CN101516388B (zh) 2006-07-21 2012-10-31 诺和诺德公司 通过o-联糖基化序列的肽的糖基化
US8969532B2 (en) 2006-10-03 2015-03-03 Novo Nordisk A/S Methods for the purification of polypeptide conjugates comprising polyalkylene oxide using hydrophobic interaction chromatography
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
EP2144923B1 (en) 2007-04-03 2013-02-13 BioGeneriX AG Methods of treatment using glycopegylated g-csf
EP2150264A4 (en) 2007-04-26 2014-09-24 Bayer Healthcare Llc STABILIZATION OF LIQUID SOLUTIONS OF A RECOMBINANT PROTEIN FOR FROZEN STORAGE
WO2008154639A2 (en) 2007-06-12 2008-12-18 Neose Technologies, Inc. Improved process for the production of nucleotide sugars
PL2167117T3 (pl) 2007-06-13 2013-01-31 Csl Behring Gmbh Zastosowanie stabilizowanego VWP preparatu FVIII do podawania pozanaczyniowego w terapii i profilaktyce zaburzeń krzepliwości krwi
US20130189239A1 (en) 2008-02-27 2013-07-25 Novo Nordisk A/S Conjugated Factor VIII Molecules
EP2352515A4 (en) * 2008-11-03 2012-04-25 Bayer Healthcare Llc METHOD FOR TREATING HEMOPHILIA
EP2385825B1 (en) 2008-11-07 2018-10-10 University of Connecticut Factor viii formulations
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
GB201007356D0 (en) 2010-04-30 2010-06-16 Leverton Licence Holdings Ltd Conjugated factor VIIa
BR112013011041B1 (pt) 2010-11-05 2021-05-25 Baxalta GmbH variante de fator viii, método para produzir uma variante de fviii, uso da variante de fator viii, e, composição farmacêutica
US9393289B2 (en) 2011-10-18 2016-07-19 Csl Behring Gmbh Use of sulfated glycosaminoglycans for improving the bioavailability of factor VIII
EP2768521B1 (en) 2011-10-18 2016-07-13 CSL Behring GmbH Combined use of a sulfated glycosaminoglycan and a hyaluronidase for improving the bioavailability of factor viii
HK1200695A1 (en) * 2012-04-16 2015-08-14 Cantab Biopharmaceuticals Patents Limited Optimised subcutaneous therapeutic agents
US20150080309A1 (en) 2012-04-24 2015-03-19 Nova Nordisk A/S Compounds Suitable for Treatment of Haemophilia
ES2926798T3 (es) * 2013-03-15 2022-10-28 Bioverativ Therapeutics Inc Formulaciones de polipéptido de factor VIII
AU2013203062C1 (en) 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
EP2796145B1 (en) 2013-04-22 2017-11-01 CSL Ltd. A covalent complex of von willebrand factor and faktor viii linked by a disulphide bridge
BR112016026842A2 (pt) 2014-06-06 2017-12-12 Octapharma Ag preparação compreendendo fator viii e peptídeos de fator de von willebrand
GB201417589D0 (en) * 2014-10-06 2014-11-19 Cantab Biopharmaceuticals Patents Ltd Pharmaceutical Formulations
US20200093901A1 (en) 2016-07-08 2020-03-26 CSL Behring Lengnau AG Subcutaneous administration of long-acting factor ix in humans
JP2020504082A (ja) 2016-11-11 2020-02-06 ツェー・エス・エル・ベーリング・レングナウ・アクチエンゲゼルシャフト 血液凝固障害の処置又は予防における血管外投与のための切断型フォン・ヴィルブランド因子ポリペプチド
WO2021165226A1 (en) 2020-02-17 2021-08-26 Biotest Ag Subcutaneous administration of factor viii

Family Cites Families (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS56127308A (en) * 1980-03-11 1981-10-06 Green Cross Corp:The Blood-coagulation factor 8 pharmaceutical
US4965199A (en) * 1984-04-20 1990-10-23 Genentech, Inc. Preparation of functional human factor VIII in mammalian cells using methotrexate based selection
IL74909A (en) * 1984-04-20 1992-01-15 Genentech Inc Preparation of functional human factor viii and dna sequences,expression vectors,transformed microorganisms and cell lines used therein
SE8501050D0 (sv) * 1985-03-05 1985-03-05 Kabivitrum Ab Biologically active fragments of human antihemophilic factor and method for preparation thereof
US5576194A (en) * 1986-07-11 1996-11-19 Bayer Corporation Recombinant protein production
SE465222C5 (sv) * 1989-12-15 1998-02-10 Pharmacia & Upjohn Ab Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning
DE4001451A1 (de) * 1990-01-19 1991-08-01 Octapharma Ag Stabile injizierbare loesungen von faktor viii und faktor ix
NL9001681A (nl) * 1990-07-24 1992-02-17 Rijksuniversiteit Transmucosale geneesmiddelpreparaten en transmucosale toediening.
ATE173405T1 (de) * 1991-07-10 1998-12-15 Takeda Chemical Industries Ltd Arzneimittel auf basis von hyaluronsäure
GB9122609D0 (en) * 1991-10-24 1991-12-04 Brownlee George G Improvements relating to the treatment of haemophilia
WO1993022336A1 (en) * 1992-04-30 1993-11-11 Alpha Therapeutic Corporation Improved solubilization and stabilization of factor viii complex
GB9211538D0 (en) * 1992-06-01 1992-07-15 Blake David R Antiinflammatory agent
ATE198277T1 (de) * 1992-10-02 2001-01-15 Genetics Inst Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
SE9301581D0 (sv) * 1993-05-07 1993-05-07 Kabi Pharmacia Ab Protein formulation
SE504074C2 (sv) * 1993-07-05 1996-11-04 Pharmacia Ab Proteinberedning för subkutan, intramuskulär eller intradermal administrering

Also Published As

Publication number Publication date
IL113010A (en) 1999-10-28
DK0772452T3 (da) 2003-01-06
ATE222770T1 (de) 2002-09-15
MX9604455A (es) 1997-07-31
IL113010A0 (en) 1995-10-31
BRPI9507227B8 (pt) 2015-12-08
AU2156095A (en) 1995-10-23
FI963871A0 (fi) 1996-09-27
HU223314B1 (hu) 2004-05-28
HU9602693D0 (en) 1996-11-28
DE69527966D1 (de) 2002-10-02
FI963871L (fi) 1996-09-27
NO321139B1 (no) 2006-03-27
JPH10501522A (ja) 1998-02-10
ES2182899T3 (es) 2003-03-16
TW400234B (en) 2000-08-01
FI118171B (fi) 2007-08-15
HUT74918A (en) 1997-03-28
PL316618A1 (en) 1997-01-20
PL180282B1 (pl) 2001-01-31
CA2186126C (en) 2007-11-20
CA2186126A1 (en) 1995-10-12
JP3939750B2 (ja) 2007-07-04
NO964081D0 (no) 1996-09-27
AU690666B2 (en) 1998-04-30
DE69527966T2 (de) 2003-05-28
EP0772452A1 (en) 1997-05-14
EP0772452B1 (en) 2002-08-28
BR9507227A (pt) 1997-09-09
WO1995026750A1 (en) 1995-10-12
NZ283499A (en) 1997-08-22
US5925739A (en) 1999-07-20
NO964081L (no) 1996-11-29

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