DE69527966T2 - Pharmazeutische zubereitung für die subkutane, intramuskuläre oder intradermale verabreichung von faktor viii - Google Patents

Pharmazeutische zubereitung für die subkutane, intramuskuläre oder intradermale verabreichung von faktor viii

Info

Publication number
DE69527966T2
DE69527966T2 DE69527966T DE69527966T DE69527966T2 DE 69527966 T2 DE69527966 T2 DE 69527966T2 DE 69527966 T DE69527966 T DE 69527966T DE 69527966 T DE69527966 T DE 69527966T DE 69527966 T2 DE69527966 T2 DE 69527966T2
Authority
DE
Germany
Prior art keywords
factor viii
factor
subcutaneous
pct
intradermal administration
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.)
Expired - Lifetime
Application number
DE69527966T
Other languages
English (en)
Other versions
DE69527966D1 (de
Inventor
Jack Spira
Lars Widlund
Thomas Oesterberg
Brita Sjoestroem
Marianne Mikaelsson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Swedish Orphan Biovitrum AB
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=DE69527966(T2) "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 DE69527966D1 publication Critical patent/DE69527966D1/de
Publication of DE69527966T2 publication Critical patent/DE69527966T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
DE69527966T 1994-03-31 1995-03-31 Pharmazeutische zubereitung für die subkutane, intramuskuläre oder intradermale verabreichung von faktor viii Expired - Lifetime DE69527966T2 (de)

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 (2)

Publication Number Publication Date
DE69527966D1 DE69527966D1 (de) 2002-10-02
DE69527966T2 true DE69527966T2 (de) 2003-05-28

Family

ID=26662019

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69527966T Expired - Lifetime DE69527966T2 (de) 1994-03-31 1995-03-31 Pharmazeutische zubereitung für die subkutane, intramuskuläre oder intradermale verabreichung von faktor viii

Country Status (19)

Country Link
US (1) US5925739A (de)
EP (1) EP0772452B1 (de)
JP (1) JP3939750B2 (de)
AT (1) ATE222770T1 (de)
AU (1) AU690666B2 (de)
BR (1) BRPI9507227B8 (de)
CA (1) CA2186126C (de)
DE (1) DE69527966T2 (de)
DK (1) DK0772452T3 (de)
ES (1) ES2182899T3 (de)
FI (1) FI118171B (de)
HU (1) HU223314B1 (de)
IL (2) IL113010A (de)
NO (1) NO321139B1 (de)
NZ (1) NZ283499A (de)
PL (1) PL180282B1 (de)
PT (1) PT772452E (de)
TW (1) TW400234B (de)
WO (1) WO1995026750A1 (de)

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US5763401A (en) * 1996-07-12 1998-06-09 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar content
US7786070B2 (en) 1997-09-10 2010-08-31 Novo Nordisk Healthcare A/G Subcutaneous administration of coagulation factor VII
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
PT2130554E (pt) 1999-02-22 2012-11-19 Univ Connecticut Formulações de factor viii isentas de albumina
US8465468B1 (en) * 2000-06-29 2013-06-18 Becton, Dickinson And Company Intradermal delivery of substances
US20020156453A1 (en) * 1999-10-14 2002-10-24 Pettis Ronald J. Method and device for reducing therapeutic dosage
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 (de) 2000-05-03 2013-12-11 Novo Nordisk Health Care AG Subkutane Verabreichung des Koagulationsfaktor VII
RU2357751C2 (ru) 2001-12-21 2009-06-10 Ново Нордиск Хелт Кэр Аг Жидкая композиция полипептидов фактора vii
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US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
EP2283856B1 (de) 2002-06-21 2017-09-20 Novo Nordisk Health Care AG Stabiliserte feste Zusammensetzungen von Faktor VIIa Polypeptiden
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
PL1615945T3 (pl) 2003-04-09 2012-03-30 Ratiopharm Gmbh Sposoby glikopegylacji i białka/peptydy wytwarzane tymi sposobami
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
DE602004025100D1 (de) * 2003-05-23 2010-03-04 Novo Nordisk Healthcare Ag Stabilisierung von proteinen in lösung
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
US9005625B2 (en) 2003-07-25 2015-04-14 Novo Nordisk A/S Antibody toxin conjugates
ES2574581T3 (es) 2003-08-14 2016-06-20 Novo Nordisk Health Care Ag Composición farmacéutica líquida acuosa de polipéptidos de tipo Factor VII
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
AU2004298789A1 (en) * 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor VII polypeptides
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ES2449044T3 (es) * 2004-05-03 2014-03-18 Emory University Procedimiento de administración de fVIII sin dominio B porcino
EP1771066A2 (de) 2004-07-13 2007-04-11 Neose Technologies, Inc. Remodellierung von verzweigtem peg und klykolysierung von glucagonähnlichem peptide-1 glp-1
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EP1824988B1 (de) * 2004-11-12 2017-04-19 Bayer HealthCare LLC Ortsgerichtete modifizierung von fviii
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US20080227691A1 (en) * 2005-04-01 2008-09-18 Novo Nordisk Health Care Ag Blood Coagulation FVIII Analogues
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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
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US20100143326A1 (en) * 2007-01-03 2010-06-10 Novo Nordisk Healthcare A/G SUBCUTANEOUS ADMINISTRATION OF COAGULATION FACTOR VIIa-RELATED POLYPEPTIDES
BRPI0809670A8 (pt) 2007-04-03 2018-12-18 Biogenerix Ag métodos para aumentar a produção de célula tronco, para aumentar o número de granulócitos em um indivíduo, para prevenir, tratar e aliviar a mielossupressão que resulta de uma terapia contra o câncer, para tratar uma condição em um indivíduo, para tratar neutropenia e trombocitopenia em um mamífero, para expandir células tronco hematopoiéticas em cultura, para aumentar a hematopoiese em um indivíduo, para aumentar o número de célulars progenitoras hematopoiéticas em um indivíduo, e para fornecer enxerto estável da medula óssea, e, forma de dosagem oral.
KR101578561B1 (ko) * 2007-04-26 2015-12-17 바이엘 헬스케어 엘엘씨 냉동 저장을 위한, 재조합 단백질의 액상 용액의 안정화
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US20150086524A1 (en) * 2012-04-16 2015-03-26 Cantab Biopharmaceuticals Patents Limited Optimised subcutaneous therapeutic agents
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EP2796145B1 (de) 2013-04-22 2017-11-01 CSL Ltd. Ein kovalenter komplex bestehend aus von willebrand und faktor viii verbunden mit einer disulfidbrücke
KR20170010895A (ko) 2014-06-06 2017-02-01 옥타파마 아게 인자 ⅷ 및 폰 빌레브란트 인자 펩티드를 포함하는 조제
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Also Published As

Publication number Publication date
PL316618A1 (en) 1997-01-20
JP3939750B2 (ja) 2007-07-04
HU223314B1 (hu) 2004-05-28
CA2186126A1 (en) 1995-10-12
FI963871A (fi) 1996-09-27
ATE222770T1 (de) 2002-09-15
EP0772452A1 (de) 1997-05-14
TW400234B (en) 2000-08-01
DE69527966D1 (de) 2002-10-02
HU9602693D0 (en) 1996-11-28
PT772452E (pt) 2003-01-31
WO1995026750A1 (en) 1995-10-12
EP0772452B1 (de) 2002-08-28
HUT74918A (en) 1997-03-28
NO321139B1 (no) 2006-03-27
FI963871A0 (fi) 1996-09-27
MX9604455A (es) 1997-07-31
IL113010A (en) 1999-10-28
BRPI9507227B8 (pt) 2015-12-08
US5925739A (en) 1999-07-20
NO964081L (no) 1996-11-29
CA2186126C (en) 2007-11-20
JPH10501522A (ja) 1998-02-10
IL113010A0 (en) 1995-10-31
DK0772452T3 (da) 2003-01-06
ES2182899T3 (es) 2003-03-16
NO964081D0 (no) 1996-09-27
AU2156095A (en) 1995-10-23
BR9507227A (pt) 1997-09-09
PL180282B1 (pl) 2001-01-31
NZ283499A (en) 1997-08-22
FI118171B (fi) 2007-08-15
AU690666B2 (en) 1998-04-30

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