DE69527966D1 - 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
DE69527966D1
DE69527966D1 DE69527966T DE69527966T DE69527966D1 DE 69527966 D1 DE69527966 D1 DE 69527966D1 DE 69527966 T DE69527966 T DE 69527966T DE 69527966 T DE69527966 T DE 69527966T DE 69527966 D1 DE69527966 D1 DE 69527966D1
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
DE69527966T2 (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(D1) "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 DE69527966D1 publication Critical patent/DE69527966D1/de
Application granted granted Critical
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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (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)
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 true DE69527966D1 (de) 2002-10-02
DE69527966T2 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)

Families Citing this family (67)

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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
CA2252374C (en) * 1996-04-19 2007-08-07 Alpha Therapeutic Corporation 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
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
BR0008405B1 (pt) 1999-02-22 2014-04-22 Baxter Int Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa
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
AU2001256148A1 (en) 2000-05-03 2001-11-12 Novo-Nordisk A/S Subcutaneous administration of coagulation factor vii
IL162239A0 (en) 2001-12-21 2005-11-20 Novo Nordisk Healthcare Ag Liquid composition of factor vii polypeptides
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
ES2523655T5 (es) 2002-06-21 2018-04-23 Novo Nordisk Health Care Ag Composiciones sólidas estabilizadas de polipéptidos del Factor VIIa
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
EP2338333B1 (de) 2003-04-09 2017-09-06 ratiopharm GmbH Glycopegylierungsverfahren und durch die Verfahren hergestellte Proteine/Peptide
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
RU2364609C2 (ru) * 2003-05-23 2009-08-20 Ново Нордиск Хелт Кэр Аг Стабилизация белка в растворе
ATE547114T1 (de) * 2003-06-25 2012-03-15 Novo Nordisk Healthcare Ag Flüssige zusammensetzungen von factor vii polypeptiden
DE602004023848D1 (de) * 2003-07-01 2009-12-10 Novo Nordisk Healthcare Ag Von factor vii polypeptiden
WO2005012484A2 (en) 2003-07-25 2005-02-10 Neose Technologies, Inc. Antibody-toxin conjugates
CN102872451A (zh) * 2003-08-14 2013-01-16 诺和诺德医疗保健公司 因子vii多肽类的含水液体药物组合物
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
RU2373953C2 (ru) * 2003-12-19 2009-11-27 Ново Нордиск Хелс Кеа Аг Стабилизированная композиция, содержащая полипептид фактора vii
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]
SI2586456T1 (sl) 2004-10-29 2016-05-31 Ratiopharm Gmbh Preoblikovanje in glikopegliacija fibroblastnega rastnega faktorja (FGF)
WO2006053299A2 (en) 2004-11-12 2006-05-18 Bayer Healthcare Llc Site-directed modification of fviii
EP1858543B1 (de) 2005-01-10 2013-11-27 BioGeneriX AG Glycopegylierten Granulocyten-Kolonie-stimulierender Faktor
EP1871801A2 (de) * 2005-04-01 2008-01-02 Novo Nordisk Health Care AG Analoga des blutgerinnungsfaktors fviii
WO2006121569A2 (en) 2005-04-08 2006-11-16 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
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
EP2054521A4 (de) 2006-10-03 2012-12-19 Novo Nordisk As Verfahren zur reinigung von polypeptid-konjugate
EP2099475B1 (de) * 2007-01-03 2016-08-24 Novo Nordisk Health Care AG Subkutane verabreichung von polypeptiden in zusammenhang mit dem gerinnungsfaktor viia
ES2406267T3 (es) 2007-04-03 2013-06-06 Biogenerix Ag Métodos de tratamiento usando G-CSF glicopegilado
US8187799B2 (en) 2007-04-26 2012-05-29 Bayer Healthcare Llc Stabilization of liquid solutions of recombinant protein for frozen storage
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DK2167117T3 (da) * 2007-06-13 2012-11-19 Csl Behring Gmbh Anvendelse af VWF-stabiliserede FVIII-præparater til ekstravaskulær administration til terapeutisk og profylaktisk behandling af blødningsforstyrrelser
PL2257311T3 (pl) 2008-02-27 2014-09-30 Novo Nordisk As Koniugaty cząsteczek czynnika VIII
EP2352515A4 (de) * 2008-11-03 2012-04-25 Bayer Healthcare Llc Verfahren zur behandlung von hämophilie
US20100168018A1 (en) 2008-11-07 2010-07-01 Baxter International Inc. Factor viii formulations
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
EP2635297B1 (de) 2010-11-05 2019-02-27 Baxalta GmbH Neue variante des antihämophilen faktors viii mit erhöhter spezifischer aktivität
US9393289B2 (en) 2011-10-18 2016-07-19 Csl Behring Gmbh Use of sulfated glycosaminoglycans for improving the bioavailability of factor VIII
DK2768521T3 (en) 2011-10-18 2016-10-24 Csl Behring Gmbh Combined use of a sulfated glykosamin glycan and a Hyaluronidase to improve bio-availability of factor VIII
GB2516388A (en) * 2012-04-16 2015-01-21 Cantab Biopharmaceuticals Patents Ltd Optimised subcutaneous therapeutic agents
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RU2714154C2 (ru) 2014-06-06 2020-02-12 Октафарма Аг Препарат, содержащий фактор viii и пептиды фактора фон виллебранда
GB201417589D0 (en) * 2014-10-06 2014-11-19 Cantab Biopharmaceuticals Patents Ltd Pharmaceutical Formulations
CN109843319A (zh) 2016-07-08 2019-06-04 康诺贝林伦瑙有限公司 长效因子ix在人中的皮下施用
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
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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.
DE69227607T2 (de) * 1991-07-10 1999-04-15 Takeda Chemical Industries Ltd Arzneimittel auf Basis von Hyaluronsäure
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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
JPH10501522A (ja) 1998-02-10
FI118171B (fi) 2007-08-15
AU690666B2 (en) 1998-04-30
MX9604455A (es) 1997-07-31
JP3939750B2 (ja) 2007-07-04
PL180282B1 (pl) 2001-01-31
TW400234B (en) 2000-08-01
FI963871A0 (fi) 1996-09-27
ATE222770T1 (de) 2002-09-15
IL113010A (en) 1999-10-28
EP0772452A1 (de) 1997-05-14
IL113010A0 (en) 1995-10-31
US5925739A (en) 1999-07-20
CA2186126C (en) 2007-11-20
NO964081L (no) 1996-11-29
WO1995026750A1 (en) 1995-10-12
NO321139B1 (no) 2006-03-27
EP0772452B1 (de) 2002-08-28
ES2182899T3 (es) 2003-03-16
HU223314B1 (hu) 2004-05-28
AU2156095A (en) 1995-10-23
DE69527966T2 (de) 2003-05-28
NZ283499A (en) 1997-08-22
BRPI9507227B8 (pt) 2015-12-08
CA2186126A1 (en) 1995-10-12
PL316618A1 (en) 1997-01-20
NO964081D0 (no) 1996-09-27
HU9602693D0 (en) 1996-11-28
PT772452E (pt) 2003-01-31
FI963871A (fi) 1996-09-27
DK0772452T3 (da) 2003-01-06
BR9507227A (pt) 1997-09-09
HUT74918A (en) 1997-03-28

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