IL113010A0 - Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration - Google Patents

Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration

Info

Publication number
IL113010A0
IL113010A0 IL11301095A IL11301095A IL113010A0 IL 113010 A0 IL113010 A0 IL 113010A0 IL 11301095 A IL11301095 A IL 11301095A IL 11301095 A IL11301095 A IL 11301095A IL 113010 A0 IL113010 A0 IL 113010A0
Authority
IL
Israel
Prior art keywords
factor
factor viii
pct
intradermal administration
activity
Prior art date
Application number
IL11301095A
Other languages
English (en)
Original Assignee
Pharmacia 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=IL113010(A0) "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 Pharmacia Ab filed Critical Pharmacia Ab
Publication of IL113010A0 publication Critical patent/IL113010A0/xx

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)
IL11301095A 1994-03-31 1995-03-16 Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration IL113010A0 (en)

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
IL113010A0 true IL113010A0 (en) 1995-10-31

Family

ID=26662019

Family Applications (2)

Application Number Title Priority Date Filing Date
IL11301095A IL113010A0 (en) 1994-03-31 1995-03-16 Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration
IL11301099A IL113010A (en) 1994-03-31 1995-03-16 Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration

Family Applications After (1)

Application Number Title Priority Date Filing Date
IL11301099A IL113010A (en) 1994-03-31 1995-03-16 Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration

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) IL113010A0 (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 (69)

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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
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
WO2001082943A2 (en) 2000-05-03 2001-11-08 Novo Nordisk A/S 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
US7786070B2 (en) 1997-09-10 2010-08-31 Novo Nordisk Healthcare A/G Subcutaneous administration of coagulation factor VII
EP2921180B1 (de) 1999-02-22 2019-08-14 University of Connecticut Albuminfreie Faktor-VIII-Formulierungen
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
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
PT1517698E (pt) 2002-06-21 2014-11-19 Novo Nordisk Healthcare Ag Composições sólidas estabilizadas de polipéptidos do fator viia
RU2005132164A (ru) * 2003-03-18 2006-06-10 Ново Нордиск Хелт Кэр Аг (Ch) Жидкие, водные фармацевтические композиции полипептидов фактора vii
US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
EP2055189A1 (de) 2003-04-09 2009-05-06 Neose Technologies, Inc. Glycopegylierungsverfahren und durch die Verfahren hergestellte Proteine/Peptide
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
WO2004112828A1 (en) * 2003-06-25 2004-12-29 Novo Nordisk Health Care Ag Liquid composition of factor vii polypeptides
EP1644030B1 (de) * 2003-07-01 2009-10-28 Novo Nordisk Health Care AG Flüssige wässrige pharmazeutische zusammnesetzung von factor vii polypeptiden
WO2005012484A2 (en) 2003-07-25 2005-02-10 Neose Technologies, Inc. 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
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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
SI1750733T1 (sl) * 2004-05-03 2014-03-31 Emory University POSTOPEK DAJANJA PRAĹ IÄŚJEGA fVIII BREZ DOMENE B
WO2006010143A2 (en) 2004-07-13 2006-01-26 Neose Technologies, Inc. Branched peg remodeling and glycosylation of glucagon-like peptide-1 [glp-1]
US20080176790A1 (en) 2004-10-29 2008-07-24 Defrees Shawn Remodeling and Glycopegylation of Fibroblast Growth Factor (Fgf)
KR101468345B1 (ko) * 2004-11-12 2014-12-03 바이엘 헬스케어 엘엘씨 Ｆｖｉｉｉ의 부위 지향 변형
US9029331B2 (en) 2005-01-10 2015-05-12 Novo Nordisk A/S Glycopegylated granulocyte colony stimulating factor
JP2008534559A (ja) * 2005-04-01 2008-08-28 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 血液凝固ｆｖｉｉｉ類似体
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
WO2007056191A2 (en) 2005-11-03 2007-05-18 Neose Technologies, Inc. Nucleotide sugar purification using membranes
ES2516694T3 (es) 2006-07-21 2014-10-31 Ratiopharm Gmbh Glicosilación de péptidos a través de secuencias de glicosilación con unión en O
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
EP2099475B1 (de) * 2007-01-03 2016-08-24 Novo Nordisk Health Care AG Subkutane verabreichung von polypeptiden in zusammenhang mit dem gerinnungsfaktor viia
KR20100016160A (ko) 2007-04-03 2010-02-12 바이오제너릭스 에이지 글리코페길화 ｇ―ｃｓｆ를 이용하는 치료 방법
RU2469739C2 (ru) * 2007-04-26 2012-12-20 БАЙЕР ХЕЛСКЕА ЛЛСи Стабилизация жидких растворов рекомбинантного белка для хранения в замороженном состоянии
WO2008154639A2 (en) 2007-06-12 2008-12-18 Neose Technologies, Inc. Improved process for the production of nucleotide sugars
ES2392569T3 (es) 2007-06-13 2012-12-11 Csl Behring Gmbh Uso de preparaciones FVIII estabilizadas VWF para administración extravascular en la terapia y el tratamiento profiláctico de trastornos de hemorragias
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CA2740793A1 (en) * 2008-11-03 2010-06-03 Haiyan Jiang Method for the treatment of hemophilia
NZ593190A (en) 2008-11-07 2013-01-25 Baxter Int Factor viii formulations
KR20120061898A (ko) * 2009-08-20 2012-06-13 체에스엘 베링 게엠베하 출혈성 장애의 치료요법 및 예방 치료에 있어서의 비정맥내 투여를 위한 알부민 융합 응고 인자
GB201007356D0 (en) 2010-04-30 2010-06-16 Leverton Licence Holdings Ltd Conjugated factor VIIa
JP5922141B2 (ja) 2010-11-05 2016-05-24 バクスター・インターナショナル・インコーポレイテッドＢａｘｔｅｒ Ｉｎｔｅｒｎａｔｉｏｎａｌ Ｉｎｃｏｒｐ０Ｒａｔｅｄ 増加した比活性を有する抗血友病第ｖｉｉｉ因子の新規変異体
CA2851057A1 (en) 2011-10-18 2013-04-25 Csl Behring Gmbh Combined use of a sulfated glycosaminoglycan and a hyaluronidase for improving the bioavailability of factor viii
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
MY190257A (en) * 2012-04-16 2022-04-11 Cantab Biopharmaceuticals Patents Ltd Optimised subcutaneous therapeutic agents
JP2015515482A (ja) 2012-04-24 2015-05-28 ノヴォ ノルディスク アー／エス 血友病の治療に適する化合物
DK2968477T3 (da) * 2013-03-15 2020-03-09 Bioverativ Therapeutics Inc Faktor viii-polypeptidformuleringer
AU2013203062C1 (en) 2013-03-15 2018-06-28 Takeda Pharmaceutical Company Limited Subcutaneous administration of adamts13
EP2796145B1 (de) 2013-04-22 2017-11-01 CSL Ltd. Ein kovalenter komplex bestehend aus von willebrand und faktor viii verbunden mit einer disulfidbrücke
EP3152230B1 (de) 2014-06-06 2019-08-07 Octapharma AG Zubereitung mit faktor-viii- und von-willebrand-faktor-peptiden
GB201417589D0 (en) * 2014-10-06 2014-11-19 Cantab Biopharmaceuticals Patents Ltd Pharmaceutical Formulations
PL3481416T3 (pl) 2016-07-08 2021-03-22 CSL Behring Lengnau AG Podskórne podawanie długo działającego czynnika ix u ludzi
CA3043397A1 (en) 2016-11-11 2018-05-17 CSL Behring Lengnau AG Truncated von willebrand factor polypeptides for extravascular administration in the treatment or prophylaxis of a blood coagulation disorder
WO2021165226A1 (en) 2020-02-17 2021-08-26 Biotest Ag Subcutaneous administration of factor viii

Family Cites Families (15)

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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
FI86885C (fi) * 1984-04-20 1992-10-26 Genentech Inc Foerfarande foer framstaellning av human rekombinantfaktor viii och nukleinsyrasekvenser och vektorer anvaend daertill
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.
DE69227607T2 (de) * 1991-07-10 1999-04-15 Takeda Chemical Industries, Ltd., Osaka 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
DE69329795T2 (de) * 1992-10-02 2001-07-05 Genetics Institute, Inc. 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
FI963871A0 (fi) 1996-09-27
BR9507227A (pt) 1997-09-09
JP3939750B2 (ja) 2007-07-04
EP0772452B1 (de) 2002-08-28
NO321139B1 (no) 2006-03-27
MX9604455A (es) 1997-07-31
HU223314B1 (hu) 2004-05-28
NO964081D0 (no) 1996-09-27
PL316618A1 (en) 1997-01-20
WO1995026750A1 (en) 1995-10-12
PL180282B1 (pl) 2001-01-31
NZ283499A (en) 1997-08-22
FI963871L (fi) 1996-09-27
ES2182899T3 (es) 2003-03-16
ATE222770T1 (de) 2002-09-15
CA2186126C (en) 2007-11-20
NO964081L (no) 1996-11-29
DK0772452T3 (da) 2003-01-06
DE69527966D1 (de) 2002-10-02
AU2156095A (en) 1995-10-23
IL113010A (en) 1999-10-28
FI118171B (fi) 2007-08-15
CA2186126A1 (en) 1995-10-12
HUT74918A (en) 1997-03-28
AU690666B2 (en) 1998-04-30
US5925739A (en) 1999-07-20
DE69527966T2 (de) 2003-05-28
PT772452E (pt) 2003-01-31
BRPI9507227B8 (pt) 2015-12-08
TW400234B (en) 2000-08-01
JPH10501522A (ja) 1998-02-10
EP0772452A1 (de) 1997-05-14
HU9602693D0 (en) 1996-11-28

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