AU726498B2 - Highly concentrated, lyophilized, and liquid factor IX formulations - Google Patents

Highly concentrated, lyophilized, and liquid factor IX formulations Download PDF

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Publication number
AU726498B2
AU726498B2 AU17500/97A AU1750097A AU726498B2 AU 726498 B2 AU726498 B2 AU 726498B2 AU 17500/97 A AU17500/97 A AU 17500/97A AU 1750097 A AU1750097 A AU 1750097A AU 726498 B2 AU726498 B2 AU 726498B2
Authority
AU
Australia
Prior art keywords
factor
concentration
arginine
protein
sucrose
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.)
Ceased
Application number
AU17500/97A
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English (en)
Other versions
AU1750097A (en
Inventor
Lawrence Bush
Robert G. Schaub
Chandra Webb
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.)
Genetics Institute LLC
Original Assignee
Genetics Institute LLC
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=24366077&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU726498(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Genetics Institute LLC filed Critical Genetics Institute LLC
Publication of AU1750097A publication Critical patent/AU1750097A/en
Application granted granted Critical
Publication of AU726498B2 publication Critical patent/AU726498B2/en
Assigned to GENETICS INSTITUTE, LLC reassignment GENETICS INSTITUTE, LLC Request to Amend Deed and Register Assignors: GENETICS INSTITUTE INC.
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21022Coagulation factor IXa (3.4.21.22)

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • General Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
AU17500/97A 1996-01-25 1997-01-09 Highly concentrated, lyophilized, and liquid factor IX formulations Ceased AU726498B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/591332 1996-01-25
US08/591,332 US5770700A (en) 1996-01-25 1996-01-25 Liquid factor IX formulations
PCT/US1997/000747 WO1997026909A1 (en) 1996-01-25 1997-01-09 Highly concentrated, lyophilized, and liquid factor ix formulations

Publications (2)

Publication Number Publication Date
AU1750097A AU1750097A (en) 1997-08-20
AU726498B2 true AU726498B2 (en) 2000-11-09

Family

ID=24366077

Family Applications (1)

Application Number Title Priority Date Filing Date
AU17500/97A Ceased AU726498B2 (en) 1996-01-25 1997-01-09 Highly concentrated, lyophilized, and liquid factor IX formulations

Country Status (8)

Country Link
US (1) US5770700A (enExample)
EP (1) EP0876155B1 (enExample)
JP (4) JP2000504327A (enExample)
AT (1) ATE270557T1 (enExample)
AU (1) AU726498B2 (enExample)
CA (1) CA2241319A1 (enExample)
DE (1) DE69729786T2 (enExample)
WO (1) WO1997026909A1 (enExample)

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US6991790B1 (en) * 1997-06-13 2006-01-31 Genentech, Inc. Antibody formulation
US6171586B1 (en) * 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US20080050367A1 (en) * 1998-04-07 2008-02-28 Guriq Basi Humanized antibodies that recognize beta amyloid peptide
TWI239847B (en) 1997-12-02 2005-09-21 Elan Pharm Inc N-terminal fragment of Abeta peptide and an adjuvant for preventing and treating amyloidogenic disease
US7790856B2 (en) 1998-04-07 2010-09-07 Janssen Alzheimer Immunotherapy Humanized antibodies that recognize beta amyloid peptide
US6761888B1 (en) 2000-05-26 2004-07-13 Neuralab Limited Passive immunization treatment of Alzheimer's disease
US7964192B1 (en) 1997-12-02 2011-06-21 Janssen Alzheimer Immunotherapy Prevention and treatment of amyloidgenic disease
US7588766B1 (en) 2000-05-26 2009-09-15 Elan Pharma International Limited Treatment of amyloidogenic disease
US6787523B1 (en) * 1997-12-02 2004-09-07 Neuralab Limited Prevention and treatment of amyloidogenic disease
JP3581660B2 (ja) 1999-04-30 2004-10-27 ラ ホヤ インスティチュート フォー アラジー アンド イムノロジー 潜伏ウイルスの再活性化を予防しウイルスの複製を制御するための方法
US7112576B1 (en) 1999-12-10 2006-09-26 Regents Of The University Of Minnesota Compositions and methods for cryopreservation of peripheral blood lymphocytes
IL155002A0 (en) 2000-10-12 2003-10-31 Genentech Inc Reduced-viscosity concentrated protein formulations
US8703126B2 (en) 2000-10-12 2014-04-22 Genentech, Inc. Reduced-viscosity concentrated protein formulations
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US7700751B2 (en) 2000-12-06 2010-04-20 Janssen Alzheimer Immunotherapy Humanized antibodies that recognize β-amyloid peptide
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AU2002351755A1 (en) * 2001-12-21 2003-07-15 Novo Nordisk A/S Liquid composition of modified factor vii polypeptides
KR20040065278A (ko) * 2001-12-21 2004-07-21 노보 노르디스크 에이/에스 변경된 인자 ⅶ 폴리펩티드의 액체 조성물
ES2325653T3 (es) * 2001-12-21 2009-09-11 Novo Nordisk Health Care Ag Composicion liquida de polipeptidos del factor vii.
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US20040009918A1 (en) * 2002-05-03 2004-01-15 Hanne Nedergaard Stabilised solid compositions of modified factor VII
BRPI0311959B8 (pt) 2002-06-21 2021-05-25 Novo Nordisk Healthcare Ag composição, métodos para preparar um polipeptídeo estável do fator vii, e para tratar uma síndrome responsiva do fator vii, e, uso do polipeptídeo do fator vii
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
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US7897734B2 (en) * 2003-03-26 2011-03-01 Novo Nordisk Healthcare Ag Method for the production of proteins
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WO1995026750A1 (en) * 1994-03-31 1995-10-12 Pharmacia Ab Pharmaceutical formulation for subcutaneous, intramuscular or intradermal administration of factor viii or factor ix

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WO1995026750A1 (en) * 1994-03-31 1995-10-12 Pharmacia Ab Pharmaceutical formulation for subcutaneous, intramuscular or intradermal administration of factor viii or factor ix

Also Published As

Publication number Publication date
AU1750097A (en) 1997-08-20
JP4879104B2 (ja) 2012-02-22
JP2007262090A (ja) 2007-10-11
JP2000504327A (ja) 2000-04-11
CA2241319A1 (en) 1997-07-31
JP2010189433A (ja) 2010-09-02
US5770700A (en) 1998-06-23
WO1997026909A1 (en) 1997-07-31
ATE270557T1 (de) 2004-07-15
EP0876155A1 (en) 1998-11-11
JP2006257099A (ja) 2006-09-28
DE69729786T2 (de) 2005-07-14
DE69729786D1 (de) 2004-08-12
EP0876155B1 (en) 2004-07-07

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