WO2008078189A3 - Factor vii and viia compositions - Google Patents

Factor vii and viia compositions Download PDF

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Publication number
WO2008078189A3
WO2008078189A3 PCT/IB2007/004338 IB2007004338W WO2008078189A3 WO 2008078189 A3 WO2008078189 A3 WO 2008078189A3 IB 2007004338 W IB2007004338 W IB 2007004338W WO 2008078189 A3 WO2008078189 A3 WO 2008078189A3
Authority
WO
WIPO (PCT)
Prior art keywords
factor vii
compositions
viia
viia compositions
polypeptide
Prior art date
Application number
PCT/IB2007/004338
Other languages
French (fr)
Other versions
WO2008078189A2 (en
Inventor
Thomas Joergensen
Joern Drustrup
Kim Vilbour Andersen
Hanns-Christian Mahler
Original Assignee
Bayer Healthcare Llc
Thomas Joergensen
Joern Drustrup
Kim Vilbour Andersen
Hanns-Christian Mahler
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
Application filed by Bayer Healthcare Llc, Thomas Joergensen, Joern Drustrup, Kim Vilbour Andersen, Hanns-Christian Mahler filed Critical Bayer Healthcare Llc
Priority to JP2009542270A priority Critical patent/JP2010513462A/en
Priority to EP07870424A priority patent/EP2114379A2/en
Priority to CA002673260A priority patent/CA2673260A1/en
Publication of WO2008078189A2 publication Critical patent/WO2008078189A2/en
Publication of WO2008078189A3 publication Critical patent/WO2008078189A3/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth 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)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)

Abstract

The invention relates to stabilized compositions comprising a Factor VII or Factor VII a polypeptide or a polypeptide variant thereof and histidine as a buffering agent.
PCT/IB2007/004338 2006-12-20 2007-12-18 Factor vii and viia compositions WO2008078189A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
JP2009542270A JP2010513462A (en) 2006-12-20 2007-12-18 Factor VII and Factor VIIa compositions
EP07870424A EP2114379A2 (en) 2006-12-20 2007-12-18 Factor vii and viia compositions
CA002673260A CA2673260A1 (en) 2006-12-20 2007-12-18 Factor vii and viia compositions

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87094806P 2006-12-20 2006-12-20
US60/870,948 2006-12-20

Publications (2)

Publication Number Publication Date
WO2008078189A2 WO2008078189A2 (en) 2008-07-03
WO2008078189A3 true WO2008078189A3 (en) 2009-03-05

Family

ID=39431180

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2007/004338 WO2008078189A2 (en) 2006-12-20 2007-12-18 Factor vii and viia compositions

Country Status (4)

Country Link
EP (1) EP2114379A2 (en)
JP (1) JP2010513462A (en)
CA (1) CA2673260A1 (en)
WO (1) WO2008078189A2 (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI538916B (en) 2008-04-11 2016-06-21 介控生化科技公司 Factor vii polypeptides that are modified and uses thereof
RS60101B1 (en) * 2008-08-15 2020-05-29 Ironwood Pharmaceuticals Inc Linaclotide-containing formulations for oral administration
FR2947181B1 (en) 2009-06-26 2012-05-04 Lfb Biotechnologies FACTOR VII COMPOSITION
JP2013501071A (en) * 2009-08-06 2013-01-10 アイロンウッド ファーマシューティカルズ， インコーポレイテッド Formulations containing linaclotide
EA201290799A1 (en) 2010-02-17 2013-03-29 Айронвуд Фармасьютикалз, Инк. TREATMENT OF GASTROINTESTINAL DISORDERS
LT2603232T (en) 2010-08-11 2020-01-27 Ironwood Pharmaceuticals, Inc. Stable formulations of linaclotide
JP6055412B2 (en) * 2010-09-17 2016-12-27 バクスアルタ ゲーエムベーハー Immunoglobulin stabilization via aqueous formulations with histidine at mildly acidic to neutral pH
ES2369945B1 (en) 2011-07-29 2012-10-15 Eduardo Anitua Aldecoa PROCEDURE FOR OBTAINING A COMPOSITION CONTAINING GROWTH FACTORS FROM A BLOOD COMPOUND, AND COMPOSITION OBTAINABLE BY SUCH PROCEDURE.
PL2776055T3 (en) 2011-08-17 2017-06-30 Ironwood Pharmaceuticals, Inc. Treatments for gastrointestinal disorders
KR102058864B1 (en) * 2013-12-16 2019-12-24 주식회사 티움바이오 Pharmaceutical composition having improved stability comprising a fusion protein of factor vii
LT3138575T (en) * 2014-04-28 2021-08-25 Eisai R&D Management Co., Ltd. Freeze-dried hgf preparation
AU2017232582B2 (en) 2016-03-17 2022-07-14 Eisai R&D Management Co., Ltd. Method for producing activated hepatocyte growth factor (HGF)
WO2021030787A1 (en) 2019-08-15 2021-02-18 Catalyst Biosciences, Inc. Modified factor vii polypeptides for subcutaneous administration and on-demand treatment

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1308170A2 (en) * 1995-01-19 2003-05-07 Elan Drug Delivery Limited Dried blood factor composition comprising trehalose
US20040248793A1 (en) * 2002-06-21 2004-12-09 Jensen Michael Bech Stabilised solid compositions of factor VII polypeptides
WO2005058283A2 (en) * 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor vii polypeptides

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6017882A (en) * 1997-10-23 2000-01-25 Regents Of The University Of Minnesota Modified vitamin K-dependent polypeptides
US6693075B1 (en) * 1997-10-23 2004-02-17 Regents Of The University Of Minnesota Modified vitamin K-dependent polypeptides
US6423826B1 (en) * 2000-06-30 2002-07-23 Regents Of The University Of Minnesota High molecular weight derivatives of vitamin K-dependent polypeptides
ATE488581T1 (en) * 2002-04-30 2010-12-15 Bayer Healthcare Llc FACTOR VII OR FACTOR VIIA POLYPEPTIDE VARIANTS
CA2502162C (en) * 2002-09-30 2014-04-15 Maxygen Holdings Ltd. Fvii or fviia variants having increased clotting activity

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1308170A2 (en) * 1995-01-19 2003-05-07 Elan Drug Delivery Limited Dried blood factor composition comprising trehalose
US20040248793A1 (en) * 2002-06-21 2004-12-09 Jensen Michael Bech Stabilised solid compositions of factor VII polypeptides
WO2005058283A2 (en) * 2003-12-19 2005-06-30 Novo Nordisk Health Care Ag Stabilised compositions of factor vii polypeptides

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
BENAROUDJ N ET AL: "Trehalose Accumulation during Cellular Stress Protects Cells and Cellular Proteins from Damage by Oxygen Radicals", JOURNAL OF BIOLOGICAL CHEMISTRY 20010629 US, vol. 276, no. 26, 29 June 2001 (2001-06-29), pages 24261 - 24267, XP002508385, ISSN: 0021-9258 *

Also Published As

Publication number Publication date
WO2008078189A2 (en) 2008-07-03
EP2114379A2 (en) 2009-11-11
CA2673260A1 (en) 2008-07-03
JP2010513462A (en) 2010-04-30

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