WO2010048275A3 - Lyophilized recombinant vwf formulations - Google Patents

Lyophilized recombinant vwf formulations Download PDF

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Publication number
WO2010048275A3
WO2010048275A3 PCT/US2009/061470 US2009061470W WO2010048275A3 WO 2010048275 A3 WO2010048275 A3 WO 2010048275A3 US 2009061470 W US2009061470 W US 2009061470W WO 2010048275 A3 WO2010048275 A3 WO 2010048275A3
Authority
WO
WIPO (PCT)
Prior art keywords
lyophilized recombinant
formulations
recombinant vwf
vwf formulations
lyophilized
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
PCT/US2009/061470
Other languages
French (fr)
Other versions
WO2010048275A2 (en
Inventor
Kurt Schnecker
Eva Haidweger
Peter Turecek
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.)
Baxter Healthcare SA
Baxter International Inc
Original Assignee
Baxter Healthcare SA
Baxter International Inc
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=42109151&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2010048275(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to MX2011004247A priority Critical patent/MX2011004247A/en
Priority to SI200930558T priority patent/SI2349314T1/en
Priority to CA2740919A priority patent/CA2740919A1/en
Priority to EP09740822A priority patent/EP2349314B1/en
Priority to ES09740822T priority patent/ES2409032T3/en
Priority to HRP20130414AT priority patent/HRP20130414T1/en
Priority to KR1020177011494A priority patent/KR101953494B1/en
Priority to PL09740822T priority patent/PL2349314T3/en
Priority to CN200980142453.5A priority patent/CN102387784B/en
Application filed by Baxter Healthcare SA, Baxter International Inc filed Critical Baxter Healthcare SA
Priority to KR1020117011539A priority patent/KR101772674B1/en
Priority to BRPI0919693-5A priority patent/BRPI0919693A2/en
Priority to JP2011532347A priority patent/JP5781931B2/en
Priority to NZ592704A priority patent/NZ592704A/en
Priority to DK09740822.3T priority patent/DK2349314T3/en
Priority to AU2009307648A priority patent/AU2009307648C1/en
Publication of WO2010048275A2 publication Critical patent/WO2010048275A2/en
Anticipated expiration legal-status Critical
Publication of WO2010048275A3 publication Critical patent/WO2010048275A3/en
Priority to SM201300093T priority patent/SMT201300093B/en
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Hematology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

The present invention provides long-term stable pharmaceutical formulations of lyophilized recombinant von-Willebrand Factor (rVWF) and methods for making and administering said formulations.
PCT/US2009/061470 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations Ceased WO2010048275A2 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
AU2009307648A AU2009307648C1 (en) 2008-10-21 2009-10-21 Lyophilized recombinant VWF formulations
KR1020117011539A KR101772674B1 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations
CA2740919A CA2740919A1 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations
EP09740822A EP2349314B1 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations
ES09740822T ES2409032T3 (en) 2008-10-21 2009-10-21 Lyophilized formulations of recombinant vwf
HRP20130414AT HRP20130414T1 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations
KR1020177011494A KR101953494B1 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations
PL09740822T PL2349314T3 (en) 2008-10-21 2009-10-21 Formulations of lyophilized recombinant VWF
CN200980142453.5A CN102387784B (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations
MX2011004247A MX2011004247A (en) 2008-10-21 2009-10-21 RECOMBINANT VWF LIOFILIZED FORMULATIONS.
JP2011532347A JP5781931B2 (en) 2008-10-21 2009-10-21 Lyophilized recombinant VWF formulation
SI200930558T SI2349314T1 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations
BRPI0919693-5A BRPI0919693A2 (en) 2008-10-21 2009-10-21 lyophilized stable pharmaceutical formulation
NZ592704A NZ592704A (en) 2008-10-21 2009-10-21 Lyophilized recombinant von willebrand factor (rVWF) formulation comprising buffering agents, amino acids, stabilising agents and surfactants
DK09740822.3T DK2349314T3 (en) 2008-10-21 2009-10-21 Lyophilized preparations of recombinant VWF
SM201300093T SMT201300093B (en) 2008-10-21 2013-08-16 Lyophilized recombinant vwf formulations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10727308P 2008-10-21 2008-10-21
US61/107,273 2008-10-21

Publications (2)

Publication Number Publication Date
WO2010048275A2 WO2010048275A2 (en) 2010-04-29
WO2010048275A3 true WO2010048275A3 (en) 2011-09-15

Family

ID=42109151

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/061470 Ceased WO2010048275A2 (en) 2008-10-21 2009-10-21 Lyophilized recombinant vwf formulations

Country Status (21)

Country Link
US (4) US20100099603A1 (en)
EP (2) EP2349314B1 (en)
JP (6) JP5781931B2 (en)
KR (2) KR101953494B1 (en)
CN (2) CN103919736A (en)
AR (2) AR074054A1 (en)
AU (1) AU2009307648C1 (en)
BR (1) BRPI0919693A2 (en)
CA (1) CA2740919A1 (en)
CY (1) CY1113869T1 (en)
DK (1) DK2349314T3 (en)
ES (1) ES2409032T3 (en)
HR (1) HRP20130414T1 (en)
MX (1) MX2011004247A (en)
NZ (1) NZ592704A (en)
PL (1) PL2349314T3 (en)
PT (1) PT2349314E (en)
SI (1) SI2349314T1 (en)
SM (1) SMT201300093B (en)
TW (3) TWI670072B (en)
WO (1) WO2010048275A2 (en)

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DK2349314T3 (en) * 2008-10-21 2013-05-27 Baxter Int Lyophilized preparations of recombinant VWF
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KR101969515B1 (en) * 2011-06-10 2019-04-16 박스알타 인코퍼레이티드 Treatment of coagulation disease by administration of recombinant vwf
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CN106414719B (en) 2014-06-13 2020-02-14 杰特有限公司 Improved production of recombinant von Willebrand factor in a bioreactor
KR102698051B1 (en) * 2015-02-27 2024-08-26 더 보드 오브 리젠츠 오브 더 유니버시티 오브 텍사스 시스템 Polypeptide therapeutics and uses thereof
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PT3648787T (en) 2017-07-07 2025-01-20 Takeda Pharmaceuticals Co Treatment of patients with severe von willebrand disease undergoing elective surgery by administration of recombinant vwf
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BR112021015068A2 (en) 2019-02-01 2021-10-05 Takeda Pharmaceutical Company Limited PROPHYLATIC TREATMENT METHODS USING RECOMBINANT VWF (RVWF)
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