AU2010204552B2 - New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein - Google Patents

New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein Download PDF

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Publication number
AU2010204552B2
AU2010204552B2 AU2010204552A AU2010204552A AU2010204552B2 AU 2010204552 B2 AU2010204552 B2 AU 2010204552B2 AU 2010204552 A AU2010204552 A AU 2010204552A AU 2010204552 A AU2010204552 A AU 2010204552A AU 2010204552 B2 AU2010204552 B2 AU 2010204552B2
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AU
Australia
Prior art keywords
neug
neutropenia
subject
dose
pegfilgrastim
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Ceased
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AU2010204552A
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AU2010204552A1 (en
Inventor
Adam Carr Bell
Jason Benjamin Bock
Jeffrey Herpst
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Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
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Publication of AU2010204552A1 publication Critical patent/AU2010204552A1/en
Application granted granted Critical
Publication of AU2010204552B2 publication Critical patent/AU2010204552B2/en
Priority to AU2014208224A priority Critical patent/AU2014208224A1/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • A61K38/385Serum albumin
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19Cytokines; Lymphokines; Interferons
    • A61K38/193Colony stimulating factors [CSF]
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/38Albumins
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/62Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
    • A61K47/64Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/643Albumins, e.g. HSA, BSA, ovalbumin or a Keyhole Limpet Hemocyanin [KHL]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/04Immunostimulants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2010204552A 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein Ceased AU2010204552B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2014208224A AU2014208224A1 (en) 2009-01-16 2014-07-30 New Stable Formulations of Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor Fusion Protein

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US14544009P 2009-01-16 2009-01-16
US14543609P 2009-01-16 2009-01-16
US61/145,436 2009-01-16
US61/145,440 2009-01-16
PCT/US2010/021241 WO2010083439A2 (en) 2009-01-16 2010-01-15 Recombinant human albumin-human granulocyte colony stimulating factor for the prevention of neutropenia

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2014208224A Division AU2014208224A1 (en) 2009-01-16 2014-07-30 New Stable Formulations of Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor Fusion Protein

Publications (2)

Publication Number Publication Date
AU2010204552A1 AU2010204552A1 (en) 2011-08-04
AU2010204552B2 true AU2010204552B2 (en) 2014-05-01

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AU2010204552A Ceased AU2010204552B2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein
AU2010204547A Ceased AU2010204547B2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2010204547A Ceased AU2010204547B2 (en) 2009-01-16 2010-01-15 New stable formulations of recombinant human albumin-human granulocyte colony stimulating factor fusion protein

Country Status (16)

Country Link
US (4) US20100227818A1 (enExample)
EP (2) EP2387419A2 (enExample)
JP (2) JP2012515222A (enExample)
KR (2) KR20110132327A (enExample)
CN (2) CN102395379B (enExample)
AU (2) AU2010204552B2 (enExample)
BR (2) BRPI1005159A2 (enExample)
CA (2) CA2749786A1 (enExample)
EA (2) EA201190079A1 (enExample)
IL (2) IL214052A0 (enExample)
MX (2) MX2011007582A (enExample)
NZ (2) NZ594056A (enExample)
SG (3) SG172941A1 (enExample)
UA (2) UA105201C2 (enExample)
WO (2) WO2010083439A2 (enExample)
ZA (1) ZA201105171B (enExample)

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EP2945703A4 (en) * 2013-01-15 2016-08-31 Teva Pharma ALBU-BCHE FORMULATIONS, PREPARATION THEREOF AND USES THEREOF
US20140271538A1 (en) 2013-03-15 2014-09-18 Teva Pharmaceutical Industries Ltd. Recombinant Human Albumin-Human Granulocyte Colony Stimulating Factor for the Prevention of Neutropenia in Pediatric Patients
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CN107530341B (zh) 2015-03-06 2021-10-01 大连万春布林医药有限公司 治疗与ras突变相关的癌症的方法
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AU2017217426B2 (en) 2016-02-08 2022-12-01 Beyondspring Pharmaceuticals, Inc. Compositions containing tucaresol or its analogs
SG11201810872UA (en) 2016-06-06 2019-01-30 Beyondspring Pharmaceuticals Inc Composition and method for reducing neutropenia
CN106222221A (zh) * 2016-08-05 2016-12-14 山东科兴生物制品有限公司 制备重组人粒细胞刺激因子原液的纯化方法
ES2985905T3 (es) 2016-11-22 2024-11-07 Lts Device Tech Ltd Aparato para suministrar una sustancia terapéutica
CN110431135A (zh) 2017-01-06 2019-11-08 大连万春布林医药有限公司 微管蛋白结合化合物及其治疗用途
CN110381938A (zh) 2017-02-01 2019-10-25 大连万春布林医药有限公司 减少中性粒细胞缺乏症的方法
WO2018187786A1 (en) * 2017-04-07 2018-10-11 La Jolla Institute For Allergy And Immunology Unipotent neutrophil progenitor cells, methods of preparation, and uses thereof
CN109420159A (zh) * 2017-08-23 2019-03-05 江苏泰康生物医药有限公司 一种重组蛋白药物的新型稳定制剂
CA3089226A1 (en) 2018-01-24 2019-08-01 Beyondspring Pharmaceuticals, Inc. Composition and method for reducing thrombocytopenia via the administration of plinabulin
KR20200116477A (ko) * 2018-02-01 2020-10-12 비욘드스프링 파마수티컬스, 인코포레이티드. 플리나불린 및 g-csf 제제의 투여를 통해 화학요법-유도된 호중구감소증을 감소시키기 위한 조성물 및 방법
US11583633B2 (en) 2018-04-03 2023-02-21 Amgen Inc. Systems and methods for delayed drug delivery
ES2986346T3 (es) 2018-10-05 2024-11-11 Lts Device Tech Ltd Secuencia de activación
CN111383745A (zh) * 2018-12-29 2020-07-07 医渡云(北京)技术有限公司 计算机数据处理方法、装置、存储介质及设备
US11684655B2 (en) * 2019-05-31 2023-06-27 Spectrum Pharmaceuticals, Inc. Methods of treating neutorpenia using G-CSF protein complex
US11267858B2 (en) 2019-05-31 2022-03-08 Spectrum Pharmaceuticals, Inc. Methods of treatment using G-CSF protein complex
CN112316120A (zh) * 2019-08-05 2021-02-05 天津派格生物技术有限公司 使用低动员型g-csf有效且安全治疗粒细胞减少症的方法
KR20220110747A (ko) * 2019-12-05 2022-08-09 한미약품 주식회사 화학 요법 또는 방사선 요법으로 유도된 호중구감소증을 치료하는 방법
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US5665863A (en) * 1992-01-31 1997-09-09 Rhone-Poulenc Rorer S.A. Polypeptides having granulocyte colony stimulating activity, their preparation and pharmaceutical compositions containing them
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WO2003076567A2 (en) * 2002-03-05 2003-09-18 Eli Lilly And Company Heterologous g-csf fusion proteins

Also Published As

Publication number Publication date
BRPI1004940A2 (pt) 2018-06-19
AU2010204552A1 (en) 2011-08-04
MX2011007583A (es) 2011-12-14
SG172941A1 (en) 2011-08-29
WO2010083434A2 (en) 2010-07-22
EA023344B1 (ru) 2016-05-31
IL214051A0 (en) 2011-08-31
CA2749802A1 (en) 2010-07-22
US20150202268A1 (en) 2015-07-23
US20100297062A1 (en) 2010-11-25
SG196821A1 (en) 2014-02-13
AU2010204547B2 (en) 2014-01-23
KR20110132326A (ko) 2011-12-07
CA2749786A1 (en) 2010-07-22
NZ594055A (en) 2013-03-28
JP5753095B2 (ja) 2015-07-22
IL214052A0 (en) 2011-08-31
EA201190080A1 (ru) 2014-03-31
JP2012515221A (ja) 2012-07-05
NZ594056A (en) 2013-03-28
KR20110132327A (ko) 2011-12-07
BRPI1005159A2 (pt) 2018-04-03
US20100227818A1 (en) 2010-09-09
WO2010083434A3 (en) 2010-09-10
US8323634B2 (en) 2012-12-04
WO2010083439A3 (en) 2010-09-10
MX2011007582A (es) 2011-12-14
ZA201105171B (en) 2015-12-23
US8993519B2 (en) 2015-03-31
EA201190079A1 (ru) 2013-02-28
US20130129669A1 (en) 2013-05-23
AU2010204547A1 (en) 2011-07-28
SG172940A1 (en) 2011-08-29
JP2012515222A (ja) 2012-07-05
CN102395379A (zh) 2012-03-28
CN102395379B (zh) 2015-07-22
CN102378635A (zh) 2012-03-14
EP2387419A2 (en) 2011-11-23
EP2387420A2 (en) 2011-11-23
WO2010083439A2 (en) 2010-07-22
CA2749802C (en) 2016-08-23
UA105201C2 (uk) 2014-04-25
UA103221C2 (uk) 2013-09-25

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