AU2017213103B2 - Liquid formulation of a VEGF antagonist - Google Patents

Liquid formulation of a VEGF antagonist Download PDF

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Publication number
AU2017213103B2
AU2017213103B2 AU2017213103A AU2017213103A AU2017213103B2 AU 2017213103 B2 AU2017213103 B2 AU 2017213103B2 AU 2017213103 A AU2017213103 A AU 2017213103A AU 2017213103 A AU2017213103 A AU 2017213103A AU 2017213103 B2 AU2017213103 B2 AU 2017213103B2
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histidine
pharmaceutical composition
aflibercept
concentration
polysorbate
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AU2017213103A
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AU2017213103A1 (en
Inventor
Rainer Sigl
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Formycon AG
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Formycon AG
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    • 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
    • A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
    • A61K38/179—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • 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
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A61P27/10—Ophthalmic agents for accommodation disorders, e.g. myopia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Cell Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2017213103A 2016-01-26 2017-01-26 Liquid formulation of a VEGF antagonist Active AU2017213103B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP16152767.6 2016-01-26
EP16152767 2016-01-26
EP16199497.5 2016-11-18
EP16199497 2016-11-18
PCT/EP2017/051662 WO2017129685A1 (en) 2016-01-26 2017-01-26 Liquid formulation of a vegf antagonist

Publications (2)

Publication Number Publication Date
AU2017213103A1 AU2017213103A1 (en) 2018-07-26
AU2017213103B2 true AU2017213103B2 (en) 2022-08-11

Family

ID=57882094

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2017213103A Active AU2017213103B2 (en) 2016-01-26 2017-01-26 Liquid formulation of a VEGF antagonist

Country Status (6)

Country Link
US (3) US10576128B2 (enExample)
EP (1) EP3407868A1 (enExample)
JP (1) JP6953433B2 (enExample)
AU (1) AU2017213103B2 (enExample)
CA (1) CA3011638C (enExample)
WO (1) WO2017129685A1 (enExample)

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RU2432155C3 (ru) 2006-06-16 2017-11-17 Ридженерон Фармасьютикалз, Инк. Составы антагониста vegf, подходящие для интравитреального введения
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
EP3518971A4 (en) * 2016-09-28 2020-05-13 Board Of Regents, The University Of Texas System Antibody and protein therapeutic formulations and uses thereof
EP3541365A1 (en) * 2016-11-21 2019-09-25 Just Biotherapeutics, Inc. Aflibercept formulations and uses thereof
US10918754B2 (en) 2017-03-27 2021-02-16 Regeneron Pharmaceuticals, Inc. Sterilisation method
WO2019020777A1 (en) 2017-07-26 2019-01-31 Formycon Ag LIQUID FORMULATION OF A VEGF ANTAGONIST
EP3684332A1 (en) 2017-09-18 2020-07-29 Amgen Inc. Vegfr-fc fusion protein formulations
MA50908A (fr) * 2017-11-17 2020-09-23 Amgen Inc Formulations de protéines de fusion vegfr-fc
CN111356471A (zh) 2017-11-20 2020-06-30 济世发展生物药业有限公司 包含赖氨酸盐作为张力调节剂的阿柏西普制剂及其用途
KR20210021299A (ko) 2018-05-10 2021-02-25 리제너론 파아마슈티컬스, 인크. 고농도 vegf 수용체 융합 단백질 함유 제제
BR112020026348A2 (pt) * 2018-08-30 2021-03-30 Regeneron Pharmaceuticals, Inc. Método para avaliar a estequiometria e distribuição de tamanho de complexos de proteínas, para selecionar um medicamento de proteína principal e para caracterizar complexos de proteínas, e, composição farmacêutica
KR20200029374A (ko) * 2018-09-10 2020-03-18 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
WO2020087003A1 (en) 2018-10-26 2020-04-30 Amgen Inc. Formulations comprising a tris buffer and a protein
IL281717B2 (en) * 2018-10-29 2025-07-01 Hoffmann La Roche Antibody formulation
CN120241997A (zh) 2019-02-18 2025-07-04 伊莱利利公司 治疗性抗体制剂
KR20230152810A (ko) 2019-12-06 2023-11-03 리제너론 파아마슈티컬스, 인크. 항-vegf 단백질 조성물 및 이를 생산하는 방법
KR20220149690A (ko) * 2020-03-04 2022-11-08 상하이 헨리우스 바이오테크, 인크. 베바시주맙을 포함하는 약물 조제용 제제
JP2023525034A (ja) 2020-05-08 2023-06-14 リジェネロン・ファーマシューティカルズ・インコーポレイテッド Ｖｅｇｆトラップおよびミニトラップならびに眼障害およびがんの治療方法
US20230312683A1 (en) * 2020-07-31 2023-10-05 Celltrion Inc. Stable pharmaceutical preparation
US11723955B1 (en) 2022-05-13 2023-08-15 Allgenesis Biotherapeutics Inc. VEGFR fusion protein pharmaceutical composition
WO2025217334A1 (en) * 2024-04-09 2025-10-16 Regeneron Pharmaceuticals, Inc. Low concentration vegf receptor fusion protein containing formulations

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007149334A2 (en) * 2006-06-16 2007-12-27 Regeneron Pharmaceuticals, Inc. Vegf antagonist formulations suitable for intravitreal administration
US20150157709A1 (en) * 2012-06-01 2015-06-11 Ophthotech Corporation Compositions Comprising an Anti-PDGF Aptamer and a VEGF Antagonist
US20150182623A1 (en) * 2012-06-01 2015-07-02 Ophthotech Corporation Compositions Comprising an Anti-PDGF Aptamer and a VEGF Antagonist

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US6124449A (en) 1990-06-11 2000-09-26 Nexstar Pharmaceuticals, Inc. High affinity TGFβ nucleic acid ligands and inhibitors
US5731424A (en) 1990-06-11 1998-03-24 Nexstar Pharmaceuticals, Inc. High affinity TGFβ nucleic acid ligands and inhibitors
US5731144A (en) 1990-06-11 1998-03-24 Nexstar Pharmaceuticals, Inc. High affinity TGFβ nucleic acid ligands
US6582959B2 (en) 1991-03-29 2003-06-24 Genentech, Inc. Antibodies to vascular endothelial cell growth factor
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IL117645A (en) 1995-03-30 2005-08-31 Genentech Inc Vascular endothelial cell growth factor antagonists for use as medicaments in the treatment of age-related macular degeneration
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SI1695985T1 (sl) 1997-04-07 2011-06-30 Genentech Inc Postopki za tvorbo humaniziranih protiteles z naključno mutagenezo
WO1998045331A2 (en) 1997-04-07 1998-10-15 Genentech, Inc. Anti-vegf antibodies
US20020032315A1 (en) 1997-08-06 2002-03-14 Manuel Baca Anti-vegf antibodies
US6703020B1 (en) 1999-04-28 2004-03-09 Board Of Regents, The University Of Texas System Antibody conjugate methods for selectively inhibiting VEGF
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WO2015173260A1 (en) 2014-05-12 2015-11-19 Formycon Ag Pre-filled plastic syringe containing a vegf antagonist
KR101808234B1 (ko) * 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
EP3377151A1 (en) 2015-11-18 2018-09-26 Formycon AG Pre-filled plastic syringe containing a vegf antagonist

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Publication number Priority date Publication date Assignee Title
WO2007149334A2 (en) * 2006-06-16 2007-12-27 Regeneron Pharmaceuticals, Inc. Vegf antagonist formulations suitable for intravitreal administration
US20150157709A1 (en) * 2012-06-01 2015-06-11 Ophthotech Corporation Compositions Comprising an Anti-PDGF Aptamer and a VEGF Antagonist
US20150182623A1 (en) * 2012-06-01 2015-07-02 Ophthotech Corporation Compositions Comprising an Anti-PDGF Aptamer and a VEGF Antagonist

Also Published As

Publication number Publication date
US20200237862A1 (en) 2020-07-30
CA3011638A1 (en) 2017-08-03
WO2017129685A1 (en) 2017-08-03
AU2017213103A1 (en) 2018-07-26
US20230248806A1 (en) 2023-08-10
US10576128B2 (en) 2020-03-03
EP3407868A1 (en) 2018-12-05
JP2019504882A (ja) 2019-02-21
US20190030123A1 (en) 2019-01-31
JP6953433B2 (ja) 2021-10-27
CA3011638C (en) 2023-01-10

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