AU2017213103B2 - Liquid formulation of a VEGF antagonist - Google Patents

Liquid formulation of a VEGF antagonist Download PDF

Info

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
Authority
AU
Australia
Prior art keywords
histidine
pharmaceutical composition
aflibercept
concentration
polysorbate
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.)
Active
Application number
AU2017213103A
Other languages
English (en)
Other versions
AU2017213103A1 (en
Inventor
Rainer Sigl
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.)
Formycon AG
Original Assignee
Formycon AG
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 Formycon AG filed Critical Formycon AG
Publication of AU2017213103A1 publication Critical patent/AU2017213103A1/en
Application granted granted Critical
Publication of AU2017213103B2 publication Critical patent/AU2017213103B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61K38/177—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 or 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IG], 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)
  • Public Health (AREA)
  • Animal Behavior & Ethology (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)
  • Molecular Biology (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (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 2016-01-26
EP16152767.6 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 (https=)
EP (1) EP3407868A1 (https=)
JP (1) JP6953433B2 (https=)
AU (1) AU2017213103B2 (https=)
CA (1) CA3011638C (https=)
WO (1) WO2017129685A1 (https=)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2654510C (en) 2006-06-16 2015-03-17 Regeneron Pharmaceuticals, Inc. Vegf antagonist formulations suitable for intravitreal administration
KR101808234B1 (ko) 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
US10576128B2 (en) 2016-01-26 2020-03-03 Formycon Ag Liquid formulation of a VEGF antagonist
EP3518971A4 (en) * 2016-09-28 2020-05-13 Board Of Regents, The University Of Texas System ANTIBODIES AND THERAPEUTIC PROTEIN FORMULATIONS AND USES THEREOF
JP7116059B2 (ja) * 2016-11-21 2022-08-09 ジャスト－エヴォテック バイオロジックス、インコーポレイテッド アフリベルセプト製剤及びその使用
FI3600456T3 (fi) 2017-03-27 2023-10-26 Regeneron Pharma Sterilointimenetelmä
WO2019020777A1 (en) 2017-07-26 2019-01-31 Formycon Ag LIQUID FORMULATION OF A VEGF ANTAGONIST
US20200255496A1 (en) 2017-09-18 2020-08-13 Amgen Inc. Vegfr-fc fusion protein formulations
MX2020005170A (es) * 2017-11-17 2020-10-16 Amgen Inc Formulaciones de proteinas de fusion vegfr-fc.
MY202872A (en) * 2017-11-20 2024-05-28 Just Evotec Biologics Inc Aflibercept formulations containing a lysine salt as tonicifying agent and uses thereof
DK4364724T3 (da) * 2018-05-10 2025-12-22 Regeneron Pharma Formuleringer med høj koncentration af VEGF-receptorfusionsprotein
JP7511542B2 (ja) * 2018-08-30 2024-07-05 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 タンパク質複合体を特徴づけるための方法
WO2020055123A1 (ko) * 2018-09-10 2020-03-19 삼성바이오에피스 주식회사 단백질을 포함하는 액상 조성물
US20210353713A1 (en) 2018-10-26 2021-11-18 Amgen Inc. Formulations comprising a tris buffer and a protein
MY195550A (en) * 2018-10-29 2023-01-31 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
EP3886946A1 (en) 2019-06-05 2021-10-06 Regeneron Pharmaceuticals, Inc. Devices and methods for precision dose delivery
SG11202110968VA (en) 2019-12-06 2021-10-28 Regeneron Pharma Anti-vegf protein compositions and methods for producing the same
IL296119A (en) * 2020-03-04 2022-11-01 Shanghai Henlius Biotech Inc Pharmaceutical formulation comprising bevacizumab
AU2021268026A1 (en) 2020-05-08 2023-01-19 Regeneron Pharmaceuticals, Inc. VEGF traps and mini-traps and methods for treating ocular disorders and cancer
CA3190325A1 (en) * 2020-07-31 2022-02-03 Celltrion Inc. Stable pharmaceutical preparation
US11723955B1 (en) 2022-05-13 2023-08-15 Allgenesis Biotherapeutics Inc. VEGFR fusion protein pharmaceutical composition
USD1120314S1 (en) 2022-11-30 2026-03-24 Regeneron Pharmaceuticals, Inc. Dose delivery device
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

Family Cites Families (26)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
AU687727B2 (en) 1992-10-28 1998-03-05 Genentech Inc. Vascular endothelial cell growth factor antagonists
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
JP4531132B2 (ja) 1995-06-02 2010-08-25 ギリード・サイエンシズ・インコーポレーテッド 増殖因子に対する高親和性オリゴヌクレオチドリガンド
KR100816621B1 (ko) 1997-04-07 2008-03-24 제넨테크, 인크. 항-ｖｅｇｆ 항체
PT971959E (pt) 1997-04-07 2006-05-31 Genentech Inc Anticorpos humanizados e metodos para formar anticorpos humanizados
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
CN101433715B (zh) 1999-06-08 2013-04-17 里珍纳龙药品有限公司 具有改善的药物动力学特性的修饰嵌合多肽
WO2005044853A2 (en) 2003-11-01 2005-05-19 Genentech, Inc. Anti-vegf antibodies
ES2633574T3 (es) 2005-03-25 2017-09-22 Regeneron Pharmaceuticals, Inc. Formulaciones de antagonistas de VEGF
EP2446862B1 (en) * 2006-06-20 2017-08-09 Ben Gurion University Of The Negev Research And Development Authority Amphiphilic peptides and hydrogel matrices thereof for bone repair
EP2167127A1 (en) 2007-07-10 2010-03-31 F. Hoffmann-Roche AG Novel formulation
BRPI0914251B1 (pt) 2008-06-25 2022-07-19 Novartis Ag Imunoligante recombinante, seu fragmento de ligação ao antígeno, uso dos mesmos, e composição
BRPI0921469B1 (pt) 2008-11-03 2022-01-18 Molecular Partners Ag Proteínas de ligação que inibem a interação com o receptor de vegf-a, composição farmacêutica
AR081361A1 (es) 2010-04-30 2012-08-29 Molecular Partners Ag Proteinas de union modificadas que inhiben la interaccion de receptor del factor de crecimiento endotelial vascular de glicoproteina a vegf-a
EP2890389A1 (en) * 2012-08-28 2015-07-08 Novartis AG Use of a vegf antagonist in treating ocular vascular proliferative diseases
US20160137717A1 (en) * 2013-06-20 2016-05-19 Gabriela Burian Use of a vegf antagonist in treating choroidal neovascularisation
EP3071181B1 (en) 2013-11-18 2021-03-24 Formycon AG Pharmaceutical composition of an anti-vegf antibody
CN106456757A (zh) 2014-05-12 2017-02-22 福尔密孔股份公司 含有vegf拮抗剂的预填充塑料注射器
KR101808234B1 (ko) * 2015-06-23 2017-12-12 (주)알테오젠 IgG Fc 도메인을 가지는 융합 단백질의 안정한 액상 제제
CN108290004A (zh) 2015-11-18 2018-07-17 福尔密孔股份公司 含有vegf拮抗剂的预填充塑料注射器
US10576128B2 (en) 2016-01-26 2020-03-03 Formycon Ag Liquid formulation of a VEGF antagonist

Patent 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

Also Published As

Publication number Publication date
US12551529B2 (en) 2026-02-17
JP6953433B2 (ja) 2021-10-27
US20230248806A1 (en) 2023-08-10
JP2019504882A (ja) 2019-02-21
US20190030123A1 (en) 2019-01-31
US20200237862A1 (en) 2020-07-30
AU2017213103A1 (en) 2018-07-26
CA3011638C (en) 2023-01-10
EP3407868A1 (en) 2018-12-05
CA3011638A1 (en) 2017-08-03
WO2017129685A1 (en) 2017-08-03
US10576128B2 (en) 2020-03-03

Similar Documents

Publication Publication Date Title
US12551529B2 (en) Liquid formulation of a VEGF antagonist
US20250229010A1 (en) Pre-filled plastic syringe containing a vegf antagonist
US10568951B2 (en) Pharmaceutical composition of an anti-VEGF antibody
RU2702748C2 (ru) Предварительно заполненный пластиковый шприц, содержащий антагонист vegf
AU2007238677B2 (en) Use of IL-I antibodies for treating ophthalmic disorders
WO2019020777A1 (en) LIQUID FORMULATION OF A VEGF ANTAGONIST
TW202308689A (zh) 高濃度的雙特異性抗體調配物
JP2010512356A (ja) 非経口ａベータ抗体製剤
JP2020534255A (ja) 治療用タンパク質の凍結乾燥医薬配合物のためのプロセス
US20230173069A1 (en) Formulation comprising anti-il-23p19 antibody, method for preparing same and use thereof
CN113453719A (zh) 包含抗cd47抗体的制剂及其制备方法和用途
JP2025537803A (ja) トランスサイレチン媒介性アミロイドーシスを治療又は予防するための医薬組成物
CN116688115B (zh) 一种PD-L1/TGF-β双功能融合蛋白制剂及其用途
CA3005692C (en) Pre-filled plastic syringe containing a vegf antagonist
TW202541841A (zh) 用於治療ｃ１ｓ介導病症的包含抗體的醫藥組成物及其使用方法
HK40018131A (en) Liquid protein formulations containing ionic liquids
HK40059591A (en) Preparations containing anti-cd47 antibody, and preparation method and use therefor
HK40060532A (en) Formulations containing anti-cd47/pd-l1 bispecific antibody and preparation method therefor and use thereof
EA042435B1 (ru) Стабильный препарат раствора белка, содержащего анти-vegf антитело в высокой концентрации
HK1225982A1 (zh) 包含离子性液体的液体蛋白质制剂

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)