AU2015236340B2 - Lyophilized factor IX formulations - Google Patents

Lyophilized factor IX formulations Download PDF

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Publication number
AU2015236340B2
AU2015236340B2 AU2015236340A AU2015236340A AU2015236340B2 AU 2015236340 B2 AU2015236340 B2 AU 2015236340B2 AU 2015236340 A AU2015236340 A AU 2015236340A AU 2015236340 A AU2015236340 A AU 2015236340A AU 2015236340 B2 AU2015236340 B2 AU 2015236340B2
Authority
AU
Australia
Prior art keywords
fix
vial
formulation
polypeptide
lyophilization
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.)
Withdrawn - After Issue
Application number
AU2015236340A
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English (en)
Other versions
AU2015236340A1 (en
Inventor
Brandon W. LEVEILLE
Cherie Parkhurst-Lang
Brian M. THOME
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.)
Bioverativ Therapeutics Inc
Original Assignee
Bioverativ Therapeutics 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=54196282&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2015236340(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bioverativ Therapeutics Inc filed Critical Bioverativ Therapeutics Inc
Publication of AU2015236340A1 publication Critical patent/AU2015236340A1/en
Assigned to BIOVERATIV THERAPEUTICS INC. reassignment BIOVERATIV THERAPEUTICS INC. Request for Assignment Assignors: BIOGEN MA INC.
Application granted granted Critical
Publication of AU2015236340B2 publication Critical patent/AU2015236340B2/en
Priority to AU2020202863A priority Critical patent/AU2020202863B2/en
Priority to AU2022215218A priority patent/AU2022215218B2/en
Withdrawn - After Issue legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K38/43—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
    • A61K47/22—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
    • A61K9/14—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
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/21022—Coagulation factor IXa (3.4.21.22)
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26—DRYING
    • F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00—Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
    • F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mechanical Engineering (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Monitoring And Testing Of Transmission In General (AREA)
  • Mobile Radio Communication Systems (AREA)
AU2015236340A 2014-03-24 2015-03-24 Lyophilized factor IX formulations Withdrawn - After Issue AU2015236340B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2020202863A AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations
AU2022215218A AU2022215218B2 (en) 2014-03-24 2022-08-10 Lyophilized factor IX formulations

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24
US61/969,801 2014-03-24
PCT/US2015/022141 WO2015148444A1 (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2020202863A Division AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations

Publications (2)

Publication Number Publication Date
AU2015236340A1 AU2015236340A1 (en) 2016-09-29
AU2015236340B2 true AU2015236340B2 (en) 2020-02-06

Family

ID=54196282

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2015236340A Withdrawn - After Issue AU2015236340B2 (en) 2014-03-24 2015-03-24 Lyophilized factor IX formulations
AU2020202863A Active AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations
AU2022215218A Active AU2022215218B2 (en) 2014-03-24 2022-08-10 Lyophilized factor IX formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2020202863A Active AU2020202863B2 (en) 2014-03-24 2020-04-30 Lyophilized factor IX formulations
AU2022215218A Active AU2022215218B2 (en) 2014-03-24 2022-08-10 Lyophilized factor IX formulations

Country Status (16)

Country Link
US (3) US10772942B2 (enExample)
EP (1) EP3123090A4 (enExample)
JP (4) JP7058940B2 (enExample)
KR (1) KR102385372B1 (enExample)
AR (1) AR099838A1 (enExample)
AU (3) AU2015236340B2 (enExample)
CA (1) CA2943034C (enExample)
CL (1) CL2016002386A1 (enExample)
EA (2) EA202092926A3 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG10201808249VA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
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SG11201505926VA (en) 2013-03-15 2015-09-29 Biogen Ma Inc Factor ix polypeptide formulations
EA201691111A1 (ru) 2014-01-10 2017-01-30 Байоджен Ма Инк. Химерные белки фактора viii и их применение
EA202092926A3 (ru) 2014-03-24 2021-10-29 Биовератив Терапьютикс Инк. Лиофилизированные составы, содержащие фактор ix
KR20190090827A (ko) * 2016-12-02 2019-08-02 바이오버라티브 테라퓨틱스 인크. 키메라 응고 인자를 사용해 혈우병성 관절증을 치료하는 방법
JP7198264B2 (ja) * 2017-07-11 2022-12-28 ユニバーサル スタビリゼイション テクノロジーズ，インコーポレイテッド バイオ医薬品を保存するための方法
CN112175088B (zh) * 2019-07-02 2023-03-28 江苏晟斯生物制药有限公司 改进的fix融合蛋白、缀合物及其应用
WO2021158759A2 (en) 2020-02-04 2021-08-12 Regeneron Pharmaceuticals, Inc. Target residual moisture content for lyophilized drug product
KR20230008759A (ko) * 2020-05-11 2023-01-16 엘커메스 파마 아일랜드 리미티드 Il-2 융합 폴리펩티드 조성물 및 그의 제조 및 사용 방법
CN118557531B (zh) * 2024-08-02 2024-10-18 成都蓉生药业有限责任公司 一种重组人凝血因子VIII-Fc融合蛋白冻干制剂的制备方法

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Also Published As

Publication number Publication date
IL272257A (en) 2020-02-27
JP2020063313A (ja) 2020-04-23
EA202092926A2 (ru) 2021-07-30
US20210069307A1 (en) 2021-03-11
US20250121042A1 (en) 2025-04-17
BR112016021777A2 (pt) 2017-10-03
AU2022215218B2 (en) 2025-12-18
US12128092B2 (en) 2024-10-29
PH12016501877A1 (en) 2016-12-19
EP3123090A1 (en) 2017-02-01
CL2016002386A1 (es) 2017-06-23
MX2021012939A (es) 2021-11-25
JP2022044689A (ja) 2022-03-17
AU2020202863B2 (en) 2022-09-01
TWI700101B (zh) 2020-08-01
IL247869A0 (en) 2016-11-30
JP2024053015A (ja) 2024-04-12
AU2015236340A1 (en) 2016-09-29
IL281197B (en) 2022-06-01
CA2943034A1 (en) 2015-10-01
EA038573B1 (ru) 2021-09-16
CA2943034C (en) 2022-06-14
SG10201808249VA (en) 2018-10-30
EA202092926A3 (ru) 2021-10-29
WO2015148444A1 (en) 2015-10-01
EP3123090A4 (en) 2017-12-13
MX2016012447A (es) 2017-01-06
AU2022215218A1 (en) 2022-09-01
JP2017510585A (ja) 2017-04-13
SG10201913735SA (en) 2020-03-30
US10772942B2 (en) 2020-09-15
IL281197A (en) 2021-04-29
TW201605492A (zh) 2016-02-16
JP7759978B2 (ja) 2025-10-24
JP7503583B2 (ja) 2024-06-20
JP7058940B2 (ja) 2022-04-25
US20170173122A1 (en) 2017-06-22
IL247869B (en) 2020-02-27
MA39779A (fr) 2017-02-01
NZ724351A (en) 2023-10-27
KR20160137577A (ko) 2016-11-30
AU2020202863A1 (en) 2020-05-21
IL272257B (en) 2021-03-25
MX387269B (es) 2025-03-18
SG11201607642RA (en) 2016-10-28
AR099838A1 (es) 2016-08-24
EA201691807A1 (ru) 2017-03-31
KR102385372B1 (ko) 2022-04-11

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