SG10201808249VA - Lyophilized factor ix formulations - Google Patents

Lyophilized factor ix formulations

Info

Publication number
SG10201808249VA
SG10201808249VA SG10201808249VA SG10201808249VA SG10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA
Authority
SG
Singapore
Prior art keywords
fix
formulations
polypeptide
factor
present
Prior art date
Application number
SG10201808249VA
Inventor
Brian M Thome
Cherie Parkhurst-Lang
Brandon W Leveille
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=SG10201808249V(A) "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 SG10201808249VA publication Critical patent/SG10201808249VA/en

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
    • A61K38/43—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)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mechanical Engineering (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

Abstract

LYOPHILIZED FACTOR IX FORMULATIONS The present invention provides, among other things, pre-tyophilization formulations, reconstituted formulations, and lyophilate powder compositions comprising a Factor IX (FIX) polypeptide. The present invention also provides lyophilization methods for producing lyophilate powder comprising a FIX polypeptide.The present invention is directed to a pre- tyophilization formulation comprising: (a) a Factor IX (FIX) polypeptide having FIX coagulation activity; (b) a buffering agent; (c) a stabilizing agent; (d) a bulking agent; and (e) a surfactant, wherein the formulation has a fill volume of less than about 5 mL,and wherein each of (a) - (e) are at an amount per vial (mg/vial) sufficient to allow (1) improved stability of the FIX polypeptide when lyophilized. Fig. 1
SG10201808249VA 2014-03-24 2015-03-24 Lyophilized factor ix formulations SG10201808249VA (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US201461969801P 2014-03-24 2014-03-24

Publications (1)

Publication Number Publication Date
SG10201808249VA true SG10201808249VA (en) 2018-10-30

Family

ID=54196282

Family Applications (3)

Application Number Title Priority Date Filing Date
SG10201808249VA SG10201808249VA (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations
SG10201913735SA SG10201913735SA (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations
SG11201607642RA SG11201607642RA (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
SG10201913735SA SG10201913735SA (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations
SG11201607642RA SG11201607642RA (en) 2014-03-24 2015-03-24 Lyophilized factor ix formulations

Country Status (16)

Country Link
US (2) US10772942B2 (en)
EP (1) EP3123090A4 (en)
JP (4) JP7058940B2 (en)
KR (1) KR102385372B1 (en)
AR (1) AR099838A1 (en)
AU (3) AU2015236340B2 (en)
CA (1) CA2943034C (en)
CL (1) CL2016002386A1 (en)
EA (2) EA038573B1 (en)
IL (3) IL247869B (en)
MA (1) MA39779A (en)
MX (2) MX2016012447A (en)
PH (1) PH12016501877A1 (en)
SG (3) SG10201808249VA (en)
TW (1) TWI700101B (en)
WO (1) WO2015148444A1 (en)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2968498A4 (en) * 2013-03-15 2016-09-07 Biogen Ma Inc Factor ix polypeptide formulations
EA038573B1 (en) * 2014-03-24 2021-09-16 Биовератив Терапьютикс Инк. Lyophilized factor ix formulation for preventing bleeding episodes
CA3069444A1 (en) * 2017-07-11 2019-01-17 Universal Stabilization Technologies, Inc. Method for preserving biopharmaceuticals
CN112175088B (en) * 2019-07-02 2023-03-28 江苏晟斯生物制药有限公司 FIX fusion proteins, conjugates and uses thereof
MX2022009558A (en) * 2020-02-04 2022-09-09 Regeneron Pharma Target residual moisture content for lyophilized drug product.
CA3172874A1 (en) * 2020-05-11 2021-11-18 Alkermes Pharma Ireland Limited Il-2 fusion polypeptide compositions and methods of making and using the same

Family Cites Families (52)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3572982D1 (en) 1984-03-06 1989-10-19 Takeda Chemical Industries Ltd Chemically modified lymphokine and production thereof
WO1990006952A1 (en) 1988-12-22 1990-06-28 Kirin-Amgen, Inc. Chemically modified granulocyte colony stimulating factor
DE69029799T2 (en) 1989-02-21 1997-05-28 Washington University, St. Louis, Mo. MODIFIED FORMS OF REPRODUCTION HORMONES
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
DK0575545T3 (en) 1991-03-15 2003-09-15 Amgen Inc Pegylation of polypeptides
FR2686899B1 (en) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa NOVEL BIOLOGICALLY ACTIVE POLYPEPTIDES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM.
EP0627924B1 (en) * 1992-10-02 2000-12-27 Genetics Institute, Inc. Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer
DE4405426A1 (en) * 1994-02-21 1995-08-24 Boehringer Mannheim Gmbh Pharmaceutical preparation containing plasminogen activator (t-PA) or its derivatives
US6372716B1 (en) 1994-04-26 2002-04-16 Genetics Institute, Inc. Formulations for factor IX
US6685940B2 (en) 1995-07-27 2004-02-03 Genentech, Inc. Protein formulation
US5770700A (en) 1996-01-25 1998-06-23 Genetics Institute, Inc. Liquid factor IX formulations
IN184589B (en) 1996-10-16 2000-09-09 Alza Corp
JP2001151694A (en) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd Method for producing protein powder
WO2001021187A1 (en) * 1999-09-17 2001-03-29 Takeda Chemical Industries, Ltd. Process for producing protein powder
ATE336514T1 (en) 2000-02-11 2006-09-15 Merck Patent Gmbh INCREASE THE CIRCULATION HALF-LIFE OF ANTIBODIES-BASED FUSION PROTEINS
WO2002040544A2 (en) 2000-11-14 2002-05-23 Board Of Regents, University Of Texas Systems Mutant human factor ix with an increased resistance to inhibition by heparin
WO2003020764A2 (en) 2001-09-04 2003-03-13 Merck Patent Gmbh Modified factor ix
EP2990417A1 (en) 2001-12-21 2016-03-02 Human Genome Sciences, Inc. Albumin insulin fusion protein
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
TWI353991B (en) * 2003-05-06 2011-12-11 Syntonix Pharmaceuticals Inc Immunoglobulin chimeric monomer-dimer hybrids
EP3552627A1 (en) 2003-05-06 2019-10-16 Bioverativ Therapeutics Inc. Clotting factor-fc chimeric proteins to treat hemophilia
JP2005060378A (en) 2003-07-28 2005-03-10 Yamanouchi Pharmaceut Co Ltd Freeze-dried preparation containing physiologically active protein
US20050152979A1 (en) 2003-09-05 2005-07-14 Cell Therapeutics, Inc. Hydrophobic drug compositions containing reconstitution enhancer
JP2007526329A (en) 2004-03-04 2007-09-13 ワイス Freeze-drying method to improve excipient crystallization
WO2006029467A1 (en) * 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
WO2006053299A2 (en) 2004-11-12 2006-05-18 Bayer Healthcare Llc Site-directed modification of fviii
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
AU2006272804B2 (en) * 2005-07-22 2011-02-24 Amgen Inc. Concentrated protein lyophilates, methods, and uses
WO2007044616A2 (en) * 2005-10-06 2007-04-19 Xencor, Inc. Optimized anti-cd30 antibodies
BRPI0618133A2 (en) * 2005-11-01 2011-08-16 Wyeth Corp sodium chloride solution for drug reconstitution or dilution
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
PL2631242T3 (en) 2006-04-04 2023-03-20 Takeda Pharmaceutical Company Limited A process for concentration of a polypeptide
EP2423305A1 (en) 2006-06-19 2012-02-29 Catalyst Biosciences, Inc. Modified coagulation factor IX polypeptides and use thereof for treatment
US8015841B2 (en) 2006-09-08 2011-09-13 Praxair Technology, Inc. Cryogenic refrigeration system for lyophilization
US7700734B2 (en) 2007-01-09 2010-04-20 Shu-Wha Lin Recombinant human factor IX and use thereof
PL2369005T3 (en) 2007-06-21 2013-10-31 Univ Muenchen Tech Biological active proteins having increased in vivo and/or in vitro stability
WO2009051717A2 (en) 2007-10-15 2009-04-23 The University Of North Carolina At Chapel Hill Human factor ix variants with an extended half life
CN101952422A (en) 2007-12-27 2011-01-19 巴克斯特国际公司 The factors IX of chemically modified
AU2009244633A1 (en) 2008-04-16 2009-11-12 Bayer Healthcare Llc Modified Factor IX polypeptides and uses thereof
WO2009140015A2 (en) 2008-04-16 2009-11-19 Bayer Healthcare Llc Site-directed modification of factor ix
CN102105582A (en) 2008-04-21 2011-06-22 诺沃-诺迪斯克有限公司 Hyperglycosylated human coagulation factor IX
ES2755029T3 (en) 2008-08-05 2020-04-21 Wyeth Llc Freeze-drying above collapse temperature
US20110236412A1 (en) 2008-09-24 2011-09-29 Stabilitech Ltd. Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine
CN102695499A (en) 2009-06-18 2012-09-26 惠氏有限责任公司 Lyophilized formulations for small modular immunopharmaceuticals
WO2011017070A1 (en) * 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
KR20180118808A (en) 2010-07-09 2018-10-31 바이오버라티브 테라퓨틱스 인크. Factor ix polypeptides and methods of use thereof
SI2623497T1 (en) 2010-09-30 2016-04-29 Toyama Chemical Co., Ltd. Meglumine salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide
SG192671A1 (en) 2011-02-09 2013-09-30 Glaxosmithkline Llc Lyophilized formulations
WO2013185113A1 (en) 2012-06-08 2013-12-12 Biogen Idec Ma Inc. Procoagulant compounds
TWI750197B (en) * 2012-09-25 2021-12-21 美商百歐維拉提夫治療公司 Methods of using fix polypeptides
EP2968498A4 (en) * 2013-03-15 2016-09-07 Biogen Ma Inc Factor ix polypeptide formulations
EA038573B1 (en) * 2014-03-24 2021-09-16 Биовератив Терапьютикс Инк. Lyophilized factor ix formulation for preventing bleeding episodes

Also Published As

Publication number Publication date
EA038573B1 (en) 2021-09-16
AU2020202863A1 (en) 2020-05-21
BR112016021777A2 (en) 2017-10-03
JP2024053015A (en) 2024-04-12
IL272257B (en) 2021-03-25
AU2015236340B2 (en) 2020-02-06
SG11201607642RA (en) 2016-10-28
AR099838A1 (en) 2016-08-24
JP2022044689A (en) 2022-03-17
NZ724351A (en) 2023-10-27
EA202092926A3 (en) 2021-10-29
AU2020202863B2 (en) 2022-09-01
JP7058940B2 (en) 2022-04-25
IL247869B (en) 2020-02-27
MA39779A (en) 2017-02-01
IL281197A (en) 2021-04-29
US10772942B2 (en) 2020-09-15
JP7503583B2 (en) 2024-06-20
IL281197B (en) 2022-06-01
KR20160137577A (en) 2016-11-30
TWI700101B (en) 2020-08-01
EP3123090A1 (en) 2017-02-01
SG10201913735SA (en) 2020-03-30
TW201605492A (en) 2016-02-16
JP2020063313A (en) 2020-04-23
US20170173122A1 (en) 2017-06-22
EA202092926A2 (en) 2021-07-30
AU2015236340A1 (en) 2016-09-29
US20210069307A1 (en) 2021-03-11
PH12016501877A1 (en) 2016-12-19
IL272257A (en) 2020-02-27
WO2015148444A1 (en) 2015-10-01
CA2943034C (en) 2022-06-14
CL2016002386A1 (en) 2017-06-23
JP2017510585A (en) 2017-04-13
EA201691807A1 (en) 2017-03-31
MX2021012939A (en) 2021-11-25
IL247869A0 (en) 2016-11-30
EP3123090A4 (en) 2017-12-13
AU2022215218A1 (en) 2022-09-01
KR102385372B1 (en) 2022-04-11
CA2943034A1 (en) 2015-10-01
MX2016012447A (en) 2017-01-06

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