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Withdrawn - After Issue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Withdrawn - After Issue legal-status Critical Current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

Links

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
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor 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)
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/19Particulate 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
    • 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
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y304/00Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21Serine endopeptidases (3.4.21)
    • C12Y304/21022Coagulation factor IXa (3.4.21.22)
    • FMECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F26DRYING
    • F26BDRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
    • F26B5/00Drying solid materials or objects by processes not involving the application of heat
    • F26B5/04Drying 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
    • F26B5/06Drying 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)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mechanical Engineering (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (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) EA038573B1 (enExample)
IL (3) IL247869B (enExample)
MA (1) MA39779A (enExample)
MX (2) MX387269B (enExample)
PH (1) PH12016501877A1 (enExample)
SG (3) SG11201607642RA (enExample)
TW (1) TWI700101B (enExample)
WO (1) WO2015148444A1 (enExample)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI788044B (zh) 2013-03-15 2022-12-21 美商百歐維拉提夫治療公司 因子ix多肽調配物
US10772942B2 (en) 2014-03-24 2020-09-15 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations
IL319473A (en) * 2016-12-02 2025-05-01 Bioverativ Therapeutics Inc Methods for treating hemophilic arthritis using chimeric blood clotting factors
BR112020000592A2 (pt) * 2017-07-11 2020-07-14 Universal Stabilization Technologies, Inc. método para conservar materiais biológicos
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
BR112022022869A2 (pt) * 2020-05-11 2023-01-31 Alkermes Pharma Ireland Ltd Composições de polipeptídeo de fusão de il-2 e métodos de fabricação e uso destas
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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010038859A1 (en) * 1996-10-16 2001-11-08 Maskiewicz Victoria Knepp Stable protein and nucleic acid formulations using non-aqueous, anhydrous, aprotic, hydrophobic, non-polar vehicles with low reactivity

Family Cites Families (57)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0154316B1 (en) 1984-03-06 1989-09-13 Takeda Chemical Industries, Ltd. Chemically modified lymphokine and production thereof
JP2989002B2 (ja) 1988-12-22 1999-12-13 キリン―アムジエン・インコーポレーテツド 化学修飾顆粒球コロニー刺激因子
AU648020B2 (en) 1989-02-21 1994-04-14 Washington University Modified forms of reproductive hormones
US6552170B1 (en) 1990-04-06 2003-04-22 Amgen Inc. PEGylation reagents and compounds formed therewith
ATE240740T1 (de) 1991-03-15 2003-06-15 Amgen Inc Pegylation von polypeptiden
FR2686899B1 (fr) 1992-01-31 1995-09-01 Rhone Poulenc Rorer Sa Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant.
MX9306133A (es) * 1992-10-02 1994-04-29 Kabi Pharmacia Ab Composicion que comprende una formulacion del factor de coagulacion viii, proceso para su preparacion y uso de un surfactante como estabilizador.
DE4405426A1 (de) 1994-02-21 1995-08-24 Boehringer Mannheim Gmbh Pharmazeutisches Präparat enthaltend Plasminogenaktivator (t-PA) oder dessen Derivate
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
US20010031721A1 (en) 1999-05-05 2001-10-18 Chandra Webb Highly concentrated, lyophilized, and liquid factor IX formulations
AU7313400A (en) * 1999-09-17 2001-04-24 Takeda Chemical Industries Ltd. Process for producing protein powder
JP2001151694A (ja) 1999-09-17 2001-06-05 Takeda Chem Ind Ltd タンパク質粉体の製造法
MXPA02007733A (es) 2000-02-11 2004-09-10 Merck Patent Gmbh Mejoramiento de la vida media circulante de proteinas de fusion basadas en anticuerpos.
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
PL369065A1 (en) 2001-09-04 2005-04-18 Merck Patent Gmbh Modified factor ix
EP2277888A3 (en) 2001-12-21 2011-04-27 Human Genome Sciences, Inc. Fusion proteins of albumin and erythropoietin
EP3002012A1 (en) 2003-05-06 2016-04-06 Biogen Hemophilia Inc. Clotting factor-fc chimeric proteins to treat hemophilia
TWI353991B (en) * 2003-05-06 2011-12-11 Syntonix Pharmaceuticals Inc Immunoglobulin chimeric monomer-dimer hybrids
US7348004B2 (en) 2003-05-06 2008-03-25 Syntonix Pharmaceuticals, Inc. Immunoglobulin chimeric monomer-dimer hybrids
JP2005060378A (ja) 2003-07-28 2005-03-10 Yamanouchi Pharmaceut Co Ltd 生理活性蛋白質含有凍結乾燥製剤
US20050152979A1 (en) 2003-09-05 2005-07-14 Cell Therapeutics, Inc. Hydrophobic drug compositions containing reconstitution enhancer
ATE507822T1 (de) 2003-12-19 2011-05-15 Novo Nordisk Healthcare Ag Stabilisierte zusammensetzungen von faktor-vii- polypeptiden
BRPI0509117A (pt) 2004-03-04 2007-08-28 Wyeth Corp método de liofilização para melhorar a cristalização de excipientes
WO2006029467A1 (en) * 2004-09-16 2006-03-23 Btf Pty Ltd Rapid freeze drying process
PT2371856T (pt) 2004-11-12 2022-08-12 Bayer Healthcare Llc Modificação de fviii direcionada a sítio
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
NZ555503A (en) 2004-12-15 2010-01-29 Biovitrum Ab Publ Therapeutic formulations of keratinocyte growth factor
AU2006272804B2 (en) * 2005-07-22 2011-02-24 Amgen Inc. Concentrated protein lyophilates, methods, and uses
EP1951757B1 (en) * 2005-10-06 2014-05-14 Xencor, Inc. Optimized anti-cd30 antibodies
PT3225233T (pt) * 2005-11-01 2019-10-24 Wyeth Llc Solução de cloreto de sódio para reconstituição de fármacos.
US8048848B2 (en) 2006-02-03 2011-11-01 Prolor Biotech Ltd. Long-acting interferons and derivatives thereof and methods thereof
PL2650305T3 (pl) 2006-03-24 2024-09-16 Bioverativ Therapeutics Inc. PC5 jako enzym przetwarzający propeptyd czynnika IX
US20090246187A1 (en) 2006-04-04 2009-10-01 Shire Pharmaceuticals Ireland Limited Process for concentration of a polypeptide
TW200804416A (en) 2006-06-19 2008-01-16 Nautilus Technology Llc 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
CN101970678B (zh) 2007-06-21 2014-08-20 慕尼黑科技大学 具有增加的体内和/或体外稳定性的生物学活性蛋白
AU2008311973B2 (en) 2007-10-15 2013-10-03 Cangene Corporation Human Factor IX variants with an extended half life
BRPI0821591A2 (pt) 2007-12-21 2016-05-03 Inspiration Biopharmaceuticals Inc composição liofilizada e métodos de preparação de composição seca estável do fator ix e de liofilização de formulação farmacêutica
NZ603997A (en) 2007-12-27 2013-02-22 Baxter Int Chemically Modified Factor IX
JP2011517950A (ja) 2008-04-16 2011-06-23 バイエル・ヘルスケア・エルエルシー 第ix因子の部位特異的修飾
EP2288622A4 (en) 2008-04-16 2012-04-18 Bayer Healthcare Llc FACTOR IX MODIFIED POLYPEPTIDES AND USES THEREOF
EP2444491B1 (en) 2008-04-21 2016-11-16 Novo Nordisk Healthcare Ag Hyperglycosylated human coagulation factor IX
CA2722169A1 (en) 2008-04-24 2009-10-29 Celtic Pharma Peg Ltd. Factor ix conjugates with extended half-lives
CA2729972C (en) 2008-08-05 2018-11-20 Wyeth Llc Lyophilization above collapse
CA2737407A1 (en) 2008-09-24 2010-04-01 Stabilitech Ltd. Method for preserving polypeptides using a sugar and polyethyleneimine
MX2011013722A (es) 2009-06-18 2012-05-08 Wyeth Llc Formulaciones liofilizadas para inmunofarmaceuticos modulares pequeños.
EP2458990B1 (en) 2009-07-28 2016-03-30 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
CN103140237A (zh) * 2010-07-09 2013-06-05 比奥根艾迪克依蒙菲利亚公司 因子ix多肽及其使用方法
TWI507397B (zh) 2010-09-30 2015-11-11 Toyama Chemical Co Ltd 6-氟-3-羥-2-吡羧醯胺之美洛明鹽
EA029972B1 (ru) 2011-02-09 2018-06-29 ГЛЭКСОСМИТКЛАЙН ЭлЭлСи Способы получения полипептидных композиций
AU2013270682A1 (en) 2012-06-08 2014-12-11 Biogen Ma Inc. Procoagulant compounds
EP3542861A1 (en) * 2012-09-25 2019-09-25 Bioverativ Therapeutics Inc. Methods of using fix polypeptides
TWI788044B (zh) 2013-03-15 2022-12-21 美商百歐維拉提夫治療公司 因子ix多肽調配物
US10772942B2 (en) 2014-03-24 2020-09-15 Bioverativ Therapeutics Inc. Lyophilized factor IX formulations

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010038859A1 (en) * 1996-10-16 2001-11-08 Maskiewicz Victoria Knepp Stable protein and nucleic acid formulations using non-aqueous, anhydrous, aprotic, hydrophobic, non-polar vehicles with low reactivity

Also Published As

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

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Owner name: BIOVERATIV THERAPEUTICS INC.

Free format text: FORMER APPLICANT(S): BIOGEN MA INC.

MK12 Application lapsed section 141(1)/reg 8.3(2) - applicant filed a written notice of withdrawal