AU2014237111B2 - Recombinant factor VIII formulations - Google Patents

Recombinant factor VIII formulations Download PDF

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Publication number
AU2014237111B2
AU2014237111B2 AU2014237111A AU2014237111A AU2014237111B2 AU 2014237111 B2 AU2014237111 B2 AU 2014237111B2 AU 2014237111 A AU2014237111 A AU 2014237111A AU 2014237111 A AU2014237111 A AU 2014237111A AU 2014237111 B2 AU2014237111 B2 AU 2014237111B2
Authority
AU
Australia
Prior art keywords
leu
ser
lys
thr
glu
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.)
Ceased
Application number
AU2014237111A
Other languages
English (en)
Other versions
AU2014237111A1 (en
Inventor
Xinghang Ma
Nelly Tsvetkova
De Qian Wang
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.)
Bayer Healthcare LLC
Original Assignee
Bayer Healthcare LLC
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 Bayer Healthcare LLC filed Critical Bayer Healthcare LLC
Publication of AU2014237111A1 publication Critical patent/AU2014237111A1/en
Application granted granted Critical
Publication of AU2014237111B2 publication Critical patent/AU2014237111B2/en
Ceased 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
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • 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
    • A61K47/22—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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • 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
    • 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
    • C07K14/745—Blood coagulation or fibrinolysis factors
    • C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Toxicology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2014237111A 2013-03-15 2014-03-11 Recombinant factor VIII formulations Ceased AU2014237111B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361799495P 2013-03-15 2013-03-15
US61/799,495 2013-03-15
US201361869191P 2013-08-23 2013-08-23
US61/869,191 2013-08-23
PCT/US2014/023357 WO2014150477A1 (en) 2013-03-15 2014-03-11 Recombinant factor viii formulations

Publications (2)

Publication Number Publication Date
AU2014237111A1 AU2014237111A1 (en) 2015-10-08
AU2014237111B2 true AU2014237111B2 (en) 2018-06-21

Family

ID=51580768

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2014237111A Ceased AU2014237111B2 (en) 2013-03-15 2014-03-11 Recombinant factor VIII formulations

Country Status (17)

Country Link
US (1) US20160030524A1 (cg-RX-API-DMAC10.html)
EP (1) EP2970430A4 (cg-RX-API-DMAC10.html)
JP (1) JP2016518321A (cg-RX-API-DMAC10.html)
KR (1) KR20150132449A (cg-RX-API-DMAC10.html)
CN (1) CN105209487A (cg-RX-API-DMAC10.html)
AU (1) AU2014237111B2 (cg-RX-API-DMAC10.html)
BR (1) BR112015022730A2 (cg-RX-API-DMAC10.html)
CA (1) CA2905739A1 (cg-RX-API-DMAC10.html)
HK (1) HK1213273A1 (cg-RX-API-DMAC10.html)
MX (1) MX2015012905A (cg-RX-API-DMAC10.html)
PE (1) PE20160121A1 (cg-RX-API-DMAC10.html)
RU (1) RU2015144076A (cg-RX-API-DMAC10.html)
SG (2) SG10201803999UA (cg-RX-API-DMAC10.html)
TW (1) TW201521761A (cg-RX-API-DMAC10.html)
UY (1) UY35412A (cg-RX-API-DMAC10.html)
WO (1) WO2014150477A1 (cg-RX-API-DMAC10.html)
ZA (1) ZA201507684B (cg-RX-API-DMAC10.html)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016115561A1 (en) * 2015-01-18 2016-07-21 Biogen Ma Inc. Formulations and screening of biological therapeutic agents
CN108884145B (zh) 2015-11-13 2023-08-22 武田药品工业株式会社 用于血友病a的基因治疗的具有增加的表达的编码重组fviii变体的病毒载体
US12091675B2 (en) 2018-07-16 2024-09-17 Takeda Pharmaceutical Company Limited Gene therapy of hemophilia a using viral vectors encoding recombinant FVIII variants with increased expression
TWI851647B (zh) 2019-01-16 2024-08-11 日商武田藥品工業股份有限公司 用於a型血友病基因治療之編碼表現增加之重組fviii變異體的病毒載體
WO2021032646A1 (en) * 2019-08-16 2021-02-25 Octapharma Ag Stabilizing buffer for factor viii and vwf

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0818204A2 (en) * 1996-07-12 1998-01-14 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar contant
WO2000046835A1 (fr) * 1999-02-01 2000-08-10 Nippon Electric Glass Co., Ltd. Tube cathodique et son procede de fabrication
WO2000048635A1 (en) * 1999-02-22 2000-08-24 Baxter International Inc. Novel albumin-free factor viii formulations
WO2010054238A1 (en) * 2008-11-07 2010-05-14 Baxter International Inc. Factor viii formulations

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1421539B1 (en) * 2001-06-14 2009-10-28 The Scripps Research Institute Stabilized factor viii with engineered disulfide bonds
GB0207092D0 (en) * 2002-03-26 2002-05-08 Sod Conseils Rech Applic Stable pharmaceutical composition containing factor VIII
DK2371856T3 (en) * 2004-11-12 2022-08-08 Bayer Healthcare Llc Site-directed modifikation af FVIII
WO2007126808A1 (en) * 2006-03-31 2007-11-08 Baxter International Inc Pegylated factor viii
CA2748662A1 (en) * 2009-01-19 2010-07-22 Bayer Healthcare Llc Protein conjugate having an endopeptidase-cleavable bioprotective moiety

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0818204A2 (en) * 1996-07-12 1998-01-14 Bayer Corporation Stabilized albumin-free recombinant factor VIII preparation having a low sugar contant
WO2000046835A1 (fr) * 1999-02-01 2000-08-10 Nippon Electric Glass Co., Ltd. Tube cathodique et son procede de fabrication
WO2000048635A1 (en) * 1999-02-22 2000-08-24 Baxter International Inc. Novel albumin-free factor viii formulations
WO2010054238A1 (en) * 2008-11-07 2010-05-14 Baxter International Inc. Factor viii formulations

Also Published As

Publication number Publication date
EP2970430A1 (en) 2016-01-20
ZA201507684B (en) 2017-06-28
SG11201507618YA (en) 2015-10-29
CA2905739A1 (en) 2014-09-25
BR112015022730A2 (pt) 2017-10-31
SG10201803999UA (en) 2018-06-28
CN105209487A (zh) 2015-12-30
PE20160121A1 (es) 2016-03-03
HK1213273A1 (zh) 2016-06-30
WO2014150477A1 (en) 2014-09-25
KR20150132449A (ko) 2015-11-25
US20160030524A1 (en) 2016-02-04
RU2015144076A (ru) 2017-04-24
AU2014237111A1 (en) 2015-10-08
MX2015012905A (es) 2016-06-16
UY35412A (es) 2014-10-31
EP2970430A4 (en) 2017-01-11
TW201521761A (zh) 2015-06-16
JP2016518321A (ja) 2016-06-23

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired