DK2968477T3 - Faktor viii-polypeptidformuleringer - Google Patents
Faktor viii-polypeptidformuleringer Download PDFInfo
- Publication number
- DK2968477T3 DK2968477T3 DK14725816.4T DK14725816T DK2968477T3 DK 2968477 T3 DK2968477 T3 DK 2968477T3 DK 14725816 T DK14725816 T DK 14725816T DK 2968477 T3 DK2968477 T3 DK 2968477T3
- Authority
- DK
- Denmark
- Prior art keywords
- polypeptid
- formulations
- factor viii
- viii
- factor
- Prior art date
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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
-
- 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)
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2833—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against MHC-molecules, e.g. HLA-molecules
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Zoology (AREA)
- Gastroenterology & Hepatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Toxicology (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Peptides Or Proteins (AREA)
- Medicinal Preparation (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Applications Claiming Priority (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361800293P | 2013-03-15 | 2013-03-15 | |
US201361817085P | 2013-04-29 | 2013-04-29 | |
US201361829884P | 2013-05-31 | 2013-05-31 | |
US201361839477P | 2013-06-26 | 2013-06-26 | |
US201361863860P | 2013-08-08 | 2013-08-08 | |
US201361876927P | 2013-09-12 | 2013-09-12 | |
US201361879955P | 2013-09-19 | 2013-09-19 | |
US201361897742P | 2013-10-30 | 2013-10-30 | |
PCT/US2014/029354 WO2014144795A1 (en) | 2013-03-15 | 2014-03-14 | Factor viii polypeptide formulations |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2968477T3 true DK2968477T3 (da) | 2020-03-09 |
Family
ID=50771579
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK14725816.4T DK2968477T3 (da) | 2013-03-15 | 2014-03-14 | Faktor viii-polypeptidformuleringer |
Country Status (21)
Country | Link |
---|---|
US (3) | US9623088B2 (da) |
EP (3) | EP4122487A1 (da) |
JP (5) | JP6330026B2 (da) |
AU (3) | AU2014228506A1 (da) |
CA (1) | CA2899737A1 (da) |
CL (1) | CL2015002720A1 (da) |
DK (1) | DK2968477T3 (da) |
EA (2) | EA201890671A1 (da) |
ES (2) | ES2776195T3 (da) |
HK (1) | HK1220617A1 (da) |
HU (1) | HUE047933T2 (da) |
LT (1) | LT2968477T (da) |
PH (2) | PH12015501801B1 (da) |
PL (2) | PL2968477T3 (da) |
PT (2) | PT3666283T (da) |
RS (1) | RS60003B1 (da) |
SG (2) | SG10201805207QA (da) |
SI (1) | SI2968477T1 (da) |
TW (2) | TWI629993B (da) |
UY (1) | UY35462A (da) |
WO (1) | WO2014144795A1 (da) |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2880038T3 (es) * | 2009-12-06 | 2021-11-23 | Bioverativ Therapeutics Inc | Polipéptidos quiméricos e híbridos de factor VIII-Fc, y métodos de uso de los mismos |
AU2014228938B2 (en) | 2013-03-15 | 2019-05-02 | Bioverativ Therapeutics Inc. | Factor IX polypeptide formulations |
LT2968477T (lt) * | 2013-03-15 | 2020-03-10 | Bioverativ Therapeutics Inc. | Faktoriaus viii polipeptido kompozicijos |
CN106279437B (zh) * | 2016-08-19 | 2017-10-31 | 安源医药科技(上海)有限公司 | 高糖基化人凝血因子viii融合蛋白及其制备方法与用途 |
CN107759694B (zh) | 2016-08-19 | 2023-01-13 | 安源医药科技(上海)有限公司 | 双特异性抗体及其制备方法与用途 |
BR112019011115A2 (pt) | 2016-12-02 | 2019-10-01 | Bioverativ Therapeutics Inc | métodos para tratar artropatia hemofílica usando fatores de coagulação quiméricos |
BR112019011198A2 (pt) | 2016-12-02 | 2019-12-17 | Bioverativ Therapeutics Inc | métodos de indução de tolerância imune a fatores de coagulação |
JP7039308B2 (ja) * | 2017-02-08 | 2022-03-22 | 三洋化成工業株式会社 | 細胞培養用担体 |
TW201920255A (zh) | 2017-08-09 | 2019-06-01 | 美商生物化學醫療公司 | 核酸分子及其用途 |
AU2018366110A1 (en) | 2017-11-07 | 2020-06-04 | Rani Therapeutics, Llc | Clotting factor preparations for delivery into tissue of the intestinal tract using a swallowable drug delivery device |
JP2021523878A (ja) | 2018-05-18 | 2021-09-09 | バイオベラティブ セラピューティクス インコーポレイテッド | 血友病aを処置する方法 |
BR112021002017A2 (pt) | 2018-08-09 | 2021-05-11 | Bioverativ Therapeutics Inc. | moléculas de ácido nucleico e usos das mesmas para terapia genética não viral |
AU2019366942A1 (en) * | 2018-10-23 | 2021-06-10 | The Children's Hospital Of Philadelphia | Compositions and methods for modulating factor VIII function |
EP3932486A4 (en) * | 2019-02-28 | 2022-11-30 | Public University Corporation Yokohama City University | COMPLEMENT FOR THE TREATMENT OF BLOOD COAGULATION AND/OR COMPLEMENT DISORDERS |
KR20220009389A (ko) | 2019-04-17 | 2022-01-24 | 코디악 바이오사이언시즈, 인크. | 엑소좀 및 aav 의 조성물 |
TW202115127A (zh) | 2019-06-19 | 2021-04-16 | 美商百歐維拉提夫治療公司 | 治療血友病及低骨質密度之方法及組成物 |
KR20230159284A (ko) * | 2022-05-10 | 2023-11-21 | 주식회사 녹십자 | 혈장 단백질에 대한 신규한 액상 제형물 |
KR20230159285A (ko) * | 2022-05-10 | 2023-11-21 | 주식회사 녹십자 | 혈장 단백질의 동결 건조를 위한 신규한 액상 제형물 |
Family Cites Families (60)
Publication number | Priority date | Publication date | Assignee | Title |
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US4757006A (en) | 1983-10-28 | 1988-07-12 | Genetics Institute, Inc. | Human factor VIII:C gene and recombinant methods for production |
EP0154316B1 (en) | 1984-03-06 | 1989-09-13 | Takeda Chemical Industries, Ltd. | Chemically modified lymphokine and production thereof |
US4965199A (en) | 1984-04-20 | 1990-10-23 | Genentech, Inc. | Preparation of functional human factor VIII in mammalian cells using methotrexate based selection |
US4868112A (en) | 1985-04-12 | 1989-09-19 | Genetics Institute, Inc. | Novel procoagulant proteins |
KR910006424B1 (ko) | 1985-08-21 | 1991-08-24 | 인코텍스 비.브이 | 편성브리프(brief) 제조방법 |
WO1987004187A1 (en) | 1986-01-03 | 1987-07-16 | Genetics Institute, Inc. | METHOD FOR PRODUCING FACTOR VIII:c-TYPE PROTEINS |
US5595886A (en) | 1986-01-27 | 1997-01-21 | Chiron Corporation | Protein complexes having Factor VIII:C activity and production thereof |
US5610278A (en) | 1986-06-24 | 1997-03-11 | Novo Nordisk A/S | Process for producing a coagulation active complex of factor VIII fragments |
US4912040A (en) | 1986-11-14 | 1990-03-27 | Genetics Institute, Inc. | Eucaryotic expression system |
CA1331157C (en) | 1987-04-06 | 1994-08-02 | Randal J. Kaufman | Method for producing factor viii:c-type proteins |
US6060447A (en) | 1987-05-19 | 2000-05-09 | Chiron Corporation | Protein complexes having Factor VIII:C activity and production thereof |
US5171844A (en) | 1987-06-12 | 1992-12-15 | Gist-Brocades N.W. | Proteins with factor viii activity: process for their preparation using genetically-engineered cells and pharmaceutical compositions containing them |
US6346513B1 (en) | 1987-06-12 | 2002-02-12 | Baxter Trading Gmbh | Proteins with factor VIII activity: process for their preparation using genetically-engineered cells and pharmaceutical compositions containing them |
DE3720246A1 (de) | 1987-06-19 | 1988-12-29 | Behringwerke Ag | Faktor viii:c-aehnliches molekuel mit koagulationsaktivitaet |
FR2619314B1 (fr) | 1987-08-11 | 1990-06-15 | Transgene Sa | Analogue du facteur viii, procede de preparation et composition pharmaceutique le contenant |
US4994371A (en) | 1987-08-28 | 1991-02-19 | Davie Earl W | DNA preparation of Christmas factor and use of DNA sequences |
US5004803A (en) | 1988-11-14 | 1991-04-02 | Genetics Institute, Inc. | Production of procoagulant proteins |
CA2006596C (en) | 1988-12-22 | 2000-09-05 | Rika Ishikawa | Chemically-modified g-csf |
EP0461200B1 (en) | 1989-02-21 | 1997-01-22 | Washington University | Modified forms of reproductive hormones |
SE465222C5 (sv) | 1989-12-15 | 1998-02-10 | Pharmacia & Upjohn Ab | Ett rekombinant, humant faktor VIII-derivat och förfarande för dess framställning |
US6552170B1 (en) | 1990-04-06 | 2003-04-22 | Amgen Inc. | PEGylation reagents and compounds formed therewith |
JP3693671B2 (ja) | 1991-03-15 | 2005-09-07 | アムゲン インコーポレーテッド | ポリペプチドのpeg化 |
FR2686899B1 (fr) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | Nouveaux polypeptides biologiquement actifs, leur preparation et compositions pharmaceutiques les contenant. |
US6376463B1 (en) | 1992-04-07 | 2002-04-23 | Emory University | Modified factor VIII |
US5859204A (en) | 1992-04-07 | 1999-01-12 | Emory University | Modified factor VIII |
US5364771A (en) | 1992-04-07 | 1994-11-15 | Emory University | Hybrid human/porcine factor VIII |
DK0627924T3 (da) | 1992-10-02 | 2001-04-30 | Genetics Inst | Sammensætning, der omfatter koagulationsfaktor VIII formulering, fremgangsmåde til dens fremstilling og anvendelse af et overfladeaktivt middel som stabilisator |
US5563045A (en) | 1992-11-13 | 1996-10-08 | Genetics Institute, Inc. | Chimeric procoagulant proteins |
SE504074C2 (sv) | 1993-07-05 | 1996-11-04 | Pharmacia Ab | Proteinberedning för subkutan, intramuskulär eller intradermal administrering |
IL113010A (en) * | 1994-03-31 | 1999-10-28 | Pharmacia & Upjohn Ab | Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration |
SE9503380D0 (sv) | 1995-09-29 | 1995-09-29 | Pharmacia Ab | Protein derivatives |
US6458563B1 (en) | 1996-06-26 | 2002-10-01 | Emory University | Modified factor VIII |
US5763401A (en) | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
CA2225189C (en) | 1997-03-06 | 2010-05-25 | Queen's University At Kingston | Canine factor viii gene, protein and methods of use |
US6200560B1 (en) | 1998-10-20 | 2001-03-13 | Avigen, Inc. | Adeno-associated virus vectors for expression of factor VIII by target cells |
BR0008405B1 (pt) * | 1999-02-22 | 2014-04-22 | Baxter Int | Composição de fator viii formulada sem a adição de albumina, uso de uma composição de fator viii, e, método de liofilizar uma formulação farmacêutica aquosa |
ES2269366T3 (es) | 2000-02-11 | 2007-04-01 | Merck Patent Gmbh | Mejoramiento de la vida media en circulacion de proteinas de fusion basadas en anticuerpos. |
EP1463751B1 (en) | 2001-12-21 | 2013-05-22 | Human Genome Sciences, Inc. | Albumin fusion proteins |
GB0207092D0 (en) | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
US7041635B2 (en) | 2003-01-28 | 2006-05-09 | In2Gen Co., Ltd. | Factor VIII polypeptide |
US7348004B2 (en) | 2003-05-06 | 2008-03-25 | Syntonix Pharmaceuticals, Inc. | Immunoglobulin chimeric monomer-dimer hybrids |
EP2298347B1 (en) | 2003-05-06 | 2015-09-30 | Biogen Hemophilia Inc. | Clotting factor chimeric proteins for treatment of a hemostatic disorder |
TWI353991B (en) | 2003-05-06 | 2011-12-11 | Syntonix Pharmaceuticals Inc | Immunoglobulin chimeric monomer-dimer hybrids |
US7211559B2 (en) | 2003-10-31 | 2007-05-01 | University Of Maryland, Baltimore | Factor VIII compositions and methods |
RU2373953C2 (ru) * | 2003-12-19 | 2009-11-27 | Ново Нордиск Хелс Кеа Аг | Стабилизированная композиция, содержащая полипептид фактора vii |
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 |
KR20080098504A (ko) | 2006-02-03 | 2008-11-10 | 메디뮨 엘엘씨 | 단백질 제제 |
US8048848B2 (en) | 2006-02-03 | 2011-11-01 | Prolor Biotech Ltd. | Long-acting interferons and derivatives thereof and methods thereof |
WO2008077616A1 (en) | 2006-12-22 | 2008-07-03 | Csl Behring Gmbh | Modified coagulation factors with prolonged in vivo half-life |
SI2173890T1 (sl) | 2007-06-21 | 2011-06-30 | Univ Muenchen Tech | Biološko aktivni proteini, ki imajo povečano in vivo in/ali in vitro stabilnost |
US8239182B2 (en) | 2007-12-04 | 2012-08-07 | Spansion Llc | Data transmission system-on-chip memory model based validation |
JP5647899B2 (ja) | 2008-01-08 | 2015-01-07 | ラツィオファルム ゲーエムベーハーratiopharm GmbH | オリゴサッカリルトランスフェラーゼを使用するポリペプチドの複合糖質化 |
EP2417155B1 (en) * | 2009-04-06 | 2013-06-19 | Novo Nordisk A/S | Targeted delivery of factor viii proteins to platelets |
ES2880038T3 (es) | 2009-12-06 | 2021-11-23 | Bioverativ Therapeutics Inc | Polipéptidos quiméricos e híbridos de factor VIII-Fc, y métodos de uso de los mismos |
RS58578B1 (sr) | 2011-07-08 | 2019-05-31 | Bioverativ Therapeutics Inc | Faktor viii himernih i hibridnih polipeptida i postupci za njihovu upotrebu |
CA2850579A1 (en) * | 2011-10-18 | 2013-04-25 | Carsten Horn | Method for improving the stability of purified factor viii after reconstitution |
US20160000884A1 (en) * | 2012-08-13 | 2016-01-07 | Novo Nordisk A/S | Liquid Factor VIII Formulations |
WO2014070953A1 (en) * | 2012-10-30 | 2014-05-08 | Biogen Idec Ma Inc. | Methods of Using FVIII Polypeptide |
LT2968477T (lt) * | 2013-03-15 | 2020-03-10 | Bioverativ Therapeutics Inc. | Faktoriaus viii polipeptido kompozicijos |
-
2014
- 2014-03-14 LT LTEP14725816.4T patent/LT2968477T/lt unknown
- 2014-03-14 EP EP22176875.7A patent/EP4122487A1/en active Pending
- 2014-03-14 UY UY0001035462A patent/UY35462A/es not_active Application Discontinuation
- 2014-03-14 HU HUE14725816A patent/HUE047933T2/hu unknown
- 2014-03-14 ES ES14725816T patent/ES2776195T3/es active Active
- 2014-03-14 EP EP14725816.4A patent/EP2968477B1/en active Active
- 2014-03-14 EP EP19212900.5A patent/EP3666283B1/en active Active
- 2014-03-14 EA EA201890671A patent/EA201890671A1/ru unknown
- 2014-03-14 PT PT192129005T patent/PT3666283T/pt unknown
- 2014-03-14 ES ES19212900T patent/ES2926798T3/es active Active
- 2014-03-14 PL PL14725816T patent/PL2968477T3/pl unknown
- 2014-03-14 JP JP2016503069A patent/JP6330026B2/ja active Active
- 2014-03-14 SG SG10201805207QA patent/SG10201805207QA/en unknown
- 2014-03-14 PL PL19212900.5T patent/PL3666283T3/pl unknown
- 2014-03-14 PT PT147258164T patent/PT2968477T/pt unknown
- 2014-03-14 DK DK14725816.4T patent/DK2968477T3/da active
- 2014-03-14 WO PCT/US2014/029354 patent/WO2014144795A1/en active Application Filing
- 2014-03-14 AU AU2014228506A patent/AU2014228506A1/en not_active Abandoned
- 2014-03-14 EA EA201591439A patent/EA030357B1/ru unknown
- 2014-03-14 RS RS20200243A patent/RS60003B1/sr unknown
- 2014-03-14 TW TW103109616A patent/TWI629993B/zh active
- 2014-03-14 SI SI201431514T patent/SI2968477T1/sl unknown
- 2014-03-14 US US14/213,180 patent/US9623088B2/en active Active
- 2014-03-14 SG SG11201505924TA patent/SG11201505924TA/en unknown
- 2014-03-14 TW TW107113370A patent/TWI690325B/zh active
- 2014-03-14 CA CA2899737A patent/CA2899737A1/en active Pending
-
2015
- 2015-08-14 PH PH12015501801A patent/PH12015501801B1/en unknown
- 2015-09-15 CL CL2015002720A patent/CL2015002720A1/es unknown
-
2016
- 2016-07-20 HK HK16108672.0A patent/HK1220617A1/zh unknown
-
2017
- 2017-03-09 US US15/455,043 patent/US10786554B2/en active Active
-
2018
- 2018-04-23 JP JP2018082321A patent/JP2018123161A/ja not_active Ceased
-
2019
- 2019-04-16 AU AU2019202656A patent/AU2019202656B2/en active Active
- 2019-10-30 PH PH12019502452A patent/PH12019502452A1/en unknown
-
2020
- 2020-08-14 US US16/993,979 patent/US20210069300A1/en active Pending
- 2020-08-19 JP JP2020138637A patent/JP6934994B2/ja active Active
-
2021
- 2021-08-24 JP JP2021136162A patent/JP7240457B2/ja active Active
- 2021-11-29 AU AU2021277601A patent/AU2021277601A1/en active Pending
-
2023
- 2023-03-03 JP JP2023032892A patent/JP2023060146A/ja active Pending
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