JP2015519313A - 血友病の治療に適する医薬組成物 - Google Patents

血友病の治療に適する医薬組成物 Download PDF

Info

Publication number
JP2015519313A
JP2015519313A JP2015507425A JP2015507425A JP2015519313A JP 2015519313 A JP2015519313 A JP 2015519313A JP 2015507425 A JP2015507425 A JP 2015507425A JP 2015507425 A JP2015507425 A JP 2015507425A JP 2015519313 A JP2015519313 A JP 2015519313A
Authority
JP
Japan
Prior art keywords
fviii
vwf
amino acids
seq
domain
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Withdrawn
Application number
JP2015507425A
Other languages
English (en)
Japanese (ja)
Other versions
JP2015519313A5 (OSRAM
Inventor
ギアト・ボルト
ディデ・マリーイ・カープフ
フレズレク・ローゼ
イェスパ・ホーニング
キアステン・ロープストルフ
ラース・ティム
マイ・ピーダスン
マリアネ・カルケ
オーレ・ヴィルステズ・オールセン
ピーザ・リスビュー・ナービュー
イェンス・ヤコプ・ハンスン
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.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
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 Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of JP2015519313A publication Critical patent/JP2015519313A/ja
Publication of JP2015519313A5 publication Critical patent/JP2015519313A5/ja
Withdrawn legal-status Critical Current

Links

Images

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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • A61K38/37Factors VIII
    • 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
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/56Medicinal 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
    • A61K47/59Medicinal 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
    • A61K47/60Medicinal 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
    • 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
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/56Medicinal 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
    • A61K47/61Medicinal 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 the organic macromolecular compound being a polysaccharide or a derivative thereof
    • 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
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors 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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Hematology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2015507425A 2012-04-24 2013-03-13 血友病の治療に適する医薬組成物 Withdrawn JP2015519313A (ja)

Applications Claiming Priority (9)

Application Number Priority Date Filing Date Title
EP12165296 2012-04-24
EP12165296.0 2012-04-24
US201261641439P 2012-05-02 2012-05-02
US61/641,439 2012-05-02
EP13150575.2 2013-01-09
EP13150575 2013-01-09
US201361752614P 2013-01-15 2013-01-15
US61/752,614 2013-01-15
PCT/EP2013/055107 WO2013160005A1 (en) 2012-04-24 2013-03-13 Pharmaceutical composition suitable for treatment of haemophilia

Publications (2)

Publication Number Publication Date
JP2015519313A true JP2015519313A (ja) 2015-07-09
JP2015519313A5 JP2015519313A5 (OSRAM) 2016-04-14

Family

ID=49482214

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2015507425A Withdrawn JP2015519313A (ja) 2012-04-24 2013-03-13 血友病の治療に適する医薬組成物

Country Status (5)

Country Link
US (2) US20150045303A1 (OSRAM)
EP (1) EP2841091A1 (OSRAM)
JP (1) JP2015519313A (OSRAM)
CN (1) CN104411323A (OSRAM)
WO (1) WO2013160005A1 (OSRAM)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019511467A (ja) * 2016-02-11 2019-04-25 オクタファルマ・アーゲー 血液製剤から第viii因子を分離する方法
JP2020504082A (ja) * 2016-11-11 2020-02-06 ツェー・エス・エル・ベーリング・レングナウ・アクチエンゲゼルシャフト 血液凝固障害の処置又は予防における血管外投与のための切断型フォン・ヴィルブランド因子ポリペプチド

Families Citing this family (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20110046060A1 (en) 2009-08-24 2011-02-24 Amunix Operating, Inc., Coagulation factor IX compositions and methods of making and using same
CN119192402A (zh) 2012-02-15 2024-12-27 比奥贝拉蒂治疗公司 因子viii组合物及其制备和使用方法
WO2013123457A1 (en) 2012-02-15 2013-08-22 Biogen Idec Ma Inc. Recombinant factor viii proteins
WO2015023891A2 (en) 2013-08-14 2015-02-19 Biogen Idec Ma Inc. Factor viii-xten fusions and uses thereof
AR101060A1 (es) * 2014-02-12 2016-11-23 Novo Nordisk As Conjugados de fviii
BR112016026842A2 (pt) 2014-06-06 2017-12-12 Octapharma Ag preparação compreendendo fator viii e peptídeos de fator de von willebrand
WO2016198521A1 (en) 2015-06-10 2016-12-15 Novo Nordisk A/S Fviii fusion proteins
CA2994547A1 (en) 2015-08-03 2017-02-09 Bioverativ Therapeutics Inc. Factor ix fusion proteins and methods of making and using same
US12161696B2 (en) 2016-12-02 2024-12-10 Bioverativ Therapeutics Inc. Methods of treating hemophilic arthropathy using chimeric clotting factors
KR20200018690A (ko) * 2017-06-22 2020-02-19 체에스엘 베링 렝나우 아게 절단된 vwf에 의한 fviii 면역원성의 조절
CN108918235A (zh) * 2018-05-16 2018-11-30 绍兴文理学院 一种肿瘤淋巴结离体标本的固定处理方法
CN108753910A (zh) * 2018-05-16 2018-11-06 浙江思格医疗科技有限公司 一种消化液
TW202015723A (zh) 2018-05-18 2020-05-01 美商百歐維拉提夫治療公司 治療a型血友病的方法
AU2019366942B2 (en) * 2018-10-23 2025-10-30 The Children's Hospital Of Philadelphia Compositions and methods for modulating factor VIII function
AU2020300820A1 (en) * 2019-07-04 2022-03-03 CSL Behring Lengnau AG A truncated von willebrand factor (vWF) for increasing the in vitro stability of coagulation factor VIII
EP4013389A1 (en) 2019-08-16 2022-06-22 Octapharma AG Stabilizing buffer for factor viii and vwf

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009542225A (ja) * 2006-06-30 2009-12-03 ザ・リージエンツ・オブ・ザ・ユニバーシテイ・オブ・ミシガン 組換え法によりfviiiタンパク質を生産する方法
JP2010529155A (ja) * 2007-06-13 2010-08-26 ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー 出血性疾患の治療及び予防的処置における血管外投与のためのvwf安定化fviii製剤及びfviiiなしのvwf製剤の使用
WO2011005968A1 (en) * 2009-07-08 2011-01-13 Ucl Business Plc Codon-optimized factor vi i i variants and synthetic liver-specific promoter
JP2011513327A (ja) * 2008-02-27 2011-04-28 ノボ・ノルデイスク・エー/エス 結合型第viii因子分子
WO2012007324A2 (en) * 2010-07-15 2012-01-19 Novo Nordisk A/S Stabilized factor viii variants

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5952198A (en) * 1995-05-04 1999-09-14 Bayer Corporation Production of recombinant Factor VIII in the presence of liposome-like substances of mixed composition
ES2411007T3 (es) 2001-10-10 2013-07-04 Novo Nordisk A/S Remodelación y glicoconjugación de péptidos
WO2010062768A1 (en) 2008-11-03 2010-06-03 Bayer Healthcare Llc Method for the treatment of hemophilia
EP2977055A1 (en) 2010-02-16 2016-01-27 Novo Nordisk A/S Factor viii fusion protein
CN103209992A (zh) 2010-09-15 2013-07-17 诺沃—诺迪斯克有限公司 具有减少的细胞摄取的因子viii变体

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009542225A (ja) * 2006-06-30 2009-12-03 ザ・リージエンツ・オブ・ザ・ユニバーシテイ・オブ・ミシガン 組換え法によりfviiiタンパク質を生産する方法
JP2010529155A (ja) * 2007-06-13 2010-08-26 ツェー・エス・エル・ベーリング・ゲー・エム・ベー・ハー 出血性疾患の治療及び予防的処置における血管外投与のためのvwf安定化fviii製剤及びfviiiなしのvwf製剤の使用
JP2011513327A (ja) * 2008-02-27 2011-04-28 ノボ・ノルデイスク・エー/エス 結合型第viii因子分子
WO2011005968A1 (en) * 2009-07-08 2011-01-13 Ucl Business Plc Codon-optimized factor vi i i variants and synthetic liver-specific promoter
WO2012007324A2 (en) * 2010-07-15 2012-01-19 Novo Nordisk A/S Stabilized factor viii variants

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BIOTECHNOL LETT., 2003, VOL.25, P.315-319, JPN6016050838, ISSN: 0003473376 *
HAACK A.: "ANALYSIS OF EXPRESSION KINETICS 以下省略", ANNALS OF HEMATOLOGY, vol. V78 N3, JPN5015005836, 1 January 1999 (1999-01-01), DE, pages 111 - 116, ISSN: 0003624397 *
J BIOTECHNOL., 2010, VOL.147, P.198-204, JPN6016050835, ISSN: 0003473375 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019511467A (ja) * 2016-02-11 2019-04-25 オクタファルマ・アーゲー 血液製剤から第viii因子を分離する方法
JP7144113B2 (ja) 2016-02-11 2022-09-29 オクタファルマ・アーゲー 血液製剤から第viii因子を分離する方法
JP2020504082A (ja) * 2016-11-11 2020-02-06 ツェー・エス・エル・ベーリング・レングナウ・アクチエンゲゼルシャフト 血液凝固障害の処置又は予防における血管外投与のための切断型フォン・ヴィルブランド因子ポリペプチド

Also Published As

Publication number Publication date
US20150045303A1 (en) 2015-02-12
US20160120954A1 (en) 2016-05-05
CN104411323A (zh) 2015-03-11
WO2013160005A1 (en) 2013-10-31
EP2841091A1 (en) 2015-03-04

Similar Documents

Publication Publication Date Title
JP2018104459A (ja) 血友病の治療に適する化合物
JP2015519313A (ja) 血友病の治療に適する医薬組成物
JP2016522219A (ja) 血友病の治療に適する化合物
JP7015810B2 (ja) 第viii因子組成物、ならびに組成物の作製方法および用途
JP6336522B2 (ja) 細胞取込みが低下した第viii因子変異体
KR101507718B1 (ko) 연장된 생체내 반감기를 갖는 인자 viii, 폰 빌레브란트 인자 또는 이들의 복합체
CN105163751B (zh) 复合物
CA2837995A1 (en) Method of producing factor viii proteins by recombinant methods
CN103397009A (zh) 改良型人凝血因子FVII-Fc融合蛋白及其制备方法与用途
CN106279436A (zh) 活化的人凝血因子vii融合蛋白及其制备方法与用途
EP4017521A1 (en) Factor viii protein with increased half-life

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20160224

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20160224

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170110

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20170407

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20170607

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20170630

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20170828

A761 Written withdrawal of application

Free format text: JAPANESE INTERMEDIATE CODE: A761

Effective date: 20171102