DK3834841T3 - Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer - Google Patents

Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer Download PDF

Info

Publication number: DK3834841T3
Authority: DK; Denmark
Prior art keywords: stabilized liquid; adamts13 formulations; lyophilized adamts13; lyophilized; formulations
Prior art date: 2009-09-21

Application number

DK20211228.0T

Other languages

English (en)

Inventor

H Peter Matthiessen

Peter Turecek

Hans-Peter Schwarz

Original Assignee

Takeda Pharmaceuticals Co

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.)

2009-09-21

Filing date

2010-09-21

Publication date

2023-06-06

2010-09-21 Application filed by Takeda Pharmaceuticals Co filed Critical Takeda Pharmaceuticals Co

2023-06-06 Application granted granted Critical

2023-06-06 Publication of DK3834841T3 publication Critical patent/DK3834841T3/da

Classifications

- 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
- 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)
- A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- 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
- A61K9/08—Solutions
- 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
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- 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)
- C12Y304/24—Metalloendopeptidases (3.4.24)
- C12Y304/24087—ADAMTS13 endopeptidase (3.4.24.87)
- 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
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
General Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Public Health (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
Organic Chemistry (AREA)
Biochemistry (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Gastroenterology & Hepatology (AREA)
Inorganic Chemistry (AREA)
Immunology (AREA)
Molecular Biology (AREA)
Zoology (AREA)
General Engineering & Computer Science (AREA)
Wood Science & Technology (AREA)
Genetics & Genomics (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Heart & Thoracic Surgery (AREA)
Diabetes (AREA)
Urology & Nephrology (AREA)
Cardiology (AREA)
Hematology (AREA)
Vascular Medicine (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Enzymes And Modification Thereof (AREA)
Medicinal Preparation (AREA)
Dispersion Chemistry (AREA)
Dermatology (AREA)
Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

DK20211228.0T 2009-09-21 2010-09-21 Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer DK3834841T3 (da)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US24435309P	2009-09-21	2009-09-21
EP15203085.4A EP3167897B1 (en)	2009-09-21	2010-09-21	Stabilized liquid and lyophilized adamts13 formulations

Publications (1)

Publication Number	Publication Date
DK3834841T3 true DK3834841T3 (da)	2023-06-06

Family

ID=43598388

Family Applications (4)

Application Number	Title	Priority Date	Filing Date
DK20211228.0T DK3834841T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer
DK23172759.5T DK4218797T3 (da)	2009-09-21	2010-09-21	Stabiliseret væske og frysetørrede adamts13-formuleringer
DK15203085.4T DK3167897T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer
DK10759786.6T DK2480198T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige- og lyofiliserede adamts13-formuleringer

Family Applications After (3)

Application Number	Title	Priority Date	Filing Date
DK23172759.5T DK4218797T3 (da)	2009-09-21	2010-09-21	Stabiliseret væske og frysetørrede adamts13-formuleringer
DK15203085.4T DK3167897T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer
DK10759786.6T DK2480198T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige- og lyofiliserede adamts13-formuleringer

Country Status (22)

Country	Link
US (9)	US8623352B2 (da)
EP (5)	EP4218797B9 (da)
JP (2)	JP5819303B2 (da)
KR (6)	KR20210054598A (da)
CN (2)	CN102573792B (da)
AU (1)	AU2010295299B2 (da)
BR (1)	BR112012006283B1 (da)
CA (1)	CA2774556A1 (da)
DK (4)	DK3834841T3 (da)
EA (1)	EA024267B1 (da)
ES (4)	ES2865250T3 (da)
FI (2)	FI3834841T3 (da)
FR (1)	FR24C1049I1 (da)
HK (1)	HK1173968A1 (da)
HR (1)	HRP20160295T1 (da)
HU (1)	HUE028688T2 (da)
IN (1)	IN2012DN02645A (da)
MX (3)	MX362382B (da)
NZ (1)	NZ598839A (da)
PL (4)	PL4218797T3 (da)
PT (2)	PT3834841T (da)
WO (1)	WO2011035335A2 (da)

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KR20210054598A (ko)	2009-09-21	2021-05-13	다케다 야쿠힌 고교 가부시키가이샤	안정화된 액체 및 동결건조된 ａｄａｍｔｓ13 제제
EP3311847A1 (en) *	2012-02-16	2018-04-25	Atyr Pharma, Inc.	Histidyl-trna synthetases for treating autoimmune and inflammatory diseases
CN103566362B (zh) *	2012-07-21	2015-07-29	复旦大学	重组adamts13在制备脑出血药物中的用途
US10441531B2 (en) *	2012-11-09	2019-10-15	Bloodworks	Protein stabilizing factors
JP6397479B2 (ja)	2013-03-15	2018-09-26	エータイアーファーマ，インコーポレイテッド	ヒスチジル−ｔＲＮＡシンテターゼＦｃコンジュゲート
AU2013203062C1 (en) *	2013-03-15	2018-06-28	Takeda Pharmaceutical Company Limited	Subcutaneous administration of adamts13
WO2015200027A1 (en) *	2014-06-26	2015-12-30	Amgen Inc.	Protein formulations
GB201510870D0 (en) *	2015-05-26	2015-08-05	Baxalta Inc And Katholieke Universiteit Leuven And Baxalta Gmbh	Treatment of infarction
ES2902014T3 (es) *	2016-01-08	2022-03-24	Univ Kyoto	Método de diagnóstico y medicina que comprende ADAMTS13 como ingrediente principal
CN109789192B (zh) *	2016-08-04	2023-04-07	武田药品工业株式会社	使用adamts13治疗、改善和/或预防镰状细胞病、急性肺损伤和/或急性呼吸窘迫综合征中的血管阻塞危象
AU2017391165B2 (en)	2016-11-04	2023-02-02	Takeda Pharmaceutical Company Limited	Adeno-associated virus formulations
CA3060514A1 (en)	2017-04-20	2018-10-25	Atyr Pharma, Inc.	Compositions and methods for treating lung inflammation
EP3639845B1 (en) *	2017-07-25	2023-06-21	Jiangsu Hengrui Medicine Co., Ltd.	Il-15 protein complex pharmaceutical composition and uses thereof
SG11202012946RA (en) *	2018-07-11	2021-02-25	Baxalta Inc	Aav compositions
US20220339266A1 (en)	2019-10-04	2022-10-27	The Children's Medical Center Corporation	Adamts13 treatment to enhance graft survival
CA3173709A1 (en)	2020-04-02	2021-10-07	Friedmund BACHMANN	Adamts13 variant, compositions, and uses thereof
WO2021234458A1 (en)	2020-05-22	2021-11-25	Takeda Pharmaceutical Company Limited	Adamts13 compositions and methods for treating and diagnosing complications of coronavirus disease
IL300596A (en) *	2020-08-13	2023-04-01	Hadasit Medical Res Services & Development Limited	Mutants of disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (adamts-13), preparations and their uses in therapeutic methods
IL315475A (en)	2022-03-08	2024-11-01	Equashield Medical Ltd	A position for transferring liquids in a robotic system for preparing medicines
KR20240112755A (ko) *	2023-01-11	2024-07-19	주식회사 녹십자	혈전성 질환의 예방 또는 치료를 위한 신규한 액상 제형물

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2010
- 2010-09-21 KR KR1020217013486A patent/KR20210054598A/ko not_active Ceased
- 2010-09-21 HU HUE10759786A patent/HUE028688T2/en unknown
- 2010-09-21 FI FIEP20211228.0T patent/FI3834841T3/fi active
- 2010-09-21 KR KR1020247043292A patent/KR20250008986A/ko active Pending
- 2010-09-21 EP EP23172759.5A patent/EP4218797B9/en active Active
- 2010-09-21 EP EP15203085.4A patent/EP3167897B1/en active Active
- 2010-09-21 IN IN2645DEN2012 patent/IN2012DN02645A/en unknown
- 2010-09-21 EP EP20211228.0A patent/EP3834841B1/en active Active
- 2010-09-21 EA EA201200519A patent/EA024267B1/ru not_active IP Right Cessation
- 2010-09-21 CN CN201080046707.6A patent/CN102573792B/zh active Active
- 2010-09-21 PL PL23172759.5T patent/PL4218797T3/pl unknown
- 2010-09-21 PL PL10759786.6T patent/PL2480198T3/pl unknown
- 2010-09-21 ES ES15203085T patent/ES2865250T3/es active Active
- 2010-09-21 MX MX2016005314A patent/MX362382B/es unknown
- 2010-09-21 US US12/887,424 patent/US8623352B2/en active Active
- 2010-09-21 AU AU2010295299A patent/AU2010295299B2/en active Active
- 2010-09-21 NZ NZ598839A patent/NZ598839A/en unknown
- 2010-09-21 ES ES20211228T patent/ES2948612T3/es active Active
- 2010-09-21 PT PT202112280T patent/PT3834841T/pt unknown
- 2010-09-21 DK DK20211228.0T patent/DK3834841T3/da active
- 2010-09-21 MX MX2012003414A patent/MX339205B/es active IP Right Grant
- 2010-09-21 PL PL20211228.0T patent/PL3834841T3/pl unknown
- 2010-09-21 CA CA2774556A patent/CA2774556A1/en not_active Abandoned
- 2010-09-21 KR KR1020187023806A patent/KR20180095738A/ko not_active Ceased
- 2010-09-21 DK DK23172759.5T patent/DK4218797T3/da active
- 2010-09-21 WO PCT/US2010/049723 patent/WO2011035335A2/en active Application Filing
- 2010-09-21 KR KR1020197035791A patent/KR20190137954A/ko not_active Ceased
- 2010-09-21 PL PL15203085T patent/PL3167897T3/pl unknown
- 2010-09-21 ES ES23172759T patent/ES3001509T3/es active Active
- 2010-09-21 DK DK15203085.4T patent/DK3167897T3/da active
- 2010-09-21 PT PT231727595T patent/PT4218797T/pt unknown
- 2010-09-21 DK DK10759786.6T patent/DK2480198T3/da active
- 2010-09-21 EP EP10759786.6A patent/EP2480198B9/en active Active
- 2010-09-21 EP EP24192531.2A patent/EP4467160A3/en active Pending
- 2010-09-21 ES ES10759786.6T patent/ES2579906T3/es active Active
- 2010-09-21 KR KR1020227034508A patent/KR20220139456A/ko not_active Ceased
- 2010-09-21 JP JP2012529982A patent/JP5819303B2/ja active Active
- 2010-09-21 CN CN201410452647.8A patent/CN104224705B/zh active Active
- 2010-09-21 FI FIEP23172759.5T patent/FI4218797T3/fi active
- 2010-09-21 KR KR1020127009803A patent/KR101891646B1/ko active Active
- 2010-09-21 BR BR112012006283-2A patent/BR112012006283B1/pt active IP Right Grant
2012
- 2012-03-21 MX MX2019000547A patent/MX2019000547A/es unknown
2013
- 2013-01-28 HK HK13101187.6A patent/HK1173968A1/zh unknown
- 2013-11-22 US US14/088,169 patent/US9351935B2/en active Active
2014
- 2014-12-24 JP JP2014259954A patent/JP2015063556A/ja active Pending
2016
- 2016-03-22 HR HRP20160295TT patent/HRP20160295T1/hr unknown
- 2016-05-03 US US15/145,755 patent/US9572778B2/en active Active
2017
- 2017-01-06 US US15/400,526 patent/US9937244B2/en active Active
2018
- 2018-02-28 US US15/908,213 patent/US10238720B2/en active Active
2019
- 2019-02-14 US US16/275,690 patent/US10758599B2/en active Active
2020
- 2020-07-21 US US16/934,100 patent/US11564979B2/en active Active
2022
- 2022-12-23 US US18/146,212 patent/US12178861B2/en active Active
2024
- 2024-11-19 US US18/952,409 patent/US20250099559A1/en active Pending
- 2024-12-10 FR FR24C1049C patent/FR24C1049I1/fr active Active

Also Published As

Publication number	Publication date
PL3834841T3 (pl)	2023-07-24
US20190247475A1 (en)	2019-08-15
EP3167897B1 (en)	2021-01-27
KR20180095738A (ko)	2018-08-27
US20110229455A1 (en)	2011-09-22
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US9937244B2 (en)	2018-04-10
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CN104224705B (zh)	2018-02-02
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EA024267B1 (ru)	2016-09-30
KR101891646B1 (ko)	2018-08-27
EP4218797A1 (en)	2023-08-02
US8623352B2 (en)	2014-01-07

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