DK3182993T3 - Lyofiliserede formuleringer til faktor xa-antidot - Google Patents

Lyofiliserede formuleringer til faktor xa-antidot Download PDF

Info

Publication number: DK3182993T3
Authority: DK; Denmark
Prior art keywords: lyofilized; antidot; formulations; factor; lyofilized formulations
Prior art date: 2014-08-20

Application number

DK15834421.8T

Other languages

Danish (da)

English (en)

Inventor

Juan Wang

Phuong M Nguyen

Gregory A Sacha

Original Assignee

Portola Pharm 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.)

2014-08-20

Filing date

2015-08-20

Publication date

2020-09-21

2015-08-20 Application filed by Portola Pharm Inc filed Critical Portola Pharm Inc

2020-09-21 Application granted granted Critical

2020-09-21 Publication of DK3182993T3 publication Critical patent/DK3182993T3/da

Links

108010074860 Factor Xa Proteins 0.000 title 1
239000000203 mixture Substances 0.000 title 1

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
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- 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)
- 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)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor 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)
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
- 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
- A61K47/26—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
- A61K9/0012—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
- 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
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
- C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
- C12N9/64—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue
- C12N9/6421—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from animal tissue from mammals
- C12N9/6424—Serine endopeptidases (3.4.21)
- C12N9/6432—Coagulation factor Xa (3.4.21.6)
- 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)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21006—Coagulation factor Xa (3.4.21.6)

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
General Health & Medical Sciences (AREA)
Engineering & Computer Science (AREA)
Medicinal Chemistry (AREA)
Animal Behavior & Ethology (AREA)
Pharmacology & Pharmacy (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Bioinformatics & Cheminformatics (AREA)
Organic Chemistry (AREA)
Genetics & Genomics (AREA)
Biochemistry (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Zoology (AREA)
Wood Science & Technology (AREA)
Molecular Biology (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Gastroenterology & Hepatology (AREA)
Oil, Petroleum & Natural Gas (AREA)
Biomedical Technology (AREA)
General Engineering & Computer Science (AREA)
Immunology (AREA)
Microbiology (AREA)
Biotechnology (AREA)
Dermatology (AREA)
Hematology (AREA)
Biophysics (AREA)
Diabetes (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Medicinal Preparation (AREA)
Peptides Or Proteins (AREA)

DK15834421.8T 2014-08-20 2015-08-20 Lyofiliserede formuleringer til faktor xa-antidot DK3182993T3 (da)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US201462039809P	2014-08-20	2014-08-20
PCT/US2015/046173 WO2016029061A1 (en)	2014-08-20	2015-08-20	Lyophilized formulations for factor xa antidote

Publications (1)

Publication Number	Publication Date
DK3182993T3 true DK3182993T3 (da)	2020-09-21

Family

ID=55351266

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
DK15834421.8T DK3182993T3 (da)	2014-08-20	2015-08-20	Lyofiliserede formuleringer til faktor xa-antidot

Country Status (14)

Country	Link
US (6)	US20160237420A1 (2)
EP (2)	EP3750556A1 (2)
JP (4)	JP6742986B2 (2)
KR (3)	KR102867491B1 (2)
CN (2)	CN113171447B (2)
AU (3)	AU2015305413B2 (2)
CA (1)	CA2961739C (2)
DK (1)	DK3182993T3 (2)
EA (2)	EA036091B1 (2)
ES (1)	ES2814157T3 (2)
IL (2)	IL250413B (2)
SG (1)	SG11201701247RA (2)
WO (1)	WO2016029061A1 (2)
ZA (1)	ZA201701764B (2)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
EP3121271B1 (en) *	2009-03-30	2019-07-24	Portola Pharmaceuticals, Inc.	Antidotes for factor xa inhibitors and methods of using the same
EP3750556A1 (en) *	2014-08-20	2020-12-16	Portola Pharmaceuticals, Inc.	Lyophilized formulations for factor xa antidote
WO2017147522A1 (en) *	2016-02-24	2017-08-31	Portola Pharmaceuticals, Inc.	Lyophilized formulations for factor xa antidote
PT3472314T (pt) *	2016-06-17	2021-06-18	Alexion Pharma Inc	Preparação de derivados do fator xa
WO2018213151A1 (en) *	2017-05-18	2018-11-22	Merck Sharp & Dohme Corp.	Pharmaceutical formulation comprising incretin-insulin conjugates
CN112512480B (zh) *	2018-05-21	2024-10-01	中外制药株式会社	被封入玻璃容器的冷冻干燥制剂
CN110760479A (zh) *	2019-05-17	2020-02-07	上海交通大学医学院附属瑞金医院	靶向血小板表达的凝血因子Xa及其应用

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
JPH08504769A (ja)	1992-12-15	1996-05-21	コルバス・インターナショナル、インコーポレイテッド	因子Ｘａの新規インヒビター
DK1820516T3 (da) *	1999-02-22	2013-10-28	Univ Connecticut	Nye albuminfrie faktor VIII-præparater
US6586574B1 (en) *	1999-08-17	2003-07-01	Nn A/S	Stabilization of freeze-dried cake
WO2001064642A2 (en)	2000-02-29	2001-09-07	Cor Therapeutics, Inc.	Benzamides and related inhibitors of factor xa
US6586584B2 (en) *	2001-01-29	2003-07-01	Becton, Dickinson And Company	Sequences and methods for detection of Hepatitis C virus
CA2512680A1 (en) *	2003-01-08	2004-07-29	Chiron Corporation	Stabilized lyophilized compositions comprising tissue factor pathway inhibitor or tissue factor pathway inhibitor variants
PE20070717A1 (es)	2005-11-08	2007-08-17	Millennium Pharm Inc	Sal de maleato y polimorfo de [2-({4-[(dimetilamino)iminometil]fenil}carbonilamino)-5-metoxifenil]-n-(5-cloro-(2-piridil))carboxamida
US9283260B2 (en) *	2006-04-21	2016-03-15	Amgen Inc.	Lyophilized therapeutic peptibody formulations
EP2915564B1 (en) *	2007-09-28	2020-11-04	Portola Pharmaceuticals, Inc.	Antidotes for factor XA inhibitors and methods of using the same
WO2010026186A1 (en)	2008-09-03	2010-03-11	Octapharma Ag	New protecting compositions for recombinantly produced factor viii
MX2011004907A (es) *	2008-11-14	2011-07-29	Portola Pharm Inc	Antidotos para inhibidores del factor xa y metodos para el uso de los mismos en combinacion con agentes de coagulacion de sangre.
EP3121271B1 (en)	2009-03-30	2019-07-24	Portola Pharmaceuticals, Inc.	Antidotes for factor xa inhibitors and methods of using the same
ES2605801T3 (es) *	2009-07-15	2017-03-16	Portola Pharmaceuticals, Inc.	Formulación de dosis unitaria de antídoto para inhibidores del factor Xa para su uso en la prevención de la hemorragia
EP2458990B1 (en) *	2009-07-28	2016-03-30	Merck Sharp & Dohme Corp.	Methods for producing high concentration lyophilized pharmaceutical formulations
US20130165459A1 (en) *	2010-01-12	2013-06-27	Norvartis Pharma Ag	Pharmaceutical composition and dosage forms of elinogrel and methods of use thereof
CA2796729C (en) *	2010-04-20	2020-06-23	Octapharma Ag	Melezitose for stabilizing human blood plasma proteins
JP2013544271A (ja) *	2010-12-03	2013-12-12	ポートラファーマシューティカルズ，インコーポレイテッド	式（ｉ）の化合物の薬学的組成物、投薬形態、および新規の形態、ならびにその使用方法
US9683020B2 (en) *	2011-08-01	2017-06-20	Emory University	VLPS containing ligands and methods related thereto
US9371522B2 (en) *	2011-09-30	2016-06-21	The Children's Hospital Of Philadelphia	Compositions and methods for modulating hemostasis
GB201310946D0 (en) *	2013-06-19	2013-07-31	Cambridge Entpr Ltd	Antidote
EP3750556A1 (en) *	2014-08-20	2020-12-16	Portola Pharmaceuticals, Inc.	Lyophilized formulations for factor xa antidote

2015
- 2015-08-20 EP EP20170763.5A patent/EP3750556A1/en active Pending
- 2015-08-20 KR KR1020227045749A patent/KR102867491B1/ko active Active
- 2015-08-20 KR KR1020177007503A patent/KR102482517B1/ko active Active
- 2015-08-20 EP EP15834421.8A patent/EP3182993B1/en active Active
- 2015-08-20 DK DK15834421.8T patent/DK3182993T3/da active
- 2015-08-20 ES ES15834421T patent/ES2814157T3/es active Active
- 2015-08-20 KR KR1020257032508A patent/KR20250150675A/ko active Pending
- 2015-08-20 SG SG11201701247RA patent/SG11201701247RA/en unknown
- 2015-08-20 CN CN202110363277.0A patent/CN113171447B/zh active Active
- 2015-08-20 JP JP2017509739A patent/JP6742986B2/ja active Active
- 2015-08-20 WO PCT/US2015/046173 patent/WO2016029061A1/en not_active Ceased
- 2015-08-20 CN CN201580048166.3A patent/CN107073082B/zh active Active
- 2015-08-20 EA EA201790415A patent/EA036091B1/ru unknown
- 2015-08-20 EA EA202091385A patent/EA202091385A3/ru unknown
- 2015-08-20 CA CA2961739A patent/CA2961739C/en active Active
- 2015-08-20 AU AU2015305413A patent/AU2015305413B2/en active Active
2016
- 2016-04-22 US US15/136,810 patent/US20160237420A1/en not_active Abandoned
2017
- 2017-02-02 IL IL250413A patent/IL250413B/en active IP Right Grant
- 2017-03-10 ZA ZA2017/01764A patent/ZA201701764B/en unknown
- 2017-11-21 US US15/820,265 patent/US20180320160A1/en not_active Abandoned
2019
- 2019-09-12 JP JP2019165981A patent/JP2019206595A/ja not_active Withdrawn
2020
- 2020-06-08 US US16/895,443 patent/US20200299667A1/en not_active Abandoned
- 2020-06-08 US US16/895,448 patent/US11028382B2/en active Active
- 2020-08-26 IL IL276960A patent/IL276960B/en unknown
- 2020-12-16 AU AU2020289768A patent/AU2020289768B2/en active Active
2021
- 2021-05-28 US US17/334,427 patent/US20210284986A1/en not_active Abandoned
- 2021-10-22 JP JP2021172975A patent/JP7416549B2/ja active Active
2023
- 2023-09-11 JP JP2023146769A patent/JP2023158199A/ja active Pending
2024
- 2024-09-13 AU AU2024219698A patent/AU2024219698A1/en active Pending
- 2024-11-05 US US18/937,646 patent/US20250163399A1/en active Pending

Also Published As

Publication number	Publication date
AU2015305413B2 (en)	2020-09-24
KR102867491B1 (ko)	2025-10-01
JP6742986B2 (ja)	2020-08-19
JP2017525704A (ja)	2017-09-07
KR102482517B1 (ko)	2022-12-28
US20180320160A1 (en)	2018-11-08
KR20250150675A (ko)	2025-10-20
JP2023158199A (ja)	2023-10-26
CN107073082A (zh)	2017-08-18
US20200299668A1 (en)	2020-09-24
AU2020289768B2 (en)	2024-06-13
IL250413B (en)	2020-09-30
US20210284986A1 (en)	2021-09-16
EP3750556A1 (en)	2020-12-16
KR20230007550A (ko)	2023-01-12
JP7416549B2 (ja)	2024-01-17
CN107073082B (zh)	2021-04-30
WO2016029061A1 (en)	2016-02-25
EA202091385A3 (ru)	2021-06-30
KR20170042776A (ko)	2017-04-19
AU2020289768A1 (en)	2021-01-21
JP2019206595A (ja)	2019-12-05
EA202091385A2 (ru)	2021-03-31
CN113171447B (zh)	2024-05-17
IL276960A (en)	2020-10-29
CA2961739C (en)	2024-04-30
IL276960B (en)	2022-04-01
EA036091B1 (ru)	2020-09-25
CA2961739A1 (en)	2016-02-25
IL250413A0 (en)	2017-03-30
AU2015305413A1 (en)	2017-03-23
ZA201701764B (en)	2020-10-28
SG11201701247RA (en)	2017-03-30
JP2022003101A (ja)	2022-01-11
AU2024219698A1 (en)	2024-10-03
US20160237420A1 (en)	2016-08-18
EP3182993A4 (en)	2018-01-17
ES2814157T3 (es)	2021-03-26
EP3182993A1 (en)	2017-06-28
US11028382B2 (en)	2021-06-08
CN113171447A (zh)	2021-07-27
EP3182993B1 (en)	2020-07-01
EA201790415A1 (ru)	2017-08-31
US20200299667A1 (en)	2020-09-24
US20250163399A1 (en)	2025-05-22

Publication	Publication Date	Title
DK3151672T3 (da)	2021-02-01	Forbedrede t-celle-sammensætninger
DK3139982T3 (da)	2022-05-16	Forstøver
CL2015000438S1 (es)	2015-06-12	Dispensador
LT3134402T (lt)	2020-07-10	4-amino-imidazochinolino junginiai
DK3293186T3 (da)	2020-12-14	Pyrimidinoner som faktor xia-hæmmere
LT3240415T (lt)	2022-10-10	Fungicidinės kompozicijos
DK3040326T3 (da)	2020-03-30	Haloolefin-baseret sammensætning
DK3542812T3 (da)	2021-04-12	Glycopeptidsammensætninger
DK3089741T3 (da)	2021-06-07	Farmaceutiske sammensætninger omfattende azd9291
FR3024363B1 (fr)	2018-08-10	Composition thermogelifiable
BR112017001922A2 (pt)	2018-07-17	composições fungicidas
HUE053905T2 (hu)	2021-07-28	Porlasztókészülék
BR112016019110A2 (pt)	2017-08-15	Dispensador
LT4242916T (lt)	2025-12-29	Purkštuvas
DK3139984T3 (da)	2021-07-19	Forstøver
DK3129007T3 (da)	2020-11-02	Vaccinesammensætninger
CL2017000639A1 (es)	2018-01-26	Composición
DK3182993T3 (da)	2020-09-21	Lyofiliserede formuleringer til faktor xa-antidot
DK3191466T3 (da)	2020-01-20	Azetidinyloxyphenylpyrrolidinforbindelser
DK3498588T3 (da)	2022-06-07	Holdearrangement
DK3139981T3 (da)	2021-02-15	Forstøver
EP3236746C0 (en)	2024-11-27	COMPOSITION
DK3200827T3 (da)	2020-10-12	Sammensætninger
DK3148513T3 (da)	2020-05-25	Ceritinib-formulering
DK3217964T3 (da)	2019-11-25	Sammensætning