DK1820516T3 - Nye albuminfrie faktor VIII-præparater - Google Patents

Nye albuminfrie faktor VIII-præparater

Info

Publication number: DK1820516T3
Authority: DK; Denmark
Prior art keywords: factor viii; group; agent selected; raffinose; trehalose
Prior art date: 1999-02-22

Application number

DK06077229.0T

Other languages

English (en)

Inventor

Marc Besman

Erik Bjornson

Ramesh Kashi

Michael Pikal

Serguei Tchessalov

John Carpenter

Feroz Jameel

Original Assignee

Univ Connecticut

Baxter Int

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.)

1999-02-22

Filing date

2000-02-22

Publication date

2013-10-28

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26944588&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK1820516(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2000-02-22 Application filed by Univ Connecticut, Baxter Int filed Critical Univ Connecticut

2013-10-28 Application granted granted Critical

2013-10-28 Publication of DK1820516T3 publication Critical patent/DK1820516T3/da

Links

102000001690 Factor VIII Human genes 0.000 title abstract 3
108010054218 Factor VIII Proteins 0.000 title abstract 3
229960000301 factor viii Drugs 0.000 title abstract 3
238000002360 preparation method Methods 0.000 title 1
FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 abstract 6
239000000203 mixture Substances 0.000 abstract 4
HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 abstract 3
239000004475 Arginine Substances 0.000 abstract 3
ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 abstract 3
MUPFEKGTMRGPLJ-RMMQSMQOSA-N Raffinose Natural products O(C[C@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](O[C@@]2(CO)[C@H](O)[C@@H](O)[C@@H](CO)O2)O1)[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 MUPFEKGTMRGPLJ-RMMQSMQOSA-N 0.000 abstract 3
229930006000 Sucrose Natural products 0.000 abstract 3
CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 abstract 3
HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 abstract 3
MUPFEKGTMRGPLJ-UHFFFAOYSA-N UNPD196149 Natural products OC1C(O)C(CO)OC1(CO)OC1C(O)C(O)C(O)C(COC2C(C(O)C(O)C(CO)O2)O)O1 MUPFEKGTMRGPLJ-UHFFFAOYSA-N 0.000 abstract 3
HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 abstract 3
ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 abstract 3
239000006172 buffering agent Substances 0.000 abstract 3
159000000007 calcium salts Chemical class 0.000 abstract 3
238000009472 formulation Methods 0.000 abstract 3
MUPFEKGTMRGPLJ-ZQSKZDJDSA-N raffinose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO[C@@H]2[C@@H]([C@@H](O)[C@@H](O)[C@@H](CO)O2)O)O1 MUPFEKGTMRGPLJ-ZQSKZDJDSA-N 0.000 abstract 3
239000011780 sodium chloride Substances 0.000 abstract 3
239000003381 stabilizer Substances 0.000 abstract 3
239000005720 sucrose Substances 0.000 abstract 3
DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 abstract 2
102000009027 Albumins Human genes 0.000 abstract 1
108010088751 Albumins Proteins 0.000 abstract 1
FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 abstract 1
239000004471 Glycine Substances 0.000 abstract 1
229920001612 Hydroxyethyl starch Polymers 0.000 abstract 1
QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 abstract 1
229930195725 Mannitol Natural products 0.000 abstract 1
235000004279 alanine Nutrition 0.000 abstract 1
239000004067 bulking agent Substances 0.000 abstract 1
229940050526 hydroxyethylstarch Drugs 0.000 abstract 1
239000000594 mannitol Substances 0.000 abstract 1
235000010355 mannitol Nutrition 0.000 abstract 1
239000000546 pharmaceutical excipient Substances 0.000 abstract 1

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
- A61K47/08—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
- 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
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
- 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
- A61K9/14—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
- 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
- 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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S530/00—Chemistry: natural resins or derivatives; peptides or proteins; lignins or reaction products thereof
- Y10S530/827—Proteins from mammals or birds
- Y10S530/829—Blood

Landscapes

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

DK06077229.0T 1999-02-22 2000-02-22 Nye albuminfrie faktor VIII-præparater DK1820516T3 (da)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
US25527999A	1999-02-22	1999-02-22
US45275299A	1999-12-01	1999-12-01
EP00907322A EP1154796B1 (en)	1999-02-22	2000-02-22	Novel albumin-free factor viii formulations

Publications (1)

Publication Number	Publication Date
DK1820516T3 true DK1820516T3 (da)	2013-10-28

Family

ID=26944588

Family Applications (4)

Application Number	Title	Priority Date	Filing Date
DK10075019.9T DK2193809T3 (da)	1999-02-22	2000-02-22	Albumin-frie faktor-VIII-formuleringer
DK00907322T DK1154796T3 (da)	1999-02-22	2000-02-22	Nye albuminfrie Faktor VIII-formuleringer
DK06077229.0T DK1820516T3 (da)	1999-02-22	2000-02-22	Nye albuminfrie faktor VIII-præparater
DK09075396.3T DK2130554T3 (da)	1999-02-22	2000-02-22	Albuminfrie faktor VIII-præparater

Family Applications Before (2)

Application Number	Title	Priority Date	Filing Date
DK10075019.9T DK2193809T3 (da)	1999-02-22	2000-02-22	Albumin-frie faktor-VIII-formuleringer
DK00907322T DK1154796T3 (da)	1999-02-22	2000-02-22	Nye albuminfrie Faktor VIII-formuleringer

Family Applications After (1)

Application Number	Title	Priority Date	Filing Date
DK09075396.3T DK2130554T3 (da)	1999-02-22	2000-02-22	Albuminfrie faktor VIII-præparater

Country Status (19)

Country	Link
US (8)	US6586573B1 (da)
EP (5)	EP2130554B1 (da)
JP (9)	JP5149470B2 (da)
CN (3)	CN101810854A (da)
AT (1)	ATE365052T1 (da)
AU (1)	AU777972B2 (da)
BR (1)	BR0008405B1 (da)
CA (4)	CA2634663C (da)
CY (2)	CY1108030T1 (da)
CZ (3)	CZ300547B6 (da)
DE (1)	DE60035260T2 (da)
DK (4)	DK2193809T3 (da)
ES (4)	ES2541470T3 (da)
HK (1)	HK1213801A1 (da)
MX (1)	MXPA01008515A (da)
PL (4)	PL204701B1 (da)
PT (4)	PT2193809E (da)
RU (1)	RU2244556C2 (da)
WO (1)	WO2000048635A1 (da)

Families Citing this family (134)

* Cited by examiner, † Cited by third party
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GB0404586D0 (en) *	2004-03-01	2004-04-07	Britannia Pharmaceuticals Ltd	Improvements in or relating to organic materials
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2000
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2003
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2006
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2007
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2008
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2011
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2012
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2013
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2014
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2016
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Also Published As

Publication number	Publication date
US6586573B1 (en)	2003-07-01
EP2193809A1 (en)	2010-06-09
JP6038003B2 (ja)	2016-12-07
RU2244556C2 (ru)	2005-01-20
US20060205661A1 (en)	2006-09-14
DE60035260T2 (de)	2007-10-18
EP2130554B1 (en)	2012-09-05
BR0008405A (pt)	2002-04-30
EP2130554A1 (en)	2009-12-09
CN100553678C (zh)	2009-10-28
ES2394755T3 (es)	2013-02-05
JP5140539B2 (ja)	2013-02-06
DK2193809T3 (da)	2015-05-26
JP2015091902A (ja)	2015-05-14
CA2362927A1 (en)	2000-08-24
US8372800B2 (en)	2013-02-12
CN101683522B (zh)	2013-05-01
CN101683522A (zh)	2010-03-31
US9352027B2 (en)	2016-05-31
US20040116345A1 (en)	2004-06-17
CA2634674A1 (en)	2000-08-24
BR0008405B1 (pt)	2014-04-22
US7247707B2 (en)	2007-07-24
US7087723B2 (en)	2006-08-08
HK1139862A1 (en)	2010-09-30
JP2003520764A (ja)	2003-07-08
DE60035260D1 (de)	2007-08-02
HK1213801A1 (en)	2016-07-15
EP2921180B1 (en)	2019-08-14
JP2016040310A (ja)	2016-03-24
JP5149470B2 (ja)	2013-02-20
PL198123B1 (pl)	2008-05-30
PL356453A1 (en)	2004-06-28
AU2884300A (en)	2000-09-04
CA2634663A1 (en)	2000-08-24
US20170000854A1 (en)	2017-01-05
PT2193809E (pt)	2015-08-24
US20150025010A1 (en)	2015-01-22
PT1820516E (pt)	2013-10-31
CA2634664A1 (en)	2000-08-24
HK1106705A1 (en)	2008-03-20
MXPA01008515A (es)	2003-06-06
CZ300547B6 (cs)	2009-06-10
ES2435141T3 (es)	2013-12-18
EP1154796B1 (en)	2007-06-20
EP1820516B1 (en)	2013-07-24
US20120083446A1 (en)	2012-04-05
US20130184216A1 (en)	2013-07-18
JP2017125076A (ja)	2017-07-20
PL204701B1 (pl)	2010-02-26
CN1399560A (zh)	2003-02-26
CZ307715A3 (cs)	2002-03-13
CZ307715B6 (cs)	2019-03-06
US8765665B2 (en)	2014-07-01
JP2014024864A (ja)	2014-02-06
JP2012072198A (ja)	2012-04-12
EP1154796A1 (en)	2001-11-21
JP2008201801A (ja)	2008-09-04
CZ20012996A3 (cs)	2002-03-13
EP1820516A2 (en)	2007-08-22
CA2634664C (en)	2011-08-09
CA2362927C (en)	2011-07-12
AU777972B2 (en)	2004-11-04
US20080176791A1 (en)	2008-07-24
CY1113969T1 (el)	2016-07-27
JP2018172413A (ja)	2018-11-08
CN101810854A (zh)	2010-08-25
ES2541470T3 (es)	2015-07-20
CZ307322B6 (cs)	2018-06-06
PL203893B1 (pl)	2009-11-30
US9669076B2 (en)	2017-06-06
JP6253627B2 (ja)	2017-12-27
EP2193809B1 (en)	2015-04-08
EP1820516A3 (en)	2009-10-07
PT1154796E (pt)	2007-09-28
US8058226B2 (en)	2011-11-15
PL203177B1 (pl)	2009-09-30
JP5596064B2 (ja)	2014-09-24
DK2130554T3 (da)	2012-12-03
ES2288843T3 (es)	2008-02-01
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DK1154796T3 (da)	2007-09-24
CA2634663C (en)	2009-08-25
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WO2000048635A1 (en)	2000-08-24
PT2130554E (pt)	2012-11-19
EP2921180A1 (en)	2015-09-23
CY1108030T1 (el)	2013-09-04
JP2009046499A (ja)	2009-03-05
JP6155442B2 (ja)	2017-07-05
ATE365052T1 (de)	2007-07-15

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