DK2768521T3 - Kombineret anvendelse af et sulfateret glykosamin-glykan og en hyaluronidase til forbedring af bio-rådigheden af Faktor VIII - Google Patents
Kombineret anvendelse af et sulfateret glykosamin-glykan og en hyaluronidase til forbedring af bio-rådigheden af Faktor VIII Download PDFInfo
- Publication number
- DK2768521T3 DK2768521T3 DK12772969.7T DK12772969T DK2768521T3 DK 2768521 T3 DK2768521 T3 DK 2768521T3 DK 12772969 T DK12772969 T DK 12772969T DK 2768521 T3 DK2768521 T3 DK 2768521T3
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- DK
- Denmark
- Prior art keywords
- leu
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Classifications
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/727—Heparin; Heparan
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
- A61K31/728—Hyaluronic acid
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- 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)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
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- 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
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- 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
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- 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
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
- C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
- C12Y302/01025—Beta-mannosidase (3.2.1.25), i.e. mannanase
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
- C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
- C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Gastroenterology & Hepatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- Hematology (AREA)
- Biochemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Wood Science & Technology (AREA)
- Inorganic Chemistry (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Enzymes And Modification Thereof (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Peptides Or Proteins (AREA)
Claims (15)
1. Farmaceutisk præparat, omfattende Faktor VIII, et sulfateret glykosami-noglykan, og en hyaluronidase.
2. Farmaceutisk præparat ifølge krav 1, hvorved Faktor VIII, det sulfaterede glykosaminoglykan, og hyaluronidasen indeholdes i samme sammensætning.
3. Farmaceutisk præparat ifølge krav 1, hvorved henholdsvis Faktor VIII, det sulfaterede glykosaminoglykan og hyaluronidasen er tilvejebragt i separat dosisform i det farmaceutiske præparat.
4. Farmaceutisk præparat ifølge et hvilket som helst af de foregående krav, hvorved hyaluronidasen er human hyaluronidase.
5. Farmaceutisk præparat ifølge et hvilket som helst af de foregående krav, hvorved det sulfaterede glykosaminoglykan er et heparin.
6. Farmaceutisk præparat ifølge krav 5, hvorved heparinet er ufraktioneret heparin.
7. Faktor VIII til anvendelse ved behandling eller profylakse af en blødningsforstyrrelse, hvorved behandlingen eller profylaksen omfatter indgivelse af et sulfateret glukosaminoglykan og af en hyaluronidase.
8. Faktor VIII til anvendelse ifølge krav 7, hvorved Faktor VIII er human Faktor VIII.
9. Faktor VIII til anvendelse ifølge enten krav 7 eller krav 8, hvorved hyaluronidasen er en human hyaluronidase.
10. Faktor VIII til anvendelse ifølge et hvilket som helst af kravene 7 til 9, hvorved det sulfaterede glykosaminoglykan er et heparin.
11. Faktor VIII til anvendelse ifølge et hvilket som helst af kravene 7 til 10, hvorved blødningsforstyrrelsen er hæmofili A.
12. Faktor VIII til anvendelse ifølge et hvilket som helst af kravene 7 til 11, hvorved Faktor VIII, det sulfaterede glukosaminoglykan og hyaluronidasen indgives samtidig.
13. Faktor VIII til anvendelse ifølge et hvilket som helst af kravene 7 til 11, hvorved Faktor VIII, det sulfaterede glukosaminoglykan og hyaluronidasen indgives separat.
14. Faktor VIII til anvendelse ifølge et hvilket som helst af kravene 7 til 13, hvorved behandlingen eller profylaksen omfatter ikke-intravenøs indgivelse af Faktor VIII, sulfateret glykosaminoglykan og hyaluronidase.
15. Faktor VIII til anvendelse ifølge krav 14, hvorved den ikke-intravenøse indgivelse er subkutan injektion, intramuskulær injektion eller intradermal injektion.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161548612P | 2011-10-18 | 2011-10-18 | |
EP11185650 | 2011-10-18 | ||
PCT/EP2012/070620 WO2013057171A1 (en) | 2011-10-18 | 2012-10-18 | Combined use of a sulfated glycosaminoglycan and a hyaluronidase for improving the bioavailability of factor viii |
Publications (1)
Publication Number | Publication Date |
---|---|
DK2768521T3 true DK2768521T3 (da) | 2016-10-24 |
Family
ID=48140373
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12772969.7T DK2768521T3 (da) | 2011-10-18 | 2012-10-18 | Kombineret anvendelse af et sulfateret glykosamin-glykan og en hyaluronidase til forbedring af bio-rådigheden af Faktor VIII |
Country Status (10)
Country | Link |
---|---|
US (1) | US9511123B2 (da) |
EP (1) | EP2768521B1 (da) |
JP (1) | JP6029674B2 (da) |
KR (1) | KR20140083035A (da) |
CN (1) | CN103889446B (da) |
AU (1) | AU2012318303B2 (da) |
CA (1) | CA2851057A1 (da) |
DK (1) | DK2768521T3 (da) |
ES (1) | ES2595160T3 (da) |
WO (1) | WO2013057171A1 (da) |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1942588B (zh) | 2003-03-05 | 2013-06-12 | 海洋酶公司 | 可溶性透明质酸酶糖蛋白(sHASEGP)、制备它们的方法、它们的用途和包含它们的药物组合物 |
PL3044231T3 (pl) * | 2013-09-12 | 2021-01-11 | Biomarin Pharmaceutical Inc. | Wektory aav zawierające gen kodujący czynnik viii |
DE102015107307B3 (de) * | 2015-05-11 | 2016-09-08 | Labor L + S Aktiengesellschaft | Optisches Verfahren zur Gehaltsbestimmung von Hyaluronsäure |
CN114929261A (zh) * | 2020-02-17 | 2022-08-19 | 生物测试股份公司 | 凝血因子viii的皮下施用 |
WO2024117476A1 (ko) * | 2022-11-28 | 2024-06-06 | 주식회사 대웅제약 | 생체이용률이 개선된 니클로사마이드 함유 조성물 |
Family Cites Families (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4757006A (en) | 1983-10-28 | 1988-07-12 | Genetics Institute, Inc. | Human factor VIII:C gene and recombinant methods for production |
CA1341174C (en) | 1985-04-12 | 2001-01-30 | John J. Toole Jr. | Procoagulant proteins derived from factor viii: c |
FR2673632A1 (fr) | 1991-03-08 | 1992-09-11 | Lille Transfusion Sanguine | Procede de preparation de concentre de facteur von willebrand humain de tres haute purete, approprie a un usage therapeutique. |
SE504074C2 (sv) | 1993-07-05 | 1996-11-04 | Pharmacia Ab | Proteinberedning för subkutan, intramuskulär eller intradermal administrering |
IL113010A0 (en) | 1994-03-31 | 1995-10-31 | Pharmacia Ab | Pharmaceutical formulation comprising factor VIII or factor ix with an activity of at least 200 IU/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration |
DE4435485C1 (de) | 1994-10-04 | 1996-03-21 | Immuno Ag | Verfahren zur Gewinnung von hochreinem von Willebrand-Faktor |
EP0910628B1 (en) | 1996-04-24 | 2006-03-08 | The Regents of The University of Michigan | Inactivation resistant factor viii |
WO2000024759A1 (en) | 1998-10-23 | 2000-05-04 | The Trustees Of The University Of Pennsylvania | Systemic delivery of gene products via skin |
PL352060A1 (en) * | 1999-06-12 | 2003-07-28 | Merck Patent Gmbh | Hialuronidase of hiarudinaria manillensis and method of separating, purifying and obtaining thereof by recombination |
CA2450125A1 (en) | 2001-06-15 | 2002-12-27 | Andre C. Schuh | Gene therapy for hemophilia a |
US7041635B2 (en) | 2003-01-28 | 2006-05-09 | In2Gen Co., Ltd. | Factor VIII polypeptide |
US7871607B2 (en) | 2003-03-05 | 2011-01-18 | Halozyme, Inc. | Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases |
ATE497783T1 (de) | 2003-05-06 | 2011-02-15 | Syntonix Pharmaceuticals Inc | Gerinnungsfaktor vii-fc chimäre proteine zur behandlung von hämostatischen krankheiten |
ES2229931B1 (es) | 2003-10-03 | 2006-01-16 | Grifols, S.A. | Composicion liquida bilogicamente estable de fviii, de fvw o del complejo fviii/fvw humanos. |
US8173597B2 (en) | 2007-11-09 | 2012-05-08 | Baxter International Inc. | Modified recombinant factor VIII and von Willebrand factor and methods of use |
CA2715465C (en) | 2008-02-27 | 2017-03-21 | Novo Nordisk A/S | Conjugated factor viii molecules |
RU2010149797A (ru) * | 2008-05-06 | 2012-06-20 | Октафарма АГ (CH) | Комплекс |
WO2010077294A1 (en) | 2008-12-09 | 2010-07-08 | King Faisal Specialist Hospital & Research Centre | Olfactory stem cells and uses thereof |
NZ593641A (en) | 2008-12-09 | 2013-01-25 | Halozyme Inc | Extended soluble ph20 polypeptides and uses thereof |
AU2010284977A1 (en) | 2009-08-20 | 2012-03-29 | Csl Behring Gmbh | Albumin fused coagulation factors for non-intravenous administration in the therapy and prophylactic treatment of bleeding disorders |
WO2011095604A1 (en) | 2010-02-04 | 2011-08-11 | Octapharma Biopharmaceuticals Gmbh | Half-life prolongation of proteins |
KR20140083036A (ko) | 2011-10-18 | 2014-07-03 | 체에스엘 베링 게엠베하 | 인자 viii의 생체이용률을 향상시키기 위한 황산화 글리코사미노글리칸의 용도 |
-
2012
- 2012-10-18 JP JP2014536227A patent/JP6029674B2/ja not_active Expired - Fee Related
- 2012-10-18 CA CA2851057A patent/CA2851057A1/en not_active Abandoned
- 2012-10-18 WO PCT/EP2012/070620 patent/WO2013057171A1/en active Application Filing
- 2012-10-18 KR KR1020147013299A patent/KR20140083035A/ko not_active Application Discontinuation
- 2012-10-18 EP EP12772969.7A patent/EP2768521B1/en not_active Not-in-force
- 2012-10-18 US US14/351,502 patent/US9511123B2/en active Active
- 2012-10-18 DK DK12772969.7T patent/DK2768521T3/da active
- 2012-10-18 ES ES12772969.7T patent/ES2595160T3/es active Active
- 2012-10-18 AU AU2012318303A patent/AU2012318303B2/en not_active Ceased
- 2012-10-18 CN CN201280051590.XA patent/CN103889446B/zh not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
CA2851057A1 (en) | 2013-04-25 |
AU2012318303B2 (en) | 2015-09-03 |
CN103889446B (zh) | 2017-03-08 |
CN103889446A (zh) | 2014-06-25 |
JP6029674B2 (ja) | 2016-11-24 |
ES2595160T3 (es) | 2016-12-28 |
AU2012318303A1 (en) | 2013-05-02 |
JP2014532076A (ja) | 2014-12-04 |
EP2768521B1 (en) | 2016-07-13 |
US9511123B2 (en) | 2016-12-06 |
WO2013057171A9 (en) | 2014-04-03 |
EP2768521A1 (en) | 2014-08-27 |
WO2013057171A1 (en) | 2013-04-25 |
US20150023946A1 (en) | 2015-01-22 |
KR20140083035A (ko) | 2014-07-03 |
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