DK2654770T3 - PHARMACEUTICAL COMPOSITIONS OF TENECTEPLACE - Google Patents
PHARMACEUTICAL COMPOSITIONS OF TENECTEPLACE Download PDFInfo
- Publication number
- DK2654770T3 DK2654770T3 DK11851346.4T DK11851346T DK2654770T3 DK 2654770 T3 DK2654770 T3 DK 2654770T3 DK 11851346 T DK11851346 T DK 11851346T DK 2654770 T3 DK2654770 T3 DK 2654770T3
- Authority
- DK
- Denmark
- Prior art keywords
- tnk
- composition
- formulations
- treatment
- use according
- Prior art date
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 8
- 239000000203 mixture Substances 0.000 claims description 39
- 208000032382 Ischaemic stroke Diseases 0.000 claims description 34
- 238000011282 treatment Methods 0.000 claims description 31
- 230000010412 perfusion Effects 0.000 claims description 13
- 238000000855 fermentation Methods 0.000 claims description 12
- 230000004151 fermentation Effects 0.000 claims description 12
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 10
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims description 10
- 208000006011 Stroke Diseases 0.000 claims description 7
- 239000000872 buffer Substances 0.000 claims description 6
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 5
- ODKSFYDXXFIFQN-BYPYZUCNSA-N L-arginine Chemical compound OC(=O)[C@@H](N)CCCN=C(N)N ODKSFYDXXFIFQN-BYPYZUCNSA-N 0.000 claims description 4
- 229930064664 L-arginine Natural products 0.000 claims description 4
- 235000014852 L-arginine Nutrition 0.000 claims description 4
- 108010039185 Tenecteplase Proteins 0.000 claims description 4
- 229960000216 tenecteplase Drugs 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 238000002347 injection Methods 0.000 claims description 2
- 239000007924 injection Substances 0.000 claims description 2
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- 238000009472 formulation Methods 0.000 description 32
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- 238000000034 method Methods 0.000 description 21
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- 229940068977 polysorbate 20 Drugs 0.000 description 6
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- 229910000162 sodium phosphate Inorganic materials 0.000 description 6
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 6
- 102000013566 Plasminogen Human genes 0.000 description 5
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- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 4
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- UZOVYGYOLBIAJR-UHFFFAOYSA-N 4-isocyanato-4'-methyldiphenylmethane Chemical compound C1=CC(C)=CC=C1CC1=CC=C(N=C=O)C=C1 UZOVYGYOLBIAJR-UHFFFAOYSA-N 0.000 description 3
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- BWGVNKXGVNDBDI-UHFFFAOYSA-N Fibrin monomer Chemical compound CNC(=O)CNC(=O)CN BWGVNKXGVNDBDI-UHFFFAOYSA-N 0.000 description 3
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- SLXKOJJOQWFEFD-UHFFFAOYSA-N 6-aminohexanoic acid Chemical compound NCCCCCC(O)=O SLXKOJJOQWFEFD-UHFFFAOYSA-N 0.000 description 2
- 241000699802 Cricetulus griseus Species 0.000 description 2
- 108020004414 DNA Proteins 0.000 description 2
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- 108010088842 Fibrinolysin Proteins 0.000 description 2
- 101000801481 Homo sapiens Tissue-type plasminogen activator Proteins 0.000 description 2
- 108091028043 Nucleic acid sequence Proteins 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 2
- 108010023197 Streptokinase Proteins 0.000 description 2
- 108700005078 Synthetic Genes Proteins 0.000 description 2
- 108090000435 Urokinase-type plasminogen activator Proteins 0.000 description 2
- 102000003990 Urokinase-type plasminogen activator Human genes 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 2
- VREFGVBLTWBCJP-UHFFFAOYSA-N alprazolam Chemical compound C12=CC(Cl)=CC=C2N2C(C)=NN=C2CN=C1C1=CC=CC=C1 VREFGVBLTWBCJP-UHFFFAOYSA-N 0.000 description 2
- 229960002684 aminocaproic acid Drugs 0.000 description 2
- 238000002306 biochemical method Methods 0.000 description 2
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- 238000001641 gel filtration chromatography Methods 0.000 description 2
- 238000002523 gelfiltration Methods 0.000 description 2
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- 230000036512 infertility Effects 0.000 description 2
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- 229960005202 streptokinase Drugs 0.000 description 2
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- 239000013598 vector Substances 0.000 description 2
- 239000004475 Arginine Substances 0.000 description 1
- 102220487491 Arylsulfatase H_N117Q_mutation Human genes 0.000 description 1
- 108010077805 Bacterial Proteins Proteins 0.000 description 1
- 102220486713 Cytochrome b-245 chaperone 1_K296A_mutation Human genes 0.000 description 1
- 238000001712 DNA sequencing Methods 0.000 description 1
- 206010014523 Embolism and thrombosis Diseases 0.000 description 1
- 241001646716 Escherichia coli K-12 Species 0.000 description 1
- 108700028146 Genetic Enhancer Elements Proteins 0.000 description 1
- 102000003886 Glycoproteins Human genes 0.000 description 1
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- 101000605403 Homo sapiens Plasminogen Proteins 0.000 description 1
- 125000001176 L-lysyl group Chemical class [H]N([H])[C@]([H])(C(=O)[*])C([H])([H])C([H])([H])C([H])([H])C(N([H])[H])([H])[H] 0.000 description 1
- 239000004472 Lysine Substances 0.000 description 1
- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
- 102220475235 Probable C-mannosyltransferase DPY19L1_H297A_mutation Human genes 0.000 description 1
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- 239000012507 Sephadex™ Substances 0.000 description 1
- 229920002684 Sepharose Polymers 0.000 description 1
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical class [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 1
- 108090000190 Thrombin Proteins 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 108090000631 Trypsin Proteins 0.000 description 1
- 102000004142 Trypsin Human genes 0.000 description 1
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 1
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- 150000001450 anions Chemical class 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 description 1
- 235000009697 arginine Nutrition 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
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- 238000011065 in-situ storage Methods 0.000 description 1
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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
- A61K38/43—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)
-
- 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
- A61K47/26—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
- A61K9/14—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
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- 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)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21068—Tissue plasminogen activator (3.4.21.68), i.e. tPA
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Gastroenterology & Hepatology (AREA)
- Immunology (AREA)
- Zoology (AREA)
- Dermatology (AREA)
- General Engineering & Computer Science (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Inorganic Chemistry (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Peptides Or Proteins (AREA)
- Enzymes And Modification Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicinal Preparation (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IN3516MU2010 | 2010-12-23 | ||
| PCT/IN2011/000863 WO2012085933A1 (en) | 2010-12-23 | 2011-12-16 | Pharmaceutical compositions of tenecteplase |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2654770T3 true DK2654770T3 (en) | 2018-10-29 |
Family
ID=46313261
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK11851346.4T DK2654770T3 (en) | 2010-12-23 | 2011-12-16 | PHARMACEUTICAL COMPOSITIONS OF TENECTEPLACE |
Country Status (17)
| Country | Link |
|---|---|
| US (2) | US20130323227A1 (enExample) |
| EP (1) | EP2654770B1 (enExample) |
| JP (1) | JP6375112B2 (enExample) |
| CN (1) | CN103391785A (enExample) |
| AU (1) | AU2011346515B2 (enExample) |
| BR (1) | BR112013015914B1 (enExample) |
| CO (1) | CO6721059A2 (enExample) |
| DK (1) | DK2654770T3 (enExample) |
| EA (1) | EA026017B1 (enExample) |
| ES (1) | ES2687850T3 (enExample) |
| LT (1) | LT2654770T (enExample) |
| MX (1) | MX356199B (enExample) |
| MY (1) | MY171723A (enExample) |
| NZ (1) | NZ611706A (enExample) |
| PL (1) | PL2654770T3 (enExample) |
| PT (1) | PT2654770T (enExample) |
| WO (1) | WO2012085933A1 (enExample) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DK3209767T3 (da) * | 2014-10-21 | 2020-11-02 | Gennova Biopharmaceuticals Ltd | Hidtil ukendt oprensningsfremgangsmåde til isolering og kommerciel fremstilling af rekombinant tnk-tpa (tenecteplase) |
| WO2018210860A1 (en) * | 2017-05-16 | 2018-11-22 | INSERM (Institut National de la Santé et de la Recherche Médicale) | Methods and pharmaceutical compositions for the treatment of acute ischemic stroke |
| WO2019229764A1 (en) * | 2018-06-01 | 2019-12-05 | Gennova Biopharmaceuticals Limited | Process for production of recombinant tnk-tpa by packed-bed perfusion system |
| CN114984197A (zh) * | 2022-07-01 | 2022-09-02 | 江苏丰华生物制药有限公司 | 替奈普酶在制备用于治疗急性缺血性卒中的药物组合物中的应用 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10230752A1 (de) * | 2002-07-09 | 2004-01-22 | Boehringer Ingelheim Pharma Gmbh & Co. Kg | Neue Arzneimittelkompositionen auf der Basis von Magnesiumsalzen und Fibrinolytika |
| US20070014779A1 (en) * | 2002-11-14 | 2007-01-18 | Genentech, Inc. | Plasminogen activator variant formulations |
| US20070166299A1 (en) * | 2005-03-02 | 2007-07-19 | The Regents Of The University Of California | Treatment for embolic stroke |
| WO2006094120A2 (en) * | 2005-03-02 | 2006-09-08 | The Regents Of The University Of California | Treatment for embolic stroke |
| TWI439282B (zh) * | 2006-08-29 | 2014-06-01 | Genentech Inc | 以血栓溶解劑治療中風之方法 |
| WO2008070353A2 (en) * | 2006-11-07 | 2008-06-12 | Genentech, Inc. | Tissue plasminogen activator variant uses |
| EP2014760A1 (en) * | 2007-06-13 | 2009-01-14 | CMC Biopharmaceuticals A/S | A method for producing a biopolymer (e.g. polypeptide) in a continuous fermentation process |
-
2011
- 2011-12-16 EP EP11851346.4A patent/EP2654770B1/en active Active
- 2011-12-16 CN CN2011800675266A patent/CN103391785A/zh active Pending
- 2011-12-16 PT PT11851346T patent/PT2654770T/pt unknown
- 2011-12-16 US US13/993,297 patent/US20130323227A1/en not_active Abandoned
- 2011-12-16 EA EA201300746A patent/EA026017B1/ru unknown
- 2011-12-16 JP JP2013545634A patent/JP6375112B2/ja active Active
- 2011-12-16 AU AU2011346515A patent/AU2011346515B2/en active Active
- 2011-12-16 ES ES11851346.4T patent/ES2687850T3/es active Active
- 2011-12-16 DK DK11851346.4T patent/DK2654770T3/en active
- 2011-12-16 MY MYPI2013002136A patent/MY171723A/en unknown
- 2011-12-16 NZ NZ611706A patent/NZ611706A/en unknown
- 2011-12-16 BR BR112013015914-6A patent/BR112013015914B1/pt active IP Right Grant
- 2011-12-16 LT LTEP11851346.4T patent/LT2654770T/lt unknown
- 2011-12-16 MX MX2013007381A patent/MX356199B/es active IP Right Grant
- 2011-12-16 PL PL11851346T patent/PL2654770T3/pl unknown
- 2011-12-16 WO PCT/IN2011/000863 patent/WO2012085933A1/en not_active Ceased
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2013
- 2013-07-05 CO CO13159374A patent/CO6721059A2/es unknown
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2016
- 2016-04-22 US US15/136,614 patent/US9943575B2/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| WO2012085933A1 (en) | 2012-06-28 |
| BR112013015914B1 (pt) | 2021-06-08 |
| LT2654770T (lt) | 2018-09-10 |
| MY171723A (en) | 2019-10-24 |
| US20160310580A1 (en) | 2016-10-27 |
| AU2011346515A1 (en) | 2013-07-04 |
| EP2654770B1 (en) | 2018-07-11 |
| NZ611706A (en) | 2015-04-24 |
| ES2687850T3 (es) | 2018-10-29 |
| MX2013007381A (es) | 2013-08-29 |
| EA026017B1 (ru) | 2017-02-28 |
| JP2014502608A (ja) | 2014-02-03 |
| US20130323227A1 (en) | 2013-12-05 |
| CN103391785A (zh) | 2013-11-13 |
| EP2654770A4 (en) | 2014-05-21 |
| US9943575B2 (en) | 2018-04-17 |
| MX356199B (es) | 2018-05-18 |
| EA201300746A1 (ru) | 2013-11-29 |
| PL2654770T3 (pl) | 2018-12-31 |
| EP2654770A1 (en) | 2013-10-30 |
| JP6375112B2 (ja) | 2018-08-15 |
| BR112013015914A2 (pt) | 2016-10-11 |
| CO6721059A2 (es) | 2013-07-31 |
| PT2654770T (pt) | 2018-10-19 |
| AU2011346515B2 (en) | 2017-01-19 |
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