JPH11507072A - ボツリヌス毒素またはボツリヌス神経毒の薬学的組成物および製造方法 - Google Patents
ボツリヌス毒素またはボツリヌス神経毒の薬学的組成物および製造方法Info
- Publication number
- JPH11507072A JPH11507072A JP9534359A JP53435997A JPH11507072A JP H11507072 A JPH11507072 A JP H11507072A JP 9534359 A JP9534359 A JP 9534359A JP 53435997 A JP53435997 A JP 53435997A JP H11507072 A JPH11507072 A JP H11507072A
- Authority
- JP
- Japan
- Prior art keywords
- botulinum
- toxin
- composition
- compound
- neurotoxin
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
Links
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
- A61K9/0012—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
- 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
- A61K38/4893—Botulinum neurotoxin (3.4.24.69)
-
- 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
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
- A61P21/02—Muscle relaxants, e.g. for tetanus or cramps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/08—Antiepileptics; Anticonvulsants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- 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
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic 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
- A61K47/26—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
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
-
- 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
- Y10S530/82—Proteins from microorganisms
- Y10S530/825—Bacteria
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Immunology (AREA)
- Neurology (AREA)
- Gastroenterology & Hepatology (AREA)
- Pain & Pain Management (AREA)
- Physical Education & Sports Medicine (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Ophthalmology & Optometry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
Description
Claims (1)
- 【特許請求の範囲】 1.(a)ボツリヌス毒性を有する化合物と; (b)安定化タンパク質と; (c)多糖類糖質と; (d)チオアルキル化合物; とを含んでなり、チオアルキル化合物は、室温以上の温度で化合物の変性を防ぐ のに有効な量存在する、凍結乾燥した固体薬学的組成物。 2.安定化タンパク質がヒト血清アルブミンである請求項1記載の組成物。 3.チオアルキル化合物がメチオニンおよびシステインから選択される請求項1 記載の組成物。 4.多糖類糖質がトレハロースである請求項1記載の組成物。 5.ボツリヌス毒性を有する化合物がA型ボツリヌス神経毒である請求項1記載 の組成物。 6.ボツリヌス毒性を有する化合物がA型ボツリヌス毒素複合体である請求項1 記載の組成物。 7.純粋なA型ボツリヌス神経毒、および室温における組成物の保存安定性を高 めるのに有効な量のトレハロースおよびメチオニンを含んでなる室温で4カ月ま で効力を失わずに安定であるボツリヌス神経毒の凍結乾燥した固体薬学的組成物 。 8.ボツリヌス毒性を有するメンバーと、安定化タンパク質と、多糖類糖質と、 チオアルキル化合物と水とを含む予備凍結乾燥処方を作り、その処方を凍結乾燥 し、水を除去して凍結乾燥した固体組成 物を得ることを含んでなる請求項1記載の凍結乾燥した固体組成物の製造方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/624,771 US5756468A (en) | 1994-10-13 | 1996-03-27 | Pharmaceutical compositions of botulinum toxin or botulinum neurotoxin and methods of preparation |
US08/624,771 | 1996-03-27 | ||
PCT/US1996/014756 WO1997035604A1 (en) | 1996-03-27 | 1996-09-16 | Pharmaceutical compositions of botulinum toxin or botulinum neurotoxin and methods of preparation |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH11507072A true JPH11507072A (ja) | 1999-06-22 |
JP3364658B2 JP3364658B2 (ja) | 2003-01-08 |
Family
ID=24503247
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP53435997A Expired - Lifetime JP3364658B2 (ja) | 1996-03-27 | 1996-09-16 | ボツリヌス毒素またはボツリヌス神経毒の薬学的組成物および製造方法 |
Country Status (8)
Country | Link |
---|---|
US (1) | US5756468A (ja) |
EP (1) | EP0889730B1 (ja) |
JP (1) | JP3364658B2 (ja) |
AT (1) | ATE210453T1 (ja) |
AU (1) | AU7159496A (ja) |
CA (1) | CA2250251C (ja) |
DE (1) | DE69618018T2 (ja) |
WO (1) | WO1997035604A1 (ja) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2004256545A (ja) * | 2000-02-08 | 2004-09-16 | Allergan Inc | ボツリヌス毒素医薬組成物 |
JP2006502116A (ja) * | 2002-07-12 | 2006-01-19 | メダレックス, インク. | タンパク質の酸化分解を防ぐ方法及び組成物 |
JP2010070493A (ja) * | 2008-09-18 | 2010-04-02 | Kagoshima Univ | 抗菌剤およびその製造方法、化粧料ならびに医薬品 |
JP2010532784A (ja) * | 2007-07-10 | 2010-10-14 | メディ‐トックス、インク. | ボツリヌス毒素の安定性が改善された薬学的液状組成物 |
JP2011506511A (ja) * | 2007-12-21 | 2011-03-03 | メルツ・ファルマ・ゲーエムベーハー・ウント・コ・カーゲーアーアー | 副作用を軽減または防止するためのボツリヌス菌毒素複合体の神経毒成分の使用 |
JPWO2009123174A1 (ja) * | 2008-03-31 | 2011-07-28 | 一般財団法人化学及血清療法研究所 | A2型ボツリヌス神経毒素製剤 |
JP2014509644A (ja) * | 2011-03-31 | 2014-04-21 | メディ−トックス インク | ボツリヌム毒素の凍結乾燥製剤 |
WO2015076285A1 (ja) * | 2013-11-21 | 2015-05-28 | 協和メデックス株式会社 | 血清又は血漿中の低密度リポ蛋白の凍結乾燥による変性抑制剤及び変性抑制方法 |
JP2017088611A (ja) * | 2005-10-06 | 2017-05-25 | アラーガン、インコーポレイテッドAllergan,Incorporated | 非タンパク質安定化クロストリジウム毒素医薬組成物 |
US10973890B2 (en) | 2016-09-13 | 2021-04-13 | Allergan, Inc. | Non-protein clostridial toxin compositions |
US11033625B2 (en) | 2005-10-06 | 2021-06-15 | Allergan, Inc. | Method for stabilizing a toxin |
Families Citing this family (50)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2340299A (en) | 1998-01-26 | 1999-08-09 | University Of Massachusetts | Biologically active hemagglutinin from type a (clostridium botulinum) and methods of use |
TW574036B (en) * | 1998-09-11 | 2004-02-01 | Elan Pharm Inc | Stable liquid compositions of botulinum toxin |
DE19856897A1 (de) * | 1998-12-10 | 2000-06-15 | Biotecon Ges Fuer Biotechnologische Entwicklung & Consulting Mbh | Therapeutikum zur Unterdrückung von Schnarchgeräuschen |
DE19925739A1 (de) | 1999-06-07 | 2000-12-21 | Biotecon Ges Fuer Biotechnologische Entwicklung & Consulting Mbh | Therapeutikum mit einem Botulinum-Neurotoxin |
US7780967B2 (en) * | 2000-02-08 | 2010-08-24 | Allergan, Inc. | Reduced toxicity Clostridial toxin pharmaceutical compositions |
US20060269575A1 (en) * | 2000-02-08 | 2006-11-30 | Allergan, Inc. | Botulinum toxin pharmaceutical compositions formulated with recombinant albumin |
US20030118598A1 (en) * | 2000-02-08 | 2003-06-26 | Allergan, Inc. | Clostridial toxin pharmaceutical compositions |
AU2008201176B2 (en) * | 2000-02-08 | 2009-10-22 | Allergan, Inc. | Botulinum toxin pharmaceutical compositions |
US8632785B2 (en) * | 2000-02-08 | 2014-01-21 | Allergan, Inc. | Clostridial toxin pharmaceutical composition containing a gelatin fragment |
AU2005203171B2 (en) * | 2000-02-08 | 2007-12-13 | Allergan, Inc. | Botulinum toxin pharmaceutical compositions |
US6579847B1 (en) | 2000-05-01 | 2003-06-17 | Imarx Therapeutics Inc. | Method and apparatus for vascular neuromuscular blockade |
US20040220100A1 (en) * | 2000-07-21 | 2004-11-04 | Essentia Biosystems, Inc. | Multi-component biological transport systems |
AU8466501A (en) * | 2000-07-21 | 2002-02-05 | Essentia Biosystems Inc | Multi-component biological transport systems |
AU2003221050A1 (en) * | 2002-03-29 | 2003-10-13 | Juridical Foundation The Chemo-Sero-Therapeutic Research Institute | Remedy for hypermyotonia |
US7691394B2 (en) | 2002-05-28 | 2010-04-06 | Botulinum Toxin Research Associates, Inc. | High-potency botulinum toxin formulations |
US7459164B2 (en) * | 2002-05-28 | 2008-12-02 | Botulinum Toxin Research Associates, Inc. | Composition for therapeutic and cosmetic botulinum toxin |
US20040009180A1 (en) * | 2002-07-11 | 2004-01-15 | Allergan, Inc. | Transdermal botulinum toxin compositions |
BR0316871A (pt) * | 2002-12-20 | 2005-10-18 | Botulinum Toxin Res Ass Inc | Composições farmacêuticas aperfeiçoadas de toxina botulìnica |
SG150570A1 (en) * | 2004-03-03 | 2009-03-30 | Revance Therapeutics Inc | Compositions and methods for topical diagnostic and therapeutic transport |
US9211248B2 (en) | 2004-03-03 | 2015-12-15 | Revance Therapeutics, Inc. | Compositions and methods for topical application and transdermal delivery of botulinum toxins |
ES2691498T3 (es) | 2004-03-03 | 2018-11-27 | Revance Therapeutics, Inc. | Aplicación tópica y liberación transdérmica de toxinas botulínicas |
GB2416122A (en) | 2004-07-12 | 2006-01-18 | Ipsen Ltd | Botulinum neurotoxin composition |
CA2578250C (en) | 2004-07-26 | 2013-03-05 | Merz Pharma Gmbh & Co. Kgaa | Therapeutic composition with a botulinum neurotoxin |
EP1776137B1 (en) | 2004-08-04 | 2014-11-26 | Ipsen Biopharm Limited | Pharmaceutical composition containing botulinum neurotoxin a2 |
EP1778279B1 (en) * | 2004-08-04 | 2014-12-03 | Ipsen Biopharm Limited | Pharmaceutical composition containing botulinum neurotoxin a2 |
ZA200707351B (en) | 2005-03-03 | 2010-02-24 | Revance Therapeutics Inc | Compositions and methods for topical application and transdermal delivery of an oligopeptide |
CN102499981B (zh) | 2005-03-03 | 2016-08-03 | 雷文斯治疗公司 | 用于局部施用和经皮肤递送肉毒杆菌毒素的组合物和方法 |
US8323666B2 (en) | 2005-08-01 | 2012-12-04 | Allergan, Inc. | Botulinum toxin compositions |
US7910116B2 (en) * | 2005-08-24 | 2011-03-22 | Allergan, Inc. | Use of a botulinum toxin to improve gastric emptying and/or to treat GERD |
US7744904B1 (en) * | 2005-09-26 | 2010-06-29 | B.B. Scientific L.L.C. | Stabilization of Clostridium botulinum neurotoxin complex |
BRPI0618753A2 (pt) * | 2005-11-17 | 2011-09-13 | Revance Therapeutics Inc | composição para liberação transdérmica de toxina botulìnica e método de administração |
PT2085093E (pt) * | 2006-10-27 | 2015-06-26 | Chemo Sero Therapeut Res Inst | Preparação que contém uma toxina botulínica tipo a altamente purificada derivada de um agente patogénico do botulismo infantil |
US20100021502A1 (en) * | 2006-12-28 | 2010-01-28 | Waugh Jacob M | Compositions and Methods of Topical Application and Transdermal Delivery of Botulinum Toxins Stabililzed with Polypeptide Fragments Derived from HIV-TAT |
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KR20090096735A (ko) * | 2006-12-29 | 2009-09-14 | 레반스 테라퓨틱스, 아이엔씨. | Hiv-tat로부터 유래된 폴리펩티드 단편에 의해 안정화된 보툴리눔 독소의 국소 적용 및 경피 전달용 조성물 및 방법 |
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WO2010096134A1 (en) | 2008-12-04 | 2010-08-26 | Botulinum Toxin Research Associates, Inc. | Extended length botulinum toxin formulation for human or mammalian use |
KR102005930B1 (ko) | 2008-12-31 | 2019-07-31 | 레반스 테라퓨틱스, 아이엔씨. | 주사용 보툴리눔 독소 제제 |
CN102869373B (zh) | 2009-06-25 | 2017-05-10 | 雷文斯治疗公司 | 不含白蛋白的肉毒杆菌毒素制剂 |
US8129139B2 (en) | 2009-07-13 | 2012-03-06 | Allergan, Inc. | Process for obtaining botulinum neurotoxin |
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US11484580B2 (en) | 2014-07-18 | 2022-11-01 | Revance Therapeutics, Inc. | Topical ocular preparation of botulinum toxin for use in ocular surface disease |
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Publication number | Priority date | Publication date | Assignee | Title |
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CA2138020C (en) * | 1992-06-23 | 1999-02-16 | Eric A. Johnson | Pharmaceutical composition containing botulinum b complex |
EP0593176A3 (en) * | 1992-09-28 | 1995-03-01 | Wisconsin Alumni Res Found | Pharmaceutical compositions containing botulinum toxin and method of manufacture. |
US5437291A (en) * | 1993-08-26 | 1995-08-01 | Univ Johns Hopkins | Method for treating gastrointestinal muscle disorders and other smooth muscle dysfunction |
US5512547A (en) * | 1994-10-13 | 1996-04-30 | Wisconsin Alumni Research Foundation | Pharmaceutical composition of botulinum neurotoxin and method of preparation |
-
1996
- 1996-03-27 US US08/624,771 patent/US5756468A/en not_active Expired - Lifetime
- 1996-09-16 JP JP53435997A patent/JP3364658B2/ja not_active Expired - Lifetime
- 1996-09-16 AT AT96933019T patent/ATE210453T1/de not_active IP Right Cessation
- 1996-09-16 CA CA002250251A patent/CA2250251C/en not_active Expired - Lifetime
- 1996-09-16 EP EP96933019A patent/EP0889730B1/en not_active Expired - Lifetime
- 1996-09-16 DE DE69618018T patent/DE69618018T2/de not_active Expired - Lifetime
- 1996-09-16 AU AU71594/96A patent/AU7159496A/en not_active Abandoned
- 1996-09-16 WO PCT/US1996/014756 patent/WO1997035604A1/en active IP Right Grant
Cited By (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2011251988A (ja) * | 2000-02-08 | 2011-12-15 | Allergan Inc | ボツリヌス毒素医薬組成物 |
JP2004256545A (ja) * | 2000-02-08 | 2004-09-16 | Allergan Inc | ボツリヌス毒素医薬組成物 |
JP2012031194A (ja) * | 2000-02-08 | 2012-02-16 | Allergan Inc | ボツリヌス毒素医薬組成物 |
JP2006502116A (ja) * | 2002-07-12 | 2006-01-19 | メダレックス, インク. | タンパク質の酸化分解を防ぐ方法及び組成物 |
US11446382B2 (en) | 2005-10-06 | 2022-09-20 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
US11524075B2 (en) | 2005-10-06 | 2022-12-13 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
US11033625B2 (en) | 2005-10-06 | 2021-06-15 | Allergan, Inc. | Method for stabilizing a toxin |
US11285216B2 (en) | 2005-10-06 | 2022-03-29 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
US11147878B2 (en) | 2005-10-06 | 2021-10-19 | Allergan, Inc. | Animal protein-free pharmaceutical compositions |
JP2017088611A (ja) * | 2005-10-06 | 2017-05-25 | アラーガン、インコーポレイテッドAllergan,Incorporated | 非タンパク質安定化クロストリジウム毒素医薬組成物 |
JP2010532784A (ja) * | 2007-07-10 | 2010-10-14 | メディ‐トックス、インク. | ボツリヌス毒素の安定性が改善された薬学的液状組成物 |
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US10973890B2 (en) | 2016-09-13 | 2021-04-13 | Allergan, Inc. | Non-protein clostridial toxin compositions |
Also Published As
Publication number | Publication date |
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US5756468A (en) | 1998-05-26 |
CA2250251C (en) | 2001-11-06 |
DE69618018T2 (de) | 2002-05-16 |
JP3364658B2 (ja) | 2003-01-08 |
WO1997035604A1 (en) | 1997-10-02 |
AU7159496A (en) | 1997-10-17 |
EP0889730B1 (en) | 2001-12-12 |
CA2250251A1 (en) | 1997-10-02 |
DE69618018D1 (de) | 2002-01-24 |
EP0889730A1 (en) | 1999-01-13 |
ATE210453T1 (de) | 2001-12-15 |
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