WO2001093827B1 - Neurotoxin implant - Google Patents

Neurotoxin implant

Info

Publication number
WO2001093827B1
WO2001093827B1 PCT/US2001/017164 US0117164W WO0193827B1 WO 2001093827 B1 WO2001093827 B1 WO 2001093827B1 US 0117164 W US0117164 W US 0117164W WO 0193827 B1 WO0193827 B1 WO 0193827B1
Authority
WO
WIPO (PCT)
Prior art keywords
neurotoxin
release system
controlled release
polymeric matrix
botulinum toxin
Prior art date
Application number
PCT/US2001/017164
Other languages
French (fr)
Other versions
WO2001093827A3 (en
WO2001093827A2 (en
Inventor
Stephen Donovan
Daniel G Brady
Original Assignee
Allergan Sales Inc
Stephen Donovan
Daniel G Brady
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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24349017&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2001093827(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to DE60118550T priority Critical patent/DE60118550T2/en
Priority to AU2001272927A priority patent/AU2001272927B8/en
Priority to BR0111300-3A priority patent/BR0111300A/en
Priority to JP2002501400A priority patent/JP2003535117A/en
Priority to AU7292701A priority patent/AU7292701A/en
Application filed by Allergan Sales Inc, Stephen Donovan, Daniel G Brady filed Critical Allergan Sales Inc
Priority to EP01952135A priority patent/EP1289504B1/en
Priority to KR1020027016251A priority patent/KR100732810B1/en
Priority to NZ522611A priority patent/NZ522611A/en
Priority to CA002411277A priority patent/CA2411277C/en
Publication of WO2001093827A2 publication Critical patent/WO2001093827A2/en
Publication of WO2001093827A3 publication Critical patent/WO2001093827A3/en
Publication of WO2001093827B1 publication Critical patent/WO2001093827B1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/4886Metalloendopeptidases (3.4.24), e.g. collagenase
    • A61K38/4893Botulinum neurotoxin (3.4.24.69)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • A61P21/02Muscle relaxants, e.g. for tetanus or cramps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/14Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia

Abstract

A biocompatible implant for continuous in vivo release of a neurotoxin over a treatment period extending from one month to five years. The implant can be made of casting a solution of a polymer, such as an ethyl vinyl acetate copolymer and the neurotoxin. The neurotoxin can be a botulinum toxin.

Claims

AMENDED CLAIMS
[received by the International Bureau on 07 January 2002 (07.01.02);
Claims 1, 3, 4, 16, 17 and 19 have been replaced by amended claims bearing the same numbers, and all other claims remain unchanged;
(4 pages)]
1. A controlled release system, comprising:
(a) a polymeric matrix, and:
(b) a quantity of neurotoxin located within the polymeric matrix, wherein fractional amounts of the neurotoxin can be released from the polymeric matrix over a prolonged period of time without a significant immune response.
2. The controlled release system of claim 1 , wherein neurotoxin is released from the polymeric matrix in a substantially continuous or monophasic manner.
3. The controlled release system of claim 1 , wherein the prolonged period of time during which neurotoxin is released from the polymeric matrix extends over a period of time of from about 10 days to about 6 years.
4. The controlled release system of claim 1 , wherein the polymeric matrix is comprised of a substance which is non-biodegradable.
5. The controlled release system of claim 1 , wherein the neurotoxin comprises a polypeptide.
6. The controlled release system of claim 1 , wherein the neurotoxin comprises a presynaptic neurotoxin.
7. The controlled release system of claim 1 , wherein the neurotoxin is a Clostridial neurotoxin.
8. The controlled release system of claim 1 , wherein the neurotoxin is a botulinum toxin.
57
. The controlled release system of claim 1 , wherein the neurotoxin is a botulinum toxin selected from the group consisting of botulinum toxin types A, B, Cι, D, E, F and G.
10. The controlled release system of claim 1 , wherein the neurotoxin is a botulinum toxin type A.
11. The controlled release system of claim 1 , wherein the polymer which comprises the polymeric matrix is selected from the group consisting of methacrylate, vinyl pyrrolidone, vinyl alcohol, acrylic acid, polymethylmethacrylate, siloxane, vinyl acetate, lactic acid, glycolic acid, collagen, and bioceramic polymers and copolymers thereof.
12. The controlled release system of claim 1 , wherein the quantity of the neurotoxin is between about 1 unit and about 50,000 units of a botulinum toxin.
13. The controlled release system of claim 1 , wherein the quantity of the neurotoxin is between about 10 units and about 2,000 units of a botulinum toxin type A.
14. The controlled release system of claim 1 , wherein the quantity of the neurotoxin is between about 100 units and about 30,000 units of a botulinum toxin type B.
15. The controlled release system of claim 1 wherein the neurotoxin is a botulinum toxin which is released in an amount effective to cause flaccid muscular paralysis of a muscle or muscle group at or in the vicinity of the implanted system.
58
16. A controlled release system, comprising:
(a) a polymeric matrix, and;
(b) between about 10 units and about 20,000 units of a botulinum toxin within the polymeric matrix, wherein fractional amounts of the botulinum toxin can be released from the polymeric matrix over a prolonged period of time extending from about 2 months to about 5 years without a significant immune response.
17. A method for making a controlled release system which will not induce a significant immune response, the method comprising the steps of:
(a) dissolving a polymer in a solvent to form a polymer solution;
(b) mixing or dispersing a neurotoxin in the polymer solution to form a polymer-neurotoxin mixture, and;
(c) allowing the polymer-neurotoxin mixture to set or cure, thereby making a controlled release system.
18. The method of claim 17, further comprising the step after the mixing step of evaporating solvent.
19. Use of a continuous release system which includes a polymeric matrix and a neurotoxin in the manufacture of a medicament for treating a movement disorder or a disorder influenced by cholinergic innervation by injecting or implanting the continuous release system into a patient without causing a significant immune response.
59
0. A method for making a metal cation-complexed neurotoxin comprising the steps of:
(a) forming a solution containing a neurotoxin;
(b) mixing a multivalent metal cation component with the neurotoxin solution to complex the multivalent metal cation with the neurotoxin, thereby forming a metal cation-complexed neurotoxin suspension, and;
(c) drying said suspension to form the metal cation-complexed neurotoxin.
60
PCT/US2001/017164 2000-06-02 2001-05-25 Neurotoxin implant WO2001093827A2 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
CA002411277A CA2411277C (en) 2000-06-02 2001-05-25 Neurotoxin implant
AU2001272927A AU2001272927B8 (en) 2000-06-02 2001-05-25 Neurotoxin implant
BR0111300-3A BR0111300A (en) 2000-06-02 2001-05-25 Neurotoxin Implant
JP2002501400A JP2003535117A (en) 2000-06-02 2001-05-25 Neurotoxin implant
AU7292701A AU7292701A (en) 2000-06-02 2001-05-25 Neurotoxin implant
DE60118550T DE60118550T2 (en) 2000-06-02 2001-05-25 Neurotoxin implant
EP01952135A EP1289504B1 (en) 2000-06-02 2001-05-25 Neurotoxin implant
KR1020027016251A KR100732810B1 (en) 2000-06-02 2001-05-25 Neurotoxin implant
NZ522611A NZ522611A (en) 2000-06-02 2001-05-25 Controlled release botulinum toxin delivery system in the form of an implant

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/587,250 2000-06-02
US09/587,250 US6306423B1 (en) 2000-06-02 2000-06-02 Neurotoxin implant

Publications (3)

Publication Number Publication Date
WO2001093827A2 WO2001093827A2 (en) 2001-12-13
WO2001093827A3 WO2001093827A3 (en) 2002-03-14
WO2001093827B1 true WO2001093827B1 (en) 2002-05-10

Family

ID=24349017

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2001/017166 WO2001093890A2 (en) 2000-06-02 2001-05-25 Botulinum toxin implant
PCT/US2001/017164 WO2001093827A2 (en) 2000-06-02 2001-05-25 Neurotoxin implant

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2001/017166 WO2001093890A2 (en) 2000-06-02 2001-05-25 Botulinum toxin implant

Country Status (15)

Country Link
US (5) US6306423B1 (en)
EP (2) EP1289504B1 (en)
JP (2) JP2003535117A (en)
KR (1) KR100732810B1 (en)
CN (1) CN100536915C (en)
AR (1) AR028669A1 (en)
AT (1) ATE322251T1 (en)
AU (3) AU2001265043A1 (en)
BR (1) BR0111300A (en)
CA (1) CA2411277C (en)
DE (1) DE60118550T2 (en)
ES (1) ES2259665T3 (en)
NZ (1) NZ522611A (en)
TW (1) TWI250020B (en)
WO (2) WO2001093890A2 (en)

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