CA2294101A1 - A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor - Google Patents

A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor Download PDF

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Publication number
CA2294101A1
CA2294101A1 CA002294101A CA2294101A CA2294101A1 CA 2294101 A1 CA2294101 A1 CA 2294101A1 CA 002294101 A CA002294101 A CA 002294101A CA 2294101 A CA2294101 A CA 2294101A CA 2294101 A1 CA2294101 A1 CA 2294101A1
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CA
Canada
Prior art keywords
parathyroid hormone
administration
months
approximately
bone resorption
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
Application number
CA002294101A
Other languages
French (fr)
Other versions
CA2294101C (en
Inventor
John Dietrich
Sverker Ljunghall
Sven Sjogren
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shire NPS Pharmaceuticals Inc
Original Assignee
Allelix Biopharmaceuticals Inc.
John Dietrich
Sverker Ljunghall
Sven Sjogren
Nps Allelix Corp.
Nps Pharmaceuticals, Inc.
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
Application filed by Allelix Biopharmaceuticals Inc., John Dietrich, Sverker Ljunghall, Sven Sjogren, Nps Allelix Corp., Nps Pharmaceuticals, Inc. filed Critical Allelix Biopharmaceuticals Inc.
Priority to CA2698626A priority Critical patent/CA2698626C/en
Publication of CA2294101A1 publication Critical patent/CA2294101A1/en
Application granted granted Critical
Publication of CA2294101C publication Critical patent/CA2294101C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/29—Parathyroid hormone (parathormone); Parathyroid hormone-related peptides
    • 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
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/138—Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445—Non condensed piperidines, e.g. piperocaine
    • A61K31/452—Piperidinium derivatives
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • 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
    • A61K31/59—Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
    • 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
    • A61K31/66—Phosphorus compounds
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
    • A61P3/14—Drugs for disorders of the metabolism for electrolyte homeostasis for calcium homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/18—Drugs for disorders of the endocrine system of the parathyroid hormones

Abstract

The invention relates to a combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor, said preparation being adapted for (a) the administration of parathyroid hormone during a period of approximately 6 to 24 months; (b) after the administration of parathyroid hormone has been terminated, the administration of a bone resorption inhibitor during a period of approximately 12 to 36 months.

Claims (37)

1. A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor, said preparation being adapted for (a) the administration of parathyroid hormone during a period of approximately 6 to 24 months; and (b) after the administration of said parathyroid hormone has been terminated, the administration of a bone resorption inhibitor during a period of approximately 6 to 36 months.
2. A combined pharmaceutical preparation according to claim 1, adapted for said administration of parathyroid hormone for approximately 12 to 24 months.
3. A combined pharmaceutical preparation according to claim 2, adapted for said administration of parathyroid hormone for approximately 18 months.
4. A combined pharmaceutical preparation according to any one of claims 1 to 3, adapted for said administration of bone resorption inhibitor for approximately 12 to 36 months.
5. A combined pharmaceutical preparation according to claim 4, adapted for said administration of bone resorption inhibitor for approximately 12 to 18 months.
6. A combined pharmaceutical preparation according to claim 5, adapted for said administration of bone resorption inhibitor for approximately 12 months.
7. A preparation according to any one of claims 1 to 6 wherein the said parathyroid hormone is selected from the group consisting of:
(a) full-length parathyroid hormone;
(b) biologically active variants of full-length parathyroid hormone;
(c) biologically active parathyroid hormone fragments; and (d) biologically active variants of parathyroid hormone fragments.
8. A preparation according to any one of claims 1 to 7 wherein the said bone resorption inhibitor is a bisphosphonate.
9. A preparation according to claim 8 wherein the said bisphosphonate is alendronate.
10. A preparation according to any one of claims 1 to 7 wherein the said bone resorption inhibitor is a substance with estrogen-like effect.
11. A preparation according to claim 10 wherein the said substance with estrogen-like effect is estrogen.
12. A preparation according to any one of claims 1 to 7 wherein the said bone resorption inhibitor is a selective estrogen receptor modulator.
13. A preparation according to claim 12 wherein the said selective estrogen receptor modulator is selected from the group consisting of raloxifene, tamoxifene, droloxifene, toremifene. idoxifene, or levormeloxifene
14. A preparation according to any one of claims 1 to 7 wherein the said bone resorption inhibitor is a calcitonin-like substance.
15. A preparation according to claim 14 wherein the said calictonin-like substance is calcitonin.
16. A preparation according to any one of claims 1 to 7 wherein the said bone resorption inhibitor is a vitamin D analog.
17. A preparation according to any one of claims 1 to 7 wherein the said bone resorption inhibitor is a calcium salt.
18. Use of parathyroid hormone in combination with a bone resorption inhibitor in the manufacture of a medicament for the treatment or prevention of bone-related diseases, said medicament being adapted for (a) the administration of parathyroid hormone during a period of approximately 6 to 24 months; (b) after the administration of parathyroid hormone has been terminated, the administration of a bone resorption inhibitor during a period of approximately 12 to 36 months.
19. The use according to claim 18, wherein said medicament is adapted for administration of parathyroid hormone for approximately 12 to 24 months.
20. The use according to claim 19 wherein said medicament is adapted for administration of parathyroid hormone for approximately 18 months.
21. The use according to any one of claims 18 to 20, wherein said medicament is adapted for administration of bone resorption inhibitor for approximately 12 to 36 months.
22. The use according to claim 21, adapted for said administration of bone resorption inhibitor for approximately 12 to 18 months.
23. The use according to claim 22, adapted for said administration of bone resorption inhibitor for approximately 12 months.
24. The use according to any one of claims 18 to 23 wherein the said parathyroid hormone is selected from (a) full-length parathyroid hormone;
(b) biologically active variants of full-length parathyroid hormone;
(c) biologically active parathyroid hormone fragments; and (d) biologically active variants of parathyroid hormone fragments.
25. The use according to any one of claims 18 to 24 wherein the said bone resorption inhibitor is as defined in any one of claims 8 to 17.
26. The use according to any one of claims 18 to 25 in the manufacture of a medicament for the treatment of osteoporosis.
27. A method of treatment or prevention of bone-related diseases which comprises administering to a mammal, including man, in need of such treatment an effective amount of a pharmaceutical preparation according to any one of claims 1 to 17.
28. A method of treatment or prevention of bone-related diseases which comprises administering to a mammal, including man, in need of such treatment (a) an effective amount of parathyroid hormone during a period of approximately 6 to 24 months;
and (b) after the administration of parathyroid hormone has been terminated, an effective amount of a bone resorption inhibitor during a period of approximately 6 to 36 months.
29. A method of treatment or prevention of bone-related diseases which comprises administering, to a patient who has already been subject to treatment with parathyroid hormone during a period of approximately 6 to 24 months, after the administration of parathyroid hormone has been terminated, an effective amount of a bone resorption inhibitor during a period of approximately 6 to 36 months.
30. A method of treatment or prevention of bone-related diseases according to any one of claims 27 to 29, adapted for said administration of parathyroid hormone for approximately 12 to 24 months.
31. A method of treatment or prevention of bone-related diseases according to claim 30, adapted for said administration of parathyroid hormone for approximately 18 months.
32. A method of treatment or prevention of bone-related diseases according to any one of claims 27 to 31, adapted for said administration of bone resorption inhibitor for approximately 12 to 36 months.
33. A method of treatment or prevention of bone-related diseases according to claim 32, adapted for said administration of bone resorption inhibitor for approximately 12 to 18 months.
34. A method of treatment or prevention of bone-related diseases according to claim 33, adapted for said administration of bone resorption inhibitor for approximately months.
35. The method according to any one of claims 27 to 34 wherein the said parathyroid hormone is selected from (a) full-length parathyroid hormone;
(b) biologically active variants of full-length parathyroid hormone;
(c) biologically active parathyroid hormone fragments; and (d) biologically active variants of parathyroid hormone fragments.
36. The method according to any one of claims 27 to 35 wherein the said bone resoiption inhibitor is as defined in any one of claims 8 to 17.
37. The method according to any one of claims 27 to 36 for the treatment of osteoporosis.
CA2294101A 1997-06-19 1998-06-08 A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor Expired - Fee Related CA2294101C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2698626A CA2698626C (en) 1997-06-19 1998-06-08 A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SE9702401-2 1997-06-19
SE9702401A SE9702401D0 (en) 1997-06-19 1997-06-19 Pharmaceutical use
PCT/SE1998/001095 WO1998057656A1 (en) 1997-06-19 1998-06-08 A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2698626A Division CA2698626C (en) 1997-06-19 1998-06-08 A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor

Publications (2)

Publication Number Publication Date
CA2294101A1 true CA2294101A1 (en) 1998-12-23
CA2294101C CA2294101C (en) 2010-08-03

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Family Applications (2)

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CA2698626A Expired - Fee Related CA2698626C (en) 1997-06-19 1998-06-08 A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor
CA2294101A Expired - Fee Related CA2294101C (en) 1997-06-19 1998-06-08 A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor

Family Applications Before (1)

Application Number Title Priority Date Filing Date
CA2698626A Expired - Fee Related CA2698626C (en) 1997-06-19 1998-06-08 A combined pharmaceutical preparation comprising parathyroid hormone and a bone resorption inhibitor

Country Status (15)

Country Link
US (8) US6284730B1 (en)
EP (2) EP1473040B1 (en)
JP (3) JP4989811B2 (en)
AT (2) ATE275419T1 (en)
AU (1) AU753477B2 (en)
CA (2) CA2698626C (en)
CY (1) CY1110287T1 (en)
DE (2) DE69841279D1 (en)
DK (2) DK1473040T3 (en)
ES (2) ES2335404T3 (en)
HK (2) HK1029738A1 (en)
PT (2) PT1473040E (en)
SE (1) SE9702401D0 (en)
WO (1) WO1998057656A1 (en)
ZA (1) ZA984947B (en)

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