Claims for Patent: 8,765,674

Summary for Patent: 8,765,674

Title:	Methods useful in the treatment of bone resorption diseases
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.
Inventor(s):	Dietrich; John (Etobicoke, CA), Ljunghall; Sverker (Molndal, SE), Sjogren; Sven (Molndal, SE)
Assignee:	NPS Pharmaceuticals, Inc. (Bedminster, NJ)
Application Number:	13/405,093
Patent Claims:	1. A pharmaceutical preparation for sequential administration of an anabolic agent and a bone resorption inhibitor, the pharmaceutical preparation comprising parathyroid hormone as the anabolic agent and a bone resorption inhibitor, wherein the parathyroid hormone is provided separate from the bone resorption inhibitor, said preparation being adapted for (a) the administration of said 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 said bone resorption inhibitor during a period of approximately 6 to 36 months. 2. A pharmaceutical preparation according to claim 1, adapted for the administration of said parathyroid hormone for approximately 12 to 24 months. 3. A pharmaceutical preparation according to claim 2, adapted for the administration of said parathyroid hormone for approximately 18 months. 4. A pharmaceutical preparation according to claim 1 adapted for the administration of said bone resorption inhibitor for approximately 12 to 36 months. 5. A pharmaceutical preparation according to claim 4, adapted for the administration of said bone resorption inhibitor for approximately 12 to 18 months. 6. A pharmaceutical preparation according to claim 5, adapted for the administration of said bone resorption inhibitor for approximately 12 months. 7. A preparation according to claim 1 wherein 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 claim 1 wherein said bone resorption inhibitor is a bisphosphonate. 9. A preparation according to claim 8 wherein said bisphosphonate is alendronate. 10. A preparation according to claim 1 wherein said bone resorption inhibitor is a substance with estrogen-like effect. 11. A preparation according to claim 10 wherein said substance with estrogen-like effect is estrogen. 12. A preparation according to claim 1 wherein said bone resorption inhibitor is a selective estrogen receptor modulator. 13. A preparation according to claim 12 wherein said selective estrogen receptor modulator is selected from the group consisting of raloxifene, tamoxifene, droloxifene, toremifene, idoxifene, or levormeloxifene. 14. A preparation according to claim 1 wherein said bone resorption inhibitor is a calcitonin-like substance. 15. A preparation according to claim 14 wherein said calcitonin-like substance is calcitonin. 16. A preparation according to claim 1 wherein said bone resorption inhibitor is a vitamin D analog. 17. A preparation according to claim 1 wherein said bone resorption inhibitor is a calcium salt. 18. A method of manufacturing a pharmaceutical preparation for the treatment or prophylaxis of bone-related disorders, wherein the pharmaceutical preparation is a multi-component pharmaceutical preparation for sequential administration of an anabolic agent and a bone resorption inhibitor, the method comprising the steps of: preparing a first pharmaceutical preparation comprising parathyroid hormone as the anabolic agent, said first pharmaceutical preparation being adapted for administration of the parathyroid hormone during a period of approximately 6 to 24 months; and preparing a second pharmaceutical preparation comprising the bone resorption inhibitor and being adapted for administration of the bone resorption inhibitor during a period of approximately 12 to 36 months after the administration of the parathyroid hormone has been terminated. 19. The method according to claim 18, wherein said first pharmaceutical preparation is adapted for administration of the parathyroid hormone for approximately 12 to 24 months. 20. The method according to claim 19 wherein said first pharmaceutical preparation is adapted for administration of the parathyroid hormone for approximately 18 months. 21. The method according to claim 18, wherein said second pharmaceutical preparation is adapted for administration of the bone resorption inhibitor for approximately 12 to 36 months. 22. The method according to claim 21, wherein the second pharmaceutical preparation is adapted for administration of the bone resorption inhibitor for approximately 12 to 18 months. 23. The method according to claim 22, wherein the second pharmaceutical preparation is adapted for administration of the bone resorption inhibitor for approximately 12 months. 24. The method according to claim 18 wherein the 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 method according to claim 18 wherein the bone resorption inhibitor is at least one of the group consisting of a bisphosphonate, a substance with estrogen-like effect, a selective estrogen receptor modulator, a calcitonin-like substance, a vitamin D analog, and a calcium salt. 26. The method according to claim 18 wherein the multi-component pharmaceutical preparation is adapted for the treatment of osteoporosis. 27. A method of treatment or prophylaxis 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 claim 1, the method comprising (a) administering said parathyroid hormone for a period of approximately 6 to 24 months; and (b) after the administration of said parathyroid hormone has been terminated, administering said bone resorption inhibitor for a period of approximately 6 to 36 months. 28. A method of treatment or prophylaxis of bone-related diseases which comprises administering to a patient an effective amount of a bone resorption inhibitor for a period of approximately 6 to 36 months, wherein said administration of the bone resorption inhibitor is made after the patient has been treated with parathyroid hormone for a period of 6 to 24 months, and after treatment with said parathyroid hormone has been terminated. 29. A method of treatment or prophylaxis of bone-related diseases according to claim 27, wherein said parathyroid hormone is administered to the patient for approximately 12 to 24 months. 30. A method of treatment or prophylaxis of bone-related diseases according to claim 29, wherein said parathyroid hormone is administered to the patient for approximately 18 months. 31. A method of treatment or prophylaxis of bone-related diseases according to claim 27, wherein said bone resorption inhibitor is administered to the patient for approximately 12 to 36 months. 32. A method of treatment or prophylaxis of bone-related diseases according to claim 31, wherein said bone resorption inhibitor is administered to the patient for approximately 12 to 18 months. 33. A method of treatment or prophylaxis of bone-related diseases according to claim 32, wherein said bone resorption inhibitor is administered to the patient for approximately 12 months. 34. The method according to claim 27 wherein 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. 35. The method according to claim 27 wherein said bone resorption inhibitor is at least one of the group consisting of a bisphosphonate, a substance with estrogen-like effect, a selective estrogen receptor modulator, a calcitonin-like substance, a vitamin D analog, and a calcium salt. 36. The method according to claim 27, wherein the bone-related disease is osteoporosis. 37. A preparation according to claim 7 wherein said parathyroid hormone is the biologically active parathyroid hormone fragment PTH(1-34). 38. The method according to claim 34 wherein said parathyroid hormone is the biologically active parathyroid hormone fragment PTH(1-34).

Details for Patent 8,765,674

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2017-06-19