Claims for Patent: 7,097,834

Summary for Patent: 7,097,834

Title:	Osteoprotegerin binding proteins
Abstract:	A novel polypeptide, osteoprotegerin binding protein, involved in osteolcast maturation has been identified based upon its affinity for osteoprotegerin. Nucleic acid sequences encoding the polypeptide, or a fragment, analog or derivative thereof, vectors and host cells for production, methods of preparing osteoprotegerin binding protein, and binding assays are also described. Compositions and methods for the treatment of bone diseases such as osteoporosis, bone loss due to arthritis or metastasis, hypercalcemia, and Paget\'s disease are also provided.
Inventor(s):	Boyle; William J. (Moorpark, CA)
Assignee:	Amgen Inc. (Thousand Oaks, CA)
Application Number:	09/211,315
Patent Claims:	1. A method of inhibiting bone resorption in a mammal in need thereof comprising administering to the mammal an antagonist antibody or binding fragment thereof which binds to the osteoprotegerin binding protein of SEQ ID NO:39. 2. The method of claim 1 wherein the antibody is a monoclonal antibody or binding fragment thereof. 3. The method of claim 1 wherein the antibody is a recombinant antibody or binding fragment thereof. 4. The method of claim 3 wherein the antibody or fragment is a chimeric antibody or a CDR-grafted antibody or a binding fragment thereof. 5. The method of claim 1 wherein the antibody is a human antibody or binding fragment thereof. 6. The method of claim 5 wherein the antibody is prepared by immunization of a transgenic animal capable of producing human antibodies. 7. The method of claim 1 wherein the antibody or binding fragment thereof binds to an epitope on the extracellular domain or to an epitope on a fragment of the extracellular domain of an osteoprotegerin binding protein. 8. The method of claim 7 wherein the epitope comprises the BB' loop of an osteoprotegerin binding protein. 9. The method of claim 7 wherein the epitope comprises the EF loop of an osteoprotegerin binding protein. 10. The method of claim 1 wherein the antibody or binding fragment further comprises a composition comprising a pharmaceutically acceptable diluent, carrier, solubilizer, emulsifier, preservative and/or adjuvant. 11. The method of any of claims 1, 2, 3, 4, 5, 7, or 10 further comprising administering one or more of a bone morphogenic factor, transforming growth factor-.beta., a transforming growth factor-.beta. family member, a fibroblast growth factor, an interleukin-1 inhibitor, a TNF.alpha. inhibitor, a parathyroid hormone, an E series prostaglandin, a bisphosphonate, or a bone-enhancing mineral. 12. The method of any of claims 1, 2, 3, 4, 5, 7, or 10 or wherein bone resorption is associated with a bone disease selected from osteoporosis, osteomyelitis, hypercalcemia, osteopenia brought on by surgery or steroid administration, Paget's disease, osteonecrosis, bone loss due to rheumatoid arthritis, periodontal bone loss, osteopenia due to immobilization, prosthetic loosening and osteolytic metastasis. 13. The method of claim 1 wherein the antibody or binding fragment thereof binds to a membrane associated form of osteoprotegerin binding protein. 14. The method of claim 1 wherein the antibody or binding fragment thereof binds to a soluble osteoprotegerin binding protein. 15. A method of inhibiting osteoclastogenesis in a mammal in need thereof comprising administering to the mammal an antagonist antibody or binding fragment thereof which binds to the osteoprotegerin binding protein of SEQ ID NO:39. 16. The method of claim 15 wherein the antibody is a monoclonal antibody or binding fragment thereof. 17. The method of claim 15 wherein the antibody is a recombinant antibody or binding fragment thereof. 18. The method of claim 15 wherein the antibody is a chimeric antibody or a CDR-grafted antibody. 19. The method of claim 15 wherein the antibody is a human antibody or binding fragment thereof. 20. The method of claim 19 wherein the antibody is prepared by immunization of a transgenic animal capable of producing human antibodies. 21. The method of claim 15 wherein the antibody or binding fragment thereof binds to an epitope on the extracellular domain or to an epitope on a fragment of the extracellular domain of an osteoprotegerin binding protein. 22. The method of claim 21 wherein the epitope comprises the BB' loop of an osteoprotegerin binding protein. 23. The method of claim 21 wherein the epitope comprises the EF loop of an osteoprotegerin binding protein. 24. The method of claim 15 wherein the antibody or binding fragment thereof binds to a membrane associated form of osteoprotegerin binding protein. 25. The method of claim 15 wherein the antibody or binding fragment thereof binds to a soluble osteoprotegerin binding protein. 26. The method of claim 15 wherein the antibody or binding fragment further comprises a composition comprising a pharmaceutically acceptable diluent, carrier, solubilizer, emulsifier, preservative and/or adjuvant. 27. The method of any of claims 15, 16, 17, 18, 19, 21, 24, 25, or 26 further comprising administering one or more of a bone morphogenic factor, transforming growth factor-.beta., a transforming growth factor-.beta. family member, a fibroblast growth factor, an interleukin-1 inhibitor, a TNF.alpha. inhibitor, a parathyroid hormone, an E series prostaglandin, a bisphosphonate, or a bone-enhancing mineral. 28. The method of any of claims 15, 16, 17, 18, 19, 21, 24, 25, or 26 wherein osteoclastogenesis is associated with a condition selected from osteoporosis, osteomyelitis, hypercalcemia, osteopenia brought on by surgery or steroid administration, Paget's disease, osteonecrosis, bone loss due to rheumatoid arthritis, periodontal bone loss, osteopenia due to immobilization, prosthetic loosening and osteolytic metastasis. 29. The method of claims 1 or 15 wherein the mammal is a human. 30. The method of claims 1 or 15 wherein the antibody is raised against an osteoprotegerin binding protein comprising the amino acid sequence of SEQ ID NO:39 or an antigenic fragment thereof. 31. The method of claim 1 or 15 wherein the antibody is raised against an osteoprotegerin binding protein comprising the amino acid sequence of SEQ ID NO:39 from residues 69 317.

Details for Patent 7,097,834

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Amgen Inc.	PROLIA	denosumab	Injection	125320	June 01, 2010		2017-04-16
Amgen Inc.	XGEVA	denosumab	Injection	125320	November 18, 2010		2017-04-16
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015		2017-04-16

International Patent Family for US Patent 7,097,834

Country	Patent Number	Estimated Expiration
South Africa	983189
Yugoslavia	50699
World Intellectual Property Organization (WIPO)	9846751
United States of America	7923008
United States of America	7807795