Claims for Patent: 7,005,413

Summary for Patent: 7,005,413

Title:	Combination therapy for conditions leading to bone loss
Abstract:	The present invention discloses a novel secreted polypeptide, termed osteoprotegerin, which is a member of the tumor necrosis factor receptor superfamily and is involved in the regulation of bone metabolism. Also disclosed are nucleic acids encoding osteoprotegerin, polypeptides, recombinant vectors and host cells for expression, antibodies which bind OPG, and pharmaceutical compositions. The polypeptides are used to treat bone diseases characterized by increased resorption such as osteoporosis. Methods of treatment are described using the polypeptides in conjunction with various agents, including IL-1 inhibitors, TNF-.alpha. inhibitors, and serine protease inhibitors.
Inventor(s):	Boyle; William J. (Moorpark, CA), Lacey; David Lee (Newbury Park, CA), Calzone; Frank J. (Westlake Village, CA), Chang; Ming-Shi (Tainan, TW)
Assignee:	Amgen Inc. (Thousand Oaks, CA)
Application Number:	09/613,591
Patent Claims:	1. A method of treating bone loss, which comprises administering an IL-1 inhibitor, a TNF-.alpha. inhibitor, and an OPG protein, wherein "OPG protein" refers to a polypeptide comprising conserved residues from residues 22 to 185 of SEQ ID NOS: 121, 123, or 125. 2. The method of claim 1, wherein the TNF-.alpha. inhibitor comprises sTNFR-I, sTNFR-II, an sTNFR fragment, or sTNFR-Fc, wherein "sTNFR" refers to sTNFR-I or sTNFR-II. 3. The method of claim 2, wherein the sTNFR fragment is a 2.6 kD sTNFR-I fragment. 4. The method of claim 3, wherein the sTNFR-I fragment comprises 30 kD PEG. 5. The method of claim 1, wherein the TNF-.alpha. inhibitor comprises 30 kD PEG-sTNFR-I. 6. The method of claim 1, wherein the TNF.alpha. inhibitor comprises sTNFR-II linked to an Fc region. 7. The method of claim 1, wherein the TNF-.alpha. inhibitor is etanercept. 8. The method of claim 1, wherein the OPG protein is OPG-Fc. 9. The method of any of claims 1 to 8, wherein the bone loss results from rheumatoid arthritis. 10. The method of any of claims 1 to 8, wherein the bone loss results from multiple sclerosis. 11. The method of any of claims 1 to 8, wherein the bone loss results from osteoporosis. 12. The method of any of claims 1 to 8, wherein the bone loss results from osteomyelitis. 13. The method of claim 1, wherein the OPG protein comprises residues 22 to 185 of SEQ ID NO: 121. 14. The method of claim 1, wherein the OPG protein comprises residues 22 to 185 of SEQ ID NO: 123. 15. The method of claim 1, wherein the OPG protein comprises residues 22 to 185 of SEQ ID NO: 125.

Details for Patent 7,005,413

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Immunex Corporation	ENBREL	etanercept	For Injection	103795	11/02/1998		2015-12-22
Immunex Corporation	ENBREL	etanercept	For Injection	103795	05/27/1999		2015-12-22
Immunex Corporation	ENBREL	etanercept	Injection	103795	09/27/2004		2015-12-22
Immunex Corporation	ENBREL	etanercept	Injection	103795	02/01/2007		2015-12-22