Claims for Patent: 8,084,426

Summary for Patent: 8,084,426

Title:	Pharmaceutical composition comprising FGF18 and IL-1 antagonist and method of use
Abstract:	FGF18 is known to stimulate the proliferation of chondrocytes, bone, and nervous tissue, resulting in repair of diseased tissue. When an IL-1 antagonist is administered in addition to FGF18, the effects on the IL-1 mediated disease and also, the effect on cartilage, bone, and nervous cell proliferation, are found to be greater than administration of FGF18 or the IL-1 antagonist alone. The present invention encompasses a pharmaceutical composition that combines FGF18 with IL-1 antagonist and methods of treating IL-1 mediated disease using this pharmaceutical composition.
Inventor(s):	Moore; Emma E. (Seattle, WA), Ellsworth; Jeff L. (Seattle, WA)
Assignee:	ZymoGenetics, Inc. (Seattle, WA)
Application Number:	12/784,377
Patent Claims:	1. A pharmaceutical composition comprising FGF18 and an IL-1 antagonist, wherein the IL-1 antagonist is selected from the group consisting of (a) an IL-1ra and (b) a fusion protein comprising IL-1ra or an IL-1 inhibitory fragment fused with a constant domain of a heavy or light chain of human immunoglobulin. 2. The composition of claim 1 wherein the IL-1ra is recombinantly engineered. 3. The composition of claim 2 wherein the FGF18 comprises residue 28 to residue 207 of SEQ ID NO:2. 4. The composition of claim 2 wherein the FGF18 comprises residue 28 to residue 196 of SEQ ID NO:2. 5. The composition of claim 2 wherein the recombinantly engineered formulation of IL-1ra is anakinra. 6. The composition of claim 2 further comprising a negatively charged carrier selected from the group consisting of low molecular weight hyaluronans, high molecular weight hyaluronans, sulfated proteoglycans, polylactide matrices or polylactide-co-glycolide, B-cyclodextrin tetradecasulphate, hydroxyapatite, alginate microspheres, chitosans, and methylcellulose. 7. The composition of claim 2 wherein said composition is a time-release formulation. 8. The composition of claim 7 wherein said time-release formulation comprises a matrix selected from the group consisting of a solution, a gel, a paste, or a putty. 9. The composition of claim 7 wherein said time-release formulation comprises a reservoir system. 10. The composition of claim 2 further comprising an anti-inflammatory drug. 11. The composition of claim 1 wherein the IL-1 antagonist is a fusion protein comprising IL-1ra or an IL-1 inhibitory fragment fused with a constant domain of a heavy or light chain of human immunoglobulin. 12. The composition of claim 11 wherein the constant domain is a heavy chain. 13. The composition of claim 11 wherein the FGF18 comprises residue 28 to residue 196 of SEQ ID NO:2. 14. The composition of claim 11 wherein the FGF18 comprises residue 28 to residue 207 of SEQ ID. NO:2. 15. The composition of claim 11 further comprising a negatively charged carrier selected from the group consisting of low molecular weight hyaluronans, high molecular weight hyaluronans, sulfated proteoglycans, polylactide matrices or polylactide-co-glycolide, B-cyclodextrin tetradecasulphate, hydroxyapatite, alginate microspheres, chitosans, and methylcellulose. 16. The composition of claim 11 wherein said composition is a time-release formulation. 17. The composition of claim 16 wherein said time-release formulation comprises a matrix selected from the group consisting of a solution, a gel, a paste, or a putty. 18. The composition of claim 11 further comprising an anti-inflammatory drug.

Details for Patent 8,084,426

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	11/14/2001		2024-07-06