Claims for Patent: 8,877,193

Summary for Patent: 8,877,193

Title:	Transdiscal administration of anti-TNF.alpha. antibodies and growth differentiation factors
Abstract:	The present invention relates to injecting a high specificity cytokine antagonist into a diseased intervertebral disc.
Inventor(s):	Serhan; Hassan (South Easton, MA), Attawia; Mohamed (Holmdell, NJ), DiMauro; Thomas M. (Southboro, MA), Kadiyala; Sudhakar (Newton, MA), Urbahns; David (Barrington, RI), Bruder; Scott (Franklin Lakes, NJ)
Assignee:	DePuy Synthes Products, LLC. (Raynham, MA)
Application Number:	12/290,998
Patent Claims:	1. A method of treating degeneration of an extracellular matrix of a nucleus pulposus of an intervertebral disc having a degenerating nucleus pulposus in a patient in need thereof, comprising transdiscally administering a formulation comprising an anti-tumor necrosis factor-.alpha. (TNF-.alpha.) antibody and a growth differentiation factor into the degenerating nucleus pulposus, thereby effectively treating the degeneration of the extracellular matrix of the degenerating nucleus pulposus of the intervertebral disc. 2. The method of claim 1 wherein the antibody inhibits membrane bound TNF-.alpha.. 3. The method of claim 1 wherein the antibody inhibits soluble TNF-.alpha.. 4. The method of claim 1 wherein the formulation further comprises an additional therapeutic agent. 5. The method of claim 1 wherein the antibody is a monoclonal antibody. 6. The method of claim 5 wherein the monoclonal antibody is infliximab. 7. The method of claim 5 wherein the antibody is present in the formulation in a concentration of at least 100 mg/ml. 8. The method of claim 1 wherein the growth differentiation factor is GDF-5. 9. The method of claim 1 wherein the formulation is administered to the disc using a carrier. 10. The method of claim 9 wherein the carrier is selected from the group consisting of saline, hydrogels, microspheres and polymers. 11. The method of claim 1 wherein the anti-tumor necrosis factor (TNF.alpha.) antibody and growth differentiation factor is present in the formulation in an amount of no more than 0.5 mg. 12. The method of claim 1 wherein a portion of the nucleus pulposus is removed prior to administering the formulation into the intervertebral disc. 13. The method of claim 1 wherein the administration is performed through a needle. 14. A method of treating degeneration of an extracellular matrix of a nucleus pulposus of an intervertebral disc having a degenerating nucleus pulposus in a patient in need thereof, comprising transdiscally administering into the degenerating nucleus pulposus a formulation comprising infliximab and GDF-5 into an intervertebral disc, wherein said formulation is (a) administered in an amount effective to inhibit degradation of an extracellular matrix of the nucleus pulposus and (b) released from a sustained release device, wherein said sustained release device comprises a hydrogel, thereby effectively treating the degeneration of the extracellular matrix of the degenerating nucleus pulposus of the intervertebral disc.

Details for Patent 8,877,193

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2023-05-13