Claims for Patent: 9,724,391

Summary for Patent: 9,724,391

Title:	Combination preparation including a corticosteroid and exosomes
Abstract:	The present invention relates to pharmaceutical compositions for a combination therapy with a corticosteroid and exosomes. By means of the combination therapy diseases such as osteoarthritis, arthritis and/or degenerative spinal diseases can be treated.
Inventor(s):	Wehling; Peter (Dusseldorf, DE), Reinecke; Julio (Koln, DE)
Assignee:	ORTHOGEN AG (Dusseldorf, DE)
Application Number:	13/142,573
Patent Claims:	1. A pharmaceutical composition comprising a glucocorticoid together with exosomes in the presence or absence of a cytokine antagonist and/or a growth factor, wherein the exosomes are obtained from blood and the glucocorticoid is one or more selected from the group consisting of, prednisone, prednisolone, cloprednol, deflazacort, fluocortin, triamcinolone, dexamethasone, methylprednisolone, fluprednisolone, clocortolone, clobetasone, alclomethasone, flumethasone, fluoprednidene, fluorandrenolone, betamethasone, beclomethasone, fluocortolone, mometasone, fluticasone, halomethasone, fluocinolone, diflorasone, desoximethasone, fluocinonide, amcinonide, halcinonide, diflucortolone, clobetasol, paramethasone, and a salt, ester or prodrug thereof. 2. A pharmaceutical composition comprising a glucocorticoid together with exosomes in the presence or absence of a cytokine antagonist and/or a growth factor, wherein the exosomes are obtained from blood and the glucocorticoid is triamcinolone or a salt, ester or prodrug thereof. 3. The pharmaceutical composition according to claim 2, wherein the glucocorticoid is present in a concentration of 1 to 80 mg/dose in the pharmaceutical composition containing the glucocorticoid. 4. The pharmaceutical composition according to claim 2, wherein the exosomes are obtained by a method comprising the steps of: providing a blood sample containing exosomes and optionally concentrating the exosomes. 5. The pharmaceutical composition according to claim 2, wherein the exosomes are autologous or allogeneic. 6. The pharmaceutical composition according to claim 2 for the treatment of joint diseases, degenerative spinal diseases and/or joint pain. 7. The pharmaceutical composition according to claim 6, wherein the joint disease is an activated osteoarthritis or an inflammatory osteoarthritis. 8. The pharmaceutical composition according to claim 6, wherein the degenerative spinal disease is a herniated disc. 9. The pharmaceutical composition according to claim 2 for treatment of an autoimmune disease. 10. The pharmaceutical composition according to claim 9, wherein the autoimmune disease is neurodermitis or alopecia areata. 11. The pharmaceutical composition according to claim 2, wherein the pharmaceutical composition is suitable for local administration. 12. The pharmaceutical composition according to claim 11, wherein the local administration is selected from the group consisting of injection into the affected body region, or into the local environment thereof, intra-articular injection, and topical administration. 13. The pharmaceutical composition according to claim 2, wherein the pharmaceutical composition further contains a carrier and/or an excipient. 14. The pharmaceutical composition according to claim 2, wherein a cytokine antagonist is present and the cytokine antagonist is selected from the group consisting of interleukin antagonists, tumor necrosis factor antagonists, interferon antagonists and chemokine antagonists. 15. The pharmaceutical composition according to claim 14, wherein the cytokine antagonist is naturally occurring or recombinant IL-1 Ra protein. 16. The pharmaceutical composition according to claim 14, wherein the cytokine antagonist is present in a concentration of 0.5 to 150 mg/dose in the pharmaceutical composition containing the cytokine antagonist. 17. The pharmaceutical composition according to claim 2, wherein a growth factor is present and the growth factor is selected from the group consisting of TGF-.beta., IGF, BMP, HGF and VEGF. 18. The pharmaceutical composition according to claim 6, wherein the joint disease is selected from the group consisting of, osteoarthritis, arthritis, joint inflammation and inflammatory loss of cartilage. 19. The pharmaceutical composition according to claim 18, wherein the arthritis is an arthritis caused by an infection. 20. The pharmaceutical composition according to claim 19, wherein the arthritis caused by an infection is bacterial arthritis. 21. The pharmaceutical composition according to claim 14, wherein the interleukin antagonist is an IL-1 antagonist and/or the tumour necrosis factor antagonist is a TNF-.alpha. antagonist. 22. The pharmaceutical composition according to claim 21, wherein the IL-1 antagonist is IL-1 Ra and/or the TNF-.alpha. antagonist is an anti-TNF-.alpha. antagonist. 23. The pharmaceutical composition according to claim 12, wherein the injection into the affected body region is selected from the group consisting of an injection into the affected joint, an injection into the affected nerve root, an injection into the affected intervertebral disc and an injection into the local environment thereof. 24. The pharmaceutical composition according to claim 15, wherein the naturally occurring IL-1 Ra protein is autologous serum in which the IL-1 Ra is enriched and/or the recombinant IL-1 Ra protein is anakinra. 25. A kit comprising (i) a pharmaceutical composition comprising exosomes in the presence or absence of a cytokine antagonist and/or a growth factor and (ii) a pharmaceutical composition comprising a glucocorticoid in the presence or absence of a cytokine antagonist and/or a growth factor, wherein the exosomes are obtained from blood and the glucocorticoid is triamcinolone or a salt, ester or prodrug thereof. 26. A method for the preparation of a pharmaceutical composition containing a glucocorticoid and exosomes comprising the steps: providing a blood sample containing exosomes, optionally concentrating the exosomes and mixing with said glucocorticoid, wherein the glucocorticoid is triamcinolone or a salt, ester or prodrug thereof. 27. A method for the preparation of a pharmaceutical composition containing a glucocorticoid and exosomes comprising the steps: providing a blood sample containing exosomes, optionally concentrating the exosomes, and mixing with said glucocorticoid, wherein said glucocorticoid is one or more selected from the group consisting of, prednisone, prednisolone, cloprednol, deflazacort, fluocortin, triamcinolone, dexamethasone, methylprednisolone, fluprednisolone, clocortolone, clobetasone, alclomethasone, flumethasone, fluoprednidene, fluorandrenolone, betamethasone, beclomethasone, fluocortolone, mometasone, fluticasone, halomethasone, fluocinolone, diflorasone, desoximethasone, fluocinonide, amcinonide, halcinonide, diflucortolone, clobetasol, paramethasone and a salt, ester or prodrug thereof. 28. The pharmaceutical composition according to claim 19, wherein the arthritis is not caused by an infection and is selected from the group consisting of rheumatoid arthritis, psoriatic arthritis and gouty arthritis.

Details for Patent 9,724,391

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Swedish Orphan Biovitrum Ab (publ)	KINERET	anakinra	Injection	103950	11/14/2001		2029-12-10