Claims for Patent: 9,161,935

Summary for Patent: 9,161,935

Title:	Use of laquinimod for treating Crohn\'s disease patients who failed first-line anti-TNF therapy
Abstract:	This application provides for a method of treating a human patient afflicted with anti-TNF.alpha. refractory Crohn\'s disease, of treating a human patient afflicted with non-fibrostenotic Crohn\'s disease, and of treating a human patient whose Crohn\'s disease had not been surgically treated, the method comprising periodically administering to the patient an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the patient. This application also provides for a method of inducing or maintaining clinical remission in a human patient afflicted with Crohn\'s disease comprising periodically administering to the patient an amount of laquinimod effective to induce or maintain clinical remission in the patient, which amount of laquinimod is less than 0.5 mg/day.
Inventor(s):	Tarcic; Nora (Modiin, IL), Haviv; Asi (Kvutsat Shiller, IL), Blaugrund; Eran (Rehovot, IL), Kaye; Joel (Netanya, IL)
Assignee:	TEVA PHARMACEUTICAL INDUSTRIES, LTD. (Petach-Tikva, IL)
Application Number:	13/757,004
Patent Claims:	1. A method of treating a human patient afflicted with anti-TNF.alpha.refractory Crohn's disease, the method comprising periodically administering to the patient an amount of laquinimod or pharmaceutically acceptable salt thereof effective to treat the patient. 2. The method of claim 1, wherein the Crohn's disease is non-fibrostenotic Crohn's disease. 3. The method of claim 2, wherein the Crohn's disease is inflammatory Crohn's disease. 4. The method of claim 1, wherein the Cretin's disease is steroid refractory Crohn's disease. 5. The method of claim 1, wherein the patient has been administered oral steroids at baseline. 6. The method of claim 1, wherein the patient's Crohn's disease had not been surgically treated. 7. The method of claim 1, wherein the Crohn's disease is refractory to anti-TNF.alpha.treatment using infliximab, adalimimab, certolizumab or natalizumab. 8. The method of claim 1, wherein the patient is naive to anti-TNF.alpha.treatment. 9. The method of claim 1, wherein the amount of laquinimod is effective to reduce a symptom of Crohn's disease in the subject, induce clinical response, induce or maintain clinical remission, inhibit disease progression, or inhibit a disease complication in the subject. 10. The method of claim 9, wherein the amount of liaquinimod is effective to induce clinical remission in the patient. 11. The method of claim 9, wherein the amount of liaquinimod is effective to maintain clinical remission in the patient. 12. The method of claim 9, wherein the amount of laquinimod is effective to induce and maintain clinical remission in the patient. 13. The method of claim 1, wherein the amount is administered by a unit dose of 0.25 mg of laquinimod or a unit dose of 0.5 mg of laquinimod. 14. The method of claim 1, wherein the amount of laquinimod is 0.1-1.0 mg/day. 15. The method of claim 14, wherein the amount of laquinimod is 0.25 mg/day, 0.5 mg/day or 1.0 mg/day. 16. The method of claim 1, wherein the pharmaceutically acceptable salt of laquinimod is laquinimod sodium. 17. The method of claims 1, wherein the periodic administration is oral. 18. The method or claims 1, wherein the periodic administration is daily administration. 19. The method of claim 14 wherein the amount of laquinimod is 0.1-0.75 mg/day. 20. The method of claim 14, wherein the amount of laquinimod is 0.3-0.7 mg/day. 21. The method of claim. 1, wherein the laquinimod is administered as adjunct therapy with an other Crohn's disease treatment.

Details for Patent 9,161,935

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Janssen Biotech, Inc.	REMICADE	infliximab	For Injection	103772	08/24/1998		2032-02-03
Biogen Inc.	TYSABRI	natalizumab	Injection	125104	11/23/2004		2032-02-03