Claims for Patent: 8,377,903

Summary for Patent: 8,377,903

Title:	Cladribine regimen for treating multiple sclerosis
Abstract:	The present invention is related to the use of Cladribine for the preparation of a pharmaceutical formulation for the treatment of multiple sclerosis, especially relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis, wherein the preparation is to be the orally administered and wherein re-treatments are possible.
Inventor(s):	De Luca; Giampiero (Conches/Geneva, CH), Ythier; Arnaud (Collex-Bossy, CH), Munafo; Alain (Tartegnin, CH), Lopez-Bresnahan; Maria (Lincoln, MA)
Assignee:	Merck Serono SA (Coinsins, Vaud, CH)
Application Number:	12/766,173
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,377,903
Patent Claims:	1. A method of treating relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis comprising the oral administration of a formulation comprising cladribine to an individual having relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis following the sequential steps below: (i) an induction period lasting from about 2 months to about 4 months wherein said formulation is orally administered and wherein the total dose of cladribine reached at the end of the induction period is from about 1.7 mg/kg to about 3.5 mg/kg; (ii) a cladribine-free period lasting from about 8 months to about 10 months, wherein no cladribine is administered; (iii) a maintenance period lasting from about 2 months to about 4 months, wherein said formulation is orally administered and wherein the total dose of cladribine reached at the end of the maintenance period is lower than the total dose of cladribine reached at the end of the induction period (i); (iv) a cladribine-free period wherein no cladribine is administered. 2. The method according to claim 1, wherein the induction period lasts about 4 months. 3. The method according to claim 1, wherein the induction period lasts about 2 months. 4. The method according to claim 1, wherein the total dose of cladribine reached at the end of the induction period is about 1.7 mg/kg. 5. The method according to claim 1, where the total dose of cladribine reached at the end of the induction period is about 3.5 mg/kg. 6. The method according to claim 1, wherein the cladribine-free period (ii) lasts about 10 months. 7. The method according to claim 1, wherein the cladribine-free (iv) period lasts 10 months. 8. The method according to claim 1, wherein the maintenance period lasts about 2 months. 9. The method according to claim 1, wherein the formulation is orally administered following the sequential steps below: (i) an induction period wherein said formulation is administered orally and wherein the total dose of cladribine reached at the end of the induction period is from about 1.7 mg/kg to about 3.5 mg/kg; (ii) a cladribine-free period wherein no cladribine is administered; (iii) a maintenance period wherein said formulation is administered orally and wherein the total dose of cladribine reached at the end of the maintenance period is lower than the total dose of cladribine reached at the end of the induction period (i); and (iv) a cladribine-free period wherein no cladribine is administered; wherein the maintenance period (iii) lasts about 2 months; the cladribine-free period (iv) lasts about 10 months; the total dose of cladribine reached at the end of the maintenance period is about 1.7 mg/kg and steps (iii) to (iv) are repeatedly performed one, two or three times. 10. The method according to claim 1, wherein the total dose of cladribine reached at the end of the induction period is about 3.5 mg/kg and the total dose of cladribine reached at the end of the maintenance period is about 1.7 mg/kg. 11. The method according to claim 1, wherein the formulation is orally administered at a daily dose of 3 to 30 mg cladribine. 12. The method according to claim 1, wherein the formulation is orally administered at a daily dose of 10 mg cladribine. 13. The method according to claim 1, wherein the formulation is orally administered 1 to 7 days per month during the induction period. 14. The method according to claim 1, wherein the steps (iii) to (iv) are repeated at least one time. 15. The method according to claim 1, wherein the steps (iii) to (iv) are repeated at least two times. 16. The method according to claim 1, wherein the formulation is administered in combination with interferon-beta. 17. A method of treating relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis comprising the oral administration of a formulation comprising cladribine to an individual having relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis following the sequential steps below: (i) an induction period lasting from about 2 months to about 4 months wherein said formulation is orally administered and wherein the total dose of cladribine reached at the end of the induction period is from about 1.7 mg/kg to about 3.5 mg/kg; (ii) a cladribine-free period lasting from about 8 months to about 10 months, wherein no cladribine is administered; (iii) a maintenance period lasting from about 2 months to about 4 months, wherein said formulation is orally administered and wherein the total dose of cladribine reached at the end of the maintenance period is about 1.7 mg/kg; and (iv) a cladribine-free period wherein no cladribine is administered. 18. The method according to claim 17, wherein the induction period lasts about 4 months. 19. The method according to claim 17, wherein the induction period lasts about 2 months. 20. The method according to claim 17, wherein the total dose of cladribine reached at the end of the induction period is about 1.7 mg/kg. 21. The method according to claim 17, where the total dose of cladribine reached at the end of the induction period is about 3.5 mg/kg. 22. The method according to claim 17, wherein the cladribine-free period (ii) lasts about 10 months. 23. The method according to claim 17, wherein the cladribine-free (iv) period lasts 10 months. 24. The method according to claim 17, wherein the maintenance period lasts about 2 months. 25. The method according to claim 17, wherein the formulation is orally administered at a daily dose of 3 to 30 mg cladribine. 26. The method according to claim 17, wherein the formulation is orally administered at a daily dose of 10 mg cladribine. 27. The method according to claim 17, wherein the formulation is orally administered 1 to 7 days per month during the induction period. 28. The method according to claim 17, wherein the steps (iii) to (iv) are repeated at least one or two times. 29. The method according to claim 17, wherein the formulation is administered in combination with interferon-beta.