<<

US 2016.0074380A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0074380 A1 Hayden et al. (43) Pub. Date: Mar. 17, 2016

(54) TREATMENT OF NEURODEGENERATIVE Publication Classification DISEASES WITH COMBINATION OF LAQUINIMOD AND (51) Int. Cl. A613 L/4704 (2006.01) (71) Applicants: Michael Hayden, Petach-Tikva (IL); A6II 45/06 (2006.01) Liat Hayardeny, Tel Aviv (IL); David A63/37 (2006.01) Ladkani, Jerusalem (IL) (52) U.S. Cl. CPC ...... A6 IK3I/4704 (2013.01); A61 K3I/I37 (72) Inventors: Michael Hayden, Petach-Tikva (IL); (2013.01); A61K 45/06 (2013.01) Liat Hayardeny, Tel Aviv (IL); David Ladkani, Jerusalem (IL) (57) ABSTRACT This invention provides a method of treating a subject Assignee: TEVA PHARMACEUTICAL afflicted with a neurodegenerative disease comprising peri (73) odic administration of an amount of laquinimod and an INDUSTRIES LTD., Petach-Tikva (IL) amount of fingolimod, wherein the amounts when taken together are effective to treat the subject. Also provided are (21) Appl. No.: 14/854,790 packages and pharmaceutical compositions comprising laquinimod and fingolimod for treating a subject afflicted (22) Filed: Sep.15, 2015 with a neurodegenerative disease. Also provided is a pharma ceutical composition comprising laquinimod for use as an add-on therapy or in combination with fingolimod, and a Related U.S. Application Data pharmaceutical composition comprising fingolimod for use (60) Provisional application No. 62/050.842, filed on Sep. as an add-on therapy or in combination with laquinimod, for 16, 2014. treating said Subject. Patent Application Publication Mar. 17, 2016 Sheet 1 of 34 US 2016/0074380 A1

se S. o o 8 is a

48 w s

g w re o uoeuleurap go eios 9 aneuenbuias

i Patent Application Publication Mar. 17, 2016 Sheet 2 of 34 US 2016/0074380 A1

t

r C) & alosuogeupkuaa T.

n D CD

s

aloos teleutekued Patent Application Publication Mar. 17, 2016 Sheet 3 of 34 US 2016/0074380 A1

S. 9so g s r

e to co e o to to r N uul sileo . aarsod-wofon

Patent Application Publication Mar. 17, 2016 Sheet 4 of 34 US 2016/0074380 A1

övrigy/# §§§§

W