Claims for Patent: 9,980,944

Summary for Patent: 9,980,944

Title:	Preparation of and formulation comprising a MEK inhibitor
Abstract:	The present invention relates to processes for preparing 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide, processes for preparing crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide, and intermediates useful therefore. Also provided herein are pharmaceutical compositions comprising this crystallized compound.
Inventor(s):	Krell; Christoph Max (Basel, CH), Misun; Marian (Basel, CH), Niederer; Daniel Andreas (Basel, CH), Pachinger; Werner Heinz (Basel, CH), Wolf; Marie-Christine (Basel, CH), Zimmermann; Daniel (Basel, CH), Liu; Weidong (Boulder, CO), Stengel; Peter J. (Boulder, CO), Nichols; Paul (Boulder, CO)
Assignee:	Array BioPharma Inc. (Boulder, CO)
Application Number:	15/445,393
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,980,944
Patent Claims:	1. A method of treating melanoma in a patient in need thereof, the method comprising: (a) detecting a melanoma in said patient that is a BRAF-mutant melanoma; and (b) administering to said patient a therapeutically effective amount of a pharmaceutical composition comprising crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide. 2. The method of claim 1, wherein said BRAF-mutant melanoma is BRAFV600-mutant melanoma. 3. The method of claim 1, further comprising treating said patient with at least one additional therapeutic agent selected from the group consisting of mitotic inhibitors, alkylating agents, anti-metabolites, intercalating antibiotics, growth factor inhibitors, cell cycle inhibitors, enzyme inhibitors, topoisomerase inhibitors, biological response modifiers, anti-hormones, angiogenesis inhibitors, and anti-androgens. 4. The method of claim 3, wherein said pharmaceutical composition comprising crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide and said additional therapeutic agent are administered simultaneously. 5. The method of claim 4, wherein said BRAF-mutant melanoma is BRAFV600-mutant melanoma. 6. The method of claim 3, wherein said pharmaceutical composition comprising crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide and said additional therapeutic agent are administered separately. 7. The method of claim 6, wherein said BRAF-mutant melanoma is BRAFV600-mutant melanoma. 8. The method of claim 1, wherein said pharmaceutical composition comprising crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide is formulated for oral administration. 9. The method of claim 8, wherein said pharmaceutical composition is formulated as a tablet. 10. The method according to claim 9, wherein said tablet further comprises lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate. 11. The method according to claim 9, wherein said tablet comprises approximately 15 mg crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide. 12. The method according to claim 10, wherein said tablet comprises approximately 15 mg crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide.