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Last Updated: November 28, 2020

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Claims for Patent: 9,598,376

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Summary for Patent: 9,598,376
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-carboxylic 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) Novartis AG (Basel, CH)
Application Number:15/053,441
Patent Claims: 1. A method of treating a cancer is selected from melanoma, pancreatic cancer, ovarian cancer, carcinoma of the fallopian tubes, peritoneal cancer, biliary cancer, colon cancer, or rectal cancer in a patient in need thereof, comprising administering to said mammal a pharmaceutical composition comprising crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide and a pharmaceutically acceptable carrier or excipient.

2. The method according to claim 1, wherein the cancer is melanoma.

3. The method according to claim 2, wherein said melanoma is BRAFV600 or NRAS-mutant melanoma.

4. The method according to claim 3, wherein the pharmaceutical composition is formulated as a tablet.

5. The method according to claim 4, wherein the pharmaceutical composition comprises approximately 15 mg crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide.

6. The method according to claim 5, wherein the pharmaceutical composition further comprises lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, and magnesium stearate.

7. The method according to claim 6, wherein said melanoma is NRAS-mutant melanoma.

8. The method according to claim 3, further comprising administering an additional therapeutic agent.

9. The method according to claim 8, wherein the additional therapeutic agent is a chemotherapeutic agent or anti-tumor agent.

10. The method according to claim 9, wherein the pharmaceutical composition comprising crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide and the additional therapeutic agent are administered separately.

11. The method according to claim 10, wherein said melanoma is BRAFV600 mutant melanoma.

12. The method according to claim 9, wherein the pharmaceutical composition comprising crystallized 6-(4-bromo-2-fluorophenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-car- boxylic acid (2-hydroxyethyoxy)-amide and the additional therapeutic agent are administered simultaneously.

13. The method according to claim 1, wherein the cancer is colon cancer.

14. The method according to claim 1, wherein the cancer is ovarian cancer.

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