Claims for Patent: 9,868,739

Summary for Patent: 9,868,739

Title:	Salt(s) of 7-cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo- [2,3-d]pyrimidine-6-carboxylic acid dimethylamide and processes of making thereof
Abstract:	This invention relates to (1) process of making 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide and salt(s) thereof; (2) novel salt(s) of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide; (3) pharmaceutical compositions comprising the same; and (4) methods of treatment using the same.
Inventor(s):	Calienni; John Vincent (Cranford, NJ), Chen; Guang-Pei (Livingston, NJ), Gong; Baoqing (Morris Plains, NJ), Kapa; Prasad Koteswara (Parsippany, NJ), Saxena; Vishal (Quincy, MA)
Assignee:	Novartis AG (Basel, CH)
Application Number:	14/887,790
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,868,739
Patent Claims:	1. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the initial X-ray Powder Diffraction (XRPD) illustrated in FIG. 2. 2. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the post-DVS X-ray Powder Diffraction (XRPD) illustrated in FIG. 2. 3. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the initial Differential Scanning calorimetry (DSC) illustrated in FIG. 3. 4. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the post-DVS Differential Scanning calorimetry (DSC) illustrated in FIG. 3. 5. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the initial Thermogravimetric Analysis (TGA) illustrated in FIG. 4. 6. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the post-DVS Thermogravimetric Analysis (TGA) illustrated in FIG. 4. 7. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the initial X-ray Powder Diffraction (XRPD) illustrated in FIG. 6. 8. A method of treating a cancer which responds to an inhibition of cyclin dependent kinases activity comprising the step of administering to a subject in need of such treatment a therapeutically effective amount of a succinate salt of 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyr- imidine-6-carboxylic acid dimethylamide characterized by the post-DVS X-ray Powder Diffraction (XRPD) illustrated in FIG. 6. 9. The method of any one of claims 1-8 wherein the cancer is breast cancer, genitourinary cancer, lung cancer, gastrointestinal cancer, epidermoid cancer, melanoma, ovarian cancer, neuroblastoma, head and/or neck cancer, hyperplasias, larynx cancer, lymphatic system cancer, bone cancer, epidermas cancer, hematopoietic cancer, myeloma, thyroid follicular cancer, a tumor of mesenchymal origin, a tumor of the central or peripheral nervous system, seminoma, teratocarcinoma, xeroderma pigmentosum, and Kaposi's sarcoma. 10. The method of claim 9 wherein the cancer is breast cancer. 11. The method of claim 9 wherein the lymphatic system cancer is mantle cell lymphoma or large B cell lymphoma. 12. The method of claim 9 wherein the cancer is neuroblastoma. 13. The method of claim 9 wherein the lung cancer is small-cell lung cancer. 14. The method of claim 9 wherein the genitourinary cancer is bladder cancer, prostate cancer or renal cancer. 15. The method of claim 9 wherein the hematopoietic cancer is chronic lymphocytic leukaemia. 16. The method of claim 9 wherein the epidermoid cancer is keratoacanthoma. 17. The method of claim 9 wherein the bone cancer is osteosarcoma. 18. The method of claim 9 wherein the gastrointestinal cancer is gastric cancer, colon cancer, colorectal cancer, esophagus cancer, liver cancer, or pancreas cancer. 19. The method of claim 9 wherein the hematopoietic cancer is leukemias.