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WO 2016/174183 Al 3 November 2016 (03.11.2016) P O P C T

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WO 2016/174183 Al 3 November 2016 (03.11.2016) P O P C T (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date WO 2016/174183 Al 3 November 2016 (03.11.2016) P O P C T (51) International Patent Classification: dreas; Pistoriusstr. 7, 13086 Berlin (DE). NEUHAUS, Ro¬ Λ 61Κ 31/4439 (2006.01) A61K 31/519 (2006.01) land; Lauenburger Str. 28, 12157 Berlin (DE). A61K 31/454 (2006.01) A61K 31/5377 (2006.01) (74) Agent: BIP PATENTS; c/o Bayer Intellectual Property A61K 31/496 (2006.01) A61K 31/55 (2006.01) GmbH, Alfred-Nobel-Str. 10, 40789 Monheim am Rhein A61K 31/497 (2006.01) C07D 401/12 (2006.01) (DE). A61K 31/4985 (2006.01) A61P 35/02 (2006.01) A61K 31/505 (2006.01) A61P 35/00 (2006.01) (81) Designated States (unless otherwise indicated, for every A61K 31/506 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, (21) International Application Number: BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, PCT/EP2016/059576 DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KN, KP, KR, 29 April 2016 (29.04.2016) KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, (25) Filing Language: English PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, (26) Publication Language: English SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 15 166016.4 30 April 2015 (30.04.2015) EP (84) Designated States (unless otherwise indicated, for every 16152499.6 25 January 2016 (25.01.2016) EP kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (71) Applicant: BAYER PHARMA AKTIENGESELL- TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, SCHAFT [DE/DE]; Mullerstr. 178, 13353 Berlin (DE). TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (72) Inventors: BOTHE, Ulrich; KavalierstraBe 15, 13 187 DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, Berlin (DE). WENGNER, Antje Margret; Borkumstr. 12 SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, e, 13 189 Berlin (DE). SIEBENEICHER, Holger; GW, KM, ML, MR, NE, SN, TD, TG). Kruppstr. 18, 10557 Berlin (DE). SCHMIDT, Nicole; 333 Beale Street #4G, San Francisco, California 94103 (US). Declarations under Rule 4.17 : NUBBEMEYER, Reinhard; Moorweg 96, 13509 Berlin — as to applicant's entitlement to apply for and be granted a (DE). BOMER, Ulf; Leipziger Str. 49, 16548 Glienicke patent (Rule 4.1 7(H)) (DE). GUNTHER, Judith; Parkstr. 60, 13 187 Berlin (DE). STEUBER, Holger; Hannoversche Strasse 19A, Published: 101 15 Berlin (DE). LANGE, Martin; StraBburger Str. 9K, — with international search report (Art. 21(3)) 10405 Berlin (DE). STEGMANN, Christian; SchliemannstraBe 39, 10437 Berlin (DE). SUTTER, An¬ (54) Title: COMBINATIONS OF INHIBITORS OF IRAK4 WITH INHIBITORS OF BTK (57) Abstract: The present application relates to novel combinations of at least two components, component A and component B : · component A is an IRAK4 -inhibiting compound of the formula (I) as defined herein, or a diastereomer, an enantiomer, a metabolite, v a salt, a solvate or a solvate of a salt thereof; · component B is a BTK-inhibiting compound, or a pharmaceutically acceptable salt o thereof; and, optionally, · one or more components C which are pharmaceutical products; in which one or two of the above-defined compounds A and B are optionally present in pharmaceutical formulations ready for simultaneous, separate or sequential administra tion, for treatment and/or prophylaxis of diseases, and to the use thereof for production of medicaments for treatment and/or prophy o laxis of diseases, especially for treatment and/or prophylaxis of endometriosis, lymphoma, macular degeneration, COPD, neoplastic disorders and psoriasis. COMBINATIONS OF INHIBITORS OF IRAK4 WITH INHIBITORS OF BTK The present invention relates to combinations of at least two components, component A and component B: • component A is an IRAK4-inhibiting compound of the formula (I) as defined herein, or a diastereomer, an enantiomer, a metabolite, a salt, a solvate or a solvate of a salt thereof; · component B is a BTK-inhibiting compound; and, optionally, • one or more components Cwhich are pharmaceutical products; in which one or two of the above-defined compounds A and B are optionally present in pharmaceutical formulations ready for simultaneous, separate or sequential administration. A further aspect of the present invention relates t o combinations of at least two components, component A and component B: • component A is an IRAK4-inhibiting compound of the formula (I) as defined herein, or a diastereomer, an enantiomer, a metabolite, a salt, a solvate or a solvate of a salt thereof; • component B is a BTK-inhibiting compound selected from the following list: o ibrutinib, or a pharmaceutically acceptable salt thereof; o 4-tert-butyl-N-[2-methyl-3-(4-methyl-6-{[4-(morpholin-4- ylcarbonyl)phenyl]amino}-5-oxo-4,5-dihydropyrazin-2- yl)phenyl] benzamide (CG I-1746, CAS 910232-84-7); o N-{3-[(5-fluoro-2-{[4-(2-methoxyethoxy)phenyl]amino}pyrimidin-4- yl)amino] phenyl}acrylamide (AVL-292, CAS 1202757-89-8); o 6-cyclopropyl-8-fluoro-2-[2-(hydroxymethyl)-3-(l-methyl-5-{[5-(4- methylpiperazin-l-yl)pyridin-2-yl]amino}-6-oxo-l,6-dihydropyridin-3- yl)phenyl]isoquinolin-l(2H )-one (RN486, CAS 1242156-23-5); o HM71224; o N-{3-[6-({4-[(2R)-l,4-dimethyl-3-oxopiperazin-2-yl]phenyl}amino)-4- methyl-5-oxo-4,5-dihydropyrazin-2-yl]-2-methylphenyl}-4,5,6,7- tetrahydro-l-benzothiophene-2-carboxamide (GDC-0834, CAS 1133432- 50-4); o 5-amino-l-[(3R)-l-cyanopiperidin-3-yl]-3-[4-(2,4-difluorophenoxy)phenyl]- lH-pyrazole-4-carboxamide (PF-06250112, J Immunol 2013; 191:4540- 4550); o (2E)-4-(dimethylamino)-N-{7-fluoro-4-[(2- methylphenyl)amino] imidazo[l,5-a]quinoxalin-8-yl}-N-methylbut-2- enamide (CAS 1345250-62-5, Bioorg. Med. Chem. Lett. 21 (2011) 6258- 6262); o N-[3-(8-anilinoimidazo[l,2-a]pyrazin-6-yl)phenyl]-4-tert-butyl benzamide (CG I-560, CAS 845269-74-1); o 4-{4-[(4-{[3-(aryloylamino)phenyl]amino}-5-fluoropyrimidin-2- yl)amino] phenoxy}-N-methylpyridine-2-carboxamide (CNX-774, CAS1202759-32-7); o ONO-4059 (Arthritis and rheumatism 2012, 64 Suppl 10:1660). A further aspect of the present invention relates t o the use of such combinations as described herein for production of a medicament for treatment or preclusion of a disease, in particular for treatment of neoplastic disorders. Yet a further aspect of the present invention relates to methods for treatment or preclusion of neoplastic disorders, in which a therapeutically effective amount of a combination as defined herein is administered. The present invention further relates t o a kit comprising combinations of: • one or more components A consisting of an IRAK4-inhibiting compound of the formula (I) as defined herein, or a diastereomer, an enantiomer, a metabolite, a salt, a solvate or a solvate of a salt thereof; • a component B which is a BTK-inhibiting compound, or a pharmaceutically acceptable salt thereof. A further aspect of the present invention relates t o combinations of at least two components, component A and component B: • component A is an IRAK4-inhibiting compound of the formula (I) as defined herein, or a diastereomer, an enantiomer, a metabolite, a salt, a solvate or a solvate of a salt thereof; • component B is a BTK-inhibiting compound selected from the following list: ■ ibrutinib, or a pharmaceutically acceptable salt thereof; ■ 4-tert-butyl-N-[2-methyl-3-(4-methyl-6-{[4-(morpholin-4- ylcarbonyl)phenyl]amino}-5-oxo-4,5-dihydropyrazin-2-yl)phenyl] benzamide (CGI-1746, CAS 910232-84-7); ■ N-{3-[(5-fluoro-2-{[4-(2-methoxyethoxy)phenyl]amino}pyrimidin-4- yl)amino] phenyl}acrylamide (AVL-292, CAS 1202757-89-8); ■ 6-cyclopropyl-8-fluoro-2-[2-(hydroxymethyl)-3-(l-methyl-5-{[5-(4- methylpiperazin-l-yl)pyridin-2-yl]amino}-6-oxo-l,6-dihydropyridin-3- yl)phenyl]isoquinolin-l(2H)-one (RN486, CAS 1242156-23-5); ■ HM71224; N43-[6-({4-[(2R)-l,4-dimethyl-3-oxopiperazin-2-yl]phenyl}amino)-4-methyl- 5-oxo-4,5-dihydropyrazin-2-yl]-2-methylphenyl}-4,5,6,7-tetrahydro-l- benzothiophene-2-carboxamide (GDC-0834, CAS 1133432-50-4); 5-amino-l-[(3R)-l-cyanopiperidin-3-yl]-3-[4-(2,4-difluorophenoxy)phenyl]- lH-pyrazole-4-carboxamide (PF-06250112, J Immunol 2013; 191:4540-4550); ■ (2E)-4-(dimethylamino)-N-{7-fluoro-4-[(2-methylphenyl)amino]imidazo[l,5- a]quinoxalin-8-yl}-N-methylbut-2-enamide (CAS 1345250-62-5, Bloorg. Med. Chem. Lett. 21 (2011) 6258-6262); ■ N-[3-(8-anilinoimidazo[l,2-a] pyrazin-6-yl)phenyl]-4-tert-butylbenzamide (CGI-560, CAS 845269-74-1); ■ 4-{4-[(4-{[3-(aryloylamino)phenyl]amino}-5-fluoropyrimidin-2- yl)amino] phenoxy}-N-methylpyridine-2-carboxamide (CNX-774, CAS1202759-32-7); ■ ONO-4059 (Arthritis and rheumatism 2012, 64 Suppl 10: 1660), and optionally one or more pharmaceutical products; in which one or two of the above-defined compounds A and B are optionally present in pharmaceutical formulations ready for simultaneous, separate or sequential administration.
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