INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) CORRECTED VERSION (19) World Intellectual Property Organization International Bureau (43) International Publication Date 111111111111110111111111111111111111110 1 0 01 111 11111 1111111111 0 111110 111110 1111110 1111 (10) International Publication Number WO 2018/200918 A8 01 November 2018 (01.11.2018) WIP0 I PCT i'2 (51) International Patent Classification: A61K 39/395 (2006.01) C07K 16/28 (2006.01) (21) International Application Number: PCT/US2018/029728 (22) International Filing Date: 27 April 2018 (27.04.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/492,056 28 April 2017 (28.04.2017) US (71) Applicant: AMGEN INC. [US/US]; One Amgen Center Drive, Thousand Oaks, CA 91320-1799 (US). (72) Inventors: BRYCH, Stephen, Robert; 2488 Gillingham Circle, Thousand Oaks, CA 91362 (US). WONG, Lyanne, M.; 28861 Silversmith Drive, Valencia, CA 91354 (US). FALLON, Jaymille; 28915 Lodgewood Street, Newbury Park, CA 91320 (US). GOSS, Monica, Michelle; 3050 Lodgewood Street, Newbury Park, CA 91320 (US). GU, Jian, Hua; 1525 Silver Shadow Drive, Thousand Oaks, CA 91320 (US). GHATTYVENKATAKRISHNA, Pa- van, K.; 1690 Springhaven Ave., Newbury Park, CA 91320 (US). (74) Agent: HONG, Julie, J.; Marshall, Gerstein & Borun LLP, 233 S. Wacker Drive, 6300 Willis Tower, Chicago, IL 60606-6357 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, = (54) Title: FORMULATIONS OF HUMAN ANTI-RANKL ANTIBODIES, AND METHODS OF USING THE SAME ,-- ,,,, ,--, \'. .-..... 'C'' W EEKS laf: X !X.r : ;.:H .2 5.2 A.::: , ..A.atei)vseVRA>goL:PS.2.. , 3iii)H F.sa. 5,2 5.2 20g1.:1.1 5.2 hi 5.2 (57) : Disclosed herein are aqueous pharmaceutical formulations comprising denosumab or another human anti-RANKL mon- oclonal antibody or portion thereof, and characteristics of pH, buffer systems, and amino acid aggregation inhibitors. Also disclosed are presentation of the formulation for use, e.g. in a single-use vial, single-use syringe, or glass container, methods of using the formulations and articles for preventing or treating diseases, and related kits. [Continued on next page] WO 2018/200918 A8 I IIIII I 11111110111111 IIIII 11111 IIIII 11011111111111 11111 11111 11111 11111 1111111110111 SC, 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. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, 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, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Published: — with international search report (Art. 21(3)) — with sequence listing part of description (Rule 5.2(a)) (48) Date of publication of this corrected version: 17 October 2019 (17.10.2019) (15) Information about Correction: see Notice of 17 October 2019 (17.10.2019)
FORMULATIONS OF HUMAN ANTI-RANKL ANTIBODIES, AND METHODS OF USING THE SAME