Patent SG-11201906853Q-A (SG)
Title: Anti-rsv monoclonal antibody formulation
Inventor: LOBO BRIAN
IPC: C07K16/10
Filed: 2018-02-28
Abstract: 1596X+99.62 — D 0.40C El 25C © 5C 1 3 4 97.5 0 2 TIME (MONTHS) = -0.0211X+99.638 Y = -0.5254+99.373 100 99.5 >_ 99 m • 98.5 O _ 98 W O 20 18/ 1607 22 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 07 September 2018 (07.09.2018) WIP0 I PCT Iiiimmomitiaonolomomioolimommom oimIE (10) International Publication Number WO 2018/160722 Al (51) International Patent Classification: C07K 16/08 (2006.01) A61K 39/395 (2006.01) C07K 16/10 (2006.01) A61P 31/12 (2006.01) A61K 38/16 (2006.01) A61P 31/14 (2006.01) A61K 39/42 (2006.01) (21) International Application Number: PCT/US2018/020264 (22) International Filing Date: 28 February 2018 (28.02.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/465,379 01 March 2017 (01.03.2017) US (71) Applicant: MEDIMMUNE LIMITED [GB/GB]; Mil- stein Building, Granta Park, Cambridge CB21 6GH (GB). (72) Inventors; and (71) Applicants: LOBO, Brian [US/US]; Medlmmune, LLC, One MedImmune Way, Gaithersburg, MD 20878 (US). GOLDBERG, Deborah [US/US]; 6219 Sutton Court, Elkridge, MD 21075 (US). (74) Agent: JOHNSON, Nancy, A.; Mueting, Raasch & Gebhardt, P.A., P.O. Box 581336, Minneapolis, MN 55458-1336 (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, 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). (54) Title: ANTI-RSV MONOCLONAL ANTIBODY FORMULATION MEDI8897 REPRESENTATIVE DRUG PRODUCT STABILITY Fig. 3 (57) : The present invention provides a formulation comprising: (i) an anti-RSV monoclonal antibody; and (ii) an ionic ex- cipient; wherein the monoclonal antibody is present at a concentration of about 50mg/m1 or greater and the ionic excipient is present at a concentration of between 50 and 150 mM and the formulation has a pH of about 5.5 to about 7.5. [Continued on next page] WO 2018/160722 Al D ill Published: with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) with sequence listing part of description (Rule 5.2(a))