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Us 9084743 B2 Hyaluronidase USOO9084743B2 (12) UnitedO States Patent (10) Patent No.: US 9,084,743 B2 Teschner et al. (45) Date of Patent: Jul. 21, 2015 (54) STABLE CO-FORMULATION OF 4,396,608 A 8/1983 Tenold ....................... 424,177.1 HYALURONIDASE AND ; : A 3: Set al. r. 3:13; IMMUNOGLOBULIN, AND METHODS OF 26736. A 75 FAI. 53. USE THEREOF 4,876,088 A 10/1989 Hirao et al. ................... 424,101 4,952.496 A 8, 1990 Studier et al. .. 435,9141 (75) Inventors: Wolfgang Teschner, Vienna (AT); Sonja 5,033,252 A 7/1991 Carter ............................. 53.425 Svatos, Berg (AT); Leopold 5,052,558 A 10/1991 Carter ... ... 206,439 Bruckschwaiger, Vienna (AT); Alfred 5,122,373 A 6, 1992 Eibl et al. .... 424,171.1 5,122,614 A 6/1992 Zalipsky ....................... 548,520 Weber, Vienna (AT), Hans-Peter. 5,177,194. A 1/1993 Sarno et al. 530.390.1 Schwarz, Vienna (AT); Laura Lei, Los 5, 180,810 A 1/1993 Gomi et al. 530/350 Angeles, CA (US) 5,323,907 A 6/1994 Kalvelage ... ... 206,531 5,324,844 A 6/1994 Zalipsky ........ ... 548,520 (73) Assignees: Baxter International Inc., Deerfield, IL 5,409,990 A 4, 1995 Linnau et al. 525,541 (US);US); Baxter Healthcare S.Asa. Kes 5,608,0385,446,090 A 3,8/1995 1997 EibletHarris al........ .... 530,387.1525,541 Zurich-Opfikon (CH) 5,612.460 A 3/1997 Zalipsky ........ 530,391.9 5,643,575 A 7/1997 Martinez et al. ........... 424,194.1 (*) Notice: Subject to any disclaimer, the term of this 5,665,069 A 9/1997 Cumer et al. ... ... 604,116 patent is extended or adjusted under 35 5,672,662 A 9, 1997 Harris et al. ... 525/408 U.S.C. 154(b) by 713 days 5,721,348 A 2f1998 Primakoff et al. ........... 536, 22.1 M YW- y yS. 5,747,027 A 5/1998 Stern et al. ......... 424/94.62 5,766,581 A 6/1998 Bartley et al. .. ... 424/85.1 (21) Appl. No.: 12/807,991 5,795,569 A 8/1998 Bartley et al. ... 424/85.1 5,808.096 A 9/1998 Zalipsky ... 548,520 (22) Filed: Sep. 16, 2010 5,827,721. A 10/1998 Stern et al. ......... ... 435,201 5,854,046 A 12/1998 Au-Young et al. ............ 435/201 O O 5,871,736 A 2/1999 Bruegger et al. .......... 424/177.1 (65) Prior Publication Data 5,900.461. A 5/1999 Harris ................ 525,54.11 US 2011 FOO661 11 A1 Mar 17, 2011 5,919,455 A 7/1999 Greenwald et al. ........ 424,178.1 s 5,932,462 A 8/1999 Harris et al. .................. 435.188 Related U.S. Application Data (Continued) (60) Provisional application No. 61/277,045, filed on Sep. FOREIGN PATENT DOCUMENTS 17, 2009. CH 684 164 T 1994 (51) Int. Cl. EP O177836 4f1986 A 6LX39/395 (2006.01) (Continued) A6 IK39/00 (2006.01) A6 IK9/00 (2006.01) OTHER PUBLICATIONS A6 IK 47/42 (2006.01) Bee et al., “Recombinant human PH2O is well tolerated at higher C07K 16/00 (2006.01) intravenous and Subcutaneous doses in cynomolgus monkeys.” C07K 16/06 (2006.01) EUFEPS2008, Munich, Germany, 3 pages. CI2N 9/26 (2006.01) Berger et al., “Immunoglobulin replacement therapy by slow Subcu (52) U.S. Cl. taneous infusion.” Ann Intern Med 93:55-56 (1980). CPC ............... A61K 39/00 (2013.01); A61 K9/002I Berger et al., “Subcutaneous immunoglobulin therapy in primary (2013.01); A61 K39/39591 (2013.01); A61 K immunodeficiencies.” Clin Immuno. 112:1-7 (2004). 47/42 (2013.01); C07K 16/00 (2013.01); C07K Gardulfetal. “Safety of rapic Subcutaneous gammaglobulin by rapid 16/06 (2013.01); C12N 9/2474 (2013.01); infusion in patients with primary antibody deficiency.” CI2Y 302/01035 (2013.01); A61K 2039/505 Immunodeficiency 4:81-84 (1993). (2013.01); C07K 2317/21 (2013.01) (Continued) (58) Field of Classification Search None See application file for complete search history. Primary Examiner — Yunsoo Kim (74) Attorney, Agent, or Firm — McKenna Long & Aldridge (56) References Cited LLP; Stephanie Seidman U.S. PATENT DOCUMENTS (57) ABSTRACT 3,869,436 A 3/1975 FalkSveden et al. .......... 260f 112 3,966,906 A 6, 1976 Schultze et al. ........... 424,177.1 Provided herein are stable co-formulations of immunoglobu 4,002,531 A 1/1977 Royer ........................... 435.188 lin and hyaluronidase that are stable to storage in liquid form 4,093,606 A 6, 1978 Coval .... 530.390.5 4,124,576 A 11, 1978 Coval ............... 530.390.5 at room temperature for at least 6 months and at Standard 4,126,605 A 11, 1978 Schneider et al. 530.390.5 refrigerator temperatures for 1-2 years. Such co-formulations 4,165,370 A 8, 1979 Coval ............... ... 424,177.1 can be used in methods of treating IG-treatable diseases or 4,179,337 A 12, 1979 Davis et al. ................... 435/181 conditions by Subcutaneous administration. 4,186,192 A 1, 1980 Lundbladet al. .......... 424,177.1 4,362,661 A 12, 1982 Ono et al. ........ ... 424,177.1 4,374,763. A 2/1983 Takagi ....................... 530.390.5 29 Claims, No Drawings US 9,084,743 B2 Page 2 (56) References Cited 2010.0003238 A1 1/2010 Frost et al. ................. 424/94.62 2010, 0074885 A1 3/2010 Schiff et al. U.S. PATENT DOCUMENTS 2010.01434.57 A1 6/2010 Wei et al. ...................... 424/450 2010/0172892 A1 7/2010 Uvarkina et al. .......... 424/94.62 5,945,098 A 8, 1999 Sarno et al. .................. 424,85.5 2010, 0196423 A1 8/2010 Bookbinder et al. ...... 424,247.1 5,958,750 A 9, 1999 Au-Young etal 435,201 2010, 0211015 A1 8, 2010 Bookbinder et al. ......... 604,187 5,985,263. A 11/1999 Lee et al. ..................... 424/85.2 2010/0330.071 A1 12/2010 Teschner et al. ....... ... 530/412 5.990,237 A 11, 1999 Bentley et al. ............... 525,542 2011/O152359 A1 6, 2011 Bookbinder et al. ... 435/200 6,057,110 A 5, 2000 Au-Young et al. ................ 435/6 2011/0212074 A1 9/2011 Frost et al. ................... 424,85.1 6,069,236 A 5/2000 Burnouf-Radosevich 2011/0293598 Al 12/2011 Bruckschwaiger et al. .. 424/530 et al. ............................. 530/416 2011/0293638 Al 12/2011 Bruckschwaiger 6,113,906 A 9/2000 Greenwald et al. ...... 424,194.1 et al. .......................... 424,140.1 6,123,938 A 9, 2000 Stern et al. ..... 424/94.62 2012/0020951 A1 1/2012 Shepard et al. ..... ... 424,130.1 6,193,963 B1 2/2001 Stern et al. ... 424/94.6 2012/0076772 A1 3/2012 Butterweck et al. ... 424/133.1 6.2 14,966 B1 4/2001 Harris ...... 528,322 2012/0076779 A1 3/2012 Butterweck et al. ....... 424,130.1 6,258,351 B1 7/2001 Harris ...... 424/78.3 2012fOO9377O A1 4/2012 Bookbinder et al. ...... 424/94.62 6,340,742 B1 1/2002 Burg et al. .. 530,351 2012/O148555 A1 6/2012 Bookbinder et al. ........ 424/94.3 6,395,880 B1 5/2002 Linnau et al. 530,393 2012/0171153 A1 7/2012 Frost et al. ................. 424/78.17 6,413.507 B1 7/2002 Bentley et al. 424/78.02 2013/0022588 A 1 1/2013 Yang et al. ... 424/94.3 6.420,339 B1 7/2002 Gegg et al. .. ... 514/12 2013/0251786 A1 9/2013 Li et al. .... 424/94.62 6,437,025 B1 8, 2002 Harris et al. 523,406 2013/0302275 A1 11/2013 Wei et al. ..... 424/94.62 6,448,369 B1 9, 2002 Bentley et al. ..... 528,425 2013/0302400 A1 11/2013 Maneval et al. .... 435/195 6,461,802 B1 10/2002 Van Thillo et al. 430,336 2014,0199282 A1 7/2014 Bookbinder et al. ......... 435/200 6,495,659 B2 12/2002 Bentley et al. ... 528,425 6,552,170 B1 4/2003 Thompson et al. 530,351 FOREIGN PATENT DOCUMENTS 6,737,505 B2 5/2004 Bentley et al. ..... 528,425 6,828.401 B2 12/2004 Nho et al. ...... 526,333 EP O246579 5, 1987 6,828,431 B1 12/2004 Frudakis et al. ...... 536,231 EP O278422 8, 1988 6,858,736 B2 2/2005 Chang-min ETAL ....... 546,290 EP O440483 8, 1991 6,875,848 B2 4/2005 Ristol Debart et al. .... 530/390.1 EP O822199 2, 1998 7,105,330 B2 9, 2006 Stern et al. ......... 435/200 EP 1064951 6, 2000 7,148,201 B2 12/2006 Stern et al. .. ... 514/44 JP 54O2O124 2, 1979 7.309,810 B2 12/2007 Takai et al. ....................... 8003 JP 57031623 2, 1982 7,368,108 B2 5/2008 DeFrees et al. .............. 424/94.5 JP 571286.35 8, 1982 7,544.499 B2 6, 2009 Frost et al. ......... 435/200 JP S63-192724 8, 1988 7,767.429 B2 8, 2010 Bookbinder et al. 435,201 JP H10-265407 A 10, 1998 7,781,397 B2 8/2010 Stern et al. ........................ 514/2 JP 4346934 12/2002 8, 105,586 B2 1/2012 Bookbinder et al. 424/94.3 JP 2004-238.392 A 8, 2004 8, 187.855 B2 5/2012 Baker et al. ........... ... 435,201 JP 2006-524.507 A 11, 2006 8,202,517 B2 6, 2012 Bookbinder et al. ...... 424/94.62 JP 2007-511566. 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