(12) United States Patent (10) Patent No.: US 8,383,114 B2 Sloey Et Al
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USOO8383114B2 (12) United States Patent (10) Patent No.: US 8,383,114 B2 Sloey et al. (45) Date of Patent: Feb. 26, 2013 (54) PHARMACEUTICAL FORMULATIONS 6,919,426 B2 7/2005 Boone et al. 7,030,226 B2 4/2006 Sun et al. (75) Inventors: Christopher J. Sloey, Newbury Park, 7,084.2457,037.498 B2 8/20065, 2006 CohenHolmes et et al. al. CA (US); Camille Vergara, Calabasas, 7,153,507 B2 12/2006 van de Winkel et al. CA (US); Jason Ko. Thousand Oaks, CA 7,217,689 B1 5/2007 Elliott et al. (US); Tiansheng Li, Newbury Park, CA 7,220,410 B2 5/2007 Kim et al. (US) 2002/0155998 A1 10/2002 Young et al. 2002/01992 13 A1 12/2002 Tomizuka et al. 2003/0023586 A1 1/2003 Knorr (73) Assignee: Amgen Inc., Thousand Oaks, CA (US) 2003, OO31667 A1 2/2003 Deo et al. - 2003, OO77753 A1 4, 2003 Tischer (*) Notice: Subject to any disclaimer, the term of this 2003/0082749 A1 5/2003 Sun et al. patent is extended or adjusted under 35 2003/01 18592 A1 6/2003 Ledbetter et al. U.S.C. 154(b) by 0 days. 2003/0.133939 A1 7/2003 Ledbetter et al. 2003. O138421 A1 7/2003 van de Winkel et al. 2003.0143202 A1 7/2003 Binley et al. (21) Appl. No.: 12/680,128 2003/0194404 A1 10, 2003 Greenfeder et al. 2003. O19515.6 A1 10, 2003 Minet al. (22) PCT Filed: Sep. 29, 2008 2003/0215444 A1 11/2003 Elliott 2003,0229023 A1 12/2003 Oliner et al. (86). PCT No.: PCT/US2008/078193 2003/0235582 Al 12/2003 Singh et al. 2004/0009902 A1 1/2004 Boimeet al. S371 (c)(1), 2004/0018191 A1 1/2004 Wang et al. (2), (4) Date: Jul. 12, 2010 2004f0071694 A1 4/2004 DeVries et al. 2004f0071702 A1 4/2004 van de Winkel et al. 2004/0086503 A1 5/2004 Cohen et al. (87) PCT Pub. No.: WO2009/043049 2004/0091961 A1 5/2004 Evans et al. PCT Pub. Date: Apr. 2, 2009 2004/OO97712 A1 5, 2004 Varnum et al. 9 2004/0143857 A1 7/2004 Young et al. O O 2004/O157293 A1 8, 2004 Evans et al. (65) Prior Publication Data 2004/0175379 A1 9, 2004 DeVries et al. US 2010/O297106A1 Nov. 25, 2010 (Continued) Related U.S. Application Data FOREIGN PATENT DOCUMENTS EP 404097 A2 12, 1990 (60) Provisional application No. 60/975,780, filed on Sep. EP 1188.445 A1 3f2002 27, 2007. (Continued) (51) Int. Cl. OTHER PUBLICATIONS C07K I4/00 (2006.01) Altschul et al., “Basic Local Alignment Research Tool”, J Mol Biol (52) U.S. Cl. ........................ 424/134.1: 514/12: 530/350 215: 403-410 (1990). (58) Field of Classification Search ........................ None Biocca, et al., “Expression and targeting of intracellular antibodies in See application file for complete search history. mammalian cells, EMBO J. 9:101-108, 1990. Bird et al., “Single-Chain Antigen-Binding Proteins, Science 242:423-426, (1988). (56) References Cited Bruggermann et al., “Designer Mice: The Production of Human Antibody Repertoires in Transgenic Animals.”Year in Immuno. 7:33 U.S. PATENT DOCUMENTS (1993). 4.703,008 A 10, 1987 Lin Caton and Koprowski. “Influenza virus hemagglutinin-specific anti 5.44 1868 A 8, 1995 Lin bodies isolated from a combinatorial expression library are closely 5,547.933 A 8, 1996 Lin related to the immune response of the donor.” Proc. Natl. Acad. Sci. 5,618,698 A 4, 1997 Lin USA, 87:6450-6454. 1990. 5,621,080 A 4, 1997 Lin Chothia et al., “Canonical Structures for the Hypervariable Regions 5,686.292 A 11/1997 Schwall et al. of Immunoglobulins,” J. Mol.Biol. 196:901-917 (1987). 5,756,349 A 5, 1998 Lin Co, et al., “A Humanized Antibody Specific for the Platelet Integrin 5,767,078 A 6, 1998 Johnson et al. gplb/lla.” J. Immunol. 152, 2968-2976 (1994). 5,773,569 A 6/1998 Wrighton et al. Cohen, et al., “Combination Therapy Enhances the Inhibition of 5,789,554 A 8/1998 Leung et al. Tumor Growth with the Fully Human Anti-Type 1 Insulin-Like 5,830,851 A 1 1/1998 Wrighton et al. Growth Factor Receptor Monoclonal Antibody CP-751,871.” Clini 5,856.298 A 1/1999 Strickland cal Cancer Res. 11:2063-73 (2005). 5,955.422 A 9, 1999 Lin 5,986,047 A 1 1/1999 Wrighton et al. (Continued) 6,030,086 A 2/2000 Thomas 6,310,078 B1 10/2001 Connolly et al. Primary Examiner — Yunsoo Kim 6,391,633 B1 5, 2002 Stern et al. (74) Attorney, Agent, or Firm — Marshall, Gerstein & Borun 6,468,529 B1 10/2002 Schwall et al. LLP 6,583,272 B1 6, 2003 Bailon 6,586,398 B1 7/2003 Kinstler et al. (57) ABSTRACT 6,750,369 B2 6/2004 Connolly et al. A stable pharmaceutical formulation is provided that com 6,756,480 B2 6/2004 Kostenuik et al. prises a biologically active protein and an excipient selected 6,803,453 B1 10, 2004 Brunkow et al. 6,835,809 B1 12/2004 Liu et al. from carnitine, creatine or creatinine. 6,900,292 B2 5, 2005 Sun et al. 6 Claims, 12 Drawing Sheets US 8,383,114 B2 Page 2 U.S. PATENT DOCUMENTS WO WO-03/059951 A2 T 2003 2004/0175824 A1 9, 2004 Sun et al. W8 W888. Ai E58. 2004/O181033 A1 9, 2004 Han et al. WO WO-2004/002417 A2 1, 2004 2004/O197324 A1* 10, 2004 Liu et al. .................... 424,130.1 WO WO-2004/002424 A2 1, 2004 2004/0202655 A1 10, 2004 Morton et al. WO WO-2004/009627 A1 1, 2004 2004/0228859 A1 11/2004 Graus et al. WO WO-2004/O18667 A1 3, 2004 2004/0229318 A1 11/2004 Heavner WO WO-2004/O24761 A1 3, 2004 2004/0248815 A1 12/2004 Connolly et al. WO WO-2004/033651 A2 4/2004 2004/0265307 Al 12/2004 Singh et al. WO WO-2004/035603 A2 4/2004 2004/0266690 A1 12, 2004 Pool WO WO-2004/043382 A2 5, 2004 2005, 0004353 A1 1/2005 Welcher et al. WO WO-2004/058988 A2 T 2004 2005, OOO8642 A1 1/2005 Graus et al. WO WO-2004/073092 A2 8, 2004 2005, OO19914 A1 1/2005 Staerk et al. WO WO-2004/101600 A2 11/2004 2005, 0026834 A1 2/2005 Cox et al. WO WO-2004/101606 A2 11/2004 2005/OO37421 A1 2/2005 Honda et al. WO WO-2004/101611 A2 11/2004 2005, OO74821 A1 4, 2005 Wild et al. WO WO-2004/106373 A1 12/2004 2005, OO84906 A1 4/2005 Goetsch et al. WO WO-2005/001025 A2 1, 2005 2005.0089932 A1 4/2005 Kolkman et al. WO WO-2005/001136 A1 1, 2005 2005, 0096461 A1 5, 2005 COX WO WO-2005/O1697O A2 2/2005 2005/O107297 A1 5, 2005 Holmes et al. WO WO-2005/017107 A2 2, 2005 2005/0107591 A1 5, 2005 Cox WO WO-2005/021579 A2 3, 2005 2005, 0112694 A1 5, 2005 Carter et al. WO WO-2005/O25606 A1 3, 2005 2005, 0118643 A1 6/2005 Burgess et al. WO WO-2005/032460 A2 4/2005 2005, 0124045 A1 6, 2005 Sun et al. WO WO-2005/047331 A2 5, 2005 2005, 0124564 A1 6/2005 Binley et al. WO WO-2005/051327 A2 6, 2005 2005. O136049 A1 6, 2005 Ledbetter et al. WO WO-2005/058967 A2 6, 2005 2005. O136063 A1 6/2005 Wang et al. WO WO-2005/0638O8 A1 7/2005 2005, 0137329 A1 6, 2005 Holmes et al. WO WO-2005/063809 A1 7/2005 2005. O142642 A1 6, 2005 Sun et al. WO WO-2005, O70451 A1 8, 2005 2005.0143292 A1 6, 2005 DeFrees et al. WO WO-2005/081687 A2 9, 2005 2005/O153879 A1 7/2005 Svetina et al. WO WO-2005.084711 A1 9, 2005 2005. O158822 A1 7, 2005 Pecker WO WO-2005/092369 A2 10, 2005 2005. O158832 A1 7/2005 Young et al. WO WO-2005,100403 A2 10, 2005 2005/0170457 A1 8, 2005 Pool et al. WO WO-2005,103076 A2 11/2005 2005/O181359 A1 8/2005 Optelten et al. WO WO 2006/02646 A2 1, 2006 2005, 0181482 A1 8, 2005 Meade et al. WO WO-2006/013472 A2 2, 2006 2005, 0186203 A1 8/2005 Singh et al. WO WO-2006,29094 A2 3, 2006 2005, 0192211 A1 9, 2005 Gillies et al. WO WO-2006,50959 A2 5, 2006 2005/0202538 A1 9, 2005 Gillies et al. WO WO-2006/069202 A2 6, 2006 2005/0227289 A1 10/2005 Reilly et al. WO WO-2006081171 A1 8, 2006 2005/0244408 A1 11/2005 Cohen et al. WO WO-2006,138729 A2 12/2006 2005/0244409 A1 11/2005 Erickson-Miller et al. WO WO-2007,000328 A1 1, 2007 2005/0249728 A1 1 1/2005 Singh et al. WO WO-2007/01 1941 A2 1, 2007 2006,0040358 A1 2/2006 Ligensa et al. WO WO-2007/O12614 A2 2, 2007 2006,0040858 A1 2/2006 Holmes et al. WO WO-2007/057748 A2 5/2007 2006/0088906 A1 4/2006 DeFrees et al. WO WO-98.24893 A2 6, 2011 2006/0111279 A1 5, 2006 DeFrees et al. 2006, O135431 A1 6, 2006 Minet al. OTHER PUBLICATIONS 2007/0110747 A1 5/2007 Paszty et al.