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WO 2010/025328 Al (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 4 March 2010 (04.03.2010) WO 2010/025328 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/00 (2006.01) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (21) International Application Number: CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, PCT/US2009/055306 DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (22) International Filing Date: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, 28 August 2009 (28.08.2009) KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (25) Filing Language: English NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, (26) Publication Language: English SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (30) Priority Data: 61/092,497 28 August 2008 (28.08.2008) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): FOR¬ GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, EST LABORATORIES HOLDINGS LIMITED [IE/ ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, —]; 18 Parliament Street, Milner House, Hamilton, TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, Bermuda HM12 (BM). ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, SM, (72) Inventor; and TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, (75) Inventor/Applicant (for US only): BIEK, Donald ML, MR, NE, SN, TD, TG). [US/US]; 1765 Walnut Drive, Mountain View, CA 94040 (US). Published: (74) Agents: KHANNA, Hemant et al.; Forest Laboratories, — with international search report (Art. 21(3)) Inc., 48 Mall Drive, Commack, NY 11725 (US). (54) Title: COMPOSITIONS AND METHODS OF TREATMENT COMPRISING CEFTAROLINE (57) Abstract: The present invention provides compositions comprising ceftaroline or a pharmaceutically acceptable salt, solvate or a prodrug thereof alone or in combination with an antibacterial agent. The present invention provides methods of treating bacte- rial infection, which include administering an effective amount of ceftaroline or a pharmaceutically acceptable salt, solvate or a prodrug thereof alone or in combination with an antibacterial agent. COMPOSITIONS AND METHODS OF TREATMENT COMPRISING CEFTAROLINE FIELD OF THE INVENTION The present invention relates to compositions comprising ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil) alone or in combination with an antibacterial agent and methods of treating bacterial infections comprising administering ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil) alone or in combination with an antibacterial agent. BACKGROUND OF THE INVENTION Ceftaroline is a novel parenteral cephalosporin with a broad spectrum of activity against clinically important community-acquired and hospital-acquired Gram-negative and Gram-positive pathogens including methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcuspneumoniae. U.S. Patent No. 6,417,175 discloses compounds having excellent antibacterial activities for a broad range of Gram-positive and Gram-negative bacteria. These compounds are represented by the general formula: wherein R1-R4, Q, X, Y and n are as defined therein. U.S. Patent No. 6,417,175 discloses methods for preparing the compounds, and genetically discloses formulations of the compounds, such as aqueous and saline solutions for injection. One such compound is 7β-[2(Z)-ethoxyimino-2-(5- phosphonoamino- 1,2,4-thiadiazole-3-yl)acetamido]-3-[4-(1-methyl-4-pyridinio)-2- thiazolythio]-3-cephem-4-carboxylate. U.S. Patent No. 6,906,055 discloses a chemical genus which includes compounds of formula: Ceftaroline fosamil is a sterile, synthetic, parenteral prodrug cephalosporin antibiotic. The N-phosphonoamino water-soluble prodrug is rapidly converted into the bioactive ceftaroline, which has been demonstrated to exhibit antibacterial activity. Ceftaroline fosamil is known as (6R ,7R )-7-{(2Z)-2-(ethoxyimino)-2-[5- (phosphonoamino)- 1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1-methylpyridin-1-ium-4- yl)-l,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-l-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. Ceftaroline fosamil may be an acetic acid hydrous form. U.S. Patent Nos. 6,417,175 and 6,906,055 are incorporated herein by reference, in their entirety. There remains a need in the art for new and improved compositions and methods directed to the treatment of bacterial infections. It has been surprisingly and unexpectedly found that ceftaroline in combination with various antibacterial agents acts synergistically against bacterial strains. Furthermore, the combination of ceftaroline and antibacterial agents does not show evidence of antagonism. Thus, the findings suggest that ceftaroline may be suitable for administration in combination with one or more antibacterial agents. SUMMARY OF THE INVENTION The present invention provides compositions comprising a therapeutically effective amount of ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil) alone or in combination with an antibacterial agent. In addition, the present invention provides methods of treating bacterial infection by administering to a patient in need thereof, a therapeutically effective amount of ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil) alone or in combination with an antibacterial agent. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows synergistic combinations (mean values) demonstrated with time-kill curves for clinical isolates (A) 2 ESBL-producing E. coli, (B) 2 ESBL-producing K. pneumoniae, (C) 2 AmpC-derepressed E. cloacae and (D) 3 P. aeruginosa isolates. The legends used are as follows: (-•-) Growth control, (-¥-) Ceftaroline, (-o-) Meropenem, (- ∆ -) Ceftaroline plus Meropenem, (-■ -) Piperacillin-Tazobactam (4/1), (-□ -) Ceftaroline plus Piperacillin-Tazobactam, (-♦-) Amikacin, (-0-) Ceftaroline plus Amikacin, ( • ) Aztreonam, (-o-) Ceftaroline plus Aztreonam and (...) Limit of detection. Figure 2 shows in vitro activity of ceftaroline, vancomycin and tobramycin alone or in combination at V MIC against 4 HA-MRSA. Results are presented as time-kill curves for (A) isolate R3875 (AVISA), (B) isolate R2303 (VISA), (C-D) isolates R3804 and R4039. The legends used are as follows: (•) Growth control, (o) Ceftaroline, (W) Tobramycin, (■ ) Vancomycin, (∆ ) Ceftaroline plus Tobramycin, (D) Vancomycin plus Tobramycin and (...) Limit of detection. DETAILED DESCRIPTION OF THE INVENTION The present invention provides compositions comprising ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil) and methods for treating bacterial infections comprising administering a therapeutically effective amount of ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil). In one aspect, the present invention provides pharmaceutical compositions comprising a therapeutically effective amount of ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil) alone or in combination with an antibacterial agent. In some embodiments, the compositions may comprise ceftaroline or a pharmaceutically acceptable salt or a solvate thereof. In other embodiments, the compositions may comprise ceftaroline prodrug or a pharmaceutically acceptable salt or a solvate thereof (e.g., ceftaroline fosamil). In exemplary embodiments, the prodrug may be a phosphono prodrug. In some examples, the ceftaroline prodrug may be ceftaroline fosamil. In some embodiments, the ceftaroline fosamil may be a hydrous from, e.g., a monohydrate form. In still other embodiments, ceftaroline fosamil may be in an anhydrous form. In some embodiments, ceftaroline or a prodrug thereof may be a solvate form. For example, ceftaroline or prodrug of ceftaroline may be an acetic acid solvate form. In exemplary embodiments, the compositions comprise ceftaroline or a pharmaceutically acceptable salt, solvate or prodrug thereof (e.g., ceftaroline fosamil) alone or in combination with an antibacterial agent for intravenous or intramuscular route of administration. In some embodiments, the antibacterial agent, may include, but is not limited to, β-lactams, aminoglycosides, tetracyclines, sulfonamides, trimethoprim, fluoroquinolones, vancomycin, macrolides, polymyxins, chloramphenicol and lincosamides. In exemplary embodiments, the antibacterial agent may include, but is not limited to, amoxicillin, ampicillin, azlocillin, mezlocillin, apalcillin, hetacillin, bacampicillin, carbenicillin, sulbenicillin, ticarcillin, azlocillin, mecillinam, pivmecillinam, methicillin, ciclacillin, talampicillin, aspoxicillin, oxacillin, cloxacillin, dicloxacillin, flucloxacillin, nafcillin, pivampicillin, cephalothin, cephaloridine, cefaclor, cefadroxil, cefamandole, cefazolin, cephalexin, cephradine, ceftizoxime, cefoxitin, cephacetrile, cefotiam, cefotaxime, cefsulodin, cefoperazone, ceftizoxime, cefmenoxime, cefrnetazole, cephaloglycin, cefonicid, cefodizime, cefpirome, ceftazidime,
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